Sterilization; Control And Testing; Visual And Functional Inspection / Check - Delmont imaging flexible bipolar electrodes Instrucciones Para El Uso

Instructions for use: flexible bipolar electrodes
3.3.

Sterilization

Products sterilization with fractional pre-vacuum procedure, in accordance with ISO 17665 has been validated
using the following parameters:
Time of exposure (min)
4
Packaging: The products are delivered non-sterile in sealed plastic or in a protective box/foam packaging. Trans-
port packaging is not suitable for sterilization. Devices have to be packed into suitable sterilization packaging
systems (e.g. STERICLIN pouch used during sterilization validation) acc. to ISO 11607 and/or AAMI / ANSI
ST77:2006 in order to be sterilized.
As HF electrodes are made out of thin metallic components, sterilization wrap made out of paper
should not be used as the electrodes could perforate the paper seal.
3.4.

Control and testing

The electrodes have to be visually examined for cleanliness after every cleaning and disinfection. They have to be
macroscopically clean from visual residual and soil.
- If residue, liquids, impurities are visible, repeat cleaning process.
- Ensure that the electrode is faultless prior to each application.
- The insulation and HF connector must be intact.
- Plastic components should be checked before sterilization. Electrode must be replaced if plastic com-
ponents are brittle, cracked or worn (see Figure 1).

4. Visual and functional inspection / check

New medical products have to be inspected thoroughly visually and functionally after delivery and
prior to each use.
- Prior to subsequent use, products should be visually examined for bent, broken or loose parts, damaged
insulation, fissures, scratches as well as worn out or cracked parts.
- Check that function is as described in the instructions.
- Damaged or faulty products should not be used and should be taken out of circulation immediately.
- Damaged parts should be immediately replaced by original manufacturer parts.
D900 700 027 B
Temperature (°C)
Figure 1
Rev 07/2018
132 ± 1
Figure 2
delmont
imaging
Drying time (min)
10
6