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NIRA Temp Instructions

Important: Read instructions carefully before use. High, prolonged fever requires medical attention. If symptoms persist, contact your healthcare provider.

Welcome to NIRA Temp, continuous temperature monitoring.

NIRA Temp is a Bluetooth continuous temperature monitoring device with disposable patches. The devices 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 4.0 capability running the NIRA Health app). This product is suitable for people of all ages.

Position the device in the underarm area.

Apply device to clean, dry skin.

Peel and attach bandage directly over the device. Ensure that the device is fully covered by the bandage.

The arm should be relaxed along your side to enclose the device in the armpit. Temperature measurements can be affected by cold ambient temperatures.

The NIRA Health App can be downloaded from the App Store or Google Play Store.

Remove the device and a patch from the packaging. Ensure the patch is placed on clean, dry skin near the armpit.

Pair the device to the NIRA Health App via Bluetooth.
Register to assign the device to yourself or a loved one.

Get a real-time look at your temperature and get notified at the first sign of a health concern.

The device uses color coding to aid the user:

GREEN

Ready to Use - (Temperature is less than 100.4°F)

YELLOW

Caution - Prompt response by user is required. (Temperature is greater than 100.4°F)

RED

Warning - Immediate response by user is required. (Temperature exceeds user defined limit)

GREY

Offline - Device is not collecting data.

The wireless thermometer, Model 1, is a battery-operated electronic device with an intended use of measuring human body temperature precisely. The device measures under-the-arm "axillary" temperature and converts this to an oral equivalent temperature measurement.

This device is reusable and intended for armpit temperature readings for people of all ages.

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 results in inaccurate temperature readings resulting in a delay in treatment, or could result in skin irritation and mild discomfort.

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 immerse the device in water. Device may be removed for a bath or shower and then re-applied afterwards.

DO NOT use the device if it has been damaged or immersed in water.

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

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

Model Number

NIRA Health Thermometer

Device Dimensions

30 mm x 22 mm

Device Weight

4 grams

Device Operating Life

1 Year

Environmental Conditions

  • Storage
  • Shipping
  • Use

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

Temperature Measurement Location

Axillary (under the arm) - app converts axillary temperature to body temperature which is equivalent to temperature meas

Temperature Range

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

Temperature Indications

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

Accuracy or Essential Performance

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.

Battery

Non-rechargeable
Nominal Voltage Range: 3.2 - 3.6 V

Accuracy

Accuracy ± 0.1C in the range of 25-45C

Transmission Distance

90 feet

Compatible Smart Devices

iOS, Android

Standards

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 Of Clinical Thermometers For Body Temperature Measurement
ISO 80601-2-56 First Edition 2009-10-01 Medical 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
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

Regulatory Requirements

NIRA Temp shall comply with the medical device and radio frequency emitting device regulations for the territories it will be marketed to. In particular, it shall comply with Class II medical device regulations of the US Food and Drug Administration (FDA) in the United States of America and FCC regulations for intentional emitters of RF radiation.

Water Ingress Protection

IP67

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.

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

© 2020 Dermal Photonics Corp.
NIRA and other related marks are owned by Dermal Photonics Corp.

Contact customer service at 1-877-607-NIRA or email us at info@niraskin.com.