TEM Combination System Instruction Manual Ver 7.0 Jan 2010

GERMANY RICHARD WOLF GmbH 75438 Knittlingen Pforzheimerstr. 32 Telephone: +49 70 43 35--0 Telefax: +49 70 43 35--300 MANUFACTURER [email protected] www.richard--wolf.com

USA RICHARD WOLF Medical Instruments Corp. 353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Telephone: +1 84 79 13 11 13 Telefax: +1 84 79 13 14 88 sales&[email protected] www.richardwolfusa.com

UK RICHARD WOLF UK Ltd. Waterside Way Wimbledon SW17 0HB Telephone: + 44 20 89 44 74 47 Telefax: + 44 20 89 44 13 11 [email protected] www.richardwolf.uk.com

BELGIUM / NETHERLANDS N.V. Endoscopie RICHARD WOLF Belgium S.A. Industriezone Drongen Landegemstraat 6 9031 Gent Drongen Telephone: +32 92 80 81 00 Telefax: +32 92 82 92 16

FRANCE RICHARD WOLF France S.A.R.L. Rue Daniel Berger Z.A.C. La Neuvillette 51100 Reims Telephone: +33 3 26 87 02 89 Telefax: +33 3 26 87 60 33

AUSTRIA RICHARD WOLF Austria Ges.m.b.H. Wilhelminenstraße 93 a 1160 Vienna Telephone: +43 14 05 51 51 Telefax: +43 14 05 51 51 45

[email protected]

[email protected] www.richard--wolf.at

[email protected] www.richard--wolf.be Marketing Office U.A.E RICHARD WOLF Middle East P.O. Box 500283 AL Thuraya Tower 1 9th Floor, Room 904, Dubai Telephone: + 9 71 43 68 19 20 Telefax: + 9 71 43 68 61 12 [email protected] www.richard--wolf.com

MANUFACTURER

INDIA RICHARD WOLF India Private Ltd. JMD Pacific Square No. 211 A, Second Floor Behind 32nd Milestone Gurgaon -- 122 001 National Capitol Region Telephone: + 91 12 44 31 57 00 Telefax: + 91 12 44 31 57 05 [email protected] www.richard--wolf.com

U--shaped support arm Clamp socket, insulated

8840.9721 8840.9722

GEOMED Medizin--Technik GmbH & Co. KG Postfach 4047 D--78505 Tuttlingen Tel.: Fax:

++49 (0) 7461/9355--0 ++49 (0) 7461/9355--93

E--mail: [email protected] Internet: www.geomed.de

0

GA--AS 001

Transanal Endoscopic Microsurgery (TEM)

Contents Important information Important general instructions for use... III Safety instructions used in this manual... III Overview diagram for TEM application... IV

Section 1 -- 8 1. 1.1 1.2 1.3 1.4 1.5 1.6 1.7

Intended purpose Technical description... 1 -- 2 Intended use... 1 -- 2 Side effects... 1 -- 5 Indications and field of use... 1 -- 5 Contraindications... 1 -- 5 Combinations... 1 -- 6 Electromagnetic compatibility (EMC)... 1 -- 8

2 2.1 2.2 2.3 2.4

Illustrations / Controls and indicators Symbols / Labeling... 2 -- 2 Controls and indicators... 2 -- 4 Device connections... 2 -- 7 Illustrations... 2 -- 8

3. 3.1 3.2 3.3

Setup Installation of the TEM Combination System... 3 -- 3 Prepare the TEM Irrigation Cannula and NaCl irrigation bottle... 3 -- 4 Connect the Tube Set for TEM applications... 3 -- 5

4. 4.1 4.2 4.3

Use TEM application... 4 -- 2 Preparing the TEM Instrument Set... 4 -- 3 TEM Stereo Telescope and Documentation Telescope / Documentation Telescope / PANOVIEW Telescope... 4 -- 8 4.4 Use without silicone sealing insert / without camera... 4 -- 10 4.5 Video--assisted TEM application... 4 -- 11 4.6 TEM Accessories... 4 -- 14 4.7 Additional notes and instructions for use... 4 -- 16 4.8 TEM Combination System... 4 -- 18 4.9 Additional notes and instructions for use... 4 -- 19 4.10 Alarm functions... 4 -- 21 5 5.1 5.2

Checks Visual check... 5 -- 2 Functional checks... 5 -- 4

GA--AS 001

I

Transanal Endoscopic Microsurgery (TEM)

6 6.1 6.2 6.3 6.4

6.6 6.7 6.8 6.9

Reprocessing and maintenance TEM Combination System... 6 -- 4 TEM Irrigation Cannula... 6 -- 6 TEM Reprocessable Tube Set... 6 -- 8 TEM Stereo Telescope and Documentation Telescope / Documentation Telescope / PANOVIEW Telescope / TEM Instrument Set... 6 -- 9 TEM Accessories (Double blower / Disposable (single--use) filtration attachment / tube section)... 6 -- 13 TEM Accessories (TEM Clip Applicator)... 6 -- 14 TEM Accessories (Needle Holder)... 6 -- 16 TEM Accessories (HF Scalpel, unipolar)... 6 -- 17 TEM Accessories (Retractable Needle)... 6 -- 18

7 7.1 7.2 7.3

Error message / Corrective action Device errrors... 7 -- 2 Error messages for LAPARO CO2 PNEU... 7 -- 2 Error messages for TEM PUMP... 7 -- 3

6.5

8 8.1 8.2 8.3 8.4 8.5 8.6

Technical data and order data LAPARO CO2 PNEU automatic insufflator... 8 -- 2 TEM PUMP... 8 -- 4 Spare parts and accessories for TEM Combination System... 8 -- 5 TEM Irrigation Cannula... 8 -- 6 TEM Tube Set... 8 -- 6 TEM Stereo Telescope and Documentation Telescope / Documentation Telescope / PANOVIEW Telescope... 8 -- 7 8.7 TEM Instrument Set... 8 -- 7 8.8 TEM Accessories... 8 -- 10 8.9 Additional spare parts and accessories... 8 -- 13 8.10 Replacing device fuses... 8 -- 14 8.11 Operating, storage, transport and shipping conditions... 8 -- 14

A. A. 1

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

A. 2

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

II

GA--AS 001

Important information 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.

IMPORTANT! Fields of use / Devices and instruments used: Z Transanal Endoscopic Microsurgery (TEM) The LAPARO CO2 PNEU with TEM PUMP is used in conjunction with ' TEM irrigation cannula ' TEM Tube Set ' TEM Stereo Telescope and Documentation Telescope / Documentation Telescope / PANOVIEW Telescope ' TEM instrument Set ' TEM Accessories. Z Laparoscopic Surgery The LAPARO CO2 PNEU without TEM PUMP is used in conjunction with ' Veress cannula ' RIWO ART Trocar Sleeve ' High Flow Trocar Sleeve ' Insufflation Tube Set ' Laparoscopic Accessories. The use is described in GA-A153, “LAPARO CO2 PNEU” Automatic Insufflator

.

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 4.8).

GA--AS 001

III

Important information Overview diagram for TEM application This overview diagram helps in preparing a TEM application showing in 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. 1.1 1.2

Intended purpose Technical description... 1 -- 2 Intended use... 1 -- 2 1.2.1 LAPARO CO2 PNEU automatic insufflator... 1 -- 2 1.2.2 TEM PUMP... 1 -- 2 1.2.3 TEM Irrigation Cannula... 1 -- 2 1.2.4 TEM Tube Set... 1 -- 2 1.2.5 TEM Stereo Telescope and Documentation Telescope / Documentation Telescope eyepiece at 12 o’clock / PANOVIEW Telescope 30 and 50... 1 -- 2 1.2.6 TEM Instrument Set consisting of:... 1 -- 3 1.2.7 TEM Accessories... 1 -- 4 1.2.8 Important surgical information... 1 -- 4

1.3

Side effects... 1 -- 5 1.3.1 TEM Accessories... 1 -- 5

1.4 1.5 1.6

Indications and field of use... 1 -- 5 Contraindications... 1 -- 5 Combinations... 1 -- 6 1.6.1 General requirements on products / components of a combination 1 -- 7 1.6.2 Specific requirements on products / components of a combination 1 -- 8

1.7

Electromagnetic compatibility (EMC)... 1 -- 8

GA--AS 001

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 Z LAPARO-- CO2 PNEU automatic insufflator Z TEM PUMP Z TEM Irrigation Cannula Z TEM Tube Set Z TEM Stereo Telescope and Documentation Telescope / DocumentationTelescope eyepiece at 12 o’clock / PANOVIEW Telescope Z TEM Instrument Set Z 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 Stereo Telescope and Documentation Telescope, TEM instrument set and TEM accessories while evacuating blood, secretion, smoke and/or CO2 gas from the rectal cavity and 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 automatic insufflator ' 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 rinsing the telescope window 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 to rinse the stereo and/or documentation telescope.

1.2.4

TEM Tube Set ' connects the TEM combination system to the TEM instruments for insufflation, irrigation, evacuation.

1.2.5

TEM Stereo Telescope and Documentation Telescope / Documentation Telescope eyepiece at 12 o’clock / PANOVIEW Telescope 30 and 50 Z TEM Stereo Telescope and Documentation Telescope, with fixed and adjustable eyepiece assemblies, consisting of: D TEM Basic Telescope and Documentation Telescope with fixed eyepiece assembly. D Adjustable eyepiece assembly D Protection cap (against current leakage) D Protection cap (against the effects of extraneous light) D TEM Basic Telescope with fixed and inserted adjustable eyepiece assembly ' for 3D viewing of the operating area. The eyebase can be adjusted via a control knob ' for rinsing the distal telescope window via the small luer connector ' for insufflating CO2 gas via the large luer connetor D Documentation Telescope eyepiece in 12 o’clock position ' for monocular video visualization of the operating area ' for connection of video camera and and work / documentation via the monitor

1 --

2

GA--AS 001

1. Intended purpose

D Protection cap (against current leakage) ' for insulation against leakage currents during HF applications in the case of contact between the TEM Stereo Telescope and the user’s nose. The protection cap cannot be removed. D Protection cap (against the effects of extraneous light) ' for protection against extraneous light when working with the TEM stereo telescope without camera. The protection cap is removable. Z Documentation Telescope eyepiece in 12 o’clock position ' for monocular video visualization of the operating area ' for the connection of a video camera and work/documentation via the monitor Z PANOVIEW Telescopes, 30 and 50 ' for monocular visualization of the operating area ' for the connection of a video camera and work/documentation via the monitor 1.2.6

TEM Instrument Set consisting of: Z Rectoscope tube ' is used as a working channel / port. Z Obturator ' serves to atraumatically insert the rectoscope tube into the rectum. Z Housing ' is used to lock the rectoscope tube and obturator in place. Z Adapter with observation window ' is used for sealing, observing and adjusting the operating area. Z Working insert ' For holding and fixing in place the -- TEM Stereo Telescope and Documentation Telescope -- irrigation and insufflation insert -- irrigation and insufflation external tube set -- silicone sealing insert assembly ' for introducing auxiliary instruments Z Silicone sealing insert assembly ' serves to change instruments of different diameters via one large and two smaller flexible ports, keeping the gas losses low. Z Irrigation and insufflation insert ' for holding and fixing the documentation telescope in place ' for rinsing the documentation telescope via a small luer connector ' for illuminating the operating area ' for insufflating CO2 gas into the rectal cavity via the large luer connector Z Irrigation and insufflation external tube set ' for holding and fixing the 30 or 50 PANOVIEW telescopes in place ' for rinsing the 30 or 50 PANOVIEW telescope via a small luer connector ' for insufflating CO2 gas into the rectal cavity via the large luer connector Z U--shaped support arm ' serves to hold the TEM instruments and to precisely adjust the operating area. The U--shaped support arm is vertically and horizontally adjustable.

GA--AS 001

1 -- 3

1

1. Intended purpose

1

1.2.7

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 TEM Clip Applicator ' 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 Suture clip (silver clip) / titanium clip / clip holder / ejector D Suture clip (silver clip) / titanium clip ' the knot replacement is used to secure the surgical suture used for closing surgical wounds until the wound has healed or until the suture has been resorbed. D Clip holder ' serves to remove the titanium clips from the sterile packaging and load them into the TEM Clip Applicator. The clip is positively locked in the profile of the clip holder. D Ejector ' serves to remove any clips which weren’t applied from the TEM Clip Applicator. Z Needle Holder ' is used for the fixation and takeover of curved needles, etc. ETHICON SH 2--0 ' 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 Needle ' for injections under tissue parts that are to be removed. Z Reprocessing basket ' for safe and gentle packaging of the TEM Stereo Telescope and Documentation Telescope during -- transport -- reprocessing -- sterilization -- storage

1.2.8

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 recto--sigmoidal region, 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 rectum. ' 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 carcinomas 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 --

4

GA--AS 001

1. Intended purpose 1.3

Side effects

1.3.1

TEM Accessories

1

Z Suture clip (silver clip) / Titanium clip ' Suture clips / clips can occasionally grow in, in particular if the clip is unfavorably positioned.

1.4

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. ' 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.

1.5

Contraindications 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. Precautions: Use of a hydrophobic bacterial filter is strongly recommended to prevent patient cross--contamination.

GA--AS 001

1 -- 5

1. Intended purpose

1

1.6

Combinations The system is used in conjunction with Z light sources and fiber light cables Z video cameras Z HF surgical devices Z 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). The cold--light connector can be unscrewed and replaced by suitable adapters to connect fiber light cables of other manufacturers. For order data please refer to the latest catalog sheets.

1 --

6

GA--AS 001

1. Intended purpose 1.6.1

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 60601-- 1: 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 isolating transformer **

NMP

μ MP

NMP

μ

μ

MP

MP or NMP

μ

μ

additional isolating 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 60601--1, 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 A (300 A for systems in acc.with UL 60601--1).

**

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

GA--AS 001

1 -- 7

1

1. Intended purpose

1

1.6.2

Specific requirements on products / components of a combination

.

1.7

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.

Electromagnetic compatibility (EMC)

NOTE ! The device or system in the following is called product always relates to the TEM Combination System. Guidance and manufacturer’s declaration -- electromagnetic emissions The product is intended for use in the environment specified below. The user should assure that the product is used in such an environment. Emissions measurement/test

Compliance

HF emissions to CISPR 11

Group 1

HF emissions to CISPR 11

Class B

Harmonic emissions to IEC 61000--3--2

Class A

In conformity with IEC 61000--3--3 “Voltage fluctuations / flicker emissions”

Electromagnetic environment -- Guidance

The product uses HF energy for its internal function. The HF emission level is extremely low and it is not likely to cause any interference in nearby electronic equipment. The product is suitable for use in all establishments, including domestic establishments and those directly connected to the public low--voltage power supply network that supplies buildings used for domestic purposes.

Guidance and manufacturer’s declaration -- electromagnetic immunity The product is intended for use in the environment specified below. The user should assure that the product is used in such an environment. Immunity tests

IEC 60601 test level

Compliance

Electromagnetic environment -- guidance

Electrostatic Discharge (ESD) to IEC 61000--4--2

 6 KV contact  8 KV air

Yes

Floors should be made of wood, concrete or ceramic tile. If the floors are covered with synthetic material, the releative humidity should be at least 30%.

Electrical fast transients, bursts to IEC 61000--4--4

 2 KV for power supply lines  1 KV for input/output lines

Yes

Mains/line power quality should be that of a typical commercial or hospital environment.

Surge voltage (surges) to IEC 61000--4--5

 1 KV voltage external conductor--external conductor  2 KV voltage external conductor--earth/ground

Yes

Mains/line power quality should be that of a typical commercial or hospital environment.

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

Voltage dip for 0.5 cycle > 95% UT * Voltage dip for 5 cycles > 60% UT * Voltage dip for 25 cycles > 30% UT * Voltage dip for 5 sec > 95% UT *

Yes

Mains/line power quality should be that of a typical commercial or hospital environment. If the user of the product requires continued operation during power mains/line interruptions it is recommended that the product be powered from an uninterrupted power supply or battery.

Power frequency (50/60 Hz) magnetic field, to IEC 61000--4--8

3 A/m

Yes

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

* NOTE: UT is the line/mains voltage prior to application of the test level.

1 --

8

GA--AS 001

1. Intended purpose Guidance and manufacturer’s declaration -- electromagnetic immunity for products that are not life--supporting The product is intended for use in the environment specified below. The user should assure that the product is used in such an environment. Immunity test

Compliance level

IEC 60601 test levels

Electromagnetic environment -- guidance

Portable and mobile RF communications equipment should be used no closer to any part of the product, including cables, than the recommended separation distance calculated from equation applicable to the frequency of the transmitter. Recommended separation distance:

d = 1.2 p P Conducted HF interference to IEC 61000--4--6 Radiated HF interference to IEC 61000--4--3

d = 1.2 p P for 80 MHz to 800 MHz 3 Vrms 150kHz to 80 MHz

d = 2.3 p P for 800 MHz to 2.5 GHz Yes

3 V/m 80 MHz to 2.5 GHz

P = Nominal power output rating of the transmitter in watts (W) (according to the transmitter manufacturer)

d = recommended separation distance in meters (m) Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey1, should be less than the compliance level in each frequency range2. Interference may occur in the vicinity of devices with the following symbol:

REMARKS:

At 80 MHz and 800 MHz the higher frequency range applies. These guidelines may no apply in all situations, as the propagation of electromagnetic waves is affected by absorption and reflexion from buildings, objects and people.

1 = The field strength of fixed transmitters (e.g. base stations for radio telephones, land mobile radios, amateur radio, radio broadcast and TV broadcast, ...), cannot be predicted theoretically with accuracy. To assess the EMC environment due to fixed transmitters an electromagnetic site survey should be conducted. If the measured field strength in the location in which the product is used exceeds the applicable compliance level above, the product should be observed to verify normal operation. If abnormal performance is observed, additional measures may be required, such as reorienting or relocating the product. 2 = Over the frequency range between 150 kHz and 80 MHz the field strength should be below 3 V/m.

The recommended separation distances between portable and mobile HF telecommunication devices and devices which are not life--supporting The product is intended for use in an electromagnetic environment with HF disturbances are controlled. The user can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile HF telecommunications equipment and the product. Separation distance as a function of transmitter frequency (m) Rated nominal output power of the transmitter (Watts)

150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

d = 1.2 p P

d = 1.2 p P

d = 2.3 p P

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

For transmitters rated at a nominal output power not listed in the table above, the recommended separation distance (d) in meters (m) can be determined using the applicable equation (observe frequency). P = nominal power of the transmitter in Watts (W). REMARKS: At 80 MHz and 800 MHz the higher frequency range applies. These guidelines may no apply in all situations. Electromagnetic propagation is affected by absorption and reflexion from buildings, objects and people.

GA--AS 001

1 -- 9

1

1. Intended purpose

1

1 -- 10

GA--AS 001

2. Illustrations / Controls and indicators

Contents

2

Section 2 2 2.1

Illustrations / Controls and indicators Symbols / Labeling... 2 -- 2 2.1.1 LAPARO CO2 PNEU automatic insufflator / TEM PUMP / Packaging... 2 -- 2 2.1.2 LAPARO CO2 PNEU automatic insufflator... 2 -- 2 2.1.3 TEM PUMP... 2 -- 2 2.1.4 Packaging... 2 -- 3

2.2

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

2.3

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

2.4

Illustrations... 2 -- 8 2.4.1 TEM Irrigation Cannula / TEM Stereo Telescope and Documentation Telescope / Documentation Telescope / PANOVIEW Telescope / TEM Instrument Set... 2 -- 8 2.4.2 TEM Accessories... 2 -- 10

GA--AS 001

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 Symbols / Labeling

2

Meaning

Symbols / Labeling

Meaning

Attention, consult ACCOMPANYING DOCUMENTS!

Identification plate

TYPE BF APPLIED PART

Do not place product in general waste bin. Recycle separately.

TYPE CF APPLIED PART

Fuse

Measuring line, for rectal pressure

μ

Alternating current (AC)

Equipotentality

=

DC

Protective earth / ground connection

A Registered Trademark of ETL, a Recognized Testing Laboratory, listing compliance as Medical Electrical Equipment to standard CAN/CSA C 22.2 No. 601.1 (c) and UL 60601--1 (us) Identification in conformity 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

2

Caution! Attention!

Follow instructions for use

REF

Order number Lot identification number

SN

Serial number Manufacturing date Units, quantity



Number, Quantity Use--by date: Do not reuse (for single use only) Latex free

Contains phtalates or phtalates are present: Diethylhexylphtalate (DEHP)

Sterilized with ethylene oxide Sterilization by radiation Steam sterilization -- using the fractional pre--vacuum method 25 15

Permissible temperature range Keep away from heat

<60

< 60 %

GA--AS 001

Keep dry, atmospheric 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