User's Manual

Polytel
®
Data Transmission System
8-1500-R - 15 -
• IEC 60601-1-4: Medical Electrical Equipment – Collateral standard: Programmable
medical electrical systems
• UL 60601: Medical Electrical Equipment, Part 1 – General Requirements for Safety
• CSA: Medical Electrical Equipment, Part 1: C22.2601 No. 601.1 – M9 – General
Requirements for Safety
• The manufacturer of this device complied with the following requirements
applicable at time of manufacture:
o ISO 13485:2003
o ISO 13485/8 under Canadian Medical Device Conformity Assessment
System (CMDCAS)
5.4 Label depictions and Locations
5.4.1 Label locations
Label on 120V power supply Label on 230V power supply
Label on PWA-08-01 PWR-08-01 label
PWR-08-02 label PWR-08-03 label
Figure 6 Label locations