Integra MAYFIELD A1023, Инструкция по эксплуатации

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Indications for Use/Intended Purpose/
Description
The MAYFIELD® Wall Storage Unit (REF A-1023) is designed for
the storage of the complete MAYFIELD Neurosurgical Headrest
System. Each instrument silhouette is printed on the board
to ensure easy and proper storage. Each MAYFIELD Headrest
component is placed on a specific custom-made holding bracket.
Intended Population
MAYFIELD Skull Clamp fixation devices are not recommended
for use on children under five (5) years of age. Extreme caution
should be exercised in pediatric cases because of the thin skull.
Inspection
Always inspect instruments before and after each use. If
an instrument appears damaged and/or does not seem to
function properly, immediately send the instrument for repair
or replacement. This is to prevent increasing operative time and
needless endangerment to the patient’s life.
WARNING:
Failure to read and follow instructions furnished in this
product insert may result in serious injury.
Installation
Mount the MAYFIELD Instrument Wall Storage Unit to the
appropriate wall according to hospital protocol.
CAUTION:
Be sure the appropriate mounting anchors can support
the weight of the instruments and storage unit.
Cleaning and Sterilization
When necessary, use an antiseptic solution to wipe the plastic
laminate surface, brackets, and aluminum frame.
CAUTION:
Do not sterilize.
The life expectancy of the MAYFIELD products is expected to be
as long as 7 years.
NOTE – Any serious incident that has occurred in relation to the
device for the user and/or the patient should be reported to the
manufacturer and the competent authority of the member state
in which the user and/or patient is established.
Integra Standard Warranty
INTEGRA LIFESCIENCES CORPORATION (“INTEGRA”) warrants
to the original purchaser only that each new MAYFIELD product
is free from manufacturing defects in material and workmanship
under normal use and service for a period of one year (except
as otherwise expressly provided as to accessory items) from the
date of delivery by INTEGRA to the first purchaser, but in no
event beyond the expiration date stated on any product labeling.
• Surgical instruments are guaranteed to be free from defects
in material and workmanship when maintained and cleaned
properly and used normally for their intended purpose.
• Any covered product that is placed by INTEGRA under a
lease, rental or installment purchase agreement and that
requires repair service during the term of such placement
agreement shall be repaired in accordance with the terms
of such agreement.
If any covered defect occurs during the warranty period or
term of such placement agreement, the purchaser should
communicate directly with INTEGRA’s home office. If purchaser
seeks to invoke the terms of this warranty, the product must be
returned to INTEGRA at its home office. The defective product
should be returned promptly, properly packaged and postage
prepaid. Loss or damage in return shipment to INTEGRA shall
be at CUSTOMER’s risk. INTEGRA’s sole responsibility under
this warranty shall be repair or replacement, at INTEGRA’s sole
discretion at INTEGRA’s expense, subject to the terms of this
warranty and applicable agreements.
IN NO EVENT SHALL INTEGRA BE LIABLE FOR ANY INCIDENTAL,
INDIRECT, CONSEQUENTIAL OR PUNITIVE DAMAGES IN
CONNECTION WITH THE ACQUISITION OR USE OF ANY
INTEGRA PRODUCT. Further, this warranty shall not apply to,
and INTEGRA shall not be responsible for, any loss arising in
connection with the purchase or use of any INTEGRA product
that has been repaired by anyone other than an authorized
INTEGRA service representative or altered in any way so as, in
INTEGRA’s judgment, to affect its stability or reliability, or which
has been subject to misuse, negligence or accident, or which has
been used otherwise than in accordance with the instructions
furnished by INTEGRA. THIS LIMITED WARRANTY IS EXCLUSIVE
AND IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR
IMPLIED, AND OF ALL OTHER OBLIGATIONS OR LIABILITIES
ON INTEGRA’S PART, AND INTEGRA NEITHER ASSUMES NOR
AUTHORIZES ANY REPRESENTATIVE OR OTHER PERSON TO
ASSUME FOR IT ANY OTHER LIABILITY IN CONNECTION WITH
INTEGRA’S PRODUCTS. INTEGRA DISCLAIMS ALL OTHER
WARRANTIES, EXPRESSED OR IMPLIED INCLUDING ANY
IMPLIED WARRANTY OF MERCHANTABILITY OR OF FITNESS FOR
A PARTICULAR PURPOSE OR APPLICATION OR WARRANTY OF
QUALITY AS WELL AS ANY EXPRESSED OR IMPLIED WARRANTY
TO PATIENTS. No warranty or guarantee may be created by any
act or statement nor may this Standard Warranty be modified
in any way, except as a result of a writing signed by an officer of
INTEGRA. These limitations on the creation or modification of this
warranty may not be waived or modified orally or by any conduct.