Emc Information - Bowa 801-030 Instrucciones De Uso

2.2. Use-related
1. The user must be trained in and familiar with the basic principles, rules of application, and risks of HF surgery.
2. Instruments must be used by trained medical staff only.
3. Not for use on metallic implanted objects, such as stents.
4. Not for use on the heart, central circulatory system, or central nervous system.
5. Seek appropriate professional advice before use on patients with pacemakers or other active implants.
6. Not for use for contraceptive tubal coagulation.
7. Not for use in the presence of flammable or explosive materials.
8. The instrument must not contact other, uninsulated instruments or objects.
9. Comply with the recommended power settings and maximum voltage.
Always choose the lowest required power setting.
The setti gs' effe tive ess ust e assessed
10. Activate only when the contact surfaces are within your field of view. To prevent personal injury in case of
inadvertent HF activation, do not set down active HF instruments on the patient.
11. The BF / CF applied part of the e plo ed HF u it is e te ded
12. All serious incidents arising in connection with the product must be reported to the manufacturer and the
competent authority of the member state in which the user is established.

2.3. EMC information

Medical electrical devices are subject to special EMC precautions, so please observe the following directions:
1. BOWA accessories are only provided for connection to BOWA HF devices.
2. The use of the accessories of medical devices from manufacturers other than those described may lead to elevated
emissions or reduced interference immunity.
NOTE
Combining medical devices is safe only if
 the instructions for use in question allow the desired combination or
 the purpose and the interface specification of the products used in the combination allow it.
The instructions for use and the interface specification of the medical devices used in the combination must
be strictly observed.
3 Sterility
WARNING!
Sterile only if packaging is free from damage!
Handles that were already in contact with the patient or have been contaminated must not be reprocessed
and must be discarded.
Handles are supplied individually packed and sterile.
If the sterile packaging is open, torn, or damaged, the handles must be considered nonsterile. The same applies
if the ha dles' e pir date has ee e eeded. I
The handles are intended for single use; contaminated products must not be reprocessed. Handles that have
come into contact with blood, tissue, or bodily fluids must be discarded.
WARNING!
Reprocessing not permitted!
Risk of
•
•
•
loss of function
loss of insulation due to potentially incompatible materials, and
microbial transmission
BOWA-electronic GmbH & Co. KG
Phone (+49) 7072-6002-0 Fax (+49) 7072-6002-33
the user.
the o
oth ases, the ha dles ust ot e used.
Heinrich-Hertz-Str. 4-10 72810 Gomaringen/Germany
info@bowa.de www.bowa-medical.com
e ted i stru e t.