Aulisa Guardian Angel GA1000 Series Instructions For Use Manual
Adult/pediatric oximeter module
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- Instructions for use manual (32 pages) ,
- Instructions for use manual (42 pages) ,
- Instructions for use manual (49 pages)
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Summary of Contents for Aulisa Guardian Angel GA1000 Series
- Page 1 Guardian Angel ® Adult/Pediatric Oximeter Module Instructions For Use ____________________________________________________________ 7MN00028-01...
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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 Warnings ........................ 5 Cautions ......................... 6 Device Overview ......................8 Device Components ....................8 Device Description ....................9 Device Intended Use .................... 10 Device Principle of Operation ................ -
Page 4: Guide To Symbols
Guide to Symbols... -
Page 6: Welcome
Warnings Anemia may affect the accuracy of the measurement. Only use the sensor cables manufactured by Aulisa. These sensor cables are manufactured to meet the accuracy specifications for this device. Using other manufacturers' sensor cables can result in improper device performance and injury may occur. -
Page 7: Cautions
accuracy of the measurement. 10. Use this device only when it is within the specified distances, approximately 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. - Page 8 16. The device is not for use during exercise.
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Page 9: Device Overview
Device Overview Device Components Oximeter Box Oximeter Sensor Cable (Adult) Oximeter Sensor Cable (Pediatric) -
Page 10: Device Description
Wristband Charging Adaptor Device Description Oximeter Box The Oximeter Box worn on the wrist includes a Bluetooth transmitter and a sensor chip along with electronics for vital sign measuring and analyzing. The Oximeter Box must be used within 32.8 feet (10 meters) spherical radius to the Display Unit (for GA1000 Series), or to the Receiver/Transponder (for GA2000 Series). -
Page 11: Device Intended Use
Oximeter Sensor Cable for Adult is intended for those weighing more than 40 kilograms. Oximeter Sensor Cable for Pediatric is intended for those weighing from 10 to 40 kilograms. CAUTION!!! Only use cables supplied or manufactured by Taiwan Aulisa Medical Devices Technologies, Inc. - Page 12 CAUTION!!! Do not charge the device via this port. Charging through this port will cause permanent damage to the device. Step 2: Secure the Wristband onto the wrist with the Oximeter Box holder facing outwards. Slip the velcro end through the hole and loop around to secure the Wristband.
- Page 13 Step 5: Set up the Display Unit. Step 6: Set up the Receiver/Transponder (for GA2000 Series). NOTE: Refer to the GA1000 Series Instructions for Use (7MN00026-01) or GA2000 Series Instructions for Use (7MN00027-01) for setting up instructions and verifying system operation.
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Page 14: Device Pairing
Device Pairing Automatic Pairing GA1000 Series The Display Unit automatically detects and connects to the Oximeter 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 Oximeter Module in the same starter kit only when the connection between the Display Unit... - Page 15 connection status icon on the MAIN screen of the Display Unit is lit blue. NOTE: The Oximeter Module remains paired with the system until the serial number is deleted from the list. NOTE: The Oximeter 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).
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Page 16: Device Power Off
It takes around 3 hours to fully charge the Oximeter Box. NOTE: The power LED indicator lights blue during charging and goes off when fully charged. NOTE: The Oximeter Box will power off during charging. CAUTION!!! Only use charging adaptor supplied or manufactured by Taiwan Aulisa Medical Devices Technologies, Inc. -
Page 17: Alarms
Alarms The Oximeter Box is equipped with an Alarm LED indicator that will blink red when a high priority alarm occurs and blink yellow for medium priority alarm. For more information about the alarm, refer to the GA1000 Series Instructions for Use (7MN00026-01) or GA2000 Series Instructions for Use (7MN00027-01). -
Page 18: Troubleshooting
Troubleshooting Problem Possible Solution Cannot turn on the Oximeter Press the Power button again. Module Fully charge the Oximeter Box until the LED blue light goes off. Unable to obtain a valid SpO Reposition the sensor probe or reinsert the or pulse rate reading finger and keep the hand motionless for at least 10 seconds. - Page 19 Aulisa by going online at www.aulisa.com under "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 or repair the electronics.
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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 0.7" x 1.3" x 2.7" (16mm x 32mm x 68mm) Weight 1 oz (28g) Ingress Protection IP22 Display Range Blood Oxygen Saturation (SpO 1% to 100% Pulse Rate 30 to 290 bpm Accuracy Blood Oxygen Saturation (SpO 70-100% ±3 digits Pulse Rate ±3% Measurement Wavelengths and Output Power... -
Page 32: Parts And Accessories
For more information about the Display Unit and Receiver/Transponder, refer to the GA1000 Series Instructions for Use (7MN00026-01) or GA2000 Series Instructions for Use (7MN00027-01). You may also contact your distributor or contact Aulisa by going online at www.aulisa.com under "Contact Us".
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