Bowa 101-150 Manual Del Usuario página 3

INSTRUCTIONS FOR USE
en
Reusable cables for neutral electrodes
REF No. Label
101-150 Cable, single neutral electrode, to ALSA, Eschmann, 4.5 m
294-050 Cable, single neutral electrode, to Erbe, 4.5 m
380-050 Cable, single neutral electrode, international, 4.5 m
386-050 Cable, single neutral electrode, international (Non-REM), 4.5 m
101-003 Cable, rubber neutral electrode, to Erbe, 4.5 m
295-050 Cable, rubber neutral electrode, to Martin, 4.5 m
385-050 Cable, rubber neutral electrode, international, 4.5 m
380-145* Cable, Ultravision, single neutral electrode, international, 4.5 m
380-245* Cable, Ultravision, single neutral electrode, to Erbe, 4.5 m
* only for use with an Alesi Ultravision generator.
Follow the generator's instructions for use (REF. No. DLU-001-001).
European Medical Device Regulation
This product complies with Regulation 2017/745 on medical devices.
1 Intended Purpose
Electrosurgical equipment for cutting and coagulation of tissue.
1.1 Indications
Monopolar HF-cables / HF-adapters form the electrical connection between a HF surgical unit and a mo-
nopolar application part to transmit HF current.
1.2 Contraindications
Do not use HF cables / HF adapters in direct contact with the heart, central circulatory system or the central
nervous system.
Do not use HF cables / HF adapters where its surgical techniques are contraindicated.
Do not use monopolar application if, in the opinion of an experienced physician or according to current
professional literature, such use would cause endangerment of the patient, for example due to the gen-
eral condition of the patient, or if other contraindications are present.
2 Physical principle of operation
Via the neutral electrode, the monopolar electrical current is fed back from the patient over a large
surface to the HF generator. This special transition point prevents burns to the patient under the neutral
electrode.
3 Safety instructions
3.1 Device-related
• Goods which are delivered non-sterile must be cleaned and sterilised before use! Sterilisable up
to 137°C.
• Do not sterilise the product in hot air.
• Check the device for damage after reprocessing and before use
CAUTION:
A simple visual inspection on its own is not sufficient to ensure the integrity of the insulation.
Visual and functional inspection: visually under magnification and with high-voltage test
apparatus, or by means of functional test.
• If necessary, check the functional integrity with a suitable test device (e.g. 050-230).
• Discontinue using the device if damaged or modified.
• BOWA recommends the use of original BOWA accessories.
• The HF cable must not be strained beyond its mechanical limits (e.g. severe kinking or crushing
from being driven over by a device trolley).
• Follow the instructions for use for the HF generator.
• Follow the instructions for use for the neutral electrode.
• To disconnect, hold the HF cable by the plug and never pull directly on the HF cable itself.
• Do not carry out any repair work or maintenance on the device.
• Route the cables, ensuring that no loops form and that they remain isolated from other cables or
do not come in contact with the patient.
• No servicing or maintenance should be carried out on the BOWA medical devices during an HF
surgical application.
• In order to avoid the risk of injuries and electric shocks for the patient and operating personnel,
ensure that the power supply is switched off before connecting or disconnecting the adapter /
HF cables and accessories to/from the electrosurgical device.
3.2 Use-related
• Users must be trained in, and familiar with, the basic principles & rules of the application, and
risks of HF surgery.
• The products may only be used at medical facilities by trained medical personnel.
• The HF cable and matching plug must be correctly connected with the neutral electrode and the
HF generator.
• Approved HF generators and accessories: see the latest accessory compatibility list.
• Ensure that there are no explosive gases or inflammable fluids and materials in the surgical
area.
• In the case of patients with pacemakers, consult a cardiologist before the application.
• BOWA medical devices must not come in contact with other unisolated instruments, objects or
persons.
• Comply with the recommended power settings and maximum voltage.
- Always choose the lowest required power setting.
- The settings' effectiveness must be assessed by the user.
• Make sure that the cables do not come into contact with the patient.
• Position antistatic cloths on areas of the patient where substantial sweating is expected or there
is skin-to-skin contact.
• Before increasing the output power, check whether:
- the neutral electrode is correctly positioned;
- the working electrodes are clean;
Printed in Germany
Subject to technical and design changes
Copyright by BOWA-electronic GmbH & Co. KG, Gomaringen | Germany
12394-S1
- the plug connections are correct.
"An obviously low output value or failure of the HF surgical device during normal operation can
be caused by a poorly fitting neutral electrode or inadequate contact in its connections."
• Do not use the cable as a tool for removing the neutral electrode from the patient. This can
cause the skin to peel away or result in other skin injuries.
• Check the functioning of the CQM system in accordance with the rules for the HF generator.
• The "BF"-/"CF" application device of the HF device is extended by the connected instrument.
• Report any incidents or near misses to your country's medical devices regulatory agency. When
doing so, follow your own facility's internal reporting system. Notify your local BOWA specialist
retailer in such cases.
3.3 EMC information
Medical electrical devices are subject to special EMC precautions, so please follow the below-men-
tioned instructions.
• BOWA accessories are intended only for connection to the specified HF devices.
• Using the accessories with medical devices from other manufacturers can result in higher
emission levels or reduced interference immunity.
Combining medical devices is only safe if
the relevant instructions for use permit the desired combination or

 the intended use and the interface specification of the products used in the
combination are compatible.
Strict attention must be given to the instructions for use and interface specifications of
medical devices used in combination.
4 Procedure during use
HF cables 101-150; 294-050; 380-050; 386-050, 380-145, 280-245
1. Ensure that the clamping lever is in the open (upper) position. Insert the tab of the neutral electrode
into the slot in the terminal.
2. Ensure that the entire neutral electrode flap is centred in the terminal and is inserted all the way to the
base of the electrode.
3. Press the lever arm until it comes in the fully closed (lower) position and is flush with the top side of
the terminal.
4. At the end of the surgical operation, remove the terminal from the neutral electrode and then remove
the neutral electrode from the patient.
HF cables 101-003, 295-050, 385-050
1. Prior to the surgical operation, affix the rubber neutral electrode to the intended patient extremity
with the help of the elastic (rubber) bandage, but do not apply excessive pressure. Do not use "contact
gel" under the rubber neutral electrode.
2. Connect the rubber neutral electrode with the associated connector cable. Then connect the
connector cable to the HF generator.
3. CAUTION: During the surgery, repeatedly check for the correct fit of the rubber neutral electrode in
order to prevent burns around the rubber neutral electrode. If the rubber neutral electrode becomes
loose or is displaced, interrupt the surgery and correctly re-position the rubber neutral electrode.
4. At the end of the surgery, disconnect the plug connector between the connector cable and the neutral
electrode; thereafter remove the neutral electrode from the patient.
4.1 HF unit/power settings
The maximum permissible voltage is 500 V
The HF cable should always be used with a monopole electric current.
4.2 Connection combinations
HF cable
Neutral electrode
5 Reprocessing
5.1 General information
The following information on the allowed number of reprocessing cycles should be regarded as a
guideline. The actual number may vary depending on the demands placed on the product.
Manual reprocessing methods are not recommended due to their significantly lower effectiveness.
Follow the chemical manufacturers' statements on concentrations and working times. If other types of
cleaning agents and disinfectants are used, the medical device manufacturer cannot be held liable.
5.2 Product-specific information
Do not clean cables and adapters in an ultrasonic bath.
Isolated parts must not come into contact with hard, sharp or heavy products, as this could compromise
the electrical isolation.
Do not use wire brushes, abrasives or other products which could damage the surface.
BOWA-IFU-12394-NEUTRAL-ELECTRODE-CABLE-REUSABLE-S1-ML-20210701
BOWA MEDICAL
BOWA-electronic GmbH & Co. KG
Heinrich-Hertz-Str. 4-10
72810 Gomaringen/Germany
p
101-150, 294-050, 380-050, 386-050, 101-003
380-145, 380-245
815-110 816-042 816-112 193-008
815-140 816-071 816-141 193-016
518-070 816-072 816-161
815-040 816-092 816-162
Tel. +49 7072-6002-0
Fax +49 7072-6002-33
info@bowa-medical.com
www.bowa-medical.com
295-050, 385-050
232-003
242-003
3 /20