VALES and HILLS BIOMEDICAL TECH ICV200BLE ECG Acquisition System User Manual SELLER
VALES & HILLS BIOMEDICAL TECH. LTD. ECG Acquisition System SELLER
user manual
®CardioView®Family
iCV200(BLE) User Manual
1
VH-JS-08(60F) Version A/0
VALES & HILLS BIOMEDICA TECH. LTD.
Tel: 0086-010-51665548
Fax: 0086-010-67856343
E-mail: sales@vhmedical.com
Website: http://www.vhECG.com
Address: Bldg 46-1, No2 North Street Jingyuan, Beijing Economic-technological Development
Area, 100176 Beijing, China
CARDIO SYSTEMES 6 rue Descartes 78370 PLAISIR France
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Table of Contents
Preface..................................................................................................................................................................................3
1 iCV200BLE......................................................................................................................................................7
1.1About the iCV200(BLE).........................................................................................................................7
1.2List of packing ........................................................................................................................................8
1.3Accessories ..............................................................................................................................................8
2.Installation........................................................................................................................................................ 9
2.1 iCV200(BLE)ECG Acquisition Recorder............................................................................................9
2.2 Down Load vhECG HD from Apple App Store...............................................................................10
3.Electrodes Hookup.........................................................................................................................................11
3.1Hoopup...................................................................................................................................................11
4.Getting Start................................................................................................................................................... 12
4.1Recorder Setting....................................................................................................................................12
4.2Communication Between the Recorder and iPad............................................................................... 13
5.vhECG Resting ECG System........................................................................................................................14
5.1System Setting....................................................................................................................................... 15
5.2Patient Records Archive....................................................................................................................... 16
5.3Monitoring and Recording....................................................................................................................16
5.4Records Review.....................................................................................................................................17
5.4.1 Records State...................................................................................................................................17
5.4.2 ECG Review....................................................................................................................................18
5.4.3 Average ECG...................................................................................................................................19
5.5 VHCloud..................................................................................................................................................... 20
6.Cleaning and Maintenance............................................................................................................................21
7.Guidance and Manufacture’s Declarations..................................................................................................23
Annex I : iCV200(BLE) ECG Recorder Technical Specifications........................................................ 26
Annex II : Definitions and Rules For ECG Measurements.....................................................................27
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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
iCV200(BLE) is a portable ECG system with CardioView family. It includes a data acquisition recorder
and iPad with vhECG 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.
The device is intended to provide reference for medical diagnosis, not intended for a replacement of
diagnosis clinicians.
Precautions
Radio Frequency (RF) interference between the iCV200BLE 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 iCV200BLE 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.
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.
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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
dose 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 no limited to defibrillators, ultrasound machines, pacemakers,
and other simulators, may be used simultaneously with the electrocardiograph. However, such devices
may disturb the electrocardiograph signal.
Can not touch the patient during Defibrillation.
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
Changes or modifications not expressly approved by the party responsible for compliance could void
the user's authority to operate the 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.
Warranty and Service
V&H provides a one-year warranty and life-time service to all CadioView 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 personnel.
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.
Troubleshooting
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Most of the problem can be solved by contacting V&H service department support@vhmedical.com. To
get the prompt and efficient response you will provide:
Product name and its serial number.
A complete problem description
The complete name, address and phone number of your facility
For out-of-warranty repairs or spare parts order, a purchase order
For parts order, the required spare or replacement part number
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 4 years.
Classification
Degree of protection against electrical shock
Type CF, defibrillation-proof
The power supply of ECG Acquisition box
2XAA 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
10s
List of Symbols
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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 iCV200(BLE) usage.
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
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1. iCV200(BLE)
iCV200(BLE) Rest ECG for iOS (iPad, iPad-mini and iPhone)
Thank you for your purchase of iCV200(BLE) 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 support@vhmedical.com
1.1 About iCV200(BLE)
iCV200(BLE) is a portable ECG system. It includes a data acquisition recorder and patient cable. 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 iCV200(BLE) Rest ECG Composition
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1.2 List of packing
The ECG Acquisition Systems consists of the following items:
Part No.
Description
QTY
CV060F-010
ECG Acquisition Box
1
iCV200(BLE) software
(Note1)
1
M0201120
ECG cable
1
CV060F-060
User manual
1
Note1: About the software download please see 2.2 Download vhECG HD from Apple App Store.
1.3 Accessories
Item No.
Description
Intended Use
CV-022010-M0201120
ICV200(BLE) patient cable
Cables allow connection to the
electrode leads, which adhere to
the patient for detection of ECG
signals
CV-021010-M0201044
Standard Patient Cable
CV-040002
Battery
Power for ECG acquisition box
Note：
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. 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 M0201020.If use the manufacturer approval
attachment may reduce the safety of the products.
3.iCV200(BLE) is powered by two AA LR06 batteries.Insufficient of power may affect the
communication between the recorder and iPad.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
AA LR06.
4.For the sake of environmental protection, please recycle disposal of the battery.
5.For products and accessories that are no longer used, it will be the cause of environmental pollution, it
should be properly treated.
6.Do not include standard Patient cable and battery when we sale.
7.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:0086-010-51665548
E-mail:service@vhmedical.com
Website: http://www.vhecg.com
Fax:0086-010-67856343
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2. Installation
A complete iCV200(BLE) system consists of iCV200(BLE) data acquisition recorder and iPad or iPad-
mini with Apple App – vhECG HD. This section will guide you iCV200(BLE) recorder composition
and vhECG HD installation.
2.1Hardware Connection
iCV200(BLE) ECG Acquisition Recorder
Fig 2.1 iCV200(BLE) Recorder
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iCV200(BLE) Connecting further accessories
The illustration on the Fig2.2 show further accessories and the interface where they are
connected.
patient
patient cable (F-TYPE APPLIED PART)
Bluetooth
ipad/iphone iCV200(BLE) ECG acquisition box
Fig 2.2
2.2. Download vhECG HD from Apple App Store
iCV200(BLE) Resting ECG System has its software running on iPad or iPad-mini named vhECG HD
approved by Apple.
Purchase
Find vhECG HD in App Store and download it wth your Apple ID and registered credit card.
Free Download
If you have got a promotion code from V&H, you can use it to download vhECG HD to your iPad or
iPad-mini 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. In AppStore, scroll to the bottom and find <Redeem> button.
Step 3. Click <Redeem>, and then enter your promotion code in the popup dialog.
Step 4. After step 3, you will be asked to enter your Apple ID password again.
Step 5. Download in process and you get vhECG HD
Note: The promotion code is valid within four weeks.You should download vhECG HD within this
period.
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4. Getting Start
The communication between iPad and iCV200(BLE) Recorder is through Bluetooth.
iCV200(BLE) Resting ECG System for iPad is vhECG. It currently runs with the following languages:
The running language of vhECG 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 will run in English.
vhECG 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 iCV200(BLE) recorder and iPad is through Bluetooth.
Battery: Set two AA 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 four seconds): Power insufficient -- change the batteries.
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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.
Step 5: Come back to the home page ,click on the top-right corner of your iPad.
When the connection is successed, you will see “Device Connected” at the bottom of your iPad.
Click the round icon with numbers to start work.
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.
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5. vhECG Rest ECG System
vhECG is designed as an easy using application program which offers professional ECG tools and
fantastic user experience. Most of its usages follow to iOS operating style. If you are familiar with any
Apple App and have a general knowledge of ECG, you will have no problem and be happy working
with vhECG.
Click iPad App icon to enter vhECG Resting ECG System.
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5. 1 System Settings
You can customize your vhECG to your own preference. Click Fig 5.2 to enter vhECG Settings which
consist of four parts:
1. General
Hospiomtal Name - Input your hospital or organization name, etc.①
Doctor Name - vhECG user’s name
2. Live Monitor
Use Demo Data - ON/OFF: Use DEMO data in monitoring
New Born Baby Mode – Select a set of chest leads for newborns
Recording Time – Time of recording: 10-30 seconds
Lowpass – Cutoff frequency of low-pass filter: 30-250Hz, default: 70Hz
AC Notch – OFF/50/60(Hz): to eliminate power-line interference
Baseline Wander Erase – ON/OFF: to keep the baseline stable②
EMG Filter –ON/OFF: to remove muscle noise from ECG signal③
Patients Queue Mode –ON/OFF: ON for patients collected recording④
3. Communication
ECG Device Connectivity – BLE
Device SN Last Digit – the last digit of your iCV200(BLE) recorder’s serial number
ECG Cloud / FTP Address – ECG Network (e.g. www.vhcloud.net)
4. Report
To custom the printing form:
Report Title – Title on the print report
Report Format – PDF or JPEG
Lead Layout –1×12 or 2×6
Paper Orientation – A4 or B5, Portrait or Landscape
Print Grid – ON / OFF: with or without grid in printing report
①If you have registered in an ECG Network (e.g. vhCloud) group, the group name has its priority. To
restore the input name you should exit from the group.
②This function can efficiently remove baseline wandering due to respiration or body movement
without impacting ECG frequency response, such as ST segment. The function works only to ECG
signal with QRS complex exist, that means it is not applicable to signals like square or sine waves, etc.
③Patented by V&H. Muscle noise can be removed by setting LPF with low cutoff frequency but it will
severely affect ECG high frequency component such us QRS complex. vhECG EMG filter can
effectively remove muscle noise with little affection to ECG signal.
④With Patient Queue Mode, vhECG asks you to pre-
collect a queue of patients, from HIS or manual input,
before recording. It is for a convenient using when there
is a set of patients’ ECGs to be recorded and sent to
ECG Network for diagnosing. When you click, you will
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get fig5.2 to set up your patient list.
5.2 Patient Records Archive
This section shows how to create a new patient record or assign the recording ECG data to an existing
patient. You can do it either in ECG “Recording” or “Reviewing” at any time by click or in
fig5.1.
Create a new patient record:
5.3 Monitoring and Recording
This section shows how to record ECGs.
1. Place the electrodes on the patient
2. Turn on the recorder and make sure it is connected to iPad with BLE.
3. Click to start recording
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Display Layout: 12×1, 6×2 and 3×4 display formats switch. In 3×4 format there is a rhythm strip
(default: lead-II) at the bottom. You can switch to any other lead as rhythm strip by click the lead
window.
Display Gain: You can change the ECG gain (5mm/mV, 10mm/mV and 20mm/mV) by two fingers
sliding.
Recording and Save: Click to start recording while the ECG signal displayed stably. When the
recording finished, you get a window pop-up with three selections:
* Record Next: Record the next ECG while #numerical order plus one
* Review Now: Enter “5.4.2 ECG Reviewing” page to review the current ECG recorded
* Return: Return to the main menu
Note: The duration of the record for 8s.
Restart Recording: Double click the screen to restart recording when you find the ECG signal not good.
Leadoff: iCV200(BLE) has the function to detect electrode disconnect. When there is any electrode
disconnected, the color of the lead name in its related window(s) will turn in red with a mark [×] and
the trace shows zero-line.
5.4 Records Review
5.4.1 Patient Records State
Click to select a record to review when at “Select Mode”, or select records to delete when at
“Cancel” (Top-Right corner button)
Fig5.5 Recorder List
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5.4.2 ECG Reviewing
vhECG offers various views on an ECG with automatic parameter measurements and diagnostic
interpretations. vhECG also offers effective tools for you to measure parameters and edit interpretations.
①Interpretations list:You can select the diagnostic terms from the list when you edit your ECG
diagnosis（See Fig.5.7）.
②Doctor confirm: Sign your name to confirm the diagnosis. The signature is keeped for printing and
email(See Fig.5.8).
Tips:
1.) Zoom: With two fingers sliding to zoom in and zoom out ECG display.
2.) Gain: Double click the screen with one finger to change the ECG gain.
3.) Speed: Double click the screen with two fingers to change the ECG speed.
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5.4.3 Average ECG
Average ECG is calculated the dominant beats of the recorded ECG based on QRS complex
morphology. vhECG offers two forms of average ECG, single lead average ECG and superimposition
average ECG of 12 leads for your convenient using.
Marks positioning:
There are three sets of marks: P(onset, offset), QRS(onset, offset) and T(offset). You can adjust the mark
by moving your finger. To delete a set of marks: move it to the rightmost of the screen. To add a set of
marks: move your finger from the rightmost to left. The related parameters will be corrected
simultaneously while the mark position(s) in changing.
Measurements:
You can measure the distance (in ms) and the gain (in mV) of the two points either on average ECG or
ECG strip conveniently by sliding your two fingers (V&H patented). See Fig. 5.9
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5.5 vhCloud
vhECG is a full functional ECG network designed on group permissions by V&H. Depends on your
authority in the group you are belonging, you can store, achieve, diagnose and share the ECGs in the
group. For more information, please contact support@vhmedical.com
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6. Cleaning and Maintenance
It is recommended to check your iCV200(BLE) regularly to keep it in perfect condition.
Note: Only the qualified personnel authorized by V&H may service iCV200(BLE).
Cleaning
Use a moist cloth to wipe the recorder surface and patient cable cleaning. Do not allow
liquids to enter the recorder. All cleaning agents and disinfectants without alcohol
commonly used in hospitals are suitable. If liquids have entered the recorder, notify
Service to have the system inspected for damage before it is used again.
DO NOT use disinfectants with a phenol base or peroxide compounds to disinfect the
external surfaces.
Note: When pull off the cable from the recorder, be sure to hold the plug, not the cable.
Battery Care
If a longer period of time without using ECG acquisition box, remove the battery to avoid battery
leakage risk.
Important: For environment protection, please disposal the used batty to the recycling bin.
Operating Environment
Temperature: 5℃～35℃
Humidity: 25%～95%
Pressure :860hPa～1060hPa
Transport and Storage
Temperature: -20℃～55℃
Humidity: <93%
Pressure :860hPa～1060hPa
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Troubleshooting
The following table contains a list of iCV200(BLE) recorder troublesome scenarios accompanied by
suggestions for problem solving.
Trouble
Responses to the trouble
Cannot Start
Check the batteries to have sufficient power.
Cannot connet to
iPad
Check your iPad setting statues at the correct mode.
Keep your iPad and Recorder in a reasonable distance,
recommend visual distance: five meters, but it is some extent
dependent on the environment around.
Check the router if the recorder at Net-work mode.
With a fixed
ECG signal
Your vhECG is in DEMO mode. Enter your iPad vhECG’s setting part
and set “Use Demo Data” OFF.
Without ECG
signal or with too
much noise
Check the connection between the recorder and patient cable
Check the connection between the patient cable and electrodes
Check the connection between the electrodes and patient skin
Skin treatment if necessary
Check if there are forceful electrical power or strong magnetic
field around
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7. Guidance and Manufacture’s Declarations
Declarations:
iCV200(BLE) needs special precautions regarding EMC and needs to be installed and put into
service according to the EMC information provided in the User Manual;
Portable and mobile RF communication equipment can affect iCV200(BLE).
Electromagnetic emissions
iCV200(BLE) is intended for use in the electromagnetic environment specified below. The customer or
the user of iCV200(BLE) should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment –guidance
RF emissions
CISPR 11
Group 1
iCV200(BLE) 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.
RF emissions
CISPR 11
Class B
iCV200(BLE) is suitable for use in all establishments, including
domestic establishments and those directly connected to the public
low-voltage power supply network that supplies buildings used for
domestic purposes.
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Electromagnetic immunity
iCV200(BLE) is intended for use in the electromagnetic environment specified below. The customer or
the user of the ECG Acquisition Systems should assure that it is used in such an environment.
Immunity test
IEC 60601
test level
Compliance
level
Electromagnetic environment –guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete or ceramic tile.
If floors are covered with synthetic material, the
relative humidity should be at least 30 %.
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2,5
GHz
3 V/m
3,5
[ ]
3
d p
80 MHz to 800 MHz
7
[ ]
3
d p
800 MHz to 2,5 GHz
where Pis the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and dis the recommended separation
distance in meters (m). Field strengths from fixed RF
transmitters, as determined by an electromagnetic site
survey, ashould be less than the compliance level in
each frequency range.bInterference may occur in the
vicinity of equipment marked with the following
symbol:
aField 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 iCV200(BLE) is used exceeds the applicable RF compliance level above,
iCV200(BLE) should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as reorienting or relocating the ECG Acquisition Systems.
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.
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Recommended separation distances between portable and mobile RF
communication equipment and iCV200(BLE)
iCV200(BLE) is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of iCV200(BLE) can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and iCV200(BLE) as recommended below, according to the maximum output power of
the communications equipment.
Rated maximum
output power
of transmitter
(W)
Separation distance according to frequency of transmitter (m)
150Hz to 80MHz
80 MHz to 800 MHz
800 MHz to 2,5 GHz
0.01
0.117
0.117
0.2333
0.1
0.36999
0.36999
0.73681
1
1.17
1.17
2.33
10
3.69986
3.69986
7.36811
100
11.6667
11.6667
23.3
For transmitters rated at a maximum output power not listed above, the recommended separation
distance din meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where Pis the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
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Annex I: iCV200(BLE) ECG Recorder Technical Specifications
Sampling Rate:
A/D: 24K/SPS/Ch
Recording: 1K/SPS/Ch
Quantization Precision:
A/D: 24Bits
Recording: 16Bits
Resolution: 0.4μV
Common Mode Rejection: >90dB
Input Impedance: >20MΩ
Frequency Response: 0.05-150Hz
Time Constant: ≥3.2 Sec.
Maximum Electrode Potential: ±300mV
Dynamic Range: ±15mV
Defibrillation Protect: Build-in
Data Communication: BLE
Power: 2×AA( LR06)
Recovery time after defibrillation：≤10S
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Annex II: Definitions and Rules for ECG Measurements
1. ECG Waveform and Contour Classification
The ECG waveform consists of P-QRS-T complex which measured as:
P-onset, P-offset：
Pb, Pe
QRS- onset, QRS- offset：
Qb, Se(J)
T- offset：
Te
Note: Globally, i.e. for all LEADS valid, Durations or intervals of P-QRS-T are defined, based on
physiological reasons, by the earliest onset (for ST interval, the latest offset) of any LEAD to the latest
offset (for PR interval, the earliest onset) of any other LEAD.
All parameters used in the diagnostic criteria of the contour classification are measured in the
representative P-QRS-T complex. The lead-independent, overall parameters are presented in the table
bellowing:
Name Descriptions
Heart Rate Ventricular rate (in beats per minute, bpm)
P duration From P-onset to P-offset (in ms)
PR interval From P-onset to QRS-onset (in ms)
QRS duration From QRS-onset to QRS-offset (in ms)
QT interval From QRS-onset to T-offset (in ms)
Corrected QT interval QT interval correct for heart rate: QTc=QT*√(HR/60) (in ms)
P/QRS/T axis Axis of P, QRS or T wave (in degree, from -180°to 180°)
2. Duration and Amplitude Measurements
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4. Acceptance of minimum waves
The labeling of the QRS complex depends by definition on the first wave detected. A tiny positive wave
at beginning is called r or R following Q and may mask a true. The acceptance criteria of initial
waveforms should be clearly defined and standardized. The rule for acceptance of minimum waves is:
the signal with amplitudes smaller than 20uV cannot be accepted.