ACE Solution Einthoven CR1000 User manual

筑波科技股份有限公司
ACE Solution Co., Ltd.
EinthovenTM CR1000
愛多芬TM 生理感知器
Health Sensation System
衛部醫器製字 第 號
User Manual V1.0

Please read carefully and follow the instructions
before use
Please read through this user manual carefully
before using the Product, and follow the
instructions. Please keep this manual for future
reference.
❑Indications
Einthoven Health Sensation System (Model: CR1000) is designed to
continuously measuring, recording and transmitting physiological
information. This Product is able to monitor and display
Electrocardiography (ECG), heart rate, and events of arrhythmia.
❑Product description
An Einthoven Health Sensation System (Model: CR1000) consists of a
Sensing Patch (“Patch”) and a Host Module. This Product receives ECG
signals through attaching the Product to auser’s left chest and analyzes
heart rate / arrhythmia events with the Host Module combined with the
Patch; the analyzed data can be transmitted to the user’s iOS device through
Bluetooth connection. This product is expected to be used in at homes or in
hospitals.
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❑Product Contents
1. One (1) Host Module;
2. Two (2) Sensing Patches.
3. Einthoven iOS App (Requires manual download from Apple App Store)
Host Module must be combined with Patch in order to perform its functions.
❑Components Identification
✓Host Module
Indication
Arrow (Host) LED Light
(Invisible when not lit)
Top side Bottom side
Connector
Caution:
1. When connecting Host Module to the Patch, make sure
the both indication arrows are pointing to each other.
2. The connector should always be kept dry.
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✓Sensing Patch (Patch)
Switch
Top Side
Bottom Side
Indication Arrow (Patch)
Patch connector
Attaching
direction line
Water-retaining trench
Sensing
electrode
Medical adhesive (this
side attaches to skin)
Caution:
1. Patches are intended for single use only.
2. Please partially remove the releasing
strips only following the manual’s
direction.
Releasing
strip 
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Attaching direction arrow
Attaching
direction arrowReleasing strip 
Releasing
strip
Releasing strip
Description Cautions How to Use Specifications Troubleshooting

✓Einthoven iOSApp
Einthoven iOS App receives analyzed physiological information from the
Product and display/store the information in your portable device. Please
download and install the App through Apple App Store and follow the
instructions to use.
(*System requirement: iOS 10 or higher)
❑Product Usages
➢Monitoring and collecting personal physiological information;
➢Real-time analyzing common arrhythmia events;
➢Providing reference for clinical diagnosis related to heart rhythm or
arrhythmia events.
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❑How to Clean the Product
➢Please clean the outside surface of the Host Module with a clean cloth
moistened with ethanol.
Description Cautions How to Use Specifications Troubleshooting

❑Legends
Manufacturer
For single use only
Do not reuse
Manufacturing
date
Please carefully read through
the user manual before use
Manufacturing batch number
Avoid high temperature or
exposure to sunlight
Product serial number
Keep it dry
Expiry date
Storage humidity range
Non
-ionizing radiation
Storage temperature range
IP Code (protection level)
Solid particle protection: 3
Liquid ingress protection: 3
Direct
current
Do
not use if the package is
damaged
Type
BF applied part
Electronic waste shall be
recycled properly
Caution: Please pay attention
to the important notice in
order to prevent unwanted
consequences
IP33
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❑
◎Please carefully read through this manual before use, and following all
the instructions while use.
◎Please check the packages of each components carefully after receiving
the Product. The Patch is sealed within an aluminum moisture-proof bag,
if the bag or the Patch itself is damaged, please do not use that Patch.
◎Do not use this Product out of its intended use.
◎Do not disassemble the Patch or the Host Module themselves; it might
cause undesired consequences.
◎After combining the Host Module and the Patch and attached the Patch to
auser’s body, please do not remove the Host Module from the Patch
before the end of monitoring.
◎The Patch is for single use only. Reuse may make the user feel
uncomfortable and derogate normal functions of the Product.
◎Do not use this Product on patients who has acute or severe syndrome.
◎Do not use this Product when user’s skin is allergic to adhesives or gel.
◎Do not use this Product if a patient potentially has life-threatening
arrhythmia.
◎This Product is not designed for users under age 16.
◎Patch attached to skin for an extended period might cause an itch or
allergic reaction.
Side Effects
Contraindication
Cautions and Important Notices
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◎This Product is not designed for self-diagnosis purpose. Please seek for
physicians’ advice or diagnosis. Self-diagnosis may cause life-threatening
consequences.
◎Remove this Product before being conducted an MRI scanning.
◎This product shall not be used along with cardiac pacemaker or
internal/external defibrillator.
◎This product shall not be used near a high-frequency signal generator;
there might be signal interference or loss of real-time data.
◎If feeling uncomfortable after attaching the Product to your skin, please
remove the Product immediately.
◎Please do not attach the Product to allergic/inflammatory/wounded skin
or skin with any other illness.
◎In order to keep an unused Product in good status, please store it safely at
a dry and clean place before use, and prevent direct sunlight.
◎The Host Module and Patch individually shall be kept dry before
combined. The Product (when the Host Module is combined with the
Patch) is water-resistant but not water-proof; do not soak the Product in
water. (It is fine to take a shower while wearing it, but please do not
swim or take a bath.)
◎The Product contains small components, please keep it away from
children to prevent choking hazard.
◎Please do not store the Product under temperature below -25°C (-13°F) or
over 70°C (158°F).
◎Please do not use Product after its expiration date.
◎When dispose the Host Module or the Patch, please follow applicable
waste disposal laws and regulations in your region. Please note that the
Host Module contains printed circuit board and the Patch contains
lithium battery.
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❑This Product Complies with the following Requirements in Administrative
Regulations on Low Power Radio Waves Radiated Devices in Taiwan
◎Art.12: Without permission granted by the NCC, any company, enterprise, or
user is not allowed to change frequency, enhance transmitting power or alter
original characteristic as well as performance to a approved low power radio-
frequency devices.
◎Art. 14: The low power radio-frequency devices shall not influence aircraft
security and interfere legal communications; If found, the user shall cease
operating immediately until no interference is achieved.
The said legal communications means radio communications is operated in
compliance with the Telecommunications Act.
The low power radio-frequency devices must be susceptible with the
interference from legal communications or ISM radio wave radiated devices.
❑Europe –EU Declaration of Conformity
This device complies with the essential requirements of the Radio Equipment
directive: 2014/53/EU. The following test methods have been applied in order
to prove presumption of conformity with the essential requirements of the
Radio Equipment directive:
The minimum distance between the user and/or any bystander and the
radiating structure of the transmitter is 20 cm.
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➢2014/53/EU
➢IEC 60601-1
➢IEC 60601-1-2
➢IEC 60601-1-11
➢IEC 60601-2-47
➢EN 300 328
➢EN 301 489-17
➢FCC 47 CFR Part 15B
➢FCC 47 CFR Part 15C
➢LP0002
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❑Federal Communication Commission Interference Statement
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 and, if not installed and used in accordance with the
instructions, may cause harmful interference to radio communications.
However, there is no guarantee that interference will not occur in a particular
installation. If this equipment does 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 of the
following measures:
➢Reorient or relocate the receiving antenna.
➢Increase the separation between the equipment and receiver.
➢Connect the equipment into an outlet on a circuit different from that to
which the receiver is connected.
➢Consult the dealer or an experienced radio/TV technician for help.
FCC Caution：Any changes or modifications not expressly approved by the
party responsible for compliance could void the user's authority to operate
this equipment.
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 undesired operation.
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IMPORTANT NOTE:
Radiation Exposure Statement：
The product comply with the US portable RF exposure limit set forth for an
uncontrolled environment and are safe for intended operation as described in
this manual. The further RF exposure reduction can be achieved if the product
can be kept as far as possible from the user body or set the device to lower
output power if such function is available.
This transmitter must not be co-located or operating in conjunction with any
other antenna or transmitter.
FCC ID：2AO36BIOTEK-EINCR1K
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❑How to use
releasing strip
◆Step 1: Release Releasing Strip
1) Take out the Patch from its sealed package, and remove the release paper
of releasing strip. (Note: The Patch is for single-use only, open its seal
will make it be seemed as used.)
Before use:
1. Please remove body hair covering the intended attaching
area (left chest).
2. Please clean the attaching area (left chest) before use, in
order to prevent discomfort.
3. Keep the attaching area clean and dry, please do not apply
lotion, perfume or other oils.
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◆Step 2: Combine the Host Module with Patch and Turn on
the Power
1) Put the Patch horizontally on the desk top to continuing the combining
process.
2) Make sure the two indication arrows on the Host Module and on the
Patch are pointing to each other, and insert Host Module into the patch
opening as the figure below shows.
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pointing to each other
desk top
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3) Press down the Host Module to combine the connectors of the Host
module and the Patch; make sure to press the Host Module hard until it
is tightly combined with the Patch.
4) Long press the power switch on the Patch for 2 seconds until the LED
light on the Host Module start to blink in green (indicating it is ready for
pairing); the LED light will be off after 10 seconds and the Host Module
will turn into stand-by mode at the same time, waiting for setting up
connection with a mobile device. If the green light is not on after
pressing the switch, please repeat step 2 and make sure the Host Module
is tightly combined with the Patch.
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desk top
Switch
Description Cautions How to Use Specifications Troubleshooting

◆Step 3: Turn on Einthoven iOS App and pairing it with
the Host Module
1) Download Einthoven iOS App from Apple App Store to your mobile
device (which is supported by the App), and turn on the App and
Bluetooth connection.
2) At the first-time use or when adding a new user, please press “Register”
to enter the registration page; for log-in, press “Log in” to enter the main
menu.
3) After entering the registration page, please enter name and gender, then
press “confirm”.
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4) After entering the main menu, press “Start recording” to enter the
pairing screen; press “Historical record lookup” to enter the historical
record list.
5) After entering the pairing screen, please refer to the last two digits of the
serial number on the back of the Host Module or on its package, and
select the corresponding name of Host Module (e.g. If the last two digits
is “00”, please select “Einthoven CR1K-00”from the list); a monitoring
screen will shown up if the connection is successfully set up.
6) First after entering the monitoring screen, a message suggesting
attaching the Product will be shown on the screen. Please be prepared to
attach the Product onto the user’s left chest. The App will make a beep
sound every 10 seconds until the Product has been attached to a human
body.
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◆Step 4: Attach the Product to User’s left chest
1) By pulling Releasing strip, Partially remove the release paper on the
bottom side of the Patch to the extend shown in the 2nd figure below.
Releasing
strip
The bottom side
of the Patch
Partially remove the release paper
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2) The Product should be attached onto the left chest, and the distance from
the lower limit of the neck to the Product is about 3 cm (roughly the width
of two fingers); the expected attaching area is shown as the dotted circle in
the figure below.
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3) Attach the Product (which the release paper is partially removed) to the
left chest with the attaching direction arrow and attaching direction lines
pointing upwards.
Description Cautions How to Use Specifications Troubleshooting

4) Remove the remaining part of release paper of the Patch bottom, and
attach the whole Patch firmly to the chest.
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5) Remove the release paper covering the top surface by pulling the releasing
strip toward the direction shown in the figure below.
6) Press the adhesive surrounding the Patch toward user’s skin, make sure the
Patch is attached firmly to the skin.
Description Cautions How to Use Specifications Troubleshooting

◆Step 5: The Monitoring Screen
➢Arrhythmia detection: shows the real-time analysis of user’s heart
rhythm; the detectable abnormal heart rhythms are:
✓“Normal”: Normal heart rhythm
✓“VEB” (with yellow frame) : Ventricular ectopic beats
✓“SVEB” (with yellow frame) : Supraventricular ectopic beats
✓“Unreadable”: Too much noise, unable to analyze.
➢ECG display: Showing user’s real-time single-lead ECG.
➢Settings: User can change language and heart-rate notification settings
here.
➢Stop recording: To stop recording and return to the main menu.
➢Amplitude adjustment:To change the amplitude unit in the ECG
display.
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