Aulisa Guardian Angel Rx User manual

Instructions For Use

____________________________________________________________

7MN00057-00

Guardian Angel® Rx

Infant Oximeter Module

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.

Aulisa is a registered trademark of Taiwan Aulisa Medical Devices Technologies, Inc.

Taiwan Aulisa Medical Devices Technologies, Inc.

No. 218-2, Chong Yang Rd., Nangang Dist.

11573 Taipei City , Taiwan

Tel.: +886 809 083 100

Distributed by

Aulisa Medical USA, Inc.

999 Commercial Street, Suite 208

Palo Alto, CA 94303,USA

Tel.: 1.833.828.5472

www.aulisa.com

CAUTION!!! Read this entire manual carefully before using Guardian Angel® Rx Infant

Oximeter.

2 
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..............................................................................................9
Device Principle of Operation ................................................................................9
Device Set Up.................................................................................................................9
Device Pairing...............................................................................................................12 
Automatic Pairing.................................................................................................12 
Manual Pairing.....................................................................................................12 
Device Power Off..........................................................................................................13 
Device Charging............................................................................................................13 
Alarms ..........................................................................................................................14 
Care and Maintenance.................................................................................................14 
Cleaning................................................................................................................14 
Reuse Life.............................................................................................................14 
Troubleshooting ...........................................................................................................16 
Device Performance.....................................................................................................18 
SpO2 Accuracy......................................................................................................18 
Pulse Rate Accuracy .............................................................................................19 
Equipment Response Time ..................................................................................19 
Manufacturer’s Declaration.........................................................................................20 
FCC Compliance ...........................................................................................................27 
Service, Support, and Warranty...................................................................................27 
Specifications ...............................................................................................................28 
Parts and Accessories...................................................................................................30 
 
 

Guide to Symbols

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. Do not use any part of this device in an MRI environment.

2. Explosion Hazard: Do not use this device in an explosive atmosphere or in the

presence of flammable anesthetics or gases.

3. This device is not a replacement for a caregiver.

Warnings

1. This device is intended only as an adjunct in patient assessment. It must be used

in conjunction with other methods of assessing clinical signs and symptoms.

2. A functional tester cannot be used to assess the accuracy of this device. This

device does not require calibration.

3. This device readings may be affected by the use of an electrosurgical unit.

4. Anemia may affect the accuracy of the measurement.

5. 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.

6. The operator must verify the compatibility of the accessories before use,

otherwise injury can result.

7. As with all medical equipment, carefully route all cables to reduce the possibility

of entanglement, strangulation or injury to the patient.

8. Be careful with small parts that can be removed from the device and swallowed.

They are hazardous to children.

9. Excessive pressure to the sensor application site for prolonged periods may

cause damage to the skin beneath the sensor probe.

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. Significant

levels of dysfunctional hemoglobin, such as methemoglobin, might affect the

accuracy of the measurement.

14. Use this device only when it is within the specified distances, approximately

32.8 feet (10 meters) spherical radius to Guardian Angel® Rx Digital Vital Sign

Monitoring System. Moving outside this range may cause missing, lost, and/or

inaccurate data.

15. Loss of monitoring can result if any objects hinder the pulse measurement.

Ensure that no blood flow restrictors (e.g. blood pressure cuff) hinder pulse

measurements.

16. This device is not a substitution for physician supervision.

17. Always refer to Instructions For Use for full warnings and instructions.

18. Failure to follow instructions and warnings may result in serious injury or death.

Cautions

1. 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. However, because of the

proliferation of radio-frequency transmitting equipment and other sources of

electrical noise in healthcare and other environments, it is possible that high

levels of interference due to close proximity or strength of a source might

disrupt the device's performance.

2. Radios and cell phones or similar devices can affect the wireless connection of

this device and must be kept at least 6.5 feet (2 meters) away from it.

3. If this device fails to respond as described, discontinue use until the situation is

corrected by qualified personnel.

4. Cardiogreen and other intravascular dyes may affect the accuracy of SpO2

measurements.

5. This device might not work on cold extremities due to reduced circulation.

Warm or rub the foot to increase circulation or reposition the sensor.

6. This device might misinterpret motion as good pulse quality. Minimize motion

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. Do not gas sterilize or autoclave this device.

13. Batteries might leak or explode if used or disposed of improperly.

14. Follow local governing ordinances and recycling instructions regarding disposal

or recycling of the device and device components, including batteries.

15. Do not subject the device to extreme hot or cold temperatures, humidity, or

direct sunlight.

16. Do not fasten the Leg Band too tightly around the leg. Inaccurate readings and

discomfort could result.

17. System connection failure (Bluetooth/Wi-Fi wireless connection) may result in

loss of data transfer.

Device Overview

Device Components

Infant Oximeter Box

Infant Oximeter Disposable Sensor Cable

Infant Oximeter Reusable Sensor Cable

Adhesive Patch

Leg Band

Charging Adaptor

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. Discard the sensor cable

after each use. It can be purchased separately.

Infant Oximeter Reusable Sensor Cable

The Infant Oximeter Reusable Sensor Cable is intended to be attached to the Infant

Oximeter Box on one end and to the toe on the other end using the Adhesive Patch.

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

Monitoring System for display.

Device Principle of Operation

This device measures SpO2 and pulse rate based on non-invasive light-emitting diode

(LED) reflectance technology, measuring the absorbance of red and infrared light

passed through the perfused tissue during each pulse.

Device Set Up

Before you begin your monitoring session, unpack the device and become familiar

with its parts. It is recommended to fully charge the Infant Oximeter Box prior to

setting up. It takes approximately 1 hour to fully charge. Refer to “Device Charging”

section for detailed instructions.

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