ChM STERILE VH202 Instrucciones De Utilizacion página 8

pital protocol. ChM does not recommend re-processing of contaminated
implants. Should the contaminated implant be re-processed, ChM bears
no responsibility.
4. Prior to use of a non-sterile device, the following rules apply:
1) The device must undergo cleaning, disinfection and sterilization proce-
dures.
2) Effective cleaning is a complicated procedure depending on the follow-
ing factors: the quality of water, the type and the quantity of used deter-
gent, the technique of cleaning (manual, automated), the proper rinsing
and drying, the proper preparation of the device, the time, the tempera-
ture and carefulness of the person conducting this process.
3) The hospital facility remains responsible for the effectiveness of the con-
ducted cleaning, packaging and sterilization processes with the use
of existing equipment, materials and properly trained personnel.
5. Preparation for washing and disinfection (for all methods)
1) Prior to cleaning, remove the implant from the original unit packaging.
Dispose of the packaging. Protect patient labels, provided with the im-
plant, against accidental loss or damage.
2) To avoid contamination, the implants should not have contact with
the contaminated devices/instruments.
3) Rinse under running water and remove possible surface dirt (resulting
from e.g.: damage to the unit packaging) using a disposable cloth, paper
towel or plastic brushes (nylon brushes are recommended).
4) CAUTION: It is forbidden to use brushes made of metal, bristles or materi-
als which could damage the implant.
6. Cleaning and disinfection process
1) This Instructions for Use describes two validated by ChM clean-
ing and disinfection methods: manual with ultrasound cleaning
and automated method. It is recommended to use automated proce-
dures for cleaning and disinfection (in the washer-disinfector).
2) The chosen washing and disinfecting agents must be suitable and ap-
proved for use with medical devices. It is important to follow the instruc-
tions and restrictions specified by the producer of those cleaning agents.
It is recommended to use aqueous solutions of washing-disinfecting
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
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