APC 300 Handbook Standard Version V2.xx May 2005

Contents

Chapter

Title ... Page

1

How to Use these Operating Instructions? Intended Purpose of APC 300. ...1

2

Notes on Safety ... 1

3

Notes on Safety in the Medical Specialties ... 1

4

Installation ... 1

5

Changing Cylinders ... 1

6

Description of the Front and Back Panels ... 1

7

Description of the Graphical Interface of the APC 300 ... 1

8

Connection and Actuation Configurations for ERBE Electrosurgical Equipment in Conjunction with the APC 300 ... 1 ICC 200

1. Configuration

APC probe for flexible endoscopes ... 1

2. Configuration

APC handle for APC and ARGON CUT ... 4

ICC 300 1. Configuration

APC probe for flexible endoscopes ... 7

2. Configuration

APC handle for APC and ARGON CUT, electrode handle for CUT and COAG with two buttons, instrument for BIPOLAR COAG ... 10

ICC 350 1. Configuration

APC probe for flexible endoscopes ... 14 ICC Software V. 1.06 and V. 1.07

2. Configuration

APC handle for APC and ARGON CUT, electrode handle for CUT and COAG with two buttons, instrument for BIPOLAR COAG ... 17 ICC Software V. 1.06 and V. 1.07

3. Configuration

APC handle for APC and ARGON CUT, electrode handle for CUT and COAG with two buttons, instrument for BIPOLAR COAG (This actuation configuration differs from number 2) ... 20 ICC Software V. 1.07 only

4. Configuration

APC handle for APC and ARGON CUT, instrument for BIPOLAR COAG and BIPOLAR CUT ... 23 ICC Software V. 1.07 only

ACC 450 1. Configuration

APC probe for flexible endoscopes ... 33

2. Configuration

APC handle for APC and ARGON CUT, electrode handle for CUT and COAG with two buttons, instrument for BIPOLAR COAG ... 37

9

Troubleshooting ... 1

10

Cleaning, Disinfecting and Sterilizing ... 1

11

Maintenance ... 1

12

Service and Warranty ... 1

13

Technical Data, Standard Parameters Programmed by ERBE ... 1

14

Information on Electromagnetic Compatibility (EMC) ... 1 Addendums: Notes on using electrosurgical devices of other manufacturers in combination with the APC 300 Literature Glossary Addresses

Purge

user programs

user Flow adjustments Priority cylinder number Sound level adjustment

General cylinder information Change cyl. data

Screen brightness Instrument purging parameters

2

How to use the APC 300 Operating Instructions. Intended Purpose of the APC 300 • 1

CHAPTER 1

How to Use these Operating Instructions. Intended Purpose of the APC 300

Do I have to read all of the Operating Instructions?

These operating instructions are very extensive. There are several reasons for this: the APC 300 can be used in many medical fields. The equipment can be combined with a number of electrosurgical devices and instruments. Lastly, the user can adapt the software of the equipment to his own requirements, although it is not always necessary to do this. So in order to work safely and effectively with the APC 300, it is not necessary to read every chapter of the operating instructions. Please proceed as follows:

Preparation

• Please first read the Notes on safety and the Notes on safety in the medical specialties: CHAPTER 2 and 3 à. • If it has not already been done, carry out the electrical Installation: CHAPTER 4 à. • Connect the argon gas cylinders: CHAPTER 5 à. • Make yourself familiar with the operating elements: Foldout 1, CHAPTER 6 à.

Quick start

• If you wish to begin working with the APC 300 as soon as possible and not preoccupy yourself with the equipment's additional functions: First read Quick start: CHAPTER 7 à. • Then select a suitable Connection and actuation configuration. Implement it step by step: CHAPTER 8 à.

Additional functions

• If you wish to adapt the equipment to your particular needs, perhaps to program and store your own COAG flow or CUT flow parameters for one of the application programs: Read the section entitled Additional functions of the APC 300: CHAPTER 7 à. Foldout 2 can help you.

Intended purpose of the APC 300 The APC 300 is an argon plasma coagulator. It is designed for argon plasma coagulation and argon-enhanced cutting in combination with ERBE HF surgical units, ERBE APC applicators, and APC probes. The APC 300 can be used in many medical disciplines. These include open surgery, flexible endoscopy, and bronchoscopy. The range of applications is constantly increasing.

1

1 • How to use the APC 300 Operating Instructions. Intended Purpose of the APC 300

2

Notes on Safety • 2

CHAPTER 2

Notes on Safety

This chapter contains general notes on safety. For safety notes relating to special applications or special fields of application, please refer to CHAPTER 3 à. Safety instructions marked with an exclamation mark (!) should always be read before using the APC 300.

WARNING! The safety instruction WARNING denotes a danger which can cause damage to persons.

CAUTION!

The safety instruction CAUTION denotes a danger which can cause damage to property.

ATTENTION

The safety instruction ATTENTION denotes a danger which can cause failure of the device.

Argon Plasma Coagulation, a safe and learnable technique Safety of the method

Argon Plasma Coagulation (APC) is a high frequency surgical method. When used according to instructions and safety notes, APC does not represent a danger either to users, patients or to the environment.

Safety role of medical personnel

Working with high high frequency voltages and compressed argon always holds certain risks for medical personnel and patient. Design precautions alone do not suffice to completely rule out risks. The safety of the APC does not depend only on the equipment. Safety is dependent to a large extent on factors which are in the hands of the user. These factors are discussed in the safety notes and warnings of this chapter.

Safety of the equipment

APC 300 and ERBE electrosurgical equipment meet all relevant generally recognized rules of technology as well as the applicable work safety and accident-avoidance regulations. The combination of the APC 300 and one of the electrosurgical units listed below together with an ERBE APC applicator is a well-thought-out system of interrelated elements. This is especially true of the level of electrical safety, the pneumatics, argon dosage, error monitoring, error messages, and protection against operating errors and confusion. These operating instructions represent an important component in the safety concept. Only instruments and accessories authorized by ERBE Elektromedizin should be used. Otherwise ERBE Elektromedizin cannot be held in any way responsible.

1

2 • Notes on Safety

The following electrosurgical units are suitable for use in conjunction with the APC 300: ERBOTOM ACC 450 ERBOTOM ICC 200 ARGON COAG ERBOTOM ICC 300 ERBOTOM ICC 350

Instructions, training of medical personnel Who should read these operating instructions?

All those involved in preparing, setting, working with, stripping down, cleaning or disinfecting the equipment and instruments should read the operating instructions of the APC 300 and the notes on the use of the instruments. Please pay particular attention to the notes on safety and the warnings contained in each chapter.

Reading the operating instructions of the electrosurgical equipment

Operation of the electrosurgical equipment is not the subject of these operating instructions. Aside from the following notes on safety, all safety regulations concerning monopolar HF surgery apply to argon plasma coagulation. This is particularly the case for the correct handling of the neutral electrode. It is imperative that you refer to the notes on safety contained in the operating instructions of the electrosurgical equipment.

Training

The APC 300 may only be used by persons who have been given training in the correct use of the APC 300 or the combination of appliances (APC 300 electrosurgical equipment, instrumentation) which has taken these operating instructions into consideration. Training may only be conducted by persons whose knowledge and practical experience qualify them to do so. ERBE Elektromedizin GmbH cannot be held responsible for damage caused by improper usage. If anything is unclear or questions arise, please contact an ERBE employee or the ERBE office nearest to your location. We will be glad to help you and appreciate comments on these operating instructions.

Safety precautions against the threat of electric shocks The APC 300 complies with the requirements of type CF (cardiac floating) according to EN 60-601-1 and it has a patient leakage current of less than 10 µA. The APC 300 is protected against defibrillator voltages. Mains lead, mains socket

WARNING! Only connect the APC 300 using the mains lead supplied by ERBE, or one of at least the same quality, to a faultlessly installed grounded socket. If you use an equipment trolley, this applies to the mains lead of the trolley. The mains lead must bear the national mark of conformity. For safety reasons multiple sockets and extension leads should not be used. If their use is unavoidable, they, too, must be provided with faultless protective grounding.

2

Notes on Safety • 2

Mains fuses

WARNING! The unit is protected by mains fuses. If one of these fuses blows, the unit must not be used on patients until it has been checked by an experienced technician. Only replacement fuses of the rating specified on the unit's name plate may be used.

Potential equalization

Connect the potential equalization pins of the electrosurgical unit and the APC 300 to the equipment trolley via potential equalization conductors. Connect the potential equalization of the equipment trolley to the potential equalization of the operating theatre.

Visual check of the electrical insulation

WARNING! A high frequency voltage of several thousand V is needed to ionize argon. Check that there is no visible damage to the electrical insulation of the applicators and all leads prior to every use.

Environment Ambient temperature, humidity

ATTENTION: The APC 300 can be operated at a room temperature of between 10 and 40° C. The effective humidity can be between 30 and 75 %, non-condensing. If these tolerances are exceeded either way, the unit may break down. ATTENTION: If the APC 300 has been stored or transported at temperatures below +10° C, or especially below 0°, the equipment will require about 3 hours to acclimatize to room temperature.

Ventilation

ATTENTION: The APC 300 must be set up in a way that permits air to freely circulate around the case. The unit must not be set up in narrow niches or shelves.

Protection against moisture

CAUTION! The APC 300 is protected against penetration by liquids according to EN 60-601-2-2 . The case is not absolutely watertight. For this reason, do not set up the unit in the direct vicinity of tubes or vessels containing liquids. Do not place any liquids on the APC 300.

Portable and mobile communication equipment HF

Portable and mobile communication equipment HF can influence the device.

Caution when handling argon cylinders No force of any kind

Argon is a non-flammable, non-toxic, physiologically inactive, odorless and colorless noble gas. WARNING! No force of any kind should be exerted on cylinders, cylinder connections or pressure reducers. Protect the argon cylinder by means of chains, straps, or safety belts from tipping over or falling during transport, storage and use.

Pressure reducer

WARNING! Argon cylinders may only be transported with valve protection (cylinder cap) in vertical position and secured in place.

Confusion

WARNING! Argon cylinders may only be connected to the APC 300 with the pressure reducers and hoses provided by ERBE.

3

2 • Notes on Safety

WARNING! The APC 300 may only be operated with argon. A cylinder containing a dangerous gas could be connected to the cylinder connection of the unit. Check each cylinder to ensure that it really does contain argon: identification must not be damaged or missing. Danger of suffocation: uncontrolled argon flow

WARNING! Argon build-up in the air being breathed can cause suffocation. Symptoms are drowsiness, rising blood pressure and breathing difficulties. In an atmosphere of pure argon, sudden loss of consciousness and suffocation occur without prior warning. When the APC is used in the manner intended the concentration of argon in a room reaches about 1% in a room measuring 6m x 6m x 3m in 100 min. this argon/air mixture is completely harmless. A short hissing noise will be heard when the gas valves are opened due to the argon flowing in the hoses. If this hissing continues for longer than 2 sec. when a cylinder is opened, there is a leak and the argon cylinder must be closed again immediately. The unit may not be used until the leak has been rectified. Make sure that the hoses are faultlessly (tightly) connected to the APC 300 and the gas cylinder. This also applies to the connection of the pressure reducer to the argon cylinder.

Precautionary measures

Close the safety valves of the argon cylinders after use.

Operating errors, confusion, disregarding error messages

4

Operating errors

WARNING! The APC 300 possesses an instrument identification facility which assigns to each instrument appropriate CUT flow and COAG flow values (l/min) for the application. The set values can naturally be altered within limits. If an insufficient flow rate is selected, the applicator can sustain damage. Read CHAPTER 7: Description of the graphical interface of the APC 300 à.

Confusing actuation switches and actuation signals

WARNING! A large number of different instruments can be connected to the APC 300 or to the electrosurgical unit, e.g. for cutting, bipolar cutting, coagulation, bipolar coagulation and for argon plasma coagulation. Depending on the actuation concept and setting, these can be activated via foot and/or finger switches. Do not confuse the actuation switches and actuation signals. Read CHAPTER 8: Actuation concepts à. Please comply at all costs with the settings and connections described. If in doubt, check which instrument is actuated by which key and which pedal! Never place instruments on the patient or in the immediate vicinity of the patient.

Disregarding or falsely interpreting error messages

WARNING! The APC 300 is equipped with an error recognition and error reporting system. Take note of visual and audible error indications. Do not set the volume of the actuation signals for COAG, CUT and PURGE too low.

Do not use laser safety goggles

It is possible that the APC 300 display may no longer be visible with laser safety goggles.

Notes on Safety • 2

Dangers associated with argon plasma coagulation Argon Plasma Coagulation is a monopolar high frequency surgical method i.e., high frequency current flows through the patient's body to the neutral electrode, as is generally the case in monopolar electrosurgery. Burns, damage to tissue

WARNING! All safety regulations concerning monopolar high frequency surgery are applicable. One must therefore particularly ensure in endoscopic applications that adjacent tissue structures are not inadvertently damaged thermally by uncontrolled high frequency currents. The active electrode must not directly contact the tissue, as this could trigger the cutting effect and lead to uncontrolled coagulation of the contacted tissue.

Danger of explosion of endogenic gases, particularly in the colon

WARNING! When performing electrosurgery on the gastrointestinal tract, no flammable or potentially explosive endogenic gases must be present. Particular care is required during the resection or coagulation of tumors obstructing the colon using an HF loop or argon plasma coagulation. Flammable gases must be suspected behind every stenosis in the colon. Be certain to flush out at-risk sections of the intestine with CO2 or argon before activating the electrosurgical unit or argon plasma coagulator.

Danger of fires in the tracheobronchial system

WARNING! Argon gas is non-combustible. It does not cause fire in burnable materials or help them to burn. The high temperature of argon plasma, on the other hand, can cause easily burning materials to ignite if oxygen or other burnable gases are nearby or are mixed with argon when applied to these materials (for example plastic insulation at the distal end of the bronchoscope or a tracheal tube). This is especially true of highly concentrated or pure oxygen. For this reason, please always observe the following rules: 1. Never permit oxygen or other combustible gases or fluids to enter the tracheobronchial system before or above all during APC in the tracheobronchial system. 2. When using APC in the tracheobronchial system for more than a few seconds, alternate oxygen ventilation of the patient with APC, that is, use them in turns. 3. Always keep the distal end of the APC applicator in view in the endoscope before and during activation of the argon plasma. Never activate argon plasma if you cannot see the distal end. Please read the special notes on this topic in CHAPTER 3: APC in flexible endoscopy, APC in bronchoscopy à.

Gas embolisms, gas emphysema

WARNING! The use of Argon Plasma Coagulation units during laparoscopy has been associated with gas embolisms in a small number of cases. The use of argon should be limited to those situations where the advantages outweight the risks. To avoid gas embolisms, the argon flow rate should not be set so high that argon is blown into open vessels. To avoid gas embolisms and emphsema, do not direct the distal end of APC applicators toward open vessels or press against tissue.

5

2 • Notes on Safety

Pressure rise in body cavities

WARNING! When applying APC in body cavities, it is imperative to ensure that the endoluminal gas pressure does not rise excessively.

Maintenance The APC 300 should be safety-checked at least once a year. Alterations and repairs may only be performed by ERBE or by persons expressly authorized by ERBE.

Portable and mobile communication equipment HF ATTENTION: Portable and mobile communication equipment HF can influence the device.

6

Notes on Safety in the Medical Specialties • 3

CHAPTER 3

Notes on Safety in the Medical Specialties

Argon Plasma Coagulation in Flexible Endoscopy Electric insulation of the endoscope

WARNING! For Argon Plasma Coagulation (APC) use only endoscopes whose electric insulation is absolutely reliable both exteriorly and in the instrument channel. Defective or inadequate insulation can cause patient burns.

Training

The APC 300 may only be used by persons who have been given training in the correct use of the equipment or the combination of appliances (APC 300electrosurgical equipment) which has taken these operating instructions into consideration.

1. Installation, connection and actuation configuration

Please read the operating instructions for the electrosurgical equipment and CHAPTERS 4 and 8 of this handbook à.

2. Preoperative Test of APC probe function

Check the function of the APC probe as follows before inserting it into the working channel of an endoscope: 1. Hold the tip of the APC probe approx. 3-5 mm from a non-insulated, bare metal object. This must not have any electrically conductive contact with the patient, other people or electrical appliances. 2. Activate the APC unit. 3. Note whether argon plasma develops between the probe tip and the metal object. WARNING! Do not touch the tip with bare fingers when it is activated!

Figure 1: Test of APC Probe Function

3 - 5 mm

1

3 • Notes on Safety in the Medical Specialties

3. Insert APC probe into the endoscope

Insert the APC probe into the working channel of the endoscope until the distal end emerges at least 10 mm from the distal end of the endoscope. This is indicated when the first black ring on the distal end of the probe is seen to emerge from the endoscope.

Figure 2: The distal end of the endoscope with the first black ring

4. Select power limitation

Power should be set as low as possible:

The recommended dosages as noted above apply for ERBE electrosurgical units ICC 200, 300, 350. Of course the physician takes the final responsibility in each case.

5. Application of the APC probe

• WARNING! When performing electrosurgery on the gastrointestinal tract, no flammable or potentially explosive endogenic gases must be present. Particular care is required during the resection or coagulation of tumors obstructing the colon using an HF loop or argon plasma coagulation. Flammable gases must be suspected behind every stenosis in the colon. Be certain to flush out at-risk sections of the intestine with CO2 or argon before activating the electrosurgical unit or argon plasma coagulator. • The distal end of the APC probe should be not less than 3 mm and no more than 5 mm from tissue to ensure safe ignition and application of the argon plasma.

2

Notes on Safety in the Medical Specialties • 3

• Never activate the APC probe while it is in contact with tissue. • Never press the distal tip of the APC probe against an organ wall before or during activation. 6. Prevention of excessive argon insufflation within the GIT or TBS

During APC, distention of the organ being treated can cause discomfort to the patient. To avoid this: • Set the argon flow rate as low as possible. • Apply repeated suction if using a single-channel endoscope. • Apply continuous or interrupted suction through the second channel if using a double-channel therapeutic endoscope. • Insert a deflation tube (3 - 5 mm ø) parallel to the endoscope, e.g. when using APC in the rectum. • Always monitor the patient’s abdominal wall tension.

7. Intraoperative cleaning of the APC probe's distal tip

Coarse crusts of debris or tissue on the tip of the APC probe may inhibit argon flow through the probe. In such a case, remove the APC probe and clean its tip with a wet swab. Before reinserting the APC probe into the endoscope, recheck its function as described under No. 2 above.

8. Postoperative cleaning, disinfection and sterilization of reusable APC probe

Thoroughly rinse the APC probe from proximal to distal as soon as possible after use with a suitable rinsing or disinfection solution. Also clean its exterior. The APC probes can be resterilized in autoclaves to 134 °C. (Where applicable)

3

3 • Notes on Safety in the Medical Specialties

The 10 Commandments of APC in Flexible Endoscopy

4

1.

You shall not confuse Argon Plasma Coagulation with Argon Laser. The two are completely different.

2.

You shall always test Argon Plasma ignition and the electric arc outside the endoscope before inserting the APC probe into the working channel.

3.

You shall insert the APC probe at least far enough into the endoscope’s working channel that the first distal black ring becomes visible.

4.

You shall always carry out Argon Plasma Coagulation (as long as you are not expert in its use) under visual control.

Notes on Safety in the Medical Specialties • 3

5.

You shall take care that the APC probe does not touch the organ wall during activation; however, your application shall be near enough to ensure Argon Plasma ignition. for ignition closer when ignited distance 3 to 10 mm

6.

You shall never press the activated probe into tissue or against the organ wall, since this can lead emphysema / wall damage.

7.

You shall not touch metal stents directly with the APC probe; here too, you shall, maintain an adequate distance.

8.

You shall avoid distentions caused by inflowing argon and shall therefore check and vacuum repeatedly and lay a decompression catheter if necessary.

5

3 • Notes on Safety in the Medical Specialties

9.

You shall set the power limit of the electrosurgical unit and the activation duration adequately according to wall thickness in the affected organ (e.g. an upper limit of max. 40 W in the right colon, but higher power for a large tumor, see Recommended Dosages).

1 - 2 mm!

10. You shall prefer many short-duration activations to few long-duration activations (as long as you are not an expert).

6

Notes on Safety in the Medical Specialties • 3

APC in bronchoscopy Emphysemas

WARNING! Argon plasma coagulation in a non contact procedure. Do not hold the distal end of the activated applicator against or insert it into tissue. Emphysemas can result.

Intraluminal gaspressure

WARNING! When using argon plasma coagulation, argon flows into the lumen of the organ. The intraluminal gas pressure increases if the argon cannot simultaneously escape from the lumen or is not extracted. Monitor the intraluminal gas pressure regularly.

Danger of burns

The high temperature of argon plasma can cause flammable materials to ignite if oxygen or other flammable gases are nearby or are mixed with argon when applied to these materials (for example plastic insulation at the distal end of the bronchoscope or a tracheal tube). This is especially true of highly concentrated or pure oxygen. for this reason, please observe the following rules:

WARNING!

• Never permit oxygen, other combustibel gases or fluids to enter the tracheobronchial system before or above all during APC. • When using APC for more than a few seconds, alternate oxygen ventilation of the patient with APC, that is, use them in turns. • Always keep the distal end of the APC applicator in view in the endoscope before and during activation of the argon plasma. Never activate APC if you cannot see the distal end.

Video interference

ATTENTION: Due to the relatively high-frequency voltages required for APC, interference can occur in video systems. Digital video systems are normally less sensitive to this interference than analog systems.

Cardiac pacemakers

WARNING! APC is a monopolar high-frequency surgical procedure in which high-frequency electrical current flows through the body of the patient to the neutral electrode (grounding pad). In case of doubt, when operating on a patient with cardiac pacemaker, consult the patient’s cardiologist concerning the risk involved using APC. This applies in particular to APC application in the thoracic region.

7

3 • Notes on Safety in the Medical Specialties

8