Fukuda VaSera VS-2000 Series User manual

SphygmomanometerandSphygmograph
Series
*
Before using the product,
please read this manual thoroughly.
*
Store this manual where it can be
always referred to.
Ver. 03
OperationManual

©2015 Fukuda Denshi Co., Ltd.
No part of this document may be reproduced or transmitted in any form without the prior written
permission of Fukuda Denshi Co., Ltd.
If this manual has pages missing or out of order, contact Fukuda Denshi for replacement.
●Only physician or persons instructed by physicians are allowed to use the equipment.
●The information contained in this document is subject to change without notice due
to improvement in the equipment.
CAUTION
This manual is for the VS-2000 Series Version 03.
Federal Law restricts this device to sale by or on the order of a physician.
CAUTION

Preface
Thank you for purchasing our product.
This operation manual is a guide to the correct and safe use of the VaSera VS-2000 series.
Read this operation manual carefully and make sure that you understand the instructions before using this device. It
is recommended to keep this operation manual nearby at all times when operating this device.
For details on this product or this manual, please contact your local Fukuda Denshi service representative.
This is an operation manual for the following device:
• VS-2000
A mark is used to indicate explanations of the functions of the toe blood pressure option.
T

1
Safety Notations
The following safety notations are used throughout this manual. Each of these notations has a different meaning, as shown
below.
Read the following information thoroughly to ensure proper, correct and safe use of the product.
An Example of Safety Symbol
DANGER Failure to follow this message may result in death or serious injury to the patient or
operator, damage the device, or create a fire hazard.
WARNING Failure to follow this message may result in death or serious injury to the patient or
operator or create a fire hazard.
CAUTION Failure to follow this message may cause injury or failure to the device.
The mark is displayed on the main unit of the device to protect the device
from damage, and is used throughout the explanations in this operation manual.
NOTE A note is not related to product safety, but provides information about the proper
usage methods to prevent incorrect operation and malfunction.
Indicates prohibited actions. Refer to the instruction.
Indicates a matter of Danger, Warning, or Caution that calls attention for safety. Refer to the
instruction.
Indicates mandatory or instructed actions. Refer to the instruction.
Precaution from Fukuda Denshi
Fukuda Denshi is liable for the safety, reliability, and performance of its medical devices only if: Maintenance,
modifications, and repairs are carried out by authorized personnel. Components are used in accordance with Fukuda Denshi
operating instructions.
If the device is used incorrectly and becomes unusable as a result, Fukuda Denshi is not liable for the malfunction. Use the
device only for the purposes specified in this manual.

2
Safety Labels
Warning (safety) labels are attached to this device to indicate precautions that need to be followed to ensure proper and safe use
of the device. Make sure to follow the instructions of the warning labels attached to this device when operating the device. The
positions of the labels attached to this device are indicated below.
Symbols on the Device
Below is a list of symbols used on this device.
• Do not damage or erase the warning labels attached to the device.
These warning labels contain important information for handling and operating the device properly
and safely. If any of these labels are damaged, it may not be able to ensure safety when using the
device.
Caution: Explained in this manual.
Indicates the potential equalization terminal.
Indicates the alternating current (AC) power supply.
Indicates the LAN connector.
Indicates the SD card slot.
Indicates the USB port.
Indicates a defibrillation-proof type CF applied part.
Indicates an operation explained in this operating manual.
Refer to this operating manual.
CAUTION

3
Safety
●Design Specifications
This device complies with ANSI/AAMI ES 60601-1: "Medical Electrical Equipment - Part1: General Requirements for
Basic Safety and Essential Performance" and is classified as follows:
1. Protection against electrical shock
Class I, Internally Powered Device.
2. Degree of protection against electrical shock
Type CF applied part.
3. Degree of protection against ingress of water
No special protection against ingress of water. (IPX0)
4. Degree of safety when using in air, flammable anesthetic gas, or in areas where oxygen, nitrous oxide
or flammable anesthetic gas are used
To be used in environments without flammable anesthetic gas or other flammable substances.
5. Operation Mode
Can be used continuously.
●Preventive Maintenance
Preventive maintenance should be performed to ensure that the device can be used safely at all times and prevent various
problems from occurring in future.
This maintenance needs to be performed at least once every 12 months.
Inspect the mainframe and all connectors and cables for any external damage.
If any of the following events occurs, perform maintenance immediately.
The device receives a strong impact due to dropping, etc.
Liquid is spilled on or into the device
The device does not function normally
The enclosure of the device is cracked, broken or damaged
Cables such as the power cable and lead wires have deteriorated in performance
Check all cables, devices and accessories for damage, leakage current and accuracy.

4
Non-Explosion Proof
Using with MRI
Using with Defibrillators
Application to Heart
• Never operate the equipment where flammable gas or fluid such as anesthetic, oxygen and
hydrogen are used.
Explosion or fire may result.
• Never operate the equipment in the presence of flammable anesthetics, high concentration
of oxygen.
This may cause an explosion or fire.
• Never operate the equipment inside a hyperbaric chamber.
This may cause an explosion or fire.
• Do not ground with a gas pipe.
Explosion or fire may result.
• Do not use this product with a magnetic resonance imaging (MRI) device.
This device may be pulled towards the MRI device. The local heating caused by the induced
electromotive force may also cause burns to the patient or cause the performance of this product
to deteriorate.
• Use only the supplied lead cable when defibrillating.
• Do not touch this device during defibrillation.
• This device will return to standard operating mode within 10 seconds. The measurement
accuracy will temporarily decrease during defibrillation, but it will not compromise the
safety of patient and the device.
• Although this device has a type CF applied part, it is not designed to be applied directly to
the heart.
DANGER
WARNING
WARNING
CAUTION

5
Using with High Frequency Surgical Devices
Using Accessories and Optional Accessories
Device and Accessories
• When using this devices with a high frequency surgical device (electrical scalpel), make
sure the contact between the patient and the ground plate is secured.
If the connection is incomplete, the patient may suffer a burn at the electrode site.
• When using with electrical scalpels, make sure the contact between the patient and the
ground plate can be sufficiently secured.
If the connection is incomplete, the current from the electrical scalpel may run into the electrodes of
this device and the patient may suffer a burn at the electrode site.
• Plug the electrical scalpel into a hospital grade outlet as far away as possible from the outlet
of this device. This will reduce interference from the electrical scalpel.
• Use only the cables specified by Fukuda Denshi.
Use of other cables may result in increase in emission or decrease in immunity.
• Contact your local Fukuda Denshi service representative for more information on
connecting the cables.
• Do not bend, crush or twist the air hose of the cuff.
The blockage of the hose will stop the cuff deflation, resulting in obstruction of the blood flow.
• Connect the power cable to a hospital grade outlet.
Use the battery when operating in areas with no hospital grade outlet.
Use an outlet with a power supply sufficient for the power consumption of this device.
• Use the battery when operating in areas with no hospital grade outlet.
Use an outlet with a power supply sufficient for the power consumption of this device.
• Never disassemble or modify the device.
Disassembly may cause a fire hazard or electric shock.
• Do not touch this device during defibrillation.
This may cause an electric shock.
• Use only the specified lead cable.
The device may be damaged or become unsafe if a lead cable without a defibrillation protection
function is used instead of the specified lead cable when using this device with a defibrillator.
• Make sure to use the specified PCG microphone (MA-310HDS(V)).
The device may become unsafe if an unspecified microphone is used.
• Contact your local Fukuda Denshi service representative when connecting other
equipment to the device.
It is necessary to determine whether the device to be connected complies with IEC or ISO
standards, related JIS safety standards or technology standards stipulated in the Electrical
Appliance and Material Safety Act. If it does not, it must be of an equivalent safety level.
Otherwise, danger such as electric shock may result to the patient and operator.
WARNING
WARNING
WARNING

6
Connection to Other Devices
Disposal
Connecting the Power Cable
Leakage Current
• Do not connect any unauthorized devices.
• When disposing of this product and accessories, contact a specialized waste disposal
company
• When operating this device using an AC power supply, make sure to connect the power
cable to a hospital grade outlet.
Use the battery when operating in areas with no hospital grade outlet.
• Multi-tap power outlets cannot be used as they may make the device unsafe for the patient
and operator.
• If the power cables of multiple devices are plugged into the same outlet, increase in
leakage current may cause danger to the patient.
• A danger may occur if the patient is using a pacemaker or other electrical stimulator.
Follow the instructions in the operation manual of the pacemaker or other electrical stimulator.
• When using this device with other devices, perform equipotential grounding to prevent
potential difference between the devices.
If potential difference occurs between the devices, danger may result to the patient and operator.
• Do not touch the electrodes of this device or the conductive part of the attached
connectors. Touching these may cause danger to the patient.
• Do not touch the metal part of this device or the conductive part of the connector and the
patient at the same time.
WARNING
WARNING
WARNING
CAUTION

7
Precautions for Safe Operation of Medical Electrical Equipment
• Although this device is a transportable equipment that is designed to be used in different
areas, safe operation may be compromised if it is subjected to strong impact such as being
dropped or getting caught in elevator doors during transportation.
• Do not use or store the device in an area where it will be subject to splashing water.
Otherwise, danger such as electric shock may result to the patient and operator.
• Do not drop the device or subject it to strong impact or vibration.
This may result in electric shock or a fire hazard.
Contact your local Fukuda Denshi service representative if this device is dropped or otherwise
damaged.
• Do not subject the LCD screen to strong impact.
Doing so may cause damage.
• Do not allow the patient to come in contact with this device, other electrical devices or
metals.
This may increase leakage current, which may result in danger to the patient.
• Do not insert the SD card or USB memory in reverse direction or use excessive force when
inserting them.
This may damage this device and the media.
• Always hold the plug when removing cables. Do not pull on the cable. Do not insert or
remove cables with wet hands.
This may cause electric shocks, short circuiting or injury.
• Always use your fingers to operate the touch panel or keys.
Using other items may cause damage such as scratching the surface of the touch panel.
• Do not use the touch panel with film or adhesive tape attached to it. It may cause
malfunction or damage the touch panel.
• Remove dirt from the surfaces by wiping with ethanol on a soft cloth.
• Make sure to use the specified battery pack (BTE-001) when operating the device on
battery power.
Otherwise, leakage, overheating or explosion may occur.
• If using the stand, do not use or store it where it will be subject to an inclination of 5
degrees or more.
The device and trolley may fall down, resulting in injury to the operator or damage to the device.
Make sure that all 5 casters are locked when the device is in use or in a storage position.
Otherwise, the trolley may move or fall down, resulting in injury to the operator or damage to the
device.
[Inspections]
• Perform daily checks to maintain safety.
• Perform periodic inspections every 12 months to maintain safety.
• Check all cables, devices and accessories for damage, leakage current and accuracy.
To operate the device correctly, read the following precautions carefully.
• User should have a thorough knowledge of the operation before using this device.
• Pay attention to the following when installing or storing the device.
CAUTION

8
• Do not install or store in an area where the environmental conditions, such as atmospheric
pressure, temperature, sunlight, dust, sodium, sulfur, will adversely affect the system.
• Take care to ensure stability with no inclination, vibration, or impact (including during
transportation). Do not install on an unstable surface.
• Place the device with the base side downward. Do not allow other surfaces (such as the
back or sides) to touch the floor.
• Do not install or store in an area where chemicals are stored or gases are evolved.
• Do not subject the device to excessive vibration or impact when moving to a new
installation location.
• Verify the power frequency, voltage and allowable current (or power consumption).
• Ensure proper grounding by connecting the accompanying power cable to the hospital
grade outlet.
• To ensure the safety of medical devices, do not keep standard electrical devices in areas
with patients.
Before operating the system, verify the following items:
• Verify the power voltage.
• Multi-tap power outlets cannot be used as they may make the device unsafe for the patient
and operator.
• Check the cable connection and polarity of the device and its connectors to ensure proper
operation of the equipment.
• Make sure the power system has adequate earth ground.
• Ensure that all cables and air hoses are correctly and safely connected.
• Pay special attention when the equipment is used in conjunction with other equipment as it
may cause erroneous diagnosis and danger.
• Ensure that all cables directly connected to patients are correctly connected.
During operation of the system, verify the following items:
• Make sure that the electrodes and lead cord tips do not touch metal areas of the bed or
other conductive items.
• Always observe the device and patient to ensure safe operation of the device.
• If you notice any abnormalities in the device or the patient, stop the device or take other
appropriate measures to ensure the safety of the patient.
• Do not allow the patient to come in contact with the device.
• Do not block the vents.
This may result in overheating or a fire hazard.
• Do not drop the device or subject it to strong impact or vibration.
This may result in electric shock or a fire hazard. Contact your local Fukuda Denshi service
representative if this device is dropped or damaged.
CAUTION

9
Other precautions specific to each media can be found on the pages concerning these media. Make sure to read these
precautions in addition to those on this page.
Precautions Concerning the PCG Microphone
• Do not pull strongly on cables such as the lead cable and sensor cable.
After using the system, verify the following items:
• Unplug all the cables from the patient before turning OFF the power.
• When unplugging the cables, do not apply excessive force by pulling on the cord. Pull by
the connector part of the cable.
• Keep the accessories and cables together in one place after cleaning.
• Keep the device clean to ensure proper operation for the next use.
• If the device is damaged, stop the examination, label the unit “OUT OF ORDER” and
contact our service representative.
• Do not remodel the device.
• If using a defibrillator while using this device, check the paste volume, output energy, etc.
to prevent the risk of burning the patient. Also, verify that each equipment is properly
grounded.
[Precautions when Using the SD card and USB memory]
• Turn OFF the power when inserting/removing the media.
An error may occur if the media is inserted or removed during operation. If the media needs to be
inserted or removed while the power is ON, make sure that the icon indicating the media status
has changed before operating the device.
• Use only the media specified by Fukuda Denshi.
Using unspecified media may cause failure to the device, such as damage or loss of waveform
data.
The warranty does not cover data retrieval or repair that is required when problems such as these
are caused by using unspecified devices.
Various icons are displayed in the device status display area when inserting specified media.
• Do not remove the media while data is being saved to the media.
The data may become unreadable. This may include the data that was already saved in addition
to the data that was being saved at the time.
• If connecting an extension cable to the USB port, use an extension cable that is no longer
than 2m. Do not supply power via the USB port.
The device may not work properly if a cable longer than 2m is used.
• Take measurements in a quiet room with no noise or vibration in the surrounding area.
• Do not drop the PCG microphone, subject it to strong impact or pull strongly on the cable.
CAUTION
CAUTION

10
Precautions Concerning the Cuffs
Precautions Concerning the Toe Cuffs
Precautions Concerning the Limb Cushion (Optional)
• Wash only the cuff cover in water, and clean only the surface of the cuff. Washing the cuff
in water may cause water to get inside the cuff, which may damage the cuff or cause
deterioration in performance.
• Select the appropriate cuff size according to the patient’s brachial/ankle circumference.
<CUF-139>
• This product is made of synthetic rubber and does not contain natural rubber. Synthetic
rubber is unlikely to cause allergic reactions such as itchiness, redness, hives, swelling,
fever, breathing difficulties, asthma-like symptoms, low blood pressure or shock, but if
such symptoms do occur, stop using the device immediately and consult a doctor.
• Do not pressurize toe cuffs before wrapping them around toes. Otherwise, they may burst.
• Do not wrap the toe cuffs too loosely or at an angle. Otherwise, they may burst.
Precautions for Storage
• Store this product in a cool area. Avoid areas with direct sunlight, UV rays, high
temperatures and high humidity.
• Do not store this device together with volatile chemicals.
Precautions for Disinfection
• Disinfect the cuffs by wiping gently with water or alcohol. Do not place in an area with
direct sunlight, UV rays or high temperatures when drying.
• Do not use disinfection methods such as high-pressure steam disinfection, gas
disinfection or radiation disinfection.
Usage Count
• Even when these precautions are followed, the cuffs cannot be used more than 200 times.
• The inner part under the cover cannot be washed.
• Do not open the fastener of the inner part under the cover. This will scatter the filling.
• The cover cannot be ironed.
CAUTION
CAUTION
CAUTION

11
Precautions Concerning the LAN
• Do not wash the cover with chlorine detergent.
• Dry the cover by hanging it in the shade.
• Avoid leaving the cover folded for long periods of time as this will leave creases.
• The length, width and height of the cushion (and cover) differ. Make sure to put the cover
on the right way after washing.
• The devices to be connected to the network must be located outside the patient
environment. (IEC 60601-1-1: 2000 / EN 60601-1-1: 2001)
• Use only Ethernet hubs specified by Fukuda Denshi when connecting this device to the
network (LAN).
• Do not use a LAN cable longer than 50m when connecting this device to the network (LAN).
[Precautions Concerning Use of the USB Wireless LAN Adapter]
• Turn OFF the power of this device before inserting the USB wireless LAN adapter. Never
remove the wireless LAN adapter during wireless LAN communication.
An error may occur if the wireless LAN adapter is inserted or removed during operation.
• Do not use this device in areas with static electricity or electromagnetic interference, in
rooms insulated with a metal door or near devices that emit radio waves (microwaves,
thermotherapy devices, etc.) The device may not be able to receive a signal in some
operating environments.
• Due to the characteristics of radio waves, the communication range and communication
speed vary depending on the installation location and operating environment.
[Precautions Concerning Use With Other Devices when Using the Wireless LAN Adapter]
• When using a wireless LAN, make sure to check the operation of any medical devices
nearby. Stop using the wireless LAN immediately if unexpected waveform noise occurs or
interference occurs in surrounding equipment.
[Precautions Concerning the Wireless LAN Adapter]
• Use the wireless LAN adapter specified by Fukuda Denshi.
If an unspecified wireless LAN adapter is used, it may not be possible to communicate with the
DMS, and the main unit of the device may even be damaged. The warranty does not cover data
retrieval or repair that is required when problems such as these are caused by using unspecified
devices.
[Prior Precautions Concerning Static Electricity]
• The wireless LAN adapter is extremely delicate and is very vulnerable to damage from
electrostatic discharge. If the human body comes into contact with the metal part of the
wireless LAN adapter, static electricity may be discharged onto the parts or into the circuit
of the wireless LAN adapter, which may damage the wireless LAN adapter. Make sure to
follow the precautions below to protect the wireless LAN adapter and this device from
damage from static electricity.
• Remove static electricity from the body before using.
• Hold the end of the wireless LAN adapter when handling it. Never touch the metal part of the
wireless LAN adapter.
CAUTION
CAUTION

12
Storage and Cleaning
Transportation
Cleaning and Disinfecting the Device
Use the following procedures to clean and disinfect the enclosure of the device.
Cleaning
Disinfecting
• Do not open the housing.
• Remove dirt from the surfaces of the housing by wiping with ethanol on a soft cloth.
• Perform daily inspection to maintain safety.
• Perform periodic inspection every 12 months to maintain safety.
• Check all cables, devices and accessories for earth impedance and accuracy.
• If the device has not been used for a while, make sure to check that the device operates
properly and safely before using it.
• Do not allow alcohol or other liquids to enter the device.
• If the optional software is installed, make sure to keep the software (SD card). If the main
unit needs to be repaired, send the optional software (SD card) to Fukuda Denshi along
with the main unit.
• Pack this device in packaging specified by Fukuda Denshi when transporting.
• This device has no handle. Carry it with both hands when transporting.
• Immerse a cloth in a solution of domestic neutral detergent and water, wring it out
thoroughly and then wipe the main unit.
• Do not use ether or benzine as they may damage the enclosure.
• Wipe the device with a cloth that has been thoroughly wrung out after being sprayed with a
solution of alcohol and water or glutaraldehyde. Then, wipe with a soft lint cloth.
CAUTION
CAUTION
CAUTION
CAUTION

13
Cleaning the System Devices
Precautions for Safe Operation under Electromagnetic Interference (EMC)
Precautions Concerning Printing of Interpretation
Other precautions specific to each media can be found on the pages concerning these media. Make sure to read these precautions
in addition to those on this page.
• Clean the connected devices according to the instructions in their respective manuals.
■Malfunctions Due to EMC
While this device complies with the IEC 60601-1-2 (2004) and JIS T 0601-2-25 (2006) safety standards,
malfunctions may occur if there are strong electromagnetic (radio) waves nearby that exceed the limit.
Please take the necessary countermeasures in such cases.
■Effects of Emitted Electromagnetic Interference
• The use of mobile phones may cause malfunction.
Mobile phones and radio sets should be turned OFF in the facility where the medical device is located.
• The use of microwave therapy devices nearby or in an adjacent room may affect the waveform. Keep
these devices a sufficient distance apart according to the Guidance on Electromagnetic Compatibility.
■Effects of Burst and Conducted Electromagnetic Interference
High frequency noise interference may occur from other devices through the power outlet. Check the
source of the noise and stop the device that is causing the noise if it is possible to do so. If it cannot be
stopped, take countermeasures to change the path of the noise, such as using a filtering device.
■Effects of Static Electricity
Malfunctions may be caused by the discharge of static electricity in dry environments (rooms), such as in
winter. Measures such as humidifying the room should be taken, and both the operator and the patient
should remove any static electricity before the device is used.
■Effects of Surges (Lightning)
A lightning nearby may induce excessive voltage to the equipment. Unplug the power cable from the AC
outlet in such situation.
Use an uninterruptible power supply system if available.
The interpretations printed from this device may indicate possible arterial stenosis or occlusion, possible
arteriosclerosis or high blood pressure based on measurements such as the ankle-brachial index (ABI),
cardio-ankle vascular index (CAVI) and brachial blood pressure. However, please note that some patients
with latent diseases may have measurements within the normal range, and some patients with no diseases
may have abnormal measurements.
Clinical diagnoses of diseases such as arteriosclerosis or arteriosclerosis obliterans should therefore
combine measurements from this device with other interpretations.
CAUTION
CAUTION
CAUTION

14
●EMC Guidance
This device complies with the Safety Standard IEC 60601-1-2 (2004). However, if portable transmitter or wireless LAN
equipment is used extremely nearby, the electromagnetic influence may largely exceed the compliance level and may cause
unexpected phenomenon such as noise interference on the waveform, etc.
This device should be used in a location specified by each medical institution.
If any unexpected noise interference on the waveform or failure to the peripheral device occurs, stop using the device and follow
the instruction of the technical engineer.
The following is the information relating to EMC (Electromagnetic Compatibility).
(When using this device, verify that it is used within the environment specified below.)
●Compliance to the Electromagnetic Emissions
The VS-2000 is intended for use in the electromagnetic environment specified below.
Emission Test Compliance Electromagnetic Environment/Guidance
RF emissions:
CISPR 11 Group 1 The VS-2000 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby
electronic equipment.
RF emissions:
CISPR 11 Class B The VS-2000 is suitable for use in all establishments, including domestic, and those directly connected to the public low-voltage power supply network that
supplies buildings used for domestic purposes.

15
●Compliance to the Electromagnetic Immunity (1)
The VS-2000 is intended for use in the electromagnetic environment specified below. The customer or the user of the VS-
2000 should assure that it is used in such an environment.
Immunity Test IEC 60601-1-2
Test Level Compliance Level Electromagnetic Environment/Guidance
Electrostatic
Discharge (ESD)
IEC 61000-4-2
±2, 4, 6 kV: contact
±2, 4, 8 kV: air
±2, 4, 6 kV: contact
±2, 4, 8 kV: air
Floors should be made of wood, concrete or
ceramic tile. If floors are covered with synthetic
material, the relative humidity should be at least
30%
Electrical fast
transient/burst
IEC 61000-4-4
±2kV: power supply
lines
±1kV: input/output
lines
±2kV: power supply
lines
±1kV: input/output
lines
Mains power quality should be that of a typical
commercial or hospital environment.
Surge:
IEC 61000-4-5
±0.5, 1kV:
differential mode
±0.5, 1, 2kV:
common mode
±0.5, 1kV:
differential mode
±0.5, 1, 2kV:
common mode
Mains power quality should be that of a typical
commercial or hospital environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
<5% UT (>95% dip in
UT) for 0.5 cycles
40% UT (60% dip in
UT) for 5 cycles
70% UT (30% dip in
UT) for 25 cycles
<5% UT (95% dip in
UT) for 5 sec.
<5% UT (>95% dip in
UT) for 0.5 cycles
40% UT (60% dip in
UT) for 5 cycles
70% UT (30% dip in
UT) for 25 cycles
<5% UT (95% dip in
UT) for 5 sec.
Mains power quality should be that of a typical
commercial or hospital environment.
If it is required to continuously operate the VS-
2000 during power failure, it is recommended to
operate on an uninterrupted power supply or a
battery (optional).
Power Frequency (50/
60Hz)
Magnetic Field
IEC 61000-4-8
3A/m 3A/m Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
Note UTis the AC mains voltage prior to application of the test level.

16
●Compliance to the Electromagnetic Immunity (2)
The VS-2000 is intended for use in the electromagnetic environments specified below. The customer or the user of the VS-
2000 should assure that it is used in such an environment.
1Field 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 can not 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 VS-2000 is used exceeds the applicable RF compliance level
above, the VS-2000 should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the VS-2000.
2Over the frequency range 150kHz to 80MHz, field strength should be less than 3V/m.
Immunity Test IEC 60601-1-2
Test Level Compliance Level Electromagnetic Environment/Guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3Vrms
150kHz to 80MHz
3 V/m
80MHz to 2.5GHz
3Vrms
3 V/m
PPortable and mobile RF communications
equipment should be used no closer to any part of
this device, including cables, than the
recommended separation distance calculated from
the equation applicable to the frequency of the
transmitter.
Recommended Separation Distance:
d = 1.2 26MHz to 80MHz
d = 1.2 80MHz to 800MHz
d = 2.3 800MHz to 2.5GHz
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 strengths from fixed RF transmitters, as
determined by an electromagnetic site survey*1,
should be less than the compliance level in each
frequency range*2.
Interference may occur in the vicinity of equipment
marked with the following symbol.:
Note 1At 80MHz and 800MHz, the separation distance for the higher frequency range applies.
Note 2These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
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