DIACAPSUTOM Instruction Manual Ver 10.05

EN ISO 9001 EN ISO 13485

Instruction manual

Art. no. 80172-081

DIACAPSUTOM

Art. no. 10743-000 Art. no. 10743-001 Art. no. 10743-002

All rights to this instruction manual, particularly the right to reproduction, distribution and translation, are reserved. No part of this instruction manual may be reproduced in any form (including photocopying, microfilm or other means), or processed, reproduced or distributed by means of electronic systems without prior written permission from ERBE Elektromedizin GmbH. The information contained in this instruction manual may be revised or extended without prior notice and represents no obligation on the part of ERBE Elektromedizin GmbH.

Printed by: ERBE Elektromedizin Printed in Germany Copyright © ERBE Elektromedizin GmbH, Tübingen 2005

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Contents

Chapter

Title ... Page

1

Intended use, safety instructions ... 9

2

Maintenance and care of the unit and accessories ... 10

3

Instructions on the use of high-frequency surgical units ... 12

4

Ambient conditions ... 14

5

Installation of the DIACAPSUTOM ... 15

6

Testing the performance ... 17

7

Working with the DIACAPSUTOM ... 18

8

Cleaning, disinfection, sterilization ... 21

9

Visual and acoustic error messages ... 22

10

Safety inspections ... 22

11

Conditions of the guarantee ... 23

12

Technical data ... 24

13

Information on electromagnetic compatibility (EMC) ... 27

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Figures ERBE DIACAPSUTOM

Fig. 1: DIACAPSUTOM front panel

Fig. 2: DIACAPSUTOM back

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DIACAPSUTOM operator controls 1 Power switch:ON/OFF switch for the power supply. 2 Symbol: Applied part Type BF 3 Symbol: "Attention, heed the instruction manual" 4 (See under 6) 5 Mode key. By using this key, the various operating modes or setting parameters can be selected. 6 +/A and -/B keys. Using these keys, program values and setup parameters can be changed. 7 Display. Indicates the following information to the user: • Setting values • Error messages • Using the softkeys +/A and -/B, the setup values can be changed. 8 Yellow LED (Bipolar). Lights up if the Diathermy 1 or Diathermy 2 is preselected. 9 Bipolar socket. Connecting socket for bipolar forceps and bipolar electrodes. 10 Capsulotomy socket. Connecting socket for capsulotomy electrode. 11 Yellow LED (capsulotomy). Lights up when the Capsulotomy operating mode is preselected. 12 ERBEBUS. This is a further developed interface system, which has a simple connecting cable. In this way it is possible to operate the DIACAPSUTOM via the footswitch on the ERBE ASPIMAT E. 13 Footswitch socket. Connection for single or dual-pedal footswitches. 14 Speaker. During activation, a corresponding activation sound is emitted according to the operating mode. 15 Power connection socket 16 Power fuses. The unit has 2-phase fuse protection.When replacing, make certain to check the fuse ratings. 17 Terminal for potential equalization

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Figures single-pedal footswitch and accessories

Fig. 3: Single-pedal footswitch (explosion-proof)

Fig. 4: Dual-pedal footswitch (explosion-proof)

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Fig. 5: Capsulotomy electrode with handle

Fig. 6: Bipolar forceps and coagulation probes

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Footswitch The unit may be activated via the explosion-proof, single-pedal footswitch (Art. nos 20711-008 and 20711-009) or the explosion-proof dual-pedal footswitch (Art. nos. 20743-003 and 20743-004). If activated via the dual-pedal footswitch, the operating mode may be preselected using the black pedal and activated with the gray pedal. CAUTION!

If the program is changed using the black pedal, this must be confirmed by pressing the black pedal again (protection against unintentional operating mode change).

Single-pedal footswitch, explosion-proof (Art. no. 20711-008) Single-pedal footswitch, non-explosion-proof, not shown. (Art. no. 20711-009) Dual-pedal footswitch, explosion-proof (Art. no. 20743-003) Dual-pedal footswitch, non-explosion-proof, not shown (Art. no. 20743-004)

Accessories • Handle with cable for capsulotomy electrode (Art. no. 20743-001) • Capsulotomy electrode (Art. no. 20743-002) • Bipolar forceps for closure of conjunctiva (pointed) compl. with cable (Art. no. 20739-017) • Bipolar forceps (angled, blunt) compl. with cable (Art. no. 20739-061) • Bipolar forceps (straight, blunt) compl. with cable (Art. no. 20739-062) • Endodiathermy probe with suction (Art. no. 20738-054) • Endodiathermy probe without suction (Art. no. 20738-060) • Bipolar coagulation probe (Art. no. 20738-064) • HF bipolar cable for Art. nos. 20738-054/-060/-064 and 20738-028 CAUTION!

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Only the accessories listed here may be operated on the ERBE DIACAPSUTOM

1. Intended use, safety instructions Intended use The ERBE DIACAPSUTOM is a high-frequency bipolar unit for diathermy and capsulotomy. It has the operating modes: Operating modes

• Diathermy 1 • Diathermy 2 • Capsulotomy The unit may be operated as a single unit or together with ERBE phako equipment.

Diathermy 1 and 2

1. Diathermy 1 and 2: Two programs for bipolar application (bipolar forceps, bipolar pin and endodiathermy. Different intensities may be preprogramed for various intstruments or different applications such as "Wet-Field" coagulation and conjunctival closure. This can be activated via the pedal or multifunction footswitch (ASPIMAT E) .

Capsulotomy

2. Capsulotomy: HF generator for performing HF capsulotomy with special electrode. The following characteristics are of particular interest in HF capsulotomy: • automatic cutting control, • automatic adaptation of HF current during various cutting phases, • minimal vapor bubble formation, • very solid capsulotomy edge, • clear view during cutting, • automatic cutting control, • very little sticking of the electrodes. This may be activated via the pedal or multifunction footswitch (ASPIMAT E).

Explanation of the safety instructions Make certain to read all safety instructions marked with an exclamation point before using the DIACAPSUTOM .

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WARNING!

The WARNING safety instruction indicates a danger which can result in injury.

CAUTION!

The CAUTION safety instruction indicates a danger which can result in property damage.

ATTENTION

The ATTENTION safety instruction indicates the danger which can cause functional failure of the unit.

Instructions for the user The DIACAPSUTOM conforms to all relevant, generally recognized technical rules, as well as the valid regulations for occupational safety and accident prevention. Only use accessories approved by ERBE Elektromedizin. If not, ERBE Elektromedizin assumes no responsibility. Who should read this instruction manual?

Everyone who prepares, adjusts, works with, dismantles, cleans or disinfects the unit and instrument set should read the DIACAPSUTOM instruction manual and the instructions for use for the accessories. Please pay particular attention to the safety instructions in every chapter.

Training

WARNING! The DIACAPSUTOM must only be used by persons who, under consideration of this instruction manual, have been trained in the proper handling of the DIACAPSUTOM or the unit combination (DIACAPSUTOM, accessories). Training may only be conducted by persons whose knowledge and practical experience qualify them to do so. ERBE Elektromedizin GmbH assumes no liability for damage due to improper application.

Questions, ERBE Customer Hotline

If anything is unclear or if you have questions, please contact an ERBE employee or your local ERBE business office, or use the ERBE Customer Hotline. We would be pleased to assist you and appreciate your suggestions regarding this instruction manual.

2. Maintenance and care of the unit and accessories Maintenance Maintenance of the unit and the reusable accessories includes preventive and corrective measures for servicing. Thus specified, regularly performed safety inspections (see Chapter 10) represent preventive measures, while changes and repairs can be summarized under the concept of corrective maintenance. Through regular maintenance of the unit, including the reusable accessories, the required status specified in the technical data should be maintained, and the functionality and safety should be guaranteed at least until the next maintenance deadline.

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Changes and repairs Safety inspection only by a service technician authorized by ERBE

Changes and repairs to the unit or accessories must not inhibit the safety of the patient, the user and the surroundings. This is considered to be fulfilled if the structural and functional characteristics have not been changed to the detriment of safety. Changes and repairs to the unit must only be performed by the manufacturer or by persons expressly authorized to do this by him in consideration of the special safety requirements for high-frequency surgical equipment. If nonauthorized persons perform incorrect changes and repairs to the unit or accessories, the manufacturer accepts no liability. In addition, the guarantee becomes void in this case.

Care of the unit Effective protection of the unit from damage also includes, in addition to correct operation and maintenance, safe setting up of the unit. Besides secure fixation of the unit to its base, this also includes its protection from moisture, contamination and contact with flammable or explosive materials. To ensure good radiation of unit heat resulting during operation, air circulation must not be impeded.

Care of the accessories To protect the accessories from premature wear, the following instructions must be observed: • Do not clean and store forceps with insulated branches together with other hard or pointy instruments, since the insulation may become damaged in this way. Do not bend the forceps branches apart since otherwise the coating may possibly chip off. • Electrode handles. Do not wind the electrode handle cable around the handle so that the cable is greatly stressed. • Do not carry the footswitch while holding by the cable. Do not wind the cable tightly around the footswitch. • Cable and plug. Do not roll up, kink or fold the cable. Pull the plug by the plug shaft - never pull the cable forcefully from the sockets on the highfrequency surgical unit. • Electrodes are best cleaned with a fine brush - moving from the connection end toward the front. Electrodes may also be cleaned in an ultrasonic bath or in the washing machine up to +95 °C. Please also observe the Notes on Use for the electrodes.

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3. Instructions for the use of high-frequency surgical equipment General information 1. The patient must not come into contact with metal parts that are grounded or have a substantial capacity at ground (e.g. operating table, brackets, etc.). Use of antistatic cloths is recommended for this purpose. 2. Skin-to-skin contact (e.g. between arms and body of the patient) should be prevented, e.g. by packing with dry gauze. 3. When using HF surgical and physiological monitoring equipment on a patient at the same time, monitoring electrodes that have no protective resistors or HF chokes should be attached as far as possible from the surgical electrodes. Needle electrodes are not recommended for monitoring. 4. The lines to the surgical electrodes should be arranged in such a way that they contact neither the patient nor other lines. 5. The power output should be set at the lowest possible value necessary for the intended purpose. 6. Use of explosive anesthetics, dinitrogen monoxide N2O (laughing gas) and oxygen should be avoided when operating in the area of the thorax or head, unless these agents have been suctioned off or a unit with anesthetic proof test is used. Flammable substances used as cleaning agents, disinfectants or solvents for adhesive should have evaporated before applying HF surgery. There is a danger that flammable liquids will collect beneath the patient or in bodily depressions such as the navel or bodily cavities such as the vagina. Liquid that has collected in these locations should be wiped away before using the unit. Warning should be given of the danger of ignition of endogenous gases. Materials such as cotton and gauze may be ignited by sparks occurring during intended use of the HF surgical unit if they are saturated with oxygen. 7. For patients with cardiac pacemakers or pacemaker electrodes, there is a risk that the pacemaker function may be disturbed or the pacemaker could be damaged. Monitoring such patients by means of measuring devices is recommended. In case of doubt, the cardiology department should be consulted. 8. The chance for disturbance of other electromedical equipment by operation of the HF surgical unit WARNING!

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Unintentional activation of a high-frequency generator can lead to burns on the patient if the active electrode hereby contacts the patient directly or indirectly through electrically conductive objects or wet cloths.

Unintentional activation of a high-frequency generator can be caused, for example, by: • Unintentional pressing of a footswitch pedal, • Short within a cable to the footswitch, • Penetration of electrically conductive liquids into a footswitch. Electrically conductive liquids are, for example, blood, amniotic fluid, urine, physiological saline solutions, irrigation liquids, etc., • Errors within the high-frequency surgical unit. To prevent burns to the patient due to unintentional activation of a highfrequency generator, the following rules for use should be observed: 1. Never lay active electrodes onto or next to a patient in such as way that they may contact the patient directly or indirectly through electrically conductive objects or wet cloths. 2. The lines to the active electrodes should be arranged in such a way that they contact neither the patient nor other lines. 3. Always set up the unit in such a way that acoustic signals may be heard well.

Instructions for bipolar application The bipolar surgical technique is especially suitable for thermal coagulation of blood vessels, i.e. for stopping hemorrhage. Here, the following complications may occur:

Adhesive effect During the coagulation process, the coagulum may adhere more or less firmly to the tip of the bipolar forceps, so that the coagulum is partially or entirely separated from the surrounding tissue when removing the electrode and the blood vessel is torn open by this.The adhesive effect primarily results due to thermal conversion of collagen into glucose and the rapid dessication of the more or less glucose-containing coagulum. To prevent the adhesive effect or at least keep it as minimal as possible, the HF current must be switched off as soon as sufficient coagulum is present, particularly because extending the time limit of the HF current beyond the point at which coagulation has occurred has no advantage. In addition, make certain that the bipolar forceps and electrodes are always clean, i.e. that no tissue remnants from previous coagulations adhere to the electrode surfaces. The adhesive effect particularly results when coagulating relatively dry tissue. In this case, sufficiently moistening the tissue to be coagulated with sterile water or physiological saline solution is recommended before coagulation.The blood flowing out of the vessel to be coagulated is not suitable for this purpose when stopping hemorrhage, because it also coagulates during the coagulation process. If the forceps or electrode adheres to the coagulum in spite of observing the above instructions, it should not be removed forcibly from the tissue but instead left for a few seconds on the

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tissue after switching off the HF current. Due to the capillary effect, tissue fluid flows from the coagulum surroundings to the marginal areas between the coagulum and forceps tips and stops the adhesive effect. If necessary, a drop of sterile water of physiological saline solution also helps.

Bursting of the coagulum If the high-frequency power is set too high during bipolar coagulation, the intensity of the HF current flowing between the bipolar forceps tips through the coagulum is so great that extreme vapor pressure results due to a sudden severe increase in temperature in the tissue, which tears apart the coagulum explosively.This undesirable effect can be prevented by the correct setting of HF power.

Nonapplication of the coagulation effect With every coagulation, the surface of the bipolar forceps is coated with bodily fluid. After the coagulation process, while the forceps are not being used, the tissue fluid dries off of the forceps surface and leaves behind an electrically insulating coating. If such a forceps is reused without removing this coating first, not enough HF current can flow, especially for dry tissue. It is therefore recommended that the bipolar forceps be cleaned with a moist sterile cloth between coagulations. After use, the bipolar forceps should be treated in accordance with Chap. 8, Cleaning, disinfection and sterilization of accessories. The unit has not been tested for defibrilation resistance. It is therefore essential that no DIACAPSUTOM applied parts be in contact to the patient during defibrilation.

4. Ambient conditions Operation CAUTION!

The DIACAPSUTOM should be operated at a room temperature between +10 °C and +40 °C.

Storage, transport CAUTION!

The DIACAPSUTOM should be stored and transported at a room temperature between -40 °C and +70 °C.

Portable and mobile communication equipment HF ATTENTION

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Portable and mobile communication equipment HF can influence the device.

5. Installation of the DIACAPSUTOM Spatial requirements High-frequency surgical equipment must only be operated in rooms intended for medical use which fulfill the appropriate requirements. The spatial requirements, regarding electrical installation, concern for example the grounded conductor system, the potential equalization and the ground fault interrupt system.

Set-up possibilities in the operating room In principle, the DIACAPSUTOM can be set up on tables, ceiling suspended or wall-mounted arm consoles, as well as on special equipment carts.

Power connection High-frequency surgical equipment must only be connected via the power cable supplied by the equipment manufacturer or of equal quality, labelled with the national test symbol, to properly installed, grounded plugs. In this case, no multiple power outlets or extension cords should be used if possible for reason of safety. If their use is unavoidable, these too must be fitted with a proper grounded conductor. The power outlet must be secured with a fuse of at least 10 A rated current.

Potential equalization Equipment used during intracardiac interventions must be connected to the potential equalization of the room. This is intended to prevent low-frequency electrical currents, e.g. low-frequency leakage currents from a defective grounded conductor system, from endangering the patient. Although the DIACAPSUTOM is not intended for intracardiac interventions, it has been equipped with a potential equalization connection pin on the rear panel of the unit to fulfill the safety requirement. In this way, the unit can be connected via a potential equalization line to a potential equalization connection in the room where it is set up.

Explosion protection High-frequency surgical equipment intentionally generates electric sparks between the active electrode and tissue. Electric sparks may also result within the unit. For this reason, high-frequency surgical equipment must not be used in potentially explosive areas. Considered potentially explosive is the area up to 20 cm above the floor and the area around and beneath the operating table, if flammable or explosive cleaning agents, disinfectants, anesthetics etc. are used. High-frequency surgical equipment is normally installed outside the zone designated as potentially explosive.

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WARNING!

Footswitches must be designed as explosion-proof if they are used in potentially explosive areas.

Protection from moisture The DIACAPSUTOM high-frequency surgical unit is protected against the penetration of moisture in accordance with EN60601-1. Nevertheless, this unit should not be set up in the vicinity of tubes or containers which contain liquid. Liquids should not be placed above or even on the unit. Only those single-pedal footswitches should be used which are watertight in accordance with EN 60601-2-2, § 44.6 aa.

Cooling The ERBE Diacapsutom must be set up in such a way that free air circulation around the housing is ensured. Therefore setting up in narrow corners, shelves etc. is not permissible.

HF disturbances High-frequency surgical equipment intentionally generates high-frequency voltages and currents. Therefore, care must be taken during set-up and operation that the function of other electromedical equipment cannot be disturbed. Note: The ERBE DIACAPSUTOM produces far less HF disturbance than conventional high-frequency surgical equipment, thanks to automatic regulation, which is particularly advantageous when used in combination with video monitors.

Setting the dialogue language Language

When switching on, continue pressing the +/A key. Appearing then on the display, for example, is: Deutsch A:â

B: Okay

Now you may select one of the languages Deutsch, English, Français, Italiano, Espanol, Polska, Portugues by repeated switching of the +/A key. By pressing the B key, the selected language is accepted. Now all texts appear in this language.

Programming the unit In the Diathermy 1 and Diathermy 2 programs, intensities can be programmed: 1. Keep tapping the Mode key until Diathermy 1 appears on the display. 2. Using the +/A und -/B keys, the required intensity can now be set.

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3. Change to Diathermy 2 using the Mode key 4. Now the required intensity can also be set using the +/A and -/B keys Important: The intensity values set remain stored until the next change. In the Capsulotomy program, the intensity need not be set, since the cutting control provides optimal power for every situation.

6. Testing the performance To check the functional readiness of the unit, the operator should carry out a performance test before every use. 1. If the DIACAPSUTOM is properly connected to the AC power supply via the supply cable, the pilot lamp in the power switch should be illuminated when the power switch is switched on. 2. Connect the bipolar forceps of bipolar electrode to the appropriate socket. 3. Bring this into contact with a wet sponge. 4. Activate the unit at the maximum power setting with the footswitch. During activation, an acoustic signal must be heard. 5. It is possible to verify with the help of a wet sponge whether high-frequency power is available at the bipolar output. If properly functioning, water vapor results as soon as both tips of the bipolar forceps or bipolar electrode contact the sponge. WARNING!

The DIACAPSUTOM may only be used when it functions properly in the test.

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Fig. 7: Guide the electrode slowly and evenly over the capsule within the required diameter. Set the electrode down carefully and tilt it slightly in the direction of pull.

Diathermy 1 MODE

Diathermy 2 MODE

MODE

Capsulotomy MODE

A: Setups

+/A

Volume 50 % MODE

Diath.1 max. 10 s MODE

Diath.2 max. 10.0 s MODE

Fig. 8: Flowchart for changing the set values (see page 20).

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MODE

Capsulot. max. 60 s

7. Working with the DIACAPSUTOM Procedure The DIACAPSUTOM can be activated via three possibilities: • Via the single-pedal footswitch, • Via dual-pedal footswitch, i.e. during the operation, nothing need be set on the unit. This means high operational convenience during surgery, • Via multifunction footswitch (ERBE phako equipment).

Putting into operation Once the bipolar forceps or bipolar electrode has been connected as described in the Performance test chapter and tested with the unit, proceed as follows: 1. Switch the unit on at the green master switch (1). The unit performs a self-check. When this has been successfully completed, a melody is heard and the unit introduces itself on the display with its name and software version. 2. Then the program that was last used appears. At the same time, the LED for the associated connecting socket and the intensity setting blinks on the display. By pressing one of the keys Mode A or the black pedal (dualpedal footswitch), this is acknowledged. 3. If work is to proceed at a different intensity, this can be changed accordingly using the +/A and -/B keys. 4. To change to a different program, the Mode key or the black pedal (dualpedal footswitch) is pressed. If the program is changed using the black pedal (dual-pedal footswitch), this must be acknowledged by pressing again. To activate, the gray pedal (dualpedal footswitch) is pressed.

Operating modes Working with the single pedal footswitch

1. Single-pedal footswitch: If working with the single-pedal footswitch, the operating mode can be repeatedly switched using the Mode key.

Working with the multifunction footswitch ERBE phako equipment

2. Multifunction footswitch ERBE phako equipment: The unit can be connected to ERBE phako equipment via the connecting cable (Art. no. 20720-019). It is activated using the black key. With the yellow key, the operating modes can be selected and acknowledged. CAUTION: If the ASPIMAT E is in a vitrectomy program, the yellow key is used to control the vitrectomy part.

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Working with the "Diathermy 1 and 2" programs

3. Diathermy 1 and 2: With these programs it is possible to store intensities for various instruments (e.g. bipolar forceps, bipolar pins or endodiathermy) or surgical steps. Using the Mode key or the black pedal (dual-pedal switch) the required program is selected and acknowledged. Using the +/A and -/B keys, the intensity is adjusted. The values remain stored in memory until the next change. It is activated using the gray pedal (dual-pedal footswitch).

Working with the "Capsulotomy" program

4. Capsulotomy: No power need be adjusted here, since the cutting control guarantees a uniform incision here. The program is selected or acknowledged using the Mode key or the black pedal (dual-pedal footswitch). For HF capsulotomy, the anterior chamber is filled with a viscoelastic solution. It is activated using the gray pedal (dual-pedal footswitch). Important: The electrode is moved slowly and evenly on the capsule in the required diameter. In this way a clean and smooth incision is achieved!

Changing the adjustment values (see also Page 18) Volume

Via keys +/A and -/B, the volume of the speaker (14) and the max. activation times can be changed. To change the volume, proceed as follows: 1. Tap the Mode key so many times until A: Setups appears on the display. By pressing the +/A key again, Volume xx% appears on the display. 2. Now set the required volume using the +/A and -/B keys. 3. Keep tapping the Mode key to return to the application program.

Activation time limit

An activation time limit can be set for every program. 1. Keep tapping the Mode key until A: Setups appears on the display. By presing the +/A key again, Volume appears on the display . 2. Keep tapping the Mode key so many times until the operating mode, the activation time limit of which is to be changed, appears on the display. 3. Now you can set the required activation time limit (from 0.1 seconds) using the +/A and -/B keys. 4. By pressing the Mode key again, you reach the Diathermy 2 program to set the time there. 5. Pressing again allows you to set the time for the capsulotomy. 6. By pressing the Mode key once again, you return to the application program. 7. To return to the necessary application program, the Mode key must be tapped an appropriate number of times.

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