User's Manual

BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual
2
Contents
CHAPTER 1 ........................................................................................................................................ 4
INFORMATION ABOUT SAFETY ................................................................................................... 4
1.1 INFORMATION ABOUT THE MANUAL ......................................................................... 4
1.1.1 CONVENTIONS ........................................................................................................... 5
1.2 DECLARATION OF RESPONSIBILITY BY THE MANUFACTURER .......................... 6
1.3 USAGE RESTRICTIONS AND SAFETY PRECAUTIONS .............................................. 7
1.3.1 ELECTRIC SAFETY .................................................................................................... 7
1.3.2 SAFETY OF THE OPERATING ENVIRONMENT .................................................. 10
1.3.3 OTHER PRECAUTIONS ............................................................................................ 12
1.4 GRAPHIC SYMBOLS IN COMPLIANCE WITH THE IEC 60601-1 STANDARD . 13
1.5 OTHER GRAPHIC SYMBOLS ......................................................................................... 15
1.6 ATTENTION SYMBOL ..................................................................................................... 18
1.7 PRODUCT TRACEABILITY ............................................................................................ 18
1.8 VIGILANCE SYSTEM ...................................................................................................... 18
1.9 INFORMATION ABOUT RECYCLING OF MATERIALS ............................................ 22
1.10 ELECTROMAGNETIC COMPATIBILITY .................................................................. 23
1.10.1 RECOMMENDED DISTANCES FROM RADIOFREQUENCY (RF)
COMMUNICATION SYSTEMS .............................................................................................. 27
1.11 BIOCOMPATIBILITY AND INFECTIONS CONTROL ............................................. 29
1.12 CAUTION FOR THE U.S. MARKET ............................................................................ 29
CHAPTER 2 ...................................................................................................................................... 30
DESCRIPTION OF THE DEVICE ................................................................................................... 30
2.1 GENERAL OVERVIEW .................................................................................................... 30
2.2 BODYGUARDIAN CONTROL UNIT DESCRIPTION ................................................... 34
2.2.1 PATIENT CONNECTION .......................................................................................... 35
2.2.2 BLUETOOTH CONNECTION ................................................................................... 36
2.2.3 SIGNALING LEDS ..................................................................................................... 36
2.2.4 MULTIFUNCTION PUSH BUTTON ........................................................................ 38
2.3 BODYGUARDIAN CHARGING CRADLE ..................................................................... 39
2.4 AC/DC MEDICAL POWER SYPPLY ............................................................................... 40
2.5 DISPOSABLE ADHESIVE ELECTRODES PATCH ....................................................... 40
CHAPTER 3 ...................................................................................................................................... 41
POWERING UP THE DEVICE ........................................................................................................ 41
3.1 BATTERY CHARGING .................................................................................................... 41
3.1.1 RECORDING AUTONOMY ...................................................................................... 42
3.2 SWITCHING ON/OFF THE DEVICE ............................................................................... 43
CHAPTER 4 ...................................................................................................................................... 44
WORKING MODE............................................................................................................................ 44
4.1 PREPARING THE PATIENT ............................................................................................ 44
4.1.1 DISPOSABLE ADHESIVE ELECTRODES PATCH APPLICATION SITE ........... 44
4.1.2 PREPARING THE SKIN ............................................................................................ 44
4.1.3 PLACING THE DISPOSABLE ADHESIVE ELECTRODES PATCH ..................... 45
4.2 OPERATIVE MODES ........................................................................................................ 46
4.2.1 MONITORING MODE ............................................................................................... 46
4.2.2 STREAMING MODE.................................................................................................. 47
4.2.3 EVENT MONITORING .............................................................................................. 47
4.3 INSTALLATION AND INSTRUCTIONS FOR THE PATIENT ..................................... 48