Gabi SMARTCARE Pediarity Instructions For Use Manual

System caregiver

Hide thumbs

Table Of Contents

Table of Contents

Quick Links

Download this manual

The Gabi™ System

Caregiver Instructions for Use

Table of Contents

Troubleshooting

Need help?

Do you have a question about the Pediarity and is the answer not in the manual?

Questions and answers

Summary of Contents for Gabi SMARTCARE Pediarity

Page 1 The Gabi™ System Caregiver Instructions for Use...
Page 2 Caregiver IFU – EN Version 14 FEB 2022 All rights reserved ©2022 Gabi SmartCare® S.A. All content in these Instructions for Use, including the texts, trademarks, service marks, logos, illustrations, photos, graphics, design, etc., are the property of Gabi SmartCare® S.A. Gabi SmartCare® S.A. owns all rights with respect to any trademarks, service marks, logos, and copyrights appearing in these Instructions for Use.
Page 3: Table Of Contents
Table of Contents WELCOME TO GABI™ ..........................5 ABOUT YOUR GABI™ SYSTEM ........................6 .......................... 6 EVICE NDICATIONS FOR ..........................6 RODUCT ESCRIPTION ............................. 6 ONTRAINDICATIONS GENERAL WARNINGS AND CAUTIONS ......................7 ..............................7 ARNINGS ..............................7 AUTIONS .............................. 8 RECAUTIONS 3.3.1 ..........................
Page 4 ......................... 27 QUIPMENT PECIFICATIONS 4.2.1 ........................27 IOMETRICS RANGE AND ACCURACY 4.2.2 ..........................27 SED PEAK WAVELENGTHS ..............................27 LECTRICAL 4.3.1 ................................27 OWER 4.3.2 ................................. 27 ATTERY .......................... 28 HYSICAL HARACTERISTICS ..............................28 IFETIME TROUBLESHOOTING ..........................29 ™ B .....................
Page 5: Welcome To Gabi
Welcome to Gabi™ Thank you for joining us and our Gabi™ community! Thank you also for your trust in our product. For a maximal use of your Gabi™ system and to ensure product safety, we strongly recommend you read the following instructions before starting to use the Gabi™ system. This manual includes information for the proper installation and use of the Gabi™...
Page 6: About Your Gabi™ System
About your Gabi™ System The Gabi™ system is to be used on the order of a physician. Be aware that you need an internet connection to be able to share the recorded data with your physician. Device Indications for Use The Gabi™...
Page 7: General Warnings And Cautions
General Warnings and Cautions Warnings Do not charge the Gabi™ Band while being worn or positioned close to your child. Do not use the Gabi™ Band while in charge because the cord can pose a strangulation hazard. Do not use the Gabi™ system if it appears to be damaged. Do not repair, open, disassemble, or modify.
Page 8: Precautions
Do not use caustic or abrasive cleaning agents. Precautions 3.3.1 Device Use and Storage The Gabi™ Band and the tablet are not toys. You shall ensure to keep the Gabi™ Band (while not in use) and the tablet out of reach of children. The tablet has been configured in kiosk mode, which means that it can be used for the sole purpose of monitoring.
Page 9: Your Gabi™ System - Operating Information
Your Gabi™ system – Operating Information Gabi™ Kit Content The enclosed Gabi™ Kit contains this user manual, a quick setup guide and the following components: A Gabi™ Band sensor A charger to The Gabi™ Monitor Application unit and 3 bracelets of charge the Gabi™...
Page 10: The Gabi™ Monitor Tablet
Figure 1: Gabi Band main components 3.5.2 The Gabi™ Monitor Tablet The data collected by the Gabi™ Band are wirelessly transmitted via Bluetooth to a dedicated tablet, the Gabi™ Monitor Tablet. Figure 2: Gabi Monitor Tablet It is composed of: A power plug, to charge it with the dedicated power charger Two volume buttons, to increase or decrease the volume A power ON/OFF button, to switch it ON/OFF...
Page 11 Figure 3: main screens of Gabi Monitor Application See below the main features of the Gabi™ Monitor Application: Patient’s first name Gabi™ Band Serial Number: serial number (format GB-XXXX-XXXXX) of the Gabi™ Band that is connected to the App. Link to Gabi Monitor user guide Status of the internet connection and of data sharing with your physician: •...
Page 12 general health, body size, activity levels and medical conditions. Your pulse rate is lower when you are resting or sleeping than when you are awake or exercising/moving. Infants and young children’s pulse rates vary as well but are inherently higher than adults’ pulse rates.
Page 13 Gabi™ Band serial number Gabi™ Band status Gabi™ Band battery level Gabi™ Band firmware version Force the firmware update on the Gabi™ Band Send logs to Gabi SmartCare (can be helpful during troubleshooting or when contacting customer support for assistance)
Page 14: Install Your Gabi™ System - Setup Instructions
Install your Gabi™ system – Setup Instructions 3.6.1 Setup the Gabi™ Band Take the Gabi™ Band out of the box. You can keep the box to easily travel with your Gabi™ system. Select the bracelet of the right size based on the upper arm circumference of your child (if known) or on his weight.
Page 15: Setup The Tablet
Connect the Gabi™ Band charger to the Gabi™ Band charging port. Connect the charger to a power outlet (not accessible to children). A white light should start blinking on the Gabi™ Band, indicating charging. Do not charge the Gabi™ Band while being worn or when positioned close to your child. Figure 7Gabi Band charging 3.6.2 Setup the tablet...
Page 16 Figure 8: Gabi Monitor Application setup process - welcome screen Configure your Wi-Fi network, by pressing on the ‘WI-FI SETTINGS’ button. In the detected Wi-Fi list, select the correct network and enter the required password. When the Gabi™ Monitor Tablet is connected to internet, press the back button of the tablet (triangle on the bottom of the screen).
Page 17 Figure 10: Gabi Monitor Application setup process - plug the band screen Pair the Gabi™ Band with the Gabi™ Monitor Tablet. The Gabi™ Monitor Application is scanning the Bluetooth communication to find the Gabi™ Band. Check your Gabi™ Band ID number on the back side of your Gabi™...
Page 18 Figure 12: Gabi Monitor Application setup process - QR code The Gabi™ Monitor Application requests you to confirm your child’s first name. If it is your child’s first name, press the ‘YES’ button and when the account has been created, press the ‘NEXT’...
Page 19 Figure 14: Gabi Monitor Application setup process - date & time check The Gabi™ Monitor Application requests you to secure the access to the Gabi™ Monitor Tablet by defining a pin code or a pattern to unlock it. Press the ‘Security settings’ button, you are redirected to the Gabi™...
Page 20 Figure 16: Gabi Monitor Application setup process - end of process If you face any issue during the setup, feel free to contact our customer support.
Page 21: Use Your Gabi™ System - Operating Instructions
Use your Gabi™ system – Operating Instructions 3.7.1 Before starting a recording Each time you plan a recording (i.e., when your child is about to go to sleep/nap), follow the steps below: Disconnect the Gabi™ Band from its charger. Figure 17: Gabi Band and its charger Verify that the sensor unit’s green and red lights are blinking, indicating that the Gabi™...
Page 22 Fold the free extremity of the bracelet and pull on the extremity until reaching the appropriate bracelet size. The Gabi™ Band bracelet size needs to be adjusted in a way that it will not move, without being too tight either. Attach the scratch of the bracelet to close it.
Page 23: At The End Of The Recording Period
Figure 20: Start of recording (11) Leave the tablet within 5 meters (16 feet) from the child and out of reach of children during the recording to ensure the proper data collection. Do not place the tablet in any position that might cause it to fall on the patient. (12) Leave the tablet connected to power during the recording.
Page 24 Figure 21: Stop recording and upload data Remove the Gabi™ Band from the child’s arm. Be aware that light, temporary marks may appear after wearing the Gabi™ Band for several hours. They should disappear within 10 minutes after removal of the device. If the Gabi™...
Page 25: Cleaning Instructions
When no recording is on-going, you can click on “View Last Recording” to see an overview of the last recording. When finished, you can go back to the previous screen by clicking on the back arrow in the top bar. Figure 23: Last recording overview Cleaning Instructions You should clean the device on a regular basis.
Page 26: 3.8.2 Cleaning The Gabi™ Monitor Tablet
If the textile of Gabi™ Band is dirty, dismount it from the Gabi™ Band sensor unit. Proceed to the cleaning of the textile: you can wash it in a washing machine at a maximum temperature of 30° and a maximum spin speed of 800rpm. Do not tumble dry it! When fully dry, attach back gently the buckle extremity of the bracelet to the discontinued part of the Gabi™...
Page 27: Technical Specifications
Technical Specifications Operational Specifications The Gabi™ Band and tablet are tracked by serial numbers. The Gabi™ Band can safely operate in the following environment: Operating temperature range: 10°C to 45°C Humidity range: 40% to 80% Atmospheric pressure: 700hPa to 1060hPa After 500 battery cycles, the battery performance might be reduced.
Page 28: Physical Characteristics
Battery of Gabi™ Band Type: rechargeable Lithium Ion battery Capacity: 115mAh Charging time: < 2 hours (time to reach 80% capacity at 25°C) Discharging time: > 18 hours in typical continuous usage. Physical Characteristics Gabi™ Monitor Tablet Dimensions: 230mm x 138mm x 25mm Weight: 740g Display characteristics: LCD 1920 x 1200 Gabi™...
Page 29: Troubleshooting
Troubleshooting This section details troubleshooting for the Gabi™ system. If your question or problem is not addressed in the following, please contact the customer support. Troubleshooting specific to the Gabi™ Band A summary of the Gabi™ Band light indications is available in section 6. 5.1.1 The white light of the Gabi™...
Page 30: An Orange Light Is Blinking On The Gabi™ Band
Figure 26: Sensor unit lights 5.1.3 An orange light is blinking on the Gabi™ Band If the orange light is blinking on the Gabi™ Band, it means the software of the Gabi™ Band is being updated. Please do not disconnect the Gabi™ Band from its charger until the orange light turns off and turns white.
Page 31: Troubleshooting Specific To The Gabi™ Monitor Application
The Bracelet is tightened enough to prevent the Gabi™ Band from moving/rotating. The Bracelet is not too tight, to allow blood to circulate normally. Figure 29: Gabi Band correct positioning Figure 30: Gabi Band wrong positionings Troubleshooting specific to the Gabi™ Monitor Application 5.2.1 I cannot start the recording and the “Connection with Gabi Band”...
Page 32 If the problem persists, connect the Gabi™ Band to its charger, once plugged in, the “Connection with Gabi Band” icon should turn green indicating the Gabi™ Band is connected. Figure 31: connection with Gabi Band issue If the icon turns blue again, it means that the Bluetooth is disconnected and that the Gabi™ Band is not paired with the tablet anymore.
Page 33 Figure 32: switching Gabi Monitor Tablet Bluetooth ON b. If the Bluetooth symbol is not missing: Go to “Settings”, then to “Connected devices”, verify if the Gabi™ Band appears in the list of Connected devices. If not, select “Pair new device”, select your Gabi™...
Page 34: Icannot Start The Recording And The "Battery " Icon Is Red
5.2.2 I cannot start the recording and the “Battery” icon is red If you cannot start the recording and the battery status is red, it means the battery of the Gabi™ Band is not sufficiently charged to perform a recording. Please charge the Gabi™ Band before proceeding to the next recording.
Page 35 therefore, could not have been sent to your physician. This happens when the tablet is not connected to Wi-Fi when you press “Stop recording”. To send the pending Gabi recordings, follow the steps below: Click on the red Gabi Cloud icon If the Gabi™...
Page 36: The Gabi™ Monitor Application Is Loading Endlessly When Attempting To Open It
Figure 37: Switch Gabi Monitor Tablet Wi-Fi ON Once done, go back to the Gabi™ Monitor Application, and repeat steps 1 and 3 above. If the problem persists, restart the tablet by holding the power button until shutdown and repeat steps 1, 2 and 3 above.
Page 37: Troubleshooting Specific To The Tablet
Troubleshooting specific to the Tablet 5.3.1 The tablet does not power on If the tablet does not power on, connect it to its charger and wait a few minutes then hold the power button until the tablet turns on. A battery symbol could appear, which means that the battery of the tablet was fully depleted.
Page 38: Gabi™ Band Light Indications
Gabi™ Band Light indications A summary of the Gabi™ Band light indications and their meaning is provided in the table below. Color State Meaning White light Blinking The Gabi™ Band is connected to the power connector every and the battery is charging. second The Gabi™...
Page 39 Green and red sensor unit lights Blinking The Gabi™ Band is ready to be put in contact with the every 5 skin and is checking every 5 seconds if it is being worn or seconds not.
Page 40: Symbols On Product Or Package Labeling
Symbols on Product or Package Labeling Certification and safety-related symbols Equipment Classification per IEC 60601-1 Type of Protection: Class II (AC power) / Internally powered (Battery power) Degree of Protection of Electrical Shock: Defibrillation proof BF-Applied Part Protection against harm from solid and liquid ingress: IP67 for the Gabi Band Mode of Operation: Continuous operation Electromagnetic emissions: XXX (IEC 60601-1-2) Electromagnetic immunity: YYY (IEC 60601-1-2)
Page 41 Caution: Federal Law (USA) restricts this device for sale by or on the order of a physician Lot code Storage temperature range Storage humidity range Storage atmospheric pressure range...
Page 42: Additional Information
Additional Information Clinical Studies To be filled when done. Travel or International Use If you want to use Gabi™ system in foreign countries, you will need an adapter, and may need a converter to convert to the proper voltage. Please check with the carrier to confirm that Gabi™ system can be carried on the airplane.
Page 43: User Assistance Information
User Assistance Information GABI SMARTCARE® SA Rue Emile Francqui, 6 1435 Mont-Saint-Guibert (Belgium) Device name: Pediarity Model number: GS-001 To contact our customer support: Email: support@gabismartcare.com Notes: Medical equipment supplier: ___________________________________________________ home health care agency: _____________________________________________________ Physician: __________________________________________________________________ Referral for disposal of the device: _______________________________________________...

This manual is also suitable for:

Gs-001