FCC ID: 2ABK3-91285 Gateway for TENA IQ Solution

TENA SmartCareTM/MC Gateway Manual www.tena.com INFORMATION This guide is intended for Family Caregivers or Professionals using the TENA SmartCareChange 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. x 2 Sensor Strip Read the full TENA SmartCare Change Indicator Instructions For Use before using the product. Transmitter LED Buttons Symbols used in this guide:

WARNING x 2 Quick Guide 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. Battery, CR2032 REF SN REF MD SN IP65 MD NOTE Important information or advise/tip FCC ID:

IP65 Parts you need to set-up gateway:

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10 40 40 Power Plug 10 gateway LED light Button Mounting bracket 2 REF SET-UP GATEWAY SN MD 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. 10 m (33 ft) 10 m (33 ft) FCC ID:

IP65 10 m (33 ft) 10 m (33 ft) Placement 10 m (33 ft) 40 10 Screws or adhesive tape Screws or adhesive tape 1 Screws or adhesive tape Screws or adhesive tape x2or x2or Screws or adhesive tape x2or x2or x2or 3 IC:

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CLICK!

CLICK!

2 CLICK!

CLICK!

CLICK!

Alternative placement NOTE If an internet connection cannot be established please try to change location of the TENA SmartCare gateway. IP65 FCC ID:

It is preferred that the gateway is placed so it has clear line of sight towards the Transmitter. 3 REF SN MD IC:

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LIGHTS & BUTTONS & CLEANING 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. FCC ID:

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LED light 40 10 Button Clean the gateway with a dry cloth when needed. Gateway installation After attaching the gateway to a power outlet. Colour LED light What it means Blinking blue light:

Wait. The system is connecting. Steady green light:

All is OK. No light:

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. 4 5 FCC ID:

TECHNICAL SPECIFICATION IC:

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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. 40 10 Interference may occur in the vicinity of equipment marked with this symbol. Product weight (g/ ounce) COMPONTENT WEIGHT Gateway 174 g/ 6.14 oz Mounting bracket 7 g/ 0.25 oz TECHNICAL SPECIFICATION Type of communication BLE, LTE-M, 2 G Frequency BLE Peak Power Average Power Input Voltage 2.4 GHz 10 Watt 0.7 Watt 5 V Product component dimensions (mm/ inch) ITEM LENGTH WIDTH HEIGHT Environmental conditions CONDITION MINIMUM MAXIMUM Storage & transport temp.

+10C / 50F

+40C / 104F Storage & transport humidity 65% Rh 90% Rh Operating temp.

+15C / 59F

+45C / 113F Operating humidity

(non-condensing) 15% Rh 90% Rh Gateway 134 mm/ 5.28 86 mm/ 3.39 25 mm/ 0.98 Pressure 700 hPa 1060 hPa 6 7 TROUBLESHOOT TROUBLESHOOT PROBLEM RESOLUTION PROBLEM RESOLUTION What is Dark mode?

There is something wrong with the connection to the TENA SmartCare Change Indicator system. 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 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 Smart-

Care support if your gateway isnt activa ted in your warehouse - to remote activation. If it still does not work, please contact TENA SmartCare support. 8 9 WARNINGS IMPORTANT INFORMATION Only use the power supply provided with the gateway. NOTE:

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. 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 users 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, and (2) this device must accept any interference received, including interference that may cause undesired operation. 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 protec-

tion 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 in-

structions, may cause harmful interference to radio communica-

tions. 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. 10 11 WARNINGS IMPORTANT INFORMATION This device contains licence-exempt transmitter(s)/receiver(s) that comply with Innovation, Science and Economic Development Canadas licence-exempt RSS(s). Operation is subject to the following two conditions:

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. This device may not cause interference. This device must accept any interference, including interfer-

ence that may cause undesired operation of the device. Le prsent appareil est conforme aux CNR dIndustrie Canada applicables aux appareils radio exempts de licence. Lexploitation est autorise aux deux conditions suivantes : (1) lappareil ne doit pas produire de brouillage, et (2) lutilisateur de lappareil doit accepter tout brouillage radiolectrique subi, mme si le brouillage est susceptible den compromettre le fonctionnement. Cet quipement est conforme aux limites dexposition aux radiations ICES dfinies pour un environnement non contrl . Cet quipement doit tre install et utilis une distance minimale de 20 cm entre le radiateur et une partie de votre corps. 13 12 REF SN MD LABELLING SYMBOLS REF MD REF MD IP65 FCC ID:

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

IP65 SN SN FCC ID:

IP65 WEEE-marking. Dispose of electrical components in FCC ID:

accordance with your local regulations. IC:

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Radio Frequency Radiation Symbol European Conformity mark 40 10 Instruction manual UDI:

40 10 40 10 90 % Rh 65 % Rh 1060 hPa 700 hPa Storage- and transport temperarture Humidity limitation Atmospheric pressure limitation 15 14 REF Manufactured by: Essity Hygiene and Health AB SE-405 03 Gteborg, Sweden Visiting address: Mlndals Bro 2, Mlndal 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 MD SN Made in Sweden www.essity.com IP65 FCC ID:

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FCC ID: 2ABIC3-91285 IC: 10866A-91285 Contains FCC ID: N7NWP77B Contains IC: 2417C-WP77B REF 91285 Version: NA 2020-08-20 SN MD 40 10 IP65 TENA an Essity brand

FCC ID: 2ABK3-91285 FCC ID: 2ABK3-693930 VI N 1.0 H VI N 1.0 H HVIN 1.0 Marking label is located on the backside of the product Essity Internal

essity ery ferUim ist ical) Direct line Renee hg Email 2020-02-17 ac =)t Tamed 8 00 UROL ET

+46 31-746 11 22

+46 31-746 19 00 peter.blomstrom@essity.com 2020-02-17 ae Request for Confidentiality Applicant: Essity Hygiene and Health AB FCC ID: 2ABK3-91285 To Whom It May Concern:

EUR M Lasse Request is hereby submitted by Essity Hygiene and Health AB to withhold permanently from public review certain portions of the application for equipment certification for the referenced FCC identifiers. This request for confidentiality is made pursuant to 47 CFR 0.457(d) and 0.459 of the FCC Rules. In particular, the following sections of the application are to be kept permanently confidential:

Schematics Detailed Block Diagrams Detailed Operational/Functional Description CML Rationale for request for confidentiality:

Essity Hygiene and Health AB has invested considerable time and materials in research and development to produce the referenced product. Disclosure of the permanently confidential portions of this application to competitors would not only give them significant competitive advantages in developing similar products, but would also disclose successful implementation of unpublished, leading edge technology developed by us. The fee for confidentiality has been submitted along with the fee for certification. If you have questions or need further information, please contact the undersigned. Sincerely, ede le= a1 (0)0 tol aT Global Brand Director Emerging Arenas Essity Hygiene and Health AB eee mei eee m eit itd SE-405 03 GOTEBORG eg]

Visitors address:

Mdindals bro 2, Mindal aiken} +46 31 746 00 tg Coie Me) Seat: Gteborgs kommun. Registration number SE5560072356

essity er) emcee) Direct line ace Het bg Pad tarsi) SE-405 03 GOTEBORG PSL ta) Visitors address:

Mindais bro 2, Mindal Phone +46 31 746 00 00 Lr.) a +46 31 746 1806 2020-02-17 Peter Blomstrm SOME oi mya

+46 31-746 19 00 peter.blomstrom@essity.com 2020-02-17 Federal Communications Commission 445 12th Street SW Washington, DC 20554 Subject: Limited Agency Agreement NAAN RCM ELAR FCC ID: 2ABK3-91285 To Whom It May Concern:

We, Essity Hygiene and Health AB hereby authorized Intertek Testing Services to act as our Agent for the purpose of preparing application for FCC ID number 2ABK3-91285 under all applicable parts of the FCC rules and regulations. The effective date of this limited agency agreement is 2020.02.13. The Limited Agency Agreement expires on 2020.06.13 unless sooner terminated or extended by written notice to Intertek Testing Services and the Federal Communications Commission. This is to advise that we are in full compliance with the Anti-Drug Abuse Act. The applicant is not subject to a denial of federal benefits pursuant to Section 5301 of the Anti-Drug Act of 1988, 21 U.S.C. 862, and no party to the application is subject to a denial of federal benefits pursuant to that section. If you have any questions or comments, please do not hesitate to contact me. Sincerely, each) i=) 080) kel e a Global Brand Director Emerging Arenas Essity Hygiene and Health AB aS meer eet Tied Seat: Goteborgs kommun. Registraton number SE5560072356. 1(1)