PSD-10 ELECTROSURGICAL UNIT Instructions

Page 2

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.

Non-Controlled Document

Page 3

CONTENTS

1

FEATURES AND MAIN SPEClFlCATlONS

1

1-1

1-2

1-3

1

2

5

Features

Main Specifications

Safety Precautions

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

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

23

23

23

Replacement of Fuse

Cleaning of Ventilation Grills

Periodic Inspection

ELECTROSURGICAL SYSTEM CHART

Non-Controlled Document

24

Page 4

1

1-1

FEATURES AND MAIN SPECIFICATIONS

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.

Non-Controlled Document

Page 5

1-2 Main Specifications

Applicable field

Endoscopic electrosurgery

Applicability

Compatible endoscopes

Waveform

Olympus fiberscopes suitable for electrosurgery

CUT

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

Non-Controlled Document

Page 6

’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

Non-Controlled Document

Page 7

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)

Non-Controlled Document

Page 8

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.

Non-Controlled Document

Page 9

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.

Non-Controlled Document

Page 10

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).

Non-Controlled Document

Page 11

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)

Non-Controlled Document

Power Cord

Page 12

3

CONSTRUCTION

Panel

Control

Circuit

OsciIlator

Waveform

Generating

Circuit

Panel

Display

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.

Non-Controlled Document

Patient

Body cavity

Patient-plate

(neutral

electrode)

Page 13

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

Non-Controlled Document

1

2

1

1

Page 14

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.

Non-Controlled Document

Page 15

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

Non-Controlled Document

Page 16

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.

Non-Controlled Document

Page 17

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.

Non-Controlled Document

Page 18

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.

Non-Controlled Document

Page 19

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.

Non-Controlled Document

Page 20

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.

Non-Controlled Document

Page 21

7-2 Setup of Patient-plate

Incomplete attachment of the Patient-plate may cause patient burns.

Put gauze pads which are slightly larger than the Patient-plate and moistened

with physiological saline or conductive paste (e.g., Conductive Gel #1103, 3M)

on the Patient-plate. Attach it to the patient’s thigh or calf with the fastening

band, or lay it under the hip.

Wet gauze pads with

saline or conductive

paste.

The gauze pads should be wet throughout the operation. If they become

dry, wet again.

Do not apply the Patient-plate to a hairy or cicatrized skin area.

Do not deform the Patient-plate. The entire surface of the Patient-plate

should be in contact with the patient.

When a disposable patient plate (#1149, 3M) is being used:

Remove the protective paper and attach the plate to the patient.

The plate may become detached easily unless thoroughly dry.

Avoid a hairy or cicatrized skin area.

Do not wrinkle the plate.

with the patient’s skin.

Its entire surface should be in direct contact

The plate should not be reused.

Entire surface of plate should be in

direct contact with patient’s skin.

Non-Controlled Document

Page 22

7-3 Electrosurgery

The type of output current and its intensity must be determined by reference to related papers and based on one’s own experience.

1

Power Feeding

Turn ON the power switch.

2

Selection of Current

Press the desired current selector switch (CUT, BLEND or COAG).

If none of the current selector switches are pressed, none of the current

indicators above them will be lit; instead, the warning tone sounds and

current will not be delivered when the footswitch is depressed.

If more than two current selector switches are pressed, the current indicators

corresponding to the pressed switches will light: in this case also, the warning tone sounds and the output is inhibited.

3 Selection of Output Level

Press the desired output adjustment switch.

If none of the output adjustment switches are pressed, none of the LEVEL

indicators above them will be lit; instead, the warning tone sounds and

current will not be delivered when the footswitch is depressed.

If more than two output adjustment switches are pressed, the LEVEL

indicators above them corresponding to the pressed switches will light;

in this case also, the warning tone sounds and the output is inhibited.

Non-Controlled Document

Page 23

4

Connection of A-Cord

SD-handle

Connect the A-cord to the PSD-10 and to the electrosurgical accessory.

A-cord

Only Olympus A-cord MA-255 is compatible with this equipment.

As an added precaution, connect to the accessory as the final step before depressing the footswitch.

5

Operation

Depress the footswitch and operate on the tissue.

Attach A-cord as the final step

before depressing the footswitch.

If the electrosurgical procedure is not progressing as expected, do not increase the power hastily. Inspect the whole circuitry again (connection of

cords, contact of Patient-plate, etc.) for any abnormality.

If the output tone sounds and the output indicator lights when the footswitch

is not operated, immediately stop the use of the equipment and turn OFF the

power switch.

If the output tone does not sound and the output indicator does not light,

it may be because some abnormality is detected by the monitor and the

output is inhibited. The table below lists some possible remedies. (For

detailed discussion refer to the “Radio-frequency Cutting and Coagulation in

Endoscopic Use” booklet.)

Symptom

Remedy

Metal portion of endoscope’s distal

end is touching the target tissue.

Move endoscope tip back from the

tissue.

The metal portion above is indirectly

touching the tissue via fluids.

Suction fluids from around the tissue

and move endoscope tip back from

the tissue.

The metal portion is touching electrode tip.

Move electrode tip well away from

the tissue and bring electrode tip into clear view.

Non-Controlled Document

Page 24

7-4 After Operation

Turn OFF the power switch.

Disconnect the power plug from the hospital grade receptacle if the PSD-10

is not going to be sued for an extended period.

Non-Controlled Document

Page 25

8

CARE

AND

STORAGE

8-1 Care After Use

Disconnect the A-cord, S-P cord and footswitch from the PSD-10.

Lightly wipe all surfaces using a soft cloth or gauze sponge. If dirt remains,

moisten the gauze with disinfectant ethanol and wipe again.

For disinfection, wipe with a gauze sponge moistened with disinfectant ethanol

or 2% glutaraldehyde solution. If a glutaraldehyde solution is used, wipe

again with disinfectant ethanol to remove all residue.

Wipe cords clean.

Avoid touching the electrical contacts and connectors: poor electrical contact

will result.

To prevent scratches, do not use harsh or abrasive wiping material.

Surfaces must be thoroughly dry before use.

Wipe panel clean.

8-2 Storage

Band

Wind the power cord around the hanger on the rear of the PSD-10.

Place the PSD-10 on a stable surface in the horizontal position.

Put on the vinyl dust cover.

Storage area must be maintained at normal temperature and humidity,

and away from water splashes.

Do not subject to heavy blows or impacts.

Put on the vinyl cover.

Non-Controlled Document