Konica Minolta AeroDR Portable UF Unit User manual

Operation Manual
EN 10
A4RNBA01EN10
2015-11-30
(MA)
AeroDR Portable RF Unit
SYSTEM
DIRECT DIGITIZER

3
Contents
Introduction ................5
Introduction ..............................6
Summary of usability specications
(for IEC/EN 60601-1-6, IEC/EN 62366) .......7
Disclaimer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Trademark .............................8
Term description.........................8
Structure of pages .......................9
Chapter 1
Safety Precautions & Warnings ..11
1.1 Symbols relating to safety ............12
1.1.1 Safety alert symbol ..............12
1.1.2 Warning notice (signal words) ......12
1.1.3 Description of graphic symbols .....12
1.2 Warning labels.....................13
1.2.1 AeroDR Portable RF Unit. . . . . . . . . . 13
1.2.2 Mount kits. . . . . . . . . . . . . . . . . . . . . . 14
1.3 Safety precautions..................16
1.3.1 Precautions before usage .........16
1.3.2 Precautions for usage ............16
1.3.3 Precautions regarding
electromagnetic waves ...........17
1.3.4 Precautions regarding wireless
communication..................22
1.3.5 Precautions for installing, moving,
and storing .....................22
1.3.6
Precautions regarding maintenance ..22
1.3.7 Precautions on service life.........23
Chapter 2
Product Overview ..........25
2.1 Overview of the AeroDR Portable RF Unit ..26
2.1.1 Functions ......................26
2.1.2 System conguration .............26
2.2 Component names and functions ......30
2.2.1 AeroDR Portable RF Unit. . . . . . . . . . 30
2.2.2 AeroDR Portable Unit Battery ......31
Chapter 3
General Operations .........33
3.1 Startup and shutdown . . . . . . . . . . . . . . . 34
3.1.1 Startup of each system device......34
3.1.2 Shutdown of each system device ...36
3.2 Operations on the AeroDR Portable
RF Unit ..........................38
3.2.1 Preparation to take radiography. . . . . 38
3.2.2 Exposure ......................39
3.2.3 Operations after radiography .......40
3.2.4 Mounting or dismounting the AeroDR
Portable Unit Battery ............. 41
3.2.5 Operating a mount kit. . . . . . . . . . . . . 43
3.2.6 Precautions of operations .........44
3.2.7 Storage method .................47
3.3 Recharging of the AeroDR Portable Unit
Battery ...........................49
3.3.1 Recharging. . . . . . . . . . . . . . . . . . . . . 49
3.3.2 Charging time guide..............50
3.3.3 Charging indication ..............50
Chapter 4
Status (LED) Display ........51
4.1 LED display of respective devices......52
4.1.1 AeroDR Portable RF Unit. . . . . . . . . . 52
4.1.2 AeroDR Portable Unit Battery ......52
Chapter 5
Troubleshooting ...........53
5.1 Various problems and countermeasures ..54
5.1.1 AeroDR Portable RF Unit. . . . . . . . . . 54
Chapter 6
Maintenance...............55
6.1 Maintenance and inspection items .....56
6.1.1 Maintenance schedule............ 56
6.1.2 Cleaning.......................56
6.1.3 Periodical replacement parts .......56

Contents
4
Chapter 7
Specications .............57
7.1 Specications .....................58
7.1.1 AeroDR Portable RF Unit. . . . . . . . . . 58
7.1.2 AeroDR Portable Unit Battery ......59
7.1.3 General AeroDR Portable RF Unit... 59
7.1.4 Product conguration............. 60

5
Introduction

66
Introduction
The Direct Digitizer AeroDR SYSTEM picks up an X-ray image of human body using the X-ray planar detector, and
enters digital output signals into the image processing device. The system then acquires this image as diagnostic im-
age data using the digital image acquisition device, and transfers the image data to the ling system, the printer, the
image display unit and others. Especially, the AeroDR Portable RF Unit can be combined with a X-ray device, and
used as a portable radiography unit anywhere inside hospital facilities.
Note that the Direct Digitizer AeroDR SYSTEM can be used for radiography diagnosis, but not for mammography.
The AeroDR Detector, AeroDR Interface Unit, AeroDR Battery Charger, and the DIRECT DIGITIZER CS-7 or Image-
Pilot (hereafter referred to as the image processing controller), which controls the receiving, processing, and output
of image data of this device, are required for the operation of AeroDR Portable RF Unit. For the operation of the im-
age processing controller, refer to the "Operation Manual" of the image processing controller.
This Operation Manual describes the basic functions of AeroDR Portable RF Unit so that you or the operator of this
unit can understand the basic unit functions. When you use the AeroDR Portable RF Unit for the rst time, be sure to
read this manual and start the actual operation. Also, after you have read this manual, keep this manual close to the
AeroDR Portable RF Unit and use it as a guidebook to operate the AeroDR Portable RF Unit in the best conditions.
* If the pages of the operation manual are smudged or illegible, replace it with a new one (Charged).
* Illustrations of X-ray device included in this manual are an example.
CAUTION
• The AeroDR Portable RF Unit can be used together with the AeroDR SYSTEM and
AeroDR SYSTEM 2.
• This manual collectively refers to both the AeroDR SYSTEM and AeroDR SYSTEM 2
as the "AeroDR SYSTEM".
• Before using the AeroDR Portable RF Unit, carefully read the AeroDR SYSTEM/
AeroDR SYSTEM 2 Operation Manual and the image processing controller Opera-
tion Manual, and refer to the operation manuals for the AeroDR Access Point and
any optional devices.
• In this manual, the AeroDR Interface Unit and the AeroDR Battery Charger are used
in the examples. Replace the device names with the devices to be used.

7
Introduction
Summary of usability specications (for IEC/EN 60601-1-6, IEC/EN 62366)
1) Medical purposes
• Provision and reading of disease and injury diagnostic images.
2) Patient groups
• No patient population exists who uses the device.
• Patient population for the X-ray images read is not specied.
3) Parts of body or organizations to which the device is mounted or that interact with the device.
• The AeroDR Portable RF Unit comes in contact with the skin of an operator.
4) Operating principle
• The AeroDR Portable RF Unit is used together with the X-ray device which takes radiography. The built-in
AeroDR Access Point (wireless communication device) communicates with the AeroDR Detector and image
processing controller. Also, this point interfaces with the X-ray device.
• AeroDR Detector forms the still images according to the X-ray energy passing through human and animal
bodies; after digitizing the exposed image, it is transmitted to the image processing controller console via the
AeroDR Portable RF Unit by wireless communication.
• Connect the AeroDR Interface Unit to the AeroDR Detector using the AeroDR I/F Cable in order to recharge
the AeroDR Detector and to register the AeroDR Detector used for the X-ray device.
• The AeroDR Battery Charger is used to recharge the AeroDR Detector and to register the AeroDR Detector
used for the X-ray device.
• The image processing controller processes the image data into the diagnostic image, and then stores and
outputs the images along with relevant patient information.
5) Signicant physical characteristics
• Refer to "7.1 Specications".
6) Signicant performance characteristics
• Refer to "2.1 Overview of the AeroDR Portable RF Unit".
7) User of this device
• No special training is required to use this device. The intended users of this device are as follows.
A professional in good health with specialist knowledge/qualications who has fully understood the content of
this document. (Such as a doctor or radiological technologist)
Disclaimer
(1) This manual may not be reproduced in whole or in part without the permission of Konica Minolta, Inc.
(2) The contents of this manual may be subject to change without prior notice.
(3) Konica Minolta, Inc. is not responsible for any claims made for malfunction or damage caused by installation,
relocation, modification, maintenance, and repair made by anyone except Konica Minolta and contractors
designated by Konica Minolta.
(4) Konica Minolta, Inc. is not responsible for any claims made for malfunction or damage to Konica Minolta
products, caused by third-party products not installed by Konica Minolta.
(5) Konica Minolta, Inc. is not responsible for any claims made for malfunction or damage caused by maintenance
and repair using maintenance parts other than those specied by Konica Minolta.
(6) Konica Minolta, Inc. is not responsible for any claims made for malfunction or damage caused by not observing
the precautions and operation methods described in the operation manual.
(7) Konica Minolta, Inc. is not responsible for any claim for malfunction or damage of system units based on the
environmental conditions that deviate from installation or application conditions of power supply and installation
environment described in the Installation Requirements or Operation Manual.
(8) Konica Minolta, Inc. is not responsible for any claims for malfunction or damage caused by acts of nature such
as res, earthquakes, oods, or lightning strikes.
(9) Konica Minolta, Inc. is not responsible for any claims for malfunction or damage caused by using this device for
any purpose other than that specied for this device.
(10) Diagnostic and treatment action is performed under the responsibility of the physician(s). Konica Minolta, Inc. is
not responsible for any diagnostic/treatment conditions or diagnostic/treatment results.

8
Introduction
Trademark
Company names and product names in this manual are trademarks or registered trademarks of their respective
owners.
Please note that ©, ® and ™ marks are omitted hereafter.
Copyright © 2011 - 2015 Konica Minolta, Inc. All Rights Reserved.
Term description
The meanings of terms used in this operation manual are as follows:
Terms Explanation
AeroDR Detector Collective term referring to AeroDR 1417HQ, AeroDR 1417S, AeroDR 1717HQ, AeroDR
1012HQ, AeroDR 2 1417HQ, and AeroDR 2 1417S.
AeroDR Interface Unit It supplies the electric power to the AeroDR Detector when the AeroDR I/F Cable is used. Also,
it has the hub function.
AeroDR Battery Charger It recharges the AeroDR Detector. Also, it has the registration function of AeroDR Detector.
AeroDR I/F Cable It connects between the AeroDR Detector and AeroDR Interface Unit. Also, it has the charging
and registration functions of the AeroDR Detector.
Image processing controller The image processing workstation (CS-7 or ImagePilot) is referred to as the image processing
controller.
Mount kit This kit mounts the AeroDR Portable RF Unit, image processing controller and 17-inch monitor
on the X-ray device.

9
Introduction
Structure of pages
(1)
(2)
(4)

1.1 OperationsontheAeroDRPortableRFUnit
IMPORTANT

 


 



4 RemovetheEthernetcable,whichiscon-
nectedtothehubontheregistrationside
oftheAeroDRDetector,fromthehubon
theX-raydeviceside.

HINT 
 





1.1.1 Preparationtotakeradi-
ography


1 RegistertheAeroDRDetectorontheim-
ageprocessingcontrollertobeusedfor
theX-raydevice.
2 RegisterX-rayexaminationinformation
ontheimageprocessingcontrollertobe
usedfortheX-raydevice.
Reference

 



3 WhenchargingtheAeroDRPortableRF
Unitandtheimageprocessingcontroller,
removethepowercablefromtherecepta-
cleandconrmthattheAeroDRPortable
RFUnithasshutdown.
 




Exampleofpagestructure
(5)
(3)
Number Item Description Icon
(1) Item heading Describes the titles of described content. -
(2) Operation procedure The operating procedure is described in sequential numerical
steps. -
(3) Hint Describes important information. HINT
(4) Reference Describes reference items. Refer to these as necessary.
Reference
(5) Important items Describes the important items for operation. Be sure to read
them.
IMPORTANT

10

11
Chapter 1
Safety Precautions & Warnings
This chapter describes precautions and warnings
to ensure safe use of the AeroDR Portable RF Unit.

12
1.1.1 Safety alert symbol
This is a "safety alert symbol". This symbol alerts you
to matters and/or operation potentially hazardous to
yourself and other people. Read these messages and
follow the instructions carefully.
1.1.2 Warning notice (signal
words)
Signal words indicate the degree of potential hazards
in the use of the product.
Signal words include the following three types, which
are used according to risk of damage caused by dan-
ger and the severity of damage.
DANGER
Indicates an imminently hazardous situation which, if
not avoided, will result in death or serious injury.
WARNING
Indicates a potentially hazardous situation which, if not
avoided, could result in death or serious injury.
CAUTION
Indicates a potentially hazardous situation which, if
not avoided, could result in minor or moderate injury.
It may also be used to indicate hazardous situation
where only physical damage is likely to occur.
1.1.3 Description of graphic
symbols
Indicates the Power On or Standby po-
sition.
Indicates that it is necessary to read the
Operation Manual before use or opera-
tion of this device.
Indicates devices including radio fre-
quency transmitters.
Indicates possibility of squeezing ngers
in the moving part of the image process-
ing controller.
Indicates possibility of squeezing ngers
in the moving part of the image process-
ing controller.
Indicates possibility of squeezing ngers
in the moving part of the monitor xture
or image processing controller.
Indicates possibility of squeezing ngers
in the moving part of the image process-
ing controller xture.
Indicates possibility of squeezing fin-
gers.
Indicates that a load should not be
placed on this device.
Indicates that items should not be
placed on this device.
Indicates possibility of a foot coming into
contact with this system.
This CE mark on this product indi-
cates that this product is in conformity
with the applicable requirements set
out in the Directive 93/42/EEC (Medi-
cal Device Directive) and in Directive
2011/65/EU (RoHS Directive).
EC Directive 93/42/EEC does not
cover animal use.
1.1 Symbols relating to safety

13
Chapter 1
1.2 Warning labels
Various warning labels are attached to the AeroDR Portable RF Unit and mount kits in locations shown below. Do not
remove these labels from the AeroDR Portable RF Unit and mount kits.
Warning labels are there to make sure that the user recognizes potential hazards when operating the AeroDR Por-
table RF Unit and mount kits.
* If a warning label is too dirty or damaged to read, contact Konica Minolta technical representatives to have a new
warning label attached, and redisplay by parts replacement. (There is a fee for this service.)
1.2.1 AeroDR Portable RF Unit

14
1.2 Warning labels
1.2.2 Mount kits
zAeroDR Portable CS7 17D Mount Kit G1/
AeroDR Portable CS7 12P Mount Kit Sh1/
AeroDR Portable CS7 17D Mount Kit Sh1
zAeroDR Portable 19PC Mount Kit G1/
AeroDR Portable 19PC MK-G-OP
zAeroDR Portable CS7P Mount Kit G1
zAeroDR Portable Unit Mount Kit Si1D

15
Chapter 1
1.2 Warning labels
zAccessories Cover 5
zAeroDR Portable CS7 17P Mount Kit Si1D

16
1.3.2 Precautions for usage
WARNING
• Take the following notes when using the AeroDR
Portable RF Unit:
- Do not subject the unit to strong shocks or ex-
cessive loads by dropping and others.
- Do not disassemble or modify the unit.
- Do not attach a third-party device (except for
those purchased from Konica Minolta) to this unit.
- Do not turn the Power switch Off or unplug the
power cable from the receptacle when the sys-
tem is operating.
- Take care not to drop the unit on the human body.
- Do not use the unit when it is being charged or
when the power cable is connected.
• If a smoke, smell, or noise is found on the unit, im-
mediately turn the Power switch Off and unplug
the power cable from the receptacle. Then, contact
Konica Minolta technical representatives.
• Take the following notes to prevent a fire, electric
shock, and electrical leakage:
- Use the specified cables such as the power
cable only.
- Plug the power cable into the receptacle having
the specied ratings.
- Confirm that the power plug is properly con-
nected to the wall outlet without any slack.
- Use the power supply having the ground (GND)
terminal.
- Unplug the power cable from the receptacle if
you do not use the unit for a long time.
- The power cable and recharger unit contained in
the accessory pack can be used for the AeroDR
Portable RF Unit only. Do not use them for an-
other purpose.
- Take care not to drop the water and other liquids
in the unit.
- Take care not do drop or insert foreign materials
such as metals and wires in the unit.
- Do not handle the power plug with wet hands.
- Take care to avoid contaminating the power plug
with dust and others.
- Do not use extension cables.
- Do not use the star-burst connection of power cables.
- Take care not to damage the power cable. Also,
do not use the power cable if it is damaged.
- Do not connect a metal wire or other conductors
to the terminal of AeroDR Portable Unit Batteries.
- Do not carry or store the AeroDR Portable Unit
Batteries together with metallic items such as
necklaces, hairpins, coins and keys.
• If the housing is deformed or cracked, stop using
the unit immediately and contact Konica Minolta
technical representatives.
1.3 Safety precautions
Read all safety precautions thoroughly before using
the AeroDR Portable RF Unit.
Be sure to observe the safety precautions described in
this section.
CAUTION
Before using the AeroDR Portable RF Unit, read
the "Safety Warnings and Cautions" of the AeroDR
SYSTEM/AeroDR SYSTEM 2 Operation Manual and
be familiar with the unit handling precautions.
1.3.1 Precautions before usage
CAUTION
• The operator (hospital or clinic) is responsible to the
usage and maintenance of the AeroDR Portable RF
Unit. Any person other than the physician or other
than certied person under law must not use this unit.
• The AeroDR Portable RF Unit is suitable to use
outside of patient environment.
• Before using the AeroDR Portable RF Unit, check
to see that the unit operates normally.
• If the AeroDR Portable RF Unit has failed, turn its
power switch Off and place a warning tag showing
the "Out of order" or others. Contact Konica Minolta
technical representatives.
• As the AeroDR Portable RF Unit is not explosion-
proof, do not use any flammable or an explosive
gas near this unit.
• If you dispose the AeroDR Portable RF Unit, its ac-
cessories, options, consumables, storage media
and their packing materials, follow the applicable
Waste Management Law (the Waste Disposal and
Public Cleaning Law) and ask an authorized indus-
trial waste disposal contractor for their disposal. For
the disposal method, follow the applicable regula-
tions and rules of local government.
This symbol means: Do not dispose of this
product together with your household waste!
Please refer to the information of your local
community or contact our dealers regarding
the proper handling of end-of-life electric and
electronic equipments.
Recycling of this product will help to conserve
natural resources and prevent potential negative
consequences for the environment and human
health caused by inappropriate waste handling.

1.3 Safety precautions
17
Chapter 1
WARNING
• Register the AeroDR Detector using the AeroDR In-
terface Unit, AeroDR Interface Unit2, AeroDR Battery
Charger or AeroDR Battery Charger2 which supports
the image processing controller to be used and the
AeroDR Portable RF Unit. If an incorrect device is
registered, the AeroDR Detector may be selected
from another CS-7.
• If the buzzer of AeroDR Portable RF Unit sounds
(and the orange Power LED blinks), immediately
stop the radiography and recharge the AeroDR Por-
table Unit Batteries.
• Do not leave the AeroDR Portable Unit Batteries in
a high temperature such as direct sunlight or a ve-
hicle parking under the hot sun. If done, the battery
uid may leak.
• The AeroDR Portable Unit Batteries are consum-
able parts. If the operation time of AeroDR Portable
RF Unit has been shortened, replace the AeroDR
Portable Unit Batteries with new ones.
• Take the following notes to prevent an overheating, an
explosion, and a re of AeroDR Portable Unit Batteries:
- Keep the batteries away from a heat source
such as a space heater.
- Do not give a strong shock to the batteries by
dropping them from height or others. Also, do
not throw the batteries.
- Do not point a nail into batteries, do not hammer
the batteries, and do not step on the batteries.
- Recharge the specied rechargeable batteries only.
CAUTION
• Take the following notes when using the AeroDR
Portable RF Unit:
- Do not use devices that emit electromagnetic
waves such as high-frequency therapy equipment,
mobile phones, or pocket pagers, close to this unit.
- Take note of the reception status for radios and
TVs near this unit, since an interference may oc-
cur in them when this unit is in use.
- Use under the specified environmental condi-
tions. Failure to do so may result in degradation
of performance or malfunction of this unit.
• When the AeroDR Portable RF Unit is being
charged while stored in the X-ray device, do not
move the X-ray device to another place.
• Take the following notes when handling the monitor
or the mount kit of the image processing controller:
- When moving the base, check to see that no
person is around and move the base quietly.
- When moving the X-ray device, retract and se-
cure the arm of the monitor or the mount kit of
the image processing controller.
- Take care not to bump your head and body to
the arm.
CAUTION
- Take care as the monitor or the mount kit of the
image processing controller also moves when
you move the arm of X-ray device.
- Do not lean on the device, and do not press it
with force.
- Take care that your fingers and cables are not
caught in the arm of the monitor or the mount kit
of the image processing controller.
1.3.3 Precautions regarding
electromagnetic waves
zEMC Statement
The AeroDR Portable RF Unit (called This Device) has
been tested and found to comply with the IEC 60601-
1-2: 2007 Standard.
These limits are designed to provide reasonable pro-
tection against harmful interference in a typical medi-
cal installation. The device generates, uses and can
radiate radio frequency energy and, if not installed and
used in accordance with the instructions, may cause
harmful interference to other devices in its vicinity.
However, there is no guarantee that interference will
not occur in a particular installation.
Whether this device does cause harmful interference
to other devices can be determined by turning this de-
vice off and on. If it causes harmful interference, the
user is encouraged to try to correct the interference by
1 or more of the following measures:
• Reorient or relocate the receiving device.
• Increase the separation between the devices.
• Connect this device into a wall outlet on a circuit differ-
ent from that to which the other devices are connected.
• Contact Konica Minolta technical representatives.

1.3 Safety precautions
18
zSupplementary information regarding IEC 60601-
1-2: 2007
(1) Take precautions against this device especially
regarding EMC. Install and put into service
according to the electromagnetic compatibility
(EMC) information provided in the manual (Table
1 - Table 4).
(2) Do not use mobile phones or pocket pagers in
the vicinity of this device. Use of mobile phones
or pocket pagers near this device can cause
errors in operation due to electromagnetic wave
interference, so such devices should be turned off
in the vicinity of this device.
(3) Cable list
• Power cable (1.8 m/3-Wire/Without shield; in-
cluded in the recharger unit package.)
• AeroDR Portable XG CBL
• Various I/F Connection Cable
• Various hand switch interface cables
• Various hand switch cables
• Ethernet cable (max 20 m/With shield)
(4) The use of accessories, transducers and cables
other than those sold by Konica Minolta, Inc. as
internal components, may result in increased
emissions or decreased electromagnetic immunity
of this device.
(5) Do not use this device adjacent to or stacked
with other devices. If adjacent or stacked use
is necessary, confirm normal operation in the
conguration in which this device will be used.
Normal operation has been checked when
mounted on the X-ray device. For applicable
X-ray devices, contact Konica Minolta technical
representatives.
(6) Specifications regarding RF transmitters
frequency:
• Frequency: 5150 to 5350 MHz, 5470 to 5850
MHz
• Modulation: OFDM
• Maximum effective radiation power: +15 dBm
• This device may be interfered with by other de-
vices that conform to CISPR emission require-
ments.

19
Chapter 1
1.3 Safety precautions
Table 1
Guidelines and manufacture's declaration - electromagnetic emissions
This device is intended for use in the electromagnetic environment specied below.
The customer or the user of this device should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidelines
RF emissions
CISPR 11 Group 1
The device 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
This device is suitable for use in all establishments including the following:
Domestic establishments and those directly connected to the public low-
voltage power supply network that supplies buildings for domestic purposes.
Harmonic emissions
IEC 61000-3-2 Class A
Voltage uctuations/
icker emissions
IEC 61000-3-3
Complies
Table 2
Guidelines and manufacturer's declaration - electromagnetic immunity
This device is intended for use in the electromagnetic environment specied below.
The customer or the user of this device should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment -
guidelines
Electrostatic discharge
(ESD)
IEC 61000-4-2
± 6 kV contact ± 6 kV contact Floors should be wood, concrete or
ceramic tile. If oors are covered with
synthetic material, the relative humidity
should be at least 30%. Mains power
quality should be that of a typical com-
mercial or hospital environment.
± 8 kV air ± 8 kV air
Electrical fast transient/
burst
IEC 61000-4-4
± 2 kV for power supply
lines
± 2 kV for power supply
lines
± 1 kV for input/output
lines
± 1 kV for input/output
lines
Surge
IEC 61000-4-5
± 1 kV differential mode ± 1 kV differential mode Mains power quality should be that of a
typical commercial or hospital environ-
ment.
± 2 kV common mode ± 2 kV common mode
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 cycle
<5% UT(>95% dip in UT)
for 0.5 cycle Mains power quality should be that of a
typical commercial or hospital environ-
ment. If the user of the device requires
continued operation during power mains
interruptions, it is recommended that the
device be powered from an uninterrupted
power supply or a battery.
40% UT(60% dip in UT)
for 5 cycles
40% UT(60% dip in UT)
for 5 cycles
70% UT(30% dip in UT)
for 25 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 5 sec
Power frequency
(50/60 Hz) magnetic
eld
IEC 61000-4-8
3 A/m 3 A/m
Power frequency magnetic elds should
be at levels characteristic of a typical lo-
cation in a typical commercial or hospital
environment.
[NOTE] UTis the AC mains voltage prior to application of the test level.

20
1.3 Safety precautions
Table 3
Guidelines and manufacturer's declaration - electromagnetic immunity
This device is intended for use in the electromagnetic environment specied below.
The customer or the user of this device should assure that it is used in such an environment.
Immunity test IEC 60601
test level
Compliance
level Electromagnetic environment - guidelines
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms 150 kHz
to 80 MHz
3 V/m 80 MHz
to 2.5 GHz
[3] V
[3] V/m
Portable and mobile RF communications equipment
should be used no closer to any part of this device, includ-
ing cables, than the recommended separation distance
calculated from the equation applicable to the frequency of
the transmitter.
Recommended separation distance
d=[1.2] √P
d=[1.2] √P 80 MHz to 800 MHz
d=[2.3] √P 800 MHz to 2.5 GHz
where P is the maximum output power rating of the trans-
mitter in watts (W) according to the transmitter manufac-
turer and d is the recommended separation distance in
meters (m).
Field strengths from xed RF transmitters, as determined
by an electromagnetic site surveya, should be less than the
compliance level in each frequency rangeb.
Interference may occur in the vicinity of equipment marked
with the following symbol:
[NOTE] At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
[NOTE] These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reection from structures, objects and people.
a Field strengths from xed 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 xed RF transmitters, an electromagnetic site survey should be
considered. If the measured eld strength in the location in which this device is used exceeds the applicable RF com-
pliance level above, this device should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as reorienting or relocating this device.
b Over the frequency range 150 kHz to 80 MHz, eld strength should be less than [3] V/m.