THERME-PNEU 7070T User Manual

Federal Law restricts this device to sale, distribution, use by or on the order of a physician with appropriate training and experience.

Intended Use The WISAP THERME-PNEU 7070T may only be used for building up a pneumoperitoneum with CO2 gas for diagnostic or operative Pelviscopy/Laparoscopy. The Flow-Therme integrated in the device allows preheating of insufflation gas to body temperature.

Contraindications •

Use of this device is contraindicated, whenever Pelviscopy/Laparoscopy is contraindicated.

•

Use of this device is restricted to building up a pneumoperitoneum during diagnostic or operative Pelviscopy/Laparoscopy.

•

Please also observe the operator manual of your endoscope regarding contraindications during Pelviscopy/Laparoscopy.

•

The device must not be used for Hysteroscopy.

•

Do not use prolonged Hi-FLO insufflation. The effects on the patient are unknown.

Warnings •

Use of this device should be restricted only to personnel authorized by a physician.

•

Proper device function is only guaranteed, if the pointer of the CO2 reserve manometer is in the green range. Have filled replacement gas cylinders available to prevent interruptions during a procedure owing to lack of CO2 gas.

• of

CO2 cylinders may never be completely emptied and should only be stored with closed cylinder valve! Thus contamination cylinders until the next filling is avoided and proper function of your device is guaranteed.

•

Only use medical grade CO2.

•

Absorption of CO2 during insufflation may result in hypercarbia or gas embolism. Pneumoperitoneum pressure may create blockage of the vena cava and pulmonary circulation. Use the lowest insufflation pressure possible during the procedure to minimize the risks.

• Excessive CO2 absorption results from either excessive flow rate and/or excessive pressure. The abdomen can be adequately distended by pressures in the range of 12 - 16 mmHg. It is uncommon to use an abdominal pressure greater than 20 mmHg. Pressures exceeding 20 mmHg must not be used for a longer period of time. •

Be aware of metabolic acidosis and resultant cardiac irregularity. Prolonged intraabdominal pressures greater than 20 mmHg should be avoided. Intraabdominal pressures greater than 20 mmHg can cause any of the following: ∗ Decreased respiration with compromised diaphragmatic excursion ∗ Decreased venous return ∗ Decreased cardiac output

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•

Adequate respiration helps avoid problems related to CO2 insufflation.

•

Idiosyncratic reactions: patients with sickle cell disease or pulmonary insufficiency may pose increased risks of metabolic imbalance related to excessive CO2 absorption.

•

Beware of carbonic acid irritation of the diaphragm.

•

Carefully monitor the patient’s intraabdominal pressure when other potential sources of gas are in use. Potential sources of gas are: ∗ Laser ∗ Gas-driven irrigation systems

Important Hints •

Please study this manual and accompanying labelings prior to putting the unit and its accessories into operation for the first time!

•

The WISAP THERME-PNEU 7070T is a precision device, which is solely to be operated with original WISAP accessories!

•

Check device and accessories as to their proper function prior to each intervention. If any faults are assumed or detected, application of this unit is strictly prohibited (see ”functional control”).

•

Interventions requiring the use of devices, instruments and accessories described in this manual may only be performed by personnel with adequate training and experience.

•

Prior to each intervention, please consult the pertinent medical literature for techniques, complications and hazards!!

• and

Independent from the general recommendations in this manual, the selection of equipment required for the intervention the determination of the static intraabdominal pressure, as well as selection of flow rate (gas flow) are within the sole responsibility of the operating surgeon.

•

The user is fully responsible for observing the cleaning, disinfection or sterilisation instructions. The manufacturer cannot be held liable for faults resulting from non-compliance with the above-mentioned regulations. Any warranty claims would be declared null and void in such case.

•

For avoiding cross-contamination, backflow and contamination, the original WISAP gas filter needs to be used. Gas filter, heating tubing and all accessories additionally used have to be changed before treatment of another patient. The gas filter

is disposable and thus not re-sterilisable! Heating tubing and further accessories need to be sterilised after each operative intervention (see ”cleaning, disinfection and sterilisation”). •

It needs to be taken care that cleansers and disinfectans are completely removed respectively that the heating tubing is sterilised prior to operative interventions.

•

Have a replacement insufflator available in the operating room to be used in case of failure.

•

Flush the system with insufflation gas before each procedure, and replace the unit or accessories with clean or sterilised devices, if any evidence of liquid contamination is found.

•

Position the patient port of the insufflator and the heating tubing above the insufflation site, so that any patient fluids inadvertently entering the tubing do not drain back into the insufflator under gravity.

•

Manual reduction of the intraabdominal pressure must NOT be effected by detaching the heating tubing from the device or 3

by deflation through the unit, but only by deflation through the insufflation instruments or separation of the heating tubing from the insufflation instruments! •

The device is not destined for being operated in explosive-endangered areas!

•

Install unit out of patient’s reach!

•

Please ensure that no liquid penetrates into the device or that the unit does not get in touch with any liquids.

•

In order to ensure good dissipation of heat generated during operation of the device, covering with cloths is to be avoided.

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Opening of the chassis, repairs, modifications and calibrations may only be performed by the manufacturer or by persons explicitly authorized by him!

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Device Description FRONT PANEL

REAR PANEL

1 2

14 15

Gas flow display in l/min Minus LED - display for negative pressure

3

Mains switch Rotating knob for preselection of static intraabdominal pressure Connecting socket for cable of heating tubing

16

3a

Green LED displaying state of operation

16a

3b

Red blinking-LED displaying faults

16b

4

Connection for gas filter

16c

5

Gas filter

17

6 7 7a 7b 8 9 10 11 12 13

Gas filter adaptor Heating tubing Cable of heating tubing with plug Connection cap for insufflation unit CO2- reserve manometer Reset button for displayed gas volume used, green Display for gas volume used in liter Key button yellow, Insufflation ”HI-FLO” Key button green, Insufflation ”1l/min” Display of insufflation pressure in mmHg

18 19 20 21 22 23 24 25 26

Display for static intraabdominal pressure in mmHg Intraabdominal pressure indicator LED yellow (preselected pressure not reached yet) Intraabdominal pressure indicator - LED green (preselected pressure reached) Intraabdominal pressure indicator - blinking red LED (warning - pressure by approx. 7 mmHg higher than preselected value) LED’s yellow - oscillating gas flow dis- play (flow indicator) Type plate Plug for mains connection Fuse drawer Grounding connection Replacement fuse holder CO2- gas connection Bottle support Volume regulator for excessive pressure alarm Circuit breaker

5

Device Description 1

Mains switch for turning on the device, ON = I, OFF = 0. Green rocker switch illuminates, when device is ON. The device is only separated from the mains at all poles, when mains plug is disconnected. Device should only be turned on, if all connections are established.

2

Rotating knob for preselection of the requested static intraabdominal pressure (recommendation 12-14 mmHg, max . 24 mmHg).

3

To this socket, connecting cable 7a of heating tubing 7 is attached.

3a

Illumination of the green LED indicates that the supply voltage for the heating tubing is available inside the unit.

3b

The red blinking LED and simultaneous illumination of green LED refer to an internal or external interruption of the heating circuit. Possible causes are: • Heating tubing is not connected • Heating tubing is defective • Circuit breaker 26 at the rear of the unit has released

4

Gas filter is attached to this connection.

5

Gas filter - only use original gas filter taken out of undamaged packing (WISAP Art.-No. 7070TF). The gas filter is disposable and thus not re-sterilisable! For avoiding crosscontamination, gas filter, heating tubing and all accessories additionally used need to be replaced after each intervention.

6

Adaptor (WISAP-Art.-Nr. 7070TA) for connecting heating tubing with gas filter; needs to be exchanged after each patient.

7

The heating tubing warming up the insufflation gas to body temperature needs to be exchanged after each intervention.

7a

The cable of heating tubing is connected to the correspondent socket 3 of the unit.

7b

With the connection cap, the heating tubing is attached to connection 4 through adaptor 6 and gas filter 5. We would recommend to use the heating tubing with a sterile drape (WISAP Art.-No. 7742 SR).

8

The CO2-reserve manometer indicates the gas reserve of the CO2 cylinder. • Green, hatched range = bottle exchange necessary • Green range = sufficient gas reserve • Red range = excessive pressure inside the bottle

9

Depressing the green Reset button causes reset of the value indicated on the display for gas volume used 10.

10

4-digit display of gas volume used in liter

11

By depressing the yellow Hi-FLO button, the flow is increased to approx. 20 l/min -10% (measured at free flow, otherwise dependent on the flow resistance of insufflation tubing/Veress needle or trocar). For safety reasons, the operating mode ”HI-FLO” can only be activated after having started the insufflation with key button insufflation ”1 l/min” 12. ”HI-FLO” can be terminated by repeated activation of the HI-FLO button and automatically switches over to Low-Flow (1 l/min.).

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Insufflation with a gas flow (flow) of approx. 1 l/min. is started by means of the green key button insufflation ”1l/min”. If key button is depressed during insufflation, gas supply is stopped, regardless of having ”HI-FLO” additionally activated or not. 6

13

2-digit display of insufflation pressure in mmHg (dynamic pressure at Veress needle or trocar while filling)

14

3digit display of gas flow in l/min.

15

Minus-LED ”-” indicates negative intraabdominal pressure

16

2digit display for static intraabdominal pressure in mmHg

16a

Intraabdominal pressure indicator LED yellow = intraabdominal pressure is lower than the preselected value.

16b

Intraabdominal pressure indicator LED green = intraabdominal pressure has not reached the preselected value

16c

Intraabdominal pressure indicator, blinking red LED = intraabdominal pressure is higher than the preselected value, insufflation is immediately stopped, alarm sound is released.

17

The 5 yellow, oscillating LED lights reveal the insufflation phases of the Therme-Pneu as follows: • slow = low flow • rapid = high flow

18

The technical data, as well as type and serial number of your device are identified on the type plate. Please indicate these data when ordering spare parts or in case of any questions.

19

Plug for mains connection - disconnect mains plug prior to opening the chassis! Device may only be operated with the voltage indicated on the type plate.

20

Fuse drawer with mains fuses. Device may only be operated with the voltage indicated on the type plate.

21

Connection for grounding cable. CAUTION: Adequate grounding is only guaranteed, if a connection between the pin at the unit and the central potential equalization bar has been established.

22

Storage space for replacement fuses: turn cap to the left = open, turn cap to the right = close. CAUTION: risk of fire, only use rated fuses, see type label

23

Connection for CO2- gas cylinder (see technical description)

24

The bottle holder serves for receipt and fixation of the CO2-cylinder.

25

Volume regulator for adjusting the requested volume of the excessive pressure alarm. For safety reasons, the volume cannot be set to zero.

26

Circuit breaker releases in case of excessive strain exerted on heating tubing or tubing cable, for instance by squeezing, bending or overturning. Released fuse can be reset by depressing the black fuse knob.

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Technical Description These instructions are to be kept at a well-visible place nearby the unit. Unpack device and accessories and remove all packaging. The device may only be operated in medically utilized rooms, if those are installed according to the guidelines of VDE 0107. Install device onto a plane surface at a dry location. The device is not destined for being operated in explosive-endangered areas. If explosive anaesthetics are in use, the device must not be operated in the marked zone.

Connection to the gas supply CO2 cylinder connection acc. to DIN 477. Attach CO2-cylinder to gas connection 23.

Connection to the mains Before putting your new unit into operation for the first time, please check, whether the local mains voltage is in conformity with the voltage indicated on type plate 18. Only then your unit may be connected to the power supply. Plug mains cable into socket 19 at the rear of the unit. CAUTION:

The device is only separated from the power supply with all poles, when the mains plug is disconnected. Do not turn the device on immediately - please wait until the temperature of the appliance is almost aequivalent to the ambient temperature.

Grounding The unit is equipped with pin 21 acc. to DIN 42801 for connection of the grounding conductor which is destined for earthing the unit (”guidelines for avoiding danger of ignition due to electrostatic charge”).

Technical Data Therme-Pneu Classification acc. to: - 93/42/EWG: - Type of protection against electric shock: - Degree of protection against electric shock: - Degree of protection against penetration of water: - Operating mode: - Mains connection: - Fuses: - Current acceptance: - Chassis: - Weight (total): - Gas connection: - Insufflation pressure: - Static intraabdominal pressure:

IIA Protection class I Device type BF IPX1 Continuous operation available for alternating voltage 100 V, 110 V, 115 V, 127 V, 220 V, 230 V, 240 V / 48 - 62 Hz (Please indicate local voltage upon ordering) 2 x 1,0 AT for 100 ... 127 V 2 x 0,5 AT for 220 ... 240 V 90 VA w x h x d = max. 350 x 420 x 160 mm 9,8 kg for CO2-Gas acc. to DIN 477 0 ... 50 mmHg 0 ... 24 mmHg 8

Preselection range: - Gas flow: LOW-FLOW: HI-FLO: - Gas volume display:

0 ... 24 mmHg 1 l/min ± 10% 20 l/min - 10% 0 ... 999,9 l ± 10%

CE labeling is performed in conformity with the EC guidelines 93/42/EWG Annex II. Circuit diagrams, spare part lists, adusting instructions and other documents useful for repairing unit parts - if the manufacturer considers them to be repairable - will be made available to qualified technicians upon request.

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Fuse Exchange

Attention: Disconnect mains before! Disconnect mains

Press right side hold

change fuses

press left side hold

pull out fuse holder

insert fuse holder Until both sides click in

Symbols

ʺ &

!

Switch position „OFF“

Switch position "ON"

Grounding connection

Device protection class B

;

Caution: Observe accompanying labelings!

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ɜ

Gas reserve display

Patient

Flow

Intraabdominal pressure

Connecting socket ”cable of heating tubing”

Connection Gas heating

ɚ

ɡ ə

Gas volume used

Reset „gas volume used“

Connection ”to patient” (through filter)

11

SN

Serial number

REF

Type

IPX1

Protection against water drops

1275

CE-Label and ID number of authorized body. This product is following the Guidelines for medical devices 93/42/EWG

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Operating Instructions 1. Introduction The electronically controlled, digital measuring of the insufflation pressure and of the actual static intraabdominal pressure became possible by the monofil-bivalent system according to SEMM→. During operative Endoscopies (endoscopic intraabdominal surgery), an electronic system controls the gas flow according to the preselected static intraabdominal pressure in optimal, physiologically acceptable rapidity. Handling of the appliance is restricted to 2 operations: • Preselection of the requested static intraabdominal pressure • Preselection of the requested gas flow (as measure for the filling rapidity) Insufflation of gas not heated to body temperature leads to hypothermia of the abdominal cavity resulting in a peritoneal catarrh, which may cause postoperative pains. After insufflation of gas heated to body temperature, the postoperative use of analgesics is significantly reduced, whereby the well-being of the patient is much better. The heating of carbon dioxide gas is effected through the FLOW-THERME integrated in the THERME-PNEU.

2. Putting the Unit into Operation The unit is put into operation by performing the steps outlined below. The order described has to be followed. a) Electrical connection • Grounding (see ”technical description”) Grounding pin 21 of the device is to be joined with the central potential equalization of the operating theatre by means of a grounding cable or with the grounding connection at an equipment trolley upon installment of the device. • Mains connection (see ”technical description”) Priot to connection of the device to the power supply, set mains switch ”I” to position ”0” = OFF (rocker switch to the left). Attach mains cable to pin 19 and connect it to the mains. Only establish connection with the power supply outside explosive-endangered areas; do not operate device with defective mains cable! b) Connection of CO2-gas supply (see ”technical description”) The device is destined for the support of CO2 cylinders with a nominal value of approx. 60 bar and a filling weight of 750 g. In order to ensure that sufficient gas reserve is available for the operative intervention, only sufficiently filled gas cylinders should be used! In case of too low bottle pressure, the pointer of the CO2 reserve manometer moves to the green hatched range. The bottle should be exchanged immediately! Please always stop gas insufflation prior to exchange of the gas cylinder! Gas cylinders with a pressure greater than 80 bar are excessively filled and constitute a safety risk. In case of such pressure values, the pointer of the manometer for gas reserve moves to the red range. Exchange of bottles with pressure values higher than 80 bar is absolutely required! • Attachment of CO2-cylinders with German, Italian or Swiss connection Pull out rod of bottle support 24, place CO2 cylinder onto rod and apply onto gas connection 23, whereby correct seat of the sealing is to be ensured. Tighten coupling nut with wrench (device accessory). • Connection of CO2-bottles to Pin-Index

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Completely unscrew handwheel of gas connection 23. Pull out rod of bottle support 24, place CO2-cylinder onto rod and have it locked in place at the arresting bolts of the gas connection while simultaneously observing correct seat of the sealing. Tighten handwheel of connection. • Attachment of CO2 cylinder via high-pressure connection tubing By connecting the CO2 cylinder via a high-pressure tubing, the device can be operated separately from the cylinder. Furthermore, the use of bottles with higher filling weight/volume is thus possible. When connecting a high-pressure tubing to the device connection 23, correct seat of the sealing and tight screwing are to be ensured. Connect CO2-cylinder on the other end of the high-pressure tubing, whereby correct seat of the sealing and tight screwing are also required. CAUTION:

The CO2-cylinder must not be operated in horizontal position. It needs to be ensured that the bottle valve is located higher than the bottom. A minimum incliniation angle of 20° is to be observed. If these instructions are not followed, serious malfunctions at the unit may occur!

The CO2-cylinder is to be adequately positioned and to be fixed with appropriate means (bottle support, strap)! • Connection to the central gas supply The device is not destined for connection to a central gas supply! Upon request, the unit can be modified for connection to a central gas supply in the manufacturer’s facility. c) Connection of heating tubing Attach connection plug of heating tubing cable 7a to the correspondent receptacle 3, while observing the red marking on plug and socket. Join connection cap 7b of heating tubing 7 to connection 4 for gas filter through adaptor 6 and gas filter 5. We would recommend to use the heating tubing with a sterile drape (Art.-No. 7742 SR). CAUTION:

Do not bend, squeeze, overstrain or overturn heating tubing. Hold heating tubing tightly while attaching Veress needle or trocar, and turn instruments onto tubing coupling, not vice versa.

3. Turning on the Device a) Activation of mains switch Set mains switch to ”I” = ON • Rocker switch illuminates green • Zeroes appear on the LED displays • Heating tubing is warmed up, green LED 3a illuminates • Deaerator inside the device is in operation (gentle humming) The device should be turned on approx. 15 minutes prior to insufflation. After this warming-up period, the heating tubing is warm to the touch. b) Opening of cylinder valve The CO2 bottle valve can be opened by rotation to the left. As consequence of the gas pressure now being applied to the device connection, the pointer of the reserve manometer must be in the green range in case of full and correctly filled gas cylinder.

4. Building up of a Pneumoperitoneum a) Needle test Prior to insertion of the Veress needle into the abdomen, its flow resistance is checked at a flow (gas flow) of 1 l/min. and at a preselected intraabdominal pressure ”Preset” (displayed under 16) of 12 mmHg. For such purpose, green button insufflation ”1 l/min.” 12 is to be activated after connection of the Veress needle to heating tubing 7, whereby gas insufflation is being started. During gas insufflation, the actual insufflation phases are interrupted by measuring phases, in which the intraabdominal pressure is being detected. The permanent change between both phases is, among other things, detectable by the click sound of the valves. If Veress needle is absolutely open, the following values should be indicated on the displays: 14

• Display 13: Insufflation pressure is not higher than 4 ... 8 mmHg. • Display 14: ”Flow” display indicates 0,9 ... 1,1 l/min during the insufflation phases and 0,0 l/min. during the measuring phases. • Display 16: Intraabdominal pressure is 0 mmHg. • Oscillating light 17: The five yellow LED’s of the ”FLOW INDICATOR” slowly illuminate from the top to the bottom during the insufflation phases. • Display 10: On the display for gas volume used, the gas consumption since the beginning of the insufflation phase is indicated • The yellow LED 16a of the LED intraabdominal pressure indicator illuminated If Veress needle is partly closed, the insufflation pressure is higher than 4 ... 8 mmHg. If Veress needle is completely closed during a measuring phase (”Flow” display 0,0 l/min, no flow indicator), an insufflation pressure even higher than before (45 ... 50 mmHg at the maximum) is generated in the following insufflation phase. In the following measuring phase, the same measuring value appears on the display for ”static intraabdominal pressure”. As the intraabdominal pressure is thus by more than 7 mmHg greater than the preselected ”Preset” pressure of 12 mmHg, an alarm sound is released and the red blinking LED 16c of the LED intraabdominal pressure indicator is activated. Insufflation is immediately stopped and automatically continued, as soon as the intraabdominal pressure is below the preselected ”Preset” pressure (open Veress needle). If proper function of the Veress needle including its snap mechanism (snap test) has been detected, gas insufflation is terminated by depressing green key button ”1 l/min” 12 followed by repeated control of the static intraabdominal pressure (”Preset”), which can be corrected by activation of the rotating knob for pressure preselection 2, if need arises. The value indicated on the display for gas volume used is reset to 0,0 l by shortly depressing the green Reset button 9. b) Insertion of the Veress needle and aspiration test After detachment of the successfully tested Veress needle from heating tubing 7, the needle is commonly, for instance intraumbilically, inserted into the abdominal cavity followed by instillation of approx. 5 ml saline solution with attempted reaspiration. If the aspiration test turns out negatively, the Veress needle is re-attached to heating tubing 7. c) Diminished pressure test (manometer test) When strongly elevating the abdominal wall, diminished pressure is generated in the abdomen. If the Veress needle is correctly positioned in the abdomen, diminished pressure is signalised by a negative sign (minus) 15 accompanying the displayed ”intraabdominal pressure” and by simultaneous illumination of the yellow LED 16a of the LED intraabdominal pressure indicator. If a fault is detected or assumed when performing the steps mentioned above, building up of the pneumoperitoneum must not be continued! d) Insufflation of CO2-Gas While re-elevating the abdominal wall, the green key button insufflation ”1 l/min” 12 is to be depressed. The following values should appear on the displays: • If needle is freely positioned in the abdomen, the insufflation pressure during the insufflation phase (visible at the flow indicator) must, at first, not exceed the test value detected with Veress needle absolutely open and a flow of 1 l/min. • The gas flow display 14 indicates a value of 0,9 to 1,1 l/min during the insufflation phase (during the measuring phase 0,0 l/min.). • The display for gas volume used shows the gas volume used since start of the insufflation and thus the size of the intraabdominal gas bladder • The intraabdominal pressure increases during insufflation of the first liter CO2 gas from 0 mmHg to 2 mmHg. • Despite the intermittent change between insufflation and measuring phase, insufflation pressure and intraabdominal pressure are continuously displayed. • As long as the intraabdominal pressure is lower than the preselected value, the yellow LED 16a of the LED intraabdominal pressure indicator illuminates. 15

Up to a filling volume of 1 l, the displayed insufflation and intraabdominal pressure values should not significantly change. If the value of the displayed intraabdominal pressure skips to a value close to the insufflation pressure, the needle is not freely positioned in the abdominal cavity (volume test). The insufflation needs to be terminated immediately followed by repositioning of the Veress needle! e) Continuation and termination of insufflation in pos. ”1 l/min” (actual flow 0,9 ... 1,1 l/min) As of approx. 1 l filling volume, the intraabdominal pressure display slowly starts to indicate the increasing pressure of 2, 3 to 5 mmHg. At the same time, the insufflation pressure (display 13) increases owing to the addition of intraabdominal and insufflation pressure. With increasing intraabdominal pressure, the electronics gradually reduces the time of insufflation phases until complete stop, as soon as the intraabdominal pressure has reached the preselected ”Preset pressure”. With insufflation stop, the LED intraabdominal pressure indicator switches over from the yellow LED 16a to the green LED 16b. At the same time, the characteristic insufflation sounds disappear. We would urgently recommend to record the gas volume used until the preselected pneumoperitoneum has been reached, in order to be exactly informed of the intraabdominal gas bladder volume. Gas losses at the instruments lead to additional insufflation phases. Many operating surgeons already activate the ”HI-FLO” function after 1 l filling volume by depressing the yellow HI-FLO button 11. During the insufflation phase, the flow indicator 17 is being activated. Depending on the flow resistance of the Veress needle, a gas insufflation of approx. 3 ... 4 l/min is possible. This considerable shortens the insufflation time. However, it is important that the surgeon has the necessary experience for this rapid filling cycle and that he has discussed this with the anaesthesist in advance. Furthermore, the insufflation pressure displayed under ”Gas in” increases, depending on the quality of the Veress needle, to 30 - 50 mmHg within a very short period of time owing to the transport of a higher gas volume. The intraabdominal static pressure must not exceed the preselected value under ”Preset”. If the intraabdominal pressure also exceeds 15 or even 20 mmHg, the insufflation procedure has to be stopped immediately. The Veress needle is not located in the free abdomen or the patient is not sufficiently relaxed. As soon as the intraabdominal pressure is by approx. 7 mmHg greater than the preselected pressure under ”Preset”, the red blinking LED 16c at the LED intraabdominal pressure indicator and an acoustic warning signal are simultaneously activated. Insufflation needs to be terminated immediately. The warning signal and the flashing red LED only disappear at an ”excessive pressure” of 5 mmHg. f) Insertion of the optics trocar After performance of the sounding test as precaution to ensure that the space for placing the trocar is free from adhesions, the Veress needle is removed, the trocar is inserted by Z-puncture and connected with heating tubing 7. Prior to insertion of the optics, function ”HI-FLO” is activated by depressing the yellow HI-FLO button 11, so that the electronics is able to compensate the gas loss of the optics trocar. In order to minimize the gas loss, we would recommend to interrupt the insufflation by depressing the green key button insufflation ”1 l/min.” 12 and to continue insufflation by repeated activation of the same button with subsequent depressing of HI-FLO, after having changed from Veress needle to trocar. g) Termination of gas supply Upon completion of the endoscopic intervention, the trocar valve is to be closed followed by detaching the heating tubing from the trocar and by termination of the preselected insufflation mode (1 l/min. or HI-FLO) by re-activating the green key button insufflation ”1 l/min.”. Thus a backflow through gas filter 5 and a vacuum in the measuring system are prevented after termination of the gas supply (uncontrolled vacuum in the measuring system leads to destruction of the pressure measuring system inside the unit). After the total CO2 volume used has been recorded according to the value shown on display 14, the latter can be reset to 0,0 l by depressing the green Reset button 9.

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Functional Control The functional control is prescribed by the standards of IEC 601-1. It is to be performed prior to each operative intervention. The functional control serves for checking insufflators, filters, gas filter adaptors, heating tubings and Veress needle. Hint:

Please sterilise re-usable instruments prior to each intervention in order to prevent infections.

1. Checking of rotating knob 2 for preselection of the static intraabdominal pressure

Description of Functional Control ⇒ Upon activation of the rotating knob, its left and right stop must be noticeable and be in conformity with beginning and end of the scale. After succesful check, set preselection to 12 mmHg.

2. Join insufflator with central potential equalization via grounding cable. 3. Connect mains cable to insufflator and join with supply network. 4. Activation of mains switch 1

5. Attach gas cylinder to the correspondent gas connection 23 at the rear of the unit and open cylinder valve. 6. Attempt to start insufflation by activation of key button ”HI-FLO” 11. 7. Activation of insufflation by depressing key button ”1 l/min” 12.

8. Additional activation of ”HI-FLO” with key button 11.

⇒ Rocker switch illuminates green. ⇒ The following values are displayed: - display of insufflation pressure 13: 00 ... 01 - display of gas flow 14: 0.0 ... 0.1 - display for static intraabdominal pressure 16: 00 ... 01 - display for gas volume used 10: 000.0 ... 000.1 ⇒ CO2- reserve manometer 8: - pointer is at its left stop ⇒ Green LED 3a illuminates ⇒ Red blinking LED 3b flashes ⇒ Flow indicator 17 is deactivated ⇒ Key buttons ”HI-FLO” 11 and ”1l/min” 12 do not illuminate ⇒ Yellow LED indicator 16a for intraabdominal pressure illuminates ⇒ Both LED indicators 16b and 16c for intraabdominal pressure are deactivated. ⇒ Internal aerator in operation (gentle humming) ⇒ If gas cylinder is filled (bottle pressure approx. 3080 bar), the pointer of CO2 reserve manometer 8 must be in the green range. ⇒ Start not possible, no change on displays ⇒ Key button illuminates green ⇒ Oscillating light of flow indicator 17 is activated ⇒ Device starts to cycle. During the filling phase, the gas flow display indicates 14, 1l ±0,1. The oscillating light of the flow indicator is activated three times. ⇒ The CO2- gas volume used is indicated on gas volume display 10. ⇒ Key button illuminates yellow. ⇒ The gas flow indicator on gas flow display 14 increases to 20 l/min -10%. ⇒ The oscillating light flashes faster.

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9. Repeated activation of ”HI-FLO” button 11 leads to switch-over to 1 l/min. insufflation.

⇒ Key button ”HI-FLO” is no longer illuminated ⇒ Remaining displays like described under point 7.

10. Termination of insufflation by activation of key button ”1l/min” 12 beenden. 11. Attach gas filter 5, gas filter adaptor 6, heating tubing 7 and Veress needle to connection for gas filter 4 and join cable of heating tubing 7a with the correspondent socket 3. 12. Activation of insufflation by depressing key button ”1 l/min” 12; valve of Veress needle is open

⇒ Key button is no longer illuminated

13. Preselection knob at its right stop; additional activation of ”HI-FLO” with key button 11; close Veress needle at the beginning of the filling phase

⇒ Key button illuminates yellow ⇒ Red blinking LED 16c of the intraabdominal pressure indicator flashes. ⇒ Yellow LED 16a of intraabdominal pressure indicator does not illuminate ⇒ Acoustic alarm sound is activated (it must be possible to set the volume requested with regulator 25; the alarm sound cannot be turned off completely) ⇒ The following values are displayed: - display for insufflation pressure 13: 50 ±2 mmHg - display for static intraabdominal pressure 16: 48 ±3 mmHg

14. Termination of insufflation by depressing key button ”1l/min” 12, 15. Open Veress needle and have pressure decreased to 19 mmHg; close Veress needle .

⇒ Key button is no longer illuminated

16. Carefully open Veress needle until the displayed intraabdominal pressure has decreased to 12 mmHg; close Veress needle.

⇒ Upon activation of rotating knob 2, switch-over between the green and yellow LED has to take place in the range of 11 - 13 mmHg. (The yellow LED illuminates, if the preselected pressure is higher than the displayed intraabdominal pressure). ⇒ Slowly increase preselection by rotation to the right; at a preselected value being aequivalent to the displayed value +/- 1 mmHg, the insufflation must start ⇒ Key button is no longer illuminated

17. Pressure preselection with rotating knob 2 to 8 mmHg; activation of insufflation by depressing key button ”1l/min” 12; 18. Termination of insufflation by depressing key button ”1l/min” 12 beenden. 20. Check heating tubing and accessories as to potential leakage! Pressure preselection with rotating knob 2 to 12 mmHg; with valve of insufflation instrument closed, start insufflation by depressing key button ”1 l/min” 12.

⇒ Red blinking-LED 3b is no longer activated

⇒ The following value is shown on insufflation pressure display 13: 04 ... 08 (with original WISAP Veress needle). ⇒ Remaining displays like described under point 7.

⇒ Yellow LED 16a illuminates ⇒ Turn rotating knob 2 for preselection to the left until change from yellow LED 16a to green LED 16b have been performed; continue to turn rotating knob to the left; change from green LED 16b to red blinking LED 16c and activation of acoustic alarm sound need to take place at a preselected pressure of 11 - 13 mmHg

⇒ The value indicated on the display for static intra- abdominal pressure 16 should decrease by 1 mmHg in 1 s.

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21. Check high-pressure connection as to potential leakage! Terminate insufflation by depressing key button ”1 l/min” 12; close valve of gas cylinder

⇒ Pointer of CO2-reserve manometer 8 must keep its position for at least 15 min.

22. Upon completion of the functional control, set mains switch 1 to position ”0”.

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Cleaning, Disinfection and Sterilisation In order to maintain the performance of the unit, care, maintenance and storage need to be effected thoroughly. The accessories coming into contact with human tissue need to be sterilised for avoiding infections to the patient.

Cleaning of the Device After use, the device is to be switched off followed by removal of mains cable, gas cylinder and remaining accessories. For cleaning the outer surfaces of the device, an aquaeous solution is suitable. Observe solution concentration specified by the disinfectant manufacturer! Wipe the surface of the unit with a cloth dampened with disinfectant. Penetration of liquid into the device is to be avoided.

The device must not be sterilised! Cleaning of Heating Tubing, Gas Filter Adaptor and Veress Needle Rinse heating tubing, gas filter adaptor and Veress needle with running cold and warm water. After careful cleaning with demineralised water, the parts are to be dried with sterile cloths.

Disinfection of Heating Tubing, Gas Filter Adaptor and Veress Needle Only parts carefully cleaned may be disinfected. Soak parts in solution, and observe the manufacturer’s instructions regarding solution concentration and soaking time. Prolonged soaking time or wrongful concentration may lead to damage of the parts. Do not staple parts on top of each other. Disinfectant residues should be rinsed with sterile water under sterile conditions. Dry all parts with a sterile cloth followed by wrapping them in a sterile cloth. The disinfected parts must be stored in a closed, sterile container. CAUTION:

The heating tubing should not be soaked in disinfecting solution for more than 30 minutes. Silicone absorbs different disinfectants and will be damaged during subsequent steam sterilisation!

Sterilisation of Heating Tubing, Gas Filter Adaptor and Veress Needle The parts to be sterilised should be clean, disinfected and dried. Wrapping in transparent sterile packings, transport after sterilisation and deaeration time determined are described in the operator manual of the gas sterilising unit. WISAP recommends the following sterilisation methods: 1.

Steam sterilisation at 121 °C / 2,1 bar / 15 min.

Please see the tabular overview on page 21 for further cleaning, disinfection and sterilisation information. CAUTION:

It is recommended to gas-sterilise the heating tubing, as steam sterilisation for a prolonged period would impair reliability of the tubing (warranty conditions would not be applicable in such case).

WISAP would recommend that the personnel responsible for sterilisation studies the operator manuals of the different sterilising units. Please read the instructions for metal articles with lumen and porous articles with lumen. It is important to know that these recommended sterilisation parameters are only valid, if the sterilisation equipment is properly maintained and calibrated.

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