Coa Comp M Instruction Manual IBBAB021016-1 Feb 2008

Instructions Dokument nr/Document No

Datum-Date

IBBAB 021016-1

2008-02-08

Page 1(12) Identitet-Identity

(ccmsys;D42E)ccmanu2.xco;2

Coa-Comp/Mini INSTRUCTIONS FOR USE

Table of contents 1.

Foreword and Introduction ...

2

2.

Start and test. ...

2

2.1 2.2 2.3 2.4 2.5

Mains connection ... Turning ON ... Self test and forceps connection ... Activation ... Operator´s cable and forceps test. ...

2 2 3 3 3

3.

Operation. ...

4

3.1 3.2 3.3 3.4

Power setting. ... The work cycle. ... To use the footswitch. ... Advices and Hints. ...

4 4 4 5

4.

Forceps, Scissors and cables. ...

6

5.

Coa-Comp "Hose cable", (Part no IBBAB 981027-1) ...

6

6.

Warnings. ...

7

7.

Cleaning, Maintenance. ...

8

8.

Front and rear panels ...

9

8.1 8.2 8.3

Front panel controls and indicators. ... Rear panel controls and indicators. ... Various symbols used. ...

9 10 11

9.

Technical data ...

11

10.

Contact information. ...

12

11.

What version of the instructions is for what version of the Coa-Comp/M ? ...

12

Instructions Dokument nr/Document No

Datum-Date

IBBAB 021016-1

1.

Page 2 Identitet-Identity

2008-02-08

(ccmsys;D42E)ccmanu2.xco;2

Foreword and Introduction Safe and effective electrosurgery is dependent not only on equipment design but also to a large extent, on factors under the control of the operator. It is important that the instructions supplied with the equipment be read, understood and followed in order to enhance safety and effectiveness. As all medical electrical equipment Coa-Comp/M needs special precautions regarding electromagnetic compatibility (EMC) when put into service. Information on this can be found in the Technical manual (IBBAB doc no 910518-1) Technical data chapter. Coa-Comp/M is an automatic bipolar coagulator (automatic bipolar electrosurgery generator). With automatic means that a) it starts if conducting material (tissue) is grasped between the forceps tips b) shuts off when coagulation is finished. With a pedal (optional) you can change from automatic start to operator controlled (triggered), start and vice versa. With Bipolar we mean that the current flows between the forceps tips, there is no need for a patient plate like in monopolar electrosurgery. Coa-Comp/M coagulating.

2.

indicates

with

a

beep

and

a

blue

light

that

it

is

positions

in

Start and test. (For use of a footswitch with the Coa-Comp/M see chapter 3.3.) Numbers within parentheses, the figures of chapter 8.

2.1

(x),

refers

to

corresponding

Mains connection Check that the Coa-Comp is set for the proper mains voltage. Voltage selector (12) can be set for operation at 110-120 V or 220-240 V (50 or 60 Hz). Connect the unit to an outlet with protective earth.

2.2

Turning ON Turn on the unit (11). The led (1) shall light. Then for a few seconds (while the machine performs a self test) the message "IBBAB" (or some other company name) followed by "Coa-Comp" shall be seen in window (4). After a brief period of time the message "Revxx OK" shall then be seen (xx is the current systems version, for example "1B" ). If nothing can be seen or if an error message, for example "ERROR PS" is shown then switch off the unit and then make a new switch-on after a few seconds. If you can't get the "Revxx OK" message despite repeated trials then contact your service department or supplier. During this start-up process the Coa-Comp also sometimes will emit a short beep and also lights up the blue led for a second.

Instructions Dokument nr/Document No

IBBAB 021016-1

2.3

Datum-Date

2008-02-08

Page 3 Identitet-Identity

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Self test and forceps connection After the message "TEST OK" has been shown for a few seconds it is replaced by the message "Ready 16" (or some other number). Coa-Comp/M is now ready for use. Connect cable with bipolar forceps to the banana jacks (8).

2.4

Activation The Coa-Comp/M can now be made active by a brief push on the "Auto-Start" button (2). Then the unit sends out short Radio-Frequency power impulses. The pulses are too short to cause any coagulation by themselves but are used by the Coa-Comp to find out if there is conducting material between the forceps points. The power impulses are indicated by blinking the blue led (3). One more push on the green button (2) returns the unit to "Ready". When the pulses are sent out the message "Auto 16" (or some other number) is displayed.

2.5

Operator´s cable and forceps test. The "Auto" message is replaced every 5 seconds by an animated "forceps" that show how to press the forceps points together to test the forceps, cabling and the Coa-Comp/M. If this is done successfully, that is a short circuit is obtained, then a pushed-together-forceps are shown together with an "OK". After the OK message no animated forceps are shown for one hour. However, you can do the test anytime by just pushing the forceps points together. Fault-finding, if you do not get "OK" when short-circuiting the forceps: a) Check that the forceps points are clean. b) Try to change the forceps cable, the cables often break down when autoclaving. The cable end with the forceps connector is the part that is most likely to break down. c) Contact service department. After the cable/forceps test the unit is ready to be used. Do not try to operate if the cable/forceps test is NO GO !

Instructions Dokument nr/Document No

IBBAB 021016-1

3.

Operation.

3.1

Power setting.

Datum-Date

2008-02-08

Page 4 Identitet-Identity

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By pushing one of the power buttons the power can be changed. Arrow up (6) increases the power and arrow down (7) decreases the power. Choose setting 8, 16 or highest setting in combination with broad forceps (weather open surgery or laparoscopic procedure) or big bipolar scissors. Use setting 2 or 4 with fine forceps. With fine bipolar scissors (open or laparoscopic surgery) setting 8 or 16 is recommended. Certain procedures may need lower settings than normal when working in sensitive areas, in these cases one also have to allow more time for the bipolar scissors to cut and coagulate. If the unit is used for more than four hours with a certain setting you will get that setting at start-up next time. When delivered from the factory setting 16 is the start-up value. However the highest setting (40) will never be a default setting.

3.2

The work cycle. When "Auto" is shown the unit is active and if tissue is touched with the forceps points and if the tissue conducts the current (is not too dry for example) then power output is started and the tissue becomes heated. When power is emitted the Coa-Comp/M sounds. Power is emitted until the Coa-Comp has decided that the coagulation of the tissue is finished. Then power output is stopped. The surgeon is made aware of this by listening to the cessation of the sound signal. He then looses the grip and Coa-Comp/M waits for half a second before it tries to detect tissue again. If the surgeon so wishes he can hold on to the tissue and get another heating cycle. If the Coa-Comp/M cannot detect the signs for terminating heating within 5 seconds the power output is stopped anyway.

3.3

To use the footswitch. If a footswitch is connected to the Coa-Comp/M it displays "Pedal 16" (or some other power figure depending on power setting) at start up. When the footswitch is pushed lightly the display shows "Trigg 16" and at the same time RF-pulses are output in the same manner as in Auto-start but with about twice the repetition rate. When Coa-Comp/M then detects tissue it starts coagulation in the same way as in Auto-start. It also stops coagulation when it has decided that the vessel is finished. It is important to understand that by pushing the pedal you just tell the Coa-Comp/M to start to search for something to coagulate. Equally important to understand is that once started the Coa-Comp/M does not care weather the foot-switch is up or down. The coagulation goes on until Coa-Comp/M has decided the vessel is finished or the grip is losened or for a maximum of 5 seconds.

Instructions Dokument nr/Document No

IBBAB 021016-1

Datum-Date

2008-02-08

Page 5 Identitet-Identity

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By pushing the footswitch to the bottom, "kick-down" and releasing it you get normal Auto-start operation. A light push and release in Auto-start brings it back to the "Pedal" state and the forceps can be used for other tasks like dissection etc. For laparoscopic purposes a special version of the footswitch can be supplied. This version has the kick-down feature mechanically interlocked so it cannot activate the Auto-start. The footswitch must not be used together with the Coa-Comp "hose cable".

3.4

Advices and Hints. • Take a loose grip on the tissue! The current shall pass through the tissue, between the forceps points. If you hold too tight you will most likely get a short circuit and very little heating occurs. • Do not irrigate more than necessary to keep the tissue moist for physiological purposes. Dry tissue (skin for example) can be moistened with a few drops of saline if the Coa-Comp refuse to start. Fat does not conduct the current and cannot be coagulated either. • When using bipolar scissors, allow time for the heating to take place, i.e. cut slowly. The Coa-Comp will start and stop repeatedly during the cutting procedure until all tissue is cut and coagulated. • When using bipolar scissors, (with or without the Coa-Comp "hose cable") the Coa-Comp may make brief "beeps" also when the scissors are laying aside. These beeps are due to blood or moist between the cutting edges or the joint between the two parts of the scissors. Cleaning the blades and putting aside with the scissors open will usually help. If still beeping briefly and you do not need the scissors for a while one of the cable sockets can be detached from the scissors. • Try to route the forceps/scissors cable in a way that it does not come close to monopolar electrode cables (that can cause monopolar RF-currents to leak over to the forceps) or other cables. This also avoids mixing up Coa-Comp cable with other cables. • When using bipolar instruments like bipolar scissors (either for open surgery or laparoscopic surgery) or bipolar laparoscopic forceps, faults in the instruments may cause leakage currents or even totally shorted circuits. Coa-Comp, unlike other bipolar coagulators, react on such faults and alerts the operator by lighting the blue led and beeping (when activated by the footswitch or if in Auto-Start) even if nothing is between the prongs or jaws. A short circuit will also cause the "Test OK" message to show up. Hence anytime the Coa-Comp beeps when it should not the cause of this need to be investigated. Using instruments with high leakage currents or intermittent shorts cause unpredictable results. • The normal beep-generator in the Coa-Comp sounds with a tone height of accented a, i.e. 880 Hz. By pushing both up- and downarrow buttons simultaneously when switching on *) the Coa-Comp this fixed tone height beep is replaced by a beep that is proportional to the tissue impedance. This can be of help for example in laparoscopic hysterectomy where

Instructions Dokument nr/Document No

IBBAB 021016-1

Datum-Date

2008-02-08

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large amounts of tissue is coagulated and the surgeon can learn to judge the efficiency of the procedure by listening. It is also useful for general training with the Coa-Comp. *) The Coa-Comp "reads" the buttons just prior to the display of the "Test OK" message.

4.

Forceps, Scissors and cables. • Coa-Comp/M can be used with common bipolar instruments that can be found on the market. • Forceps with insulated handles are preferred since they are less up to start the Coa-Comp/M by just being hold with wet hands or by laying on a wet surface. Symmetric forceps cables are best. Avoid type "coaxial" cables as they are unsymmetrical and can increase RF-leakage currents. • Avoid using too long forceps cables (> 3.5 m) as the possibility of RF intereference from and to other equipment can increase. See also technical manual for information on electromagnetic compatibility, technical data chapter. • Two pin plugs with US standard center to center distance of 28.6 mm are the preferred type of connector for the Coa-Comp/M end of the cable. IBBAB can supply such cables. If 4 mm banana plugs are used then it is recommended to have the isolated type of banana plugs. • When doing laparoscopic surgery the same rules apply for selecting the forceps as in open surgery: Use broad forceps for coagulating large vessels. For maximum capacity 3mm laparoscopic forceps are recommended. • The Johnson and Johnson "Power star" series of bipolar scissors have been extensively tested with the Coa-Comp and are the recommended type for open surgery. They are available in a standard range and a fine range. The latter have the insulation to cover more of the blades. This can be important when operating in confined surgical sites (thyroid surgery, tonsillectomy etc.) to avoid the RF currents reaching places it should not. By using the Coa-Comp "hose cable" one has also a pair of forceps at hand for extra haemostasis, see paragraph 5..

5.

Coa-Comp "Hose cable", (Part no IBBAB 981027-1) • Coa-Comp Hose cable must be used with Coa-Comp/M the Auto-Start must be activated. Footswitch must not be connected.

only and

• Coa-Comp Hose cable can be used with common bipolar forceps with German type 4 x 7 mm rectangular flat-tab connector (Bowa, Select-Sutter, Erbe, Rudolf etc) and a pair of Bipolar scissors from the Ethicon PowerStar® Series (there are different sizes and models). • The cable connects the instruments in parallel to the diathermy voltage and therefore the forceps and the scissors shall be used one at a time. If both are used at the same moment (i.e. two surgeons) the performance becomes unpredictable (uneven coagulation/cutting) as the diathermy current then is shared between the two instruments. If the instruments

Instructions Dokument nr/Document No

IBBAB 021016-1

Datum-Date

2008-02-08

Page 7 Identitet-Identity

(ccmsys;D42E)ccmanu2.xco;2

also are used in close proximity to each other and they are used at the same moment one can also get uneven heating because of some current passing from one of the forceps points to one of the scissors blades and vice versa. • Before surgery starts: The assistant hands over the two-prong connector end of the sterile cable to the nurse standing by the Coa-Comp. This nurse then pushes the connector in place and activates the Auto-Start (blinking light). From now on the cable and the instruments are active and they should be treated accordingly. The assistant then connects the forceps and the scissors to the other ends of the hose cable. When this is done the forceps and the scissors shall be tested in turn. Follow the procedure in paragraph 2.5. The required short circuiting of the scissors is done by closing them and holding a clamp around the scissors blades. • The power setting on the Coa-Comp(/M) is selected from experience and depending upon the sizes of the scissors and forceps (a start setting of 8 for the smallest instruments and 16 or 18 on the bigger is recommended). The scissors both cut and coagulate and as the coagulation takes some time it is important to allow for this to elapse. If the cutting is done too fast there will not be enough coagulation and a risk of bleeding. • When not in use place the scissors and forceps with the blades and prongs respectively, pointing upwards on a dry, non conducting and fully visible place, not directly on the skin of the patient. Before putting it aside open the scissors blades fully and wipe them off as needed to prevent the Coa-Comp from sounding the short beeps (when trying to coagulate nothing but some remaining blood or saline solution between the blades). If needed one of the connectors can be detached temporarily from the contact pins of the scissors.

6.

Warnings. • When not in use never place the bipolar forceps or bipolar scissors on the patient bare skin. It is preferable that the forceps be placed in an insulated container or on a dry cloth on the assistant table. The bipolar scissors that are best stored in open position, see chapter 3.4 can be placed on a dry cloth also. Unexpected "beeps" from a Coa-Comp shall always be investigated ! • The use of flammable anaesthetics and nitrous oxide (N2O) and oxygen should be avoided if a surgical procedure is carried out in the region of the thorax and the head, unless these agents are sucked away or anaesthetic-proof equipment is used. • Flammable agents used for cleaning or disinfection or as solvents of adhesives should be allowed to evaporate before the application of RF-surgery. There is a risk of pooling of flammable solutions under the patient or in body depressions such as the umbilicus and in body cavities such as the vagina. Any fluid pooled in these areas should be mopped up before the equipment is used.

Instructions Dokument nr/Document No

IBBAB 021016-1

Datum-Date

2008-02-08

Page 8 Identitet-Identity

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• Attention should be called to the danger of ignition of endogenous gases. Some materials, for example cotton wool and gauze when saturated with oxygen may be ignited by sparks produced in normal use of the equipment. • A pacemaker can be disturbed by the Coa-Comp/M if the pacemaker electrodes or leads are touched with the forceps. Otherwise there will be no problems with pacemakers and the Coa-Comp can be used for haemostasis when inserting or removing the pacemaker. For further information consult your Biomedical engineer. • TV-equipment and similar instrumentation will not be disturbed by the Coa-Comp but there is a small risk that some other equipment may be disturbed.

7.

Cleaning, Maintenance. • Coa-Comp/M can be cleaned with pads soaked with common cleaning agents. Make sure that no liquid penetrates the unit while cleaning it. • If the footswitch is put in a plastic bag when in use, cleaning is simplified a lot. • To disassemble the footswitch for cleaning etc.: Put the footswitch on a table with the pedal towards you. place the palm of your hand on the pedal and grip with your fingers inside the cable bracket. Squeeze your hand, this will release the cable bracket from the rest of the footswitch. When assembling again watch the wire spring that give the return force for the pedal and also holds the cable bracket in position. The foot-switch mechanical parts can be washed and rinsed more thoroughly while the connector end of the cable assembly has to be kept away from the water. • Instruments and cables are cleaned and sterilized according to the instructions supplied with them. Here are also some general advices: When used as intended diathermy cables and instruments are more or less subject to wear depending on the intensity of use. This kind of wear is caused by technical factors and cannot be avoided. Therefore carry out a visual examination prior to each application of the cable and instruments. If there are any visual defects, do not use them and report according to the rules of your hospital. If the insulation is defective there is a risk of unwanted current leakage that could cause burns or interference with other instruments or medical devices. • Coa-Comp Hose cable: Disconnect forceps and scissors from the cable after the surgery and clean them immediately in dishwasher/disinfector. Watch out for sharp edges that could damage the insulation ! Max temp 95°C. It is also possible to handwash the cables (use a mild cleaner) and wipe with an alcoholic surface disinfectant. Before the sterilisation takes place the cable shall be dry. Pay special attention to the forceps and scissors connectors where water is likely to remain.

Instructions Dokument nr/Document No

Page 9

Datum-Date

IBBAB 021016-1

Identitet-Identity

2008-02-08

8.

Front and rear panels

8.1

Front panel controls and indicators.

(ccmsys;D42E)ccmanu2.xco;2

(1)

A light emitting diode indicates switched on and supplied by the mains.

that

Coa-Comp/M

is

(2)

With "Auto-Start"

(3)

"HF Out"

(4)

In the display-window a message of 8 letters/numbers can be shown.

(5)

With this knob the volume of the indication (warning) sound can be changed.

(6)&(7)

With the yellow buttons power can be changed. (6) Increases the power, one step per push. (7) decreases the power.

(8)

From these banana-jacks come the current to the forceps.

the unit is made active.

blinks or lights when current is output.

Instructions Dokument nr/Document No

Datum-Date

IBBAB 021016-1

8.2

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Rear panel controls and indicators.

(9)

Connector for the pedal.

(10)

Equipotential connector . Ask your service department if this shall be used.

(11)

Mains switch.

(12)

Mains voltage selector. Check before operating in a new place. For 110 - 120 VAC use 1AT fuses (14), for 220 - 240 VAC use 800 mAT fuses.

(13)

is the power inserted.

(15)

Push these tabs to remove "drawer" for replacing fuses.

inlet.

Check

that

mains

cord

is

fully

Instructions Dokument nr/Document No

Datum-Date

IBBAB 021016-1

8.3

2008-02-08

Identitet-Identity

(ccmsys;D42E)ccmanu2.xco;2

Various symbols used. Symbol

Class I

9.

Page 11

Description 1

Attention! Read instructions.

2

Type cardiac float. Defibrillator protected.

3

Forceps connection, see (8) on the front.

4

Volume control, see (5) on the front.

5

Footswitch connection, see (9) on the rear.

6

Equipotentiality, see (10) on the rear. 7

Shall be operated from a protective earth mains outlet.

Technical data Input, supply: • Two versions: a) Rated voltage 110 - 120 VAC/220 - 240 VAC (switch selectable), 50 - 60 Hz. b) Rated voltage 100 VAC, 50-60 Hz. • Input power: 20 VA at stand-by, 90 VA at 40 W output. Output: • Coagulation voltage (512 +/- 0.05) kHz. • Constant voltage source with current limitation. • Max output is 40 - 44 W. Settings: • Settings are indicated by the figures 2, 4, 8, 16 and 40 on the display respectively. • Coagulation time 0.2 - 5 seconds depending on power setting, vessel size, forceps size. • Default power setting is 16 (factory setting). • A custom adapted default setting is achieved after more than four hours in auto-start at same setting. (Except for highest setting). This function can be blocked in later version, ask the supplier. Connections: • Power inlet is IEC type for plug according to CEE22/V. • Power outlet is 2 x 4 mm banana jacks for uninsulated or insulated banana plugs of make MC. Center to center distance is 29 mm. Environmental conditions: • Ambient temperature min 0 C max +40 C operating. Min -30 C max +60 C storage and transport. • Humidity max 90 % relative, operating, and no condensation allowed. • Cover and panels stands cleaning with normal hospital cleaning agents. Mechanical: • Width x deep x height: 155 x 200 x 100 mm excluding handle. Handle is 50 mm high. • Weight: 2.6 kg

Instructions Dokument nr/Document No

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Datum-Date

IBBAB 021016-1

Identitet-Identity

2008-02-08

(ccmsys;D42E)ccmanu2.xco;2

Control system: • 8 figure alpha numeric display, different languages can be factory selected for alpha numerics. • Warning beep for HF power out has 880 Hz frequency (factory default). Sound frequency proportional to impedance can be set as an alternative . Volume regulated by knob on front panel. • Emergency beep generator (if processor fails) has frequency 1000 Hz (+/-200) • Auto-Start button, Power up and power down are the three control buttons. • Maximum coagulation time if no minimum is detected: 5 seconds. Footswitch: • Weight: 1.2 kg including cable. Measures: L x W x H =200 x 95 x 120 mm. Actuating force: 10N < "Light push" < 20N. 50N < "Kick down" < 100N Hose cable: • Reusable silicon rubber type. Coa-Comp (proximal) end has plug with 2 off 4 mm banana pins with center to center distance of 29 mm. Cable length total: 3000 mm. • Forceps plug fits German 4x7 mm rektangular connector. Scissors plug fits Ethicons Bipolar scissors. • Steam autoclavable at 134 C.

10.

Contact information. The Coa-Comp/M Bergdahl AB.

is

manufactured

Company address: Hällesås Phone: +46 31 910787 Fax: +46 31 911414 E-mail: [email protected]

11.

byväg

and sold 31,

by

427

Ingenjörsfirman 51

Billdal,

Björn

Sweden.

What version of the instructions is for what version of the Coa-Comp/M ? There are different versions both of the Coa-Comp/M hardware and software. This edition of the instructions are for Coa-Comp/M's displaying "Rev 2D OK" at start up. For finding out differences regarding other versions and for obtaining instructions for other versions, please contact Ingenjörsfirman Björn Bergdahl AB or the company from which you obtained the Coa-Comp/M.