Aulisa Guardian Angel Rx GA2000 User manual

Guardian Angel Rx
™
GA2000
Digital Vital Sign
Monitoring System
Instructions For Use
TM

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.
Read this entire manual carefully before using Aulisa GA2000
Digital Vital Sign Monitoring System.
Caution!
©2019 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 [phone]
Distributed by
Aulisa Medical USA, Inc.
999 Commercial Street, Suite 208
Palo Alto, CA 94303,USA
www.aulisa.com
TM

.............................................................................. 1
Precautions for Use .......................................................................... 3
11
Intended Use ............................................................................
11
Principle of Operation
System Overview
....................................................................
..........................................................................
12
15
Device Overview
...........................................................................
21
Displays, Indicators, and Controls
..............................................
25
30
32
System Connection
..............................................
................................................................ 33
Alarms and Limits
Powering and Charging
34
44
Alarms
Charging the Oximeter Box
34
44
Powering the Display Unit
..................................................................
............................................................
38
46
Alarm Delay Function
Powering the Receiver/Transponder
42
47
43
Care and Maintenance
48
Troubleshooting 49
Technical Information 53
Service, Support, and Warranty 63
Specifications
71
....................................................................... 75
Cleaning and Disinfection
48
Guide to Symbols
...... 7
Table of
Contents
Device Performance 53
Manufacture's Declaration
FCC Compliance
55
60
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11
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Guide to
Symbols
Type BF-Applied Part (patient isolation
from electrical shock)
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
1

Prescription use only
Temperature limit
NON
STERILE
Non-sterile
Date of Manufacturer
Classification for water ingress and
particulate matter
IP22
Warning
Charging Port
2

Precautions
for Use
1. Aulisa GA2000 Digital Vital Sign Monitoring System
is intended only as an adjunct in patient
assessment. It must be used in with other methods
of assessing clinical signs and symptoms.
2. A functional tester cannot be used to assess the
accuracy of an oximeter sensor cable or an
oximeter box. Aulisa GA2000 Digital Vital Sign
Monitoring System does not require calibration.
3. Aulisa GA2000 Digital Vital Sign Monitoring System
readings may be affected by the use of an
electrosurgical unit.
4. Only use the sensor cables manufactured by Aulisa.
These sensor cables are manufactured to meet the
accuracy specifications for Aulisa GA2000 Digital
Vital Sign Monitoring System. Using other
manufacturers' sensor cables can result in
improper pulse oximeter performance and patient
injury may occur.
5. The operator must verify the compatibility of the
sensor cable with Aulisa GA2000 Digital Vital Sign
Monitoring System before use, otherwise
patient injury can result.
6. As with all medical equipment, carefully route all
cables to reduce the possibility of entanglement,
1. Do not use any part of this system in an MRI
environment.
2. Explosion Hazard: Do not use this system in an
explosive atmosphere or in the presence of
flammable anesthetics or gases.
3. This device is not a replacement for a caregiver.
Contraindications
Warnings
Warning!
Caution!
3

strangulation or injury to the patient.
7. Be careful with small parts that can be removed
from the device and swallowed, such as port
covers. They are hazardous to children.
8. Excessive pressure to the sensor application site
for prolonged periods may cause damage to the
skin beneath the sensor.
9. Do not use a damaged sensor. If the sensor is
damaged in any way, discontinue use immediately
and replace the sensor.
10. Do not use in or around water or any other liquid
when AC power adaptor is used.
11.Only use Aulisa GA2000 Digital Vital Sign
Monitoring System with charging adaptors
provided by Aulisa.
12. Aulisa GA2000 Digital Vital Sign Monitoring
System 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.
13. Anemia may affect the accuracy of the
measurement.
14.Use Aulisa GA2000 Digital Vital Sign Monitoring
System only when the components are installed
within the specified distances from the monitored
patient-Oximeter Box must be approximately
10 meters (10.9 yards) from the Receiver/
Transponder. 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 product 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.
4

Caution!
Cautions
1. This equipment 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, home care 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 the system and must be
kept at least 2 meters (6.5 feet) away from the
system.
3. If Aulisa GA2000 Digital Vital Sign Monitoring
System 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. The sensor probe might not work on cold
extremities due to reduced circulation. Warm or rub
the finger to increase circulation, or reposition the
sensor probe.
6. Aulisa GA2000 Digital Vital Sign Monitoring
System 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. Some nail polish colors or artificial nails can
reduce light transmission and affect SpO2
accuracy.
9. Inspect and relocate the sensor application site at
least every 6 to 8 hours to ensure correct sensor
alignment and skin integrity. Patient sensitivity to
sensors may vary due to medical status or skin
condition.
10. Do not place liquids on top of the device.
11. Do not immerse the device or any of the
5

components in any liquids.
12. Do not use caustic or abrasive cleaning agents
on the device.
13. Do not gas sterilize or autoclave this pulse
oximetry system.
14. Batteries might leak or explode if used or disposed
of improperly.
15.Follow local governing ordinances and recycling
instructions regarding disposal or recycling of the
device and device components, including batteries.
16.Do not subject the system to extreme hot or cold
temperatures, humidity, or direct sunlight.
17.Do not fasten the Wristband too tightly around
the patient's wrist. Inaccurate readings and patient
discomfort could result.
18.System connection failure (Bluetooth/ Wi-Fi
wireless connection) may result in loss of data
transfer.
19. The device is not for use during exercise.
6

Using Aulisa GA2000
Digital Vital Sign
Monitoring System
This chapter describes how to use Aulisa GA2000 Digital Vital Sign
Monitoring System (hereinafter referred to as Aulisa GA2000 system).
The system includes the following components and accessories*:
*The system comes with either two Pediatric or two Adult Oximeter
Sensor Cables.
Oximeter Box
Display Unit
Receiver/Transponder
7

Adult Oximeter Sensor
Cable
Wristband
Pediatric Oximeter Sensor
Cable
8

Stand-Display Unit
Charging Adaptor-
Oximeter Box
Charging Adaptor-
Display Unit
9

Sticker-
Receiver/Transponder
Clamp-
Receiver/Transponder
Velcro Strap-
Receiver/Transponder
Charging Adaptor-
Receiver/Transponder
10

Intended Use
The Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System is
indicated for use in measuring and displaying functional oxygen
saturation of arterial hemoglobin (SpO2) and pulse rate of adult and
pediatric patients. It is indicated for spot-checking and / or continuous
monitoring of patients during non-motion and under well-perfused
conditions. The intended environment of use is hospital, medical facilities,
home care, and subacute environments. This system is a reusable device.
Principle of Operation
Aulisa GA2000 Digital Vital Sign Monitoring System measures SpO2
and pulse rate based on non-invasive light-emitting diode (LED)
transmittance technology, measuring the absorbance of red and
infrared light passed through the perfused tissue during each pulse.
It can be operated by the caregiver or by the patient.
System Overview
(Wi-Fi 802.11)
(Wi-Fi 802.11)
Physiological data&
Audio/video data
Physiological data
(Bluetooth 4.0)
NOTE: Aulisa GA2000 System utilizes a customer Wi-Fi network to
communicate between the Receiver/Transponder and the
Display Unit. The customer Wi-Fi network is to be
implemented and managed by end users.
Wi i
TM
11

Device Overview
Oximeter Box
The Oximeter box includes a Bluetooth transmitter and a sensor chip,
which is worn by the patient for vital sign monitoring. It features a
sensor chip, along with electronics for vital sign measuring and
analyzing.
The Oximeter Box must be used within 10 meters from the
Receiver/Transponder.
1
2
3
4
5
Power On/Off button
Power On/Off LED
Alarm LED
Charging port
Sensor cable port
SE NSO R
1
2
3
4
5
Front View Back View
12

Receiver/Transponder
The Receiver/Transponder features Bluetooth/Wi-Fi communication
interfaces and an audio/video camera. It receives vital signs monitoring
data from the Oximeter Box via Bluetooth, integrates audio and video
of the patient, and then converts the data to Wi-Fi signals, which are
transmitted to and displayed by the Display Unit.
1
2
4
5
6
Power On/Off button
Power On/Off LED
AC Power LED
Charging LED
Battery Low LED
1
3
456
Front View Back View
7Charging port
7
Top View
3Wi-Fi Link LED
2
13

Display Unit
The Display Unit features a 10.1” LCD multi-touch display with Wi-Fi
connectivity capability. The Display Unit displays real-time vital signs
measured by the Oximeter Box.
The Display Unit will display informational text messages, alarm text
messages, and beep made audible upon an alarm condition trigger
event.
The Display Unit incorporates a talking and listening function that
allows audio messages to be received and sent via the Receiver/
Transponder.
NOTE: It is recommended that the Display Unit be placed on the
stand provided.
NOTE: Only use fingers to operate keys on the touch screen.
NOTE: Close the cover of charging port when the charging adaptor
is not in use.
Power On/Off button
Volume button
Charging port
14

Displays, Indicators, and Controls
This section describes the displays, indicators, and controls for the
Aulisa GA2000 System.
Display Icons and Indicators
This icon identifies the window
showing the pulse rate in bpm.
Pulse Rate
This icon identifies the window
showing the functional blood
oxygen saturation in percent.
Blood Oxygen
This icon identifies the window
showing the pulse amplitude.
Pulse
Amplitude
When the vital signs cannot be
measured, the Display Unit
shows dashes“- - -”in each of
the vital sign windows.
No data
SpO2 %
This icon displays whether the
Oximeter Box is connected to
the system via Bluetooth. It will
turn blue once the Oximeter Box
is paired with the system.
Bluetooth
Connection
Status of
Oximeter Box
Name
bpm
This icon displays the pulse
signal strength.
NOTE: When the vital sign
values are inadequate, the
pulse amplitude indicator will
turn yellow.
Pulse Amplitude
Indicator
15

This icon displays whether
there is a finger inserted in the
sensor. A system alarm will be
displayed on the Display Unit if
no fingers are detected.
Measurement
Site Status
This icon displays whether the
sensor cable is connected to
the Oximeter Box. A system
alarm will be displayed on the
Display Unit if the cable is
disconnected.
Sensor Cable
Connection Status
These icons signify the battery
level at Full, Medium, or Low.
A medium priority system alarm
will be displayed on the
Display Unit when the
Oximeter Box battery is low.
Battery Level of
Oximeter Box
These icons signify the battery
level of the Display Unit.
A medium priority system alarm
will be displayed on the
Display Unit when the
Display Unit battery is low.
This icon indicates whether
there is a connection
established between the
Display Unit and the Receiver/
Transponder. This icon
will turn blue when there is a
connection between the Display
Unit and the Receiver/
Transponder and turn red when
the connection is lost.
Battery Level of
Display Unit
Receiver/
Transponder
Connection
Indicator
NameIndicator Description
RT
16

NameIndicator Description
Wi-Fi Strength
Indicator
This icon indicates whether
there is a strong connection
between the Display Unit and
customer Wi-Fi Network.
This icon identifies an alarm
condition exists.
!!! represents high priority and
!! represents medium priority
Alarm Indicator
This icon indicates that the
alarm is turned off for the
corresponding physiological
condition.
Alarm Off
This icon indicates that the
alarm audio is silenced for
2 minutes.
Audio Paused
This icon indicates that the
alarm audio is silenced
permanently.
Audio Off
17