Manual Equipo Biomedico

Instructions
2232
LAPARO
C02- PNEU
2232
TEM PUMP
E 2003 by RICHARD WOLF GMBH, Pforzheimer Straße 32, D--75434 Knittlingen
TEM Combination System

(LAPARO CO2 PNEU with TEM PUMP)
with TEM Instrument Set

for Transanal Endoscopic Microsurgery
LAPARO CO2 PNEU (without TEM PUMP)

j
for Laparoscopic Surgery
GA--AS 001 / en / Index: 08--03--1.0 / ÄM: KG 03--224

GERMANY USA UK
RICHARD WOLF GmbH RICHARD WOLF RICHARD WOLF UK Ltd.
D--75438 Knittlingen Medical Instruments Corp. Waterside Way
Pforzheimerstr. 32 353 Corporate Woods Parkway Wimbledon
Tel.: (..49)--(0)7043--35--0 Vernon Hills, Illinois 60061 SW 17 0HB
Fax:(..49)--(0)7043--35300 Tel.: 847--913 1113 Tel.: 020--8944 7447
MANUFACTURER Fax: 847--913 1488 Fax: 020--8944 1311
E--mail: info@richard--wolf.com E--mail: sales&marketing@richardwolfusa.com E--mail: admin@richardwolf.uk.com

Internet: www.richard--wolf.com Internet: www.richardwolfusa.com Internet: www.richardwolf.uk.com
BELGIUM FRANCE AUSTRIA

N.V. Endoscopie RICHARD WOLF France S.A.R.L. RICHARD WOLF Austria
RICHARD WOLF Belgium S.A. Rue Daniel Berger Ges.m.b.H.
Industriezone Drongen Z.A.C. La Neuvillette Wilhelminenstraße 93 a
Landegemstraat 6 F--51100 Reims A--1160 Wien
B--9031 Gent --Drongen Tel.: +33 3.26.87.02.89 Tel.: +43 1-- 405 51 51
Tel.: +32 9.280.81.00 Fax: +33 3.26.87.60.33 Fax: +43 1-- 405 51 51--45
Fax: +32 9.282.92.16
E--mail: endoscopy@richard--wolf.be E--mail: endoscopes@richardwolf.fr E--mail: info@richard--wolf.at

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: info@geomed.de
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

1. Intended purpose
1.1 Technical description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 -- 2
1.2 Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 -- 2
1.3 Indications and field of application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 -- 3
1.4 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 -- 4
1.5 Combinations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 -- 4
2 Illustrations / Controls and indicators
2.1 Symbols / Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 -- 2
2.2 Controls and indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 -- 4
2.3 Device connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 -- 7
2.4 Illustrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 -- 8
3. Set up
3.1 Installation of the TEM Combination System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 -- 2
3.2 Prepare the TEM Irrigation Cannula and NaCl irrigation bottle . . . . . . . . . . . . . . . . . . 3 -- 4
3.3 Connect the tube set for TEM applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 -- 4
4. Use
4.1 TEM Instrument Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 -- 2
4.2 TEM Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 -- 9
4.3 Additional notes and instructions for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 -- 10
4.4 TEM Combination System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 -- 12
4.5. Additional notes and instructions for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 -- 13
4.6. Alarm functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 -- 15
5 Checks
5.1 Visual checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 -- 2
5.2 Functional checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 -- 3
6 Reprocessing and maintenance
6.2 TEM Irrigation Cannula . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 -- 5
6.4 Double blower / Disposable filtration adaptor / tube section . . . . . . . . . . . . . . . . . . . . 6 -- 9
6.5 Suture Clip Forceps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 -- 10
6.6 Needle Holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 -- 12
6.7 HF Scapel, unipolar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 -- 13
6.8 Retractable Syringe Needle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 -- 14
GA--AS 001 I
7 Error message / Correctiv action

7.1 Device errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 -- 2
7.2 Error messages for LAPARO CO2 PNEU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 -- 2
7.3 Error messages for TEM PUMP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 -- 3
8 Technical data and order data
8.1 LAPARO CO2 PNEU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 -- 2
8.2 TEM PUMP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 -- 4
8.3 Spare parts and accessories for TEM Combination System . . . . . . . . . . . . . . . . . . . . 8 -- 5
8.6 TEM Tube Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 -- 8
8.7 TEM Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 -- 9
8.8 Additional spare parts and accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 -- 11
8.9 Replacing device fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 -- 12
8.10 Operating, storage, transport and shipping conditions . . . . . . . . . . . . . . . . . . . . . . . . . 8 -- 12
Overview diagram for laparoscopic surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 2
1 Intended purpose
1.2 Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 3
1.3 Indications and field of application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 3
1.5 Combinations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 3
3 Set up
3.3 Connecting insufflation tube . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 4
4 Use
4.1 LAPARO CO2 PNEU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 6
5 Checks
8.1 Accessories for laparoscopic surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 11
8.2 Insufflation tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 11
A Annex
A.1 Literature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A -- 2
A.2 Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A -- 3
A.3 Literature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A -- 5
A.4 Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A -- 6
II 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 in-
struction 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 prod-
uct’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 can-
nula, 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 infor-
mation in this manual.
Prepare TEM products
Want to use no Want to use no Want to use

TEM Disposable Tube Set ERBE Multifunctional TEM Disposable Tube Set Section 3
8170.841? Instrument? 4170.801?
yes yes yes
Prepare sterile hygiene filter Use TEM Disposable Tube Set

4170.804
yes
Setup TEM Combination System
yes
Want to use no
CO2 connector for gas cylinder
up to max. 2 liters?
yes
Section 3
Install CO2 gas cylinder mounting Connect CO2 connector
bracket. to central gas supply
yes
Prepare TEM Irrigation Cannula and Alarm functions Section 4

pierce NaCl irrigation bottle
yes
Error message / Correctiv action Section 7
Carry out automatic function test /
Section 5 check of CO2 gas supply
yes no
Could fault Contact the Richard
Is be eliminated? Wolf service department
no
LAPARO CO2 PNEU
Section 4 in standby mode yes
and ready?
(a signal is sounded) yes Switch off LAPARO CO2 Pneu,
switch on again after approx. 30 s
Connect the hygiene filter Connect the TEM Tube Set

and TEM Tube Set 8170.841 4170.801 or 4170.804
Section 3
to the device to the device
yes
Carry out manual checks Section 5

yes
Connect the TEM Tube Set Section 3

to the instrument
IV GA--AS 001
1. Intended purpose
1
Contents
Section 1
1. Intended purpose
1.2 Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 -- 2
1.2.1 LAPARO CO2 PNEU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 -- 2
1.2.2 TEM PUMP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 -- 2
1.2.3 TEM Irrigatation Cannula . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 -- 2
1.2.4 TEM Tube Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 -- 2
1.2.5 TEM Instrumentarium consists of: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 -- 2
1.2.6 TEM Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 -- 3
1.2.7 Important surgical informations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 -- 3
1.3 Indications and field of use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 -- 3
1.5 Combinations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 -- 4
1.5.1 General requirements on products/components of a combination . . . . . . 1 -- 5
GA--AS 001 1- 1
1. Intended purpose
1 1
1.1
Dies ist eine unsichtbare Komponente ohne Sprachvariante
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 clean-
ing 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 instru-
ments.
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 TEM Accessories

Z Double blower
1
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 ex-
traperitoneal 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 accesso-
ries ( 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 instru-
ment 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
1
environment.
R = 1.5 m Patient environment
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 Non--medically Requirements / measures

Inside the patient environment outside the patient used room Leakage currents to clause 19
environment IEC/EN 60601--1--1 *
MP MP
-- -- --
µ µ
MP NMP
µ µ
MP NMP
a) additional protective earth connection
** -- -- (to be clarified with manufacturer),
µ
or
MP
b) with additional separating transformer **
NMP
MP NMP
-- --
µ µ
MP or a) common protective earth connection, or

MP NMP b) additional protective earth connection
(to be clarified with manufacturer), or
µ c) additional separating device (to avoid
µ earth/ground loops in the case of a
potential difference)
additional separating transformer additional separating device Functional µ power supply grid
according to IEC/ EN 60601--1--1 ** according to IEC/ EN 60601--1--1 connection
MP = medical electrical device according to IEC/ EN 60601--1, UL 2601, CSA C22.2 No. 601
NMP = 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. Intended purpose
1 Z Specific requirements on the products/components of a combination
. 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 environ-
ment 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.
1 -- 6 GA--AS 001
2. Illustrations / Controls and indicators
Contents
Section 2 2
2 Illustrations / Controls and indicators
2.1 Symbols / Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 -- 2
2.1.1 LAPARO CO2 PNEU / TEM PUMP / Packaging . . . . . . . . . . . . . . . . . . . . . 2 -- 2
2.1.2 LAPARO CO2 PNEU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 -- 2
2.1.3 TEM PUMP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 -- 2
2.1.4 Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 -- 3
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- 1
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
Identification plate
ACCOMPANYING DOCUMENTS!
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 / Rear panel

Labeling Meaning
front rear
Output, insufflation connector x --
Sub D socket, 15--pole

2232 -- x
TEM PUMP (electrical connection to TEM PUMP)
ONLY FOR CO2 !

Use only CO2 gas (pressure between 3--150 bar) -- x
3--150 bar
Fuse
Use of device fuses -- x
T 2.0 L A
2.1.3 TEM PUMP
Symbols / Rear panel

Labeling Meaning
front rear
Hygiene filter x --
Output, irrigation pressure x --
Input, pressure measurement, patient x --
Socket for foot switch -- x
2232 Sub D socket, 15--pole

LAPARO -- x
CO2 PNEU (electrical connection to LAPARO CO2 PNEU automatic insufflator)
2 -- 2 GA--AS 001
2.1.4 Packaging
Symbols / Meaning
Labeling
Attention, consult
ACCOMPANYING DOCUMENTS!
2
REF 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°
Permissible temperature range
15°
Protect against heat
<60
< 60 %
protect against water spray, humidity < 60 %
GA--AS 001 2- 3
2.2 Controls and indicators
16 14 13 8 7 17 18
19
20
21
1
2
15 12 11 10 9 6 5 43
T E M. P U M P
2 -- 4 GA--AS 001
Controls and indicators

Item Functional description
Control Indicator Button
Power switch
-- ON
1 ' power: connection to the mains / power supply
-- OFF ' power: disconnection from the mains / power supply 2
INSUFFLA- Switch insufflation on / off
2 --
TION ' Intrarectal pressure is increased to the preset value
Pressure
3 -- preselection
“PLUS” Pressure monitoring -- Pressure pre--select
' can be changed between 3 mmHg and 25 mmHg,
mmHg in
Pressure
4 -- preselection steps of 1 mmHg.
“MINUS”
5 -- Indicator -- ' indicates the actual intrarectal pressure
6 -- Indicator -- ' indicates the preselected pressure
' indicates the actual intrarectal pressure
7 -- Digital display -- ' displays the corresponding intrarectal pressure during
preselection
8 -- -- Intrarectal pressure
Flow monitoring -- Gas flow rate pre--select

Flow ' can be changed between 1 l/min and 8 l/min, in steps of
9 -- preselection 1l/min
“PLUS” ' keep depressed for some time: Quick, continuous in-
crease of the gas flow
Flow
10 -- preselection ' adjustments are only possible in steps of 1l/min.
“MINUS”
11 -- Indicator -- ' indicates the actual gas flow rate
12 -- Indicator -- ' indicates the preselected gas flow rate
' indicates the actual gas flow rate
13 -- Indicator --
' indicates the corresponding gas flow during preselection
14 -- -- Gas flow
Alarm function
' Alarm stages -- 3 different sound sequences :
15 --
LOW ALARM; MEDIUM ALARM; HIGH ALARM
' the volume can be changed in 16 stages
Control CO2 gas supply -- Insicator CO2 gas supply
' Green continuous light: sufficient gas supply
16 -- --
' Yellow continuous light and acoustic signal:
CO2 LOW ALARM -- only approx. 30 l of gas supply
' Yellow blinking light and acoustic signal:
MEDIUM ALARM -- only approx. 3.0 l of gas supply
17 -- -- Gas consumption -- Gas consumption (volume)
18 -- Digital display -- ' indicates gas consumption
19 0 -- RESET ' Gas consumption can be reset to zero (digital display)
20 -- HIGH High Flow (only for the Laparoscopic use)
21 -- -- -- Insufflation outlet connector
GA--AS 001 2- 5
2.2.2 TEM PUMP
2
40
CO2
.PUMP
TEM
31
39 38 37 36 35 34 33 32
Controls and indicators

Item Functional description
Control Indicator Button
Switch TEM PUMP on / off
31 -- TEM PUMP ' TEM PUMP is switched off:
Buttons and symbols have night illumination
(dimmed background lighting)
Irrigation bottle pressure output
32 -- -- -- ' Fixed value control of the saline irrigation bottle pressure
to 1 bar
33 -- -- -- Rectal pressure input (patient)
Suction
34 -- preselection
“PLUS” po e -- Preselect
Suct o power
Suction ese ect suction
suct o power
po e
Suction ' variable between 0.5 l/min and 1.5 l/min
35 -- preselection
“MINUS”
Suction pump
' Indicator is lit: TEM PUMP is switched on
' Indicator blinks:
36 -- -- -- in case of malfunction after approx. 5 seconds
-- in case of LOW ALARM on LAPARO CO2 PNEU
Error message E37 appears
To reset: Switch the TEM PUMP on and off
' indicates the preselected suction power
37 -- Indicator --
(variable in 20 stages)
Suction pump malfunction
38 -- -- ' Indicator is lit: if the pump cover is open (suction pump
cannot be activated)
39 -- -- -- Suction pump
CO2 indicator
' Indicator is lit: if CO2 supply pressure is normal, indi-
cates stand--by mode
40 -- CO2 --
' Indicator blinks: if pressure is too high or too low; at the
same time
MEDIUM ALARM is sounded
2 -- 6 GA--AS 001
2.3 Device connections
2
49
46 48
2232
TEM PUMP
45
47
44
43
42 41
59
60
2
61
51
58 57 56 55 54 53 52
Item Designation Item Designation

41 Identification plate 46 Gas supply connector
Sub--D--socket 15--pole
42 Power (mains) input socked with fuse holder 47
(for electrical connection to TEM PUMP)
Connection of CO2 gas supply

43 48 Spacer sleeve for CO2 fuse holder
for TEM PUMP
44 Measurement connection for rectal pressure 49 Phillips head screw for CO2 fuse holder
45 Equipotential connector
2.3.2 TEM PUMP

51 Identification plate 57 Cylindrical screw for protective earth connection
52 Socket for foot switch 58 Protective earth connection
Sub--D--socket 15--pole
53 59 Trim plate
(for electrical connection to LAPARO CO2 PNEU)
54 Measurement connection for rectal pressure 60 Hex key (size 4)

Connection of CO2 gas supply
55 61 Device foot
for TEM PUMP
56 Equipotential connector
GA--AS 001 2- 7
2.4 Illustrations
2.4.1 TEM Irrigation Cannula / TEM Instrument Set
2 77
77.1
76
75
78 74 70
71.5 80.4
71.4 80.5
71.3 71.2 71.1 71 80.3

73 80.2
72 80.6
80.1
72.1
80
83.2 83.3
82
81
83.4 84
83.1 83
83.5
87.1
83.6
84.3 84.2 84.1
85.2 85.3 86.1
87.2
87 87.3
85.1 85 85.5 85.4 86 86.4 86.3 86.2

89
88
2 -- 8 GA--AS 001
Z Legend for TEM Irrigation Cannula

70 TEM Irrigation Cannula complete
71 Irrigation Cannula 73 Silicone seal with lateral hole
71.1 Irrigation channel 74 Non--return valve 2
71.2 Discharge for CO2 gas 75 Valve slide
Luer--Lock fitting
71.3 76 Silicone seal with central hole
“ERBE multifunctional instrument TEM” (option)
71.4 Luer connector for flushing of telescope window 77 Screw cap
71.5 Valve housing 77.1 Compression spring
72 Luer part 78 Luer locking cap
72.1 Luer--Lock fitting for CO2
. NOTE :
For the illustration of the TEM tube set and the connection diagram please see section 3
“Setup”
Z Legend TEM Instrument Set

80 U--shaped support arm 85 Working insert
80.1 Support arm 85.1 O--ring
80.2 Clamping lever, insulated 85.2 Locking pins
Locking lever for locking the stereo endo-
80.3 Toggle, sliding 85.3
scope in place
80.4 Clamping base, insulated 85.4 Sleeve for endoscope
80.5 Clamping toggle 85.5 Locking pin
80.6 Central joint 86 Sealing insert assembly
81 Rectoscope tube 86.1 Locating bores
82 Obturator 86.2 Large flexible instrument port
83 Housing 86.3 Small flexible instrument ports
83.1 Lock nut 86.4 Push tongue
83.2 Sealing ring (silicone flat) 87 Stereo endoscope
83.3 Connector (pressure measurement) 87.1 Control wheel (for interpupillary distance)
83.4 Locking lever 87.2 Sealing / Locking cone
83.5 Handle 87.3 Clamping toggle
83.6 Hexagon on handle 88 Documentation endoscope
84 Attachment with observation window 89 Irrigation and insufflation tube
84.1 Connector for cold light
84.2 O--ring
84.3 Observation insert
# Type no
GA--AS 001 2- 9
93.8
2
93.6 93.7 93.9
# 93
90.1
90
90.2 #
91.1 94 95
92.1 93.5 93.4
91 extreme magnification
93.3 93.2 93.1

#
92
97.6 97.7 # 97.8
97
97.5 97.4 97.3 97.2
96
97.1
98 99.2 99.3
99
99.1
100.8 100.9
100
100.7 100.6 100.4 100.2

100.5 100.3 100.1
2 -- 10 GA--AS 001
Z Legend for TEM Accessories

Disposable (single--use) filtration
90 96 Needle holder straight
attachment
90.1
90.2
Luer connector, female
Luer connector, male
97
97.1
Needle holder with downward offset
Handle
2
91 Tube part 97.2 Clamping screw
91.1 Luer connector, male 97.3 Luer sealing cap
92 Double blower 97.4 Luer connector
92.1 Luer connector, female 97.5 Firm jaw
93 Suture Clip Forceps 97.6 Moveable jaw
93.1 Handle 97.7 Sheath
93.2 Ball 97.8 Locking screw
93.3 Internal part (part that closes the clamp) 98 HF Scalpel, unipolar, left
93.4 Lock screw 99 HF Scalpel, unipolar, right
93.5 External part 99.1 Handle
93.6 Receptacle for suture clamp 99.2 Instrument tip
93.7 Tube holder 99.3 HF connector
93.8 Ball receptacle 100 Retractable Syringe Needle
93.9 Slide 100.1 Thumb grip
94 Ejector 100.2 Internal tube
95 Suture clamp 100.3 Knurled nut
100.4 Compression spring
100.5 Handle
100.6 External tube
100.7 Needle tip
100.8 Luer connector
100.9 Luer locking cap
# Type no.
GA--AS 001 2 - 11
2 -- 12 GA--AS 001
3. Setup
Contents
Section 3
3. Setup
3.1 Installation of the TEM Combination System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 -- 2
3.1.1
3.1.2
Attaching the irrigation bottle holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Establish electric (protective earth/ground) and CO2 connections . . . . . .
3 --
3 --
2
3
3
3.1.3 CO2 connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 -- 3
3.2 Prepare the TEM Irrigation Cannula and NaCl--irrigation bottle . . . . . . . . . . . . . . . . . 3 -- 4
3.3 Connect the tube set for TEM application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 -- 4
3.3.1 Selecting the TEM tube sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 -- 4
3.3.2 Before connecting the TEM tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 -- 4
3.3.3 Prepare the TEM PUMP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 -- 4
3.3.4 Connection diagram for TEM application . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 -- 5
GA--AS 001 3- 1
3. Setup

WARNING!
Explosion hazard!
The device is not protected against explosions.
Do not operate this device in areas where there is a danger of explosion.
WARNING!
Use the TEM combination system only in conjunction with the tubes and hygiene filters specified
by Richard Wolf.
If spare parts of other manufacturers are used or parts are assembled incorrectly, this may cause
malfunctions such as gas pressure or gas flow losses. Danger of infection due to unsterile ac-
cessories
3 CAUTION!
Before you connect the power cable have an expert connect the protective earth / ground
connection between the LAPARO CO2 PNEU automatic insufflator and the TEM PUMP. For this,
the supplied allen key should be used.
Do not unscrew the protective earth connection already connected to the LAPARO CO2 PNEU.
CAUTION!
The TEM pump must be enabled to properly perform the TEM procedures.
It is possible to engage the laparoscopic insufflator function when the TEM configuration is de-
sired. When performing TEM applications be sure that the pump indicator is illuminated.
If the pump is not enabled, the insufflator will cycle between its insufflation and measurement peri-
ods. This can be detected by a visual pulsing of the gas flow indicator and an audible pause in the
insufflation mode. If this situation is detected, change the mode as written in paragraph 4.4.2.
Check all connections and assure that the pump is enabled.
. NOTE :
Check that the mains/line voltage is the same as the voltage specified on the identification plate.
Connect the device only with the supplied power cable or a power cable meeting the same specifications.
. NOTE :
During operation the TEM Combination System should be on a level surface.
3.1 Installation of the TEM Combination System

. IMPORTANT!
Carry out a visual check of the parts required for assembly (section 5)
3.1.1 Attaching the irrigation bottle holder
. NOTE :
Attach the irrigation bottle holder before you place the devices on top of each other.
1. Position the TEM PUMP laterally.
2. Install the Phillips head screws and remove the device foot.
3 3. Slide the trim plate from the holding rail.
4 5 4. Unscrew the Phillips head screws and remove the mounting rail.
' Carefully store the trim plate and the mounting rail.
5. Attach the irrigation bottle holder using the 2 supplied M4x10
Phillips screws.
2 6 6. Attach the device foot.
Z Place the TEM PUMP onto an even level surface.

1 Z Set the LAPARO CO2 PNEUS to TEM PUMP.
3- 2 GA--AS 001
3. Setup
3.1.2 Establishing electric (protective earth / ground) and CO2 connections

Z Remove the hex head socket screw with an allen wrench.
' The allen wrench is fastened to the rear panel of the TEM PUMP.
1. Fasten the protective earth / ground cable to the TEM PUMP
6 using the hex head socket screw. For this, proceed in the follow-
ing order:
6 ' TEM PUMP backplate (1a)
5 ' Toothed locking washer A 5.3 (1b)
' Protective earth connection (1c)
4
3 ' Washer B 5.3 (1d)
2
' Hex head socket screw M5x10 (1e)
3
Establish the other connections
2. Socket for foot switch
Side view 3. CO2 gas supply
4. Measurement for rectal pressure
5. Electrical connection cable
1 6. Power cable for the LAPARO CO2 PNEU automatic insufflator.
1a 1b 1c 1d 1e
3.1.3 CO2 connection
WARNING!
Danger of liquid CO2 entering the LAPARO CO2 PNEU automatic insufflator if gas cylinder is incor-
rectly positioned!
The patient may be endangered by possible malfunctions or failure of the LAPARO CO2 PNEU auto-
matic insufflator during the operation.
Make sure you operate the gas cylinder only in vertical position with the valve on top.
Preparation of CO2 operation with gas cylinder

1
1. Connect the high pressure connection hose and tighten the union
nut with a size 14 open--end wrench.
2 Attaching the CO2 mounting bracket (if required)

2. Remove the Phillips head screws and spacer sleeves.
3. Position the spacer sleeves between the rear panel of the LA-
PARO CO2 PNEU automatic insufflator and theCO2 cylinder
mounting bracket and tighten with a Phillips screwdriver.
. IMPORTANT!
When using gas cylinders with a volume of more then 2.0 l use:
' use a separate holder
6 Side view
(do not attach to the LAPARO CO2 PNEU automatic insufflator)
' secure the gas cylinder against falling.
5 4. Place the gas cylinder (max. volume 2 l) in the cylinder holder and
fasten with the belt.
3 5. Connect the high pressure connection hose to the gas cylinder and
4 firmly tighten union nut with an open end wrench (size 30).
6. Open the cylinder valve by turning counterclockwise.
Preparation of CO2 supply from central gas supply system

Z Connect connection hose (8170.311) to the gas supply connector of the device and to the wall connector for
central gas supply.
GA--AS 001 3- 3
3. Setup
3.2 Prepare the TEM Irrigation Cannula and NaCl irrigation bottle
Z The TEM Irrigation Cannula is inserted into the rubber stopper of a 0.5 or 1.0 liter glass irrigation bottle.
1. Tighten Luer part and screw cap.

2. Pierce the center of the rubber stopper on the glass bottle with
1 TEM Irrigation Cannula.
3. Slide the TEM Irrigation Cannula past the step (larger diameter)
on the sheath (i.e. push it over the first resistance).
The ERBE Multifunctional Instrument is used
4
4. Remove the Luer sealing cap.
3 2 . MPORTANT!
If the ERBE Multifunctional Instrument for TEM is not connected,
ensure that the Luer--Lock fitting is closed with a Luer sealing
3 cap.
Z Insert the saline irrigation bottle in the bottle holder.
3.3 Connect the tube set for TEM applications

3.3.1 Selecting the TEM tube sets
CAUTION!
The TEM Disposable Tube Set is designed for single use only and is sterilely packed. Do not use
the TEM Disposable Tube Set if
' the sterile packaging is damaged
' the shelf life of the set has expired
For the connection diagrams of the following TEM Tube Sets please see paragraph 3.3.4
Z 8170.841 -- TEM Reprocessable (multi--use) Tube Set (not for the USA)
Z 4170.801 -- TEM Disposable Tube Set
Z 4170.804 -- TEM Disposable Tube Set (ERBE Multifunctional Instrument)
3.3.2 Before connecting the TEM tubes

CAUTION!
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 Perform an automatic function check and a check of the CO2 --gas supply, see section 5
Z Upon successful complesion of the function test: Connect the TEM tubing set to the device,
see paragraph 3.3.4
. IMPORTANT!
Error messages E05 and E30 are displayed, if the hygiene filter or the TEM Disposable Tube Set is
connected before the automatic function check is performed.
3.3.3 Preparing the TEM PUMP
CAUTION!
Make sure your fingers don’t get caught in the pump!
When installing the pump tube be careful not to jam your
fingers. Work carefully.
1. Open the pump cover.
2. Install the pump tube (E) in accordance with coding
2 ' Rotate the roller clockwise to engage the pump tube (E)
in the roller pump.
. NOTE :
1 Ensure correct position of the pump tube (E).
The pump connote be operated without cover.
3. Close pump cover.
3 -- 4 GA--AS 001
3. Setup
3.3.4 Connection diagram for TEM application

. NOTE :
When connecting the TEM Tube Set make sure the tubes are positioned correctly. Prevent any kinking
of the tubes (such as by gravity).
Z 8170.841 -- TEM Reprocessable (multi--use) Tube Set (not for theUSA)
CO
2 l/min Liter 2232
3
LAPAR O
CO - PN EU
2
HIGH
!
B
C
E
2232
TEM .PU M P
F
Tube set, consisting of: Type no.
B A Measuring tube, rectal pressure
B Insufflation tube
C
..8170.841
C Irrigation tube
D Suction tube
A
E Pump tube ....................................8170.861
F Connection tube..............................8170.862
B
C
D D D
GA--AS 001 3- 5
3. Setup
Z 4170.801 -- TEM Disposable Tube Set
blue
white
CO
2 l/min Liter 2232
LAPAR O
C O2 - PN EU
3
HIGH
!
B
C
E
2232
TEM .PU M P
green F
Tube set, consisting of: Type no.
B Insufflation tube ..4170.842
C
red C Irrigation tube
D Suction tube
A
E Pump tube ..................................4170.864
F Connection tube ...........................4170.862
B white
blue C
green
red
D D D
3 -- 6 GA--AS 001
3. Setup
Z 4170.804 -- TEM Disposable Tube Set (ERBE Multifunctional Instrument)
blue
white
blue
CO
2 l/min Liter 2232
LAPAR O
CO - PN EU
2
B
HIGH
!
G 3
C
E
2232
TEM .PU M P
green F
Tube set, consisting of: Type no
B Insufflation tube C
red ..4170.843
C Irrigation tube G
D Suction tube
A E Pump tube. ..................................4170.864
F Connection tube............................4170.862
G Irrigation tube ERBE .....................4170.867
B white
blue C
green
blue
D red
D D D
. NOTE :
After having connected the TEM Tube Set to the device, run through the manual checks (see section 5).
GA--AS 001 3- 7
3. Setup
3 -- 8 GA--AS 001
4. Use
Contents
Section 4
4. Use
4.1.1 Function principle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 -- 2
4.1.2 Surgical method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 -- 2
4.1.3 Preparing the TEM Instrument Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 -- 3
4.1.4 Additional notes and instructions for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 -- 8
4.2 TEM Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 -- 9
4.2.1
4.2.2
Preparing the Suture Clip Forceps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Preparing the Needle Holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4 --
4 --
9
9
4
4.2.3 Preparing the HF Scalpel, unipolar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 -- 10
4.2.4 Preparing the Retractable Syringe Needle . . . . . . . . . . . . . . . . . . . . . . . . . . 4 -- 10
4.3.1 Light . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 -- 10
4.3.2 Irrigation fluid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 -- 10
4.3.3 Electrical current . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 -- 10
4.3.4 HF application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 -- 11
4.4.1 Function principle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 -- 12
4.4.2 Selecting the TEM mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 -- 12
4.5. Additional notes and instructions for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 -- 13
4.5.1 Inflating the rectal cavity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 -- 13
4.5.2 Irrigation / suction control via the footswitch . . . . . . . . . . . . . . . . . . . . . . . . . 4 -- 14
4.5.3 Possible alarm messages during use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 -- 14
4.5.4 Power failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 -- 14
4.5.5 Measures after insufflation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 -- 14
4.6. Alarm functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 -- 15
4.6.1 Adjusting the alarm volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 -- 16
GA--AS 001 4- 1
4. Use

4.1 TEM Instrument Set
CAUTION !
The products have only limited strength !
Exerting excessive force will cause damage, impair the function and therefore endanger the pa-
tient.
Immediately before and after each use, check the products for damage, loose parts and com-
pleteness.
Ensure that no missing instrument parts remain in the patient.
Do not use products which are damaged, incomplete or have loose parts.
4.1.1 Function principle

The resectoscope is used to visualize the operating area endoscopically.
To obtain stable exposure of the operating area the resectoscope is firmly connected to the operating table by
4
means of a support arm. For the surgical procedure a stereoscopic angled endoscope is used, allowing dis-
section under microsurgical conditions.
Up to three surgical instruments can be inserted at the same time. Continuous dilation by means of pressure--
controlled gas insufflation is essential to maintain good visibility and access throughout the procedure. Irriga-
tion of the endoscope window is achieved by pressing a foot switch.
4.1.2 Surgical method
Z Mucosectomy
Using a monopolar diathermal instrument, a circular cut is made
around the adenoma, including a margin of healthy mucosal tissue.
The margin of healthy mucosal tissue together with the adenoma is

separated from the annular layer of the muscularis propria and the
adenoma carefully removed in its entirety.
Z Full--wall excision
In the case of broad--based polyps in the extraperitoneal section of
the rectum, in most cases full--wall resection is performed.
Hemostasis is achieved by coagulation using the suction device or
insulated forceps. After excision, a continuous transversal monocryl
suture is made, and the thread is fixed with a metal clip.
Z Surgical procedure for excision of a small rectal carcinoma

A circular cut is made around the tumor, including a broad margin of
healthy rectal wall tissue. This cut should penetrate all the layers of
the wall, including the muscularis propria. Careful hemosthasis is re-
quired. Full--wall excision is indicated only in the extraperitoneal sec-
tion of the rectum.
4 -- 2 GA--AS 001
4. Use
4.1.3 Preparing the TEM Instrument Set

Z Carry out a visual check of the parts required for assembly: see section 5
Z Attaching the U--shaped support arm to the operating table
WARNING!
In order to guarantee the dielectric strength of the insulated clamping base make sure you ob-
serve the correct assembly of the insulated clamping base to the rail. The insulated clamping
lever must face downwards.
The insulated clamping base must be dry and clean. Humidity or contamination can also elimi-
nate the insulation effect.
. NOTE :
The permissible weight capacity of the U--shaped support arm is 10 kg (100 N).
The dielectric strength of the insulated clamping base is 4.5 kV.
Mounting the insulated clamping base

1. Position the insulated clamping base to the mounting rail either
or on the left or on the right hand side of the operating table
4
near the the foot end.
1 2. Tighten the clamping lever.
Mounting the U--shaped support arm

1. After draping the patient, insert the support arm from the low into
the insulated clamping base and position below the patient’s anus.
2. Lock in place with the clamping toggle.
3. Place the articulated part of the U--shaped support arm between
the patient’s legs in such a way that any contact with grounded
parts can be excluded.
2 3
1
GA--AS 001 4 -- 3
4. Use
Z Inserting the rectoscope tube with obturator into the rectum
. NOTE :
The different lengths and shapes of the rectoscope tubes and lengths of the obturators have been de-
signed for different applications.
For a combination of the rectoscope tubes and obturators see section 8
Locking the rectoscope tube in the housing

1. Place rectoscope tube into housing.
2. Turn lock nut in direction of arrow ”lock” as far as it will go.
' The rectoscope tube is pushed axially against integrated seal.
2
lock
1
4
unlock
Locking the obturator in the housing with rectoscope tube

1. Insert obturator in the housing and rectoscope tube assembly.
1 ' The obturator projects from the rectoscope tube.
unlock 2. Turn locking lever in direction of arrow ”lock” as far as it will go.
' The obturator is locked in place.
2 . NOTE :
lock For inserting the rectoscope tube with obturator use
sterile hospital lubricant.
Z Indroduce rectoscope tube with obturator in the rectum.
Z Turn locking lever in direction ”unlock” and remove the obturator.
Inserting adapter with viewing window in housing and connect

4 6 double blower
1. Insert adapter with viewing window.
2. Turn clamping lever in direction of arrow ”lock” as far as it will
go.
3. Connect the tube to the fitting.
4. Connect the male luer fittings to the female luer fittings.
3 1
5. Connect a dia. 4.5 mm flexible light cable to the cold--light connector
and to the light source and switch on the light source.
6. Compress double bellows to inflate the intestine.
unlock
5
lock
2
4 -- 4 GA--AS 001
4. Use
Fastening the housing in the U--shaped support

1. Insert hexagonal of handle in prism of support arm.
2. Tighten the clamping screw to lock the housing in place.
1
2
Adjusting the operating area and locking TEM Instrumentarium

Proceed in analogy with conventional rectoscopy. The joints of
the support arm can be moved freely.
Z Accurately adjust the operating area and lock arm in position
using the star grip.
' The operating table, u--shaped support arm and TEM 4
instruments form a stable unit.
Removing the attachment with observation window from the

housing
1. Remove the tube together with the disposable filtration adapter
1 and double bellows.
2. Remove the flexible light cable.
3. Turn the locking lever to ”unlock” .
4 4. Remove the attachment with observation window.
3
unlock
lock
2
Preparing the working insert

Z Place sealing cap 89.10 onto endoscope port
' Color code red
for instruments dia. 13.0 mm to 13.8 mm dia.
GA--AS 001 4 -- 5
4. Use
Preparing the silicone sealing insert assembly

The silicone sealing insert has valve flaps permitting the instruments to be changed without major gas loss.
. NOTE :
Prepare the required instruments and apply the corresponding sealing caps to the silicone sealing insert.
Allocation of instruments and sealing caps see section 8 -- paragraph 8.7
Use only the instruments recommended for TEM applications.
1. Equipping the large flexible instrument port with sealing caps.

2. Equipping the small flexible instrument port with sealing caps.
2 1
2
4
Connecting the silicone sealing insert to the working insert
To lock
1. Engage slotted openings in locating pins.
2. Push tongue with your thumb in direction of arrow.
1
' Tongue engages in locking pin
CAUTION !
Caution if the locking pins are not correctly positioned in
the openings. In this case the rectum cannot be inflated
with CO2 gas.
Check for correct position of the locking holes and make
sure the tongues are properly held by the locking pins.
To open
Z Place your index finger against the locking lever and push
the tongue with your thumb in the direction indicated by
the arrow.
4 -- 6 GA--AS 001
4. Use
Connecting the assembled working insert to the housing

1 1. Insert the preassembled working insert.
2. Turn the locking lever in direction of arrow ”lock” as far as it will
go.
unlock
2
lock
Inserting the stereo endoscope / documentation endoscope
CAUTION !
Danger of injury if the stereo telescope /documentation telescope is inserted into the operating
4
area too far !
This may cause inadvertent tissue damage.
Insert the stereo telescope /documentation telescope only under adequate illumination and visual
control and position it within the tube.
Inserting the stereo endoscope

1. Turn the locking lever in direction of arrow ”unlock”.
2 2. Connect the flexible light cable to the cold--light connector. Con-
nect the other end to the light source and illuminate the operat-
1/5 ing area.
unlock lock 3 3. Turn the control wheel to adjust the eyepieces to your interpupil-
lary distance.
Check the image quality before you insert the telescope:
' Check both systems of the stereo telescope individually by clos-
ing one eye.
4. Insert the stereo endoscope until the lower edge (x) of the tube
appears in the field of view and then keep sliding it forward until
4 the lower edge (x) is no longer visible in the field of view.
5. Turn the locking lever in direction of arrow ”lock”.
' The stereo endoscope is locked in place.
x
Field of view
Inserting the documentation endoscope

1. Move the locking lever to position ”I” .
Before you insert the documentation telescope,
' check the image quality with your eye.
2. Insert the documentation endoscope in the stereo endoscope
ba 2 ' The pin (a) engages in groove (b).
3. Turn the locking lever to position ”II”.
' The documentation endoscope is locked in place.
I 1 . IMPORTANT!
3 II If the documentation endoscope is not used, close the stereo
endoscope with sealing cone to avoid a gas loss.
GA--AS 001 4 -- 7
4. Use
4.1.4 Additional notes and instructions for use
Working without sealing insert
. NOTE :
Gas dilation / inflation is not possible in this case.
If required by the surgical intervention it is also possible to work

with conventional instruments (grasping, suction, coagulationin-
strument) under direct vision without the sealing insert.
This method also lends itself when removing the excised tissue.
In this case the operating area is illuminated via the endoscope
which is locked in place in the working insert.
4
Video--assisted TEM
1/5 2 TEM exclusively performed via the video screen is possible

when using the rigid irrigation and insufflation tube.
unlock lock
1. Turn clamping lever in direction of arrow ”unlock”.
2. Connect the flexible light cable to the cold--light connector, con-
nect the other end to the light source and illuminate the operat-
ing area.
3 3. Insert the irrigation and insufflation tubes in the working insert.
Before inserting the documentation telescope,
4 ' check the image quality with your eye.
4. Insert the documentation telescope in the irrigation and insuffla-
tion tube until the lower edge (x) of the tube becomes visible and
x continue to push it forward until the lower edge (x) disappears.
Field of view 5. Turn clamping lever in direction of arrow ”lock”.
' Documentation endoscope is locked in place.
4 -- 8 GA--AS 001
4. Use
4.2 TEM Accessories
4.2.1 Preparing the Suture Clip Forceps

Z Check assembly: section 6
Z Run through the checks: section 5
Outside the body:
(B) 1. Apply suture clip (B) at a distance of 8 cm (x) from the curved
needle (recommendation)
Squeeze grips of handle together as far as it will go.
2. Pull by the thread to check firm seating of suture clip (B).
3 3. Cut the thread behind the suture clip (B).
x 1
2
Adjusting the working position: 4

1. Release the lock screw.
2 2. Turn the forceps tube to the required working position.
3. Tighten the lock screw.
1 /3
Z Check that the tube is securely locked in working position.
. IMPORTANT!
Place the suture clip in such a way that it lies in the free
lumen of the intestine to allow excretion once the suture
material has been absorbed.
5
Removing a suture clip (is nescessary only if clip is not used):
Z Insert ejector in the distal hole and eject suture clip.
4.2.2 Preparing the Needle Holder

Z Screw on the luer sealing cap.
1. Slide sealing cap 89.02 over the closed jaws onto the sheath.
2. Place the tip area of the curved needle between the jaws and
1 actuate the handle.
3. Lock the needle holder: section 5
' Check needle for firm seating.
Z Install the sealing cap on the instrument port of the silicone seal-
ing insert.
GA--AS 001 4 -- 9
4. Use
Adjusting the working position

1. Slacken off the clamping screw.
2. Turn sheath (7) to the required working position
2 1 /3 (preferably the offset, irrigation connector and handle are
aligned).
3. Tighten the clamping screw.
Z Check for proper fixation in the working position.
Z Then insert the needle holder through the silicone sealing insert
into the tube, use a lubricant if necessary.
4.2.3 Preparing the HF Scalpel, unipolar

Z Apply neutral electrode.
4
Z Connect HF connection cable to HF connector.
4.2.4 Preparing the Retractable Syringe Needle

Z Check assembly: section 6
Z Screw on the luer sealing cap.
4.3 Additional notes and instructions for use
4.3.1 Light
. IMPORTANT!
Use only products with BF classified applied parts in conjunction with this endoscope.
For maximum light output the fiber cross--section of the flexible light cable and of the endoscope must
be the same.
WARNING !
High temperatures due to high light energy!
Danger of inadvertent tissue damage as a result of insufficient distance between the light exit
area and the tissue
Do not touch the light exit area and avoid direct contact the tissue.
WARNING !
Fire hazard!
If the endoscope is placed against heat sensitive flammable surfaces (such as dark drapes) the
intense heat at the light exit area will cause extreme temperatures or even ignition.
Clean the light exit area and store the endoscope in a safe place.
If you do not use the endoscope for some time, switch off the light source at the light projector.
4.3.2 Irrigation fluid
CAUTION !
Check electrical conductivity of irrigation fluid!
The user must choose a low- conductivity irrigation fluid suitable for the application.
Evacuate conductive liquids before HF applications.
4.3.3 Electrical current
WARNING !
Danger of electric shock !
Patient leakage currents can add up if endoscopes are combined with electrically powered endo-
scopic accessories.
Make sure that a combination of devices won’t exceed the admissible patient leakage currents.
4 -- 10 GA--AS 001
4. Use
4.3.4 HF applications
Follow the “Notes and instructions on HF applications“, order no.: GA--S 002 as well as the HF device
manufacturer’s instructions.
WARNING !
Danger of injury if the HF instrument is not in the surgeon’s field of view !
Inadvertent tissue damage as well as damage to the distal end of the endoscope and to
instrument parts is possible.
Activate HF- Instruments only after the part under HF- current has become fully visible through
the endoscope and the instrument is in contact with the intended aera.
WARNING !
Danger of injury due to damaged insolation of HF instruments !
Exceeding the maximum recurrent peak voltage of HF instruments in conjunction with surgical
HF devices and/or the wrong mode will destroy the insulation.
Possible tissue damage in the patient, user or others.
4
In combination with surgical HF devices use HF instruments only up to the maximum recurrent
peak voltage (see data in table, paragraph 8.7).
Any use with forced coagulation or spray coagulation is not permissible.
Use HF instruments only for brief coagulations of minor hemorrhages.
WARNING !
HF sparking !
Danger of injury from incorrect HF use and insufficient
distance between live parts carrying HF and other con-
ductive parts.
During activation live HF parts of HF instruments must be
kept at a distance of at least 10 mm from the distal end of
10mm the rectoscope tube and / or must have a sufficient dis-
tance from other, non- insulated instruments.
GA--AS 001 4 -- 11
4. Use
4.4 TEM Combination System
4.4.1 Operating principle

With the TEM system the rectal cavity can be inflated and the inflation maintained under continuous insufflation
with pressure monitoring. The TEM PUMP monitors the rectal pressure via an additional tube to the instrument
set. The maximum insufflation rate is 8 l/min.
With activated insufflation and an intrarectral pressure of more than 3 mmHg the TEM PUMP provides additional
continuous suction. The suction rate can be set between 0.5 and 1.5 l/min.
If required the optical window is cleaned with sterile saline from blood and secretion by operating the foot
switch.
4.4.2 Selecting the TEM mode
. NOTE :
The TEM mode can only be selected when the LAPARO CO2 PNEU automatic insufflator is in standby
mode .
4 Standby mode of LAPARO CO2 PNEU
l/min
30 s 1. Switch off power switch: Press the button.
2
3 2. Remove all hygiene filters.
!
1
3. Switch on power switch after 30 seconds: Press the button.
Always after switching on:

!
2 ' The LAPARO CO2 PNEU automatic insufflator runs through an
automatic function check (duration approx. 15 s).
' The suction pump is activated.
' In case of an error, error code (error no.) is displayed, see section 7.
' The LEDs of the display flash alternately.
' The LEDs of the level indicators indicate the duration of the test.
A signal is sounded:
' The LEDs stop blinking.
' The LAPARO CO2 PNEU is in standby mode (ready).
Previous switch--on (shorter than 30 seconds):
' The LAPARO CO2 PNEU displays the state which had pre-
viously been set.
' LAPARO CO2 PNEU is not in standby mode (not ready). Repeat
items 1 -- 3.
Switching on the TEM--PUMP

1. Install all hygiene filters.
l/min
2. To switch on the TEM--PUMP: Press the button.
1 ' The system is in TEM mode.
' The button and display are lit.
!
' The button on the LAPARO CO2 PNEU blinks.
' The suction pump is ready.
1 2 . NOTE :
! The preselected gas flow rate of 4.0 l/min is selected auto-
matically.
4 -- 12 GA--AS 001
4. Use
. IMPORTANT!
Before you start TEM, observe and perform the sections 3 „Setup“ and 5 „Checks“.
. IMPORTANT!
The suction function (peristaltic pump) is only active with insufflation switched on, the rectal pressure is
at least 3 mmHg.
4.5.1 Inflating the rectal cavity
Preselecting the nominal gas flow rate

The preselected value is 4 l/min
l/min
1. To increase the gas flow rate: Press the button.
2. The decrease the gas flow rate: Press the button.
1
' Pressing the button briefly:
2
! changes the values between 1.0 l/min and 8.0 l/min,
in steps of 1.0 l/min. 4
' Keeping the button depressed:
quick, continuous increase of gas flow rate.
' The preselected gas flow rate is displayed on the
!
level indicator.
Increasing the nominal pressure

1. To increase the nominal pressure: Press the button.
l/min 2. To decrease the nominal pressure: Press the button.
1 changes the pressure between 3 mmHg and 25 mmHg,
in steps of 1 mmHg.
!
' The preselected pressure is displayed on the level indicator.
2
. NOTE :
We recommend preselecting a pressure of 12 mmHg and
15 mmHg.
!
Starting insufflation
1. To start insufflation: Press the button.
l/min ' The button is lit
' Intrarectal pressure is generated until the preselected value is
reached.
1! ' The intrarectal pressure reaches 3 mmHg:
The suction pump is automatically activated and operates at the
preselected suction stage.
GA--AS 001 4 - 13
4. Use
Preselecting the suction power (suction stage)

1. To increase the suction power: Press the button.
l/min 2. Decreasing the suction power: Press the button.
changes the value between 0.5 l/min and 1.5 l/min.
!
. NOTE :
Normally a low suction power (stage) should be selected.
1
2 !
4
4.5.2 Irrigation / suction control via the footswitch
Z Actuate the footswitch

Irrigation:
' Footswitch is depressed for more than half a second:
Irrigation of telescope window with sterile saline is active.
Maximal irrigation time 20 seconds. Then irrigation switches off.
Suction:
' Footswitch pressed less than half a second:
Switchover between preselected and maximum suction power.
Irrigation is not active.
The procedure can be repeated as described.
4.5.3 Possible alarm messages during use

see paragraph 4.6
4.5.4 Power failure
Should the power supply fail:

' selected modes are stored for approx. 20 s
When the power supply is restored:
' Power failure for less than 20 seconds: The application is continued with the settings previously selected.
' If the power failure is longer than 20 seconds: The LAPARO CO2 PNEU runs through the automatic
function test.
4.5.5 Measures after insufflation
WARNING!
Danger of infection if the hygiene filter is used more than once and unsterile tubing.
Contamination residues in the tubing could be pumped into the patient’s body.
When the application is completed:
' discard hygiene filter and Disposable Tube Set.
' reprocess and sterilize the Reprocessable Tube Set.
' close the gas cylinder valve.
4 -- 14 GA--AS 001
4. Use
4.6 Alarm functions
The LAPARO CO2 PNEU automatic insufflator has 3 different alarm

stages differing from each other both acoustically and in the sound
1a l/min
E38 sequence.
1b 1. LOW alarm is sounded (2 consecutive beeps)
! ' Error message during self check

' Remaining gas supply is only 30.0 l: indicator is lit (1a).
1c ' Emergency insufflation: Digital display blinks (1b).
-- suction pump operates only at minimum speed
! Error message E38
' Suction pump defective: button blinks (1c).

-- Current gas flow rate is higher than the preselected gas
flow rate.
(+ 2.0 l/min, for more than 2 seconds)
Z Do not switch off the LAPARO CO2 PNEU.
4
Z Eliminate the fault.
' The device carries out an automatic function test.
2. MEDIUM alarm is sounded (3 consecutive beeps)
2a l/min
' Remaining gas supply is only 3.0 l: indicator blinks (2a).
E35
' Gas flow preselection: Digital display blinks (2b).
2b -- Current gas flow rate is higher than the preselected gas flow
!
rate.
' CO2 supply pressure too high: CO2 indicator
blinks (2c).
-- Error message E35 is displayed.
Z Do not switch off the LAPARO CO2 PNEU.
2c Z Eliminate the fault.
!
' The device carries out an automatic function test.
3. HIGH alarm is sounded

(2 consecutive beeps -- pause -- 2 consecutive beeps)
l/min
E09
' Indicator is lit (3a):
3b
3a (Insufflation is switched off, the button is not lit)
! -- a nominal value is ambiguous or invalid (3b)
Error message E09
-- Gas supply with helium instead of CO2 gas
Error message E10
! -- Power supply outside the tolerance window
Error message E03
-- a pneumatic component is defective
Error messages E04--E08, E13, E31, E32, E39--E41
Z Switch off the LAPARO CO2 PNEU and go back to the basic
setting (standby mode) (see 4.4.2)
GA--AS 001 4 - 15
4. Use
4.6.1 Adjusting the alarm volume
1. Press the button and keep depressed.

l/min ' A continous alarm is sounded.
2 2. To increase the volume: Press the button.

1 3. To decrease the volume:Press the button.
!
' The volume can be changed in 16 steps which are displayed on
3 the digital display.
4 -- 16 GA--AS 001
5. Checks
Contents
Section 5
5 Checks
5.1 Visual checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 -- 2
5.1.1 LAPARO CO2 PNEU / TEM PUMP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 -- 2
5.1.2 TEM Irrigation Cannula . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 -- 2
5.1.3 TEM Tubing Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 -- 2
5.1.4 TEM Instrument Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 -- 2
5.1.5 TEM Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 -- 3
5.2.1 Automatical check TEM Combination System . . . . . . . . . . . . . . . . . . . . . . . 5 -- 3
5.2.2 Checking the remaining CO2 gas supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 -- 4
5.2.3 Manuel check of TEM Combination System . . . . . . . . . . . . . . . . . . . . . . . . . 5 -- 4
5.2.4
5.2.5
TEM Instrument Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
TEM Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5 --
5 --
5
5
5
GA--AS 001 5- 1
5. Checks

CAUTION !
Caution if products are damaged or incomplete !
Possible injury of patient, user or others.
Run through the checks before and after each use.
Do not use products which are damaged or incomplete or have loose parts.
Return damaged products together with loose parts for repair.
Do not attempt to do any repairs yourself.
5.1 Visuel check

Z Any lettering, labeling or identification necessary for the safe intended use must be legible.
' Missing or illegible lettering, labeling or identification which may lead to wrong handling and reprocessing
must be restored.
5.1.1 LAPARO CO2 PNEU / TEM PUMP

Z Check protective earth connection between LAPARO CO2 PNEU and TEM PUMP (paragraph 7.3).
Z LAPARO CO2 PNEU / TEM PUMP and accessories for damage, hygiene condition and completeness.
Z Check all connection cables for damage.
5.1.2 TEM Irrigation Cannula

Z Check for damage and completeness:
5 ' Non--return valve

' Valve slide
' Silicone seals
' Depending on irrigation cannula version
a) Compression spring welded to screw cap
b) Loose compression spring
' Cannula tip
5.1.3 TEM Tube Set

Z Check TEM Tube Set for damage.
5.1.4 TEM Instrument Set

Z Check instruments and accessories for damage, sharp edges, loose or missing parts and rough surfaces.
Z Check seals, o--rings and sealing caps for damage.
U--shaped suspension arm

Z Lubricate the joints with a suitable physiologically safe lubricant before you carry out the function check.
Attachment with observation window

Z Check o--ring for correct seating.
' The o--ring must be seated in the first groove which has a
square cross section.
Working insert
1. Check O--ring for correct seating.
2 ' The o--ring must be seated in the first groove which has a
square cross section.
1 2. Check clamping lever for easy operation.
Sealing insert assembly

Z Check sealing insert assembly for damage.
5 -- 2 GA--AS 001
5. Checks
5.1.5 TEM accessories
Needle Holder
Z Make sure to check the area of the hinge/hinge pin with particular
care. Check for surface changes, such as hair cracks, at the
hinge pin.
Z Check the carbide insert for possible damage.
Z Check that the jaws close completely.
Z HF Scalpel, unipolar
Z Check the isolation for damage.
Z Retractable Syringe Needle

Z Check the oblique tip of the needle for damage.
5.2 Functional checks

Z Check for compatibility of cold--light connector, flexible light cable and light projector.
Z Check the entire system for tightness and free passage (patency).
5.2.1 Automatic check of TEM Combination System

5
The system detects, reports and stores faults and errors automatically:
' during the automatic function test or
' during operation
1. Connect the power plug to the power supply.
l/min
2. Switch on power supply: Press the button.

! 2 ' The LAPARO CO2 PNEU automatic insufflator runs through an
automatic function test routine (duration approx. 15 s).
1 ' In case of a fault/error and error code (error no.) is displayed
!
(see section 7).
' The LEDs of the display blink alternately.
' The LEDs of the level indicators indicate the test duration.
' The LEDs have stopped blinking.
' The LAPARO CO2 PNEU is in standby mode (basic setting) and
ready.
. IMPORTANT !
Error messages E05 and E30 are displayed, if, prior to the automatic safety check, the hygiene filters or
the TEM Disposable Tube Set are connected.
GA--AS 001 5- 3
5. Checks
5.2.2 Checking the remaining CO2 gas supply
Z Display of CO2 gas supply

' Green continuous light: sufficient gas supply
CO2
' Yellow continuous light and acoustic signal (LOW--Alarm):
only approx. 30.0 l of gas supply *
(sufficient gas supply if connected to a central gas supply system)
. NOTE :
Have a new CO2 gas cylinder ready.
' Yellow blinking light and acoustic signal (MEDIUM--Alarm): only approx. 3.0 l of gas supply *
*The specified contents relates to gas cylinders with a volume of 1 liter (e.g. 2046.95). In larger gas cylinders a larger
gas volume, which is a function of the larger cylinder volume, is available.
. IMPORTANT!
Stop the operation and replace the CO2 gas cylinder immediately.
Z If during the selfcheck the CO2 gas supply is insufficient:

' Error message E01 is displayed
' LAPARO CO2 PNEU is not operational
Z Replace the CO2 gas cylinder.
Z Please note the alarm function: see paragraph 4.6
5 5.2.3 Manual check of TEM Combination System
. NOTES :
Precondition for manual checking:
' Automatic function check passed and
' TEM combination system connected to the device
Insufflation function
l/min
1. Switch on TEM PUMP: Press the button
' System is in TEM mode.
' The button and indicator are lit.
2 !
' The button on the LAPARO CO2 PNEU blinks.
' Preselected gas flow rate: 4 l/min.
2. Switch on Insufflation: Press the button.
!
1 ' The button is lit.
' LAPARO CO2 PNEU automatic insufflator insufflates at a pre-
selected flow rate.
Current pressure value: 0 mmHG
Suction and irrigation functions

l/min
E38 Z Remove the measuring tube for rectal pressure (A) and the
hygiene filter.
' The suction pump is activated and switches on as soon as the
!
intrarectal pressure exceeds 3 mmHg.
' The LAPARO CO2 PNEU is in “Emergency insufflation” mode
' Error message E38 is displayed.
5 -- 4 GA--AS 001
5. Checks
Double function footswitch for
l/min
1. Remove the connection tube (F) and hold it into a container
(should be prepared beforehand).
2. Actuate the footswitch.
Irrigation:
4!
' If the footswitched is pressed for more than half a second:
Irrigation of the telescope window with sterile saline is active.
Irrigation time max. 20 seconds. Then the irrigation is stopped.
' The TEM irrigation cannula must enable the liquid flow into the
! irrigation tube
Suction:
1/3
(F) ' If the footswitch is pressed for less than half a second:
2 Switchover between preselected and maximum suction power.
Irrigation is not active.
The procedure can be repeated as required.
3. Plug the measuring tube with hygiene filter back onto the measuring
input.
' The suction pump stops. Current pressure value 0 mmHg.
4. Switch off Insufflation: Press the button.
' The button is not lit.
5.2.4 TEM Instrument Set 5

U--shaped support arm
Z Carry out the function checks only after the components have cooled down (after sterilization).
Z After locking the joints, check the arm for stability against rotation and proper locking action.
' If the locking forces are insufficient, discard the u--shaped suspension arm.
Stereo endoscope / Documentation endoscope

Z The spray jet must clean the entire surface of the telescope windows of the stereo telescope / documentation
telescope.
Z For more informations please follow the latest ”Notes and instructions on the reprocessing of R.Wolf
products, accessories and devices”, order no.: GA--J 020.

Suture Clip Forceps
Z Check internal part (i.e. clip closing part) for easy movement.
Z Check that suture clip engages properly:
' Place suture clip into receptacle. For this it is necessary to
overcome the resistance of the retaining spring.
2/3 Needle Holder

Z The jaws must open and close easily.
Z Check locking screw and clamping screw on handle for proper
functioning.
Check that the needle is firmly clamped:

1. Insert the curved needle in the area of the tip between the jaws
1 (90° from the longitudinal axis) and actuate the handle.
2. To lock the needle holder: Turn locking screw as indicated by the
arrow.
' Check for firm seating of needle.
3. Unlock the needle holder: Turn locking screw counter clockwise
as indicated by the arrow.
GA--AS 001 5- 5
5. Checks
5 -- 6 GA--AS 001
6. Reprocessing and maintenance
Contents
Section 6
6 Reprocessing and maintennance
6.1.1 Manual reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 -- 3
6.1.2 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 -- 3
6.2.1 Disassembly before cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 -- 5
6.2.3 Machine reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 -- 6
6.2.4 Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 -- 6
6.2.5 Assembly before sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 -- 6
6.2.6 Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 -- 6
6.3.4 Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 -- 7
6.4
6.3.6 Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Double blower / Disposable filtration adapter / tube section . . . . . . . . . . . . . . . . . . . .
6 --
6 --
8
9
6
6.4.3 Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 -- 9
6.5 Suture Clip Forceps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 -- 10
6.5.4 Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 -- 10
6.5.6 Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 -- 11
6.6 Needle Holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 -- 12
6.6.3 Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 -- 12
6.6.4 Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 -- 12
6.7 HF Scalpel, unipolar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 -- 13
6.7.3 Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 -- 13
6.7.4 Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 -- 13
6.8 Retractable Syringe Needle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 -- 14
6.8.4 Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 -- 14
6.8.6 Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 -- 14
GA--AS 001 6- 1
6 ies ist eine unsichtbare Komponente ohne Sprachvariante
. IMPORTANT !
The “Notes and instructions on reprocessing and maintenance”listed below as well as the
“Sterilisation procedures” are valid for the individual products and must be observed provided that no
product related notes and sterilization procedures are described in the individual sections.
. IMPORTANT !
Follow the current ”Notes and instructions on the reprocessing of R.Wolf products, accessories and
devices”, order no.: GA--J 020.
Do not use disinfectants containing peracetic acid without corrosion protection agents, phenols or chlo-
rine components for the reprocessing of Richard Wolf products.
Do not exceed the maximum exposure time specified by the manufacturer of the disinfectants used.
. IMPORTANT !
Sterilization processes:
Z Steam sterilization
Steam sterilization at 134° C (272° F) using the fractional pre--vacuum method.
Z Sterilization procedures Sterist and Sterradt

The Sterist and Sterradt sterilization procedures have been approved for use on our endoscopes
and endoscopic accessories only with regard to material compatibility.
For information about possible limitations, such as discoloration of plastic materials, see the latest
version of ”Notes and instructions on the reprocessing of Richard Wolf products, accessories and
devices”, order no. GA--J 020.
6
Efficacy has been certified by the sterilizer manufacturers in microbiological tests. Follow the
manufacturer’s instructions.
Z Sterilization procedure Sterist

Connect all channels to the system to ensure thorough reprocessing. Follow the manufacturer’s
instructions.
6 -- 2 GA--AS 001
6.1 TEM Combination System

6.1.1 Manual reprocessing
Z Wet preparation at the point of use
Z Cleaning / disinfection
WARNING!
Danger of electric shock because of humidity may enter the device system.
Switch off the device system and disconnect it from mains/power supply before reprocessing.
Z TEM Combination System cleans with a soft cloth moistened with surface disinfectant, alcohol or spirit.
. IMPORTANT!
Make sure that no humidity enters the device. Do not use any cleaning or scouring agents or solvents
for the care of the device.
6.1.2 Maintenance
Z Maintenance intervals
. IMPORTANT!
To prevent incidents caused by aging and wear, the TEM Combination System and its accessories must
be serviced at adequate intervals. Depending on the frequency of use, however at least once a year, an
expert must check the device and carry out a safety test.
Z Quarterly inspection
. IMPORTANT!
This inspection may only be carried out by qualified operator personne.
Do not use the TEM Combination System, if
' the specified values are not indicated / displayed
' the device is not functioning properly.
Perform a visual check: section 5 6
If the specified measurements and tolerances are not fulfilled the device system must be checked by an
authorized service technician.
Test of the pressure and gas flow control system of the LAPARO
CO2 PNEU automatic insufflator
l/min
. IMPORTANT!
3a 4a For checking the LAPARO CO2 PNEU do not switch on the
2 3b TEM PUMP.
4a 1 3/5
!
Z Prepare the following measuring equipment and auxiliary means:
' Reprocessable insufflation tube, 2.5 m long
' Hygiene filter
' Measuring cup with scaling (contents approx. 1 liter)
!
Z The LAPARO CO2 PNEU is in stand--by mode and ready.
1. Preselect the nominal pressure of 12 mmHg: Press the button.
2. Connect the hygiene filter and insufflation tube to the insufflation
4/6 connector.
3. Switch on insufflation: Press the button.
' The level and digital displays (3a) display the current gas flow
rate and must be the same as on level indicator (3b) for the pre-
selected gas flow rate 1 l/min.
' Permissible tolerance: ± 0.5 l/min
4. Close the insufflation tube with your thumb.
' As soon as the current pressure (level indicator and digital dis-
play 4a) exceeds the preselected pressure (level indicator 4b)
the device must vent the system.
5. Switch off insufflation: Press the button.
6. Open the insufflation tube.
GA--AS 001 6- 3
Leakage test
l/min 1. Preselect a nominal pressure of 12 mmHg: Press the button.

2. Fill the container with water and immerse the instrument end of the
insufflation tube (B) approx. 5 -- 10 cm below the water level.
1 3/4
! 3. Switch on insufflation: Press the button.
' Gas bubbles must emerge from the end of the tubing.
' No gas bubbles must emerge from the end of the tubing.
!
. IMPORTANT!
(B) Immediately after the end of the test remove insufflation tube (B)
from the water container as otherwise vacuum would draw water
2 into the tubing and to the inside of the device.
Measuring devices and auxiliary equipment for TEM--PUMP
l/min . NOTE :
For this check do not connect the measuring tube (A) with
2 hygiene filter to the TEM PUMP.
!
Z Prepare the following measuring devices and auxiliary means:
(B) 1 ' TEM reprocessable tube set
6 !
' Pump tube
' Hygiene filter
' Container with 1 liter of water
(E) ' Measuring vessel with scale (contents approx. 1 liter)
3 (A) 1. Install pump tube (E) as described in paragraph 3.3.3.
2. Connect hygiene filter and insufflation tube (B).
(D)
3. Connect suction tube (D) of TEM tube set to pump tube (E).
4. Switch on TEM--PUMP: Press the button.

l/min
. NOTE :
5 The preselected gas flow rate of 4.0 l/min is selected auto-
matically.
7! ' The suction pump is activated.
5. Set gas flow rate LAPARO CO2 PNEU to 8.0 l/min.:
(E) Press the button.
4 6. Immerse end of pump tube (E) in measuring vessel and suction
!
A tube (D) in container with 1 liter of water.
(D) ' Suction rate of TEM PUMP is automatically set to the minimum
value.
6 ' After 1 minute at least 300 ml of water must have been pumped
from the container into the measuring vessel.
. NOTE :
Ensure that the opening of the suction tube (D) is not pulled
against the wall or bottom of the water container as this may
reduce the suction rate.
6 -- 4 GA--AS 001
6.2 TEM Irrigation Cannula

. IMPORTANT!
Clean the TEM irrigation cannula immediately after each use. Dried saline can cause the valve slide or
non--return valve to block and will promote pitting corrosion.
Z Prepare the following auxiliary items:

' Luer--Lock 3 mm with silicone tube, internal diameter 4 x 2 mm;
approx. 100 mm long
' Disposable syringe 20 ml
' Cleaning gun
' Cloths
1 1. Connect Luer--Lock with silicone tube to CO2 Luer--Lock
connector.
2. Rinse out TEM irrigation cannula with a disposable syringe filled
2 with water.
' Liquid must be discharged from the CO2 gas outlet
6.2.1 Disassembly before cleaning
. NOTE :
When opening, the screw cap must be on top to prevent the
valve slide and the non--return valve from falling down.
2
1. Unscrew Luer locking cap
4 2. Depending on the irrigation cannula version:
1 3 a) Unscrew screw cap with firmly attached compression spring.
b) Unscrew screw cap and remove separate compression
spring. 6
3. Remove valve slide and non--return valve.
6 4. Remove silicone seal from screw cap.
5. Unscrew Luer part.
5 6. Remove silicone seal from Luer part.

Z Disassembly before cleaning: see paragraph 6.2.1
Cleaning:
1 2 1. Slide silicone tubing with distal Luer--Lock over irriga-
tion channel and keep rinsing out with a disposable
syringe filled with water through the Luer--Lock until
the water running out is clear.
2. Rinse out on both Luer--Lock connectors / fittings of
3 valve body with the cleaning gun.
Z Carefully clean all parts.
Z Then rinse thoroughly inside and out and dry with
compressed air and cloths.
GA--AS 001 6- 5
Disinfection:
Z Immerse all parts in a disinfectant solution.
' Follow the disinfectant manufacturer’s instructions.
1. Slide the silicone tube with distal Luer--Lock connector over irrigation channel and rinse out with a dispos-
able syringe filled with disinfectant through the Luer--Lock ensuring that the inside of the TEM Irrigation Can-
nula is also filled with disinfectant.
2. Rinse out on both Luer--Lock connectors / fittings of the valve body with a cleaning gun.
Z Then rinse thoroughly inside and out and dry with compressed air and cloths.
6.2.3 Machine reprocessing

Z Dry preparation at the point of use
Z Use a silicone tube to connect the Luer--Lock to the CO2 Luer--Lock connector and rinse out with a dispos-
able syringe filled with water.
Z Connect the distal end of TEM irrigation cannula and Luer--Lock connectors / fittings and to the automatic
washer / disinfector.
. NOTE :
For machine reprocessing of the small parts we recommend using a perforated tray for small items.
6.2.4 Checks
Z Visual check of the parts required for assembly: see paragraph 5.1.2
6.2.5 Assembly before sterilization
6 . IMPORTANT!
Observe the markings on valve body:
Marking “ D “ = assembly of screw cap
6 Marking “ d “ = assembly of Luer part
3
4 1. Place the silicone sealing disc with the lateral bore into the luer part
and apply a slight pressure.
5 2. Screw on the Luer part.
3. Depending on irrigation cannula version:
a) Compression spring, firmly welded to screw cap
b) Compression spring, loose:
1 Place the compression spring onto the pin inside the screw cap.
2 4. Install silicone seal in screw cap and compress slightly.
5. Insert valve slide and non--return valve.
6. Tighten screw cap.
6.2.6 Sterilization
. IMPORTANT!
Luer--Lock connectors / fittings must be open during steam sterilization.
Loose screw cap at least one full turn.
6 -- 6 GA--AS 001

Z Disassemble all parts of the TEM instrument set.
Z Remove the following parts using forceps:
' Sealing ring in base
' O--ring on attachment with observation window / working insert
Z Remove all sealing caps.

Z U--shaped suspension arm

Z Clean with soft cleaning brushes and a soft cloth.
Do not use metal brushes! Be particularly careful not to damage critical areas such as movable parts.
Z Then rinse thoroughly inside and out and dry with compressed air and cloths.
Z Rinse the u--shaped support arm once again with fully desalted water and sufficiently dry as soon as the
rinsing is completed.
Z All other parts of the TEM instrument sets

Z Immediately after use, immerse all parts in disassembled condition in a combined disinfection and cleaning
solution.
6
1. Clean the instruments with cleaning brushes and a soft cloth.
' Use a bottle brush for the resectoscope tubes.
2. Then clean with a cleaning gun.
1 2
Z Finally thoroughly rinse inside and out and dry with compressed
air and cloths.

Z U--shaped suspension arm

Z Open the joints:
' before machine cleaning
' before immersion in cleaning solutions
' before ultrasound cleaning
6.3.4 Checks
Z Visual check of the parts required for assembly

Z Disassemble the following parts using forceps:
' Sealing ring in base: see paragraph 2.4.1
' O--ring on attachment with observation window / on the working insert: see paragraph 5.1.4
GA--AS 001 6- 7
6.3.6 Sterilization
Z U--shaped support arm
. IMPORTANT!
Plasma sterilization is not allowed because of the use of plastic materials which would be destroyed by
this procedure.
Z Stereo endoscope
. IMPORTANT!
The stereo telescope should only be gas or plasma sterilized.
6 -- 8 GA--AS 001
6.4 Double blower / Disposable filtration adapter / tube section

Z Immediately after use remove and discard the discardable filtration attachment and the tube section.

Z Spray and wipe outside of double blower with disinfectant.

6.4.3 Checks
Z Visual check of the parts required for assembly: see secton 5
GA--AS 001 6- 9
6.5 Suture Clip Forceps

1. Unscrew the lock screw as far as it will go.

3 2 2. Lift off the preassembled forceps tube and remove.
3. Pull out internal part (i.e. clip closing part).

Z Clean all parts with a cloth and all hollow spaces and cavities
with cleaning brushes. Rinse out the external tube with a clean-
ing gun.
Z Dry the outside of the parts with a cloth, and all openings and
hollow spaces with compressed air.
Z Lubricate movable parts with 2 -- 3 drops of WO 53 oil while actu-
ating the handle several times.
6 Suture clip:
Z Immerse the suture clips in a cleaning solution and then rinse
and dry.

Z Ultrasound cleaning
' Ensure that the external part (tube) is rinsed out properly in the washer / disinfector.
' Place the suture clips in a small parts basket.
6.5.4 Checks
Z Visual check of the parts required for assembly.
1. Insert the internal part (rod) into the external part (tube) as far as
3 4 it will go. Make sure that the markings (a) and (b) are aligned.
2. Push handle grips together.
3. Insert preassembled forceps part (i.e. external tube with actua-
tion rod) in tube holder and lift.
5 4. Release handle and lower forceps part until the ball--shaped end
of the rod engages in receptacle.
5. Tighten the lock screw.
2
1
b a
6 -- 10 GA--AS 001
Z Lubricate movable parts with 2 -- 3 drops of WO 53 oil while actu-

ating the handle several times.
. NOTE :
Before sterilization connect the screw--connections only
loosely to allow a sufficient flow of the sterilization medium.
6.5.6 Sterilization
Z Use a container for small parts to house the suture clips.
GA--AS 001 6 - 11
6.6 Needle Holder

1. Remove luer sealing cap.
2 2. Clean needle holder with a cleaning brush and a piece of cloth.
3. Rinse out the luer connector with a cleaning gun while actuating
3 the handle several times until the water running out is clear.
Z Clean inside of needle holder with compressed air and outside with
a cloth.
Z Lubricate the needle holder in the area of the hinge pins and on the
slide with WO 53 (2--3 drops), while you actuate the handle several
times.
6
Z Ultrasound cleaning
' Make sure that the jaws are open.
' Connect the needle holder via luer connector (4) inside the washer/disinfector.
6.6.3 Checks
Z Perform a visual check: see paragraph 5.1.5
6.6.4 Sterilization
6 -- 12 GA--AS 001
6.7 HF Scalpel, unipolar

. IMPORTANT !
Do not use metal tools or tools with sharp edges (e.g. brush) for cleaning plastic parts (such as plastic
coat of the HF blade).
Remove any coagulation residues with the help of 3% H2 O2 solution.


6.7.3 Checks
Z Perform a visual check: see paragraph 5.1.5
6.7.4 Sterilization
GA--AS 001 6 - 13
6.8 Retractable Syringe Needle

1. Remove the luer locking cap.
4 2. Slacken off the knurled nut.
1 3. Remove the internal tube.
4. Remove the compression spring.
3
2

1. Clean all parts with a cloth, all openings and hollow spaces /
recesses with cleaning brushes, rinse out the external part with
the
1 cleaning gun.
2. Dry all parts outside with a cloth, all openings and hollow spaces
with compressed air.
2
6 Z Lubricate the internal tube using WO 53.

' Ensure that the external part is rinsed out in the washer/disinfector.
6.8.4 Checks
Z Visual check of the parts required for assembly: see section 5

1. Insert the compression spring.
1 2. Insert the internal tube.
3. Tighten the knurled nut.
. NOTE :
Before steam sterilization:
To prevent stress cracks and to ensure free access of steam,
2
3 slacken off the knurled nut at least one full rotation.
6.8.6 Sterilization
6 -- 14 GA--AS 001
7. Error message / Correctiv action
Contents
Section 7
7 Error message / Correctiv action
7.1 Device errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 -- 2
7.2 Error messages for LAPARO CO2 PNEU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 -- 2
7.3 Error messages for TEM PUMP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 -- 3
GA--AS 001 7- 1
. IMPORTANT!
If the faults cannot be repaired with the help of this table please inform the service department or return
the device for repair.
' Do not attempt your own repairs!
7.1 Device errrors
Fault Possible cause Corrective action Section

Power / mains switch not switched on 'Actuate power / mains switch 2.2 / 4.4.2
Device does not Power / mains cable not connnected 'Connect power / mains cable 2.3 / 5.2.1
work Device fuse defective 'Replace fuse 8.9
No mains / line voltage 'Check in--house power supply -
Insufflation not switched on 'Insufflation switch on 2.2 / 4.5
No gas flow
Gas cylinder empty or not open 'Change or open gas cylinder 3.1.3 / 5.2.2
With manipulations the user increases the 4.2.3
'Eliminate cause
pressure in the abdomen section 9
Preselected pres-
sure is exceeded LAPARO CO2 PNEU defective 'Call service department -
Other equipment causes pressure increase 'Eliminate cause -
No pressure Tube system leaking 'Check tube and connections 3.3.4

build- up Flow preselection too low 'Increase preselected flow 2.2 / 4.5
7.2 Error messages for LAPARO CO2 PNEU
Fault / error Possible cause Corrective action Section

Gas supply interrupted 'Open gas cylinder or connect filled gas 3.1.3 / 5.2.2
cylinder
7
E01 CO2 pressure sensor defective 'In the case of repeated error message with -
filled open gas cylinder:
contact service department
E02 Button is pressed when the device is 'If no operator’s error call service -
switched on department
E03 Internal supply voltage not within tolerance 'Contact service department -
E04 Valve V1 defective 'Contact service department -
E05 Insufflation tube connected when swichting 'Remove tubing and after 30 s switch device 3.3.4 / 4.4.2
on the LAPARO CO2 PNEU off and on again.
E06 Pressure measurement defective 'Contact service department -
E07 Flow measurement defective 'Contact service department -
E09 Nominal value invalid 'Service verständigen -
E10 Helium 'CO2 --Gas verwenden 3.1.3
E11 Overpressure alarm: 'Reduce intraabdominal pressure 4.2.3
Pact greater than 30 mmHg for more than 5 s 'Contact service department section 9
E12 General hardware error 'Contact service department -
E13 Pressure switch for ”input pressure” 'Contact service department -
defective
E14 Pressure monitoring defective 'Contact service department -
E15 DIL switch incorrectly set 'Contact service department -
7 -- 2 GA--AS 001
7.3 Error messages for TEM PUMP

Fault / error Possible cause Corrective action Section
E30 Hygiene filter connected, to measuring input 'Remove hygiene filter and switch off mains 4.4.2
when switching on / power switch on LAPARO CO2 PNEU
after 30 s and switch on again.
E31 Pressure sensor pressure measurement 'Contact service department -
defective
E32 Pressure sensor pressure measurement 'Check pneumatic connections between 3.1.2
defective LAPARO CO2 PNEU and TEM PUMP
'If fault is not eliminated,
E33 Actual rectal pressure has exceeded limit 'Reduce rectal pressure 2.2 / 4.5.1
value 'If fault is not eliminated,
E34 Button is depressed when switching on 'Switch TEM PUMP off and on again 2.3 / 4.4.2
E35 CO2 supply for TEM PUMP defective 'Contact service department -
E36 Not assigned
E37 Wrong pump tube 'Use original pump tube 3.3.4 / 8.6
Suction pump defective 'Contact service department -
E38 Emergency insufflation, measuring line with 'Connect measuring line with hygiene filter 5.2.3
hygiene filter not connected to the TEM to TEM PUMP
PUMP 'If fault is not eliminated, contact service
department
E39 Pressure switch defective 'Contact service department -
E40 Data transmission defective 'Switch off system and switch on again 4.4.2
after 30 s
'If fault is not eliminated, contact service
department
E41 Pneumatic fault 'Check rectal pressure measuring line on 3.1.2
device rear panel for leakage
'If fault is not eliminated, contact service
department 7
GA--AS 001 7- 3
7 -- 4 GA--AS 001
8. Technical data and order data
Contents
Section 8
8.1 LAPARO CO2 PNEU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 -- 2
8.1.1 Application parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 -- 2
8.1.2 Safety features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 -- 2
8.1.3 Additional options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 -- 2
8.1.4 lnterfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 -- 3
8.2 TEM PUMP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 -- 4
8.2.1 Application parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 -- 4
8.2.2 Safety features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 -- 4
8.2.3 Interfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 -- 4
8.3 Spare parts and accessories for TEM Combination System . . . . . . . . . . . . . . . . . . . . 8 -- 5
8.4.1 Spare parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 -- 7
8.5.1 Spare parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 -- 7
8.6 TEM Tube Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 -- 8
8.7 TEM Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 -- 9
8.8 Additional spare parts and accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 -- 11
8.9 Replacing of device fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 -- 12
8.10 Operating, storage, transport and shipping conditions . . . . . . . . . . . . . . . . . . . . . . . . . 8 -- 12
8.10.1 Disposal of the product, packaging material and accessories . . . . . . . . . . 8 -- 12
GA--AS 001 8- 1
8.1 LAPARO CO2 PNEU
Voltage Frequency Power Current Fuse

Model consumption rating
Vµ Hz VA A A
2232.041 100--230 50 / 60 80 0,8 T 2,0 L
Electromagnetic compatibility (EMC) in acc. with EN 60601--1--2 / IEC 601--1--2

Medical Devices Directive 93/42/EEC Class II b
Protection against electric shock Type CF applied part
Protection class in acc. with EN 60601--1/IEC 601--1;
I
(UL 2601--1 / CSA C22.2 No.601.1 -- for USA)
Degree of protection against the ingression of liquid IP 20 (Not protected)
Mode of operation Continuous operation
This device is not protected against explosions
Degree of protection when flammable gasses are present (Do not operate this device in areas where explosive
substances are present)
Weight (without CO2 cylinder) 9.5 kg (20.9 lbs)
Dimensions (without cylinder holder) w x h x d 330 mm x 155 mm x 390 mm
8.1.1 Application parameters
Insufflation medium med. CO2 (degree of purity > 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 1 l/min to 8 l/min (¦ 20 %), preselectable in steps of 1 l/min
Laparoscopy
-- Gas flow rate primary filling 1 l/min (¦ 50 %)
8 -- Gas flow rate high flow

1 l/min to 30 l/min (¦ 20 %), preselectable in steps of 1 l/min
-- Consumption display 0 l to 999 l (¦ 20 %)
8.1.2 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 adjustable in 16 steps
Alarm system 3 alarms: LOW / MEDIUM / HIGH
Hygiene filter on outlet Sterile item
8.1.3 Additional options
Indication of insufflation pressure during primary filling ' Quadro Test yes
8 -- 2 GA--AS 001
8.1.4 Interfaces
Data transmission and supply voltage for TEM PUMP Sub D socket, 15--pole
Gas connection 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
GA--AS 001 8- 3
8.2 TEM PUMP
Voltage Power consumption Current rating

Model
V= VA A
2232.244 24 30 1,3
Electromagnetic compatibility (EMC) in acc. with EN 60601--1--2 / IEC 601--1--2
Medical Products Directive 93/42/EEC Class II b

Protection against electric shock Type BF applied part
Protection class in acc.with EN 60601--1/IEC 601--1;
I
(UL 2601--1 / CSA C22.2 No.601.1 -- for USA)
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 Device is not protected against explosions
flammable mixtures (Do not operate this device in inflammable environment)
Weight (without CO2 cylinder) 6.9 kg (15.2 lbs)
Dimensions (without cylinder holder) wxhxd 330 mm x 100 mm x 390 mm
8.2.1 Application parameters
Pressure connection 3 bar
Output pressure for irrigation bottle 1 bar , med. CO2 (degree of purity > 99,5 %)
Suction rate 0.5 to 1.5 l/min
8.2.2 Safety features
Automatic function check Self check after switching on the device
8
Automatic fault/error detection yes
Automatic error message yes
Automatic error memory yes
Alarm system see LAPARO CO2 PNEU
Hygiene filter on outlet Sterile item
8.2.3 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 Luer connector, 3 mm male
Measuring input hygiene filter connection Luer connector, 3 mm female
Foot switch connector Tube type connector
8 -- 4 GA--AS 001
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)
Hygiene filter, in sterile package for measurement input and irrigation pressure output
4171.112
(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 b c
ISO connection 8170.303 DIN connection 8170.301 PIN index connection 8170.302
The products can be combined as required provided the relevant technical data and intended uses are ob-
served. For the general overview please refer to the latest catalog sheets and brochures, or contact Richard
Wolf or your Richard Wolf representative. 8
GA--AS 001 8- 5

Obturator (Pos. 2) for tube
Designation 15016.197 15016.198
Item Illustration
and Model / type
Rectoscope tube
dia. 40 mm; WL= 120 mm
J j
with obturator
8840.02
Rectoscope tube
81 dia. 40 mm; WL= 137 mm
J j
(82) with obturator
8840.031
Rectoscope tube
dia. 40 mm; WL= 200 mm
j J
with obturator
8840.04
U--shaped
support arm
80 8840.9721 ------
Manufactured by
GEOMED
Clamping base, insulated

8840.9722
80.4 ------
Manufactured by
GEOMED
Housing
83 ------
8840.20
Attachement with
84 observation window ------
8840.25
Working insert
8 85 ------
8840.241
Sealing insert
86 8840.242
------
Stereo endoscope
dia.13.8mm; WL=259mm
87 Viewing direction 50_ ------
Image angle 70_
4840.501
Locking cone
87.2 ------
8840.591
Documentation
88 endoscope ------
8840.401
Irrigation and
89 insufflation tube ------
8840.501
J Use obturator
j Do not use obturator
8 -- 6 GA--AS 001
8.4.1 Spare parts
Item Illustration Model / type Designation
83.6 15 564.003 Sealing ring for housing 8840.20
84.2/ O--Ring for

15 364.095 attachment with observation window 8840.25 and
85.1 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
8.5 TEM Irrigation Cannula
TEM Irrigation Cannula,

70 8170.865
external dia. 5.0 mm; internal dia. 2,0 mm; WL= 215 mm
8.5.1 Spare parts
8
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
Depending on the irrigation cannula version:

77.1 64248.027
Compression spring (5 / pkg)
GA--AS 001 8- 7
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)
TEM disposable Tube Set consisting of:
4170.864 Pump tube
4170.801
4170.862 Connection tube
4170.842 Tube set
TEM Disposable Tube Set for ERBE Multifunctional Instrument consisting of:
4170.864 Pump tube
4170.804 4170.862 Connection tube
4170.843 Tube set
4170.867 Irrigation tube ERBE
8 -- 8 GA--AS 001
8.7 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 com-
pleted in due course.
Sealing cap
red blue grey red blue red
15 mm 17 mm 17 mm
d d d
Designation /
Illustration
Model / type
for instruments dia. (in mm)
Ø2.4 Ø3.4 Ø5.1 Ø13.0
Ø4.0 to Ø7.5 to
to to to to
Ø6.0 Ø8.5
Ø3.4 Ø5.1 Ø6.0 Ø13.8
KV1) 89.01 89.02 89.03 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
-- j j J J j
8840.762*
for the above
Suture Clamp (50 / pkg)
-- -- -- -- -- --
8840.764
Needle Holder, straight;
840.241
dia. 4.6 mm, WL= 405 mm -- j J j J j
8840.604*
884
Needle Holder with
downward offset;
dia. 4.6 mm; WL= 405 mm
-- j J j J j
working insert
8
8840.605*
in
Curved needle
ETHICON SH 3--0 or
-- -- -- -- -- --
BRAUN--DEXON, MAXON
3--0, HR 26
only for w
HF Scalpel, unipolar
right;
1.5 j J j J j
dia. 4 mm WL= 420 mm
8840.711*
HF Scalpel, unipolar
left;
1.5 j J j J j
dia. 4 mm WL= 420 mm
8840.712*
Retractable Syringe Needle;
dia. 4.0 mm; WL= 325 mm -- j J j J j
8840.74
1) KV = do not exceed maximum recurring J Use sealing cap
peak voltage! j Do not use sealing cap
GA--AS 001 8- 9
Sealing cap
red blue grey red blue red
15 mm 17 mm 17 mm
d d d
Designation /
Illustraion Model / type for instruments dia. (in mm)
Ø13.
Ø2.4 Ø3.4 Ø5.1 Ø4.0 Ø7.5
0 to
to to to to to
Ø13.
Ø3.4 Ø5.1 Ø6.0 Ø6.0 Ø8.5
8
KV1) 89.01 89.02 89.03 89.141 89.161 89.10
Coagulation Suction Tube,
unipolar
dia. 5.6 mm; WL= 470 2.0 j j J J j
mm
GA--B152 8840.731*
HF combination forceps,
unipolar, offset,
curved right; 2.0 j J j J j
Ø 4.8 mm; WL= 405 m
0.241
GA--S008 8840.621
8840.
unipolar, offset,
curved left; 2.0 j J j J j
working insert
Ø 4.8 mm; WL= 405 mm
GA--S008 8840.622
i
unipolar,curved right;
2.0 j J j J j
Ø 4.8 mm; WL= 405 mm
GA--S008 8840.623
only for w
unipolar, curved left;
2.0 j J j J j
dia. 4.8 mm; WL= 405 mm
GA--S008 8840.624
8 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 -- j J j J j
GA--S003 8840.644
1) KV = do not exceed maximum recurring J Use sealing cap

peak voltage! j Do not use sealing cap
8 -- 10 GA--AS 001
8.8 Additional spare parts and accessories
Illustration Model / type Designation
15 023.133 Luer locking cap

74014.069 Compression spring
HF connection cable
8106.032 / 8106.052 =3m/=4m
8106.132 / 8106.152 =3m/=4m
8106.031 / 8106.051 =3m/=4m
8106.033 / 8106.053 =3m/=4m
8106.034 / 8106.054 =3m/=4m
Sterilization and storage basket for:

- 38043.011 Stereo endoscope 4840.501 and
Documentations endoscope 8840.401
200.532 Instrument oil WO53
6.07 Cleaning brush

-- Bottle brush
86.90 Cleaning brush
GA--AS 001 8 - 11
8.9 Replacing device fuses

CAUTION!
The specification of the fuses in the device must correspond with the fuse ratings on the identi-
fication plate.
Use only the fuses specified in the spare parts list.
L Power input connector with fuse holder.
l/min
1. Switch off the power switch: Press the button.
2. Disconnect the power input connector from the wall socket.

!
1
!
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 2 3
8.10 Operating, storage, transport and shipping conditions
+10°C to +40°C , 30% to 75% rel. humidity,

Operating conditions
atmospheric pressure 700 hPa to 1060 hPa
-- 20°C to +60°C , 10% to 90% rel. humidity,
Storage, transport and shipping conditions
atmospheric pressure 700 hPa to 1060 hPa
. NOTE :
To prevent damage during transport or shipment of the products we recommend using the original pack-
aging material.
8.10.1 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.
8 -- 12 GA--AS 001
Contents
Section 9
Overview diagram for laparoscopic surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 2
1 Intended purpose
1.2 Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 3
1.2.1 Insufflation tube . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 3
1.3 Indications and field of use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 3
1.5 Combinationen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 3
3 Set up
3.3 Connecting the insufflation tube . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 4
3.3.1 Choosing the insufflation tube . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 4
3.3.2 Before connecting the insufflation tube . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 4
3.3.3 Connection diagrams for laparoscopic surgery . . . . . . . . . . . . . . . . . . . . . . . 9 -- 4
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
4.2.1 Establishing pneumoperitoneum . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 7
4.2.2 Secondary filling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 8
4.2.3 Alarm messages not relating to device defects . . . . . . . . . . . . . . . . . . . . . . 9 -- 8
5 Checks
5.2.3 Manual check for laparoscopy mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 9

8.1
8.2
Laparoscopic surgery accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 11
Insufflation tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 11
9
GA--AS 001 9- 1
Overview diagram for laparoscopic surgery

Make sure you observe the special sections on laparoscopic applications.
Section
Sections which have already been described in transanal endoscopic
Section microsurgery (section 1 -- 8) and which are also used in laparoscopic surgery.
Technical description General requirements for products / components

of a combination
Intended use
Paragraph 1.5.1
Section 1 Indication and field of use
Kontraindikationen
Contraindications
Combinations
Section 2 Illustrations / Controls and indicators Paragraph 2.1.1
Setup Section 3
Assemble irrigation bottle holding bracket Paragraph 3.1.2
Section 3 Electrical (protective earth) and CO2 gas supply connections Paragraph 3.1.1
CO2 connection Paragraph 3.1.3
Insufflation tubes
Use
Possible alarms during use Paragraph 4.5.3
Power failure Paragraph 4.5.4

Section 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

Section 5
Automatic function checks Paragraph 5.2.1
Checking the CO2 gas supply Paragraph 5.2.2
Manual check during operation
Manual reprocessing Paragraph 6.1.1
9 Section 6
Maintenance
Maintenance intervals, quarterly inspection,
Test of the pressure and gas flow control on the LAPARO CO2 PNEU,
Paragraph 6.1.2
Leakage test
Error messages / Correctiv actions Section 7

Section 7 Device errors Paragraph 7.1
Error messages for LAPARO CO2 PNEU Paragraph 7.2
Technical data and order data Paragraph 8.1 –

Paragraph 8.1. 4
Section 8 LAPARO CO2 PNEU
Instrument Set
9 -- 2 GA--AS 001
1 Intended purpose
1.1 Technical description
The portable system is a desktop unit for laparoscopic surgery consisting of the LAPARO CO2 PNEU, an in-
sufflation 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.
. NOTE :
Before the first use we recommend reading relevant literature (see appendix A--3).
1.4 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.
9
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
3 Set up
3.1
3.2
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
. 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.
3.3.3 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 2 2 3 2
B2
LAPAR O
C O2 - PN EU
(x)
0
HIGH
B1
9
B1
B2 B1
B1 B1
B2 B2
9- 4 GA--AS 001
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 2 2 3 2
white
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.
GA--AS 001 9- 5
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
1. Switch off power switch: Press the button.

l/min
30 s
2 2. Remove all hygiene filters.
3
!
1 3. After 30 seconds switch on the power switch: Press the button.

' The LAPARO CO2 PNEU runs through an automatic function test
! routine (duration approx. 15 seconds).
' 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.
' 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 dis-
played.
' The LAPARO CO2 PNEU is not in standby mode (not ready).
Repeat items 1--3.
9 Primary insufflation mode
1. Attach the hygiene filter.

l/min
1 2. To start insufflation: Press the button.

' The button is lit.
! ' Primary insufflation 1.0 l/min is activated.
2/3 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 button.
9 -- 6 GA--AS 001
High Flow mode
. NOTE :
The “High Flow” mode can only be selected if primary insufflation
l/min
2/3 is activated.
! 1. To start insufflation: Press the button.
1 ' The button is lit.

' Primary insufflation at 1.0 l/min is activated.
2. To start High--Flow: Press the button.
!
' The 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 button.
' The device is in “Primary insufflation” mode.

. 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
9
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
4.2.2 Secondary filling
WARNING!
Danger of gas embolism
Use the ”High Flow” mode only for the secondary filling.
. 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.
Z Introduce the trocar sleeve with the trocar in place into the abdomen.
Z Connect the insufflation tube to the closed insufflation tap.
Z Remove the trocar and insert the endoscope.
Z After ensuring the correct incision position, open the insufflation tap.
Z Switch from primary insufflation to high flow insufflation by pressing the ”High Flow” button.
. 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.
4.2.3 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 -- 8 GA--AS 001
5 Checks
5.1
5.2 Functional checks
5.2.1
5.2.2
5.2.3 Manual check for laparoscopy mode
. NOTE :
Precondition for the manual check:
' Automatic function check passed and
' TEM--PUMP switched off
Insufflation function
Z Preselect the nominal pressure.
l/min
1b 2b 3a
Gas flow check -- Primary insufflation
2 1. Switch on insufflation: Press the button.
! ' The intraabdominal pressure increases to the preselected value.
' The level indicator (1a) and digital display (1b) must read a gas
1a 2a 1/3 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.
Control check
l/min
1b 2b ' 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
1a 2a 1/2 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.
9
GA--AS 001 9- 9
Z Preselect a nominal gas flow rate of 10.0 l/min.

Z Remove the Veres cannula.
l/min
3a 2/4
1a 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.
1/6 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.
3/4 ' 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.
' The level indicator (1a) and digital display (1b) read the prese-
lected gas flow rates.
9 -- 10 GA--AS 001
6
7

8.1 Laparoscopic surgery accessories
Model / type Designation Instructions

4171.111 Hygiene filter, sterilely packed, for insufflation connector (10 / pkg) --
8302.12 Veres cannula HA--EF 45a
8923.013 RIWO--ART Trocar sleeve, dia. 10.0 mm
8923.0421) High Flow Trocar sleeve, dia. 10.0 mm GA--B 129
8924.0421) High Flow Trocar sleeve, dia. 12.5 mm
8923.801 VARIO--PORT Reducing adapter to dia. 5.5 mm
GA -B
GA- B 135
8924.801 VARIO--PORT Reducing adapter to dia. 10.0 mm
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 ob-
served. 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
GA--AS 001 9 - 11
9 -- 12 GA--AS 001
Annex
Contents
A. Annex
A.1 Literature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A -- 2
A.2 Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A -- 3
A.3 Literature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A -- 5
A.4 Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A -- 6
GA--AS 001 A- 1
Annex
A. 1 Literature
. 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 -- 2 GA--AS 001
Annex
A. 2 Index
A E
Accessories: 8-- 5, 11 Electrical current: 4-- 10
ERBE Multifunctional Instrument: 3-- 4, 7
Adapter with viewing window: 4-- 4
Error message: 7-- 1
Additional notes and instructions for use: 4-- 8, 10, 13
Error messages for LAPARO--CO2--PNEU: 7-- 2
Additional options: 8-- 2 Error messages for TEM--PUMP: 7-- 3
Additional spare parts: 8-- 11 Establishing electric (protective earth / ground): 3-- 3
Alarm functions: 4-- 15
Alarm volume: 4-- 16
Application parameters: 8-- 2, 4 F
Attachment with observation window: 1-- 2; 5-- 2
Automatic check: 5-- 3 Flexible instrument port: 4-- 6
Function principle: 4-- 2
Functional checks: 5-- 3
C G
Checks: 5--1; 6-- 6, 9, 10, 12, 13, 14 General requirements on products/components of a
Clamping base: 4-- 3 combination: 1-- 5
Cleaning / disinfection: 6-- 3, 5, 7, 9, 10, 12, 13, 14
CO2 connection: 3-- 3
CO2 gas supply: 5-- 4 H
CO2 --Betrieb: 3-- 3 HF Applications: 4-- 11
Combinations: 1-- 4 HF Scalpel, unipolar: 1-- 3; 4-- 10; 5-- 3; 6-- 13
Connection diagram: 3-- 5 HIGH alarm: 4-- 15
Contraindications: 1-- 4 Housing: 1-- 2
Controls and indicators: 2-- 1, 4
Correctiv action: 7-- 1
I
Illustrations: 2-- 1, 9
Important surgical information: 1-- 3
D Indications and field of use: 1-- 3
Inflating the rectal cavity: 4-- 13
Device connections: 2-- 8 Installation of the TEM Combination System: 3-- 2
Device errrors: 7-- 2 Insufflation: 4-- 13
Disposable (single--use) filtration attachment: 1-- 3 Insufflation function: 5-- 4
Disposable filtration adaptor: 6-- 9 Intended purpose: 1-- 1
Disposal of product , packaging material and Intended use: 1-- 2
accessories: 8-- 12 Interfaces: 8-- 3, 4
Documentation endoscope: 1-- 2; 4-- 7; 5-- 5 Irrigation: 4-- 14
Double blower: 1-- 3; 4-- 4; 6-- 9 Irrigation bottle holder: 3-- 2
Double function footswitch: 5-- 5 Irrigation / suction control via the footswitch: 4-- 14
Dry preparation at the point of use: 6-- 6, 7, 9, 10, Irrigation and insufflation tube: 1-- 2
A
12, 13, 14 Irrigation fluid: 4-- 10
GA--AS 001 A- 3
Annex
L S
LAPARO CO2 PNEU: 1-- 2; 2-- 2; 5-- 2; 8-- 2 Safety features: 8-- 2, 4
Leakage test: 6-- 4 Sealing insert assembly: 5-- 2
Light: 4-- 10 Seals / o--rings: 5-- 2
LOW alarm: 4-- 15 Setup: 3-- 1
Silicone sealing insert: 1-- 2; 4-- 6
Spare parts: 8-- 5, 7
Standby mode of LAPARO CO2 PNEU: 4-- 12
M Steam sterilization: 6-- 2
Stereo endoscope: 1-- 2; 4-- 7; 5-- 5; 6-- 8
Machine reprocessing: 6-- 6, 7, 9, 10, 12, 13, 14 Sterilization: 6-- 6, 8, 11, 12, 13, 14
Maintenance: 6-- 1, 3 Sterilization method: 6-- 2
Manual check: 5-- 4 Sterilization procedure Sterist : 6-- 2
Manual reprocessing: 6-- 3, 5, 7, 9, 10, 12, 13, 14 Sterilization procedures Sterist and Sterradt: 6-- 2
Measuring devices and auxiliary equipment for Suction: 4-- 14
TEM PUMP: 6-- 4
Suction and irrigation functions: 5-- 4
MEDIUM alarm: 4-- 15 Suction power: 4-- 14
Surgical method: 4-- 2
Suture Clip: 6-- 10
N Suture Clip Forceps: 1-- 3; 5-- 5; 6-- 10
Symbols / Labeling: 2-- 2
NaCl irrigation bottle: 3-- 4
Needle Holder: 1-- 3; 4-- 9; 5-- 3, 5; 6-- 12
Nominal gas flow rate: 4-- 13 T
Nominal pressure: 4-- 13
Notes and instructions on reprocessing and Technical description: 1-- 2
maintenance: 6-- 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
O 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
Obturator: 1-- 2; 4-- 4
TEM mode: 4-- 12
Operating area: 4-- 5
TEM PUMP: 1-- 2; 2-- 2; 3-- 4; 4-- 12; 5-- 2; 8-- 4
Operating principle: 4-- 12
TEM Reprocessable (multi--use) Tube Set: 3-- 5
Operating, storage, transport and shipping
TEM Tube Set: 1-- 2; 3-- 4; 5-- 2; 8-- 8
conditions: 8-- 12
Tube section: 6-- 9
Order data: 8-- 1
U
P
U--shaped support arm: 1-- 2; 4-- 3; 5-- 2, 5; 6-- 7, 8
Packaging: 2-- 3 Ultrasound cleaning: 6-- 10, 12
Power failure: 4-- 14 Use: 4-- 1
Pressure and gas flow control system: 6-- 3
Previous switch--on (shorter than 30 seconds): 4-- 12
Pump cover: 3-- 4 V
A Pump tube: 3-- 4
Video--assisted TEM: 4-- 8
Visuel check: 5-- 2
R
Rectoscope tube: 1-- 2; 4-- 4 W
Replacing device fuses: 8-- 12 Wet preparation at the point of use: 6-- 3, 5, 7, 9, 10, 12,
Reprocessing: 6-- 1 13, 14
Retractable Syringe Needle: 1-- 3; 4-- 10; 5-- 3; 6-- 14 Working insert: 1-- 2; 4-- 5, 8; 5-- 2
A -- 4 GA--AS 001
Annex
A. 3 Literature
. 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
GA--AS 001 A- 5
Annex
A. 4 Index
A L
Accessories: 9-- 11 LAPARO CO2 PNEU: 9-- 6
Additional notes and instructions for use: 9-- 7
C M
Checks: 9-- 9 Manual check: 9-- 9
Combinations: 9-- 3
Connection diagrams: 9-- 4
Contraindications: 9-- 3
O
D Operating principle: 9-- 6
Order data: 9-- 11
Disposable Insufflation Tube: 9-- 4, 5 Overpressure alarm (E11): 9-- 8
Overview diagram for laparoscopic surgery: 9-- 2
E
Establishing pneumoperitoneum: 9-- 7
R
Reprocessable Insufflation Tube: 9-- 4
F
Functional checks: 9-- 9
S
G Safety instructiones used in this manual: III
Gas flow check -- High Flow: 9-- 9 Secondary filling: 9-- 8
Gas flow check -- Primary insufflation: 9-- 9 Set up: 9-- 4
Signal is sounded: 9-- 6
Standby mode of LAPARO CO2 PNEU automatic
H insufflator: 9-- 6
Structure and use of this manual: III
High Flow mode: 9-- 7
I T
If you switch on before the 30 seconds Technical data: 9-- 11
have elapsed: 9-- 6 Technical description: 9-- 3
Important informations: III
Indications and field of use: 9-- 3
Insufflation function: 9-- 9
Insufflation tube: 9-- 3, 4, 11 U
A Intended purpose: 9-- 1
Intended use: 9-- 3 Use: 9-- 6
A- 6 GA--AS 001

Manual Equipo Biomedico

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Instructions

TEM Combination System

with TEM Instrument Set

LAPARO CO2 PNEU (without TEM PUMP)

for Laparoscopic Surgery

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

E--mail: info@richard--wolf.com E--mail: sales&marketing@richardwolfusa.com E--mail: admin@richardwolf.uk.com

BELGIUM FRANCE AUSTRIA

E--mail: endoscopy@richard--wolf.be E--mail: endoscopes@richardwolf.fr E--mail: info@richard--wolf.at

MANUFACTURER U--shaped support arm 8840.9721

Transanal Endoscopic Microsurgery (TEM)

7 Error message / Correctiv action

Important general instructions for use

Z CAUTION -- USA only:

Safety instructions used in this manual

Structure and use of this manual

GA--AS 001 III

Overview diagram for TEM application

Prepare TEM products

Want to use no Want to use no Want to use

yes yes yes

Prepare sterile hygiene filter Use TEM Disposable Tube Set

Setup TEM Combination System

Prepare TEM Irrigation Cannula and Alarm functions Section 4

Connect the hygiene filter Connect the TEM Tube Set

Carry out manual checks Section 5

Connect the TEM Tube Set Section 3

1.2 Intended use

1.2.1 LAPARO CO2 PNEU

1.2.2 TEM PUMP

1.2.3 TEM Irrigation Cannula

1.2.4 TEM Tube Set

1.2.5 TEM Instrument Set consisting of:

1.2.6 TEM Accessories

1.2.7 Important surgical information

1.3 Indications and field of use

The TEM procedure is indicated for:

1.5.1 General requirements on products/components of a combination

R = 1.5 m Patient environment

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

Medically used room Non--medically Requirements / measures

MP or a) common protective earth connection, or

1 Z Specific requirements on the products/components of a combination

2 Dies ist eine unsichtbare Komponente ohne Sprachvariante

2.1.1 LAPARO CO2 PNEU automatic insufflator / TEM PUMP / Packaging

TYPE BF APPLIED PART Fuse

Measuring line, for rectal pressure µ Alternating current (AC)

Protective earth / ground connection

2.1.2 LAPARO CO2 PNEU automatic insufflator

Symbols / Rear panel

Sub D socket, 15--pole

ONLY FOR CO2 !

2.1.3 TEM PUMP

Symbols / Rear panel

Output, irrigation pressure x --

Input, pressure measurement, patient x --

Socket for foot switch -- x

2232 Sub D socket, 15--pole

Lot identification number

Units, pieces, items per package

To be used before (date):

Sterilized with ethylene oxide