Integra MAYFIELD A2008, Instruction Manual

Page: 8 / 52

8
EN – ENGLISH
3. Load device into the washer and place small parts in
container or tray inside the washer unit in order to avoid
loosing small components.
NOTE – Load devices carefully into washer in order to
avoid collision.
4. Follow the instructions listed below and set washer
machine to these exact parameters:
Phase Time
(Min.)
Water
Temperature
Detergent and
Concentration
Pre-wash 1 4:00 Cold water N/A
Enzyme
Wash
4:00 Hot water Neutral pH
enzymatic (e.g.
Endozime® AW
Triple Plus with
APA, Ratio 1:128)
Wash 1 10:00 60.0ºC
(140º F)
Neutral pH
detergent
(e.g. Renu-Klenz™ ,
Steris, Ratio 1:256)
Rinse 1 0:30 Hot water N/A
Thermal
Rinse**
2:00 82.2ºC
(180º F)
N/A
** Optional phase for disinfection of components – minimum
water temperature as indicated or per worker manufacturer
specifications for the thermal rinse cycle.
NOTE
– Any deviation from this guideline could result in
damage to the equipment as well as improper cleaning
results.
Rinse with purified water. Do not perform if parameters
cannot be achieved.
5. Remove from washer and dry completely if needed.
6. Inspect equipment to make sure there is no visible organic
debris or residue from cleaning agent.
Repeat process if any visible soil is detected.
The life expectancy of the MAYFIELD products is expected to
be as long as 7 years.
Maintenance and Care
To ensure proper function and to extend the life and
performance of the equipment, Integra LifeSciences
recommends the following:
In the absence of proper care and servicing of the device,
negative effects may be seen after repeated processing over
time which may lead to reduced performance.
Contact information: See the Service and Repair section
for contact information on how to return your device for
periodic servicing and to request periodic inspections.
See Inspection and/or Service notes section for routine
checks to be performed on the device.
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.
Device Disposal
NOTE: Follow hospital procedures for disposal of this device.
Integra LifeSciences Warranty Statement
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
Recommended Action Recommended
Frequency
Return the device to the Integra
LifeSciences Repairs department for
detailed inspection and servicing.
Once / year
Request that Integra NeuroSpecialists
perform routine inspections of the device
Twice / year