Appendix

Appendix

Construction

Schematic

 Monopolar

A-cord
Accessory I
S-cord
I
Electrode
Operator Patient Patient plate PSD-30

Bed
P cord I

I : High frequency current

74 ELECTROSURGICAL UNIT PSD-30

 Appendix

System chart
The recommended combinations of equipment and accessories that can be
used with this electrosurgical unit are listed below. New products released after
the introduction of this electrosurgical unit may also be compatible for use in
combination with this electrosurgical unit. For further details, contact Olympus.

If combinations of equipment other than those shown below

are used, the full responsibility is assumed by the medical
treatment facility.

ELECTROSURGICAL UNIT PSD-30 75

Appendix

Endoscopic treatment with PSD-30 system chart

Videoscope without
the S-cord
connector mount

Fiberscope without
the S-cord
connector mount Foot switch
(MAJ-811)

Videoscope equipped with the

S-cord connector mount

PSD-30
Fiberscope equipped with the
S-cord connector

S-cord
(MAJ-813)

A-cord (MA-255)
(MH-969)

Compatible Olympus high

frequency accessory

P plate P cord (MAJ-814)

P plate P cord P adapter (MAJ-812)

(MB-574) (MAJ-3)

76 ELECTROSURGICAL UNIT PSD-30

 Appendix

Operating environment

Operating environment Ambient temperature 10 – 40°C (50 – 104°F)

Relative humidity 30 – 85%
Air pressure 700 – 1060 hPa
(0.7 – 1.1 kgf/cm2)
(10.2 – 15.4 psia)
Storage environment Ambient temperature −25 – 70°C (−13 – 158°F)
Relative humidity 10 – 90%

ELECTROSURGICAL UNIT PSD-30 77

Appendix

Specifications

Item Specification
Applicability Applicable Endoscopic electrosurgery (restricted to endoscopes
field suitable for electrosurgery).
High Output
Monopolar modes
frequency method
output Output types Cut modes: 3 modes (PURE, BLEND1, BLEND2)
Coagulation modes: 3 modes (SOFT, AUTO STOP,
FORCED)
The AUTO STOP output uses an identical waveform
to SOFT and is provided with the auto stop function.
Fundamental
350 kHz
frequency
Output Output power limitation
characteristics setting at 50 watts
60
(1)
50 (3) (2)

40
(6)

30 (4)
(5)
20
10

0
0 500 1000 1500 2000 2500 3000
RESISTANCE (Ω)

Output power limitation

setting at 25 watts
35
30
(1)
25 (3)
(6) (2)
20
15
(4)
10 (5)

5
0
0 500 1000 1500 2000 2500 3000
RESISTANCE (Ω)

78 ELECTROSURGICAL UNIT PSD-30

 Appendix

Item Specification
High Output Output power limitation
frequency characteristics setting at 15 watts
18
output
16 (2)
(3) (1)
14
(6)
12
10
8
6 (4)
(5)
4
2
0
0 500 1000 1500 2000 2500 3000
RESISTANCE (Ω)
(1) PURE
(2) BLEND1
(3) BLEND2
(4) SOFT
(5) AUTO STOP
(6) FORCED

Maximum PURE: 50 W
output BLEND1: 50 W
BLEND2: 50 W
SOFT: 50 W
AUTO STOP: 50 W
FORCED: 50 W
(Rated load resistance 300 Ω,
SOFT, AUTO STOP: 100 Ω)
Adjustment
5 W increments (below 5 W can be set on 2 W)
steps

ELECTROSURGICAL UNIT PSD-30 79

Appendix

Item Specification
High Output control Control by foot switch
frequency Output time 10 seconds ON and 30 seconds OFF output (to
output continue the output, keep the output time below
10 seconds)
Output power Rated load resistance 300 Ω
vs setting
PURE
50

25

0 25 50
SETTING (W)

BLEND1
50

25

0 25 50
SETTING (W)

BLEND2
50

25

0 25 50
SETTING (W)

80 ELECTROSURGICAL UNIT PSD-30

 Appendix

Item Specification
High Output power Rated load resistance 300 Ω,
frequency vs setting (SOFT, AUTO STOP: 100 Ω)
output
SOFT
50

25

0 25 50
SETTING (W)

AUTO STOP
50

25

0 25 50
SETTING (W)

FORCED
50

25

0 25 50
SETTING (W)

ELECTROSURGICAL UNIT PSD-30 81

Appendix

Item Specification
Safety Patient/S-cord The function detects improper connections of cords
functions and broken wires in the patient plate and S-cord. It
activates the following functions if irregularities are
detected:
• Patient/S-cord warning indicator will light or flash.
• If the above condition continues for a while, an
alarm will sound and high frequency will stop.
(When using an endoscope without S-cord, an
alarm will sound and the high frequency output will
stop immediately.)
High The function detects whether the output level is in
frequency accordance with the output setting. It activates the
output monitor following functions if irregularities are detected:
• High frequency output warning indicator will light.
• An alarm will sound.
• Output will be prevented.
Output time The function detects the high frequency output time.
monitor It activates the following functions if continuous
output time exceeds the specified time:
• Output time warning Indicator will flash after
15 seconds of continuous output.
• If output continues for 15 more seconds (i.e.
30 seconds continuous output), the output time
warning indicator will light constantly, the warning
alarm will sound (in 5 second intervals), and
output will be prevented.
Foot switch The function detects short-circuit of the foot switch. It
monitor activates the following functions if a short-circuit is
detected:
• The alarm display on the output setting indicator
will flash.
• An alarm will sound.
• Change of setting will be prevented.
• Output will be prevented.
CQM monitor The function turns the CQM indicator on when a
split-type patient plate is used and the connection
between patient and patient plate is correct.

82 ELECTROSURGICAL UNIT PSD-30

 Appendix

Item Specification
Safety Self-check The function detects whether the safety monitor
functions monitor functions mentioned above are working correctly or
not. It activates the following functions if
abnomalities are detected:
• All indicators on the front panel will flash.
• An alarm will sound.
• Change of setting will be prevented.
• Output will be prevented.
Feedback ratio The irregularities are detected by calculating the
monitor ratio of delivered current (through either A-cord) to
return current (through patient plate and S-cord). If
the irregularities are detected, the following functions
are triggered:
• High frequency output warning indicator will light.
• If the above condition continues for a while, an
alarm will sound and high frequency output will be
prevented.
When using an endoscope without a S-cord, high
frequency output warning indicator will light, an
alarm will sound and high frequency output will be
prevented.
Additional Stand-by mode When output is not performed for a long period and
functions the stand-by mode is selected, the following
operations are prevented:
• High frequency output.
• Change of setting classification (electromedical
equipment)
Adjusting the • The output volume can be adjusted in the stand-by
volume mode.
PROGRAM Call the setting and CUT/COAG. mode stored in the
mode memory.

ELECTROSURGICAL UNIT PSD-30 83

Appendix

Item Specification
Classification Type of
(electromedical protection
Class I (3 pin power cord)
equipment) against electric
shock
Degree of TYPE CF (the patient leakage current below
protection 10 µA)
against electric Note: Direct application to the heart should not
shock be attempted as spark discharge during
electrosurgery may affect the cardiac function
of the patient (refer to dangers, warnings and
cautions and EN standard (EN60601-1)).
Degree of Never use the electrosurgical unit where there
protection is a risk of flammable gases.
against
explosion
Additional Defibrillation-protected equipment.
Output circuit Neutral electrode isolated from earth at high
frequency.
Power supply Voltage 220, 230, 240 V
Frequency 50/60 Hz
Input current 2A
Voltage
Within ±10%
fluctuation
Fuse rating 3.15 A, 250 V
Fuse size 5.0 × 20 mm
Size Dimensions 295 mm (W) × 160 mm (H) × 420 mm (L)
Weight 7.8 kg

84 ELECTROSURGICAL UNIT PSD-30

 Appendix

Medical Device This device complies with the

Directive requirements of Directive 93/42/EEC
concerning medical devices.
Classification: Class II b

This device complies with the EMC

requirements of EN 60601-1-2: 2001
when used in combination with
devices bearing CE marking either
on the products or in its instructions
for use.
Emission: Class B of EN 55011
WEEE Directive In accordance with European
Directive 2002/96/EC on Waste
Electrical and Electronic Equipment,
this symbol indicates that the product
must not be disposed of as unsorted
municipal waste, but should be
collected separately.

Refer to your local Olympus

distributor for return and/or collection
systems available in your country.
EMC Applied standards; This instrument complies with the
IEC 60601-1-2: 2001 standards listed in the left column.
IEC 60601-2-2: 1998

CISPR 11 of emission:

Group 1, Class B (standby mode)

This instrument complies with the

EMC standard for medical electrical
equipment; edition 2 (IEC 60601-1-2:
2001). However, when connecting to
an instrument that complies with the
EMC standard for medical electrical
equipment; edition 1 (IEC 60601-1-2:
1993), the whole system complies
with edition 1.
Year of manufacture 7112345
The year of manufacture is given in
the second digit of the serial number.

ELECTROSURGICAL UNIT PSD-30 85

Appendix

EMC information
This model is intended for use in the electromagnetic environments specified
below. The user and the medical staff should ensure that it is used only in these
environments.

 Magnetic emission compliance information and

recommended electromagnetic environments

Emission standard Compliance Guidance

RF emissions Group 1 This instrument uses RF (Radio Frequency) energy only for its
CISPR 11 internal function. Therefore, its RF emissions are very low and are
not likely to cause any interference in nearby electronic equipment.
Radiated emissions Class B This instrument’s RF emissions are very low and are not likely to
CISPR 11 cause any interference in nearby electronic equipment.
Main terminal
conducted emissions
CISPR 11
Harmonic emissions Class A This instrument’s harmonic emissions are low and are not likely to
IEC 61000-3-2 cause any problem in the typical commercial power supply
connected to this instrument.
Voltage Complies This instrument stabilizes its own radio variability and has no affect
fluctuations/flicker such as flicker in lighting apparatus.
emissions
IEC 61000-3-3

86 ELECTROSURGICAL UNIT PSD-30

 Appendix

 Electromagnetic immunity compliance information and

recommended electromagnetic environments

IEC 60601-1-2
Immunity test Compliance level Guidance
test level
Electrostatic Contact: Same as left Floors should by be made of wood, concrete,
discharge (ESD) ±2, ±4, ±6 kV or ceramic tile that hardly produces static. If
IEC 61000-4-2 floors are covered with synthetic material that
Air:
tends to produce static, the relative humidity
±2, ±4, ±8 kV
should be at least 30%.
Electrical fast ±2 kV Same as left Mains power quality should be that of a typical
transient/burst for power supply lines commercial (original condition feeding the
facilities) or hospital environment.
IEC 61000-4-4 ±1 kV
for input/output lines
Surge Differential mode: Same as left Mains power quality should be that of a typical
IEC 61000-4-5 ±0.5, ±1 kV commercial or hospital environment.
Common mode:
±0.5, ±1, ±2 kV
Voltage dips, short < 5% UT Same as left Mains power quality should be that of a typical
interruptions and (> 95% dip in UT) commercial or hospital environment. If the
voltage variations for 0.5 cycle user of this instrument requires continued
on power supply operation during power mains interruptions, it
40% UT
input lines is recommended that this instrument be
(60% dip in UT)
IEC 61000-4-11 powered from an uninterruptible power supply
for 5 cycle or a battery.
70% UT
(30% dip in UT)
for 25 cycle
< 5% UT
(> 95% dip in UT)
for 5 seconds
Power frequency 3 A/m Same as left It is recommended to use this instrument by
(50/60 Hz) maintaining enough distance from any
magnetic field equipment that operates with high current.
IEC 61000-4-8

UT is the AC mains power supply prior to application of the

test level.

ELECTROSURGICAL UNIT PSD-30 87

Appendix

 Cautions and recommended electromagnetic environment

regarding portable and mobile RF communications
equipment such as cellular phones

IEC 60601-1-2 Compliance

Immunity test Guidance
test level level
Formula for recommended separation distance
(V1=E1=3 according to the compliance level)
Conducted RF 3 Vrms 3 V (V1) 3.5
(150 kHz – 80 MHz) d = --------- P
IEC 61000-4-6 V1
Radiated RF 3 V/m 3 V/m (E1) 3.5
(80 MHz – 2.5 GHz) d = --------- P
IEC 61000-4-3 E1
80 MHz – 800 MHz

7
d = ----- P
E1
800 MHz – 2.5 GHz

• Where “P” is the maximum output power rating of the

transmitter in watts (W) according to the transmitter
manufacturer and “d” is the recommended separation
distance in meters (m).
• This instrument complies with the requirements of
IEC 60601-1-2: 2001. However, under electromagnetic
environment that exceeds its noise level, electromagnetic
interference may occur on this instrument.
• Electromagnetic interference may occur on this instrument
near a high-frequency electrosurgical equipment and/or other
equipment marked with the following symbol:

88 ELECTROSURGICAL UNIT PSD-30

 Appendix

 Recommended separation distance between portable and

mobile RF communications equipment and this instrument

Separation distance according to frequency of transmitter (m)

Rated maximum output (calculated as V1=3 and E1=3)
power of transmitter 150 kHz – 80 MHz 80 MHz – 800 MHz 800 MHz – 2.5 GHz
P (W)
d = 1.2 P d = 1.2 P d = 2.3 P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23

The guidance may not apply in some situations.

Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
Portable and mobile RF communications equipment such as
cellular phones should be used no closer to any part of this
instrument, including cables than the recommended
separation distance calculated from the equation applicable
to the frequency of the transmitter.

ELECTROSURGICAL UNIT PSD-30 89

©2001 OLYMPUS MEDICAL SYSTEMS CORP. All rights reserved.
No part of this publication may be reproduced or distributed without the
express written permission of OLYMPUS MEDICAL SYSTEMS CORP.

OLYMPUS is a registered trademark of OLYMPUS CORPORATION.

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