Apparatus in Electronic Medical Records Systems that Determine and Communicate Multi-Vital-Signs from Electromagnetic Radiation of a Subject

Info

Publication number: 20190350470
Type: Application
Filed: Aug 7, 2018
Publication Date: Nov 21, 2019
Applicant: ARC Devices Ltd. (Dublin)
Inventors: Mark Khachaturian (Boca Raton, FL), Michael Smith (Lakeway, TX), Irwin Gross (Boca Raton, FL)
Application Number: 16/056,524

Abstract

In some implementations, an apparatus includes a physiological light monitoring subsystem that includes a source-detector assembly having a first side that has three transmitters of electromagnetic radiation frequencies in ranges of 375-415 nm, 640-680 nm and 920-960 nm frequencies and a first photodiode receiver of electromagnetic radiation in a 350-1100 nm range to measure an amount of electromagnetic radiation that is reflected by a subject, a microprocessor configured to determine an indication of an amount of glucose in the subject calculated from a ratio of electromagnetic radiation received by a first photodiode receiver of electromagnetic radiation in the 350-1100 nm range to measure an amount of electromagnetic radiation that is absorbed by the subject at the 375-415 nm frequency range in comparison to electromagnetic radiation received at the 920-960 nm frequency range, the subject being positioned between the first side and a second side.

Description

Description

RELATED APPLICATION

This application is a continuation of, and claims the benefit and priority of U.S. Original patent application Ser. No. 15/985,672 filed 21 MAY 2018.

FIELD

This disclosure relates generally to detecting multiple vital signs such as blood glucose levels and communicating the detected multiple vital signs to a medical records system.

BACKGROUND

Prior techniques of capturing multiple vital signs including blood glucose levels from human subjects have implemented problematic sensors and have been very cumbersome in terms of affixing the sensors to the patient, recording, analyzing, storing and forwarding the vital signs to appropriate parties.

BRIEF DESCRIPTION

In one aspect, a device measures blood glucose levels, temperature, heart rate, heart rate variability, respiration, SpO2, blood flow, blood pressure, total hemoglobin (SpHb), PVi, methemoglobin (SpMet), acoustic respiration rate (RRa), carboxyhemoglobin (SpCO), oxygen reserve index (ORi), oxygen content (SpOC) and/or EEG of a human.

In another aspect, an apparatus including a microprocessor, the apparatus further including a physiological light monitoring subsystem operably coupled to the microprocessor, the physiological light monitoring subsystem including a source-detector assembly having a first flexible side and a second flexible side, and the apparatus further including a hard structure surrounding a portion of the physiological light monitoring subsystem, the first flexible side having three transmitters of electromagnetic radiation frequencies in ranges of 375-415 nm, 640-680 nm and 920-960 nm frequencies and a first photodiode receiver of electromagnetic radiation in a 350-1100 nm range to measure an amount of electromagnetic radiation that is reflected by a subject, the source-detector assembly also having a first photodiode receiver of electromagnetic radiation in the 350-1100 nm range to measure an amount of electromagnetic radiation that is absorbed by the subject, the microprocessor configured to determine an indication of an amount of oxygen in the subject calculated from a ratio of electromagnetic radiation received at a 640-680 nm frequency range in comparison to electromagnetic radiation received at a 920-960 nm frequency range, the microprocessor configured to determine an indication of an amount of glucose in the subject calculated from a ratio of electromagnetic radiation received at a 375-415 nm frequency range in comparison to electromagnetic radiation received at the 920-960 nm frequency range, the subject being positioned between the first flexible side and the second flexible side.

Apparatus, systems, and methods of varying scope are described herein. In addition to the aspects and advantages described in this summary, further aspects and advantages will become apparent by reference to the drawings and by reading the detailed description that follows.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross-section diagram of a multi-vital-sign (MVS) finger cuff that determines transmissive SpO2, reflective SpO2, reflective glucose and other vital signs such as blood pressure, according to an implementation;

FIG. 2 is a cross-section diagram of a MVS finger cuff that determines transmissive SpO2 and other vital signs such as blood pressure, according to an implementation;

FIG. 3 is a cross-section diagram of a MVS finger cuff that determines reflective SpO2 and other vital signs such as blood pressure, according to an implementation;

FIG. 4 is a cross-section diagram of a MVS finger cuff that determines reflective glucose and other vital signs such as blood pressure, according to an implementation;

FIG. 5 is a cross-section diagram of a MVS finger cuff that determines transmissive SpO2, reflective SpO2, reflective glucose and other vital signs such as blood pressure, according to an implementation;

FIG. 6 is a cross-section diagram of a MVS finger cuff that determines transmissive SpO2, reflective glucose and other vital signs such as blood pressure, according to an implementation;

FIG. 7 is a cross-section diagram of a MVS finger cuff that determines transmissive SpO2 and reflective SpO2 and other vital signs such as blood pressure, according to an implementation;

FIG. 8 is an isometric diagram of MVS finger cuffs in FIG. 1-FIG. 7, according to an implementation;

FIG. 9 is an exploded isometric diagram of the MVS finger cuff in FIG. 1-FIG. 8, according to an implementation;

FIG. 10 is an exploded isometric diagram of a MVS finger cuff in FIG. 1-FIG. 9, according to an implementation;

FIG. 11 is an exploded isometric diagram of the MVS finger cuff in FIG. 1-FIGS. 2 and 6-FIG. 7;

FIG. 12 is a cross section diagram of a MVS finger cuff accessory, according to an implementation;

FIG. 13 is an isometric diagram of a mechanical design of a MVS finger cuff accessory, according to an implementation;

FIG. 14 is an isometric diagram of a MVS finger cuff accessory with the topskin removed to view the interior components, according to an implementation;

FIG. 15 is block diagram of a MVS finger cuff accessory with the topskin removed to view the interior components, according to an implementation;

FIG. 16 is an exploded isometric diagram of a MVS finger cuff accessory, according to an implementation;

FIG. 17 is a block diagram of a MVS finger cuff smartphone system, according to an implementation;

FIG. 18 is a block diagram of a front end of a MVS finger cuff accessory, according to an implementation;

FIG. 19-FIG. 25 are views of a MVS finger clip that reads physiological light signals and other vital signs, but not blood pressure, according to implementations;

FIG. 26 is a block diagram of a MVS smartphone, according to an implementation;

FIG. 27 is a block diagram of a MVS smartphone, according to an implementation;

FIG. 28 is a data flow diagram of a MVS smartphone, according to an implementation;

FIG. 29 is a block diagram of a MVS smartphone system, according to an implementation;

FIG. 30 is a block diagram of a MVS smartphone system, according to an implementation;

FIG. 31 is a block diagram of a MVS smartphone system, according to an implementation;

FIG. 32 is a block diagram of a MVS smartphone device that includes a digital infrared sensor, a biological vital sign generator and a temporal motion amplifier, according to an implementation;

FIG. 33 is a block diagram of a MVS smartphone device that includes a no-touch electromagnetic sensor with no temporal motion amplifier, according to an implementation;

FIG. 34 is a block diagram of an apparatus to estimate a body core temperature from a temperature sensed by an infrared sensor, according to an implementation;

FIG. 35-FIG. 36 are block diagrams of an apparatus to derive an estimated body core temperature from one or more tables that are stored in a memory that correlate a calibration-corrected voltage-corrected object temperature to the body core temperature in reference to the corrected ambient air temperature, according to an implementation;

FIG. 37 is a block diagram of a digital infrared sensor, according to an implementation.

FIG. 38 is a block diagram of a communication system, according to an implementation;

FIG. 39 is a block diagram of an apparatus to generate a predictive analysis of vital signs, according to an implementation;

FIG. 40 is a flowchart of a method of motion amplification from which to generate and communicate biological vital signs, according to an implementation;

FIG. 41 is a block diagram of a system of interoperation device manager, according to an implementation;

FIG. 42 is a block diagram of apparatus of an EMR capture system, according to an implementation in which an interoperability manager component manages all communications in the middle layer;

FIG. 43 is a flowchart of a method to perform real time quality check on finger cuff data, according to an implementation;

FIG. 44 is a block diagram of a method of MVS detection and communication method, according to an implementation;

FIG. 45 is a display screen of the MVS smartphone showing results of successful MVS measurements, according to an implementation; and

FIG. 46 is a display screen of the MVS smartphone showing history of successful MVS measurements, according to an implementation.

DETAILED DESCRIPTION

In the following detailed description, reference is made to the accompanying drawings that form a part hereof, and in which is shown by way of illustration specific implementations which may be practiced. These implementations are described in sufficient detail to enable those skilled in the art to practice the implementations, and it is to be understood that other implementations may be utilized and that logical, mechanical, electrical and other changes may be made without departing from the scope of the implementations. The following detailed description is, therefore, not to be taken in a limiting sense.

The detailed description is divided into twelve sections. In the first section, an overview is described. In the second section, apparatus of multi-vital-sign (MVS) finger cuffs are described in FIG. 1-FIG. 11. In the third section, implementations of apparatus of MVS finger cuff accessories are described in FIG. 12-FIG. 18. In the fourth section, implementations of apparatus of MVS finger clips are described in FIG. 19-FIG. 25. In the fifth section, implementations of MVS smartphones are described in FIG. 26-FIG. 28. In the sixth section, implementations of MVS smartphone systems are described in FIG. 29-FIG. 31. In the seventh section, implementations of MVS devices are described in FIG. 32-FIG. 33. In the eighth section, implementations of vital-sign components are described in FIG. 34-FIG. 40. In the ninth section, implementations of interoperability device manager components of an EMR System are described in FIG. 41-FIG. 42. In the tenth section, methods of MVS detection and communication are described in FIG. 43-FIG. 44. In the eleventh section, implementations of displays of MVS smartphones are described in FIG. 45-FIG. 46. Finally, in the twelfth section a conclusion of the detailed description is provided.

1. Overview

Table 1 below shows seven implementations of physiological light monitoring of glucose and/or SpO2 with blood pressure and other vital-signs. In Table 1, transmissive electromagnetic radiation (ER) is read by emitting an amount of ER at a specific wavelength and then detecting an amount of the ER at the specific wavelength (or within a range such as the specific wavelength±20 nm) that passes through the subject. ‘nm’ is nanometers. Reflective ER is read by emitting an amount of ER at a specific wavelength and then detecting an amount of the ER at that specific wavelength (or within a range of wavelengths) that is reflected by the subject. Measurements of ER at 395 nm are performed to determine the amount of nitric oxide (NO) in the subject as a proxy for the amount of glucose in the subject. Measurements of ER at 395 nm are performed to determine the amount of oxygen in the subject. Measurements of ER at 940 nm are performed as a baseline reference that is not affected by oxygen or nitric oxide.

In Table 1 below, in implementation #1, transmissive SpO2 is determined by reading transmissive ER (electromagnetic radiation) at 660 nm and transmissive ER at 940 nm and then dividing the amount of transmissive ER at 660 nm by the amount of transmissive ER at 940 nm, reflective SpO2 is determined by reading reflective ER at 660 nm and reflective ER at 940 nm and then dividing the amount of reflective ER at 660 nm and by the amount of reflective ER at 940 nm and the reflective glucose is determined by reading reflective ER at 395 nm and reflective ER at 940 nm, and then dividing the amount of reflective ER at 395 nm by the amount of reflective ER at 940 nm.

In implementation #2, transmissive SpO2 is determined by reading transmissive ER at 660 nm and transmissive ER at 940 nm and then dividing the amount of transmissive ER at 660 nm by the amount of transmissive ER at 940 nm.

In implementation #3, reflective SpO2 is determined by reading reflective ER at 660 nm and reflective ER at 940 nm and then dividing the amount of reflective ER at 660 nm and by the amount of reflective ER at 940 nm. In implementation #4, reflective glucose is determined by reading reflective ER at 395 nm and reflective ER at 940 nm, and then dividing the amount of reflective ER at 395 nm by the amount of reflective ER at 940 nm.

In implementation #5, reflective SpO2 is determined by reading reflective ER at 660 nm and reflective ER at 940 nm and then dividing the amount of reflective ER at 660 nm and by the amount of reflective ER at 940 nm and reflective glucose is determined by reading reflective ER at 395 nm and reflective ER at 940 nm, and then dividing the amount of reflective ER at 395 nm by the amount of reflective ER at 940 nm. In implementation #6, transmissive SpO2 is determined by reading transmissive ER at 660 nm and transmissive ER at 940 nm and then dividing the amount of transmissive ER at 660 nm by the amount of transmissive ER at 940 nm and reflective glucose is determined by reading reflective ER at 395 nm and reflective ER at 940 nm, and then dividing the amount of reflective ER at 395 nm by the amount of reflective ER at 940 nm.

In implementation #7, reflective SpO2 is determined by reading reflective ER at 660 nm and reflective ER at 940 nm and then dividing the amount of reflective ER at 660 nm and by the amount of reflective ER at 940 nm and transmissive SpO2 is determined by reading transmissive ER at 660 nm and transmissive ER at 940 nm and then dividing the amount of transmissive ER at 660 nm by the amount of transmissive ER at 940 nm.

In implementations that use transmissive configurations for at least some of the measurements rather than reflective transmissions (such as transmissive SPO2 in implementations 1, 2, 6 and 7), transmissive configurations are used because transmissive is more accurate than reflective. Transmissive techniques have higher accuracy because more of the signal is transmitted through the finger than reflected, so transmissive techniques have a stronger detected signal, and assuming the same emitted signal strength from a signal that is reflected and a signal that is transmitted and assuming that background ER noise is the same for both transmissive configurations and reflective configurations, the result is a higher signal-to-noise ratio for transmissive techniques.

IMPLEMENTATON DETERMINATION(S) READING(S) DETECT(S) 1 transmissive SpO2 a) reflective 395 nm transmissive 660 nm/transmissive 940 nm reflective SpO2 b) transmissive 660 nm reflective 660 nm/reflective 940 nm reflective glucose c) reflective 660 nm reflective 395 nm/reflective 940 nm d) transmissive 940 nm e) reflective 940 nm 2 transmissive SpO2 a) transmissive 660 nm transmissive 660 nm/transmissive 940 nm b) transmissive 940 nm 3 reflective SpO2 a) reflective 660 nm reflective 660 nm/reflective 940 nm b) reflective 940 nm 4 reflective glucose a) reflective 395 nm reflective 395 nm/reflective 940 nm b) reflective 940 nm 5 reflective SpO2 a) reflective 395 nm reflective 660 nm/reflective 940 nm reflective glucose b) reflective 660 nm reflective 395 nm/reflective 940 nm c) reflective 940 nm 6 transmissive SpO2 a) reflective 395 nm transmissive 660 nm/transmissive 940 nm reflective glucose b) transmissive 660 nm reflective 395 nm/reflective 940 nm c) transmissive 940 nm d) reflective 940 nm 7 transmissive SpO2 a) transmissive 660 nm transmissive 660/transmissive 940 nm reflective SpO2 b) reflective 660 nm reflective 660/reflective 940 nm c) transmissive 940 nm d) reflective 940 nm

Furthermore, the devices in FIG. 1-FIG. 34 can determine within reasonable clinical accuracy the following vital signs: blood glucose levels, heart rate, heart rate variability, respiration rate, SpO2, blood flow, blood pressure, total hemoglobin (SpHb), PVi, methemoglobin (SpMet), acoustic respiration rate (RRa), carboxyhemoglobin (SpCO), oxygen reserve index (ORi), oxygen content (SpOC) and EEG. More specifically, heart rate, heart rate variability, respiration rate, SpO2, blood flow, blood pressure, total hemoglobin (SpHb), PVi, methemoglobin (SpMet), acoustic respiration rate (RRa), carboxyhemoglobin (SpCO), oxygen reserve index (ORi), oxygen content (SpOC) and EEG can be determined by reading ER at 660 nm and ER at 940 nm by the PLM subsystem and then dividing the amount of ER at 660 nm by the amount of ER at 940 nm and then applying a transformation function that is specific to the vital sign to the quotient of the division.

$R_{Y} = \frac{{\log (\frac{I_{AC} + I_{DC}}{I_{DC}})}_{Y [nm]}}{{\log (\frac{I_{AC} + I_{DC}}{I_{DC}})}_{940 [nm]}}$

where Y={660 [nm], 395 [nm]}

The relationship between R_Yand the parameters, P, below is a general transfer function T(R_Y), where

$Z_{N} = {\begin{matrix} SpO 2 \\ total hemoglobin (SpHb) \\ PVi \\ methmoglobin (SpMet) \\ acoustic respiration rate (RRa) \\ carboxyhemoglobin (SpCO) \\ oxygen reserve index (ORi) \\ oxygen content (SpOC) \end{matrix}}$ $Z_{N} = T_{N} (R_{660}, R_{395})$

The respiration rate and heart rate variability and the blood pressure diastolic is estimated from data from the mDLS sensor and the PLM subsystem. The respiration and the blood pressure systolic is estimated from data from the mDLS sensor. The blood flow is estimated from data from the PLM subsystem.

2. Apparatus of Multi-Vital-SignFinger Cuffs

FIG. 1-FIG. 11 are diagrams of multi-vital-sign (MVS) finger cuffs that read physiological light signals to determine vital signs such as blood glucose level, according to implementations. The MVS finger cuffs in FIG. 1-FIG. 11 include a main body that is mechanically and electrically coupled to a Physiological Light Monitoring (PLM) subsystem. The PLM subsystem is mechanically and electrically coupled to a finger occlusion cuff 104. In some implementations, the PLM subsystem includes one or more emitters of electromagnetic radiation (ER) and one or more detectors of ER which are discussed in greater detail below.

The main body 102 includes a printed circuit board that is mechanically and electrically coupled to a cable 108 that is mechanically and electrically coupled to a detector of ER in a range of 350 to 1100 nanometers (nm). ER in a range of 350 to 1100 nm includes both visible and near-infrared light. The printed circuit board includes a microprocessor.

The finger occlusion cuff 104 includes a cuff housing 112 that surrounds a bladder tube 114 that mounts an inflatable bladder 116. Two identical collars 118 and 120 at open ends of the cuff housing 112 position the bladder tube 114 and the inflatable bladder 116. The MVS finger cuff 100 also includes a slide travel 122 that slideably mounts the PLM subsystem to the main body.

In FIG. 1-FIG. 37, only transmissive/transmissive or reflective/reflective measurements are performed. In FIG. 1-FIG. 25, reflective/transmissive measurements or transmissive/reflective measurements are never performed because there is no usefulness to these measurements. In implementations 1 and 4-6 in table 1 above and in FIG. 1 and FIG. 4-FIG. 6, nitric oxide measurements that are performed as a proxy for glucose are always reflective measurements and never transmissive measurements because the 395 nm ER emission that is performed to measure nitric oxide as a proxy for glucose is visible light which will not be transmitted all the way through a human finger.

FIG. 1 is a cross-section diagram of a multi-vital-sign (MVS) finger cuff 100 that determines transmissive SpO2, reflective SpO2, reflective glucose and other vital signs such as blood pressure, according to an implementation. MVS finger cuff 100 operates in accordance with Table 1 above, in implementation #1. MVS finger cuff 100 is particularly useful for clinical applications.

In MVS finger cuff 100, the PLM subsystem is PLM subsystem 124 that includes an emitter in an emitter/detector 126 that emits ER at 395 nm, 660 nm and 940 nm and that includes a detector in the emitter/detector 126 that detects the ER in the ranges of 375-415 nm, 640-680 nm and 920-960 nm to measure ER that is reflected by the subject finger that is positioned in the PLM subsystem 124 at 395 nm, 660 nm and 940 nm. The PLM subsystem 124 also includes an emitter 128 that emits ER in the ranges of 640-680 nm and 920-960 nm to transmit the ER through the subject finger that is positioned in the PLM subsystem 124 at 660 nm and 940 nm and the detector in the emitter/detector 126 detects the ER that is emitted by the emitter 128 at 660 nm and 940 nm and that is transmitted through the subject finger that is positioned in the PLM subsystem 124.

A microprocessor of a printed circuit board 106 or a microprocessor that is mounted on a printed circuit board in FIG. 18-FIG. 37 determines transmissive SpO2 at 660 nm by dividing the amount of transmissive ER at 660 nm by the amount of transmissive ER at 940 nm, reflective SpO2 is determined by dividing the amount of reflective ER at 660 nm and by the amount of reflective ER at 940 nm and the reflective glucose is determined by dividing the amount of reflective ER at 395 nm by the amount of reflective ER at 940 nm. MVS finger cuff 100 includes non-volatile memory such as flash memory on the printed circuit board 106 or non-volatile memory in the microprocessor of the printed circuit board 106.

In MVS finger cuff 100, the emitter/detector 126 includes both an emitter and a detector so that an amount of the electromagnetic energy that is reflected by the subject is detected, such as the finger of the patient. The amount or level of glucose in the blood of a subject is determined by a ratio of the amount of ER in the 375-415 nm range that detected by the detector in the emitter/detector 126 is divided by the amount of ER in the 920-960 nm range that detected by the emitter/detector 126, which is then converted to units of mg/dL or mmol/L in reference to a non-linear serpentine function. Only the amount of radiation detected by the emitter/detector 126 in the 375-415 nm range during the resting period of the heartbeat (in between heartbeats) is included in the determination of the amount or level of glucose in the blood of the subject. The resting period of the heartbeat is determined by a ratio of the amount of ER detected in the 640-680 nm range by the emitter/detector 126 divided by the amount of radiation detected in the 920-960 nm range by the emitter/detector 126.

FIG. 2 is a cross-section diagram of a multi-vital-sign (MVS) finger cuff 200 that determines transmissive SpO2 and other vital signs such as blood pressure, according to an implementation. MVS finger cuff 200 operates in accordance with Table 1 above, in implementation #2.

In MVS finger cuff 200, the PLM subsystem is PLM subsystem 224 that includes an emitter 226 of 660 nm ER and 940 nm ER. The PLM subsystem 224 also includes an detector 228 that detects ER in the ranges of 640-680 nm and 920-960 nm that is transmitted from the emitter 226 through the subject finger that is positioned in the PLM subsystem 224 at 660 nm and 940 nm.

The microprocessor of the printed circuit board 206 or a microprocessor that is mounted on a printed circuit board in FIGS. 2 and 8-FIG. 37 determines transmissive SpO2 at 660 nm by dividing the amount of transmissive ER at 660 nm by the amount of transmissive ER at 940 nm.

FIG. 3 is a cross-section diagram of a multi-vital-sign (MVS) finger cuff 300 that determines reflective SpO2 and other vital signs such as blood pressure, according to an implementation. MVS finger cuff 300 operates in accordance with Table 1 above, in implementation #3.

In MVS finger cuff 300, the PLM subsystem is PLM subsystem 324 that includes an emitter in an emitter/detector 326 that emits ER at 660 nm and 940 nm. The emitter/detector 326 also includes a detector that detects ER in the ranges of 640-680 nm and 920-960 nm to measure ER that is reflected by the subject finger that is positioned in the PLM subsystem 324 at 660 nm and 940 nm. The PLM subsystem 324 does not include a detector on the opposite side of the PLM subsystem from the emitter/detector 326 to detect ER that is transmitted through the subject finger that is positioned in the PLM subsystem.

The microprocessor of the printed circuit board 306 or a microprocessor that is mounted on a printed circuit board in FIGS. 3 and 8-FIG. 37 determines reflective SpO2 by dividing the amount of reflective ER at 660 nm and by the amount of reflective ER at 940 nm.

FIG. 4 is a cross-section diagram of a multi-vital-sign (MVS) finger cuff 400 that determines reflective glucose and other vital signs such as blood pressure, according to an implementation. MVS finger cuff 400 operates in accordance with Table 1 above, in implementation #4.

In MVS finger cuff 400, the PLM subsystem is PLM subsystem 424 that includes an emitter in an emitter/detector 426 that emits ER at 395 nm and 940 nm and the emitter/detector 426 also includes a detector that detects ER in the ranges of 375-415 nm and 920-960 nm to measure ER that is reflected by the subject finger that is positioned in the PLM subsystem 424 at 395 nm and 940 nm. The PLM subsystem 424 does not include a detector on the opposite side of the PLM subsystem from the emitter/detector 426 to detect ER that is transmitted through the subject finger that is positioned in the PLM subsystem.

The microprocessor of the printed circuit board 406 or a microprocessor that is mounted on a printed circuit board in FIG. 4 and FIG. 8-FIG. 37 determines reflective glucose by dividing the amount of reflective ER at 395 nm by the amount of reflective ER at 940 nm.

FIG. 5 is a cross-section diagrams of a multi-vital-sign (MVS) finger cuff 500 that determines transmissive SpO2, reflective SpO2, reflective glucose and other vital signs such as blood pressure, according to an implementation. MVS finger cuff 500 operates in accordance with Table 1 above, in implementation #5. MVS finger cuff 100 is particularly useful for non-clinical wellness applications.

In MVS finger cuff 500, the PLM subsystem is PLM subsystem 524 that includes an emitter in an emitter/detector 526 that emits ER at 395 nm, 660 nm and 940 nm and the emitter/detector 526 includes a detector that detects ER in the ranges of 375-415 nm, 640-680 nm and 920-960 nm to measure ER that is reflected by the subject finger that is positioned in the PLM subsystem 524 at 395 nm, 660 nm and 940 nm. The detector in the emitter/detector 526 is mounted on the same side of the PLM subsystem 524 as the emitter in the emitter/detector 526 so that the detector in the emitter/detector 526 detects an amount of the electromagnetic energy that is reflected by the subject, such as the finger of the patient.

The microprocessor of the printed circuit board or a microprocessor that is mounted on a printed circuit board in FIG. 5 and FIG. 8-FIG. 37 determines reflective SpO2 by dividing the amount of reflective ER at 660 nm and by the amount of reflective ER at 940 nm and the reflective glucose is determined by dividing the amount of reflective ER at 395 nm by the amount of reflective ER at 940 nm.

The amount or level of glucose in the blood of a subject is determined by a ratio of the amount of radiation detected by the emitter/detector 526 in the 375-415 nm range divided by the amount of radiation detected by the emitter/detector 526 in the 920-960 nm range, which is then converted to units of mg/dL or mmol/L in reference to a non-linear serpentine function, regardless of the amount of radiation detected by the emitter/detector 526 in the 375-415 nm range during the resting period of the heartbeat (in between heartbeats). All of radiation detected by the emitter/detector 526 in the 375-415 nm range during the resting period of the heartbeat is used in the determination of the amount or level of glucose in the blood of the subject.

FIG. 6 is a cross-section diagram of a multi-vital-sign (MVS) finger cuff 600 that determines transmissive SpO2, reflective glucose and other vital signs such as blood pressure, according to an implementation. MVS finger cuff 600 operates in accordance with Table 1 above, in implementation #6.

In MVS finger cuff 600, the PLM subsystem is PLM subsystem 624 that includes an emitter in an emitter/detector 626 that emits ER at 395 nm, 660 nm and 940 nm and the emitter/detector 626 includes a detector that detects ER in the ranges of 375-415 nm and 920-960 nm to measure ER that is reflected by the subject finger that is positioned in the PLM subsystem 624 at 395 nm and 940 nm. The PLM subsystem 624 also includes an emitter 628 that emits ER in the ranges of 640-680 nm and 920-960 nm to transmit ER through the subject finger that is positioned in the PLM subsystem 624 at 660 nm and 940 nm. The detector in the emitter/detector 626 detects the ER in the ranges of 640-680 nm and 920-960 nm that is emitted by the emitter 628.

The microprocessor of the printed circuit board 606 or a microprocessor that is mounted on a printed circuit board in FIG. 6 and FIG. 8-FIG. 37 determines transmissive SpO2 at 660 nm by dividing the amount of transmissive ER at 660 nm by the amount of transmissive ER at 940 nm and the reflective glucose is determined by dividing the amount of reflective ER at 395 nm by the amount of reflective ER at 940 nm.

FIG. 7 is a cross-section diagram of a multi-vital-sign (MVS) finger cuff 700 that determines transmissive SpO2 and reflective SpO2 and other vital signs such as blood pressure, according to an implementation. MVS finger cuff 700 operates in accordance with Table 1 above, in implementation #1.

In MVS finger cuff 700, the PLM subsystem is PLM subsystem 724 that includes an emitter in an emitter/detector 726 that emits ER at 660 nm and 940 nm and the emitter/detector 726 includes a detector that detects ER in the ranges of 375-415 nm, 640-680 nm and 920-960 nm to measure ER that is reflected by the subject finger that is positioned in the PLM subsystem 724 at 660 nm and 940 nm. The PLM subsystem 724 also includes an emitter 728 that emits ER in the ranges of 640-680 nm and 920-960 nm to transmit ER through the subject finger that is positioned in the PLM subsystem 724 at 660 nm and 940 nm. The detector in the emitter/detector 726 detects the ER in the ranges of 640-680 nm and 920-960 nm that is emitted by the emitter 628.

The microprocessor of the printed circuit board 706 or a microprocessor that is mounted on a printed circuit board in FIG. 7 and FIG. 8-FIG. 37 determines transmissive SpO2 at 660 nm by dividing the amount of transmissive ER at 660 nm by the amount of transmissive ER at 940 nm and reflective SpO2 is determined by dividing the amount of reflective ER at 660 nm and by the amount of reflective ER at 940 nm.

FIG. 8 is an isometric diagram of a MVS finger cuff 800, according to an implementation.

FIG. 9 is an exploded isometric diagram of the MVS finger cuff 800, according to an implementation.

FIG. 10 is an exploded isometric diagram of the (MVS finger cuff 700, according to an implementation. FIG. 10 shows a flexible ribbon cable 1002 that electrically couples the PLM subsystem to the PCB board in the main body 102 through apertures 1004 and 1006 in the slide travel 122.

In FIG. 8-FIG. 10, MVS finger cuff 800 includes a slide travel 122 that slidably mounts the MVS finger cuffs in FIG. 1-FIG. 7 to the main body 102, the finger occlusion cuff 104 includes the cuff housing 112 that surrounds the bladder tube 114 that mounts the inflatable bladder 116 and the identical collars 118 and 120 at open ends of the cuff housing 112 position the bladder tube 114 and the inflatable bladder 116.

FIG. 11 is an exploded isometric diagram of the MVS finger cuff 1100 in FIG. 1-FIG. 2 and FIG. 6-FIG. 7. The MVS finger cuff 1100 includes a finger occlusion cuff 104 that includes a DLS emitter printed circuit board 702 mounted on the interior of the bladder tube 114. The finger occlusion cuff 104 is mounted on a main body 102, and the main body 102 includes a cable that connects the printed circuit board 106 to the emitter/detector 126 of FIG. 1, the detector 228 of FIG. 2, the emitter/detector 626 of FIG. 6 and the emitter/detector 726 of FIG. 7. A flexible ribbon cable 1102 electrically connects the emitter/detector 126 to the emitter 128 of FIG. 1, the detector 228 to the emitter 226 of FIG. 2, the emitter/detector 626 to the emitter 628 of FIG. 6 and the emitter/detector 726 to the emitter 728 of FIG. 7; and to the cable 108.

3. Apparatus of Multi-Vital-Sign Smartphone Accessory

FIG. 12 is a cross-section diagrams of a multi-vital-sign finger cuff accessory (MVSFCA) that can determine transmissive SpO2, reflective SpO2, reflective glucose and other vital signs such as blood pressure, according to an implementation. An outer silicon shell 1201 is a solid piece with tongues for securing into a base of a PLM subsystem 1202, and an internal recess for a flexible ribbon cable 1102 to fit into and the rigid parts with components to sit in the slide travel 122. Examples of the PLM subsystem 1202 include the PLM subsystems 124 in FIG. 1, 224 in FIG. 2, 324 in FIG. 3, 424 in FIG. 4, 524 in FIG. 5, 624 in FIGS. 6 and 724 in FIG. 7. A translucent silicone fitting 1206, which is a little wider than the flexible ribbon cable 1102, is positioned over the cable/components and glued in place. The translucent silicone fitting 1206 has shape effects 1208 in the interior to aid in location and positioning of a finger in the PLM subsystem 1202. The flexible ribbon cable 1102 electrically connects the emitter/detector 1210 and an emitter 1212 to the cable 108. The cable 108 is electrically coupled to a printed circuit board 1214. The printed circuit board 1214 includes a microprocessor that performs the determinations described in FIG. 1-FIG. 7, FIG. 34-FIG. 36, FIG. 39-FIG. 40 and/or FIG. 43-FIG. 44, and a non-volatile memory such as flash memory. The printed circuit board 106 of the MVS finger cuff (such as 100, 200, 300, 400, 500, 600 or 700) is electrically coupled to the printed circuit board 1214 of the MVSFCA 1200.

In some implementations, the MVSFCA 1200 operably couples to a MVS smartphone via direct connect charging contacts 1726 of the MVS finger cuff smartphone system in FIG. 17 and/or a charging port on the end of the MVS smartphone in which the MVSFCA 1200 receives power and control signals from the MVS smartphone and through which data from the MVSFCA 1200 is transmitted to the MVS smartphone. In some implementations, the MVSFCA 1200 operably couples to the MVS smartphone via the contact charging of the MVS smartphone 3003 in FIG. 30 or the direct connect charging contacts 1726 of the MVS finger cuff accessory in FIG. 17 and a charging port on the back of the MVS smartphone in which the MVSFCA 1200 receives power and control signals from the MVS smartphone and through which data from the MVSFCA 1200 is transmitted to the MVS smartphone. In some implementations, the MVSFCA 1200 operably couples to the MVS smartphone via the Bluetooth® or other wireless communication modules of the MVSFCA 1200, such as Zigbee® or Z-Wave®. The MVS smartphone in which the MVSFCA 1200 includes a battery and receives control signals from the MVS smartphone and through which data from the MVSFCA 1200 is transmitted to the MVS smartphone. The MVS smartphone is a smartphone whose memory stores software that causes the microprocessor of the smartphone to analyze vital sign data from the MVSFCA 1200 and to display the vital sign data from the MVSFCA 1200, to display the result of the analysis of vital sign data from the MVSFCA 1200 and to transmit the vital sign data from the MVSFCA 1200, to transmit the result of the analysis of vital sign data from the MVSFCA 1200.

FIG. 13 is an isometric diagram of a mechanical design of a MVS finger cuff accessory (MVSFCA) 1200, according to an implementation. The MVSFCA 1200 can be coupled to a MVS smartphone, such as MVS smartphone 2600 in FIG. 26, MVS smartphone 2700 in FIG. 27, MVS smartphone 2800 in FIG. 28, MVS smartphone 2904 in FIG. 29, MVS smartphone 3003 in FIG. 30 and MVS smartphone 3102 in FIG. 31. The MVSFCA 1200 includes a MVS finger cuff (such as 100, 200, 300, 400, 500, 600 or 700) that includes the PLM subsystem 1202 and a finger occlusion cuff 104. Some implementations of the MVS finger cuff accessory 1200 also include a camera and/or a digital infrared sensor 1312. LED 1316 in the MVSFCA 1200 displays in indication of temperature of a subject detected through the digital infrared sensor.

FIG. 14 is an isometric diagram of a mechanical design of a multi-vital-sign finger (MVS) cuff accessory(MVSFCA) 1200 with the topskin removed to view the interior components, according to an implementation.

FIG. 15 is a block diagram of a MVSFCA with the topskin removed to view the interior components, according to an implementation. The MVSFCA 1200 includes an air pump 1402 that is operably coupled to an air line 1404 and a pressure sensor 1406. The MVSFCA 1200 also includes a battery.

FIG. 16 is an exploded isometric diagram of a multi-vital-sign (MVS) finger cuff accessory (MVSFCA) 1200, according to an implementation. The MVSFCA 1200 includes a MVS finger cuff (such as MVS finger cuff 100 in FIG. 1 or MVS finger cuff 300 in FIG. 3) that includes a finger occlusion cuff 104. In some implementations, the MVSFCA 1200 operably couples to the MVS smartphone (such as MVS smartphone 2904 in FIG. 29, MVS smartphone 3003 in FIG. 30, MVS smartphone 2600 in FIG. 26 and MVS smartphone 3102 in FIG. 31) via the direct connect charging contacts 1726 of the MVS finger cuff smartphone system in FIG. 3100 and a charging port on the end of the MVS smartphone in which the MVSFCA 1200 receives power and control signals from the MVS smartphone and through which data from the MVSFCA 1200 is transmitted to the MVS smartphone. In some implementations, the MVSFCA 1200 operably couples to the MVS smartphone via the direct connect charging contacts 1726 of the MVS finger cuff smartphone system in FIG. 31 and a charging port on the back of the MVS smartphone in which the MVSFCA 1200 receives power and control signals from the MVS smartphone and through which data from the MVSFCA 1200 is transmitted to the MVS smartphone. In some implementations, the MVSFCA 1200 operably couples to the MVS smartphone via the Bluetooth® or other wireless communication modules of the MVSFCA 1200, such as Zigbee® or Z-Wave®. The MVS smartphone in which the MVSFCA 1200 includes a battery and receives control signals from the MVS smartphone and through which data from the MVSFCA 1200 is transmitted to the MVS smartphone. LED 1316 in the MVSFCA 1200 displays temperature of a subject detected through the digital infrared sensor. The MVS smartphone is a smartphone whose memory stores software that causes the microprocessor of the smartphone to analyze vital sign data from the MVSFCA 1200 and to display the vital sign data from the MVSFCA 1200, to display the result of the analysis of vital sign data from the MVSFCA 1200 and to transmit the vital sign data from the MVSFCA 1200, to transmit the result of the analysis of vital sign data from the MVSFCA 1200.

The MVSFCA 1200 includes an air pump 1402 that is operably coupled to an air line 1404, a pressure sensor 1406 and a valve 1408, that is ultimately coupled to the finger occlusion cuff 104. The MVSFCA 1200 also includes a shield 1608 over electronic components. The MVSFCA 1200 includes a top skin 1610, a printed circuit board (PCB) 1612, an outer housing 1614 and a bottom skin 1616. PCB 1612 also includes an aperture 1618 and the bottom skin 1616 includes a recess 1620.

FIG. 17 is a block diagram of a multi-vital-sign finger cuff accessory (MVSFCA) 1700, according to an implementation. MVSFCA 1700 is one implementation of MVSFCA 2902 in FIG. 29, MVSFCA 1700 is one implementation of MVSFCA 3002 in FIG. 30 and MVSFCA 1700 is one implementation of MVSFCA 3104 in FIG. 31. The MVSFCA 1700 captures, stores and exports raw data from all supported sensors in the system. MVSFCA 1700 supports a variety measurement methods and techniques. The MVSFCA 1700 can be used in a clinical setting for the collection of human vital signs.

A microprocessor 1702 controls and receives data from a multi-vital-sign finger cuff 1704 (such as 100, 200, 300, 400, 500, 600 or 700), a pneumatic engine 1706, an infrared finger temperature sensor 1708, ambient temperature sensor 1710, a proximity sensor 1712 and another sensor 1714. In some implementations the microprocessor 1702 is an advanced reduced instruction set processor.

The MVS finger cuff 1704 is affixed into the MVSFCA 1700, rather than the replaceable, detachable and removable MVS finger cuff 2908 in FIG. 29. The MVS finger cuff 1704 includes a PLM subsystem (such as 124, 224, 324, 424, 524, 624 or 724) and at least one mDLS sensor. The MVS finger cuff 1704 is powered via an air line (e.g. 1404 in FIG. 14) by the pneumatic engine 1706 that provides air pressure to inflate the cuff bladder of the MVS finger cuff 1704 and the that provides control signal to deflate the cuff bladder of the MVS finger cuff 1704.

In some implementations, a body surface temperature of a human is also sensed by the infrared finger temperature sensor 1708 that is integrated into the MVSFCA 1700 in which the body surface temperature is collected and managed by the MVSFCA 1700.

In some implementations, a single stage measurement process is required to measure all vital signs in one operation by the MVSFCA 1700 by the replaceable, detachable and removable MVS finger cuff 2908 or the MVS finger cuff 1704 or the infrared finger temperature sensor 1708. However, in some implementations, a two stage measurement process is performed in which the MVSFCA 1700 measures some vital signs through the replaceable, detachable and removable MVS finger cuff 2908 or the MVS finger cuff 1704; and in the second stage, the body surface temperature is measured through an infrared finger temperature sensor 1708 in the MVS Smartphone device 3003.

The MVS smartphone 3003, when connected to a wireless Bluetooth® communication component 1718 of the MVSFCA 1700 via a wireless Bluetooth® communication component 3014, is a slave to the MVSFCA 1700. In other implementations, Zigbee® or Z-Wave® can be used instead of Bluetooth®. The MVS Smartphone 3003 reports status, measurement process, and measurements to the user via the MVSFCA 1700.

In some implementations, the measurement process performed by the MVSFCA 1700 is controlled and guided from the MVS Smartphone 3003 via the GUI on the MVS Smartphone 3003. The measurements are sequenced and configured to minimize time required to complete all measurements. In some implementations, the MVSFCA 1700 calculates the secondary measurements of heart rate variability and blood flow. The MVSFCA 1700 commands and controls the MVS Smartphone 3003 via a wireless Bluetooth® protocol communication path. In other implementations, Zigbee® or Z-Wave® can be used instead of Bluetooth®. In some further implementations, the MVS Smartphone 3003 communicates with the MVSFCA 1700, which could also be concurrent.

MVSFCA 1700 includes a USB port 1718 that is operably coupled to the microprocessor 1702 for interface with slave devices only, such as the MVS Smartphone 3003, to perform the following functions: recharge internal rechargeable batteries 1722, export sensor data sets to a windows based computer system, firmware update of the MVSFCA 1700 via an application to control and manage the firmware update of the MVSFCA 1700 and configuration update of the MVSFCA 1700.

In some implementation recharging the internal rechargeable batteries 1722 via the USB port 1718 is controlled by a battery power management module 1724. The battery power management module 1724 receives power from a direct connect charging contact(s) 1726 and/or a wireless power subsystem 1728 that receives power from a RX/TX charging coil 1730. The internal rechargeable batteries 1722 of the MVSFCA 1700 can be recharged when the MVSFCA 1700 is powered-off but while connected to USB port 1720 or DC input via the direct connect charging contacts 1726. In some implementations, the MVSFCA 1700 can recharge the MVS Smartphone 3003 from its internal power source over a wireless charging connection. In some implementations, the internal rechargeable batteries 1722 provide sufficient operational life of the MVSFCA 1700 on a single charge to perform at least 2 full days of measurements before recharging of the internal rechargeable batteries 1722 of the MVSFCA 1700 is required. In some implementations, system voltage rails 1732 are operably coupled to the battery power management module 1724.

In some implementations, the MVSFCA 1700 includes an internal non-volatile, non-user removable, data storage device 1734 for up to 2 full days of human raw measurement data sets. In some implementations, the MVSFCA 1700 includes a Serial Peripheral Interface (SPI) 1736 that is configured to connect to an eternal flash storage system 1738.

In some implementations, the MVSFCA 1700 includes a Mobile Industry Processor Interface (MIPI) 1740 that is operably connected to the microprocessor 1702 and a display screen 1742. The microprocessor 1702 is also operably coupled to the visual indicators 1744.

The MVSFCA 1700 also includes a Wi-Fi® communication module 1746 for communications via Wi-Fi® communication frequencies and the MVSFCA 1700 also includes an enterprise security module 1748 a cellular communication module 1750 for communications via cell phone communication frequencies. The Wi-Fi® communication module 1746 and the cellular communication module 1750 are operably coupled to an antenna 1752 that is located with a case/housing of the MVSFCA 1700.

The MVSFCA 1700 also includes an audio sub-system 1754 that controls at one or more speakers 1756 to enunciate information to an operator or patient. In some implementations, the microprocessor 1702 also controls a haptic motor 1758 through the audio sub-system 1754. User controls 1760 also control the haptic motor 1758. A pulse-width modulator 1762 that is operably coupled to a general-purpose input/output (GPIO) 1764 (that is operably coupled to the microprocessor 1702) provides control to the haptic motor 1758.

The MVSFCA 1700 is hand held and portable. The MVSFCA 1700 includes non-slip/slide exterior surface material.

In some further implementations the MVSFCA 1700 in FIG. 17 perform continuous spot monitoring on a predetermined interval with automatic transfer to remote systems via Wi-Fi®, cellular or Bluetooth® communication protocols, with and without the use of a MVS Smartphone device, and alarm monitoring and integration into clinical or other real time monitoring systems, integration with the sensor box, with the MVSFCSS acting as a hub, for third party sensors, such as ECG, or from direct connect USB or wireless devices, e.g. Bluetooth® patches.

In other implementations, Zigbee® or Z-Wave® can be used instead of Bluetooth®. Wireless/network systems (Wi-Fi®, cellular 3G, 4G, 5G or Bluetooth®) are quite often unreliable. Therefore in some implementations, the MVS Smartphone devices and the MVSFCSS devices store vital sign measurements for later transmission.

FIG. 18 is a block diagram of a front end of a multi-vital-sign (MVS) finger cuff accessory 1800, according to an implementation. The front end of a MVS finger cuff 1800 is one implementation of a portion of a MVS finger cuff 2908 in FIG. 29. The front end of a MVS finger cuff 1800 captures, stores and exports raw data from all supported sensors in the system. The front end of a MVS finger cuff 1800 supports a variety measurement methods and techniques. The front end of a MVS finger cuff 1800 can be used in a clinical setting for the collection of human vital signs.

The front end of a MVS finger cuff 1800 includes a front-end sensor electronic interface 1802 that is mechanically coupled to a front-end subject physical interface 1804. The front-end sensor electronic interface 1802 includes a PLM subsystem 1806 that is electrically coupled to a multiplexer 1808 and to a PLM controller 1810. The front-end sensor electronic interface 1802 includes a mDLS sensor 1812 that is electrically coupled to a multiplexer 1814 which is coupled to a mDLS controller 1816. The front-end sensor electronic interface 1802 includes a mDLS sensor 1818 that is electrically coupled to a multiplexer 1820 and mDLS controller 1822. The front-end sensor electronic interface 1802 includes an ambient air temperature sensor 1710. The front-end sensor electronic interface 1802 includes a 3-axis accelerator 1824.

The PLM controller 1810 is electrically coupled to a controller 1826 through a Serial Peripheral Interface (SPI) 1828. The mDLS controller 1816 is electrically coupled to the controller 1826 through a SPI 1830. The mDLS sensor 1818 is electrically coupled to the controller 1826 through a SPI 1832. The ambient air temperature sensor 1710 is electrically coupled to the controller 1826 through a I2C interface 1834. The 3-axis accelerator 1824 is electrically coupled to the controller 1826 through the I2C interface 1834.

Visual indicator(s) 1744 are electrically coupled to the controller 1826 through a general-purpose input/output (GPIO) interface 1836. A serial port 1832 and a high speed serial port 1838 are electrically coupled to the controller 1826 and a serial power interface 1840 is electrically coupled to the high speed serial port 1838. A voltage regulator 1842 is electrically coupled to the controller 1826. A sensor front-end test component is electrically coupled to the controller 1826 through the GPIO interface 1836.

A sensor cover 1848 is mechanically coupled to the PLM subsystem 1806, a pressure finger cuff 1850 is mechanically coupled to the front-end subject physical interface 1804 and a pneumatic connector 1852 is mechanically coupled to the pressure finger cuff 1850.

4. Apparatus of Multi-Vital-Sign Finger Clip

FIG. 19-FIG. 25 are views of a multi-vital-sign (MVS) finger clip 1900 that reads physiological light signals and other vital signs, but not blood pressure, according to implementations.

The MVS finger clip in FIG. 19-FIG. 25 include a main body 1902 that is mechanically and electrically coupled to a Physiological Light Monitoring (PLM) subsystem 1904. The MVS finger clip in FIG. 19-FIG. 25 does not include a finger occlusion cuff, such as finger occlusion cuff 104 in FIG. 1-FIG. 7. In some implementations, the PLM subsystem 1904 includes one or more emitters of electromagnetic radiation (ER) and one or more detectors of ER which are discussed in greater detail below.

The main body 1902 includes a printed circuit board that is mechanically and electrically coupled to a cable that is mechanically and electrically coupled to a detector of ER in a range of 350 to 1100 nanometers. ER in a range of 350 to 1100 nm includes both visible and near-infrared light. The printed circuit board includes a microprocessor. A flexible ribbon cable electrically connects the detector and an emitter printed circuit board to the cable.

Similar to FIG. 1-FIG. 7, in FIG. 19-FIG. 25, only transmissive/transmissive or reflective/reflective measurements are performed. In FIG. 19-FIG. 25, reflective/transmissive measurements or transmissive/reflective measurements are never performed because there is no usefulness to these measurements. In implementations 1 and 4-6 in table 1 above and in FIG. 19-FIG. 25, the nitric oxide measurements that are performed as a proxy for glucose are always reflective measurements and never transmissive measurements because the 395 nm ER emission that is performed to measure nitric oxide as a proxy for glucose is visible light which will not be transmitted all the way through a human finger.

Some implementations of the MVS finger clip 1900 includes a digital infrared sensor, such as digital IR sensor 1312 in FIG. 13 and FIG. 16 to measure skin surface temperature. Some implementations of the MVS finger clip 1900 includes a thermistor or a thermocouple to measure skin surface temperature.

In accordance with implementation #1 in Table 1 that is particularly useful for clinical applications, the multi-vital-sign (MVS) finger clip 1900 that determines transmissive SpO2, reflective SpO2, reflective glucose and other vital signs but not blood pressure, according to an implementation. In MVS finger clip 1900, the PLM subsystem 1904 includes an emitter in an emitter/detector that emits ER at 395 nm, 660 nm and 940 nm and that detects ER in the ranges of 375-415 nm, 640-680 nm and 920-960 nm to measure ER that is reflected by the subject finger that is positioned in the PLM subsystem 1904 at 395 nm, 660 nm and 940 nm. The PLM subsystem 1904 also includes a detector that detects ER in the ranges of 640-680 nm and 920-960 nm to transmit ER through the subject finger that is positioned in the PLM subsystem 1904 at 660 nm and 940 nm. The microprocessor of the printed circuit board or a microprocessor that is mounted on a printed circuit board determines transmissive SpO2 at 660 nm by dividing the amount of transmissive ER at 660 nm by the amount of transmissive ER at 940 nm, reflective SpO2 is determined by dividing the amount of reflective ER at 660 nm and by the amount of reflective ER at 940 nm and the reflective glucose is determined by dividing the amount of reflective ER at 395 nm by the amount of reflective ER at 940 nm. In MVS finger clip 1900, the emitter/detector includes both an emitter and a detector so that an amount of the electromagnetic energy that is reflected by the subject is detected, such as the finger of the patient. The amount or level of glucose in the blood of a subject is determined by a ratio of the amount of ER in the 375-415 nm range that detected by the detector in the emitter/detector is divided by the amount of ER in the 920-960 nm range that detected by the emitter/detector, which is then converted to units of mg/dL or mmol/L in reference to a non-linear serpentine function. Only the amount of radiation detected by the emitter/detector in the 375-415 nm range during the resting period of the heartbeat (in between heartbeats) is included in the determination of the amount or level of glucose in the blood of the subject. The resting period of the heartbeat is determined by a ratio of the amount of ER detected in the 640-680 nm range by the emitter/detector divided by the amount of radiation detected in the 920-960 nm range by the emitter/detector.

In accordance with implementation #2 in Table 1, the multi-vital-sign (MVS) finger clip 1900 that determines transmissive SpO2 and other vital signs but not blood pressure, according to an implementation. In MVS finger clip 1900, the PLM subsystem 1904 includes an emitter in an emitter 226 of 660 nm ER and 940 nm ER. The PLM subsystem 1904 also includes a detector that detects ER in the ranges of 640-680 nm and 920-960 nm to transmit ER through the subject finger that is positioned in the PLM subsystem 1904 at 660 nm and 940 nm. The microprocessor of the printed circuit board 2406 or a microprocessor that is mounted on a printed circuit board determines transmissive SpO2 at 660 nm by dividing the amount of transmissive ER at 660 nm by the amount of transmissive ER at 940 nm.

In accordance with implementation #3 in Table 1, the multi-vital-sign (MVS) finger clip 1900 that determines reflective SpO2 and other vital signs but not blood pressure, according to an implementation. In MVS finger clip 1900, the PLM subsystem 1904 includes an emitter in an emitter/detector that emits ER at 660 nm and 940 nm and that detects ER in the ranges of 640-680 nm and 920-960 nm to measure ER that is reflected by the subject finger that is positioned in the PLM subsystem 1904 at 660 nm and 940 nm. The PLM subsystem 1904 does not include a detector on the opposite side of the PLM subsystem 1904 from the emitter that detects ER that is transmitted through the subject finger that is positioned in the PLM subsystem 1904. The microprocessor of the printed circuit board or a microprocessor that is mounted on a printed circuit board determines reflective SpO2 by dividing the amount of reflective ER at 660 nm and by the amount of reflective ER at 940 nm.

In accordance with implementation #4 in Table 1, the multi-vital-sign (MVS) finger clip 1900 that determines reflective glucose and other vital signs but not blood pressure, according to an implementation. In MVS finger clip 1900, the PLM subsystem 1904 includes an emitter in an emitter/detector that emits ER at 395 nm and 940 nm and that detects ER in the ranges of 375-415 nm and 920-960 nm to measure ER that is reflected by the subject finger that is positioned in the PLM subsystem 1904 at 395 nm and 940 nm. The microprocessor of the printed circuit board 406 or a microprocessor that is mounted on a printed circuit board determines reflective glucose by dividing the amount of reflective ER at 395 nm by the amount of reflective ER at 940 nm.

In accordance with implementation #5 in Table 1 that is particularly useful for non-clinical wellness applications, the multi-vital-sign (MVS) finger clip 1900 that determines transmissive SpO2, reflective SpO2, reflective glucose and other vital signs but not blood pressure, according to an implementation. In MVS finger clip 1900, the PLM subsystem 1904 that includes an emitter in an emitter/detector that emits ER at 395 nm, 660 nm and 940 nm and that detects ER in the ranges of 375-415 nm, 640-680 nm and 920-960 nm to measure ER that is reflected by the subject finger that is positioned in the PLM subsystem 1904 at 395 nm, 660 nm and 940 nm. The detector in the emitter/detector is mounted on the same side of the PLM subsystem 1904 as the emitter in the emitter/detector so that the detector in the emitter/detector detects an amount of the electromagnetic energy that is reflected by the subject, such as the finger of the patient. The microprocessor of the printed circuit board or a microprocessor that is mounted on a printed circuit board determines reflective SpO2 by dividing the amount of reflective ER at 660 nm and by the amount of reflective ER at 940 nm and the reflective glucose is determined by dividing the amount of reflective ER at 395 nm by the amount of reflective ER at 940 nm. The amount or level of glucose in the blood of a subject is determined by a ratio of the amount of radiation detected by the emitter/detector in the 375-415 nm range divided by the amount of radiation detected by the emitter/detector in the 920-960 nm range, which is then converted to units of mg/dL or mmol/L in reference to a non-linear serpentine function, regardless of the amount of radiation detected by the emitter/detector in the 375-415 nm range during the resting period of the heartbeat (in between heartbeats). All of radiation detected by the emitter/detector in the 375-415 nm range during the resting period of the heartbeat is used in the determination of the amount or level of glucose in the blood of the subject.

In accordance with implementation #6 in Table 1, the multi-vital-sign (MVS) finger clip 1900 that determines transmissive SpO2, reflective glucose and other vital signs but not blood pressure, according to an implementation. In MVS finger clip 1900, the PLM subsystem 1904 includes an emitter in an emitter/detector that emits ER at 395 nm, 660 nm and 940 nm and that detects ER in the ranges of 375-415 nm and 920-960 nm to measure ER that is reflected by the subject finger that is positioned in the PLM subsystem 1904 at 395 nm and 940 nm. The PLM subsystem 1904 also includes a detector that detects ER in the ranges of 640-680 nm and 920-960 nm to transmit ER through the subject finger that is positioned in the PLM subsystem 1904 at 660 nm and 940 nm. The microprocessor of the printed circuit board or a microprocessor that is mounted on a printed circuit board determines transmissive SpO2 at 660 nm by dividing the amount of transmissive ER at 660 nm by the amount of transmissive ER at 940 nm and the reflective glucose is determined by dividing the amount of reflective ER at 395 nm by the amount of reflective ER at 940 nm.

In accordance with implementation #7 in Table 1, the multi-vital-sign (MVS) finger clip 1900 that determines transmissive SpO2 and reflective SpO2 and other vital signs but not blood pressure, according to an implementation. In MVS finger clip 1900, the PLM subsystem 1904 that includes an emitter in an emitter/detector that emits ER at 660 nm and 940 nm and that detects ER in the ranges of 375-415 nm, 640-680 nm and 920-960 nm to measure ER that is reflected by the subject finger that is positioned in the PLM subsystem 1904 at 660 nm and 940 nm. The PLM subsystem 1904 also includes a detector that detects ER in the ranges of 640-680 nm and 920-960 nm to transmit ER through the subject finger that is positioned in the PLM subsystem 1904 at 660 nm and 940 nm. The microprocessor of the printed circuit board or a microprocessor that is mounted on a printed circuit board determines transmissive SpO2 at 660 nm by dividing the amount of transmissive ER at 660 nm by the amount of transmissive ER at 940 nm and reflective SpO2 is determined by dividing the amount of reflective ER at 660 nm and by the amount of reflective ER at 940 nm.

In some implementations of FIG. 1-FIG. 34, the PLM subsystem includes a single light-emitting diode structure capable of emitting the three wavelengths required for oximetry and dye dilution measurements. A ring counter causes three semiconductor chips in the device to be energized in sequence. Light is directed toward the blood sample and the reflected light is extended to three synchronous detectors. Each detector operates only when a corresponding semiconductor chip in the light-emitting diode is energized; each detector thus responds only to the intensity of light at a respective wavelength. The outputs of two of the detectors are extended to a ratio circuit for deriving a final measurement. The ratio circuit itself has a high accuracy over the relatively low dynamic range of the ratio values.

In some implementations of FIG. 1-FIG. 34, the PLM subsystem is an infra-red light emitting and detecting system which has a frequency selected for maximum light absorption by the blood. In some implementations, the PLM subsystem uses a wavelength of approximately 940 nm which measures the light absorption spectrum of oxygenated blood by silicon phototransistors which have peak response at about 940 nm, such as gallium arsenide light emitting diodes. The wavelength (940 nm) is within the absorption spectrum of the hydroxyl constituents of arterial blood. Some devices use measurements of light reflection to indicate blood pulse rates. In some implementations, the PLM subsystem measures light absorption by the blood, using a decrease in back scatter to indicate increased absorption, which in turn indicates increased volume of flow. So the occurrence of each pulse is readily detected. The energy needed in a light absorption device of the type discussed herein is only about 1/1000 of the energy needed in the light reflecting devices, which causes a reduction in power requirements. In some implementations, the light-detecting photocells and the light-emitting diodes are soldered to one side of a printed circuit board. In some implementations, the PLM subsystem there is no direct electrical connection between the light sources and the detectors. In some implementations of the PLM subsystem, the light which enters detectors does not measure the reflection of light by the artery, but instead the back scatter which remains after the absorption of light by the oxygenated blood in the artery and arterioles. Each light source is an infra-red light emitting diode. Each light emitting diode is essentially monochromatic and does not involve the waste of white light, which has a broad frequency spectrum. The light detectors are photocells which have high sensitivity to the wavelength emitted by the light sources. In some implementations, the PLM subsystem includes a single light detecting device that is very position sensitive, i.e., their placement is vet important because light detection efficiency is dependent on exact location. On the other hand a plurality of detectors eliminates positioning problems, and ensures effective functioning of the sensor in spite of reasonable variations in its location. In some implementations of the PLM subsystem each light detector is physically paired with a light emitter which is the most effective means for obtaining a reliable and consistent sensor signal.

In some implementations of the PLM subsystem of FIG. 1-FIG. 34, light at two or more frequencies is transmitted through the finger of a subject, and the intensity of the transmitted light is measured on the other side of the finger, which is affected by such variables as depth of blood in the finger and differences in the total hemoglobin concentration in the blood. Inaccuracies caused by these variables can be eliminated or greatly reduced by taking the derivative of the intensity of the transmitted light, and processing the values of these derivatives in association with a set of predetermined pseudo coefficients by applying these to newly developed relationships disclosed in the specification. The result of such processing yields the value of oxygen saturation of the blood of the subject.

In some implementations of FIG. 1-FIG. 34, the apparatus includes a circuit for the determination of the concentration of any component of a liquid containing three different components having different optical properties, for the determination of the concentration sum of all components and of one other component, for the determination of the product and of the quotient which is formed by the third component, and for the calculation of the blood volume per minute of the heart. One or more light sources, a light sensing element, an optical filter and a lens are disposed in the circuit, and also power supply circuits and control circuits. To these are added a signal converting unit or a sensing system operating on three wavelengths other than the isobestic points or on a range containing these points, containing optical measurement channels, and measuring on the transmission or reflection principle. The signals delivered by the three-channel sensor or by the signal converter, as the case may be, are processed by circuits. The circuits are connected to channel amplifiers, and to the latter are connected subtraction circuits and multiplication circuits. By means of the electronics of suitable construction it is possible to determine in vivo and in vitro both the change with time of the concentration of the dye placed in the blood at any point in the circulatory system, and the volume of the blood.

In some implementations of FIG. 1-FIG. 34, the PLM subsystem includes a wavelength range within the 700-1300 nm wavelength range. Oxygenated hemoglobin (HbO₂) which has extremely low absorption characteristics, whereas disoxygenated hemoglobin (Hb) displays some weak absorption which slowly rises with decreasing wavelengths below 815 nm to a small peak in absorption around 760 nm. Because of these optical properties, the Hb-HbO₂steady state (i.e., the venous-arterial average) can be monitored. In some implementations, the PLM subsystem includes light shielding associated with a light source-detector assembly which is effective both as to extraneous near-infrared as well as extraneous ambient light such that the light entering the body as well as the light detected will be only those wavelengths and only from those light sources intended to be associated with the measurements. Extraneous photon energy at the measuring location which might otherwise enter the body and affect the measurements is therefore desirably absorbed by means associated with the light source-detector assembly of the invention. Another important feature is that the relative space between the light source and the detector elements remain fixed during the measuring period and not be subject to alterations by physical changes in body geometry brought about by breathing, flexing of the body, trauma, and the like. Another spacing important to the invention operation is the relative spacing between the point of light entry, optical face of light source terminal and the point of collecting the measured reflected and scattered light (i.e. optical face) of measuring light detector terminal. In order for the PLM subsystem to accommodate a relatively wide range of body contours, spacing between the points of light entry and exit can be changed. In this regard, an optical module is formed with the light source terminal and the light detector terminal preformed and positioned in optical module.

5. Multi-Vital-Sign Smartphones

FIG. 26 is a block diagram of a multi-vital-sign (MVS) smartphone 2600, according to an implementation. The MVS smartphone 2600 includes a number of modules such as a main processor 2602 that controls the overall operation of the MVS smartphone 2600. Communication functions, including data and voice communications, can be performed through a communication subsystem 2604. The communication subsystem 2604 receives messages from and sends messages to wireless networks 2606. In other implementations of the MVS smartphone 2600, the communication subsystem 2604 can be configured in accordance with the Global System for Mobile Communication (GSM), General Packet Radio Services (GPRS), Enhanced Data GSM Environment (EDGE), Universal Mobile Telecommunications Service (UMTS), data-centric wireless networks, voice-centric wireless networks, and dual-mode networks that can support both voice and data communications over the same physical base stations. Combined dual-mode networks include, but are not limited to, Code Division Multiple Access (CDMA) or CDMA2000 networks, GSM/GPRS networks (as mentioned above), and future third-generation (3G) networks like EDGE and UMTS. Some other examples of data-centric networks include Mobitex™ and DataTAC™ network communication systems. Examples of other voice-centric data networks include Personal Communication Systems (PCS) networks like GSM and Time Division Multiple Access (TDMA) systems.

The wireless link connecting the communication subsystem 2604 with the wireless network 2606 represents one or more different Radio Frequency (RF) channels. With newer network protocols, these channels are capable of supporting both circuit switched voice communications and packet switched data communications.

The main processor 2602 also interacts with additional subsystems such as a Random Access Memory (RAM) 2608, a flash memory 2610, a display 2614, an auxiliary input/output (I/O) subsystem 2616, a data port 2618, a keyboard 2620, a speaker 2622, a microphone 2624, short-range communications subsystem 2626 and other device subsystems 2628. The other device subsystems 2628 can include any one of the finger occlusion cuff 104 such as and/or the physiological light monitoring (PLM) subsystem 124, 224, 324, 424, 524, 624 or 724 that provide signals to the biological vital sign generator 2658. In some implementations, the flash memory 2610 includes a hybrid femtocell/Wi-Fi® protocol stack 2614. The hybrid femtocell/Wi-Fi® protocol stack 2614 supports authentication and authorization between the MVS smartphone 2600 into a shared Wi-Fi® network and both a 3G, 4G or 5G mobile networks.

The MVS smartphone 2600 can transmit and receive communication signals over the wireless network 2606 after required network registration or activation procedures have been completed. Network access is associated with a subscriber or user of the MVS smartphone 2600. User identification information can also be programmed into the flash memory 2610.

The MVS smartphone 2600 is a battery-powered device and includes a battery interface 2636 for receiving one or more batteries 2634. In one or more implementations, the battery 2634 can be a smart battery with an embedded microprocessor. The battery interface 2636 is coupled to a regulator 2638, which assists the battery 2634 in providing power V+ to the MVS smartphone 2600. Future technologies such as micro fuel cells may provide the power to the MVS smartphone 2600.

The MVS smartphone 2600 also includes an operating system 2640 and modules 2642 to 2658 that are executed by the main processor 2602 are typically stored in a persistent nonvolatile medium such as the flash memory 2610, which may alternatively be a read-only memory (ROM) or similar storage element (not shown). Those skilled in the art will appreciate that portions of the operating system 2640 and the modules 2642 to 2658, such as specific device applications, or parts thereof, may be temporarily loaded into a volatile store such as the RAM 2608. Other modules can also be included.

The subset of modules 2642 that control basic device operations, including data and voice communication applications, will normally be installed on the MVS smartphone 2600 during its manufacture. Other modules include a message application 2644 that can be any suitable module that allows a user of the MVS smartphone 2600 to transmit and receive electronic messages. Various alternatives exist for the message application 2644 as is well known to those skilled in the art. Messages that have been sent or received by the user are typically stored in the flash memory 2610 of the MVS smartphone 2600 or some other suitable storage element in the MVS smartphone 2600. In one or more implementations, some of the sent and received messages may be stored remotely from the MVS smartphone 2600 such as in a data store of an associated host system with which the MVS smartphone 2600 communicates.

The modules can further include a device state module 2646, a Personal Information Manager (PIM) 2648, and other suitable modules (not shown). The device state module 2646 provides persistence, i.e. the device state module 2646 ensures that important device data is stored in persistent memory, such as the flash memory 2610, so that the data is not lost when the MVS smartphone 2600 is turned off or loses power.

The PIM 2648 includes functionality for organizing and managing data items of interest to the user, such as, but not limited to, e-mail, contacts, calendar events, voice mails, appointments, and task items. A PIM application has the ability to transmit and receive data items via the wireless network 2606. PIM data items may be seamlessly integrated, synchronized, and updated via the wireless network 2606 with the MVS smartphone 2600 subscriber's corresponding data items stored and/or associated with a host computer system. This functionality creates a mirrored host computer on the MVS smartphone 2600 with respect to such items.

The MVS smartphone 2600 also includes a connect module 2650, and an IT policy module 2652. The connect module 2650 implements the communication protocols that are required for the MVS smartphone 2600 to communicate with the wireless infrastructure and any host system, such as an enterprise system, with which the MVS smartphone 2600 is authorized to interface. Examples of a wireless infrastructure and an enterprise system are given in FIGS. 26 and 63, which are described in more detail below.

The connect module 2650 includes a set of APIs that can be integrated with the MVS smartphone 2600 to allow the MVS smartphone 2600 to use any number of services associated with the enterprise system. The connect module 2650 allows the MVS smartphone 2600 to establish an end-to-end secure, authenticated communication pipe with the host system. A subset of applications for which access is provided by the connect module 2650 can be used to pass IT policy commands from the host system to the MVS smartphone 2600. This can be done in a wireless or wired manner. These instructions can then be passed to the IT policy module 2652 to modify the configuration of the MVS smartphone 2600. Alternatively, in some cases, the IT policy update can also be done over a wired connection.

The IT policy module 2652 receives IT policy data that encodes the IT policy. The IT policy module 2652 then ensures that the IT policy data is authenticated by the MVS smartphone 2600. The IT policy data can then be stored in the RAM 2608 in its native form. After the IT policy data is stored, a global notification can be sent by the IT policy module 2652 to all of the applications residing on the MVS smartphone 2600. Applications for which the IT policy may be applicable then respond by reading the IT policy data to look for IT policy rules that are applicable.

The programs 2637 can also include a temporal-motion-amplifier 2656 and a biological vital sign generator 2658. In some implementations, the temporal-motion-amplifier 2656 includes a skin-pixel-identification module, a frequency filter, a regional facial clusterial module and a frequency filter. In some implementations, the temporal-motion-amplifier 2656 includes a skin-pixel-identification module, a spatial bandpass filter, a regional facial clusterial module and a temporal bandpass filter. In some implementations, the temporal-motion-amplifier 2656 includes a pixel-examiner, a temporal motion determiner and a signal processor. In some implementations, the temporal-motion-amplifier 2656 includes a skin pixel identification module, a frequency-filter module, a spatial-cluster module and a frequency filter module. In some implementations, the temporal-motion-amplifier 2656 includes the skin pixel identification module, a spatial bandpass filter module, a spatial-cluster module and a temporal bandpass filter module. In some implementations, the temporal-motion-amplifier 2656 includes a pixel-examination-module, a temporal motion determiner module and a signal processing module. Furthermore, the solid-state image transducer 2660 captures images 2662 and the biological vital sign generator 2658 generates the biological vital sign(s).

In some implementations, the biological vital sign generator 2658 performs the same functions as biological vital sign generator 3234 in FIG. 32 from data received from a MVSFCA in FIG. 12-FIG. 18 and FIG. 29-FIG. 31 or a finger clip in FIG. 19-FIG. 25. In some implementations, the MVS smartphone 2600 includes no biological vital sign generator 2658 and the determined biological vital signs are received through the data port 2618, the communication subsystem 2604 or the short-range communications subsystem 2626 from a MVSFCA such as the MVSFCAs in FIG. 12-FIGS. 18 and 29-FIG. 31 or the MVS finger clip in FIG. 19-FIG. 25.

The biological vital sign that is generated or received is then displayed by display 2614 or transmitted by the communication subsystem 2604 or the short-range communications subsystem 2626, enunciated by the speaker 2622 or stored by the flash memory 2610. Examples of the biological vital signs that are displayed on the display 2614 are FIG. 45-FIG. 46.

Other types of modules can also be installed on the MVS smartphone 2600. These modules can be third party modules, which are added after the manufacture of the MVS smartphone 2600. Examples of third party applications include games, calculators, utilities, etc.

The additional applications can be loaded onto the MVS smartphone 2600 through of the wireless network 2606, the auxiliary I/O subsystem 2616, the data port 2618, the short-range communications subsystem 2626, or any other suitable device subsystem 2628. This flexibility in application installation increases the functionality of the MVS smartphone 2600 and may provide enhanced on-device functions, communication-related functions, or both. For example, secure communication applications enables electronic commerce functions and other such financial transactions to be performed using the MVS smartphone 2600.

The data port 2618 enables a subscriber to set preferences through an external device or module and extends the capabilities of the MVS smartphone 2600 by providing for information or module downloads to the MVS smartphone 2600 other than through a wireless communication network. The alternate download path may, for example, be used to load an encryption key onto the MVS smartphone 2600 through a direct and thus reliable and trusted connection to provide secure device communication.

The short-range communications subsystem 2626 provides for communication between the MVS smartphone 2600 and different systems or devices, without the use of the wireless network 2606. For example, the short-range communications subsystem 2626 may include an infrared device and associated circuits and modules for short-range communication. Examples of short-range communication standards include standards developed by the Infrared Data Association (IrDA), Bluetooth®, and the 802.11 family of standards developed by IEEE. In other implementations, Zigbee® or Z-Wave® can be used instead of Bluetooth®.

Bluetooth® is a wireless technology standard for exchanging data over short distances (using short-wavelength radio transmissions in the ISM band from 2400-2480 MHz) from fixed and mobile devices, creating personal area networks (PANs) with high levels of security. Created by telecom vendor Ericsson in 1994, Bluetooth® was originally conceived as a wireless alternative to RS-232 data cables. Bluetooth® can connect several devices, overcoming problems of synchronization. Bluetooth® operates in the range of 2400-2483.5 MHz (including guard bands), which is in the globally unlicensed Industrial, Scientific and Medical (ISM) 2.4 GHz short-range radio frequency band. Bluetooth® uses a radio technology called frequency-hopping spread spectrum. The transmitted data is divided into packets and each packet is transmitted on one of the 79 designated Bluetooth® channels. Each channel has a bandwidth of 1 MHz. The first channel starts at 2402 MHz and continues up to 2480 MHz in 1 MHz steps. The first channel usually performs 1600 hops per second, with Adaptive Frequency-Hopping (AFH) enabled. Originally Gaussian frequency-shift keying (GFSK) modulation was the only modulation scheme available; subsequently, since the introduction of Bluetooth® 2.0+EDR, π/4-DQPSK and 8DPSK modulation may also be used between compatible devices. Devices functioning with GFSK are said to be operating in basic rate (BR) mode where an instantaneous data rate of 1 Mbit/s is possible. The term Enhanced Data Rate (EDR) is used to describe π/4-DPSK and 8DPSK schemes, each giving 2 and 3 Mbit/s respectively. The combination of these (BR and EDR) modes in Bluetooth® radio technology is classified as a “BR/EDR radio”. Bluetooth® is a packet based protocol with a master-slave structure. One master may communicate with up to 7 slaves in a piconet; all devices share the master's clock. Packet exchange is based on the basic clock, defined by the master, which ticks at 312.5 μs intervals. Two clock ticks make up a slot of 625 μs; two slots make up a slot pair of 1250 μs. In the simple case of single-slot packets the master transmits in even slots and receives in odd slots; the slave, conversely, receives in even slots and transmits in odd slots. Packets may be 1, 3 or 5 slots long but in all cases the master transmit will begin in even slots and the slave transmit in odd slots. The devices can switch roles, by agreement, and the slave can become the master (for example, a headset initiating a connection to a phone will necessarily begin as master, as initiator of the connection; but may later become a slave). The Bluetooth® Core Specification provides for the connection of two or more piconets to form a scatternet, in which certain devices simultaneously play the master role in one piconet and the slave role in another. At any given time, data can be transferred between the master and one other device (except for the little-used broadcast mode. The master chooses which slave device to address; typically, the master switches rapidly from one device to another in a round-robin fashion. Since the master chooses which slave to address, whereas a slave is (in theory) supposed to listen in each receive slot, being a master is a lighter burden than being a slave. Being a master of seven slaves is possible; being a slave of more than one master is difficult. Many of the services offered over Bluetooth® can expose private data or allow the connecting party to control the Bluetooth® device. For security reasons it is necessary to be able to recognize specific devices and thus enable control over which devices are allowed to connect to a given Bluetooth® device. At the same time, it is useful for Bluetooth® devices to be able to establish a connection without user intervention (for example, as soon as the Bluetooth® devices of each other are in range). To resolve this conflict, Bluetooth® uses a process called bonding, and a bond is created through a process called pairing. The pairing process is triggered either by a specific request from a user to create a bond (for example, the user explicitly requests to “Add a Bluetooth® device”), or the pairing process is triggered automatically when connecting to a service where (for the first time) the identity of a device is required for security purposes. These two cases are referred to as dedicated bonding and general bonding respectively. Pairing often involves some level of user interaction; this user interaction is the basis for confirming the identity of the devices.

In use, a received signal such as a text message, an e-mail message, or web page download will be processed by the communication subsystem 2604 and input to the main processor 2602. The main processor 2602 will then process the received signal for output to the display 2614 or alternatively to the auxiliary I/O subsystem 2616. A subscriber may also compose data items, such as e-mail messages, for example, using the keyboard 2620 in conjunction with the display 2614 and possibly the auxiliary I/O subsystem 2616. The auxiliary I/O subsystem 2616 may include devices such as: a touch screen, mouse, track ball, infrared fingerprint detector, or a roller wheel with dynamic button pressing capability. The keyboard 2620 is preferably an alphanumeric keyboard and/or telephone-type keypad. However, other types of keyboards may also be used. A composed item may be transmitted over the wireless network 2606 through the communication subsystem 2604.

For voice communications, the overall operation of the MVS smartphone 2600 is substantially similar, except that the received signals are output to the speaker 2622, and signals for transmission are generated by the microphone 2624. Alternative voice or audio I/O subsystems, such as a voice message recording subsystem, can also be implemented on the MVS smartphone 2600. Although voice or audio signal output is accomplished primarily through the speaker 2622, the display 2614 can also be used to provide additional information such as the identity of a calling party, duration of a voice call, or other voice call related information.

FIG. 27 is a block diagram of a MVS smartphone 2700, according to an implementation. MVS Smartphone 2700 is one implementation of MVS Smartphone 2904 in FIG. 29. The MVS Smartphone 2700 includes a sensor printed circuit board (PCB) 2702. The sensor PCB 2702 includes proximity sensors 2704, 2706 and 2708, and temperature sensor 2710, autofocus lens 2712 in front of camera sensor 2714 and an illumination light emitting diode (LED) 2716. The includes proximity sensors 2704, 2706 and 2708 are operably coupled to a first FC port 2718 of a microprocessor 2720. One example of the microprocessor 2720 is a Qualcomm Snapdragon microprocessor chipset. The temperature sensor 2710 is operably coupled to a second FC port 2722 of the microprocessor 2720. The FC standard is a multi-master, multi-slave, single-ended, serial computer bus developed by Philips Semiconductor (now NXP Semiconductors) for attaching lower-speed peripheral ICs to processors and microcontrollers in short-distance, intra-board communication. The camera sensor 2714 is operably coupled to a MIPI port 2724 of the microprocessor 2720. The MIPI standard is defined by the MIPI Alliance, Inc. of Piscataway, N.J. The MIPI port 2724 is also operably coupled to a MIPI RGB bridge 2726, and the MIPI RGB bridge 2726 is operably coupled to a display device 2728 such as a TFT Color Display (2.8″). The illumination LED 2716 is operably coupled to a pulse-width modulator (PWM) 2730 of the microprocessor 2720. The PWM 2730 is also operably coupled to a haptic motor 2732. The microprocessor 2720 also includes a GPIO port 2734, the GPIO port 2734 being a general-purpose input/output that is a generic pin on an integrated circuit or computer board whose behavior—including whether GPIO port 2734 is an input or output pin—is controllable by the microprocessor 2720 at run time. The GPIO port 2734 is operably coupled to a keyboard 2736, such as a membrane keypad (3× buttons). The microprocessor 2720 is also operably coupled to an audio codec 2738 with is operably coupled to a speaker 2740. The microprocessor 2720 also includes a Bluetooth® communication port 2742 and a Wi-Fi® communication port 2744, that are both capable of communicating with a PCB antenna 2746. In other implementations, Zigbee® or Z-Wave® can be used instead of Bluetooth®. The microprocessor 2720 is also operably coupled to a micro SD slot (for debugging purposes), a flash memory unit 2750, a DDR3 random access memory unit 2752 and a micro USB port 2754 (for debugging purposes). The micro USB port 2754 is operably coupled to voltage rails and a battery power/management component 2758. The battery power/management component 2758 is operably coupled to a battery 2760, which is operably coupled to a charger connector 2762.

Biological vital signs are received through the micro USB connector 2754, the Wi-Fi® 2744 or the Bluetooth® 2742 from a MVSFCA such as the MVSFCAs in FIG. 12-FIG. 18 and FIG. 29-FIG. 31 or the MVS finger clip in FIG. 19-FIG. 25. The biological vital signs that are received are then displayed by display 2728 and/or transmitted by the Wi-Fi® 2744 or the Bluetooth® 2742, enunciated by the speaker 2740 or stored by the flash memory 2750. Examples of the biological vital signs that are displayed on the display 2728 are FIG. 45-FIG. 46.

FIG. 28 is a data flow diagram 2800 of the MVS smartphone 3003, according to an implementation. Data flow diagram 2800 is a process of the MVSFCA 3002 via a graphical user interface on a LCD display 3016 on the MVS smartphone device 3003.

In data flow diagram 2800, a main screen 2802 is displayed by the MVS Smartphone device 3003 that provides options to exit the application 2804, display configuration settings 2806, display data export settings 2808 or display patient identification entry screen 2810. The configuration settings display 2806 provides options for the configuration/management of the MVS Smartphone device 3003. In some implementations, the data flow diagram 2800 includes low power operation and sleep, along startup, initialization, self check and measurement capability of the MVS Smartphone device 3003. The display of data export settings 2808 provides options to take individual measurement of a given vital sign. After the patient identification entry screen 2810 or and alternatively, bar code scanning of both operator and subject, has been completed, one or more sensors are placed on the patient 2812, the MVS Smartphone device 3003 verifies 2814 that signal quality from the sensors is at or above a predetermined minimum threshold. If the verification 2814 fails 2816 as shown in FIG. 45, then the process resumes where one or more sensors are placed on the patient 2812. If the verification 2814 succeeds 2818 as shown in FIG. 46, then measurement 2820 using the one or more sensors is performed and thereafter the results of the measurements are displayed 2822 as shown in FIG. 34 and thereafter the results of the measurements are saved to EMR or clinical cloud 2824, and then the process continues at the main screen 2802. The “para n done” actions the measurement 2820 are indications that the sensing of the required vital-signs is complete. Examples of the measurements 2820 that are displayed 2822 are FIG. 45-FIG. 46.

6. Apparatus of Multi-Vital-Sign System

FIG. 29 is a block diagram of a multi-vital-sign (MVS) smartphone system 2900, according to an implementation. The MVS system 2900 includes two communicatively coupled devices; a multi-vital-sign finger cuff accessory MVSFCA 2902 and a multi-vital-sign smartphone (MVS Smartphone) 2904. The MVSFCA 2902 includes a MVS finger cuff 2908. The MVS system 2900 is one example of the MVS apparatus 4104. In some implementations, the MVS system 2900 captures, stores and exports raw data from all supported sensors in the MVS finger cuff 2908. MVS system 2900 provides a flexible human vital sign measurement methodology that supports different measurement methods and techniques. The MVS system 2900 can be used in a clinical setting or a home setting for the collection of human vital signs. The MVSFCA 2902 can be configured to detect blood pressure only, SpO2 only, blood glucose levels only, heart rate only, respiration only, or any combination of vital signs that the MVSFCA is capable of detecting. The MVS Smartphone 2904 includes non-slip/slide exterior surface material. Heart-rate can be determined in all devices, apparatus and methods disclosed herein from the pulsatile component of the SpO2 measurement. The SpO2 measurement used in the determination of the heart-rate can either transmissive SpO2 (transmissive 660 nm/transmissive 940 nm) or reflective SpO2 (reflective 660 nm/reflective 940 nm). The number of pulses is counted in the pulsatile component to determine the heart-rate. Heart-rate variability can be determined in all devices, apparatus and methods disclosed herein as the maximum deviation time from the average heartbeat duration, in a particular period. The deviation time is the time between any two successive heartbeats in the particular period. The maximum deviation time is the largest or greatest deviation of the deviation times in the particular period. In more specific analysis of heart-rate variability, methods such as time-domain methods, geometric methods, frequency-domain or non-linear methods are implemented. Respiration rate can be determined in all devices, apparatus and methods disclosed herein from cardiac output based on pulse analysis (from SpO2) and stroke volume (from DLS blood pressure sensors). Cardiac output has a linear relationship with respiration rate, as published by Wallin et al.

The MVSFCA 2902 includes a pneumatic engine 2906 and a MVS finger cuff 2908 that are operably coupled to each other through an air line 1404 and a communication path 2910, such as a high speed serial link A high speed serial link is especially important because the cable of a serial link is quite a bit a bit thinner and more flexible than a parallel cable, which provides a lighter cable that can be more easily wrapped around the MVSFCA 2902. A cuff bladder of the MVS finger cuff 2908 expands and contracts in response to air pressure from the air line 1404.

Some implementations of the MVS finger cuff 2908 include a finger occlusion cuff 2916 and a PLM subsystem 2918. The MVS finger cuffs in FIG. 1-FIG. 7 are examples of the MVS finger cuff 2908. The finger occlusion cuff 2916 and the PLM subsystem 2918 are shown in greater detail in FIG. 1-FIG. 12. In some implementations, the MVS finger cuff 2908 includes at least one miniaturized dynamic light scattering (mDLS) sensor and the PLM subsystem 2918. The PLM subsystems in FIG. 1-FIG. 12 are examples of the PLM subsystem 2918. PLM subsystem 2918 and the finger occlusion cuff 2916 are operably coupled to a common board in the MVS finger cuff 2908 (such as printed circuit boards 106, 206, 306, 406, 506, 606 and 706 in FIG. 1, FIG. 2, FIG. 3, FIG. 4, FIG. 5, FIG. 6 and FIG. 7, respectively) and the common board is operably coupled through the communication path 2910 (such as finger sensor cable 3110 in FIG. 31) to a printed circuit board (such as printed circuit board 1214 in FIG. 12) that is in the base of MVSFCA 2902.

In some implementations, the MVS finger cuff 2908 integrates the PLM subsystem and at least one miniaturized dynamic light scattering (mDLS) sensor into a single sensor. Both of the which are attached to the MVS finger cuff 2908. The PLM and mDLS implementation of the MVS finger cuff 2908 measures the following primary and secondary human vital sign measurements through a PLM subsystem from either an index finger or a middle finger; on both the left or right hands at heart height to ensure an accurate measurement: Primary human vital sign measurements such as blood pressure (diastolic and systolic), SpO2, heart rate and respiration rate. Secondary human vital sign measurements include heart rate variability and blood flow. The PLM subsystem optically measures light that passes through tissue from at least one IR light emitters. The PLM subsystem includes one infrared detector that detects infrared energy at two different transmitted wavelengths; red and near infrared. Signal fluctuations of the light are generally attributed to the fluctuations of the local blood volume due to the arterial blood pressure wave, which means that the amount of blood in the illuminated perfused tissue fluctuates at the rate of heartbeats. So does the light transmission or light refraction. Therefore, PLM data is an indirect method of the estimation of the blood volume changes. The blood pressure is estimated from data from the mDLS sensor in conjunction with a blood pressure finger cuff which mimics pressure cycle to create an occlusion like the arm cuff. The biological target is illuminated by a laser, the signal is collected by a detector and the time dependency of the laser speckle characteristics are analyzed. The mDLS geometry is designed to create direct signal scattering reflection of the signal into the detector. Each mDLS sensor includes two photo diode receivers and one laser transmitter.

In some implementations, the MVS finger cuff 2908 is replaceable, detachable and removable from the MVSFCA 2902. In some implementations, the MVS finger cuff 2908 is integrated into the MVSFCA 2902. The MVS finger cuff 290 that is replaceable, detachable and removable from the MVSFCA 2902 is beneficial in two ways: 1) the MVS finger cuff 2908 is replaceable in the event of damage 2) the MVS finger cuff 2908 can be detached from the MVSFCA 2902 and then attached to a custom connector cable (pneumatic and electrical) that allows a patient to wear the MVS finger cuff 2908 for continuous monitoring, and (3) servicing the device. The replaceable MVS finger cuff 2908 can have photo optic component(s) (e.g. 2×mDLS) that are cleanable between patients and replaceable in the event of failure of the inflatable cuff or the photo optic component(s). In some implementations, the cuff bladder of the removable MVS finger cuff 2908 is translucent or transparent to transparent to the mDLS laser wavelengths and which in some implementations allows the position of the MVS finger cuff 2908 to be adjusted in relation to specific parts of human anatomy for optimal function of the sensors and comfort to the patient.

The MVSFCA 2902 and the MVS Smartphone 2904 can be operably coupled to each other through a communication path 2912 to exchange data and control signals and a 4 point electrical recharge interface (I/F) line 2914 recharge from a conventional wall outlet. In some implementations, the 4 point electrical recharge interface (I/F) line 2914 is a 3 point electrical recharge interface (I/F) line. The MVSFCA 2902 and the MVS Smartphone 2904 do not need to be physically attached to each other for measurement operation by either the MVSFCA 2902 or the MVS Smartphone 2904. In some implementations, the MVSFCA 2902 has at least one universal serial bus (USB) port(s) for bi-directional communication, command, control, status and data transfer with another devices with both standard and propriety protocols using USB infrastructure. USB protocol is defined by the USB Implementers Forum at 5440 SW Westgate Dr. Portland Oreg. 94221. In some implementations, the MVS Smartphone 2904 has at least one USB port(s) for communication with other devices via USB, such as connected to a MVSFCA 2902 for the purposes of transferring the raw sensor data from the device to a computer for analysis. Biological vital signs are received by MVS Smartphone 2904 through the Bluetooth® link 2912 from a MVSFCA such as in FIG. 12-FIG. 18 or a MVS finger cuff in FIG. 19-FIG. 25 in FIG. 12-FIG. 18 or the MVS finger clip in FIG. 19-FIG. 25. The biological vital signs that are received are then displayed by display 2728 an/or transmitted by the Wi-Fi® 2744 or the Bluetooth® 2742, enunciated by the speaker 2740 or stored by the flash memory 2750. Examples of the biological vital signs that are displayed on the display 2728 are FIG. 45-FIG. 46. In other implementations, Zigbee® or Z-Wave® can be used instead of Bluetooth®.

FIG. 30 is a block diagram of a MVS smartphone system 3000, according to an implementation. The MVS smartphone system 3000 includes three communicatively coupled devices; a MVS finger cuff accessory (MVSFCA) 3002, a multi-vital-sign smartphone (MVS Smartphone) 3003 and a multi-vital-sign finger cuff accessory Recharge Station (MVSFCARS) 3004. MVSFCA 3002 is one implementation of MVSFCA 2902 in FIG. 29. MVS Smartphone 3003 is one implementation of MVS Smartphone 2904 in FIG. 29. MVS smartphone system 3000, the MVSFCA 3002 and the MVS Smartphone 3003 are all examples of the MVS apparatus 4104. The MVS Smartphone 3003 captures, stores and exports raw data from all supported sensors in the system. More specifically, the MVS Smartphone 3003 extracts and displays vital signs and transfers the vital-signs to either a remote third party, hub, bridge etc., or a device manager, or directly to remote EMR/HER/Hospital systems or other third party local or cloud based systems. MVS smartphone system 3000 provides a flexible human vital sign measurement methodology that supports different measurement methods and techniques. The MVS smartphone system 3000 can be used in a clinical setting for the collection of human vital signs.

Some implementations of the MVSFCA 3002 include a MVS finger cuff 1704 that is fixed into the MVSFCA 3002, rather than the replaceable, detachable and removable MVS finger cuff 2908 in FIG. 29. The MVS finger cuff 1704 includes a PLM subsystem and at least one mDLS sensor. The MVS finger cuff 1704 is powered via an air line (e.g. 1404 in FIG. 29) by a pneumatic engine 1706 that provides air pressure to inflate the cuff bladder of the MVS finger cuff 1704 and the controlled release of that pressure. In some implementations, the air line 1404 is ⅙″ (4.2 mm) in diameter.

In some implementations, a body surface temperature of a human is also sensed by an infrared finger temperature sensor 1708 that is integrated into the MVSFCA 3002 in which the body surface temperature is collected and managed by the MVSFCA 3002. One example of the pneumatic engine 1706 is the pneumatic engine 2906.

In some implementations, a single stage measurement process is required to measure all vital signs in one operation by the MVS Smartphone 3003 by the replaceable, detachable and removable MVS finger cuff 2908 or the MVS finger cuff 1704 or the infrared finger temperature sensor 1708. However, in some implementations, a two stage measurement process is performed in which the MVSFCA 3002 measures some vital signs through the replaceable, detachable and removable MVS finger cuff 2908 or the MVS finger cuff 1704; and in the second stage, the body surface temperature is measured through an infrared finger temperature sensor 1708 in the MVS Smartphone device 3003. One implementation of the infrared finger temperature sensor 1708 is digital infrared sensor 1312 in FIG. 37.

The MVSFCA 3002 operates in two primary modes, the modes of operation based on who takes the measurements, a patient or an operator. The two modes are: 1) Operator Mode in which an operator operates the MVSFCA 3002 to take a set of vital sign measurements of another human. The operator is typically clinical staff or a home care giver. 2) Patient Mode in which a patient uses the MVSFCA 3002 to take a set of vital sign measurements of themselves. In some implementations, the MVSFCA 3002 provides both the main measurement modes for patient and operator. The primary measurement areas on the human to be measured are 1) Left hand, index and middle finger, 2) right hand, index and middle finger, and 3) human temperature (requires the other device to perform temperature measurement). The MVSFCA 3002 is portable, light weight, hand held and easy to use in primary and secondary modes of operation in all operational environments.

Given the complex nature of integration into hospital networks, in some implementations the MVSFCA 3002 does not include site communication infrastructure, rather the collected data (vital sign) is extracted from the MVSFCA 3002 via a USB port or by a USB mass storage stick that is inserted into the MVSFCA 3002 or by connecting the MVSFCA 3002 directly to a PC system as a mass storage device itself.

The MVS smartphone 3003, when connected to a wireless Bluetooth® communication component 1718 of the MVSFCA 3002 via a wireless Bluetooth® communication component 3014, can be a slave to the MVSFCA 3002. The MVS Smartphone 3003 reports status, measurement process, and measurement measurements to the user via the MVSFCA 3002. The MVS Smartphone 3003 provides a user input method to the MVSFCA 3002 via a graphical user interface on a LCD display 3016 which displays data representative of the measurement process and status. In one implementation, the wireless Bluetooth® communication component 1718 of the MVSFCA 3002 includes communication capability with cellular communication paths (3G, 4G and/or 5G) and/or Wi-Fi® communication paths and the MVSFCA 3002 is not a slave to the captures vital sign data and transmits the vital sign data via the wireless Bluetooth® communication component 1718 in the MVSFCA 3002 to the middle layer 4206 in FIG. 42 or the MVS Smartphone 3003 transmits the vital sign data via the communication component 3018 of the MVS Smartphone 3003 to the bridge 4220, a Wi-Fi® access point, a cellular communications tower, a bridge 4220 in FIG. 42. In other implementations, Zigbee® or Z-Wave® can be used instead of Bluetooth®.

In some implementations, the MVS Smartphone 3003 provides communications with other devices via a communication component 3018 of the MVS Smartphone 3003. The communication component 3018 has communication capability with cellular communication paths (3G, 4G and/or 5G) and/or Wi-Fi® communication paths. For example, the MVSFCA 3002 captures vital sign data and transmits the vital sign data via the wireless Bluetooth® communication component 1718 in the MVSFCA 3002 to the wireless Bluetooth® communication component 3014 in the MVS Smartphone 3003, and the MVS Smartphone 3003 transmits the vital sign data via the communication component 3018 of the MVS Smartphone 3003 to the middle layer 4206 in FIG. 42 or the MVS Smartphone 3003 transmits the vital sign data via the communication component 3018 of the MVS Smartphone 3003 to the bridge 4220, a Wi-Fi® access point, a cellular communications tower, a bridge 4220 in FIG. 42.

In some implementations, when the MVS Smartphone 3003 is connected to the MVSFCA 3002, the MVS Smartphone 3003 performs human bar code scan by a bar code scanner 3020 or identification entry as requested by MVSFCA 3002, the MVS Smartphone 3003 performs an operator bar code scan or identification entry as requested by MVSFCA 3002, the MVS Smartphone 3003 performs human temperature measurement as requested by MVSFCA 3002, the MVS Smartphone 3003 displays information that is related to the MVSFCA 3002 direct action, the MVS Smartphone 3003 starts when the MVSFCA 3002 is started, and the MVS Smartphone 3003 is shutdown under the direction and control of the MVSFCA 3002, and the MVS Smartphone 3003 has a self-test mode that determines the operational state of the MVSFCA 3002 and sub systems, to ensure that the MVSFCA 3002 is functional for the measurement. In other implementations, when the MVS Smartphone 3003 is connected to the MVSFCA 3002, the MVS Smartphone 3003 performs human bar code scan or identification entry as requested by MVS Smartphone 3003, the MVS Smartphone 3003 performs an operator bar code scan or identification entry as requested by MVS Smartphone 3003, the MVS Smartphone 3003 performs human temperature measurement as requested by MVS Smartphone 3003 and the MVS Smartphone 3003 displays information that is related to the MVSFCA 3002 direct action. In some implementations, the information displayed by the MVS Smartphone 3003 includes date/time, human identification number, human name, vitals measurement such as blood pressure (diastolic and systolic), SpO2, heart rate, temperature, respiratory rate, MVSFCA 3002 free memory slots, battery status of the MVS Smartphone 3003, battery status of the MVSFCA 3002, device status of the MVSFCA 3002, errors of the MVS Smartphone 3003, device measurement sequence, measurement quality assessment measurement, mode of operation, subject and operator identification, temperature, measurement, display mode and device revision numbers of the MVS Smartphone 3003 and the MVSFCA 3002. In some implementations, when a body surface temperature of a human is also sensed by an infrared sensor in the MVS smartphone 3003, the body surface temperature is collected and managed by the MVSFCA 3002. In other implementations, when a body surface temperature of a human is sensed by an infrared sensor in the MVS smartphone 3003, the body surface temperature is not collected and managed by the MVSFCA 3002.

In some implementations, the multi-vital-sign finger cuff accessory (MVSFCA) 3002 includes the following sensors and sensor signal capture and processing components that are required to extract the required primary and secondary human vital signs measurements: the MVS finger cuff 1704 that includes a PLM subsystem and two mDLS sensors, the infrared finger temperature sensor 1708 and an ambient air temperature sensor 1710, and in some further implementation, non-disposable sensors for other human measurements. In some implementations, data sample rates for PLM subsystem is 2×200 Hz×24 bit=9600 bits/sec, for each of the mDLS sensors is 32 kHz×24 bit=1,572,864 bit/sec and for the ambient air temperature sensor is less than 1000 bps. Two mDLS sensors are included in the MVSFCA 3002 to ensure that one or both sensors delivers a good quality signal, thus increasing the probability of obtaining a good signal from a mDLS sensor.

The MVS Smartphone 3003 performs concurrent two stage measurement processes for all measurements. The measurement process performed by the MVS Smartphone 3003 is controlled and guided from the MVS Smartphone 3003 via the GUI on the MVSFCA 3002. The measurements are sequenced and configured to minimize time required to complete all measurements. In some implementations, the MVS Smartphone 3003 calculates the secondary measurements of heart rate variability and blood flow. The MVS Smartphone 3003 commands and controls the MVSFCA 3002 via a wireless Bluetooth® protocol communication path 2912 and in some further implementations, the MVSFCA 3002 communicates to other devices through Bluetooth® protocol communication line (not shown), in addition to the communications with the MVS Smartphone 3003 which could also be concurrent. in some further implementations, the MVS Smartphone 3003 communicates to other devices through Bluetooth® protocol communication line (not shown), in addition to the communications with the MVSFCA 3002 device, which could also be concurrent.

MVSFCA 3002 includes a USB port 1720 for interface with the MVS Smartphone 3003 only, such as the MVS Smartphone 3003, to perform the following functions: recharge the internal rechargeable batteries 1722 of the MVSFCA 3002, export sensor data sets to a windows based computer system, firmware update of the MVSFCA 3002 via an application to control and manage the firmware update of the MVSFCA 3002 and configuration update of the MVSFCA 3002. The MVSFCA 3002 does not update the MVS Smartphone 3003 firmware. The MVSFCA 3002 also includes internal rechargeable batteries 1722 that can be recharged via a USB port 3028, which transmits charge, and the MVSFCA 3002 also includes an external direct DC input providing a fast recharge. The internal batteries of the MVSFCA 3002 can be recharged when the MVSFCA 3002 is powered-off but while connected to USB or DC input. In some implementations, the MVSFCA 3002 can recharge the MVS Smartphone 3003 from its internal power source over a wireless charging connection. In some implementations, the internal rechargeable batteries 1722 provide sufficient operational life of the MVSFCA 3002 on a single charge to perform at least 2 days of full measurements before recharging of the internal rechargeable batteries 1722 of the MVSFCA 3002 is required.

In some implementations, the MVSFCA 3002 includes an internal non-volatile, non-user removable, data storage device 1734 for up to 20 human raw measurement data sets. The data storage device 1734 can be removed by a technician when the data storage device 1734 is determined to be faulty. A human measurement set contains all measurement data and measurements acquired by the MVSFCA 3002, including the temperature measurement from the MVS Smartphone 3003. The internal memory is protected against data corruption in the event of an abrupt power loss event. The MVSFCA 3002 and the MVS Smartphone 3003 have a human-form fit function sensor and device industrial/mechanical design. The MVSFCA 3002 also includes anti-microbial exterior material to and an easy clean surface for all sensor and device surfaces. The MVSFCA 3002 stores in the data storage device 1734 an “atomic” human record structure that contains the entire data set recording for a single human measurement containing all human raw sensor signals and readings, extracted human vitals, and system status information. The MVSFCA 3002 includes self-test components that determine the operational state of the MVSFCA 3002 and sub systems, to ensure that the MVSFCA 3002 is functional for measurement. The MVSFCA 3002 includes a clock function for date and time. In some implementations. The date and time of the MVSFCA 3002 is be updated from the MVS Smartphone 3003. In some implementations, the MVSFCA 3002 includes user input controls, such as a power on/off switch (start/stop), an emergency stop control to bring the MVS finger cuff to a deflated condition. In some implementations, all other input is supported via the MVS Smartphone 3003 via on screen information of the MVS Smartphone 3003. In some implementations, the MVSFCA 3002 includes visual indicators 1744 such as a fatal fault indicator that indicates device has failed and will not power up, a device fault indicator (that indicates the MVSFCA 3002 has a fault that would affect the measurement function), battery charging status indicator, battery charged status indicator, a battery fault status indicator.

The components (e.g. 1704, 1706, 1708, 1710, 1718, 1720, 1722, 3028, 1734 and 1744) in the MVSFCA 3002 are controlled by a control process and signal processing component 3030. The control process and signal processing component can implemented by a microprocessor or by a FPGA.

The multi-vital-sign finger cuff accessory Recharge Station (MVSFCARS) 3004, provides electrical power to recharge the MVSFCA 3002. The MVSFCARS 3004 can provide electrical power to recharge the batteries of the MVSFCA 3002 either via a physical wired connection or via a wireless charge 3034. In some implementations, the MVSFCARS 3004 does not provide electrical power to the MVSFCA 3002 because the MVSFCA 3002 includes internal rechargeable batteries 1722 that can be recharged via either USB port 3028 or a DC input.

MVS Smartphone 3003 includes a connection status indicator (connected/not connected, fault detected, charging/not charging), a connected power source status indicator, (either USB or DC input) and a power On/Off status indicator. The visual indicators are visible in low light conditions in the home and clinical environment.

The MVSFCA 3002 is hand held and portable. The MVSFCA 3002 includes non-slip/slide exterior surface material.

Vital signs are received through the wireless Bluetooth® communication component 3014 from a MVSFCA such as the MVSFCAs in FIG. 12-FIG. 18 and FIG. 29-FIG. 31 or the MVS finger clip in FIG. 19-FIG. 25. The vital signs that are received are then displayed by LCD display 3016 and/or transmitted by the communication component 3018, enunciated by a speaker or stored by a flash memory. Examples of the biological vital signs that are displayed on the display 3016 are FIG. 45-FIG. 46.

FIG. 31 is a block diagram of a MVS smartphone system 3100, according to an implementation. The MVS smartphone system 3100 includes two communicatively coupled devices; a MVS smartphone 3102 and a MVS finger cuff accessory(MVSFCA) 3104. MVS smartphone 3102 is one implementation of MVS smartphone 2904 in FIG. 29 and one implementation of MVS smartphone 3003 in FIG. 30. MVSFCA 3104 is one implementation of MVSFCA 2902 in FIG. 29 and one implementation of MVSFCA 3002 in FIG. 30. The MVS smartphone system 3100, the MVSFCA 3104 and the MVS smartphone 3102 are all examples of the MVS apparatus 4104. The MVS smartphone 3102 captures, stores and exports raw data from all supported sensors in the MVS smartphone system 3100. More specifically, the MVS smartphone 3102 extracts the vital signs through the MVSFCA 3104, displays the vital signs and transfers the vital signs to either a remote third party, hub, bridge etc., or a device manager, or directly to remote EMR/HER/Hospital systems or other third party local or cloud based systems. MVS smartphone system 3100 provides a flexible human vital sign measurement methodology that supports different measurement methods and techniques. The MVS smartphone system 3100 can be used in a clinical setting for the collection of human vital signs.

The MVSFCA 3104 include a MVS finger cuff 3106 (such as MVS finger cuff 1704 in FIG. 17) that is fixed into the MVSFCA 3104, rather than the replaceable, detachable and removable MVS finger cuff 2908 in FIG. 29. MVS finger cuff 3106 is electrically coupled to the MVSFCA 3104 via a serial line 3108. The MVS finger cuff 3106 includes a PLM subsystem 1806 and at least one mDLS sensor 1812 and/or 1818. The MVS finger cuff 3106 is powered by and connected to a finger sensor cable (FSC) 3110 that includes an air line (e.g. 1404 in FIG. 14), the air line being powered by a pneumatic engine 1706 in the MVSFCA 3104 that provides air pressure to inflate a cuff bladder of the pressure finger cuff 1850 and the controlled release of that air pressure.

In some implementations, a body surface temperature of a human is also sensed by an infrared finger temperature sensor 1708 that is integrated into the MVS finger cuff 3106 in which the body surface temperature is collected and managed by the MVS finger cuff 3106.

In some implementations, a single stage measurement process is required to measure all vital signs in one operation by the MVS smartphone 3102, the MVSFCA 3104 and the MVS finger cuff 3106 working cooperatively. However, in some implementations, a two stage measurement process is performed in which the MVSFCA 3104 measures some vital signs through the MVS finger cuff 3106; and in the second stage, the body surface temperature is measured through an infrared finger temperature sensor 1708 in the MVS smartphone 3102. One implementation of the infrared finger temperature sensor 1708 is digital infrared sensor 1312 in FIG. 37.

The MVSFCA 3104 operates in two primary modes, the modes of operation based on who takes the measurements, a patient or an operator. The two modes are: 1) Operator Mode in which an operator operates the MVSFCA 3104 through the MVS smartphone 3102 to take a set of vital sign measurements of another human. The operator is typically clinical staff or a home care giver. 2) Patient Mode in which a patient uses the MVSFCA 3104 through the MVS smartphone 3102 to take a set of vital sign measurements of themselves. In some implementations, the MVSFCA 3104 provides both the main measurement modes for patient and operator. The primary measurement areas on the human to be measured are 1) Left hand, index and middle finger, 2) right hand, index and middle finger, and 3) human temperature (requires the MVS smartphone 3102 to perform temperature measurement). The MVSFCA 3104 is portable, light weight, hand held and easy to use in primary and secondary modes of operation in all operational environments.

Given the complex nature of integration into hospital networks, in some implementations, in some implementations the MVSFCA 3104 does not include site communication infrastructure, rather the collected data (vital sign) is extracted from the MVSFCA 3104 via a USB port 3028 or by a USB mass storage stick that is inserted into the MVSFCA 3104 or by connecting the MVSFCA 3104 directly to a PC system as a mass storage device itself.

The MVSFCA 3104, when connected to a wireless Bluetooth® communication component 3014 of the MVS smartphone 3102 via a wireless Bluetooth® communication component 1718, can be a slave to the MVS smartphone 3102. The MVSFCA 3104 reports status, measurement process, and measurement measurements to the user via the MVS smartphone 3102. The MVS smartphone 3102 provides a user input method to the MVSFCA 3104 via a graphical user interface on a LCD display 3016 which displays data representative of the measurement process and status. In one implementation, the wireless Bluetooth® communication component 3014 of the MVS smartphone 3102 includes communication capability with cellular communication paths (3G, 4G and/or 5G) and/or Wi-Fi® communication paths, the MVS smartphone 3102 is not a slave to the MVSFCA 3104 and the MVSFCA 3104 captures vital sign data and transmits the vital sign data via the wireless Bluetooth® communication component 3014 in the MVS smartphone 3102 and the MVS smartphone 3102 transmits the vital sign data to the middle layer 4206 in FIG. 42 or the MVSFCA 3104 transmits the vital sign data via the wireless Bluetooth® communication component 1718 of the MVSFCA 3104 to the bridge 4220, a Wi-Fi® access point, a cellular communications tower or a bridge 4220 in FIG. 42. In other implementations, Zigbee® or Z-Wave® can be used instead of Bluetooth®.

In some implementations, the MVS smartphone 3102 provides communications with other devices via a communication component 3018 of the MVS smartphone 3102. The communication component 3018 has communication capability with cellular communication paths (3G, 4G and/or 5G) and/or Wi-Fi® communication paths. For example, the MVSFCA 3104 captures vital sign data and transmits the vital sign data via the wireless Bluetooth® communication component 1718 in the MVSFCA 3104 to the wireless Bluetooth® communication component 3014 in the MVS smartphone 3102, and the MVS smartphone 3102 transmits the vital sign data via the communication component 3018 of the MVS smartphone 3102 to the middle layer 4206 in FIG. 42 or the MVS smartphone 3102 transmits the vital sign data via the communication component 3018 of the MVS smartphone 3102 to the bridge 4220, a Wi-Fi® access point, a cellular communications tower or a bridge 4220 in FIG. 42.

In some implementations, when the MVS smartphone 3102 is connected to the MVSFCA 3104, the MVS smartphone 3102 performs human bar code scan by a bar code scanner 3020 or identification entry as requested by MVSFCA 3104, the MVS smartphone 3102 performs an operator bar code scan or identification entry as requested by MVSFCA 3104, the MVS smartphone 3102 displays information that is related to the MVSFCA 3104, the MVS smartphone 3102 starts when the MVSFCA 3104 is started, and the MVS smartphone 3102 is shutdown under the direction and control of the MVSFCA 3104, and the MVS smartphone 3102 has a self-test mode that determines the operational state of the MVSFCA 3104 and sub systems, to ensure that the MVSFCA 3104 is functional for the measurement. In other implementations,

In some implementations, when the MVS smartphone 3102 is connected to the MVSFCA 3104, the MVS smartphone 3102 performs human bar code scan by a bar code scanner 3020 or identification entry as requested by the MVSFCA 3104, the MVS smartphone 3102 performs an operator bar code scan or identification entry as requested by the MVSFCA 3104, and the MVS smartphone 3102 displays information that is related to the MVSFCA 3104. In some implementations, the information displayed by the MVS smartphone 3102 includes date/time, human identification number, human name, vitals measurement such as blood pressure (diastolic and systolic), SpO2, heart rate, temperature, respiratory rate, MVSFCA 3104 free memory slots, battery status of the MVS smartphone 3102, battery status of the MVSFCA 3104, device status of the MVSFCA 3104, errors of the MVS smartphone 3102, device measurement sequence, measurement quality assessment measurement, mode of operation, subject and operator identification, temperature, measurement, display mode and device revision numbers of the MVS smartphone 3102 and the MVSFCA 3104. In some implementations, when a body surface temperature of a human is also sensed by an infrared sensor in the MVS smartphone 3102, the body surface temperature is collected and managed by the MVSFCA 3104. In other implementations, when a body surface temperature of a human is sensed by an infrared sensor in the MVS smartphone 3102, the body surface temperature is not collected and managed by the MVSFCA 3104.

In some implementations, the MVS finger cuff accessory (MVSFCA) 3104 includes the following sensors and sensor signal capture and processing components that are required to extract the required primary and secondary human vital signs measurements: the pressure finger cuff 1850, the PLM subsystem 1806 and two mDLS sensors 1812 and 1818, the infrared finger temperature sensor 1708 and an ambient air temperature sensor 1710, and in some further implementations, non-disposable sensors for other human vital sign measurements. In some implementations, data sample rates for the PLM subsystem 1806 is 2×200 Hz×24 bit=9600 bits/sec, for each of the mDLS sensors 1812 and 1818 is 31 kHz×24 bit=1,572,864 bit/sec and for the ambient air temperature sensor is less than 1000 bps. Two mDLS sensors 1812 and 1818 are included in the MVS finger cuff 3106 to ensure that one or both sensors 1812 and 1818 delivers a good quality signal, thus increasing the probability of obtaining a good signal from at least one of the mDLS sensors 1812 and 1818.

The MVS smartphone 3102 performs concurrent two stage measurement processes for all measurements. The measurement process performed by the MVSFCA 3104 is controlled and guided from the MVS smartphone 3102 via the GUI on the MVSFCA 3104. The measurements are sequenced and configured to minimize time required to complete all measurements. In some implementations, the MVS smartphone 3102 calculates the secondary measurements of heart rate variability and blood flow from signals from the PLM subsystem 1806. The MVS smartphone 3102 commands and controls the MVSFCA 3104 via a wireless Bluetooth® protocol communication line and in some further implementations, the MVSFCA 3104 communicates to other devices through Bluetooth® protocol communication line (not shown), in addition to the communications with the MVS smartphone 3102, which could also be concurrent. In some further implementations, the MVS smartphone 3102 communicates to other devices through Bluetooth® protocol communication line (not shown), in addition to the communications with the MVSFCA 3104 device, which could also be concurrent.

MVSFCA 3104 includes USB port 3028 to perform the following functions: recharge the internal rechargeable batteries 1722 of the MVSFCA 3104, export sensor data sets to a windows based computer system 3114, firmware update of the MVSFCA 3104 via an application to control and manage the firmware update of the MVSFCA 3104 and configuration update of the MVSFCA 3104. The MVSFCA 3104 does not update the MVS smartphone 3102 firmware. The internal rechargeable batteries 1722 can be recharged via a USB port 3028, which provides charge, and the MVSFCA 3104 can also include an external direct DC input providing a fast recharge. The internal batteries 1722 of the MVSFCA 3104 can be recharged when the MVSFCA 3104 is powered-off but while connected to USB or DC input. In some implementations, the MVSFCA 3104 can recharge the MVS smartphone 3102 from its internal power source over a wireless charging connection. In some implementations, the internal rechargeable batteries 1722 provide sufficient operational life of the MVSFCA 3104 on a single charge to perform at least 2 days of full measurements before recharging of the internal rechargeable batteries 1722 of the MVSFCA 3104 is required.

In some implementations, the MVSFCA 3104 includes an internal non-volatile, non-user removable, data storage device 1734 for up to 20 human raw measurement data sets. The data storage device 1734 can be removed by a technician when the data storage device 1734 is determined to be faulty. A human measurement set contains all measurement data and measurements acquired by the MVSFCA 3104, including the temperature measurement from the MVS smartphone 3102. The internal memory is protected against data corruption in the event of an abrupt power loss event. The MVSFCA 3104 and the MVS finger cuff 3106 have a human-form fit function. The MVSFCA 3104 also includes anti-microbial exterior material to and an easy clean surface for all sensor and device surfaces. The MVSFCA 3104 stores in the data storage device 1734 an “atomic” human record structure that contains the entire data set recording for a single human measurement containing all human raw sensor signals and readings, extracted human vitals, and system status information. The MVSFCA 3104 includes self-test components that determine the operational state of the MVSFCA 3104 and sub systems, to ensure that the MVSFCA 3104 is functional for measurement. The MVSFCA 3104 includes a clock function for date and time. In some implementations. The date and time of the MVSFCA 3104 is be updated from the MVS smartphone 3102. In some implementations, the MVSFCA 3104 includes user input controls, such as a power on/off switch (start/stop), an emergency stop control to bring the pressure finger cuff 1850 to a deflated condition. In some implementations, all other input is supported via the MVS smartphone 3102 via on screen information of the MVS smartphone 3102. In some implementations, the MVSFCA 3104 includes visual indicators 1744 such as a fatal fault indicator that indicates device has failed and will not power up, a device fault indicator (that indicates the MVSFCA 3104 has a fault that would affect the measurement function), battery charging status indicator, battery charged status indicator or a battery fault status indicator.

The components (e.g. 1706, 1718, 1722, 3028, 1734 and 1744) in the MVSFCA 3104 are controlled by a control process and signal processing component 3030. The control process and signal processing component 3030 be can implemented in a microprocessor or by a FPGA.

The external USB charger 3112 provides electrical power to recharge the MVSFCA 3104. The external USB charger 3112 can provide electrical power to recharge the batteries of the MVSFCA 3104 either via a physical wired connection or via a wireless charger. In some implementations, the external USB charger 3112 does not provide electrical power to the MVSFCA 3104 because the MVSFCA 3104 includes internal rechargeable batteries 1722 that can be recharged via either USB port 3028 or a DC input. The MVSFCA 3104 is hand held and portable. The MVSFCA 3104 includes non-slip/slide exterior surface material.

Vital signs are received through the wireless Bluetooth® communication component 3014 from a MVSFCA such as the MVSFCAs in FIG. 12-FIG. 18 and FIG. 29-FIG. 31 or the MVS finger clip in FIG. 21-FIG. 25. The vital signs that are received are then displayed by display 2728 an/or transmitted by the communication component 3018, enunciated by a speaker or stored by flash memory. Examples of the vital signs that are displayed on the display 2728 are FIG. 45-FIG. 46.

MVS Smartphones 2600 in FIG. 26, MVS smartphone 2700 in FIG. 27, MVS smartphone 2800 in FIG. 28, MVS smartphone 2904 in FIG. 29, MVS smartphone 3003 in FIG. 30, and MVS smartphone 3102 in FIG. 31 are production smartphones that have been modified by either downloading software to volatile memory or including non-volatile memory to receive, determine/calculate, display and/or transmit the multi-vital signs. In some implementations, the downloaded software is a flag or key that enables use of portions of the volatile memory or the non-volatile memory to process a specific vital sign, such as glucose blood levels. In some implementations, of the apparatus, systems and methods described herein, a heart rate is estimated from data from a PLM subsystem, a respiration rate and a heart rate variability and/or a blood pressure diastolic is estimated from data from a micro dynamic light scattering sensor and the PLM subsystem. In some implementations, SpO2 blood oxygenation is estimated from data from the PLM subsystem, respiration rate is estimated from data from the micro dynamic light scattering sensor and blood pressure is estimated from data from the micro dynamic light scattering sensor in conjunction with data from the finger cuff.

7. Apparatus of Multi-Vital-Sign Devices

FIG. 32 is a block diagram of a MVS device 3200 that includes a digital infrared sensor, a biological vital sign generator and a temporal motion amplifier, according to an implementation. MVS device 3200 is an apparatus to measure body core temperature and other biological vital signs. The MVS device 3200 is one example of the MVS apparatus 4104.

The MVS device 3200 includes a microprocessor 3202. The MVS device 3200 includes a battery 3204, in some implementations a single button 3206, and a digital infrared sensor 3208 that is operably coupled to the microprocessor 3202. The digital infrared sensor 3208 includes digital ports 3210 that provide only digital readout signal 3212. One example of the digital infrared sensor 3208 is digital infrared sensor 1312 in FIG. 37. In some implementations the MVS device 3200 includes a display device 3218 that is operably coupled to the microprocessor 3202. In some implementations, the display device 3218 is a LCD color display device or a LED color display device, which are easy to read in a dark room, and some pixels in the display device 3218 are activated (remain lit) for about 5 seconds after the single button 3206 is released. After the display has shut off, another body core temperature reading can be taken by the apparatus. The color change of the display device 3218 is to alert the operator of the apparatus of a potential change of body core temperature of the human or animal subject. The body core temperature reported on the display device 3218 can be used for treatment decisions.

The microprocessor 3202 is configured to receive from the digital ports 3210 that provide only digital readout signal 3212. In some implementations, the digital readout signal 3212 is representative of an infrared signal 3220 of a surface temperature that is detected by the digital infrared sensor 3208. In other implementations, the digital readout signal 3212 is representative of an infrared signal 3220 of a surface temperature of a human other than the surface that is detected by the digital infrared sensor 3208. A body core temperature estimator 3222 in the microprocessor 3202 is configured to estimate the body core temperature 3224 from the digital readout signal 3212 that is representative of the infrared signal 3220 of the (or other surface), a representation of an ambient air temperature reading from an ambient air sensor 1710, a representation of a calibration difference from a memory location that stores a calibration difference 3226 and a memory location that stores a representation of a bias 3228 in consideration of a temperature sensing mode. In some implementations, the MVS device 3200 does not include an analog-to-digital converter 3214 operably coupled between the digital infrared sensor 3208 and the microprocessor 3202. Furthermore, the digital infrared sensor 3208 also does not include analog readout ports 3216. The dashed lines of the A/D converter 3214 and the analog readout ports 3216 indicates absence of the A/D converter 3214 and the analog readout ports 3216 in the MVS device 3200.

A temperature estimation table 3230 is a lookup table that correlates a sensed temperature to an estimated body core temperature 3224. The sensed temperature is derived from the digital readout signal 3212.

The temperature estimation table 3230 is stored in a memory. In FIG. 34-FIG. 36, the temperature estimation table 3230 is shown as a component of the microprocessor 3202. The memory that stores the temperature estimation table 3230 can be separate from the microprocessor 3202 or the memory can be a part of the microprocessor 3202, such as cache on the microprocessor 3202. Examples of the memory include Random Access Memory (RAM) 2608 and flash memory 2610 in FIG. 26. In implementations of the MVS smartphone systems in FIG. 29, FIG. 30 and FIG. 31, the apparatus that estimates a body core temperature in FIG. 34-FIG. 36, apparatus of the motion amplification in FIG. 40, the MVS smartphone 2600 in which speed of the MVS smartphone systems in FIG. 29, FIG. 30 and FIG. 31 and the apparatus that estimate a body core temperature of an external source point in FIG. 34-FIG. 36 is very important, storing the temperature estimation table 3230 in memory that is a part of the microprocessor 3202, such as cache on the microprocessor 3202, is very important.

The correlation between the sensed temperature to an estimated body core temperature varies based on age, sex, and a febrile (pyretic) or hypothermic condition of the patient and intraday time of the reading. Accordingly, in some implementations, the MVS apparatus 4104 includes temperature estimation tables 3230 that are specific to the combinations and permutations of the various situations of the age, sex, and a febrile (pyretic) or hypothermic condition of the patient and the intraday time of the reading. For example, in one implementation, the MVS apparatus 4104 include a temperature estimation table 3230 for male humans of 3-10 years old, that are neither febrile nor hypothermic, for temperature readings taken between 10 am-2 pm. In another example, in another implementation, the MVS apparatus 4104 include a temperature estimation table 3230 for female humans of greater than 51 years of age, that are febrile and for temperature readings taken between 2 am-8 am.

Some implementations of the MVS device 3200 include a solid-state image transducer 2660 that is operably coupled to the microprocessor 3202 and is configured to provide two or more images 2662 to a temporal-motion-amplifier 3232 and a biological vital sign generator 3234 in the microprocessor 3202 to estimate one or more biological vital signs 3236 that are displayed on the display device 3218.

The MVS device 3200 includes any one of a pressure sensor 3238, a pressure cuff 3240, a micro dynamic light scattering (mDLS) sensor 3242 and/or a physiological light monitoring (PLM) subsystem 3244 that provide signals to the biological vital sign generator 3234. The mDLS sensor uses a laser beam (singular wavelength) of light and a light detector on the opposite side of the finger to detect the extent of the laser beam that is scattered in the flesh of the finger, which indicates the amount of oxygen in blood in the fingertip. The PLM subsystem uses projected light and a light detector on the opposite side of the finger to detect the extent of the laser beam that is absorbed in the flesh of the finger, which indicates the amount of oxygen in blood in the fingertip, which is also known as pulse oximetry. The pressure sensor 3238 is directly linked to the pressure cuff 3240. In some implementations, the MVS device 3200 includes two mDLS sensors to ensure that at least one of the mDLS sensors provides a good quality signal. In some implementations, the biological vital sign generator 3234 generates blood pressure measurement (systolic and diastolic) from signals from the pressure sensor 3238, the finger pressure cuff 3240 and the mDLS sensor 3242. In some implementations, the biological vital sign generator 3234 generates blood glucose levels from signals from the PLM subsystem 3244. In some implementations, the biological vital sign generator 3234 generates SpO2 measurement and heart rate measurement from signals from the PLM subsystem 3244. In some implementations, the biological vital sign generator 3234 generates respiration (breathing rate) measurement from signals from the mDLS sensor 3242. In some implementations, the biological vital sign generator 3234 generates blood flow measurement from signals from the mDLS sensor 3242. In some implementations, the biological vital sign generator 3234 generates heartrate variability from signals from the PLM subsystem 3244. In some implementations, the body core temperature estimator 3222 is implemented in the biological vital sign generator 3234.

The MVS device 3200 also includes a wireless communication subsystem 2604 or other external communication subsystem, such as an Ethernet port, that provides communication to the EMR data capture systems 4200 and 4200 or other devices. In some implementations, the wireless communication subsystem 2604 is communication subsystem 2604 in FIG. 38. The wireless communication subsystem 2604 is operable to receive and transmit the estimated body core temperature 3224 and/or the biological vital sign(s) 3236.

In some implementations, the digital infrared sensor 3208 is a low noise amplifier, 17-bit ADC and powerful DSP unit through which high accuracy and resolution of the estimated body core temperature 3224 by the MVS smartphone systems in FIG. 29, FIG. 30 and FIG. 31, the apparatus that estimates a body core temperature in FIG. 34-FIG. 36 and the MVS smartphone 2600.

In some implementations, the digital infrared sensor 3208, 10-bit pulse width modulation (PWM) is configured to continuously transmit the measured temperature in range of −20 . . . 120° C., with an output resolution of 0.14° C. The factory default power on reset (POR) setting is SMBus.

In some implementations, the digital infrared sensor 3208 is packaged in an industry standard TO-39 package.

In some implementations, the generated object and ambient air temperatures are available in RAM of the digital infrared sensor 3208 with resolution of 0.01° C. The temperatures are accessible by 2 wire serial SMBus compatible protocol (0.02° C. resolution) or via 10-bit PWM (Pulse Width Modulated) output of the digital infrared sensor 3208.

In some implementations, the digital infrared sensor 3208 is factory calibrated in wide temperature ranges: −40 . . . 85° C. for the ambient air temperature and −70 . . . 380° C. for the object temperature.

In some implementations of the digital infrared sensor 3208, the measured value is the average temperature of all objects in the Field Of View (FOV) of the sensor. In some implementations, the digital infrared sensor 3208 has a standard accuracy of ±0.5° C. around room temperatures, and in some implementations, the digital infrared sensor 3208 has an accuracy of ±0.2° C. in a limited temperature range around the human body core temperature.

These accuracies are only guaranteed and achievable when the sensor is in thermal equilibrium and under isothermal conditions (there are no temperature differences across the sensor package). The accuracy of the detector can be influenced by temperature differences in the package induced by causes like (among others): Hot electronics behind the sensor, heaters/coolers behind or beside the sensor or by a hot/cold object very close to the sensor that not only heats the sensing element in the detector but also the detector package. In some implementations of the digital infrared sensor 3208, the thermal gradients are measured internally and the measured temperature is compensated in consideration of the thermal gradients, but the effect is not totally eliminated. It is therefore important to avoid the causes of thermal gradients as much as possible or to shield the sensor from the thermal gradients.

In some implementations, the digital infrared sensor 3208 is configured for an object emissivity of 1, but in some implementations, the digital infrared sensor 3208 is configured for any emissivity in the range 0.1 . . . 1.0 without the need of recalibration with a black body.

In some implementations of the digital infrared sensor 3208, the PWM can be easily customized for virtually any range desired by the customer by changing the content of 2 EEPROM cells. Changing the content of 2 EEPROM cells has no effect on the factory calibration of the device. The PWM pin can also be configured to act as a thermal relay (input is To), thus allowing for an easy and cost effective implementation in thermostats or temperature (freezing/boiling) alert applications. The temperature threshold is programmable by the microprocessor 3202 of the MVS smartphone system. In a MVS smartphone system having a SMBus system the programming can act as a processor interrupt that can trigger reading all slaves on the bus and to determine the precise condition.

In some implementations, the digital infrared sensor 3208 has an optical filter (long-wave pass) that cuts off the visible and near infra-red radiant flux is integrated in the package to provide ambient and sunlight immunity. The wavelength pass band of the optical filter is from 5.5 to 14 μm.

In some implementations, the digital infrared sensor 3208 is controlled by an internal state machine, which controls the measurements and generations of the object and ambient air temperatures and does the post-processing of the temperatures to output the body core temperatures through the PWM output or the SMBus compatible interface.

Some implementations of the MVS smartphone system includes 2 IR sensors, the output of the IR sensors being amplified by a low noise low offset chopper amplifier with programmable gain, converted by a Sigma Delta modulator to a single bit stream and fed to a DSP for further processing. The signal is treated by programmable (by means of EEPROM contend) FIR and IIR low pass filters for further reduction of the bandwidth of the input signal to achieve the desired noise performance and refresh rate. The output of the IIR filter is the measurement result and is available in the internal RAM. 3 different cells are available: One for the on-board temperature sensor and 2 for the IR sensors. Based on results of the above measurements, the corresponding ambient air temperature Ta and object temperatures To are generated. Both generated body core temperatures have a resolution of 0.01° C. The data for Ta and To is read in two ways: Reading RAM cells dedicated for this purpose via the 2-wire interface (0.02° C. resolution, fixed ranges), or through the PWM digital output (10 bit resolution, configurable range). In the last step of the measurement cycle, the measured Ta and To are rescaled to the desired output resolution of the PWM) and the regenerated data is loaded in the registers of the PWM state machine, which creates a constant frequency with a duty cycle representing the measured data.

In some implementations, the digital infrared sensor 3208 includes a SCL pin for Serial clock input for 2 wire communications protocol, which supports digital input only, used as the clock for SMBus compatible communication. The SCL pin has the auxiliary function for building an external voltage regulator. When the external voltage regulator is used, the 2-wire protocol for a power supply regulator is overdriven.

In some implementations, the digital infrared sensor 3208 includes a slave deviceA/PWM pin for digital input/output. In normal mode the measured object temperature is accessed at this pin Pulse Width Modulated. In SMBus compatible mode the pin is automatically configured as open drain NMOS. Digital input/output, used for both the PWM output of the measured object temperature(s) or the digital input/output for the SMBus. In PWM mode the pin can be programmed in EEPROM to operate as Push/Pull or open drain NMOS (open drain NMOS is factory default). In SMBus mode slave deviceA is forced to open drain NMOS I/O, push-pull selection bit defines PWM/Thermal relay operation. The PWM/slave deviceA pin the digital infrared sensor 3208 operates as PWM output, depending on the EEPROM settings. When WPWM is enabled, after POR the PWM/slave deviceA pin is directly configured as PWM output. When the digital infrared sensor 3208 is in PWM mode, SMBus communication is restored by a special command In some implementations, the digital infrared sensor 3208 is read via PWM or SMBus compatible interface. Selection of PWM output is done in EEPROM configuration (factory default is SMBus). PWM output has two programmable formats, single and dual data transmission, providing single wire reading of two temperatures (dual zone object or object and ambient). The PWM period is derived from the on-chip oscillator and is programmable.

The microprocessor 3202 has read access to the RAM and EEPROM and write access to 9 EEPROM cells (at addresses 0x00, 0x01, 0x02, 0x03, 0x04, 0x05, 0x0E, 0x0F, 0x09). When the access to the digital infrared sensor 3208 is a read operation, the digital infrared sensor 3208 responds with 16 data bits and 8 bit PEC only if its own slave address, programmed in internal EEPROM, is equal to the SA, sent by the master. A slave feature allows connecting up to 127 devices (SA=0x00 . . . 0x07F) with only 2 wires. In order to provide access to any device or to assign an address to a slave device before slave device is connected to the bus system, the communication starts with zero slave address followed by low R/W bit. When the zero slave address followed by low R/W bit sent from the microprocessor 3202, the digital infrared sensor 3208 responds and ignores the internal chip code information. In some implementations, two digital infrared sensors 3208 are not configured with the same slave address on the same bus.

In regards to bus protocol, after every received 8 bits, the slave device should issue ACK or NACK. When a microprocessor 3202 initiates communication, the microprocessor 3202 first sends the address of the slave and only the slave device which recognizes the address will ACK, the rest will remain silent. In case the slave device NACKs one of the bytes, the microprocessor 3202 stops the communication and repeat the message. A NACK could be received after the packet error code (PEC). A NACK after the PEC means that there is an error in the received message and the microprocessor 3202 attempts resending the message. PEC generation includes all bits except the START, REPEATED START, STOP, ACK, and NACK bits. The PEC is a CRC-8 with polynomial X8+X2+X1+1. The Most Significant Bit of every byte is transferred first.

In single PWM output mode the settings for PWM1 data only are used. The temperature reading can be generated from the signal timing as:

$T_{OUT} = (\frac{2 t_{2}}{T} \times (T_{O_MAX} - T_{O_MIN})) + T_{O_MIN}$

where Tmin and Tmax are the corresponding rescale coefficients in EEPROM for the selected temperature output (Ta, object temperature range is valid for both Tobj1 and Tobj2 as specified in the previous table) and T is the PWM period. Tout is TO1, TO2 or Ta according to Config Register [5:4] settings.

The different time intervals t1 . . . t4 have following meaning:

t1: Start buffer. During t1 the signal is always high. t1=0.125s×T (where T is the PWM period)

t2: Valid Data Output Band, 0 . . . ½T. PWM output data resolution is 10 bit.

t3: Error band—information for fatal error in EEPROM (double error detected, not correctable).

t3=0.25s×T. Therefore a PWM pulse train with a duty cycle of 0.875 indicates a fatal error in EEPROM (for single PWM format). FE means Fatal Error.

In regards to a format for extended PWM, the temperature can be generated using the following equation:

$T_{OUT 1} = (\frac{4 t_{2}}{T} \times (T_{MAX 1} - T_{MIN 1})) + T_{MIN 1}$

- For Data 2 field the equation is:

$T_{OUT 2} = (\frac{4 t_{5}}{T} \times (T_{MAX 2} - T_{MIN 2})) + T_{MIN 2}$

In some implementations of FIG. 34-FIG. 36, the microprocessor 3202, the image transducer 2660, the pressure sensor 3238, the pressure cuff 3240, the micro dynamic light scattering (mDLS) sensor 3242 and/or the physiological light monitoring (PLM) subsystem 3244 are located in the MVS finger cuff smartphone system and the display devices 3218 and 3314 are located in the MVS smartphone.

In some implementations of FIG. 34-FIG. 36, the image transducer 2660, the pressure sensor 3238, the pressure cuff 3240, the micro dynamic light scattering (mDLS) sensor 3242 and/or the physiological light monitoring (PLM) subsystem 3244 are located in the MVS finger cuff smartphone system and the microprocessor 3202 and the display devices 3218 and 3314 are located in the MVS smartphone.

FIG. 33 is a block diagram of a MVS device 3300 that includes a non-touch electromagnetic sensor with no temporal motion amplifier, according to an implementation. The MVS device 3300 is one example of the MVS apparatus 4104 and one example of the MVS finger cuff accessory (MVSFCA) 3002. The MVS device 3300 includes a battery 3204, in some implementations a single button 3206, in some implementations a display device 3218, a non-touch electromagnetic sensor 3302 and an ambient air sensor 1710 that are operably coupled to the microprocessor 3202. The microprocessor 3202 is configured to receive a representation of an infrared signal 3220 of the or other external source point from the non-touch electromagnetic sensor 3302. The microprocessor 3202 includes a body core temperature estimator 3222 that is configured to estimate the body core temperature 3312 of the subject from the representation of the electromagnetic energy of the external source point.

The MVS device 3300 includes a pressure sensor 3238, a pressure cuff 3240, a mDLS sensor 3242 and a PLM subsystem 3244 that provide signals to the biological vital sign generator 3234. The pressure sensor 3238 is directly linked to the pressure cuff 3240. In some implementations, the MVS device 3300 includes two mDLS sensors to ensure that at least one of the mDLS sensors provides a good quality signal. In some implementations, the biological vital sign generator 3234 generates blood pressure measurement (systolic and diastolic) from signals from the pressure sensor 3238, the finger pressure cuff 3240 and the mDLS sensor 3242. In some implementations, the biological vital sign generator 3234 generates SpO2 measurement and heart rate measurement from signals from the PLM subsystem 3244. In some implementations, the biological vital sign generator 3234 generates respiration (breathing rate) measurement from signals from the mDLS sensor 3242. In some implementations, the biological vital sign generator 3234 generates blood flow measurement from signals from the mDLS sensor 3242. In some implementations, the biological vital sign generator 3234 generates heartrate variability from signals from the PLM subsystem 3244.

The body core temperature correlation table for all ranges of ambient air temperatures provides best results because a linear or a quadratic relationship provide inaccurate estimates of body core temperature, yet a quantic relationship, a quintic relationship, sextic relationship, a septic relationship or an octic relationship provide estimates along a highly irregular curve that is far too wavy or twisting with relatively sharp deviations.

The non-touch electromagnetic sensor 3302 detects temperature in response to remote sensing of a surface a human or animal. In some implementations, the MVS smartphone system having an infrared sensor is an infrared temperature sensor. All humans or animals radiate infrared energy. The intensity of this infrared energy depends on the temperature of the human or animal, thus the amount of infrared energy emitted by a human or animal can be interpreted as a proxy or indication of the body core temperature of the human or animal The non-touch electromagnetic sensor 3302 measures the temperature of a human or animal based on the electromagnetic energy radiated by the human or animal The measurement of electromagnetic energy is taken by the non-touch electromagnetic sensor 3302 which constantly analyzes and registers the ambient air temperature. When the operator of apparatus in FIG. 33 holds the non-touch electromagnetic sensor 3302 about 5-8 cm (2-3 inches) from the and activates the radiation sensor, the measurement is instantaneously measured. To measure a temperature using the non-touch electromagnetic sensor 3302, pushing the button 3206 causes a reading of temperature measurement from the non-touch electromagnetic sensor 3302 and in some implementations the measured body core temperature is thereafter displayed on the display device 3218. Various implementations of the non-touch electromagnetic sensor 3302 can be a digital infrared sensor, such as digital infrared sensor 3208 or an analog infrared sensor.

The body core temperature estimator 3222 correlates the temperatures sensed by the non-touch electromagnetic sensor 3302 to another temperature, such as a body core temperature of the subject, an axillary temperature of the subject, a rectal temperature of the subject and/or an oral temperature of the subject. The body core temperature estimator 3222 can be implemented as a component on a microprocessor, such as main processor 2602 in FIG. 26 or on a memory such as flash memory 2610 in FIG. 26.

The MVS device 3300 also detects the body core temperature of a human or animal regardless of the room temperature because the measured temperature of the non-touch electromagnetic sensor 3302 is adjusted in reference to the ambient air temperature in the air in the vicinity of the apparatus. The human or animal must not have undertaken vigorous physical activity prior to temperature measurement in order to avoid a misleading high temperature. Also, the room temperature should be moderate, 50° F. to 80° F.

The MVS device 3300 provides a non-invasive and non-irritating means of measuring human or animal body core temperature to help ensure good health. When evaluating results, the potential for daily variations in body core temperature can be considered. In children less than 6 months of age daily variation is small In children 6 months to 4 years old the variation is about 1 degree. By age 6 variations gradually increase to 4 degrees per day. In adults there is less body core temperature variation.

The MVS device 3300 also includes a wireless communication subsystem 2604 or other external communication subsystem, such as an Ethernet port, that provides communication to the EMR data capture systems 4200 and 4200. In some implementations, the wireless communication subsystem 2604 is communication subsystem 2604 in FIG. 38.

8. Apparatus of Multi-Vital-Sign Components

FIG. 34 is a block diagram of an apparatus 3400 to estimate a body core temperature from a temperature sensed by an infrared sensor, according to an implementation. Apparatus 3400 includes a power-initializer 3402 for the infrared sensor 3404 and a time delay 3406 that delays subsequent processing for a period of time specified by the time delay 3406 after power initialization of the infrared sensor 3404 by the power-initializer 3402, such as a delay of a minimum of 340 ms (+20 ms) to a maximum of 360 ms.

Apparatus 3400 includes a voltage level measurer 3408 of the infrared sensor 3404 that outputs a representation of the sensor voltage level 3410 of the infrared sensor 3404. When the sensor voltage level 3410 is below 2.7V or is above 3.5V, a reading error message 3412 is generated and displayed.

Apparatus 3400 also includes a sensor controller 3414 that initiates four infrared measurements 3416 of the surface by the infrared sensor 3404 and receives the four infrared measurements 3416. In some implementations, each of the four infrared measurements 3416 of the surface are performed by the infrared sensor 3404 with a period of at least 135 ms (+20 ms) to a maximum of 155 ms between each of the infrared measurements 3416.

If one of the up to 15 infrared measurements 3416 of the surface by the infrared sensor 3404 that is received is invalid, a reading error message 3412 is displayed.

Apparatus 3400 also includes an ambient air temperature controller 3418 that initiates an ambient air temperature (Ta) measurement 3420 and receives the ambient air temperature (Ta) measurement 3420. If the ambient air temperature (Ta) measurement 3420 of the ambient air temperature is invalid, a reading error message 3412 is displayed. The ambient air temperature controller 3418 compares the ambient air temperature (Ta) measurement 3420 to a range of acceptable values, such as the numerical range of 283.15K (10° C.) to 313.15° K (40° C.). If the ambient air temperature (Ta) measurement 3420 is outside of this range, a reading error message 3412 is displayed. The sensor controller 3414 compares all four of the infrared measurements 3416 of the surface by the infrared sensor 3404 to determine whether or not are all four are within 1 Kelvin degree of each other. If all four infrared measurements of the surface by the infrared sensor 3404 are not within 1 Kelvin degree of each other, a reading error message 3412 is displayed.

The sensor controller 3414 averages the four infrared measurements of the surface to provide a received object temperature (Tobj) 3422 when all four infrared measurements of the surface by the infrared sensor 3404 are within 1 degree Kelvin of each other. The sensor controller 3414 also generates a voltage-corrected ambient air temperature (COvTa) 3424 and a voltage-corrected object temperature (COvTobj) 3426 by applying a sensor voltage correction 3428 to the ambient air temperature (Ta) and the Tobj 3422, respectively. For example, the sensor voltage correction 3428 in Kelvin=Tobj−(voltage at sensor−3.00)*0.65. In some implementations, a sensor calibration offset is applied to the COvTobj, resulting in a calibration-corrected voltage-corrected object temperature (COcaCOvTobj) 3430. For example, a sensor calibration offset of 0.60 Kelvin is added to each voltage-corrected object temperature (COvTobj) from the infrared sensor 3404 of a particular manufacturer.

An estimated body core temperature generator 3432 reads an estimated body core temperature 3434 from one or more tables 3436 that are stored in a memory 3438 (such as memory 3438 in FIG. 34) that correlates the COcaCOvTobj to the body core temperature in reference to the COvTa 3424. One implementation of the estimated body core temperature generator 3432 in FIG. 34 is apparatus 3500 in FIG. 35. The tables 3436 are also known as body core temperature correlation tables.

A scale converter 3440 converts the estimated body core temperature 3434 from Kelvin to ° C. or ° F., resulting in a converted body core temperature 3442. There is a specific algorithm for pediatrics (<=8 years old) to account for the different physiological response of children in the febrile >101 deg F. range.

FIG. 35-FIG. 36 are block diagrams of an apparatus 3500 to derive an estimated body core temperature from one or more tables that are stored in a memory that correlate a calibration-corrected voltage-corrected object temperature to the body core temperature in reference to the corrected ambient air temperature, according to an implementation. Apparatus 3500 is one implementation of the estimated body core temperature generator 3432 in FIG. 34.

Apparatus 3500 includes an ambient air temperature operating-range comparator 3502 that is configured to compare the COvTa (3824 in FIG. 34) to an operational temperature range of the apparatus to determine whether or not the COvTa 3424 is outside of the operational temperature range of the apparatus. The operational temperature range is from the lowest operational temperature of the apparatus 3500 to the highest operational temperature of the MVS system 2900. In one example, the operational temperature range is 10.0° C. to 40.0° C. In a further example, if the C.OvTa is 282.15° K (9.0° C.), which is less than the exemplary lowest operational temperature (10.0° C.), then the COvTa is outside of the operational temperature range.

Apparatus 3500 includes an ambient air temperature table-range comparator 3504 that determines whether or not the COvTa 3424 is outside of the range of the tables. For example, if the C.OvTa is 287.15° K (14.0° C.), which is less than the lowest ambient air temperature in the tables, then the COvTa is outside of the range of the tables. In another example, if the COvTa is 312.25° K (39.1° C.), which is greater than the highest ambient air temperature (37.9° C.) of all of the tables, then the COvTa is outside of the range of the tables.

When the ambient air temperature table-range comparator 3504 determines that the COvTa 3424 is outside of the range of the tables, then control passes to an ambient air temperature range-bottom comparator 3506 that is configured to compare the COvTa (3924 in FIG. 34) to the bottom of the range of the tables to determine whether or not the COvTa 3424 is less than the range of the tables. The bottom of the range of the tables is the lowest ambient air temperature of all of the tables, such as 14.6° C. In a further example, if the C.OvTa is 287.15° K (14.0° C.), which is less than the lowest ambient air temperature (14.6° C.) of the tables, then the COvTa is less than the bottom of the range of the tables.

When the ambient air temperature range-bottom comparator 3506 determines that the COvTa 3424 is less than the range of the tables, control passes to an estimated body core temperature calculator for hypo ambient air temperatures 3508 sets the estimated body core temperature 3434 to the COcaC.OvTobj 3430+0.19° K for each degree that the COvTa is below the lowest ambient body core table.

For example, when the COvTa is 12.6° C., which is less than the range of the tables, 14.6° C., and the COcaCOvTobj 3430 is 29° C. (302.15° K) then the estimated body core temperature calculator for hypo ambient air temperatures 3508 sets the estimated body core temperature 3434 to 302.15° K+(0.19° K*(14.6° C.-12.6° C.)), which is 302.53° K.

When the ambient air temperature range-bottom comparator 3506 determines that the COvTa 3424 is not less than the range of the tables, control passes to an estimated body core temperature calculator 3510 for hyper ambient air temperatures that sets the estimated body core temperature 3434 to the COcaC.OvTobj 3430−0.13° K for each degree that the COvTa is above the highest ambient body core table.

For example, when the COvTa is 45.9° C., which is above the range of all of the tables, (43.9° C.), and the COcaCOvTobj 3430 is 29° C. (302.15° K) then the estimated body core temperature calculator 3510 for hyper ambient air temperatures sets the estimated body core temperature 3434 to 302.15° K−(0.13° K*(45.9° C.-43.9° C.)), which is 301.89° K.

When the ambient air temperature table-range comparator 3504 determines that the COvTa 3424 is not outside of the range of the tables, then control passes to an ambient air temperature table comparator 3512 that determines whether or not the COvTa is exactly equal to the ambient air temperature of one of the tables, when the estimated body core temperature calculator 3510 for hyper ambient air temperatures determines that the COvTa is within of the range of the tables. When the ambient air temperature table comparator 3512 determines that the COvTa is exactly equal to the ambient air temperature of one of the tables, then the estimated body core temperature table value selector for exact ambient air temperatures 3514 sets the estimated body core temperature 3434 to the body core temperature of that one table, indexed by the COcaCOvTobj 3430.

For example, when the COvTa is 34.4° C. (the ambient air temperature of Table D) and the COcaCOvTobj 3430 is 29.1° C., then the estimated body core temperature table value selector for exact ambient air temperatures 3514 sets the estimated body core temperature 3434 to 29.85 C, which is the body core temperature of Table D indexed at the COcaCOvTobj 3430 of 29.1° C.

Apparatus 3500 includes a table interpolation selector 3516. When the ambient air temperature table comparator 3512 determines that the COvTa is not exactly equal to the ambient air temperature of one of the tables, then the table interpolation selector 3516 identifies the two tables which the COvTa falls between.

For example, if the C.OvTa is 293.25° K (20.1° C.), this ambient value falls between the tables for ambient air temperatures of 19.6° C. and 24.6° C., in which case, the 19.6° C. table is selected as the Lower Body Core Table and the 24.6° C. table is selected as the Higher Body Core Table.

Thereafter, apparatus 3500 includes a table interpolation weight calculator 3520 that calculates a weighting between the lower table and the higher table, the table interpolation weights 3522.

For example, when Tamb_bc_low (the COvTa for the Lower Body Core Table)=19.6° C. and T amb_bc_high (the COvTa for the Higher Body Core Table)=24.6 C, then the amb_diff=(Tamb_bc_high−Tamb_bc_low/100)=(24.6−19.6)/100=0.050° C. Further, the Higher Table Weighting=100/((Tamb−Tamb_bc_low)/amb_diff)=100/((20.1−19.6)/0.050)=10% and the Lower Table Weighting=100−Higher Table Weighting=100−10=90%.

Apparatus 3500 includes a body core temperature reader 3524 that reads the core body core temperature that is associated with the sensed temperature from each of the two tables, the Lower Body Core Table and the Higher Body Core Table. The COcaCOvTobj 3430 is used as the index into the two tables.

Apparatus 3500 also includes a correction value calculator 3526 that calculates a correction value 3528 for each of the Lower Body Core Table and the Higher Body Core Table. For example, where each of the tables has an entry of COcaCOvTobj 3430 for each 0.1° Kelvin, to calculate to a resolution of 0.01° Kelvin, the linear difference is applied to the two table values that the COcaCOvTobj 3430 falls between.

For example, when the COcaC.OvTobj 3430 is 309.03° K, then the COcaCOvTobj 3430 falls between 309.00 and 309.10. The correction value 3528 is equal to a+((b−a)*0.03), where a=body core correction value for 309.0° K and b=body curve correction value for 309.1° K.

Thereafter, apparatus 3500 includes an estimated body core temperature calculator for interpolated tables 3530 that determines the body core temperature of the sensed temperature in reference to the ambient air temperature by summing the weighted body core temperatures from the two tables. The estimated body core temperature is determined to equal (Tcor_low*Lower Table Weighting/100)+(Tcor_high*Higher Table Weighting/100).

For example, when the C.OvTa is 293.25° K (20.10° C.), then in this case 90% (90/100) of the Table) and 10% (10/100) are summed to set the estimated body core temperature 3434.

The comparator 3502, comparator 3504 and comparator 3506 can be arranged in any order relative to each other.

FIG. 37 is a block diagram of a digital infrared sensor 1312, according to an implementation. The digital infrared sensor 1312 contains a single thermopile sensor 3702 that senses only infrared electromagnetic energy 3704. The digital infrared sensor 1312 contains a CPU control block 3706 and an ambient air temperature sensor 3708, such as a thermocouple. The single thermopile sensor 3702, the ambient air temperature sensor 3708 and the CPU control block 3706 are on separate silicon substrates 3710, 3712 and 3714 respectively. The CPU control block 3706 digitizes the output of the single thermopile sensor 3702 and the ambient air temperature sensor 3708.

The digital infrared sensor 1312 has a Faraday cage 3716 surrounding the single thermopile sensor 3702, the CPU control block 3706 and the ambient air temperature sensor 3708 to prevent electromagnetic (EMF) interference in the single thermopile sensor 3702, the CPU control block 3706 and the ambient air temperature sensor 3708 that shields the components in the Faraday cage 3716 from outside electromagnetic interference, which improves the accuracy and the repeatability of a device that estimates body core temperature from the ambient and object temperature generated by the digital infrared sensor 1312. The digital IR sensor 1312 also requires less calibration in the field after manufacturing, and possibly no calibration in the field after manufacturing because in the digital infrared sensor 1312, the single thermopile sensor 3702, the CPU control block 3706 and the ambient air temperature sensor 3708 are in close proximity to each other, which lowers temperature differences between the single thermopile sensor 3702, the CPU control block 3706 and the ambient air temperature sensor 3708, which minimizes or eliminates calibration drift over time because they are based on the same substrate material and exposed to the same temperature and voltage variations. In comparison, conventional infrared temperature sensors do not include a Faraday cage 3716 that surrounds the single thermopile sensor 3702, the CPU control block 3706 and the ambient air temperature sensor 3708. The Faraday cage 3716 can be a metal box or a metal mesh box. In the implementation where the Faraday cage 3716 is a metal box, the metal box has an aperture where the single thermopile sensor 3702 is located so that the field of view of the infrared electromagnetic energy 3704 is not affected by the Faraday cage 3716 so that the infrared electromagnetic energy 3704 can pass through the Faraday cage 3716 to the single thermopile sensor 3702. In the implementation where the Faraday cage 3716 is a metal box, the metal box has an aperture where the ambient air temperature sensor 3708 is located so that the atmosphere can pass through the Faraday cage 3716 to the ambient air temperature sensor 3708. In other implementations the ambient air temperature sensor 3708 does not sense the temperature of the atmosphere, but instead senses the temperature of the sensor substrate (silicon) material and surrounding materials because the ambient air temperature sensor 3708 and the target operating environment temperature are required to be as close as possible in order to reduce measurement error, i.e. the ambient air temperature sensor 3708 is to be in thermal equilibrium with the target operating environment.

In some further implementations, the Faraday cage 3716 of the digital infrared sensor 1312 also includes an multichannel analogue-to-digital converter (ADC) 3718 that digitizes an analogue signal from the single thermopile sensor 3702. The ADC 3718 also digitizes an analogue signal from the ambient air temperature sensor 3708. In another implementation where the ADC is not a multichannel ADC, separate ADCs are used to digitize the analogue signal from the single thermopile sensor 3702 and the analogue signal from the ambient air temperature sensor 3708. There is no ADC between the digital infrared sensor 1312 and microprocessor(s), main processor(s) and controller(s) that are outside the digital IR sensor 1312, such as the microprocessor 3202 in FIG. 32.

The single thermopile sensor 3702 of the digital infrared sensor 1312 is tuned to be most sensitive and accurate to the human body core temperature range, such as surface temperature range of 25° C. to 39° C. The benefits of the digital IR sensor 1312 in comparison to conventional analogue infrared temperature sensors include minimization of the temperature difference between the analogue and digital components effects on calibration parameters (when the temperature differences are close there is a smaller AT which mimics the calibration environment) and reduction of EMC interference in the datalines. The digital infrared sensor 1312 outputs a digital representation of the surface temperature in absolute Kelvin degrees (° K) that is presented at a digital readout port of the digital infrared sensor 1312. The digital representation of the surface temperature is also known as the body surface temperature in FIG. 37, digital readout signal 3212 in FIG. 32, digital signal that is representative of an infrared signal of a temperature that is detected by the digital infrared sensor in FIG. 59, the body core temperature in FIG. 33, the temperature measurement in FIG. 61, the sensed temperature in FIG. 34 and the numerical representation of the electromagnetic energy of the external source point in FIG. 63.

The digital infrared sensor 1312 is not an analog device or component, such as a thermistor or a resistance temperature detector (RTD). Because the digital infrared sensor 1312 is not a thermistor, there is no need or usefulness in receiving a reference signal of a resister and then determining a relationship between the reference signal and a temperature signal to compute the surface temperature. Furthermore, the digital infrared sensor 1312 is not an array of multiple transistors as in complementary metal oxide (CMOS) devices or charged coupled (CCD) devices. None of the subcomponents in the digital infrared sensor 1312 detect electromagnetic energy in wavelengths of the human visible spectrum (380 nm-750 nm). Neither does the digital infrared sensor 1312 include an infrared lens.

FIG. 38 is a block diagram of a wireless communication system 3800, according to an implementation. The wireless communication system 3800 includes a communication subsystem 2604 that includes a receiver 3802, a transmitter 3804, as well as associated components such as one or more embedded or antennas 3806 and 3808, Local Oscillators (LOs) 3810, and a processing module such as a digital signal processor (DSP) 3812. The particular implementation of the wireless communication subsystem 2604 is dependent upon communication protocols of a wireless network 2606 with which the mobile de MVS smartphone systems vice is intended to operate. Thus, it should be understood that the implementation illustrated in FIG. 38 serves only as one example. Examples of the MVS smartphone system 2900 include MVS smartphone systems in FIG. 30 and FIG. 31, apparatus that estimates a body core temperature in FIG. 34-FIG. 36 and MVS smartphone 2600. Examples of the wireless network 3805 include network 2606 in FIG. 26.

Signals received by the antenna 3806 through the wireless network 3805 are input to the receiver 3802, which may perform such common receiver functions as signal amplification, frequency down conversion, filtering, channel selection, and analog-to-digital (A/D) conversion. A/D conversion of a received signal allows more complex communication functions such as demodulation and decoding to be performed in the DSP 3812. In a similar manner, signals to be transmitted are processed, including modulation and encoding, by the DSP 3812. These DSP-processed signals are input to the transmitter 3804 for digital-to-analog (D/A) conversion, frequency up conversion, filtering, amplification and transmission over the wireless network 3805 via the antenna 3808. The DSP 3812 not only processes communication signals, but also provides for receiver and transmitter control. For example, the gains applied to communication signals in the receiver 3802 and the transmitter 3804 may be adaptively controlled through automatic gain control algorithms implemented in the DSP 3812.

The wireless link between the MVS apparatus 4104 and the wireless network 3805 can contain one or more different channels, typically different RF channels, and associated protocols used between the MVS apparatus 4104 and the wireless network 3805. An RF channel is a limited resource that must be conserved, typically due to limits in overall bandwidth and limited battery power of the MVS apparatus 4104.

When the MVS apparatus 4104 are fully operational, the transmitter 3804 is typically keyed or turned on only when it is transmitting to the wireless network 3805 and is otherwise turned off to conserve resources. Similarly, the receiver 3802 is periodically turned off to conserve power until the receiver 3802 is needed to receive signals or information (if at all) during designated time periods.

Each patient record 3814 is received by the wireless communication subsystem 2604 from the main processor 2602 at the DSP 3812 and then transmitted to the wireless network 3805 through the antenna 3806 of the receiver 3802. In some implementations, each patient record 3814 is a patient file that is managed or controlled by an ambulatory medical facility or a private medical office, such as a Patient Portal Medical Record or a Patient-Generated Health Data (PGHD)) and conforms to the Patient Care Device Technical Framework standard published by the Integrating the Healthcare Enterprise of 820 Jorie Boulevard, Oak Brook, Ill. 60523 or the Fundamentals of Data Exchange standard published by the Personal Connected Health Alliance of 4300 Wilson Boulevard—Suite 250, Arlington, Va. 22203, or data exchange requirement of various EHR and EMR vendors.

FIG. 39 is a block diagram of an apparatus 3900 to generate a predictive analysis of vital signs, according to an implementation. The apparatus 3900 can be implemented on the MVS finger cuff accessory (MVSFCA) 2902 in FIG. 29, the MVS smartphone (MVS Smartphone) 2904 in FIG. 29, the MVS finger cuff accessory (MVSFCA) 3002 in FIG. 30 or the MVS smartphone 3003 in FIG. 30, the sensor management component 3302 in FIG. 33, the microprocessor 3320 in FIG. 33, the MVS finger cuff 1704 in FIG. 17 and FIG. 7, the microprocessor 1702 in FIG. 17, controller 1826 in FIG. 18, the microprocessor 3320 in FIG. 31 and/or main processor 2602 in FIG. 26. In apparatus 3900, blood glucose levels 3902, heartrate data 3904, respiratory rate data 3906, estimated body core temperature data 3908 (such as estimated body core temperature 3224 in FIG. 32 or estimated body core temperature 3434 in FIG. 34-FIG. 36), blood pressure data 3910, EKG data 3912 and/or SpO2 data 3914 is received by a predictive analysis component 3916 that evaluates the data 3902, 3904, 3906, 3908, 3910, 3912 and/or 3914 in terms of percentage change over time. More specifically, the relative change and the rate of change or change in comparison to an established pattern that is described in terms of frequency and amplitude. When the percentage change over time exceeds a predetermined threshold, a flag 3918 is set to indicate an anomaly. The flag 3918 can be transmitted to the EMR/clinical data repository 4244, as shown in FIG. 42.

FIG. 40 is a flowchart of a method 4000 of motion amplification from which to generate and communicate biological vital signs, according to an implementation. FIG. 40 uses spatial and temporal signal processing to generate biological vital signs from a series of digital images.

Method 4000 analyzes the temporal and spatial motion in digital images of an animal subject in order to generate and communicate the biological vital signs.

In some implementations, method 4000 includes cropping plurality of images to exclude areas that do not include a skin region, at block 4002. For example, the excluded area can be a perimeter area around the center of each image, so that an outside border area of the image is excluded. In some implementations of cropping out the border, about 72% of the width and about 72% of the height of each image is cropped out, leaving only 7.8% of the original uncropped image, which eliminates about 11/12 of each image and reduces the amount of processing time for the remainder of the actions in this process by about 12-fold. This one action alone at block 4002 in method 4000 can reduce the processing time of the plurality of images 2662 by 86%, which is of significant difference to the health workers who used devices that implement method 4000. In some implementations, the remaining area of the image after cropping in a square area and in other implementation the remaining area after cropping is a circular area. Depending upon the topography and shape of the area in the images that has the most pertinent portion of the imaged subject, different geometries and sizes are most beneficial. In other implementations a cropper module that performs block 4002 is placed at the beginning of the modules to greatly decrease processing time of the apparatus.

In some implementations, method 4000 includes identifying pixel-values of the plurality of or more cropped images that are representative of the skin, at block 4004. Some implementations of identifying pixel-values that are representative of the skin include performing an automatic seed point based clustering process on the least two images.

In some implementations, method 4000 includes applying a spatial bandpass filter to the identified pixel-values, at block 4006. In some implementations, the spatial filter in block 4002 is a two-dimensional spatial Fourier Transform, a high pass filter, a low pass filter, a bandpass filter or a weighted bandpass filter.

In some implementations, method 4000 includes applying spatial clustering to the spatial bandpass filtered identified pixel-values of skin, at block 4008. In some implementations the spatial clustering includes fuzzy clustering, k-means clustering, expectation-maximization process, Ward's method or seed point based clustering.

In some implementations, method 4000 includes applying a temporal bandpass filter to the spatial clustered spatial bandpass filtered identified pixel-values of skin, at block 4010. In some implementations, the temporal bandpass filter is a one-dimensional spatial Fourier Transform, a high pass filter, a low pass filter, a bandpass filter or a weighted bandpass filter.

In some implementations, method 4000 includes determining temporal motion of the temporal bandpass filtered spatial clustered spatial bandpass filtered identified pixel-values of skin, at block 4012.

In some implementations, method 4000 includes analyzing the temporal motion to generate and visually display a pattern of flow of blood, at block 4014. In some implementations, the pattern flow of blood is generated from motion changes in the pixels and the temporal motion of color changes in the skin. In some implementations, method 4000 includes displaying the pattern of flow of blood for review by a healthcare worker, at block 4016.

In some implementations, method 4000 includes analyzing the temporal motion to generate heartrate, at block 4018. In some implementations, the heartrate is generated from the frequency spectrum of the temporal motion in a frequency range for heart beats, such as (0-10 Hertz). In some implementations, method 4000 includes displaying the heartrate for review by a healthcare worker, at block 4020.

In some implementations, method 4000 includes analyzing the temporal motion to determine respiratory rate, at block 4022. In some implementations, the respiratory rate is generated from the motion of the pixels in a frequency range for respiration (0-5 Hertz). In some implementations, method 4000 includes displaying the respiratory rate for review by a healthcare worker, at block 4024.

In some implementations, method 4000 includes analyzing the temporal motion to generate blood pressure, at block 4026. In some implementations, the blood pressure is generated by analyzing the motion of the pixels and the color changes based on the clustering process and potentially temporal data from the infrared sensor. In some implementations, method 4000 includes displaying the blood pressure for review by a healthcare worker, at block 4028.

In some implementations, method 4000 includes analyzing the temporal motion to generate EKG, at block 4030. In some implementations, method 4000 includes displaying the EKG for review by a healthcare worker, at block 4032.

In some implementations, method 4000 includes analyzing the temporal motion to generate pulse oximetry, at block 4034. In some implementations, the pulse oximetry is generated by analyzing the temporal color changes based in conjunction with the k-means clustering process and potentially temporal data from the infrared sensor. In some implementations, method 4000 includes displaying the pulse oximetry for review by a healthcare worker, at block 4034.

9. Apparatus of Interoperability Device Manager Components of an EMR System

FIG. 41 is a block diagram of a system of interoperability device manager component 4100, according to an implementation. The interoperability device manager component 4100 includes a device manager 4102 that connects one or more MVS apparatus 4104 and middleware 4106. The MVS apparatus 4104 are connected to the device manager 4102 through via a plurality of services, such as a chart service 4108, an observation service 4110, a patient service 4112, a user service and/or an authentication service 4116 to a bridge 4118 in the interoperability device manager 4102. The MVS apparatus 4104 are connected to the device manager 4102 to a plurality of maintenance function components 4120, such as push firmware 4122, a push configuration component 4124 and/or a keepalive signal component 4126. The keepalive signal component 4126 is coupled to the middleware 4106. In some implementations, the APIs 4130, 4132, 4134 and 4136 are health date APIs, observation APIs, electronic health record (EHR) or electronic medical record (EMR) APIs.

The bridge 4118 is operably coupled to a greeter component 4128. The greeter component 4128 synchronizes date/time of the interoperability device manager 4102, checks device log, checks device firmware, checks device configuration and performs additional security. The greeter component 4128 is coupled to the keepalive signal component 4126 through a chart application program interface component 4130, a patient application program interface component 4132, a personnel application program interface component 4134 and/or and authentication application program interface component 4136. All charted observations from the chart application program interface component 4130 are stored in a diagnostics log 4138 of a datastore 4140. The datastore 4140 also includes interoperability device manager settings 4142 for the application program interface components 4130, 4132, 4134 and/or 4136, current device configuration settings 4144, current device firmware 4146 and a device log 4148.

The interoperability device manager 4102 also includes a provision device component 4150 that provides network/Wi-Fi® Access, date/time stamps, encryption keys—once for each of the MVS apparatus 4104 for which each MVS apparatus 4104 is registered and marked as ‘active’ in the device log 4148. The provision device component 4150 activates each new MVS apparatus 4104 on the interoperability device manager component 4100 through a device activator 4152. Examples of the MVS apparatus 4104 include the MVS finger cuff accessories in FIG. 12-FIG. 18, apparatus of the MVS finger clips in FIG. 19-FIG. 25, the MVS smartphones in FIG. 26-FIG. 28, the MVS smartphone systems in FIG. 29-FIG. 31 and the MVS devices in FIG. 32-FIG. 33.

FIG. 42 is a block diagram of apparatus of an EMR capture system 4200, according to an implementation in which an interoperability manager component manages all communications in the middle layer. In EMR capture system 4200, an interoperability device manager component 4100 manages all communications in the middle layer 4206 between the device/user layer 4202 and the first set of application program interfaces 4214, the optional second set of application program interfaces 4216, one or more hubs 4218, bridges 4220, interface engines 4222 and gateways 4224 in the middle layer 4206. The EMR/clinical data repository 4244 includes an EMR system 4246, a clinical monitoring system 4252 and/or a clinical data repository 4254. The EMR system 4246 is located within or controlled by a hospital facility. One example of Bluetooth® protocol is Bluetooth® Core Specification Version 2.1 published by the Bluetooth® SIG, Inc. Headquarters, 5209 Lake Washington Blvd NE, Suite 350, Kirkland, Wash. 98033. In other implementations, Zigbee® or Z-Wave® can be used instead of Bluetooth®.

Some other implementations of an electronic medical records capture system include a bridge that transfers patient record 3814 from MVS apparatus 4104 to EMR systems in hospital and clinical environments. Each patient record 3814 includes patient measurement data, such as biological vital sign 3236 in FIG. 32-FIG. 33, blood glucose level 4502 in FIG. 45, biological vital sign 3236 in FIG. 32-FIG. 33 and vital sign in FIG. 42. The EMR data capture system includes two important aspects: 1.A server bridge to control the flow of patient measurement data from MVS apparatus 4104 to one or more and to manage local MVS apparatus 4104. 2. The transfer of patient measurement data in a patient record 3814, anonymous, and other patient status information to a cloud based EMR/clinical data repository 4244. The bridge controls and manages the flow of patient measurement data to an EMR/clinical data repository 4244 and another EMR/clinical data repository 4244 and provides management services to MVS apparatus 4104. The bridge provides an interface to: a wide range of proprietary EMR/clinical data repository 4244, location specific services, per hospital, for verification of active operator, and if necessary, patient identifications, and a cloud based EMR/clinical data repository 4244) of one or more MVS apparatus 4104, for the purpose of storing all measurement records in an anonymous manner for analysis. A setup, management and reporting mechanism also provided. The bridge accepts communications from MVS apparatus 4104 to: Data format conversion and transferring patient measurement records to EMR/clinical data repository 4244, manage the firmware and configuration settings of the MVS apparatus 4104, determine current health and status of the MVS apparatus 4104, support device level protocol for communications, TCP/IP. The support device level protocol supports the following core features: authentication of connected device and bridge transfer of patient measurement records to bridge with acknowledgement and acceptance by the bridge or EMR acceptance, support for dynamic update of configuration information and recovery of health and status of the MVS apparatus 4104, support for firmware update mechanism of firmware MVS apparatus 4104. The EMR data capture system provides high availability, 24/7/365, with 99.99% availability. The EMR data capture system provides a scalable server system to meet operational demands in hospital operational environments for one or both of the following deployable cases: 1) A local network at an operational site in which the bridge provides all features and functions in a defined operational network to manage a system of up to 10,000+ MVS apparatus 4104. 2) Remote or cloud based EMR/clinical data repository 4244 in which the bridge provides all services to many individual hospital or clinical sites spread over a wide geographical area, for 1,000,000+ MVS apparatus 4104. The bridge provides a central management system for the MVS apparatus 4104 that provides at least the following functions: 1) configuration management and update of the MVS apparatus 4104 2) device level firmware for all of the MVS apparatus 4104 and 3) management and reporting methods for the MVS apparatus 4104. The management and reporting methods for the MVS apparatus 4104 provides (but not limited to) health and status of the MVS apparatus 4104, battery level, replacement warning of the MVS apparatus 4104, check/calibration nearing warning of the MVS apparatus 4104, rechecking due to rough handling or out of calibration period of the MVS apparatus 4104, history of use, number of measurements, frequency of use etc. of the MVS apparatus 4104, display of current device configuration of the MVS apparatus 4104, Date/time of last device communications with each of the MVS apparatus 4104. The bridge provides extendable features, via software updates, to allow for the addition of enhanced features without the need for additional hardware component installation at the installation site. The bridge provides a device level commission mechanism and interface for the initial setup, configuration and test MVS apparatus 4104 on the network. The bridge supports MVS smartphone systems that are not hand-held. Coverage of the EMR data capture system in a hospital can include various locations, wards, ER rooms, offices, physician's Offices etc. or anywhere where automatic management of patient biological vital sign information is required to be saved to a remote EMR system. The MVS apparatus 4104 can communicate with a third party bridge to provide access to data storage services, EMR systems, MVS smartphone system cloud storage system etc. Networking setup, configuration, performance characteristics etc. are also determined and carried out by the third party bridge or another third party, for the operational environments. The MVS smartphone system can support the network protocols for communication with the third party bridge devices. In some implementations the bridge is a remote cloud based bridge. The remote cloud based bridge and the EMR/clinical data repositories 4244 are operably coupled to the network via the Internet.

In some implementations, a push data model is supported by the EMR data capture system between the MVS apparatus 4104 and the bridge in which connection and data are initially pushed from the MVS apparatus 4104 to the bridge. Once a connection has been established and the MVS apparatus 4104 and the bridge, such as an authenticated communication channel, then the roles may be reversed where the bridge controls the flow of information between the MVS apparatus 4104 and the EMR/clinical data repository 4244. In some implementations, the MVS apparatus 4104 are connected via a wireless communication path, such as a Wi-Fi® connection to Wi-Fi® access point(s). In other implementations, the MVS apparatus 4104 are connected to a docking station via a wireless or physical wired connection, such as local Wi-Fi®, Bluetooth®, Bluetooth® Low Energy (BLE), serial, USB, etc., in which case the docking station then acts as a local pass-through connection and connects to the bridge via a LAN interface and/or cellular or Wi-Fi® link from the docking station to the bridge. In some implementations, the MVS apparatus 4104 are connected via a 3G, 4G or a 5G cellular data communication path to a cellular communication tower which is operably coupled to a cell service provider's cell network which is operably coupled to a bridge/access point/transfer to a LAN or WLAN. In some implementations one or more MVS apparatus 4104 are connected a smartphone via a communication path such as a Bluetooth® communication path, a 3G, 4G or a 5G cellular data communication path, a USB communication path, a Wi-Fi® communication path, or a Wi-Fi® direct communication path to the cell phone; and the smartphone is connected to a cellular communication tower via a 3G, 4G or a 5G cellular data communication path. These portable MVS apparatus 4104 support various power saving modes and as such each device is responsible for the initiation of a connection to the wireless network or a wired network and the subsequent connection to the bridge that meets their own specific operational requirements, which provides the MVS apparatus 4104 additional control over their own power management usage and lifetime. In some implementations in which the MVS apparatus 4104 attempt connection to the bridge, the bridge is allocated a static Internet protocol (IP) address to reduce the IP discovery burden on the MVS apparatus 4104 and thus connect the MVS smartphone system to the bridge more quickly. More specifically, the MVS apparatus 4104 are not required to support specific discovery protocols or domain name service (DNS) in order to determine the IP address of the bridge. It is therefore important in some implementations that the bridge IP address is static and does not change over the operational lifetime of EMR data capture system on the network. In other implementations, a propriety network discovery protocol using UDP or TCP communications methods is implemented. In other implementations, the MVS apparatus 4104 have a HTTP address of a remote sever that acts as a discovery node for the MVS apparatus 4104 to obtain a connection to a remote system or to obtain that remote systems network address. In some implementations installation of a new MVS apparatus 4104 on the network requires configuration of the MVS apparatus 4104 for the bridge of IP address and other essential network configuration and security information. Commissioning of a MVS apparatus 4104 on the network in some implementations is carried out from a management interface on the bridge. In this way a single management tool can be used over all lifecycle phases of a MVS apparatus 4104 on the network, such as deployment, operational and decommissioning. In some implementations the initial network configuration of the MVS apparatus 4104 does not require the MVS apparatus 4104 to support any automated network level configuration protocols, WPS, Zeroconfi etc. Rather the bridge supports a dual network configuration, one for operational use on the operational network of the hospital or clinic, or other location, and an isolated local network, with local DHCP server, for out of the box commissioning of a new MVS apparatus 4104 and for diagnostic test of the MVS apparatus 4104. MVS apparatus 4104 can be factory configured for known network settings and contain a default server IP address on the commissioning network. In addition the MVS apparatus 4104 are required in some implementations to support a protocol based command to reset the MVS apparatus 4104 to network factory defaults for test purposes. In some situations, the firmware revision(s) of the MVS apparatus 4104 are not consistent between all of the MVS apparatus 4104 in the operational environment. Therefore the bridge is backwards compatible with all released firmware revisions from firmware and protocol revision, data content and device settings view point of the MVS apparatus 4104. As a result, different revision levels of the MVS apparatus 4104 can be supported at the same time on the network by the bridge for all operations.

Implementation Alternatives Operational Features and Implementation Capability

Some implementations of the EMR data capture systems 4200 have limited operational features and implementation capability. A significant function of the EMR data capture systems 4200 with the limited operational features and implementation capability in the bridge 4220 is to accept data from a MVS apparatus 4104 and update the EMR/Clinical Data Repository 4244. The EMR/Clinical Data Repository 4244 can be one or more of the following: Electronic Medical Records System(EMR) 4246, Clinical Monitoring System 4252 and/or Clinical Data Repository 4254.

The following limited feature set in some implementations is supported by the EMR data capture systems 4200 and 4200 for the demonstrations:

Implementation to a local IT network on a server of the local IT network, OR located on a remote-hosted network, whichever meets the operational requirements for healthcare system.

Acceptance of patient medical records from a MVS apparatus 4104:

a. Date and Time

b. Operator identification

c. Patient identification

d. Vital Sign measurement(s)

e. Device manufacturer, model number and firmware revision

Acceptance of limited status information from a MVS apparatus 4104:

a. Battery Level

b. Hospital reference

c. location reference

d. Manufacturer identification, serial number and firmware revision

e. Unique identification number

Transfer of patient records from a MVS apparatus 4104 to a third party EMR capture system and to the EMR data capture systems 4200, respectively in that order.

User interface for status review of known MVS apparatus 4104.

Configuration update control for active devices providing configuration of:

a. Hospital reference b. Unit location reference

Limited Operational Features and Implementation Capability

The following features are supported limited operational capability:

A Patient Record Information and measurement display interface for use without submission of that data to an EMR/Clinical Data Repository 4244.

Update of device firmware to support and activate determination of blood glucose levels over the wireless network. In some implementations, components for determination of blood glucose levels (or other vital signs) is in the firmware or other nonvolatile memory, but the components are not active or activated as indicated by a flag in flash memory of the device. Subsequently, action is taken to activate the components by changing the flag in the flash memory.

Operational Use Local Network Based—Single Client

In some implementations, the MVS apparatus 4104 are deployed to a local hospital, or other location, wireless IT network that supports Wi-Fi® enabled devices. The MVS apparatus 4104 supports all local network policy's including any local security policy/protocols, such as WEP, WPA, WPA2, WPA-EPA as part of the connection process for joining the network. In some implementations, the MVS apparatus 4104 operates on both physical and virtual wireless LAN's, WAN's, and the MVS apparatus 4104 are configured for operation on a specific segment of the network. Depending on the IT network structure, when the MVS apparatus 4104 is configured for operation on a specific segment of the network, the MVS apparatus 4104 network connection ability is limited to the areas of the operational environment for which it as be configured. Therefore, the MVS apparatus 4104 in network environments that have different network configurations are configured to ensure that when the MVS apparatus 4104 are used in various locations throughout the environment that the MVS apparatus 4104 has access in all required areas.

In some implementations the bridge 4220 system is located on the same IT network and deployed in accordance with all local IT requirements and policy's and that the MVS apparatus 4104 on this network are able to determine a routable path to the bridge 4220. The MVS apparatus 4104 and the server are not required to implement any network name discovery protocols and therefore the bridge 4220 is required to be allocated static IP address on the network. In the case where a secondary bridge device is deployed to the network as a backup for the primary, or the bridge 4220 supports a dual networking interface capability, then the secondary bridge IP address is also required to be allocated a static IP address. It is important to note that this is a single organization implementation and as such the bridge 4220 is configured to meet the security and access requirements of a single organization.

An implementation of a remote cloud-based bridge 4220 for a single client is similar to the local network case described at the end of the description of FIG. 13, with the exception that the bridge 4220 may not be physically located at the physical site of the MVS apparatus 4104.

The MVS apparatus 4104 include a temperature estimation table (not shown in FIG. 13). The temperature estimation table is stored in memory. The temperature estimation table is a lookup table that correlates a sensed surface temperature to a body core temperature.

The physical locale of the bridge 4220 is transparent to the MVS apparatus 4104.

Remote Based—Multiple Client Support

In some implementations for smaller organizations or for organizations that do not have a supporting IT infrastructure or capability that a remote bridge 4220 system is deployed to support more than one organization. Where the bridge 4220 is deployed to support more than one organization, the bridge 4220 can be hosted as a cloud based system. In this case the MVS apparatus 4104 are located at the operational site for the supported different geographical location organizations and tied to the bridge 4220 via standard networking methods via either private or public infrastructure, or a combination thereof.

Where a remote, i.e. non-local IT network, system is deployed to support more than one hospital or other organization EMR data capture systems 4200 includes components that isolate each of the supported organizations security and user access policy's and methods along with isolating all data transfers and supporting each organizations data privacy requirements. In addition system performance is required to be balanced evenly across all organizations. In this case each organization can require their specific EMR data capture systems 4200 be used and their EMR data capture systems 4200 are concurrently operational with many diverse EMR/Clinical Repository systems such as Electronic Medical Record System EMR 4246, Clinical Monitoring System 4252 and/or Clinical Data Repository 4254.

Single Measurement Update

The primary function of the MVS apparatus 4104 is to take vital sign measurements, for example, blood glucose level, display the result to the operator and to save the patient information and the blood glucose level to an EMR/Clinical Data Repository 4244. Normally the MVS apparatus 4104 are in a low power state waiting for an operator to activate the unit for a patient measurement. Once activated by the operator EMR data capture system 4200 will power up and under normal operating conditions guide the operator through the process of blood glucose level measurement and transmission of the patient record to the bridge 4220 for saving using the EMR data capture system 4200.

Confirmation at each stage of the process by the operator is required, to ensure a valid and identified patient result is obtained and saved to the EMR, the key last confirmation point is: Saving of data to the bridge 4220.

In some implementations, the confirmation at each stage in some implementations is provided by the operator through either the bridge 4220, MVS apparatus 4104, or the EMR/Clinical Data Repository 4244.

When confirmation is provided by the bridge 4220 it is an acknowledgment to the MVS apparatus 4104 that the bridge 4220 has accepted the information for transfer to the EMR/Clinical Data Repository 4244 in a timely manner and is now responsible for the correct management and transfer of that data.

When confirmation is provided by the EMR, the bridge 4220 is one of the mechanisms via which the confirmation is returned to the MVS apparatus 4104. That is the MVS apparatus 4104 sends the data to the bridge 4220 and then waits for the bridge 4220 to send the data to the EMR and for the EMR to respond to the bridge 4220 and then the bridge 4220 to the MVS apparatus 4104,

In some implementations depending on the operational network and where the bridge 4220 is physically located, i.e. local or remote, that the type of confirmation is configurable.

In some implementations, the MVS apparatus 4104 maintains an internal non-volatile storage mechanism for unsaved patient records if any or all of these conditions occur: The MVS apparatus 4104 cannot join the network. The MVS apparatus 4104 cannot communicate with the bridge 4220. The MVS apparatus 4104 does not receive level confirmation from either the bridge 4220 or the EMR/Clinical Data Repository 4244. The MVS apparatus 4104 must maintain the internal non-volatile storage mechanism in order to fulfill its primary technical purpose in case of possible operational issues. When the MVS apparatus 4104 has saved records present in internal memory of the MVS apparatus 4104, then the MVS apparatus 4104 attempts to transfer the saved records to the bridge 4220 for processing in a timely automatic manner

Periodic Connectivity

The MVS apparatus 4104 in order to obtain date/time, configuration setting, provides status information to the bridge 4220, transfers saved patient records and checks for a firmware update to provide a mechanism on a configured interval automatically that powers up and communicates to the configured bridge 4220 without operator intervention.

Accordingly, outside of the normal clinical use activation for the MVS apparatus 4104, the MVS apparatus 4104 can both update its internal settings, and provide status information to the bridge 4220 system.

Automatic Transfer of Saved Patient Measurement Records (PMRs)

If the MVS apparatus 4104 for an unknown reason has been unable to either join the network or connect to the bridge 4220 or receive a bridge 4220 or EMR data level acknowledge that data has been saved the MVS apparatus 4104 allows the primary clinical body core temperature measurement function to be performed and saves the resultant PMR in non-volatile internal memory up to a supported, configured, maximum number of saved patient records on the MVS apparatus 4104.

When the MVS apparatus 4104 are started for a measurement action the MVS apparatus 4104 determines if the MVS apparatus 4104 contains any saved patient records in its internal memory. If one or more saved patient records are detected then the MVS apparatus 4104 attempts to join the network immediately, connect to the bridge 4220 and send the patient records one at a time to the bridge 4220 device while waiting for the required confirmation that the bridge 4220 has accepted the patient record. Note in this case confirmation from the EMR is not required. On receipt of the required validation response from the remote system the MVS apparatus 4104 deletes the patient record from its internal memory. Any saved patient record that is not confirmed as being accepted by the remote device is maintained in the MVS apparatus 4104 internal memory for a transfer attempt on the next power up of the MVS apparatus 4104.

The MVS apparatus 4104 on a configured interval will also carry out this function. In some implementations the MVS apparatus 4104 reduces the interval when saved patient records are present on the MVS apparatus 4104 in order to ensure that the records are transferred to the bridge 4220, and subsequently the EMR/Clinical Data Repository 4244, in a timely manner once the issue has been resolved. When this transfer mechanism is active status information is presented to the operator on the MVS apparatus 4104 screen.

Under this operation it is possible for the bridge 4220 device to receive from a single MVS apparatus 4104 multiple patient record transfer requests in rapid sequence.

Device Configuration

The MVS apparatus 4104 upon 1) connection to the bridge 4220, 2) configured interval or 3) operator initiation, transmits to the bridge 4220 with the model number and all appropriate revisions numbers and unique identification of the MVS apparatus 4104 to allow the bridge 4220 to determine the MVS apparatus 4104 capabilities and specific configurations for that MVS apparatus 4104.

The bridge 4220 acts as the central repository for device configuration, either for a single device, a group of defined devices or an entire model range in which the MVS apparatus 4104 queries the bridge 4220 for the device vital-signs of the MVS apparatus 4104 and if the queried device vital-signs are different from the MVS apparatus 4104, the MVS apparatus 4104 updates the current setting to the new setting values as provided by the bridge 4220.

Device Status Management

In some implementations the bridge 4220 provides a level of device management for the MVS apparatus 4104 being used with EMR data capture system 4200. In some implementations, the bridge 4220 is able to report and determine at least the following:

Group and sort devices by manufacture, device model, revisions information and display devices serial numbers, unique device identification, asset number, revisions, etc. and any other localized identification information configured into the MVS apparatus 4104, e.g. ward location reference or Hospital reference.

The last time a specific unit connected to EMR data capture system 4200.

The current status of the given device, battery level, last error, last date of re-calibration of check, or any other health indicator supported by the MVS apparatus 4104.

Report devices out of their calibration period, or approaching their calibration check.

Report devices that require their internal battery replaced.

Report devices that require re-checking due to a detected device failure or error condition, or that have been treated in a harsh manner or dropped.

Firmware Update

In some implementations a firmware update for a given device model is scheduled on the network as opposed to simply occurring. When a MVS apparatus 4104 is activated for a patient measurement firmware, updates are blocked because the update process delays the patient biological vital sign measurement. Instead the bridge 4220 system includes a firmware update roll out mechanism where the date and time of the update can be scheduled and the number of devices being updated concurrently can be controlled.

In some implementations, when a MVS apparatus 4104 connects to the bridge 4220 due to a heartbeat event that the MVS apparatus 4104 queries the bridge 4220 to determine if a firmware update for that model of device is available and verify if the firmware MVS apparatus 4104 (via revision number), is required to be updated. The bridge 4220 responds to the query by the MVS apparatus 4104 based on whether or not a firmware update is available and the defined schedule for the update process. If an update is available at the bridge 4220 but the current time and date is not valid for the schedule then the bridge 4220 transmits a message to the MVS apparatus 4104 that there is an update but that the update process is delayed and update the MVS apparatus 4104 firmware check interval configuration. The firmware check interval setting will then be used by the MVS apparatus 4104 to reconnect to the bridge 4220 on a faster interval than the heartbeat interval in order to facilitate a more rapid update. For e.g. the firmware update schedule on the bridge 4220 in some implementations is set to every night between 2 am and 4 am and the interval timer in some implementations is set to for example, every 15 minutes.

In some implementations the bridge 4220 manages the firmware update process for many different MVS apparatus 4104 each with their specific update procedure, activated vital sign determination processes, file formats, and verification methods and from a date and time scheduling mechanism and the number of devices being update concurrently. In addition in some implementations the bridge 4220 will provide a mechanism to manage and validate the firmware update files maintained on the bridge 4220 for use with the MVS apparatus 4104.

This section concludes with short notes below on a number of different aspects of the EMR data capture system 4200 follow on numerous topics:

Remote—single client operation: The bridge 4220 architecture provide remote operation on a hospital network system. Remote operation is seen as external to the network infrastructure that the MVS apparatus 4104 are operational on but considered to be still on the organizations network architecture. This can be the case where a multiple hospital—single organization group has deployed EMR data capture system 4200 but one bridge 4220 device services all hospital locations and the bridge 4220 is located at one of the hospital sites or their IT center.

Remote—multiple client operation: The bridge 4220 architecture in some implementations is limited to remote operation on a cloud based server that supports full functionality for more than one individual separate client concurrently when a cloud based single or multiple server system is deployed to service one or more individual hospital/clinical organizations.

Multiple concurrent EMR support: For a single remote bridge 4220 servicing multiple clients EMR data capture system 4200 supports connectivity to an independent EMR, and a different EMR vendor, concurrently for each supported client. With one bridge 4220 servicing multiple clients in some implementations, each client requires the configuration to send data securely to different EMR/Clinical Data Repositories.

Support Different EMR for same client: The bridge 4220 architecture for operation in a single client organization supports the user by the organization of different EMR/Clinical Data Repository 4244 from different departments of wards in the operational environment. It is not uncommon for a single organization to support multiple different EMR/Clinical Data Repository 4244 for different operational environments, for example, Cardiology and ER. EMR data capture system 4200 in some implementations takes this into account and routes the patient data to the correct EMR/Clinical Data Repository 4244. Therefore the bridge 4220 is informed for a given MVS apparatus 4104 which indicates to the EMR the medical data has to be routed to.

Segregation of operations for multiple client operations on a single bridge 4220: EMR data capture system 4200 supports per client interfaces and functionality to ensure that each client's configurations, performance, user accounts, security, privacy and data protection are maintained. For single server implementations that service multiple independent hospital groups the bridge 4220 in some implementations maintain all functionality, and performance per client separately and ensure that separate user accounts, bridge 4220 configuration, device operation, patient and non-patient data, interfaces etc. are handled and isolated per client. A multiple cloud based implementation obviates this function as each client includes their own cloud based system.

Multiple organization device support: The bridge 4220 supports at least 1 million+ MVS apparatus 4104 for a remote implementations that services multiple separate hospital systems. The supported MVS apparatus 4104 can be MVS apparatus 4104 from different manufacturers.

EMR capture system support: The MVS apparatus 4104 supports a wide range implementations of the EMR data capture system 4200 and is capable of interfacing to any commercially deployed EMR/Clinical Data Repository 4244.

EMR capture system interface and approvals: The bridge 4220 device provides support for all required communication, encryption, security protocols and data formats to support the transfer of PMR information in accordance with all required operational, standards and approval bodies for EMR/Clinical Data Repository 4244 supported by the EMR data capture system 4200.

Remote EMR capture system(s): The bridge 4220 supports interfacing to the required EMR/Clinical Data Repository 4244 independent of the EMR data capture system 4200 location, either locally on the same network infrastructure or external to the network that the bridge 4220 is resided on or a combination of both. The EMR data capture system 4200, or systems, that the bridge 4220 is required to interact with and save the patient to can not be located on the same network or bridge 4220 implementation location, therefore the bridge 4220 implementation in some implementations ensure that the route to the EMR exists, and is reliable.

Bridge buffering of device patient records: The bridge 4220 device provides a mechanism to buffer received PMRs from connected MVS apparatus 4104 in the event of a communications failure to the EMR/Clinical Data Repository 4244, and when communications has been reestablished subsequently transfer the buffered measurement records to the EMR. From time to time in normal operation, the network connection from the bridge 4220 is lost. If communications has been lost to the configured EMR data capture system 4200 then the bridge 4220 in some implementations accepts measurement records from the MVS apparatus 4104 and buffers the measurement records until communications has be reestablished. Buffering the measurement records allows the medical facility to transfer the current data of the medical facility to the bridge 4220 for secure subsequent processing. In this event the bridge 4220 will respond to the MVS apparatus 4104 that either 1. Dynamic validation of EMR acceptance is not possible, or 2. The bridge 4220 has accepted the data correctly.

Bridge 4220 real time acknowledge of EMR save to device: The bridge 4220 provides a mechanism to pass to the MVS apparatus 4104 confirmation that the EMR has accepted and saved the PMR. The bridge 4220 when configured to provide the MVS apparatus 4104 with real time confirmation that the EMR/Clinical Data Repository 4244 (s) have accepted and validated the PMR. This is a configuration option supported by the bridge 4220.

Bridge 4220 real time acknowledgement of acceptance of device PMR: The bridge 4220 provides a mechanism to pass to the MVS apparatus 4104 confirmation that the bridge 4220 has accepted the PMR for subsequent processing to the EMR. The MVS apparatus 4104 in some implementations verifies that the bridge 4220 has accepted the PMR and informs the operator of the MVS apparatus 4104 that the data is secure. This level of confirmation to the MVS apparatus 4104 is considered the minimum level acceptable for use by the EMR data capture system 4200. Real time acknowledgement by the bridge 4220 of acceptance of the PMR from the device is a configuration option supported by the bridge 4220.

Bridge Date and Time: The bridge 4220 maintains internal date and time against the local network time source or a source recommended by the IT staff for the network. All transitions and logging events in some implementations are time stamped in the logs of the bridge 4220. The MVS apparatus 4104 will query the bridge 4220 for the current date and time to update its internal RTC. The internal time MVS apparatus 4104 can be maintained to a+/−1 second accuracy level, although there is no requirement to maintain time on the MVS apparatus 4104 to sub one-second intervals.

Graphical User Interface: The bridge 4220 device provides a graphical user interface to present system information to the operator, or operators of EMR data capture system 4200. The user interface presented to the user for interaction with EMR data capture system 4200 in some implementations can be graphical in nature and use modern user interface practices, controls and methods that are common use on other systems of this type. Command line or shell interfaces are not acceptable for operator use though can be provided for use by system admin staff.

Logging and log management: The bridge 4220 is required to provide a logging capability that logs all actions carried out on the bridge 4220 and provides a user interface to manage the logging information. Standard logging facilities are acceptable for this function for all server and user actions. Advanced logging of all device communications and data transfers in some implementations is also provided, that can be enabled/disabled per MVS smartphone system or for product range of MVS smartphone system.

User Accounts: The bridge 4220 device provides a mechanism to support user accounts on the MVS apparatus 4104 for access control purposes. Standard methods for user access control are acceptable that complies with the operational requirements for the install/implementation site.

User Access Control: The bridge 4220 device supports multiple user access control that defines the access control privileges for each type of user. Multiple accounts of each supported account type are to be support. Access to EMR data capture system 4200 in some implementations be controlled at a functional level, In some implementations, the following levels of access is provided:

System Admin: provides access to all features and functions of EMR data capture system 4200, server and device based.

Device Admin: provides access only to all device related features and functions supported by the EMR data capture system 4200.

Device Operator: provides access only to device usage.

Device Installer: provides access only to device commissioning and test capabilities.

A user account can be configured for permissions for one or more account types.

Multi-User Support: The bridge 4220 device is required to provide concurrent multi-user support for access and management of the bridge 4220 system across all functions. Providing multiple user access is deemed a necessary operational feature to support.

Modify User Accounts: The bridge 4220 provides a method to create, delete, and edit the supported user accounts and supported access privileges per account.

Bridge Data Corruption/Recovery: The bridge 4220 architecture and implementation in some implementations ensure that under an catastrophic failure of EMR data capture system 4200 or a storage component that no data is lost that has not been confirmed as saved to the either the EMR for PMRs or localize storage for operational data pertaining to the non-patient data maintained by the EMR data capture system 4200. The bridge 4220 supports a method to ensure zero data lost under critical and catastrophic system failure of the bridge 4220 or any of the bridge 4220 components, network interfaces, storage systems, memory contents, etc. for any data handled by the EMR data capture system 4200. In the event of a recovery action where a catastrophic failure has occurred EMR data capture system 4200 supports both the recovery action and its normal operational activities to ensure that EMR data capture system 4200 is active for clinical use.

Bridge availability: The bridge 4220 device is a high availably system for fail safe operation 24/7/365, with 99.99% availability, i.e. “four nines” system. The bridge 4220 implementation meets an availability metric of 99.99%, i.e. a “four nines” system because the bridge 4220 hardware in some implementations is implemented with a redundant dual server configuration to handle single fault conditions. The bridge 4220 has an independent power source or when the installation site has a policy for power loss operation the bridge 4220 installation in some implementations complies with the policy requirements.

Bridge Static IP address and port Number: The bridge 4220 provides a mechanism to configure the bridge 4220 for a primary use static IP address and port number. For MVS apparatus 4104 connection to the bridge 4220, the bridge 4220 in some implementations has a static IP address and that IP address in some implementations is known by the MVS apparatus 4104.

Bridge Dual network capability: The bridge 4220 system provides a mechanism to support a dual operational network interface to allow for failure of the primary network interface. This secondary network interface supports a configurable static IP address and port number. A redundant network connection in some implementations is provided to cover the event that the primary network interface has failed. Note if the bridge 4220 implementation for EMR data capture system 4200 employs two separate bridges 4220 or other redundant mechanism to provide a backup system then this requirement can be relaxed from an operational view point, however EMR data capture system 4200 in some implementations support this mechanism.

Local Wi-Fi® commissioning network: The bridge 4220 provides a mechanism on the local operational network to commission new MVS apparatus 4104 for operational use. EMR data capture system 4200 supplies a localized isolated network for the use of commissioning new devices onto the operational network. The bridge 4220 has a known default IP address on this network and provides a DHCP server for the allocation of IP address to devices on EMR data capture system 4200. The commissioning of new devices is to be considered a core aspect of the bridge 4220 functions. However it is acceptable that a separate non server based application in some implementations will manage the configuration process provided the same user interface is presented to the user and the same device level configuration options are provided. In some implementations, the configuration of a new MVS apparatus 4104 on the network is carried out in two stages: Stage 1: network configuration from the commissioning network to the operational network. Stage 2: Once joined on the operational network specific configuration of the MVS apparatus 4104 for clinical/system function operation.

Remote commissioning of devices: EMR data capture system 4200 provides a mechanism where the bridge 4220 device is not present on the local network for a new device is to be commissioned on the operational network. Even when the bridge 4220 is on a cloud server external to the operational site network new devices in some implementations can be commissioned onto the network in the same manner as if the bridge 4220 was a local server. This does not preclude the installation of a commission relay server on to the operational network that supports this mechanism.

Device setup: The bridge 4220 supports the configuration of a device level network operation and security settings for an existing or new MVS apparatus 4104 on either the commissioning network or the operational network. New devices are configured on the commissioning network. Existing devices on the operational network are also configurable for network and security requirements independent of the network that the MVS apparatus 4104 are currently connected to the bridge 4220 provides the required user interface for the configuration of the network operational and security settings by the operator. Once configured, a method of verifying that the MVS apparatus 4104 have been configured correctly but be presented to the operator to prove that the MVS apparatus 4104 are operational. Devices support a network command to reboot and rejoin the network for this verification purpose.

Bridge Configuration: The bridge provides a mechanism to support configuration of all required specific control options of the bridge 4220. A method to configure the bridge 4220 functions in some implementations is provided for all features where a configuration option enable, disable or a range of vital-signs are required.

Bridge MVS smartphone system acknowledgement method: The bridge 4220 provides a configuration method to control the type of acknowledgement required by the EMR data capture system 4200, one of: device configuration dependent, EMR level acknowledgment, bridge 4220 level acknowledgement. In some implementations, a MVS apparatus 4104 requires from the bridge an acknowledgement that the PMR has been saved by the EMR data capture system 4200 or accepted for processing by the bridge 4220.

EMR Level: Bridge 4220 confirms save by EMR data capture system 4200.

Bridge Level: bridge 4220 controlled, accepted for processing by the bridge 4220.

Enabled/Disable of firmware updated mechanism: The bridge 4220 provides a method to globally enable or disable the supported MVS apparatus 4104 firmware updated feature. A global enable/disable allows the control of the firmware update process.

Server Management: The bridge 4220 is required to provide a user interface that provides configuration and performance monitoring of the bridge 4220 and platform functions.

System Reporting: The bridge 4220 is required to provide a mechanism to provide standard reports to the operator on all capabilities of the bridge 4220 system. Standard reporting in some implementations includes selection of report vital-sign, sorting of report vital-signs, printing of reports, export of reports to known formats, WORD, excel, PDF etc., identification of reports, organization name, location, page numbers, name of report etc., date and time of log, generate by user type and extent of provides full reporting for all system features and logs, examples are: List of devices known to EMR data capture system 4200, with location reference and date and time of last connection Report on the battery status for all known MVS apparatus 4104. Report on any devices that reported an error Report on devices that have expired there calibration dates. Report on devices that are approaching their calibration dates.

Demo Patient Interface: The bridge 4220 provides a mechanism for demo only purposes where an EMR data capture system 4200 is not available for interfacing to EMR data capture system 4200 to allow patient records received from a given device to be viewed and the biological vital sign data presented. For demonstrations of EMR data capture system 4200 where there is no EMR data capture system 4200 to connect the bridge 4220 the system provides a user interface method to present the data sent to the bridge 4220 by the connected MVS apparatus 4104. In some implementations this patient data interface manages and stores multiple patients and multiple record readings per patient and present the information to the operator in an understandable and consistent manner

Interface to EMR/clinical data repository 4244: The bridge 4220 device provides an interface to the EMR/clinical data repository 4244 for the purpose of storing patient records. Also, anonymous PMRs are stored for the purposes of data analysis as well as provide a mechanism to monitor the operation of the MVS apparatus 4104.

Device PMRs: The bridge 4220 in some implementations accepts propriety formatted measurement records from MVS apparatus 4104 connected and configured to communicate with the bridge 4220 and translate the received measurement record into a suitable format for transfer to a EMR data capture system 4200. The bridge 4220 is the MVS apparatus 4104 that will take the MVS apparatus 4104 based data and translate that data into a format suitable to pass along to a local or remote EMR/Clinical Data Repository 4244 system using the required protocols of that EMR/Clinical Data Repository 4244.

Device non patient measurement data: The bridge 4220 in some implementations accepts data from connected MVS apparatus 4104 and provides data to a connected device. This is data or setting vital-signs associated with the MVS apparatus 4104 that in some implementations is managed by the bridge 4220, e.g. device configuration settings, firmware images, status information etc.

Device to Bridge 4220 interface protocol: The bridge 4220 supports a MVS apparatus 4104 to bridge 4220 interface protocol, BRIP, for all communications between the MVS apparatus 4104 and the bridge 4220 device. Each device supports a single interface protocol, BRIF and individual device or manufacture level protocols can be supported by the bridge 4220.

Network communications method: The bridge 4220 supports a LAN based interface for processing connection requests and data transfers from remote MVS apparatus 4104. Standard communications methods such as UDP/TCP/IP etc. are supported but the interface is not restricted to this transfer mechanism, the architecture of EMR data capture system 4200 in some implementations support other transfer methods such as UDP. Where more than one MVS apparatus 4104 type is supported in EMR data capture system 4200 the bridge 4220 supports different transfer mechanism concurrently MVS apparatus 4104: The bridge 4220 in some implementations accept connections and measurement data records from MVS apparatus 4104.

Non-conforming MVS apparatus: The bridge 4220 in some implementations accepts connections and measurement data records from non-MVS system using device interface protocols specific to a given device or manufacture of a range of device. The EMR data capture system 4200 support third party MVS apparatus 4104 to provide the same core features and functions as those outlined in this document. In some implementations, a core system supports all MVS apparatus 4104 connected to EMR data capture system 4200, for the purposes of measurement data, body core temperature, ECG, blood pressure, plus other biological vital signs, both single and continuous measurement based, for transfer to the selected EMR/Clinical Data Repository 4244, along with per device configuration and status monitoring.

Single Vital-sign Measurement Data: The bridge 4220 in some implementations accept and processes for transfer to the configured EMR/Clinical Data Repository 4244, single event measurement data. Single event measurement data is defined as a patient biological vital sign single point measurement such as a patient body core temperature, blood pressure, heart rate or other data that is considered a one-time measurement event for a single measurement vital-sign. This type of data is generated from a MVS apparatus 4104 that supports a single biological vital sign reading.

Multiple Vital-sign Measurement Data: The bridge 4220 in some implementations accept and process for transfer to the EMR multiple event measurement data. Multiple event measurement data is defined as a patient biological vital sign single point measurement such as a patient blood glucose levels or other vital sign that is considered a one-time measurement event for more than one vital sign.

Continuous Vital-sign Measurement Data: The bridge 4220 in some implementations accept and process for transfer to the EMR single vital-sign continuous measurement data. Continuous measurement data is defined as a stream of measurement samples representing a time domain signal for a single or multiple biological vital sign vital-sign.

Unique MVS smartphone system identification: The bridge 4220 supports a unique identifier per MVS apparatus 4104, across all vendors and device types, for the purposes of device identification, reporting and operations. Each MVS apparatus 4104 that is supported by the EMR data capture system 4200 provides a unique identification based on the manufacture, product type, and serial number or other factors such as the FDA UID. The bridge 4220 is required to track, take account of, and report this number in all interactions with the MVS apparatus 4104 and for logging. This device identification can also be used in the authentication process when a MVS apparatus 4104 connects to the bridge 4220.

Device connection authentication: The bridge 4220 provides a mechanism to authenticate a given MVS apparatus 4104 on connection to ensure that the MVS apparatus 4104 are known and allowed to transfer information to the bridge 4220. Access to the bridge 4220 functions in some implementations is controlled in order to restrict access to currently allowed devices only. Acceptance of a MVS apparatus 4104 making connection the bridge 4220 for 2 main rationales. The MVS apparatus 4104 are known to the bridge 4220, and that 2. A management function to control access for a given device, i.e. allow or bar access.

Last connection of device: The bridge 4220 is required maintain a history of the connection dates and times for a given MVS apparatus 4104. This is required from a reporting and logging viewpoint. In some implementations will also be used to determine if a MVS apparatus 4104 are lost/stolen or failed.

Calibration/Checker Monitoring: The bridge 4220 is required to track the valid calibration dates for a given device and present to the operator those devices that are out of calibration or approaching calibration. All MVS apparatus 4104 in some implementations be checked for operation and accuracy on a regular bases. EMR data capture system 4200 can provide the facility to generate a report and highlight devices that are either out of calibration and those approaching calibration. The check carried out by the bridge 4220 is on the expiry date exposed by the MVS apparatus 4104. The bridge 4220 is not required to check the MVS apparatus 4104 for calibration, only report if the MVS apparatus 4104 are out of calibration based on the MVS apparatus 4104 expiry date. In some implementations the expiry date is updated at the time of the MVS apparatus 4104 recalibration check.

Error/Issue monitoring: The bridge 4220 is required to track the issues/errors reported by a given device and present that information to the operator in terms of a system report. Reporting of device level errors dynamically for a given device is diagnostics tool for system management. Providing the issue/error history for a given device provides core system diagnostic information for the MVS apparatus 4104.

Battery Life monitoring: The bridge 4220 is required to track the battery level of a given device and report the battery level information to the operator. EMR data capture system 4200 is to highlight to the operator that a given device has an expired or nearly expired or failed internal battery based on the information exposed by the MVS apparatus 4104. It is the MVS apparatus 4104 responsibility to determine its own internal power source charge level or battery condition. The bridge 4220 can provide a mechanism to report the known battery condition for all devices, e.g. say all devices that have 10% battery level remaining.

Lost/Stolen/Failed monitoring: The bridge 4220 is required to determine for a given MVS apparatus 4104 if it has been lost/stolen/or failed and disable the MVS apparatus 4104 for system operation. Being able to determine if a system has not connected to the bridge 4220 for a period of time is a feature for failed, lost or stolen reporting to the operator. If a MVS apparatus 4104 has not connected to EMR data capture system 4200 for a period of time, EMR data capture system 4200 determines that the MVS apparatus 4104 has been stolen or lost, in this event the operator is informed in terms of a system report and the MVS apparatus 4104 removed from the supported devices list. If and when the MVS apparatus 4104 reconnects to EMR data capture system 4200 the MVS apparatus 4104 are to be lighted as “detected” and forced to be rechecked and re-commissioned again for use on the network.

Reset device to network default: A method to reset a target device or group of selected devices to factory settings for all network parameters in some implementations.

Reset device to factory default: A method to reset a target device or group of selected devices to their factory default settings in some implementations is supported.

Dynamic Device Parameter Configuration: The bridge 4220 provides a mechanism to provide configuration information to a MVS apparatus 4104 when requested by the MVS apparatus 4104 on connection to the bridge 4220 or via the keep device alive mechanism. Upon connecting to a bridge 4220 a MVS apparatus 4104 as part of the communications protocol determines if its current configuration is out of date, if any aspect of the MVS apparatus 4104 configuration is out of date and is required to be updated then the bridge 4220 provides the current configuration information for the MVS apparatus 4104 model and revision This is intended to be as simple as the MVS apparatus 4104 getting the configuration setting for each of its supported parameters. The bridge 4220 is responsible to ensure that the supplied information is correct for the MVS apparatus 4104 model and revision level.

Device Configuration Grouping: Single device: The bridge 4220 provides a mechanism to configure a single device, based on unique device ID, to known configuration parameters. The bridge 4220 in some implementations allows a single MVS apparatus 4104 to be updated when it connects to the bridge 4220 either via the heart beat method or via operator use. This effectively means that the bridge 4220 provides a method to manage and maintain individual device configuration settings and have those settings available dynamically for when the MVS apparatus 4104 connects. Further the bridge 4220 supports per device configurations for different revisions of device firmware, for example revision 1 of the MVS apparatus 4104 has configuration parameters x, y and z, but revision 2 of the MVS apparatus 4104 has configuration parameters has x, y, z and k and the valid allowed range for the y parameter has been reduced.

Device Configuration Grouping—MVS apparatus 4104 model group: The bridge 4220 provides a mechanism to configure all devices within a model range to known configuration parameters. The facility to reconfigure a selected sub-group of devices that are model x and at revision level all with the same configuration information.

Device Configuration Grouping—selected group within model range: The bridge 4220 provides a mechanism to configure a selected number of devices within the same model range to known configuration parameters. The facility to reconfigure a selected sub-group of devices that are model x and at revision level y Device Configuration Grouping—defined sub group: The bridge 4220 provides a mechanism to configure a selected number of devices with the same model based on device characteristics e.g. revision level, operational location etc. The facility to reconfigure all devices that are model x and at revision level y, OR all model x devices that are in operation in Ward 6 is a feature.

Device Configuration files: The bridge 4220 provides a method to save, load, update and edit a configuration file for a MVS apparatus 4104 model number and/or group settings. The ability to save and load configuration files and change the configuration content in the file is a required feature for EMR data capture system 4200. A file management mechanism in some implementations is also provided for the saved configuration files.

Dynamic configuration content: The bridge 4220 in some implementations dynamically per MVS apparatus 4104 connection determine upon request by the MVS apparatus 4104 the new configuration settings for that device, given that the medical devices connect in a random manner to the bridge 4220, the bridge 4220 is required for the connected device, model, revision, unique identification etc. to maintain the configuration settings for that device.

The bridge 4220 provides a mechanism to control the patient record received from a MVS apparatus 4104 to transfer the record to one or more of the supported EMR/Clinical Data Repository 4244. Where more than one EMR/Clinical Data Repository 4244 is maintained by a single organization, e.g. one for ER, cardiology use and possibility one for outpatients etc. EMR data capture system 42 4200 in some implementations manage either by specific device configuration or bridge 4220 configuration which EMR the patient record is to be transmitted to by the bridge 4220.

Device Configuration and Status Display: In some implementations, when a MVS apparatus 4104 connects to the bridge 4220 that the MVS apparatus 4104 queries its current configuration settings against the bridge 4220 settings for that specific device type and device as outlined below: 1. A given device based on a unique ID for that device. Note each device is required to be uniquely identified in EMR data capture system 4200. 2. A group of devices allocated to a physical location in the hospital, i.e. Based on a ward number of other unique location reference. Accordingly, in some implementations a group of devices in a given location in some implementations is updated separately from other devices of the same type located in a different location in the same hospital environment, i.e. a recovery ward 1 as opposed to an emergency room. A group of devices based on product type, i.e. all MVS apparatus 4104, updated with the same settings. Bridge 4220 device configuration options adjusted based on MVS apparatus 4104. The bridge 4220 in some implementations adjusts the configuration options presented to the operator based on the capabilities of the MVS apparatus 4104 being configured. Where multiple different MVS apparatus 4104 are supported by the EMR data capture system 4200 it cannot be assumed that each device from a different manufacture or from the same manufacture but a different model of the same device level configuration parameters. Therefore the bridge 4220 in some implementations determine the configuration capabilities for the MVS apparatus 4104 to be configured and present only valid configuration options for that device with valid parameter ranges for these options.

Device parameter Validation: The bridge 4220 provides a mechanism for a given model MVS apparatus 4104 to validate that a given configuration parameter is set within valid parameter ranges for that device model and revision. The bridge 4220 is required based on the MVS apparatus 4104 model and revision level to present valid parameter ranges for the operator to configure a MVS apparatus 4104 level parameter with. Device patient record acceptance check response source. The bridge 4220 provides a mechanism to configure the MVS apparatus 4104 to require either: 1) a confirmation from the bridge 4220 device only that a patient record has been received for processing or 2) a confirmation from the bridge 4220 device that the EMR data capture system 4200 has received and saved the patient information. In some implementations of the configuration of the MVS apparatus 4104 the MVS apparatus 4104 reports to the operator a status indicator.

Device Hospital/Clinic Reference: A device setting to allow an organization identifier to be configured on the MVS apparatus 4104. The MVS apparatus 4104 can be configured with an alphanumeric identification string, max 30 characters that allows the organization to indicate to the hospital/clinic that the MVS apparatus 4104 are in use with, e.g. “Boston General”.

Device Ward Location reference: A device setting to allow an operational location identifier to be configured on the MVS apparatus 4104. The MVS apparatus 4104 are to be configured with an alphanumeric identification string, max 30 characters that allows the organization to indicate an operational area within the organization, e.g. “General Ward #5”.

Device Asset Number: A device setting to allow an organization asset number to be configured on the MVS apparatus 4104. The MVS apparatus 4104 are to be configured with an alphanumeric identification string, max 30 characters to allow the organization to provide an asset tag for the MVS apparatus 4104.

Display device Manufacture Name, Device Model and Serial Number: A method to display the manufacturer name, device model number and device serial number for the unit is provided. EMR data capture system 4200 can provide a method to determine the manufacturer name, model number and device level serial number of for the MVS apparatus 4104. Alphanumeric identification string, max 60 characters in length for each of the three parameters.

Display MVS apparatus 4104 unique identification reference tag: A method to display the device level unique identifier for the unit. For regulatory traceability reasons each device is to support a unique identification number this number in some implementations be displayed by the EMR data capture system 4200.

Device last Check/Calibration Date: A method to display and set the date of the last check or re-calibration action for the MVS apparatus 4104. This allows the bridge 4220 to determine which devices are required to be re-checked and present that information to the operator of EMR data capture system 4200. All MVS apparatus 4104 with a measurement function are required to be checked for accuracy on a regular basis. EMR data capture system 4200 provides a mechanism to update the MVS apparatus 4104 date of last check/calibration when a device level check has been carried out.

10. Methods of Multi-Vital-Sign Detection and Communication

In this section, the particular methods performed by FIGS. 13, 29, 32, 33, 37 and 37 are described by reference to a series of flowcharts.

FIG. 43 is a flowchart of a method 4300 to perform real time quality check on finger cuff data, according to an implementation. The method 4300 uses signals from physiological light monitoring (PLM) subsystems to perform quality check. The method 4300 can be performed by any of the printed circuit boards or any of the microprocessors in FIG. 1-FIG. 37, such as the printed circuit board 106 in FIG. 1-FIGS. 7 and 12, the MVS finger cuff accessory (MVSFCA) 2902 in FIG. 29, the MVSFCA 3002 in FIG. 30, the sensor management component 3302 in FIG. 33, the microprocessor 3320 in FIG. 33, the MVS finger cuff 1704 in FIG. 17 and FIG. 11, the microprocessor 1702 in FIG. 17, controller 1826 in FIG. 18, the microprocessor 3202 in FIG. 32-FIGS. 36 and 37 and/or main processor 2602 in FIG. 26.

In method 4300, raw data 4302 is received from a PLM subsystem, such as PLM subsystem in the MVS finger cuff in FIG. 1-FIG. 18, 1704 in FIGS. 17, 30 and 33, FIG. 19-FIG. 25, FIG. 29-FIG. 31 and/or 3244 in FIG. 32-FIG. 33, raw data 4304 is received from two mDLS sensors, such as mDLS sensor in the MVS finger cuff in FIG. 1-FIG. 18, 1704 in FIG. 17, FIG. 30-FIG. 33, FIG. 29-FIG. 31 and/or 3242 in FIG. 32-FIG. 36, raw data 4306 is received from pressure cuff, such as MVS finger cuff in FIG. 1-FIG. 18, 1704 in FIG. 17, FIG. 30-FIG. 33, FIG. 29-FIG. 31, 3242 in FIG. 32-FIG. 33 and/or the pressure sensor 4208 in FIG. 42, raw data 4324 is received from an accelerometer and raw data 4332 is received from a three-axis gyroscope. The raw data 4306 received from the pressure cuff can be received from the pneumatic pressure sensor 4208 in FIG. 42.

The raw data 4302 that is received from the PLM subsystem is analyzed in PLM signal processing 4308, the raw data 4304 that is received from the mDLS sensors is analyzed in mDLS signal processing 4310, the raw data 4306 that is received from the pressure cuff is analyzed in cuff pressure processing 4312, the raw data 4324 that is received from the accelerometer is analyzed in accelerometer processing 4326 and the raw data 4332 that is received from the three axis gyroscope is analyzed in gyroscope processing 4334. If the analysis in the PLM signal processing 4308 and the mDLS signal processing 4310 indicates a poor signal-to-noise ratio 4314 in the raw data 4302 that is received from the PLM subsystem or the raw data 4304 that is received from the mDLS sensors, the measurement is ended 4315. If the analysis in the PLM signal processing 4308 and the mDLS signal processing 4310 indicates a good signal-to-noise ratio 4314 in both the raw data 4302 that is received from the PLM subsystem and the raw data 4304 that is received from the mDLS sensors, then a waveform analysis 4318 is performed on both the raw data 4302 that is received from the PLM subsystem and the raw data 4304 that is received from the mDLS sensors. If the analysis in the cuff pressure processing 4312 indicates the bladder of the finger occlusion cuff can not be inflated to a required pressure or that the required amount of pressure can not be maintained in the bladder of the MVS finger cuff 4316 then the measurement is ended 4315. If the analysis in the accelerometer processing 4326 indicates unreliable data from the accelerometer, then the measurement is ended 4315. If the analysis in the three axis gyroscope processing 4334 indicates unreliable data from the three axis gyroscope, then the measurement is ended 4315.

From the waveform analysis 4318 that is performed on both the raw data 4302 that is received from the PLM subsystem and the raw data 4304 that is received from the mDLS sensors, flags indicating that status of heartrate, respiratory rate and/or are generated 4320. From the cuff pressure processing 4312, flags indicating the blood pressure (diastolic and systolic) are generated 4322. From the accelerometer processing 4326, flags indicating the quality of the accelerometer data 4324 are generated 4330. From the three axis gyroscope processing 4334, flags indicating the quality of the three axis gyroscope data 4332 are generated 4338.

FIG. 44 is a block diagram of a method of MVS (MVS) detection and communication method 4400, according to an implementation. The MVS detection and communication method 4400 in FIG. 44 can include any combination and permutation of three general processes including glucose and other monitoring at block 4402, temperature monitoring at block 4404 and motion amplification monitoring 4406.

The glucose and other monitoring 4402 in FIG. 44 includes receiving data from a SpO2/glucose subsystem having photodiode receivers of ER at block 4408. One example of the SpO2/glucose subsystem is Physiological Light Monitoring (PLM) subsystem in FIG. 1 and Physiological Light Monitoring (PLM) subsystem 304 in FIG. 3. In some implementations, the glucose and other monitoring 4402 also includes estimating a blood glucose level from the data of the photodiode receivers at block 4410. In some implementations, the glucose and other monitoring at block 4402 includes estimating an SpO2 level from the data of the photodiode receivers 4412. The glucose and other monitoring 4402 thereafter includes estimating a heart rate, a respiration rate, a heart rate variability and a blood pressure diastolic from the data of the photodiode receivers at block 4414.

One implementation of the temperature monitoring 4404 in FIG. 44 includes detecting through an infrared sensor an infrared signal that is representative of a body surface temperature at block 4416, receiving the body surface temperature from the digital infrared sensor at block 4418 and providing a vital sign (such as a body core temperature) correlated to the body surface temperature at block 4420.

The temperature monitoring 4404 in FIG. 44 can be performed by apparatus in FIG. 12-FIG. 25, 29-FIG. 33, 34-FIGS. 37 and 39.

The motion amplification monitoring at block 4406 in FIG. 44 includes examining pixel values of a plurality of images at block 4424, determining a temporal motion of the pixel values between the plurality of images being below a particular threshold at block 4426, amplifying the temporal motion resulting in an amplified temporal motion at block 4428 and visualizing a pattern of flow of blood in the amplified temporal-motion in the plurality of images and block 4430.

After completion of the glucose and other monitoring 4402, the temperature monitoring 4404 and/or the motion amplification monitoring 4406, the vital signs are transmitted from a wireless communication subsystem via a short distance wireless communication path at block 4432. In some implementations, the vital signs are transmitted by the communication subsystem through an Internet Protocol tunnel at block 4434. One implementation of the communication subsystem is communication subsystem 2604 In FIG. 38.

11. Displays of Multi-Vital-Sign Smartphones

FIG. 45 is a display screen 4500 of the MVS smartphone 3003 showing results of successful multi-vital sign measurements, according to an implementation. The display screen 4500 includes display of the blood glucose levels 4502, heartrate variability 4504, battery charge level 4506, measured blood pressure 4510 (systolic and diastolic in terms of millimeters of mercury) of the patient, measured core temperature 4512, measured heartrate in beats per minute 4514, measured SpO2 levels 4516 in the patient bloodstream and/or measured respiratory rate 4518 in terms of breaths per minute of the patient. Other data that can be displayed by display screen 4500 is level of Wi-Fi® connectivity or the level of Bluetooth® connectivity or the level of cellular connectivity, the current time and the patient name of the patient whose vital signs are measured. In other implementations, Zigbee® or Z-Wave® can be used instead of Bluetooth®.

CONCLUSION

A MVS device senses blood glucose levels, body core temperature, heart rate, heart rate variability, respiration, SpO2, blood flow and/or blood pressure and transmits the vital signs to an electronic medical record system. In some implementations, the transmission is performed through a smartphone. A technical effect of the apparatus and methods disclosed herein is wireless electronic transmission of a plurality of vital signs, including blood glucose levels from an electromagnetic sensor, to an electronic medical record system. Another technical effect of the apparatus and methods disclosed herein is generating a temporal motion of images from which a biological vital sign can be transmitted to an electronic medical record system. Although specific implementations are illustrated and described herein, it will be appreciated by those of ordinary skill in the art that any arrangement which is generated to achieve the same purpose may be substituted for the specific implementations shown. This application is intended to cover any adaptations or variations. Further implementations of power supply to all devices includes A/C power both as a supplemental power supply to battery power and as a substitute power supply.

In particular, one of skill in the art will readily appreciate that the names of the methods and apparatus are not intended to limit implementations. Furthermore, additional methods and apparatus can be added to the modules, functions can be rearranged among the modules, and new modules to correspond to future enhancements and physical devices used in implementations can be introduced without departing from the scope of implementations. One of skill in the art will readily recognize that implementations are applicable to future vital sign and non-touch temperature sensing devices, different temperature measuring sites on humans or animals, new communication protocols for transmission (of user service, patient service, observation service, and chart service) and all current and future application programming interfaces and new display devices.

The terminology used in this application meant to include all temperature sensors, processors and operator environments and alternate technologies which provide the same functionality as described herein.

Claims

1. An apparatus comprising:

a microprocessor;

a physiological light monitoring subsystem operably coupled to the microprocessor, the physiological light monitoring subsystem including a source-detector assembly having a first flexible side and a second flexible side; and

a hard structure surrounding at least a portion of the physiological light monitoring subsystem,

the first flexible side having three transmitters of electromagnetic radiation frequencies in ranges of 375-415 nm, 640-680 nm and 920-960 nm frequencies and a first photodiode receiver of electromagnetic radiation in a 350-1100 nm range to measure an amount of electromagnetic radiation that is reflected by a subject,

the source-detector assembly also having a first photodiode receiver of electromagnetic radiation in the 350-1100 nm range to measure an amount of electromagnetic radiation that is absorbed by the subject,

the microprocessor configured to determine an indication of an amount of oxygen in the subject calculated from a ratio of electromagnetic radiation received at the 640-680 nm frequency range in comparison to electromagnetic radiation received at the 920-960 nm frequency range,

the microprocessor configured to determine an indication of an amount of glucose in the subject calculated from a ratio of electromagnetic radiation received at the 375-415 nm frequency range in comparison to electromagnetic radiation received at the 920-960 nm frequency range,

the subject being positioned between the first flexible side and the second flexible side.

2. The apparatus of claim 1 further comprising a main body comprising the microprocessor, the main body further comprising a visual display component that is operably coupled to the microprocessor and a USB port that is operably coupled to the microprocessor.

3. The apparatus of claim 1 wherein the first photodiode receiver of electromagnetic radiation in the second flexible side receives the electromagnetic radiation at the 640-680 nm frequency range and wherein the first photodiode receiver of electromagnetic radiation in the first flexible side receives the electromagnetic radiation at the 375-415 nm frequency range.

4. The apparatus of claim 3 the source-detector assembly further comprising a light shielding that shields extraneous near-infrared and extraneous ambient light such that electromagnetic radiation entering the subject as well as the electromagnetic radiation detected will be only in the 350-1100 nm range of the first photodiode receiver of electromagnetic radiation and the 350-1100 nm range of the first photodiode receiver of electromagnetic radiation.

5. The apparatus of claim 3 having no further receivers or transmitters.

6. The apparatus of claim 3 wherein the apparatus is verified by a second apparatus as known by the second apparatus and as allowed by the second apparatus to transfer information to the second apparatus.

7. The apparatus of claim 3 further comprising a digital infrared sensor having no analog sensor readout ports.

8. The apparatus of claim 7, wherein a digital infrared sensor further comprises an analog-to-digital converter.

9. The apparatus of claim 3 not including a finger occlusion cuff.

10. The apparatus of claim 3 further comprising:

a first circuit board including: the microprocessor; the microprocessor operably coupled to the physiological light monitoring subsystem; and a first digital interface that is operably coupled to the microprocessor.

11. The apparatus of claim 10 further comprising a first housing that contains the first circuit board and an aperture for a camera and that does not contain the camera.

12. The apparatus of claim 11 further comprising:

a second circuit board in a smartphone, the smartphone having a second housing and the camera, the second circuit board including: a second digital interface, the second digital interface being operably coupled to the first digital interface; and a second microprocessor operably coupled to the second digital interface, the second microprocessor being configured to determine a plurality of vital signs.

13. The apparatus of claim 12 wherein a wireless communication subsystem is operably coupled to the second microprocessor and the wireless communication subsystem is configured to transmit a representation of each of the plurality of vital signs via a short distance wireless communication path.

14. The apparatus of claim 13 wherein a connection is established and the plurality of vital signs are pushed from the apparatus through the wireless communication subsystem, thereafter an external device controls transmission of the plurality of vital signs between the apparatus and the external device, wherein the connection further comprises an authenticated communication channel.

15. The apparatus of claim 13, wherein the wireless communication subsystem further comprises a component that is configured to transmit a representation of date and time, operator identification, patient identification, manufacturer and model number of the apparatus.

16. The apparatus of claim 12 further comprising:

the camera that is operably coupled to the second microprocessor and configured to provide a plurality of images to the second microprocessor; and

the microprocessor including a cropper module that is configured to receive the plurality of images and configured to crop the plurality of images to exclude a border area of the plurality of images, generating a plurality of cropped images, the second microprocessor also including a temporal-motion-amplifier of the plurality of cropped images that is configured to generate a temporal variation, the second microprocessor also including a biological vital sign generator that is operably coupled to the temporal-motion-amplifier that is configured to generate a biological vital sign from the temporal variation, wherein the biological vital sign is a vital sign of the plurality of vital signs.

17. The apparatus of claim 16 wherein a heart rate is determined from data from the first photodiode receiver of electromagnetic radiation, a respiration rate and a heart rate variability and a blood pressure diastolic is determined from data from the first photodiode receiver of electromagnetic radiation and the first photodiode receiver of electromagnetic radiation.

18. The apparatus of claim 16 further wherein a blood pressure systolic is determined from data from the first photodiode receiver of electromagnetic radiation.

19. The apparatus of claim 1 where the apparatus is operable to receive a flag or key that enables use of portions of a volatile memory or a non-volatile memory to determine the indication of the amount of glucose in the subject.

20. The apparatus of claim 1, wherein the microprocessor is further configured to determine an amount of glucose in the subject when the amount of oxygen in the subject indicates a resting period of a heartbeat from an indication of a ratio of electromagnetic radiation received at the 640-680 nm frequency range in comparison to electromagnetic radiation received at the 920-960 nm frequency range.