(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)

(19) World Intellectual Property

Organization
International Bureau
(10) International Publication Number
(43) International Publication Date WO 2017/013582 Al
26 January 2017 (26.01.2017) PO PCT

(51) International Patent Classification: BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM,
A61B 5/01 (2006.01) A61M 19/00 (2006.01) DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT,
HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KN, KP, KR,
(21) International Application Number: KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG,
PCT/IB20 16/054286 MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM,
(22) International Filing Date: PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC,
19 July 2016 (19.07.2016) SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN,
TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW.
(25) Filing Language: English
(84) Designated States (unless otherwise indicated, for every
(26) Publication Language: English kind of regional protection available): ARIPO (BW, GH,
(30) Priority Data: GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ,
3 721 /CHE/20 15 20 July 2015 (20.07.2015) IN TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU,
TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE,
(71) Applicant: BEMPU HEALTH PRIVATE LIMITED DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU,
[IN/IN]; 102 Eden Park, 20 Vittal Mallya Rd., Bangalore, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK,
Karnataka 560001 (IN). SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ,
GW, KM, ML, MR, NE, SN, TD, TG).
(72) Inventor: NARAIN, Ratul; 15605 Crimson Spire C , Sil
ver Spring, Maryland 20905 (US). Declarations under Rule 4.17 :
(74) Agents: BHATNAGAR, Gitanjali et al; B-41, Nizamud- — of inventorship (Rule 4. 1 7(iv))
din East, New Delhi 1 10013 (IN).
Published:
(81) Designated States (unless otherwise indicated, for every — with international search report (Art. 21(3))
kind of national protection available): AE, AG, AL, AM,
AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY,

(54) Title: METHOD AND DEVICE FOR DETECTING HYPOTHERMIA

(101 ) (102) (103)

Sensor Control Unit Alerting Unit

FIGURE 2A
©
(57) Abstract: A device for monitoring and detecting hypothermia, comprising one or more sensors (101) configured to sense and
o measure body temperature and one or more physiological phenomena as parameters continuously or at regular intervals; one or more
control units (102) operatively connected to the one or more sensors and configured to determine if one or more parameters is out
o side an acceptable range and accordingly signal the alerting unit; and an alerting unit (103) operatively connected to the one or more
control units and comprising of one or more alarms configured to provide one or more alerts based on the signals received from the
control unit.
 METHOD AND DEVICE FOR DETECTING HYPOTHERMIA

FIELD

The present invention is generally directed towards providing a low cost and easy t o use device t o

measure essential health parameters and detect abnormal health conditions and in particular,

towards a method and device for detecting hypothermia

BACKGROUND

Hypothermia and infection are among top health issues facing several patients including Indian

newborns. Regular temperature monitoring is an effective means of prevention but it is very difficult

t o regularly practice in under-resourced clinics and uneducated homes

As an example, an estimated 4-12 million of India's newborns experience hypothermia yearly, often

resulting in poor organ development, life-debilitating illness and death. Also, every year bacterial

infections (sepsis) cause approximately 250,000 infant deaths in addition t o millions of life-impacting
illnesses. Hypothermia and infection are also among the top pain-points and the standard of care

technologies and practices are presently inadequate.

Hypothermia and infection are especially significant neonatal concerns in India. 1 in 3 of India's

infants is born under 2.5 kgs compared t o rates of almost 1 in 12 in the developed world. These low

birth weight infants are at much higher risk for hypothermia and sepsis. Whereas in developed

countries, these babies are almost never discharged from hospitals until they reach a weight of

2.2kgs, it is not uncommon t o see 1.4kg babies discharged in Indian clinics, assuming that the babies

were born in a clinic in the first place. Furthermore, the majority of India's babies are born in

government centers or homes often lacking adequate staff, equipment and central heating. And,
with India's 65% female literacy rate, a large proportion of mothers are not educated impacting their

ability t o manage their newborn's health.

The WHO promotes the concept of "warm-chain management," a series of 10 interconnected steps,

such as a warmed delivery room, delayed bathing, skin-to-skin warming, t o prevent any opportunity

for an infant t o become cold. However, many aspects of "warm chain management" are impractical.

Furthermore, there is almost no awareness of warm chain management in most Indian homes.

Regular temperature monitoring has the ability t o prevent hypothermia and t o catch infections,

which often present as fever or hypothermia in newborns. In fact, regular temperature monitoring is

the standard of care in developed countries. However,

1. In Indian clinics, there are few nurses and they often skip temperature readings in light of

competing priorities.

2. In Indian homes, mothers cannot operate and interpret thermometers due t o lack of

awareness and education.

Current practices for temperature monitoring and maintenance are inadequate. As a "jugaad"

solution for temperature monitoring, a person's body is felt t o determine temperature and mothers

are taught t o feel their baby's arms for coldness and take action if necessary. But, using these

techniques and even while practicing this method regularly, they still miss 25% of hypothermia

cases. Similarly, mothers are often instructed t o practice kangaroo mother care as a means t o

prevent an infant from becoming cold, but compliance, especially at home, is low.

SUMMARY

It is an objective of the present invention t o provide a device for monitoring and detecting

hypothermia, comprising of one or more temperature sensors configured t o sense and measure

body temperature and one or more physiological phenomena as parameters continuously or at

regular intervals, one or more control units operatively connected t o the one or more sensors and
configured t o determine if one or more parameters is outside an acceptable range and accordingly

signal the alerting unit , and an alerting unit operatively connected t o the one or more control units

and comprising of one or more alarms configured t o provide one or more alerts based on the signals

received from the control unit.

It is another objective of the present invention t o provide a method for monitoring and detecting

hypothermia, comprising the steps of measuring the body temperature and one or more

physiological phenomena as parameters continuously or at regular intervals; determining

hypothermia based on the difference of the measured temperature and the ambient temperature

and previous tem perature measurements; and activating one or more alarms if hypothermia is

detected

The key physiological phenomenon considered is that of peripheral temperature decrease (caused

by peripheral vasoconstriction of blood vessels) of the human body prior t o the subsequent decrease

in temperature of the core body. Detection of this phenomenon can lead t o early detection of

hypothermia and enable intervention.

The primary goal of the invention is t o be able t o use this device t o drastically reduce rates of death

and illness due t o detectable diseases such as hypothermia and sepsis. In a preferred embodiment,

the device is a simple and low-cost wearable device capable of monitoring and detecting

abnormalities in health parameters, such as temperature and heart rate, and intuitively providing an

alert in case of abnormalities such as hypothermia or infection.

In a preferred embodiment, the device is a wearable monitoring wristband that continuously

monitors a patient's health parameters. For example, if the infant becomes cold, intuitive and well-

designed alarms alert a mother t o warm her infant before the baby can become hypothermic.

Repeated and more severe alarms signal that the infant is unable t o stay warm implying that an

underlying infection may be present. The more severe alarms alert the mother early t o get skilled

intervention before the infection worsens. These alarms can be set or programmed t o be periodic

and repetitive at desired time intervals and may be in the form of sound alarms or colour or light
alarms. The type and duration of the alarm may signify the severity of the symptom o r provide an

indication of the problem

The device of the present invention is more accurate than touch-monitoring. Hand-touch

monitoring, while low-cost and culturally acceptable, is shown t o have low accuracy in detecting

hypothermia. Furthermore, it is not de facto taught t o everyone especially in settings with low staff.

Furthermore, the practice is not complied t o nor regularly practiced even when training is given.

The device of the present invention is cheaper than vital monitoring systems. These high end

systems monitor multiple vital parameters and currently only exist for hospital use or use by skilled

staff.

BRIEF DESCRIPTION O F DRAWINGS

The detailed description is described with reference t o the accompanying figures. In the figures, the

left-most digit(s) of a reference number identifies the figure in which the reference number first

appears. The same numbers are used throughout the drawings t o reference like features and

components.

• FIGU R E 1 shows a low-weight infant being exposed t o cold temporarily

• FIGU RES 2A and 2 B show block diagrams of a preferred embodiment of the device, defining

the main components used, for example a temperature sensor, buzzer and microcontroller.

• FIGU R E 3 depicts a flow-chart of the control method and how the device functions and can

be used

• FIGU RES 4A and 4 B depict a preferred band embodiment of innovation with a skin sensor
 • FIGU R E 5 depicts an embodiment of the invention with an intuitive alert for hypothermia.

DETAILED DESCRIPTION O F THE DRAWINGS

Exemplary embodiments now will be described with reference t o the accompanying drawings. The

disclosure may, however, be embodied in many different forms and should not be construed as

limited t o the embodiments set forth herein; rather, these embodiments are provided so that this

disclosure will be thorough and complete, and will fully convey its scope t o those skilled in the art.

The terminology used in the detailed description of the particular exemplary embodiments

illustrated in the accompanying drawings is not intended t o be limiting. In the drawings, like

numbers refer t o like elements.

The specification may refer t o "an", "one" or "some" embodiment(s) in several locations. This does

not necessarily imply that each such reference is t o the same embodiment(s), or that the feature

only applies t o a single embodiment. Single features of different embodiments may also be

combined t o provide other embodiments.

As used herein, the singular forms "a", "an" and "the" are intended t o include the plural forms as

well, unless expressly stated otherwise. It will be further understood that the terms "includes",

"comprises", "including" and/or "comprising" when used in this specification, specify the presence

of stated features, integers, steps, operations, elements, and/or components, but do not preclude

the presence or addition of one or more other features, integers, steps, operations, elements,

components, and/or groups thereof. It will be understood that when an element is referred t o as

being "connected" or "coupled" t o another element, it can be directly connected or coupled t o the

other element or intervening elements may be present. Furthermore, "connected" or "coupled" as

used herein may include wirelessly connected or coupled. As used herein, the term "and/or"

includes any and all combinations and arrangements of one or more of the associated listed items.
Unless otherwise defined, all terms (including technical and scientific terms) used herein have the

same meaning as commonly understood by one of ordinary skill in the art t o which this disclosure

pertains. It will be further understood that terms, such as those defined in commonly used

dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the

context of the relevant art and will not be interpreted in an idealized or overly formal sense unless

expressly so defined herein.

The figures depict a simplified structure only showing some elements and functional entities, all

being logical units whose implementation may differ from what is shown. The connections shown

are logical connections; the actual physical connections may be different. It is apparent t o a person

skilled in the art that the structure may also comprise other functions and structures.

In addition, all logical units described and depicted in the figures include the software and/or

hardware components required for the unit t o function. Further, each unit may comprise within

itself one or more components, which are implicitly understood. These components may be

operatively coupled t o each other and be configured t o com municate with each other t o perform

the function of the said unit.

The device is designed t o improve health outcomes specifically in the Indian context. In preferred

embodiments, key features of the device include:

• Intuitive and useable by uneducated persons; does not require skilled staff nor training

time from hospital staff

• Useable in a home setting, in addition t o a clinic

• Does not require a power supply

• Designed t o look culturally acceptable and appealing

• Fits small (low birth weight or premature) babies as well as large patients

• Promotes Kangaroo Mother Care, a proven health intervention for low-resource settings
In a preferred embodiment, the device is a simplified thermometer. A vast majority of people in

India and other developing countries have never used a thermometer. Similarly, although doctors

and nurses have tried training uneducated mothers t o use thermometers, they cannot trust such a

newly trained mother t o now be able t o maintain normo-thermia o r detect infections in her

newborn. In such situations, the device adds continuous monitoring, which is especially useful at

night-time.

FIGU R E 1 explains the physiological phenomenon of cold peripheries caused by vasoconstriction of

peripheral vessels which enables the device t o detect hypothermia earlier than other temperature

monitoring devices. The figure shows a low-weight infant being exposed t o a cold environment

temporarily. This is illustrated by the bar at Time =14. The baby's core temperature (Tc) drops almost

t o hypothermia when the cold exposure is stopped. Accordingly there is a large drop in peripheral

limb temperature (Tp) first which the device will alarm. This figure depicts the phenomenon of

peripheral skin temperature, for example at the wrist, dropping significantly colder and earlier than

the core (for example abdomen) temperature for a human. This is caused due t o peripheral

vasoconstriction of blood vessels at the peripheries causing warm blood t o be conserved for the core

organs and not the peripheries. Note that hypothermia is typically defined when the core body

temperature goes below 36.5 C, however the peripheries will be colder than this due t o the

physiological phenomenon described. Since the present invention can monitor at the peripheries,

this phenomenon can be detected early allowing intervention before core temperature decreases

causing organ injury and other consequences.

FIGU RES 2A and 2 B show block diagrams of a preferred embodiment of the device. The device can

be described as containing multiple subsystems contained in a physical embodiment. Figure 2A

shows a simplified view of the subsystems. One or more sensors (101) are configured t o sense and

measure body temperature and one or more physiological phenomena as parameters at continuous

or regular intervals. The one or more control units (102) use a technique as described later in Figure

3 t o determine whether t o signal the alerting unit (103). The control unit (102) has the ability t o

trigger another measurement if required t o make a further evaluation of the health state. Figure 2 B

shows a basic example layout of the major components of the innovation. The temperature sensor

(101) provides information t o the control unit (102) which makes the decision t o signal the alerting

unit (103)
a . The sensors (101) make contact with the skin of the patient. They measure the skin temperature

and transfer this measurement t o the control unit (102) at continuous, regular or scheduled

intervals. In the preferred embodiment, this unit has a thermistor temperature sensor which is

placed inside a steel cup. The cup is filled with conductive glue t o hold the thermistor in place and

t o facilitate faster skin temperature measurement. The cup is placed at the bottom of the band

and makes flush contact with the skin. A separate temperature sensor sits inside the body of the

casing o r just outside the casing and measures the "ambient" temperature. The ambient

temperature and skin temperature may be compared by the control unit t o determine if the

device is o n or off the wearer. This sensor can also be used t o better interpret whether the

patient has been exposed t o a cold ambient temperature warranting an alert.

b. The control unit (102) commands the sensors (101) t o take a temperature measurement. It then

receives the temperature measurement value and applies a technique that is specifically

designed t o be sensitive and specific for hypothermia in the target population. The technique is

designed specifically t o rely on the physiological phenomenon of peripheries becoming cold as an

early sign of hypothermia. Based o n the result of the technique the control unit (102) then

commands the alerting unit (103) t o give the appropriate alert t o the user. If the device alerts the

user t o take action (such as warm the baby), the device monitors for the result of the action (a

warmer temperature) or else sounds a subsequent alarm. This subsystem consists of a PCB with a

microchip and several ports. The ports are connected t o the 2 thermistors, a buzzer and an LED.

c. The alerting unit (103) interfaces and communicates with the user. Upon receiving a command

from the control unit (102), the alerting unit (103) may turn of or on a light, o r sound a sequence

of tones or audio recordings t o inform the user that the patient is normotheric o r hypothermic. In

a preferred embodiment this unit consists of a single multi-color LED and a magnetic buzzer.

There are different alert states for the patient being normothermic, the patient being

hypothermic, the patient being still hypothermic, and for the band being removed from the wrist.

In a preferred embodiment, the device may also comprise of a storage unit for storing data

regarding one o r more alerts provided by the alerting unit i.e. previous detections of hypothermia,

data about the device wearer, predetermined acceptable ranges and thresholds etc. In another
preferred embodiment, the device may also comprise of a display unit for displaying the stored data

or measured values of one or more parameters

The device may have all the units located within the same small casing t o enable portability. The

device may be embodied as a bracelet, anklet, shoe, armband, thigh band or a mitten.

Physiologically, if an infant is becoming hypothermic, the body first conserves heat by restricting

blood flow (vasoconstriction of vessels) t o the arms and legs. This causes the limbs t o become

significantly colder as an early sign of hypothermia. Based o n this, in a preferred embodiment, the

device of the present invention uses a technique based o n a temperature threshold and drop in

temperature rate at the wrist t o sound an early the alarm t o take action.

FIGU R E 3 depicts a flow-chart of the control method and how the device functions and can be used.

The technique begins by measuring the skin temperature (at a peripheral location) and an ambient

temperature location (201). The technique is defined by two decision stages: first t o determine if the

band is being worn and another t o determine if the baby is hypothermic. To determine if the band is

worn, the algorithm compares the skin temperature and the ambient room temperature. If the

difference is significant, the device can expect the device is being worn (202A) and the technique can

move t o the second stage of looking for hypothermia. However, if the difference is not significant,

the device may not be worn o n the patient (202B) and the algorithm will wait for another

measurement after some time.

In the second stage of the technique, the skin temperature measurement is used t o determine if the

baby is at risk for hypothermia (203A, 203B). The technique will consider several previous

temperature measurements and calculate a parameter, in the form of the mean, median, min o r

max of the measurements (204) and compare t o a predetermined threshold. Should the threshold

be exceeded, this would imply that the baby is hypothermic (205A). In a preferred embodiment,

core hypothermia is detected when the core temperature (rectal, intra-esophogeal or similar) is

below 36.5. However, the threshold for hypothermia as measured by the device will be different

since a peripheral skin temperature is being interpreted. Also, the threshold may be raised or

lowered depending on the age of the patient or the sensitivity required. If the technique determines
the patient is hypothermic, the device activates an alarm sequence (206) and then waits for a

predetermined time (207) t o measure temperature again (208). The time before measurement again

may be shorter if hypothermia is present. If the patient is not hypothermic (205B), no alarm o r a

normothermic indication is triggered and the device waits for another period of time before

repeating the evaluation again.

FIGU RES 4A and 4 B depict a preferred band embodiment with a skin sensor. They depict a preferred

embodiment of the device as a wristband as shown. In the left image, the front face of the

embodiment is shown. A single light is visible in the centre of the device which has the ability t o

change colours and blink indicating normal or abnormal temperature for the wearer. The device also

contains a buzzer o r speaker inside the casing which gives an audio alert if needed. The control unit

is contained within the body of the device. The right image shows the skin-facing side of the device.

A sensor assembly is located o n this surface as shown by the metal cup which comes in contact with

the skin t o measure temperature. The metal cup contains a temperature sensor which conveys the

measurement t o the control unit contained in the body of the device.

FIGU R E 5 depicts an embodiment of the invention with an intuitive alert for hypothermia. A

preferred embodiment of the device is a wrist band with a simple and intuitive interface for a parent

t o understand the health status of their infant. As described in the left image, the device may blink

an indication at regular intervals (in this case a blue light every 30 seconds) t o indicate that the

infant's temperature is normal. As described in the right picture, the device could have a different

sound and visual alarm (in this case an orange blinking light with sound) indicating that the baby is

hypothermic.

It will be understood that each block of the flowchart illustrations and/or block diagrams, and

combinations of blocks in the flowchart illustrations and/or block diagrams, can be implemented by

computer program instructions. These computer program instructions may be provided t o a

processor of a general purpose computer, special purpose computer, or other programmable data

processing apparatus t o produce a machine, such that the instructions, which execute via the

processor of the computer o r other programmable data processing apparatus, create means for

implementing the functions/acts specified in the flowchart and/or block diagram block o r blocks.
Instructions may also be stored in a computer- readable memory that can direct a computer or other

programmable data processing apparatus t o function in a particular manner, such that the

instructions stored in the computer-readable memory produce an article of manufacture including

instruction means which implement the function/act specified in the flowchart and/or block diagram

block or blocks.

Instructions may also be loaded onto a computer or other programmable data processing apparatus

like a scanner/check scanner t o cause a series of operational steps t o be performed on the computer

or other programmable apparatus t o produce a computer implemented process such that the

instructions which execute on the computer or other programmable apparatus provide steps for

implementing the functions/acts specified in the flowchart and/or block diagram block or blocks.

The flowchart and schematic diagrams of Figures 1 t o 3 illustrate the architecture, functionality, and

operations of some embodiments of methods, systems, and computer program products for time

related interaction of a user with a handheld device. In this regard, each block may represent a

module, segment, or portion of code, which comprises one or more executable instructions for

implementing the specified logical function(s). It should also be noted that in other

implementations, the function(s) noted in the blocks may occur out of the order noted in the figures.

For example, two blocks shown in succession may, in fact, be executed substantially concurrently or

the blocks may sometimes be executed in the reverse order, depending on the functionality

involved.

In the drawings and specification, there have been disclosed exemplary embodiments of the

invention. Although specific terms are employed, they are used in a generic and descriptive sense

only and not for purposes of limitation, the scope of the invention being defined by the following

claims.
We claim :

1. A device for monitoring and detecting hypothermia, comprising:

one or more sensors (101) configured t o sense and measure body temperature and one or

more physiological phenomena as parameters continuously or at regular intervals;

one or more control units (102) operatively connected t o the one or more sensors and

configured t o determine if one or more parameters is outside an acceptable range and

accordingly signal the alerting unit; and

an alerting unit (103) operatively connected t o the one or more control units and comprising

of one or more alarms configured t o provide one or more alerts based on the signals

received from the control unit

2 . A device as claimed in claim 1, wherein the one or more sensors (101) measure temperature at

one or more peripheries of the body

3 . A device as claimed in claim 1 or 2 wherein at least one sensor (101) is placed in contact with the

skin t o measure body temperature

4 . A device as claimed in any of claims 1 t o 3, comprising of at least two sensors (101) of which one

sensor is used t o measure the ambient temperature

5 . A device as claimed in claim 4, wherein the control unit (102) is configured t o determine the

difference between the ambient temperature and body temperature and t o signal the alerting unit if

the difference is outside a predetermined range

6 . A device as claimed in claim 1, wherein the type or duration of the alarm indicates the severity of

the condition or urgency with which intervention is required

7 . A device as claimed in claim 1, wherein the type or duration of alarm indicates one or more causes

for intervention because of which at least one parameter is outside the related acceptable range

8 . A device as claimed in claim 1, wherein the type or duration of alarm indicates one or more

actions t o be taken

9 . A device as claimed in claim 1, wherein one or more alarms are periodic or repetitive at one or

more pre-set intervals

10. A device as claimed in claim 1, wherein one or more alarms are a buzzer, sound, colour and/or

light alarm

11. A device as claimed in claim 1, wherein the alarm type indicates the device has lost contact with

the device wearer

12. A device as claimed in claim 1, wherein the acceptable range is pre-set or is based on the age or

weight of the device wearer

13. A device as claimed in claim 1, wherein the control unit (102) is configured t o monitor the

parameters falling outside the acceptable range for a pre-determined period

14. A device as claimed in claim 13, wherein the control unit (102) is configured t o send one or more

subsequent signals t o the alerting unit (103) if one or more parameters do not fall within a p re

determined range by the end of a pre-determined period

15. A device as claimed in claim 1, wherein the control unit (102) is configured t o control the alerting

unit (103) based on one or more inputs received from a user

16. A device as claimed in claim 1, wherein the device is battery operated

17 A device as claimed in claim 16, wherein the device is a wristband, armband or ankleband and

wherein at least one temperature sensor detects a drop in temperature at the wrist, arm or ankle.

18. A device as claimed in claim 1, comprising a storage unit (104) configured t o store data regarding

one or more alerts provided by the alerting unit

19. A device as claimed in claim 1, comprising of a display unit (105) configured t o display the stored

data or measured values of one or more parameters

20. A device as claimed in claim 1, wherein the sensors (101), control units (102) and/or alerting unit

(103) are operatively connected wirelessly

21. A method for monitoring and detecting hypothermia, comprising the steps of:

measuring the body temperature and one or more physiological phenomena as parameters

continuously or at regular intervals (201);

determining hypothermia based on the difference of the measured temperature and the

ambient temperature and previous temperature measurements (202A, 202B, 203A, 203B,

204); and

activating one or more alarms if hypothermia is detected (205A)

22. A method as claimed in claim 21, wherein the temperature is measured at one or more

peripheries of the body

23. A method as claimed in claim 21, comprising the step of alerting that skin contact is lost if the

difference between the measured body temperature and ambient temperature is within a

predefined range

24. A method as claimed in claim 21, comprising the step of determining any one of average,

median, min or max of the current and previously measured temperature values

25. A method as claimed in claim 21 or claim 24, determining if the measured value or computed

value is outside a predetermined range

26. A method as claimed in claim 21, wherein the type or duration of the alarm indicates the severity

of the condition or urgency with which intervention is required

27. A method as claimed in claim 21, wherein the type or duration of alarm indicates one or more

causes for intervention because of which at least one parameter is outside the related acceptable

range

28. A method as claimed in claim 21, wherein the type or duration of alarm indicates one or more

actions t o be taken

29. A method as claimed in claim 21, wherein one or more alarms are periodic or repetitive at one or

more pre-set intervals

30. A method as claimed in claim 21, wherein one or more alarms are a buzzer, sound, colour and/or

light alarm

31. A method as claimed in claim 21, wherein the alarm type indicates the device has lost contact

with the device wearer

32. A method as claimed in claim 21, wherein the acceptable range is pre-set or is based on the age

or weight of the person whose body temperature is being measured

33. A method as claimed in claim 21, comprising the step of monitoring the parameters falling

outside the acceptable range for a pre-determined period

34. A method as claimed in claim 33, comprising the step of activating one or more alarms if one or

more parameters do not fall within a pre-determined range by the end of a pre-determined period

35. A method as claimed in claim 34, comprising the step of controlling one or more alarms based on

one or more inputs received from a user

36. A method as claimed in claim 21, comprising the step of storing data regarding one or more

alerts provided by the alerting unit

37. A method as claimed in claim 21, comprising the step of displaying the stored data or measured

values of one or more parameters

 nternat ona app cat on o.

PCT/IB2016/054286

A CLASSIFICATION O F SUBJECT MATTER

A61B5/01, A61M19/0 0 Version=2016 .0 1

According to International Patent Classification (IPC) or to both national classification and IPC
B FIELDS SEARCHED
Minimum documentation searched (classification system followed by classification symbols)

A61B, 6 1M

Documentation searched other than minimum documentation to the extent that such documents are included in the fields searched

Electronic data base consulted during the international search (name of data base and, where practicable, search terms used)

Databses :Patseer, IPO Internal Database

SearchTerms :trough, slid, holder, control, interface, memory;

C. DOCUMENTS CONSIDERED TO BE RELEVANT

Category* Citation of document, with indication, where appropriate, of the relevant passages Relevant to claim No

KR101123085 B l (LEE Eui Keon),16 March 1-20

2012(16-03-2012) Abstract ;claims 1, ,5 , ;pages
1-3, page 4 paragraph [0025] ,page 6
paragraph [0025 ]), page 7

Further documents are listed in the continuation of Box C. See patent family annex

* Special categories of cited documents: later document published after the international filing date or priority
"A" document defining the general state of the art which is not considered date and not in conflict with the application but cited to understand
to be of particular relevance the principle or theory underlying the invention
"E" earlier application or patent but published on or after the international document of particular relevance; the claimed invention cannot be
filing date considered novel or cannot be considered to involve an inventive
"L" document which may throw doubts on priority claim(s) or which is step when the document is taken alone
cited to establish the publication date of another citation or other
special reason (as specified) document of particular relevance; d claimed invention cannot be
considered to involve an inventive step when the document is
"O" document referring to an oral disclosure, use, exhibition or other combined with one or more other such documents, such combination
means being obvious to a person skilled in the art
"P" document p lished prior to t international filing date but later than document member of the same pate family
the priority date claimed
Date of the actual completion of the international search Date of mailing of the international search report

18-10-2016 18-10-2016

Name and mailing address of h e ISA/ Authorized officer

Indian Patent Office C S Paikra
Plot No. 32, Sector 14,Dwarka, ew Delhi-110075
Facsimile No. Telephone No. +91-1125300200
Form PCT/ISA/210 (second sheet) (January 2015)
 nterna ona app ca on o.
PCT/IB2016/054286

Box No. Π Observations where certain claims were foand unsearchable (Continuation of item 2 of first sheet)

This international search report has not been established in respect of certain claims under Article 17(2)(a) for the following reasons:

Claims Nos.: 21-37

because they relate to subject matter not reauired to be searched by this Authority, namely:
Subject matter " of the claims 21-37 relates t o monitoring and
detecting hypothermia which contains step o f determining hypothermia
based on the difference o f the measured temperature and the ambient
temperature a s well a s previous temperature measurements which i s a
diagnostic method and which does not require search by the

Claims Nos.:
because they relate to parts of the international application that do not comply with the prescribed requirements to such an
extent that no meaningful international search can be carried out, specifically:

3. Claims Nos.:
because they are dependent claims and are not drafted in accordance with ihe second and third sentences o f Rule 6.4(a).

Box No. Ill Observations where unity of invention is lacking (Continuation of item 3 of first sheet)

This International Searching Authority found multiple inventions in this international application, as follows:

As all required additional search fees were timely paid by the applicant, this international search report covers al searchabl
claims.

2. j [ As all searchable claims could be searched without effort justifying additional fees, this Authority did not invite payment of
additional fees.

As only some of the required additional search fees were timely paid by the applicant, this international search report covers
only those claims for which fees were paid, specifically claims Nos.:

No required additional search fees were timely paid by the applicant. Consequently, this international search report is
restricted to the invention first mentioned in ihe claims; it is covered by claims Nos.:

Remark on Protest The additional search fees were accompanied by the applicant's protest and, where applicable, the
payment of a protest fee.
The additional search fees were accompanied by the applicant's protest but the applicable protest
fee was not paid within the time limit specified in ihe invitation.
No protest accompanied the payment of additional search fees.

Form PCT ISA/21 (continuation of first sheet (2)) (January 2015)

 nternat ona app cat on o .
PCT/IB2016/054286

Continuation of Claims found unsearchable (Box II)

International Searching Authority in accordance with PCT Article

17(2) (a) (i) and Rule 39.1 (iv) under PCT regulations.

Form PCT ISA/210 (extra sheet) (January 2015)