19
User Manual
General indications:
• Only use cleaning and disinfection agents that have been checked and authorized by the competent national boards (disin fection agent
list of the VAH, RKI list or DHGM list). In case of mechanical cleaning and disinfection, it has to be assured that the disinfector’s effi-
cacy is approved (e.g. DHGM- or FDA approval or a CE mark according to EN ISO 15883).
• The handpiece can be sterilized together with the cable in the autoclave in the foil sterilization pouch (e.g. steriCLIN heat seal bag).
• Only the handpiece head is suitable for mechanical cleaning and disinfection.
Limitation of reprocessing:
Frequent reprocessing has only got a small impact on this instrument. The instrument shelf life is mainly determined by wear and damage by use.
Place of handling:
Clean surface with a disposable cloth or paper towel.
Storage and transport:
No special requirements
Preparations for cleaning:
Disassemble product into its components (see separate user manual for electrode)
Cleaning:
Only use suitable cleansers, carefully following the instructions of the respective manufacturer. No
mechanical cleaning. Keep away from running water.
Disinfection:
Only use suitable disinfecting solutions, carefully following the instructions of the respective
manufacturer. No mechanical disinfection
.
Keep away from running water.
Maintenance:
No special requirements.
Packaging:
Standardized packing material for sterilisation can be used.
Sterilisation:
Vapor sterilisation at 134 °C for 5 minutes at 2 bar overpressure.
Control/Functional Check:
Sight check on damages, wear, deformation.
Storage:
No special requirements.
The a.m. instructions have been validated as SUITABLE for preparation of a medical device and its re-use by the medical device manufacturer. It is the reprocessor’s re-
sponsibility that the actual reprocessing achieves the required results with the equipment and materials applied and personnel involved in the reprocessing site. Nor-
mally, validation and routine control are necessary. Furthermore, the reprocessor should evaluate any deviation from the provided instructions regarding efficiency and
possible adverse consequences.
Conditioning advice for hand pieces of hf Surg (DIN ISO 17664:2004)
Environment-directive
The device must not be disposed of with household waste.
At the end of the device’s operating life, the user is legally bound to return the device to the point of sale or to
any of the public collecting points that have been set up for this purpose.
Please adhere to the EU Directive 2012/19/EU on the disposal of electronic and electric devices:
HF CUT & CUT COAG
PRG
No.
Program
Power
(Watt)
Coagulation
grade
Indications & remarks
1
CUT
ca. 28
6
(filtered wave)
- sulcus dilatation
- gingivectomy
- internal gingivectomy
- open curetage
- tumor resection
- lap preparation
- vestibulum plastic
- excision
3
CUT
ca. 22
5
2
CUT COAG
ca. 22
6
(slightly modulated or non filtered wave)
- gingivoplastic
- exposure of teeth, stubs, approximal steps or crown edges
- removal of hyperplasia
for ablation of tissue if simultaneous coagulation is requested with the cut
(Attention: 10% loss of tissue about 24 h post operatively due to extended
lateral heat)
Use only if distance to bone or periost is sufficient!
4
CUT COAG
ca. 17
7
Application examples: HF
