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| Title: | MEDICAL ELECTRICAL EQUIPMENT-PART 1:GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE | |
| Company: | C-RAD POSITIONING AB - Uppsala, SWEDEN | |
| Product Information: |
Positioning system Catalyst+ (generic product number: SP-003): Model Nos. Catalyst+ Scanner HY-004 and HY-005, Gating Box Varian EXGI HZ-009, Gating Box Varian EXGI TrueBeam HZ-022, Gating Box UBTI HZ-025, Gating box UGI HZ-026, Laser Control Box HZ-020 and Laser elevator column HD-010. Also tested to: IEC 60601-1-6.
Positioning System, part of Sentinel SP001 System, Model Nos. Laser Scanner LS200, Gating Control Box HZ-006 Philips BigBore, Gating Control Box HZ-008, Siemens Open Interface, Gating Control Box HZ-011 Toshiba Interface, Gating Control Box HZ019 GE Interface, Laser Control Box HZ-020 and Laser elevator column HD-010 Also tested to IEC 60825-1, IEC 60601-1-6. | |
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| Evaluated to the following: | A representative sample of the listed devices have been tested, investigated and found to comply with the requirements of the Standard(s) for Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance (CAN/CSA C22.2 No. 60601-1) and are identified as CLASSIFIED with the cETL Listed Mark.; A representative sample of the listed devices have been tested, investigated and found to comply with the requirements of the Standard(s) for Outline of Investigation for Medical Electrical Equipment and Systems (CAN/CSA-C22.2 No. 60601-1) and are identified with the CETL Classified Mark.; A representative sample of the listed devices have been tested, investigated and found to comply with the requirements of the Standard(s) for Outline of Investigation for Medical Electrical Equipment and Systems - Medical Equipment General Requirements (CAN/CSA-C22.2 No. 60601-1) and are identified with the CETL Classified Mark. | |
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