Richard Wolf

Piranha 2208 Suction Pump Instructions for Use V5.0 July 2020

Instructions for Use

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Instructions for use

Suction pump PIRANHA 2208

GA-A252 / en / 2020-07 V5.0 / PK20-0076 /

Richard Wolf reserves all rights in this document, in particular relating to reproduction, distribution, public communication and public dissemination. This document may not be modified, and texts and images must not be reproduced or translated without the express prior permission of Richard Wolf GmbH.

Subject to technical changes! Due to ongoing development, the product descriptions, illustrations and technical data may deviate slightly from the current state. For further information about our products please contact Richard Wolf GmbH or your representative.

Manufacturer RICHARD WOLF GmbH Pforzheimer Straße 32 75438 Knittlingen GERMANY Telephone: +49 70 43 35-0 Telefax: +49 70 43 35-4300

www.richard-wolf.com

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Contents 1

General safety instructions and guidance for use ...

General information ...

2.1

Safety instructions and levels of danger...

2.2

Symbols...

2.3 2.3.1

Intended use... Performance characteristics ...

8 8

2.4

Indications and field of use ...

2.5 2.5.1 2.5.2

Contraindications and side effects ... Contraindications... Side effects...

9 9 9

2.6 2.6.1 2.6.2

Combinations ... 10 Equipotentality ... 10 Requirements for the products / components of a combination ... 11

2.7

Electromagnetic compatibility (EMC) – IEC 60601-1-2:2007 ... 13

2.8

Electromagnetic compatibility (EMC) – IEC 60601-1-2:2014 ... 16

Illustration ... 19

3.1 3.1.1

Figure showing front panel of PIRANHA suction pump... 19 Legend ... 19

3.2 3.2.1

Figure showing rear panel of PIRANHA suction pump ... 20 Legend ... 20

Commissioning ... 21

4.1 4.1.1 4.1.2 4.1.3 4.1.4 4.1.5 4.1.6

Preparation ... 22 Preparing the device ... 22 System connection between PIRANHA 2208 suction pump and POWER CONTROL 2303 ... 23 Connection diagram ... 24 Description of connections ... 25 Footswitch connector ... 26 Language selection ... 26

Checks... 27

5.1

Visual checks ... 27

5.2

Function check ... 28

Use ... 29

6.1

Operating principle ... 29

6.2 6.2.1 6.2.2 6.2.3 6.2.4

Control elements and operating modes ... 29 Control elements and indicators ... 29 PIRANHA suction pump ON/OFF... 29 connection cable ... 29 Inserting / removing the suction tube ... 29

6.3 6.3.1

General notes and instructions on the menu selection and button functions ... 30 Menu selection overview ... 31

6.4

Operating level ... 32

6.5

Configuration level... 33

6.6 6.6.1 6.6.2

Operation of the device ... 33 Modes of operation – footswitch functions ... 35 Additional notes and instructions for use with morcellation in urology in the case of a system combination of PIRANHA and POWER CONTROL 2303 ... 35 Reprocessing and reprocessing cycles for the device and its accessories... 36

6.6.3

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6.6.4

Taking out of service ... 36

6.7 6.7.1 6.7.2

Error messages ... 36 Messages in the self-test mode... 36 Messages in operating mode ... 37

Reprocessing and maintenance ... 38

7.1

Reprocessing of the device ... 38

7.2

Reprocessing and disposal cycles of applied parts and accessories... 39

7.3 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5 7.3.6 7.3.7 7.3.8 7.3.9 7.3.10 7.3.11

Reprocessing of containers and accessories ... 39 Preparation at the point of use ... 39 Transport ... 39 precleaning ... 39 Disassembly before cleaning ... 40 Manual cleaning / disinfection ... 40 Machine cleaning / disinfection ... 41 Visual check and function check ... 41 Packaging... 41 sterilization... 41 Storage ... 41 Additional instructions ... 41

7.4

Reprocessing of reusable tubes ... 42

7.5 7.5.1

Maintenance ... 43 Maintenance intervals ... 43

Technical description... 44

8.1

Troubleshooting... 44

8.2 8.2.1 8.2.2

Technical data of PIRANHA suction pump... 45 Interfaces... 45 Safety features ... 45

8.3

Technical data of footswitch ... 46

8.4

Operating, storage, transport, and shipping conditions ... 46

8.5

Spare parts and accessories ... 46

8.6 8.6.1 8.6.2

Replacing parts ... 47 Device fuses ... 47 Disposal of the product, packaging material, and accessories ... 47

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General safety instructions and guidance for use The product and its accessories must only be used as intended following the 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 application and if the performance characteristics and safety requirements are still fulfilled. The product must not be altered in any way. Reprocess the products and the accessories in accordance with the instruction manual before and after each use and before any return shipment to protect the patient, user, and others. The instruction manual is an integral part of the product and must be stored in such a way that it is accessible at all times during the entire life cycle. It 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. Any severe incident occurring in conjunction with this product must be reported to the manufacturer and the competent authority of the country where the user and/ or patient resides.

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General information

2.1

Safety instructions and levels of danger WARNING This signal word is used to indicate a potentially dangerous situation. Not avoiding this situation can result in death or extremely serious injuries.

CAUTION This signal word is used to indicate a potentially dangerous situation. Not avoiding this situation can result in minor or moderate injury.

ATTENTION This signal word without warning sign is used to indicate a potential danger of material damage.

NOTE This signal word indicates additional useful information for the reader, such as hints for easier operation as well as cross references.

2.2

Symbols

Designation Caution Follow the manual Follow the instruction manual OFF (no power supply, separation from grid) ON (power supply, connection to the grid) Equipotentality Fuse Alternating current (AC) Type BF applied part

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Symbol: vacuum in secretion container

Footswitch

Data input / output

Connection for filter Product number Lot code Manufacturing date Manufacturer

Units, amount Expiry date Do not reuse! Do not resterilize

Latex-free Contains phthalates or phthalates are present: diethylhexyl phthalate (DEHP)

Number, amount

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

Temperature, limitation

Atmospheric pressure, limitation

Humidity, limitation

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Maximum temperature range for shipment, transport, and storage

Sterilized with ethylene oxide Steam sterilization – fractionated method Recycle the product separately. Do not discard together with other waste.

A Registered Trademark of a Recognized Testing Laboratory, confirms 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, confirms the compliance to the standard of Medical Electrical Equipment CAN/CSA C22.2 No.60601-1 (c) and ANSI/AAMI ES60601-1 (US) CE identification with code number of the competent authority in conformity with Directive 93/42/ EEC on medical products. Is only valid if the product and/or packaging is marked with this identification. Products of category I, with the exception of sterile products and products with measuring function, are marked without the four-digit code number of the competent authority. The CE identification on the title page of these instructions for use relates exclusively to the Richard Wolf main product or, if serveal identical products are described, to the Richard Wolf product with the highest classification. The CE identification of the other Richard Wolf products and, if applicable, of products made by other manufacturers, described in these instructions for use results exclusively from the identification on the product and/or packaging.

2.3

Intended use The intended use of the PIRANHA 2208 suction pump is the aspiration of tissue fragments out of the patient's bladder during urologic procedures. The PIRANHA 2208 suction pump is used in conjunction with the POWER CONTROL 2303 and the POWER STICK M4 (8564.121) to morcellate and aspirate enucleated prostate adenomas out of the bladder after laser transurethral resection. The product is intended exclusively for use by medical experts and may only be used by adequately qualified and trained medical personnel.

2.3.1

Performance characteristics n

Controlled suction of tissue parts in urology.

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2.4

Indications and field of use The PIRANHA 2208 suction pump is mainly used for the fragmentation and aspiration of enucleated prostatic tissue. Accordingly, it is used exclusively with the corresponding working elements POWER CONTROL 2303 with the POWER STICK M4 during morcellation and has no direct patient contact. Please see the instruction manuals of the products used in combination with this product.

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

NOTE We recommend reading relevant literature for the planned application.

2.5

Contraindications and side effects

2.5.1

Contraindications The use of the PIRANHA 2208 suction pump is contraindicated if morcellation after laser TUR is contraindicated. Contraindications resulting from the patient's general condition and described in the relevant literature must be observed.

2.5.2

Side effects Side effects directly related to the product are currently unknown.

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2.6

Combinations The PIRANHA 2208 suction pump is used in conjunction with: ⊳ POWER CONTROL 2303 ⊳ POWER STICK M4 (8564.121) ⊳ Endoscopic accessories

ATTENTION In addition to this instruction manual, be sure to also follow the instruction manuals for POWER CONTROL 2303 (GA-A 202) as well as the instruction manuals of the products used in combination with this product.

CAUTION Incorrect combination of products! Injuries to 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. The instructions for use of the products used in the product combination must be observed.

2.6.1

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

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2.6.2

Requirements for the products / components of a combination The general requirements depend on whether the products/components are inside or outside the patient environment.

Medically used room within the patient environment

outside the patient environment -------

Non-medically used room

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

-------

Measurement of leakage currents a) additional protective earth connection (to be clarified with the corresponding manufacturer), or b) additional isolating transformer **

-------

Measurement of leakage currents a) no plugs with metal housing, or b) additional separating device (to avoid voltage differentials) Verification of leakage currents a) joint protective earth connection, or b) additional protective earth connection at MP (verify with the corresponding manufacturer), or c) additional separating device (to avoid voltage differentials), or d) no plugs with metal housing in the patient environment

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additional "isolating transformer with galcanic separation to IEC/EN 60601-1 **

additional isolating device to IEC/ EN 60601-1

Multi-socket strip*

----

Functional connection

Power supply grid

= medical electrical device to IEC/ EN 60601-1, ANSI/AAMI es60601-1, CSA C22.2 No. 60601-1

NMP

= 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 60 V DC / 42.4 V AC peak to the connectors for electrical connections, i.e. the signal inputs and outputs.

ATTENTION 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 choosing the system components make sure that these meet the necessary requirements for the medical environment they are used in, in particular IEC/EN 60601-1. 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.

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2.7

Electromagnetic compatibility (EMC) – IEC 60601-1-2:2007 NOTE The device / system, in the following referred to as the product, always relates to the product and its accessories mentioned in the section on "Intended use".

Guidelines and manufacturer's declaration – Electromagnetic emissions The product is intended for use in the environment specified below. The user must make sure that the product is used in such an environment. Emissions measurement/test

Conformity 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

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.

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

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

IEC 60601 test level

Compliant

Electromagnetic environment – Guidelines

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. 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 cables Yes ± 1 kV for input/output cables

Line power quality should be that of a typical commercial or hospital environment.

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

± 1 kV line-to-line voltage ± 2 kV line-to-ground voltage

Yes

Line power quality should be that of a typical commercial or hospital environment.

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

Dip for 0.5 cycles > 95% UT * Dip for 5 cycles 60% UT * Dip for 25 cycles 30% UT * Dip for 5 s > 95% UT *

Yes

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

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The product is intended for use in the environment specified below. The user must make sure that the product is used in such an environment. Immunity tests

IEC 60601 test level

Compliant

Electromagnetic environment – Guidelines

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

3 A/m

Yes

Power frequency magnetic fields should be at levels characteristic of a typical commercial or hospital environment.

* NOTE: UT is the line voltage prior to application of the test level. 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 make sure that the product is used in such an environment. Immunity tests

IEC 60601 test level

Conducted HF interference 3 Vrms to IEC 61000-4-6 150 kHz to 80 MHz Radiated HF interference to IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

Compliance

Electromagnetic environment – Guidelines

Yes

Portable and mobile RF communications equipment should be used no closer to any part of the product, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: d = 1.2

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 sur1 vey , should be less than the compliance level in each frequency range². Interference may occur in the vicinity of devices with the following symbol:

NOTES: At 80 MHz and 800 MHz the higher frequency range applies. These guidelines may not apply in all situations. The propagation of electromagnetic waves is affected by absorption and reflection from buildings, objects, and people. 1 = The field strength of stationary transmitters (e.g., wireless phone base stations, radio devices, amateur radio stations, broadcasting and television transmitters) cannot be precisely predicted in theory. With regard to the EMC environment of stationary transmitters, a study of the site should be made. 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.

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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 telecommunications equipment and the product. Rated nominal output power Separation distance as a function of transmitter frequency (m) of the transmitter (W) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz d = 1.2

d = 1.2

d = 2.3

0.01

0.12

0.23

0.1

0.38

0.73

1.2

2.3

3.8

7.3

100

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). NOTES: At 80 MHz and 800 MHz the higher frequency range applies. These guidelines may not apply in all situations. The propagation of electromagnetic waves is affected by absorption and reflection from buildings, objects, and people.

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2.8

Electromagnetic compatibility (EMC) – IEC 60601-1-2:2014 NOTE The device / system, in the following referred to as the product, always relates to the product and its accessories mentioned in the section on "Intended use".

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"

IEC 60601 test level

Compliance Electromagnetic environment – Guidelines

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 caYes bles ± 1 kV for input/output cables

Line power quality should be that of a typical commercial or hospital environment.

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

± 1 kV line-to-line voltage ± 2 kV line-to-ground voltage

Line power quality should be that of a typical commercial or hospital environment.

Yes

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The product is intended for use in the environment specified below. The user must make sure that the product is used in such an environment. Immunity tests

IEC 60601 test level

Compliance Electromagnetic environment – Guidelines

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

0% UT * ; 1/2 period at Yes 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 % UT * ; 250/300 periods

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

30 A/m

Power frequency magnetic fields should be at levels characteristic of a typical commercial or hospital environment.

Yes

* NOTE: UT is the line voltage prior to application of the test level.

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

Test level acc. to IEC 60601

Compliance level

Electromagnetic environment – Guidelines

Conducted HF interference to IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

Portable and mobile RF communications equipment should be used no closer to any part of the device (including cables) than the recommended separation distance of 30 cm. The field strength from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the comb pliance level at all frequencies. Interference may occur in the vicinity of devices with the following symbol:

Radiated HF interference to IEC 61000-4-3

6 Vrms ISM frequency bands 150 kHz to 80 MHz

3 V/m 80 MHz to 2.7 GHz

NOTES: These guidelines may not apply in all situations. The propagation of electromagnetic waves is affected by absorption and reflection from buildings, objects, and people. a) The ISM 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 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 in terms of fixed transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location where the device is used exceeds the applicable compliance levels above, the device must be observed to verify it is functioning normally. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device.

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Recommended separation distances between portable and mobile HF telecommunication devices and the product Definition for high-frequency wireless communication equipment Frequency band

Test frequency (MHz)

Modulation a

Compliance level (V/m)

380-390

385

Pulse – 18 Hz

430-470

450

FM ± 5 kHz deviation or a pulse – 18 Hz

704-787

710, 745, 780

Pulse – 217 Hz

800-960 1700-1990 2400-2570 5100-5800

810, 870, 930 1720, 1845, 1970 2450 5240, 5500, 5785

Pulse – 18 Hz Pulse – 217 Hz Pulse – 217 Hz Pulse – 217 Hz

NOTES: A minimum safety distance of 30 cm should be maintained between the product and portable HF communication devices emitting in the specified frequency band. This includes cell phones as well as WLAN, RFID, and Bluetooth devices, for example. Non-compliance may impair the product's performance. a) Pulse modulation is defined as a square-wave signal with a 50% duty cycle.

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Illustration

3.1

Figure showing front panel of PIRANHA suction pump

3.1.1

Legend

Power switch

Holder for secretion container

Footswitch connector

Retaining plate

LCD display

footswitch

Sensor buttons

9.1

PIRANHA mode (morcellation with suction)

Tube clamping valve

9.2

SUCTION mode (only suction pulse)

Vacuum connector (BF type applied part)

connection cable

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3.2

Figure showing rear panel of PIRANHA suction pump

3.2.1

Legend

Power input connector with fuse holder

Potential equalization

Sound absorber (optional)

Socket for connection cable to POWER CONTROL 2303

Identification plate

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