PSD-10 ELECTROSURGICAL UNIT Instructions

IMPORTANT The Olympus Electrosurgical Unit PSD-10 has been designed for endoscopic electrosurgery (coagulation, polypectomy, sphincterotomy, etc.) in conjunction with Olympus fiberscopes that are applicable to electrosurgery, Olympus electrosurgical accessories and light sources. Do not use the equipment for any purpose other than its intended use.

Please read this entire manual carefully before using the equipment in order to acquaint yourself with the proper care and handling of your new electrosurgical unit. Then prepare and inspect the equipment following these instructions.

Safety precautions must be exercised when handling electrical equipment to prevent operator/ patient shock, fire hazard and equipment damage.

If you have any questions concerning the material contained in this manual or concerning the operation or safety of the equipment, please contact your Olympus representative or the nearest Olympus Service Center.

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CONTENTS FEATURES AND MAIN SPEClFlCATlONS

1

1-1 1-2 1-3

Features Main Specifications Safety Precautions

1 2 5

2

DESCRIPTION OF CONTROLS

7

3

CONSTRUCTION

9

4

STANDARD SET

10

5

PREPARATION FOR USE

11

5-1 5-2 5-3 5-4

11 11 12 12

1

Installation of PSD-10 Connection to AC Power Connection of Footswitch Connection of S-P Cord

6

INSPECTION OF ELECTROSURGICAL SYSTEM

13

7

ENDOSCOPIC ELECTROSURGERY

17

7-1 7-2 7-3 7-4

17 18 19 21

8

CARE AND STORAGE 8-1 8-2

9

10

Precautions against Patient/Operator Burns Setup of Patient-plate Electrosurgery After Operation

Care After Use Storage

22 22 22

MAINTENANCE

23

9-1 9-2 9-3

Replacement of Fuse Cleaning of Ventilation Grills Periodic Inspection

23 23 23

ELECTROSURGICAL SYSTEM CHART

24

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1 FEATURES AND MAIN SPECIFICATIONS 1-1

Features

1. Simplified pre-procedural test, using a Check Lead, of the power output of the PSD-10 alone as well as that of the entire electrosurgical system including the endoscope and endoscopic electrodes. Test results confirmed by TEST “OK” or “FAULT” indicator lights on the front panel. 2. Push-button selection of CUT, COAG or BLEND current. Output power is controlled by a single-pedal footswitch. 3. The connection monitor circuit detects loose or inadvertent misconnection of cords or broken wires in the S-P cord (Safety cord and Patient cord). If any irregularity is present, the monitor activates an alarm and inhibits output (current is not delivered when the footswitch is depressed) to ensure safety of the procedure. 4. The feedback ratio monitor scans the entire circuit when the footswitch is depressed. If excessive leakage current is present, the output is inhibited to ensure safety of the procedure. 5. Flat switches and display panel can be easily wiped clean. 6. Compact, lightweight and portable.

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1-2 Main Specifications Applicable field

Endoscopic electrosurgery

Compatible endoscopes

Olympus fiberscopes suitable for electrosurgery

Waveform

CUT

Applicability

BLEND COAG

Output Radio-frequency Current

Output (watts) Max. rated output (Load: 5OO CUT:

80 W

BLEND: 60W COAG:

40 W Output setting

Max. open-curcuit output voltage: less than 1800 Vp-p

Output Adjustment

Type

Flat switches

Range

0.5 – 5.0

Steps

10 steps with 0.5 increment from 0.5 to 5.0.

Selection of output current Flat switches (CUT, BLEND or COAG) Output Current control

Footswitch

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’Monitors

Connection

Classification (Electromedical equipment)

Output check

• When the Check Lead is connected and the footswitch depressed, either the “OK” or “FAULT” light will come on. • Checks the PSD-10 or the entire electrosurgical system. The entire electrosurgical system cannot be tested when using PSD-10 in combination with CD-3U/L or CD-40/L.

Connection monitor

Detects defective connections of cords and broken wires in the S-P cord, and activates: • A warning light (P-cord or S-cord symbol), a warning buzzer, and inhibits output.

Feedback ratio monitor

Computes return current/delivered current ratio. If the ratio is less than a preset value, it inhibits output.

S-P cord

Plug-in (PSD-10) and screw-on (P-plate and endoscope)

A-cord

Plug-in

Check lead

Plug-in

Footswitch

Screw-on

Type of protection against electric shock

Class I equipment

Degree of protection against electric shock

Type BF (Body Floating) equipment

Degree of protection against explosion

The PSD-10 should never be used where there is a risk of flammable gases.

Other

Defibrillator-protected equipment

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Operating Environment

Dimensions & Weight

Power requirements

110, 120, 220, 240 V (a.c.) Voltage: Frequency: 50/60 Hz Input: 4 A (110, 120V), 2A (220, 240V) Voltage fluctuation: Within ±10 %

Ambient temperature

10 – 40°C (50 – 104ºF)

Relative humidity

30 – 75%

Atmospheric pressure

700 –1060hPa (700 – 1060 mbar)

290 mm (W) x 162 mm (H) x 300 mm (D) max., 8 kg or 17.6 lb (PSD-10 main body)

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1-3 Safety Precautions The PSD-10 should be used only in a medical facility under the supervision of a trained physician. The PSD-10 is designed (floating) to function integrally with insulated patient attachments (active electrode and patient plate) to prevent operator/patient shock. To prevent shocks which may be caused by leakage current from other apparatus applied to the patient, endoscopes and cameras used with the PSD-10 should not be grounded. The endoscopist and his assistant should wear rubber handgloves as an added precaution. When using a camera (except the SC16-10) an insulating hood should be attached to the camera’s eyepiece. The enclosure of the PSD-10 must be grounded securely and effectively. Do not defeat the line cord ground connection. The PSD-10 should never be applied to the heart directly. Never install and operate the PSD-10 where there is a risk of flammable gases. Should any irregularity or abnormality be suspected during operation, immediately stop the use of instrument and turn OFF the power switch. Keep liquids away from all electrical equipment to prevent operator shock and instrument damage. Do not use the PSD-10 if spilled fluids have entered the unit. Please investigate the possibility of electronic interference for other electromedical equipment in conjunction with the PSD-10 prior to use. Do not install the patient plate adjacently to an artificial bone (metal), etc.

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Keep adequately away from cords of electric scalpel (scalpel holder, scalpel cord and patient plate cord), scalpel main body and cords, main body of other electromedical equipment. Do not loop cords of electric scalpel (scalpel holder, scalpel cord and patient plate cord). Do not contact these cords with the patient or metallic portion of an operating table, etc. The PSD-10 should not be used in conjunction with electrical apparatus whose safety against leakage current is not guaranteed. Radio-frequency and spark discharge “noise” may adversely affect other electro-medical equipment being used in the proximity. Do not apply the electric scalpel to the patient who has a pacemaker in his body. The use of a radio-frequency noise filter in monitor electrode lines may reduce interference. Patient monitor electrodes must be placed as far away as possible from the operative field. Needle type electrodes should not be used as they increase the risk of burns. To prevent instrument damage, the active electrode and the patient plate should not be short-circuited. Do not activate the electrode for an extended time when it is not touching the target tissue. The PSD-10 should be used in accordance with the operating environment specified in 1 – 2 Main Specifications; otherwise improper performance, compromised safety or instrument damage may result. Repairs should be carried out only by an Olympus Service Center.

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2 DESCRIPTION OF CONTROLS Selected Current Indicators Light when the switch under the indicator is pressed. Output Test Indicators Indicate normal or abnormal test conditions.

Output Indicators Light to indicate the selected current (CUT, BLEND or COAG) is being delivered when the footswitch is depressed.

Defective Connection Indicators Light to indicate defective connection of cords or broken wire in S-P cord.

Output Level Indicators Light when the switch under the indicator is pressed.

Current Selector Switches

Output Adjustment Switches Output level from 0.5 to 5.0 (with 0.5 increment) is selected.

Power Switch Patient-plate Connector

Footswitch Connector TEST Connector Accepts the smaller plug of Check Lead (for test).

Accepts S-P cord. Active Cord Connector Accepts A-cord (for electrosurgery) or the larger (clip-tipped) plug of Check Lead (for test).

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Cord Hanger

Main Body & Components

Carrying Handle

Ventilation Grill

(rear) Power Cord Connector (Appliance Inlet)

(front) Ventilation Grills

Fuse Holder Ratings Plate

Terminal

TEST plug

PATIENT plug

Check Lead

S-P Cord

S-cord

(to endoscope) (to Patient-plate)

ACTIVE plug P-cord

Patient-plate

Pedal

Footswitch

FOOT SW. plug

S-P Cord for disposable patient plate (optional)

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Power Cord

3 CONSTRUCTION

OsciIlator

Panel Control Circuit

Panel Display Circuit

Waveform Generating Circuit

Control Circuit

Amplifier

Comparator Endoscope Footswitch Active electrode

When the footswitch is depressed, active current (I A) flows through the A-cord. Return current (IP ) flowing through the patient plate to the P-cord connector is monitored. The feedback ratio I P /IA is computed. If the ratio is more than a preset value, the feedback ratio monitor determines that excessive current leakage is not present in the circuitry and allows the selected current to flow. The current stops when the footswitch is released. Waveform and output level can be selected by push-button switches.

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Patient

Body cavity Patient-plate (neutral electrode)

4 STANDARD SET Please check each item in the set against the list of standard components below. Contact Olympus if there are any missing or defective parts. Electrosurgical Unit PSD-10 S-P Cord (MB-575) Patient-plate (MB-574) Footswitch (MB-585 or MB-399).

1 1 1 1

Check Lead (MB-576) Fuses (spare) Vinyl Dust Cover Power Cord

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1 2 1 1

5 PREPARATION FOR USE Also refer to the instruction manuals provided with the endoscope, electrosurgical accessories and light source, as well as the “Radio-frequency Cutting and Coagulation in Endoscopic Use” booklet and related literature.

5-1 Installation of PSD-10 Check that all safety precautions described in Section 1 – 3 are met. Place the PSD-10 on a stable surface in a horizontal position. Ventilation must not be obstructed. Carts and stands must be of adequate size and strength to support load. Do not place in a vertical position, such as on the ventilation grill on the side panel.

5-2 Connection to AC Power Make sure the power switch is in the “OFF” position.

Power switch should be in the “OFF” position.

Ratings plate

Connect the power cord to a properly grounded “HOSPITAL GRADE” receptacle (or wall mains outlet with grounding contact) that meets the input requirements indicated on the ratings plate on the rear panel. Use only the supplied power cord. Do not use a 3-pin to 2-pin adapter or a cable tap. Connect the power cord securely to prevent accidental disconnection during procedure. The cord should not be sharply bent, twisted or crushed. If an additional protective earth is required to guard against electric shock which may be caused by trouble of the protective earth conductor: Screw a suitable lead wire firmly to the additional protective earth terminal provided on the rear panel of the electrosurgical unit (PSD-10).

Power cord Power plug

Hospital grade receptacle with grounding contact

Connect the other end of the lead wire to the earth terminal facility of the room.

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5-3 Connection of Footswitch Connect the footswitch to the FOOT SW. connector on the PSD-10, with the red positioning dot on the plug facing upward. Fully tighten the clamping ring on the plug by turning clockwise.

Red mark

5-4 Connection of S-P Cord Connect the S-P cord to the PATIENT connector on the PSD-10, with the red dot facing upward. Push the plug until it is locked in place.

Red mark

Connect the P-cord connector to the Patient-plate. Fully tighten the clamping ring.

P-cord connector Terminal S-cord connector

Patientplate

S-cord connector mount

Lever

Disposable patient plate

Connect the S-cord to the endoscope (S-cord connector mounted on the light guide connector), which has been plugged in the output socket of the light source. Fully tighten the clamping ring. The alarm will be activated when the power switch is turned on, if above connections (Steps through are defective. In case a disposable patient plate (Scotchplate ®#1149, 3M) is being used: Lift the lock lever of the special S-P cord (MB-583, optional) and insert the terminal of the patient plate into the port. Press the lever back down to secure plate.

Clamp Terminal Connection of disposable patient plate

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6 INSPECTION 1

OF

ELECTROSURGICAL

SYSTEM

Power Feeding Turn ON the power switch. The power indicator and LED (Light-Emitting Diode) indicators on the front panel will light and the cooling fan will be heard. If the unit fails to turn on, inspect the power cord connection.

Turn on power switch.

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2

Output Check 1 (PSD-10 alone) The Check Lead plugs are at an extremely high potential when the footswitch is depressed. DO NOT TOUCH! Severe burns may result. Connect the Check Lead to the TEST connector and to the ACTIVE connector on the PSD-10, by pushing each plug fully into the connector.

Check Lead

CUT indicator lights.

Depress the footswitch for approximately 1 second (until the output tone ceases to sound). Make sure the CUT output indicator (yellow) lights and the TEST “OK” light (green) comes on after the output tone has stopped. The TEST “FAULT” light (red) may come on if the pedal is released before the output tone stops or if the allowable voltage fluctuation range is exceeded. The “FAULT” light comes on: if the footswitch is depressed when the WARNING light is glowing red. Re-connect the S-P cord correctly and repeat above procedure. (If the red WARNING light fails to go out, consult an Olympus service center.) Do not touch the Patient-plate; burns may occur. Disconnect the Check Lead from the PSD-10.

“OK” indicator should light.

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3

Active plug

Clip

Output Check 2 (Electrosurgical system) After proper operation of the PSD-10 has been confirmed by Output Check 1, insert the electrosurgical accessory into the endoscope and proceed with the following steps. The entire electrosurgical system cannot be tested when using PSD-10 in combination with CD-3U/L or CD-4U/L. Be sure to perform the Output Check 1 for the PSD-10 to ensure the proper connection of the system. Connect the A-cord to the PSD-10 (ACTIVE connector) and to the electrosurgical accessory (A-cord plug on SD-handle).

Electrode wire Endoscope Attach spring-loaded clip to electrode wire.

Light source

SD-handel

A-cord

S-P cord

S-cord P-cord

Check Lead Footswitch

Patientplate Electrode wire

Assembled electrosurgical system (for test)

Only Olympus A-cord MA-255 is compatible with this equipment. Push each end of the A-cord until a click is felt and heard. Connect the smaller plug of the Check Lead to the PSD-10 TEST connector. Connect the larger plug (spring-loaded clip) to the electrode tip/snare wire which is protruding out of the endoscope. Before connection, wipe the clip clean with gauze dampened with alcohol. When attaching the clip to the wire, be careful not to deform or damage the wire (snare, loop, etc.) Depress the footswitch and ascertain that the TEST “OK” light (green) comes on. If the TEST “FAULT” light (red) comes on: a. Connection between the A-cord and the electrosurgical accessory is defective. b. Wire is broken in the above line, or c. The electrode tip is in contact with the metal portion of the endoscope tip. Do not touch the Patient-plate; burns may occur. After performing this check, disconnect the Check Lead and the A-cord from the PSD-10.

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4

Checking the Output Adjustment Switches Press a given output adjustment switch (0.5 to 5.0): the indicator above the switch should light.

5

Checking the Current Selector Switches Press a given current selector switch: the waveform pattern above the switch should light.

6

Checking the Connection Monitor Connection between S-cord and endoscope Loosen the clamping ring on the S-cord connector. Check that: a. S-cord indicator (red) lights and the warning tone (intermittent) sounds simultaneously. b. Depress the footswitch. Make sure output indicators and output tone are not activated. Re-tighten the clamping ring to resume correct connection. Connection between P-cord and Patient-plate Loosen the clamping ring on the Patient-plate connector. Check that: a. The P-cord indicator (red) lights and the warning tone sounds simultaneously. b. Depress the footswitch. Make sure output indicators and output tone are not activated.

Loosen clamping ring and check

Re-tighten the clamping ring.

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7 ENDOSCOPIC ELECTROSURGERY This section outlines a general procedure for endoscopic electrosurgery. The endoscopist should evaluate the clinical factors involved and decide on the specific details of the procedure.

7-1 Precautions against Patient/Operator Burns To prevent accidental burns, attention must be paid to the following points. The patient should not come into contact with grounded metal objects (e.g., iron bar of bed, external surface of an appliance). Patient skin surfaces should not touch each other (e.g., bare arm and chest). Patient’s clothes must be dry. Patient monitoring electrodes should be placed as far away from the operative field as possible. The A-cord or S-P cord should not touch or lay on the patient. When using lower GI endoscopes, intestinal gas should be replaced with nonflammable gas (CO2 , etc.) before operation. The operator and assistant should wear rubber handgloves.

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