FCC ID: 2AI5QCB0001 Combo Sensor Module

 

Combo Sensor Module-

ECG and PPG

____________________________________________________________

Instructions For Use

7MN00050-01

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.

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

Vital Sign Monitoring System.

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.

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

Temperature limit

Non-sterile

Federal law (USA) restricts this device to

sale by or on the order of a licensed

health care professional only.



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

2. The Combo Sensor Module is not intended for use on users who have implanted

patient during an emergency.

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:

o The Combo Sensor Module must be properly adhered to the patient.

o The patient must remain within 32.8 feet (10 meters) to the Display Unit (for

GA1000 series), or to the Receiver/Transponder (for GA2000 series).

o The 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.

1

1 Power On/Off Button

2 Power LED

3 Battery Chamber

4 SD card

5 Cable port

3

4

2

1

5

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.

1 Sensor Box connector

3

2

1

4

5

2 PPG Probe

3 Right Arm ECG Lead

4 Left Leg ECG Lead

5 Left Arm ECG Lead

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,

home care, and subacute environments. The Aulisa Combo Sensor Module is calibrated using a

manual method or any AAMI 81060 compliant BP device. All parameters derived by Aulisa

Combo Sensor Module are reported to Aulisa’s Digital Vital Sign Monitoring System via

standard radio transmission protocols.

Device Principle of Operation

The Combo Sensor Module captures the bio-signals of electrocardiography (ECG) and

Photoplethysmography (PPG). The device computes heart rate (HR) and respiration rate (RR)

from QRS complexes of ECG, and it estimates blood pressure via Pulse Transit Time (PTT)

measurement from ECG and PPG.

Device Setting Up

Before you begin your monitoring session, unpack the Combo Sensor Module and become

familiar with its parts. It is recommended to fully charge the battery of the Combo Sensor

Module prior to setting up. It takes approximately 2.5 hours to fully charge.

NOTE: Refer to “Device Charging” section below for detailed instructions.

Step 1. Assemble Combo Sensor Module.

Secure the Sensor Box to the holder with the cable port of the Sensor Box inserted inward.

Connect the Sensor Box connector of the Sensor Cable with the Sensor Box as shown below.

Attach the holder to the patient.



Step 2: Prepare skin.

NOTE: Ensure hands are clean and dry before handling the Combo Sensor Module.

Gloves are recommended when handing the device.

NOTE: When handling the Combo Sensor Module, do not touch the adhesive. The steps

below should minimize the chance of touching the adhesive. Contact with the adhesive

prior to application to the patient will deteriorate the adhesive and compromise wear

duration.

The application site is located on the upper left chest as shown below. For a good connection

and proper operation, the device should NOT be worn over areas with a high concentration of

body hair. Remove body hair in the area of device placement before applying the device.

NOTE: For all patients, use an alcohol wipe to clean skin where the adhesives will

contact skin and allow site to dry. The application site should be free of oils and lotions

to maximize adhesion.

Step 3: Position Combo Sensor Module on the body.

Attach the ECG electrodes to the ECG leads of the Sensor Cable as shown below. Ensure they are

well secured.

Place the ECG/PPG Position Guide flat on the chest. Align the upper section of the ECG/PPG

Position Guide to the center of the torso as shown on the diagram below. Remove the releasing

paper of the ECG electrodes. Attach the ECG electrodes onto the positions indicated by the

ECG/PPG Position Guide.

Then, place the PPG probe per the ECG/PPG Position Guide. Remove the ECG/PPG Position

Guide and secure the PPG probe with the adhesive tape.

Step 5: Power-on Combo Sensor Module.

Locate and press the Power On/Off Button. Look for a green light illuminating to confirm the

device is powered on.

Step 6: Set up the GA1000 Series or GA2000 Series.

NOTE: Refer to the GA1000 Series Instructions for Use (7MN00026-02) or GA2000 Series

Instructions for Use (7MN00022-02) for setting up instructions and verifying system

operation.

Step 7: Connect Combo Sensor Module to the system.

Wait for the wireless connection of the system to be established. Once connected, the vital

signs of the Combo Sensor Module status information will appear on the MAIN screen.

NOTE: Refer to “Device Pairing” section below for more information.

NOTE: The Power LED on the Sensor Box will blink green when pairing succeeds, and

data transmission starts.

Device Pairing

Automatic Pairing

GA1000 Series

GA2000 Series

The Display Unit automatically detects and connects to the Combo Sensor Module in the same

starter kit. Press the "PAIR" button on the MAIN screen to force the system pairing when the

connection is not established automatically.

The Receiver/Transponder automatically detects and connects to the Combo Sensor Module in

the same starter kit only when the connection between the Display Unit and the

Receiver/Transponder has been established first.

NOTE: The Combo Sensor Module must be placed within 32.8 feet (10 meters) to the

Display Unit (for GA1000 Series), or to the Receiver/Transponder (for GA2000 Series).

NOTE: The Bluetooth connection status icon will turn blue once the pairing succeeds.

Manual Pairing

Follow the below instructions to manually setup pairing.

NOTE: Up to two (2) Combo Sensor Modules can be stored on the Display Unit.

Step 1: Turn on the Display Unit.

Step 2: In the Setting menu, select “PAIRING”. (for GA1000 Series)

In the Setting menu, select “PAIRING” → “COMBO SENSOR MODULE”. (for GA2000

Series)

device.

Step 3: Scan the QR Code or key in the serial number located on the back of the Aulisa X Box.

Step 4: Check if the serial number (SN) displayed matches with the one on the Aulisa X Box.

Step 5: Press “CONFIRM” on the Display Unit.

Step 6: Assemble the Combo Sensor Module and position on to the body to power on the

Step 7: To confirm that the process as successful, ensure that the Bluetooth connection status

on the MAIN screen of the Display Unit is lit blue.

NOTE: Make sure the battery is installed and fully charged before use.

NOTE: The Combo Sensor Module remains paired with the system until the serial

number is deleted from the list.

NOTE: The Combo Sensor Module must be placed within 32.8 feet (10 meters) to the

Display Unit (for GA1000 Series), or to the Receiver/Transponder (for GA2000 Series).

NOTE: The Power LED lights green when the power is ON.

Device Power Off and Removal

The device will be turned off by either way:

1. Press the Power button on the Sensor Box.

2. When the Combo Sensor Module detects no signal for 3 minutes.

NOTE: The power LED goes off when power off.

When removing the device, use of an adhesive tape remover is recommended. Gently sweep

the remover pad under the device and pull away from the skin.

NOTE: The adhesives are for Single Use Only. Do not reapply to the ECG electrode once

it is removed.

Device Charging

The Combo Sensor Module is powered by a rechargeable battery. When the low battery alarm

appears on the MAIN screen of the Display Unit, the battery is exhausted and needs recharging.

Follow the instructions below to recharge the battery.

1. Slide to remove the back cover of Sensor Box. Remove the battery by lifting the outward

end of the battery upward.



2. Plug the connector end of the charging adaptor into the cable port of the Battery

Charger. Attach the wall adaptor to a power outlet.

NOTE: The power LED of the battery charger lights green when it is plugged in.

NOTE: The charging LED of the battery charger lights blue when the battery is charging.

Device SD card Installation and Removal

The Combo Sensor Module contains a SD card for data storage. The SD card needs to be

installed before using the device. Follow the instructions below to install the SD card.

1. Slide to remove the back cover of Sensor Box. Insert the SD card into the slot of Sensor Box

until it is fully in.

To transfer the data to a computer, follow the instructions below to remove the SD card.

1. Slide to remove the back cover of Sensor Box.

2. Click on the SD card. The SD card will automatically pop out.

Alarm

For more information about the alarm, refer to the GA1000 Series Instructions for Use

(7MN00026-02) or GA2000 Series Instructions for Use (7MN00022-02).

Care and Maintenance

The advanced digital circuitry within the Combo Sensor Module requires no calibration or

periodic maintenance, except for the blood pressure feature which needs to be calibrated

manually or with any AAMI 81060 compliant BP device for the first time use and every 4 hours

of use. Field service or repair of this system is not possible. Do not attempt to open the case

other than the battery cover for that will cause damage and void the warranty. If the Combo

Sensor Module is not functioning properly, see “Troubleshooting” section for more information.

The expected service life of the Combo Sensor Module is 3 years.

Cleaning and Disinfection

Clean surface of Sensor Box and clean and disinfect the Sensor Cable before each use. For

surface cleaning and disinfection, follow the recommended actions below.

Surface cleaning: Clean the surface of the sensor box and Sensor Cable with a soft cloth

dampened with rubbing alcohol. Lightly wipe the surface of the device.

Disinfection: Use a soft cloth saturated with a solution of 10% chlorine bleach in tap water,

lightly wiping the surface of the Sensor Cable.

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.

Troubleshooting

Problem

Cannot power on the Combo

Sensor Module

Unusual vital sign data

Possible Solution

1. Recharge the battery.

2. Press the Power button again.

1. Recheck device's location or contact with

2. Ensure Sensor Cable is connected firmly to

3. Reduce patient motion.

4. Check the Sensor Cable for any visible signs

5. Use this device under instructed operation

the skin.

the Sensor Box.

of deterioration.

conditions.

1. Make sure the Combo Sensor Module is

within 32.8 feet (10 meters) spherical

radius to the Display Unit (for GA1000

Series), or to the Receiver/Transponder (for

GA2000 Series).

2. Power off the system and retry.

Cannot establish

system connection

For additional troubleshooting, refer to the GA1000 Series Instructions for Use (7MN00026-02)

or GA2000 Series Instructions for Use (7MN00022-02).

If these solutions do not correct the problem, please contact your distributor, or contact 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 other than the battery cover or repair the electronics.



Manufacturer’s Declaration

Refer to the following table for specific information regarding compliance to IEC/ EN 60601-1-2 for this

device.

Guidance and manufacturer’s declaration - electromagnetic emissions - for all EQUIPMENT and SYSTEMS

Guidance and manufacture’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.

Emissions test

Compliance

RF emissions CISPR 11

Group 1

RF emissions CISPR 11

Class B

Harmonic emissions

IEC 61000-3-2

Voltage fluctuations/ flicker

Emissions IEC 61000-3-3

Complies

Complies

Electromagnetic environment -guidance

This device uses RF energy only for its

internal function. Therefore, its RF

emissions are very low and are not likely

to cause any interference in nearby

electronic equipment.

This device is suitable for use in all

establishments, including

domestic and those directly connected to

the public low-voltage power supply

network that supplies buildings used for

domestic purposes.

Guidance and manufacturer’s declaration - electromagnetic immunity - for all EQUIPMENT and SYSTEMS

Guidance and manufacture’s declaration - electromagnetic immunity

Immunity test

Compliance level

IEC/ EN 60601-1-2

test level

±8 kV contact

±15 kV air

Electrostatic

Discharge (ESD)

IEC 61000-4-2

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.

Electromagnetic

environment -

guidance

Floors should be

wood, concrete, or

ceramic tile. If floors

are covered with

synthetic material,

relative humidity

should be at least

30%.

Mains power quality

should be that of a

typical commercial

or hospital

environment.

Mains power quality

should be that of a

typical commercial

±2 kV for power

supply lines

±1 kV for

input/output lines

±1 kV differential

mode

±2 kV for power

supply lines

±1 kV for

input/output lines

±1 kV differential

mode

Electrical Fast

Transient/Burst

IEC 61000-4-4

Surge

IEC 61000-4-5

±8 kV contact

±15 kV air

±2 kV common mode or hospital

environment.

±2 kV common

mode

±0% UT in 0.5 cycle

at 0°, 45°, 90°, 135°,

180°, 225°, 270° and

315°

±0% UT in 1 cycle at

0°

±70% UT in 25/30

cycles at 0°

±0% UT in 250/300

cycles at 0° and 180°

30 A/m

±0% UT in 0.5 cycle at

0°, 45°, 90°, 135°,

180°, 225°, 270° and

315°

±0% UT in 1 cycle at

0°

±70% UT in 25/30

cycles at 0°

±0% UT in 250/300

cycles at 0° and 180°

30 A/m

Voltage dips, short

interruptions,

and voltage variations

on power

supply input lines

IEC 61000-4-11

Power Frequency

(50/60 Hz)

Magnetic Field

IEC 61000-4-8

Mains power quality

should be that of a

typical commercial

or hospital

environment.

Power frequency

magnetic fields

should be at levels

characteristic of a

typical location in a

typical commercial

or hospital

environment.

NOTE: UT is the AC mains voltage before application of the test level.

Guidance and manufacturer’s declaration - electromagnetic immunity - for EQUIPMENT and SYSTEMS that are

not LIFE-SUPPORTING

Guidance and Manufacture’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

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

IEC/ EN 60601-

1-2 test level

3 V/m

150 kHz to 80

MHz

10 V/m

80 MHz to 2.7

GHz

Compliance

level

3 V/m

10 V/m

Electromagnetic environment -

guidance

Recommended Separation

Distance

The MANUFACTURER should

consider reducing the minimum

separation distance, based on

RISK MANAGEMENT, and using

higher IMMUNITY TEST LEVELS that

are appropriate for the reduced

minimum separation distance.

Minimum separation distances for

higher IMMUNITY TEST LEVELS

shall be calculated using the

following equation:

E = 6/d√P

Where P is the maximum power in

W, d is the minimum separation

distance in m, and E is the

IMMUNITY TEST LEVEL in V/m.

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is

affected by absorption and reflection from structures, objects, and people.

a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)

telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV

broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic

environment due to fixed RF transmitters, an electromagnetic site survey should be

considered. If the measured field strength in 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/m.

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.

Federal Communications Commission (FCC) Notice

This equipment has been tested and found to comply with the limits for a Class B digital device,

pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection

against harmful interference in a residential installation. This equipment generates, uses, and

can radiate radio frequency energy.

If not installed and used in accordance with the instructions, it may cause harmful interference

to radio or television reception, which can be determined by turning the equipment off and on.

The user is encouraged to try to correct the interference by one or more of the following

9measures:

(1) Reorient or relocate the receiving antenna.

(2) Increase the separation between the equipment and receiver.

(3) Connect the equipment into an outlet on a circuit different from that to which the receiver is

connected.

(4) Consult the dealer or an experienced radio/TV technician for help.

The device is designed and manufactured not to exceed the emission limits for exposure to

radio frequency (RF) energy set by the Federal Communications Commission of the U.S.

Government. These limits are part of comprehensive guidelines and establish permitted levels

of RF energy for the general population. The guidelines are based on the safety standards

previously set by both U.S. and international standards bodies. This equipment has been shown

to be capable of

compliance for localized specific absorption rate (SAR) for uncontrolled environment/ general

population exposure limits specified in ANSI/IEEE Std. C95.1-1992 and has been tested in

accordance with the measurement procedures specified in IEEE Std. 1528-200X (Draft 6.5,

January 2002).

FCC Radiation Exposure Statement

For body worn operation, to maintain compliance with FCC RF exposure guidelines, use only

accessories that contain nonmetallic components. RF exposure separation distance is 5 mm.

Use of other accessories may violate FCC RF exposure guidelines 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

This Privacy Policy was last updated on March 22, 2019.

Our Policy

This privacy policy applies to personal information collected by Taiwan Aulisa Medical Devices

Technologies, Inc. (“Aulisa”, “we”, “us” and/or “our”) from users of the Aulisa remote

monitoring devices (the “Devices”). “Personal Information” includes any information that can be

used on its own or with other information to identify or contact a single person or to identify an

individual in context. If we can link particular information (directly or indirectly) to an individual,

we will consider this information “Personal Information,” and we will protect it.

WE AT AULISA VALUE KEEPING YOUR PERSONAL INFORMATION CONFIDENTIAL AND USING IT

SOLELY IN THE CONTEXT OF OUR MISSION TO PROVIDE CONTINUOUS MONITORING OF VITALS

IN ORDER TO AID PEOPLE BEING MONITORED, HEALTHCARE PROVIDERS (“PROVIDERS”), AND

CAREGIVERS MAKE INFORMED DECISIONS ABOUT YOUR CARE.

THE PERSONAL INFORMATION WE COLLECT AND TRANSMIT MAY INCLUDE HEALTHCARE

INFORMATION, INCLUDING MEDICAL INFORMATION. THEREFORE, OUR PRIVACY PRACTICES ARE

INTENDED TO COMPLY WITH THE HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT

(“HIPAA”). WE WILL MAINTAIN THE PRIVACY OF YOUR HEALTH INFORMATION AS REQUIRED BY

HIPAA AND THE REGULATIONS PROMULGATED UNDER THAT ACT. FOR ADDITIONAL

INFORMATION RELATED TO YOUR HEALTHCARE INFORMATION, PLEASE CONTACT

information@aulisa.com.

We believe that transparency about the use of your personal information is important. In this

privacy policy, we provide you detailed information about our collection, use, maintenance, and

disclosure of your personal information. The policy explains what kind of information we collect,

when and how we might use that information, how we protect the information, and your rights

regarding your personal information.

Please read the following carefully to understand our views and practices regarding your

Personal Information and how we will treat it. For the purposes of Applicable Data Protection

Laws including the European Economic Area data protection law (the “Data Protection Law”):

Non-Provider Users: The data controllers are the Provider and Taiwan Aulisa Medical Devices

Technologies, Inc., No. 218-2, Chong Yang Rd., Nangang Dist., 11573 Taipei

City, Taiwan

Provider Users: The data controller is Taiwan Aulisa Medical Devices Technologies, Inc., No. 218-

2, Chong Yang Rd., Nangang Dist., 11573 Taipei City, Taiwan

Data Protection Officer: Paul Liu

BY USING THE DEVICES, YOU ARE ACKNOWLEDGING THAT YOU HAVE READ AND AGREE TO THE

TERMS OF THIS PRIVACY POLICY. IF YOU DO NOT AGREE, PLEASE DO NOT USE THE DEVICES AND

DO NOT SUBMIT ANY INFORMATION TO US.

Access to and use of the Devices by a Provider who is an Aulisa customer (a “Customer”) and

such Customer's authorized users is subject to and governed by the agreement between Aulisa

and the applicable Customer executed by authorized representatives of each party (the

“Customer Agreement”). Aulisa may collect, use and disclose information from a Customer and

such Customer's authorized users as set forth in the Customer Agreement. If you would like

more information about the Devices or becoming a Customer, please contact us at

information@aulisa.com.

Changes

PLEASE NOTE THAT WE OCCASIONALLY UPDATE THIS PRIVACY POLICY AND THAT IT IS YOUR

RESPONSIBILITY TO STAY UP TO DATE WITH ANY AMENDED VERSIONS. IF WE MODIFY THIS

PRIVACY POLICY, WE WILL NOTIFY YOU OF THE CHANGES ON OUR WEBSITE, AN IN-SERVICE

NOTICE OR OTHER REASONABLE MEANS. YOU CAN STORE THIS POLICY AND/OR ANY AMENDED

VERSION(S) DIGITALLY, PRINT IT, OR SAVE IT IN ANY OTHER WAY. ANY CHANGES TO THIS PRIVACY

POLICY WILL BE EFFECTIVE IMMEDIATELY UPON POSTING, AND SHALL APPLY TO ALL

INFORMATION WE MAINTAIN, USE AND DISCLOSE. IF YOU CONTINUE TO USE THE DEVICES

FOLLOWING SUCH NOTICE, YOU ARE AGREEING TO THOSE CHANGES.

Capitalized terms, if not defined in this Privacy Policy, are defined in the documentation that

came with your Devices.

❖ What Information Do We Collect and Why?

Personal Data that You Provide Through the Devices

We collect Personal Information (e.g. demographic information) from you when you voluntarily

provide such information to us, use the Devices (including without limitation, the software

featured on the Devices and/or platforms), contact us with inquiries, or use certain features of

the Devices. We use this information to allow the Devices to provide the information to you

and/or your Provider.

In addition to demographic information, if you are a person being monitored, we collect Health

Data through the Devices. Such Health Data may include information about your vital signs,

health conditions, age, gender, weight, and height. We collect this information to communicate

information to your healthcare provider.

Primarily, the collection of your Personal Information assists us in providing a means to track

your vital signs in order to better enable you to communicate information with caregivers and

healthcare providers and be an active participant with those providers in monitoring your care,

tailoring interventions, and assessing treatment outcomes. We may also use your Personal

Information to (1) store data; (2) comply with the law; (3) respond to requests from public and

government authorities; (4) to enforce our terms and conditions; (5) manage and improve our

operations and applications; (6) provide additional functionality; (7) protect our rights, privacy,

safety or property, and/or that of yours or others; and (8) allow us to pursue available remedies

or limit the damages we may sustain.

Failure to Provide Information

Providing your Personal Information is not statutorily or contractually mandated. If you choose

not to provide this information, we cannot monitor your vital signs, and you will be unable to

use our Devices.

Support Information

If you contact Aulisa for support or to lodge a complaint, we may collect technical or other

information from you. Such information will be used for the purposes of troubleshooting,

customer support, software updates, and improvement of the Devices in accordance with this

Privacy Policy. Calls with Aulisa may be recorded or monitored for training, quality assurance,

customer service, and reference purposes.

Aggregated Personal Data: In an ongoing effort to better understand and serve our customers,

other users of the Devices, and communities of people with similar health conditions, Aulisa

may conduct research on its user demographics and behavior based on the Personal

Information we collect from you and the other information provided to us. This research may be

compiled and analyzed on an aggregate basis, and Aulisa may share this research and related

information in aggregated, de-identified and/or anonymized format with its affiliates, agents

and other healthcare research and services entities, including without limitation insurance and

pharmaceutical companies. For the avoidance of doubt, this aggregate information does not

identify you personally. Aulisa may also disclose aggregated, de-identified and/or anonymized

information in order to describe our business and the Devices to current and prospective

business partners and Customers, and to other third parties for other lawful purposes.

❖ Where Is My Personal Information Stored And/Or Processed?

Information Aulisa collects through the Devices will be processed and/or stored on secure third-

party cloud-based servers or through a Wi-Fi network. All of the information you share with us

through the Devices is double-encrypted during transmission using AES-128 data encryption as

well as an Aulisa private encryption method.

❖ Will You Share My Personal Information With Anyone Else?

We consider your information to be a vital part of our relationship with you. There are,

however, certain circumstances in which we may share your Personal Information with certain

third parties without further notice to you. Those circumstances are described below:

With Our Provider Customers: If you are a person being monitored, we will share your Personal

Information and Health Data with our Provider Customer(s) that provide healthcare services to

you. This will enable your Provider to track your Health Data and combine such Health Data

with other information about you that your Provider obtains in providing healthcare services to

you.

With Caregivers: If you are a person being monitored, family and/or friends may view certain of

your Personal Information and/or Health Data and related alerts.

In the Event of a Business Transfer: We might sell or buy businesses or assets. In the event of a

corporate sale, merger, reorganization, dissolution or similar event, Personal Information may

be part of the transferred assets.

With Related Companies: We may also share Personal Information with Aulisa Related

Companies for purposes consistent with this Privacy Policy.

With Our Agents, Consultants and Related Third Parties: Aulisa, like many businesses,

sometimes hires other companies to perform certain business-related functions. Examples of

such functions include data hosting and billing management. When we employ another entity

to perform a function of this nature, we only provide the entity with the information that it

needs to perform its specific function.

To Meet Our Legal Requirements: We may disclose your Personal Information if required to do

so by law or if we have a good faith belief that such action is necessary to (i) comply with a legal

obligation, (ii) protect and defend our rights or property, (iii) act in urgent circumstances to

protect the personal safety of you, us, other users of the Devices or the public, or (iv) protect

against legal liability.

NOTE: We may, from time to time, rent or sell aggregated data and/or other

information that does not contain any personal identifiers (i.e., if the information has

been anonymized by stripping out identifiers such as name, address, phone number,

etc.). The purpose of this type of disclosure is to allow research institutions to learn

more about symptoms associated with your medical condition(s).

❖ How Long Will You Retain the Information?

We only store certain of your Personal Information for as long as you use the Devices and up to

five (5) years after you cease to use the Devices. At the end of this five-year period, we will

remove your Personal Information from our databases and will request that our business

partners remove your Personal Information from their databases. However, once we disclose

your Personal Information to third parties, we may not be able to access that Personal

Information any longer and cannot force the deletion or modification of any such information

by the parties to whom we have made those disclosures. Written requests for deletion of

Personal Information other than as described should be directed to information@aulisa.com.

We retain anonymized data indefinitely.

❖ How Do You Protect My Personal Information?

Aulisa is committed to protecting the security and confidentiality of Personal Information. We

use a combination of reasonable physical, technical, and administrative security controls to

maintain the security and integrity of your Personal Information, to protect against any

anticipated threats or hazards to the security or integrity of such information, and to protect

against unauthorized access to or use of such information in our possession or control that

could result in substantial harm or inconvenience to you. However, Internet data transmissions,

whether wired or wireless, cannot be guaranteed to be 100% secure. As a result, we cannot

guarantee the security of information you transmit to us. By using the Devices, you are

assuming this risk.

Safeguards

The information Aulisa collects and stores on secure servers is protected by a combination of

technical, administrative, and physical security safeguards, such as authentication, encryption,

backups, and access controls. If Aulisa learns of a security concern, we may attempt to notify

you and provide information on protective steps, if available, through the e mail address that

you have provided to us or other reasonable notification. Depending on where you live, you

may have a legal right to receive such notices in writing.

NOTWITHSTANDING ANY OF THE STEPS WE TAKE, IT IS NOT POSSIBLE TO GUARANTEE THE

SECURITY OR INTEGRITY OF DATA TRANSMITTED OVER THE INTERNET. THERE IS NO GUARANTEE

THAT YOUR INFORMATION WILL NOT BE ACCESSED, DISCLOSED, ALTERED, OR DESTROYED BY

BREACH OF ANY OF OUR PHYSICAL, TECHNICAL, OR ADMINISTRATIVE SAFEGUARDS.

THEREFORE, WE DO NOT AND CANNOT ENSURE OR WARRANT THE SECURITY OR INTEGRITY OF

ANY INFORMATION YOU TRANSMIT TO US AND YOU TRANSMIT SUCH INFORMATION AT YOUR

OWN RISK.

❖ How Can I Protect My Personal Information?

We will NEVER send you an e-mail requesting confidential information such as account

numbers, or social security numbers, and you should NEVER respond to any e-mail requesting

such information. If you receive such an e-mail purportedly from Aulisa, DO NOT RESPOND to

the e-mail and DO NOT CLICK on any links and/or open any attachments in the e-mail, and

notify Aulisa support at information@aulisa.com.

You are responsible for taking reasonable precautions to safeguard the Device from exposure to

unauthorized third parties, and you are not permitted to circumvent the use of required

encryption technologies.

EU DATA SUBJECT RIGHTS

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If you are an EU data subject, you have the following rights under certain circumstances:

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to receive communications related to the processing of your personal data that are

concise, transparent, intelligible and easily accessible;

to be provided with a copy of your personal data held by us;

to request the rectification or erasure of your personal data held by us without undue

delay;

to request that we restrict the processing of your personal data (while we verify or

investigate your concerns with this information, for example);

to object to the further processing of your personal data, including the right to object to

marketing;

to request that your personal data be moved to a third party;

to receive your personal data in a structured, commonly used and machine-readable

format;

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to lodge a complaint with a supervisory authority.

Where our processing of your Personal Information is based on consent, you have the right to

withdraw that consent without detriment at any time by contacting us at

information@aulisa.com.

You can also exercise the rights listed above at any time by contacting us at

information@aulisa.com.

❖ How Can I Update, Correct Or Delete My Personal Information?

If you need to make changes or corrections to your information, you may make such changes or

corrections on the Device.

❖

Information Submission By Minors

If the Device is being utilized by a minor, and the Devices are being used to monitor a minor, you

represent, warrant and covenant that by agreeing to the terms of this Privacy Policy, you have

the legal authority to accept this Privacy Policy on behalf of such minor as the minor's parent or

legal guardian. If you do not have such legal authority, do NOT accept this Privacy Policy and do

not use the Devices on behalf of such minor.

❖ How Can I Contact Aulisa?

If you have any questions or comments about this Privacy Policy, our practices, or our Devices,

please feel free to e-mail us at information@aulisa.com.

Specifications

Dimensions

Weight

Ingress Protection

Display range

61.8mm x 60.7mm x 21.0mm

63.5 g

IP23

Systolic Blood Pressure

75 to 225 mmHg

Diastolic Blood Pressure

Heart Rate

Respiration Rate

45 to155 mmHg

30 to 290 bpm

10 to 30 bpm

Accuracy

Blood Pressure

Heart Rate

Respiration Rate

Battery Type

Battery Life

Temperature

Operating

Storage/Transportation

Humidity

Operating

Storage/Transportation

Operating Altitude

Atmospheric Pressure

Wireless Communication

Range

Protocol

Direction

Data rate

± 5 mmHg

±3%

±3 rpm

Lithium Polymer Battery

38 hours of continuous operation

+5°C to +40°C

-25°C to +70°C

15% to 90% R.H. non-condensing

10% to 93% R.H. non-condensing

altitude ≤ 3 000 m

700 hPa to 1013 hPa

32.8 feet (10 meters) spherical radius

Bluetooth 4.0

Bi-direction

Up to 100k Bps

Parts and Accessories

Parts and Accessories

Combo Sensor Box

Combo Sensor Cable

Combo Sensor Battery

ECG Electrode

PPG Adhesive Patch

Battery Charger

Charging Adaptor- Battery Charger

Model Number

GA-CB0001

GA-CA0001

GA-BA0001

GA-AP0012

GA-AP0004

GA-BC0001

GA-CR0002

For more information about the Display Unit and Receiver/Transponder, refer to the GA1000

Series Instructions for Use (7MN00026-02) or GA2000 Series Instructions for Use (7MN00022-

02).

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.

may result in inaccurate measurements. Always use parts and accessories by Taiwan

Aulisa Medical Devices Technologies, Inc.



 

 

 

 

 

 

 

 

 

 

 

 

 

 

Yautisa Equipment Autorisation Division Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 DATE: 2021/06/29 FCC ID: 2AI5QCB0001 Request for Confidentialit Pursuant to Sections 0.457 and 0.459 of the commissions rules, we hereby request that the following documents be held confidential:

(List here the documents for which you are seeking confidentiality for example ...) e Schematics e Block diagram e Operation description These materials contain trade secrets and proprietary information and are not customarily released to the public. The public disclosure of this information might be harmful to the company and provide unjustified benefits to our competitors. Name/Title: Augustine Lien Company Name: Taiwan Aulisa Medical Devices Technologies, Inc Address: 10F, No.32, YuanQu St., Nangang Dist., 11503 Taipei City, Taiwan TEL: +886-2-26557297 FAX: +886-2-26557260 Email: Augustine.Lien@aulisa.com

 

 

Yautisa DATE: 2021/06/29 FCC ID: 2AI5QCB0001 Dear Sir,

| hereby have entrusted the following person to be a proxy regarding application for Type Certification. Company name: International Standards Laboratory Corp. Address: No. 120, Lane 180, Hsin Ho Rd., Lung-Tan Dist., Tao Yuan City 325, Taiwan Name: Jerry Liu (Assistant Manager) For instances where our authorized agent signs the application for certification on our behalf, |

acknowledge that all responsibility for complying with the terms and conditions for certification, as specified by Nemko North America, Inc, still resides with us. Name/Title: Augustine Lien Company Name: Taiwan Aulisa Medical Devices Technologies, Inc Address: 10F, No.3-2, YuanQu St., Nangang Dist., 11503 Taipei City, Taiwan TEL: +886-2-26557297 FAX: +886-2-26557260 Email: Augustine.Lien@aulisa.com