STARmed VIVA combo RF Generator User manual

User’s Guide
RF Lesion generator for tissue
ablation during surgical procedures
with
Coagulation Electrode
(ST-UM-15E Rev.9)

User’s Guide for RF Lesion generator for tissue ablation during surgical procedures with coagulation Electrode (ST-UM-15E(Rev.9))
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Only the certified medical doctors, capable of conducting surgical treatment using special techniques
should use the described equipment in this user’s guide. The purpose of this user’s guide is to present
the way to use the radiofrequency lesion generator and the electrode of STARmed.
Caution
This product can be sold only to the medical professional or based only on their
request in accordance to the Medical Devices Law.
Equipment covered in this manual
Radiofrequency (RF) Lesion generator for tissue ablation during surgical procedures
with coagulation electrode.
Part No.
Effective date 25th November 2019
Notices
No part of this document may be reproduced, stored in a retrieval system, or
transmitted, in any form or by any means-electronic, mechanical photocopying,
recording, or otherwise-without written consent of STARmed. Additional copies of this
document can be provided if requested.
EC Authorised Representative
EMERGO EUROPE
Prinsessegracht 20 2514 AP The Hague The Netherlands
Device is compliant with the European Communities council directive
2007/47/EC, medical device directive.
Manufactured by:
STARmed Co., Ltd.
(Jungsan-dong, Daebang-Triplaon Business Tower), B-dong, 4F & 12F, 158,
Haneulmaeul-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do, Korea
TEL: [phone]
FAX: [phone]
website
www.STARmed4U.com

User’s Guide for RF Lesion generator for tissue ablation during surgical procedures with coagulation Electrode (ST-UM-15E(Rev.9))
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Product warranty
Warranty is for one year.
The company will repair this product for free during the warranty period, one year from the
date of purchase, when there is malfunction or product defect that may have been a result
of normal transportation and use.
Repair is charged in the following cases.
▪ Malfunction resulting from natural calamity such as fire, earthquake, fall etc.
▪ Malfunction resulting from inappropriate move of the product and user’s
negligent use after installation
▪ Malfunction resulting from unlawful renovation or repair
▪ Defect or malfunction occurring after the warranty period expires
▪ Malfunction resulting when user neglects the warning specified in this user’s
guide
▪ Replacement of consumable parts such as battery due to inevitable wear and
tear resulting from use

User’s Guide for RF Lesion generator for tissue ablation during surgical procedures with coagulation Electrode (ST-UM-15E(Rev.9))
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Safety warning
Danger
Indication of the hazardous situation that could result in death, serious injury,
or permanent impairment.
Warning
Indication of the hazardous situation that could result in minor or moderate
harm to a body structure.
Important
Information on the proper use, storage, and maintenance of the product.
Caution
Precaution that describes an unsafe situation that could cause equipment
damage or product malfunction.

User’s Guide for RF Lesion generator for tissue ablation during surgical procedures with coagulation Electrode (ST-UM-15E(Rev.9))
v
Product warranty.................................................................................................................................................................. iii
Safety warning....................................................................................................................................................................... iv
1. System overview...........................................................................................................................................................1
Caution for electric safety............................................................................................................................................ 2
Radiofrequency lesion generator......................................................................................................................... 2
Peristaltic pump.............................................................................................................................................................2
Caution for general safety ...........................................................................................................................................3
Radiofrequency lesion generator with coagulation electrodes ..........................................................3
Grounding pads .............................................................................................................................................................4
Coagulation Electrode................................................................................................................................................5
Surgical treatment cautions........................................................................................................................................6
Intended use ........................................................................................................................................................................ 6
Contraindications .............................................................................................................................................................6
Complications..................................................................................................................................................................... 6
Intended PATIENT population....................................................................................................................................6
Intended USER PROFILE..............................................................................................................................................7
Intended conditions of use..........................................................................................................................................7
Operating principle ..........................................................................................................................................................7
Essential Performance...................................................................................................................................................7
System description..........................................................................................................................................................8
Applied part......................................................................................................................................................................8
Components.....................................................................................................................................................................8
EMC Information ...............................................................................................................................................................9
Preparations before use............................................................................................................................................. 10
Radiofrequency lesion generator...................................................................................................................... 10
Peristaltic pump.......................................................................................................................................................... 10
Electrode tubing set connection ....................................................................................................................... 10
Grounding pads inspection.................................................................................................................................. 10
Checking RF electrode and tubing set........................................................................................................... 11
2. Radiofrequency lesion generator..................................................................................................................... 13
Description of generator’s front panel............................................................................................................... 14
Description of generator’s rear panel ................................................................................................................ 15
Description of generator’s side panel ................................................................................................................ 16
Main screen....................................................................................................................................................................... 17
Usage 19
(1) AUTO Mode............................................................................................................................................................. 19
(2) GENERAL Mode ................................................................................................................................................... 20
(3) CONTINUANCE Mode(TRACK ABLATION)........................................................................................... 21
(4) TEMPERATURE Mode....................................................................................................................................... 22

User’s Guide for RF Lesion generator for tissue ablation during surgical procedures with coagulation Electrode (ST-UM-15E(Rev.9))
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(5) Measuring Impedance ...................................................................................................................................... 23
A. Operation and storage of PC linked monitor program .................................................................... 24
B. Installing and running of monitoring software on tablet PC (VIVALogger) ......................... 29
C. Foot switch installation and operations guide .................................................................................... 31
Labeling & Packaging ................................................................................................................................................. 34
Labeling........................................................................................................................................................................... 34
Packaging....................................................................................................................................................................... 34
Explanation of symbols.............................................................................................................................................. 35
RF generator ................................................................................................................................................................. 35
Box 36
Generator output power characterization....................................................................................................... 37
Diagram of power output data ............................................................................................................................. 38
Radiofrequency lesion generator specifications ......................................................................................... 39
3. Peristaltic pump ......................................................................................................................................................... 40
Description ........................................................................................................................................................................ 41
Preparations ..................................................................................................................................................................... 43
Explanation of symbols.............................................................................................................................................. 43
Peristaltic pump specifications ............................................................................................................................. 44
4. Others.................................................................................................................................................................................. 45
Device Classification ................................................................................................................................................... 46
Storage and management after use .................................................................................................................... 46
Equipment waste and management .................................................................................................................... 47
Cleaning and Disinfection......................................................................................................................................... 47
Maintenance and Service .......................................................................................................................................... 48
Other matters ................................................................................................................................................................... 49

User’s Guide for RF Lesion generator for tissue ablation during surgical procedures with coagulation Electrode (ST-UM-15E(Rev.9))
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1. System overview
Caution
Use this equipment only after reading the warning, cautions and information on
the product’s usage.
Use other accessories related to this equipment only after reading the
warnings, cautions, and information on the product’s usage. The user’s guide
for the electrode is provided separately.

User’s Guide for RF Lesion generator for tissue ablation during surgical procedures with coagulation Electrode (ST-UM-15E(Rev.9))
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Caution for electric safety
Radiofrequency lesion generator
The equipment is designed for the safety and effectiveness of performance, but it is also
important how user utilizes the equipment. Read the user’s guide before operating the RF
Lesion generator and the pump.
Caution
User should not disassemble the equipment. Inquire with the STARmed on how
to prevent electric shock.
Disconnect the device from the power before cleaning or performing
maintenance
Electrical medical equipment requires special precautions regarding EMC. The
product needs to be installed according to EMC requirements.
Use of this equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary,
this equipment and the other equipment should be observed to verify that they
are operating normally.
Warning
Do not use on patients with cardiac pacemakers or other active implants.
This equipment outputs energy that can exert physical harm.
This equipment must only be connected to a grounded power supply.
Be cautious not to connect any conductive items to a patient except for
grounding pads.
Connect this equipment to a grounded power supply. The user or patient could
be injured due to electric shock if a grounded power supply isn’t used.
modification of this equipment is not allowed.
Do not use this equipment at a place that is vulnerable to explosion and/or
where there is flammable material.
Caution
A time interval of approximately five minutes is required (after a coagulation
procedure) to stabilize the equipment before the next procedure is started.
Instructions that indicate the output power should be set as low as possible for
the intended purpose.
Peristaltic pump
Warning
Stop the pump immediately and remove the power cord if the pump becomes
wet.
User should not disassemble the equipment. Inquire with STARmed on how to
prevent electric shock.
Do not use this pump at a place that is vulnerable to explosion and/or where
there is flammable material.

User’s Guide for RF Lesion generator for tissue ablation during surgical procedures with coagulation Electrode (ST-UM-15E(Rev.9))
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Caution for general safety
VIVA combo RF Generator is radiofrequency generator for the cautery of tissue
concerning the electrode’s tip due to the radiofrequency current. This equipment is safe
from electric danger and it has obtained a permit based on the Medical Equipment Law.
VIVA combo RF Generator was certified as appropriate by the EN60601-1, EN60601-2-2,
EN60601-1-2. This is a Class 1 Type BF medical device.
warning
The risk of ignition by combustible gas or material at the time of electrosurgery
is very high. Thus, if possible, do not place the equipment near combustible
materials before the electrosurgery. Avoid using combustible anesthetic drugs,
nitrogen oxide, and oxygen on the thorax or head when conducting treatment.
Do not place these items near the equipment.
Remove combustible materials used for cleaning and/or removing
contaminants before conducting the radiofrequency treatment. Combustible
materials remaining on the patient’s body could cause a dangerous situation.
There is risk of ignition even when the equipment is used normally.
Be careful of the danger of ignition due to the endogenous gas. Materials such
as cotton wool and gauze adhere to the oxygen. Thus, there is risk of ignition
resulting from flame even when the equipment is used normally.
Radiofrequency lesion generator with coagulation electrodes
warning
All electrodes from STARmed Co., Ltd. are recommended for use only with
STARmed radiofrequency lesion generators. Please inquire with STARmed on
the use of the VIVA, star, and Octopus radiofrequency electrodes.
VIVA combo RF Generator’s Maximum output voltage is 275Vp-p.Use the
accessories with rated voltage above 275Vp-p.
A warning indicating failure of HF surgical equipment could result in an
unintended increase of output power.
Caution
When fitting the tube into the pump’s head, check the exact location after
confirming the tube’s measurement. Then, secure the tube by pulling on the
lever so that the tube will not deviate during use.
Always use the STARmed inflow-outflow tubing set. Use a new tubing set for
each patient.
Use only non-flammable agents for cleaning and disinfecting.
Allow any flammable agents used for cleaning or disinfecting to evaporate
before the electrosurgery.
Information indicating, there is a risk of pooling of flammable solutions under
the patient or in body depressions such as the umbilicus, and in body cavities
such as the vagina
warning
When radiofrequency output is suspected, even after the button on the front
panel or foot switch is pressed to stop the radiofrequency output, press the
main power switch located on the equipment’s rear panel immediately to stop
the power. Then, remove the electrode’s connector from the RF generator. Stop
using the equipment and request service.
Use this equipment only at a place where emergency electric power is supplied,
or use it with an UPS (Uninterruptible Power Supply) to prepare for the risk of
power failure while operating the equipment.
RF communications equipment (including peripherals such as antenna cables
and external antennas) should not be used within 30 cm (12 inches) of any part

User’s Guide for RF Lesion generator for tissue ablation during surgical procedures with coagulation Electrode (ST-UM-15E(Rev.9))
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of the VCS10, including cables specified by STARMED.
Otherwise, this could result in performance degradation.
Caution
There may be a defect with the grounding pads or electrode cable connection
if the radiofrequency output comes out too low or when the output does not
come out after starting the electrosurgery. Do not increase the radiofrequency
output before identifying the root cause. Confirm that the grounding pads are
attached to the patient’s skin correctly after a patient moves or changes
posture.
The radiofrequency lesion generator and pump may cause electromagnetic
wave obstruction in other equipment even when it is operating normally. Place
the other equipment as far away as possible if electromagnetic wave
obstruction is generated.
Electrodes and probes used for monitoring and imaging can disrupt the
radiofrequency current. To avoid unintentional burns, place all other electrodes
and probes as far away as possible from the grounding pads and the area to
be treated. The use of needle injected monitoring electrodes is prohibited.
It is possible that noise beyond the guaranteed immunity requirements of IEC
60601-1-2, such as any radiofrequency transmitting equipment and/or other
sources of electrical noise, can result in disruption of the device’s operation.
It is recommended to use monitoring systems that incorporate high frequency
current-limiting devices.
It is recommended to position a patient in such a way that contact with the
patient or other leads is avoided.
Recommendation to, temporarily, store unused active electrodes in a location
isolated from patient
Instructions stating, use of bipolar techniques may be desirable in order to
avoid unwanted tissue damage for surgical procedures where HF current could
flow through relatively small cross-sectional area of body.
Foot switch operation type is non-continuance activation and press the switch
for more than 1 second to start the RF output. Refer to foot switch operation
guide.
The EMISSIONS characteristics of this equipment make it suitable for use in
industrial areas and hospitals (CISPR 11 class A). If it is used in a residential
environment (for which CISPR 11 class B is normally required) this equipment
might not offer adequate protection to radio-frequency communication services.
The user might need to take mitigation measures, such as relocating or re-
orienting the equipment.
Grounding pads
warning
Attaching the Grounding pads correctly at the appropriate part is crucial for the
safe and effective use of this equipment, as well as to avoid grounding pad
burns. Read the Instruction for Use (IFU) that is included with all electrodes
from STARmed Co., Ltd for the correct grounding pad usage. The IFU includes
the information on the preparation of the grounding pads, location for
attachment, inspection, and removal.
When using a single electrode, attach two grounding pads. It is necessary to
attach four grounding pads when using multi electrodes. The radiofrequency
current gets distributed more evenly when the grounding pads are attached to
a wider area. This can also help prevent heat generation within the pad. The
distance between each attached pad and cautery lesion should be made as
equal as possible to prevent burning.

User’s Guide for RF Lesion generator for tissue ablation during surgical procedures with coagulation Electrode (ST-UM-15E(Rev.9))
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Be careful not to overheat the grounding pads during ablation.
Avoid air bubbles by carefully attach the grounding pads completely onto a
patient. Remove body hair from the grounding pad area if necessary.
To prevent the incident burn due to the contact between patient’s skin and skin,
place gauze pad in the part where there is contact between the skin and skin
in an appropriate manner.
Coagulation Electrode
warning
Use caution after removing the electrode from the package to avoid
contamination. Avoid applying excessive force to the electrode to prevent
damage before use.
Check whether there is groove or crevice in the electrode’s insulation and/or
cable before using the electrode. The radiofrequency current may leak out if
there is an insulation defect. This means that the amount of current that flows
at the electrode’s tip can decrease, and there is high possibility that burning
may result in an unintended area.
The measurement of the body’s temperature through the electrode may be
inaccurate even when the pump is turned off. The coolant’s temperature is
bound to decrease due to the circulation when the pump is being operated.
When using the CONTINUANCE mode, adjust the settings so that the stable
performance is maintained, and that the radiofrequency output can increase
slowly.
Caution
Conduct periodical performance and safety tests for the reusable cables and
accessories.
Note: Problem may result when the supplementary accessories are used once.
Note: Conduct periodical test of the accessories at all times, and record the results.

User’s Guide for RF Lesion generator for tissue ablation during surgical procedures with coagulation Electrode (ST-UM-15E(Rev.9))
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Surgical treatment cautions
warning
A standard biopsy procedure is required to place the coagulation electrode to
the part that is subject to cautery.
It is necessary to use diagnostic imaging to predicate the necrotic tissue area.
Pre-clinical training is required for the doctors by appropriate literature or
education to use the electrode of RF lesion generator for tissue ablation during
surgical procedures .
Caution
The equipment’s performance is important to obtain safe and effective
coagulation results, but the operator’s skill is a significant factor as well. Please
read all instructions on how to use the radiofrequency lesion generator and
pump. Please provide this user’s guide to operating and/or maintenance users.
Important
If the VIVA combo RF generator is affected by an electrostatic discharge(ESD)
or power surge, the PC connection may get disconnected. If that happens, the
PC linked program should be connected again.
The electrode should only be used with STARmed Co., Ltd. products.
Intended use
RF Lesion generator for tissue ablation during surgical procedures is intended for
coagulation of tissue during percutaneous, laparoscopic, and intraoperative surgical
procedures.
Contraindications
The RF Lesion generator for tissue ablation during surgical procedures is contraindicated
for use in patients with Implantable Pacemakers and Automatic Implantable
Cardioverter/Defibrillators (AICDs), as they may be adversely affected by radiofrequency
(RF) current.
Complications
The following types of complications may result due to the use of the radiofrequency lesion
generator and electrode.
- tumor recurrence
- burn due to the over-heating of the surgical equipment
- dangerous situation due to the unskilled equipment control
- cross-infection or complications due to the re-use of the inappropriate
electrode
- ascites/diarrhea
- bleeding of the coagulated part
- ventricular fibrillation
Intended PATIENT population
a) Age : newborns to geriatric
b) Weight : > 2.5kg
c) Gender : Male and Female
d) Health: Use for the patient with liver cancer, thyroid cancer, lung cancer, kidney cancer,
or other lesions.
e) Nationality : multiple
f) Patient’s state: The patient is not the device user. Not relevant unless the patient
is agitated.

User’s Guide for RF Lesion generator for tissue ablation during surgical procedures with coagulation Electrode (ST-UM-15E(Rev.9))
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Intended USER PROFILE
Considerations
Requirement description
Education
Minimum
• Medical doctor who has medical license.
Maximum
• N/A
Knowledge
Minimum
• Knowledge of the side effect or complications due to the
error of medical device.
• Clinical expertise with appropriate literature or training
Maximum
• N/A
Language
comprehension
Minimum
• Understand the manual
• Understand the meaning of the abbreviation.
Maximum
• N/A
Experience
Minimum
•Procedure performance and specific technology training
•Device usage and safety training
Maximum
• N/A
Intended conditions of use
Considerations
Requirement description
Environment
General
• Only for professional use
• Use at the operating room in the hospital
• Keep the accuracy of output when function is operating.
• No flammable materials
• Connect electrode to peristaltic pump with activating
coolant.
• Use only after installing the device on a flat surface
• An electrode from a different device shall be located far
away
Frequency
of use
• Use for a maximum of 30 minutes.
• The power cycle is 10 seconds on / 30 seconds off.
Mobility
• The device can be transported inside of hospital operating rooms.
Operating principle
The RF generator works at 500kHz. The frequency flows to the electrode’s tip and then
is applied to the tissue. Frictional heat occurs and causes the ions to move from the
negative pole to the positive pole and from the positive pole to the negative pole forty to
fifty thousand times per second. Tissue necrosis is the principle that occurs by using heat
generated from the tissue impedance.
Essential Performance
Essential performance of this equipment are as followings;
- Accuracy of output control setting
- Monotonicity of output control setting
- Accuracy of maximum output voltage

User’s Guide for RF Lesion generator for tissue ablation during surgical procedures with coagulation Electrode (ST-UM-15E(Rev.9))
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System description
The VIVA combo RF system consists of an RF generator, Peristaltic pump, cables,
and accessories. This VIVA combo RF Lesion generator is designed to coagulate
local tissue through a coagulation electrode.
Radiofrequency power is supplied and controlled with maximum of 200 Watt.
Power, impedance, current and temperature are monitored. The temperature of
the electrode’s tip is monitored for charring.
Power, impedance, current and temperature are stored through a PC software
program after connecting the communication terminal of the rear panel of the RF
generator with the PC via the communication cable.
Applied part
Grounding pads, Electrode tip
Components
1. VIVA combo RF Generator
2. coagulation electrode set (optional: supplied separately)
3. electrode conversion cable (optional)
- Total Length : 0.28m±10, SPP Series
4. Peristaltic pump
5. foot switch (1 tier: blue) (optional): RF ON/OFF button function
- Total Length : 4.1m±10, SN Series
6. foot switch (2 tier: blue/yellow) (optional): RF power adjustment function
- Total Length : 4.1m±10, SN Series
7. power cable
- Total Length : 1.8m±10
8. USB communication cable
- Total Length : 1.9m±10, USB A B Type
9. CD (user’s guide, PC linked monitor program, USB driver)
10. equipotential earthing cable
- Total Length : 2.1m±10, MC POAG Series
11. user’s guide
Caution
Use of accessories, transducers and cables other than those specified or
provided by the manufacturer of this equipment could result in increased
electromagnetic emissions of decreased electromagnetic immunity of this
equipment and result in improper operation.
1.
Caution
Refer to the list of components above for all the cables and maximum lengths
of cables, transducers and other ACCESSORIES that are replaceable by the
RESPONSIBLE ORGANIZATION and that are likely to affect compliance of the
ME. Refer to above list of components.

User’s Guide for RF Lesion generator for tissue ablation during surgical procedures with coagulation Electrode (ST-UM-15E(Rev.9))
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EMC Information
Phenomenon
Basic EMC
standard or test
method
Port tested
Test level/requirement
Mains terminal
disturbance voltage
CISPR11:2015
AC Mains
Group2, Class A
Radiated disturbance
CISPR11:2015
Enclosure
Group2, Class A
Harmonic Current Emission
IEC 61000-3-2:2014
AC Mains
Class A
Voltage change,
Voltage fluctuations and
Flicker Emission
IEC 61000-3-3:2013
AC Mains
Pst: 1
Plt: 0.65
Tmax:0.5
dmax: 4%
dc: 3.3%
Electrostatic Discharge Immunity
IEC 61000-4-2:2008
Enclosure
±8 kV/Contact
±2, ±4, ±8,
±15 kV/Air
Radiated RF
Electromagnetic Field Immunity
IEC 61000-4-3:2006
A1:2007+A2:2010
Enclosure
3 V/m
80 MHz-2.7 GHz
80% AM at 1 kHz
Immunity to
Proximity Fields
from RF wireless Communications
Equipment
IEC 61000-4-3:2006
A1:2007+A2:2010
Enclosure
Table 9 in
IEC 60601-1-2:
2014
Electrical Fast Transient/Burst
Immunity
IEC 61000-4-4:2012
AC Mains
±2 kV, 100 kHz repetition frequency
Surge Immunity
IEC 61000-4-5:2014
AC Mains
Line to Line
±0.5 kV, ±1 kV
Line to Ground
±0.5 kV, ±1 kV, ±2 kV
Immunity to
Conducted Disturbances Induced by
RF fields
IEC 61000-4-6:2013
AC Mains
3 V
0.15-80 MHz
6 V in ISM bands
Between 0.15 MHz and 80 MHz
80% AM at 1 kHz
Sip/Sop
Patient
Connected
Power Frequency Magnetic Field
Immunity
IEC 61000-4-8:2009
Enclosure
30 A/m
50 Hz & 60 Hz
Voltage dips
IEC 61000-4-11:
2004
AC Mains
0 % U
T: 0.5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°, 270°
and 315°
0 % U
T; 1 cycle and 70 %
U
T; 25/30
Cycles Single phase: at 0º
Voltage interruptions
IEC 61000-4-11:
2004
AC Mains
0 % U
T; 250/300 cycle

User’s Guide for RF Lesion generator for tissue ablation during surgical procedures with coagulation Electrode (ST-UM-15E(Rev.9))
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Preparations before use
Radiofrequency lesion generator
1. Check the rated voltage is correct for the equipment before connecting the
power .
Caution
The equipment may be damaged if it is not connected to the correct voltage.
2. Warning: To avoid risk of electric shock, this equipment must only be connected
to a power supply with protective earth.
3. Avoid using the equipment at an unsanitary or flammable place.
4. Power on, Power off Procedure
4-1 Before Surgery
1) Connect the power cable to the RF generator
2) Press the power switch
3) Check the main menu
4-2. After Surgery
1) The output is stopped
2) Press the power switch
3) Disconnect the power cable from the RF Generator
Peristaltic pump
1. Connect the power cable to the pump’s rear part.
2. Warning : to avoid risk of electric shock, this equipment must only be connected
to a power supply with protective earth.
Electrode tubing set connection
Preparation materials:
 Coolant container (3L capacity)
 Cooled sterilized saline solution bag (1 - 3L)
1. Make sure that the IV bag is sufficiently cooled before the treatment.
2. Use the saline solution as coolant before the treatment.
Note: 2L coolant is appropriate for a 12 minutes-long treatment. The pump’s flow rate
is appropriately 100ml/min.
3. The coolant temperature is indicated on the generator when the coolant is connected
and circulating through the pump. The cooling temperature is normally less than 20℃.
When the cooling temperature is over 25℃, ensure that the coolant’s temperature is
maintained by placing the IV bag into the coolant’s storage container.
Grounding pads inspection
1. When attaching the grounding pads to the patient’s thigh, please make the
pads are firmly attached without air bubbles or irregularity.
2. There is a risk of burning when the grounding pads are not completely attached
to the patient’s thigh. Double-check the location and attachment of the
grounding pads.
3. Connect the grounding pads with the ground Plate connector (P9532-EXT).
Then, plug the grounding connector to the generator’s front panel.

User’s Guide for RF Lesion generator for tissue ablation during surgical procedures with coagulation Electrode (ST-UM-15E(Rev.9))
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Checking RF electrode and tubing set
Connect the electrode and the tubing set in the following sequence:
Note: Confirm that the power cables for the generator and the pump are
connected.
[VP01]
1. Place the IV bag above the patient and equipment to allow the air in the IV bag
to elevate upward.
2. Pull the tube’s compression lever indicated in the following photo in a
counterclockwise direction.
3. Place the pump’s tube in the roller that is located inside of the pump’s head.
Adjust the tube so that the left and right parts of the tube are similar in length.
Note: Check that the coolant’s flow direction is set in the correct direction of the
pump’s head. Check the direction of the arrow on the front of the pump.
4. Pull down the roller head’s cover by pushing the tube compression lever to the
very end towards the right side up to 180°. Check to make sure the tube is tight
and placed correctly.
[Location for the pump diagram]
5. Push the input tube’s spike into the inside of the saline solution bag while the
input tube’s roller clamp is temporarily closed.
6. Place the ends of the output tube in the water container after connecting the
output tube to the electrode’s coolant outflow connector.
7. Open the Input tubing’s roller clamp.

User’s Guide for RF Lesion generator for tissue ablation during surgical procedures with coagulation Electrode (ST-UM-15E(Rev.9))
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[VP01-1]
1. The saline solution bag should be located above the equipment and the patient
so that the force of gravity helps the solution to flow downward.
2. Flip the cover upwards as indicated in the photo below.
3. Place the pump’s tubing in the roller located inside the pump’s head. Adjust the
tubing so that the length of the tubing is equal on both sides of the pump.
Note: Check that the arrow on the pump and tubing is facing the same direction.
Check that the coolant flows in the same direction as indicated on the arrow.
4. Flip the cover down and check that the tubing is secure.
[Location for the pump diagram]
5. Push the inflow tubing’s spike into the inside of the saline solution bag while
the inflow tubing’s roller clamp is temporarily closed.
6. Place the end of the outflow tubing in a water container after connecting the
outflow tubing to the electrode’s coolant outflow connector.
7. Open the inflow tubing’s flip cover.
Warning
All RF electrodes from STARmed and tubing set are sterilized products for
disposable use. Re-sterilization and reuse are prohibited.
Stop using the electrode if the patient’s body temperature is not indicated on
the screen of the generator after all the preparations are completed, after the
electrode is inserted into the human body, and before the radiofrequency
ablation starts. After starting the pump, the lowered temperature in combination
with the coolant’s temperature is displayed.

User’s Guide for RF Lesion generator for tissue ablation during surgical procedures with coagulation Electrode (ST-UM-15E(Rev.9))
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2. Radiofrequency lesion generator
Caution
Use the equipment only after reading the warnings, cautions, and information
on the product’s usage.
Use other accessories related to this equipment only after reading the
warnings, cautions, and information on the product’s usage. The user’s guide
for the electrode is provided separately.

User’s Guide for RF Lesion generator for tissue ablation during surgical procedures with coagulation Electrode (ST-UM-15E(Rev.9))
14
Description of generator’s front panel
No.
Feature name
Function
1
OHM/RESET
button
Measures the impedance of targeted tissue from the
active tip.
2
MODE button
Mode selected (General, Continuance, Auto,
Temperature) button
3
Digital Display
Indicates the menu setting concerning equipment
operation, and indicated status including the power,
impedance, temperature, time.) at the time of
operation.
Refer to the explanation on the Main screen.
4
RF
START/STOP
button
Pressing this button turns the RF output ON and OFF.
5
RF POWER
control dial
Adjusts the RF power output and other settings. (AUTO
mode is an exception)
6
RF CABLE
connector
These are the electrosurgical electrode couplers for the
RF output. The electrode’s cable is connected here.
7
GROUND
PADS
connectors
These are the couplers for the RF current to be
released from the RF electrode. The grounding pad’s
cable is connected here.
8
Display the
temperature
values
Measures the temperature of targeted tissue from the
active tip.
9
TIME
Indicates the lap time for a RF ablation.
10
Display the
IMPEDANCE
values
Indicates the resistance value of the targeted tissue at
the time of RF output.
11
Display the RF
POWER values
Indicates the actual amount of radiofrequency power
that is supplied to the electrode and targeted tissue.