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

iCV200S User Manual Cardio View®Family
Version: A/1 Page 1 of 58
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.