RF4 Instruction Manual Ver 4.0 April 2018

Important general notes and instructions Make sure that this product is used only as intended and described in this instruction manual, by adequately trained and qualified medical personnel, Maintenance and repair must be carried out by authorized experts. Use the product only in the combinations and with the accessories and spare parts specified in this instruction manual. Use other combinations, accessories and replacement parts only if they are expressly intended for the planned appli­ cation and if the performance characteristics and safety requirements are met. The product must not be altered in any way. Reprocess the product in accordance with the manual before every use and before return shipment to protect the pa­ tient, user and third parties. This manual is an integral part of the product and must be stored in such a way that it is accessible at any time during its entire life cycle. This manual must be passed on to any subsequent owner or user. Immediately on receipt, check the product and its accessories for completeness and possible damage. Should the shipment give rise to complaints, please inform the manufacturer or supplier immediately. Subject to technical changes! Due to ongoing developments the illustrations and technical data may deviate slightly.

Safety instructions and levels of danger Symbol

Level of danger

WARNING!

Failure to observe can result in death or serious injury.

CAUTION!

Failure to observe can result in slight injury or damage to the product.

. .

0

IMPORTANT!

Failure to observe can result in damage to the product or surroundings.

NOTE!

User tips for optimum device use and other useful information. GERMANY RICHARD WOLF GmbH 75438 Knittlingen Pforzheimerstr. 32 Telephone: +49 70 43 35-0 Telefax: +49 70 43 35-4300 MANUFACTURER [email protected] www.richard-wolf.com

USA RICHARD WOLF Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Toll Free: 001 (800) 323 - 9653 Phone: 001 (847) 913 - 1113 Fax: 001 (847) 913 - 1488 [email protected] www.richardwolfusa.com

UK RICHARD WOLF UK Ltd. Waterside Way Wimbledon SW17 0HB Telephone: + 44 20 89 44 74 47 Telefax: + 44 20 89 44 13 11 [email protected] www.richardwolf.uk.com

BELGIUM / NETHERLANDS N.V. Endoscopie RICHARD WOLF Belgium S.A. Industriezone Drongen Landegemstraat 6 9031 Gent Drongen Telephone: +32 92 80 81 00 Telefax: +32 92 82 92 16 [email protected] www.richard-wolf.be

FRANCE RICHARD WOLF France S.A.R.L. Rue Daniel Berger Z.A.C. La Neuvillette F-51100 Reims Telephone: +33 3 26 87 02 89 Telefax: +33 3 26 87 60 33

AUSTRIA RICHARD WOLF Austria Ges.m.b.H. Wilhelminenstraße 93 a A-1160 Vienna Telephone: +43 14 05 51 51 Telefax: +43 14 05 51 51 45

[email protected]

[email protected] www.richard-wolf.com

Marketing Office U.A.E RICHARD WOLF Middle East P.O. Box 500283 AL Thuraya Tower 1 9th Floor, Room 904, Dubai Telephone: + 9 71 43 68 19 20 Telefax: + 9 71 43 68 61 12 [email protected] www.richard-wolf.com

INDIA RICHARD WOLF India Private Ltd. JMD Pacific Square No. 211 A, Second Floor Behind 32nd Milestone Gurgaon - 122 001 National Capitol Region Telephone: + 91 12 44 31 57 00 Telefax: + 91 12 44 31 57 05 [email protected] www.richard-wolf.com

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Contents 1 1.1 1.1.1 1.2 1.2.1 1.3 1.4 1.4.1 1.4.2 1.5 1.5.1 1.5.2 1.6 1.6.1 1.7 1.7.1

General information... Symbols... Explanation of abbreviations used... Intended use... Performance characteristics... Indications and field of use... Contraindications and side effects... Contraindications... Side effects... Combinations... Potential equalization... Requirements for products / components of a combination... Electromagnetic compatibility (EMC) - IEC 60601-1-2 : 2007... Guidelines and manufacturer's declaration on electromagnetic compatibility... Electromagnetic compatibility (EMC) - IEC 60601-1-2 : 2014... Guidelines and manufacturer's declaration on electromagnetic compatibility...

1 1 2 3 3 3 4 4 4 4 5 5 6 6 9 9

2 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8

Safety measures... General information... Positioning the patient... Applying the neutral electrode... Cardiac pacemakers, implants... Interference with other devices... Accessories... Operation with bipolar cutting current... Risks due to high electrical voltages...

11 11 11 12 13 13 13 14 14

3 3.1 3.1.1 3.2 3.2.1 3.3 3.3.1

Illustration... Front view... Legend... Illustration of rear panel... Legend... Illustration of footswitch... Legend...

15 15 15 16 16 17 17

4 4.1 4.1.1 4.1.2 4.1.3 4.1.4 4.1.5 4.1.6 4.1.7

Setup... Initial preparation... Switching the device on and off... Selftest... Connecting the footswitch... Connecting the neutral electrode... Connecting monopolar RF instruments... Connecting bipolar RF instruments... Bipolar instruments with automatic instrument recognition...

18 19 19 19 19 20 20 20 21

5 5.1 5.2 5.2.1

Checks... Visual check... Function check... Function test...

22 22 22 23

6 6.1

Use... 24 Operating principle... 24

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I

6.2 6.3 6.4 6.5 6.6

Selecting the mode... Power setting... Program memory... Autostart... Taking out of service...

25 26 27 28 28

7 7.1 7.1.1 7.1.2 7.1.3 7.2 7.2.1

Reprocessing and maintenance... Reprocessing and maintenance... Reprocessing of device... Footswitch... Accessories... Maintenance... Technical safety check...

29 29 29 29 29 30 30

8 8.1 8.1.1 8.2 8.2.1 8.2.2 8.2.3 8.3 8.4 8.5 8.6 8.6.1 8.6.2 8.6.3

Technical description... Troubleshooting... Error messages... Technical Data... Technical data of radioblator... Technical data of footswitch... RF output parameters... Operating, storage, transport and shipping conditions... Disposal of product, packaging material and accessories... Environmental protection... Diagrams... RF power... RF voltage (no load)... Control characteristics...

31 31 32 33 33 33 34 34 34 34 35 35 37 39

9 9.1 9.1.1

Accessories... 40 Replacing parts... 41 Device fuses... 41

II

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1

General information

1.1

Symbols Symbols

Designation Attention, Caution Follow the instruction manual OFF (no power supply, separation from mains) On (power: connection to the power/mains) Equipotentality Footswitch Recycle the product separately. Do not discard together with other waste. Volume control

...

P1 to P4 program memory locations (for storing device settings) Increase / decrease setting Monopolar / bipolar cutting Monopolar cutting with coagulation Monopolar contact coagulation Monopolar contactless coagulation Bipolar cutting with initial cutting support Standard for bipolar coagulation Bipolar coagulation using fine instruments Bipolar coagulation with auto-start Connection for monopolar instruments Connection for bipolar instruments Neutral electrode insulated from earth

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1

Symbols

Designation Display "Neutral electrode not connected" (blinking in red) TYPE CF APPLIED PART The device is defibrillator-proof High-frequency currents - Caution, high voltage

REF

Order number Lot identification Manufacturer Manufacturing date

XX° XX°

Permissible temperature range

XXhPa

Permissible atmospheric pressure range XXhPa XX%

Permissible humidity range XX%

A Registered Trademark of a Recognized Testing Laboratory, confirm the compliance to the standard of Medical Electrical Equipment CAN/CSA C22.2 No.60601-1 (c) and ANSI/AAMI ES60601-1 (us) A Registered Trademark of a Recognized Testing Laboratory, confirm the compliance to the standard of Medical Electrical Equipment CAN/CSA C22.2 No.601­1 (c) and UL60601­1 (us) A Registered Trademark of ETL, a Recognized Testing Laboratory, confirm the compliance to the standard of Medical Electrical Equipment CAN/CSA C 22.2 No. 601.1 (c) and UL 60601-1 (us)

TÜV test symbol for UL/CSA. Identification in conformity with medical devices directive 93/42/EEC only valid if the product and/or packaging is marked with this symbol. Products of category IIa and above, as well as sterile products or products with measuring function of category I, are additionally identified with the code no. of the notified body (0124).

1.1.1

Explanation of abbreviations used  A AC CF dB DC Display Err F hPA Hz kHz mA

2

Ohm Ampere Alternating Current Cardiac Floating Decibel Direct Current Display field on generator Error Floating Hectopascal Hertz Kilohertz Milliampere

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MDD 93/42 (EEC) MHz MPG LF P PE Peak R RF V V VA

1.2

EU Medical Device Directive Megahertz Medical Product Law (Germany) Low Frequency Power Equipotentality Peak Resistance Radio Frequency Volt Version Volt­Ampere

Intended use The Radioblator RF device has a maximum output power of 100 watt and is suitable for monopolar and bipolar electrosurgical cutting and coagula­ tion in therapeutic interventions. This product is designed exclusively for use by specialized medical per­ sonnel and may only be applied by medically qualified and adequately trained persons.

1.2.1

Performance characteristics Monopolar and bipolar electrosurgical cutting and coagulating during a therapy.

1.3

Indications and field of use Therapy in conjunction with endoscopic accessories in the following disci­ plines: Spinal surgery, neurosurgery, ENT, plastic/cosmetic surgery, oral maxillofacial surgery, dermatology and orthopedics. On the basis of the patient’s general condition, the user in charge must decide whether the planned use is possible or not. For further notes and instructions please refer to the latest medical literature.

CAUTION! In case of therapeutic applications an adequate backup device with the same capabilities must be available should the device fail.

.

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NOTE! We recommend reading relevant literature for the planned application.

3

1.4

Contraindications and side effects

1.4.1

Contraindications

Any application requiring an RF power higher than the maximum power specified for the corresponding type of current in the technical data are contraindicated. In the case of interventions in/on body parts with a small cross-section compared to their elongation (filament structures and pieces of skin), the bipolar technique or even no RF surgery at all is indicated to avoid unin­ tentional coagulation at other points. Contraindications directly related to the product are presently unknown. On the basis of the patient's general condition the doctor in charge must decide whether the planned use is possible or not. For further notes and instructions please refer to the latest medical litera­ ture.

1.4.2

Side effects

1.5

Combinations

Side effects directly related to the product are currently unknown.

The radioblator is used in conjunction with the accessory items listed un­ der section 9. Furthermore, a suitable irrigation can be connected.

.

4

IMPORTANT! In addition to this instruction manual, follow the manuals for the products used in combination with this product.

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1.5.1

Potential equalization The potential equlization cable represents a direct connection between a medical electrical device and a potential equlization rail. It serves to avoid or to equalize differences in potential between enclos­ ures of electrical equipment and firmly installed conductive parts in the patient environment.

1.5.2

Requirements for products / components of a combination 1.5m

1.5m The general requirements depend on whether the products / components are inside or outside the patient environment.

1.5m

IEC 60601-1, 3. Ed.

Medically used room inside the patient environment MP

MP

~

~

MP

MP

~

NMP

~

~

MP

NMP

MP

Non-medically used room

-

-

Requirements / measures Leakage currents to section 16.6 IEC 60601-1:2005 / EN 60601-1:2006 *

Verification of the total patient leakage current

**

MP

~

outside the patient environment

**

-

Verification of leakage currents

**

a) additional protective earth connection (consult the corresponding manufacturer),

-

or

NMP

b) additional isolating transformer for medical applications **

~ MP

NMP

~ MP / NMP

MP

~

**

MP

NMP

~

~

MP

MP / NMP

~

~

additional "isolating transformer" to IEC/ EN60601-1 ** Functional connection MP NMP

* **

Verification of leakage currents a) no plugs with metal housing, or b) additional isolation device (to avoid voltage differentials)

-

~

Verification of leakage currents a) common protective earth connection, or b) additional protective earth connection at MP (clarify with the corres­ ponding manufacturer), or c) additional isolation device (to avoid voltage differentials), or d) no plugs with metal housing in the patient environment

additional isolating device to IEC/ EN 60601-1

Multiple socket strip

Power supply grid

= medical electrical device to IEC/ EN 60601-1, ANSI/AAMI es60601-1, CSA C22.2 No. 60601-1 08 = non-medical electrical device in accordance with product-specific IEC/EN/UL standards When connected via a multiple socket strip under standard conditions, the earth leakage current of the socket strip must not exceed 5 mA. e.g. Richard Wolf video cart with "isolating transformer"

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5

.

IMPORTANT! The persons combining products to form a system are responsible for not impairing the system's compliance with performance and safety requirements, and that the technical data and the intended use are adequately fulfilled. Possible electromagnetic or other interference that may occur between the product and other products can cause faults or malfunctions. When selecting the system components, make sure that they meet the necessary requirements of the medical envi­ ronment they are used in, in particular IEC/ EN 60601-1 (3. Edition IEC/EN 60601-1, section 16). In case of doubt, contact the manufacturer(s) of the system components. Do not touch connectors for electrical connections between various components (such as signal input connectors and signal output connectors for video signals, data exchange, controls etc.) and the patient at the same time.

1.6

Electromagnetic compatibility (EMC) - IEC 60601-1-2 : 2007

1.6.1

Guidelines and manufacturer's declaration on electromagnetic compatibility

Guidelines and manufacturer's declaration in accordance with IEC 60601­1­2 section 6.8.3.201 a) 3) table 201: Electromagnetic emis­ sions The RADIOBLATOR has been designed for operation in an electromagnetic environment as described below. The customer or user of the RADIOBLATOR should make sure that it is used in such an environment. Immunity tests

Compliance level

Electromagnetic environment - Guidelines

HF emissions to DIN EN 55011

Group 2

The RADIOBLATOR must emit electromagnetic energy to ensure its intended function. Neighboring electronic devices may be influ­ enced.

HF emissions to DIN EN 55011

Class B

The device complies with this class only in standby mode when the RF current is not activated!

Harmonic emissions to DIN EN 61000­3­2

Class A

Emissions of voltage fluctuations / flicker to DIN EN 61000­3­3

Conforms with

The RADIOBLATOR is suitable for use in all establishments, inclu­ ding domestic establishments and those directly connected to the public power supply network.

Guidelines and manufacturer's declaration in accordance with IEC 60601­1­2 section 6.8.3.201 a) 3) table 201: Electromagnetic emissions The RADIOBLATOR has been designed for operation in the electromagnetic environment specified below. The customer or user of the RADIOBLATOR should make sure that it is used in such an environment. Immunity tests

Test level to DIN EN 60601

Compliance level

Electrostatic discharge (ESD) to DIN EN 61000­4­2

±6 kV contact discharge

±6 kV contact discharge

±8 kV air discharge

±8 kV air discharge

±2 KV for power/mains sup­ ply lines

±2 KV for power/mains sup­ ply lines

±1 kV for input and output lines

±1 kV for input and output lines

±1 kV differential mode vol­ tage

±1 kV differential mode vol­ tage

±2 kV common-mode voltage

±2 kV common-mode voltage

<5 % UT (>95 % dip in UT) for 0.5 cy­ cle

0 % UT (100 % dip in UT) for 0.5 cy­ cle

40 % UT (60 % dip in UT) for 5 cycles

40 % UT (60 % dip in UT) for 5 cycles

70 % UT (30 % dip in UT) for 25 cycles

70 % UT (30 % dip in UT) for 25 cycles

<5 % UT (>95 % dip in UT) for 5 se­ conds

0 % UT (100 % dip in UT) for 5 se­ conds

3 A/m

3 A/m

Electrical fast transients / bursts to DIN EN 61000­4­4 Voltage surges to DIN EN 61000­4­5

Voltage dips, short inter­ ruptions and voltage va­ riations in power supply input lines to DIN EN 61000­4­11

Power frequency (50/60 Hz) magnetic field to DIN EN 61000­4­8

Electromagnetic environment - Gui­ delines Flooring should be wood or concrete or provided with ceramic tiles. If the floor is covered with synthetic material, the re­ lative humidity must be at least 30%. The mains/line power quality should be that of a typical commercial or hospital environment. The mains/line power quality should be that of a typical commercial or hospital environment. The mains/line power quality should be that of a typical commercial or hospital environment. If the user of the RADIO­ BLATOR requires continued operation during power/mains interruptions, it is re­ commended that the RADIOBLATOR be powered from an uninterrupted power supply or a battery. The power frequency magnetic field emissions should be at levels characteri­ stic of a typical location in a typical com­ mercial or hospital environment.

REMARK: UT is the is the alternating line/mains voltage before applying the test levels.

6

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Guidelines and manufacturer's declaration in accordance with IEC 60601­1­2 section 6.8.3.201 b) table 204: Electromagnetic immunity The RADIOBLATOR has been designed for operation in the electromagnetic environment specified below. The customer or user of the RADIOBLATOR should make sure that it is used in such an environment. Radiocommunications equipment and mobile phones or other transmitters operated in the immediate vicinity may impair the function of this device.

Immunity tests

Test level in to DIN EN 60601

Compliance level

Electromagnetic environment - Guidelines Portable and mobile RF communications equipment should be used no closer to any part of the RADIOBLATOR (including ca­ bles) than the recommended separation distance, calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: d=1.17pP

Conducted HF interfe­ rence to DIN EN 61000­4­6

Radiated HF interfe­ rence to DIN EN 61000­4­3

3 Veff 150 kHz to 80 Mhz 3 V/m 80 MHz to 2.5 GHz

d=1.17pP for 80 MHz to 800 MHz 3 Veff 150 kHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz

d=2.33pP for 800 MHz to 2.5 GHz

P = nominal power output rating of the transmitter in watts (W) according to the transmitter manufacturer and d = recommended separation distance in meters (m). The field strength from fixed HF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in all frequencies.b Interference may occur in the vicinity of devices with the following symbol:

NOTE 1: NOTE 2:

At 80 MHz and 800 MHz the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is also affected by absorption and reflection from structures, objects and people.

a Field strengths of fixed transmitters such as base stations for radio (cellular, cordless) telephones and land mobile radios, amateur radio, AM and FM radio and TV transmitters cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the RADIOBLATOR is used exceeds the applicable compliance level above, the device should still be functioning normally. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the RADIOBLATOR RF4®. b Over the frequency range between 150 kHz and 80 MHz, field strengths should be less than 3 V/m.

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7

Recommended separation distances between portable and mobile HF telecommunications equipment and the RADIOBLATOR in accordance with IEC 60601­1­2 section 6.8.3.201 b), table 206 The RADIOBLATOR is intended for use in an electromagnetic environment in which radiated HF disturbances are controlled. The customer or end user of the RADIOBLATOR can help prevent electromagnetic interference by maintaining a minimum distance bet­ ween portable and mobile HF telecommunications devices (transmitters) and the RADIOBLATOR as recommended below, according to the maximum output power of the communications equipment. Radiocommunications equipment and mobile phones or other transmitters operated in the immediate vicinity may impair the function of this device. Recommended separation distance depending on the transmitted frequency (in m) Rated maximum output power of transmitter W

150 kHz to 80 MHz

d [

3.5 ] P V1

80 MHz to 800 MHz

d [

3.5 ] P E1

800 MHz to 2.5 GHz

d [

7 ] P E1

0.01

0.12

0.12

0.23

0.1

0.37

0.37

0.74

1

1.17

1.17

2.33

10

3.7

3.7

7.4

100 11.7 11.7 23.3 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the trans­ mitter in watts (W) according to the transmitter manufacturer. NOTE 1: At 80 MHz and 800 MHz the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is also affected by absorption and reflection from structures, objects and people.

8

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1.7

Electromagnetic compatibility (EMC) - IEC 60601-1-2 : 2014

1.7.1

Guidelines and manufacturer's declaration on electromagnetic compatibility

Guidelines and manufacturer's declaration in accordance with IEC 60601­1­2 section 6.8.3.201 a) 3) table 201: Electromagnetic emis­ sions The RADIOBLATOR has been designed for operation in an electromagnetic environment as described below. The customer or user of the RADIOBLATOR should make sure that it is used in such an environment. Immunity tests

Compliance level

Electromagnetic environment - Guidelines

HF emissions to DIN EN 55011

Group 2

The RADIOBLATOR must emit electromagnetic energy to ensure its intended function. Neighboring electronic devices may be influ­ enced.

HF emissions to DIN EN 55011

Class B

The device complies with this class only in standby mode when the RF current is not activated!

Harmonic emissions to DIN EN 61000­3­2

Class A

Emissions of voltage fluctuations / flicker to DIN EN 61000­3­3

Conforms with

The RADIOBLATOR is suitable for use in all establishments, inclu­ ding domestic establishments and those directly connected to the public power supply network.

Guidelines and manufacturer's declaration - Electromagnetic immunity The product is intended for use in the environment specified below. The user must assure that the product is used in such an environment. Immunity tests

IEC 60601 test level

Electrostatic discharge (ESD) to IEC 61000-4-2

 8 KV contact discharge  15 KV air discharge

Yes

Floors should be wood, concrete or ceramic tile. With floors made of synthetic material, the relative humidity of the ambient air must be at least 30%.

Electrical fast transience, bursts to IEC 61000-4-4

 2 KV for power supply lines  1 KV for input and output lines

Yes

Mains/line power quality should be that of a typical commercial or hospital environment.

Surge voltage (surges) to IEC 61000-4-5

 1 KV line to line voltage  2 KV line to ground voltage

Yes

Mains/line power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and sup­ ply voltage variations to IEC 61000-4-11

0% UT * ; 1/2 period at 0.45, 90, 135, 180, 225, 270 and 315 degrees 0% UT * ; 1 Period and 70% UT * ; 25/30 Periods single-phase: at 0 degrees

Yes

Mains/line power quality should be that of a typical commercial or hospital environment. If the user of the product requires continued operation during power mains/line interruptions it is recommended that the product be powered from an uninterrupt­ ible power supply or battery.

Power frequency (50/60 Hz) magnetic field, to IEC 61000-4-8

30A/m

Yes

Power frequency magnetic fields should be at lev­ els characteristic of a typical location in a commer­ cial or hospital environment.

Compliance

Electromagnetic environment - Guidelines

* NOTE! UT is the line / mains voltage prior to application of the test level.

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9

Guidelines and manufacturer's declaration - Electromagnetic immunity for products that are not life-supporting The product is intended for use in the environment specified below. The user must assure that the product is used in such an environment. Immunity tests

IEC 60601 test level

Compliance

Electromagnetic environment - Guidelines Portable and mobile RF communications equipment should be used no closer to any part of the product, including ca­ bles, than the recommended separation distance calculated from the equation applicable to the frequency of the transmit­ ter. Recommended separation distance: d = 1.2 p P d = 1.2 p P for 80 MHz to 800 MHz

Conducted HF interference to IEC 61000-4-6

6 Vrms 150 kHz to 80 MHz

Yes

Radiated HF interference to IEC 61000-4-3

3 V/m 80 MHz to 2.7 GHz

Yes

d = 2.3 p P for 800 MHz to 2.5 GHz P = Nominal power output rating of the transmitter in watts (W) (according to the transmitter manufacturer)

d = recommended separation distance in meters (m) Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey1, should be less than the compliance level in each frequency range2. Interference may occur in the vicinity of devices with the following symbol:

REMARKS: At 80 MHz and 800 MHz the higher frequency range applies. These guidelines may not apply in all situations. The propagation of electromag­ netic waves is affected by absorption and reflexion from buildings, objects and people. 1 = The field strength of stationary transmitters (e.g. base station for radio phone, earth to earth radio stations,, amateur radio stations, radio and television transmitters) cannot be exactly predicted in theory. To assess the EMC environment due to fixed transmitters an electromagnetic site survey should be conducted. If the measured field strength in the location in which the product is used exceeds the applicable compliance level above, the product should be observed to verify normal operation. If abnormal performance is observed, additional measures may be required, such as reorienting or relocating the product. 2 = Over the frequency range between 150 kHz and 80 MHz the field strength should be below 3 V/m.

Recommended separation distances between portable and mobile HF telecommunication devices and devices which are not life-supporting The product is intended for use in an electromagnetic environment where HF disturbances are controlled. The user can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile HF telecommunica­ tions equipment and the product. Separation distance as a function of transmitter frequency (m) Rated nominal output power of thetransmitter (W)

150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

d = 1.2 p P

d = 1.2 p P

d = 2.3 p P

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

For transmitters rated at a nominal output power not listed in the table above, the recommended separation distance (d) in meters (m) can be determined using the applicable equation (observe frequency). P = nominal power of the transmitter in Watts (W). REMARKS: At 80 MHz and 800 MHz the higher frequency range applies. These guidelines may not apply in all situations. The propagation of electromag­ netic waves is affected by absorption and reflexion from buildings, objects and people.

10

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Safety measures

2.1

General information

.

RF devices are high-frequency generators generating high voltages and currents in order to execute their intended use. To avoid any hazard for the patient, the operating personnel or third parties, the device must be used carefully and the operating and safety instructions must be strictly adhered to at all times!

NOTE! A fault in an RF device may cause an unintended increase in the output power. To avoid this, the RADIOBLATOR contains a safety circuit against over­ dosage! Set the RF power as low as possible to achieve the desired surgical ef­ fect. On the other hand, please observe that an excessively low power setting may also represent a risk e.g. if as result of insufficient power, no initial cutting support is provided and a local coagulation is caused in­ stead at a point where it is not required or even dangerous. If an insufficient effect is observed under the usual settings, this may be due to poor contact of the neutral electrode, poor contact in the connec­ tors, parted cables under the insulation or encrusted electrodes. Check the components and replace defective parts. Avoid the use of ignitable anesthetics, nitrous oxide (N2O) and oxygen. The use of RF devices may cause sparking at the active electrode. Any flammable substances used as cleaning agents, disinfectants or solvents must have evaporated before using RF surgery. There is a danger that flammable liquids will collect under the patient or in bodily depressions such as the navel or body cavities such as the vagina. Wipe off any liq­ uids that may have collected at these points before using the RF device. The user is cautioned that endogenous gases may be ignited. The sparks occuring during the intended use of the RF device may also ignite materi­ als such as cotton or gauze that are saturated with oxygen.

2.2

Positioning the patient During monopolar applications, the electrical current of the RF device fed into the patient via the active electrode can return to the device via two paths closing the electrical circuit. The regular path leads via the neutral electrode which guides the current back to the device via a large surface and therefore without causing the heat effect observed at the active elec­ trode. The second path is an undesired byway which may form if the pa­ tient is in contact with electrically conductive parts which in turn are con­ nected to the earth/ground potential. The latter are all large-surface metal parts such as the undercarriage of treatment beds, operating tables but also chairs with metal feet as well as the housings/cases of electrical de­ vices connected to the power supply network. The patient must not have any contact with grounded metal parts because otherwise there is the danger of localized/point burns at the contact areas. In particular the ex­ tremities of the patient should not touch metal devices. If the patient is on an operating table or treatment bed that has a metal undercarriage, adequate high-frequency insulation relative to the metal

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11

surface must be guaranteed by a sufficient number of intermediate layers (drapes). If humidity, perspiration etc. is to be expected during the opera­ tion, wetting of these intermediate layers must be prevented by a water­ proof sheet or foil. Avoid fluid accumulations under the patient under all circumstances. Use further dry drapes if necessary. The RF current flowing through the body should reach the neutral elec­ trode on the shortest possible path. Make sure that on the way to the neutral electrode the current will not exit the body and enter it again at a different point e. g. at a contact point between the hand and the thigh or the elbow and the trunk. At such contact points there is the risk of burns due to this current bypath. It is therefore necessary to keep the areas with increased perspiration, extremities making contact with the trunk or skin-to-skin contact areas dry by placing intermediate layers of drapes (arm­trunk, leg-leg, mammae). Make sure that the specified insulation requirements are also fulfilled if during the operation the patient is positioned differently!

. 2.3

IMPORTANT! After changing the patient's position, check the electrodes and lines for correctness.

Applying the neutral electrode

Apply the electrodes and cables carefully. In particular, make sure that Z the neutral electrode is as close to the operating area as possible and makes reliable and full-surface contact with the patient's body. Z Make sure that the neutral electrode makes reliable contact during the entire duration of the RF application. When applying the neutral elec­ trode to extremities, the blood circulation must not be impaired. Z If disposable adhesive electrodes are used, the use-by date must still be valid. Z Make sure that the supply lines to the RF electrodes are routed without loops in such a way they neither touch the patient or other lines. This is particularly true for the neutral electrode. Use only the lines de­ signed for the device by the manufacturer. Z Make sure that the current paths in the body are as short as possible and are aligned in longitudinal or diagonal direction of the body, not transversally, the latter by no means on the thorax. Remove an metal parts in or on the body if possible, insulate and take particular care.

Z To guarantee a permanent application during the entire duration of the operation, we recommend using a split disposable adhesive neutral electrode. Continued monitoring of the patient is only guaranteed if the split adhesive neutral electrode is used.

.

IMPORTANT! Z A single-part neutral electrode cannot be monitored. If the contact is

poor, no warning signal is triggered!

Z Do not apply the neutral electrode on top of implants and other metal

parts and not top of bony prominences and scar tissue. Prepare the contact area by cleaning and degreasing and the removal of heavy body hair. Do not use any removal products that dry out the skin (e. g. alcohol).

12

GA-A 291

Z To remove the neutral do not pull at the cable or at the connection tab.

If adhesive electrodes are used, tear them off slowly to avoid skin in­ juries.

2.4

Cardiac pacemakers, implants

.

IMPORTANT! Apply the bipolar method if possible! D As a general rule, please observe that in the case of patients with metal implants, RF current paths must not be routed via these im­ plants. This must be taken into account when placing the active and neutral electrodes, i. e. never place the neutral electrode above en­ doprostheses and never above metal implants. D In patients with active implants, e. g. pacemakers or implanted elec­ trodes, the use of the RF device represents a hazard potential. This may cause irreparable damage of the active implant or impairment of its function. Because of this uncertainty, use the radio frequency in such patients only if there is no adequate alternative. The following guidelines and rules are absolutely imperative. It is recommended to monitor such patients using a suitable monitoring routine. Keep a defibrillator as well as an external pacemaker at hand. Keep the output power of the RF device as low as possible at all times. The active electrode of the RF device must not be used at distances of less than 15 cm from the implant or its electrodes. Carefully apply the application rules e. g. for applying the neutral electrode!

2.5

Interference with other devices

.

IMPORTANT! If RF surgery and monitoring screens are used on a patient at the same time, only monitoring electrodes with protective resistors or RF chokes in the supply lines may be used. No needle electrodes may used for moni­ toring purposes. Do not use the active surgical electrode in the vicinity of ECG electrodes (minimum distance 15 cm)! If used as intended, the RADIOBLATOR can interfere with other elec­ tromedical devices (e. g. ECG monitoring) and electronic devices (e. g. telephone, PC). To reduce this interference, take the following countermeasures: D Connect the power cable of the RADIOBLATOR to a different

power circuit / multisocket strip.

D Increase the distance between the RADIOBLATOR and the device the RADIOBLATOR interferes with. D Route the instrument cables in such a way that they are not in the vicinity of other devices and their connection cables. D Make sure the potential equalization (26) is duly grounded. D Route the connection cables in such a way that they are not in the vicinity of other devices.

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13

2.6

2.7

Accessories

Use the device only in conjunction with accessories, wear and tear parts and disposably items that are safe to use and which must have their con­ formity with the requirements proven on the basis of a declaration of con­ formity. The use of unsuitable accessory items of other manufacturers can represent a potential hazard. In case of doubt, please refer to the specialized dealer or the manufacturer.

.

IMPORTANT! We strongly recommend that exclusively the accessories listed in section 9 is used. The cable length of the accessories must not exceed 3.0 m.

.

IMPORTANT! Avoid any settings on the device where the maximum output voltage ex­ ceeds the specified voltage for the accessory item (for this, see voltage diagrams under section 8.6).

Operation with bipolar cutting current

In particular in microsurgical applications, unintended activation of a bipo­ lar cutting current (e. g. by using the wrong pedal of the footswitch) there is a potential hazard for the patient. If the radioblator has been used in bipolar cutting mode (BICUT1, BICUT 2) during the last application, the BICUT 1 (5) or BICUT 2 (6) button blinks after switch-on and the function is not active. The displayed power setting must be confirmed by pressing the blinking button.

.

2.8

14

NOTE! For safety reasons we recommend leaving the power setting of a bipolar cutting mode on "0" if there are no intentions to work with this mode.

Risks due to high electrical voltages

The use of a current type with high voltage, in particular monopolar highvoltage coagulation current, can cause neuromuscular irritations in the patient.

GA-A 291

3

Illustration

3.1

Front view 2

3

5

4

7

6

8

10

9

1

21 20 19 3.1.1

18

16

17a 17

Power ON/OFF switch

2

Program memory P1 … P4

3

Display of RF cutting power (CUT1, CUT2, BICUT1, BICUT2 modes)

14 14a

4

Increase / decrease power setting (CUT1, CUT2, BICUT1, BICUT2 modes)

15

5

CUT1 button Monopolar cutting

16

6

CUT2 button Monopolar cutting with coagulation

17 17a

7

Indicator light for monopolar mode

8

BICUT1 button Bipolar cutting

9

BICUT2 button Bipolar cutting with initial cutting support

11 12

13

14a 14

12 11

Legend

1

10

15

Inidcator light for bipolar mode AUTOSTART button Bipolar coagulation with auto-start PRECISE button Bipolar coagulation using fine instruments

GA-A 291

13

18

STANDARD button Bipolar coagulation Connection socket for bipolar instruments Auxiliary contacts - 2 mm SPRAY button Monopolar contactless coagulation CONTACT button Monopolar contact coagulation Connection socket for monopolar instruments Connection for "Bovie-Jack" Increase / decrease power setting (CONTACT, SPRAY, STANDARD, PRECISE modes)

19

Display of RF coagulation power (CONTACT, SPRAY, STANDARD, PRECISE)

20

Indicator lamp (blinks in red): Neutral electrode not connected.

21

Connection socket for neutral electrode

15

3.2

Illustration of rear panel

28

22

27

X

23

26

24

29

X

25

3.2.1

Legend

22

Socket for footswitch

26

Potential equalization connector

23

Connection socket for pump

27

Power supply connector

24

Volume control

28

Device fuses

25

Identification plate

29

Fuse plate

16

GA-A 291