Inspection; Maintenance / Using Service Oil; Packaging; Sterilisation - Coltene CanalPro Jeni Manual De Instrucciones

CanalPro Jeni
1.5.

Inspection

After cleaning or cleaning/disinfection, check all products/product components for corrosion, damaged surfaces, chipping, dirt and
discolouration, and remove damaged products/product components (for the numerical restriction on reuse see the chapter `Reusability´).
Products/product components that are still dirty must be cleaned and disinfected again.
1.6.

Maintenance / using service oil

Reassemble the dismantled product if required.
(see chapter `Special instructions´).
Instrument oils must not be used with this product. (see chapter `Special instructions´).
1.7.

Packaging

Please pack the products/product components in disposable sterilisation packaging (one-way packaging) which corresponds to the following
requirements (material/process):
- DIN EN ISO 11607
- Suitable for steam sterilisation (temperature resistance up to min. 138°C (280°F) sufficient vapour permeability)
- Products/product components or sterilisation packaging are sufficiently protected against mechanical damages
1.8.

Sterilisation

Only the sterilization methods listed below are to be used for sterilising the products/product components; other sterilisation methods are
not permitted.
1.9.

Steam sterilisation

- Fractionated vacuum method
- Steam steriliser according to DIN EN 13060/DIN EN 285
- Validated according to DIN EN ISO 17665 (valid IQ/OQ (picking) and product-specific performance appraisal (PQ))
- Maximum sterilisation temperature 134°C (273°F; plus tolerance according to DIN EN ISO 17665)
- Sterilisation time (exposure time at sterilisation temperature):
Country Fractionated vacuum method
Minimum of 5 min
Germany/Europe
minimum drying time of 20 min
1
At least three vacuum steps
2
Use of the less effective gravitation method is only permitted if the fractionated vacuum method is not available. It requires significantly longer sterilisation times and must be
validated by the user for specific products, devices, methods and parameters.
3
The actual drying time required directly depends on parameters that are the sole responsibility of the user (load configuration and density, steriliser condition,...) and must
therefore be determined by the user. Nevertheless, drying times should not be less than 20 minutes.
4
or 18 min (prion inactivation, not relevant for USA)
Flash sterilisation is generally not permitted.
Do not use hot air sterilisation, radiation sterilisation, formaldehyde or ethylene oxide sterilisation, or plasma sterilisation.
An independent accredited and recognised (§ 15 (5) MPG) test laboratory (Medical Device Services – DR: ROSSBERGER GmbH, Gilching)
has provided proof of the general suitability of the products/product components for effective steam sterilisation by using the steam steriliser
HST 6x6x6 (Zirbus technology GmbH, Bad Grund) and using the fractionated vacuum method and the special oil spray item no. 00-108-005
(Dr. Schumacher GmbH, Melsungen. Typical conditions in clinics and doctor's practices as well as the method described above were
considered here.

1.10. Storage

After sterilisation, the products/product components must be stored in the sterilisation packaging in a dry and dust-free manner.

1.11. Reusability

The products/product components can – with due care and provided that they are undamaged and free of dirt – be reused at least up to the
number indicated in the chapter `Special instructions´. The user is responsible for any further use beyond this. The use of damaged and/or
dirty products/product components is not permitted. All liability is excluded in the event of non-observance.
18
1 2
or gravitation method (with sufficient product drying
4
at 132°C (270°F)/134°C (273°F),
3
3
)
Gravitation method
not recommended