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70 Leica M525 OH4 / Ref. 10 714 367 / Version -
Notes on reprocessing of resterilizable
products
Products
Reusable products supplied by Leica Microsystems (Schweiz)
AG such as rotary knobs, objective protective glasses and
capping pieces.
Limitation of reprocessing:
For the medical devices used on patients suffering from
Creutzfeldt Jacob Disease (CJD) or suspected of having CJD or
variant CJD, the local statutory requirements have to be met.
Normally resterilizable products used on this group of patients
are to be eliminated without risk by incineration.
Occupational safety and health protection
Particular attention must be paid to the occupational safety and
health protection of the persons responsible for preparing cont-
aminated products. Current regulations of hospital hygiene and
prevention of infection must be observed in the preparation,
cleaning and disinfection of the products.
Limitation of reprocessing
Frequent reprocessing has little effects on these products.
The end of the product life cycle is usually determined by wear
and year and damage through use.
Instructions
Workplace
Remove surface contamination with a disposable cloth / paper
cloth.
Storage and transport
No special requirements.
It is recommended to perform the reprocessing of a product
immediately following its use.
Preparation for cleaning
Remove the product from the Leica M525 OH4 surgical
microscope.
Cleaning: manual
Equipment: running water, rinsing agent, spirit, micro-fiber cloth
Procedure:
1. Rinse surface contamination off of the product (temp. <40°C).
Use some rinsing agent depending upon degree of
contamination.
2. If the optics is heavily contaminated, e.g. finger marks, fat
streaks etc., use spirit for cleaning.
3. Dry off products, except for optical components, with a
disposable cloth/paper cloth. Dry off optical surfaces with a
micro-fiber cloth.
Cleaning: automatic
Equipment: Cleaning/disinfecting device
It is not recommended to clean products with optical
components in a cleaning/disinfecting device. In addition,
optical components must not be cleaned in ultrasonic baths in
order to prevent damage.
Disinfection
The alcohol disinfection solution "Mikrozid, Liquid" may be used
in accordance with the instructions on the label.
Please note that optical surfaces must be rinsed thoroughly
with fresh drinking water, followed by fresh demineralized
water, after disinfection. The products must be dried thoroughly
before the subsequent sterilization.
Maintenance
No special requirements.
Control and functional test
Check the snap-on behavior of rotary knobs and CAN handles.
Packaging
Separate: A standard PE bag may be used. The bag must be
large enough for the product so that the closure is not under
tension.
Sterilization
See Table 1
Storage
No special requirements.
Additional information
None
Contact information of manufacturer
Address of local agent
Leica Microsystems (Schweiz) AG verified that the
aforementioned instructions for the preparation of a product
are suitable for its reuse. The processing person is responsible
for reprocessing with the equipment, materials and personnel
and for achieving the desired results in the reprocessing instal-
lation. In general, this requires validations and routine monitor-
ing of the process. Every deviation from the supplied
instructions should also be examined carefully by the
processing person to determine effectiveness and possible
detrimental consequences.
Care and maintenance