Certificate of Compliance

Transcription

1 Certificate of Compliance Certificate: Master Contract: Issued to: SonoSite, Inc th Dr SE Bothell, WA USA Attention: Jean Bishop 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. Issued by: Joseph Poon Joseph Poon, AScT PRODUCTS CLASS CLASS MEDICAL ELECTRICAL EQUIPMENT - MEDICAL ELECTRICAL EQUIPMENT/SYSTEMS - Certified to US Standards Diagnostic Ultrasound System, Nano Series Ultrasound System, mobile, cord connected, consisting of a dedicated external power supply, Elpac Electronics, model 4083F, a control unit, model NanoMaxx or NanoPICC with ultrasound transducers, a dock/port replicator, model Nano Dock, V-Universal stand, PowerPark Stand Module, and accessories, rated V, Hz, A, or internally powered, battery operated. Notes: 1. Type of protection against electric shock: Class I or Internally powered/battery operated 2. Degree of protection against electric shock: Transducers - Type BF; ECG - Type CF 3. Degree of protection against ingress of water: System IPX0, Ultrasound probe to IPX7 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. DQD 507 Rev Page: 1

2 Certificate: Master Contract: Mode of operation: Continuous 6. Environmental Conditions: Normal: C, 15-95% rh, hPa APPLICABLE REQUIREMENTS CAN/CSA C M90 - Medical Electrical Equipment part 1: General requirements for Safety adopted IEC ed (90) CAN/CSA C S Supplement No 1-94 to CAN/CSA C M90 CAN/CSA C B-98 - Amendment 2 to CAN/CSA C M90 CAN/CSA C Medical Electrical Equipment part 2-37: Particular requirements for the safety of Ultrasonic Medical Diagnostic and Monitoring Equipment adopted IEC (01) CAN/CSA C A-05 - Amendment 1:2005 to CAN/CSA C Medical Electrical Equipment part 2-37: Particular requirements for the safety of Ultrasonic Medical Diagnostic and Monitoring Equipment adopted am 1 to IEC (01), am1 (04) CAN/CSA C Medical Electrical Equipment part 1-1: General requirements for Safety - Collateral Standard Safety Requirements for Medical Electrical Systems adopted IEC (2000) UL (1st edition) - Medical Electrical Equipment part 1: General requirements for Safety Reference Standards IEC Publication (1988) + A1 (1991) + A2 (1995) - Safety of Medical Electrical Equipment, Part I: General Requirements for Safety IEC (2001) + A1 (2004) + A2 (2005) - Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment IEC (2000) -Collateral Standard: Safety Requirements for Medical Electrical Systems Subject to the followingqualifications: (1) The equipment has not been investigated for the protection against hazards of explosions in medically used rooms. (2) The main supply cord set provided with the equipment must be an approved type acceptable to the authorities in the country where the equipment is sold. DQD 507 Rev Page: 2

3 Certificate: Master Contract: (3) Evaluated to IEC/CSA 6011 Amendment 2 excluding requirements for Electromagnetic compatibility (Clause 36), Biocompatibility (Clause 48) and Programmable Electronic Systems (IEC referenced in subclause 52.1). (4) SAFETY HAZARDS resulting from the intended physiological function of EQUIPMENT covered by this Standard are not considered. DQD 507 Rev Page: 3

4 Supplement to Certificate of Compliance Certificate: Master Contract: 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 August 17, 2010 Update Report to include new transducers, new accessories and alternate construction (C/US and CB Scheme) June 19, 2009 Diagnostic ultrasound sytem, Nano Series (CSA/CUS+CB) Page: 1

5 Ref. Certif. No. CA/12083/CSA IEC SYSTEM FOR MUTUAL RECOGNITION OF TEST CERTIFICATES FOR ELECTRICAL EQUIPMENT (IECEE) CB SCHEME SYSTEME CEI D ACCEPTATION MUTUELLE DE CERTIFICATS D ESSAIS DES EQUIPEMENTS ELECTRIQUES (IECEE) METHODE OC CB TEST CERTIFICATE CERTIFICAT D ESSAI OC Product Produit Diagnostic Ultrasound System Name and address of the applicant Nom et adresse du demandeur SonoSite, Inc th Drive S.E. Bothell, WA USA Name and address of the manufacturer Nom et adresse du fabricant Same as applicant Name and address of the factory Nom et adresse de l usine Note: When more than one factory, please report on page 2 Note: Lorsque il y plus d'une usine, veuillez utiliser la 2 ème page Same as applicant Additional Information on page 2 Ratings and principal characteristics Valeurs nominales et caractéristiques principales Trademark (if any) Marque de fabrique (si elle existe) Input V, Hz, 2-1 A; or Battery Operated; Type BF Patient Applied Part (Ultrasound Transducers) and Type CF Defib-proof (ECG Leads). Type of Manufacturer's Testing Laboratories used Type de programme du laboratoire d'essais constructeur Model / Type Ref. Ref. De type WMT-011 SonoSite Nano Series Ultrasound System, consisting of external power supply, model 4083F, controller model NanoMaxx or NanoPICC, Dock, V-Universal Stand and accessories. Additional information (if necessary may also be reported on page 2) Les informations complémentaires (si nécessaire,, peuvent être indiqués sur la 2 ème page A sample of the product was tested and found to be in conformity with Un échantillon de ce produit a été essayé et a été considéré conforme à la As shown in the Test Report Ref. No. which forms part of this Certificate Comme indiqué dans le Rapport d essais numéro de référence qui constitue partie de ce Certificat Additional Information on page 2 IEC :1988 Amendment No 1 (1991) and Amendment No 2 (1995), excluding requirements for Electromagnetic Compatibility (Clause 36), Biocompatibility (Clause 48) and Programmable Electronic Systems (Clause 52.1); IEC : 2000, IEC : 2001+A1 (2004); and AU, CA, CH, DK, IL, NZ, SG and US National Differences, per CB Bulletin on IECEE site ( ) This CB Test Certificate is issued by the National Certification Body Ce Certificat d essai OC est établi par l Organisme National de Certification CSA International 178 Rexdale Boulevard Toronto, ON M9W 1R3 Date: August 18, 2010 Signature: Tiki Wong, P.Eng., DQD Rev (CB Issued ) 1/1