Declaration of conformity, Limited warranty and limitation of liability – Precision Medical PM66 EasyGoVac Aspirator User Manual
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LIMITED WARRANTY AND LIMITATION OF LIABILITY
Precision Medical, Inc. warrants that Easy Go Vac Aspirator (the Product) and the following component parts thereof will be free of
defects in workmanship and/or material for the following periods:
Easy Go Vac Aspirator
Two (2) years from shipment
Battery
Six (6) months from shipment
Should any failure to conform to this warranty appear within the applicable period, Precision Medical, Inc. shall, upon written
notification thereof and substantiation that the goods have been stored, installed, maintained and operated in accordance with
Precision Medical, Inc.’s instructions and standard industry practice, and that no modifications, substitutions, or alterations have
been made to the goods, correct such defect by suitable repair or replacement at its own expense.
ORAL STATEMENTS DO NOT CONSTITUTE WARRANTIES.
The representatives of Precision Medical, Inc. or any retailers are not authorized to make oral warranties about the merchandise
described in this contract, and any such statements shall not be relied upon and are not part of the contract for sale. Thus, this
writing is a final, complete and exclusive statement of the terms of that contract.
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ANY WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR
PURPOSE OR OTHER WARRANTY OF QUALITY, WHETHER EXPRESS OR IMPLIED.
Precision Medical, Inc. shall not under any circumstances be liable for special, incidental or consequential damages including but
not limited to lost profits, lost sales, or injury to person or property. Correction of non-conformities as provided above shall constitute
fulfillment of all liabilities of Precision Medical, Inc. whether based on contract, negligence, strict tort or otherwise. Precision Medical,
Inc. reserves the right to discontinue manufacture of any product or change product materials, designs, or specifications without notice.
Precision Medical, Inc. reserves the right to correct clerical or typographical errors without penalty.
507099rev2 7/15 (??m) Printed in USA
DECLARATION OF CONFORMITY
Precision Medical, Inc.
300 Held Drive
Northampton PA 18067, USA
Emergo Europe (European Office)
Molenstraat 15
2513 BH, The Hague
The Netherlands
Phone: +31 (0) 70.345.8570
Fax: +31 (0) 70.346.7299
PM66AC-R, PM66AC-D , PM66S-R, PM66S-D,
PM66LI-R & PM66LI-D
Classification:
IIa
Classification criteria:
Clause 3.2 Rule 11 of Annex IX of MDD
We hereby declare that an examination of the under mentioned production quality assurance
system has been carried out following the requirements of the UK national legislation to which
the undersigned is subjected, transposing Annex II, 3 of the Directive 93/42/EEC and Directive
2007/47/EC on medical devices.
We certify that the production quality system conforms to the relevant provisions of the aforementioned
legislation, and the result entitles the organization to use the CE 0473 marking on those products
listed above.
Applied Standards: BS EN 1041, EN 60601-1, EN 60601-1-2, EN ISO 10079-1, EN ISO 14971,
ISO 15223-1, ISO 13485
Notified Body:
AMTAC Certification Services Limited
Address: Davy Avenue Knowlhill Milton Keynes MK5 8NL, UK
Certification Registration No’s: 1126 A CE
Date of Expiry: 03 August 2017
Devices already manufactured: S/N traceability Device History Records
Validity of DOC:
04 August 2012 to Date of Expiry
Manufacture Representative: Quality Manager
Position:
Quality Systems/ISO Representative
Date of Issue:
04 August 2012