Guardian Angel® Rx Infant Oximeter Module Instructions For Use ____________________________________________________________ 7MN00057-00
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
MR Unsafe: must not be used in an MRI environment.
Welcome This manual will help you get started with monitoring using the Infant Oximeter Module of Guardian Angel® Rx Digital Vital Sign Monitoring System. The Infant Oximeter Module is intended for use with Guardian Angel® Rx Digital Vital Sign Monitoring System . Refer to the system Instructions for Use for detailed instructions. Precautions for Use Contraindications 1. 2. Do not use any part of this device in an MRI environment.
10. Do not use this device if it is damaged in any way. Discontinue using it immediately and replace a new one. 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.
of the monitored site. 7. Excessive ambient light may affect the accuracy of the measurement. 8. 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. 9. Do not place liquids on top of the device. 10. Do not immerse the device or any of the components in any liquids. 11. Do not use caustic or abrasive cleaning agents on the device. 12.
Device Overview Device Components Infant Oximeter Box Infant Oximeter Disposable Sensor Cable Infant Oximeter Reusable Sensor Cable Adhesive Patch Leg Band Charging Adaptor 8
Device Description Infant Oximeter Box The Infant Oximeter Box worn on the leg includes a Bluetooth transmitter and a sensor chip along with electronics for vital sign measuring and analyzing. It must be used within 32.8 feet (10 meters) to Guardian Angel® Rx Digital Vital Sign Monitoring System. Infant Oximeter Disposable Sensor Cable The Infant Oximeter Disposable Sensor Cable is intended to be attached to the Infant Oximeter Box on one end and to the toe on the other end.
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.
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® Rx Digital Vital Sign Monitoring System for set up instructions and verifying system operation. Step 6: Wait for the wireless connection of the system to be established.
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. NOTE: The Bluetooth connection status icon will turn blue once the pairing succeeds. NOTE: The power LED on the Infant Oximeter Box will blink green when pairing succeeds, and data transmission starts.
NOTE: The device remains paired with the system until the serial number is deleted from the list. NOTE: The device must be placed within 32.8 feet (10 meters) to Guardian Angel® Rx Digital Vital Sign Monitoring System. NOTE: The Power On/Off LED indicator lights green when the power is ON. Device Power Off The device will be turned off by either: 1. press the Power button on the Infant Oximeter Box, or 2. when the device detects no signal for 3 minutes. NOTE: The power LED goes off when power off.
Alarms The Infant Oximeter Box is equipped with an 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 system, refer to the Instructions for Use of Guardian Angel® Rx Digital Vital Sign Monitoring System. Care and Maintenance The advanced digital circuitry within the device requires no calibration or periodic maintenance. Field service or repair of this system is not possible.
- 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. CAUTION!!! Do not immerse the device in liquid and do not use caustic or abrasive cleaning agents on the device. CAUTION!!! The Infant Oximeter Disposable Sensor Cable is for single use.
Troubleshooting Problem Possible Solution Cannot turn on the device 1. 2. Unable to obtain a valid 1. Reposition the sensor cable and keep it 2. 3. motionless for at least 10 seconds. Relocate the sensor cable to a different site. Make sure the device is assembled firmly and attached to the toe securely. SpO2 or pulse rate reading NOTE: In some instances, perfusion of person being monitored may be 4. 5. Check the accessories for any visible signs of deterioration.
4. 5. “---“ appears on the vital sign displays 1. Make sure the device is assembled firmly and attached to the toe securely. 2. Reposition the sensor cable and keep it motionless for at least 10 seconds. Relocate the sensor cable to a different site. 3. 4. 5. Data update period has exceeded the limit Cannot establish Check the accessories for any visible signs of deterioration. Reduce motion. Make sure the device is within 32.
Device Performance SpO2 Accuracy SpO2 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. (2007) Agreement between methods of measurement with multiple observations per individual.
The graph below shows the error (SpO2 – SaO2) plots of each subject measured by this device with upper and lower 95% limits of agreement. Each sample data point is 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 SpO2 settings of 100%, 95%, 90%, 85%, 80%, 75% and 70%.
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.
*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. Immunity test IEC 60601-1-2 test level Compliance level Electromagnetic environment -guidance Floors should be wood, concrete, or Electrostatic ceramic tile.
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.
*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.
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. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [3] V.
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”).
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 (SpO2) 1-100% Pulse Rate 30-300 bpm Accuracy Blood Oxygen Saturation (SpO2) 70-100% ±3 digits Pulse Rate 30-300 bpm ±3 digits Measurement Wavelengths and Output Power Red 660 nanometers Infrared 940 nanometers Battery Type 3.
Internally powered (on battery power) Type of Protection Type BF-Applied Part Mode of Operation Continuous 29
Parts and Accessories Parts and Accessories Model Number Infant Oximeter Box GA-OB0004 Infant Oximeter Disposable Sensor Cable GA-DS0004 Infant Oximeter Reusable Sensor Cable GA-RS0007 Adhesive Patch GA-AP0013 Leg Band GA-LB0002 Charging Adaptor GA-AD0001 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".
