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Cardioline HD+, User Manual

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Cardioline HD+ User Manual Download Page 16

 

HD+ 

3. 

ELECTROMAGNETIC COMPATIBILITY (EMC)

 
 

 

12 

 

 
 

is the maximum output power rating of the transmitter in watts (W) according to the specifications supplied 
by the manufacturer. 
 

NOTE 1: At 800 MHz, the separation distance for the higher frequency range applies. 
 
NOTE 2: These guidelines may not apply in all situations. Electromagnetic 
propagation is affected by absorption and reflection from structures, objects and people. 

 

Summary of Contents for HD+

Page 1: ...1936 Rev 14 23 04 2019 HD User manual...

Page 2: ...ne SpA CARDIOLINE is a registered trademark of Cardioline SpA This publication may not be reproduced in whole or in part in any form or manner without prior written authorisation by Cardioline Spa Via...

Page 3: ...and the device 11 4 SYMBOLS AND LABEL 13 4 1 Explanation of the symbols 13 4 2 Device label 13 5 INTRODUCTION 15 5 1 Purpose of the manual 15 5 2 Recipients 15 5 3 Intended use 15 5 4 Description of...

Page 4: ...Precautions 29 8 2 Switching off the device 29 8 3 Check 29 8 4 Patient cable cleaning 29 8 5 Cleaning the device 30 8 6 Accessory cleaning 30 8 7 Regular maintenance 30 8 8 Operation check 30 8 9 Rec...

Page 5: ...written with the utmost care Should you find any details which do not correspond to those contained in this manual please inform Cardioline SpA who will correct such inconsistencies as soon as possib...

Page 6: ...HD 1 GENERAL INFORMATION 2...

Page 7: ...gnosis of the patient The device is intended for use by properly trained operators Have the operator carefully read and understand the contents of the operator manual and the other annexed documents b...

Page 8: ...such as those produced by electro surgery equipment The battery powered device transmits data that reflects the physiological condition of the patient to a receiver Should a malfunction occur the tra...

Page 9: ...worn Do not pull or stretch patient cables as this could result in mechanical and or electrical failures Patient cables should be stored after forming them into a loose loop The device will operate ex...

Page 10: ...ers or other stimulators is used simultaneously with the device however disturbances to the signal may occur If the electrodes are not properly connected to the patient or one or more patient leads ar...

Page 11: ...idity 25 95 Atmospheric pressure 700 mbar 1060 mbar The HD must be connected to the receiver before use In order to be used with the HD the receiver must be pre set in the factory or meet the hardware...

Page 12: ...HD 2 SAFETY INFORMATION 8...

Page 13: ...nded for use in the electromagnetic environment specified in the table below The customer or the user should assure that the device is used in the appropriate environment Emission test Conformity Elec...

Page 14: ...to the application of the test level 3 3 Guidance and manufacturer s declaration on electromagnetic immunity The device is intended for use in the electromagnetic environment specified in the table b...

Page 15: ...ance is observed additional measures may be necessary such as reorienting or relocating the device b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 3 4 Recommende...

Page 16: ...W according to the specifications supplied by the manufacturer NOTE 1 At 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations...

Page 17: ...evice Comply with the instructions in the use manual CE marking compliance with the European Union directives Year of manufacture Type CF equipment protected against electrical shock Separate collecti...

Page 18: ...HD 4 SYMBOLS AND LABEL 14...

Page 19: ...other standard platforms both for Resting ECG and Stress ECG applications The device implements the wireless communication via Bluetooth wireless technology Connected with a receiver via Bluetooth HD...

Page 20: ...ees the acquisition of an ECG signal meeting the most severe standards used in clinical and diagnostic applications AAMI ANSI AHA ACC HD is light and compact comfortable to wear minimizing motion arte...

Page 21: ...HD 5 INTRODUCTION 17 5 5 General overview Front view of the device with patient cable Patient cable Applied part CF type Power key Operation LED...

Page 22: ...atus of the device The statuses of the device corresponding to the LED indicators are listed below LED Status of the device Off The HD is off Flashing The HD is connecting to the receiver Quick flashi...

Page 23: ...ce to the patient while executing an stress test in order to improve trace quality and patient comfort Made in neoprene it is perfectly suitable to use during the stress test and with the patient swea...

Page 24: ...e module to reduce the data jitter and transmission delay 5 7 2 Bluetooth functions Below are defined all functions implemented wirelessly and possible risks associated with delayed or failed communic...

Page 25: ...ss emitters The users of HD are trained nurses and physicians operating in hospitals clinics and medical practices In these environment several devices either medical or not using various kind of wire...

Page 26: ...HD 5 INTRODUCTION 22...

Page 27: ...tor is designed to allow for the insertion of the patient cable in one direction only Should the plug of the patient cable not go into the connector do not force it but try to rotate it NOTE to preven...

Page 28: ...HD 6 PREPARATION FOR USE 24...

Page 29: ...skin generated by sources such as hair sebum and dry or dead skin Adequately prepare the skin to minimize the aforementioned effects and optimize the quality of the ECG signal To prepare the skin If n...

Page 30: ...e precordial leads It is possible to locate the fourth intercostal space starting from the first intercostal space Given the variable conformation of the patient palpating the first intercostal space...

Page 31: ...st R Red RA White On the deltoid muscle the forearm and wrist F Green LL Red On the thigh or the ankle N Black RL Green On the thigh or the ankle 7 3 ECG acquisition Use the LED indicator to check the...

Page 32: ...ions described in the user manual of the CARDIOLINE software installed on the receiver to acquire print and save a tracing 6 At the end of the acquisition the HD automatically enters stand by mode It...

Page 33: ...ected contact a service authorised person Check the proper connection of all the cables and connectors Check the casing for any damage Check the cables and connections for any visible damage Check tha...

Page 34: ...ay be cleaned with a soft lint free cloth slightly moistened with a solution of water and neutral soap Clean and air dry For disinfection clean with a soft lint free cloth using a Sodium Hypochlorite...

Page 35: ...By pressing the power on button the LED remains off and no acoustic signal is emitted Low battery If the LED is off device off and when pressing the power on button the LED remains off and no acousti...

Page 36: ...st be replaced V2 or C2 V2 or C2 anomaly Check if the terminal is connected or if the relevant electrode must be replaced V3 or C3 V3 or C3 anomaly Check if the terminal is connected or if the relevan...

Page 37: ...500 m s Pacemaker detection Hardware detection coupled with digital convolution filter De fibrillation protection AAMI IEC standard Front end performance ANSI AAMI IEC 60601 2 25 2011 Data transfer Bl...

Page 38: ...basic safety and essential performance EN 60601 1 2 Medical electrical equipment Part 1 General requirements for basic safety and essential performance Collateral standard Electromagnetic compatibili...

Page 39: ...Agl 63030107 4 peripheral ECG electric clamp pediatric 63030163 6 chest ECG electric suction type Ag agcl 66030040C Disposable electrodes ECG tab 100 pcs pack of 10 66030036C ECG Disposable electrode...

Page 40: ...HD 9 TECHNICAL SPECIFICATIONS 36...

Page 41: ...ction of the machine other circumstances not attributable to manufacturing defects Unless otherwise specified the removable parts the accessories and the parts which are subject to normal wear are exc...

Page 42: ...HD 10 WARRANTY 38...

Page 43: ...stes Therefore when disposing of the product at the end of its service life the user is required to contact the supplier or the manufacturer Suitable differentiated collection to allow for the subsequ...

Page 44: ...HD 40...

Page 45: ...HD 41...

Page 46: ...HD 42...

Page 47: ...HD 43...

Page 48: ...Head Office and Production Via Linz 151 38121 Trento Italy T 39 0463 850125 F 39 0463 850088 Sales Office Via F lli Bronzetti 8 20129 Milan Italy T 39 02 94750470 F 39 02 94750471...

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