XLTEK Protektor32 Instructions for Use
3
TABLE OF CONTENTS
PROTEKTOR32 – INTRAOPERATIVE NEUROPHYSIOLOGICAL MONITORING .................. 6
Indications for Use ............................................................................................................................................. 6
Protocols ........................................................................................................................................................... 6
SAFETY INFORMATION ........................................................................................................................ 7
Critical Warnings and Cautions ........................................................................................................................... 7
General Warnings .............................................................................................................................................. 7
General Cautions .............................................................................................................................................. 11
Audio/Visual Stimulation Warnings ................................................................................................................... 11
Protektor32 with the Electro-Surgical Units (ESU) – Guidelines .......................................................................... 12
Output Waveforms ........................................................................................................................................... 12
Electrostatic Discharge (ESD) handling procedures and warnings ....................................................................... 13
PROTEKTOR32 SAFETY AND STANDARDS CONFORMITY .................................................... 14
Essential Performance ....................................................................................................................................... 14
Standards Compliance and Normative References Information ......................................................................... 14
Declaration of Compliance for IEC 60601-1-2 ..................................................................................................... 17
Table 4 - Immunity Test Levels - Enclosure Port ...................................................................................................... 17
Table 5 – Immunity Test Levels – Input A.C. Power Port ......................................................................................... 17
Table 7 – Patient Coupling Port ............................................................................................................................... 18
Table 8 – Immunity Test Levels - Signal Input / Output Parts Port .......................................................................... 18
Table 9 - Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment ......... 19
Declaration of Compliance for FCC .................................................................................................................... 20
REGULATORY SYMBOLS .................................................................................................................... 21
PROTEKTOR32 SYSTEM CONFIGURATION ................................................................................. 23
Protektor Headbox............................................................................................................................................ 24
Protektor32 Headbox Features ............................................................................................................................... 24
USING THE TCMEP STIMULATOR WITH PROTEKTOR32 ...................................................... 28
Safety Information ............................................................................................................................................ 28
Contra-Indications and Exclusions ........................................................................................................................... 28
Protocol for Elicitation of TcMEPs ...................................................................................................................... 28
TcMEP Warnings and Cautions .......................................................................................................................... 29
Stimulation limitations of the TcMEP modality .................................................................................................. 30
Pulse Train Safety Limits .......................................................................................................................................... 30
Current Density ........................................................................................................................................................ 31
To Next Page
General
