Instructions for use: flexible bipolar electrodes
3.1.
Warning and precautions
Country-specific regulations and laws for cleaning medical products have to be observed.
- For patients with Creutzfeld-Jakob-Disease, CJK-on-spec or its possible variants, Bovine Spongiform
Encephalopathy or Transmissible Spongiform Encephalopathy country-specific regulations and laws concerning
cleaning of instruments have to be observed.
- Do not use metal brushes, sponges, abrasive cleanser, hard or sharp tools to clean electrodes.
- Do not bend or deform the electrode or the cutting wire.
Limitation of reprocessing: Delmont imaging´s devices are made out of different materials. These were chosen
regarding their ability to withstand to several cleaning, disinfection and sterilization cycles and thus, the multiple
high temperature application. There are no concerns regarding material resistance or any known sensitivity to
process parameters during reprocessing (heat, cleaning agents etc.) which may affect the safety of our devices.
Nevertheless, the ability of Delmont imaging devices to withstand several reprocessing cycles has been validated
up to 20 times.
Due to different surgical procedures and use of Delmont imaging electrodes in terms of time-effort, we
recommend replacing the electrodes after every use even if a deep inspection has been performed following
this IFU.
3.2.
Cleaning
Manual pre-cleaning:
- Rinse electrodes for 5 min under cold water.
- Brush electrodes until no debris is detectable with the naked-eye.
- Rinse electrodes under cold water.
Cleaning, i.e. RDA Miele G7735:
Step
Process step
1
Pre-cleaning
2
Drain
3
Cleaning
4
Drain
5
Neutralisation
6
Drain
7
Rinsing
8
Drain
Disinfection: Thermal disinfection has been validated using the following parameters:
Do not immerse electrodes in chemical disinfectant. Disinfectant residues can cause adverse effects
in function.
D900 700 027 B
Tap water with 0,5% concentration of cleaning agent
such as neodisher MediClean ( Dr.
Time
95 sec
Rev 07/2018
Reagents
Tap water
Weigert, Hamburg )
Deionized water
Deionized water
Time (min)
2
5
3
2
Temperature
95 °C
delmont
imaging
T (°C)
55
5