PSD-30 ELECTROSURGICAL UNIT Instructions April 2005

Contents

Contents Labels and Symbols...

1

Important Information - Please Read Before Use...

3

Intended use...

3

Applicability of endoscopic treatment...

3

Instruction manual...

4

User qualifications...

4

Instrument compatibility...

4

Repair and modification...

5

Signal words...

5

Dangers, warnings and cautions...

5

Chapter 1

Checking the Package Contents...

12

Chapter 2

Nomenclature and Functions...

14

2.1

Symbols and descriptions...

14

2.2

Front panel...

17

2.3

Rear panel...

21

2.4

Foot switch (MAJ-811)...

22

2.5

S-cord (MAJ-813)...

23

2.6

P cord (MAJ-814)...

23

Installation and Connection...

24

3.1

Installation of equipment...

24

3.2

Connection to an AC mains power supply...

25

3.3

Connection of the foot switch...

26

3.4

Connection of the patient plate...

27

3.5

Connection of the S-cord (when using an endoscope with a S-cord

Chapter 3

connector mount)...

32

Connection of the A-cord...

33

Inspection...

35

4.1

Inspection of the power supply...

35

4.2

Inspection of the foot switch...

38

4.3

Inspection of the warning functions...

39

4.4

Inspection of the cut mode and output...

40

4.5

Inspection of the coagulation mode and output...

41

3.6

Chapter 4

ELECTROSURGICAL UNIT PSD-30

i

Contents

Chapter 5

Operation...

43

5.1

Turn the power ON...

44

5.2

Selection of cut mode...

45

5.3

Selection of coagulation mode...

46

5.4

Setting output...

47

5.5

Program mode...

48

5.6

Electrosurgery...

51

5.7

Stand-by mode...

53

5.8

Adjusting the volume...

55

5.9

Procedure after use...

56

Care, Storage and Disposal...

58

6.1

Care...

58

6.2

Storage...

59

6.3

Disposal...

59

Troubleshooting...

60

7.1

Troubleshooting guide...

60

7.2

Alarm functions...

69

7.3

Returning the electrosurgical unit for repair...

73

Appendix...

74

Construction...

74

System chart...

75

Operating environment...

77

Specifications...

78

EMC information...

86

Chapter 6

Chapter 7

ii

ELECTROSURGICAL UNIT PSD-30

Labels and Symbols

Labels and Symbols Safety-related labels and symbols are attached to the instrument at the location shown below. If labels or symbols are missing or illegible, contact Olympus.

Fuse rating FUSE T3.15AL250V

CE marking

Potential equalization terminal

Foot switch connector

Electrical rating Product name, rated voltage and current are displayed. Serial number Crossed-out wheeled bin’ symbol

ELECTROSURGICAL UNIT PSD-30

1

Labels and Symbols

Electrical rating

ELECTROSURGICAL UNIT MODEL INPUT

PSD-30 220V -- 240V∼ 2A 50/60Hz

MONOPOLAR : 50W/300Ω (SOFT/AUTO STOP 100Ω) 350kHz INT.10S/30S

2

ELECTROSURGICAL UNIT PSD-30

Important Information -- Please Read Before Use

Important Information - Please Read Before Use S High frequency leakage current or spark discharge may cause patient, operator and assistant burns. Follow the dangers, warnings and cautions described in this instruction manual when using this electrosurgical unit. S Always prepare for an emergency operation in case of unintentional patient burn, bleeding and perforation.

Intended use This electrosurgical unit has been designed to be used with an Olympus endoscope (fiberscope or videoscope) compatible with electrosurgery, light source, electrosurgical accessories and other ancillary equipment for general and endoscopic electrosurgery (cutting and coagulation). Do not use this electrosurgical unit for any purpose other than its intended use.

Applicability of endoscopic treatment If there is an official standard on the applicability of endoscopic treatment as defined by a national or local medical administration, or other institution, such as an academic society, follow that standard when performing the procedure. Before performing endoscopic treatment, thoroughly study the properties, purposes, effects and possible risks (the nature, extent, probability and imminence) of the planned treatment and any alternative therapeutic method that can be performed. Carry out endoscopic treatment only when its benefits outweigh its risks. Fully explain to the patient the possible benefits and risks of endoscopic treatment as well as those of any therapeutic method(s) that can be performed instead of endoscopy, and perform endoscopic treatment only after patient consent is granted. During endoscopic treatment, continue to evaluate the potential benefits and risks, and stop the treatment if the risks become greater than the possible benefit to the patient.

ELECTROSURGICAL UNIT PSD-30

3

Important Information -- Please Read Before Use

Instruction manual This instruction manual contains essential information on using this electrosurgical unit safely and effectively. Before use, thoroughly review this manual and the manuals of all equipment which will be used during the procedure and use the equipment as instructed. Keep this and all related instruction manuals in a safe, accessible location. If you have any questions or comments about any information in this manual, please contact Olympus.

` Terms used in this manual Wall mains outlet An electrical outlet that has a terminal used exclusively for grounding.

User qualifications If there is an official standard that outlines the qualifications required of medical personnel performing endoscopic treatments as defined by a national or local medical administration or other institution, such as an academic society, follow that standard. If there is no such standard, the operator of this instrument must be a physician who has been approved by the hospital’s medical safety manager or surgical department manager.

Instrument compatibility Refer to the “System chart” in the Appendix to confirm that this electrosurgical unit is compatible with the ancillary equipment being used. Using incompatible equipment can result in patient injury and/or equipment damage.

4

ELECTROSURGICAL UNIT PSD-30

Important Information -- Please Read Before Use

Repair and modification This electrosurgical unit does not contain any user-serviceable parts. Do not disassemble, modify or attempt to repair it; patient or user injury and/or equipment damage can result. This instrument is to be repaired by Olympus technicians only. Some problems that appear to be malfunctions may be correctable by referring to Chapter 7, “Troubleshooting”. If the problem cannot be resolved using the information in Chapter 7, contact Olympus.

Signal words The following signal words are used throughout this manual:

Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury.

Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices or potential equipment damage.

Indicates additional helpful information.

Dangers, warnings and cautions Follow the dangers, warnings and cautions described below when handling this electrosurgical unit. This information is to be supplemented by the dangers, warnings and cautions given in each chapter.

ELECTROSURGICAL UNIT PSD-30

5

Important Information -- Please Read Before Use

S The HF equipment, when applied to a patient with a pacemaker implanted, may cause malfunctioning or failure of the pacemaker and may seriously affect the patient. Always confirm that it is safe to proceed with a cardiologist and the manufacturer of the pacemaker before proceeding. S To prevent shock hazards, never apply the PSD-30 to the heart in combination with TYPE B or TYPE BF applied parts. S When using the electrosurgical unit on or in the vicinity of the heart, be sure to use it with the minimum necessary output. Spark discharge during operation may affect the heart. S Never install or operate the electrosurgical unit in locations where: -- the concentration of oxygen is high. -- oxidizing agents (such as nitrous oxide (N2O)) are present in the atmosphere. -- flammable anesthetics are present in the atmosphere. -- flammable gases are present in the atmosphere. Otherwise, explosion or fire may result and cause damage to human body. Because this electrosurgical unit is not explosion-proof. S The PSD-30 has been designed for flexible endoscopic applications. Therefore, do not use it for surgical operations.

S Always use the S-cord when endoscopic treatment is performed with an endoscope equipped with the S-cord connector mount. When using an endoscope without the S-cord connector mount, refer to the instruction manual and confirm that the electrosurgery is feasible with this endoscope. If the electrosurgical unit is used in conjunction with an endoscope that is not feasible with the electrosurgery, a burn to the patient, the operator or the assistant may occur. S If the electrosurgical unit fails and the output is stopped during treatment, it may be impossible to continue treatment due to adhesion of the endo-therapy accessory to a mucous tissue or other accident. Prepare a spare electrosurgical unit as backup to ensure that the procedure can be completed without complication in case of a malfunction.

6

ELECTROSURGICAL UNIT PSD-30

Important Information -- Please Read Before Use

S Always have a defibrillator ready in case of a cardiac emergency. During operation of the defibrillator, remove the endoscope from the patient. S To respond to possible patient bleeding, prepare at least the following three hemostatic procedures: coagulation, clipping and local injection. S To prepare for possible accidents, emergency equipment for life-saving, intubation and appropriate pharmaceuticals should be located in or near the procedure room. S Never attach the patient plate in the vicinity of a metal implant. The tissue in the vicinity of the metal implant may be burned. S Keep the electrosurgical unit and ancillary cords (A-cord, P cord, S-cord) as far away as possible from other electromedical equipment and cords. If placed too close, high frequency signals or spark discharge noise from the electrosurgical unit may interfere with the operation of other equipment. S To prevent patient burns, the electrosurgical unit and ancillary cords (A- cord, P cord, S-cord) should not come in contact with the patient or metal parts of the operating table. Furthermore, patients should also keep away from metallic parts of the operating table or other devices. S Never loop the cords (A-cord, P cord, S-cord) or bundle cords together with cords belonging to other medical equipment. The high frequency signals or spark discharge noise generated by the electrosurgical unit may interfere with the operation of other medical equipment. S The electrosurgical unit may interfere with electromedical equipment used in conjunction with it. Before use, thoroughly confirm the compatibility of all the equipment. S Do not bring the tip of the electrosurgical accessory close to a metal clip or other accessories. The tissue around the metal clip or the accessory may be burned. S To prevent electric shock, the electrosurgical unit is designed to function with insulated connectors that have Type CF electromedical equipment classifications (A-cord, P cord, P plate, S-cord). Therefore, to prevent shock caused by leakage current from other electrical equipment applied to the patient, the connectors from the other equipment should not be grounded. ELECTROSURGICAL UNIT PSD-30

7

Important Information -- Please Read Before Use

S Should any abnormal output be suspected during operation, immediately terminate the use of the equipment and turn OFF the electrosurgical unit. S To prevent operator shock, electrosurgical unit malfunction and electrosurgical unit damage, keep liquids away from all electrical equipment. If liquid gets on or into the electrosurgical unit, terminate operation immediately and contact Olympus. S To prevent patient burns, the patient’s skin surfaces should not touch each other (e.g. bare arm and side of chest) or any metal items in the procedure room. Remove any metallic items from the patient (wristwatches, jewelry, etc.) before starting the procedure. S To prevent patient burns, the patient’s clothes must be dry. S To prevent operator and assistant burns, be sure to wear chemical-resistant gloves during operation. S If the intestines contain a flammable gas, replace this gas with air or a non-flammable gas before performing the operation, to minimize the risk of fire or explosion. S The endoscopic treatment performed should not include a therapy with which part of the treated tissue (poly head, etc.) or part of the endoscope distal end or endo-therapy accessory is in contact with or close to normal tissue. Otherwise, current flows to the normal tissue through the part of the treated tissue, the metallic parts at the endoscope’s distal end or endo-therapy accessory and may cause burns. S Be sure that the distal end of endoscope or accessory does not contact bridging fluids surrounding the target tissue. Electric current may flow to the surrounding normal tissue via the fluids and cause burns. S Never grasp the target tissue with non-insulated grasping forceps. Non-insulated grasping forceps will disperse the electric current and normal operation may be impeded. S To ensure electrical safety, the electrosurgical unit should not be used in conjunction with: -- Electrical equipment whose safety against leakage current is not guaranteed. -- Electrosurgical equipment whose safety in combined use is not guaranteed.

8

ELECTROSURGICAL UNIT PSD-30

Important Information -- Please Read Before Use

S If the electrosurgical unit is used in conjunction with a non-Olympus electrosurgical unit, keep the electrosurgical accessory away from the target area while the electrosurgical unit is in operation. Do not activate output of both units simultaneously. Patient or operator injury may occur due to the concentration of electric current. S When using an electrocardiograph or other physiological monitoring equipment simultaneously with the electrosurgical unit on a patient, any monitoring electrodes should be placed as faraway as possible from the electrodes and patient plate used with the electrosurgical unit. If placed too close, high frequency signals or spark discharge noise from the electrosurgical unit may interfere with the operation of an electrocardiograph or other physiological monitoring equipment. Needle monitoring electrodes should not be used, as they may cause patient burns. Physiological monitoring equipment incorporating high frequency current limiting devices is recommended. S Use physiological monitoring equipment throughout the entire procedure, for continuous observation of the patient’s condition. S The open-circuit voltage output characteristics of the electrosurgical unit are shown below. When setting the output level, first set it to a low output level and increase it gradually. If the output is initially set to an excessive level, the electrode’s insulation could be damaged, which could cause operator and/or patient burns. Furthermore, it is recommended that you perform basic experiments before using the electrosurgical unit. If the instruction manual for the endoscopic accessory to be used stipulates a rated voltage, the output should be set so that it does not exceed that voltage.

ELECTROSURGICAL UNIT PSD-30

9

Important Information -- Please Read Before Use

OPEN-CIRCUIT OUTPUT VOLTAGE (V)

1000

(1)

800

(3)

600

(2)

(6)

400

(1) PURE (2) BLEND1 (3) BLEND2 (4) SOFT (5) AUTO STOP (6) FORCED

(4) (5) 200 0

0

20

40

60

OUTPUT (W)

S Flammable agents used for cleaning and disinfection must be allowed to evaporate before the electrosurgical unit is used. Also ensure that flammable solutions are neither on the patient’s skin nor in the patient’s body cavity when the electrosurgical unit is used. S To prevent patient burns when the electrosurgical unit is used in conjunction with a non-Olympus electrosurgical unit, ensure that each unit is supplied with power from wall mains outlets. Also ensure that each unit is supplied with power from separate breakers. S During operation, temporarily unused electrodes should be stored in an electrically insulated container. Unused electrodes should never be placed on the patient otherwise it may cause operator and/or patient burns. S The electrosurgical unit should not be used for performing circumcisions. S To prevent patient burns, never use cords with scratches or cracks. S Studies have shown that smoke generated during electrosurgical procedures can be irritating and potentially harmful to surgical personnel. These studies recommend the use of surgical masks and adequate ventilation of smoke by the use of surgical smoke evacuators or other means.

10

ELECTROSURGICAL UNIT PSD-30

Important Information -- Please Read Before Use

-- William S.Sawchuk, et al., “Infections Papilomavirus in the Vapor of Warts Treated With Laser or Electrocoagulation: Detection and Protection”, Journal of American Academy of Dermatology, Vol.21, No.1 (July, 1989): 41-49. Yoshifumi Tomita, et al., “Mutagencity of Smoke Condensates Induced by CO2-Laser Irradiation and Electrocauterization”, Mutation Research, Vol.89 (1989): 145-149. Evaluation Report No.85-126. (National Technical Information Service, 1985): 1-28. S When the patient is moved after the dispersive electrode has been attached, confirm that the dispersive electrode is still in proper contact with the patient otherwise it may cause operator and/or patient burns. S Do not use the electrosurgical unit in a location exposed to strong electromagnetic radiation (microwave medical treatment equipment, short wave medical treatment equipment, MRI, radio or mobile phone). Electrosurgical unit malfunction can occur.

S To prevent electrosurgical unit damage, never short-circuit electrodes (accessories, patient plate). S Repairs should be performed only by Olympus. S The electrosurgical unit should only be used in accordance with the conditions described in “Operating environment” in the Appendix. The use under other conditions may impede normal performance, and/or result in equipment damage. S During treatment, be sure that the distal (metallic) end of the endoscope, and metallic parts of accessory do not touch the normal tissue surrounding the target tissue. This action may cause severe burns.

ELECTROSURGICAL UNIT PSD-30

11

Chapter 1 Checking the Package Contents

Chapter 1 Checking the Package Contents Match all items in the package with the components shown below. Inspect each item for damage. If the electrosurgical unit is damaged, a component is missing or you have any questions, do not use the electrosurgical unit; immediately contact Olympus.

Power cord

Electrosurgical unit (PSD-30)

P cord (MAJ-814)

S-cord (MAJ-813) Foot switch (MAJ-811)

Spare fuse (MAJ-1052, 2 pcs) Instruction manual

12

ELECTROSURGICAL UNIT PSD-30

P plate (MAJ-897, 10 pcs)

Chapter 1 Checking the Package Contents

The following Olympus items are optional and may be purchased separately: S A-cord (MA-255, MH-969) S P plate (MB-574) S P cord (MAJ-3) S P adapter (MAJ-812) For other combinations, refer to the “System chart” in the Appendix.

S Place the instruction manual next to the electrosurgical unit or in another easily accessible place. S Before using an optional item, thoroughly review and understand the instruction manual provided with that item.

ELECTROSURGICAL UNIT PSD-30

13

Chapter 2 Nomenclature and Functions

Chapter 2 Nomenclature and Functions 2.1

Symbols and descriptions ` Warning section

Refer to instructions

Patient plate

S-cord

High frequency output

Output timer

` Coag. section

Soft

Auto stop

Forced

14

ELECTROSURGICAL UNIT PSD-30

Chapter 2 Nomenclature and Functions

` Cut section

Pure

Blend1

Blend2

` Power switch

Power ON/OFF

` Front panel

Type CF applied parts (defibrillation protected equipment)

STAND-BY

Program

ELECTROSURGICAL UNIT PSD-30

15

Chapter 2 Nomenclature and Functions

` Connector section

Active

S-cord

Patient plate

Refer to instructions Connection for neutral electrode (isolated from earth at high frequency)

` Rear panel

Potential equalization terminal

Foot switch

Fuse

Alternating current

Serial number

16

ELECTROSURGICAL UNIT PSD-30

Chapter 2 Nomenclature and Functions

2.2

Front panel

3. Cut mode selector

2. Program switch

4. Output control buttons

1. Stand by switch

WARNING

PATIENT

POWER

PROGRAM

BLEND2

FORCED

BLEND1

AUTO STOP

PURE

W

ACTIVE

PATIENT

7. Active connector 9. Power switch

TIMER

COAGULATION

CUT

CQM STAND- BY

OUTPUT

S CORD

SOFT

W

S CORD

5. Coagulation mode selector

8. Patient plate connector 6. S-cord connector

ELECTROSURGICAL UNIT PSD-30

17