Guardian Angel® Rx Thermometer Module Instructions For Use ____________________________________________________________ 7MN00025-01
Disclaimer At the time of publication, this manual is believed to be accurate and up-to-date. In the interest of continued product development, Taiwan Aulisa Medical Devices Technologies, Inc. reserves the right to make changes and improvements to this manual and the products described within at any time, without notice or obligation. References to “Aulisa” in this manual shall imply Taiwan Aulisa Medical Devices Technologies, Inc.
Table of Contents Disclaimer....................................................................................................................... 1 Guide to Symbols ........................................................................................................... 3 Welcome ........................................................................................................................ 5 Precautions for Use ....................................................................................
Guide to Symbols 3
4
Welcome This manual will help you get started with monitoring using the Thermometer Module of Aulisa Guardian Angel® Rx Digital Vital Sign Monitoring System. GA1000 Series The Thermometer Module is intended for use with the Display Unit. Refer to the GA1000 Series Instructions for Use (7MN00021-01) for detailed instructions. GA2000 Series The Thermometer Module is intended for use with the Display Unit and Receiver/Transponder.
14. 15. 16. 17. 32.8 feet (10 meters) spherical radius to the Display Unit (for GA1000 Series), or to the Receiver/Transponder (for GA2000 Series). Moving outside this range may cause missing, lost, and/or inaccurate data. This device complies with International Standard IEC 60601-1-2: 2014 for electromagnetic compatibility for medical electrical equipment and/or systems. This standard is designed to provide reasonable protection against harmful interference in a typical medical installation.
Device Overview Device Components Thermometer Box Sensor Patch Device Description The Thermometer Module is composed of Thermometer Box and Sensor Patch. It must be used within 32.8 feet (10 meters) to the Display Unit (for GA1000 Series), or to the Receiver/Transponder (for GA2000 Series). Thermometer Box The reusable, compact-sized, battery-operated Thermometer Box is embedded with a Bluetooth module. The battery is changeable.
Sensor Patch The medical grade and disposable Sensor Patch which is equipped with a Thermometer Box holder and a Sensor probe can be used up to 24 hours, while some users may want to change adhesives more often depending on skin type and comfortability. Additional Sensor Patch can be purchased separately as needed. Device Intended Use The Thermometer Module is indicated for continuous armpit body temperature monitoring for adult, pediatric, and infant patients.
Device Setting Up Before you begin your monitoring session, unpack the Thermometer Module and become familiar with its parts. Step 1: Make sure the connector of the Thermometer Box aligns with the connector on the holder. Step 2: Secure the Thermometer Box onto the holder of the Sensor Patch. NOTE: The Power LED will blink green when the power is ON. Step 3: Peel the releasing paper off the Sensor Patch.
Step 5: Let the arm drop naturally at the side to cover the sensor probe for 12 minutes before attempting a reading. Step 6: Set up the GA1000 Series or GA2000 Series. NOTE: Refer to the GA1000 Series Instructions for Use (7MN00021-01) or GA2000 Series Instructions for Use (7MN00022-01) for setting up instructions and verifying system operation. Step 7: Wait for the wireless connection of the system to be established.
Device Pairing Automatic Pairing GA1000 Series The Display Unit automatically detects and connects to the Thermometer Module in the same starter kit. Press the "PAIR" button on the MAIN screen to force the system pairing when the connection is not established automatically. GA2000 Series The Receiver/Transponder automatically detects and connects to the Thermometer Module in the same starter kit only when the connection between the Display Unit and the Receiver/Transponder has been established first.
connection status icon on the MAIN screen of the Display Unit is lit blue. NOTE: Make sure the battery is installed before use. NOTE: The Thermometer Module remains paired with the system until the serial number is deleted from the list. NOTE: The Thermometer Module must be placed within 32.8 feet (10 meters) to the Display Unit (for GA1000 Series), or to the Receiver/Transponder (for GA2000 Series). NOTE: The Power LED blinks green when the power is ON.
Normal Body Temperature Ranges Type Age 0-2y 3-10y 11-65y > 65y Axillary (Armpit) Oral 94.5°F – 99.1°F N/A (34.7°C – 37.3°C) Ear Rectal 97.5°F – 100.4°F 97.9°F – 100.4°F (36.4°C – 38.0°C) (36.6°C – 38.0°C) 96.6°F – 98.0°F 95.9°F – 99.5°F 97.5°F – 100.0°F 97.9°F – 100.4°F (35.9°C – 36.7°C) (35.5°C – 37.5°C) (36.4°C – 37.8°C) (36.6°C – 38.0°C) 95.3°F – 98.4°F 97.6°F – 99.6°F 96.6°F – 99.7°F 98.6°F – 100.6°F (35.2°C – 36.9°C) (36.4°C – 37.6°C) (35.9°C – 37.6°C) (37.0°C – 38.1°C) 96.
CAUTION!!! Do not pour or spray any liquids onto this device, and do not allow any liquids to enter any openings in the device. CAUTION!!! Do not immerse the device in liquid and do not use caustic or abrasive cleaning agents on the device.
Troubleshooting Problem Possible Solution Cannot power on the Thermometer Module 1. 2. Change a new battery. Make sure the Thermometer Box is assembled with the Sensor Patch firmly. Unusual temperature data 1. Recheck device's location or contact with the armpit. Keep this device attached for twelve (12) minutes before reading temperature. Keep arm in natural dropping position consistently. Use this device under instructed operation temperature. Cover the sensor probe with arm. 2. 3. 4. 5.
Manufacturer’s Declaration Refer to the following table for specific information regarding compliance to IEC 60601-1-2 for this device.
Guidance and manufacturer's declaration – electromagnetic immunity - for all EQUIPMENT and SYSTEMS 17
Guidance and manufacturer's declaration – electromagnetic immunity - for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING 18
FCC Compliance Declaration of Conformity with FCC for Electromagnetic Compatibility 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 undesignated operation.
and should be avoided. The FCC requires the user to be notified that any changes or modifications to this device that are not expressly approved by Taiwan Aulisa Medical Devices Technologies, Inc. may void the user's authority to operate the equipment. CAUTION!!! No modifications to this device are allowed that in any way affect or alter its antenna or antenna configuration.
Service, Support, and Warranty Taiwan Aulisa Medical Devices Technologies, Inc. (“Aulisa”) warrants to the purchaser that each of Aulisa's product will be free from material defect for a period of one year from the date of purchase (the “Warranty Period”), and Aulisa will repair or replace at its discretion, free of charge, each Aulisa's product found to be materially defective during the Warranty Period and for which Aulisa has been notified during the Warranty Period (the “Warranty”).
Privacy Policy This Privacy Policy was last updated on March 22, 2019. Our Policy This privacy policy applies to personal information collected by Taiwan Aulisa Medical Devices Technologies, Inc. (“Aulisa”, “we”, “us” and/or “our”) from users of the Aulisa remote monitoring devices (the “Devices”). “Personal Information” includes any information that can be used on its own or with other information to identify or contact a single person or to identify an individual in context.
Non-Provider Users: The data controllers are the Provider and Taiwan Aulisa Medical Devices Technologies, Inc., No. 218-2, Chong Yang Rd., Nangang Dist., 11573 Taipei City, Taiwan Provider Users: The data controller is Taiwan Aulisa Medical Devices Technologies, Inc., No. 218-2, Chong Yang Rd., Nangang Dist., 11573 Taipei City, Taiwan Data Protection Officer: Paul Liu BY USING THE DEVICES, YOU ARE ACKNOWLEDGING THAT YOU HAVE READ AND AGREE TO THE TERMS OF THIS PRIVACY POLICY.
What Information Do We Collect and Why? Personal Data that You Provide Through the Devices We collect Personal Information (e.g. demographic information) from you when you voluntarily provide such information to us, use the Devices (including without limitation, the software featured on the Devices and/or platforms), contact us with inquiries, or use certain features of the Devices. We use this information to allow the Devices to provide the information to you and/or your Provider.
Aggregated Personal Data: In an ongoing effort to better understand and serve our customers, other users of the Devices, and communities of people with similar health conditions, Aulisa may conduct research on its user demographics and behavior based on the Personal Information we collect from you and the other information provided to us.
With Related Companies: We may also share Personal Information with Aulisa Related Companies for purposes consistent with this Privacy Policy. With Our Agents, Consultants and Related Third Parties: Aulisa, like many businesses, sometimes hires other companies to perform certain business-related functions. Examples of such functions include data hosting and billing management.
security or integrity of such information, and to protect against unauthorized access to or use of such information in our possession or control that could result in substantial harm or inconvenience to you. However, Internet data transmissions, whether wired or wireless, cannot be guaranteed to be 100% secure. As a result, we cannot guarantee the security of information you transmit to us. By using the Devices, you are assuming this risk.
EU DATA SUBJECT RIGHTS If you are an EU data subject, you have the following rights under certain circumstances: to receive communications related to the processing of your personal data that are concise, transparent, intelligible and easily accessible; to be provided with a copy of your personal data held by us; to request the rectification or erasure of your personal data held by us without undue delay; to request that we restrict the processing of your personal data (while we verify or investigat
How Can I Contact Aulisa? If you have any questions or comments about this Privacy Policy, our practices, or our Devices, please feel free to e-mail us at information@aulisa.com.
Specifications Dimensions Thermometer Box 51.5mm x 30.0mm x 6.7mm Sensor Patch 117.8mm x 42.0mm x 7.4mm Weight 5.5g Ingress Protection IP22 Display range 89.6°F-107.6°F (32°C-42°C) <89.6°F (32.0°C) displays “Lo” Accuracy >107.6°F (42.0°C) displays “Hi” 89.6°F-107.6°F: ±0.2°F (32°C-42°C: ±0.1°C) Battery Type CR2025 Battery Life 7 days Temperature Operating +5°C to +40°C Storage/Transportation -25°C to +70°C Humidity Operating 15% to 90% R.H.
Parts and Accessories Parts and Accessories Model Number Thermometer Box GA-TB0001 Sensor Patch GA-AP0011 For more information about the Display Unit and Receiver/Transponder, refer to the GA1000 Series Instructions for Use (7MN00021-01) or GA2000 Series Instructions for Use (7MN00022-01). You may also contact your distributor or contact Aulisa by going online at www.aulisa.com under "Contact Us". CAUTION!!! Using accessories not by Taiwan Aulisa Medical Devices Technologies, Inc.
