ZERONE ZEUS-100/80 User manual

ZERONE Electrosurgical Unit
ZEUS-100/80
OPERATION MANUAL
ZERONE CO., LTD.

ZEUS-100/80 ZO-OM-008
ZEUS-100 /80 Operation manual
ZERONE CO., LTD

ZEUS-100/80 ZO-OM-008
REV : 08 1 ZERONE
- Contents -
1. INTRODUCTION ............................................................................................................. 2
1.1 PRIOR NOTICE ................................................................................................................... 2
2. INSTALLATION NOTICE................................................................................................ 7
2.1 BEFORE APPLICATION........................................................................................................ 7
3. APPLICATION NOTICE .................................................................................................. 9
4. FOLLOW-UP WAYS FOR STORAGE AND MAINTENANCE ........................................ 12
5. CONFIGURATION ......................................................................................................... 13
5.1 FEATURE ........................................................................................................................ 13
5.2 SAFETY FUNCTION .......................................................................................................... 13
5.3 INDICATION FOR USE........................................................................................................ 14
5.4 CONFIGURATION AND ACCESSORIES ................................................................................. 15
5.5 NAME AND FUNCTION OF EACH PART .............................................................................. 16
5.6 USING METHOD AND PROCEDURE..................................................................................... 21
5.7 ACCESSORY DIAGRAM ...................................................................................................... 22
6. PERIODIC INSPECTION................................................................................................ 24
7. TECHNICAL FACTORS ................................................................................................ 24
7.1 SPECIFICATION................................................................................................................ 24
7.2 OUTPUT.......................................................................................................................... 25
8. STANDARD OUTPUT TABLE BY SURGERY PART..................................................... 26
9. TROUBLES AND WHAT TO DO WITH THEM ............................................................. 27
10. LOAD REGULATION................................................................................................... 28
10.1 PURE CUTTING ............................................................................................................. 28
10.2 BLEND .......................................................................................................................... 28
10.3 CONTACT COAGULATION ............................................................................................... 28
10.4 BIPOLAR COAGULATION................................................................................................. 29
11. VOLTAGE OUTPUT GRAPHIC ................................................................................... 29
11.1 PURE CUTTING ............................................................................................................. 29
11.2 BLEND .......................................................................................................................... 29
11.3 CONTACT COAGULATION ............................................................................................... 30
11.4 BIPOLAR COAGULATION................................................................................................. 30
12. APPENDIX................................................................................................................... 31
12.1 ELECTROMAGNETIC COMPATIBILITY (EMC) INFORMATION ............................................. 31

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1. Introduction
1.1 Prior Notice
● How to Contact Us
- Contact us on the following telephone numbers and address in order to receive
our service and products.
For Supplying ZERONE Co., Ltd. - Sales Dept.
Products and (Shinil IT UTO Bldg., Dangjeong-dong)
Ordering Supplies #810, LS-Ro 13, Gunpo-si, Gyeonggi-do, Korea
(zip 435-831)
Tel : [phone]
Fax : [phone]
For Repair Service Tel : [phone]
Technical For technical inquiries, contact us with the following
Assistance telephone number.
Tel : [phone]
Homepage URL : http://www.01zeus.com
EUR CMC Medical Devices & Drugs S.L.
REPRESENTATIVE C/ Horacio Lengo Nº18, CP 29006, Málaga, Spain
Tel/Fax : [phone]
※If any faults or malfunctions, contact us, providing the model and serial
number of the damaged product.

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●Warranty Period
- This product was made under the strict quality control system and inspections.
- The warranty period is one year.
- Compensation standard for repairs and replacement complies for “Guidelines for
Consumer Protection” quoted by the Korean Economic Planning Board.
- If the product fails to operate during this period, our service center will provide
free repair service to you.
- The manufacturer or agency does not take responsibility for any breakages
or damages if malfunctions are caused by customer's improper use or
careless treatment.

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●Warning, Caution, Notice
This manual adopts several terms to draw your attention to what must be informed
of or aware of. Please read carefully and be fully aware of them before you start
operating the equipment.
Serious physical injury. death or property damage might occur to patients
if this not observed.
Warning
Slight physical injury (not causing death) might occur if this is not observed.
Caution
Something important. not dangerous that might occur when users install.
use and maintain the equipment.
Notice

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●Signs
No
Symbol
Description
1
Type BF Applied Part
2
RF Isolated : Earth referenced patient circuit for high
frequency
3
Refer to the manual
4
Non-ionizing Radiation : This equipment intentionally
supplies non-ionizing RF energy for physiological effect.
5
High Voltage Warning
6
Caution
7
Protective Earth
8
EU Representatives information
9
Manufacturer information
10
Made date
11
Serial number
12
Electronics Disposal Information
13
Do not re-use
14
Keep dry
15
Keep away from sunlight

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●Cautions
- Do not use/store this equipment under the following environments.
Wet hands or humid
areas.
Direct rays.
Out of these temperature
and humidity ranges:
T:10℃ ~ 40℃,
H: 20%~ 95%.
Near to electronic
heaters.
Areas with high humidity
or ill ventilation.
Excessive shock or
vibration.
Areas contaminated
chemical materials or
leaked gas.
Dust or metals that
could be stuck.
Taking to pieces. in this
case, this company would
not take any responsibility
Plugging the
installation
uncompleted. In this
case, the equipment
can be damaged.

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2. Installation Notice
This operating manual describes the function and handling of the Radio Frequency
Surgery Equipment ZEUS-100/80. The manual serves as an instruction reference and
should be read thoroughly before operating the equipment. Only then can the correct
handling of the equipment be assured. In case of incorrect handling no liability will be
taken on by the manufacturer
2.1 Before Application
●About Accessories
①Electric Shock
Don't connect wet accessories to the surgical unit; precisely connect all accessories
to adapters; don't expose metal materials to the air.
②Check the linkage condition between all accessories and Electrosurgical Unit before
using them. If the connection is bad, it can cause unintentional operation effects like
spark or accessory malfunction.
③Don't wrap up the accessory code or Patient Return Plate in metal materials.
This can generate shock and fire, inflicting an injury on patients or operators.
④Before using accessories, always check if reusable accessories and codes are not
broken, cracked, scratched, etc. If this is not done, patients or operators can be
injured or struck by electricity.
⑤Connect accessories to the appropriate sockets because bad connection can cause
dangerous situations. Unused accessories (active electrode) must not be placed on
the patient body.
⑥ZERONE Co., Ltd. Supplied accessories have appropriate for rating for ZEUS-100/80.
CE marked or UL approved components with more than Monopolar: 1800Vpp, Bipolar:
500Vpp rated voltage rating can be used as accessories.
If the rating of the accessory is lower than the max output of the applicable mode, set
up the output as much as the rating of the applicable accessory.
Safety hazard may occur if products with lower quality are utilized.
⑦Connect Bipolar accessories to corresponding Bipolar sockets.
If any malfunction or breakage. do not use it for patients and instead contact
with medical equipment technicians or suppliers.
Warning
Check the followings before using this product.
Warning

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①Don't throw away disposable accessories in a certain area where problems may
occur. Keep in mind the environmental problem at any time and place.
②Use the “Disposable”accessories once. Don't use/sterilize them again.
When reusing, it may cause the equipment malfunction or unintended operation effect
to injure doctors or patients.
③Before operation, check all the accessories to see if they are sterilized. After
operation, sterilize all reusable accessories and then store them. “Disposable”
accessories should be used after checking the validity period expiration date.
④When disposing of this electrosurgical unit, or any of its components (such as fuses),
follow all applicable national and local laws and guidelines.
⑤This electrosurgical unit should be recycled separately from household waste.
When this product reaches its end of life, follow the local laws and regulations of
Disposal. The improper disposal of waste electronic equipment from consumer may
be subject to fines.
⑥For more information on repair, please refer to the service manual.
●Patient Return Plate
It is recommended that Patient Return Plate be applied to REM system of ZERONE Co.,
Ltd. Monitors the size of contact area between a patient and the pad. If the size is
inappropriate, it automatically blocks the high-frequency current to minimize the
danger of burning incidents.
①Do not apply Patient Return Plate to Bipolar-only operation.
Otherwise, the effects of Electrosurgical Unit cannot be limited to the organization
between Bipolar electrodes.
②Don't cut Patient Return Plate in half, which can make a patient burned.
●Electrical Safety
①Warning: To avoid the risk of electric shock, this equipment must only be connected
to a supply mains with protective earth
Check the followings before using this product.
Caution
Check the followings before using this product.
Warning
Check the followings before using this product.
Caution

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Check the followings before using this product.
Warning
②Use the power code provided by the equipment supplier or a other test-completed
product that has equal quality.
③Don't use a extended code that has no ground connection.
④Connection for potential equalization : Connection pins for potential equalization
cable between RF equipment and potential equalization bar in or room. The yellow-
green potential equalization cable supplied by the manufacturer must be used.
①Don't place any equipment on Electrosurgical Unit, which can prevent this unit
from being cooled.
②Do not leave any water container on the main system. If any water is spilled, wipe it
up immediately, and never run the system if water is soaked into it.
③Electrosurgical Unit should be kept apart, as much as possible, from other
electronic equipment because the use of the unit can have negative effects on other
medical units that are using other electricity.
④Check the linkage condition of equipment ground.
⑤Impressed voltage (AC120V/AC230V) should be used in accordance with the rating.
Before providing power, check an operation voltage and power frequency marked in
the label on the back of the product. Inappropriate power could cause output
fluctuation and a direct fault in the product. To prevent over-standard voltage
fluctuation, it is recommended that Automatic Voltage Regulator (AVR) be used.
⑥Before you start surgical operation, check if the power output is correctly adjusted
for your operation.
3. Application Notice
Electrosurgical Unit is supposed to generate high voltage and current for its
application. To avoid exposing a patient, an operator and the third parties
into a dangerous situation, operation should be carefully conducted, and
safety rules should be strictly kept.
●About Patients
①Eliminate or isolate all the patient’s metal materials and handle them with special
Interests
Check the followings before using this product.
Warning

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②A patient must be isolated from grounded metal materials. Be careful to see if they
are contacted to the patient. The isolation status must be maintained even if a
patient who is going through an operation is moved into other positions.
③Do avoid skin-to-skin contact, including fingers touching legs.
Place dry gauze on patient’s skin where possibilities of skin-to-skin contact is high,
to avoid any skin burn.
④Unused accessories should be stored in untouchable, electricity-isolated and
conspicuous areas. Hot accessories just used can lead to a fire. Do not place them
near to the inflammable materials.
⑤Check if the output level of Electrosurgical Unit was arranged to the appropriate
level for an operation. It is recommended that the output power be lowered as soon
as possible, so that a user can expect possible problems generated from inappropriate
location or connection of Patient Return Plate during ordinary output, and then slowly
increase the output power.
⑥Minimize the possibility of burning incidents by using Active Electrode for the time
only required for wanted operation effects. In particular, apply this method to
operations for such patients as infants, newborns and, those who are in small auxiliary
institutes.
⑦Avoid the use of inflammable anesthetics like N2O and O2. Electrosurgical Unit using
high frequency can generate a flame at an always-operating electrode by contacting
the anesthetics. Therefore, the materials should be completely evaporated for
cleanliness and sterilization before using the unit. Naturally generated gases
accumulated in intestines, the deep navel or vagina in human body can be also
inflammable so that these liquefied gases must be eliminated before using the unit.
After sterilizing the body with the dangerous anesthetics, it is necessary to ventilate
them since the gases are likely to explode.
⑧Neuromuscular can be stimulated. The stimulus can occur when low frequency
current is generated from the supplier of low-frequency current or electrical arc
located between the electrode and patient’s organization. A spasm or muscular clamp
is likely to be generated while arc is created during Cutting or Coagulation (contact/
spray) is somewhat rectifying high-frequency current.
⑨Extreme caution must be taken for patients with pacemaker or implantable electrode.
Performance of devices may be temporarily affected which may cause ventricular
fibrillation. In case of any doubts concerning safety of patient contact qualified and
concerned pacemaker manufacturer or Cardiology department.
⑩Do not use Active Electrode near to Electrocardiograph electrode. ESU electrode
must be kept apart at least 150mm from ECG electrode. It is necessary to use
Monitoring Electrode with protective resistors to survive high frequency. Do not use a
needle-typed electrode.

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⑪Most sweated parts of human body (armpit, knee, skin-to-skin parts) can be burned
when Patient Return Plate or other materials contacts with those parts, therefore,
some dried and absorbable towels should be used to dry them.
⑫Lower output or performance of electrical surgical device despite correct surgical
setting may be caused due to incorrectly applied patient plate or bad connection.
In this case, before setting a higher output, you must check the connection status.
⑬The output from electrodes may change during use.
⑭A failure of the electrosurgical unit could result in an unintended increase of output
power.
①The patient leads should be positioned in such a way that contact with the patient or
other leads is avoided. Temporarily unused electrodes should be stored in a location
that is isolated from the patient.
②For surgical procedures where the HF current could flow through parts of the body
having a relatively small cross sectional area, the use of BIPOLAR techniques may
be desirable in order to avoid unwanted tissue damage.
●About Patient Return Plate
①Plate Electrode should be near to an operation part of human body and adhere closely
to the patient’s body. Periodically check if the electrode firmly contacts to the body
when moving the patient or performing a long operation.
②Contact Plate Electrode closely to the place whose direction is the opposite from the
heart based on the operated part.
③If Patient Plate is not closely adherent to the patient body, he/she can get a burn sine
high frequency current flows between Dispersive Electrode and the skin.
When using Patient Plate, you should bind it by something like band, after putting gel
(‘Use a gel for medical.’) all over the patient skin on which Patient Plate will be
adhered in order it to be adhered to the patient skin completely.
①Don’t use Plate Electrode on implant, metal material, protruding bones and scars.
Clean skin required for operation and eliminate the oil and hair on it.
Check the followings before using this product.
Warning
Check the followings before using this product.
Caution
Check the followings before using this product.
Caution

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②Make a short cut of the current path between Active Electrode and Dispersive.
4. Follow-Up Ways for Storage and Maintenance
- When removing a series of codes, don’t unplug them at a time.
- Don’t screw, bind or stack the cables.
- After performing an operation, sterilize all accessories and then store them.
- Turn off the power after using equipment and remove the power plug and store it
when leaving the office or not using for a long time.
①About Cleaning
- Clean the main unit and foot switch with soft fabric which is wet with warm water
or alcohol at least once a month. If you use the material is designated cleaning, you
have to ask chemical manufacturer regarding effect of microbe.
Clean its external appearance with non-ignitable, non-explosive materials.
Don’t use corrosive, easily-grinding materials that can damage it such as lacquer,
thinner, ethylene and oxidizing agents, etc. Don’t let the liquid into equipment.
- You should use 70% isopropyl alcohol or ethylalcohol when you clean accessories.
②About Sterilization
- Use the accessories that can be sterilized after sterilizing them.
Accessory
Sterilization
Auto Clave
Reusable Bipolar Forceps
- Gravity Displacement (121℃(250℉))
: 30minutes
- Drying time
: 20 minutes
Reusable Electrodes Tips
Reusable Monopolar Handle
- Gravity Displacement (121℃(250℉))
: 20minutes
- Drying time
: 20 minutes
①During sterilization, don’t increase temperature and pressure more than the standard,
which can cause damage to the accessories.
②Don’t sterilize disposable accessories.
Check the followings before using this product.
Warning

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5. Configuration
5.1 Feature
①A DISPLAY window allows you to easily check output values, indicated as digits.
②This provides necessary functions like Pure Cut, Blend, Contact Coagulation, Bipoar
Coagulation, under operation by one equipment
③Holding the button for each mode for more than 3 seconds, the output ratio on
Display will be changed to 1W to be facilitated to shift from the low to high output.
④Twin Button Handles provide remote-control function. (Select Cutting or Coagulation)
⑤Foot Switch is available for Cutting and Coagulating.
⑥Bipolar coagulation of by Foot Switch.
⑦Microprocessor can straighten, stabilize the output.
⑧Operations of Cutting, Coagulation and Bipolar Coagulation can be distinct from
each other by sound and indication lamp.
⑨Each application mode (Cutting, Coagulation, Bipolar Coagulation) has a different
sound, which enables you to easily distinguish an operation type.
⑩If the area between a patient and the pad is not appropriate, REM(Return Electrode
Monitoring) gives the alarm with a warning sound and stop an operation of the product
to prevent a burning incident.
⑪The selected output ratio of Cut, Coagulation, and Bipolar Coagulation will displayed
by reenergizing the device after power OFF.
5.2 Safety Function
①A fuse built in a power circuit prevent an over current from flowing through the
equipment.
②When the plate attached to the patient is separated from the equipment, the red
alarm light begins flickering. Pressing the button of Twin Button Handle or pedal of
Foot Switch will stop the alarm sound and the equipment.
③REM (Return Electrode Monitoring) monitors the size of contacting area between a
patient and the pad. If the size is inappropriate, it automatically blocks the high-
frequency current to minimize the danger of burning incidents.
④To protect a patient, the case is fully grounded so that a leakage current can flow
into the earth.

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5.3 Indication for use
Electrosurgical unit is a device to perform a medical operation like cut and
coagulation in the biological tissue using high-frequency current
●Operator Profile
Considerations
Requirement description
Education
Minimum
A physician or medical personnel under the
supervision of a physician
Maximum
N/A
Language
understanding
Minimum
Languages specified in the instruction for use
Maximum
N/A
Experience
Minimum
A person who received sufficient training in
electrosurgical procedures
Maximum
N/A
Permissible
impairments
N/A
●Intended Patient Population
Considerations
Requirement description
Age
No limitation
Weight
Check a marking in kg indicating the maximum a
patient weight on end use packaging for Disposable
Patient Return Plate
Healthy
Except for patients who get an implantable
pacemakers or implantable defibrillators transplant.
Nationality
No limitation
PATIENT state
A patient is not user : not relevant, unless patient is
agitated

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5.4Configuration and Accessories
●Configuration
①Electrosurgical Unit 1EA
②single Foot Switch 1EA
③Disposable Twin Button Handle 1EA
④Power Cord 1EA
⑤Knife Electrode 2.4 * 70mm 1EA
⑥Needle Electrode 2.4 * 70mm 1EA
⑦Needle Electrode (Angled) 2.4 * 70mm 1EA
⑧Ball Electrode 5mm 1EA
●Accessories (Optional Products)
①Reusable Silicone Patient Plate

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5.5Name and Function of Each Part
●Front Side
●Back Side
⑧Connection for Main Power
⑨Connection for Grounding
⑩Connection for Cutting, Coagulation Foot switch
①Power Switch
②Cutting Mode
③Coagulation Mode
④Connection to Patient Plate
⑤Connection for Bipolar Forceps
⑥Connection1 for Cutting,
Coagulating Electrode
⑦Connection2 for Cutting,
Coagulating Electrode

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①Power ON / OFF Switch
②Cutting Mode
ⓐPure Cutting
Select this button for the cutting with the lowest level of arrest of bleeding.
If it is selected, the lamp above the button turns on.
ⓑCoagulation Blend Cutting
Select this button for the cutting with the minimized level of arrest of bleeding.
If it is selected, the lamp above the button turns on.
ⓒCutting Output Confirmation Lamp
When a selected cutting mode is operated, the lamp turns on.
ⓓCutting Output Set-Up Indicator
It displays Cutting and Blend Output as Watt.
ⓔCutting Output Increase
This button increases the output of selected mode. When this button is pressed
one time, the output get raised by 1Watt. Continuously-pressing leads the output
to its highest level.
ⓕCutting Output Decrease
This button decreases the output of selected mode. When this button is pressed
one time, the output get reduced by 1Watt. Continuously-pressing leads the output
to its lowest level.
ⓐPure Cutting
ⓑCoagulation Blend Cutting
ⓒCutting Output Confirmation Lamp
ⓔCutting Output Increase
ⓓCutting Output Set-Up Indicator
ⓕCutting Output Decrease

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③Coagulation Mode
ⓐCoagulation Output Set-Up Indicator
Coagulation and bipolar coagulation output is displayed in W.
ⓑCoagulation Output Confirmation Lamp
When a selected coagulation mode is operated, the lamp turns on.
ⓒBipolar Coagulation
Bipolar hemostasis using Foot Switch.
If it is selected, the lamp above the button turns on.
ⓓContact Coagulation
Select this button for the coagulation with the minimized level of arrest of bleeding.
If it is selected, the lamp above the button turns on.
ⓔCoagulation Output Increase
This button increases the output of selected mode. When this button is pressed
one time, the output get raised by 1Watt. Continuously-pressing leads the output
to its highest level.
ⓕCoagulation Output Decrease
This button decreases the output of selected mode. When this button is pressed
one time, the output get reduced by 1Watt. Continuously-pressing leads the output
to its lowest level.
ⓓContact Coagulation
ⓔCoagulation Output Increase
ⓕCoagulation Output Decrease
ⓒBipolar Coagulation
ⓑCoagulation Output Confirmation Lamp
ⓐCoagulation Output Set-Up Indicator