ZERONE Electrosurgical Unit

ZEUS-400 / 300 / 200

OPERATION MANUAL

ZERONE CO., LTD.

ZEUS-400 / 300 / 200 Operation manual

ZERONE CO., LTD

 ZEUS-400/300/200 ZO-OM-001

- Contents -

1. Introduction 2
1.1 Prior Notice 2
2. Installation Notice 7
2.1 Before Application 7
3. Application Notice 10
4. Follow-Up Ways for Storage and Maintenance 12
5. Configuration 13
5.1 Feature 13
5.2 Safety Function 14
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 24
5.7 Accessories Diagram 26
6. Periodic Inspection 29
7. Technical Factors 30
7.1 Specification 30
7.2 Output 30
8. Standard Output Table by Surgery Part 32
9. Troubles and What to do with them 33
10. Load Regulation 34
10.1 Pure Cutting 34
10.2 Blend1 34
10.3 Blend2 34
10.4 Blend3 35
10.5 Contact Coagulation 35
10.6 Spray Coagulation 35
10.7 Bipolar Coagulation 36
10.8 Bipolar Cut 36
11. Voltage Output Graphic 36
11.1 Pure Cutting 36
11.2 Blend1 37
11.3 Blend2 37
11.4 Blend3 37
11.5 Contact Coagulation 38
11.6 Spray Coagulation 38
11.7 Bipolar Coagulation 38
11.8 Bipolar Cut 39
12. Appendix 40
12.1 Electromagnetic Compatibility (EMC) 40

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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.

Products and (Shinil IT UTO Bldg., Dangjeong-dong)
Ordering Supplies #810, LS-Ro 13, Gunpo-si, Gyeonggi-do, Korea
(zip 435-831)
Tel : +82 31 427 2772
Fax : +82 31 427 2332

For Repair Service Tel : +82 31 427 2772

Technical For technical inquiries, contact us with the following

Assistance telephone number.
Tel : +82 31 427 2772

Homepage URL : http://www.01zeus.com

EUR CMC Medical Devices & Drugs S.L.

REPRESENTATIVE C/ Horacio Lengo Nº 18, CP 29006, Málaga, Spain
Tel/Fax : +34-661-416-622

※ 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.

- 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.

Warning

Serious physical injury. death or property damage might occur to patients

if this not observed.

Caution

Slight physical injury (not causing death) might occur if this is not observed.

Notice

Something important. not dangerous that might occur when users install.
use and maintain the equipment.

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● Signs

No Symbol Description

1 Type CF Applied Part

RF Isolated : Count electrode isolated to an earth for high

2
frequency

3 Refer to the manual

Non-ionizing Radiation : This equipment intentionally

4
supplies non-ionizing RF energy for physiological effect.

5 High Voltage Warning

6 Caution

7 Potential Equalization conductor

8 Protective Earth

9 EU Representatives information

10 Manufacturer information

11 Made date

12 Serial number

13 Electronics Disposal Information

14 Do not re-use

15 Keep dry

16 Keep away from sunlight

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● Cautions
- Do not use/store this equipment under the following environments.

Wet hands or humid

Direct rays.
areas.

Out of these temperature

and humidity ranges: Near to electronic
T:10℃ ~ 40℃, heaters.
H: 20%~ 95%.

Areas with high humidity Excessive shock or

or ill ventilation. vibration.

Areas contaminated
Dust or metals that
chemical materials or
could be stuck.
leaked gas.

Plugging the
Taking to pieces. in this
installation
case, this company would
uncompleted. In this
not take any responsibility
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-400/300/200. 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

Warning

If any malfunction or breakage. do not use it for patients and instead contact
with medical equipment technicians or suppliers.

● About Accessories

Warning

Check the followings before using this product.

① Electric Shock
Don't connect wet accessories to the surgical unit; precisely connect all accessories
to adapters; don't expose metal materials to the air.

② Check 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.

③ Don'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.

④ Before 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.

⑤ Connect accessories to the appropriate sockets because bad connection can cause
dangerous situations. Unused accessories (active electrode) must not be placed on
the patient body.

⑥ ZERONE Co., Ltd. Supplied accessories have appropriate for rating for. ZEUS-400/
300/200 CE marked or UL approved components with more than Monopolar: 3000V,
Bipolar: 1000V 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.

⑦ Connect Bipolar accessories to corresponding Bipolar sockets.

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Caution

Check the followings before using this product.

① Don't throw away disposable accessories in a certain area where problems may occur.
Keep in mind the environmental problem at any time and place.

② Use 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

③ Before 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.

④ When disposing of this electrosurgical unit, or any of its components (such as fuses),
follow all applicable national and local laws and guidelines.

⑤ This 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.

⑥ For more information on repair, please refer to the service manual.

● Patient Return Plate

Warning

Check the followings before using this product.

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 minimize the danger of burning incidents

① Do not apply Patient Return Plate to Bipolar-only operation.

Otherwise, the effects of Electrosurgical Unit cannot be limited to the organization
between Bipolar electrodes.

② Don't cut Patient Return Plate in half, which can make a patient burned.

● Electrical Safety
Caution

Check the followings before using this product.

① Warning : To avoid the risk of electric shock, this equipment must only be connected
to a supply mains with protective earth

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② Use the power code provided by the equipment supplier or a other test-completed
product that has equal quality.

③ Don't use a extended code that has no ground connection.

④ Connection 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.

Warning

Check the followings before using this product.

① Don't place any equipment on Electrosurgical Unit, which can prevent this unit from
being cooled.

② Don't reduce the volume of display indication sound, which provides alarms to the
operator during an operation of the surgical unit.

③ When using Smoke Evacuator connecting Electrosurgical Unit, keep them apart each
other, and set up the output sound at the maximum level so that the output sound and
and the alarm indication sound can be heard well.

④ Electrosurgical 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 medical units that are using other electricity.

⑤ Check the linkage condition of equipment ground.

⑥ Impressed voltage (AC120V/230V) 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.

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

Warning

Check the followings before using this product.

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① Eliminate or isolate all the patient’s metal materials and handle them with special
interests.

② A 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.

③ Do 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.

④ Unused 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.

⑤ Check 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.

⑥ Minimize 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.

⑦ Avoid 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.

⑧ Neuromuscular 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.

⑨ Extreme 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.

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⑩ Do 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.

⑪ Most 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.

⑫ Lower 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.

⑬ The output from electrodes may change during use.

⑭ A failure of the electrosurgical unit could result in an unintended increase of

output power.
Caution

Check the followings before using this product.

① The 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.

② For 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

Warning

Check the followings before using this product.

① Plate 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.

② Contact Plate Electrode closely to the place whose direction is the opposite from the
heart based on the operated part.

③ If 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.

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Caution

Check the followings before using this product.

① Don’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.

② Make 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.

① About 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.

② About Sterilization
- Use the accessories that can be sterilized after sterilizing them.

Accessory Sterilization

Accessory Auto Clave E/O Gas

- Gas Mixtures :
Reusable Monopolar Handle
EO 20%+CO2 80%
- Gravity
-We recommend to use according
displacement
Reusable Bipolar Forceps to the usage criteria written at the
- 121℃(250℉) for
manual of sterilizer (Exposure
20minutes
Temperature, Pressure, Exposure
Reusable Electrodes Tips time, and Aeration time).

Warning

Check the followings before using this product.

① During sterilization, don’t increase temperature and pressure more than the standard,
which can cause damage to the accessories.

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② Constantly-sterilizing Auto Clave can easily wear a cable so that E/O gas sterilization
is recommended.

③ Don’t sterilize disposable accessories.

5. Configuration
5.1 Feature
① A DISPLAY window allows you to easily check output values, indicated as digits.

② One equipment provides such functions that are required to perform an operation
as Functional Cutting (Pure Cut, Blend1, Blend2, Blend3), Coagulation (Spray
Coagulation, Contact Coagulation), Bipolar Coagulation (Hand Bipolar, Foot Switch
Bipolar).

③ Two Twin Button Handles provide remote-control function. (Select Cutting or

Coagulation)

④ Foot Switch is available for Cutting and Coagulating.

⑤ Hand Bipolar(Auto Bipolar) can be used only by contacting Forceps.

⑥ Microprocessor can straighten, stabilize the output.

⑦ Operations of Cutting, Coagulation and Bipolar Coagulation can be distinct from

each other by sound and indication lamp.

⑧ Each application mode (Cutting, Coagulation, Bipolar Coagulation) has a different

sound, which enables you to easily distinguish an operation type.

⑨ If 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.

⑩ The level of alarm sound can be adjusted during an operation of application mode.

5.2 Safety Function

① A fuse built in a power circuit prevent an over current from flowing through the
equipment.

② When 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 the pedal of
Cutting and Coagulation of Double Foot Switch will stop the alarm sound and the
equipment.

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③ REM (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.

④ To protect a patient, the case is fully grounded so that a leakage current can flow
into the earth.

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

A physician or medical personnel under the

Minimum
Education supervision of a physician

Maximum N/A

Language Minimum Languages specified in the instruction for use

understanding Maximum N/A

A person who received sufficient training in

Minimum
Experience electrosurgical procedures

Maximum N/A

Permissible
N/A
impairments

● Intended Patient Population

Considerations Requirement description

Age No limitation

Check a marking in kg indicating the maximum a patient

Weight weight on end use packaging for Disposable Patient Return
Plate
Except for patients who get an implantable pacemakers or
Healthy
implantable defibrillators transplant.

Nationality No limitation

A patient is not user : not relevant, unless patient is

PATIENT state
agitated

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5.4 Configuration and Accessories

● Configuration
① Electrosurgical Unit 1EA
② Double Foot Switch 1EA
③ Single Foot Switch 1EA
④ Disposable Twin Button Handle 1EA
⑤ Reusable Monopolar Handle 1EA
⑥ Bipolar Cable 1EA
⑦ Disposable Patient Return Plate 2EA
⑧ Reusable Patient Return Plate Cable 1EA
⑨ Power Cord 1EA
⑩ Bipolar Forceps 1EA
⑪ Knife Electrode 2.4*70mm 1EA
⑫ Needle Electrode 2.4*70mm 1EA
⑬ Needle Electrode (Angled) 2.4*70mm 1EA
⑭ Ball Electrode 5mm 1EA
⑮ Ground Cable 1EA

● Accessories (Optional Products)

① Loop Electrode 6mm
② Reusable Silicone Patient Plate

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5.5 Name and Function of Each Part

● Front Side

① Power Switch ④ Bipolar Coagulation Mode

② Cutting Mode
③ Coagulation Mode ⑤ Connection to Patient Plate

⑥ Connection for Bipolar Forceps

⑦ Connection 1 for Cutting, ⑦ Connection 1 for Cutting, Coagulating Electrode
Coagulating Electrode
※This accessory cannot be connected with ZEUS-200

⑧ Connection 2 for Cutting, Coagulating Electrode

※ This connector cannot be connected with Option Function

● Back Side

⑨ Sound Volume Controller ⑩ Connection for Main Power

⑪ Connection for Grounding

⑫ Connection for Cutting, Coagulation Foot switch

⑬ Connection for Bipolar Coagulation Foot switch

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① Power ON / OFF Switch

② Cutting Mode

ⓗ Cutting Output Confirmation Lamp

ⓖ Cutting Output Set-Up Indicator

ⓕ Cutting Output Increase

ⓔ Cutting Output Decrease

ⓓ Coagulation Blend Cutting 3

ⓒ Coagulation Blend Cutting 2
ⓑ Coagulation Blend Cutting 1
ⓐ Pure Cutting

ⓐ 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 1
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.
ⓒ Coagulation Blend Cutting 2
Select this button for the cutting with the intermediate level of arrest of bleeding.
If it is selected, the lamp above the button turns on.
ⓓ Coagulation Blend Cutting 3
Select this button for the cutting with the maximized level of arrest of bleeding.
If it is selected, the lamp above the button turns on.
ⓔ 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.
ⓕ 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 Set-Up Indicator
It displays Cutting and Blend Output as Watt.
ⓗ Cutting Output Confirmation Lamp
When a selected cutting mode is operated, the lamp turns on.

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③ Coagulation Mode

ⓕ Coagulation Output Confirmation Lamp

ⓔ Coagulation Output Set-Up Indicator

ⓓ Coagulation Output Increase

ⓒ Coagulation Output Decrease

ⓑ Spray Coagulation
ⓐ Contact Coagulation

ⓐ 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.
ⓑ Spray Coagulation
Select this button for the coagulation with the maximized level of arrest of bleeding.
If it is selected, the lamp above the button turns on.
ⓒ 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.
ⓓ 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 Set-Up Indicator
It displays Contact and Spray and Coagulation as Watt.
ⓕ Cutting Output Confirmation Lamp
When a selected coagulation mode is operated, the lamp turns on.

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④ Bipolar Coagulation Mode

ⓕ Bipolar Coagulation Output Confirmation Lamp

ⓔ Bipolar Coagulation Output Set-Up Indicator

ⓓ Bipolar Coagulation Output Increase

ⓒ Bipolar Coagulation Output Decrease

ⓑ Bipolar Coagulation Foot

ⓐ Bipolar Coagulation Hand

ⓐ Bipolar Coagulation Hand

Pressing this button enable the bipolar arrest of bleeding without Foot Switch.
If it is selected, the lamp above the button turns on.
ⓑ Bipolar Coagulation Foot
Pressing this button enables to use Foot Switch for the bipolar arrest of bleeding.
If it is selected, the lamp above the button turns on.
ⓒ Bipolar Coagulation Output Decrease
This button decreases the output of selected mode. When this button is pressed one
time, the output get reduced by 1W. Continuously-pressing leads the output to its
lowest level.
ⓓ Bipolar Coagulation Output Increase
This button increases the output of selected mode. When this button is pressed one
time, the output get raised by 1W. Continuously-pressing leads the output to its
highest level.
ⓔ Coagulation Output Set-Up Indicator
It indicates the using out as Watt.
ⓕ Bipolar Cutting Output Confirmation Lamp
If a selected mode is operated, the lamp turns on.

⑤ Connection for Patient Plate-Applied part

Use Patient Return Electrode when using Monopolar. If Patient Return Cable is not
proper to use, the alarm sound rings and the lamp above is blinked.

⑥ Connection for Bipolar Forceps-Applied part

Connection Terminal for Bipolar Forceps

⑦ Connection 1 for Cutting and Coagulation-Applied part

Connection Terminal for Twin Button Handle

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⑧ Connection 2 for Cutting and Coagulation-Applied part

Connection Terminal for Monopolar Handle

⑨ Sound Volume Controller

Controls the sound volume of Cutting, Coagulation, Bipolar Coagulation.

⑩ Connection for Main Power

Connects with Main Power Code.

⑪ Connection for Grounding

Connection terminal to earth through Grounding Cable.

⑫ Connection for Cutting, Coagulation Foot switch

Double Foot Switch connection terminal using Monopolar Handle during an operation
of Cutting and Coagulation.

⑬ Connection for Bipolar Coagulation Foot switch

Single Foot Switch connection terminal during an operation of Bipolar Coagulation
Foot Switch mode

● Optional Function(UPGRADED VERSION)

① Bipolar Cut

Pressing this button enables to use Foot Switch for the bipolar arrest of
cutting.
If it is selected, the lamp above the button turns on.

② Memory Indicator

ⓑ Memory number selection and Memory button.

ⓐ Memory number display
ⓐ Memory number display
Mark the Memory number 0~9.
ⓑ Memory number selection and Memory button.
- Press on the memory button once to select a save number.
- Select Cutting Mode (Cut, Blend1, Blend2, Blend3) and set a wanted output (W)
by using UP and DOWN buttons.

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- Select Coagulation Mode (Contact, Spray) and set a wanted output (W) level by
using UP and DOWN buttons.
- Select Bipolar Coagulation Mode (Bipolar Cut, Foot, Hand) and set a wanted
output (W) level by using UP and DOWN buttons.
- press the memory button longer to save.

③ Monopolar output selector Indicator

ⓐ Monopolar output M1 selector Confirmation Lamp

ⓑ Monopolar output M2 Confirmation Lamp

ⓐ Monopolar output M1 selector Confirmation Lamp

Choose the monopolar output selector switch on the rear side as M1, the light is
turned on. When the Foot switch is pressed, output comes from the connection
part of cutting and coagulation electrode.
ⓑ Monopolar output M2 Confirmation Lamp
Choose the monopolar output selector switch on the rear side as M2, the light is
turned on. When the Foot switch is pressed, output comes from the connection
part of cutting and coagulation electrode.

④ Monopolar output selector switch

Select the output part 1, 2 of cutting and coagulation electrode and use
them.
M1 and M2 selected on the monopolar output selector mark area is ON.

● Accessories
① Double Foot Switch

Connect it to 4pin Connector on the back side of the

product. The yellow pedal is for Cutting and the blue one
is for Coagulation.
4pin plug, Cable 4m

② Single Foot Switch

Connect it to 3pin Connector on the back side of the

product during an operation of Bipolar function.
3pin plug, Cable 4m

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③ Disposable Twin Button Handle

Connect it to the terminal of Connection 1 for Cutting and

Coagulation Electrode. The yellow key operation is for
Cutting and the blue is for Coagulation.
3pin Plug, Cable 3m, Rated Voltage(Umax):3000Vpp
Expiration date of Disposable Twin Button Handle: Check
the packaging for Disposable Twin Button Handle

④ Reusable Monopolar Handle

Coagulation Electrode. The yellow pedal is for Cutting and

the blue is for Coagulation.
Cable 3m, Rated Voltage(Umax):3000Vpp

⑤ Reusable Patient Return Plate Cable

Connect it to the connection part of Patient Plate.

Connect Patient Return Plate to Clamp.
Cable 4m, Rated Voltage(Umax):3000Vpp

⑥ Bipolar Cable

Use it to link the Connection for Bipolar Forceps with

Bipolar Forceps.
2pin Plug, Cable 3m, Rated Voltage(Umax):1000Vpp

⑦ Disposable Patient Return Plate

Connect it to the clamp of Patient Return Plate Cable.

180 * 120mm
Expiration date of Disposable Patient Return Plate: Check
the packaging for Disposable Patient Return Plate

⑧ Power Cord

Connect it to Main Power Connection on the back side of

the product.
Cable 1.8m

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⑨ Bipolar Forceps

Connect it to the connection terminal of Bipolar Cable.

Use it during Bipolar Coagulation.
Bayonet Forceps, 17.8cm, Tip 1mm
Rated Voltage(Umax):1000Vpp

⑩ Electrodes

Use it during Cutting and Coagulation

Knife Electrode 2.4 * 70mm
Needle Electrode 2.4 * 70mm
Needle Electrode(Angled) 2.4 * 70mm
Ball Electrode 5mm
Loop Electrode 6mm

⑪ Ground Cable
Connect the cable to compensate for potential equalization
Cable 2m

● Accessories (Optional Products)

① Reusable Silicone Patient plate

Connect it to the connection part of Silicone Patient Plate.

240*150mm, Cable 3m
Rated Voltage(Umax):3000Vpp

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5.6 Using Method and Procedure

● Monopolar

① After confirming power and voltage (AC120V/230V), connect a ground power cable
to the power connection part on the back side of Electrosurgical Unit. If there is no
ground at Main Power, link an earth ground to the ground connection on the back
side of the product.

② Turn on the Power Switch.

Check if Front Display indicates a number and then if REM alarm lamp flickers.

③ Connect Patient Return Plate Cable to the Patient Plate connection at the surgical unit.

- Single Patient Plate

Connect Single Patient Plate to Patient Return plate Cable Clamp. Alarm lamp stops
Flickering and the standby state starts. Attach Pad to a patient’s body.

- Double Patient Return Plate

Connect Double Patient Return Plate to Patient Return plate Cable Clamp. Attach Pad
to a patient’ body. Alarm lamp stops flickering and the standby state starts

④ Select Cutting Mode (Cut, Blend1, Blend2, Blend3) and set a wanted output (W) by
using UP and DOWN buttons.

⑤ Select Coagulation Mode (Contact, Spray) and set a wanted output (W) level by
using UP and DOWN buttons.

⑥ In case of using Twin Button Handle, connect it to the connection 1 for Cutting
and Coagulation Electrode.

⑦ In case of using Foot Switch, connect Double Foot Switch Connector to Cutting,
Coagulation Foot Switch connection. If pressing Foot Switch, output is generated
from the Connection 2 for Cutting and Coagulation Electrode.

Notice

In the case of ZEUS-400/300. both two Twin Button Handle(3-pin) and one
Monopolar Handle(1-pin) can mounted on it. Although the unit can be used
With the three accessories connected at the same time. output is not
Generated from them at the same time. Only first-selected connection can
Generated the output. It is recommended that unused accessories not be
connected to the unit.

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Notice

In the case of ZEUS-200. both one Twin Button Handle(3-pin) and one
Monopolar Handle(1-pin) can mounted on it. Although the unit can be used
With the two accessories connected at the same time. output is not generated
from them at the same time. Only first-selected connection can generated
the output. It is recommended that unused accessories not be connected to
the unit.

⑧ Press Twin Button Handle Switch or Double Foot Switch

● Bioplar

① Foot Mode
- Connect Bipolar Single Foot Switch to Bipolar Foot Switch connection on the back
of the product.

- Select Foot node and set a wanted output (W) level by using UP and DOWN buttons.

- Connect Bipolar Cable to Bipolar Forceps connection.

- Press Singe Foot Switch

② Hand Mode(Auto Bipolar)

- Set a wanted output level by using UP and DOWN buttons.

- Connect Bipolar Cable to Bipolar Forceps connection.

- Select Hand Mode.

Caution

When using Forceps. don’t activate this surgical unit until it makers contact
with a patient.
Note that bipolar TIPs should not short-circuited. each other to prevent a
direct cause of product faults.

● Power off : Turn the electrosurgical unit OFF and disconnect the power cord from the
Receptacle(wall mains outlet).

● Make sure that the electrosurgical unit and foot switch are completely dry before
Storage.

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5.7 Accessory Diagram

● Diagram of Twin Button Handle and Patient Plate

(Twin Button Handle) (Patient Return Plate Cable) (Silicone Patient Plate)

* Optional products(UPGRADED VERSION)

(Twin Button Handle) (Patient Return Plate Cable) (Silicone Patient Plate)

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● Diagram of Monopolar Handle and Patient Plate

(MonoPolar Handle) (Patient Return Plate Cable)(Silicone Patient Plate)

* Optional products(UPGRADED VERSION)

(MonoPolar Handle) (Patient Return Plate Cable)(Silicone Patient Plate)

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● Diagram of Double Foot Switches

(Double Foot Switch)

● Diagram of Bipolar Forceps and Cable

(Bipolar Forceps)

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● Diagram of Single Foot switches

(Single Foot Switch)

● Diagram of Ground Cable

(Ground Cable)

6. Periodic Inspection
Every six months, visually inspect the ZEUS-400/300/200 Electrosurgical Generator for
signs of wear or damage.

In particular, look for any of the following problems:

 Damage to the power cord

 Damage to the power cable receptacle
 Obvious damage to the unit
 Damage to any receptacle
 Accumulation of lint or debris in or around the unit

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 ZEUS-400/300/200 ZO-OM-001

7. Technical Factors
7.1 Specification

Model Name ZEUS-400 ZEUS-300 ZEUS-200

Rated Voltage AC120V / AC230V
Rated Frequency 50Hz / 60Hz
Power Consumption 1200VA +10% 1100VA +10% 1000VA +10%
Fuse T10AH when AC120V / T6.3AL when AC230V
Protection class Class 1, Type CF
Leakage current in acc. with IEC601,Part2-2
Carrier Frequency 400㎑, 500㎑
Repeat Frequency 33㎑
Size (W×D×H) 330mm × 455mm × 150mm
Weight 13Kg
Using Environment
Operation temperature 10℃ to 40℃
Storage temperature -10℃ to 60℃
Humidity 20% to 95% RH,
Operation altitude 700mbar ~ 1060mbar
Operation Cycle 10sec ON 30sec Idle
Cooling 1 inner fan

※ These parameters can be changed without notice.

7.2 Output

● ZEUS-400
Tolerance : ±20%
Mode output power Carrier Crest Duty Repeat
Freq. Factors Rate Freq.
Pure Cut 400W at 300ohm 400 ㎑ 1.6 100% Continuous
Blend1 250W at 300ohm 400 ㎑ 2.0 80% 33 ㎑
Blend2 200W at 300ohm 400 ㎑ 2.2 60% 33 ㎑
Blend3 150W at 300ohm 400 ㎑ 2.4 50% 33 ㎑
Contact coagulation 120W at 300ohm 400 ㎑ 3.3~1.5 10% 33㎑~153㎑
Spray coagulation 100W at 300ohm 400 ㎑ 4.5 8.0% 33 ㎑
Bipolar coagulation 99W at 100ohm 500 ㎑ 1.5 100% Continuous

Optional(UPGRADED VERSION)
Bipolar coagulation 100W at 100ohm 500 ㎑ 1.5 100% Continuous
Bipolar Cut 100W at 200ohm 500 ㎑ 1.5 100% Continuous

※ These parameters can be changed without notice.

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 ZEUS-400/300/200 ZO-OM-001

● ZEUS-300

Tolerance : ±20%
Mode output power Carrier Crest Duty Repeat
Freq. Factors Rate Freq.
Pure Cut 300W at 300ohm 400 ㎑ 1.6 100% Continuous
Blend1 230W at 300ohm 400 ㎑ 2.0 80% 33 ㎑
Blend2 180W at 300ohm 400 ㎑ 2.2 60% 33 ㎑
Blend3 120W at 300ohm 400 ㎑ 2.4 50% 33 ㎑
Contact coagulation 100W at 300ohm 400 ㎑ 3.3~1.5 10% 33㎑~153㎑
Spray coagulation 80W at 300ohm 400 ㎑ 4.5 8.0% 33 ㎑
Bipolar coagulation 80W at 100ohm 500 ㎑ 1.5 100% Continuous

Optional(UPGRADED VERSION)
Bipolar Cut 80W at 200ohm 500 ㎑ 1.5 100% Continuous

※ These parameters can be changed without notice.

● ZEUS-200

Tolerance : ±20%
Mode output power Carrier Crest Duty Repeat
Freq. Factors Rate Freq.
Pure Cut 200W at 300ohm 400 ㎑ 1.6 100% Continuous
Blend1 150W at 300ohm 400 ㎑ 2.0 80% 33 ㎑
Blend2 120W at 300ohm 400 ㎑ 2.2 60% 33 ㎑
Blend3 100W at 300ohm 400 ㎑ 2.4 50% 33 ㎑
Contact coagulation 100W at 300ohm 400 ㎑ 3.3~1.5 10% 33㎑~153㎑
Spray coagulation 80W at 300ohm 400 ㎑ 4.5 8.0% 33 ㎑
Bipolar coagulation 80W at 100ohm 500 ㎑ 1.5 100% Continuous

Optional(UPGRADED VERSION)
Bipolar Cut 80W at 200ohm 500 ㎑ 1.5 100% Continuous

※ These parameters can be changed without notice.

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8. Standard Output Table by Surgery Part

Cut Coagulation Coagulation

Part Cut Mode Bi-coag.
POWER(W) Mode POWER(W)
Pure or 10~120
Skin Incision
Blend1 8~100
Muscle Pure or Above 15
Dessection Blend1 Above 15
Tumor Blend2 15~80
Spray 10~15
Excision Blend3 15~70
Stomach,
Blend2 or 20 and Up
Intestine
Blend3 20 and Up
resection
Pure
Hemostasis 10~65 3~22
Coagulation
Loop
Neuro Blend2 or Pure Ball
20~80 1~8
Surgery Blend3 Coagulation 10~25
20~70
Massive Spray
10~30
Coagulation Coagulation
Prostatic Pure or 65 and Up
Spray 15 and Up
Resection Blend1 55 and Up
Bladder
Spray 12~30
Fulguration
Cervical Pure
Blend2 10~80 25~70
Conization Coagulation
Bartholin
Blend3 15~30 Spray 12~22
and Skeneis
Tubal Blend2 8~50 10~20

Proctologic Blend3 8~40 Spray 10~22

Abscess/Cyst Blend3 10~80 Spray 10~15

Lancet
Rectal, 8~30
Blend3 Pure 12~30
Sigmoid Loop
10~20

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9. Troubles and What to do with them

● There are no lights on the Display Number window.

1. Check if the power cord is connected to the power cord input plug on the back
side of the surgery unit.
2. Check if the power switch of the surgery unit is on.
3. Check the fuse (AC120V: T10AH 250V/ AC230V: T6.3AL 250V) on the back side
of the equipment.
4. If the trouble continues, use the auxiliary equipment.

● No output.

1. Check if the plug of patient return plate cable is connected to the surgery unit.
2. Check if the patient return plate is accurately connected with the patient.
3. Check if the accessories (Twin Button Handle, Monopolar Handle and Foot Switch)
are connected.
4. Change the accessories such as Twin Button Handle, Monopolar Handle and Foot
Switch and others.
5. Check if the output is set low.
6. If the trouble continues, use the auxiliary equipment.

● The alarm rings all the time.

1. When the patient plate has troubles.

① Check if the plug of patient plate cable is connected to the surgery unit.
② Change the patient plate.
③ If the trouble continues, use the auxiliary equipment.

2. When the patient return plate has troubles.

① Check if the plug of patient return plate cable is connected to the surgery unit.
② Check if the entire surface of patient return plate is adhered to the patient.
③ Check if the patient return plate is connected to the patient return plate cable.
④ Change the patient return plate cable.
⑤ If the trouble continues, use the auxiliary equipment.

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 ZEUS-400/300/200 ZO-OM-001

10. Load Regulation

10.1 Pure Cutting

400
350
300
250
WATT

400W
200
150 200W
100
50
0
100
200
300
400
500
600
700
800
900
1000
1100
1200
1300
1400
1500
2000
OHM

10.2 Blend1

250
200
150
WATT

250W
100 125W
50
0
100
200
300
400
500
600
700
800
900
1000
1100
1200
1300
1400
1500
2000

OHM

10.3 Blend2

200

150
WATT

200W
100
100W
50

0
100
200
300
400
500
600
700
800
900
1000
1100
1200
1300
1400
1500
2000

OHM

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10.4 Blend3

160
140
120
100
WATT

150W
80
60 75W
40
20
0
100
200
300
400
500
600
700
800
900
1000
1100
1200
1300
1400
1500
2000
OHM

10.5 Contact Coagulation

140
120
100
WATT

80 120W
60 60W
40
20
0
100
200
300
400
500
600
700
800
900
1000
1100
1200
1300
1400
1500
2000

OHM

10.6 Spray Coagulation

100
80
60
WATT

100W
40 50W
20
0
100
200
300
400
500
600
700
800
900
1000
1100
1200
1300
1400
1500
2000

OHM

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10.7 Bipolar Coagulation

120
100
80
WATT

99W
60
50W
40
20
0
25

50

100

200

300

400

500

600

700

800

900

1000

1100

1200

1300

1400
OHM

10.8 Bipolar Cut

120

100

80
WATT

120W
60
60W
40

20

0
10

50

100

200

300

400

500

600

700

800

900

1000

1200

1400

1600

1800

OHM

11. Voltage Output Graphic

11.1 Pure Cutting (Load 300Ω) Max Peak Output Voltage : 1070Vpp

1200
1000
Voltage(Vpp)

800
600
400
200
0
10

25

50

75

100

125

150

175

200

225

250

275

300

325

350

400

Watt

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11.2 Blend1 (Load 300Ω) Max Peak Output Voltage : 1061Vpp

1200
1000
Voltage(Vpp)

800
600
400
200
0
10

20

30

40

50

60

70

90

110

130

150

170

190

210

230

250
Watt

11.3 Blend2 (Load 300Ω) Max Peak Output Voltage : 1083Vpp

1200
1000
Voltage(Vpp)

800
600
400
200
0
10

20

30

40

50

60

70

80

90

100

110

120

140

160

180

200
Watt

11.4 Blend3 (Load 300Ω) Max Peak Output Voltage: 1014Vpp

1200
1000
Voltage(Vpp)

800
600
400
200
0
10

20

30

40

50

60

70

80

90

100

110

120

130

140

150

W att

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11.5 Contact Coagulation (Load 300Ω) Max Peak Output Voltage : 759Vpp

800
700
600
Voltage(Vpp)

500
400
300
200
100
0
5

10

20

30

40

50

60

70

80

90

100

110

120
Watt

11.6 Spray Coagulation (Load 300Ω) Max Peak Output Voltage : 1479Vpp

1600
1400
1200
Voltage(Vpp)

1000
800
600
400
200
0
5

10

20

30

40

50

60

70

80

90

100
W att

11.7 Bipolar Coagulation (Load 100Ω) Max Peak Output Voltage : 281Vpp

300
250
Voltage(VPP)

200
150
100
50
0
5

10

20

30

40

50

60

70

80

90

99

Watt

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11.8 Bipolar Cut (Load 200Ω) Max Peak Output Voltage : 473Vpp

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12. Appendix
12.1 Electromagnetic Compatibility (EMC) Information

Warning

Check the followings before using this product.

① Medical electrical equipment needs special precautions regarding Electromagnetic

Compatibility (EMC). Observe the EMC instructions in this appendix during
installation and operation.

② The use of portable and mobile RF equipment may have an impact on this and other
pieces of medical equipment.

NOTE: The tables and guidelines that are included in this Appendix provide information
to the customer or user that is essential in determining the suitability of the
equipment or system for the electromagnetic environment of use, and in managing
the electromagnetic environment of use to permit the equipment or system to
perform its intended use without disturbing other equipment and systems or non-
medical electrical equipment. If this equipment does cause harmful interference with
other devices, the user is encouraged to try to correct the interference by one or
more of the following measures:
- reorient or relocate the receiving device
- increase the separation between the equipment
- connect the equipment into an outlet on a circuit different from that to which the
other device(s) is connected.

Table 201
Guidance and manufacturer’s declaration – electromagnetic emissions
ZEUS-400/300/200 model is intended for use in the electromagnetic environment specified
below. The customer or user of the ZEUS-400/300/200 model should ensure that it is used in
such an environment.
Emissions test Compliance Electromagnetic environment - guidance

RF emissions Group 1
CISPR 11
RF emissions Class A The ZEUS-400/300/200 model is suitable for
CISPR 11 usage in all establishments (e.g. hospitals and
Harmonic emissions Class A doctors’ offices) except domestic establishments
IEC 61000-3-2 those directly connected to the public low-voltage
Voltage fluctuations/flicker Complies power supply network that supplies buildings used
emissions for domestic purposes.
IEC 61000-3-3

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Table 202
Guidance and manufacturer’s declaration – electromagnetic immunity
ZEUS-400/300/200 model is intended for use in the electromagnetic environment specified below. The
customer or user of the ZEUS-400/300/200 model should ensure that it is used in such an environment.
Emissions test EN/IEC 60601 test Compliance level Electromagnetic environment -
level guidance
Electrostatic ± 6 kV contact Complies Floors should be wood,
Discharge (ESD) ± 8 kV air ± 6 kV contact concrete or ceramic tile. If
IEC 61000-4-2 ± 8 kV air floors are covered with
synthetic material, the relative
humidity should be at least
30%.
Electrical fast ± 2 kV for power supply Complies Mains power quality should be
transient/burst lines ± 1 kV ± 2 kV for power that of a typical commercial or
IEC 61000-4-4 for input/output lines supply hospital environment. If image
Lines ± 1 kV for input/ distortion occurs it may be
output lines necessary to further filter the
power quality by using a AC
line filter.
Surge ± 1 kV differential mode Complies Mains power quality should be
IEC 61000-4-5 ± 2 kV common mode ± 1 kV differential that of a typical commercial or
mode hospital environment.
± 2 kV common mode
Voltage dips, <5% UT * Complies Mains power quality should be
short (>95% dip in UT) <5% UT* (>95% dip in UT) that of a typical commercial or
interruptions and for 0.5 cycle for 0.5 cycle hospital environment.
voltage Complies If the user of the equipment or
variations on 40% UT 40% UT system requires continued
power supply (60% dip in UT) (60% dip in UT) operation during power mains
input lines for 5 cycles for 5 cycles interruptions,
IEC 61000-4-11 Complies it is recommended that the
70% UT 70% UT equipment or system be
(30% dip in UT) (30% dip in UT) powered from an
for 25 cycles for 25 cycles uninterruptible power supply or
Complies a battery.
<5% UT <5% UT
(>95% dip in UT) (>95% dip in UT)

for 5 sec for 5 sec

Power 3 A/m Complies Power frequency magnetic

frequency 3 A/m fields should be at levels
(50/60 Hz) characteristic of a typical
magnetic field location in a typical
IEC 61000-4-8 commercial or hospital
environment.
* Note: UT is the a.c. mains voltage prior to application of the test level.

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Table 204
Guidance and manufacturer’s declaration – electromagnetic immunity –
for equipment and systems that are not life-supporting
ZEUS-400/300/200 model is intended for use in the electromagnetic environment specified below. The
customer or user of the ZEUS-400/300/200 model should ensure that it is used in such an environment.
Emissions test EN/IEC 60601 Compliance Electromagnetic environment - guidance
test level level
Portable and mobile RF communications
equipment should be used no closer to any part
of the ZEUS-400/300/200 model, including
cables, than the recommended separation
distance calculated from the equation applicable
to the frequency of the transmitter.
Recommended separation distance:
Conducted RF 3 Vrms 3 Vrms d = [3.5 / 3] P 150 kHz to < 80 MHz
IEC 61000-4-6 150 kHz to < 80 MHz

Radiated RF 3 V/m 3 V/m d = [3.5 / 3] P 80 MHz to < 800 MHz

IEC 61000-4-3 80 MHz to 2.5 GHz

d = [7 /3] P 800 MHz to 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 in meters [m]. Field
strengths from fixed RF transmitters, as
determined by an electromagnetic site surveya ,
should be less than the compliance level in each
frequency rangeb. Interference may occur in the
vicinity of equipment marked with the following
symbol:

Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection by structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio [cellular/cordless] telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which
the unit is used exceeds the applicable RF compliance level above, the unit should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the unit.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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Table 206
Recommended separation distances between portable and mobile RF communications
equipment and the ZEUS-400/300/200 model
The ZEUS-400/300/200 model is intended for use in an electromagnetic environment in
which radiated RF disturbances are controlled. The customer or user of the unit can help
prevent electromagnetic interference by maintaining a minimum distance between portable
and mobile RF communications equipment (transmitters) and the unit as recommended below,
according to The maximum output power of the communications equipment.

Separation distance d [m]

Rated maximum according to frequency of transmitter
output power of
transmitter[W]
150 kHz to < 80 MHz 80 MHz to < 800 MHz 800 MHz to 2.5 GHz

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.27
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

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Warranty

Name of product Electrosurgical Unit

Model no. ZEUS-400/300/200

License no.

Product no.

Term of guarantee Within one year from the date of purchase

Name of
hospital

Address
Customer
Detail Name

Phone

Name of seller

ZERONE Co., Ltd.

(Shinil IT UTO Bldg., Dangjeong-dong)
#810, LS-Ro 13, Gunpo-si, Gyeonggi-do, Korea
Name of manufacture
(zip 435-831)
Phone : +82 31 427 2772
Fax : +82 31 427 2332

※ Thanks for purchasing of ZEUS-400/300/200 from ZERONE Co., Ltd.

※ This product is made under thorough quality control and passed strict inspections.

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 ZEUS-400/300/200 ZO-OM-001

Document History

REV.No Edited Date Corrections

0 2006.06.08 Initial issued

1 2009.06.12 Add 300 MODEL
2 2012.03.20 Change address and add section 11
3 2012.08.13 Applied to 60601-1 3rd Edition.
4 2016.06.16 Add Caution
5 2016.10.12 Change of address (European agent)
6 2016.11.10 Add Caution
7 2017.06.08 Change CE number

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