Instructions
2232
LAPARO
C02- PNEU
2232
TEM Combination System
(LAPARO CO2 PNEU with TEM PUMP)
with TEM Instrument Set
for Transanal Endoscopic Microsurgery
j
E 2003 by RICHARD WOLF GMBH, Pforzheimer Straße 32, D--75434 Knittlingen
TEM PUMP
LAPARO CO2 PNEU (without TEM PUMP)
for Laparoscopic Surgery
GA--AS 001 / en / Index: 08--03--1.0 / ÄM: KG 03--224
GERMANY
RICHARD WOLF GmbH
D--75438 Knittlingen
Pforzheimerstr. 32
Tel.: (..49)--(0)7043--35--0
Fax:(..49)--(0)7043--35300
MANUFACTURER
USA
RICHARD WOLF
Medical Instruments Corp.
353 Corporate Woods Parkway
Vernon Hills, Illinois 60061
Tel.: 847--913 1113
Fax: 847--913 1488
UK
RICHARD WOLF UK Ltd.
Waterside Way
Wimbledon
SW 17 0HB
Tel.: 020--8944 7447
Fax: 020--8944 1311
E--mail: info@richard--wolf.com
Internet: www.richard--wolf.com
E--mail: sales&marketing@richardwolfusa.com
Internet: www.richardwolfusa.com
E--mail: admin@richardwolf.uk.com
Internet: www.richardwolf.uk.com
BELGIUM
N.V. Endoscopie
RICHARD WOLF Belgium S.A.
Industriezone Drongen
Landegemstraat 6
B--9031 Gent --Drongen
Tel.: +32 9.280.81.00
Fax: +32 9.282.92.16
FRANCE
RICHARD WOLF France S.A.R.L.
Rue Daniel Berger
Z.A.C. La Neuvillette
F--51100 Reims
Tel.: +33 3.26.87.02.89
Fax: +33 3.26.87.60.33
AUSTRIA
RICHARD WOLF Austria
Ges.m.b.H.
Wilhelminenstraße 93 a
A--1160 Wien
Tel.: +43 1-- 405 51 51
Fax: +43 1-- 405 51 51--45
E--mail: 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
Transanal Endoscopic Microsurgery (TEM)
1.
Intended purpose
1.1
1.2
1.3
1.4
1.5
Technical description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Indications and field of application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Combinations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2
Illustrations / Controls and indicators
2.1
2.2
2.3
2.4
Symbols / Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Controls and indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Device connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Illustrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.
Set up
3.1
3.2
3.3
Installation of the TEM Combination System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 -- 2
Prepare the TEM Irrigation Cannula and NaCl irrigation bottle . . . . . . . . . . . . . . . . . . 3 -- 4
Connect the tube set for TEM applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 -- 4
1 -1 -1 -1 -1 --
2
2
3
4
4
2 -2 -2 -2 --
2
4
7
8
4.
Use
4.1
4.2
4.3
4.4
4.5.
4.6.
TEM Instrument Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
TEM Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Additional notes and instructions for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
TEM Combination System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Additional notes and instructions for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Alarm functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5
Checks
5.1
5.2
Visual checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 -- 2
Functional checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 -- 3
6
Reprocessing and maintenance
6.1
6.2
6.3
6.4
6.5
6.6
6.7
6.8
TEM Combination System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
TEM Irrigation Cannula . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
TEM Instrument Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Double blower / Disposable filtration adaptor / tube section . . . . . . . . . . . . . . . . . . . .
Suture Clip Forceps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Needle Holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
HF Scapel, unipolar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Retractable Syringe Needle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
GA--AS 001
4 -4 -4 -4 -4 -4 --
6 -6 -6 -6 -6 -6 -6 -6 --
2
9
10
12
13
15
3
5
7
9
10
12
13
14
I
Transanal Endoscopic Microsurgery (TEM)
Laparoscopic Surgery
7
Error message / Correctiv action
7.1
7.2
7.3
Device errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 -- 2
Error messages for LAPARO CO2 PNEU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 -- 2
Error messages for TEM PUMP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 -- 3
8
Technical data and order data
8.1
8.2
8.3
8.4
8.5
8.6
8.7
8.8
8.9
8.10
LAPARO CO2 PNEU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
TEM PUMP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Spare parts and accessories for TEM Combination System . . . . . . . . . . . . . . . . . . . .
TEM Instrument Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
TEM Irrigation Cannula . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
TEM Tube Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
TEM Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Additional spare parts and accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Replacing device fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Operating, storage, transport and shipping conditions . . . . . . . . . . . . . . . . . . . . . . . . .
8 -- 2
8 -- 4
8 -- 5
8 -- 6
8 -- 7
8 -- 8
8 -- 9
8 -- 11
8 -- 12
8 -- 12
Laparoscopic Surgery
Overview diagram for laparoscopic surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 2
II
1
Intended purpose
1.1
1.2
1.3
1.4
1.5
Technical description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Indications and field of application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Combinations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3
Set up
3.3
Connecting insufflation tube . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 4
4
Use
4.1
4.2
LAPARO CO2 PNEU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 6
Additional notes and instructions for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 7
5
Checks
5.2
Functional checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 9
8
Technical data and order data
8.1
8.2
Accessories for laparoscopic surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 11
Insufflation tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 11
A
Annex
A.1
Literature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A -- 2
Transanal Endoscopic Microsurgery (TEM)
A.2
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A -- 3
Transanal Endoscopic Microsurgery (TEM)
A.3
Literature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A -- 5
Laparoscopic Surgery
A.4
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A -- 6
Laparoscopic Surgery
9 -9 -9 -9 -9 --
3
3
3
3
3
GA--AS 001
Important informations
Important general instructions for use
Z Ensure that this product is used only as intended and described in this instruction manual, by adequately
trained and qualified personnel.
Z Ensure that maintenance and repair is only carried out by authorized specialized technicians.
Z Use this product only in the combinations and with the accessories and spare parts listed in this instruction
manual. Use other combinations, accessories and replacement parts only if they are expressly intended for
this use and if the performance and safety requirements are met.
Z Reprocess the products before each application and before returning them for repair as required by the instruction manual in order to protect the patient, user or third parties.
Z This manual is an integral part of the product. It is therefore necessary to keep the manual during the product’s entire service life.
Z This manual must be passed on to each subsequent owner or user.
Z Subject to technical changes!
Due to continuous development of our products, illustrations and technical data may deviate slightly from
the data in this manual.
Z CAUTION -- USA only:
Federal law restricts this device to sale by or on the order of a physician.
Safety instructions used in this manual
Symbol
Level of danger
WARNING!
Failure to observe can result in death or serious injury
CAUTION!
Failure to observe can result in slight injury or damage to the product.
.
.
IMPORTANT!
Failure to observe can result in damage to the product or surrounding.
NOTE!
Tips for optimum use and other useful information.
Structure and use of this manual
.
IMPORTANT!
Fields of use / Devices and instruments used:
Z Transanal Endoscopic Microsurgery (TEM)
LAPARO CO2 PNEU automatic insufflator with TEM PUMP in conjunction with TEM irrigation cannula, TEM tube set, TEM instrument set and TEM accessories.
Z Laparoscopic Surgery
LAPARO CO2 PNEU automatic insufflator without TEM PUMP in conjunction with Veres cannula /
RIWO ART trocar sleeve, High flow trocar sleeve, insufflation tube set and laparoscopic accessories.
.
IMPORTANT!
For laparoscopic surgery -- Notes and instructions for use see section 9
The TEM describes displays, indicators and controls, device functions, illustrations as well as necessary
control steps and actions of the LAPARO CO2 PNEU automatic insufflator which in part are also used in
laparoscopic surgery.
To find this information quickly and easily please refer to the overview diagram at the beginning of section 9
(Cross reference to the corresponding section of TEM).
.
IMPORTANT!
Changing the mode of operation:
The mode of operation can only be selected if the LAPARO CO2 PNEU automatic insufflator is in basic
mode (standby mode) (see paragraph 4.4).
GA--AS 001
III
Important informations
Overview diagram for TEM application
This overview diagram helps in preparing a TEM application showing under what section you find specific information in this manual.
Prepare TEM products
Want to use
TEM Disposable Tube Set
8170.841?
no
Want to use
ERBE Multifunctional
Instrument?
yes
Prepare sterile hygiene filter
no
yes
Want to use
TEM Disposable Tube Set
4170.801?
Section 3
yes
Use TEM Disposable Tube Set
4170.804
yes
Setup TEM Combination System
yes
Want to use
CO2 connector for gas cylinder
up to max. 2 liters?
no
yes
Section 3
Install CO2 gas cylinder mounting
bracket.
Connect CO2 connector
to central gas supply
yes
Prepare TEM Irrigation Cannula and
pierce NaCl irrigation bottle
Alarm functions
Section 4
Error message / Correctiv action
Section 7
yes
Section 5
Carry out automatic function test /
check of CO2 gas supply
yes
Section 4
Is
LAPARO CO2 PNEU
in standby mode
and ready?
(a signal is sounded)
Connect the hygiene filter
and TEM Tube Set 8170.841
to the device
yes
Connect the TEM Tube Set
4170.801 or 4170.804
to the device
no
Could fault
be eliminated?
no
Contact the Richard
Wolf service department
yes
Switch off LAPARO CO2 Pneu,
switch on again after approx. 30 s
Section 3
yes
Carry out manual checks
Section 5
yes
Connect the TEM Tube Set
to the instrument
IV
Section 3
GA--AS 001
1. Intended purpose
1
Contents
Section 1
1.
Intended purpose
1.1
Technical description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 -- 2
1.2
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.1
LAPARO CO2 PNEU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.2
TEM PUMP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.3
TEM Irrigatation Cannula . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.4
TEM Tube Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.5
TEM Instrumentarium consists of: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.6
TEM Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.7
Important surgical informations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.3
Indications and field of use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 -- 3
1.4
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 -- 4
1.5
Combinations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 -- 4
1.5.1
General requirements on products/components of a combination . . . . . . 1 -- 5
GA--AS 001
1 -1 -1 -1 -1 -1 -1 -1 --
2
2
2
2
2
2
3
3
1- 1
1. Intended purpose
1
1
Dies ist eine unsichtbare Komponente ohne Sprachvariante
1.1
Technical description
The mobile system is a desktop unit for Transanal Endoscopic Microsurgery (TEM) consisting of the LAPARO-CO2 PNEU automatic insufflator, TEM PUMP, TEM Irrigation Cannula, TEM Tube Set, TEM Instrument Set and
TEM Accessories.
1.2
Intended use
The system is used for pressure--controlled inflation of the colon (rectal cavity and lower portion of the sigmoid)
with CO2 gas in order to perform transanal endoscopic microsurgery.
The target is the excision of polyps and/or the removal of tumors in conjunction with the TEM instrument set and
TEM accessories while evacuating blood, secretion, smoke and/or CO2 gas from the rectal cavity and for cleaning the telescope window.
The TEM instruments and their endoscopic accessories must be chosen in such a way
that their dimensions suit the anatomical requirements.
1.2.1
LAPARO CO2 PNEU
for pressure--controlled dilation of the colon (rectal cavity and lower portion of the sigmoid) with CO2 gas.
1.2.2
TEM PUMP
' for continuous measurement of the rectal pressure
' for continuous evacuation of blood, secretion, smoke and / or CO2 gas
' for flushing the telescope window clean with sterile saline
CAUTION!
In therapeutic applications a backup unit must be available if the device fails.
1.2.3
TEM Irrigation Cannula
serves to control the flow of irrigation fluid and for rinsing the stereo and/or documentation telescope.
1.2.4
TEM Tube Set
serves to connect/insufflate, irrigate, evacuate between the TEM combination system and the TEM instruments.
1.2.5
TEM Instrument Set consisting of:
Z Resectoscope tube
serving as a working channel / port.
Z Obturator
serves to atraumatically insert the rectoscope tube into the rectum.
Z Housing
is used to lock the resectoscope tube and obturator in place.
Z Attachment with observation window
is used for sealing and observing the operating area.
Z Working insert
serves to house the silicone sealing insert, the stereo telescope and to insert instruments.
Z Silicone sealing insert
serves to change instruments of different diameters via one large and two smaller flexible ports, keeping the
gas losses low.
Z U--shaped support arm
serves to hold the TEM instruments and to precisely adjust the operating area. The arm is vertically and
horizontally adjustable.
Z Stereo endoscope
allows 3D--visualization of the operating area via the natural passage and telescope rinsing as well as
insufflation with CO2 gas. The interpupillary distance is adjustable.
Z Documentation endoscope
can be connected to a video camera, allowing work/documentation via the monitor.
Z Irrigation and insufflation tube
is used for rinsing the documentation telescope and for insufflating CO2 gas into the rectal cavity. The irrigation
and insufflation insert is exclusively used in video monitored TEM applications.
1 -- 2
GA--AS 001
1. Intended purpose
1.2.6
1
TEM Accessories
Z Double blower
for dilating the intestine when adjusting the operating area visually.
Z Disposable (single--use) filtration attachment
preventing germs from entering the double blower.
Z Suture Clip Forceps
is used to apply an initial and an end clip to replace knots when making a continuous suture to close a
wound using absorbable suture material.
Z Needle holder
is used for the fixation and takeover of curved needles and for making surgical suture.
Z HF Scalpel, unipolar
is used for coagulating and cutting (e.g. resection and preparation of mucous membrane and tissue) by
means of high--frequency current under endoscopic view.
Z Retractable Syringe Needle
for infections under tissue parts that are be removed.
1.2.7
Important surgical information
.
NOTE :
The literature listed (see Annex A--1) gives an overview over the last years. The notes listed below were
obtained from the corresponding relevant literature.
' Sessile adenomas are predominantly located in the rectum and lower sigmoid colon.
' For lesions located in the intraperitoneal region of the rectum, partial wall excision (dividing the circular
layer from the longitudinal muscle layer) is recommended to reduce the risk of perforation. Full thickness
excision is recommended only for lesions in the extraperitoneal region of the sigmoid.
' Segmental resection is suggested for circularly growing adenomas.
' CAUTION is suggested when removing a tumor from the anterior wall of the rectum. The close proximity
of the vagina to the anterior wall increases the risk of rectovaginal fistula in females or the risk of prostate
hemorrhage in males.
' Suture line dehiscence is known as the most common complication of a TEM procedure.
' Follow--up examinations are recommended once a year for patients who have had adenomas removed
and every 3 months after local excision of cancer for the first 2 years. Long--term follow--up to asess the
recurrence rate for benign adenomas and the role of TEM in the treatment of invasive cancer is needed to
confirm efficacy.
1.3
Indications and field of use
The TEM is indicated in the case of a wide--base rectum adenoma and early rectum carcinoma. The rectum
adenoma can be removed using the mucosectomy method or also the full--wall method in the areas of the extraperitoneal rectum.
Early carcinoma should always be removed using the full wall method.
On principle the TEM technique can be used in the areas of the colon and sigma which can be reached with
the operating rectoscope.
.
NOTE :
Before the first use we recommend reading the relevant literature in addition to participation in
an operating course.
The TEM procedure is indicated for:
' histologically confirmed sessile adenomas located in the rectum and lower sigmoid colon.
' histologically confirmed, moderately well differentiated cancer which has been staged pre--operatively as
CS1 or T1 carcinoma confined to the submucosa; and
' histologically confirmed, moderately well differentiated cancer which has been staged pre--operatively as
T2 in patients >70 years, or younger for patients with high risk factors.
GA--AS 001
1- 3
1. Intended purpose
1
1.4
Contraindications
WARNING!
The device has a high flow rate.
The device cannot be used for hysteroscopy.
The device must not be used for inflating the cavum uteri.
TEM is contraindicated for patients who have general contraindications to surgery, severe infection and/or a
serious metabolic disorder.
On the basis of the patient’s general condition the physician/surgeon in charge must decide whether the
planned application is possible or not.
For further information please refer to the current medical literature.
1.5
Combinations
The system is used in conjunction with light sources, videao cameras, HF devices and endoscopic accessories ( see section 8).
WARNING!
Danger of intrarectal overpressure if a second gas source is used.
If argon plasma coagulators are used additional visual or manual pressure monitoring by the
user is imperative, because pressure monitoring or the pressure release function (venting) of the
LAPARO CO2 PNEU automatic insufflator, e.g. due to a kinked insufflation tube or a closed instrument tap could be deactivated.
The preselected gas flow rates of an argon plasma coagulator should not exceed 2 l/min.
Activate the argon plasma coagulator only for a short time.
WARNING!
Danger of potentionally fatal gas or air embolism.
Purge the connection tubes with a sufficient amount of CO2 before use.
The use of devices applying additional gaseous media in combination with a TEM Combination
System or LAPARO CO2 pneu automatic insufflator lies exclusively in the responsibility of the user.
CAUTION!
Caution if products are incorrectly combined!
Possible injury of the patient, user or others as well as possible damage to the product.
Different products should only be used in combination if their intended use and relevant technical
data (working length, diameter, peak voltage, etc.) are the same.
Follow the instruction manuals of the products used in conjunction with this product (see section 8).
1 -- 4
GA--AS 001
1. Intended purpose
1.5.1
General requirements on products/components of a combination
The general requirements depend on whether the products/components are inside or outside the patient
environment.
Patient environment
R = 1.5 m
h = 2.5 m
Patient environment
Acc. to UL-- 2601: R = 1.83 m (6 feet) ; h = 2.29 m (71/2 feet)
Medically used room
Inside the patient environment
MP
MP
µ
µ
MP
NMP
µ
µ
MP
NMP
µ
**
outside the patient
environment
Non--medically
used room
Requirements / measures
Leakage currents to clause 19
IEC/EN 60601--1--1 *
--
--
--
--
--
a) additional protective earth connection
(to be clarified with manufacturer),
or
MP
b) with additional separating transformer **
NMP
µ
MP
NMP
µ
µ
MP
MP or
NMP
µ
µ
additional separating transformer
according to IEC/ EN 60601--1--1 **
MP
=
NMP =
--
--
additional separating device
according to IEC/ EN 60601--1--1
a) common protective earth connection, or
b) additional protective earth connection
(to be clarified with manufacturer), or
c) additional separating device (to avoid
earth/ground loops in the case of a
potential difference)
Functional
connection
µ
power supply grid
medical electrical device according to IEC/ EN 60601--1, UL 2601, CSA C22.2 No. 601
non-- medical electrical device in accordance with the relevant product--specific IEC/ EN/ UL/ IEC standards
* If connected via a joint mains/power cord under normal conditions the earth leakage current of the system must not exceed 500 mA
(300 mA for products marked ”UL”.).
**
e.g. Richard Wolf Video Trolley with ”separating transformer”.
GA--AS 001
1- 5
1
1. Intended purpose
1
Z Specific requirements on the products/components of a combination
.
1 -- 6
IMPORTANT!
Persons combining products to form a system are responsible for not impairing the system’s compliance
with the performance and safety requirements, and that the technical data and the intended use are
adequately fulfilled.
Electromagnetic interference or other types of interference occurring between this product and other
products can cause failures or malfunctions.
When selecting the system components ensure that they meet the requirements for the medical environment they are used in, in particular IEC/ EN 60601--1--1. In case of doubt contact the manufacturer(s) of
the system components.
Do not touch connecting devices for electrical connections between the different components (such as
signal input and output connections for video signals, data exchange, control circuits, etc.) and the
patient at the same time.
GA--AS 001
2. Illustrations / Controls and indicators
Contents
2
Section 2
2
Illustrations / Controls and indicators
2.1
Symbols / Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.1.1
LAPARO CO2 PNEU / TEM PUMP / Packaging . . . . . . . . . . . . . . . . . . . . .
2.1.2
LAPARO CO2 PNEU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.1.3
TEM PUMP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.1.4
Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.2
Controls and indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 -- 4
2.2.1
LAPARO CO2 PNEU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 -- 4
2.2.2
TEM PUMP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 -- 6
2.3
Device connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 -- 7
2.3.1
LAPARO CO2 PNEU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 -- 7
2.3.2
TEM PUMP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 -- 7
2.4
Illustrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 -- 8
2.4.1
TEM Irrigation Cannula / TEM Instrument Set . . . . . . . . . . . . . . . . . . . . . . . 2 -- 8
2.4.2
TEM Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 -- 10
GA--AS 001
2 -2 -2 -2 -2 --
2
2
2
2
3
2- 1
2. Illustrations / Controls and indicators
2
Dies ist eine unsichtbare Komponente ohne Sprachvariante
2.1
Symbols / Labeling
2.1.1
LAPARO CO2 PNEU automatic insufflator / TEM PUMP / Packaging
2
Symbols /
Labeling
Meaning
Symbols /
Labeling
Meaning
Attention, consult
ACCOMPANYING DOCUMENTS!
Identification plate
TYPE BF APPLIED PART
Fuse
Measuring line, for rectal pressure
µ
Alternating current (AC)
Equipotentality
=
DC
Protective earth / ground connection
Identification in conformaty with Medical Devices Directive 93/42/EEC only valid if the product and/or
packagingis marked with this symbol. Products of category IIa and above, as well as sterile products or
products with measuring function pertaining to category I, are additionally marked with the code number of
the notified body (0124)
2.1.2
LAPARO CO2 PNEU automatic insufflator
Symbols /
Labeling
2232
TEM PUMP
ONLY FOR CO2 !
3--150 bar
Fuse
T 2.0 L A
2.1.3
Rear panel
front
rear
Output, insufflation connector
x
--
Sub D socket, 15--pole
(electrical connection to TEM PUMP)
--
x
Use only CO2 gas (pressure between 3--150 bar)
--
x
Use of device fuses
--
x
TEM PUMP
Symbols /
Labeling
2232
LAPARO
CO2 PNEU
2 --
Meaning
2
Meaning
Rear panel
front
rear
Hygiene filter
x
--
Output, irrigation pressure
x
--
Input, pressure measurement, patient
x
--
Socket for foot switch
--
x
Sub D socket, 15--pole
(electrical connection to LAPARO CO2 PNEU automatic insufflator)
--
x
GA--AS 001
2. Illustrations / Controls and indicators
2.1.4
Packaging
Symbols /
Labeling
Meaning
Attention, consult
ACCOMPANYING DOCUMENTS!
REF
2
Order number
Lot identification number
Manufacturing date
Units, pieces, items per package
To be used before (date):
Do not reuse!
Sterilized with ethylene oxide
Steam sterilization -- using the fractional pre--vacuum method
25°
15°
Permissible temperature range
Protect against heat
<60
< 60 %
GA--AS 001
protect against water spray, humidity < 60 %
2- 3
2. Illustrations / Controls and indicators
2.2
Controls and indicators
2.2.1
LAPARO CO2 PNEU automatic insufflator
2
16
14 13
8 7
17 18
2
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
2. Illustrations / Controls and indicators
Item
Controls and indicators
Control
Functional description
Indicator
Button
--
ON
Power switch
' power: connection to the mains / power supply
--
OFF
' power: disconnection from the mains / power supply
2
--
INSUFFLATION
Switch insufflation on / off
' Intrarectal pressure is increased to the preset value
3
--
Pressure
preselection
“PLUS”
4
--
Pressure
preselection
“MINUS”
1
Pressure monitoring -- Pressure pre--select
' can be changed between 3 mmHg and 25 mmHg,
mmHg in
steps of 1 mmHg.
5
--
Indicator
--
' indicates the actual intrarectal pressure
6
--
Indicator
--
' indicates the preselected pressure
7
--
Digital display
--
' indicates the actual intrarectal pressure
' displays the corresponding intrarectal pressure during
preselection
8
--
--
9
--
Flow
preselection
“PLUS”
10
--
Flow
preselection
“MINUS”
Intrarectal pressure
Flow monitoring -- Gas flow rate pre--select
' can be changed between 1 l/min and 8 l/min, in steps of
1l/min
' keep depressed for some time: Quick, continuous increase of the gas flow
' adjustments are only possible in steps of 1l/min.
11
--
Indicator
--
' indicates the actual gas flow rate
12
--
Indicator
--
' indicates the preselected gas flow rate
13
--
Indicator
--
' indicates the actual gas flow rate
' indicates the corresponding gas flow during preselection
14
--
--
Gas flow
--
Alarm function
' Alarm stages -- 3 different sound sequences :
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
' Yellow continuous light and acoustic signal:
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
--
Gas consumption -- Gas consumption (volume)
' indicates gas consumption
15
16
--
17
--
18
--
Digital display
--
19
0
--
RESET
--
HIGH
--
--
20
21
GA--AS 001
--
CO2
' Gas consumption can be reset to zero (digital display)
High Flow (only for the Laparoscopic use)
Insufflation outlet connector
2- 5
2
2. Illustrations / Controls and indicators
2.2.2
TEM PUMP
2
40
CO2
.PUMP
TEM
31
38 37 36 35 34
39
Item
Controls and indicators
Control
31
Indicator
Button
--
TEM PUMP
33 32
Functional description
Switch TEM PUMP on / off
' TEM PUMP is switched off:
Buttons and symbols have night illumination
(dimmed background lighting)
32
--
--
--
Irrigation bottle pressure output
' Fixed value control of the saline irrigation bottle pressure
to 1 bar
33
--
--
--
Rectal pressure input (patient)
--
Suction
preselection
“PLUS”
--
Suction
preselection
“MINUS”
34
35
36
--
--
Suct o power
Suction
po e -- Preselect
ese ect suction
suct o power
po e
' variable between 0.5 l/min and 1.5 l/min
Suction pump
' Indicator is lit: TEM PUMP is switched on
' Indicator blinks:
-- 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
37
38
--
39
--
40
2 --
6
--
--
Indicator
--
CO2
--
' indicates the preselected suction power
(variable in 20 stages)
--
Suction pump malfunction
' Indicator is lit: if the pump cover is open (suction pump
cannot be activated)
--
Suction pump
--
CO2 indicator
' Indicator is lit: if CO2 supply pressure is normal, indicates stand--by mode
' Indicator blinks: if pressure is too high or too low; at the
same time
MEDIUM ALARM is sounded
GA--AS 001
2. Illustrations / Controls and indicators
2.3
Device connections
2
46
45
49
48
2232
TEM PUMP
47
44
43
42
41
59
60
61
51
2
58 57
2.3.1
55 54
53
52
LAPARO CO2 PNEU automatic insufflator
Item
2.3.2
56
Designation
Item
Designation
41
Identification plate
46
Gas supply connector
42
Power (mains) input socked with fuse holder
47
43
Connection of CO2 gas supply
for TEM PUMP
48
Spacer sleeve for CO2 fuse holder
44
Measurement connection for rectal pressure
49
Phillips head screw for CO2 fuse holder
45
Equipotential connector
Sub--D--socket 15--pole
(for electrical connection to TEM PUMP)
TEM PUMP
Item
Designation
Item
Designation
51
Identification plate
57
Cylindrical screw for protective earth connection
52
Socket for foot switch
58
Protective earth connection
59
Trim plate
53
Sub--D--socket 15--pole
(for electrical connection to LAPARO CO2 PNEU)
54
Measurement connection for rectal pressure
60
Hex key (size 4)
55
Connection of CO2 gas supply
for TEM PUMP
61
Device foot
56
Equipotential connector
GA--AS 001
2- 7
2. Illustrations / Controls and indicators
2.4
Illustrations
2.4.1
TEM Irrigation Cannula / TEM Instrument Set
2
77
77.1
76
75
74
78
70
80.4
71.5
80.5
71.4
71.3
71.2
71.1
71
80.3
73
72
80.2
80.6
80.1
72.1
80
83.3
83.2
82
81
83.4
83
83.1
84
83.5
87.1
83.6
85.2
85.3
86.1
84.3 84.2 84.1
87.2
87
85.1
85
85.5 85.4
86
86.4 86.3 86.2
87.3
89
88
2 --
8
GA--AS 001
2. Illustrations / Controls and indicators
Z Legend for TEM Irrigation Cannula
Item
Designation
Item
Designation
70
TEM Irrigation Cannula complete
71
Irrigation Cannula
73
Silicone seal with lateral hole
71.1
Irrigation channel
74
Non--return valve
71.2
Discharge for CO2 gas
75
Valve slide
76
Silicone seal with central hole
77
Screw cap
71.3
Luer--Lock fitting
“ERBE multifunctional instrument TEM” (option)
71.4
Luer connector for flushing of telescope window
71.5
Valve housing
72
Luer part
72.1
.
77.1
78
2
Compression spring
Luer locking cap
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
Item
80
Designation
U--shaped support arm
Item
85
Designation
Working insert
80.1
Support arm
85.1
O--ring
80.2
Clamping lever, insulated
85.2
Locking pins
80.3
Toggle, sliding
85.3
Locking lever for locking the stereo endoscope 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)
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
Attachment with observation window
89
Irrigation and insufflation tube
#
Type no
84
84.1
Connector for cold light
84.2
O--ring
84.3
Observation insert
GA--AS 001
87
Stereo endoscope
2- 9
2. Illustrations / Controls and indicators
2.4.2
TEM Accessories
93.8
2
93.6
90
91.1
91
90.2
93.9
93
#
95
94
92.1
93.7
#
90.1
93.5
93.4
extreme magnification
93.3
#
93.2
93.1
92
97.6
#
97.7
97.8
97
97.5
97.4
96
97.3 97.2
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
2 -- 10
100.1
GA--AS 001
2. Illustrations / Controls and indicators
Z Legend for TEM Accessories
Item
90
Designation
Disposable (single--use) filtration
attachment
Item
Designation
96
Needle holder straight
97
Needle holder with downward offset
90.1
Luer connector, female
90.2
Luer connector, male
97.1
Handle
Tube part
97.2
Clamping screw
Luer connector, male
97.3
Luer sealing cap
Double blower
97.4
Luer connector
Luer connector, female
97.5
Firm jaw
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
91
91.1
92
92.1
93
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
#
GA--AS 001
Type no.
2 - 11
2
2. Illustrations / Controls and indicators
2
2 -- 12
GA--AS 001
3. Setup
Contents
Section 3
3.
Setup
3.1
Installation of the TEM Combination System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.1.1
Attaching the irrigation bottle holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.1.2
Establish electric (protective earth/ground) and CO2 connections . . . . . .
3.1.3
CO2 connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.2
Prepare the TEM Irrigation Cannula and NaCl--irrigation bottle . . . . . . . . . . . . . . . . . 3 -- 4
3.3
Connect the tube set for TEM application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.3.1
Selecting the TEM tube sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.3.2
Before connecting the TEM tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.3.3
Prepare the TEM PUMP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.3.4
Connection diagram for TEM application . . . . . . . . . . . . . . . . . . . . . . . . . . . .
GA--AS 001
3 -3 -3 -3 -3 -3 -3 -3 -3 --
2
2
3
3
4
4
4
4
5
3- 1
3
3. Setup
3
Dies ist eine unsichtbare Komponente ohne Sprachvariante
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 accessories
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 desired. 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 periods. 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.
3.1
.
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.
Installation of the TEM Combination System
.
3.1.1
IMPORTANT!
Carry out a visual check of the parts required for assembly (section 5)
Attaching the irrigation bottle holder
.
4
NOTE :
Attach the irrigation bottle holder before you place the devices on top of each other.
3
5
2
1
3- 2
Position the TEM PUMP laterally.
Install the Phillips head screws and remove the device foot.
Slide the trim plate from the holding rail.
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.
6. Attach the device foot.
1.
2.
3.
4.
6
Z Place the TEM PUMP onto an even level surface.
Z Set the LAPARO CO2 PNEUS to TEM PUMP.
GA--AS 001
3. Setup
3.1.2
Establishing electric (protective earth / ground) and CO2 connections
6
6
5
4
3
2
1
1b 1c 1d
Establish the other connections
2.
3.
4.
5.
6.
Side view
1a
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
using the hex head socket screw. For this, proceed in the following order:
' TEM PUMP backplate (1a)
' Toothed locking washer A 5.3 (1b)
' Protective earth connection (1c)
' Washer B 5.3 (1d)
' Hex head socket screw M5x10 (1e)
1e
Socket for foot switch
CO2 gas supply
Measurement for rectal pressure
Electrical connection cable
Power cable for the LAPARO CO2 PNEU automatic insufflator.
CO2 connection
3.1.3
WARNING!
Danger of liquid CO2 entering the LAPARO CO2 PNEU automatic insufflator if gas cylinder is incorrectly positioned!
The patient may be endangered by possible malfunctions or failure of the LAPARO CO2 PNEU automatic 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 LAPARO CO2 PNEU automatic insufflator and theCO2 cylinder
mounting bracket and tighten with a Phillips screwdriver.
.
6
' use a separate holder
(do not attach to the LAPARO CO2 PNEU automatic insufflator)
' secure the gas cylinder against falling.
Side view
5
4
IMPORTANT!
When using gas cylinders with a volume of more then 2.0 l use:
3
4. Place the gas cylinder (max. volume 2 l) in the cylinder holder and
fasten with the belt.
5. Connect the high pressure connection hose to the gas cylinder and
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
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
1. Tighten Luer part and screw cap.
2. Pierce the center of the rubber stopper on the glass bottle with
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
.
3
MPORTANT!
If the ERBE Multifunctional Instrument for TEM is not connected,
ensure that the Luer--Lock fitting is closed with a Luer sealing
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
.
3.3.3
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.
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
' Rotate the roller clockwise to engage the pump tube (E)
2
in the roller pump.
1
.
NOTE :
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)
3
CO
2
l/min
Liter
2232
LAPAR O
CO
2
- PN EU
0
HIGH
!
B
C
E
2232
TEM .PU M P
F
F
B
A
Tube set, consisting of:
Type no.
A
B
C
D
..8170.841
Measuring tube, rectal pressure
Insufflation tube
Irrigation tube
C
Suction tube
E Pump tube ....................................8170.861
F Connection tube..............................8170.862
B
C
D
D
GA--AS 001
D
D
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
0
HIGH
!
B
C
E
2232
TEM .PU M P
F
F
green
Tube set, consisting of:
B
A
B
C
D
red
A
Type no.
Measuring tube, rectal pressure
Insufflation tube
..4170.842
Irrigation tube
Suction tube
C
E Pump tube ..................................4170.864
F Connection tube ...........................4170.862
B
white
C
blue
green
D
red
D
3 -- 6
D
D
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
2
- PN EU
0
HIGH
G
!
B
C
E
2232
TEM .PU M P
F
F
green
Type no
Tube set, consisting of:
B
A
B
C
D
red
A
Measuring tube, rectal pressure
Insufflation tube
..4170.843
Irrigation tube
Suction tube
G
E Pump tube. ..................................4170.864
F Connection tube............................4170.862
G Irrigation tube ERBE .....................4170.867
B
white
C
blue
green
blue
D
red
D
.
C
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
3. Setup
3
3 -- 8
GA--AS 001
4. Use
Contents
Section 4
4.
Use
4.1
TEM Instrument Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.1.1
Function principle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.1.2
Surgical method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.1.3
Preparing the TEM Instrument Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.1.4
Additional notes and instructions for use . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4 -4 -4 -4 -4 --
2
2
2
3
8
4.2
TEM Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.2.1
Preparing the Suture Clip Forceps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.2.2
Preparing the Needle Holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.2.3
Preparing the HF Scalpel, unipolar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.2.4
Preparing the Retractable Syringe Needle . . . . . . . . . . . . . . . . . . . . . . . . . .
4 -4 -4 -4 -4 --
9
9
9
10
10
4.3
Additional notes and instructions for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.3.1
Light . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.3.2
Irrigation fluid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.3.3
Electrical current . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.3.4
HF application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4 -4 -4 -4 -4 --
10
10
10
10
11
4.4
TEM Combination System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 -- 12
4.4.1
Function principle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 -- 12
4.4.2
Selecting the TEM mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 -- 12
4.5.
Additional notes and instructions for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.5.1
Inflating the rectal cavity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.5.2
Irrigation / suction control via the footswitch . . . . . . . . . . . . . . . . . . . . . . . . .
4.5.3
Possible alarm messages during use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.5.4
Power failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.5.5
Measures after insufflation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.6.
Alarm functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 -- 15
4.6.1
Adjusting the alarm volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 -- 16
GA--AS 001
4 -4 -4 -4 -4 -4 --
13
13
14
14
14
14
4- 1
4
4. Use
4
Dies ist eine unsichtbare Komponente ohne Sprachvariante
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 patient.
Immediately before and after each use, check the products for damage, loose parts and completeness.
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
means of a support arm. For the surgical procedure a stereoscopic angled endoscope is used, allowing dissection 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. Irrigation of the endoscope window is achieved by pressing a foot switch.
4.1.2
Surgical method
4
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 required. Full--wall excision is indicated only in the extraperitoneal section 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 observe 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 eliminate 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
near the the foot end.
2. Tighten the clamping lever.
1
2
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
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 designed for different applications.
For a combination of the rectoscope tubes and obturators see section 8
Locking the rectoscope tube in the housing
lock
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
1
4
unlock
Locking the obturator in the housing with rectoscope tube
1
unlock
2
lock
1. Insert obturator in the housing and rectoscope tube assembly.
' The obturator projects from the rectoscope tube.
2. Turn locking lever in direction of arrow ”lock” as far as it will go.
' The obturator is locked in place.
.
NOTE :
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.
4
3
Inserting adapter with viewing window in housing and connect
double blower
6
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.
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.
1
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
instruments form a stable unit.
Removing the attachment with observation window from the
housing
1. Remove the tube together with the disposable filtration adapter
and double bellows.
2. Remove the flexible light cable.
3. Turn the locking lever to ”unlock” .
4. Remove the attachment with observation window.
1
4
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
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
1. Engage slotted openings in locating pins.
2. Push tongue with your thumb in direction of arrow.
' 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.
2
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
1
unlock
Connecting the assembled working insert to the housing
1. Insert the preassembled working insert.
2. Turn the locking lever in direction of arrow ”lock” as far as it will
go.
2
lock
Inserting the stereo endoscope / documentation endoscope
CAUTION !
Danger of injury if the stereo telescope /documentation telescope is inserted into the operating
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
unlock
1/5
2
3
lock
1. Turn the locking lever in direction of arrow ”unlock”.
2. Connect the flexible light cable to the cold--light connector. Connect the other end to the light source and illuminate the operating area.
3. Turn the control wheel to adjust the eyepieces to your interpupillary distance.
Check the image quality before you insert the telescope:
' Check both systems of the stereo telescope individually by closing 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
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.
4
x
Field of view
Inserting the documentation endoscope
1. Move the locking lever to position ”I” .
ba
3 II
I 1
GA--AS 001
2
Before you insert the documentation telescope,
' check the image quality with your eye.
2. Insert the documentation endoscope in the stereo endoscope
' The pin (a) engages in groove (b).
3. Turn the locking lever to position ”II”.
' The documentation endoscope is locked in place.
.
IMPORTANT!
If the documentation endoscope is not used, close the stereo
endoscope with sealing cone to avoid a gas loss.
4 -- 7
4
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, coagulationinstrument) 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
2
1/5
unlock
TEM exclusively performed via the video screen is possible
when using the rigid irrigation and insufflation tube.
lock
3
4
Field of view
4 --
8
x
1. Turn clamping lever in direction of arrow ”unlock”.
2. Connect the flexible light cable to the cold--light connector, connect the other end to the light source and illuminate the operating area.
3. Insert the irrigation and insufflation tubes in the working insert.
Before inserting the documentation telescope,
' check the image quality with your eye.
4. Insert the documentation telescope in the irrigation and insufflation tube until the lower edge (x) of the tube becomes visible and
continue to push it forward until the lower edge (x) disappears.
5. Turn clamping lever in direction of arrow ”lock”.
' Documentation endoscope is locked in place.
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
(B)
x
1
3
Outside the body:
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. Cut the thread behind the suture clip (B).
2
2
1 /3
Adjusting the working position:
1. Release the lock screw.
2. Turn the forceps tube to the required working position.
3. Tighten the lock screw.
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.
Z Run through the checks: section 5
1
GA--AS 001
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
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 sealing insert.
4 -- 9
4
4. Use
2
4.2.3
1 /3
Adjusting the working position
1. Slacken off the clamping screw.
2. Turn sheath (7) to the required working position
(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.
Preparing the HF Scalpel, unipolar
Z Run through the checks: section 5
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 Run through the checks: section 5
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 endoscopic 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.
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 conductive parts.
10mm
GA--AS 001
During activation live HF parts of HF instruments must be
kept at a distance of at least 10 mm from the distal end of
the rectoscope tube and / or must have a sufficient distance from other, non- insulated instruments.
4 -- 11
4
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
.
4
NOTE :
The TEM mode can only be selected when the LAPARO CO2 PNEU automatic insufflator is in standby
mode .
Standby mode of LAPARO CO2 PNEU
30 s
l/min
2
3
1
!
2
!
1. Switch off power switch: Press the
button.
2. Remove all hygiene filters.
3. Switch on power switch after 30 seconds: Press the
button.
Always after switching on:
' 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 previously 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.
2. To switch on the TEM--PUMP: Press the
l/min
1
button.
' The system is in TEM mode.
!
' The
button and
' The
button on the LAPARO CO2 PNEU blinks.
display are lit.
' The suction pump is ready.
1
4 -- 12
!
2
.
NOTE :
The preselected gas flow rate of 4.0 l/min is selected automatically.
GA--AS 001
4. Use
4.5
Additional notes and instructions for use
4.5.1
.
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.
Inflating the rectal cavity
Preselecting the nominal gas flow rate
The preselected value is 4 l/min
1. To increase the gas flow rate: Press the
l/min
button.
2. The decrease the gas flow rate: Press the
1
!
2
!
button.
' Pressing the button briefly:
changes the values between 1.0 l/min and 8.0 l/min,
in steps of 1.0 l/min.
' 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
2. To decrease the nominal pressure: Press the
l/min
1
!
2
button.
' Pressing the button briefly:
changes the pressure between 3 mmHg and 25 mmHg,
in steps of 1 mmHg.
' The preselected pressure is displayed on the level indicator.
.
!
button.
NOTE :
We recommend preselecting a pressure of 12 mmHg and
15 mmHg.
Starting insufflation
1. To start insufflation: Press the
' The
l/min
1!
button.
button is lit
' Intrarectal pressure is generated until the preselected value is
reached.
' 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
4. Use
Preselecting the suction power (suction stage)
l/min
1. To increase the suction power: Press the
button.
2. Decreasing the suction power: Press the
button.
' Pressing the button briefly:
changes the value between 0.5 l/min and 1.5 l/min.
!
1
2
4
4.5.2
.
NOTE :
Normally a low suction power (stage) should be selected.
!
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
1a
The LAPARO CO2 PNEU automatic insufflator has 3 different alarm
stages differing from each other both acoustically and in the sound
sequence.
l/min
E38
1. LOW alarm is sounded (2 consecutive beeps)
1b
!
' Error message during self check
' Remaining gas supply is only 30.0 l:
indicator is lit (1a).
' Emergency insufflation: Digital display blinks (1b).
-- suction pump operates only at minimum speed
Error message E38
1c
!
button blinks (1c).
' Suction pump defective:
-- 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.
Z Eliminate the fault.
' The device carries out an automatic function test.
2. MEDIUM alarm is sounded (3 consecutive beeps)
2a
' Remaining gas supply is only 3.0 l:
l/min
E35
2b
!
indicator blinks (2a).
' Gas flow preselection: Digital display blinks (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.
Z Eliminate the fault.
' The device carries out an automatic function test.
2c
!
3. HIGH alarm is sounded
(2 consecutive beeps -- pause -- 2 consecutive beeps)
l/min
' Indicator
E09
3a
3b
is lit (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
4. Use
4.6.1
Adjusting the alarm volume
1. Press the
' A continous alarm is sounded.
l/min
1
button and keep depressed.
2
!
3
2. To increase the volume: Press the
button.
3. To decrease the volume:Press the
button.
' The volume can be changed in 16 steps which are displayed on
the digital display.
!
4
4 -- 16
GA--AS 001
5. Checks
Contents
Section 5
5
Checks
5.1
Visual checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.1.1
LAPARO CO2 PNEU / TEM PUMP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.1.2
TEM Irrigation Cannula . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.1.3
TEM Tubing Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.1.4
TEM Instrument Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.1.5
TEM Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5 -5 -5 -5 -5 -5 --
2
2
2
2
2
3
5.2
Functional checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.2.1
Automatical check TEM Combination System . . . . . . . . . . . . . . . . . . . . . . .
5.2.2
Checking the remaining CO2 gas supply . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.2.3
Manuel check of TEM Combination System . . . . . . . . . . . . . . . . . . . . . . . . .
5.2.4
TEM Instrument Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.2.5
TEM Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5 -5 -5 -5 -5 -5 --
3
3
4
4
5
5
GA--AS 001
5- 1
5
5. Checks
5
Dies ist eine unsichtbare Komponente ohne Sprachvariante
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:
' Non--return valve
' Valve slide
' Silicone seals
' Depending on irrigation cannula version
a) Compression spring welded to screw cap
b) Loose compression spring
5
' 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
2
1
1. Check O--ring for correct seating.
' The o--ring must be seated in the first groove which has a
square cross section.
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
5
Automatic check of TEM Combination System
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.
2. Switch on power supply: Press the
l/min
!
2
1
!
button.
Always after switching on:
' The LAPARO CO2 PNEU automatic insufflator runs through an
automatic function test routine (duration approx. 15 s).
' The suction pump is activated.
' 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.
A signal is sounded:
' 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
CO2
.
Z Display of CO2 gas supply
' Green continuous light: sufficient gas supply
' 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
5
Z Replace the CO2 gas cylinder.
Z Please note the alarm function: see paragraph 4.6
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
1. Switch on TEM PUMP: Press the button
' System is in TEM mode.
l/min
2
!
' The
button and
' The
button on the LAPARO CO2 PNEU blinks.
indicator are lit.
' Preselected gas flow rate: 4 l/min.
!
1
2. Switch on Insufflation: Press the
' The
button.
button is lit.
' LAPARO CO2 PNEU automatic insufflator insufflates at a preselected 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.
!
A
5 -- 4
GA--AS 001
5. Checks
Double function footswitch for
1. Remove the connection tube (F) and hold it into a container
(should be prepared beforehand).
2. Actuate the footswitch.
l/min
4!
!
Irrigation:
' 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)
2
' If the footswitch is pressed for less than half a second:
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
' The
5.2.4
button.
button is not lit.
5
TEM Instrument Set
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.
5.2.5
TEM Accessories
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
GA--AS 001
1. Insert the curved needle in the area of the tip between the jaws
(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.
5- 5
5. Checks
5
5 -- 6
GA--AS 001
6. Reprocessing and maintenance
Contents
Section 6
6
Reprocessing and maintennance
6.1
TEM Combination System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 -- 3
6.1.1
Manual reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 -- 3
6.1.2
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 -- 3
6.2
TEM Irrigation Cannula . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.2.1
Disassembly before cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.2.2
Manual reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.2.3
Machine reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.2.4
Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.2.5
Assembly before sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.2.6
Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6 -6 -6 -6 -6 -6 -6 --
5
5
5
6
6
6
6
6.3
TEM Instrument Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.3.1
Disassembly before cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.3.2
Manual reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.3.3
Machine reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.3.4
Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.3.5
Assembly before sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.3.6
Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6 -6 -6 -6 -6 -6 -6 --
7
7
7
7
7
7
8
6.4
Double blower / Disposable filtration adapter / tube section . . . . . . . . . . . . . . . . . . . .
6.4.1
Manual reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.4.2
Machine reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.4.3
Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6 -6 -6 -6 --
9
9
9
9
6.5
Suture Clip Forceps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.5.1
Disassembly before cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.5.2
Manual reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.5.3
Machine reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.5.4
Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.5.5
Assembly before sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.5.6
Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6 -6 -6 -6 -6 -6 -6 --
10
10
10
10
10
10
11
6.6
Needle Holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.6.1
Manual reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.6.2
Machine reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.6.3
Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.6.4
Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6 -6 -6 -6 -6 --
12
12
12
12
12
6.7
HF Scalpel, unipolar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.7.1
Manual reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.7.2
Machine reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.7.3
Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.7.4
Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6 -6 -6 -6 -6 --
13
13
13
13
13
6.8
Retractable Syringe Needle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.8.1
Disassembly before cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.8.2
Manual reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.8.3
Machine reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.8.4
Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.8.5
Assembly before sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.8.6
Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6 -6 -6 -6 -6 -6 -6 --
14
14
14
14
14
14
14
GA--AS 001
6- 1
6
6. Reprocessing and maintenance
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 chlorine 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.
Efficacy has been certified by the sterilizer manufacturers in microbiological tests. Follow the
manufacturer’s instructions.
6
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. Reprocessing and maintenance
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.
.
6.1.2
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.
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
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
2
3b
3a
4a
4a
1
!
3/5
!
IMPORTANT!
For checking the LAPARO CO2 PNEU do not switch on the
TEM PUMP.
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
4/6
button.
2. Connect the hygiene filter and insufflation tube to the insufflation
connector.
button.
3. Switch on insufflation: Press the
' The level and digital displays (3a) display the current gas flow
rate and must be the same as on level indicator (3b) for the preselected 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 display 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
6
6. Reprocessing and maintenance
Leakage test
1. Preselect a nominal pressure of 12 mmHg: Press the
l/min
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.
!
3/4
1
3. Switch on insufflation: Press the
button.
' Gas bubbles must emerge from the end of the tubing.
4. Switch off insufflation: Press the
button.
' No gas bubbles must emerge from the end of the tubing.
!
.
(B)
2
IMPORTANT!
Immediately after the end of the test remove insufflation tube (B)
from the water container as otherwise vacuum would draw water
into the tubing and to the inside of the device.
Measuring devices and auxiliary equipment for TEM--PUMP
.
l/min
2
!
6
Z Prepare the following measuring devices and auxiliary means:
1
(B)
' TEM reprocessable tube set
' Pump tube
' Hygiene filter
' Container with 1 liter of water
' Measuring vessel with scale (contents approx. 1 liter)
!
(E)
3
NOTE :
For this check do not connect the measuring tube (A) with
hygiene filter to the TEM PUMP.
(A)
1. Install pump tube (E) as described in paragraph 3.3.3.
2. Connect hygiene filter and insufflation tube (B).
3. Connect suction tube (D) of TEM tube set to pump tube (E).
(D)
4. Switch on TEM--PUMP: Press the
.
l/min
5
' The suction pump is activated.
5. Set gas flow rate LAPARO CO2 PNEU to 8.0 l/min.:
4
6. Immerse end of pump tube (E) in measuring vessel and suction
tube (D) in container with 1 liter of water.
Press the
(D)
6
A
4
button.
7. Switch on insufflation: Press the
button.
' Suction rate of TEM PUMP is automatically set to the minimum
value.
' After 1 minute at least 300 ml of water must have been pumped
from the container into the measuring vessel.
.
6 --
NOTE :
The preselected gas flow rate of 4.0 l/min is selected automatically.
7!
(E)
!
button.
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.
GA--AS 001
6. Reprocessing and maintenance
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. Connect Luer--Lock with silicone tube to CO2 Luer--Lock
connector.
2. Rinse out TEM irrigation cannula with a disposable syringe filled
with water.
' Liquid must be discharged from the CO2 gas outlet
1
2
6.2.1
Disassembly before cleaning
.
2
1. Unscrew Luer locking cap
2. Depending on the irrigation cannula version:
a) Unscrew screw cap with firmly attached compression spring.
b) Unscrew screw cap and remove separate compression
spring.
3. Remove valve slide and non--return valve.
4. Remove silicone seal from screw cap.
5. Unscrew Luer part.
6. Remove silicone seal from Luer part.
4
3
1
6
5
6.2.2
NOTE :
When opening, the screw cap must be on top to prevent the
valve slide and the non--return valve from falling down.
Manual reprocessing
Z Wet preparation at the point of use
Z Disassembly before cleaning: see paragraph 6.2.1
Z Cleaning / disinfection
1
3
GA--AS 001
2
Cleaning:
1. Slide silicone tubing with distal Luer--Lock over irrigation 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
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.
6- 5
6
6. Reprocessing and maintenance
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 disposable syringe filled with disinfectant through the Luer--Lock ensuring that the inside of the TEM Irrigation Cannula 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 disposable syringe filled with water.
Z Disassembly before cleaning: see paragraph 6.2.1
Z Cleaning / disinfection
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
.
6
4
3
5
1
2
6.2.6
1. Place the silicone sealing disc with the lateral bore into the luer part
and apply a slight pressure.
2. Screw on the Luer part.
3. Depending on irrigation cannula version:
a) Compression spring, firmly welded to screw cap
b) Compression spring, loose:
Place the compression spring onto the pin inside the screw cap.
4. Install silicone seal in screw cap and compress slightly.
5. Insert valve slide and non--return valve.
6. Tighten screw cap.
Sterilization
.
6 --
IMPORTANT!
Observe the markings on valve body:
Marking “ D “ = assembly of screw cap
Marking “ d “ = assembly of Luer part
6
IMPORTANT!
Luer--Lock connectors / fittings must be open during steam sterilization.
Loose screw cap at least one full turn.
GA--AS 001
6. Reprocessing and maintenance
6.3
TEM Instrument Set
6.3.1
Disassembly before cleaning
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.
6.3.2
Manual reprocessing
Z Wet preparation at the point of use
Z Disassembly before cleaning: see paragraph 6.3.1
Z Cleaning / disinfection
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.
1
6.3.3
2
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.
Z Finally thoroughly rinse inside and out and dry with compressed
air and cloths.
Machine reprocessing
Z Dry preparation at the point of use
Z Disassembly before cleaning: see paragraph 6.3.1
Z Cleaning / disinfection
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
6.3.5
Assembly before sterilization
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
6. Reprocessing and maintenance
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
6 --
8
GA--AS 001
6. Reprocessing and maintenance
6.4
Double blower / Disposable filtration adapter / tube section
Z Immediately after use remove and discard the discardable filtration attachment and the tube section.
6.4.1
Manual reprocessing
Z Wet preparation at the point of use
Z Cleaning / disinfection
Z Spray and wipe outside of double blower with disinfectant.
6.4.2
Machine reprocessing
Z Dry preparation at the point of use
Z Cleaning / disinfection
6.4.3
Checks
Z Visual check of the parts required for assembly: see secton 5
6
GA--AS 001
6- 9
6. Reprocessing and maintenance
6.5
Suture Clip Forceps
6.5.1
Disassembly before cleaning
1. Unscrew the lock screw as far as it will go.
2. Lift off the preassembled forceps tube and remove.
3. Pull out internal part (i.e. clip closing part).
2
3
1
6.5.2
Manual reprocessing
Z Wet preparation at the point of use
Z Disassembly before cleaning: see paragraph 6.5.1
Z Cleaning / disinfection
Z Clean all parts with a cloth and all hollow spaces and cavities
with cleaning brushes. Rinse out the external tube with a cleaning 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 actuating the handle several times.
6
Suture clip:
Z Immerse the suture clips in a cleaning solution and then rinse
and dry.
6.5.3
Machine reprocessing
Z Dry preparation at the point of use
Z Disassembly before cleaning: see paragraph 6.5.1
Z Ultrasound cleaning
Z Cleaning / disinfection
' 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.
6.5.5
Assembly before sterilization
3
1. Insert the internal part (rod) into the external part (tube) as far as
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 actuation rod) in tube holder and lift.
4. Release handle and lower forceps part until the ball--shaped end
of the rod engages in receptacle.
5. Tighten the lock screw.
4
5
b a
6 -- 10
1
2
GA--AS 001
6. Reprocessing and maintenance
Z Lubricate movable parts with 2 -- 3 drops of WO 53 oil while actuating the handle several times.
.
6.5.6
NOTE :
Before sterilization connect the screw--connections only
loosely to allow a sufficient flow of the sterilization medium.
Sterilization
Z Use a container for small parts to house the suture clips.
6
GA--AS 001
6 - 11
6. Reprocessing and maintenance
6.6
Needle Holder
6.6.1
Manual reprocessing
Z Wet preparation at the point of use
Z Cleaning / disinfection
3
2
1. Remove luer sealing cap.
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
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.
1
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
6.6.2
Machine reprocessing
Z Dry preparation at the point of use
Z Ultrasound cleaning
Z Cleaning / disinfection
' 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. Reprocessing and maintenance
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.
6.7.1
Manual reprocessing
Z Wet preparation at the point of use
Z Cleaning / disinfection
6.7.2
Machine reprocessing
Z Dry preparation at the point of use
Z Cleaning / disinfection
6.7.3
Checks
Z Perform a visual check: see paragraph 5.1.5
6.7.4
Sterilization
6
GA--AS 001
6 - 13
6. Reprocessing and maintenance
6.8
Retractable Syringe Needle
6.8.1
Disassembly before cleaning
4
1
3
6.8.2
1.
2.
3.
4.
Remove the luer locking cap.
Slacken off the knurled nut.
Remove the internal tube.
Remove the compression spring.
2
Manual reprocessing
Z Wet preparation at the point of use
Z Disassembly before cleaning: see paragraph 6.8.1
Z Cleaning / disinfection
1. Clean all parts with a cloth, all openings and hollow spaces /
recesses with cleaning brushes, rinse out the external part with
the
cleaning gun.
2. Dry all parts outside with a cloth, all openings and hollow spaces
with compressed air.
1
2
6
Z Lubricate the internal tube using WO 53.
6.8.3
Machine reprocessing
Z Dry preparation at the point of use
Z Disassembly before cleaning: see paragraph 6.8.1
Z Cleaning / disinfection
' 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
6.8.5
Assembly before sterilization
1. Insert the compression spring.
2. Insert the internal tube.
3. Tighten the knurled nut.
1
.
2
6.8.6
3
NOTE :
Before steam sterilization:
To prevent stress cracks and to ensure free access of steam,
slacken off the knurled nut at least one full rotation.
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
7
GA--AS 001
7- 1
7. Error message / Correctiv action
7
ies ist eine unsichtbare Komponente ohne Sprachvariante
.
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!
Device errrors
Fault
Device does not
work
No gas flow
Preselected pressure is exceeded
No pressure
build- up
7.2
Corrective action
Section
Power / mains switch not switched on
'Actuate power / mains switch
2.2 / 4.4.2
Power / mains cable not connnected
'Connect power / mains cable
2.3 / 5.2.1
Device fuse defective
'Replace fuse
No mains / line voltage
'Check in--house power supply
Insufflation not switched on
'Insufflation switch on
Gas cylinder empty or not open
'Change or open gas cylinder
With manipulations the user increases the
pressure in the abdomen
'Eliminate cause
LAPARO CO2 PNEU defective
'Call service department
-
Other equipment causes pressure increase
'Eliminate cause
-
Tube system leaking
'Check tube and connections
Flow preselection too low
'Increase preselected flow
8.9
2.2 / 4.5
3.1.3 / 5.2.2
4.2.3
section 9
3.3.4
2.2 / 4.5
Error messages for LAPARO CO2 PNEU
Fault / error
7
Possible cause
Possible cause
Corrective action
Gas supply interrupted
'Open gas cylinder or connect filled gas
cylinder
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
switched on
'If no operator’s error call service
department
-
E03
Internal supply voltage not within tolerance
'Contact service department
-
E04
Valve V1 defective
'Contact service department
-
E05
Insufflation tube connected when swichting
on the LAPARO CO2 PNEU
'Remove tubing and after 30 s switch device
off and on again.
E05
Valve V2 defective
'Contact service department
-
E06
Pressure measurement defective
'Contact service department
-
E07
Flow measurement defective
'Contact service department
-
E08
Valve V3 defective
'Contact service department
-
E09
Nominal value invalid
'Service verständigen
-
E10
Helium
'CO2 --Gas verwenden
3.1.3
E11
Overpressure alarm:
'Reduce intraabdominal pressure
Pact greater than 30 mmHg for more than 5 s 'Contact service department
E12
General hardware error
'Contact service department
-
E13
Pressure switch for ”input pressure”
defective
'Contact service department
-
E14
Pressure monitoring defective
'Contact service department
-
E15
DIL switch incorrectly set
'Contact service department
-
7 -- 2
Section
3.1.3 / 5.2.2
3.3.4 / 4.4.2
4.2.3
section 9
GA--AS 001
7. Error message / Correctiv action
7.3
Error messages for TEM PUMP
Fault / error
Possible cause
Corrective action
E30
Hygiene filter connected, to measuring input
when switching on
'Remove hygiene filter and switch off mains
/ power switch on LAPARO CO2 PNEU
after 30 s and switch on again.
E31
Pressure sensor pressure measurement
defective
'Contact service department
E32
Pressure sensor pressure measurement
defective
'Check pneumatic connections between
LAPARO CO2 PNEU and TEM PUMP
'If fault is not eliminated,
contact service department
E33
Actual rectal pressure has exceeded limit
value
'Reduce rectal pressure
'If fault is not eliminated,
contact service department
2.2 / 4.5.1
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
Suction pump defective
'Use original pump tube
'Contact service department
3.3.4 / 8.6
-
E38
Emergency insufflation, measuring line with
hygiene filter not connected to the TEM
PUMP
'Connect measuring line with hygiene filter
to TEM 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
after 30 s
'If fault is not eliminated, contact service
department
4.4.2
E41
Pneumatic fault
'Check rectal pressure measuring line on
device rear panel for leakage
'If fault is not eliminated, contact service
department
3.1.2
GA--AS 001
Section
4.4.2
3.1.2
5.2.3
-
7
7- 3
7. Error message / Correctiv action
7
7 -- 4
GA--AS 001
8. Technical data and order data
Contents
Section 8
8
Technical data and order data
8.1
LAPARO CO2 PNEU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8.1.1
Application parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8.1.2
Safety features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8.1.3
Additional options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8.1.4
lnterfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8 -8 -8 -8 -8 --
2
2
2
2
3
8.2
TEM PUMP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8.2.1
Application parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8.2.2
Safety features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8.2.3
Interfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8 -8 -8 -8 --
4
4
4
4
8.3
Spare parts and accessories for TEM Combination System . . . . . . . . . . . . . . . . . . . . 8 -- 5
8.4
TEM Instrument Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 -- 6
8.4.1
Spare parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 -- 7
8.5
TEM Irrigation Cannula . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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
8
GA--AS 001
8- 1
8. Technical data and order data
8
ies ist eine unsichtbare Komponente ohne Sprachvariante
8.1
LAPARO CO2 PNEU
Voltage
Frequency
Vµ
100--230
Model
2232.041
Current
rating
A
Fuse
Hz
Power
consumption
VA
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;
(UL 2601--1 / CSA C22.2 No.601.1 -- for USA)
I
Degree of protection against the ingression of liquid
IP 20 (Not protected)
Mode of operation
Continuous operation
Degree of protection when flammable gasses are present
This device is not protected against explosions
(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
8.1.1
330 mm x 155 mm x 390 mm
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
8
A
Laparoscopy
-- Gas flow rate primary filling
-- Gas flow rate high flow
1 l/min to 8 l/min (¦ 20 %), preselectable in steps of 1 l/min
1 l/min (¦ 50 %)
1 l/min to 30 l/min (¦ 20 %), preselectable in steps of 1 l/min
-- Consumption display
8.1.2
0 l to 999 l (¦ 20 %)
Safety features
Automatic function check
Self check after switching on the device
Automatic fault/error recognition
yes
Automatic error message
yes
Automatic error memory
yes
Volume of acoustic signal
Alarm system
Hygiene filter on outlet
8.1.3
3 alarms: LOW / MEDIUM / HIGH
Sterile item
Additional options
Indication of insufflation pressure during primary filling ' Quadro Test
8 --
adjustable in 16 steps
2
yes
GA--AS 001
8. Technical data and order data
8.1.4
Interfaces
Data transmission and supply voltage for TEM PUMP
Gas connection
Sub D socket, 15--pole
M12 x 1.5
C02 gas measuring line
Quick action coupling
Irrigation pressure supply line
Quick action coupling
Hygiene filter connector
Conical connection, Æ 15.0 mm dia, DIN ISO 5356 T1
8
GA--AS 001
8- 3
8. Technical data and order data
8.2
TEM PUMP
Model
Voltage
V=
Power consumption
VA
Current rating
A
2232.244
24
30
1,3
Electromagnetic compatibility (EMC) in acc. with
Medical Products Directive 93/42/EEC
Protection against electric shock
Class II b
Type BF applied part
Protection class in acc.with EN 60601--1/IEC 601--1;
(UL 2601--1 / CSA C22.2 No.601.1 -- for USA)
I
Degree of protection against the ingression of liquid
IP 20 (Not protected)
Mode of operation
Continuous operation
Degree of protection if used in the presence of
flammable mixtures
Weight (without CO2 cylinder)
Dimensions (without cylinder holder) wxhxd
8.2.1
Output pressure for irrigation bottle
Suction rate
8.2.2
Device is not protected against explosions
(Do not operate this device in inflammable environment)
6.9 kg (15.2 lbs)
330 mm x 100 mm x 390 mm
Application parameters
Pressure connection
3 bar
1 bar , med. CO2 (degree of purity > 99,5 %)
0.5 to 1.5 l/min
Safety features
Automatic function check
8
EN 60601--1--2 / IEC 601--1--2
Self check after switching on the device
Automatic fault/error detection
yes
Automatic error message
yes
Automatic error memory
yes
Alarm system
Hygiene filter on outlet
8.2.3
see LAPARO CO2 PNEU
Sterile item
Interfaces
Data transmission and supply voltage for TEM PUMP
Sub D plug, 15--pole
C02 measuring line
Quick release coupling
Irrigation supply line
Quick release coupling
Irrigation pressure hygiene filter connection
Measuring input hygiene filter connection
Foot switch connector
8 --
4
Luer connector, 3 mm male
Luer connector, 3 mm female
Tube type connector
GA--AS 001
8. Technical data and order data
8.3
Spare parts and accessories for TEM Combination System
Mode / type
Designation
64268.014
Device fuse T 2.0 L (10 / pkg)
2440.03
Mains / power cable (Europe), 3.0 m
9500.016
Open end wrench size 30
8170.301
High pressure tube -- DIN connection
8170.303
High pressure tube -- ISO connection
8170.311
Connection tube for central CO2 gas supply
74002.128
O--Ring (a) for cylinder connection of high pressure tube 8170.303
64016.151
Teflon seal (c) for cylinder connection of high pressure connection tube 8170.302
2221.951
Holding bracket for CO2 cylinder , (Æ 80 to 90 mm dia.)
2221.952
Holding bracket for CO2 cylinder, (Æ 100 to 115 mm dia.)
2046.961
0.75 kg CO2 cylinder (approx. 350 l of CO2) with DIN connector, (Æ 80 mm dia.)
64321.106
Protective earth connection with assembly accessories
64226.014
Spare pump tube (5 / pkg)
4171.111
Hygiene filter, in sterile package, for insufflation connector (10 / pkg)
4171.112
Hygiene filter, in sterile package for measurement input and irrigation pressure output
(10 / pkg)
2232.841
Holder for irrigation bottle
2030.231
Pneumatic foot switch
2232.852
CO2 connection tube LAPARO CO2 PNEU ' TEM PUMP
further accessories on request
a
ISO connection 8170.303
b
DIN connection 8170.301
c
PIN index connection 8170.302
The products can be combined as required provided the relevant technical data and intended uses are observed. For the general overview please refer to the latest catalog sheets and brochures, or contact Richard
Wolf or your Richard Wolf representative.
GA--AS 001
8- 5
8
8. Technical data and order data
8.4
TEM Instrument Set
Obturator (Pos. 2) for tube
Item
81
(82)
8
Illustration
Designation
15016.197
15016.198
Rectoscope tube
dia. 40 mm; WL= 120 mm
with obturator
8840.02
J
j
Rectoscope tube
dia. 40 mm; WL= 137 mm
with obturator
8840.031
J
j
Rectoscope tube
dia. 40 mm; WL= 200 mm
with obturator
8840.04
j
J
and Model / type
80
U--shaped
support arm
8840.9721
Manufactured by
GEOMED
------
80.4
Clamping base, insulated
8840.9722
Manufactured by
GEOMED
------
83
Housing
8840.20
------
84
Attachement with
observation window
8840.25
------
85
Working insert
8840.241
------
86
Sealing insert
8840.242
------
87
Stereo endoscope
dia.13.8mm; WL=259mm
Viewing direction 50_
Image angle 70_
4840.501
------
87.2
Locking cone
8840.591
------
88
Documentation
endoscope
8840.401
------
89
Irrigation and
insufflation tube
8840.501
------
J
j
8 --
6
Use obturator
Do not use obturator
GA--AS 001
8. Technical data and order data
8.4.1
Spare parts
Item
Illustration
83.6
84.2/
85.1
8.5
Model / type
Designation
15 564.003
Sealing ring for housing 8840.20
15 364.095
O--Ring for
attachment with observation window 8840.25 and
working insert 8840.241
86
8840.242
Sealing insert
--
89.01
Sealing cap, red
--
89.02
Sealing cap, blue
--
89.03
Sealing cap, grey
--
89.141
Sealing cap, blue
--
89.161
Sealing cap, red
--
89.10
Sealing cap, red
TEM Irrigation Cannula
Item
Illustration
8170.865
70
8.5.1
Model / type
Designation
TEM Irrigation Cannula,
external dia. 5.0 mm; internal dia. 2,0 mm; WL= 215 mm
Spare parts
Item
Illustration
Model / type
Designation
72
64110.487
Luer part
73
64018.010
Silicone seal with lateral hole (5 / pkg)
74
64104.074
None--return valve
75
64103.013
Valve slide
76
64018.011
Silicone seal with central hole (5 / pkg)
77
64136.007
Screw cap
77.1
64248.027
Depending on the irrigation cannula version:
Compression spring (5 / pkg)
GA--AS 001
8
8- 7
8. Technical data and order data
8.6
TEM Tube Set
Model / type
Designation
8170.841
TEM Reprocessable Tube Set (not for USA)
8170.861
Reprocessable pump tube (not for USA)
8170.862
Reprocessable connection tube (not for USA)
4170.801
TEM disposable Tube Set consisting of:
4170.864
Pump tube
4170.862
Connection tube
4170.842
Tube set
4170.804
TEM Disposable Tube Set for ERBE Multifunctional Instrument consisting of:
4170.864
Pump tube
4170.862
Connection tube
4170.843
Tube set
4170.867
Irrigation tube ERBE
8
8 --
8
GA--AS 001
8. Technical data and order data
TEM accessories
.
NOTES :
For the instruments marked ” * ” we recommend that you always have a spare (backup) unit available
to ensure immediate adequate replacement in case of sudden failure so that the operation can be completed in due course.
Sealing cap
red
blue
grey
red
d
Designation /
Model / type
KV1)
Ø3.4
to
Ø5.1
Ø5.1
to
Ø6.0
d
89.01 89.02 89.03
Ø4.0 to Ø7.5 to
Ø6.0
Ø8.5
Ø13.0
to
Ø13.8
89.141
89.161
89.10
Disposable filter
(sterilely packed),
(50 / pkg)
2148.95
--
--
--
--
--
--
Double blower with luer
lock tube fitting 886.00
127.00
--
--
--
--
--
--
Suture Clip Forceps,
dia 6.0 mm; WL= 405 mm
8840.762*
for the above
--
j
j
J
J
j
Suture Clamp (50 / pkg)
8840.764
--
--
--
--
--
--
Needle Holder, straight;
dia. 4.6 mm, WL= 405 mm
8840.604*
--
j
J
j
J
j
Needle Holder with
downward offset;
dia. 4.6 mm; WL= 405 mm
8840.605*
--
j
J
j
J
j
Curved needle
ETHICON SH 3--0 or
BRAUN--DEXON, MAXON
3--0, HR 26
--
--
--
--
--
--
HF Scalpel, unipolar
right;
dia. 4 mm WL= 420 mm
8840.711*
1.5
j
J
j
J
j
HF Scalpel, unipolar
left;
dia. 4 mm WL= 420 mm
8840.712*
1.5
j
J
j
J
j
Retractable Syringe Needle;
dia. 4.0 mm; WL= 325 mm
8840.74
--
j
J
j
J
j
KV = do not exceed maximum recurring
peak voltage!
GA--AS 001
d
for instruments dia. (in mm)
Ø2.4
to
Ø3.4
1)
red
17 mm 17 mm
15 mm
Illustration
blue
J
j
only for w
working insert
in
884
840.241
8.7
Use sealing cap
Do not use sealing cap
8- 9
8
8. Technical data and order data
Sealing cap
red
blue
grey
red
blue
17 mm 17 mm
15 mm
d
Designation /
Model / type
KV1)
Ø3.4
to
Ø5.1
Ø5.1
to
Ø6.0
89.01 89.02 89.03
Ø4.0
to
Ø6.0
Ø7.5
to
Ø8.5
Ø13.
0 to
Ø13.
8
89.141
89.161
89.10
2.0
j
j
J
J
j
GA--B152
Coagulation Suction Tube,
unipolar
dia. 5.6 mm; WL= 470
mm
8840.731*
2.0
j
J
j
J
j
GA--S008
HF combination forceps,
unipolar, offset,
curved right;
Ø 4.8 mm; WL= 405 m
8840.621
2.0
j
J
j
J
j
GA--S008
HF combination forceps,
unipolar, offset,
curved left;
Ø 4.8 mm; WL= 405 mm
8840.622
2.0
j
J
j
J
j
GA--S008
HF combination forceps,
unipolar,curved right;
Ø 4.8 mm; WL= 405 mm
8840.623
2.0
j
J
j
J
j
GA--S008
HF combination forceps,
unipolar, curved left;
dia. 4.8 mm; WL= 405 mm
8840.624
--
j
J
j
J
j
GA--S003
Scissor, curved right;
dia. 4.0 mm; WL= 405 mm
8840.643
--
j
J
j
J
j
GA--S003
Scissor, curved left;
dia. 4.0 mm; WL= 405 mm
8840.644
1)
8 -- 10
KV = do not exceed maximum recurring
peak voltage!
d
for instruments dia. (in mm)
Ø2.4
to
Ø3.4
8
d
J
j
only for w
working insert
i
8840.
0.241
Illustraion
red
Use sealing cap
Do not use sealing cap
GA--AS 001
8. Technical data and order data
8.8
Additional spare parts and accessories
Illustration
-
Model / type
Designation
15 023.133
Luer locking cap
74014.069
Compression spring
8106.032 / 8106.052
8106.132 / 8106.152
8106.031 / 8106.051
8106.033 / 8106.053
8106.034 / 8106.054
HF connection cable
=3m/=4m
=3m/=4m
=3m/=4m
=3m/=4m
=3m/=4m
38043.011
Sterilization and storage basket for:
Stereo endoscope 4840.501 and
Documentations endoscope 8840.401
200.532
Instrument oil WO53
6.07
Cleaning brush
--
Bottle brush
86.90
Cleaning brush
8
GA--AS 001
8 - 11
8. Technical data and order data
8.9
Replacing device fuses
CAUTION!
The specification of the fuses in the device must correspond with the fuse ratings on the identification plate.
Use only the fuses specified in the spare parts list.
L Power input connector with fuse holder.
1. Switch off the power switch: Press the
l/min
button.
2. Disconnect the power input connector from the wall socket.
!
1
!
2
1. Push together the clamps of the fuse holder and pull out the fuse
holder.
2. Pull out and replace fuses.
3. Reinsert fuse holder and push it in.
' Fuse holder snaps into place.
8
1
8.10
2
3
Operating, storage, transport and shipping conditions
Operating conditions
+10°C to +40°C , 30% to 75% rel. humidity,
atmospheric pressure 700 hPa to 1060 hPa
Storage, transport and shipping conditions
-- 20°C to +60°C , 10% to 90% rel. humidity,
atmospheric pressure 700 hPa to 1060 hPa
.
8.10.1
NOTE :
To prevent damage during transport or shipment of the products we recommend using the original packaging material.
Disposal of product , packaging material and accessories
For the disposal observe the regulations and laws valid in your country.
' For further information please contact the manufacturer.
8 -- 12
GA--AS 001
Laparoscopic Surgery
Contents
Section 9
Overview diagram for laparoscopic surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 2
1
Intended purpose
1.1
Technical description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 3
1.2
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 3
1.2.1
Insufflation tube . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 3
1.3
Indications and field of use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 3
1.4
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 3
1.5
Combinationen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 3
3
Set up
3.3
Connecting the insufflation tube . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.3.1
Choosing the insufflation tube . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.3.2
Before connecting the insufflation tube . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.3.3
Connection diagrams for laparoscopic surgery . . . . . . . . . . . . . . . . . . . . . . .
4
Use
4.1
LAPARO CO2 PNEU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 6
4.1.1
Operating principle laparoscopy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 6
4.1.2
Selecting the laparoscopy mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 6
4.2
Additional notes and instructions for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Establishing pneumoperitoneum . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.2.1
4.2.2
Secondary filling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.2.3
Alarm messages not relating to device defects . . . . . . . . . . . . . . . . . . . . . .
5
Checks
5.2
Functional checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 9
5.2.3
Manual check for laparoscopy mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 9
8
Technical data and order data
8.1
Laparoscopic surgery accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 11
8.2
Insufflation tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 -- 11
GA--AS 001
9
9
9
9
-----
9 -9 -9 -9 --
4
4
4
4
7
7
8
8
9- 1
9
Laparoscopic Surgery
Overview diagram for laparoscopic surgery
Section
Section
Make sure you observe the special sections on laparoscopic applications.
Sections which have already been described in transanal endoscopic
microsurgery (section 1 -- 8) and which are also used in laparoscopic surgery.
Technical description
Intended use
Section 1
General requirements for products / components
of a combination
Paragraph 1.5.1
Indication and field of use
Kontraindikationen
Contraindications
Combinations
Section 2
Illustrations / Controls and indicators
Setup
Section 3
Paragraph 2.1.1
Section 3
Assemble irrigation bottle holding bracket
Paragraph 3.1.2
Electrical (protective earth) and CO2 gas supply connections
Paragraph 3.1.1
CO2 connection
Paragraph 3.1.3
Insufflation tubes
Use
Section 4
Section 5
Possible alarms during use
Paragraph 4.5.3
Power failure
Paragraph 4.5.4
Measures after insufflation
Paragraph 4.5.5
Alarm functions
Paragraph 4.6
Adjusting the alarm volume
Paragraph 4.6.1
Visual check
Paragraph 5.1
LAPARO CO2 PNEU
Paragraph 5.1.1
Function check
Paragraph 5.2
Automatic function checks
Paragraph 5.2.1
Checking the CO2 gas supply
Paragraph 5.2.2
Manual check during operation
Manual reprocessing
9
Section 6
Maintenance
Maintenance intervals, quarterly inspection,
Test of the pressure and gas flow control on the LAPARO CO2 PNEU,
Leakage test
Error messages / Correctiv actions
Section 7
Paragraph 6.1.2
Section 7
Device errors
Paragraph 7.1
Error messages for LAPARO CO2 PNEU
Paragraph 7.2
Technical data and order data
Section 8
Paragraph 6.1.1
LAPARO CO2 PNEU
Paragraph 8.1 –
Paragraph 8.1. 4
Instrument Set
9 -- 2
GA--AS 001
Laparoscopic Surgery
1
Intended purpose
1.1
Technical description
The portable system is a desktop unit for laparoscopic surgery consisting of the LAPARO CO2 PNEU, an insufflation tube set and various instruments.
1.2
Intended use
The LAPARO CO2 PNEU is used for establishing and maintaining the pneumoperitoneum using CO2 gas.
CAUTION!
In therapeutic applications a backup unit must be available if the device fails.
1.2.1
Insufflation tube
It provides the connection between the LAPARO CO2 PNEU automatic insufflator and laparoscopic instruments, for
insufflation purposes.
1.3
Indications and field of use
The LAPARO CO2 PNEU is used in diagnostic and operative laparoscopy.
.
1.4
NOTE :
Before the first use we recommend reading relevant literature (see appendix A--3).
Contraindications
The LAPARO CO2 PNEU is contraindicated in all cases where laparoscopy is contraindicated.
WARNING!
The device has a high flow rate.
The device cannot be used for hysteroscopy.
The device must not be used for inflating the cavum uteri.
On the basis of the patient’s general condition the physician/surgeon in charge must decide whether the
planned use is possible or not.
For further information see the latest medical literature.
1.5
Combinations
WARNING!
Danger of potentially fatal gas or air embolism.
Purge the connection tubes with a sufficient amount of CO2 before use.
The use of devices applying additional gaseous media in combination with a TEM Combination
System or LAPARO CO2 PNEU automatic insufflator lies exclusively in the responsibility of the user.
WARNING!
Danger of intraabdominal overpressure if a second gas source is used.
If argon plasma coagulators are used additional visual or manual pressure monitoring by the
user is imperative, because pressure monitoring or the pressure release function (venting) of the
LAPARO CO2 PNEU automatic insufflator could be deactivated, e.g. due to a kinked insufflation
tube or a closed instrument tap .
The preselected gas flow rates of an argon plasma coagulator should not exceed 2 l/min.
Activate the argon plasma coagulator only for a short time.
CAUTION!
Caution if products are incorrectly combined !
Possible injury of the patient, user or others as well as possible damage to the product.
Different products should only be used in combination if their intended use and relevant technical
data (working length, diameter, peak voltage, etc.) are the same.
Follow the instruction manuals of the products used in conjunction with this product
(see paragraph 8.3).
GA--AS 001
9- 3
9
Laparoscopic Surgery
2
3
3.1
3.2
Set up
3.3
Conneting the insufflation tube
3.3.1
Choosing the insufflation tube
CAUTION!
The Disposable Insufflation Tube is designed for single use only and is sterilely packed. Do not
use the Disposable Insufflation Tube if
' the sterile packaging is damaged
' the shelf life of the set has expired
For the connection diagrams of the insufflation tubes listed below, see paragraph 3.3.3
Z Reprocessable insufflation tube (not for USA)
Z Disposable insufflation tube
3.3.2
Before connecting the insufflation tube
IMPORTANT!
Risk of contamination of the TEM insufflation system through backflow of gas or body liquid.
Always use hygiene filters between the device connections and the tubes.
Z Carry out an automatic function check and a check of the CO2 gas supply, see section 5
Z Function check passed: Connect TEM Tube Set to the device, see paragraph 3.3.3
.
3.3.3
IMPORTANT!
Error messages E05 and E30 are displayed if the hygiene filter or the disposable insufflation tube is
connected before the automatic function check is carried out.
Connection diagrams for laparoscopic surgery
Z Reprocessable Insufflation Tube (not for USA)
' 8170.101 -- for Veres cannula / RIWO--ART trocar sleeve dia. 10 mm (B1)
' 8170.232 -- for High--Flow trocar sleeve dia. 10 mm and dia. 12.5 mm (B1, B2)
Disconnect the luer lock fitting from the insufflation tube
and plug the end of the tube onto fitting (x)
CO
2
l/min
Liter
B2
2 2 3 2
LAPAR O
C O2 - PN EU
(x)
0
HIGH
!
B1
9
B1
B2 B1
9- 4
B1
B1
B2
B2
GA--AS 001
Laparoscopic Surgery
Z Disposable Insufflation Tube
' 4170.501 -- for Veres cannula / RIWO--ART trocar sleeve dia. 10 mm / High--Flow trocar sleeve dia. 10 mm
and dia. 12.5 mm (B)
Disconnect the luer lock fitting from the insufflation tube
and plug the end of the tube onto fitting (x)
CO
2
l/min
Liter
white
2 2 3 2
LAPAR O
C O2 - PN EU
(x)
0
HIGH
!
white
white
B
.
B
B
NOTE :
After having connected the insufflation tube to the device perform the manual check as described in
paragraph 5.2.3.
9
GA--AS 001
9- 5
Laparoscopic Surgery
4
Use
4.1
LAPARO CO2 PNEU
4.1.1
Operating principle
Pneumoperitoneum is established by insufflating CO2 gas in the abdominal cavity. The gas is supplied to
the LAPARO CO2 PNEU automatic insufflator from CO2 cylinders or a central gas supply system. The gas
pressure and the gas flow rate are controlled by the LAPARO CO2 PNEU in accordance with the requirements
(i.e. the settings) of the user.
The preset values remain stored and active when the device is switched off and on again. Safe insufflation is
guaranteed through microprocessor--controlled monitoring and display of the pressure and flow values as well
as several independent safety features.
There are 2 modes of insufflation:
Primary insufflation: The insufflation always starts in this mode with a fixed flow rate of 1.0 l/min.
High Flow:
After establishing pneumoperitoneum this mode can be selected to maintain pneumo-peritoneum.
4.1.2
Selecting the laparoscopy mode
Standby mode of LAPARO CO2 PNEU automatic insufflator
30 s
l/min
2
!
3
1
1. Switch off power switch: Press the
button.
2. Remove all hygiene filters.
3. After 30 seconds switch on the power switch: Press the
button.
Always after switching on:
' The LAPARO CO2 PNEU runs through an automatic function test
routine (duration approx. 15 seconds).
' The suction pump is activated.
' In case of a fault / error an error code (error no.) is displayed, see
section 7.
!
' The LEDs of the
indicator blink alternately.
' The LEDs of the level indicators show the test duration.
A signal is sounded:
' The LEDs stop blinking.
' The LAPARO CO2 PNEU is in standby mode and ready.
If you switch on before the 30 seconds have elapsed:
' The state previously set on the LAPARO CO2 PNEU is displayed.
' The LAPARO CO2 PNEU is not in standby mode (not ready).
Repeat items 1--3.
9
Primary insufflation mode
1. Attach the hygiene filter.
1
l/min
2. To start insufflation: Press the
' The
!
2/3
!
button is lit.
' Primary insufflation 1.0 l/min is activated.
If the Veres cannula is connected:
' On the level indicator (2a) the
-- current intraabdominal pressure and
-- the insufflation pressure (LEDs of level indicator (2b) blink) are
indicated.
3. To stop insufflation: Press the
' The
9 -- 6
button.
button.
button is not lit.
GA--AS 001
Laparoscopic Surgery
High Flow mode
.
l/min
2/3
!
1
NOTE :
The “High Flow” mode can only be selected if primary insufflation
is activated.
1. To start insufflation: Press the
' The
button.
button is lit.
' Primary insufflation at 1.0 l/min is activated.
!
2. To start High--Flow: Press the
' The
button.
button is lit.
' The preselected gas flow rate (up to 30.0 l/min) is activated.
.
NOTE :
When actuating this button for the first time after switching on
the device, the value of the gas flow rate last preselected is
selected, however maximum 20.0 l/min.
3. To stop High Flow: Press the
' The
button.
button is not lit.
' The device is in “Primary insufflation” mode.
4.2
Additional notes and instructions for use
. IMPORTANT!
Before performing a laparoscopy observe and perform the measures described in sections 3 „Setup“ and
5 „Checks“.
4.2.1
Establishing pneumoperitoneum
Z Introduce the Veress cannula into the abdomen and find the correct position.
Z Connect the Veress cannula to the insufflation tube.
Z Lift the abdominal wall by pulling vigorously.
' When the Veress cannula is positioned freely in the abdomen a vacuum must be indicated on the
”intraabdominal pressure” level indicator and digital display and an acoustic signal must be sounded.
Z Start primary insufflation.
' The pressure is increased to the preselected value.
Quadro test after Prof. Semm
Monitor insufflation by checking / monitoring the following values:
' Gas flow (the gas flow must not be substantially below 1.0 l/min)
' intraabdominal pressure and insufflation pressure
(the insufflation pressure (blinking single bar) can be max.15 mmHg higher than the intraabdominal
pressure, if exceeded a signal is sounded)
' Gas volume consumed
This test is used to check the Veress cannula for free position within the abdominal cavity and correct
functioning of the Laparo CO2 Pneu.
If the aforementioned parameters do not correspond, the cannula is not positioned freely in the abdominal
cavity.
Once the preselected pressure is reached, no further insufflation takes place. Secondary filling is performed
in ”High Flow” mode.
We recommend recording / documenting the gas supply used in the primary filling.
GA--AS 001
9- 7
9
Laparoscopic Surgery
4.2.2
Secondary filling
WARNING!
Danger of gas embolism
Use the ”High Flow” mode only for the secondary filling.
.
Z
Z
Z
Z
Z
Introduce the trocar sleeve with the trocar in place into the abdomen.
Connect the insufflation tube to the closed insufflation tap.
Remove the trocar and insert the endoscope.
After ensuring the correct incision position, open the insufflation tap.
Switch from primary insufflation to high flow insufflation by pressing the ”High Flow” button.
.
4.2.3
IMPORTANT!
With the 5.0 mm insufflation tubing and a standard trocar sleeve a flow of only approx. 10.0 l/min can be
achieved.
If a higher flow rate is required (up to 30,0 l/min), use a high flow insufflation tubing and high flow trocar
sleeve.
NOTE :
If insufflation is performed at a high flow rate over a prolonged period of time this may cause severe cooling
of the CO2 gas supply and a temporary pressure loss in the supply container. ”LOW ALARM” is triggered.
When insufflation is switched off the original pressure in the supply container is restored.
Alarm messages not relating to device defects
Overpressure alarm (E11)
Possible causes:
' With the anesthesia wearing out the patient starts pumping.
' The user exerts pressure on the abdomen.
' additonal gas or liquid is supplied to the abdomen.
Corrective action:
' Reduce overpressure and restart insufflation.
9
9 -- 8
GA--AS 001
Laparoscopic Surgery
5
5.1
Checks
5.2
Functional checks
5.2.3
Manual check for laparoscopy mode
5.2.1
5.2.2
.
NOTE :
Precondition for the manual check:
' Automatic function check passed and
' TEM--PUMP switched off
Insufflation function
l/min
1b
Z Preselect the nominal pressure.
2b 3a
Gas flow check -- Primary insufflation
2
1. Switch on insufflation: Press the
!
1a
1/3
2a
button.
' The intraabdominal pressure increases to the preselected value.
' The level indicator (1a) and digital display (1b) must read a gas
flow of 1.0 l/min ± 0.5 l/min.
Gas flow check -- High Flow
2. Switch on High Flow: Press the
button.
' The values on the level indicator (2a) and digital display (2b) must
be the same as the preselected gas flow of the level indicator
(± 20% of the preselected value).
' After the gas flow check, the digital display (3a) must read a clear
gas consumption.
!
3. Switch off insufflation: Press the
button.
Control check
l/min
1b
2b
!
1a
2a
1/2
!
button.
1. Switch on insufflation: Press the
' The level indicator (1a) and digital display (1b) must read a gas
flow of 1.0 l/min ± 0.5 l/min.
' The insufflation pressure indicator must read a value between
4 and 10 mmHg
(the individiual LEDs of the level indicator (2a) blink), independent
of the preselected pressure.
' The insufflation pressure is higher than 10 mm Hg:
Check the Veres cannula for a defect or clogging,
replace if necessary.
2. Switch off insufflation: Press the
' The
GA--AS 001
button.
button is not lit.
9- 9
9
Laparoscopic Surgery
Z Preselect a nominal gas flow rate of 10.0 l/min.
Z Remove the Veres cannula.
l/min
1a
3a
2/4
!
1/6
!
3/4
1. Switch on insufflation: Press the
button.
2. Switch on High Flow: Press the
button.
' The level indicator (1a) and digital display (1b) must read a gas
flow of 10.0 l/min ± 2.0 l/min.
3. Close the insufflation tube with your thumb.
' If the actual pressure exceeds the preselected pressure, the device
must release excessive pressure (click sound). Actual pressure is
reduced to 0 mmHg until the next insufflation phase.
4. Open the insufflation tube.
5. Switch off High Flow: Press the
button.
' After 15 s at the latest the level indicator (1a) and digital display (1b)
should read a gas flow rate of 1.0 l/min ± 0.5 l/min.
' Primary insufflation is active.
6. Switch off insufflation: Press the
' The
button.
button is not lit.
' The level indicator (1a) and digital display (1b) read the preselected gas flow rates.
9
9 -- 10
GA--AS 001
Laparoscopic Surgery
6
7
8
Technical data and order data
8.1
Laparoscopic surgery accessories
Model / type
Designation
4171.111
Hygiene filter, sterilely packed, for insufflation connector (10 / pkg)
8302.12
Veres cannula
8923.013
RIWO--ART Trocar sleeve, dia. 10.0 mm
8923.0421)
High Flow Trocar sleeve, dia. 10.0 mm
8924.0421)
High Flow Trocar sleeve, dia. 12.5 mm
8923.801
VARIO--PORT Reducing adapter to dia. 5.5 mm
8924.801
VARIO--PORT Reducing adapter to dia. 10.0 mm
Instructions
-HA--EF 45a
GA--B 129
GA -B
GAB 135
1)Preferably the afore mentioned trocar sleeves should be used. If other Richard Wolf trocar sleeves are used,
in connection with high preselected gas flow rates ( > 10.0 l/min) this will result in a reduction of the gas flow rate due to
relatively high pressure losses in the insufflation system
further accessories on request
The products can be combined as required provided the relevant technical data and intended uses are observed. For the general overview please refer to the latest catalog sheets and brochures, or contact Richard
Wolf or your Richard Wolf representative.
8.2
Insufflation tubes
Model / type
Designation
8170.101
Reprocessable Insufflation Tube, dia. 5.0 mm , length 2.5 m
8170.232
High Flow Insufflation Tube, dia. 8.0 mm , length 2.5 m
4170.501
Disposable Insufflation Tube
9
GA--AS 001
9 - 11
Laparoscopic Surgery
9
9 -- 12
GA--AS 001
Annex
Contents
A.
Annex
A.1
Literature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A -- 2
Transanal Endoscopic Microsurgery (TEM)
A.2
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A -- 3
Transanal Endoscopic Microsurgery (TEM)
A.3
Literature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A -- 5
Laparoscopic Surgery
A.4
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A -- 6
Laparoscopic Surgery
A
GA--AS 001
A- 1
Annex
A. 1
Literature
Transanal Endoscopic Microsurgery (TEM)
.
IMPORTANT!
As we cannot provide a comprehensive bibliography we would ask users to keep themselves informed
of all new developments in this field.
Z Benefit in therapy of superficial rectal neoplasms objectivized: transanal endoscopic microsurgery
(TEM) compared to surgical standards.
G.Winde, G.Blasius, R.Herwig, N.Lügering, R.Keller & R.Fischer.
1997, Min Invas Ther & Allied Technol, 6:315--323.
Z Technique and results of transanal endoscopic microsurgery in early rectal cancer.
G.Buess, B.Mentges, K.H.Manncke, M.Starlinger, H.D.Becker
1992 Jan, Am--J--Surg. 163(1): 63--9, discussion 69--70
Z Transanal Endoscopic Microsurgery using the Buess’s rectoscope -Tübingen Experience --Endoscopic digestiva (Japan).
E.Kanehira, H.Raestrup, G.Bueß, K.H.Manncke, B.Mentges, J.M.Mayer, H.D.Becker
1993, Endoscopic digestiva 4:557--562
Z Transanal Endoscopic Microsurgery in Italy.
M.M.Lirici, L.Chiavellati, E.Lezoche, S.Martelli, G.Melotti, M.Morino, M.Guerrieri, I.Selmi, S.Stipa, L.Angelini.
1994, End Surg 2:255--8
Z Indications and Technique for TEM (Transanal Endoscopic Microsurgery).
H.Raestrup, K.H.Manncke, B.Mentges, G.Bueß, H.D.Becker
1994, ESAT 5:241--246
Z Experience with TEM in Germany.
R.Salm, H.Lampe, A.Bustos, Matern
1994, End Surg 2:251--254
Z Transanal endoscopic microsurgery -- initial experience from three centres in the United Kingdom.
R.J.C.Steele, M.J.Hershman, NJMcCMortensen, et al.
1996, Brit J Surg 83 207--210
A
A -- 2
GA--AS 001
Annex
A. 2
Index
Transanal Endoscopic Microsurgery (TEM)
A
E
Accessories: 8-- 5, 11
Adapter with viewing window: 4-- 4
Additional notes and instructions for use: 4-- 8, 10, 13
Additional options: 8-- 2
Additional spare parts: 8-- 11
Alarm functions: 4-- 15
Alarm volume: 4-- 16
Application parameters: 8-- 2, 4
Attachment with observation window: 1-- 2; 5-- 2
Automatic check: 5-- 3
Electrical current: 4-- 10
ERBE Multifunctional Instrument: 3-- 4, 7
Error message: 7-- 1
Error messages for LAPARO--CO2--PNEU: 7-- 2
Error messages for TEM--PUMP: 7-- 3
Establishing electric (protective earth / ground): 3-- 3
C
F
Flexible instrument port: 4-- 6
Function principle: 4-- 2
Functional checks: 5-- 3
G
Checks: 5--1; 6-- 6, 9, 10, 12, 13, 14
Clamping base: 4-- 3
Cleaning / disinfection: 6-- 3, 5, 7, 9, 10, 12, 13, 14
CO2 connection: 3-- 3
CO2 gas supply: 5-- 4
CO2 --Betrieb: 3-- 3
Combinations: 1-- 4
Connection diagram: 3-- 5
Contraindications: 1-- 4
Controls and indicators: 2-- 1, 4
Correctiv action: 7-- 1
D
Device connections: 2-- 8
Device errrors: 7-- 2
Disposable (single--use) filtration attachment: 1-- 3
Disposable filtration adaptor: 6-- 9
Disposal of product , packaging material and
accessories: 8-- 12
Documentation endoscope: 1-- 2; 4-- 7; 5-- 5
Double blower: 1-- 3; 4-- 4; 6-- 9
Double function footswitch: 5-- 5
Dry preparation at the point of use: 6-- 6, 7, 9, 10,
12, 13, 14
GA--AS 001
General requirements on products/components of a
combination: 1-- 5
H
HF Applications: 4-- 11
HF Scalpel, unipolar: 1-- 3; 4-- 10; 5-- 3; 6-- 13
HIGH alarm: 4-- 15
Housing: 1-- 2
I
Illustrations: 2-- 1, 9
Important surgical information: 1-- 3
Indications and field of use: 1-- 3
Inflating the rectal cavity: 4-- 13
Installation of the TEM Combination System: 3-- 2
Insufflation: 4-- 13
Insufflation function: 5-- 4
Intended purpose: 1-- 1
Intended use: 1-- 2
Interfaces: 8-- 3, 4
Irrigation: 4-- 14
Irrigation bottle holder: 3-- 2
Irrigation / suction control via the footswitch: 4-- 14
Irrigation and insufflation tube: 1-- 2
Irrigation fluid: 4-- 10
A- 3
A
Annex
L
S
LAPARO CO2 PNEU: 1-- 2; 2-- 2; 5-- 2; 8-- 2
Leakage test: 6-- 4
Light: 4-- 10
LOW alarm: 4-- 15
Safety features: 8-- 2, 4
Sealing insert assembly: 5-- 2
Seals / o--rings: 5-- 2
Setup: 3-- 1
Silicone sealing insert: 1-- 2; 4-- 6
Spare parts: 8-- 5, 7
Standby mode of LAPARO CO2 PNEU: 4-- 12
Steam sterilization: 6-- 2
Stereo endoscope: 1-- 2; 4-- 7; 5-- 5; 6-- 8
Sterilization: 6-- 6, 8, 11, 12, 13, 14
Sterilization method: 6-- 2
Sterilization procedure Sterist : 6-- 2
Sterilization procedures Sterist and Sterradt: 6-- 2
Suction: 4-- 14
Suction and irrigation functions: 5-- 4
Suction power: 4-- 14
Surgical method: 4-- 2
Suture Clip: 6-- 10
Suture Clip Forceps: 1-- 3; 5-- 5; 6-- 10
Symbols / Labeling: 2-- 2
M
Machine reprocessing: 6-- 6, 7, 9, 10, 12, 13, 14
Maintenance: 6-- 1, 3
Manual check: 5-- 4
Manual reprocessing: 6-- 3, 5, 7, 9, 10, 12, 13, 14
Measuring devices and auxiliary equipment for
TEM PUMP: 6-- 4
MEDIUM alarm: 4-- 15
N
NaCl irrigation bottle: 3-- 4
Needle Holder: 1-- 3; 4-- 9; 5-- 3, 5; 6-- 12
Nominal gas flow rate: 4-- 13
Nominal pressure: 4-- 13
Notes and instructions on reprocessing and
maintenance: 6-- 2
O
Obturator: 1-- 2; 4-- 4
Operating area: 4-- 5
Operating principle: 4-- 12
Operating, storage, transport and shipping
conditions: 8-- 12
Order data: 8-- 1
Technical description: 1-- 2
Technical data: 8-- 1
TEM Accessories: 1-- 3; 2-- 11; 4-- 9; 8-- 9
TEM Combination System: 4--12; 6-- 3
TEM Disposable Tube Set: 3-- 6
TEM Instrument Set: 1-- 2; 4-- 2; 5-- 2, 5; 6-- 7; 8-- 6
TEM Irrigation Cannula: 1-- 2; 3-- 4; 5-- 2; 6-- 5; 8-- 7
TEM mode: 4-- 12
TEM PUMP: 1-- 2; 2-- 2; 3-- 4; 4-- 12; 5-- 2; 8-- 4
TEM Reprocessable (multi--use) Tube Set: 3-- 5
TEM Tube Set: 1-- 2; 3-- 4; 5-- 2; 8-- 8
Tube section: 6-- 9
U
P
A
T
Packaging: 2-- 3
Power failure: 4-- 14
Pressure and gas flow control system: 6-- 3
Previous switch--on (shorter than 30 seconds): 4-- 12
Pump cover: 3-- 4
Pump tube: 3-- 4
R
Rectoscope tube: 1-- 2; 4-- 4
Replacing device fuses: 8-- 12
Reprocessing: 6-- 1
Retractable Syringe Needle: 1-- 3; 4-- 10; 5-- 3; 6-- 14
A -- 4
U--shaped support arm: 1-- 2; 4-- 3; 5-- 2, 5; 6-- 7, 8
Ultrasound cleaning: 6-- 10, 12
Use: 4-- 1
V
Video--assisted TEM: 4-- 8
Visuel check: 5-- 2
W
Wet preparation at the point of use: 6-- 3, 5, 7, 9, 10, 12,
13, 14
Working insert: 1-- 2; 4-- 5, 8; 5-- 2
GA--AS 001
Annex
A. 3
Literature
Laparoscopic Surgery
.
IMPORTANT!
As we cannot provide a comprehensive bibliography we would ask users to keep themselves informed
of all new developments in this field.
Z Semm, K.:
Operationslehre für endoskopische Abdominal--Chirurgie.
F.K. Schattauer Verlag 1984
Z Monagle J., Bradfield S., Norrle P.:
Carbon Dioxide, Temperature and Laparoscopic Cholecystectomy
Aust NZJ Surg. 1993, 63, 186--189
Z Seitzinger MR. Dugeon LS.:
Decreasing the Degree of Hypothermia during prolonged Laparoscopic Procedures.
J. Reproduct Med. 1993, 38(7): 511--513
Z Goldberg MJ Roe CF.:
Temperature Changes during Anesthesia and Operations
ARch. Surgery 1966, 93: 365--369
Z Manger Th., Fahlke J., Settmacher U., Zanow J., Lippert H.:
(1994) Komplikationen bei 1000 laparoskopischen Eingriffen.
Min. Invas. Chir. 2: 64--80
A
GA--AS 001
A- 5
Annex
A. 4
Index
Laparoscopic Surgery
A
L
Accessories: 9-- 11
Additional notes and instructions for use: 9-- 7
LAPARO CO2 PNEU: 9-- 6
C
M
Checks: 9-- 9
Combinations: 9-- 3
Connection diagrams: 9-- 4
Contraindications: 9-- 3
Manual check: 9-- 9
D
Operating principle: 9-- 6
Order data: 9-- 11
Overpressure alarm (E11): 9-- 8
Overview diagram for laparoscopic surgery: 9-- 2
Disposable Insufflation Tube: 9-- 4, 5
O
E
Establishing pneumoperitoneum: 9-- 7
R
F
Reprocessable Insufflation Tube: 9-- 4
Functional checks: 9-- 9
S
G
Gas flow check -- High Flow: 9-- 9
Gas flow check -- Primary insufflation: 9-- 9
H
Safety instructiones used in this manual: III
Secondary filling: 9-- 8
Set up: 9-- 4
Signal is sounded: 9-- 6
Standby mode of LAPARO CO2 PNEU automatic
insufflator: 9-- 6
Structure and use of this manual: III
High Flow mode: 9-- 7
A
I
T
If you switch on before the 30 seconds
have elapsed: 9-- 6
Important informations: III
Indications and field of use: 9-- 3
Insufflation function: 9-- 9
Insufflation tube: 9-- 3, 4, 11
Intended purpose: 9-- 1
Intended use: 9-- 3
Technical data: 9-- 11
Technical description: 9-- 3
A- 6
U
Use: 9-- 6
GA--AS 001