Certificate of Compliance

Certificate of Compliance
Certificate:
1934871 (LR 115987)
Master Contract:
201161
Project:
2302420
Date Issued:
July 2, 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 M-Turbo Ultrasound System, M-Turbo MiniDock, Mobile Docking
System, and accessories, rated 100-240 V, 50-60 Hz, 2.0- 1.0 A (Ultrasound System/MiniDock), or Battery
Operated; Type BF Patient Applied Part (Ultrasound Transducers) and Type CF defib-proof (ECG Leads).
Notes:
1.
Type of protection against electric shock: Class I equipment (when powered from power supply or part
of the Mobile Docking System); and Internally Powered equipment (M-Turbo Ultrasound System w/o power
supply).
2.
Degree of protection against electric shock: Type BF transducers / Type CF ECG leads
3.
Degree of protection against ingress of water: IPX7 for ultrasound probes only
4.
Degree of safety of application in the presence of a flammable anesthetic mixture with air or with oxygen
or nitrous oxide: Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or
with oxygen or nitrous oxide.
5.
Mode of operation: Continuous.
DQD 507 Rev. 2009-09-01
Page: 1
Certificate:
1934871 (LR 115987)
Master Contract:
201161
Project:
2302420
Date Issued:
July 2, 2010
6.
Environmental Conditions: 10 to 40ºC, 15 to 95% (non-condensing) RH, 700 to 1060 hPa
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 - Particular Requirements for the Safety of Ultrasonic Medical
Diagnostic and Monitoring Equipment
CAN/CSA C22.2 No. 60601-2-37A-03 - Amendment 1:2005 Medical Electrical Equipment - Part 2-37:
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 I: General Requirements for
Safety
REFERENCE STANDARDS
IEC 60601-1-1:2000 - Collateral Standard: Safety Requirements for Medical Electrical Systems
IEC 60601-2-37:2001 + am1 (2004) + am2 (2005) - 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 (IEC 60601-1-4 referenced in
sub-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:
1934871
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
2302420
July 2, 2010
2210433
2142896
2120802
February 15, 2010
April 17, 2009
February 26, 2009
2096587
December 4, 2008
2064344
2035753
October 15, 2008
June 12, 2008
1934871
August 28, 2007
Update Report 1934871 to include alternative construction for M-Tubo
Ultrasound System. (C/US)
Update report to include alternate construction.
Update Report to include RF Remote Control.
Update Report 1934871 (M-Turbo) to include alternative transducers and ECG
Cable/Module (C/US)
Update Report 1934871 to include an alternative construction (C/US) with
WMTC qualification.
Update to Report to include alternative li-ion battery pack.
Update to Report 1934871 to include alternative transducers. Also includes
corrections/revisions to critical component list for clarity.
Diagnostic Ultrasound System and Accessories (C/US). (Original Date August
9, 2007 - workflow reset)
Page: 1
Ref. Certif. No.
CA/11925/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) and Type CF
Defib-proof (ECG Leads)
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 M Series; M-Turbo Ultrasound System, M-Turbo
MiniDock, Mobile Docking System, 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, 2:1988, 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 60601-1-1,
2:2000 and IEC 60601-2-37: 2001; and CA, and US National
Differences, per CB Bulletin 112a.
201161 – 1940315 (2302419)
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 5, 2010
DQD 506.04 Rev. 2009-03-23 (CB Issued 2009-03)
Signature:
1/1
Tiki Wong, P.Eng.