GE SEER 1000 - Table of Contents

2067634-077 Revision B SEER™ 1000 3
Contents
1 Introduction...................................................................................................................9
Intended User.............................................................................................................. 10
Indications for Use ..................................................................................................... 10
Intended Use ............................................................................................................... 10
Contraindications ....................................................................................................... 10
Prescription Device Statement................................................................................ 10
Regulatory and Safety Information ....................................................................... 10
Safety Conventions ....................................................................................... 11
Safety Hazards............................................................................................... 11
Medical Device Classification ..................................................................... 16
Certification .................................................................................................... 17
Input Signal Reproduction Accuracy ........................................................ 17
EMI/EMC/RF Caution..................................................................................... 17
Biocompatibility ............................................................................................. 18
Supply and Accessory Information ........................................................... 19
Manufacturer Responsibility....................................................................... 19
Product and Package Information ............................................................ 19
Equipment Identification .......................................................................................... 26
Product Label ................................................................................................. 26
Serial Number Format and Product Code ............................................... 27
Service Information ................................................................................................... 27
Service Requirements .................................................................................. 27
Warranty Information .................................................................................. 28
Additional Assistance ................................................................................... 28
Manual Information ................................................................................................... 28
Manual Purpose............................................................................................. 28
Document Conventions ............................................................................... 28
Related Documents ...................................................................................... 30