Related Manuals for Aulisa Guardian Angel Rx
Summary of Contents for Aulisa Guardian Angel Rx
- Page 1 Guardian Angel ® Thermometer Module Instructions For Use ____________________________________________________________ 7MN00025-01...
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Page 2: Disclaimer
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. Aulisa is a registered trademark of Taiwan Aulisa Medical Devices Technologies, Inc. -
Page 3: Table Of Contents
Table of Contents Disclaimer ........................1 Guide to Symbols ......................3 Welcome ........................5 Precautions for Use ......................5 Device Overview ......................7 Device Components ....................7 Device Description ....................7 Device Intended Use ....................8 Device Principle of Operation ................8 Device Setting Up ...................... -
Page 4: Guide To Symbols
Guide to Symbols... -
Page 6: Welcome
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. - Page 7 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. 14. This device complies with International Standard IEC 60601-1-2: 2014 for electromagnetic compatibility for medical electrical equipment and/or systems.
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Page 8: Device Overview
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. -
Page 9: Device Intended Use
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. -
Page 10: Device Setting Up
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. - Page 11 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.
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Page 12: Device Pairing
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... -
Page 13: Device Power Off
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). -
Page 14: Normal Body Temperature Ranges
Normal Body Temperature Ranges Type Axillary (Armpit) Oral Rectal 94.5°F – 99.1°F 97.5°F – 100.4°F 97.9°F – 100.4°F 0-2y (34.7°C – 37.3°C) (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 3-10y (35.9°C –... - Page 15 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.
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Page 16: Troubleshooting
"Contact Us". CAUTION!!! This system is a precision electronic instrument and must be repaired by knowledgeable and specially trained Aulisa personnel only. Do not attempt to open the case other than the battery cover or repair the electronics. -
Page 17: Manufacturer's Declaration
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 emissions - for all EQUIPMENT and SYSTEMS... - Page 18 Guidance and manufacturer's declaration – electromagnetic immunity - for all EQUIPMENT and SYSTEMS...
- Page 19 Guidance and manufacturer's declaration – electromagnetic immunity - for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING...
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Page 20: Fcc Compliance
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. - Page 21 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.
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Page 22: Service, Support, And Warranty
Aulisa's place of repair as designated by Aulisa, and Aulisa is responsible for the cost of delivery back to the purchaser. Aulisa reserves the right to charge a fee for a warranty repair request on an Aulisa product that is found to be within... -
Page 23: Privacy Policy
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. -
Page 24: Changes
NOT USE THE DEVICES AND DO NOT SUBMIT ANY INFORMATION TO US. Access to and use of the Devices by a Provider who is an Aulisa customer (a “Customer”) and such Customer's authorized users is subject to and governed by the agreement between Aulisa and the applicable Customer executed by authorized representatives of each party (the “Customer Agreement”). - Page 25 Devices. Support Information If you contact Aulisa for support or to lodge a complaint, we may collect technical or other information from you. Such information will be used for the purposes of troubleshooting, customer support, software updates, and improvement of the Devices in accordance with this Privacy Policy.
- Page 26 Personal Information we collect from you and the other information provided to us. This research may be compiled and analyzed on an aggregate basis, and Aulisa may share this research and related information in aggregated, de-identified and/or anonymized format with its affiliates, agents and other healthcare research and services entities, including without limitation insurance and pharmaceutical companies.
- Page 27 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.
- Page 28 NEVER respond to any e-mail requesting such information. If you receive such an e-mail purportedly from Aulisa, DO NOT RESPOND to the e-mail and DO NOT CLICK on any links and/or open any attachments in the e-mail, and notify Aulisa support at information@aulisa.com.
- Page 29 Where our processing of your Personal Information is based on consent, you have the right to withdraw that consent without detriment at any time by contacting us at information@aulisa.com. You can also exercise the rights listed above at any time by contacting us at information@aulisa.com.
- Page 30 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.
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Page 31: Specifications
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” >107.6°F (42.0°C) displays “Hi” Accuracy 89.6°F-107.6°F: ±0.2°F (32°C-42°C: ±0.1°C) Battery Type CR2025 Battery Life 7 days... -
Page 32: Parts And Accessories
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".
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