Certificate of Compliance Certificate: 2531570 Master Contract: 163059 Project: 2700412 Date Issued: February 13, 2014 Issued to: Communications & Power Industries Canada Inc. 45 River Dr Georgetown, ON L7G 2J4 Canada Attention: Mr. Tony Nguyen The products listed below are eligible to bear the CSA Mark shown with adjacent indicators 'C' and 'US' for Canada and US or with adjacent indicator 'US' for US only or without either indicator for Canada only. Timothy Stafrace Issued by: Timothy Stafrace, C.E.T. PRODUCTS CLASS 8780 81 CLASS 8780 01 - MEDICAL ELECTRICAL EQUIPMENT/SYSTEMS - Certified to US Standards - MEDICAL ELECTRICAL EQUIPMENT/SYSTEMS Diagnostic X-Ray Generators, Indico 100 Series, permanently connected, Models: PART A) 80 kW Series: • VZW2930RD2-YY: rated 400Vac, 3P, 50/60Hz, Rad. • VZW2930RD3-YY: rated 480Vac, 3P, 50/60Hz, Rad. • VZW2930FD2-YY: rated 400Vac, 3P, 50/60Hz, R/F. • VZW2930FD3-YY: rated 480Vac, 3P, 50/60Hz, R/F. PART B) 65 kW Series: • VZW2930RC2-YY: rated 400Vac, 3P, 50/60Hz, Rad. • VZW2930RC3-YY: rated 480Vac, 3P, 50/60Hz, Rad. • VZW2930FC2-YY: rated 400Vac, 3P, 50/60Hz, R/F. • VZW2930FC3-YY: rated 480Vac, 3P, 50/60Hz, R/F. DQD 507 Rev. 2012-05-22 Page: 1 Certificate: 2531570 Master Contract: 163059 Project: 2700412 Date Issued: February 13, 2014 PART C) 50 kW Series: • VZW2930RB2-YY: rated 400Vac, 3P, 50/60Hz, Rad. • VZW2930RB3-YY: rated 480Vac, 3P, 50/60Hz, Rad. • VZW2930FB2-YY: rated 400Vac, 3P, 50/60Hz, R/F. • VZW2930FB3-YY: rated 480Vac, 3P, 50/60Hz, R/F. PART D) 40 kW Series: • VZW2930RE5-YY: rated 230Vac, 1P, 50/60Hz, Rad. • VZW2930FE5-YY: rated 230Vac, 1P, 50/60Hz, R/F. • VZW2930RE2-YY: rated 400Vac, 3P, 50/60Hz, Rad. • VZW2930FE2-YY: rated 400Vac, 3P, 50/60Hz, R/F. • VZW2930FE3-YY: rated 400/480Vac, 3P, 50/60Hz, R/F. PART E) 32 kW Series: • VZW2930RH5-YY: rated 230Vac, 1P, 50/60Hz, Rad. • VZW2930RH2-YY: rated 400Vac, 3P, 50/60Hz, Rad. • VZW2930FH2-YY: rated 400/480Vac, 3P, 50/60Hz, R/F. Note: In the Generator model number the eighth character will be designated "R" or "F". "R" is used to indicate Radiographic units only and "F" indicates Radiographic and Fluoroscopic X-ray modes of operation. The ninth and tenth characters respectively indicate the Generator power level and the compatible input voltage connected directly to the unit. The suffix YY is a number between "00" and "99" and represents other hardware and software options provided in the generator configuration and available to most models. 1. Type of protection against electric shock: Class I 2. Degree of protection against electric shock: Not Classified 3. Degree of protection against ingress of water: IPX0 4. Degree of safety of application in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide: Equipment not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide. 5. Mode of operation: 6. Environmental Conditions: DQD 507 Rev. 2012-05-22 Continuous with Intermittent loading Normal: 10-40°C, 20-80% rH (non-condensing), 700-1100hPa. Page: 2 Certificate: 2531570 Master Contract: 163059 Project: 2700412 Date Issued: February 13, 2014 APPLICABLE REQUIREMENTS CSA Standards: CAN/CSA-C22.2 No. 60601-1-08 CAN/CSA-C22.2 No. 60601-1:08 TC 2:2011 (Corrigendum 2) CAN/CSA-C22.2 No. 60601-2-54:11 ANSI/AAMI Standards: ANSI/AAMI ES60601-1:2005 (IEC 60601-1:2005, MOD) ANSI/AAMI ES60601-1:2005 / C1:2009 ANSI/AAMI ES60601-1:2005 / A2:2010 Medical Electrical Equipment - Part 1: General Requirements for basic safety and essential performance Technical Corrigendum 2:2011 to CAN/CSA-C22.2 No. 60601-1:08 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance (Adopted IEC 60601-1:2005 - CORR.2) Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy Medical Electrical Equipment - Part 1: General Requirements for basic safety and essential performance Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Corrigendum C1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Amendment A2 IEC Standards: IEC 60601-2-54:2009 DQD 507 Rev. 2012-05-22 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy Page: 3 Certificate: 2531570 Master Contract: 163059 Project: 2700412 Date Issued: February 13, 2014 Subject to the following qualifications: 1. The user replaceable mains (line) fuse must be an approved type acceptable to the authorities where the equipment is sold. 2. Evaluated to CAN/CSA-C22.2 No. 60601-1-08 and ANSI/AAMI ES60601-1:2005 excluding requirements for Electromagnetic compatibility (Clause 17), Biocompatibility (Clause 11.7), Programmable Electronic Systems (Clause 14), Usability (Clauses 7.1.1 & 12.2) & Alarms (Clause 12.3 & CSA 60601-1-8). 3. SAFETY HAZARDS resulting from the intended physiological function of EQUIPMENT covered by this Standard are not considered. 4. Interconnection of this medical device with other medical devices, medical used systems or non medical devices shall be evaluated to the requirements of Clause 16 in the end use application. 5. A means to disconnect from mains on all poles shall be provided in the end use system. DQD 507 Rev. 2012-05-22 Page: 4 Supplement to Certificate of Compliance Certificate: 2531570 Master Contract: 163059 The products listed, including the latest revision described below, are eligible to be marked in accordance with the referenced Certificate. Product Certification History Project Date Description 2700412 Feb 13, 2014 2531570 Jun 5, 2012 Update to the report to cover alternate EMI filter for models indicated in Part B of the Report. Evaluation to 60601-1 3rd Edition DQD 507 Rev. 2012-05-22 Page: 1