Nira TEMP User manual

Quick Start & Instructions For Use
820.009 Rev 01
TEMP

The NIRA Health App can be downloaded
from the App Store or Google Play Store.
Pair the device to the NIRA Health App
via Bluetooth. Register to assign the
device to yourself or a loved one.
Remove the device and a patch from the
packaging. Ensure the patch is placed on
clean, dry skin near the armpit.
Get a real-time look at your temperature
and get notified at the first sign of a
health concern.
1. Download & Install App
3. Pair & Assign User
2. Stick To Activate
4. Monitor In Real Time

Device measures under-the-arm “axillary” temperature and converts this to and oral
equivalent temperature measurement.
GREEN
YELLOW
RED
GREY
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)
Offline – Device is not collecting data.
Introduction to NIRA Temp
Intended Use
Important: Read instructions carefully before use. High,
prolonged fever requires medical attention. If symptoms
persist, contact your healthcare provider.
Welcome to NIRA Temp, 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 4.0 capability running the NIRA Health
app). This product is suitable for ages 3 and up.
The wireless thermometer, Model 1, is a battery-operated electronic device with an intended
use of measuring human body temperature precisely. This device is reusable and intended
for armpit temperature readings for people of all ages.
Temperature Measurement
Alert Levels
The device uses color coding to aid the user:

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.
Clean the application area with 99% alcohol.
Position the device in the underarm area.
Apply device to clean dry skin.
Peel and attach tape directly over the device. Ensure that the device is fully covered
by the tape.
The arm should be relaxed along your side to enclose the device in the armpit.
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 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 irritations persists.
Warnings and Precautions
For Best Results

NIRA Temp Model 2
30 mm x 22 mm
4 grams
1 Year
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) - app converts axillary temperature to body temperature which is equivalent to
temperature measurement taken orally
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: 3.2 – 3.6 V
Accuracy ±0.1C in the range of 25-45 C
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 2009-10-01, 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
The NIRA HEALTH 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:
Type BF Applied Part
Specifications

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.
This 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 call NIRA Temp Customer Care
at 1 (877) 607-NIRA for return instructions, or email [email protected]om.
WARNING:
Warrenty

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.
Customer Care
NIRAtemp.com
[email protected]
[phone]
Dermal Photonics Corp
200 Corporate Place, Suite 2B
Peabody, MA 01960
FCC Statement and Legal