Ultrasonic Surgical Unit

Operator Manual

LS-2000
 Warning!

This user manual and the device it describes should only be used by certified healthcare
professionals experienced in the particular technique and surgical procedure to be performed.

Any changes or modifications not approved by the party held responsible for compliance could void
the user’s authority to operate the instrument.

: LHbiomed Co., Ltd.

MGB EndoskopischeGeräte GmbH Berlin

Schwarzschildstraβe 6, D-12489 Berlin Germany

TEL: 49 30 / 63 92 7000

FAX: 49 30 / 63 92 7002

LHBIOMED LS-2000-EN-OPM(Rev.2.1)
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Table of Contents

1. Introduction ............................................................................................................................................. 1
1.1 General Warnings ............................................................................................................................. 1
1.2 Product Cautions .............................................................................................................................. 2
1.3 LS-2000 Symbols and definition ..................................................................................................... 3
1.4 Intended Use ..................................................................................................................................... 4
1.5 Contraindications.............................................................................................................................. 4
2. Equipment Description........................................................................................................................... 5
2.1 Overview ........................................................................................................................................... 5
2.2 Shape and Structure ......................................................................................................................... 5
2.3 Rear View .......................................................................................................................................... 6
2.4 Package Contents ............................................................................................................................. 7
3. Operating LS-2000 ................................................................................................................................. 8
3.1 Before Surgery .................................................................................................................................. 8
3.2 During Surgery .................................................................................................................................. 8
3.3 After Surgery..................................................................................................................................... 8
3.4 Probe Selection ................................................................................................................................. 9
3.5 Tuning ................................................................................................................................................ 9
3.6 Power and mode selection ............................................................................................................ 10
3.7 Foot Switch Operation................................................................................................................... 12
4. Cleaning, Sterilization, and Maintenance ........................................................................................... 13
4.1 Cleaning LS-2000 hand piece and probe .................................................................................... 13
4.2 Sterilizing Instruments .................................................................................................................... 14
4.2.1 Sterilization Option ................................................................................................................. 14
4.2.2 Instruments .............................................................................................................................. 14
4.3 Sterilization Methods for Instruments .......................................................................................... 15
4.4 Routine Maintenance ..................................................................................................................... 15
5. Fuse Replacement ................................................................................................................................ 16
6. Disposal of LS-2000 ............................................................................................................................. 16
7. Troubleshooting .................................................................................................................................... 17
8. Specification .......................................................................................................................................... 18

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8.1 Voluntary Standards ....................................................................................................................... 18

8.2 LS-2000Specification ..................................................................................................................... 18
9. Reuse Lifetime & Warranty ................................................................................................................. 19
10. Guidance and Manufacturer’s Declaration ...................................................................................... 20

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1. Introduction

LS-2000 is designed to minimize damage to connective tissues, leading to greater fat removal with
less blood loss and a reduction in recovery time and discomfort. It simplifies body contouring
applications and maximizes efficiency for fat reduction.

1.1 General Warnings

Warning Indicates personal safety of patients could result in injury.

Caution Indicates a possible situation that may cause damage to the instrument.

Note Indicates the simplest way of carrying out the procedure.

Warning The volume of the blood loss and endogenous body fluid loss may adversely affect
intra and/or postoperative hemodynamic stability and patient safety. The
capability of proving adequate, timely replacement is essential for patient safety.

Warning This device should be used with extreme caution in patients with chronic medical
conditions, such as diabetes, heart, lung, circulatory system disease, or obesity.

Warning The amount of fat removal should be limited to that necessary to achieve a desired
cosmetic effect.

Warning Result of this procedure will vary depending upon patient age, surgical site, and
experience of the physician.

Warning This device will not, in and of itself, produce a significant weight reduction.

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

Warning This device is designed to contour the body by removing localized deposits of
excess fat through small incisions.

Warning Use of this device is limited to those physicians who, by means of formal
professional training or sanctioned continuing medical education (including
supervised operative experience), have attained proficiency in suction lipoplasty.

Warning Results of this procedure may or may not be permanent.

Warning All reusable components of the device must be sterilized, and all disposable
components replaced before using the device system on another patient.

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Caution Do not use in a difficult place to remove the plug or appliance coupler.

Caution Do not operate the system in the presence of flammable anesthetics.

Caution This device can interfere with other electrical devices. See IEC 60601-1-2.

Caution This device is designed to contour the body by removing localized deposits of
excess fat through small incisions.

Caution Use of this device is limited to those physicians who, by means of professional
training or sanctioned continuing medical education (including supervised
operative experience), have attained proficiency in suction lipoplasty.

Caution During surgery do not bring the vibrating surgical probe into contact with metal
objects such as hemostats, clips, or other metal instruments. Probe damage may
result.

Caution Restrict entry to the operating room when LS-2000 is working.

Caution Sterilize all usable components of the device and replace all disposable
components before using the device on another patient.

Note The best use of this device depends largely on the operator. It is important for the
operator to read and follow the steps before hand.

1.2 Product Cautions

Caution Avoid using the device with wet hands or humid atmosphere. (Proper humidity
ranges: 30% ~ 85%)

Caution Do not place the product under direct sunlight.

Caution Do not use the device under big temperature variation. (Proper temperature
ranges: T: 20 ℃ ~ 30 ℃)

Caution Do not place the product near the vicinity of electric heaters.

Caution Do not place the product around high humidity and bad ventilation.

Caution Avoid excessive impact or vibration of the product.

Caution Avoid explosive gas exposure or chemical substance exposure of the product.

Caution Do not insert dusty or metal material to the product.

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Caution No modification of the product is allowed.

Caution Do not connect the power cord before the setting is done.

Caution Improper cleaning and reusing of the handpiece and probe could potentially cause
damage resulting in malfunction of the device.

1.3 LS-2000 Symbols and definition

Symbol Definition Symbol Definition

TYPE BF Applied Part per Warning: Precaution for

IEC 60601-1 Patient Safety

Caution: Precaution for Non-ionizing

Product Damage Electromagnetic Radiation

User Manual Reference High Voltage; Risk of electric

shock

WEEE (Waste Electrical Protective earth

and Electronic Equipment)

Equipotentiality Humidity Limitation

Serial Number Manufacturer

Atmospheric Pressure Temperature Limitation

Limitation

Authorized European European Conformity Mark

Representative

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1.4 Intended Use

LS-2000 is intended for use in the following such as, fragmentation and emulsification of
subcutaneous fatty tissues for aesthetic body contouring.

• Plastic and Reconstruction Surgery

• Orthopedic Surgery

1.5 Contraindications

Use of this device is contraindicated for patients with chronic medical conditions, such as obesity,
diabetes, blood clotting disorders, heart, lung, or circulatory system disease, or vascular problems,
including common circulation problems and coagulation problems associated with certain
medications.

The following conditions may affect the safety or effectiveness of this device. Presence of
collagen, scarring, or connective tissue disorders; presence of stretch marks or potential for stretch
mark formation; Lupus Erythematosus; endocrine disorders; pregnancy or the possibility of
pregnancy; or other active diseases that may affect the procedure outcome or increase risk of
complication.

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2. Equipment Description

2.1 Overview
LS-2000 emanates ultrasound frequency vibration to create a surgical effect from LS-2000
ultrasonic surgical probe. The ultrasonic frequency vibration is created using the piezoelectric
property of PZT ceramic crystals located in the LS-2000 Handpiece. The PZT ceramic crystals
expand and contract in cooperation with electrical power supplies to the handpiece from the
amplifier(driver) of LS-2000. The LS-2000 controls and maintains vibration amplitude and frequency
through two methods of vibration, N mode (continuous mode) and Z mode (pulsed mode).

2.2 Shape and Structure

LS-2000 Main Body

1. LCD Display and Touch Screen User Interface

2. Handpiece Cable Connector Connector for Handpiece connection (Applied Part:

Handpiece and probe)

3. Secondary Power Button Switch to turn on and off the secondary power

4. Power LED Indicator 1. When power on

- White: During Self-Test
- Green: Self-Test Pass
- Red: Self-Test Fail
- Blue: Ready for Operation (Blinking)

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2. During Tuning process:

- Yellow: Turns on sequentially while tuning is
in progress.
3. During Operation
- Green: the output is near to setting.
- Orange: the output is far to setting.
- Red: the output is very far to setting.
4. Red: When the main is on but secondary power
is off

5. T (Tuning) Button Tuning Mode to (re)tune the probe

6. ↵ (Return) Button Return to probe selection screen or confirm

selection

7. N (Mode) Button Continuous mode operation button

8. Z (Mode) Button Pulse mode operation button

9. Up Button Increases the output of ultrasonic power

10. Down Button Reduces the output of ultrasonic power

2.3 Rear View

1. Foot switch Connector The connector for Foot Switches

2. Protective Earth Terminal Terminal for connecting Protective Ground
Cable
3. Main Power Switch Switch to turn on and off the Main Power
4. AC Power Inlet Input: AC 100 ~ 240V

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2.4 Package Contents

Content Name (Quantity) Function

Main Body TFT LCD Display, Buttons and Touch

pad for User Interface

Hand piece Convert electric power to ultrasonic

power
(1 EA)

Foot Switch Turns on and off the output of the

ultrasonic power
(2 EA)

Probes
ø3.7(1EA)

ø2.9(1EA)
Convert the ultrasonic power to
ø1.9(1EA) mechanical vibration energy
ø1.2(optional)

ø4.0(optional)

Spanner A tool used to tighten or loosen a

probe to the handpiece
Wrench

Power Cord AC Power Connection

(1 EA)

Operator Manual Operating Instruction for use

(1 EA)

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3. Operating LS-2000

3.1 Before Surgery

Note All handpiece and probes need to be properly cleaned and sterilized before every use.

1. Place the LS-2000 outside the sterile field and connect to a source of AC power.
2. Connect the foot switch to the foot switch connector of LS-2000 main body.
3. Connect the hand piece cord to the hand piece cable connector of LS-2000 main body.
4. Connect the probe to the hand piece.
5. Turn on the LS-2000 using the main power switch.
6. Tune the probe. Select the relevant probe on the menu screen and press the foot switch
until the tuning process is completed.

3.2 During Surgery

Caution Do not lay the handpiece on the patient when not in use.

Note Do not start the ultrasonic vibration with the probe in the free air; damage to the probe
may occur.

1. Select the mode of operation using the N or Z button.

2. Adjust the vibration amplitude using the up or down button.
3. Activate ultrasonic vibration by depressing the foot switch.

3.3 After Surgery

1. Remove all LS-2000 components from the sterile field.

2. Turn off the power on the LS-2000.
3. Disconnect the hand piece from the LS-2000 and set apart for cleaning.
4. Wipe down and disinfect the LS-2000.

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3.4 Probe Selection

Before using the device, connect all LS-2000 components to the LS-2000 main body. Turn on the
power switch located on the rear end panel. After running the self-test routine, probe selection
screen is shown as figure 1.

Figure 1
Please select a probe type by touching the
appropriate probe diameter on the LCD panel. Tuning
mode will initiate automatically as the next step.

Figure 2
Note: If LCD shows a message “Please connect the
hand piece,” check the connection between the main
body and hand piece.

3.5 Tuning
Tuning process starts as figure 3 when the foot switch is pressed. Until the tuning process is
completed, please keep pressing the foot switch (figure 4), until it finally shows a message
“Completed!!!” as figure 5.

Figure 3 Figure 4 Figure 5

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Figure 6
If LCD shows a message “Tuning error!!!”,
it means the tuning process is not completed. Please
reinitiate the tuning process.

3.6 Power and mode selection

Figure 7
After the tuning process is completed, the LCD is
displayed as figure 7. Operator can modify output and
operating mode for each surgery application.

Operator can control the output power by touching Up/Down button ( ) on LCD or by
pressing or buttons on the front panel of main body.

Figure 8 Figure 9

Current Operation mode is displayed on the top left side of the screen.

The mode is automatically set to N-mode by the manufacturer. To change the mode, operator can
touch the icon on LCD or press button on the front panel of main body.

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Table 1. shows LCD display icon description

Name Icon Description

Tune When the current output power is weak or not emitted, touch
the icon on the LCD to retune the probe.

Mode To change from N mode to Z – mode, press the Z button for

more than 1 second for the switch.
Z mode types are available in the order of Z1->Z2->Z0->Z1.
There are three (3) types of Z – modes.
Z0: 5Hz Pulsed mode operation
Z1: 10Hz Pulsed mode operation
Z2: 15Hz Pulsed mode operation

Exit

Figure 10
When the probe is changed and need to retune, touch the icon
on the LCD to return to the “Select Probe” display as
seen in figure 10.

Time Resets the timer to (00:00). The unit of the timer is MM: SS
Reset

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3.7 Foot Switch Operation

A foot switch is a soft key button that is used to trigger signal to the main MCU input port through
a Level Shifter into an ON state. If the two-foot switches are ON at the same time, the result will
be same because of the logical ‘OR’ gate operation as shown in figure 11.

The purpose of utilizing two-foot switches is first, for safety use, and second is for convenience.
When one-foot switch is disabled, the other foot switch can operate the machine in turn. An
optimal use is placing the foot switches on the either side of the surgical bed without the need to
move the switch during the surgery.

Figure 11

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4. Cleaning, Sterilization, and Maintenance

4.1 Cleaning LS-2000 hand piece and probe

LS-2000 handpiece should be disassembled, cleaned, and disinfected as described below.

Follow the cleaning procedures and guidelines recommended by your institute. The followings are
guidelines that may be used in conjunction with your institute’s procedures and guidelines. Improper
cleaning and reusing of the handpiece and probe could lead to potential damage that causes
malfunction of the device.

Note: DO NOT unscrew hex-shaped cable connection on the back of the Hand piece.

Note: DO NOT use ultrasonic or automated washers.

Note: DO NOT use chlorinated and abrasive cleaning agents. (Bleach)

Note: DO NOT soak the handpiece in enzymatic cleaner or water.

1. Disconnect the hand piece from the LS-2000 main body.

2. Disassemble the probe from the hand piece by unscrewing the probe cap (nosecone) and
removing it. Using the hand piece wrench, unscrew the probe form the hand piece.
3. Once the handpiece and the probe are disassembled, thoroughly rinse, and scrub the probe
cap (nosecone) and probes in warm water with an instrument cleaning detergent until all
visible debris has been removed.
4. Soak the probe cap (nosecone) and probe in an enzymatic cleaner.
5. After soaking, rinse the probe cap (nosecone) and probe with clean water.
6. Gently dry the rinsed probe cap (nosecone) and probe with soft, dry cloth.
7. Thoroughly clean the handpiece by spraying the surface of the handpiece with enzymatic
cleaner and clean it with a soft, dry cloth.
8. Repeat the cleaning process if there is a remaining visible debris upon inspection.

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4.2 Sterilizing Instruments

4.2.1 Sterilization Option

The Ultrasonic hand piece and instruments may be combined or separated for the sterilization
according to your facility’s capabilities and the sterilization methods described below. Combine or
separate the instruments in the sterilization trays to best suit your facility’s capabilities.

The recommended approach is to separate the hand piece from the rest of the instruments and to
sterilize them separately. If possible, sterilize the hand piece using the Sterrad method and the rest
of the instruments using one of the two recommended steam autoclave cycles shown below. If
Sterrad is not available, then the steam autoclave cycles shown below may be used for the Hand
piece.

Note: The use of FDA/ EUMDR certified wrap, pouch, or others to maintain the sterility for the
intended sterilization cycle is recommended.

4.2.2 Instruments
Applicable instruments: Hand piece, Probes, Caps, and Wrench.

Follow your institution’s guidelines for the following types of sterilization. If autoclave cycles longer
than what is shown in the Table 2; it will slowly degrade the performance and useful life of the hand
piece.

Note: DO NOT unscrew hex-shaped cable connection on the back of the Hand piece.

Note: DO NOT use CEDEX (glutaraldehyde) or STERIS (peracetic acid, liquid or plasma) processes
on the hand piece.

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4.3 Sterilization Methods for Instruments

Table 2. Sterilization Methods for Instruments

Sterilization Method Recommended Parameters

Sterrad for Ultrasonic hand piece Manufacture’s recommended cycle

Steam (gravity, wrapped), for all 132℃ (270℉) minimum, gravity single wrap, 20
instruments minutes exposure, 20 – 30 minutes dry time

Steam (vacuum, wrapped), for all 132℃ (270℉) minimum, gravity single wrap, 4-5
instruments minutes exposure, 20 – 30 minutes dry time

If using an autoclave to sterilize the hand piece, remove the hand piece immediately after the
autoclave dry cycle is completed. Do not let the hand piece sit in a hot autoclave past the
recommended drying period. Let the hand piece cool at least 30 minutes before use, 2 hours is
preferable.

Once the applicable instruments have been sterilized and sufficiently cooled down, a visual
inspection is needed to examine for any sign of damage or remaining debris on the applicable
instruments. If damaged, the part needs to be inspected and replaced. If there’s visible sign of
remaining debris, repeat the cleaning and sterilizing process till the remaining debris is removed.

After successful visual inspection of sterilized instruments, assemble the parts by connecting the
probe and probe cap (nosecone) to the hand piece using handpiece wrench. Safely store the
instrument following your institute’s procedures and guidelines for future use.

4.4 Routine Maintenance

Table 3. Routine Maintenance Check

Number Item When Task

1 LS-2000 Main After each Disinfect and wipe dry

body usage

2 Foot Switch After each Disinfect and wipe dry

usage

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5. Fuse Replacement

To replace the fuse in the LS-2000:

1) Disconnect the AC power cord from either the wall plugs or the other power source.

2) Detach the AC power cord from the Power Inlet of the main body on the rear panel.

3) Using a small Philips screwdriver, unlock and take out the fuse cartridge from the power
inlet.

4) Remove the old fuse and install the new fuse.

5) Snap the fuse cartridge back into the place.

6) Reconnect the AC power cord to the power inlet then to power source.

※ Fuse: 2A/250V, Length: 20mm, Diameter: 5mm

6. Disposal of LS-2000

When disposing of the LS-2000, adhere to all applicable laws regarding recycling. If you are
not able to dispose the LS-2000, contact your local distributor for disposal instructions. Under the
WEEE Directive, the transfer of the wastes for devices sold by manufacturer is undertaken by
distributor.

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7. Troubleshooting
Malfunction that may occur before or during the normal course of surgery usually can be corrected
by referring to Table 4. If the malfunction cannot be resolved using Table 4, discontinue the use of
LS-2000 until the malfunction has been resolved.

Table 4. Troubleshooting
Condition Possible Causes Recommended Action

LS-2000 does not operate, No power to unit. 1. Check the AC power cord
connections (both ends)
LCD display is off. 2. Check On/Off switch
3. Check fuse
4. Check wall power outlet
LS-2000 does not operate, Bad components 1. Check foot switch connection
connections. 2. Check handpiece connection
LCD display is off. 3. Check probe for looseness
Inoperative handpiece. 4. Check if the probe is broken or
cracked
Broken or cracked probe 5. Turn off the Main power and
then turn on again.
Handpiece Cable broken

Tuning is not complete Probe selection is not 1. Check the selected probe is
correct. correct.
2. Check probe for looseness
Inoperative handpiece. 3. Check if the probe is broken or
cracked
Broken or cracked probe. 4. Turn off the Main power and
then turn on again.
Broken Handpiece Cable

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8. Specification
Details about electrical, mechanical, and operating technical specification for the LS-2000. Voluntary
compliance standards are listed as well.

Table 5. Environmental Operating Specification

Operating Temperature 12 to 40℃ / 54 to 104 ℉

Operating Humidity 15% to 80% relative humidity non-condensing

Atmospheric Pressure 79.051 kPa – 101.325 kPa

The LS-2000 requires a minimum of one-hour exposure at its operating temperature range prior
to use.

8.1 Voluntary Standards

The LS-2000 has been designed to comply with the following voluntary biocompatibility,
safety/performance, and regulatory standards for medical equipment.

• ISO Standard 10993 – Biological Testing for Medical Devices

• EN 60601-1 – Medical Electrical Equipment

• EN 60601-1-2 – Electromagnetic Compatibility

8.2 LS-2000Specification

1. Model Name: LS-2000

2. Classification and type for electrical shock: Class IIb, Type BF

3. Input Power: AC 100V – 240V / 50/60 Hz
4. Maximum Power Dissipation:100VA
5. Probe Tuning Frequency Range: 35kHz – 40kHz
6. Output Acoustic Power: 0 – 90W max ± 20%

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7. Operation Modes
a. N Mode: Continuous Output
b. Z Mode: Pulsed Output (Duty cycle: 50ms on, 50ms off)
8. Handpiece: 215mm, 30Φ
9. Dimension (W X L X H): 390 X 275 X 170 mm
10. Main Body Weight: 4.2kg
11. Foot Switch: 10A / 250
12. Fuse: 250V / 2A, 20mm X 5mm (Diameter; Φ)

9. Reuse Lifetime & Warranty

Lifetime of device :5 years

A visual inspection is necessary to inspect a probe’s use of lifetime. Once a probe reaches its end
use, there are visualization of signs such as discoloration and corrosion of the probe’s tip or
broken/ cracked body of probe that can hinder the performance of the device. A continued use of
a device that exceeds its use life may result in reduced effectiveness, malfunction, or increased
risk of infection from damaged device materials.

Warranty:

• Main Body: 2 years

• Handpiece: 1 years

• Probes: 6 months

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10. Guidance and Manufacturer’s Declaration

Table 6. Electromagnetic Emission

The LS-2000 is intended for use in the electromagnetic environment specified below. The
customer or the user of the LS-2000 should assure that it is used in such an environment

Emissions test Compliance Electromagnetic Environment-Guidance

The LS-2000 use RF energy only for its internal function.

RF Emissions
Group Therefore, its RF emissions are very low and are not likely to cause
CISPR 11
any interference in nearby electronic equipment.

RF Emissions The LS-2000 is suitable for use in all establishments, including

Class A domestic establishments and those directly connected to the public
CISPR 11
low-voltage power supply network that supplies buildings used for
Harmonic
domestic purposes.
Emissions Class A
IEC 61000-3-2
Voltage
Fluctuations/
Flicker Complies
Emissions
IEC 61000-3-3

Table 7. Recommended separation distances between portable and mobile RF

communications equipment and the LS-2000

Separation distance according to frequency of transmitter

Rated [m]
maximum
150 kHz to 80MHz 80MHz to 800 MHz 800MHz to 2.5 GHz
output power
of transmitter
[W]
V1 = 3Vrms E1 = 3 V / m E1 = 3 V / m
0.01 0.12 0.11 0.23
0.1 0.1 0.36 0.73
1 1.17 1.16 2.33
10 3.69 3.68 7.37
100 11.66 11.66 23.33

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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 1) At 80MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

Table 8.1 Electromagnetic Immunity

The LS-2000 is intended for use in the electromagnetic environment specified below.
The customer or the user of the LS-2000 should assure that it is used in such an environment.
IEC60601 Electromagnetic
Immunity test Compliance level
Test level environment-guidance
Electrostatic ±6 kV Contact ±6 kV Contact Floors should be wood, concrete or
discharge (ESD) ceramic tile. If floors are covered with
synthetic material, the relative humidity
IEC 61000-4-2 ±8 kV air ±8 kV air should be at least 30%.
Electrical fast ±2 kV for ±2 kV for supply lines
transient/burst supply lines
Mains power quality should be that of a
typical commercial or hospital
IEC 61000-4-4 ±1 kV for ±1 kV for
environment.
input/output input/output lines
lines
Surge ±2 kV ±2 kV differential
differential mode Mains power quality should be that of a
mode typical commercial or hospital
IEC 61000-4-5 ±1 kV common ±1 kV common mode environment.
mode

Voltage dips, <5% UT <5% UT

short (> 96% dip in (> 96% dip in UT ) for
UT ) for 0.5 0.5 cycle
cycle Mains power quality should be that of a
interruptions 40% UT typical commercial or hospital
and voltage 40% UT ( 60 % dip in UT ) for environment. If the user of the LS-2000
( 60 % dip in 5 cycle image intensifier requires continued
variations on UT ) for 5 cycle operation during power mains
power supply 70 % UT interruptions, it is recommended that
input lines 70 % UT (30 % dip in UT ) for the LS-2000 image intensifier be
(30 % dip in 25 cycle powered from an uninterruptible power
IEC 61000-4- UT ) for 25 supply.
11 cycle <5% UT
(< 95% dip in UT) for
<5% UT 5s

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(< 95% dip in

UT ) for 5 s
power 3A/m 3A/m
frequency Power frequency magnetic fields should
(50/60 Hz) be at levels characteristic of a typical
magnetic field location in a typical commercial or
hospital environment.
IEC 61000-4-8
NOTE UT is the a.c mains voltage prior to application of the test level.

Table 8.2 Electromagnetic Immunity

IEC 60601 test Compliance Electromagnetic environment -
Immunity test
level level guidance
Conducted RF 3 Vrms 3 Vrms Portable mobile RF communications
IEC 61000-4-6 150 kHz to 80 150 kHz to 80 MHz equipment should be used no closer
MHz to any part of the LS-2000, including
cables, than the recommended
separation distance calculated from
the equation applicable to the
frequency of the transmitter.

Recommended separation distance

Radiated RF 3V / m 3V / m
IED 61000-4-3 80 MHz to 2.5 80 MHz to 2.5 GHz
GHz 80 MHz to 800 MHz

800MHz 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 distance in
meters (m)

Field strength from fixed RF

transmitters, as determined by an
electromagnetic site survey, a should
be less than compliance level in each
frequency range. b

Interference may occur in the vicinity

of equipment marked with the
following symbol:

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LHBIOMED LS-2000-EN-OPM(Rev.2.1)
 LS-2000 OPERATIONAL MANUAL

NOTE 1) At 80MHz and 800MHz, the higher frequency range applies.

NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a
Field strength from fixed transmitters, such as base stations for ratio (cellular/cordless_
telephones and land mobile radios, amateur radio. To assess the electromagnetic environment due
to fixed strength in the location in which the EUT is used exceeds the applicable RF compliance
level above, the EUT should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the LS-2000.
b
Over the frequency range 150kHz to 80MHz, field strengths should be less than [V1] V / m.

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LHBIOMED LS-2000-EN-OPM(Rev.2.1)
 LS-2000 OPERATIONAL MANUAL

TEL: 82-33-901-0411 FAX: 82-33-901-0422

#806 Medical Device Complex Center, 200 Gieopdosi-ro, Jijeong-myeon,

Wonju-si, Gangwon-do, Korea

www.lhbiomed.com

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LHBIOMED LS-2000-EN-OPM(Rev.2.1)