Certificate of Compliance

Certificate of Compliance
Certificate:
1966761
Master Contract:
201161
Project:
2302417
Date Issued:
July 19, 2010
Issued to:
SonoSite, Inc.
21919 30th Dr SE
Bothell, WA 98021-3904
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.
Mehrdad Sadeghieh
Issued by: Mehrdad Sadeghieh, P. ENG.
PRODUCTS
CLASS 8750 01
CLASS 8750 81
- MEDICAL ELECTRICAL EQUIPMENT
- MEDICAL ELECTRICAL EQUIPMENT/SYSTEMS - Certified to US
Standards
Diagnostic Ultrasound System, Models S Series Ultrasound System, S Series and V-Universal Stand,
PowerPark Stand Module, and accessories, rated 100-240 V, 50-60 Hz, 2.0- 1.0 A (Ultrasound System), or
Battery Operated; Type BF Patient Applied Part (Ultrasound Transducers).
Notes
• Type of protection against electric shock: : Class I equipment (when powered from power supply or part
of the S Series Stand System); and Internally powered equipment (S Series Ultrasound System w/o power
supply).
• Degree of protection against electric shock: Type BF (transducers)
• Degree of protection against ingress of water: IPX7 (transducers)
• 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.
• Mode of operation: Continuous.
• Environmental Conditions: Extended: 10-40°C, 15-95% rH, 700-1060hPa.
DQD 507 Rev. 2009-09-01
Page: 1
Certificate:
1966761
Master Contract:
201161
Project:
2302417
Date Issued:
July 19, 2010
Notes:
APPLICABLE REQUIREMENTS
CAN/CSA C22.2 No 601.1-M90 - Safety of Medical Electrical Equipment, Part I, General Requirements for
Safety CSA 601.1 Supplement 1:1994 CSA 601.1 Amendment 2:1998
CAN/CSA C22.2 No. 60601-1-1-02 - Collateral Standard: Safety Requirements for Medical Electrical Systems
CAN/CSA C22.2 No. 60601-2-37-03 + A1:2005 - Particular Requirements for the Safety of Ultrasonic Medical
Diagnostic and Monitoring Equipment
UL Std No 60601-1 (1st Edition) - Safety of Medical Electrical Equipment Part 1: General Requirements for
Safety
IEC Standard 60601-1-1:2000 - Medical Electrical Equipment Part 1-1 – Collateral Standard: Safety
Requirements for Medical Electrical Systems
REFERENCE STANDARDS
IEC Standard 601.1:1998 + A1:1991 + A2:1995 - Medical Electrical Equipment Part 1: General Requirements
for Medical Electrical Systems
IEC Standard 60601-1-1:2000 - Collateral Standard: Safety Requirements for Medical Electrical Equipment
IEC Standard 60601-2-37 +A1:2004 + A2:2005 - Medical Electrical Equipment Part 2: Particular
Requirements for The Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
Subject to the following qualifications:
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. 3. Evaluated to IEC/CSA 601-1 Amendment 2 excluding
requirements for Electromagnetic compatibility (Clause 36), Biocompatibility (Clause 48) and Programmable
Electronic Systems (Clause 52.1). 4. SAFETY HAZARDS resulting from the intended physiological function of
EQUIPMENT covered by this Standard are not considered.
DQD 507 Rev. 2009-09-01
Page: 2
Supplement to Certificate of Compliance
Certificate:
1966761
Master Contract:
201161
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
2302417
2210435
2142892
2120803
2054995
July 19, 2010
March 24, 2010
April 17, 2009
February 11, 2009
July 9, 2008
2011500
1966761
May 9, 2008
February 6, 2008
Update Report 196671 to include alternative construction. (C/US)
Update Report 1966761 to include alternate construction for S Series (C/US)
Update Report to include RF Remote Control.
Update Report 1966761 (S Series) to include alternative construction (C/US)
Update to Report 1966761 to Include alt xducers Models P10x/8-4 and
SLAx/13-6 and minor report corrections/revisions for clarification.
Update to Report 1966761 to Include alternative Li-ion Battery Pack - C/US
Turbo S Diagnostic Ultrasound System - C/US
Page: 1
Ref. Certif. No.
CA/11986/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 and Accessories
Name and address of the applicant
Nom et adresse du demandeur
SonoSite, Inc.
21919 30th Drive SE, Bothell, WA 98021-3904 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
Same as applicant
Note: When more than one factory, please report on page 2
Note: Lorsque il y plus d'une usine, veuillez utiliser la 2ème page
Ratings and principal characteristics
Valeurs nominales et caractéristiques principales
100-240 V, 50/60 Hz; 2.0–1.0 A; or Battery Operated; Type BF
Patient Applied Part (Ultrasound Transducers)
Trademark (if any)
Marque de fabrique (si elle existe)
Type of Manufacturer's Testing Laboratories used
Type de programme du laboratoire d'essais constructeur
WMT-011
Model / Type Ref.
Ref. De type
SonoSite S Series: S Series Ultrasound System, S Series Stand
and V-Universal Stand, PowerPark Stand Module, and
accessories.
Additional information (if necessary may also be reported
on page 2)
Les informations complémentaires (si nécessaire,, peuvent
être indiqués sur la 2ème 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
IEC 60601-1:1988 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 606011-1:2000, IEC 60601-2-37 : 2001and CA and US National
Differences, per CB Bulletin on IEC website.
201161 – 1966759 (2302418)
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: July 20, 2010
DQD 506.04 Rev. 2009-03-23 (CB Issued 2009-03)
Signature:
1/1
Tiki Wong, P.Eng.