VALES & HILLS BIOMEDICAL TECH iCV200S User manual

ECG Acquisition
ECG Acquisition
Systems
User Manua
l
iCV200S
Systems
l

No
:
iCV200S User Manual
User Manual
ECG Acquisition Systems
Model: iCV200S
:
VH-JS-08(63F)
Date: 2019.09.0
Software Version: V3.4
Cardio View
®
Family
Date: 2019.09.0
6

Manufacturer information
Company name:
VALES & HILLS BIOMEDICA
Address: Bldg. 46-
1 No.2 North Street Jingyuan, Beijing Economic
Development Area, 100176 Beijing, China
Tel: [phone]-
51665548
Fax: [phone]-
67856343
E-mail:
[e-mail]
Website:
http://www.vh
CARDIO SYSTEMES 6 rue Descartes 78370 PLAISIR
iCV200S User Manual
Manufacturer information
：
VALES & HILLS BIOMEDICA
L
TECH. LTD.
1 No.2 North Street Jingyuan, Beijing Economic
Development Area, 100176 Beijing, China
51665548
67856343
[e-mail]
http://www.vh
ECG.com
CARDIO SYSTEMES 6 rue Descartes 78370 PLAISIR
Cardio View
®
Family
TECH. LTD.
1 No.2 North Street Jingyuan, Beijing Economic
-technological
CARDIO SYSTEMES 6 rue Descartes 78370 PLAISIR
France

Table of Contents
Preface
................................
1. iCV200S
................................
1.1 About iCV200S
................................
1.2 List of packing
................................
1.3 Accessories
................................
2. Installation
................................
2.1 Hardware Connection
2.2
Download vhECG Pro from Apple App Store
3. Electrodes Hookup
................................
3.1 Hookup
................................
3.2 Electrode connection and position
4. Getting Start
................................
4.1 Recorder Setting
................................
4.2 Communication between Recorder and iPad
4.3 Communication between Recorder and Patient
5. Basic operation of vhECG Pro
5.1 Settings for vhECG Pro
5.2 Recording
................................
5.3 Preview
................................
5.4 Operation after reviewing
5.5 Confirm vhECG
................................
5.6 HIS search and patients information management
5.7 Cloud
................................
6. Cleaning and Maintenance
7. Guidance and Manufacture’s Declarations
Annex I: iCV200S ECG Recorder Technical Specifications
Annex II: Definitions and Rules for ECG Measurements
iCV200S User Manual
................................
................................................................
................................
................................
................................
................................
................................
................................
................................
................................
................................
................................
................................
................................
................................
................................
................................
................................
2.1 Hardware Connection
................................................................
................................
Download vhECG Pro from Apple App Store
................................
................................
................................
................................
................................
................................
................................
................................
3.2 Electrode connection and position
................................
................................
................................
................................
................................
................................
................................
................................
4.2 Communication between Recorder and iPad
................................
................................
4.3 Communication between Recorder and Patient
................................
................................
5. Basic operation of vhECG Pro
................................................................
................................
5.1 Settings for vhECG Pro
................................................................
................................
................................
................................
................................
................................
................................
................................
5.4 Operation after reviewing
................................................................
................................
................................
................................
................................
5.6 HIS search and patients information management
................................
................................
................................
................................
6. Cleaning and Maintenance
................................................................
................................
7. Guidance and Manufacture’s Declarations
................................
................................
Annex I: iCV200S ECG Recorder Technical Specifications
................................
Annex II: Definitions and Rules for ECG Measurements
................................
Cardio View
®
Family
................................
......................... 1
................................
.................................................. 6
................................
................................... 6
................................
.................................... 6
................................
......................................... 7
................................
................................................ 8
................................
.......................... 8
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Version: A/1
Preface
Copyright
Copyright© 2014,
Vales and Hills (V&H)
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 abilit
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 equipmen
General Description and Intended Use
iCV200S
is a portable ECG system
iCV200S 12-lead
patient cable
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 prod
uct is not intended for use in operating room or ICU

This product is not intended for
ECG Acquisition Systems will be used in the professional healthcare facility environment and the
product
is intended to provide reference for medical diagnosis,
diagnosis clinicians.
Precautions
Radio Frequency (RF) interference between the
existing RF transmitting or receiving equipment at the installation site, including electrosur
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 source
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 treatm
iCV200S User Manual
Vales and Hills (V&H). All rights reserved. N
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
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
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 equipmen
General Description and Intended Use
is a portable ECG system
with CardioView family
. It includes a data acquisition recorder and
patient cable
. The ECG waveform can be
displayed
The system is designed and manufactured by V&H for patient ECG recording with
and interpretations.
This product is not intended for use as sustain or support life devices.
This product is not intended for introcardiac use.
uct 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
is intended to provide reference for medical diagnosis, not intended for a replacement of
Radio Frequency (RF) interference between the
iCV200S
recorder or electrocardiograph and any
existing RF transmitting or receiving equipment at the installation site, including electrosur
equipment, in close proximity to the electrocardiograph should be evaluated before the equipment is
operated as they may seriously degrade performance.
is susceptible to interference from RF energy sources (lowered RF immunity) which
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 source
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 treatm
Cardio View
®
Family
Page
1 of 58
. All rights reserved. N
o 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
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
y of V&H to provide accurate and
The information contained in this manual is subject to change without notice. All changes will be in
compliance with regulations governing manufacture of medical equipmen
t.
. It includes a data acquisition recorder and
displayed
on an iOS equipment installed a
The system is designed and manufactured by V&H for patient ECG recording with
This product is not intended for use as sustain or support life devices.
ECG Acquisition Systems will be used in the professional healthcare facility environment and the
not intended for a replacement of
recorder or electrocardiograph and any
existing RF transmitting or receiving equipment at the installation site, including electrosur
gical
equipment, in close proximity to the electrocardiograph should be evaluated before the equipment is
is susceptible to interference from RF energy sources (lowered RF immunity) which
2 limits, such as power line bursts, other medical equipment, cellular products,
To reduce EMC interference the cardiograph shall be separated from the emitting source
s as much as
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 treatm
ent.

Version: A/1
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 artif
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
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
and does
not protect against hazards to the p

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 saf
ele
ctrodes and cables from the patient when exposed to HF energy.

Other medical equipment, including but no
pacemakers, and other simulators, may be used simultaneously with the electrocardiograph.
However, suc
h 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
specifie
d 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
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 interfe
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 equipmen
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 int
connected.
-
Consult the dealer or an experienced radio/TV technician for help
This device complies with Part 15 of the FCC Rules.
approved by the pa
rty responsible for compliance
equipment.
Operation is subject to the following two conditions:
(1) T
his device may not cause ha
(2) T
his device must acc
undesired operation.
iCV200S User Manual
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
The electrocardiograph has not been designed for use with high frequency (HF) surgical
not protect against hazards to the p
atient.
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 saf
ctrodes and cables from the patient when exposed to HF energy.
Other medical equipment, including but no
t
limited to defibrillators, ultrasound machines,
pacemakers, and other simulators, may be used simultaneously with the electrocardiograph.
h 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
d by the manufacturer. Otherwise degradation of the performance of this equipment could
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
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 equipmen
and on, the user is encouraged to try to correct the interference by one or more of the following
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
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
rty responsible for compliance could void the user's authority to operate the
Operation is subject to the following two conditions:
his device may not cause ha
rmful interference, and
his device must acc
ept any interference received,
including interference that may cause
Cardio View
®
Family
Page
2 of 58
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
act that may appear as narrow spikes on the cardiograph
display or on the printed report. When ESD occurs, the electrocardiograph’s interpretation may be
RF or ESD interference between V&H CardioView
series and any RF or ESD generating equipment when these levels exceed those established by
The electrocardiograph has not been designed for use with high frequency (HF) surgical
equipment
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 saf
ety is to completely remove all
ctrodes and cables from the patient when exposed to HF energy.
limited to defibrillators, ultrasound machines,
pacemakers, and other simulators, may be used simultaneously with the electrocardiograph.
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
d by the manufacturer. Otherwise degradation of the performance of this equipment could
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,
rence 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 equipmen
t off
and on, the user is encouraged to try to correct the interference by one or more of the following
o an outlet on a circuit different from that to which the receiver is
Consult the dealer or an experienced radio/TV technician for help
.
Changes or modifications not expressly
could void the user's authority to operate the
including interference that may cause

Version: A/1

The conductor parts of the electrode of ECG Acquisition Box
neutral electrode) should not contact with ot
 There wi
ll 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

Do not use the product with Pacemaker.
 During defibrillation,

Unpolarized electrode
Warranty and Service
V&H provides a one-
year
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 ex
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) A
lteration 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 a
life of device is 5 years.
iCV200S User Manual
The conductor parts of the electrode of ECG Acquisition Box
neutral electrode) should not contact with ot
her conductor parts,
including
ll 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
Do not use the product with Pacemaker.
do not touch patients, ele
ctrode and patient cable.
Unpolarized electrode
(silver/silver chloridoe) can be used for def
i
Warranty and Service
year
warranty and life-time service to all Car
dioView 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 ex
performed by V&H certified service per
.
Limited warranty statement
not cover the damages caused by:
or maintenance contrary to labeled instructions
;
lteration or repair by anyone not authorized by V&H
;
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
Unit disposal Instructions
Disposal of battery and the unit after the end of device life in municipally approved recycling a
Cardio View
®
Family
Page
3 of 58
and its connector (including the
including
the earth.
ll 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.
ctrode and patient cable.
i
brillation.
dioView 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 ex
clusively be
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.
It is recommended that all returned goods be insured. Claim for loss or damage to the product must be
Disposal of battery and the unit after the end of device life in municipally approved recycling a
rea. The

Version: A/1
Classification
Degree of protection against electrical
shock
The power supply of ECG Acquisition box
Degree of protection against harmful
ingress of water
Degree of safety of application 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
Mode of operation
The defibrillation-
proof recovery time
iCV200S User Manual
Degree of protection against electrical
Type CF, defibrillation
The power supply of ECG Acquisition box
2×AAA Battery
Degree of protection against harmful
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 a
nitrous oxide.
Method(s) of sterilization or disinfection
recommended by the manufacturer
Sterilization: not applicable
disinfection: see user manual
Continuous operation
proof recovery time
5s
Cardio View
®
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4 of 58
Type CF, defibrillation
-proof
equipment without protection against
Not suitable for use in the presence of a flammable
anesthetic mixture with a
ir or with oxygen or
Sterilization: not applicable
disinfection: see user manual
Continuous operation

Version: A/1
List of Symbols
Symbols
SN
IPX0
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
iCV200S User Manual
Meaning
Caution, consult accompanying
documents.
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
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 T
YPE 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.
Against ingress of water with harmful effects: non
Warning statements describe conditions or actions that can result in personal injury or lost of life.
Warning statements describe conditions or actions that can result in damage to the equipment of
Notes contain additional
information on iCV200S usage.
Cardio View
®
Family
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5 of 58
Meaning
documents.
Authorized representative in the European community
The CE marking with the Registration Number of the Notified
This denotes the compliance of
European Medical Device
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.
YPE CF APPLIED PART
Indicates the range of humidity to which the medical device can be
Against ingress of water with harmful effects: non
-protected
Warning statements describe conditions or actions that can result in personal injury or lost of life.
Warning statements describe conditions or actions that can result in damage to the equipment of

Version: A/1
1. iCV200S
 iCV200S
Rest ECG for i
Thank you for your purch
working with it.
If you have any comments or suggestions, we would app
Please contact support
@vh
1.1 About iCV200S
iCV200S
is a portable ECG system. It includes a data acquisition recorder
product can connect with iOS equipment such as
system is designed and manufactured by V&H
recording and analyzing patients resting ECG. This system is applicable to the heart disease analysis for
the medical treatment institution.
Fig1.1
iCV200S
1.2 List of packing
The ECG Acquisition Systems consists of the following items:
Part No.
CV001008
CV002019
CV004005
iCV200S User Manual
Rest ECG for i
OS
Thank you for your purch
ase of iCV200S Resting ECG System
and we hope that you
If you have any comments or suggestions, we would app
@vh
medical.com.
is a portable ECG system. It includes a data acquisition recorder
product can connect with iOS equipment such as
iPad, iPad-mini
and iPhone
system is designed and manufactured by V&H
, The ECG A
cquisition 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.
iCV200S
ECG Acquisition Systems connect w
ith iOS equipment
The ECG Acquisition Systems consists of the following items:
Description
ECG Acquisition Box
ECG cable (Type: ECG-
FD10X4(ZX)
User manual
Cardio View
®
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6 of 58
and we hope that you
will enjoy
If you have any comments or suggestions, we would app
reciate hearing from you.
is a portable ECG system. It includes a data acquisition recorder
and patient cable. The
and iPhone
through Bluetooth. The
cquisition System is capable of sampling,
recording and analyzing patients resting ECG. This system is applicable to the heart disease analysis for
ith iOS equipment
QTY
1
FD10X4(ZX)
)
1
1