Bowa 801-030 Instrucciones De Uso página 4

INSTRUCTIONS FOR USE for single-use handles as well as SHE SHA handle and hose
Item no./name
801-030 Electrode handle with a rocker switch, standard blade electrode, Ø 2.4
mm, 3-pin, 3 m cable, single-use, sterile
802-030 Electrode handle with 2 buttons, standard blade electrode, Ø 2.4 mm,
3-pin, 3 m cable, single-use, sterile
803-030 Electrode handle without buttons, standard blade electrode, Ø 2.4 mm,
3 m cable, single-use, sterile
802-032 SHE SHA handle, 2-switch, knife, 3m, single-use, sterile
952-001 SHE SHA hose, for handle, single use, sterile
Sterile for single use
Medical Device Directive
This product complies with the Medical Device Directive 93/42/EEC.
1 Intended use
Indications:
Electrosurgical handles are used to connect electrodes and auxiliary instruments to
HF units for monopolar cutting or coagulation.
The SHE SHA smoke evacuation handle is intended for monopolar electrosurgical
cutting and coagulation as well as the extraction of surgical smoke.
Contraindications:
The handle must not be used if, in the opinion of an experienced physician or
according to current medical literature, its use would put the patient at risk,
for i sta e, due to the patie t's ge eral o ditio , or if other o trai di atio s
exist.
HF unit/power settings:
The maximum permissible voltage is 5000 Vp.
The instruments (801-030; 802-030; 802-032; 803-030) must be used with a
monopolar applied current.
2 Safety instructions
2.1. Product-related
1. Before use, check that the product and its packaging are intact and undamaged.
2. Use only products with undamaged packaging.
3. Remove any dust from the protective packaging before opening it. If the protective packaging is opened, it must be
closed immediately thereafter for protection from dust. After opening, the protective packaging must not be
refilled. It must be properly reclosed.
4. Before each use, every surgical instrument must be checked for visible damage and wear, such as any tears,
fractures, or insulation defects. Particularly areas such as blades and tips as well as all movable parts and insulation
must be carefully checked.
5. Never use damaged instruments.
6. Do ot appl loads that e eed the i stru e ts' e ha i al li its.
7. Observe the instructions for use of the HF generator and the SHE SHA smoke evacuation system as well as the
general instructions for electrosurgical procedures.
8. Caution! Risk of injury due to sharp edges.
9. The smoke evacuation handle is not a liquid extraction system and is suitable only for smoke evacuation.
10. Defective HF cables, handles, and electrodes must not be repaired. They must be replaced by new items.
11. When disconnecting the HF cable, always pull on the plug. Never pull on the HF cable since doing so may damage
it.
12. Use aseptic techniques when removing the product from the packaging.
13. Make sure that the electrode tightly and completely fitted in the handle. This also applies when changing the
electrode.
14. If possible, use only the accessories included in the scope of delivery.
EN
MN031-713-S0 07/2018
BOWA-electronic GmbH & Co. KG Heinrich-Hertz-Str. 4-10
Phone (+49) 7072-6002-0 Fax (+49) 7072-6002-33
Symbol/
marking
0123
72810 Gomaringen/Germany
info@bowa.de www.bowa-medical.com
Symbols on product/package
Description
Reference number
Quantity
Batch code
Consult instructions for use
Manufacturer
Date of manufacture
Keep away from sunlight
Keep dry
European Conformity mark
and identification number of
0123
the named body
Sterilized using irradiation
Do not resterilize
Use-by date
Do not reuse
Do not use if package is
damaged
Temperature limit
Complies with Russian
standards