VALES & HILLS BIOMEDICAL TECH iCV200S User manual

ECG Acquisition Systems
User Manual
iCV200S

iCV200S User Manual Cardio View®Family
User Manual
ECG Acquisition Systems
Model: iCV200S
No : VH-JS-08(63F)
Date: 2019.09.06
Software Version: V3.4

iCV200S User Manual Cardio View®Family
Manufacturer information：
Company name: VALES & HILLS BIOMEDICAL TECH. LTD.
Address: Bldg. 46-1 No.2 North Street Jingyuan, Beijing Economic-technological
Development Area, 100176 Beijing, China
Tel: [phone]
Fax: [phone]
E-mail: [e-mail]
Website: http://www.vhECG.com
CARDIO SYSTEMES 6 rue Descartes 78370 PLAISIR France

iCV200S User Manual Cardio View®Family
Table of Contents
Preface......................................................................................................................................................... 1
1. iCV200S.................................................................................................................................................. 6
1.1 About iCV200S .................................................................................................................................... 6
1.2 List of packing ..................................................................................................................................... 6
1.3 Accessories ......................................................................................................................................... 7
2. Installation ................................................................................................................................................ 8
2.1 Hardware Connection.......................................................................................................................... 8
2.2 Download vhECG Pro from Apple App Store.......................................................................................... 9
3. Electrodes Hookup................................................................................................................................... 10
3.1 Hookup............................................................................................................................................. 10
3.2 Electrode connection and position ..................................................................................................... 11
4. Getting Start............................................................................................................................................ 12
4.1 Recorder Setting................................................................................................................................ 12
4.2 Communication between Recorder and iPad....................................................................................... 12
4.3 Communication between Recorder and Patient .................................................................................. 13
5. Basic operation of vhECG Pro.................................................................................................................... 14
5.1 Settings for vhECG Pro....................................................................................................................... 15
5.2 Recording ......................................................................................................................................... 18
5.3 Preview ............................................................................................................................................ 24
5.4 Operation after reviewing.................................................................................................................. 30
5.5 Confirm vhECG.................................................................................................................................. 40
5.6 HIS search and patients information management .............................................................................. 43
5.7 Cloud................................................................................................................................................ 46
6. Cleaning and Maintenance ....................................................................................................................... 52
7. Guidance and Manufacture’s Declarations ................................................................................................ 54
Annex I: iCV200S ECG Recorder Technical Specifications ................................................................................ 56
Annex II: Definitions and Rules for ECG Measurements.................................................................................. 57

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Preface
Copyright
Copyright© 2014, Vales and Hills (V&H). All rights reserved. No one is permitted to translate,
reproduce or duplicate this manual or any part thereof, in any form, without prior written permission
from V&H, V&H assumes no responsibility for any injury to anyone, or for any illegal or improper use
of the product, that may result from failure to use this product in accordance with the instructions,
cautions, warnings, or statement of intended use published in this manual. Unauthorized copying of this
publication may not only infringe copyright but also reduce the ability of V&H to provide accurate and
up-to-date information to users and operators alike.
The information contained in this manual is subject to change without notice. All changes will be in
compliance with regulations governing manufacture of medical equipment.
General Description and Intended Use
iCV200S is a portable ECG system with CardioView family. It includes a data acquisition recorder and
iCV200S 12-lead patient cable. The ECG waveform can be displayed on an iOS equipment installed a
vhECG Pro App. The system is designed and manufactured by V&H for patient ECG recording with
automatic measurements and interpretations.
This product is not intended for use as sustain or support life devices.
This product is not intended for introcardiac use.
This product is not intended for use in operating room or ICU.
This product is not intended for infant.
ECG Acquisition Systems will be used in the professional healthcare facility environment and the
product is intended to provide reference for medical diagnosis, not intended for a replacement of
diagnosis clinicians.
Precautions
Radio Frequency (RF) interference between the iCV200S recorder or electrocardiograph and any
existing RF transmitting or receiving equipment at the installation site, including electrosurgical
equipment, in close proximity to the electrocardiograph should be evaluated before the equipment is
operated as they may seriously degrade performance.
The iCV200S is susceptible to interference from RF energy sources (lowered RF immunity) which
exceed the IEC 60601-1-2 limits, such as power line bursts, other medical equipment, cellular products,
information technology equipment and radio/television transmission.
To reduce EMC interference the cardiograph shall be separated from the emitting sources as much as
possible. If assistance is needed, call V&H service.
Artifact on the ECG caused by electromagnetic interference should be evaluated by a physician or
physician authorized personnel to determine if it will negatively impact diagnosis or treatment.

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Like all electronic devices, this electrocardiograph is susceptible to electrostatic discharge (ESD). ESD
typically occurs when electrostatic energy is transferred to the patient, the electrodes, or the
electrocardiograph. ESD may result in ECG artifact that may appear as narrow spikes on the cardiograph
display or on the printed report. When ESD occurs, the electrocardiograph’s interpretation may be
inconsistent with the physician’s interpretation.
V&H assumes no liability for failures resulting from RF or ESD interference between V&H CardioView
series and any RF or ESD generating equipment when these levels exceed those established by
applicable standard.
Warnings
The electrocardiograph has not been designed for use with high frequency (HF) surgical equipment
and does not protect against hazards to the patient.
Ensure the location of the electrode and associated cables provides maximum separation away from
all sources of HF energy. The best way to ensure patient safety is to completely remove all
electrodes and cables from the patient when exposed to HF energy.
Other medical equipment, including but not limited to defibrillators, ultrasound machines,
pacemakers, and other simulators, may be used simultaneously with the electrocardiograph.
However, such devices may disturb the electrocardiograph signal.
Portable RF communications equipment including peripherals such as antenna cables and external
antennas should be used no closer than 30 cm (12 inches) to any part of the device including cables
specified by the manufacturer. Otherwise degradation of the performance of this equipment could
result.
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 or more 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.
This device complies with Part 15 of the FCC Rules. Changes or modifications not expressly
approved by the party responsible for compliance could void the user's authority to operate the
equipment.
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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The conductor parts of the electrode of ECG Acquisition Box and its connector (including the
neutral electrode) should not contact with other conductor parts, including the earth.
There will be potential risks when using the product along with installation of cardiac rhythm or
other electrical stimulator at the same time. Pay full attention to changes of the ECG to ensure
safety and to ensure that the leakage current is within the allowable range.
Do not use the product with Pacemaker.
During defibrillation, do not touch patients, electrode and patient cable.
Unpolarized electrode (silver/silver chloridoe) can be used for defibrillation.
Warranty and Service
V&H provides a one-year warranty and life-time service to all CardioView series products. Repairs on
products under warranty must be performed or approved by V&H. Unauthorized repairs will void the
warranty. In addition, whether or not covered under warranty, any product repair shall exclusively be
performed by V&H certified service per.
Limited warranty statement
The warranty will not cover the damages caused by:
1) Use or maintenance contrary to labeled instructions;
2) Alteration or repair by anyone not authorized by V&H;
3) Accidents.
Product return
If the product has to be returned for service, V&H recommends these parking instructions:
Wherever possible, use the original shipping carton and packing materials.
Including a packing list.
Including a problem description report.
It is recommended that all returned goods be insured. Claim for loss or damage to the product must be
initialed by the sender.
Unit disposal Instructions
Disposal of battery and the unit after the end of device life in municipally approved recycling area. The
life of device is 5 years.

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Classification
Degree of protection against electrical
shock
Type CF, defibrillation-proof
The power supply of ECG Acquisition box
2×AAA Battery
Degree of protection against harmful
ingress of water
Enclosed equipment without protection against
ingress of water
Degree of safety of application in the
presence of a flammable anesthetic mixture
with air or with oxygen or nitrous oxide
Not suitable for use in the presence of a flammable
anesthetic mixture with air or with oxygen or
nitrous oxide.
Method(s) of sterilization or disinfection
recommended by the manufacturer
Sterilization: not applicable
disinfection: see user manual
Mode of operation
Continuous operation
The defibrillation-proof recovery time
5s

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List of Symbols
Symbols
Meaning
Caution, consult accompanying documents.
SN
Serial Number(xxxxxxxxxxxxxxx)
Manufacturer
Date of manufacture
Authorized representative in the European community
The CE marking with the Registration Number of the Notified
Body. This denotes the compliance of European Medical Device
Directive 93/42/EEC
Waste Electrical and Electronic Equipment (WEEE) It is the
responsibility of the end user to dispose of this equipment at a
designated collection point for recycling.
DEFIBRILLATION-PROOF TYPE CF APPLIED PART
Bluetooth
Function switch button
Keep dry
temperature limits
Indicates the range of humidity to which the medical device can be
safely exposed.
IPX0
Against ingress of water with harmful effects: non-protected
Warning:
Warning statements describe conditions or actions that can result in personal injury or lost of life.
Caution:
Warning statements describe conditions or actions that can result in damage to the equipment of
software.
Note: Notes contain additional information on iCV200S usage.

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1. iCV200S
iCV200S Rest ECG for iOS
Thank you for your purchase of iCV200S Resting ECG System and we hope that you will enjoy
working with it. If you have any comments or suggestions, we would appreciate hearing from you.
Please contact [e-mail].
1.1 About iCV200S
iCV200S is a portable ECG system. It includes a data acquisition recorder and patient cable. The
product can connect with iOS equipment such as iPad, iPad-mini and iPhone through Bluetooth. The
system is designed and manufactured by V&H, The ECG Acquisition System is capable of sampling,
recording and analyzing patients resting ECG. This system is applicable to the heart disease analysis for
the medical treatment institution.
Fig1.1 iCV200S ECG Acquisition Systems connect with iOS equipment
1.2 List of packing
The ECG Acquisition Systems consists of the following items:
Part No.
Description
QTY
CV001008
ECG Acquisition Box
1
CV002019
ECG cable (Type: ECG-FD10X4(ZX))
1
CV004005
User manual
1

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Note:
If you have received the above items, you can download iCV200S software vhECG Pro from Apple
App Store. Please see “2.2 Download vhECG Pro from Apple App Store”.
1.3 Accessories
Item No.
Description
Intended Use
CV002019
iCV200S patient cable
(Type: ECG-FD10X4(ZX))
Cables allow connection to the electrode leads,
which adhere to the patient for detection of ECG
signals.
CV008002
Battery
Power for ECG acquisition box
Notes:
1) If any lead wire of lead part is failure, the user is unable to replace the lead wire, please contact with
V&H.
2) Please use the original standard patient cable which needs to be used to provide protection against the
effect of the discharge of a cardiac defibrillator and against high-frequency burns.
3) If any lead wire of lead part is failure, the user can replace the standard 6511ECG cable, the ECG
cable safety requirements tested for compliance with 93/42/EEC, should have the CE certificate. Vales
& Hills recommends Qingdao Bright medical, the model is M0201044. If use the manufacturer approval
attachment may reduce the safety of the products.
4) iCV200S is powered by two AAA LR03 batteries. Insufficient of power may affect the
communication between the recorder and iOS equipment. Check the batteries with adequacy of power
before using. If the power is low, the user can replace the new battery. Vales & Hills recommends the
battery model is AAA LR03. The product can be used continuously for at least 8 hours under normal use.
5) For the sake of environmental protection, please recycle disposal of the battery.
6) For products and accessories that are no longer used, it will be the cause of environmental pollution,
they should be properly treated.
7) Not including Standard Patient Cable and Battery when we sale.
8) If you find anything above is not included in the packing, please contact us by the following address:
Technical Support Dept. of Vales & Hills Biomedical Tech. Ltd.
Tel: [phone]
E-mail: [email protected]
Website: http://www.vhecg.com
Fax: [phone]
Address: Bldg. 46-1 No.2 North Street Jingyuan, Beijing Economic-technological Development Area,
100176 Beijing, China
CARDIO SYSTEMES, 6 rue Descartes 78370 PLAISIR, France

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2. Installation
A complete iCV200S system consists of iCV200S data acquisition recorder and iCV200S 12-lead
patient cable. This system can connect iPad, iPad-mini or iPhone with Apple App – vhECG Pro. This
section will guide you iCV200S recorder composition and vhECG Pro installation.
2.1 Hardware Connection
iCV200S ECG Acquisition Recorder
iCV200S Recorder Frontside
iCV200S Recorder Backside
Fig 2.1 iCV200S Recorder
Notes:
1) Power Indicator: Blue light for sufficient power and glint for power shortage.
2) Lead abnormal indicator: Green light for sufficient power.
Battery Compartment Cover
Button
Power Indicator
Lead abnormal indicator
15-Pin-Share-Socket
iCV200S Patient Cable Connector
Electrode connector

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iCV200S Connecting further accessories
The illustration on the Fig 2.2 shows further accessories and the interface where they are
connected.
Fig 2.2 Operation schematic
2.2 Download vhECG Pro from Apple App Store
iCV200S Resting ECG System can connect the software running on iPad, iPad-mini or iPhone named
vhECG Pro approved by Apple “ ”.
Free Download
You can download vhECG Pro to your iPad, iPad-mini or iPhone from Apple App Store for free as
following steps:
Step 1. Login with your Apple ID (Settings → Store). If you do not have an Apple ID, you can create
one with your e-mail address;
Step 2. Entry the APP store of your iPad/iPad-mini/iPhone;
Step 3. Search “vhecg pro”;
Step 4. Download the software of “vhecg pro”, then install it by operational guide and you will get
vhECG Pro “ ”.
Note:
If you have any questions about vhECG Pro download, please contact [e-mail].
Patients within
environment
Patients outside
environment
iPad/iPhone
Bluetooth
Patient
Patient cable (F-TYPE APPLIED PART)
iCV200S ECG acquisition box

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3. Electrodes Hookup
3.1 Hookup
Fig 3.1 Electrode location

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3.2 Electrode connection and position
Precordial lead: Coat the patient’s chest with conductive paste or wipe with alcohol cotton balls in
correct position, then attach the lead and suck ball to the patient in the order as below:
Electrode clip:
Limb lead：
1) Clean the skin of the patient.
2) Apply conductive paste or wipe with alcohol cotton balls.
3) Attach the electrode clip, preferably on the inside of limbs.
4) To prevent oxidation and poor connection, please clean the clips after use.
Note:
1) It is recommended that electrodes be placed by medical trained personnel.
2) To obtain correct ECG record, please previously clean the skin.
Limb leas position:
RA: Right arm
LA: Left arm
RL: Right leg
LL: Left keg
Precordial lead position
：
C1: The fourth intercostal space to the right of the sternum.
C2: The fourth intercostal space to the left of the sternum.
C3: Mid-point between V2 and V4.
C4: The fifth intercostal space in the left clavicular midline.
C5: The fifth intercostal space in the axillary line.
C6: The fifth intercostal space in the axillary midline.

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4. Getting Start
The communication between iPad and iCV200S Recorder is through Bluetooth.
iCV200S Resting ECG System for iPad is vhECG Pro. It currently runs with the following languages:
The running language of vhECG Pro depends on your iPad language setting. The default language is
English, that means if your iPad sets the language not belong to above selections, vhECG Pro will run in
English. The software vhECG Pro will support more languages in progress. V&H appreciates your
participations in vhECG development.
4.1 Recorder Setting
Referring to 2.1 to get the <terms> explaining.
The communication between iCV200S recorder and iPad is through Bluetooth.
Battery: Set two AAA batteries into the recorder.
<Button> Control:
Turn on: Click <button> to turn on the recorder.
Turn off: Keep press (two seconds) <button> to turn off the recorder.
<LED (Green)> State:
Off: The recorder is off.
On: The recorder is on.
Slow Flash (once two seconds): Power insufficient -- change the batteries.
4.2 Communication between Recorder and iPad
Step 1: Turn on the recorder.
Step 2: Click “” on iPad to enter settings.
Step 3: Click “ ” on iPad. To enable Bluetooth function of the iPad device.
Step 4: Open the vhECG software “ ”. Click “ ” to enter vhECG settings, then click “ECG Device
Connectivity” and select Bluetooth method. Such as:

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Fig 4.1 Select Bluetooth
Step 5: Come back to the home page, click “ ” on the top-right corner of your iPad.
When the connection successes, you will see “Device Connected” at the bottom of your iPad.
Click the round icon “ ” with numbers to start work.
Fig 4.2 Device connection diagram
Note:
The last five digits of the device will show on the bottom of your iPad, you need to select the same
device number on the iPad with your recorder.
4.3 Communication between Recorder and Patient
Step 1: Connect the electrode on the electrode connector.
Step 2: Clean the skin.
Step 3: According to section “3.2 Electrode connection and position”.
Note:
If the connection of the lead wire and Acquisition box is normal, green light for sufficient power. If
there’s any damage between the connection of the lead wire and Acquisition box, Green light for
corresponding to the lead wire is off. Please check Patient cable and change Patient cable.

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5. Basic operation of vhECG Pro
vhECG Pro is an easy-to-use application providing professional ECG tools and excellent user
experience. Most of the usage is the same as iOS. If you are familiar with Apple applications, there is no
problem to operate vhECG Pro. This chapter will describe the basic operation of vhECG Pro, please
read it carefully.
Tap vhECG Pro icon “ ” on the desktop to run. Enter main interface of vhECG Resting ECG
System as below：
Fig 5.1 Main interface
Bluetooth
communication
Settings

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vhECG Pro mainly consist of four parts: Settings, Recording, Review and Cloud.
Fig 5.2 vhECG Pro composition
5.1 Settings for vhECG Pro
Users can customize vhECG Pro. Tap “ ” to enter settings. It consists of four parts.
Setting Options
Operation options
Operation results
1) GENERAL Setting
Hospital Name
Input your hospital or
organization name, etc.
Group name
Doctor Name
Input the vhECG user’s name
Be used to sign for diagnosis
2) LIVE MONITOR Setting
Use Demo Data
ON / OFF
ON: Show the demo wave;
OFF: Not show the demo wave.
Backward Record
ON / OFF
ON: Record last setting-time ECG data;
OFF: Not record last setting-time ECG data.
Pediatric
Mode
OFF / V1 V3 V5 /
V5R V3R V1 V3 V5 V7
OFF: Not record new baby’s ECG data;
V1 V3 V5/ V5R V3R V1 V3 V5 V7:
Record Pediatric ECG data
Highpass
OFF / 0.05Hz / 0.08Hz / 0.1Hz
Filter out noise with higher frequency, that
is, more noise can be filtered in this mode.
Lowpass#1
OFF / 30Hz / 40Hz / 45Hz /
70Hz / 75Hz / 100Hz / 150Hz
Filter out noise with lower frequency, that is,
less noise can be filtered in this mode.
AC Notch#2
OFF / 50Hz/ 60Hz
Clear noise of alternation current.
EMG Filter#3
ON / OFF
ON: Filter out interference of EMG noise;
OFF: Not filter out interference of EMG
Settings
Recording
Review
Cloud
vhECG Pro
Hospital basic
information, filter,
recording time, hospital
info, report format and
other related parameters
New-built case,
ECG collection,
preview
Edit, delete, upload,
print and send email for
ECG
View, diagnostic and
review report uploaded

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Setting Options
Operation options
Operation results
noise.
Connect to HIS
ON / OFF
ON: Connect to HIS;
OFF: Not connect to HIS.
Patient Queue
Mode#4
ON / OFF
ON: Detect from patient menu;
OFF: Not detect from patient menu.
Enable Minnesota
Code
ON / OFF
ON: Show the diagnostic list by the code;
OFF: Not show the diagnostic list by the
code.
Print Grid
ON / OFF
ON: Grid;
OFF: No grid.
3) COMMUNICATION Setting
Ecg Device
Connectivity
Bluetooth
Connect with the Recorder and receive the
ECG from the the Recorder.
Device SN Last
Digit
Number
Edit the SN Last Digit of the Recorder.
Device ID
Numbers
Edit the ID of the Recorder.
Ecg Cloud / FTP
Adress
#5
Input ECG cloud or FTP address
Transfer the ECG to Cloud or FTP system
FTP File Format
XML / Report
XML: transfer the ECG data to FTP in XML
format
Report:
transfer the ECG data to FTP in
report format
4) REPORT Setting
Report title
Edit the title of report
Report title
Report format
PDF / Image
ECG Email format
Report password
Edit password
Patient report encryption
Lead Layout
6×2 / 12×1
Report lead layout
Paper orientation
A4 Portrait / A4 Landscape/ B5
Portrait / B5 Landscape
Report paper orientation
Default mail
address#6
Edit E-mail address
Report default recipient
Auto Delete Report
After Sent
ON / OFF
ON: Auto Delete Reports After Sent;
OFF: Retain Reports After Sent.
Notes:
#1: Lowpass: Patented by V&H. Muscle noise can be removed by setting Lowpass with low cutoff
frequency but it will severely affect ECG high frequency component such us QRS complex.
#2: AC Notch: Using "AC Notch" can effectively remove baseline wandering and clear noise of
alternation current but will affect ECG frequency response, such as ST segment.