Related Manuals for Aulisa Guardian Angel Rx
Summary of Contents for Aulisa Guardian Angel Rx
- Page 1 ® Guardian Angel Infant Oximeter Module Instructions For Use ____________________________________________________________ 7MN00057-00...
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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 Contraindications ....................5 Warnings ........................ 5 Cautions ......................... 6 Device Overview ......................8 Device Components ....................8 Device Description ....................9 Device Intended Use .................... -
Page 4: Guide To Symbols
Guide to Symbols... - Page 5 MR Unsafe: must not be used in an MRI environment.
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Page 6: Welcome
This device readings may be affected by the use of an electrosurgical unit. Anemia may affect the accuracy of the measurement. Only use the accessories manufactured by Aulisa. These accessories are manufactured to meet the accuracy specifications for this device. Using other manufacturers' components can result in improper device performance and injury may occur. -
Page 7: Cautions
11. Do not use in or around water or any other liquid when AC power adaptor is used. 12. Only use this device with charging adaptors provided by Aulisa. 13. This device is designed to determine functional oxygen saturation, the percentage of arterial oxygen saturation of functional hemoglobin. - Page 8 of the monitored site. Excessive ambient light may affect the accuracy of the measurement. Inspect and relocate the sensor application site at least every 6 hours to ensure correct sensor alignment and skin integrity. Personal sensitivity to a sensor may vary due to medical status or skin condition.
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Page 9: Device Overview
Device Overview Device Components Infant Oximeter Box Infant Oximeter Disposable Sensor Cable Infant Oximeter Reusable Sensor Cable Adhesive Patch Leg Band Charging Adaptor... -
Page 10: Device Description
The sensor cable is reusable. Discard the Adhesive Patch after each use. Device Intended Use The Aulisa Infant Oximeter Module is intended to measure SpO2 and pulse rate of infant patients during non-motion and under well-perfused conditions in hospitals, medical facilities, home care, and subacute environments. The parameters derived by Aulisa Infant Oximeter Module are transmitted to Aulisa’s Digital Vital Sign... - Page 11 Step 1: Assemble the device. Insert the Leg Band through the holder of the Infant Oximeter Box. The fluffy side of the Leg Band should face upward. And then plug in the sensor cable. Step 2: Attach the sensor to the toe. If you go with Infant Oximeter Disposable Sensor Cable, peel off the release paper on the sensor first and wrap the adhesive patch around the toe.
- Page 12 Step 3: Secure the Leg Band around the leg. Step 4: Press the Power button to turn on the Infant Oximeter Box. NOTE: The power LED will light green when the power is ON. Step 5: Set up Guardian Angel® Rx Digital Vital Sign Monitoring System. NOTE: Refer to the Instructions for Use of Guardian Angel®...
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Page 13: Device Pairing
Device Pairing Automatic Pairing The system automatically scans and pairs to the Aulisa sensor module(s) from the same starter kit. NOTE: The device must be placed within 32.8 feet (10 meters) to the Guardian Angel® Rx Digital Vital Sign Monitoring System. -
Page 14: Device Power Off
It takes approximately 1 hour to fully charge the device. NOTE: The Power On/Off LED indicator lights blue during charging and goes off when fully charged. NOTE: The device powers off while charging. CAUTION!!! Only use charging adaptor supplied or manufactured by Taiwan Aulisa Medical Devices Technologies, Inc. -
Page 15: Alarms
This device is reusable with an expected life of 1.5 years. However, if you notice any signs of deterioration from below, stop using it and replace it with a new one or contact Aulisa Customer Support by going online at www.aulisa.com: button malfunctions;... - Page 16 the strap frays or breaks and the wires inside become exposed. Using deteriorated component(s) may cause the device performance to degrade and do harm to the user. CAUTION!!! Do not pour or spray any liquids onto this device, and do not allow any liquids to enter any openings in the device.
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Page 17: Troubleshooting
Troubleshooting Problem Possible Solution Cannot turn on the device Make sure the device is kept away from any magnetic devices while using. Fully charge the device until the LED blue light on the Infant Oximeter Box goes off. Unable to obtain a valid Reposition the sensor cable and keep it or pulse rate reading motionless for at least 10 seconds. - Page 18 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 19: Device Performance
Device Performance Accuracy accuracy testing is performed by in vivo accuracy testing under laboratory conditions on healthy subjects with varying skin pigmentation in an independent research laboratory through induced hypoxia studies. Analysis of bias* was performed vs. Hemoximeter data. The limits of agreement shown are calculated per: Bland JM, Altman D. -
Page 20: Pulse Rate Accuracy
The graph below shows the error (SpO – SaO ) plots of each subject measured by with upper and lower 95% limits of agreement. Each sample data point is this device from a clinical study in healthy volunteers. Pulse Rate Accuracy Pulse rate accuracy has been functionally tested against an electronic pulse simulator from 30 to 300 bpm in 10bpm intervals, with combinations of Pulse Amplitude settings of 0.5, 1, 3, 5, 7, 10, 12, 15, 17 and 20, and SpO... -
Page 21: Manufacturer's Declaration
Manufacturer’s Declaration Refer to the following table for specific information regarding compliance to IEC 60601-1-2 for this device. *For all EQUIPMENT and SYSTEMS Guidance and Manufacturer's Declaration - Electromagnetic Emission This device is intended for use in the electromagnetic environment specified below. The customer and/or user of this device should ensure that it is used in such an environment. - Page 22 *For all EQUIPMENT and SYSTEMS Guidance and Manufacturer's Declaration - Electromagnetic Immunity This device is intended for use in the electromagnetic environment specified below. The customer and/or user of this device should ensure that it is used in such an environment. IEC 60601-1-2 test Electromagnetic Immunity test...
- Page 23 Magnetic characteristic of a Field typical location in a IEC 61000-4-8 typical commercial or hospital environment. NOTE: UT is the AC mains voltage before application of the test level.
- Page 24 *For EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING Guidance and Manufacturer's Declaration - Electromagnetic Immunity This device is intended for use in the electromagnetic environment specified below. The customer and/or user of this device should ensure that it is used in such an environment. Immunity IEC 60601-1-2 Electromagnetic...
- Page 25 the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device. b.
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Page 26: 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 27 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 28: 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 29: Specifications
Specifications Dimensions 1.9" x 1.8" x 0.6" (47.5mm x 46.2mm x 15.9mm) Weight 0.4 oz (12g) Ingress Protection IP23 Display Range Blood Oxygen Saturation (SpO 1-100% Pulse Rate 30-300 bpm Accuracy Blood Oxygen Saturation (SpO 70-100% ±3 digits Pulse Rate 30-300 bpm ±3 digits Measurement Wavelengths and Output Power 660 nanometers... - Page 30 Internally powered (on battery power) Type of Protection Type BF-Applied Part Mode of Operation Continuous...
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Page 31: Parts And Accessories
Infant Oximeter Module (Box + Disposable Sensor Cable) GA-OM0011 Infant Oximeter Module (Box + Reusable Sensor Cable) GA-OM0009 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.
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