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Instructions

2232

LAPARO C02- PNEU

2232

TEM Combination System (LAPARO CO2 PNEU with TEM PUMP)

with TEM Instrument Set for Transanal Endoscopic Microsurgery

j

E 2003 by RICHARD WOLF GMBH, Pforzheimer Straße 32, D--75434 Knittlingen

TEM PUMP

LAPARO CO2 PNEU (without TEM PUMP) for Laparoscopic Surgery

GA--AS 001 / en / Index: 08--03--1.0 / ÄM: KG 03--224

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: [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

MANUFACTURER U--shaped support arm

8840.9721 Clamping base, insulated 8840.9722

GEOMED Medizin--Technik GmbH & Co Postfach 4047 D--78505 Tuttlingen Tel.: (..49)--(0)7461--9355--0 Fax: (..49)--(0)7461--9355--93 E--mail: [email protected] Internet: www.geomed.de

0

GA--AS 001

Transanal Endoscopic Microsurgery (TEM) Laparoscopic Surgery

Contents Important general instructions for use Important informations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III Safety instructions used in this manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III Structure and use of this manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III Overview diagram for TEM application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV

Transanal Endoscopic Microsurgery (TEM) 1.

Intended purpose

1.1 1.2 1.3 1.4 1.5

Technical description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Indications and field of application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Combinations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2

Illustrations / Controls and indicators

2.1 2.2 2.3 2.4

Symbols / Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Controls and indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Device connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Illustrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.

Set up

3.1 3.2 3.3

Installation of the TEM Combination System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 -- 2 Prepare the TEM Irrigation Cannula and NaCl irrigation bottle . . . . . . . . . . . . . . . . . . 3 -- 4 Connect the tube set for TEM applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 -- 4

1 -1 -1 -1 -1 --

2 2 3 4 4

2 -2 -2 -2 --

2 4 7 8

4.

Use

4.1 4.2 4.3 4.4 4.5. 4.6.

TEM Instrument Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . TEM Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Additional notes and instructions for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . TEM Combination System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Additional notes and instructions for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Alarm functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5

Checks

5.1 5.2

Visual checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 -- 2 Functional checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 -- 3

6

Reprocessing and maintenance

6.1 6.2 6.3 6.4 6.5 6.6 6.7 6.8

TEM Combination System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . TEM Irrigation Cannula . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . TEM Instrument Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Double blower / Disposable filtration adaptor / tube section . . . . . . . . . . . . . . . . . . . . Suture Clip Forceps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Needle Holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . HF Scapel, unipolar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Retractable Syringe Needle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

GA--AS 001

4 -4 -4 -4 -4 -4 --

6 -6 -6 -6 -6 -6 -6 -6 --

2 9 10 12 13 15

3 5 7 9 10 12 13 14

I

Transanal Endoscopic Microsurgery (TEM) Laparoscopic Surgery 7

Error message / Correctiv action

7.1 7.2 7.3

Device errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 -- 2 Error messages for LAPARO CO2 PNEU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 -- 2 Error messages for TEM PUMP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 -- 3

8

Technical data and order data

8.1 8.2 8.3 8.4 8.5 8.6 8.7 8.8 8.9 8.10

LAPARO CO2 PNEU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . TEM PUMP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Spare parts and accessories for TEM Combination System . . . . . . . . . . . . . . . . . . . . TEM Instrument Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . TEM Irrigation Cannula . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . TEM Tube Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . TEM Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Additional spare parts and accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Replacing device fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Operating, storage, transport and shipping conditions . . . . . . . . . . . . . . . . . . . . . . . . .

8 -- 2 8 -- 4 8 -- 5 8 -- 6 8 -- 7 8 -- 8 8 -- 9 8 -- 11 8 -- 12 8 -- 12

Laparoscopic Surgery Overview diagram for laparoscopic surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 2

II

1

Intended purpose

1.1 1.2 1.3 1.4 1.5

Technical description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Indications and field of application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Combinations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3

Set up

3.3

Connecting insufflation tube . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 4

4

Use

4.1 4.2

LAPARO CO2 PNEU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 6 Additional notes and instructions for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 7

5

Checks

5.2

Functional checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 9

8

Technical data and order data

8.1 8.2

Accessories for laparoscopic surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 11 Insufflation tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 11

A

Annex

A.1

Literature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A -- 2 Transanal Endoscopic Microsurgery (TEM)

A.2

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A -- 3 Transanal Endoscopic Microsurgery (TEM)

A.3

Literature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A -- 5 Laparoscopic Surgery

A.4

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A -- 6 Laparoscopic Surgery

9 -9 -9 -9 -9 --

3 3 3 3 3

GA--AS 001

Important informations Important general instructions for use Z Ensure that this product is used only as intended and described in this instruction manual, by adequately trained and qualified personnel. Z Ensure that maintenance and repair is only carried out by authorized specialized technicians. Z 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. Z Reprocess the products before each application and before returning them for repair as required by the instruction manual in order to protect the patient, user or third parties. Z This manual is an integral part of the product. It is therefore necessary to keep the manual during the product’s entire service life. Z This manual must be passed on to each subsequent owner or user. Z Subject to technical changes! Due to continuous development of our products, illustrations and technical data may deviate slightly from the data in this manual. Z CAUTION -- USA only: Federal law restricts this device to sale by or on the order of a physician.

Safety instructions used in this manual 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 surrounding. NOTE! Tips for optimum use and other useful information.

Structure and use of this manual

.

IMPORTANT! Fields of use / Devices and instruments used: Z Transanal Endoscopic Microsurgery (TEM) LAPARO CO2 PNEU automatic insufflator with TEM PUMP in conjunction with TEM irrigation cannula, TEM tube set, TEM instrument set and TEM accessories. Z Laparoscopic Surgery LAPARO CO2 PNEU automatic insufflator without TEM PUMP in conjunction with Veres cannula / RIWO ART trocar sleeve, High flow trocar sleeve, insufflation tube set and laparoscopic accessories.

.

IMPORTANT! For laparoscopic surgery -- Notes and instructions for use see section 9 The TEM describes displays, indicators and controls, device functions, illustrations as well as necessary control steps and actions of the LAPARO CO2 PNEU automatic insufflator which in part are also used in laparoscopic surgery. To find this information quickly and easily please refer to the overview diagram at the beginning of section 9 (Cross reference to the corresponding section of TEM).

.

IMPORTANT! Changing the mode of operation: The mode of operation can only be selected if the LAPARO CO2 PNEU automatic insufflator is in basic mode (standby mode) (see paragraph 4.4).

GA--AS 001

III

Important informations Overview diagram for TEM application This overview diagram helps in preparing a TEM application showing under what section you find specific information in this manual.

Prepare TEM products

Want to use TEM Disposable Tube Set 8170.841?

no

Want to use ERBE Multifunctional Instrument?

yes Prepare sterile hygiene filter

no

yes

Want to use TEM Disposable Tube Set 4170.801?

Section 3

yes

Use TEM Disposable Tube Set 4170.804 yes

Setup TEM Combination System yes Want to use CO2 connector for gas cylinder up to max. 2 liters?

no

yes

Section 3

Install CO2 gas cylinder mounting bracket.

Connect CO2 connector to central gas supply

yes

Prepare TEM Irrigation Cannula and pierce NaCl irrigation bottle

Alarm functions

Section 4

Error message / Correctiv action

Section 7

yes

Section 5

Carry out automatic function test / check of CO2 gas supply yes

Section 4

Is LAPARO CO2 PNEU in standby mode and ready? (a signal is sounded)

Connect the hygiene filter and TEM Tube Set 8170.841 to the device

yes

Connect the TEM Tube Set 4170.801 or 4170.804 to the device

no

Could fault be eliminated?

no

Contact the Richard Wolf service department

yes Switch off LAPARO CO2 Pneu, switch on again after approx. 30 s

Section 3

yes

Carry out manual checks

Section 5

yes Connect the TEM Tube Set to the instrument

IV

Section 3

GA--AS 001

1. Intended purpose

1

Contents

Section 1 1.

Intended purpose

1.1

Technical description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 -- 2

1.2

Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.2.1 LAPARO CO2 PNEU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.2.2 TEM PUMP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.2.3 TEM Irrigatation Cannula . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.2.4 TEM Tube Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.2.5 TEM Instrumentarium consists of: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.2.6 TEM Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.2.7 Important surgical informations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1.3

Indications and field of use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 -- 3

1.4

Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 -- 4

1.5

Combinations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 -- 4 1.5.1 General requirements on products/components of a combination . . . . . . 1 -- 5

GA--AS 001

1 -1 -1 -1 -1 -1 -1 -1 --

2 2 2 2 2 2 3 3

1- 1

1. Intended purpose

1

1

Dies ist eine unsichtbare Komponente ohne Sprachvariante

1.1

Technical description

The mobile system is a desktop unit for Transanal Endoscopic Microsurgery (TEM) consisting of the LAPARO-CO2 PNEU automatic insufflator, TEM PUMP, TEM Irrigation Cannula, TEM Tube Set, TEM Instrument Set and TEM Accessories.

1.2

Intended use The system is used for pressure--controlled inflation of the colon (rectal cavity and lower portion of the sigmoid) with CO2 gas in order to perform transanal endoscopic microsurgery. The target is the excision of polyps and/or the removal of tumors in conjunction with the TEM instrument set and TEM accessories while evacuating blood, secretion, smoke and/or CO2 gas from the rectal cavity and for cleaning the telescope window. The TEM instruments and their endoscopic accessories must be chosen in such a way that their dimensions suit the anatomical requirements.

1.2.1

LAPARO CO2 PNEU for pressure--controlled dilation of the colon (rectal cavity and lower portion of the sigmoid) with CO2 gas.

1.2.2

TEM PUMP ' for continuous measurement of the rectal pressure ' for continuous evacuation of blood, secretion, smoke and / or CO2 gas ' for flushing the telescope window clean with sterile saline CAUTION! In therapeutic applications a backup unit must be available if the device fails.

1.2.3

TEM Irrigation Cannula serves to control the flow of irrigation fluid and for rinsing the stereo and/or documentation telescope.

1.2.4

TEM Tube Set serves to connect/insufflate, irrigate, evacuate between the TEM combination system and the TEM instruments.

1.2.5

TEM Instrument Set consisting of: Z Resectoscope tube serving as a working channel / port. Z Obturator serves to atraumatically insert the rectoscope tube into the rectum. Z Housing is used to lock the resectoscope tube and obturator in place. Z Attachment with observation window is used for sealing and observing the operating area. Z Working insert serves to house the silicone sealing insert, the stereo telescope and to insert instruments. Z Silicone sealing insert serves to change instruments of different diameters via one large and two smaller flexible ports, keeping the gas losses low. Z U--shaped support arm serves to hold the TEM instruments and to precisely adjust the operating area. The arm is vertically and horizontally adjustable. Z Stereo endoscope allows 3D--visualization of the operating area via the natural passage and telescope rinsing as well as insufflation with CO2 gas. The interpupillary distance is adjustable. Z Documentation endoscope can be connected to a video camera, allowing work/documentation via the monitor. Z Irrigation and insufflation tube is used for rinsing the documentation telescope and for insufflating CO2 gas into the rectal cavity. The irrigation and insufflation insert is exclusively used in video monitored TEM applications.

1 -- 2

GA--AS 001

1. Intended purpose 1.2.6

1

TEM Accessories Z Double blower for dilating the intestine when adjusting the operating area visually. Z Disposable (single--use) filtration attachment preventing germs from entering the double blower. Z Suture Clip Forceps is used to apply an initial and an end clip to replace knots when making a continuous suture to close a wound using absorbable suture material. Z Needle holder is used for the fixation and takeover of curved needles and for making surgical suture. Z HF Scalpel, unipolar is used for coagulating and cutting (e.g. resection and preparation of mucous membrane and tissue) by means of high--frequency current under endoscopic view. Z Retractable Syringe Needle for infections under tissue parts that are be removed.

1.2.7

Important surgical information

.

NOTE : The literature listed (see Annex A--1) gives an overview over the last years. The notes listed below were obtained from the corresponding relevant literature. ' Sessile adenomas are predominantly located in the rectum and lower sigmoid colon. ' For lesions located in the intraperitoneal region of the rectum, partial wall excision (dividing the circular layer from the longitudinal muscle layer) is recommended to reduce the risk of perforation. Full thickness excision is recommended only for lesions in the extraperitoneal region of the sigmoid. ' Segmental resection is suggested for circularly growing adenomas. ' CAUTION is suggested when removing a tumor from the anterior wall of the rectum. The close proximity of the vagina to the anterior wall increases the risk of rectovaginal fistula in females or the risk of prostate hemorrhage in males. ' Suture line dehiscence is known as the most common complication of a TEM procedure. ' Follow--up examinations are recommended once a year for patients who have had adenomas removed and every 3 months after local excision of cancer for the first 2 years. Long--term follow--up to asess the recurrence rate for benign adenomas and the role of TEM in the treatment of invasive cancer is needed to confirm efficacy.

1.3

Indications and field of use The TEM is indicated in the case of a wide--base rectum adenoma and early rectum carcinoma. The rectum adenoma can be removed using the mucosectomy method or also the full--wall method in the areas of the extraperitoneal rectum. Early carcinoma should always be removed using the full wall method. On principle the TEM technique can be used in the areas of the colon and sigma which can be reached with the operating rectoscope.

.

NOTE : Before the first use we recommend reading the relevant literature in addition to participation in an operating course.

The TEM procedure is indicated for: ' histologically confirmed sessile adenomas located in the rectum and lower sigmoid colon. ' histologically confirmed, moderately well differentiated cancer which has been staged pre--operatively as CS1 or T1 carcinoma confined to the submucosa; and ' histologically confirmed, moderately well differentiated cancer which has been staged pre--operatively as T2 in patients >70 years, or younger for patients with high risk factors.

GA--AS 001

1- 3

1. Intended purpose

1

1.4

Contraindications WARNING! The device has a high flow rate. The device cannot be used for hysteroscopy. The device must not be used for inflating the cavum uteri. TEM is contraindicated for patients who have general contraindications to surgery, severe infection and/or a serious metabolic disorder. On the basis of the patient’s general condition the physician/surgeon in charge must decide whether the planned application is possible or not. For further information please refer to the current medical literature.

1.5

Combinations The system is used in conjunction with light sources, videao cameras, HF devices and endoscopic accessories ( see section 8). WARNING! Danger of intrarectal overpressure if a second gas source is used. If argon plasma coagulators are used additional visual or manual pressure monitoring by the user is imperative, because pressure monitoring or the pressure release function (venting) of the LAPARO CO2 PNEU automatic insufflator, e.g. due to a kinked insufflation tube or a closed instrument tap could be deactivated. The preselected gas flow rates of an argon plasma coagulator should not exceed 2 l/min. Activate the argon plasma coagulator only for a short time. WARNING! Danger of potentionally fatal gas or air embolism. Purge the connection tubes with a sufficient amount of CO2 before use. The use of devices applying additional gaseous media in combination with a TEM Combination System or LAPARO CO2 pneu automatic insufflator lies exclusively in the responsibility of the user. CAUTION! Caution if products are incorrectly combined! Possible injury of the patient, user or others as well as possible damage to the product. Different products should only be used in combination if their intended use and relevant technical data (working length, diameter, peak voltage, etc.) are the same. Follow the instruction manuals of the products used in conjunction with this product (see section 8).

1 -- 4

GA--AS 001

1. Intended purpose 1.5.1

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

Patient environment

R = 1.5 m h = 2.5 m Patient environment

Acc. to UL-- 2601: R = 1.83 m (6 feet) ; h = 2.29 m (71/2 feet)

Medically used room Inside the patient environment

MP

MP

µ

µ

MP

NMP

µ

µ

MP

NMP

µ

**

outside the patient environment

Non--medically used room

Requirements / measures Leakage currents to clause 19 IEC/EN 60601--1--1 *

--

--

--

--

--

a) additional protective earth connection (to be clarified with manufacturer), or

MP

b) with additional separating transformer **

NMP

µ MP

NMP

µ

µ

MP

MP or NMP

µ

µ

additional separating transformer according to IEC/ EN 60601--1--1 **

MP = NMP =

--

--

additional separating device according to IEC/ EN 60601--1--1

a) common protective earth connection, or b) additional protective earth connection (to be clarified with manufacturer), or c) additional separating device (to avoid earth/ground loops in the case of a potential difference) Functional connection

µ

power supply grid

medical electrical device according to IEC/ EN 60601--1, UL 2601, CSA C22.2 No. 601 non-- medical electrical device in accordance with the relevant product--specific IEC/ EN/ UL/ IEC standards

* If connected via a joint mains/power cord under normal conditions the earth leakage current of the system must not exceed 500 mA (300 mA for products marked ”UL”.).

**

e.g. Richard Wolf Video Trolley with ”separating transformer”.

GA--AS 001

1- 5

1

1. Intended purpose

1

Z Specific requirements on the products/components of a combination

.

1 -- 6

IMPORTANT! Persons combining products to form a system are responsible for not impairing the system’s compliance with the performance and safety requirements, and that the technical data and the intended use are adequately fulfilled. Electromagnetic interference or other types of interference occurring between this product and other products can cause failures or malfunctions. When selecting the system components ensure that they meet the requirements for the medical environment they are used in, in particular IEC/ EN 60601--1--1. In case of doubt contact the manufacturer(s) of the system components. Do not touch connecting devices for electrical connections between the different components (such as signal input and output connections for video signals, data exchange, control circuits, etc.) and the patient at the same time.

GA--AS 001

2. Illustrations / Controls and indicators

Contents

2

Section 2 2

Illustrations / Controls and indicators

2.1

Symbols / Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.1.1 LAPARO CO2 PNEU / TEM PUMP / Packaging . . . . . . . . . . . . . . . . . . . . . 2.1.2 LAPARO CO2 PNEU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.1.3 TEM PUMP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.1.4 Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2.2

Controls and indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 -- 4 2.2.1 LAPARO CO2 PNEU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 -- 4 2.2.2 TEM PUMP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 -- 6

2.3

Device connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 -- 7 2.3.1 LAPARO CO2 PNEU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 -- 7 2.3.2 TEM PUMP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 -- 7

2.4

Illustrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 -- 8 2.4.1 TEM Irrigation Cannula / TEM Instrument Set . . . . . . . . . . . . . . . . . . . . . . . 2 -- 8 2.4.2 TEM Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 -- 10

GA--AS 001

2 -2 -2 -2 -2 --

2 2 2 2 3

2- 1

2. Illustrations / Controls and indicators 2

Dies ist eine unsichtbare Komponente ohne Sprachvariante

2.1

Symbols / Labeling

2.1.1

LAPARO CO2 PNEU automatic insufflator / TEM PUMP / Packaging

2

Symbols / Labeling

Meaning

Symbols / Labeling

Meaning

Attention, consult ACCOMPANYING DOCUMENTS!

Identification plate

TYPE BF APPLIED PART

Fuse

Measuring line, for rectal pressure

µ

Alternating current (AC)

Equipotentality

=

DC

Protective earth / ground connection

Identification in conformaty with Medical Devices Directive 93/42/EEC only valid if the product and/or packagingis marked with this symbol. Products of category IIa and above, as well as sterile products or products with measuring function pertaining to category I, are additionally marked with the code number of the notified body (0124)

2.1.2

LAPARO CO2 PNEU automatic insufflator Symbols / Labeling

2232 TEM PUMP

ONLY FOR CO2 ! 3--150 bar

Fuse

T 2.0 L A 2.1.3

Rear panel front

rear

Output, insufflation connector

x

--

Sub D socket, 15--pole (electrical connection to TEM PUMP)

--

x

Use only CO2 gas (pressure between 3--150 bar)

--

x

Use of device fuses

--

x

TEM PUMP Symbols / Labeling

2232 LAPARO CO2 PNEU

2 --

Meaning

2

Meaning

Rear panel front

rear

Hygiene filter

x

--

Output, irrigation pressure

x

--

Input, pressure measurement, patient

x

--

Socket for foot switch

--

x

Sub D socket, 15--pole (electrical connection to LAPARO CO2 PNEU automatic insufflator)

--

x

GA--AS 001

2. Illustrations / Controls and indicators 2.1.4

Packaging Symbols / Labeling

Meaning Attention, consult ACCOMPANYING DOCUMENTS!

REF

2

Order number Lot identification number Manufacturing date Units, pieces, items per package To be used before (date): Do not reuse! Sterilized with ethylene oxide Steam sterilization -- using the fractional pre--vacuum method

25° 15°

Permissible temperature range Protect against heat

99.5 %)

Device input pressure

3 bar to 150 bar

Intrarectal pressure

3 mmHg to 25 mmHg (¦ 2 mmHg) preselectable in steps of 1 mmHg

Intraabdominal pressure

3 mmHg to 25 mmHg (¦ 2 mmHg) preselectable in steps of 1 mmHg

Rectum operation -- Gas flow rate

8

A

Laparoscopy -- Gas flow rate primary filling -- Gas flow rate high flow

1 l/min to 8 l/min (¦ 20 %), preselectable in steps of 1 l/min 1 l/min (¦ 50 %) 1 l/min to 30 l/min (¦ 20 %), preselectable in steps of 1 l/min

-- Consumption display 8.1.2

0 l to 999 l (¦ 20 %)

Safety features

Automatic function check

Self check after switching on the device

Automatic fault/error recognition

yes

Automatic error message

yes

Automatic error memory

yes

Volume of acoustic signal Alarm system Hygiene filter on outlet 8.1.3

3 alarms: LOW / MEDIUM / HIGH Sterile item

Additional options

Indication of insufflation pressure during primary filling ' Quadro Test

8 --

adjustable in 16 steps

2

yes

GA--AS 001

8. Technical data and order data 8.1.4

Interfaces

Data transmission and supply voltage for TEM PUMP Gas connection

Sub D socket, 15--pole M12 x 1.5

C02 gas measuring line

Quick action coupling

Irrigation pressure supply line

Quick action coupling

Hygiene filter connector

Conical connection, Æ 15.0 mm dia, DIN ISO 5356 T1

8

GA--AS 001

8- 3

8. Technical data and order data 8.2

TEM PUMP Model

Voltage V=

Power consumption VA

Current rating A

2232.244

24

30

1,3

Electromagnetic compatibility (EMC) in acc. with Medical Products Directive 93/42/EEC Protection against electric shock

Class II b Type BF applied part

Protection class in acc.with EN 60601--1/IEC 601--1; (UL 2601--1 / CSA C22.2 No.601.1 -- for USA)

I

Degree of protection against the ingression of liquid

IP 20 (Not protected)

Mode of operation

Continuous operation

Degree of protection if used in the presence of flammable mixtures Weight (without CO2 cylinder) Dimensions (without cylinder holder) wxhxd

8.2.1

Output pressure for irrigation bottle Suction rate

8.2.2

Device is not protected against explosions (Do not operate this device in inflammable environment) 6.9 kg (15.2 lbs) 330 mm x 100 mm x 390 mm

Application parameters

Pressure connection

3 bar 1 bar , med. CO2 (degree of purity > 99,5 %) 0.5 to 1.5 l/min

Safety features

Automatic function check

8

EN 60601--1--2 / IEC 601--1--2

Self check after switching on the device

Automatic fault/error detection

yes

Automatic error message

yes

Automatic error memory

yes

Alarm system Hygiene filter on outlet

8.2.3

see LAPARO CO2 PNEU Sterile item

Interfaces

Data transmission and supply voltage for TEM PUMP

Sub D plug, 15--pole

C02 measuring line

Quick release coupling

Irrigation supply line

Quick release coupling

Irrigation pressure hygiene filter connection Measuring input hygiene filter connection Foot switch connector

8 --

4

Luer connector, 3 mm male Luer connector, 3 mm female Tube type connector

GA--AS 001

8. Technical data and order data 8.3

Spare parts and accessories for TEM Combination System Mode / type

Designation

64268.014

Device fuse T 2.0 L (10 / pkg)

2440.03

Mains / power cable (Europe), 3.0 m

9500.016

Open end wrench size 30

8170.301

High pressure tube -- DIN connection

8170.303

High pressure tube -- ISO connection

8170.311

Connection tube for central CO2 gas supply

74002.128

O--Ring (a) for cylinder connection of high pressure tube 8170.303

64016.151

Teflon seal (c) for cylinder connection of high pressure connection tube 8170.302

2221.951

Holding bracket for CO2 cylinder , (Æ 80 to 90 mm dia.)

2221.952

Holding bracket for CO2 cylinder, (Æ 100 to 115 mm dia.)

2046.961

0.75 kg CO2 cylinder (approx. 350 l of CO2) with DIN connector, (Æ 80 mm dia.)

64321.106

Protective earth connection with assembly accessories

64226.014

Spare pump tube (5 / pkg)

4171.111

Hygiene filter, in sterile package, for insufflation connector (10 / pkg)

4171.112

Hygiene filter, in sterile package for measurement input and irrigation pressure output (10 / pkg)

2232.841

Holder for irrigation bottle

2030.231

Pneumatic foot switch

2232.852

CO2 connection tube LAPARO CO2 PNEU ' TEM PUMP further accessories on request

a

ISO connection 8170.303

b

DIN connection 8170.301

c

PIN index connection 8170.302

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 catalog sheets and brochures, or contact Richard Wolf or your Richard Wolf representative.

GA--AS 001

8- 5

8

8. Technical data and order data 8.4

TEM Instrument Set Obturator (Pos. 2) for tube Item

81 (82)

8

Illustration

Designation

15016.197

15016.198

Rectoscope tube dia. 40 mm; WL= 120 mm with obturator 8840.02

J

j

Rectoscope tube dia. 40 mm; WL= 137 mm with obturator 8840.031

J

j

Rectoscope tube dia. 40 mm; WL= 200 mm with obturator 8840.04

j

J

and Model / type

80

U--shaped support arm 8840.9721 Manufactured by GEOMED

------

80.4

Clamping base, insulated 8840.9722 Manufactured by GEOMED

------

83

Housing 8840.20

------

84

Attachement with observation window 8840.25

------

85

Working insert 8840.241

------

86

Sealing insert 8840.242

------

87

Stereo endoscope dia.13.8mm; WL=259mm Viewing direction 50_ Image angle 70_ 4840.501

------

87.2

Locking cone 8840.591

------

88

Documentation endoscope 8840.401

------

89

Irrigation and insufflation tube 8840.501

------

J j

8 --

6

Use obturator Do not use obturator

GA--AS 001

8. Technical data and order data 8.4.1

Spare parts Item

Illustration

83.6 84.2/ 85.1

8.5

Model / type

Designation

15 564.003

Sealing ring for housing 8840.20

15 364.095

O--Ring for attachment with observation window 8840.25 and working insert 8840.241

86

8840.242

Sealing insert

--

89.01

Sealing cap, red

--

89.02

Sealing cap, blue

--

89.03

Sealing cap, grey

--

89.141

Sealing cap, blue

--

89.161

Sealing cap, red

--

89.10

Sealing cap, red

TEM Irrigation Cannula Item

Illustration

8170.865

70

8.5.1

Model / type

Designation TEM Irrigation Cannula, external dia. 5.0 mm; internal dia. 2,0 mm; WL= 215 mm

Spare parts Item

Illustration

Model / type

Designation

72

64110.487

Luer part

73

64018.010

Silicone seal with lateral hole (5 / pkg)

74

64104.074

None--return valve

75

64103.013

Valve slide

76

64018.011

Silicone seal with central hole (5 / pkg)

77

64136.007

Screw cap

77.1

64248.027

Depending on the irrigation cannula version: Compression spring (5 / pkg)

GA--AS 001

8

8- 7

8. Technical data and order data 8.6

TEM Tube Set Model / type

Designation

8170.841

TEM Reprocessable Tube Set (not for USA)

8170.861

Reprocessable pump tube (not for USA)

8170.862

Reprocessable connection tube (not for USA)

4170.801

TEM disposable Tube Set consisting of: 4170.864 Pump tube 4170.862 Connection tube 4170.842 Tube set

4170.804

TEM Disposable Tube Set for ERBE Multifunctional Instrument consisting of: 4170.864 Pump tube 4170.862 Connection tube 4170.843 Tube set 4170.867 Irrigation tube ERBE

8

8 --

8

GA--AS 001

8. Technical data and order data TEM accessories

.

NOTES : For the instruments marked ” * ” we recommend that you always have a spare (backup) unit available to ensure immediate adequate replacement in case of sudden failure so that the operation can be completed in due course.

Sealing cap red

blue

grey

red

d

Designation / Model / type

KV1)

Ø3.4 to Ø5.1

Ø5.1 to Ø6.0

d

89.01 89.02 89.03

Ø4.0 to Ø7.5 to Ø6.0 Ø8.5

Ø13.0 to Ø13.8

89.141

89.161

89.10

Disposable filter (sterilely packed), (50 / pkg) 2148.95

--

--

--

--

--

--

Double blower with luer lock tube fitting 886.00 127.00

--

--

--

--

--

--

Suture Clip Forceps, dia 6.0 mm; WL= 405 mm 8840.762* for the above

--

j

j

J

J

j

Suture Clamp (50 / pkg) 8840.764

--

--

--

--

--

--

Needle Holder, straight; dia. 4.6 mm, WL= 405 mm 8840.604*

--

j

J

j

J

j

Needle Holder with downward offset; dia. 4.6 mm; WL= 405 mm 8840.605*

--

j

J

j

J

j

Curved needle ETHICON SH 3--0 or BRAUN--DEXON, MAXON 3--0, HR 26

--

--

--

--

--

--

HF Scalpel, unipolar right; dia. 4 mm WL= 420 mm 8840.711*

1.5

j

J

j

J

j

HF Scalpel, unipolar left; dia. 4 mm WL= 420 mm 8840.712*

1.5

j

J

j

J

j

Retractable Syringe Needle; dia. 4.0 mm; WL= 325 mm 8840.74

--

j

J

j

J

j

KV = do not exceed maximum recurring peak voltage!

GA--AS 001

d

for instruments dia. (in mm) Ø2.4 to Ø3.4

1)

red

17 mm 17 mm

15 mm

Illustration

blue

J j

only for w working insert in 884 840.241

8.7

Use sealing cap Do not use sealing cap

8- 9

8

8. Technical data and order data

Sealing cap red

blue

grey

red

blue

17 mm 17 mm

15 mm d

Designation / Model / type

KV1)

Ø3.4 to Ø5.1

Ø5.1 to Ø6.0

89.01 89.02 89.03

Ø4.0 to Ø6.0

Ø7.5 to Ø8.5

Ø13. 0 to Ø13. 8

89.141

89.161

89.10

2.0

j

j

J

J

j

GA--B152

Coagulation Suction Tube, unipolar dia. 5.6 mm; WL= 470 mm 8840.731*

2.0

j

J

j

J

j

GA--S008

HF combination forceps, unipolar, offset, curved right; Ø 4.8 mm; WL= 405 m 8840.621

2.0

j

J

j

J

j

GA--S008

HF combination forceps, unipolar, offset, curved left; Ø 4.8 mm; WL= 405 mm 8840.622

2.0

j

J

j

J

j

GA--S008

HF combination forceps, unipolar,curved right; Ø 4.8 mm; WL= 405 mm 8840.623

2.0

j

J

j

J

j

GA--S008

HF combination forceps, unipolar, curved left; dia. 4.8 mm; WL= 405 mm 8840.624

--

j

J

j

J

j

GA--S003

Scissor, curved right; dia. 4.0 mm; WL= 405 mm 8840.643

--

j

J

j

J

j

GA--S003

Scissor, curved left; dia. 4.0 mm; WL= 405 mm 8840.644

1)

8 -- 10

KV = do not exceed maximum recurring peak voltage!

d

for instruments dia. (in mm) Ø2.4 to Ø3.4

8

d

J j

only for w working insert i 8840. 0.241

Illustraion

red

Use sealing cap Do not use sealing cap

GA--AS 001

8. Technical data and order data 8.8

Additional spare parts and accessories Illustration

-

Model / type

Designation

15 023.133

Luer locking cap

74014.069

Compression spring

8106.032 / 8106.052 8106.132 / 8106.152 8106.031 / 8106.051 8106.033 / 8106.053 8106.034 / 8106.054

HF connection cable =3m/=4m =3m/=4m =3m/=4m =3m/=4m =3m/=4m

38043.011

Sterilization and storage basket for: Stereo endoscope 4840.501 and Documentations endoscope 8840.401

200.532

Instrument oil WO53

6.07

Cleaning brush

--

Bottle brush

86.90

Cleaning brush

8

GA--AS 001

8 - 11

8. Technical data and order data 8.9

Replacing device fuses CAUTION! The specification of the fuses in the device must correspond with the fuse ratings on the identification plate. Use only the fuses specified in the spare parts list. L Power input connector with fuse holder. 1. Switch off the power switch: Press the

l/min

button.

2. Disconnect the power input connector from the wall socket. !

1 !

2

1. Push together the clamps of the fuse holder and pull out the fuse holder. 2. Pull out and replace fuses. 3. Reinsert fuse holder and push it in. ' Fuse holder snaps into place.

8 1 8.10

2

3

Operating, storage, transport and shipping conditions

Operating conditions

+10°C to +40°C , 30% to 75% rel. humidity, atmospheric pressure 700 hPa to 1060 hPa

Storage, transport and shipping conditions

-- 20°C to +60°C , 10% to 90% rel. humidity, atmospheric pressure 700 hPa to 1060 hPa

. 8.10.1

NOTE : To prevent damage during transport or shipment of the products we recommend using the original packaging material.

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.

8 -- 12

GA--AS 001

Laparoscopic Surgery

Contents

Section 9 Overview diagram for laparoscopic surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 2 1

Intended purpose

1.1

Technical description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 3

1.2

Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 3 1.2.1 Insufflation tube . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 3

1.3

Indications and field of use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 3

1.4

Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 3

1.5

Combinationen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 3

3

Set up

3.3

Connecting the insufflation tube . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.3.1 Choosing the insufflation tube . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.3.2 Before connecting the insufflation tube . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.3.3 Connection diagrams for laparoscopic surgery . . . . . . . . . . . . . . . . . . . . . . .

4

Use

4.1

LAPARO CO2 PNEU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 6 4.1.1 Operating principle laparoscopy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 6 4.1.2 Selecting the laparoscopy mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 6

4.2

Additional notes and instructions for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Establishing pneumoperitoneum . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.2.1 4.2.2 Secondary filling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.2.3 Alarm messages not relating to device defects . . . . . . . . . . . . . . . . . . . . . .

5

Checks

5.2

Functional checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 9 5.2.3 Manual check for laparoscopy mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 9

8

Technical data and order data

8.1

Laparoscopic surgery accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 11

8.2

Insufflation tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 11

GA--AS 001

9 9 9 9

-----

9 -9 -9 -9 --

4 4 4 4

7 7 8 8

9- 1

9

Laparoscopic Surgery Overview diagram for laparoscopic surgery Section Section

Make sure you observe the special sections on laparoscopic applications. Sections which have already been described in transanal endoscopic microsurgery (section 1 -- 8) and which are also used in laparoscopic surgery. Technical description Intended use

Section 1

General requirements for products / components of a combination Paragraph 1.5.1

Indication and field of use Kontraindikationen Contraindications Combinations

Section 2

Illustrations / Controls and indicators

Setup

Section 3

Paragraph 2.1.1

Section 3

Assemble irrigation bottle holding bracket

Paragraph 3.1.2

Electrical (protective earth) and CO2 gas supply connections

Paragraph 3.1.1

CO2 connection

Paragraph 3.1.3

Insufflation tubes Use

Section 4

Section 5

Possible alarms during use

Paragraph 4.5.3

Power failure

Paragraph 4.5.4

Measures after insufflation

Paragraph 4.5.5

Alarm functions

Paragraph 4.6

Adjusting the alarm volume

Paragraph 4.6.1

Visual check

Paragraph 5.1

LAPARO CO2 PNEU

Paragraph 5.1.1

Function check

Paragraph 5.2

Automatic function checks

Paragraph 5.2.1

Checking the CO2 gas supply

Paragraph 5.2.2

Manual check during operation Manual reprocessing

9

Section 6

Maintenance Maintenance intervals, quarterly inspection, Test of the pressure and gas flow control on the LAPARO CO2 PNEU, Leakage test

Error messages / Correctiv actions

Section 7

Paragraph 6.1.2

Section 7

Device errors

Paragraph 7.1

Error messages for LAPARO CO2 PNEU

Paragraph 7.2

Technical data and order data

Section 8

Paragraph 6.1.1

LAPARO CO2 PNEU

Paragraph 8.1 – Paragraph 8.1. 4

Instrument Set

9 -- 2

GA--AS 001

Laparoscopic Surgery 1

Intended purpose

1.1

Technical description The portable system is a desktop unit for laparoscopic surgery consisting of the LAPARO CO2 PNEU, an insufflation tube set and various instruments.

1.2

Intended use The LAPARO CO2 PNEU is used for establishing and maintaining the pneumoperitoneum using CO2 gas. CAUTION! In therapeutic applications a backup unit must be available if the device fails.

1.2.1

Insufflation tube It provides the connection between the LAPARO CO2 PNEU automatic insufflator and laparoscopic instruments, for insufflation purposes.

1.3

Indications and field of use The LAPARO CO2 PNEU is used in diagnostic and operative laparoscopy.

. 1.4

NOTE : Before the first use we recommend reading relevant literature (see appendix A--3).

Contraindications The LAPARO CO2 PNEU is contraindicated in all cases where laparoscopy is contraindicated. WARNING! The device has a high flow rate. The device cannot be used for hysteroscopy. The device must not be used for inflating the cavum uteri. On the basis of the patient’s general condition the physician/surgeon in charge must decide whether the planned use is possible or not. For further information see the latest medical literature.

1.5

Combinations WARNING! Danger of potentially fatal gas or air embolism. Purge the connection tubes with a sufficient amount of CO2 before use. The use of devices applying additional gaseous media in combination with a TEM Combination System or LAPARO CO2 PNEU automatic insufflator lies exclusively in the responsibility of the user. WARNING! Danger of intraabdominal overpressure if a second gas source is used. If argon plasma coagulators are used additional visual or manual pressure monitoring by the user is imperative, because pressure monitoring or the pressure release function (venting) of the LAPARO CO2 PNEU automatic insufflator could be deactivated, e.g. due to a kinked insufflation tube or a closed instrument tap . The preselected gas flow rates of an argon plasma coagulator should not exceed 2 l/min. Activate the argon plasma coagulator only for a short time. CAUTION! Caution if products are incorrectly combined ! Possible injury of the patient, user or others as well as possible damage to the product. Different products should only be used in combination if their intended use and relevant technical data (working length, diameter, peak voltage, etc.) are the same. Follow the instruction manuals of the products used in conjunction with this product (see paragraph 8.3).

GA--AS 001

9- 3

9

Laparoscopic Surgery 2

3 3.1 3.2

Set up

3.3

Conneting the insufflation tube

3.3.1

Choosing the insufflation tube CAUTION! The Disposable Insufflation Tube is designed for single use only and is sterilely packed. Do not use the Disposable Insufflation Tube if ' the sterile packaging is damaged ' the shelf life of the set has expired For the connection diagrams of the insufflation tubes listed below, see paragraph 3.3.3 Z Reprocessable insufflation tube (not for USA) Z Disposable insufflation tube

3.3.2

Before connecting the insufflation tube IMPORTANT! Risk of contamination of the TEM insufflation system through backflow of gas or body liquid. Always use hygiene filters between the device connections and the tubes. Z Carry out an automatic function check and a check of the CO2 gas supply, see section 5 Z Function check passed: Connect TEM Tube Set to the device, see paragraph 3.3.3

.

3.3.3

IMPORTANT! Error messages E05 and E30 are displayed if the hygiene filter or the disposable insufflation tube is connected before the automatic function check is carried out.

Connection diagrams for laparoscopic surgery Z Reprocessable Insufflation Tube (not for USA) ' 8170.101 -- for Veres cannula / RIWO--ART trocar sleeve dia. 10 mm (B1) ' 8170.232 -- for High--Flow trocar sleeve dia. 10 mm and dia. 12.5 mm (B1, B2) Disconnect the luer lock fitting from the insufflation tube and plug the end of the tube onto fitting (x)

CO 2

l/min

Liter

B2

2 2 3 2 LAPAR O

C O2 - PN EU

(x)

0 HIGH

!

B1

9

B1 B2 B1

9- 4

B1

B1

B2

B2

GA--AS 001

Laparoscopic Surgery Z Disposable Insufflation Tube ' 4170.501 -- for Veres cannula / RIWO--ART trocar sleeve dia. 10 mm / High--Flow trocar sleeve dia. 10 mm and dia. 12.5 mm (B) Disconnect the luer lock fitting from the insufflation tube and plug the end of the tube onto fitting (x) CO 2

l/min

Liter

white

2 2 3 2 LAPAR O

C O2 - PN EU

(x)

0 HIGH

!

white

white

B

.

B

B

NOTE : After having connected the insufflation tube to the device perform the manual check as described in paragraph 5.2.3.

9

GA--AS 001

9- 5

Laparoscopic Surgery 4

Use

4.1

LAPARO CO2 PNEU

4.1.1

Operating principle Pneumoperitoneum is established by insufflating CO2 gas in the abdominal cavity. The gas is supplied to the LAPARO CO2 PNEU automatic insufflator from CO2 cylinders or a central gas supply system. The gas pressure and the gas flow rate are controlled by the LAPARO CO2 PNEU in accordance with the requirements (i.e. the settings) of the user. The preset values remain stored and active when the device is switched off and on again. Safe insufflation is guaranteed through microprocessor--controlled monitoring and display of the pressure and flow values as well as several independent safety features. There are 2 modes of insufflation: Primary insufflation: The insufflation always starts in this mode with a fixed flow rate of 1.0 l/min. High Flow: After establishing pneumoperitoneum this mode can be selected to maintain pneumo-peritoneum.

4.1.2

Selecting the laparoscopy mode Standby mode of LAPARO CO2 PNEU automatic insufflator

30 s

l/min

2 !

3 1

1. Switch off power switch: Press the

button.

2. Remove all hygiene filters. 3. After 30 seconds switch on the power switch: Press the

button.

Always after switching on: ' The LAPARO CO2 PNEU runs through an automatic function test routine (duration approx. 15 seconds). ' The suction pump is activated. ' In case of a fault / error an error code (error no.) is displayed, see section 7.

!

' The LEDs of the

indicator blink alternately.

' The LEDs of the level indicators show the test duration. A signal is sounded: ' The LEDs stop blinking. ' The LAPARO CO2 PNEU is in standby mode and ready. If you switch on before the 30 seconds have elapsed: ' The state previously set on the LAPARO CO2 PNEU is displayed. ' The LAPARO CO2 PNEU is not in standby mode (not ready). Repeat items 1--3.

9

Primary insufflation mode 1. Attach the hygiene filter.

1

l/min

2. To start insufflation: Press the ' The !

2/3 !

button is lit.

' Primary insufflation 1.0 l/min is activated. If the Veres cannula is connected: ' On the level indicator (2a) the -- current intraabdominal pressure and -- the insufflation pressure (LEDs of level indicator (2b) blink) are indicated. 3. To stop insufflation: Press the ' The

9 -- 6

button.

button.

button is not lit.

GA--AS 001

Laparoscopic Surgery High Flow mode

. l/min

2/3 !

1

NOTE : The “High Flow” mode can only be selected if primary insufflation is activated.

1. To start insufflation: Press the ' The

button.

button is lit.

' Primary insufflation at 1.0 l/min is activated. !

2. To start High--Flow: Press the ' The

button.

button is lit.

' The preselected gas flow rate (up to 30.0 l/min) is activated.

.

NOTE : When actuating this button for the first time after switching on the device, the value of the gas flow rate last preselected is selected, however maximum 20.0 l/min.

3. To stop High Flow: Press the ' The

button.

button is not lit.

' The device is in “Primary insufflation” mode.

4.2

Additional notes and instructions for use . IMPORTANT! Before performing a laparoscopy observe and perform the measures described in sections 3 „Setup“ and 5 „Checks“.

4.2.1

Establishing pneumoperitoneum Z Introduce the Veress cannula into the abdomen and find the correct position. Z Connect the Veress cannula to the insufflation tube. Z Lift the abdominal wall by pulling vigorously. ' When the Veress cannula is positioned freely in the abdomen a vacuum must be indicated on the ”intraabdominal pressure” level indicator and digital display and an acoustic signal must be sounded. Z Start primary insufflation. ' The pressure is increased to the preselected value. Quadro test after Prof. Semm Monitor insufflation by checking / monitoring the following values: ' Gas flow (the gas flow must not be substantially below 1.0 l/min) ' intraabdominal pressure and insufflation pressure (the insufflation pressure (blinking single bar) can be max.15 mmHg higher than the intraabdominal pressure, if exceeded a signal is sounded) ' Gas volume consumed This test is used to check the Veress cannula for free position within the abdominal cavity and correct functioning of the Laparo CO2 Pneu. If the aforementioned parameters do not correspond, the cannula is not positioned freely in the abdominal cavity. Once the preselected pressure is reached, no further insufflation takes place. Secondary filling is performed in ”High Flow” mode. We recommend recording / documenting the gas supply used in the primary filling.

GA--AS 001

9- 7

9

Laparoscopic Surgery 4.2.2

Secondary filling WARNING! Danger of gas embolism Use the ”High Flow” mode only for the secondary filling.

.

Z Z Z Z Z

Introduce the trocar sleeve with the trocar in place into the abdomen. Connect the insufflation tube to the closed insufflation tap. Remove the trocar and insert the endoscope. After ensuring the correct incision position, open the insufflation tap. Switch from primary insufflation to high flow insufflation by pressing the ”High Flow” button.

.

4.2.3

IMPORTANT! With the 5.0 mm insufflation tubing and a standard trocar sleeve a flow of only approx. 10.0 l/min can be achieved. If a higher flow rate is required (up to 30,0 l/min), use a high flow insufflation tubing and high flow trocar sleeve.

NOTE : If insufflation is performed at a high flow rate over a prolonged period of time this may cause severe cooling of the CO2 gas supply and a temporary pressure loss in the supply container. ”LOW ALARM” is triggered. When insufflation is switched off the original pressure in the supply container is restored.

Alarm messages not relating to device defects Overpressure alarm (E11) Possible causes: ' With the anesthesia wearing out the patient starts pumping. ' The user exerts pressure on the abdomen. ' additonal gas or liquid is supplied to the abdomen. Corrective action: ' Reduce overpressure and restart insufflation.

9

9 -- 8

GA--AS 001

Laparoscopic Surgery 5 5.1

Checks

5.2

Functional checks

5.2.3

Manual check for laparoscopy mode

5.2.1 5.2.2

.

NOTE : Precondition for the manual check: ' Automatic function check passed and ' TEM--PUMP switched off Insufflation function l/min

1b

Z Preselect the nominal pressure.

2b 3a

Gas flow check -- Primary insufflation

2

1. Switch on insufflation: Press the !

1a

1/3

2a

button.

' The intraabdominal pressure increases to the preselected value. ' The level indicator (1a) and digital display (1b) must read a gas flow of 1.0 l/min ± 0.5 l/min. Gas flow check -- High Flow 2. Switch on High Flow: Press the button. ' The values on the level indicator (2a) and digital display (2b) must be the same as the preselected gas flow of the level indicator (± 20% of the preselected value). ' After the gas flow check, the digital display (3a) must read a clear gas consumption.

!

3. Switch off insufflation: Press the

button.

Control check l/min

1b

2b

!

1a

2a

1/2 !

button. 1. Switch on insufflation: Press the ' The level indicator (1a) and digital display (1b) must read a gas flow of 1.0 l/min ± 0.5 l/min. ' The insufflation pressure indicator must read a value between 4 and 10 mmHg (the individiual LEDs of the level indicator (2a) blink), independent of the preselected pressure. ' The insufflation pressure is higher than 10 mm Hg: Check the Veres cannula for a defect or clogging, replace if necessary. 2. Switch off insufflation: Press the ' The

GA--AS 001

button.

button is not lit.

9- 9

9

Laparoscopic Surgery Z Preselect a nominal gas flow rate of 10.0 l/min. Z Remove the Veres cannula. l/min

1a

3a

2/4 !

1/6 !

3/4

1. Switch on insufflation: Press the

button.

2. Switch on High Flow: Press the

button.

' The level indicator (1a) and digital display (1b) must read a gas flow of 10.0 l/min ± 2.0 l/min. 3. Close the insufflation tube with your thumb. ' If the actual pressure exceeds the preselected pressure, the device must release excessive pressure (click sound). Actual pressure is reduced to 0 mmHg until the next insufflation phase. 4. Open the insufflation tube. 5. Switch off High Flow: Press the

button.

' After 15 s at the latest the level indicator (1a) and digital display (1b) should read a gas flow rate of 1.0 l/min ± 0.5 l/min. ' Primary insufflation is active. 6. Switch off insufflation: Press the ' The

button.

button is not lit.

' The level indicator (1a) and digital display (1b) read the preselected gas flow rates.

9

9 -- 10

GA--AS 001

Laparoscopic Surgery 6 7

8

Technical data and order data

8.1

Laparoscopic surgery accessories Model / type

Designation

4171.111

Hygiene filter, sterilely packed, for insufflation connector (10 / pkg)

8302.12

Veres cannula

8923.013

RIWO--ART Trocar sleeve, dia. 10.0 mm

8923.0421)

High Flow Trocar sleeve, dia. 10.0 mm

8924.0421)

High Flow Trocar sleeve, dia. 12.5 mm

8923.801

VARIO--PORT Reducing adapter to dia. 5.5 mm

8924.801

VARIO--PORT Reducing adapter to dia. 10.0 mm

Instructions -HA--EF 45a

GA--B 129

GA -B GAB 135

1)Preferably the afore mentioned trocar sleeves should be used. If other Richard Wolf trocar sleeves are used, in connection with high preselected gas flow rates ( > 10.0 l/min) this will result in a reduction of the gas flow rate due to relatively high pressure losses in the insufflation system

further accessories on request 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 catalog sheets and brochures, or contact Richard Wolf or your Richard Wolf representative.

8.2

Insufflation tubes Model / type

Designation

8170.101

Reprocessable Insufflation Tube, dia. 5.0 mm , length 2.5 m

8170.232

High Flow Insufflation Tube, dia. 8.0 mm , length 2.5 m

4170.501

Disposable Insufflation Tube

9

GA--AS 001

9 - 11

Laparoscopic Surgery

9

9 -- 12

GA--AS 001

Annex

Contents A.

Annex

A.1

Literature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A -- 2 Transanal Endoscopic Microsurgery (TEM)

A.2

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A -- 3 Transanal Endoscopic Microsurgery (TEM)

A.3

Literature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A -- 5 Laparoscopic Surgery

A.4

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A -- 6 Laparoscopic Surgery

A

GA--AS 001

A- 1

Annex A. 1

Literature Transanal Endoscopic Microsurgery (TEM)

.

IMPORTANT! As we cannot provide a comprehensive bibliography we would ask users to keep themselves informed of all new developments in this field.

Z Benefit in therapy of superficial rectal neoplasms objectivized: transanal endoscopic microsurgery (TEM) compared to surgical standards. G.Winde, G.Blasius, R.Herwig, N.Lügering, R.Keller & R.Fischer. 1997, Min Invas Ther & Allied Technol, 6:315--323.

Z Technique and results of transanal endoscopic microsurgery in early rectal cancer. G.Buess, B.Mentges, K.H.Manncke, M.Starlinger, H.D.Becker 1992 Jan, Am--J--Surg. 163(1): 63--9, discussion 69--70

Z Transanal Endoscopic Microsurgery using the Buess’s rectoscope -Tübingen Experience --Endoscopic digestiva (Japan). E.Kanehira, H.Raestrup, G.Bueß, K.H.Manncke, B.Mentges, J.M.Mayer, H.D.Becker 1993, Endoscopic digestiva 4:557--562

Z Transanal Endoscopic Microsurgery in Italy. M.M.Lirici, L.Chiavellati, E.Lezoche, S.Martelli, G.Melotti, M.Morino, M.Guerrieri, I.Selmi, S.Stipa, L.Angelini. 1994, End Surg 2:255--8

Z Indications and Technique for TEM (Transanal Endoscopic Microsurgery). H.Raestrup, K.H.Manncke, B.Mentges, G.Bueß, H.D.Becker 1994, ESAT 5:241--246

Z Experience with TEM in Germany. R.Salm, H.Lampe, A.Bustos, Matern 1994, End Surg 2:251--254

Z Transanal endoscopic microsurgery -- initial experience from three centres in the United Kingdom. R.J.C.Steele, M.J.Hershman, NJMcCMortensen, et al. 1996, Brit J Surg 83 207--210

A

A -- 2

GA--AS 001

Annex A. 2

Index Transanal Endoscopic Microsurgery (TEM)

A

E

Accessories: 8-- 5, 11 Adapter with viewing window: 4-- 4 Additional notes and instructions for use: 4-- 8, 10, 13 Additional options: 8-- 2 Additional spare parts: 8-- 11 Alarm functions: 4-- 15 Alarm volume: 4-- 16 Application parameters: 8-- 2, 4 Attachment with observation window: 1-- 2; 5-- 2 Automatic check: 5-- 3

Electrical current: 4-- 10 ERBE Multifunctional Instrument: 3-- 4, 7 Error message: 7-- 1 Error messages for LAPARO--CO2--PNEU: 7-- 2 Error messages for TEM--PUMP: 7-- 3 Establishing electric (protective earth / ground): 3-- 3

C

F Flexible instrument port: 4-- 6 Function principle: 4-- 2 Functional checks: 5-- 3

G

Checks: 5--1; 6-- 6, 9, 10, 12, 13, 14 Clamping base: 4-- 3 Cleaning / disinfection: 6-- 3, 5, 7, 9, 10, 12, 13, 14 CO2 connection: 3-- 3 CO2 gas supply: 5-- 4 CO2 --Betrieb: 3-- 3 Combinations: 1-- 4 Connection diagram: 3-- 5 Contraindications: 1-- 4 Controls and indicators: 2-- 1, 4 Correctiv action: 7-- 1

D Device connections: 2-- 8 Device errrors: 7-- 2 Disposable (single--use) filtration attachment: 1-- 3 Disposable filtration adaptor: 6-- 9 Disposal of product , packaging material and accessories: 8-- 12 Documentation endoscope: 1-- 2; 4-- 7; 5-- 5 Double blower: 1-- 3; 4-- 4; 6-- 9 Double function footswitch: 5-- 5 Dry preparation at the point of use: 6-- 6, 7, 9, 10, 12, 13, 14

GA--AS 001

General requirements on products/components of a combination: 1-- 5

H HF Applications: 4-- 11 HF Scalpel, unipolar: 1-- 3; 4-- 10; 5-- 3; 6-- 13 HIGH alarm: 4-- 15 Housing: 1-- 2

I Illustrations: 2-- 1, 9 Important surgical information: 1-- 3 Indications and field of use: 1-- 3 Inflating the rectal cavity: 4-- 13 Installation of the TEM Combination System: 3-- 2 Insufflation: 4-- 13 Insufflation function: 5-- 4 Intended purpose: 1-- 1 Intended use: 1-- 2 Interfaces: 8-- 3, 4 Irrigation: 4-- 14 Irrigation bottle holder: 3-- 2 Irrigation / suction control via the footswitch: 4-- 14 Irrigation and insufflation tube: 1-- 2 Irrigation fluid: 4-- 10

A- 3

A

Annex

L

S

LAPARO CO2 PNEU: 1-- 2; 2-- 2; 5-- 2; 8-- 2 Leakage test: 6-- 4 Light: 4-- 10 LOW alarm: 4-- 15

Safety features: 8-- 2, 4 Sealing insert assembly: 5-- 2 Seals / o--rings: 5-- 2 Setup: 3-- 1 Silicone sealing insert: 1-- 2; 4-- 6 Spare parts: 8-- 5, 7 Standby mode of LAPARO CO2 PNEU: 4-- 12 Steam sterilization: 6-- 2 Stereo endoscope: 1-- 2; 4-- 7; 5-- 5; 6-- 8 Sterilization: 6-- 6, 8, 11, 12, 13, 14 Sterilization method: 6-- 2 Sterilization procedure Sterist : 6-- 2 Sterilization procedures Sterist and Sterradt: 6-- 2 Suction: 4-- 14 Suction and irrigation functions: 5-- 4 Suction power: 4-- 14 Surgical method: 4-- 2 Suture Clip: 6-- 10 Suture Clip Forceps: 1-- 3; 5-- 5; 6-- 10 Symbols / Labeling: 2-- 2

M Machine reprocessing: 6-- 6, 7, 9, 10, 12, 13, 14 Maintenance: 6-- 1, 3 Manual check: 5-- 4 Manual reprocessing: 6-- 3, 5, 7, 9, 10, 12, 13, 14 Measuring devices and auxiliary equipment for TEM PUMP: 6-- 4 MEDIUM alarm: 4-- 15

N NaCl irrigation bottle: 3-- 4 Needle Holder: 1-- 3; 4-- 9; 5-- 3, 5; 6-- 12 Nominal gas flow rate: 4-- 13 Nominal pressure: 4-- 13 Notes and instructions on reprocessing and maintenance: 6-- 2

O Obturator: 1-- 2; 4-- 4 Operating area: 4-- 5 Operating principle: 4-- 12 Operating, storage, transport and shipping conditions: 8-- 12 Order data: 8-- 1

Technical description: 1-- 2 Technical data: 8-- 1 TEM Accessories: 1-- 3; 2-- 11; 4-- 9; 8-- 9 TEM Combination System: 4--12; 6-- 3 TEM Disposable Tube Set: 3-- 6 TEM Instrument Set: 1-- 2; 4-- 2; 5-- 2, 5; 6-- 7; 8-- 6 TEM Irrigation Cannula: 1-- 2; 3-- 4; 5-- 2; 6-- 5; 8-- 7 TEM mode: 4-- 12 TEM PUMP: 1-- 2; 2-- 2; 3-- 4; 4-- 12; 5-- 2; 8-- 4 TEM Reprocessable (multi--use) Tube Set: 3-- 5 TEM Tube Set: 1-- 2; 3-- 4; 5-- 2; 8-- 8 Tube section: 6-- 9

U

P

A

T

Packaging: 2-- 3 Power failure: 4-- 14 Pressure and gas flow control system: 6-- 3 Previous switch--on (shorter than 30 seconds): 4-- 12 Pump cover: 3-- 4 Pump tube: 3-- 4

R Rectoscope tube: 1-- 2; 4-- 4 Replacing device fuses: 8-- 12 Reprocessing: 6-- 1 Retractable Syringe Needle: 1-- 3; 4-- 10; 5-- 3; 6-- 14

A -- 4

U--shaped support arm: 1-- 2; 4-- 3; 5-- 2, 5; 6-- 7, 8 Ultrasound cleaning: 6-- 10, 12 Use: 4-- 1

V Video--assisted TEM: 4-- 8 Visuel check: 5-- 2

W Wet preparation at the point of use: 6-- 3, 5, 7, 9, 10, 12, 13, 14 Working insert: 1-- 2; 4-- 5, 8; 5-- 2

GA--AS 001

Annex A. 3

Literature Laparoscopic Surgery

.

IMPORTANT! As we cannot provide a comprehensive bibliography we would ask users to keep themselves informed of all new developments in this field.

Z Semm, K.: Operationslehre für endoskopische Abdominal--Chirurgie. F.K. Schattauer Verlag 1984

Z Monagle J., Bradfield S., Norrle P.: Carbon Dioxide, Temperature and Laparoscopic Cholecystectomy Aust NZJ Surg. 1993, 63, 186--189

Z Seitzinger MR. Dugeon LS.: Decreasing the Degree of Hypothermia during prolonged Laparoscopic Procedures. J. Reproduct Med. 1993, 38(7): 511--513

Z Goldberg MJ Roe CF.: Temperature Changes during Anesthesia and Operations ARch. Surgery 1966, 93: 365--369

Z Manger Th., Fahlke J., Settmacher U., Zanow J., Lippert H.: (1994) Komplikationen bei 1000 laparoskopischen Eingriffen. Min. Invas. Chir. 2: 64--80

A

GA--AS 001

A- 5

Annex A. 4

Index Laparoscopic Surgery

A

L

Accessories: 9-- 11 Additional notes and instructions for use: 9-- 7

LAPARO CO2 PNEU: 9-- 6

C

M

Checks: 9-- 9 Combinations: 9-- 3 Connection diagrams: 9-- 4 Contraindications: 9-- 3

Manual check: 9-- 9

D

Operating principle: 9-- 6 Order data: 9-- 11 Overpressure alarm (E11): 9-- 8 Overview diagram for laparoscopic surgery: 9-- 2

Disposable Insufflation Tube: 9-- 4, 5

O

E Establishing pneumoperitoneum: 9-- 7

R

F

Reprocessable Insufflation Tube: 9-- 4

Functional checks: 9-- 9

S

G Gas flow check -- High Flow: 9-- 9 Gas flow check -- Primary insufflation: 9-- 9

H

Safety instructiones used in this manual: III Secondary filling: 9-- 8 Set up: 9-- 4 Signal is sounded: 9-- 6 Standby mode of LAPARO CO2 PNEU automatic insufflator: 9-- 6 Structure and use of this manual: III

High Flow mode: 9-- 7

A

I

T

If you switch on before the 30 seconds have elapsed: 9-- 6 Important informations: III Indications and field of use: 9-- 3 Insufflation function: 9-- 9 Insufflation tube: 9-- 3, 4, 11 Intended purpose: 9-- 1 Intended use: 9-- 3

Technical data: 9-- 11 Technical description: 9-- 3

A- 6

U Use: 9-- 6

GA--AS 001