Nira Temp 2 Manual de usuario

820.009 Rev 01

Quick Start & Instructions For Use

TEMP

Open this link from your phone or tablet:

https://testflight.apple.com/join/htMatc38

Click "View in App Store"

Download TestFlight & ensure the download has completed

Peel the patch and place the device on clean, dry skin under

the armpit. The sensor should touch the skin.

Get a real-time look at your temperature and get notified at the first

sign of an abnormal temperature.

1. Get TestFlight

3. Stick To Activate

5. Monitor In Real Time

Return to the page from Step 1, or click this link again:

https://testflight.apple.com/join/htMatc38

Click "Start Testing" to complete Step 2.

This should open the TestFlight app. You will be guided

through the installation process.

Once connected to the NIRA Temp App, assign the device to

yourself or a loved one.

2. Join the Beta

4. Connect & Assign User

Device measures under-the-arm “axillary” temperature.

The device uses color coding to aid the user:

Caution – Prompt response by user is required.

(Temperature is greater than 100.4°F)

Warning – Immediate response by user is required.

(Temperature exceeds user defined limit)

Ready to use - (temperature is less than 100.4°F)

Welcome to NIRA Temp, a wearable smart thermometer.

NIRA Temp is a Bluetooth® wearable smart thermometer with disposable patches. The

device senses, records and transmits body temperature via Bluetooth®. Temperature

information from the sensor is monitored using a smart device (Apple® or Android™ with

Bluetooth® Version 4.1 or higher capability running the NIRA Temp app). This product is

suitable for ages 3 and up.

The wireless thermometer, Model 2, is a battery-operated electronic device with an intended

use of measuring human body temperature. This device is reusable and intended for armpit

temperature readings for people of ages 3 and up.

Important: Read instructions carefully before use. High,

prolonged fever requires medical attention. If symptoms

persist, contact your healthcare provider.

Introduction to NIRA Temp

Intended Use

Temperature Measurement

Alert Levels

When using this product always follow these basic safety precautions to ensure that the

patch accurately reads temperature and to avoid skin irritation. Failure to follow these

precautions could result in inaccurate temperature readings resulting in delay in treatment,

or could result in skin irritation and mild discomfort.

Peel the adhesive patch and center the device onto the patch with the sensor side up.

Ensure that the device is fully covered by the patch.

Place the patch with the device onto clean, dry skin under the armpit.

Make sure that the sensor is touching the skin.

The device should be fully enclosed in the armpit when your arm is relaxed along

your side. Temperature measurements can be affected by cold ambient temperatures.

DO NOT use the device for any other purpose besides measuring human body

temperature.

DO NOT place the device on wounds, sores or abrasions.

DO NOT drop or throw the device.

DO NOT use the device if it has been damaged.

DO NOT attempt to take apart the device; there are no user serviceable parts.

Patch Adhesive may irritate skins. Contact doctors if irritations persists.

No modification of this equipment is allowed.

The device or its components are not intended to be serviced, replaced, or repaired.

Device is powered by a 3V non-rechargeable battery. Not intended to be recharged,

serviced, replaced, or repaired.

The device is reusable for one year.

May be safely applied to self or used on others.

May be discarded in common household waste.

CHOKING HAZARD -Small parts. Not for children under 3 yrs.

Type BF Applied Part

Warnings and Precautions

For Best Results

Model 2

30 mm x 22 mm x 6 mm

4 grams

12 Months

Storage Conditions: Temperature -4 to 95 °F (-20 to 35 °C), Relative Humidity 10–100%, Atmospheric Pressure 50-106

kPa

Transport Conditions: Temperature -40 to 122 °F (-40 to 50 °C), Relative Humidity 10–100%, Atmospheric Pressure 50-

106 kPa

Use Conditions: 77 to 113 °F (25 to 45 °C), Relative Humidity (non-condensing) 30-100%, Atmospheric Pressure: 70 =

106 kPa pressure range of 700 hPA to 1,060 hPA

Axillary (under the arm)

77 to 113°F (25 to 45°C ) Relative Humidity 30–100% Atmospheric Pressure 70-106 kPa

Green: Ready to Use Temperature is in normal range.

Yellow : Caution – prompt response by user is needed. Indicates a possible fever of 100.4°F (38.0°C)

Red : Warning – Immediate response by user is required. Indicates a temperature equal to or higher than the user defined

limit.

Accuracy and regular ability to measure and communicate results are considered as essential performance for the

purposes of risk and electrical safety analysis. Also ability to communicate battery voltage.

Non-rechargeable

Nominal voltage Range: 2.5-3.2 V

±0.3°C (±0.5°F) in the range of less than 35.8°C (96.4°F)

±0.2°C (±0.3°F) in the range of 35.8°C (96.4°F) to less than 37°C (98.0°F)

±0.1°C (±0.2°F) in the range of 37.0°C (98.0°F) to 39.0°C (102.0°F)

±0.2°C (±0.3°F) in the range of Greater than 39.0°C (102.0°F) to 41.0°C (106.0°F)

±0.3°C (±0.5°F) in the range of Greater than 41.0°C (106.0°F)

90 feet

IOS, Android.

Designed to comply with the following standards:

ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity

ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Tests for irritation and skin sensitization

ASTM E112:2018 Standard Specification for Electronic Thermometer for Intermittent Determination of Patient

Temperature

ASTM E1104:2016 Standard Specification for Clinical Thermometer Probe Covers and Sheaths

AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R) Medical

Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance.

IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential

Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests.

ISO 80601-2-56 First Edition 2009-10-01Medical Electrical Equipment - Part 2-56: Particular Requirements For

Basic Safety And Essential Performance Of Clinical Thermometers For Body Temperature Measurement.

IEC 60601-1-11:2010 Medical electrical equipment- Part 1-11: General requirements for basic safety and essential

performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical system used in

the home healthcare environment.

IEC 60601-1-2 ed4.0 (2014-02) Medical electrical equipment- Part 5.2.1.1(b): the performance of the ME

EQUIPMENT or ME SYSTEM that was determined to be ESSENTIAL PERFORMANCE and a description of what the

OPERATOR can expect if the ESSENTIAL PERFORMANCE is lost or degraded due to EM DISTURBANCES (the defined term

“ESSENTIAL PERFORMANCE” need not be used).

IEC 60601-1-2 ed4.0 (2014-02) Medical electrical equipment and systems- Part 5.2.2.1(a): the compliance for

each EMISSIONS and IMMUNITY standard or test specified by this collateral standard, e.g. EMISSIONS class and group

and IMMUNITY TEST LEVEL.

FCC Part 15 Rule 247 and/or 249 for intentional radiation of radio frequency

ASTM D4169-14 Standard Practice for Performance Testing of Shipping Containers and Systems

The NIRA Temp shall comply with the medical device and radiofrequency emitting device regulations for the territories

it will be marketed to. In particular, it shall comply with Class II medical device regulations of US Food and Drug

Administration (FDA) in the United States of America and FCC regulations for intentional emitters of RF radiation.

IP67

Read instructions carefully before use.

Model Number

Device Dimensions

Device Weight

Device Operating Life

Environmental Conditions

•Storage

•Shipping

•Use

Temperature Measurement Location

Temperature Range

Temperature Indications

Accuracy or Essential Performance

Battery

Accuracy

Transmission Distance

Compatible Smart Devices

Standards

Regulatory Requirements

Water Ingress Protection

IMPORTANT:

Specifications

NIRA is committed to quality. Each NIRA Temp device is rigorously tested for quality and

performance. This limited warranty covers defects in materials and workmanship of your NIRA

Temp device if you purchased it from an authorized partner or directly from the manufacturer (NIRA).

Your limited warranty is valid for you alone, the original purchaser and cannot be transferred. The

limited warranty begins on the date of purchase and is in effect for 30 days.

This limited warranty does not cover damage resulting from accident, misuse or abuse, or lack

of reasonable care. No responsibility is assumed for any special, incidental or consequential

damages. In order to obtain warranty replacement, simply contact our Customer Care Department

at [email protected]om.

This device complies with part 15 of the FCC rules. Operation is subject to the following two conditions (1)

this device may not cause harmful interference, and (2) this device must accept any interference received

including interference that may cause undesired operation.

FCC WARNING: any changes or modifications not expressly approved by the party

responsible for compliance could void the user's authority to operate this equipment

under FCC regulations.

NOTE: this equipment has been tested and found to comply with the limits for a Class B digital device,

pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against

harmful interference in a residential installation. This equipment generates, uses and can radiate radio

frequency energy and, if not installed and used in accordance with the instructions, may cause harmful

interference to radio communications.

However, there is no guarantee that interference will not occur in a particular installation. If this equipment

does cause harmful interference to radio or television reception, which can be determined by turning

the equipment off and on, the user is encouraged to try to correct the interference by one or more of the

following measures:

• Reorient or relocate the receiving antenna

• Increase the separation between the equipment and the receiver

• Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.

• Consult the dealer or an experienced radio/TV technician for help.

FCC ID: 2ADZENIRE

NIRA® and other related marks are owned by Dermal Photonics Corp.

Warranty

FCC Statement and Legal

The NIRA Temp needs special precautions regarding EMC and needs to be installed according to EMC information.

The device contains hardware capable of Bluetooth Low Energy (BLE) communication. This hardware can receive and

transmit RF energy in 2400—2483.5 MHz frequency range with DSSS modulation. It is compliant with CFR Title 47,

FCC part 15.247 and ETSI EN 300-400 standards, and equivalent isotropically radiated power is less than 10 dBm

(10mW).

Caution: Mobile RF communications equipment can affect the NIRA Temp device.

EMC Information

Electromagnetic Immunity Declaration

The NIRA Temp is intended for use in the electromagnetic environment speciﬁed below. The customer or the user of the NIRA Temp should assure that it is used

in such an environment.

Immunity test IEC 60601test level Compliance level Electromagnetic environment – guid-

ance

Electrostatic discharge (ESD)

IEC 61000-4-2 +8 kV contact

+15 kV air Complies

Electromagnetic Immunity Declaration

The NIRA Temp is intended for use in the electromagnetic environment speciﬁed below. The customer or the user should assure that it is used in such an environ-

ment.

Immunity test IEC 60601 test level Compliance

level Electromagnetic environment – guidance

Radiated RF

IEC 61000-4-3 10 V/m

80 MHz to 2.5 GHz 10 V/m

Portable and mobile RF communications equipment should

be used no closer to any part of the NIRA Temp, than the rec-

ommended separation distance calculated from the equation

applicable to the frequency of the transmitter.

Recommended separation distance

d = 1.17 150 kHz to 80 MHz

d = 1.17 80 MHz to 800 MHz

d = 2.33 800 MHz to 2.5 GHz

where P is the maximum output power rating of the trans-

mitter in watts (W) according to the transmitter manufacturer

and d is the recommended separation distance in meters

(m).Field strengths from ﬁxed RF transmitters, as determined

by an electromagnetic site survey,ashould be less than the

compliance level in each frequency range.b

Interference may occur in the vicinity of equipment marked

with the following symbol:

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reﬂection from structures, objects and

people.

aField strengths from ﬁxed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radio, amateur radio, AM and FM

radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to ﬁxed RF transmitters,

an electromagnetic site survey should be considered. If the measured ﬁeld strength in the location in which the NIRA Temp is used exceeds the applicable

RF compliance level above, the NIRA Temp should be observed to verify normal operation. If abnormal performance is observed, additional measures

may be necessary, such as reorienting or relocating the NIRA Temp.

bOver the frequency range 150 kHz to 80 MHz, ﬁeld strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF communications equipment and the NIRA Temp

The NIRA Temp is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the NIRA

Temp can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmit-

ters) and the NIRA Temp as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of

transmitter (W)

Separation distance according to frequency of the transmitter (m)

150 kHz to 80 MHz

d = 1.17

80 MHz to 800 MHz

d = 1.17

800 MHz to 2.5 GHz

d = 2.33

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.17 1.17 2.33

10 3.70 3.70 7.37

100 11.70 11.70 23.30

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using equation

applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufac-

turer.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reﬂection from structures, objects and

people.

Electromagnetic Emissions Declaration

The NIRA Temp is intended for use in the electromagnetic environment speciﬁed below. The customer or the user of the NIRA Temp should assure that it is used

in such an environment.

RF emissions CISPR 11 Group 1 The NIRA Temp uses RF energy only for its internal function. Therefore, its RF emissions are very low and are

not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11 Class B

The NIRA Temp is suitable for use in all establishments.

Harmonic emissions

IEC 61000-3-2 Complies

Electromagnetic Emissions Declaration

The NIRA Temp is intended for use in the electromagnetic environment speciﬁed below. The customer or the user of the NIRA Temp should assure that it is used

in such an environment.