CelonLab ENT Instructions for Use

Instructions for Use (English) CelonLab ENT RFITT power control unit REF: WB991007 (100 ... 120 V~) REF: WB991001 (200 ... 240 V~) 1.

Safety and Warnings

2.

Description 2.1 2.2 2.3 2.4

3.

Indications for Use Contraindications Features of the Unit Description of the Controls

Installation Instructions 3.1 3.2 3.3 3.4

Power Supply Connection Equipotential Bonding Moisture Protection Commissioning

4.

Instructions for Use

5.

Cleaning and Disinfection

6.

Maintenance and Repair 6.1 6.2 6.3 6.4

Changing the Power Fuses Repairs Safety Checks Disposal of the Unit

7.

Technical Data

8.

Legal Information

9.

Symbols

10.

Manufacturer

WB135116-W17

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CelonLab ENT

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Instructions for Use

1. Safety and Warnings Warning: The safety and effectiveness of electrosurgical interventions depend not only on the design of the equipment used, but also to a major extent on factors which are under the control of the user. It is therefore extremely important to read, understand and follow the instructions supplied with the coagulation electrodes, the power control unit and the accessories in order to ensure safety and effectiveness. Caution: The safety of electrosurgery will be greatly enhanced by a thorough knowledge of the medical literature on the subject. Study of specific information on the hazards and complications of the procedure in question is especially recommended. Caution: The CelonLab ENT power control unit may only be used with compatible coagulation electrodes and accessories. The electrodes must be designed for the maximum peak output voltage. (see Technical Data). Caution: Before use, the electrosurgical unit and accessories must be examined for damage. Cables and accessories with damaged insulation or connections must not be used. Caution: Wherever possible, the patient should not be able to come into contact with electrically conductive components that are earthed. Route all connecting cables so that they are not in direct contact with the patient or other cables. Warning: Electrosurgical interventions on patients with cardiac pacemakers or pacemaker electrodes can, in general, result in disturbances of the pacemaker function. This risk is minimised by the use of bipolar radiofrequency current (the current only flows in the immediate vicinity of the two active electrodes). A risk does exist, however, if the application is in close proximity to the pacemaker. Warning: The risk of flammable gases or other materials being ignited exists with any surgical application of electrical energy. Precautionary measures must be taken to keep flammable materials and substances away from the site of intervention (do not use flammable anaesthetics, nitrous oxide or oxygen). Caution: Electrodes and probes of monitoring, stimulation and imaging devices can conduct radiofrequency currents. Electrodes and probes (e.g. ECG and EEG) must be kept as far away as possible from the site of the electrosurgical intervention. Caution: The CelonLab ENT power control unit complies with the EMC (electromagnetic compatibility) standard. Nevertheless, when the power control unit is active it may disturb neighbouring electronic equipment. Please follow the instructions in the technical documentation regarding electromagnetic ambient conditions (“EMC Guidelines”). Caution: Mobile communication equipment (e.g. mobile phones) may disturb the functioning of the power control unit and other electrical medical equipment. Caution: Contact with the tip of the coagulation electrodes may cause burns when the power control unit is active. Caution: In the event of a defect or malfunction in the unit, an undesirably high output power may be emitted.

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Instructions for Use

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CelonLab ENT

Caution: When the housing is opened there is a danger of electric shock. The unit must only be serviced by authorised technicians. Caution: Federal Law of the USA restricts this device to use by or on the order of a physician.

2. Description 2.1 Indications for Use The system, comprising the CelonLab ENT and compatible coagulation electrodes, is indicated for ablation and coagulation of soft tissue in otorhinolaryngology (ENT) surgery. This method of treatment is also referred to as bipolar radiofrequency induced thermotherapy (RFITT).

2.2 Contraindications Electrosurgical interventions are contraindicated if, in the judgment of the physician, tissue coagulation could have a negative effect on the state of the patient. Radiofrequency induced coagulation may be contraindicated for patients with a weakened immune system.

2.3 Features of the Unit The CelonLab ENT power control unit supplies the compatible bipolar coagulation electrodes via its bipolar output. A neutral electrode (return electrode) is not necessary. The power control unit features clearly laid out controls. After switching on the unit, the user only has to select the power level and activate the power output using the footswitch. The power control unit provides an acoustic output of the coagulation status. With CelonLab ENT, the “generator active” signal, which usually has a fixed frequency with conventional radiofrequency generators, is designed so that its frequency is proportional to the tissue resistance at any particular moment. This permits acoustic monitoring of the coagulation status, since the latter is directly connected with the tissue resistance. If the resistance increases beyond a specific limit value, which means that the coagulation process has ended, this is indicated by the tone being pulsed and power output is ended.

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Instructions for Use

2.4 Description of the Controls

Fig. 2.1: Front panel of the RFITT power control unit CelonLab ENT

Fig. 2.2: Back of the RFITT power control unit CelonLab ENT

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CelonLab ENT

1

Power switch: The power switch is for switching the unit on and off. When the power control unit is switched on the power switch glows green. For safety reasons the unit is only ready for use after approx. 10 seconds. The power setting is always at its minimal value of 1 after switching on.

2

Connection sockets for RFITT coagulation electrodes: All compatible bipolar coagulation electrodes can be connected to this socket.

3

Connection socket for the foot switch: The CelonFootSwitch can be connected to this socket. When the footswitch is pressed, power output is activated. The generator cannot be operated without a footswitch connected.

4

Signal lamp: “Power output”: If the control unit is activated by pressing the footswitch, and if power can be emitted at the output, this is indicated by this blue lamp.

5

Signal lamp: “resistance too low”: This red lamp illuminates, in combination with an acoustic signal (intermittent tone), to indicate that the resistance is lower than 30 ohms. Possible cause: short circuit in the electrode or cable. For safety reasons the power output is automatically switched off.

6

Power display: This two-digit LED display indicates the chosen power setting (values between 1 and 25). The indicated value does not necessarily correspond to the emitted power in watts because the power depends on the tissue resistance.

7

Button for increasing the power setting: Pressing this button increases the power level by 1.

8

Button for reducing the power setting: Pressing this button decreases the power level by 1.

9

Symbol: “Unit is defibrillator-safe”: The use of a defibrillator will not cause any damage to the unit, provided that the power control unit is not active, i.e. the footswitch is not pressed.

10 Symbol: “Caution! Read the Instructions for Use”: If a unit carries this symbol, it is necessary to read the Instructions for Use before using it for the first time. 11 Connection for equipotential bonding: See Chap. 3.2 (Installation Instructions) 12 Power connection: This socket is used for connecting the unit to the power supply system. (see Chap. 3.1) 13 Holder for power fuses: The power control unit is protected by two external fuses (see Chap. 6.1). If these fuses blow, an authorised technician should check the unit for possible defects before new fuses are fitted and the unit is operated again. 14 Rating plate: Details of the manufacturer, supply voltage, maximum power input, moisture protection class (IP), serial number and relevant output data. 15 Volume switch: This switch is used for setting the volume of the acoustic signal to loud or quiet. In the standard setting (switch not pressed) the signal is loud. The sound can be decreased by pressing the switch. 16 Symbol: “Non-ionising radiation”: Units which carry this symbol emit radiofrequency energy for diagnostic or therapeutic purposes.

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Instructions for Use

3. Installation Instructions The unit must be properly installed and commissioned by Celon AG or by a person or firm (distributor) commissioned and authorised by Celon AG.

3.1 Power Supply Connection The unit must only be connected to the power supply system with the cable supplied or a cable of the same quality (see Chapter 7 Technical Data). The power socket must be correctly installed and must have an earthing contact. Before connecting up to the power supply, check that the supply voltage agrees with the electrical data on the power supply unit’s rating plate.

3.2 Equipotential Bonding To increase electrical safety, the unit can be connected to the equipotential bonding system of the treatment room. (The housings of all equipment that comes into contact with the patient are electrically connected in order to prevent low-frequency electrical currents endangering the patient in the event of a defect in the conventional protective conductor system.)

3.3 Moisture Protection The unit’s housing is drip-proof (IP 21). Nevertheless, no containers containing liquid should be placed on the unit. The CelonFootSwitch is watertight (IP 68). If it comes into contact with liquid there is no risk of short circuit.

3.4 Commissioning Before any unit is used for the first time, the following functional test must be carried out: 1.

Connect to the power supply and equipotential bonding (see above).

2.

Connect the footswitch to the socket (3).

3.

Switch on the control unit at the power switch (1); the green pilot lamp must glow. Set the maximum coagulation power with buttons (7) and (8) up to the maximal value of 25. Check that the power display (6) shows all values between 1 and 25 correctly.

8

4.

Press the footswitch: The blue signal lamp (4) must now glow, an acoustic signal (intermittent tone) must be audible.

5.

Release the footswitch.

6.

End of commissioning.

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Instructions for Use

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CelonLab ENT

4. Instructions for Use Caution: The power control unit is intended for use by qualified medical personnel trained in the use of electrosurgical equipment and targeted puncture of areas of organs. Please also observe Section 1 (Safety and Warnings) and also the Instructions for Use for the coagulation electrodes and accessories. 1.

Connect the foot switch to the socket (3).

2.

Switch on the control unit at the power switch (1). The unit is ready for operation after approx. 10 seconds.

3.

Connect an RFITT coagulation electrode to the socket (2).

4.

Set the necessary coagulation power with buttons (7) and (8) in the range between 1 and 25. The power depends on the type of treatment in question. Suggestions for suitable settings are to be found in the Instructions for Use of the compatible coagulation electrodes.

5.

Insert the coagulation electrode into the tissue area to be treated.

6.

Activate the power output by pressing the footswitch (the footswitch must be held down throughout the entire treatment).

7.

End the application by releasing the footswitch when the end of treatment (dehydration of the tissue) is indicated by a pulsed acoustic signal or at any time during the treatment.

8.

Repeat steps 4 to 7 if required by the therapy.

9.

Switch off the unit at the power switch (1).

10. Clean the components following the instructions in Section 5. Caution: When using bipolar radiofrequency induced thermotherapy (RFITT), a lower power level may lead to longer application times and therefore a larger coagulation volume.

5. Cleaning and Disinfection All surfaces of the unit’s housing can be cleaned and disinfected with the cleaning agents and surface disinfectants normally used for medical equipment (mild cleaning solution, e.g. 70 % isopropyl alcohol). No liquid must enter the connector or the unit during cleaning. The CelonFootSwitch can be spray or wipe disinfected with the products mentioned above.

6. Maintenance and Repair 6.1 Changing the Power Fuses The unit is protected by two power fuses accessible from the outside. If these fuses blow, an authorised technician should check the unit for possible defects before new fuses are fitted and the unit is operated again, as overloading of the fuses is usually the result of a defect. Caution: Disconnect the power plug before changing the fuses! The fuses inside the housing must only be changed by an authorised technician.

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Instructions for Use

6.2 Repairs If a defect occurs, Celon AG or a contact appointed by Celon AG (e.g. distributor) must be informed. The repair must only be carried out by Celon AG or a firm authorised by Celon AG (ask the Celon AG distributor responsible for your area). Service documents such as circuit diagrams, parts lists, equipment descriptions and setting instructions are available from the manufacturer for technicians who are authorised to carry out maintenance and repair. Caution: When the housing is opened there is a danger of electric shock. The unit must only be opened by authorised technicians.

6.3 Safety Checks The unit must undergo a safety check at yearly intervals in accordance with the national statutory regulations. For this purpose, Celon AG or a firm authorised by Celon AG must be commissioned by the operator.

6.4 Disposal of the Unit The unit must be disposed of as electronic special waste.

7. Technical Data

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Unit designation

CelonLab ENT power control unit REF: WB991007 (100 ... 120 V~) REF: WB991001 (200 ... 240 V~)

Outputs

bipolar

Applied part

Type BF, defibrillation-safe

Rated output power

25 W at 100 Ohm

Power selection

From 1 to 25 W in 1 W steps

Impedance dependency of the power

See information accompanying the unit

Rated output frequency

470 kHz ± 10 kHz

Max. peak output voltage

< 150 Vpeak

Max. peak output voltage as a function of the power level

See information accompanying the unit

Audio-frequency of “generator active” signal

300 Hz – 2.5 kHz (for impedance range 25 – 400 ohms)

Audio-frequency if impedance too low

300 Hz, pulsed with approx. 1 Hz

Audio-frequency if impedance too high

≈ 2.5 kHz, pulsed with approx. 1 Hz

Rated supply voltage

100 … 120 V~ 200 ... 240 V~

Rated supply frequency

50 … 60 Hz

Power input at max. power

95 VA

WB135116-W17

Instructions for Use

CelonLab ENT

EN

Power fuses (2 x)

1.6 A T-lag, 250 V, 5x20 mm, UL/CSA REF: WB991007 (100 ... 120 V~) 0.8 A T-lag, 250 V, 5x20 mm, UL/CSA REF: WB991001 (200 ... 240 V~)

Power connection line

IEC 60320-1/C13

Dimensions (W x H x D)

267 x 165 x 335 mm

Weight

Unit: Footswitch:

Protection class

I

Classification according to Medical Devices Directive: Europe / US (FDA)

IIb / II

Foreign body/moisture protection

IP 21, footswitch IP 68

Transport conditions:

Temperature Relative humidity

-34 ... +65 °C 15 ... 80 %, non-condensing

Storage conditions:

Temperature Relative humidity

-25 ... +60 °C 15 ... 80 %, non-condensing

Operating conditions:

Temperature Relative humidity

+10 ... +40 °C 15 ... 80 %, non-condensing

7.3 kg 1.0 kg

Standards and directives applied: 93/42/EEC MDD

Conformity assessment

EN ISO 13485

Quality assurance systems – Medical Devices – Specific requirements for application as per ISO 9001

EN 60601-1

Medical electrical devices

EN 60601-1-2

Medical electrical devices (EMC)

EN 60601-2-2

Medical electrical devices (electrosurgical devices)

EN ISO 14971

Medical devices risk analysis

WB135116-W17

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Instructions for Use

8. Legal Information Improper handling releases the manufacturer from its warranty obligation. In particular, these Instructions for Use must be followed. Liability for products that have been modified from the original, misused or improperly used, is excluded. RFITT is a registered trademark of Celon AG medical instruments. Federal Law of the USA restricts this device to use by or on the order of a physician.

9. Symbols Manufacturer

Observe Instructions for Use

Date of manufacture

Store in a dry place

Reference number Serial number Quantity

-25 °C (-34 °C)

(+65 °C) +60 °C

15-80 % (15-80 %)

RH

Temperature range for storage (during transport) Relative humidity for storage (during transport) Product carries the CE mark

10. Manufacturer Celon AG medical instruments Rheinstrasse 8 D-14513 Teltow/Berlin GERMANY Tel: Fax: E-mail: Internet:

+49-3328-3519-0 +49-3328-3519-23 [email protected] www.celon.com

Celon AG is a certified company in accordance with ISO 9001 and EN ISO 13485.

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––––––––––––––––––– Manufacturer –––––––––––––––––––

Celon AG medical instruments Rheinstrasse 8 , 14513 Teltow, Germany Fax: +49 3328 3519-23 Phone: +49 3328 3519-0

–––––––––––––––––––– Distributors ––––––––––––––––––––

OLYMPUS EUROPA GMBH Wendenstraße 14-18, 22097 Hamburg, Germany Fax: +49 40 237 73 -57 31 Phone: +49 40 237 73 -57 44

KEYMED LTD. KeyMed House, Stock Road, Southend-on-Sea Essex, SS2 5QH, United Kingdom Fax: +44 1 702 465 677 Phone: +44 1 702 616 333

OLYMPUS LATIN AMERICA, INC. 6100 Blue Lagoon Drive, Suite 390, Miami, FL 33126-2087, U.S.A. Fax: +1 305-26 14 421 Phone: +1 305-266 23 32

OLYMPUS AUSTRALIA PTY. LTD. 31 Gilby Road, Mount Waverly VIC 3149, Australia Fax: +61 3-9543-1350 Phone: +61 3-9265-5400

OLYMPUS (BEIJING) SALES & SERVICE, CO., LTD. 13F - 14F, East Tower, Gongyuan No. 6 Royal Palace, No. 6 Gongyuan Xijie, Jianguomennei, Dongcheng District, Beijing 100005, China Fax: +86 10-65180865 Phone: +86 10-65188080

OLYMPUS MOSCOW LIMITED LIABILITY COMPANY Ulitsa Malaya Kaluzhskaya 19, Building 1, Floor 2, 117071 Moscow, Russia Fax: +7 095 958 2277 Phone: +7 095 230 6578

OLYMPUS SINGAPORE PTE LTD. 491B River Valley Road #12-01/04, Valley Point Office Tower, Singapore 248373 Fax: +65 6834-24 38 Phone: +65 6834 -00 10

OLYMPUS AMERICA INC. Two Corporate Center Drive, PO Box 9058, Melville, New York 11747-9058, U.S.A. Fax 800-833-1432 Phone 800-548-5515

OLYMPUS MEDICAL SYSTEMS CORP. 2951 Isihikawa-cho, Hachioji-shi, Tokio 192-8507, Japan

WB135116-W17

© Celon AG medical instruments Printed in Germany