Stryker Flosteady Arthroscopy Pump 200, Руководство пользователя

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Care and Maintenance
31
EN
11 Care and Maintenance
Care and maintenance The service and maintenance of the device and its accessories has to be carried
out as per instructions to ensure the safe operation of the device. For the protec-
tion of the patient and the operating team, check that the device is complete and
functional before each use.
The reprocessing instructions are provided in accordance with AAMI ST79, AAMI
ST81, AAMI TIR12, ISO 17664, and ISO 17665. While they have been validated by
the manufacturer as being capable of preparing the devices intended for re-use
properly, it remains the responsibility of the processor to ensure that the repro-
cessing, as actually performed (using equipment, materials, and personnel in the
reprocessing facility), achieves the desired result. This normally requires valida-
tion and routine monitoring of the process. The manufacturer recommends us-
ers observe these standards when reprocessing medical devices.
WARNING!
•
To minimize the risk of infection, clean and sterilize all components intended
for re-use prior to the first use and every use thereafter.
•
Ensure all components are prepared as described in this chapter prior to initiat-
ing the reprocessing.
•
Drying time depends on several variables, including: altitude, humidity, type of
wrap, preconditioning, size of chamber, mass of load, and placement in cham-
ber. Users must verify that the drying time set in their autoclave yields dry surgi-
cal equipment.
Manufacturer’s specification The manufacturer stipulates that qualified personnel or hospital technicians
must regularly test the device to assess its functionality and technical safety.
These inspections have to be carried out on an annual basis. Regular inspections
will assist in early detection of possible malfunctions. This helps preserve the de-
vice and increases its safety and service life.
11.1 Maintenance by Authorized Service Technician
Two-year maintenance interval An authorized service technician has to inspect and service the device at appro-
priate intervals to ensure the safety and functionality of the unit. The minimum
service interval is two years, depending on frequency and duration of use. If the
service interval is not maintained, the manufacturer does not assume any liabil-
ity for the functional safety of the device.
A sticker located on the rear panel of the device will remind you of the latest date
for the next service or maintenance check.
Authorized service technicians are only trained and certified by the manufactur-
er.
Authorized trained personnel All of the service tasks, such as changes, modifications, repairs, calibrations, etc.
may be carried out only by the manufacturer or manufacturer-approved trained
and skilled technicians.
Unauthorized personnel The manufacturer is not liable for the operational safety of the device if unau-
thorized persons conduct this maintenance or any other service tasks.
Liability Unauthorized opening of the device and repairs performed by unauthorized per-
sonnel or third parties and/or changes or modifications release the manufactur-
er of any liability concerning the operational safety of the device.
Technical documents Receiving technical documentation from the manufacturer does not authorize
individuals to perform repairs, adjustments, or alterations on the device or acces-
sories/peripherals.
Certification Ask the service technician for a certificate after he or she has inspected the unit
or performed any service tasks. This certificate lists the type and scope of the ser-
vice as well as the date and name of the servicing company together wit the sig-
nature of the service technician.