SteadySense SteadyTemp Manual

EXPLANATION OF SYMBOLS

Lot number

Manufacturer

Expiration date

Medical Device

Single Use Product

Dispose of in battery bin

Storage temperature

Observe terms of use www.steadytemp.info/ifu

Safety advice

Information

QUICK USE GUIDE

Download SteadyTemp app:

USAGE INFORMATIONS

• Before applying the patch, wash with non-greasing soap and thoroughly dry the skin under the arm. The patch application area can also be cleaned using a suitable alcohol pad.
• Do not use deodorant or cream beforehand.
• When applying the patch, remove the small part of the carrier foil first.
• Do not touch the adhesive side of the patch, this could reduce overall adhesiveness.
• After applying the patch, smooth it out gently on all sides to fix it in place.
• The patch should be read via NFC at least once a day.
• Hold your smartphone as still as possible while activating and reading the patch.
• Remove the patch immediately if it becomes uncomfortable or causes skin irritation.
• Do not do physically intense sport or any other activities that cause excessive perspiring (sauna or steam room) while wearing the patch.
• Throughout the day, small variations in body temperature occur, which are shown by the continuous measurement.

USING THE SENSOR PATCH

Apply Patch

The patch should be applied to clean dry skin, free from cream or deodorant. To apply the patch relax your shoulder, put your hand on your hip and place 3 fingers directly under your arm. Make sure that the round edges of the patch point up and downwards.

Activate Patch

After 10 minutes you can activate the patch. Patch activation is a two step process. Tap on the patch icon in the app and hold the backside of your smartphone against the patch in order connect the patch to a user. After connection, hold the backside of your smartphone against the patch to activate it – a vibration will confirm successful activation.

Read Patch

After a successful data transfer the app displays your current body temperature and stored temperature curves. Please note that measured temperature values are processed by SteadyTemp for display purposes. Reliable temperature values are available about 1 hour after the patch has been activated.

Android: Ensure NFC is activated
User assignment: Follow app instructions

Position for NFC-Communication

NOTIFICATIONS

App-notifications about unusual body temperature values can temporarily appear due to extreme environmental influences. If that is the case, please check if the patch is still properly attached and read it again after some time. Should the problem persist for more than 6 hours, please contact our technical support via E-Mail: support@steadysense.at

NOTIFICATION:
"Temperature outside range"
If your currently measured temperature is outside the defined measurement range, then it will not be displayed in the temperature chart. In the field: "Last measurement", either "Lo" (for low temperature) or "Hi" (for high temperature) will be displayed.

"Threshold alert"
After patch read-out, the app will inform you when the measured temperature exceeds your selected high temperature threshold for a certain duration.

USER MANAGEMENT

In the user management you can view the data of all users created in the app. If you want to change a user name or delete the user, then swipe the user name to the left to make the changes.

DISPOSAL

The patch is powered by a button cell battery. Therefore, it should not be thrown out in the regular household waste but disposed of according to the local waste regulations for batteries and electrical goods. The SteadyTemp packaging is recyclable and can be disposed of in the paper bin.

TECHNICAL DATA

Type of device: Clinical thermometer

Measuring site: Axilla

Type of use: Single use product

Typical application duration: 7 days

Measurement range: +30 to +42°C

Measurement accuracy: SteadyTemp displays relative changes of the axillary temperature with a maximum deviation of +/-0.3°C.

Operating mode: Direct mode, continuous

Measurement interval/time response: 300 seconds

Operating conditions: Environmental temperature +15 to +42°C, RH: 15 to 95%, air pressure: 86 to 106 kPA

Transport and storage conditions: Environmental temperature: 0 to +40°C, RH: 15 to 95%, air pressure: 86 to 106 kPa

System compatibility:
Apple: iOS 13 or higher on iPhone 7 or newer models

Android: Android OS 6.0 Marshmallow or newer on an NFC enabled smartphone

Dimensions: 65 x 60 x 3 mm

Weight: 3 grams

Power source: 3V lithium button cell battery (not replacable)

IP-Classification: IPX5: Protection against waterjets from any direction

INTENDED USE

SteadyTemp is a clinical thermometer intended to continuously measure axillary temperature and to display relative changes in axillary temperature to the user.

The SteadyTemp system can be used by medical professionals in clinical environments and consumers in a home care environment. It is intended to be used on people older than 5 years of age.

The system consists of a sensor patch and a smartphone application, the body temperature data measured by the sensor is transmitted via NearField-Communication (NFC) and subsequently displayed by the smartphone application.

Contraindications

The SteadyTemp system should not be used under following circumstances:

Emergency situations

Known allergy to ingredients of skin patches

Wounds, skin diseases or abrasions in the application area of the SteadyTemp patch

SAFETY INSTRUCTIONS

• SteadyTemp is not intended for persons under 5 years of age
• SteadyTemp does not substitute the consultation of a medical professional.
• The patch shall not be used by individuals who are not capable of using the device correctly.
• Do not use the patch for any purpose other than measuring axillary temperature.
• Measured temperature values are processed by SteadyTemp for display purposes.
• Do not use the patch more than once, it is a single use product.
• Do not apply the patch on injured skin.
• Do not use the patch if it has been damaged or contaminated.
• Do not attempt to dissemble or open the patch. Do not fold or twist the SteadyTemp patch.
• Do not apply successive patches on the same body side.
• Do not use the patch when undergoing an MR or CT examination.
• The SteadyTemp Patch is a mini electronics device. Do not dispose of the patch in the regular household waste.
• Do not throw the patch in the fire, the battery could explode.
• Do not wear the patch for longer than 7 days.
• Store the patch out of the reach of children, pets and people with impairments.
• The SteadyTemp patch is not intended to be used by individuals (including children) with reduced physical, sensory or mental capabilities, or lack of experience and/or knowledge, unless they have been given supervision or instruction concerning use of the device by a person responsible for their safety.
• Children must be supervised to ensure that they do not play with the device.
• The patch must be worn in the correct position under the arm to ensure reliable temperature readings.
• Use the patch only within the specified operating conditions as operation outside the defined conditions can damage the patch and cause discrepancies in the accuracy of the measurements.
• Do not take an extended bath or go swimming while wearing the patch.
• The patch should be stored in a dry place and protected from direct sunlight.
• If the patch becomes uncomfortable, please remove it immediately.
• When applied, the patch can cause local and temporary skin irritations.

SUPPORT

For questions or problems with the product please contact us via E-Mail: support@steadysense.at

SteadySense GmbH
Kärntnerstraße 518
A-8054 Seiersberg-Pirka

IFU Version: 21_12

Publication date: 22.12.2021