Aulisa ECG Manual de usuario
Instructions For Use
____________________________________________________________
7MN00050-01
Combo Sensor Module-
ECG and PPG
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
© 2021 Taiwan Aulisa Medical Devices Technologies, Inc.
CAUTION!!! Read this entire manual carefully before using Guardian Angel® Rx Digital
Vital Sign Monitoring System.
Table of Content
Disclaimer........................................................................................................................................ 2
Welcome ......................................................................................................................................... 6
Contradictions ................................................................................................................................ 6
Warnings......................................................................................................................................... 6
Device Overview ............................................................................................................................. 8
Device Components.................................................................................................................... 8
Device Description ...................................................................................................................... 9
Device Indications for Use........................................................................................................ 10
Device Principle of Operation.................................................................................................. 11
Device Setting Up.......................................................................................................................... 11
Device Pairing............................................................................................................................ 14
Automatic Pairing...................................................................................................................... 14
Manual Pairing.......................................................................................................................... 14
Device Power Off and Removal..................................................................................................... 15
Device Charging............................................................................................................................. 15
Device SD card Installation and Removal...................................................................................... 16
Alarm............................................................................................................................................. 17
Care and Maintenance.................................................................................................................. 17
Cleaning and Disinfection ........................................................................................................ 17
Troubleshooting ............................................................................................................................ 18
Manufacturer’s Declaration.......................................................................................................... 19
FCC Compliance ............................................................................................................................ 21
Service, Support, and Warranty.................................................................................................... 22
Our Policy.................................................................................................................................. 22
Changes..................................................................................................................................... 23
Specifications ................................................................................................................................ 30
Parts and Accessories.................................................................................................................... 31
Guide to Symbols
Symbol
Description
Refer to instruction manual
Indicates separate collection for electrical
and electronic equipment (WEEE).
Non-ionizing electromagnetic radiation.
Equipment includes RF transmitters.
Interference may occur in the vicinity of
equipment marked with this symbol.
Manufacturer
Serial number
Lot number
Federal law (USA) restricts this device to
sale by or on the order of a licensed
health care professional only.
Temperature limit
Non-sterile
IP23
Classification for water ingress and
particulate matter
Date of Manufacturer
Type CF applied part
MR Unsafe
Welcome
This manual will help you get started with monitoring using the Combo Sensor Module of Aulisa
Guardian Angel® Rx Digital Vital Sign Monitoring System, GA1000/ GA2000 Series.
GA1000 Series
The Combo Sensor Module is intended for use with the Display Unit. Refer to the GA1000 Series
Instructions for Use (7MN00026-02) for detailed instructions.
GA2000 Series
The Combo Sensor Module is intended for use with the Display Unit and Receiver/Transponder.
Refer to the GA2000 Series Instructions for Use (7MN00022-02) for detailed instructions.
Contradictions
1. This device is not defibrillation-proof. Please remove the device before defibrillating a
patient during an emergency.
2. The Combo Sensor Module is not intended for use on users who have implanted
defibrillators or pacemakers.
3. The Combo Sensor Module is not intended as a stand-alone diagnostic monitor.
Warnings
1. The Combo Sensor Module is a secondary, adjunct patient monitor and is not intended to
replace existing standard-of-care patient monitoring practices.
2. Depending on wireless connectivity, a temporary interruption of data transmission is
possible, which may impact continuous or real-time monitoring.
3. The nature of the hydrocolloid adhesives may cause adverse skin reactions. Healthcare
providers should advise patients to seek medical attention if either of the following occurs:
a. A severe adverse event
b. An allergic reaction persisting beyond 2-3 days
4. Histories of skin irritations should be considered before placing the Combo Sensor Module
on a patient.
5. Do not use the Combo Sensor Module during an MRI scan or in a location where it will be
exposed to strong electromagnetic forces.
6. Only place the Combo Sensor Module on intact skin.
7. Clinical validation has not been performed on patients who are pregnant or breastfeeding.
Precautions
1. To acquire physiological data properly:
oThe Combo Sensor Module must be properly adhered to the patient.
oThe patient must remain within 32.8 feet (10 meters) to the Display Unit (for
GA1000 series), or to the Receiver/Transponder (for GA2000 series).
oThe Combo Sensor Module must have adequate power for data transmission.
Notification of the Combo Sensor Module battery level will indicate when the
battery power is low.
2. Wireless electronic devices may cause signal interference during data transmission. Avoid
close proximity with interfering devices.
3. Medical electrical equipment or electrical stimulators attached to the patient’s body may
degrade Combo Sensor Module signal quality or produce erroneous results from the
biosensor.
4. Do not use the Combo Sensor Module if the package has been opened or appears used or
damaged.
5. Wear only one Combo Sensor Module at a time.
6. If discomfort or irritation occurs, the Combo Sensor Module should be removed. If mild
soreness or redness is experienced after removing the device, do not apply a new device in
the same location. Choose another recommended location.
7. Incorrect handling, excessive force, or dropping the Combo Sensor Module may cause
malfunction or permanent damage.
8. Keep the Combo Sensor Module away from children and pets. The device may be a choking
hazard and may be harmful if swallowed.
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 this device while taking a shower.
12. If the Combo Sensor Module fails to operate, contact your healthcare provider
immediately.
13. Dispose of the Combo Sensor Module per local laws, care facility laws or hospital laws for
routine/non-hazardous electronic waste.
Device Overview
Device Components
Sensor Box
Holder
Sensor Cable
ECG Electrode
PPG Adhesive Patch
ECG/PPG Position Guide
Battery Charger
Charging Adaptor- Battery Charger
Device Description
The Combo Sensor Module is a component of the Aulisa Digital Vital Sign Monitoring System.
The Combo Sensor Module is a wireless, battery operated wearable biosensor, attached to the
chest to continuously record blood pressure (BP), heart rate (HR), respiration rate (RR),
electrocardiography (ECG) and fall detection of adult patients. The device continuously gathers
physiological data from the person being monitored and then transmits the encrypted data to
the Aulisa Digital Vital Monitoring System, GA1000/ GA2000 Series. The data provided by
Combo Sensor Module is intended to aid caregivers in making diagnoses by providing additional
information to standard of care patient monitors.
During normal operation, data is collected by the device and transmitted immediately to the
Aulisa Digital Vital Monitoring System. Data is stored on a SD card and the data can be easily
transferable to a personal computer to be viewed or printed.
Sensor Box
The reusable, compact-sized, battery-operated Sensor Box is embedded with a Bluetooth
module. It includes a slot for a SD Card for the storage of data. The battery is rechargeable.
Sensor Cable
The reusable double-ended cable contains three ECG leads and a PPG probe on one end and a
Sensor Box connector on the other end. The Sensor Box connector is to be connected to the
Sensor Box and, the ECG leads and PPG probe are to be attached to the chest.
Device Indications for Use
The Aulisa Combo Sensor Module is intended to non-invasively and continuously measure
blood pressure (BP), heart rate (HR), respiration rate (RR), and electrocardiography (ECG) of
adult patients. It is intended for use by healthcare professionals in hospitals, medical facilities,
1
5
1 Power On/Off Button
2 Power LED
3 Battery Chamber
1 Sensor Box connector
2 PPG Probe
3 Right Arm ECG Lead
4 Left Leg ECG Lead
5 Left Arm ECG Lead
2
4 SD card
5 Cable port
4
1
1
2
3
4
5
3
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