ChM CHARSPINE system Bedienungsanleitung Seite 10

agents with a pH value between 10.4 and 10.8. ChM used the following
materials during the validation process of the described recommenda-
tions for cleaning and disinfection. It is allowed to use other materials
than those listed below which may also give a comparable effect:
a) detergent - Dr.Weigert (producer) neodisher® MediClean forte (name
of the detergent);
b) disinfectant - Dr.Weigert (producer) neodisher® Septo Active (name
of disinfectant).
3) Manual with ultrasound cleaning
a) Equipment and materials: a device for ultrasound cleaning, soft, lint-
free cloths, plastic brushes, aqueous solutions: of cleaning agent, dis-
infecting agent or washing – disinfecting agent.
b) Prepare an aqueous solution of cleaning agent at temperature of 40+/-
2 °C and a pH of 10.4 - 10.8 (follow the information contained in the in-
structions prepared by the manufacturer of the agent, in respect of tem-
perature, concentration, exposure time and water quality).
c) Immerse the implant in the aqueous solution of the cleaning agent
and subject it to ultrasound cleaning for 15 minutes.
d) Rinse the implant thoroughly under running water, paying particular
attention to the holes and places difficult to be cleaned. It is recom-
mended to rinse with demineralized water.
e) Visually inspect the entire surface of the device for debris and impurity.
Damaged implants must be removed. For dirty implants, the cleaning
process should be repeated.
f) Dry the device thoroughly using disposable, soft, lint-free cloth.
g) Prepare an aqueous solution of disinfecting agent at a temperature
of 20+/-2 °C using 20g of the agent per 1 liter of water. Immerse
the implant in the solution, exposure time – 15min (follow the in-
formation contained in the instructions prepared by the manufacturer
of the agent, in respect of temperature, concentration, exposure time
and water quality).
h) After the exposure time, rinse the product thoroughly under running
water, paying particular attention to the holes and places difficult to be
cleaned. It is recommended to rinse with demineralized water.
i) Dry the device thoroughly. It is recommended to dry the implant
in a dryer at a temperature ranging from 90°C to 110°C.
j) Visually inspect the entire surface of the device.
4) The automated method using a washer - disinfector
a) Equipment and materials: a washer - disinfector, aqueous solutions
of cleaning agent.
b) CAUTION: The equipment used for washing/disinfection should meet
the requirements of ISO 15883. Procedure of washing in the washer-
disinfector shall be performed according to internal hospital pro-
cedures, recommendations of the washing machine manufacturer,
and Instructions for Use prepared by the washing-disinfecting agent
manufacturer.
c) The device should undergo a process of machine washing in the wash-
er-disinfector using the following cycle parameters: (1) - pre-washing
in cold tap water, duration – 2min; (2) - washing in an aqueous solu-
tion of cleaning agent at 55+/-2 °C and pH of 10.4 - 10.8, duration –
10min; (3) - rinsing under demineralized water, duration – 2min; (4)
- thermal disinfection in demineralised water at 90°C, minimal dura-
tion – 5min; (5) - drying at a temperature ranging from 90°C to 110°C,
duration - 40min.
6. Packaging
1) Washed and dried devices shall be packed in a packaging intended
for the recommended steam sterilization. The packaging and pack-
aging process have to meet the requirements of ISO 11607 standards.
The packaging procedure must be performed in controlled purity condi-
tions. The device must be packed in such a way that during its removal
from the packaging, when used, there is no risk for its re-contamination.
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