TENA 8544 SmartCare Change Indicator Gateway User Manual

TENA 8544 SmartCare Change Indicator Gateway

INFORMATION

This guide is intended for Family Caregivers or Professionals using the TENA SmartCare Change Indicator™/MC in a home environment or a nursing home. The Change Indicator system tracks and displays urine saturation levels in an absorbent TENA incontinence product. The TENA SmartCare Change Indicator is a system consisting of:

• An app, installed on one or more smartphones/handheld devices.
• A reusable Change Indicator consisting of two parts;
• A Sensor Strip and a Transmitter.
• A gateway that relays data from the Change Indicator.

Read the full TENA SmartCare Change Indicator Instructions For Use before using the product.

Symbols used in this guide:

WARNING

Care shall be taken to ensure safety and efficiency. Failure to do so could cause damage to equipment or lead to the receipt of incorrect data.

NOTE : Important information or advise/tip

SET-UP GATEWAY

Parts you need to set-up gateway: NOTE
The gateway should be within 10 m (33 ft) of the user and connected to an electric power outlet to use the TENA SmartCare Change Indicator System.

Placement NOTE

• If an internet connection cannot be established please try to change location of the TENA SmartCare gateway.
• It is preferred that the gateway is placed so it has clear line of sight towards the Transmitter.

LIGHTS & BUTTONS & CLEANING

NOTE

The LED light can be difficult to see if it is exposed to e.g. strong sunlight. Try to cover the sunlight to improve readability. Clean the gateway with a dry cloth when needed.

Gateway installation

After attaching the gateway to a power outlet.

Green light disappears after  a while and the system goes into dark mode. Push the button to see if it has power  and connection. If no light goes on, check the power  connection.

| Steady red light:

Error. See Troubleshoot section,  p. 8-9, in this guide for more  information.

TECHNICAL SPECIFICATION

RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12”) to the Change Indicator. Otherwise, degradation of the performance of this equipment could result. Interference may occur in the vicinity of equipment marked with this symbol.

Product component dimensions (mm/ inch)

Product weight (g/ ounce)

Environmental conditions

Operating humidity

(non-condensing)

| 15% Rh| 90% Rh
Pressure| 700 hPa| 1060 hPa

TROUBLESHOOT

What is “Dark mode”?

| The gateway LED light turns itself off after  a few seconds = goes into dark mode  in order  to avoid distur- bance during night. Press the button to wake up the gateway again. If nothing happens at a button-push, please make  sure the gateway is connected to a power  outlet
There is something wrong with the connection to the TENA SmartCare Change Indicator system.|

• There may be no battery in the transmitter or it is not properly inserted. Please install  the battery and check the installation.
• The transmitter may not be correctly attached to the Sensor Strip. Please check, and try again.
• The Transmitter code  may be wrong. Please check and try to enter it again.
• The Transmitter may be to far away from the gateway. Please try to move the transmitter closer  to the gateway, within 10 m (33ft).

If it still does not work, please contact TENA SmartCare support.

There is something wrong with the gateway connection.|

• There is no power connection.Please try to connect to another power outlet.
• Push the button once. If there is a green light it is OK. (It blinks blue during setup.) If there is a red light it is something wrong.Please contact TENA SmartCare support.
• Please try to take out the power cord and replace it.
• Please try to move the gateway to another location, maybe there is no coverage in your location.
• Please contact your TENA SmartCare support if your gateway isn’t active ted in your warehouse – to remote activation.

If it still does not work, please  contact TENA SmartCare support.

WARNINGS

• The gateway should not be sterilized.
• The gateway should not be used in an oxygen rich environment.
• The gateway should not be used in presence of flammable anaesthetics.
• Do not attempt to repair the gateway by yourself.
• Only use the power supply provided with the gateway.
• If the gateway connection cannot be established it will not be able to send information and work as expected. In such a case, please revert to a manual process for checking the incontinence product. Check the Troubleshooting section in this guide and if needed, contact TENA SmartCare support.
• Do not open or modify the gateway. Doing so will result in a void of warranty and can result in an unidentified risk to patient, operator or third party.
• Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.

IMPORTANT INFORMATION

• Save this user manual for future reference.
• If any changes to the installation are necessary, please contact TENA SmartCare support.
• Devices shown are not actual size.

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
2. This device must accept any interference received, including interference that may cause undesired operation.

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 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.

WARNINGS

This device contains licence-exempt transmitter(s)/receiver(s) that comply with Innovation, Science and Economic Development Canada’s licence-exempt RSS(s). Operation is subject to the following two conditions:

• This device may not cause interference.
• This device must accept any interference, including interference that may cause undesired operation of the device.

This equipment complies with the ICES RF radiation exposure limits set forth for an uncontrolled environment. This equipment should be installed and operated with a minimum distance of 20cm between the radiator and any part of the human body.

LABELLING SYMBOLS

The following symbols appear on your TENA SmartCare gateway or accessories and/or packaging:

• WEEE-marking: Dispose of electrical components in accordance with your local regulations.
• Radio Frequency Radiation Symbol
• European Conformity mark
• Instruction manual
• Storage- and transport temperarture
• Humidity limitation
• Atmospheric pressure limitation

Manufactured

Manufactured by: Essity Hygiene and Health AB SE-405 03 Göteborg, Sweden

Visiting address: Mölndals Bro 2, Mölndal

Distributed in the US by : Essity HMS North America Inc.
Distributed in Canada by : Essity Canada Inc.Cira Centre, 2929 Arch Street, Suite 2600. Philadelphia, PA 19104
Made in Sweden www.essity.com

FCC ID: 2ABIC3-91285 Contains FCC ID: N7NWP77B
IC: 10866A-91285 Contains IC: 2417C-WP77B Version: NA 2020-08-20

References

• Essity - A global leading hygiene and health company | Global Corporate
• TENA Countries and Regions

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