3-channel Palm-sized Electroacupuncture

OPERATION MANUAL
 CONTENTS
■Warning Symbol Marks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 01

■Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 02

■Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 03
■For Correct and Safe Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 03

■Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 06

■General Description of Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 010

■Compatible Needle Electrodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 010

■Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

■Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

■Preparations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
■Beginning Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

■Concluding Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

■Device Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

■EMC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
■Warning Symbol Marks
Following warning symbol marks are used in this manual.

DANGER
indicates a danger of death or serious injury of an operator or patient if
the operator ignores this symbol and uses the ES-130.

WARNING
indicates a possibility of death or serious injury of an operator or patient
when the operator ignores this warning and uses the ES-130.

CAUTION
indicates a possibility of death or serious injury of an operator or property
damage when the operator ignores this caution and uses the ES-130.

1
■Symbols
• Symbol for “CONSULT •S
 ymbol for
INSTRUCTIONS FOR “ATMOSPHERIC
USE” PRESSURE
LIMITATION”
• Symbol for “SERIAL
NUMBER” •S
 ymbol for “Waste
Electrical and
• Symbol for Electronic Equipment
“CATALOGUE (WEEE), Directive”
NUMBER” *T
 his symbol is valid
only in European
• Symbol for Union.
“AUTHORISED
REPRESENTATIVE IN •S
 ymbol for “TYPE BF
THE EUROPEAN APPLIED PART”
COMMUNITY”
•T
 hese marks are to be
• Symbol for used to indicate
“MANUFACTURER” conformity to
European Community
• Symbol for “DATE OF harmonisation
MANUFACTURE” legislations.

• Symbol for •S
 ymbol for “This unit
“TEMPERATURE should be used by a
LIMIT” licensed medical
practitioner”
• Symbol for
“HUMIDITY
LIMITATION”

2
■Intended Use
The indication for use of ES-130 is an ELECTROACUPUNCTURE DEVICE for
use in the practice of acupuncture by qualified practitioners of acupuncture
as determined by the states.

Prescription Use Only: As an electroacupuncture device, the ES-130 is

restricted to the sale by or on the order of an acupuncture practitioner
licensed by the law of the state in which he/she practices.

Use of this machine should be limited to properly trained individuals.

■For Correct and Safe Use

CONTRAINDICATIONS
1) Over or in the region of carotid sinus
2) Thorax of individuals with cardiac disease
3) ES-130 should not be used to people or in conjunction with the devices
listed below
a) Individuals with cardiac pacemakers or other devices implanted
b) Pump-oxygenators and other electronic devices designed for
sustentation
c) Electrocardiographs and other electronic medical devices used for
monitoring patients
4) Over or into abdomen, trunk, pelvis or low back during pregnancy
5) Over or into infected areas
6) Over or into areas of laceration or open wounds
7) Over or into areas of impaired sensory

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8) Individuals with active hemorrhage or bleeding disorders such as
hemophilia
9) Over the heart
10) Individuals with contagious disease such as tuberculosis
11) Transcranial placement of electrodes (the head in between the electrodes)
12) Electrode placement on the chest where electrical stimulation may be
applied to the heart which may result in cardiac fibrillation.

WARNINGS
1) Excessive stimulation causing muscle contraction should not be applied
over the body.
2) Stimulation should not be applied transthoracically in that the introduction
of electrical current into the heart may cause cardiac arrhythmias.
3) Stimulation should not be applied transcerebrally.
4) Stimulation should not be applied over swollen , or over skin surface with
atrophic contracture, etc.
5) Stimulation should not be applied over, or in proximity to, cancerous
lesions.
6) Do not use the device on mentally unstable patients.
7) Do not use over areas of known thrombosis or thrombophlebitis.
8) A warning on the following potential hazards.
9) Simultaneous connection of a PATIENT to a h.f. surgical EQUIPMENT may
result in burns at the site of the STIMULATOR electrodes and possible
damage to the STIMULATOR.
10) Operation in close proximity (e.g. 1 m) to a shortwave, microwave or any
high frequency EQUIPMENT, it may produce instability to the
STIMULATOR output.

4
 CAUTION
1) Caution should be used for patients with suspected or diagnosed heart
problems.
2) Caution should be used for patients with suspected or diagnosed
epilepsy.
3) Caution should be used in the presence of the following:
a) Following recent surgical procedures when muscle contraction may
disrupt the healing process
b) Individuals with menstruating
c) Patient has febrile disease
d) Patients with abnormal blood pressure or suspected vascular disease
4) Some patients may experience skin irritation or hypersensitivity due to the
electrical stimulation or electrodes.
5) The irritation can usually be reduced by using an alternate electrode, or
alternate electrode placement.
6) Electrode placement and stimulation settings should be based on the
guidance of the prescribing practitioner.
7) Stimulators should be kept out of the reach of children.
8) Stimulators should be used only with the leads and electrodes
recommended for use by the manufacturer.
9) ES-130 should not be used while driving, operating machinery, or during
any activity in which involuntary muscle contractions may put the user
under extreme risk of injury.
10) ES-130 should not be used for other patients determined unsuitable by
licensed individuals (EX. acupuncturists etc.). Practitioners using this
device should be properly trained for the safe use of this modality.
Rx ONLY
11) If an allergic reaction to the electrode is noticed, discontinue use.

5
■Components
⑤ Main Unit

④
①

②
⑧ ⑦ ⑥
Front View Rear View

① Frequency Range Selector Switch

Output frequency range is selected by the user from L setting which
represents the low ES-130 frequency range (1-20 Hz), M setting which
represents the medium ES-130 frequency range (20-150 Hz), or H setting
which represents the high ES-130 frequency range (150-500 Hz).
② Fine Frequency Adjustment Dial
After setting the Frequency Range Selector Switch, the user then rotates
the Fine Frequency Adjustment Dial to select the specific desired output
frequency within the selected frequency range. The user-selectable Fine

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 Frequency Adjustment Dial settings are S, 2, 4, 6, 8, and 10. The “S” Fine
Frequency Adjustment Dial setting corresponds to the specific frequency
at the start of the selected frequency range (minimum frequency within the
selected frequency range). The“10” Fine Frequency Adjustment Dial
setting corresponds to the specific frequency at the end of the selected
frequency range (maximum frequency within the selected frequency
range). The other numbers correspond to other specific frequencies within
the selected range. The specific frequencies corresponding to the Fine
Frequency Adjustment Dial settings, within each Frequency Range
Selector Switch setting (L, M, and H), are listed in the ES-130 Frequency
Selection Table. In addition to appearing further below in this document,
the ES-130 Frequency Selection Table also appears in the ES-130
Operation Manual and on the front of the ES-130 Main Unit.
③ Frequency Indicator Light
The green LED Frequency Indicator Light flashes at a rate corresponding
to the selected output frequency. This provides to the user a visual
confirmation of the selected output frequency. The same output frequency
applies to all three ES-130 output channels.
④ Output Level Adjustment Dials
The Output Level Adjustment Dial settings are OFF, 0, 2, 4, 6, 8, and 10.
The OFF position locks the Output Level Adjustment Dial at zero output,
avoiding any unintentional output from the corresponding channel. The 0
position unlocks the Output Level Adjustment Dial, but still keeps the
output at zero. The 2 position is the lowest output current for that channel.
Positions 4, 6, and 8 are linear increases in output current. Finally, the 10
position is the maximum output current for that channel.

7
⑤ Output Terminals
The user attaches one Electrode Cable to each Output Terminal,
corresponding to CH1, CH2, and CH3. The pulsed electroacupuncture
current is carried from the Main Unit, through the Electrode Cable, to the
Needle Electrodes placed at the treatment area.
⑥ High/Low Intensity Selector Switch
The user selects between two output voltage ranges (low or high),
depending on the desired electroacupuncture treatment protocol. The L
setting provides treatment current from 0-36 mA ±15% (0-18 V ± 15% @
500 Ω resistance load). The H setting provides treatment current from
0-60 mA ± 15% (30 V ± 15% @ 500 Ω resistance load).
⑦ Battery Level Check Button
The user presses the Battery Level Check Button to examine whether the
appropriate supply voltage is available to meet the ES-130 output
specifications. If the green LED Battery Level Indicator Light illuminates,
then the 9 V battery has sufficient voltage to operate the device
effectively. Otherwise, the user is instructed to replace the battery, in order
to maintain proper supply voltage.
⑧ Battery Level Indicator Light
This green LED illuminates when the Battery Level Check Button is
pressed and the battery has sufficient voltage to operate the device
effectively. The green LED does not illuminate when the Battery Level
Check Button is pressed and the battery has insufficient voltage (< 8.0 V)
to operate the device effectively, thus indicating to the user that
replacement of the 9 V battery is necessary.

8
Electrode Cable Each of the three Electrode Cables is composed
with Clips【ESC006】 of one connector and two clips for attaching the
acupuncture needles (positive and negative
connections). Any of the three Electrode Cables
can be attached to any of the three Output
Terminals, but are provided in three different
colors (green, yellow, and white) to assist in
distinguishing among placement of needle
electrodes, when multiple channels are used.
The part number for replacement Electrode
Cables is B180434, B180433 and B180432.
These cables are applied parts.

Carrying Bag
The carrying bag is intended to carry, protect,
and house the main unit and cable accessories
when not in use. For replacement, the Carrying
bag part number is 260182.

＊ A battery isn't attached to the standard accessories.

Purchase the battery locally. Use a DC 9 V battery.

9
■General Description of Product
The ES-130 device is an Electroacupuncture Device composed of a Main
Unit and three separate Electrode Cables. The Main Unit is powered by a
standard 9 V battery, and the handheld ES-130 device is supplied with a
Carrying Bag.

■Compatible Needle Electrodes

When using the ES-130, use only the electrodes (0.20 mm minimum
diameter) that have been determined to be compatible with the ES-130
Electroacupuncture Device.

10
■Specifications
(1) Output channel: 3 channels (individually adjustable)
(2) Maximum output voltage @ 500 Ω load (setting on back of device):
(2) 18 V ± 15% when High/Low Selector Intensity Switch = L
(2) 30 V ± 15% when High/Low Selector Intensity Switch = H
(3) Maximum output current:
(2) Output selector 14 mA ± 20% (rms, when resistance load is 500 Ω）
(4) Frequency for treatment: 1-500 Hz
(5) Pulse width: 100 μsec
(6) Output waveform: biphasic rectangular waveform

(7) Power source: DC 9 V battery

(8) Safety class according to IEC 60601-1: Internally powered equipment
Type BF
(9) Size: 96 mm (H) x 63 mm (W) x 27 mm (D)
(10) Weight: 160 g (Including battery)

11
(11) Environmental conditions:

In use Temperature: 10–40℃

Humidity: 30–85％

Barometric pressure: 800–1060 hPa

Storage Temperature: 10–60℃

and
Transportation Humidity: 30–95％

Barometric pressure: 700–1060 hPa

CAUTIONS
1) Remove batteries before storing unit for an extended period of time.
2) Avoid twisting or pulling wires, as this may cause damage.
3) When storing the machine, be sure to pay attention to the following:
a) Keep unit away from water.
b) Store unit in a climate controlled environment with proper ventilation.
c) Watch the state of stability of the machine, avoiding vibration or impact
(including when it is transported).
d) Do not place the machine in a storage of chemicals or a place where
gases are emitted.
4) Do not use any accessories or components designed for other machines
as this may cause the unit to malfunction.
5) Keep unit away from fire.
6) Combined use with other treatment equipment could affect the diagnostic
equipment.
7) Test the battery prior to each use.
8) Check the dials and controls to make sure that those components are
functioning correctly.
9) Make sure that all wires are intact and plugged in correctly.

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10) Output of the RED alligator clip is positive and the BLACK is negative.
11) Misuse or violent force may cause damage to the machine.
12) Clean unit with a damp cloth.
13) Do not use chemicals or cleaning agents.
14) When the machine is going to be operated again after it has been laid out
for a while, make sure to verify in advance that the components of
devices work normally and safely.
15) Inspect the main unit and the accessories regularly on a daily basis in
order to make sure that the main unit maintains the specified
performance, and search for any deterioration or abrasion on the
accessories at the same time.
16) Make sure to check the accessories at all times. If any of them are found
defective, replace it with new ones to prevent danger.
17) Avoid current densities exceeding 2 mA/cm2 when using this device. Use
extreme caution to reduce the chance of thermal bums due to high
current density.

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■Battery
INSTALLING AND REPLACING BATTERY
1. Turn off all Output Level Adjustment Dials A
(see A).
2. Slide the bottom battery cover open
(see B).
3. Insert the battery into the battery
compartment and then close this bottom
cover (see B).
＊Use only a 9 V battery, 6F22. B

HOW TO CHECK BATTERY

Turn on one of 3 channels and then push
the Battery Level Check Button on the
reverse side of the unit, using the point of a
ball point pen or similar object (see C):
C
Battery Level Indicator Light = ON, then
battery power is sufficient.
Battery Level Indicator Light = OFF, then
battery power is not sufficient and battery
must be replaced to operate ES-130 within
the manufacturer specifications.
The output voltage reduces linearly as the battery is depleted, resulting in
less treatment to patient when the Battery Level Indicator Light does not
illuminate. Before using the ES-130, check the battery power using the
Battery Level Check Button.

14
 CAUTIONS
Avoid environmental contamination by disposing of batteries according to
local law. When the battery is inserted in the reverse position it is hard to
close the battery lid because of its structure. In that case do not attempt to
close the battery cover by force, but instead reverse the battery to the
correct position then close the battery cover.

■Preparations
1. Instruct the patient to advise the operator when he or she feels any
abnormality or discomfort during the treatment.
2. All the Output Level Adjustment Dials should be set to the “OFF” position
before connecting any Electrode Cable to the patient.
3. Apply needle electrodes (compatible acupuncture needles) to patient.
4. Connect Electrode Cable from each output channel to needle electrodes.
5. A total of 6 individual treatment sites may be stimulated at the same time
(2 sites from each output channel). Limit the operation time to within 30
minutes.
6. Monitor device components and the patient during the treatment to
ensure that there is no abnormality. Should any irregularity be detected,
take an appropriate action. For example, shutting down the operation in a
manner that secures the safety of the patient.
7. Be careful to prevent the patient from touching the machine or meddling
with the dials and other controls. Such action could lead to an injury.
8. The alligator clip or its wire is very fragile so handle with care. Attach
alligator clips to acupuncture needles when delivering electroacupuncture
stimulation.
9. When desired, fix position of Electrode Cables by using medical adhesive
tape. Allow room so that wire can move freely if patient moves during
treatment.

15
10. Set the High/Low Intensity Selector Switch to “L” setting during
treatment protocols using acupuncture needles of short insertion depth,
as stimulation on “H” power may be too strong for patient. Minimum
insertion depth is 10 mm. Reserve the “H” setting of the High/Low
Intensity Selector Switch for treatment protocols using acupuncture
needles of long insertion depth.
11. Use only cleared acupuncture needles recognized in each area that are
larger than 0.20 mm in diameter, and compatible with the ES-130 device.
12. Select pulse frequency for treatment from the Frequency Table printed on
the unit.
13. Set the Frequency Range Selector Switch (L, M, H) and the Fine
Frequency Control Dial (S, 2, 4, 6, 8, 10) according to the table shown
below.

ES-130 FREQUENCY TABLE

Frequency Range Selector Switch Setting
L M H
1 20 150 S
1.3 23 170 2
Fine
1.5 30 210 4 Frequency
2.5 43 270 6 Adjustment
Dial Setting
5.5 80 380 8
20 150 500 10

First, the Frequency Range Selector Switch is set to L (low frequency

range of 1-20 Hz), M (medium frequency range of 20-150 Hz), or H (high
frequency range of 150-500 Hz). The Fine Frequency Adjustment Dial can
then be set to S, 2, 4, 6, 8, or 10. Each combination of Frequency Range
Selector Switch setting and Fine Frequency Adjustment Dial setting
results in a specific output frequency (between 1-500 Hz) as shown in the
table above.

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■Beginning Treatment
1. Select either High (H) or Low (L) intensity by means of the High/Low
Intensity Selector Switch found on the back of the device. Use the Low (L)
setting for electroacupuncture treatment of low insertion depth and the
high (H) setting for electroacupuncture treatment of high insertion depth.
2. Select pulse frequency for treatment from the ES-130 Frequency Selection
Table printed on the unit. Set the Frequency Range Selector Switch and
the Fine Frequency Adjustment Dial according to the table shown on the
previous page.
3. Slowly rotate the Fine Frequency Adjustment Dial clockwise to the desired
setting. The Frequency Indicator Light will flash at the rate corresponding
to the frequency chosen.
4. Carefully turn on the Output Level Adjustment Dial from the locked OFF
position.
5. Set the Output Level Adjustment Dial to an output which is comfortable for
the patient, or according to your methods of practice.

CAUTIONS
1. First, understand the diagnosis and the prescription of the patient, and
check for any specific cautions or instructions that should be known.
2. Inform the patient of the “Treatment Procedure” and instruct him or her to
immediately notify you of any pain.
3. Set the output power to an intensity that allows the patient to undergo a
pleasant treatment.
4. Some patients under anesthesia may not know the adequate amount of
treatment for them, which could often result in an excess of stimulation.
5. Ask the patient how he or she feels from time to time, not only
immediately after the outset of the treatment, but also while the treatment
lasts.

17
 Precautions Prior to Operation
Before starting treatment, be sure that the patient is relaxed so that
he or she can undergo the treatment comfortably, free from tension.

■Concluding Treatment
1. After concluding treatment, turn off all intensity Output Level Adjustment
Dials. Be sure each Output Level Adjustment Dial is turned to the locked
OFF position.
2. Remove Electrode Cables from needle electrodes.
3. Removed needle electrodes from patient.
4. Examine the patient’s skin for any unusual reactions.
5. Once the treatment is finished, return the dials and other controls to their
original positions, turn off the power, dispose of electrodes/acupuncture
needles safely according to your established medical sharps procedures,
and store the ES-130 device and accessories in an appropriate location.

18
■Device Maintenance
WARNINGS
1. To secure safety, check the ES-130 device on a regular basis. For any
information, please contact your dealer or the manufacturer.
2. Do not attempt to repair or modify the machine by yourself, lest an
accident may result. If the machine malfunctions, shut down the operation
and contact your dealer or the manufacturer.
3. Adhere to all applicable local regulations concerning environmental impact
when disposing of consumables, residue, or the system itself or
accessories at the end of their service lives.

Cleaning Instructions:
Never clean the unit and accessories using a cloth moistened with thinner,
gasoline, polishing power, hot water, or chemical agents. Only use a cloth
moistened with lukewarm water or a neutral detergent and sufficiently wrung
out.

Item Description Checking Method

Appearance Whether the machine has any
Check visually
and markings damaged parts.

Ensure that the machine works

Check by operating
Operation properly when operated as
the machine
instructed in the operation manual.
(1) Whether they have any damaged
part.
Accessories Check visually
(2) Check to see whether the wires
have any breakage.

19
■EMC
• Medical electronic devices are designed to ensure electromagnetic
compatibility (EMC).
• These devices must be installed and used in accordance with the EMC
information provided on the following pages.
• Do not use portable and/or mobile RF communication devices closer than
30 cm within the medical electronic device. If it is brought closer than 30
cm, the performance of the medical equipment may deteriorate.
• Electrode Cable (lead wire) length is 2.0 m.
• If accessories other than those supplied as spare parts by the
manufacturer are used, the emission of this unit may increase and
immunity may be reduced.
• Do not place this unit next to or on top of another device when using it. If it
has to be placed next to or on top of another device, check that this unit
and the device function properly before use.

20
 Guidance and manufacturer’s declaration – electromagnetic emissions
This unit is intended for use in the electromagnetic environment specified below.
The customer or the user of this unit should assure that it is used in such an
environment.

Emissions test Compliance Electromagnetic environment — guidance

This unit uses RF energy only for its internal

RF emissions function. Therefore, its RF emissions are very low
Group1
CISPR 11 and are not likely to cause any interference in
nearby electronic equipment.

RF emissions
Class B
CISPR 11

This unit is suitable for use in all establishments,

including domestic establishments and those
Harmonic emissions
Not applicable directly connected to the public low-voltage
IEC 61000-3-2
power supply network that supplies buildings
used for domestic purposes.
Voltage fluctuations/
flicker emissions Not applicable
IEC 61000-3-3

21
 Guidance and manufacturer’s declaration – electromagnetic immunity
This unit is intended for use in the electromagnetic environment specified below.
The customer or the user of this unit should assure that it is used in such an environment.
It does not harm users and patients within the electromagnetic environment shown below.
However, it is possible to affect the medical equipment (output stop etc.). If you suspect
any abnormality with the equipment, please suspend use and inspect it.
IEC 60601-1-2 compliance
Immunity test Electromagnetic environment — guidance
test level level

Floors should be wood, concrete or

EIectrostatic
± 8 kV contact ceramic tile. If floors are covered with
discharge (ESD)
± 15 kV air synthetic material, the relative
IEC 61000-4-2
humidity should be at least 30%.

± 2 kV for power
EIectrical fast Mains power quality should be that of
supply lines Not
transient/burst a typical home, commercial or
± 1 kV for input/ applicable
IEC 61000-4-4 hospital environment.
output lines

± 1 kV line(s)
Mains power quality should be that of
Surge to line(s) Not
a typical home, commercial or
IEC 61000-4-5 ± 2 kV line(s) applicable
hospital environment.
to earth

Voltage dips, 0%UT: for 0.5 Mains power quality should be that of
short cycle a typical home, commercial or
interruptions 0%UT: for 1 hospital environment. If the user of
and voltage cycle Not this unit requires continued operation
variations on 70%UT: for applicable during power mains interruptions, it is
power supply 25/30 cycles recommended that this unit be
input lines 0%UT: for powered from an uninterruptible
IEC 61000-4-11 250/300 cycles power supply or a battery.

Power frequency Power frequency magnetic fields

(50/60 Hz) should be at levels characteristic of a
30 A/m
magnetic field typical location in a typical home,
IEC 61000-4-8 commercial or hospital environment.

NOTE UT is the a.c. mains voltage prior to application of the test level.

22
 Guidance and manufacturer’s declaration – electromagnetic immunity
This unit is intended for use in the electromagnetic environment specified below.
The customer or the user of this unit should assure that it is used in such an environment.
It does not harm users and patients within the electromagnetic environment shown below.
However, it is possible to affect the medical equipment (output stop etc.). If you suspect
any abnormality with the equipment, please suspend use and inspect it.
IEC 60601-1-2 compliance
Immunity test Electromagnetic environment — guidance
test level level

Portable and mobile RF

communications equipment should
be used no closer to any part of this
Conducted RF 3 Vrms 3 Vrms unit. including cables, than the
IEC 61000-4-6 150 kHz recommended separation distance
to 80 MHz calculated from the equation
applicable to the frequency of the
transmitter.
6 Vrms 6 Vrms Recommended separation distance
ISM and Conducted RF
d = 1.2 P 150 kHz to 80 MHz
amateur
d = 0.58 P 150 kHz to 80 MHz
radio bands (ISM and amateur radio bands)
between Radiated RF
150 kHz d = 0.35 P 80 MHz to 800 MHz
to 80 MHz d = 0.7 P 800 MHz to 2.7 GHz
where P is the maximum output
power rating of the transmitter in
Radiated RF 10 V/m 10 V/m watts (W) according to the transmitter
IEC 61000-4-3 80 MHz manufacturer and d is the
recommended separation distance in
to 2.7 GHz
metres (m).
Field strengths from fixed RF
transmitters, as determined by an
IEC 60601-1 electromagnetic site survey,a should
-2: 2014 be less than the compliance level in
Table 9 each frequency range.b
Interference may occur in the vicinity
of equipment marked
with the following symbol:

23
 NOTE 1 At 80 MHz and 800 MHz, 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 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 this unit is used exceeds the applicable RF compliance level
above, this unit should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as
reorienting or relocating this unit.

b
O
 ver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3
V/m.

24
 Recommended separation distances between portable and mobile RF
communications equipment and this unit
This unit is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of this unit
can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment
(transmitters) and this unit as recommended below, according to the
maximum output power of the communications equipment.

Rated maximum Separation distance according to frequency of transmitter m

output power of
transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.7 GHz
W d = 1.2 P d = 0.58 P d = 0.35 P d = 0.7 P

0.01 0.12 0.06 0.04 0.07

0.1 0.38 0.18 0.11 0.22

1 1.2 0.58 0.35 0.7

10 3.8 1.8 1.1 2.2

100 12 5.8 3.5 7.0

For transmitters rated at a maximum output power not listed above, the
recommended separation distance d in metres (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 80 MHz 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.

25
 MDSS GmbH
EC REP Schiffgraben 41
30175 Hannover, Germany EC REP “AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY”

3-1-8 Sakae-cho, Kawaguchi-shi, Saitama 332-0017, Japan

TEL: 81-48-254-1031 FAX: 81-48-254-1033
URL: https://www.itocoltd.com/ E-Mail: itocoltd@itolator.co.jp

Printed in Japan C0a230968-2207 P2306DATA