MN031-464-S2 03/2017
EN
BOWA-electronic GmbH & Co. KG Heinrich-Hertz-Str. 4-10 72810 Gomaringen/Germany
MN031-464-S2
Tel. (+49) 7072-6002-0 Fax (+49) 7072-6002-33 [email protected] www.bowa-medical.com
03/2017
Symbols on packaging
Instructions for use monopolar electrodes:
500-007, 500-008, 500-009, 500-011, 500-014, 500-015, 500-016, 500-017, 500-018, 500-019, 500-020, 500-021, 500-022,
500-023, 500-024, 500-112, 500-113, 500-124, 500-125, 500-126, 500-127, 500-129, 500-130, 500-131, 500-150, 520-027,
520-028, 520-029, 520-030, 520-031, 520-032, 520-035, 520-122, 520-123, 520-124, 520-132, 520-133, 520-134, 520-135,
520-136, 530-000, 530-008, 530-009, 530-012, 530-013, 530-014, 530-015, 530-016, 530-017, 530-020, 530-021, 530-022,
530-027, 530-028, 530-029, 530-030, 530-032, 530-035, 530-070, 530-122, 530-123, 530-124, 530-125, 530-126, 530-127,
530-130, 530-132, 530-133, 530-134, 530-135, 530-136, 530-150, 530-207, 530-211, 530-224, 530-225
Medical product guideline
This product conforms to Guideline 93/42 EWG for medical products.
1. Correct use
Indications:
Monopolar electrodes are used for performing electro-surgical incisions and coagulation procedures.
Contra-indications:
none known at present
Use of the electrode is contra-indicated if, in the opinion of a responsible doctor, such an application would endanger the patient, e.g. based on the
patient’s general condition, or if there are any other contra-indications.
Detailed procedure:
1. Sterilise the electrodes (which are supplied in a non-sterile condition) before use.
2. Insert electrodes 500-xxx and 520-xxx into the handles for 4 mm shaft diameter, and electrodes 530-xxx into the handles for 2.4 mm.
It is recommended to use BOWA handles, as there is no standard in force for the plug connections from other manufacturers.
3. Take care not to exceed the maximum permitted voltage of 6000 Vp. For tungsten needle type electrodes 500-112, 500-113, 530-012 and 530-013
the maximum permitted voltage is 800 Vp, and the maximum power is 30 watts.
For loop electrodes 5x0-13x the maximum permitted voltage is 1400 Vp.
4. Use the knife type, needle type, micro-needle type and loop type electrodes for making electro-surgical incisions.
Use the spherical, knife type, flat and needle type electrodes for performing electro-surgical coagulation procedures.
2. Physical method of operation
A cutting effect is generated by the arc between the electrode and the tissue.
The thermal effect is obtained by using a high-frequency current at a frequency >300 kHz. The electrolytic effect and the irritation are not detectable
above a frequency of about 20 kHz.
The coagulation of biological tissue is caused by the thermal effect.
3. Safety instructions
1. This product may only be used by qualified medical specialists, who have been trained in the basics,
rules of application and risks of HF surgery and are familiar with them.
2. The electrodes are supplied in a non-sterile condition, and must be sterilised before use.
3. Take care to clean, disinfect and sterilise correctly.
4. Hot air sterilisation is not permitted.
5. The electrodes must be checked for any damage before being used. Damaged electrodes may no longer be used.
6. Electrodes must not be bent or loaded beyond their mechanical limits.
7. Follow the user instructions for the HF generator.
8. Follow the user instructions for the handgrips and connecting cables.
9. The operating area must be free of explosive gases or inflammable fluids and materials.
10. Be aware of the risk of irritation to nerves and muscles, which may be increased when operating with powerful arcs.
11. Immediately after the HF energy is switched off, the tips of the electrodes may still be so hot as to cause burning.
12. Live HF instruments must not be laid upon the patient, in order to avoid personal injury due to accidental HF activation.
13. The instrument must not come into contact with any other uninsulated instruments or objects.
14. Follow the recommended setup instructions and do not exceed the maximum voltage. Always select the minimum necessary power setting.
The user must assess for himself/herself the effectiveness of the setup.
15. Repair / maintenance is not permitted.
16. Take care to avoid injury due to sharp edges, e.g. with needle electrodes.
17. Consult a cardiologist before using HF surgery on patients with a cardiac pacemaker.
18. Sterilise the electrodes before they leave the hospital / surgery environment, in order to avoid spreading germs and infections.
4. Preparation
Preparation cycles
75 cycles
Soaking
Soak the instrument immediately after use, or no later than 2 hours after use. Use only aldehyde-free disinfectants
(recommended: Gigasept Instru AF) designed for the disinfection of instruments (e.g. DGHM or FDA approval, or CE mark).
Place the instrument in an ultrasonic bath for at least 5 minutes.
Use a cleaning solution to soften coagulation residues (encrustations) and remove them with a soft cleaning cloth.
Cleaning /
Disinfection
Recommendation: Machine cleaning in a cleaning/disinfection machine and thermal disinfection.
Parameters: At least 5 minutes at 90 °C or A0 value > 3000.
BOWA recommends the use of neutral to slightly alkaline cleaning agents (PH 9.5 – 11.5) or cleaning and disinfection
agents which are suitable for medical devices made of plastic and metal. Alcoholic and/or aldehydic ingredients may be
permissible, depending on the concentration. If necessary, blow off with filtered compressed air. Only dry the products with
compressed air at pressures below 3 bar, to avoid possible damage.
The manual method is not suitable for the designated products.
Effective cleaning
proven by BOWA
Machine cleaning/disinfection (90 °C, 5 min.)
using an alkaline cleaning agent with surfactant additives (Neodisher MediClean forte)
Autoclaving
Fractionated vacuum process
Retention time: 3-20 minutes, sterilisation temperature: 134-137°C
The manufacturer accepts no responsibility if other types of cleaning and disinfecting agents are used.
Follow the instructions provided by the manufacturer of the cleaning agent.
Before sterilisation, the dismantled instruments must be packed in a suitable single-use sterilisation pack (single or double pack) and/or a suitable
sterilisation container.
5. Operation and Storage
Temperature: +10°C - +40°C; Relative humidity: 0 - 75%, non-condensing; Air pressure: 500 - 1060 hPa
Protect the products from direct sunlight during storage. The storage life of the sterilized instrument depends on the type of packaging and the storage
conditions.
6. Transport
Temperature: -20°C - +50°C; Relative humidity: 0 - 75%, non-condensing; Air pressure: 500 - 1060 hPa
7. Disposal
Always dispose of medical products, packaging materials and accessories in accordance with applicable national regulations and statutes.
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