Olympus PSD-10 User manual

INSTRUCTIONS
ELECTROSURGICAL UNIT
WARNING
The user of this equipment should be thoroughly trained in the applicable procedure.
Furthermore, failure to read and thoroughly understand the contents of this instruction
manual may result in serious injury to the patient and/or user. It is essential to follow
the instructions contained in this and other manuals which pertain to any equipment
and accessories used in conjunction with this equipment. Possible injuries related
to endoscopic procedures may include electric shock, explosion, burns, perforation,
hemorrhage, etc.
Failure to follow these instructions may also result in damage to and/or malfunction
of this equipment.
CAUTION
Federal (USA) law restricts this device to sale by or on the order of a physician.
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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
1
1
1
2
5
2
3
4
5
6
7
8
9MAINTENANCE
23
10 ELECTROSURGICAL SYSTEM CHART 24
FEATURES AND MAIN SPEClFlCATlONS
1-1 Features
1-2 Main Specifications
1-3
Safety Precautions
DESCRIPTION OF CONTROLS
7
CONSTRUCTION
9
STANDARD SET
10
PREPARATION FOR USE
5-1 Installation of PSD-10
5-2 Connection to AC Power
5-3 Connection of Footswitch
5-4 Connection of S-P Cord
INSPECTION OF ELECTROSURGICAL SYSTEM
13
ENDOSCOPIC ELECTROSURGERY
17
7-1 Precautions against Patient/Operator Burns
17
7-2 Setup of Patient-plate 18
7-3
Electrosurgery
19
7-4 After Operation 21
CARE AND STORAGE
22
8-1 Care After Use 22
8-2 Storage 22
9-1 Replacement of Fuse
23
9-2 Cleaning of Ventilation Grills
23
9-3 Periodic Inspection
23
11
11
11
12
12
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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 includ-
ing 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
Applicability Compatible endoscopes Olympus fiberscopes suitable for electrosurgery
Waveform 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
Type Flat switches
Output
Adjustment
Range
0.5 – 5.0
Steps
10 steps with 0.5 increment from 0.5 to 5.0.
Output Selection of output current Flat switches (CUT, BLEND or COAG)
Current control Footswitch
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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.
’Monitors 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)
Connection A-cord
Plug-in
Check lead
Plug-in
Footswitch
Screw-on
Type of protection
against electric shock
Class I equipment
Classification
Degree of protection Type BF (Body Floating) equipment
(Electro- against electric shock
medical
equipment) Degree of protection The PSD-10 should never be used where there is a risk
against explosion of flammable gases.
Other
Defibrillator-protected equipment
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Power requirements
Voltage:
110, 120, 220, 240 V (a.c.)
Frequency: 50/60 Hz
Input: 4 A (110, 120V), 2A (220, 240V)
Operating Voltage fluctuation: Within ±10 %
Environment Ambient temperature 10 – 40°C (50 – 104ºF)
Relative humidity 30 – 75%
Atmospheric pressure
700 –1060hPa (700 – 1060 mbar)
Dimensions
& Weight 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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2DESCRIPTION OF CONTROLS
Selected Current Indicators
Light when the switch under the indicator
is pressed.
Output Indicators
Light to indicate the selected current
(CUT, BLEND or COAG) is being delivered
when the footswitch is depressed.
Current Selector Switches
Output Test Indicators
Indicate normal or abnormal test con-
ditions.
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.
OutputAdjustmentSwitches
Output level from 0.5 to 5.0 (with 0.5
increment) is selected.
Power Switch
Footswitch Connector
TEST Connector
Accepts the smaller plug of Check Lead
(for test).
Patient-plate
Connector
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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Main Body & Components
Ventilation Grill
Carrying Handle
(front)
Ventilation
Grills
Terminal
TEST plug
S-P Cord
Check Lead
ACTIVE plug
Patient-plate
Pedal
Footswitch
FOOT SW. plug
(rear)
S-P Cord for
disposable patient plate
(optional)
Cord Hanger
Power Cord
Connector
(Appliance Inlet)
Fuse Holder
Ratings Plate
PATIENT plug
S-cord
(to endoscope)
(to Patient-plate)
P-cord
Power Cord
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3CONSTRUCTION
Panel
Panel
Control Display
Circuit Circuit
OsciIlator
Waveform
Generating
Circuit
Control
Circuit Amplifier
Comparator
Endoscope
Foot-
switch
Active
electrode
When the footswitch is depressed, active current (IA) flows through the A-cord.
Return current (IP) flowing through the patient plate to the P-cord connector is moni-
tored. The feedback ratio IP/IA is computed.
If the ratio is more than a preset value, the feedback ratio monitor determines that exces-
sive 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.
Patient
Body cavity
Patient-plate
(neutral
electrode)
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4STANDARD 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
1
Check Lead (MB-576) 1
S-P Cord (MB-575)
1
Fuses (spare) 2
Patient-plate (MB-574)
1
Vinyl Dust Cover 1
Footswitch (MB-585 or MB-399).
1
Power Cord 1
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5PREPARATION 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.
Connect the power cord to a properly grounded “HOSPITAL GRADE” recep-
tacle (or wall mains outlet with grounding contact) that meets the input require-
ments indicated on the ratings plate on the rear panel. Use only the supplied
Ratings plate
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:
Power cord
Screw a suitable lead wire firmly to the additional protective earth terminal
Power plug Hospitalgrade
receptacle with
grounding con-
tact
provided on the rear panel of the electrosurgical unit (PSD-10).
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 clamp-
ing 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
P-cord connector
Connect the P-cord connector to the Patient-plate. Fully tighten the clamping
Terminal ring.
S-cord
connector 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.
Patient-
plate S-cord connector
The alarm will be activated when the power switch is turned on, if above
mount connections (Steps through are defective.
Disposable
Lever
patient plate 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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6INSPECTION OF ELECTROSURGICAL SYSTEM
1Power Feeding
Turn ON the power switch. The power indicator and LED (Light-Emitting Diode) in-
dicators 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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2Output Check 1 (PSD-10 alone)
CUT indicator lights.
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
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 ex-
ceeded.
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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3Output Check 2 (Electrosurgical system)
Active plug
Clip
Electrode wire
Endoscope
Attach spring-loaded clip to elec-
trode wire.
Light source
SD-handel
S-P cord
A-cord
S-cord
P-cord
Patient-
plate
CheckLead
Footswitch
Electrode wire
Do not touch the Patient-plate; burns may occur.
Assembled electrosurgical system
(for test)
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 electro-
surgical accessory (A-cord plug on SD-handle).
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 de-
fective.
b. Wire is broken in the above line, or
c. The electrode tip is in contact with the metal portion of the endoscope
tip.
After performing this check, disconnect the Check Lead and the A-cord from
the PSD-10.
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4Checking the Output Adjustment Switches
Press a given output adjustment switch (0.5 to 5.0): the indicator above the
switch should light.
5Checking the Current Selector Switches
Press a given current selector switch: the waveform pattern above the switch
should light.
6Checking 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 simultane-
ously.
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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7ENDOSCOPIC 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 non-
flammable gas (CO2, etc.) before operation.
The operator and assistant should wear rubber handgloves.
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