ChM CHARSPINE system Bedienungsanleitung Seite 9

of one of the following methods:
1) gamma radiation, with a minimum dose of 25 kGy,
2) hydrogen peroxide vapour.
2. The symbol designating the sterilization method used is visible on the de-
vice label (symbols are described in the footer of this Instructions For Use).
3. Prior to use of a sterile device the following rules apply:
1) Check out the expiration date of sterilization. Do not use the device with
an overstepped sterility date!
2) Check out if the sterile package is not damaged. Do not use the device
if the sterile package is damaged!
3) Check out the colour of the sterility indicator on the sterile package
which indicates that sterilization of the device was performed. Do not
use the device if the sterility indicator colour is different than:
a) red - for devices sterilized with gamma radiation,
b) blue - for devices sterilized with hydrogen peroxide vapour.
4. CAUTION: products should be removed from their packagings in accordance
with aseptic rules.
9 RECOMMENDATIONS FOR IMPLANTS PROVIDED
NON-STERILE
1. The following recommendations apply to unused non-sterile implants.
An implant that has been implanted must not be re-processed and re-
used.
2. The implant which has not been used but got contaminated by contact
with the blood, tissue and/or body fluids/materials, should not be used
again. The implant should be handled in accordance with applicable hos-
pital protocol. ChM does not recommend re-processing of contaminated
implants. Should the contaminated implant be re-processed, ChM bears
no responsibility.
3. 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.
4. 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.
5. 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
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