User Manual - ESU 350M
User Manual - ESU 350M
Model 350M
OPERATING MANUAL
Yueh Sheng Electronic Industrial Co., Ltd. Obelis European Authorized Representative
2F., No. 29, Qiangang St., Shilin District Center (O.E.A.R.C)
Taipei City, Taiwan 11170 Boulevard Général Wahis 53
Tel: +886 2 2882 2212 Fax: +886 2 2881 8635 1030 Brussels, BELGIUM
Website: www.yesng.com.tw Tel: +32 2 732 59 54 Fax: +32 2 732 60 03
E-mail: info@yesng.com.tw Website: www.obelis.net
E-mail : mail@obelis.net
MN-350M-EN-A02
MN-350M-EN-A02
Table of Contents
I
MN-350M-EN-A02
II
MN-350M-EN-A02
III
MN-350M-EN-A02
Classifications
Symbol of
Indicating equipment of the “CF” Class. The equipment is protective against cardiac
defibrillator (high voltage).
Symbol of
3. Symbol of
IV
MN-350M-EN-A02
Labels
upright.
Electrosurgical Unit
Model 350M
Figure III. Product identification tag on the outer package of ESU 350M.
V
MN-350M-EN-A02
2. Study the manual and be familiar with the unit’s functions before operating the generator.
6. The patient must not contact any metal objects while under operation. The
high-frequency currents generated by this unit may cause electrical burns if any contacts
are made between the patient and a metal object during an operation.
VI
MN-350M-EN-A02
Specifications
2. Output
Maximum
Operating Maximum Rated Load Frequency
Power
Mode Voltage (Vp-p) (Ω) (kHz)
(watts)
Pure Cut 350 2000 300 384
Mono-polar Blend I 300 3200 300 384
CUT Blend II 250 4000 300 384
Blend III 200 4000 300 384
Mono-polar Standard 120 6000 300 384
COAG Spray 100 11000 300 384
COAG 70 180 50 960
Cut 70 150 50 960
Bipolar
Blend I 60 130 50 960
Blend II 50 120 50 960
3. Dimensions:
42cm (D) x 37cm (W) x 14.5cm (L)
4. Weight:
12.5 kg
5. Applicable Standards:
ISO13485, ISO14971, ISO10993, EN ISO11135-1, EN980, EN60601-1, EN60601-1-2,
EN60601-2-2, 93/42/EEC Directive
VII
MN-350M-EN-A02
Initial Inspections
a) Visually inspect for damages that might have occurred during shipping. If any
damages are found, please contact the shipping agent and our local
representative.
c) Inspect Label 1 (the product identification tag) for the correct input voltage
before connecting to the receptacle. If there are discrepancies, please contact our
local representative or our head office.
Installations
Refer to Sections 1.2.2 and 1.2.3 for the connections of accessories.
1. Output Power Setting Display for Mono-polar Cut 20. Mono-polar / Bipolar Operating Mode Select Key
2. Output Power Increase Key for Mono-polar Cut 21. Mono-polar Operating Mode Indicator
3. Output Power Decrease Key for Mono-polar Cut 22. Bipolar Operating Mode Indicator
4. Operating Mode Select Key for Mono-polar Cut 23. Contact Impedance Display
5. Output Activation Indicator for Mono-polar Cut 24. Contact Impedance Monitor RESET
6. Output Power Setting Display for Mono-polar COAG 25. Patient Plate Circuitry FAULT Indicator
7. Output Power Increase Key for Mono-polar COAG 26. Pure Cut Operating Mode Indicator
8. Output Power Decrease Key for Mono-polar COAG 27. Blend I Cut Operating Mode Indicator
9. Operating Mode Select Key for Mono-polar COAG 28. Blend II Cut Operating Mode Indicator
10. Output Activation Indicator for Mono-polar COAG 29. Blend III Cut Operating Mode Indicator
11. Output Power Setting Display for Bipolar-cut 30. Standard COAG Operating Mode Indicator
12. Output Power Increase Key for Bipolar-cut 31. Spray COAG Operating Mode Indicator
13. Output Power Decrease Key for Bipolar-cut 32. Bipolar Cut Operating Mode Indicator
14. Operating Mode Select Key for Bipolar-cut 33. Bipolar Blend I Operating Mode Indicator
15. Output Activation Indicator for Bipolar-cut 34. Bipolar Blend II Operating Mode Indicator
16. Output Power Setting Display for Bipolar COAG 35. Memory Channel Display
17. Output Power Increase Key for Bipolar COAG 36. Memory Channel Increase Key
18. Output Power Decrease Key for Bipolar COAG 37. Memory Channel Decrease Key
19. Output Activation Indicator for Bipolar COAG 38. Memory Channel SET/ENTER Key
a) Precautions
Patient plate must be fully attached to the patient’s skin before generating
any mono-polar outputs from the ESU. False and/or improper connections
may result in skin-burn injuries. Always check for proper attachments and
connections if the patient is re-positioned during a surgery.
Avoid resting cables (such as cable for surgical pencil, patient plate, or
cables for bipolar forceps) on the patient to minimize the possibility of HF
burns to the patient.
As a general safety guideline, always start with a low output power setting.
Gradually increase the output power if necessary until the desired clinical
effect is achieved.
Figure 1.7 The contact impedance monitor located on the front panel of ESU 350M.
To connect a patient plate to its cable, lift the tab on the clip of the cable and
insert a patient plate fully into the clip as shown in Figure 1.8. Lock the clip
securely and connect the other end of the cable to the utility panel of the
ESU as shown in Figure 1.5 in Section 1.2.2.
unlock
lock
3-meter cable
clip
patient plate
Adjust the selector on the Utility Panel (as shown in Figure 1.4) to match
the chosen type of connector.
1. Mono-polar/bipolar
Operating Mode Select Key.
2. Mono-polar Operating Mode
Indicator.
3. Bipolar Operating Mode
1 2 3
Indicator.
Figure 1.9 Bipolar/mono-polar mode select key and their corresponding indicators.
The 350M can be operated under mono-polar mode, bipolar mode, or under
both modes simultaneously. The operating-mode indicators illuminate
according to the selected modes.
i) Mono-polar Cutting
1 2 3 4 5 6 7 8 9
Figure 1.10 The control interface for CUT mode on the control panel of ESU 350M.
– Pure cut
Cuts tissue with little to no coagulation effect. Provides powerful and
fast cutting results.
– Blend I Cut
Cuts tissue with low coagulation effect.
– Blend II Cut
Cuts tissue with medium coagulation effect.
– The ESU generates an output tone from its speaker when the CUT
output is activated.
Figure 1.11 The control interface for mono-polar coagulation on the 350M.
– Standard coagulation
Standard coagulation uses high-density currents to coagulate tissues
quickly and efficiently. The Standard mode is usually used for small-
to medium-hemorrhagic areas. Standard coagulation is sometimes
called desiccation or forced coagulation.
– Spray coagulation
Spray coagulation uses very high voltages to generate “arching
currents”. The current travels through air, and is “sprayed” onto the
tissue, resulting in a large coagulation area. Therefore, the Spray mode
is generally used for large-hemorrhagic surfaces. Spray coagulation is
also known as fulguration.
– The ESU generates an output tone from its speaker when the COAG
output is activated.
Figure 1.12 Electrosurgical hand-controlled pencil with remote capability (part number 80207-A).
To adjust the output power for mono-polar CUT, direct the pencil away from
the patient so that the electrode does not contact the patient. Press CUT
button once, then press F1 to increase the output power, or F2 to decrease
the output power.
To adjust the output power for mono-polar COAG, direct the pencil away
from the patient so that the electrode does not contact the patient. Press
COAG button once, then press F1 to increase the output power, or F2 to
decrease the output power.
– Bipolar operations are done with bipolar forceps. The outputs are
activated by a foot control switch.
– Connect the banana jack to the utility panel of the ESU as shown in
Figure 1.4 and Figure 1.5 in Section 1.2.2.
WARNING
Ensure that the patient plate is adhered onto the patient’s skin fully, and the cable
for patient plate is connected properly to the ESU before any mono-polar outputs
are activated. This precaution may be exempted if the surgery requires only
bipolar outputs, and the mono-polar output modes are switched OFF by using
the mode select key as mentioned in 1.2.4(c).
i) Mono-polar outputs
– With a hand-controlled surgical pencil (disposable and reusable) :
3-prong hand-controlled
surgical pencil
3-meter cable
Figure 1.15 Location of CUT and COAG buttons on a hand-controlled surgical pencil
connector
foot-controlled surgical
pencil
3-meter cable
e)
Figure 1.16 Connecting a foot-controlled surgical pencil to the ESU.
FOOT SWITCH
3-meter cable
bipolar forceps
– Connect the banana jacks to the utility panel of the ESU as shown in
Figure 1.4 in Section 1.2.2.
– Connect the foot control switch to the ESU according to Figure 1.17.
– Step on the COAG pedal of the foot control switch to activate the
bipolar coagulation output.
FOOT SWITCH
To save a preference in the memory, select a desired memory channel by using F1 and
F2 buttons. Press F1 to navigate through memory channels DOWN. Press F2 to
navigate through memory channels UP.
Once the desired memory channel has been chosen, adjust the operating modes and
their output powers to the desired settings. Press the ENTER key. The Memory
Channel display flashes three times to indicate that the chosen settings have been
saved to the memory channel shown.
The memory function saves all operating modes and their output power settings.
These settings remain in the memory even after power down. Press UP or DOWN
keys to navigate through memory channels.
a) Cleaning
Wipe the accessories with a damped sponge or a piece of cloth with a mild
b) Disinfecting
Gently wipe the accessories with a 75% methylated spirit and water solution, or
soak the accessories in a 75% alcohol solution for at least 30 minutes.
c) Sterilizing
Three sterilization methods are available. However, it is important to verify that
the product can withstand the chosen sterilization method. Cables must not be
folded or coiled during sterilization or storage.
Moist heat (autoclave) – Please follow EN554 Standards (Sterilization of
Medical Device – Validation and Routine Control of Sterilization by Moist
Heat).
Ethylene Oxide (EO) – Please follow EN550 Standards (Sterilization of
Medical Devices – Validation and Routine Control of Ethylene Oxide
Sterilization).
Irradiation (Gamma) – Please follow EN552 Standards (Sterilization of
Medical Devices – Validation and Routine Control of Sterilization by
Irradiation)
d) Care instructions
Electrodes, hand-control pencils, foot-control pencils, bipolar forceps and
their cables, can be sterilized by autoclave for up to 50 times. It is
recommended to discard these products after the maximum sterilization
count has been reached.
Electrosurgical pencils (hand-control and foot-control) and cable for bipolar
forceps must be inspected and tested after sterilization for damages which
may have occurred. An ohm meter should be used to measure the
conductivity. Please contact an authorized representative if replacements are
required.
Bipolar forceps and electrodes must be visually inspected for damages such
as apparent scratches or cracks. Using a defected accessory is hazardous to
both the user and the patient.
WARNING
Do not use sterilized products if the packaging has been damaged before
opening.
Do not reuse or re-sterile disposable accessories.
Do not use disposable products after the expiry date.
Store and use the disposable accessories according the instructions given on
their packaging.
Disposable patient plates are adhered onto a patient’s skin; therefore, they do not
require sterilization. However, do not use the product after the expiration date. The
chemical characteristics of the hydro gel may be changed significantly after the
expiration date.
Please contact our authorized representative or our head office for a complete
selection of disposable accessories.
WARNING
Turn off and unplug the generator before cleaning.
The calibration procedures should only be done by qualified technicians.
Contact our authorized representative or our head office if technical
assistance is needed.
3.1.1 Cleaning
Use a clean, soft, and slightly damped cloth to gently wipe down the exterior of the
generator. Do not use excessive water as doing so may damage the electrical circuits.
Use only dry cloth for the rear panel of the ESU. It is not necessary to sterile the ESU.
Potentiometers U8 U15
Output Types Standard Spray
Table 3.2 Potentiometers and their corresponding coagulation functions.
Potentiometer U16
Output Type Bipolar COAG
Table 3.3 The potentiometer used to calibrate bipolar COAG.
WARNING
The following procedures should only be carried out by qualified
technicians. Please contact our head office or an authorized representative if
technical assistance or repair parts are needed.
3.2.1 Troubleshooting
Generator freezes / not responding to the buttons pressed
1. Turn the generator OFF. Reset the CPU by switch S1 OFF and ON again.
2. Switch the generator back to ON.
3. If steps 1 and 2 do not solve the problem, remove the front panel and inspect the
conductivity of the push buttons.
4. Replace crystal Y1 if all of the above steps fail to correct the problem.
Alarm ON continuously
1. Check for proper attachment of the patient plate.
2. Inspect the patient plate cable for conductivity.
3. Refer to Section 3.1.2.4 for calibration procedures for Contact Impedance
Monitor.
No outputs
1. Inspect all fuses and connections.
2. Inspect the conductivity of all accessories.
3. Visually inspect for damages on all PCB’s. Repair any broken tracks.
4. Inspect transistor Q4 on the motherboard. This transistor acts a switch to hand
control outputs.
5. Inspect the diode bridge on the driver board. Replace if they are shorted.
6. Test the MOSFET’s Q8, Q5, Q4, and Q9 on the driver board. Replace if
necessary. If a MOSFET is replaced, inspect the diode Z18V and the 5.6Ω
resistor which are in series with the replaced MOSFET.
7. If Steps 1 to 6 are performed and the generator is still not producing outputs,
replace the voltage regulator YS_M04 on the motherboard. This voltage
regulator is a custom-made part, and can only be obtained from Yueh Sheng.
Please contact our head office or an authorized representative if YS_M04 is
needed.
8. If any of the parts listed in Step 5 to Step 7 are replaced, measure the standby
voltage at D71. The voltage reading should be 16V to 20V. If this reading is
incorrect, use VR5 to adjust to the correct voltage level.
9. Please contact our head office or an authorized representative if the above steps
fail to correct the problem. Do not attempt to change any components other than
those listed above. Ensure that the replaced parts are of equivalent specifications
to the original parts.
YS-3001 05/03/07
YS350M 3/16/01
page 3 of 3
page 5 of 5
2014,Feb.,25