User's Manual

2
CPR4 – UA10821A
Table of Contents
1 INTRODUCTION ................................................................................................................................................ 4
1.1 Intended purpose ............................................................................................................................................................. 4
1.2 Indication(s), target population(s) and intended user(s) .................................................................................................... 4
1.2.1 Indication(s) ................................................................................................................................................................................ 4
1.2.2 Target population(s) .................................................................................................................................................................... 5
1.2.3 Intended user(s) .......................................................................................................................................................................... 5
1.3 Contra-indications ........................................................................................................................................................... 6
1.4 Intended Clinical benefits ................................................................................................................................................. 6
1.5 Warnings and precautions ................................................................................................................................................ 6
1.6 Residual risk and undesirable effects ................................................................................................................................ 6
2 WARRANTY CONDITIONS .................................................................................................................................. 7
3 PACKAGE CONTENTS ........................................................................................................................................ 7
4 DESCRIPTION ..................................................................................................................................................... 7
4.1 COMPONENTS ................................................................................................................................................................ 7
4.2 CONNECTION TO THE PROGRAMMER ........................................................................................................................... 8
5 USING THE CPR4 ............................................................................................................................................... 8
5.1 How to position the CPR4................................................................................................................................................. 8
5.2 Troubleshooting .............................................................................................................................................................. 9
5.3 UPGRADE OF THE PROGRAMMING HEAD’S SOFTWARE ............................................................................................. 10
6 MAINTENANCE ................................................................................................................................................ 10
6.1 Cleaning ......................................................................................................................................................................... 10
6.2 Disinfection and sterilization .......................................................................................................................................... 10
6.3 System end-of-life ......................................................................................................................................................... 10
6.4 Regular maintenance ..................................................................................................................................................... 10
7 GUIDANCE AND MANUFACTURER'S DECLARATION ...................................................................................... 10
7.1 Radio equipment emission ............................................................................................................................................. 11
7.2 Recommended separation distances according to the maximum output power of the communications equipment ........ 11
7.3 Cable length ................................................................................................................................................................... 11
7.4 Electromagnetic emissions ............................................................................................................................................. 12
7.5 Magnetic and Electromagnetic Immunity ....................................................................................................................... 12
7.6 Electromagnetic Immunity, Portable Radio Frequency Equipment ................................................................................. 13
7.7 Raw materials ................................................................................................................................................................ 14
8 TECHNICAL DATA ............................................................................................................................................ 14
8.1 Conformity of the device ................................................................................................................................................ 14
8.2 Industry Canada ....................................................................................................................... Erreur ! Signet non défini.
8.3 Performances................................................................................................................................................................. 14
8.3.1 PERFORMANCE CHARACTERISTICS ......................................................................................................................................... 15
8.3.2 ESSENTIAL PERFORMANCE (REFERRING TO 60601-1-2 STANDARD) ...................................................................................... 15
8.4 Dimensions .................................................................................................................................................................... 15
8.5 Use constraints .............................................................................................................................................................. 15
8.6 Storage constraints ........................................................................................................................................................ 15