ENDOserve Instructions Manual

Important general instructions for use Ensure that this product is used only as intended and described in this instruction manual, by adequately trained and qualified personnel, and that maintenance and repair is only carried out by authorized specialized technicians. Use this product only in the combinations and with the accessories and spare parts listed in this instruction manual. Use other combinations, accessories and replacement parts only if they are expressly intended for this use and if the performance and safety requirements are met. Reprocess the products before every application and before returning them for repair as required by the instruction manual in order to protect the patient, user or third parties. Subject to technical changes! Due to continuous development of our products, illustrations and technical data may deviate slightly from the data in this manual. CAUTION - USA only: Federal law restricts this device to sale by or on the order of a physician.

0

GERMANY RICHARD WOLF GmbH D-75438 Knittlingen Pforzheimerstr. 32 Tel.: (..49)-(0)7043-35-0 Fax: (..49)-(0)7043-35300 MANUFACTURER

USA RICHARD WOLF Medical Instruments Corp. 353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Tel.: 847-913 1113 Fax: 847-913 1488

UK RICHARD WOLF UK Ltd. Waterside Way Wimbledon SW 17 0HB Tel.: 020-8944 7447 Fax: 020-8944 1311

E-mail: [email protected] Internet: www.richard-wolf.com

E-mail: sales&[email protected] Internet: www.richardwolfusa.com

E-mail: [email protected] Internet: www.richardwolf.uk.com

BELGIUM N.V. Endoscopie RICHARD WOLF Belgium S.A. Industriezone Drongen Landegemstraat 6 B-9031 Gent -Drongen Tel.: +32 9.280.81.00 Fax: +32 9.282.92.16

FRANCE RICHARD WOLF France S.A.R.L. Rue Daniel Berger Z.A.C. La Neuvillette F-51100 Reims Tel.: +33 3.26.87.02.89 Fax: +33 3.26.87.60.33

AUSTRIA RICHARD WOLF Austria Ges.m.b.H. Wilhelminenstraße 93 a A-1160 Wien Tel.: +43 1- 405 51 51 Fax: +43 1- 405 51 51-45

E-mail: [email protected]

E-mail: [email protected]

E-mail: [email protected] Internet: www.richard-wolf.at

GA-B 211

Contents I.

CHECKING THE DEVICE ... p 1

II.

GENERAL INFORMATION ... p 1

III.

PUTTING THE ENDOserve INTO USE ... p 2

IV.

CLEANING - DESINFECTION – STERILISATION ... p 4

V.

PREPARATION FOR AN OPERATION ... p 5

VI.

TECHNICAL SPECIFICATIONS - CARE / MAINTENANCE ... p 9

VII.

OPERATING, STORAGE, TRANSPORT AND SHIPPING CONDITIONS ... p 10

APPENDIX A : ENDOserve COMPONENTS ... p 11 APPENDIX B : INSTALLATION OF THE STAND ON THE OPERATING TABLE RAIL ... p 12 APPENDIX C : STANDARD ENDOserve ... p 13 APPENDIX D : OPTIONAL ACCESSORIES FOR ENDOserve... p 14

Remark: The numbers shown in brackets in the text refer to the appended diagram (Appendix C) included in this document.

Check on the: Approved on the:

GA-B 211

by: by:

I

I.

CHECKING THE DEVICE I - 1 On receipt Unpack the device and check it immediately on receipt. Check that it is complete, and in good working order. Any damage, faults or missing parts must be reported immediately ( within 48 hours) Keep the original packing in case it is necessary to return the device. The ENDOserve and its accessories are delivered non-sterile. Before use, they must be cleaned and sterilized according to the instructions in chapter IV of this manual.

I - 2 Accessories check list Unless otherwise specified your ENDOserve should be delivered with the following accessories: • One instrument-holder complete (16) • One Silicone hose with quick connector complete (30) and non return valve (31) • One packet of 3 elastic ball joints (18) for instrument holder (ø 5 - 5,5 - 10 mm) Please refer to the list of ENDOserve components at the end of this manual, Appendix A

II.

GENERAL INFORMATION The ENDOserve is a holding and manipulating arm for surgery. It allows the operating team to fix an instrument or endoscope in a given position and to change this position immediately using only one hand. The pneumatic locking mechanism makes the ENDOserve very easy to handle, and allows the arm and the instrument held to withstand a force of up to 5 da.N (5kg.f), at a gas pressure 7.5bar. The actual resistance against movement depends on the pressure of the gas.

II - 1 Main components The ENDOserve consists of: • The articulated stand, (the part fixed to the table rail) which can either be used under a sterile cover or sterilized by autoclave or gas along with part of the flexible hose. • The instrument-holder, which can be totally dismantled and sterilized (autoclave or gas), and may also undergo liquid or ultrasonic decontamination. • spherical elastic ball-joints with a hole whose diameter is adaptable to all sizes of instruments or endoscopes.

II - 2 Installation The stand is fitted onto the operating table side rails. The locking device fits all common rail sizes. The ENDOserve needs a compressed gas supply : • either the operating theatre compressed air supply, • or a compressed gas or air bottle with a pressure reducer (compressed air, carbon dioxide or nitrogen may be used) The operating pressure required is 5 to 8 bar (Optimal performance 7-8 bar)

II - 3 Operation Pressing the control lever releases the three ball-joints simultaneously. It is then possible to place the instrument in any chosen position with one hand. The ENDOserve becomes fixed and rigid as soon as the control lever is released.

1

GA-B 211

III.

PUTTING THE ENDOserve INTO USE To accustom the user in the function of the ENDOserve, we suggest using this test procedure for setting up the ENDOserve and its connection to the gas supply Recommendations concerning its position on the table and asepsis are dealt with in chapter V

III - 1 Locking the ENDOserve on to the table Position the articulated stand of the ENDOserve onto the operating table side rail and tighten the clamp tightening screw (39). The part of the silicon hose which is reinforced (30) is permanently attached to the ENDOserve. Do not attempt to dismantle it. Verify the rigidity of the fixation (check the tightness on the rail as well as the stability and rigidity of the rail fixing to the table itself.)

III - 2 Attaching the instrument-holder to the stand Attach the assembled instrument-holder fitted with an elastic ball joint of a corresponding diameter to the instrument or endoscope being used onto the threaded fixing screw (15) on the stand. This fixing screw is equipped with a lug that must be lined up with the corresponding notch on the instrumentholder. Fully tighten the tightening screw (16) by hand. Please take care that if it is planned to change instruments or endoscopes of different diameters during surgery,.that additional Endoserve instrument-holders fitted with a ball-joint of corresponding diameters are available and prepared, Caution: If the ENDOserve is used to hold an operating endoscope with integral working channel through which HF instruments are used, ensure that the isolating effect of the ball joints is not compromised. Take care that there is no secondary contact between the endoscope and the ENDOserve which could provide an inadvertent electrical pathway to the Operation table.

III - 3 Connection to the theatre compressed air supply The ENDOserve can be directly attached to the theatre compressed air outlet by a flexible hose fitted with a suitable connector. (36) The pressure available should be between 5 and 8 bar. For optimum working order of the ENDOserve use 7– 8 bar.

III - 4 Connection to a compressed gas bottle (C02 or N2) Check that the seal of the pressure reducer (3) is in good condition. Connect the pressure reducer (3) by tightening the regulator tightening screw (2) Firm hand tightening is sufficient. The pressure reducer (3) may also be screwed on to a pin-index stirrup for connection to bottles that contain < 2Kg of gas. Connect the end of the hose (5) to the pressure reducer connector, or directly if the bottle is placed under the table, or by an extension with quick connectors (34). IMPORTANT Always keep the gas bottle in an upright position with tap at the top. • Never use the ENDOserve connected to a bottle placed in a horizontal position, or upside down. • Never grease the joints (13 / 14) or pressure reducer washer (A) • Never try to unscrew the regulator tightening screw (2) from the pressure reducer (3) while the tap (1) is open, or while the circuit is under pressure. Firstly, turn off the tap (1), bring the pressure in the circuit down by pressing the ENDOserve control lever. Then unscrew the connection.

GA-B 211

2

III - 5 Turning on the device and testing Caution : Do not operate the ENDOserve if it is not screwed properly onto its stand Bottle supply: turn on the supply: (1). Check that there are no leaks. For CO2 the manometer must display a pressure of 50 bar. If under 30 bar, change the bottle. (1 bar = 100 K Pa) Compressed air supply: connect the supply hose to the theatre outlet. The ENDOserve should remain rigid and in a fixed position. To change position, keep the control lever pressed(17) releasing it when the chosen position is reached. Attach an instrument (or endoscope) with a diameter corresponding to that of the ball joint (18). Press the control lever (17) continuously while introducing the instrument. The control lever (17) should also be pressed to enable repositioning of the instrument inside the ball, or when removing it. Caution: Repeated manipulation of the ENDOserve without an instrument or Endoscope will reduce the life expectancy of the ball joint.

III - 6 Completing the test Allow the gas to escape : • turn off the tap (1), or disconnect the hose from the central compressed air supply and disconnect the quick connector (32, 33). • operate the control lever (17) to empty the gas circuit. • remove the instrument-holder from the stand, and remove the stand from the table side rail. Warning: Do not remove the instrument-holder(16) from the stand while the unit is still under pressure. The device must be cleaned as soon as possible after use.

3

GA-B 211

IV.

CLEANING - DESINFECTION - STERILISATION IV - 1 Cleaning / disinfecting: Instrument-holder and elastic ball-joints • Take the Instrument-holder apart as follows: - separate the instrument-holder from the stand, (the stand must not be immersed in any liquid) - turn the ball-tightener (19 ) a quarter of a turn and remove it. - remove the elastic ball from its housing, - remove the internal part (24) of the instrument holder and its spring (23). • Use the usual methods for the instruments • Soak in a cleaning and disinfecting solution, following the manufacturers’ instructions concerning concentration and duration. • Use a soft brush to clean encrusted stains. • Rinse carefully with distilled water. • Dry with compressed air. • After cleaning, reassemble in reverse order, do not forget the spring. • Before sterilizing verify the condition and working order of the different parts in particular the sensitive parts such as the joints, extension tubing etc, treat the moving parts such as the control lever (17) with a lubricant suitable for surgical instruments, do not lubricate the lower joint (13) or the upper joint (14) • In case of disinfection with liquid, firstly take apart, then soak and rinse in distilled sterile water. Stand • Wipe the stand with a cloth dipped in alcohol or disinfectant . • Dry with a dry cloth. • Do not use solvents. Never soak the stand in any liquid, or put it in a washing machine or ultrasound machine.

IV - 2 Sterilization Steam sterilization by Autoclave Max: 134°C – 18 min – 2 bar Respect manufacturer’s recommendations for implementation of Asepsis • If the stand is not sterilized, see section V-2 • If the stand is sterilized, see section V-3. Warning: • If sterilizing the stand, only the part of the supply hose joined to the stand can be sterilized by autoclave (white translucent reinforced silicone hose) (30). • The extension tubing (connection supply hoses) are not autoclavable and must not be soaked. • The pressure reducer cannot be sterilized or soaked.

GA-B 211

4

V.

PREPARATION FOR AN OPERATION The following must be performed by or under the supervision of a trained physician or surgeon. The purpose of this instruction manual is to explain the use of the ENDOserve, not to teach any particular surgical technique.

V - 1 Interaction with the instrument being held Initially the ENDOserve manipulating arm was created for holding endoscopes. It may be used with numerous other medical devices such as instruments, retractors, etc… as long as they have a rigid cylindrical part which can be inserted into the ENDOserve's distal ball-joint (standard dimensions see appendix A. For other dimensions, please contact us.). In this sense and in regard to EEC regulations, the ENDOserve is a class 1 accessory medical device. Please note, the choice of the type of instrument held by the ENDOserve as well as its application are the sole responsibility of the surgeon. This is fundamental to the safety of the patient and user especially where there is an association with invasive, active or therapeutic medical devices or those that have their own inherent risks (electrical or delicate items….) Any company who markets the ENDOserve in association with another medical device, is responsible for the conformity of this set-up to Essential requirements. They should evaluate the risks and ensure their compatibility. The specifications described below could help in evaluating possible compatibility of devices. The crush resistance of instruments held by the ENDOserve. Powered at 8 bar the theoretical force applied to the articulated DISTAL joint is in the order of 100 daN (about 100 kg). A force such as this exerted on the Instrument holder joints could provoke their failure if the ENDOserve is operated with no instrument or endoscope in the joint. The ball joints are semi consumable, account should be taken of their usage. They should be replaced as soon as there are any signs of deterioration. With normal usage and when the appropriate ball joints are used, the forces are correctly distributed by the ball joints and there is no risk of damage to the instruments, in particular to endoscopes Electrical risk : Under certain conditions, in particular when all the articulations of the arm are in a fully angled position, there could be electrical conduction between the instrument holder (distal part) and the operating table rail. In this case the Instrument holder ball joints made of polymer continue to provide dielectric isolation of the instrument being held. However, in cases where electrical or electromagneticly active instruments or devices sensitive to electrostatic discharges are in use, the user should make sure that no conductive part of the instrument being held can come into contact with any metal part of the arm. Unwanted discharge of gas : The ENDOserve has a pneumatic CO2 or compressed air supply. As long as the arm is not activated, there can be no gas discharge. Gas discharge occurs only during the unlocking of the articulated ball joints phase during positioning of the arm. The flow during these periods is 2 to 3 litres a minute of pressurised gas. A joint seal can be fitted to the instrument holder to prevent all gas discharge beyond the distal point (not on standard device as delivered. See drawing appendix C, ref: 20). The use of a sleeve (V-2) can direct the discharged gas back towards the stand of the ENDOserve arm. Energy emitted

5

GA-B 211

This is a non electrical device there is therefore no electromagnetic radiation.

V - 2 Positioning of the ENDOserve The easiest way of manipulating the ENDOserve is by positioning the ENDOserve stand in front of the surgeon, or laterally. Avoid positioning it too close to any of the operators. For example: laparoscopic Cholecystectomy. The surgeon stands between the patient's legs, his assistant on the left-hand side of the patient. The stand of the ENDOserve will then be positioned on the right-hand side of the patient between the hip and the sternum. laparoscopic Inguinal hernia (intra peritoneal method.) Position the stand of the ENDOserve at hip level, preferably on the same side as the hernia (on the opposite side of the surgeon.) the same installation is used for gynecological operations In all cases, once the instrument-holder is set up on the stand, the operator can choose the best position for the control lever by rotation, (upwards or downwards).

GA-B 211

6

V - 3 Aseptic operation (when the stand is not sterile)

A

C B 35

3

D 34

30

30.2

3

Pressure reducer on medical C02 bottle (fast connector)

A

Sterile zone

30

Supply hose, autoclavable part (lenght –1m) (non sterile)

B

Sterile instrument holder (autoclaved)

30.2

Connection to a non sterile extension

C

Non sterile stand, use of a single sterile drape

34

Pressure reducer connector / CO2 bottle

D

Operating drapes

35

Wall supply (6/8 bar - C02 or air) (contact us) In this section, we consider that the surgeon is scrubbed (sterile) and the assistant not yet scrubbed (non-sterile) Once the patient is lying on the table and anaesthetized, the assistant locks the stand on the table rail as seen in appendix B. Then he connects the unit to the compressed air or gas without putting it under pressure and moves the unit away from the patient as much as the primary lower joint (13) allows. The surgeon lays the operating drapes as usual. On the ENDOserve side, the drape is put over the stand leaving just the intermediary ball-joint sticking out. The assistant pushes the stand back to a vertical position, the fixing screw (15) turned towards the surgeon. The surgeon puts the instrument-holder in a sterile sleeve, leaving the tightening screw (16) sticking out. Then he turns this wheel to the assistant who tightens it on to the upper joint (14). The surgeon slides the sterile sleeve around the ENDOserve in order to cover the stand completely and fixes its end to the operating field. The other end is fixed to the middle of the instrument-holder. The assistant puts the unit under pressure. The ENDOserve is then ready to use. The surgeon chooses the best position for the control lever, upwards or downwards, before introducing the endoscope or instrument. For a laparoscopy, it is advised to introduce all trocars before holding the endoscope with the ENDOserve.

7

GA-B 211

V - 4 Aseptic operation (when the stand is sterile) Whole ENDOserve autoclaved

D

A B

35

E

3 30 34 30.1 30.2 3

3

Pressure reducer on medical CO2 bottle

A

Sterile zone

30

Supply hose, autoclavable part (Length –1m) (sterile)

B

Sterile instrument holder(autoclaved)

30.1

Directly connected to CO2 bottle

D

Operating drapes

30.2 34

Connection to a non sterile extension

E

Sterile stand (whole ENDOserve autoclaved)

35

Wall supply (6/8 bar - C02 or air) (contact us)

Pressure reducer connector / CO2 bottle

In this section, we consider that the surgeon is scrubbed (sterile) and the assistant not yet scrubbed (non-sterile) Once the patient is lying on the table and anaesthetized, the surgeon lays the operating sheets as usual. The surgeon locks the stand on the table rail as seen in sectionV - I over the operating sheets. Then he passes the free end of the supply hose ( white silicone hose) to the assistant. The surgeon tightens the instrument-holder (16) on to the upper joint (14) The assistant connects the unit to the compressed air or gas and puts the unit under pressure. The ENDOserve is then ready to use. The surgeon chooses the best position for the control lever, upwards or downwards, before positioning the endoscope or instrument. For a laparoscopy, it is advised to introduce all trocars before holding the endoscope with the ENDOserve.

GA-B 211

8

V - 5 End of operation. • Remove the instrument or the endoscope from the ENDOserve. • Turn off the gas supply pressure (turn tap off or un plug from the supply connector). If necessary release pressure with the control lever (17). • Remove the instrument-holder from the stand, and take the stand off the table. • Disassemble the instrument-holder and the elastic ball joint, have them cleaned and sterilized for the next operation (see chapter IV).

VI.

TECHNICAL SPECIFICATIONS - CARE / MAINTENANCE VI - 1 Specifications Class I medical device classified according to the EEC / 93 /42 directive on medical devices Pneumatic supply with CO2 or compressed air under a pressure of 5 to 8 bars. Main materials used: • mechanical parts : - stainless steel 316L - aluminum 2017A + hard anodization • screws, pins, springs : stainless steel 302 • seals, hoses : Viton, PTFE, and silicone • elastic ball joints: POM (Delrin.) No part or accessory is composed of latex

VI - 2 Care - Maintenance Care and maintenance of the ENDOserve consists of cleaning instructions (see chapter IV) and regular monitoring of all delicate parts such as seals, moving parts and pneumatic tubing. A general inspection by the manufacturer is necessary every year to keep it in good working order. This maintenance operation includes a complete check of the device, replacement of parts that are worn along with a final test of the ENDOserve. In the absence of this annual inspection, the manufacturer cannot guarantee that the ENDOserve conforms to specifications. The responsibility for the safe use of the device then becomes the responsibility of the surgeon, user or establishment. A service manual including technical information on the product is available on request. All the maintenance and repair operations have to be performed by people trained and qualified for repairing the ENDOserve using only original spare parts Note: The rigidity of the device can be adjusted by turning the screw (51) this ajusts the free movement of the joint. The manufacturer will not accept responsibility in cases of accident if the device is used without correct maintenance or if it has been modified in any way.

9

GA-B 211

VII. OPERATING, STORAGE, TRANSPORT AND SHIPPING CONDITIONS Operating conditions

+10° C to + 40° C , 30 % to 70 % rel. humidity, atmospheric pressure 700 hPa to 1060 hPa

Storage, transport and shipping conditions

- 40° C to + 70° C , 10 % to 100 % rel. humidity, atmospheric pressure 500 hPa to 1060 hPa

VII - 1 Disposal of product, packaging material and accessories. For the disposal observe the regulations and laws valid in your country. For further information please contact the manufacturer.

GA-B 211

10

APPENDIX A : ENDOserve COMPONENTS Diagram 1 2 3 A 3 3 A 7

10 + 39/43 10 39 41 42 43 44 30, 31, 32 13 14 15 51

ENDOserve : COMPONENTS DESCRIPTION CO2 CYLINDER Opening and closing tap of the C02 bottle. Regulator tightening screw on the C02 bottle. CO2 pressure reducer - 7 bar - Pin-Index - NON autoclavable Pin-Index supply washer - NON autoclavable CO2 pressure reducer - 7 bar - DIN 477 N° 6 - NON autoclavable CO2 pressure reducer - 7 bar French "C" connector NF-E 29653 - NON autoclavable Reducer washer - French "C" NF-E 29653 or DIN 477 N° 6 - NON autoclavable Pin-Index adapter for pressure reducers 2046.958 and 2046.959 STAND of ENDOserve - QUICK LOCKING DEVICE Stand of ENDOserve pneumatic manipulator Quick locking device (complete) - autoclavable Clamp fixed jaw - autoclavable Clamp tightening screw - autoclavable Clamp mobile jaw - autoclavable clamp spacer - autoclavable clamp spring - autoclavable Clamp washer - autoclavable Silicone supply hose with both connectors - autoclavable

Article code

2046.957 2046.958 2046.959

8064.001 15 319.014 9004.033 15 319.015 15106.308 15 006.430 15 045.552 15 219.707

Lower joint Upper joint Instrument-holder fixing screw Lower joint rigidity regulator

16 / 24 16 17 18 18 18 18 18 18 23 19 20 21 24

Instrument-holder of ENDOserve - autoclavable Instrument-holder tightening screw Control lever Shouldered black elastic ball-joint, 3,5 mm - autoclavable Shouldered white elastic ball-joint, 5 mm - autoclavable Shouldered green elastic ball-joint, 5,5 mm - autoclavable Shouldered black elastic ball-joint, 8 mm - autoclavable Shouldered red elastic ball-joint, 10mm - autoclavable Shouldered blue elastic ball-joint, 12mm - autoclavable spring of instrument holder - autoclavable Ball tightener (end cap) - autoclavable Instrument holder external seal (O-Ring R5) - autoclavable external part of instrument holder - autoclavable internal part of instrument holder - autoclavable

31 32 / 33 37 35 34

EXTENSION HOSES for ENDOserve Non-return valve Quick supply tube connector for hose (Male connector / female socket) Extension hose for compressed air including Dräger connector - NON autoclavable Extension hose for compressed air French NFS 90116 connector - NON autoclavable Extension hose for CO2 pressure reducer or compressed air Staubli connector - NON autoclavable

8064.002

8064.0035 8064.005 8064.0055 8064.008 8064.010 8064.012 15 006.427 15 135.370 15 364.321 15 106.306 15 106.307

8170.312 8170.313 8170.314

The products can be combined as required provided the relevant technical data and intended uses are observed. For the general overview please refer to the latest catalogue sheets and brochures, or contact Richard Wolf or your R.Wolf representative.

11

GA-B 211

APPENDIX B : INSTALLATION OF THE STAND ON THE OPERATING TABLE RAIL

ASSEMBLY

1

3

2

4

5

DISASSEMBLY

1

GA-B 211

2

3

4

12

APPENDIX D : OPTIONAL ACCESSORIES FOR ENDOserve

15 106.306 External part of instrument holder)

8064.002 Additional instrument holder (7 parts incl. spring ball tightener and 3 balls ø 5 - 5,5 - 10 mm)

15 106.307 Internal part of instrument holder 15 006.427 Spring of instrument holder

push to release

Ball tightener (end cap) 15 135.370

ø 3,5 - 8064.0035 ø 5 - 8064.005 ø 5,5 -8064.0055 ø 8 - 8064.008 ø 10 - 8064.010 ø 12 - 8064.012

Instrument holder external seal (O-Ring R5) 15 364.321 CO2 PRESSURE REDUCERS 7,5 bar for ENDOserve

Shouldered elastic ball-joint 2046.959 TO PIN INDEX CYLINDER TO FRENCH CO2 CYLINDER DIN 477 N° 6

2046.957

2046.958

TO PIN INDEX CYLINDER

TO GERMAN CO2 CYLINDER (DIN477 n° 6)

COMMON EXTENSION HOSES FOR ENDOserve 8170.314 Extension hose for CO2 pressure reducer or compressed air - Staubli connector

8170.313 Extension hose for compressed air French NFS 90116 connector

8170.312 Extension hose for compressed air Dräger connector

OTHER STANDARDS ON REQUEST

GA-B 211

14