Motor Control Unit 2307 Instructions for Use

Important general notes and instructions for use Ensure that this product is used only as intended and described in this instruction manual, by adequately trained and qualified medical personnel. Maintenance and repair may only be carried out by authorized specialized technicians. 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 met. Reprocess the products before every application and before returning them for repairs as required by the instruction manual in order to protect the patient, user or third parties. Check the product with accessories for completeness and possible damage immediately on receipt. Should the shipment give cause for a complaint, please notify the manufacturer or supplier immediately. Subject to technical changes! Due to continuous development of our products, illustrations and technical data may deviate slightly from the data in this manual. 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. IMPORTANT! Failure to observe can result in damage to the product or surroundings. NOTE! Tips for optimum 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 Telephone: 001 (847) 913 - 1113 Telefax: 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

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

[email protected] www.richard-wolf.be 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

2

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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TABLE OF CONTENTS 1

Product description and safety instructions

2

1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9 1.10 1.11 1.12 1.13

Indications 2 Operating principle Contraindications General safety instructions Possible combinations Safety instructions for the control unit, foot pedal and motor Safety instructions for Morcellator and Cutting Tubes Disposal considerations Technical data Ambient conditions Explanation of symbols Requirements for the products/Components of a combination Electromagnetic Compatibility (EMC)

2 2 2 4 4 4 5 6 6 7 8 9

2

Device overview

12

2.1 2.2

General overview Overview Trocar Sleeve

12 13

3

Startup

14

3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9 3.10 3.11

Device setup Assembly of Morcellator and Trocar Sleeve Assembling the morcellator with a protective sleeve Assembly of cutting tube, sterile and protective sleeve/trocar sleeve Assembling the handle and motor Assembling the adaptor for the trocar sleeve Assembling the trocar sleeve/Replacing the seal for the trocar flap Replacement of the O-ring for the Morcellator handpiece, only Version 1 Replacement of the O-ring for the Trocar Sleeve Checking 22 Adjusting the power supply

14 15 17 19 20 20 21 22 22

4

General operation

24

4.1 4.2 4.3 4.4 4.5 4.6

Switching on device Operating panel Control by ON/OFF foot pedal Switching the device on and off Cutting tube setting, “Cut/No Cut” positions Cutting tube speed recommendations

24 24 24 25 25 26

5

Cleaning, disinfection and sterilisation

26

5.1 5.2 5.3

Control unit and foot pedal Electronicmotor Morcellator and accessories

28 28 30

6

Maintenance

31

6.1

Device fuses

32

7

Errors and troubleshooting

33

8

Information on disposal

33

9

Spare parts list with order numbers

34

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23

1 1.1

Product description and safety instructions

Indications

Morcellator is intended for use in Operative Laparoscopy, including laparoscopic general surgical procedures and Laparoscopic gynaecological procedures to morcellate and remove tissue. This product is intended exclusively for use by specialized medical personnel and may be used only by medically qualified and instructed persons.

1.2

Operating principle

The MORCE POWER PLUS is a control unit for the actuation of the “R.Wolf”-Morcellator for the morcellation and extraction of tissue, as well as the removal of myomata or the uterus during laparoscopic interventions. A rotating cylindrical tube with a cutting edge on the distal end is inserted into the abdominal cavity. Forceps are used to extract the tissue.

1.3

Contraindications

Relative or absolute contraindications may result from the general medical findings or in special cases in which the patient's risk for motor-driven tools is significantly increased. Ovaries, fallopian tubes, myomata and other structures must be devascularized and dissected before morcellation. Laparoscopic power morcellators are contraindicated • for treatment of malignant tumors • for treatment of vascularized tissue • for preparation of tissue • in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy • for removal of uterine tissue containing suspected fibroids in patients who are: o peri or postmenopausal, or over 50 years of age. o candidates for en bloc tissue removal, for example through the vagina or via a minilaparotomy incision. Cases described in the relevant literature must be taken into account.

1.4

General safety instructions WARNING! Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer, and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices. WARNING! The product is to be used as intended and in compliance with the instructions for use by appropriately trained and qualified personnel only. Maintenance and repairs by authorised skilled personnel only. Operate the product in combinations and with accessories and replacement parts as specified in the instructions for use only. Only use other combinations, accessories and wearing parts when expressly identified for the intended application and which do not negatively affect performance characteristics and safety requirements. Prepare the products according to the instructions for use before each use and return shipment for the protection of patient, use and third parties. CAUTION! This device may not be modified without the manufacturer's permission.

2

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WARNING! The risk of occult cancer, including uterine sarcoma, increases with age, particularly in women over 50 years of age. This information should be shared with patients when considering surgery with the use of these devices. WARNING! Uncontained power morcellation has been associated with the spread of benign uterine tissue, i.e., parasitic myomas and disseminated peritoneal leiomyomatosis, potentially requiring additional surgeries. WARNING! Laparoscopic power morcellators should only be used with a containment system (tissue extraction bags). The containment system should be compatible with the laparoscopic power morcellator. Subject to technical change without notice! Illustrations and technical data may vary slightly due to further developments. Your safety, the safety of your team, and of course that of your patients is very important to us. It is therefore essential to bear the following information in mind:

As a matter of principle: WARNING!  The MORCE POWER PLUS may only be operated by competent trained personnel! 

The physician should read this entire manual with particular attention to the Warnings, Cautions and Precautions section and be thoroughly familiar with the use of the instrument prior to performing any clinical procedure!



Procedures performed using the MORCE POWER PLUS, as with any endoscopic instrument require adequate knowledge, training and preparation on the part of the physician/surgeon!



The use of third-party products is the responsibility of the operator!



Repairs are to be carried out by authorised Richard-Wolf service technicians exclusively!



Failure to carefully follow all applicable instructions may result in significant injury to the patient, physician, or attendants and have an adverse effect on the outcome of procedures performed!



Improper use and repair of the device, as well as failure to comply with our instructions absolves us from any performance guarantee or other claims!

In application: WARNING!  The device is delivered unsterile and must be sterilised before initial use according to chapter 5! 

The Morcellator may only be fitted with the Electronicmotor in the off state.



Never touch the cutting tube when unprotected - risk of injury!



Never actuate when the gripping mechanism of the Morcellator is running or coming to a stop! Instruments can be damaged.

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1.5

Possible combinations CAUTION! In addition to these instructions for use, the instructions for use of the products used in combination must be observed. Requirement for joint application is consistency of purpose and relevant technical data (usable length, diameter, etc.).

1.6

Safety instructions for the control unit, foot pedal and motor WARNING!  Risk of explosion! The control unit, the foot pedal and the motor are not explosion-proof. Do not operate them in an ignitable atmosphere! 

Medical electrical devices are subject to special safety precautions in regards to electromagnetic compatibility (EMC). EMC instructions in regards to installation and operation must be observed. Medical electrical devices can be affected by portable RF communications equipment.

CAUTION!  If it is necessary to stack or arrange devices directly next to RF interference, the normal operation of the devices should be monitored.

1.7



Observe the specifications for interval operation to prevent the grip of the ergonomic handle from getting too hot. Treatment must be interrupted if the motor overheats.



DO NOT ATTEMPT TO SHARPLY BEND THE MOTOR DRIVE CABLE in a diameter less than 8 inches (20 cm). Sharply bend or kinked Motor Drive Cables may cause the control unit to overheat and stop. During a procedure, a distance of 1.5 – 2.0 m should be maintained between the control unit and the Morcellator to allow the Drive Cable to hang in a large arc with no bends or loops.

Safety instructions for Morcellator and Cutting Tubes WARNING!  Stop using instruments if damaged, e.g. deformed, blunt cutting edges, tears or breaks can be identified.

4



Missing parts may not be left in the patient.



To prevent accidental injuries to the abdominal wall or similar structure, the tissue to be morcellated should be completely exposed before applying the device. In addition, it is recommended that a second pair of grasping forceps or a fixation instrument be used to prevent large pieces of tissue from uncontrollably moving. Slippage of the Cutting Tube can cause significant injury.



Keep the blade in position “Cut” when inserting or removing the instrument to prevent ripping the Fascia or the Peritoneum. Insertion and removal should be performed under direct visual control at all times.



The laparoscopic Morcellator Blade Guard should be used to prevent tissue damage while the sharp cutting edge is stationary. Exercise caution while manipulating the Morcellator. Do not place the cutter into contact with tissue that is not intended to be morcellated.



Exercise caution with the Trocar. The sharp point can cause significant injury!



Check the blades of the cutting tube for sharpness before each application. Dispose of cutting tubes after maximal 20 applications - do not resharpen!



Alternatively the Morcellator can be inserted with the usual Trocar Sleeve method. For that purpose assemble a short Trocar with adapter and seal cap slot in the Trocar Sleeve. After placement in the abdomen the Trocar can be removed gastight and the Morcellator placed under direct visual control through the Trocar Sleeve.

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1.7.1 Proper use CAUTION! The cutting tubes are to be brought up to speed before putting on the object. Avoid canting or levering which can lead to increased risk of breakage. Improper use leads to poor results and increased risk. 1.7.2 Pressing forces CAUTION! Excessive pressing forces must be avoided without fail. Such forces can damage the working part of cutting instruments with disruptions in the cutting edge. Such forces also lead to increased heat development. Instrument breakage also cannot be excluded in extreme cases. 1.7.3 Sorting out worn cutting tubes CAUTION! Chipped and misshapen blades cause vibrations. Bent or unround cutting tubes must be sorted out immediately. Blunt and chipped cutting tubes induce high pressing forces and thus increase the operating temperature. This can lead to patient injury and instrument damage.

1.8

Disposal considerations Applicable country-specific guidelines / laws must be observed when disposing of the MORCE POWER PLUS. More information can be requested from the manufacturer. Also refer to chapter 8.

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1.9

Technical data

Control unit MORCE POWER PLUS 2307101 Voltage: ... selectable: 100 V/ 115 V/ 230 V, 50-60 Hz Power supply: ... 2 x T1AL 250 VAC Power: ... 60 VA Application parts: ... Type BF Safety class: ... II Degree of protection against fluid penetration: ... IPX0 Dimensions (H x W x D): ... 115 x 120 x 180 mm Net weight: ... 1.8 kg/3.95 lbs Electronicmotor 80951.0002 Speed, Electronicmotor: ... 4000 - 40,000 rpm Max. torque, Electronicmotor:... 3.6 Ncm Diameter: ...21 mm Net weight: ... 325 g/0.72 lbs Foot pedal 2307102 Degree of protection against fluid penetration: ... IPX8 Dimensions (H x W x D) ... 65 x 75 x 240 mm Net weight: ... 1.1 kg/2.42 lbs Morcellator handpiece 8307011 Transmission ratio: ... 40:1 Max speed: ... 1000 rpm Motor coupling: ... acc. EN23964 Net weight: ... 415 g/0.92 lbs

1.10

Ambient conditions Transport and storage:

Operation:

Relative humidity:

Max. 90 %

Max. 80 %

Temperature:

0°C/32°F to 60°C/140°F

10°C/50°F to 40°C/104°F

Atmospheric pressure:

700 hPa to 1060 hPa

800 hPa to 1060 hPa

Disposable items, sterile products

6

Follow instructions on package

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1.11

Explanation of symbols

Important Information

Autoclavable at 134°C

Warning!

Suitable for thermal disinfection

Manufacturer

INT

I/O

IPX8

Degree of protection against fluid penetration

Type BF applied part. Applied parts are the instruments.

Without protection against contact

Certified by the Canadian Standards Association (CSA)

Electrical devices that have reached the end of their service life comprise hazardous waste and may not be disposed of together with household waste. Valid local disposal regulations apply.

CE marking with Notified Body

Protection class II device

Observe instructions for use

Symbol indicating the order number

Intermittent operation according to labeled handpiece

Symbol indicating the serial number with the date of manufacturing (year/month)

Pedal

Motor (Socket for shaver)

ON/OFF

Do not use if packaging is damaged

Sterilized using ethylene oxide

Date of expiry

Do not reuse.

Date of manufacturing

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1.12

Requirements for the products/Components of a combination The general requirements depend on whether the

1,5m

products/components are inside or outside the patient environment.

1,5m 1,5m

IEC 60601-1, 3. Ed.

Medically used room

Non-medically

inside the

outside the

patient environment

patient environment

MP

MP

~

~

MP

MP

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

-

-

Verification of the total patient leakage current

-

-

Verification of leakage currents a) additional protective earth connection (consult the corresponding manufacturer),

**

~

Requirements / measures

used room

or MP

NMP

~

~

MP

NMP

b) additional isolating transformer for medical applications **

**

**

~ MP NMP

~ MP

NMP

~ MP / NMP

MP

~ MP

~

**

Verification of leakage currents

-

NMP

a) no plugs with metal housing, or

~

b) additional isolation device (to avoid voltage differentials)

MP

MP / NMP

~

~

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

additional "isolating transformer" to

additional isolating device to

IEC/ EN60601-1 **

IEC/ EN 60601-1

Functional connection

~

Power supply grid

MP

= medical electrical device to IEC/ EN 60601-1, ANSI/AAMI es60601-1, CSA C22.2 No. 60601-1 08

NMP

= non-medical electrical device in accordance with product-specific IEC/EN/UL standards

8

Multiple socket strip

*

When connected via a power bar under standard conditions the earth leakage current of the power bar must not exceed 5 mA.

**

e.g. Richard Wolf video cart with "isolating transformer"

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1.13

Electromagnetic Compatibility (EMC)

Please note: The device/system identified as “product” below always refers to the MORCE POWER PLUS. This product has no performance characteristics that are classified as essential performance characteristics according to IEC/EN 60601-1. Modifications to this system not expressly approved by the manufacturer can lead to increased emissions or reduced interference immunity of the system and resulting EMC problems with this or other devices. The system is designed to meet relevant ECM regulations. Compliance with these requirements has been reviewed. The following ECM instructions are to be observed when installing and commissioning the system. Selected system components must comply with the necessary requirements for the applied medical surroundings, in particular IEC/ EN 60601-1 (3rd edition of IEC/EN 60601-1, chapter 16). In case of doubt, consult with the manufacturer(s) of the system components.

CAUTION! The use of mobile phones or other devices that work with radio frequencies can lead to unexpected or unwanted behavior in the device or system. CAUTION! Do not operate the device or system next to or on other devices. If such an arrangement of devices is required, the proper function of the device or system must be checked in each case.

Approved cables and accessories CAUTION! The use of accessories, transformers and cables other than those listed can lead to increased emissions or reduced interference immunity of the device or system. The following table lists accessories, transformers and cables for which the manufacturer guarantees electromagnetic compatibility.

Supplied accessories with no effect on electromagnetic compatibility are not listed.

Article No.

Article

Maximum length

80951.0002

Electronicmotor

2.9 m

2307102

Foot pedal ON/OFF IP 68

2.9 m

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1.13.1 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 environmental guidelines

HF emissions to CISPR 11

Group 1

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

HF emissions to CISPR 11

Class A

Harmonic emissions to IEC 61000-3-2

Class A

The product is suitable for use in buildings other than residential buildings and buildings that are immediately connected to the public power supply network that also supplies buildings used for residential purposes provided the following warning is observed: Warning: The product is only intended for use by specialized medical staff. This product can cause radio interference which may make it necessary to take suitable remedial measures such as new alignment, new positioning or screening of the product or a filter in the connection to the installation site.

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

1.13.2 Guidelines and manufacturer’s declaration - Electromagnetic immunity The product is intended for use in the environment specified below. The user must ensure that the product is operated in such an environment. In compliance

Immunity testing

IEC 60601 test level

Electromagnetic environmental guidelines

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

± 6 kV contact discharge ± 8 kV air discharge

Yes

Floors should be wood, concrete or ceramic tiles. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Electrical fast transient / bursts acc. to IEC 61000-4-4

± 2 kV for power supply lines ± 1 kV for input/output lines

Yes

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

Surges acc. to IEC 61000-4-5

 1 kV normal mode voltage  2 kV common mode voltage

Yes

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

Voltage dips, short interruptions voltage variations on power supply input lines acc. to IEC 61000-4-11

> 95 % dip in UT for 1/2 cycle * 60 % dip in UT for 5 cycles * 30 % dip in UT for 25 cycles * > 95 % dip in UT for 5 s *

Yes

Main power quality should be that of a typical commercial or hospital environment. If the user of the product requires continued operation during power mains interruptions, it is recommended to provide the device with power from an uninterruptible power supply or a battery.

Power frequency magnetic field 50/60 Hz, acc. to IEC 61000-4-8

3 A/m

Yes

The power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

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

10

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1.13.3

Guidelines and manufacturer’s declaration - Electromagnetic immunity for non life support devices

The product is intended for use in the environment specified below. The user must ensure that the product is operated in such an environment. Immunity testing

IEC 60601 test level

Conducted RF interference acc. to IEC 61000-4-6

3 Veff 150 kHz to 80 MHz

Radiated RF interference acc. to IEC 61000-4-3

3 V/m 80 MHz to 2,5 GHz

In compliance

Electromagnetic environmental guidelines

Yes

Recommended separation distance between the product, including cables, to portable and mobile RF communications equipment should be no less than calculated in the equation for the transmit frequency. Recommended separation distance: d = 1.2 d = 1.2 d = 2.3

P P for 80 MHz to 800 MHz P for 800 MHz to 2.5 GHz

P = rated power of the transmitter in watts (W) (according to the transmitter manufacturer) d = recommended separation distance in meters (m) Field strength 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 the equipment marked with the following symbol:

NOTES: The higher frequency range applies at 80 MHz and 800 MHz. These guidelines may not apply in all cases. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 1 = Field strength from fixed transmitters (e.g. base stations for wireless telephone, land mobile radios, amateur radios, AM/FM radio broadcasts, and TV/TV broadcasts) 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 product is used exceeds the applicable RF compliance level above, the product should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the product). 2 = Over the frequency range of 150 kHz to 80 MHz, the field strength should be less than 3 V/m.

1.13.4 Recommended separation distances between portable and mobile RF telecommunications equipment and non life-support devices The product is intended for use in an electromagnetic environment in which RF disturbances are controlled. The user can help to prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment and the product. Rated power of the transmitter (W)

Separation distance according to transmit 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

0.01

0.12

0.12

0.24

0.1

0.37

0.37

0.74

1

1.17

1.17

2.34

10

3.69

3.69

7.38

100

11.67

11.67

23.34

P

For transmitters rated at an 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. P = Rated power of the transmitter in watts (W). NOTES: The higher frequency range applies at 80 MHz and 800 MHz. These guidelines may not apply in all cases. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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2 2.1

Device overview

General overview

7

8

9

3

4 1 5

2

6 3 Control unit, rear

10

14

13

15

12

11

16

21

Sealing unit for instruments with Ø 12/15 mm

17

18

19

Sealing unit for instruments with Ø 20 mm

20

22

23

24

25

26

27

12

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No. Description

Art. No. Art. No. Art. No. 12 mm system 15 mm system 20 mm system

1

Foot pedal (IPX8)

2

Tread plate

3

MORCE POWER PLUS control unit

4

Operating panel with display

5

Socket for foot pedal

6

2307102 2307101

Socket for Electronicmotor

7

Power entry module with power plug socket

8

Power entry module with main switch

9

Power entry module with fuse compartment

10 Trocar for Morcellator

83071121

83071151

11 Electronicmotor

80951.0002

12 Ergonomic handle

83070111

13 Morcellator handpiece

8307011

14 Trocar Sleeve with flap and Tissue Positioner

8307112

83071201

8307115

8307120

15 Cutting tube

8307012

8307015

8307020

16 Protective sleeve

83070128

83070158

83070208

17 Tissue Seal Holder

643301131

-

18 Tissue Seal

8307502

-

19 Instrument Seal

8307503

-

20 Membrane Screw

643301130

-

21 Adapter for Trocar Sleeve

8307501

22 Tissue Seal Holder

-

-

643301132

23 Tissue Seal

-

-

83075022

24 Membrane Holder

-

-

64330861

25 Instrument Seal

-

-

8307503

-

-

64330856

4307012

4307015

-

26 Membrane Screw 27

2.2

Cutting tube, sterile

Overview Trocar Sleeve

No. Description

Art. No. Art. No. Art. No. 12 mm - system 15 mm - system 20 mm - system

28 Trocar Protective Tube

64330866

29 O-ring for Trocar Sleeve

64330867

64330868

83071123

83071203

30 Flap element, Trocar

64330864

64330865

31 Sealing for Trocar Flap

83071125

83071205

32 Seal cap slot

64330857

64330858

64330859

33 Trocar for Trocar Sleeve

83071122

83071152

83071202

28

29

30

31

32 33

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3

3.1

Startup

Device setup

• Place control unit on an even, non-slip surface and make sure you have good access to all controls. • Do not allow the operating range of the device (including cable and Instrument) to be compromised by limiting factors. • The system display must be fully visible at all times. • The pedal must be placed within stepping distance between the patient and the surgeon. • • • •

It must be explicitly ensured that no objects can fall on the pedal. The power plug at the rear of the device must be accessible at all times. The motor ventilation slots must be kept clear in order to prevent the motor temperature from becoming excessive. Sterilisable components are not supplied in a sterile condition. All sterilisable components must be sterilised before starting operation. If the components have already been sterilised, when removing the components make sure that the sterile packaging is not damaged and that the sterility indicator certifies the sterility (if no sterility indicator was included, the sterile packaging must at least bear the expiration date of the sterile storage period).

WARNING! In order to prevent the risk of electric shock, the device may only be connected to a power network with a PE protective ground conductor.

1) Insert the foot pedal connector into the foot pedal socket. 2) Insert the Electronicmotor connector into the motor socket. 3) Use the power plug to connect the control unit to the outlet. CAUTION! Do not forget that the operating voltage and supply voltage match!  If not, see Chapter “3.10 Adjusting the power supply”.

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The morcellator handpiece without internal thread is only compatible with sealing units 83075011 (Ø 12/15 mm) and 83075021 (Ø 20 mm).

Visual check

no internal thread

Compatible:

Not compatible:

Sealing unit 83075011 Ø 12/15 mm

Cutting tube nut 64330940 / 64330941

Sealing unit 83075021 Ø 20 mm

+ Old sealing unit Ø 12/15/20 mm

3.2

Assembly of Morcellator and Trocar Sleeve

Before assembling the described components you must be able to answer the following questions unequivocally with “yes”.  Sterile packaging undamaged?  Sterility indicator OK?  Sterilisation date OK? When you use the 20 mm system, omit the instrument seal while inserting the morcellator. You only insert the instrument seal and fasten it with the membrane screw after removing the trocar. Reason: Inserting the 20 mm trocar into the morcellator through the mounted instrument seal expands the hole of the instrument seal which may compromise the leak tightness of the system. 12/15 mm system

20 mm system

1) Insert the cutting tube into the handpiece until it engages in such a way that the driver pins rest in the slot.

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2) Insert the tissue seal into the tissue seal holder.

3) Screw the tissue seal holder onto the handpiece.

4) When using the 12/15 mm system, insert the instrument seal into the membrane screw. When using the 20 mm system, do not insert the instrument seal until after removing the trocar. 5) Screw the membrane screw (12/15 mm)/membrane holder (20 mm) onto the tissue seal holder.

6) Push the trocar sleeve over the cutting tube. Be careful: keep the flap in the trocar sleeve open to avoid damaging the cutting tube. Engage the handpiece. Only assemble components of the same type: 12 mm system, 15 mm system, 20 mm system. Take care to insert the cutting tube axially and straight, do not tilt! 7) Carefully insert the trocar. Set to the “Cutˮ position when inserting through the abdominal wall (see Chapter 4.5) 8) Remove the trocar after inserting through the abdominal wall. When using the 20 mm system, insert the instrument seal and screw the membrane screw onto the membrane holder.

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3.3

Assembling the morcellator with a protective sleeve

The protective sleeve has a lug at the proximal opening to facilitate tissue positioning. This lug is slightly angled towards the centre of the cutting tube to anchor the tissue optimally for cutting. Before you start assembling the components described, you must be able to answer an unequivocal “yesˮ to the following questions.  Sterile packs undamaged?  Sterile indicator OK?  Sterilization date OK? When you use the 20 mm system, omit the instrument seal while inserting the morcellator. You only insert the instrument seal and fasten it with the membrane screw after removing the trocar. Reason: Inserting the 20 mm trocar into the morcellator through the mounted instrument seal expands the hole of the instrument seal which may compromise the leak tightness of the system.

12/15 mm system 1)

Insert the cutting tube into the handpiece until it engages in such a way that the driver pins rest in the slot.

2)

Insert the tissue seal into the tissue seal holder.

3)

Screw the tissue seal holder onto the handpiece.

4)

When you are using the 12/15 mm system, insert the instrument seal into the membrane screw.

20 mm system

When you are using the 20 mm system, do not insert the instrument seal until after removing the trocar.

5)

Screw the membrane screw (12/15 mm)/membrane holder (20 mm) onto the tissue seal holder.

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6)

Push the protective sleeve over the cutting tube. Engage the handpiece.

Only assemble components of the same type: 12 mm system, 15 mm system, 20 mm system. Take care to insert the cutting tube axially and straight, do not tilt!

7) Carefully insert the trocar. Set to the “Cut” position when inserting through the abdominal wall (see Section 4.5)

8) Remove the trocar after inserting through the abdominal wall. When using the 20 mm system, insert the instrument seal and screw the membrane screw onto the membrane holder.

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