Declaration of Conformity DEMONSTRATION OF CONFORMITY WITH RECOGNIZED STANDARDS TO SATISFY THE SAFETY AND EFFECTIVENESS REQUIREMENTS OF THE CANADIAN MEDICAL DEVICES REGULATIONS Name of the medical device as it appears on the label: Clarity Acquisition Station 310C00 Name of the Manufacturer of the medical device: ELEKTA LTD. 1. List of recognized standard(s) applicable in part or in whole to this Medical Device: Full name of Standard(s) as stated on the TPD Recognized Standards List IEC 60601-2-37:2007-Ed.2.0 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment - Edition 2.0 IEC 60601-1:2012-Ed.3.1 (CSA C22.2 No. 60601-1-14:2014) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance IEC 60601-1-2:2014-Ed.4.0 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests IEC 60601-1-6:2010-Ed.3.0 Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability IEC 62304:2006-Ed.1.0 Medical device software - software life cycle processes ISO 10993-1:2009/Cor.1:2010 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process ISO 14971:2007 (CSA-ISO 14971-07) Medical devices Application of risk management to medical devices In the case where only specific parts or Sections of a recognized standard apply to the device, Sections 2 through 7 must be completed. In the case where all parts and Sections of a recognized standard apply to the device, Section 5 through 7 must be completed. 1
2. In the case where only specific parts or Sections of a recognized standard apply to the device, note the requirements that are not applicable to the medical device: Recognized Standard(s) IEC 60601-2-37:2007-Ed.2.0 IEC 60601-1:2005-Ed.3.0 Inapplicable Requirements of the Recognized Standard All clauses relating to INVASIVE TRANSDUCER ASSEMBLIES All clauses relating to Acoustic Output with TI, MI > 1.0 4.5 Alternative RISK CONTROL measures or test methods 4.9 COMPONENTS WITH HIGH-INTEGRITY CHARACTERISTICS 6.4 Method(s) of sterilization 6.5 Suitability for use in an OXYGEN RICH ENVIRONMENT 8.2.2 Connection to an external d.c. power source 8.4.1 PATIENT CONNECTIONS intended to deliver current 8.5.5 DEFIBRILLATION-PROOF APPLIED PARTS 8.6.5 Surface coatings 8.6.7 POTENTIAL EQUALIZATION CONDUCTOR 8.6.8 FUNCTIONAL EARTH TERMINAL 8.6.9 Class II ME EQUIPMENT 8.9.2 Application [CREEPAGE DISTANCES and AIR CLEARANCES] 8.9.3 Spaces filled by insulating compound 8.10.4 Cord-connected HAND-HELD parts and cord-connected foot-operated control devices 8.10.6 Guiding rollers for insulated conductors 8.11.2 MULTIPLE SOCKET-OUTLETS 8.11.4 MAINS TERMINAL DEVICES (REF 9100-00060 only) 8.11.5 Mains fuses (REF 9100-00060 only) 8.11.6 Internal wiring of the MAINS PART (REF 9100-00060 only) 9.2.4 Emergency stopping devices 9.2.5 Release of PATIENT 9.4.4 Grips and other handling devices 9.5 Expelled parts HAZARD 9.6.3 Hand-transmitted vibration 9.7 Pressure vessels and parts subject to pneumatic and hydraulic pressure 9.8.4 Systems with MECHANICAL PROTECTIVE DEVICES 10.1 X-Radiation 10.2 Alpha, beta, gamma, neutron and other particle radiation 10.3 Microwave radiation 10.5 Other visible electromagnetic radiation 2
10.6 Infrared radiation 10.7 Ultraviolet radiation 11.2.2 ME EQUIPMENT and ME SYSTEMS used in conjunction with OXYGEN RICH ENVIRONMENTS 11.2.3 SINGLE FAULT CONDITIONS related to OXYGEN RICH ENVIRONMENTS 11.4 ME EQUIPMENT and ME SYSTEMS intended for use with flammable anesthetics 11.5. ME EQUIPMENT and ME SYSTEMS intended for use in conjunction with flammable agents 11.6.2 Overflow in ME EQUIPMENT 11.6.4 Leakage 11.6.7 Sterilization of ME EQUIPMENT and ME SYSTEMS 12.3 ALARM SYSTEMS 12.4.3 Accidental selection of excessive output values 12.4.5 Diagnostic or therapeutic radiation 12.4.6 Diagnostic or therapeutic acoustic pressure 13.2.13.3 ME EQUIPMENT with motors 13.2.13.4 ME EQUIPMENT RATED for non-continuous OPERATION 15.4.3 Batteries 15.4.6 Actuating parts of controls of ME EQUIPMENT 15.4.7 Cord-connected HAND-HELD and foot-operated control devices 15.4.8 Internal wiring of ME EQUIPMENT [Aluminium wires] 15.4.9 Oil containers 15.5 MAINS SUPPLY TRANSFORMERS 16.3 Power supply [power from other equipment] 16.4 ENCLOSURES [non-me EQUIPMENT in PATIENT ENVIRONMENT subject to contact by OPERATOR] 3. In the case where only specific parts or Sections of a recognized standard apply to the device, note the deviations from the recognized standard(s). For example: To meet requirements of other Federal or Provincial legislation in Canada. Name of Recognized Standard Deviation 3
4. In the case where a standard has been adapted, note the requirements of the standard(s) have been adapted for application to this medical device. For example: In the case of a standard that offers alternative methods, specify which method has been followed. Standard IEC 60601-1-2:2014-Ed.4.0 IEC 62304:2006-Ed.1.0 ISO 10993-1:2009 Adapted Section(s) CISPR 11, Emissions: GROUP 1/ CLASS A IEC 61000-3-2, Harmonics: CLASS A Immunity: Specific Acceptance Criteria for Essential Performance CLASS C Probe material: Skin surface-contacting devices with Limited Exposure (A) ( 5.2, 5.3) 5. The medical device which was tested against the recognized standard(s) is identical to the medical device intended to be marketed in Canada: Yes No (see NOTE below) If the answer above is No, the difference(s) between the tested medical device and the medical device intended to be marketed in Canada are as follows: NOTE: There two main system configurations available for sale based around the Clarity System Acquisition Station: (a) REF 9100-00054 and (b) REF 9100-00060. Both system configurations share the same fundamental technology, design philosophy and principles of operation. REF 9100-00060 is the latest production version of the device and identical to the device that was tested against recognized safety standards by independent testing labs. REF 9100-00054 is the previous version of the device, which may still be sold in Canada while supplies last. This device includes non-significant changes since the version that was tested against recognized standards. The changes implement similar or identical specifications to those found in the REF 9100-00060 system configuration, including: (a) Identical independent power supply for the Optical Tracking System (the system was re-tested, re-certified and assessed for conformance with current standards); (b) Identical KVM/USB extender and touch-monitor for Remote Control (the system was re-tested, re-certified and assessed for conformance with current standards); (c) Improved ergonomics (e.g., reduced number of switches and indicators, re-located for easier user access); (d) Improved robustness (e.g., venting and air filter for better cooling); (e) Improved manufacturability (e.g., longer ground studs, better internal access, enclosure painting); and (f) Identical ultrasound probes and other accessories. 4
Given the difference(s) between the tested medical device and the medical device intended to be marketed in Canada, the application of the recognized standard(s) is justified for the following reason( s): The design changes to the REF 9100-00054 system configuration do not introduce new risks or increase the probability of occurrence of known hazards, do not change the way users encounter risks, and do not affect adversely the performance specifications or the safety and effectiveness of the system. Conformance of this system configuration with current recognized standards was assessed internally at Elekta Ltd, taking into account the results from re-certification testing and equivalent testing on the 9100-00060 device configuration. Additional testing was not deemed necessary to demonstrate conformity. 6. An independent testing laboratory or certification body was used to determine the conformance of the medical device with the recognized standard(s): Yes 0 (only standards indicated below) No 0 (see NOTE below) If the answer to the above is Yes, the name and address of the testing laboratory or certification body and their accreditations are as follows: Name and Address of Testing Laboratory or Certification Body. UL LLC (IEC 60601-1 and IEC 60601-2-37) SCC (ISO/IEC 17025) Nemko Canada Inc. (IEC 60601-1-2) SCC (ISO/IEC 17025) International, National or Provincial Accreditations oftbe Testing Laboratory or Certification Body NAMSA (USA) (ISO 10993) A2LA and AAALAC IntI. (ISO/IEC 17025) NOTE: Incremental changes to device REF 9100-{)0054 were evaluated internally at Elekta Ltd. 7. As a senior official of the manufacturer, having responsibility for the regulatory compliance of the medical device with the requirements of the Canadian Medical Devices Regulationsand this Declaration of Conformity, I hereby declare that the information I have provided in support of the safety and effectiveness of the medical device to be true and accurate. I also acknowledge that any false statement made with respect to the conformity of the medical device with an applicable recognized standard(s), or a determination by Health Canada that the medical device does not conform to the requirements of the recognized standard( s), could result in the suspension of any medical device licence which has been issued for the medical device subject of this Declaration of Conformity. Name of Senior Official Title of Senior Official Signature of Senior Official Date: Alex Carrillo Director QA, Americas Revised Dale: 2018106128 C2 and Pl Restricted Information and Basic Personal Data 5