2228 RESECTION PUMP with 8659.xxxx Resectoscope Instruction Manual V7.0 July 2018

Important general notes and instructions Make sure that this product is used only as intended and described in this instruction manual and 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 upon 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 Symbols

Level of danger

WARNING!

Failure to observe can result in death or extremely serious injuries.

CAUTION !

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

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

GA-AS 002

0

Contents 1 1.1 1.2 1.2.1 1.3 1.4 1.5 1.5.1 1.5.2 1.6 1.7

General information... Symbols... Intended use... Performance characteristics... Indications and field of use... Contraindications and side effects... Combinations... Equipotentality... Requirements for the products / components of a combination... Electromagnetic compatibility (EMC) - IEC 60601-1-2 : 2007... Electromagnetic compatibility (EMC) - IEC 60601-1-2 : 2014...

1 1 2 2 3 3 4 4 5 6 8

2 2.1 2.1.1 2.2 2.2.1 2.3 2.3.1 2.4 2.4.1

Illustration... Front panel of RESECTION PUMP... Legend... Rear panel of RESECTION PUMP... Legend... Illustration of monopolar resectoscope... Legend... Illustration of bipolar resectoscope... Legend...

10 10 10 11 11 12 12 13 13

3 3.1 3.1.1 3.1.2 3.1.3 3.1.4 3.1.5 3.1.6 3.1.7 3.1.8

Setup... Preparation... Preparing the device... Select language... Connection diagram for RESECTION PUMP with resectoscope... Description of connections... Preparing the resectoscope... Continuous irrigation outer sheath... Connecting the (monopolar) resectoscope... Connecting the (bipolar) resectoscope...

14 15 15 15 16 17 18 19 20 21

4 4.1 4.2

Checks... 22 Visual check... 22 Function check... 23

5 5.1 5.2 5.2.1 5.2.2 5.2.3 5.2.4 5.3 5.3.1 5.4 5.5 5.6

Use... Operation... Control elements and modes... Controls and indicators... RESECTION PUMP ON/OFF... Pulse time... Inserting/removing the shut-off tube... General notes and instruction on the menu button functions... Menu selection overview... Operation level... Configuration level... Operation of device / instrument...

GA-AS 002

24 24 24 24 24 24 25 25 26 27 28 29

I

5.6.1 5.6.2 5.6.3 5.6.4 5.6.5 5.6.6 5.6.7 5.6.8 5.6.9 5.7 5.7.1 5.7.2

Additional notes and instructions on HF applications... De-aerating the system... Pulse duration... Use... Inserting obturator into continuous flow outer sheath - option... What to do if the suction channel is clogged... DELAYED SUCTION message... Reprocessing and reprocessing cycles for the device and its accessories... Taking out of service... Error messages... Messages in self test mode... Messages in operating mode...

29 31 31 32 34 34 34 34 34 35 35 35

6 6.1 6.2 6.3 6.3.1 6.3.2 6.3.3 6.3.4 6.3.5 6.3.6 6.3.7 6.3.8 6.3.9 6.3.10 6.3.11 6.4 6.5 6.5.1 6.5.2 6.5.3 6.5.4 6.5.5 6.5.6 6.5.7 6.5.8 6.5.9 6.5.10 6.5.11 6.5.12 6.5.13 6.6 6.6.1 6.6.2 6.6.3 6.6.4 6.6.5 6.6.6

Reprocessing and maintenance... Reprocessing of device... Reprocessing or disposal cycles of the applied parts / accessories... Reprocessing of containers and accessories... Preparation at the point of use... Transport and shipment... Pre-cleaning... Disassembly before cleaning... Manual cleaning / disinfection... Machine cleaning / disinfection... Visual check and function check... Packaging... Sterilization... Storage... Additional instructions... Reprocessing of reusable tubing... Reprocessing of resectoscopes... Preparation at the point of use... Transport and shipment... Pre-cleaning... Disassembly before cleaning... Manual cleaning / disinfection... Machine cleaning / disinfection... Checks... Assembly before sterilization... Visual check and function check... Packaging... Sterilization... Storage... Additional instructions... Reprocessing of HF connection cables... Preparation at the point of use... Transport and shipment... Manual cleaning / disinfection... Machine cleaning / disinfection... Checks... Packaging...

36 36 37 38 38 38 38 38 39 39 39 39 40 40 40 41 42 42 42 42 42 43 44 44 44 44 44 45 45 45 46 46 46 46 47 47 47

II

GA-AS 002

Contents 6.6.7 6.6.8 6.6.9 6.6.10 6.7 6.7.1

Sterilization... Sterilization... Storage... Additional instructions... Maintenance... Maintenance intervals...

47 47 47 47 48 48

7 7.1 7.2 7.2.1 7.2.2 7.3 7.4 7.5 7.6 7.6.1 7.6.2

Technical description... Troubleshooting... Technical data of RESECTION PUMP... Interfaces... Safety features... Technical data of instruments... Operating, storage, transport and shipping conditions... Spare parts and accessories... Replacing parts... Device fuses... Disposal of product, packaging material and accessories...

49 49 51 51 51 51 52 52 53 53 53

8

Literature... 54

GA-AS 002

III

1

General information

1.1

Symbols Symbols

Designation Attention, Caution Follow the instruction manual Observe the instruction manual Off (power: disconnection from power/mains) On (power: connection to the power/mains) Equipotentality Mains / Line fuse

µ

Alternating current (AC) TYPE BF APPLIED PART Symbol: Vacuum in secretion container Control connection Connector for filter

REF

Order number Lot identification Manufacturing date Manufacturer Number, amount To be used before (date): Do not reuse Do not resterilize Latex-free Contains phthalates or phthalates are present: Diethylhexyl phthalate (DEHP) Number, amount

GA-AS 002

1

Symbols

Designation Do not use if package is damaged Keep away from sunlight!

XX° XX°

Permissible temperature range

XXhPa

Permissible atmospheric pressure range XXhPa XX%

Permissible humidity range

XX% -25 C

+ 50 C

Maximum temperature range for shipment, transport and storage Sterilized with ethylene oxide Steam sterilization - fractional method Recycle the product separately. Do not discard together with other waste. A Registered Trademark of ETL, a Recognized Testing Laboratory, listing compliance as Medical Electrical Equipment to standard CAN/CSA C 22.2 No. 601.1 (c) and UL 60601-1 (us) A Registered Trademark of a Recognized Testing Laboratory, confirm the compliance to the standard of Medical Electrical Equipment CAN/CSA C22.2 No.60601-1 (c) and ANSI/AAMI ES60601-1 (us) 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).

1.2

Intended use The RESECTION PUMP 2228 is designed for the aspiration of resected tissue chips in hysteroscopy and is used in combination with monopolar/ bipolar Resectoscope 8659.xxxx. Hysteroscopic resection is effected under continuous irrigation with the help of a high frequency (HF) electrode, while resected tissue chips are removed from the operating field by suction through the additional suction channel. 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

2

Performance characteristics - Controlled aspiration of tissue chips in hysteroscopic resection.

GA-AS 002

1.3

Indications and field of use The RESECTION PUMP 2228 is designed for chip aspiration during hys­ teroscopic resection and is used in combination with Resectoscope 8659.xxxx. The range of indications reaches from monopolar and bipolar endoscopically controlled chip resection of tissue parts and intrauterine polyps to intrauterine myomas.

CAUTION! In case of therapeutic applications an adequate backup device with the same capabilities must be available should the device fail. WARNING! Must only be used by medical doctors trained in hysteroscopy. If a pregnancy is suspected a pregnancy test is required before carrying out diagnostic hysteroscopy. NOTE! We recommend reading relevant literature regarding the planned use (see alsosection 8 “Literature”).

1.4

Contraindications and side effects In general, the use of the corresponding device is forbidden whenever hysteroscopic resectoscopy is contraindicated (e.g. severe anaemia, in­ tolerance to anesthesia, medical contraindications). The doctor is responsible and must decide whether the patient's general condition allows the intervention or not. There are the following contraindications for operative hysteroscopy: - Acute inflammation of the pelvis - Lack of dilatability of the uterus - Stenosis of the cervix - Severe cervical/vaginal infection - Uterus bleeding or menstruation - Pregnancy - Uterus carcinoma - Uterus perforation - Myomas not suitable for a resectoscopy treatment (no possibility to circumnavigate the myoma due to its size, e.g. intramural myomas with small submucous components)

GA-AS 002

3

1.5

Combinations The RESECTION PUMP 2228 with monopolar/bipolar Resectoscope 8659.xxx is used in conjunction with: Light sources and flexible light cables HF surgical devices with bipolar/monopolar connector for transcervical application Irrigation systems Endoscopic accessories

IMPORTANT! In addition to this instruction manual, follow the manuals for the products used in combination with this product. CAUTION! Do not combine products incorrectly! Injuries of the patient, user or others as well as damage to the product are possible. Different products may only be used together if their intended uses and relevant technical data (working length, diameter, peak voltage, etc.) are the same. Follow the instruction manuals of the products used in combination with this product. Follow the "Notes and instructions on HF applications", order no.: GA-S 002 as well as the HF device manufacturer's specifications. 1.5.1

Equipotentality

The potential equalization cable establishes a direct connection between a medical electrical device and an equipotential bonding rail. It serves to equalize differences in potential between enclosures of elec­ trical equipment and firmly installed conductive parts in the patient envi­ ronment.

4

GA-AS 002

1.5.2

Requirements for the products / components of a combination 1.5m

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

1.5m

Medically used room inside the patient environment MP

MP

~

~

MP

MP

outside the patient environment

-

Non-medically used room

-

Requirements / measures Leakage currents to IEC/EN 60601-1

Verification of the total patient leakage current

~ ** NMP

MP

~* *

~

NMP

MP

-

Verification of leakage currents

~ ** MP

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

-

or b) additional isolating transformer for medical applications **

NMP

~ 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 corre­ 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 = non-medical electrical device in accordance with product-specific IEC/EN/UL standards When connected via the same 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"

Only connect devices with a safety extra-low voltage of no more than 60V DC / 42.4V AC peak to the connectors for electrical connections, i.e. the signal inputs and outputs.

GA-AS 002

5

IMPORTANT! Persons combining products to form a system are responsible for not impairing the system's compliance with perfor­ mance 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

NOTE: The device/system, in the following referred to as product, always refers to RESECTION PUMP 2228 Guidelines and manufacturer's declaration - Electromagnetic emissions The product is intended for use in the environment specified below. The user must assure that the product is used in such an environment. Emissions measurement / test

Compliance

Electromagnetic environment - Guidelines

HF emissions to CISPR 11

Group 1

The product uses HF energy for its internal function. The HF emission level is extremely low and is not likely to cause any interference in nearby electronic equipment.

HF emissions to CISPR 11

Class B

Harmonic emissions to IEC 61000-3-2

Class A

In conformity with IEC 61000-3-3 “Emission of voltage fluctuations / flicker"

The product is suitable for use in all establishments, including domestic establishments. This also includes establishments directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes.

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

± 6 KV contact discharge ± 8 KV air discharge

Yes

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the rela­ tive humidity should 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

Voltage dip for 0.5 cycle > 95% UT * Voltage dip for 5 cycles 60% UT * Voltage dip for 25 cycles 30% UT * Voltage dip for 5 sec > 95% UT *

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

3 A/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.

6

GA-AS 002

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:

Conducted HF interference to IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

Radiated HF interference to IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

Yes

d = 1.2

P

d = 1.2

P for 80 MHz to 800 MHz

d = 2.3 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. Rated nominal output power of thetransmitter (W)

Separation distance as a function of transmitter frequency (m) 150 kHz to 80 MHz d = 1.2 p

80 MHz to 800 MHz d = 1.2 P

800 MHz to 2.5 GHz d = 2.3 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.

GA-AS 002

7

1.7

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

NOTE: The device/system, in the following referred to as product, always refers to RESECTION PUMP 2228 Guidelines and manufacturer's declaration - Electromagnetic emissions The product is intended for use in the environment specified below. The user must assure that the product is used in such an environment. Emissions measurement / test

Compliance

Electromagnetic environment - Guidelines

HF emissions to CISPR 11

Group 1

The product uses HF energy for its internal function. The HF emission level is extremely low and is not likely to cause any interference in nearby electronic equipment.

HF emissions to CISPR 11

Class B

Harmonic emissions to IEC 61000-3-2

Class A

In conformity with IEC 61000-3-3 “Emission of voltage fluctuations / flicker"

The product is suitable for use in all establishments, including domestic establishments. This also includes establishments directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes.

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 transients, 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 0% UT * ; 250/300 Periods

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.

8

GA-AS 002

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

Test level to IEC 60601

Compliance level

Electromagnetic environment - Guidelines

Conducted HF interference to IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3 Vrms 150 kHz to 80 MHz

6 Vrms a in ISM fre­ quency bands 15 kHz to 80 MHz

6 Vrms a in ISM fre­ quency bands 15 kHz to 80 MHz

Portable and mobile communication devices should not be used at a lesser distance from the device (including the lines) than the recommended safe distance of 30 cm. The field strength of stationary transmitters determined during an on site investigation should be below the compliance level in all frequencies.b In the environment of devices with the following symbol mal­ functions are possible:

3 V/m 80 MHz to 2.7 GHz

3 V/m 80 MHz to 2.7 GHz

Radiated HF interference to IEC 61000-4-3

REMARKS: These guidelines may not apply in all situations. The propagation of electromagnetic waves is affected by absorption and reflexion from build­ ings, objects and people. a) The ISM frequency frequency bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz, 13.553 MHz to 13.567 MHz, 26.957 MHz to 27.283 MHz and 40.66 MHz to 40.70 MHz. b) The field strength of stationary transmitters, such as base stations of mobile phone communication and land mobile radios, amateur radio stations, AM and FM broadcasting trannsmitters can not be precisely predetermined in theory. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength at a location where the device is used exceeds the aforementioned compliance level, the device must be observed with regard to its due function. In the case of abnormal oper­ ation, additional measures may be required, such as a changed alignment or a different location of the device.

Recommended safe distances between portable and mobile HF telecommunication devices and the product Definition with regard to high frequency wireless communications equipment Frequency band (MHz)

Test frequency (MHz)

Modulation

Compliance level (V/m)

380–390

385

Pulsea – 18 Hz

27

430–470

450

FM ± 5 kHz Hub or pulsea – 18 Hz

28

704–787

710, 745, 780

Pulsea – 217 Hz

9 28

800–960

810, 870, 930

Pulsea – 18 Hz

1700–1990

1720, 1845, 1970

Pulsea – 217 Hz

28

2400–2570

2450

Pulsea – 217 Hz

28

5240, 5500, 5785

Pulsea – 217 Hz

9

5100–5800

REMARKS: A minimum safety distance of 30 cm between portable HF communications devices operated in the specified frequency band and the product should be maintained. This includes, amongst others, mobile phones, WiFi, RFID and Bluetooth devices. Non-compliance can reduce the per­ formance specifications of the product. a) Pulse modulation is defined as a square signal with a pulse duty factor of 50%.

GA-AS 002

9

2

Illustration

2.1

Front panel of RESECTION PUMP

9 8 3

7

6

2.1.1

5

4

1

Legend

1

Power/mains switch

5

2

Connection for control tube (pulse triggering)

6

3 4

LCD display Sensor buttons

7 8 9

10

2

Tube clamping valve Vacuum connector (type BF applied part) Bottle holder for collecting container Bottle holder for secretion container Retaining rail for bottle holder

GA-AS 002

2.2

Rear panel of RESECTION PUMP

11

10

2.2.1

13

12

Legend

10

Power input connector with fuse holder

12

Identification plate

11

Sound absorber (option)

13

Equipotentality

GA-AS 002

11

2.3

Illustration of monopolar resectoscope

21.7

20

21.5

21.3 21.2

21

21.8

21.6

21.4

21.1 22 25.2

23.1 23.2

2.3.1

Legend

20

Endoscope

25

25.1

23

24

22

HF electrode, monopolar

21

Working element, monopolar

23

Continuous irrigation outer sheath

21.1

Drain hose connector (outflow)

23.1

Irrigation connector (inflow)

21.2

Suction tube connector

23.2

Insulating element

21.3

Control tube connector for pulse triggering

24

Obturator (option)

21.4

O-ring, seals pulse triggering

25

Monopolar HF connection cable

21.5

Pushbutton for locking the electrode (electrode lock)

25.1

Instrument plug connector for HF con­ nection to working element

21.6

Lever for deactivating pulse triggering, for chip evacuation

25.2

Device connector for connection to HF surgical device

21.7

HF connector for working element

21.8

Insulating element

12

GA-AS 002

2.4

Illustration of bipolar resectoscope 21.9 21.7 20

21.8

21.5

21.3

21.2

21

21.6

21.4

21.1

22

26.3

26 26.1 23.1 23.2

2.4.1

Legend

20

Endoscope

26.2

23

24

22

HF electrode

21

Bipolar working element

23

Continuous irrigation outer sheath

21.1

Drain tube connector (outflow)

23.1

Irrigation connector (inflow)

21.2

Suction tube connector

23.2

Insulating element

21.3

Control tube connector for pulse triggering

24

Obturator (option)

21.4

O-ring, seals pulse triggering

21.5

Pushbutton for locking the electrode (electrode lock)

26

HF bipolar connection cable

21.6

Lever for deactivating pulse triggering, for chip evacuation

26.1

Instrumenten plug connector (gray) for connection to neutral pin

21.7

HF connector

26.2

Instrument plug connector (black) for HF connection to working element

21.8

Insulating element

26.3

Device plug for connection to HF surgical device

21.9

Neutral Pin

GA-AS 002

13

3

Setup WARNING! The device is not protected against explosions. Explosion hazard. Do not operate this device in areas where there is a danger of explosion. WARNING! Danger if a power supply without protective earth is used. Danger of electric shock! Connect the device only to a power supply with protective earth connec­ tor. NOTE! The line / mains voltage must be the same as the voltage indicated on the identification plate. Connect the device only via the supplied power cable or a power cable with the same specifications. IMPORTANT! Do not the open the device! WARNING! Device operation may be jeopardized by other devices located in the im­ mediate vicinity or if devices are stacked. Other devices located in the immediate vicinity or stacked devices may interfere with each other and cause malfunctions, in particular if devices give off energy (e.g. HF surgical devices). If devices have to be arranged in this way, make sure that the devices work properly. WARNING! Safety distance from portable HF communication devices. Medical electrical devices can be influenced by mobile HF communication devices. Do not operate HF communication devices in the immediate vicinity of medical electrical devices. Non-compliance can cause the power charac­ teristics of the device to be impaired. WARNING! Influence on interference immunity and interference emission. Use only accessories or cables specified or supplied by the manufacturer. Other accessories and cables can cause increased electromagnetic inter­ ference or a reduced electromagnetic immunity of the device and lead to malfunctions. CAUTION! Disposable items have been designed for one single use only and are sterilely packed. Do not use disposable items if: the sterile packaging is damaged the use-by-date has been exceeded

14

GA-AS 002

3.1

Preparation

3.1.1

Preparing the device The sound absorber (silencer) (11) must be screwed to the end of the unit. The holders for the secretion container (8) and for the collecting con­ tainer (7) should be fastened to the unit. Fit each holder to the retaining rail (9) and ensure that the snap-in noses engage. If necessary, adjust the holder for the secretion container (8) with the set screw (A) to accommodate the size of the container. Connect the power cable to the power input connector and to the power supply (wall socket). Fig. 1 A

9 8

3.1.2

7

Select language The language is set at the configuration level in accordance with section 5.5 and must be set when the device is started for the first time. If a wrong language has been selected and you can no longer call up the general menu for language selection in that language, proceed as fol­ lows: Switch off the device and wait for at least 30 seconds. Press one of the sensor keys and hold down, then switch on the device and wait until the language selection menu is displayed. Let go of the button and select the required language as described in section 5.5.

GA-AS 002

15