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Operating Instructions
CE
0124
The following cleaning machines were used during validation:
Steam sterilisation in the autoclave: 134°C in saturated steam for 10 minutes, drying in vacuum
control of sterilization by moist heat) when sterilising.
The following autoclaves were used during validation:
Disinfect and clean pens with a soft brush or a a plastic fleece immediately after each use since
Monopolar RF Pens
Index: B
Applies to:
Description:
Warning notes:
Preparations for cleaning:
Manual cleaning:
Cleaning with an automatic
machine:
Sterilisation
Restrictions for
reconditioning:
Function test:
Packaging, storing,
transporting, handling
RF PEns No. 92043; 92044; 92047; 92048: 92 243; 92244;92245; 92247; 92248 Peak
voltage 4,3 KVp
The pens are intended for connecting and control RF-electrodes. A RF cable connects the
pen with the RF generator. Activation occurs with switches on RF handpiece.
New pens must be cleaned and sterilised according to a validated procedure (DIN EN 554)
using saturated steam for at least 10 minutes before use. Alkaline cleansers and solutions
(ph>7) can damage the pens. Check the insulation for absence of pressure marks or damages
prior to each use. Never use damaged pens. Do not operate in the presence of flammable
substances. The respective label indicates the maximum output voltage.
Disassembly is not required.
otherwise particles or dried secretions can stick to them, making later cleaning and sterilisation
difficult or even impossible. Make sure to clean and flush hidden areas several times.
- Hamo LS 76 cleaning automaton
with neutral cleanser and rinse aid (neodisher mediclean and neodisher mediklar)
- Cleanmaquet 203
with neutral cleanser (neodisher mediclean)
- Miele 67736 C1 and Miele 67736 C2
with neutral cleanser (neodisher mediclean)
for 15 minutes. Heed DIN EN 554 (Sterilization of medical devices - Validation and routine
- Selectomat S3000; 134°C, 5 min, vacuum drying for 15 min
- Varioclav 400E; 134°C, 5 min, vacuum drying for 15 min
- Vaculab 969 S3000; 134°C, 5 min, vacuum drying for 15 min
- KS666-2ED; 134°C, 5 min, vacuum drying for 15 min
Temperature up to 95°C
The product's service life depends on the degree of wear and damage. Frequent reconditioning
has only little effect on the service life.
Check the insulation for absence of pressure marks or damages prior to each use. Do not use
damaged pens or pens with pressure marks.
Store pens in a clean, dry environment. You should store them separately in a protective
container with separate compartments or sealed in foil. Always transport, clean, maintain,
sterilise and store pens with utmost care. This applies in particular to fine tips or other delicate
areas. The operator must ensure the sterile state is maintained after sterilisation.
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