2 General description ....................................................................................................................................20
5 Important safety information ................................................................................................................22
6 Setup and operating procedures..........................................................................................................24
6.1 Fu nction and use of bu ttons ........................................................................................................25
7 Program ...........................................................................................................................................................26
Transcutaneous electrical nerve stimulation (TENS) is a non-invasive technique in which a low-voltage electrical current is delivered through wires
from a small power unit to electrodes located on the skin. Electrodes are
temporarily attached with paste in various patterns, depending on the specic condition and treatment goals. TENS is often used to treat pain, as an
alternative or addition to pain medications. Therapy sessions may last from
minutes to hours. The use of electrical stimulus for pain relief was popularized in the 19th centur y and became wide spread in the 1960s and 1970s using
battery power.
Transcutaneous electrical nerve stimulation (TENS) was rst introduced into
current clinical practice following Melzack and Wall‘s gate control theory of
pain in 1965. Davis (1993) and Lewith (1984) explain the gate control theory
of pain as follows. An area of the dorsal horn of the spinal cord, known as
the substantia gelatinosa, acts as a gate to nociceptive impulses. It receives
myelinated nerve bres , the largest being A bres, and small non-myelinated nerve bres (C bres). If pain impulses pass along ne myelinated bres
and C bres rather than along A bres, the gate is opened, and the patient
perceives pain. If A bre transmission of impulses is greater, the gate may
be closed.
There is also evidence that the TENS machine enhances the production of
the body‘s own natural pain killing substances: endorphins and encephalins.
Human body produces endorphins and encephalins, which are opiate-like
substances to counter the pain. Low frequency stimulation causes the release of the endorphins and encephalins.
2. Why consider digital pain relief?
Pain is a warning signal -we need these signals to tell us that something may
be wrong with our body. Without it, we may do not know that part of our body
might be damaged, thereby damaging them further. However, once we have
identied damage, pain serves little purpose. In the case of chronic, regular
pain it can signicantly interfere with daily activities and the quality of life.
GB
3. How does the Digital Pain Relief (TENS) work?
Digital Pain Relief (TENS) works by passing harmless electrical signals into the
body from its pads. This relieves pain in two ways:
19
1. It blocks the body‘s pain signals. These are normally transmitted from the
area of damage through the nerve bers to the brain, TENS interrupts these
pain signals.
2. TENS stimulates the body‘s production of endorphins-its own natural
painkillers.
1
2 | General description
GB
2.1 | Contents
• Mainframe• Wires
• Electrodes (Pads)• Instruction book
• Batteries
2.2 | Description of the device
(Fig. 1)
Output plug
1
Output cable
2
3
Output plug socket
LCD Display
4
5
[ON]-Button = Switch on and Intensity (+)
6
[OFF]-Button = Switch o and Intensity (
7
[MODE/STOP]-Button = Function Selection
and Stop
3
4
-
)
2.3 | Display indicators (Fig. 2)
8
Remaining Massage Time Display
Output Intensity Display
9
10
Function Display
11
Timer Display Punkt
8
3 | Intended use
Transcutaneous Electrical Nerve Stimulators are intended
for temporary relief of pain , including:
• Various chronic pain
• Various acute pain
20
2
5
6
7
Fig .1
11
9
10
Fig.2
3.1 | Contraindications
The device is safe for all people, with the following exceptions or the people
who are receiving physiotherapy:
• People with acute disease
• Cancer patients
• People with infectious skin wounds
• Women who are in menstrual or expectant mothers
• People with heart disease
• People with high fever
• People with abnormal blood pressure
• People who have no feeling about their skins or people with abnormal skins
• People with abnormal feeling of their body except the abovge cases
4 | Product description
The AD-2011 is a battery operated pulse generator that sends electrical impulses through electrodes to the body and reaches the underlying nerves
and muscle.
• The device is provided with one controllable output channel.
• An electrode pair can be connected to the output channel.
The electronics of the AD-2011 Digital create electrical impulses whose
Intensity, Pulse Width, Pulse Rate may be altered according to the program.
Press buttons are very easy to use and the panel cover prevents changes in
the setting.
The AD-2011 corresponds to the below standards:
• IEC 60601-1: 2005/EN 60601-1:2006/AC:2010
(Medical el ectrical equipment -- Part 1: General requirements for basic safety
and essential performance).
• IEC60601-1-2:2007/EN 60601-1-2:2007/AC:2010
(Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests).
Number of treatment program:8
Anzahl Intensities:8
Range of pulse frequency:2 ~ 150 Hz
Range of output voltage:40 V ± 20% (500 Ohm load)
Classication:Internally powered, Type BF applied
GB
Machine size:approx. 55 x 122 x 19 mm
Weight:approx. 62 g (exclude batteries)
Power source:Batteries: 2 x 1.5 V Type AAA
For operation
Environmental temperature:5°C - 40°C
Environmental humidity:< 80%
For storage and transport
Environmental temperature:-20°C - 55°C
Environmental humidity:≤ 95%
Environmental pressure:80 KPa - 105 KPa
Battery life:approx. 2 months with alkaline batteries
part, IPX0, No AP or APG, Continuous
operation
and 30 min. usage per day.
5 | Important safety hints
Retain the manual for
further use and forward
it to other users!
• Read all of the information in the operation guide and
any other literature in the box before operating the
unit.
• If there is any uncomfortable during using the device, please please stop
using it immediately and consult your doctor
• Turn o the power rst before alternate the electrode pad to the other channel
22
• Do not make sharp kinks in the connecting leads or electrodes.
• Do not use the device if you are connected to, or in the vicinity of,
high-frequency surgical or industrial equipment. This may cause burn
injuries on the skin under the electrodes, as well as problems with the
stimulator.
• Observe caution when using the device in the immediate vicinity of cellular
phones that are switched on.
• This device is not intended to be used unsupervised by children, individuals
with sensory deprivation of any kind or mentally challenged individuals. Any
users falling into these categories should be assisted by a responsible adult.
• Please don‘t use it in the bathroom or other place with high humidity.
• Please do not use it when driving, otherwise, it may lead to incident.
• Please do not use the device while in sleep.
• In the process of stimulating and therapy, please do not allow metal
parts of belts, wristwatches or necklaces touch the leaf electrode pads.
• Please don‘t use it for purposes other than outlined in this manual.
• The device might not meet its performance specications or may cause
safety hazard if stored or used outside the specied temperature and
humidity ranges in specications.
• Pregnant women should not use the device during the rst trimester, and
should always consult a doctor, midwife or physiotherapist prior to use.
• 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.
• Operation in close proximity (e.g. 1 m) to a shortwave or microwave therapy
equipment may produce instability in the device output.
• Application of electrodes near the thorax may increase the risk of cardiac
brillation.
• Please do not knock down, repair, and rebuild the device privately.
• Please do not use electrode pads other than those supplied by the
manufacturer, otherwise it may bring biocompatible hazard and might
result in measurement error.
• Please do not share the electrode pads with infective persons to avoid
cross-infection.
• The output wave parameters are not be inuence by load resistance, except
output voltage. When the value of load resistance increased, the output
voltage will increase.
• Avoid strong magnetism interference, such as mobile telephone, microwave
oven, etc.
• Information regarding potential electromagnetic or other interference
between the device used and other devices together with advice regarding
GB
23
avoidance of such interference please see part ELECTROMAGNETIC
COMPATIBILITY INFORMATION. (p. 90)
• Never stick two adhesive gel pads to each other.
• Keep the adhesive gel pads clean and do not expose to heat or direct sunlight.
• If the gel pads do not attach or are dirty, wipe with a wet cloth or replace
with new ones.
• Do not clean the pad or adhesive gels with any chemical. Replacement pads
are available from your local distributor.
• Place the electrodes on intact skin only. Do not place on cuts or damaged
GB
skin.
• The adhesive pads should be attached around the area of pain before
setting the stimulation mode and output intensity
6 | Setup and operating procedures
1. Insert batteries
a Open battery cover at the back of the device.
b Insert two „AAA“ size batteries. Please pay attention to polarity.
c Close the battery cover.
• Rechargeable batteries are not suitable for this device.
• Remove the batteries if the monitor will not be used for a month or
more to avoid relevant damage of battery leakage.
• Please do not mix use new and old batteries or dierent type of batteries.
• Please do not throw battery into re.
• Avoid the battery uid to get in your eyes. If it should get in your eyes,
immediately rinse with plenty of clean water and contact a physician.
2. How to place the adhesive gel pads on the electrode?
Each adhesive gel pad is protected by 2 layers of transparent lm-one on
either side. Remove the layer of lm and place that side of the gel pad to skin.
3. Attachment of electrode lead wires
a Insert the plug into the electrode socket on the main apparatus.
b Connect the snap-fasteners at the other end of the wire to the electrode
pads.
c Place the electrode on your body as directed by your physician.
• Clean the wires by wiping with a damp cloth.
• Coating them lightly with talcum powder will reduce tangling and
prolong life.
24
4. Finishing the operation
You should hold the plug when pulling it out. Please do not pull the wire.
• Please use clear water to wash or use wet cloth (instead of facial
tissue) to gently wipe up the electrodes when cleaning them.
• Wires stay away from babies and children, prevent the winding neck
causing suocation and death.
6.1 | Function and use of buttons
[ON]-button:
• Press this button to turn on the unit and increase the output
intensity.
• Each time you press the [ON]-button the intensity of
stimulation will increase by one level. (0 - 8, 8 levels in total)
[OFF]-button:
• Press this button to turn o the unit and decrease the output
intensity.
• Each time you press the [OFF]-button the intensity of
stimulation will decrease by one level (8 - 0, 8 levels in total)
• The output intensity level will be displayed by the number on the LCD
display: «1» is the lowest, «8» is highest. The output strength will gradually
increase according to the selection of intensity level.
• If the output intensity is at «0», it means that the device is standby status
and will automatically shut o in 20 seconds.
• When the output intensity is at 1- 8, the time setting function starts to work.
The black spot on the LCD display will ash once each second.
• The adhesive pads should be attached around the area of pain before
setting the stimulation mode and output intensity.
MODE/STOP-button:
• To adjust the output function to a suitable level, press the
[MODE/STOP]-button
• There are 8 dierent selections of stimulation settings (form
A - H). For detailed descriptions please refer to the following
function chart.
The device has a memory function. Once a particular stimulation setting is chosen
it will remain on that setting even when the device is switched o and switched back
on. For example, if the device was set to «B» mode before being switched o, when
the device is restarted, it will remain in «B» mode until another mode is chosen.
GB
25
• Press the [MODE/STOP]-button will change the stimulation setting from
GH
AECBFEFA
AECBFEFA
AF
one mode to another.
7 | Program
The changing process is as follows:
ABCDEF
GB
Program Function
A Pain ReliefTapping (Slow)
B Pain ReliefTapping (Fast)
C Pain ReliefVibrating (Slow)
D MassageKneading (Slow)
EMassageKneading (Fast)
F Pain Relief/MassageVibrating (Fast)
Combined programs
G Pain Relief/Massage course:
• recommended for shoulder and neck
15 min. / cycle
H Pain Relief/Massage course:
• recommended for waist and back
FDAFED
• When the device is turned on, even if the stimulation setting or intensity is
changed, it will not aect the timer which will continue to count down the
remaining time
• The device will turn o automatically when the set time has elapsed
• The set time of the device is 15 minutes.
• Recommended usage is 1-2 times a day with at least 2-3 hours of rest between
each use.
• If you feel any pain or discomfort during use,stop use immediately and
consult your doctor.
26
15 min. / cycle
8 | Operating instructions
a Be sure you know the right points where to place the electrodes and ax
them there then, connect the electrodes to Digital Pain Relief with wire.
b Switch power on.
c After setting mode, intensity and time, you could feel stimulation at
electrodes and treatment starts. The time display is enabled and displays
the remaining time of application.
d Switch power o.
e Take electrodes o and clear them as shown in «User Manual»
Clean the electrodes.
• You should hold the plug when pulling it out. Please do not pull the wire.
• Please use clear water to wash or use wet cloth (instead of facial tissue) to
gently wipe up the electrodes when cleaning them.
• Do not use brush or ngernail to clean surface of the electrodes to avoid
scratching them.
8.1 | Usage diagrams
WaistArm
BackJoints
LegAdductors
GB
Chest and
abdomen
Buttocks
27
ShoulderFoot
9 | Troubleshooting
The following table provides information on troubleshooting:
GB
MalfunctionThe reasonCountermeasure
You have no
feeling of
stimulus.
Stimulus is weak.Do the electrode pads rmly
The skin
becomes red.
28
Are the batteries exhausted?Replace the batteries.
Are the batteries
properly loaded?
Is the wire properly connected? Firmly connect the wire.
Have you removed the
transparent protection lm
over the electrode pad?
stick to the skin?
Are the electrode pads
overlapped?
Are the electrode pads dirty?Please clean the electrode
Is intensity too weak?Turn the intensity regulation
Are the electrode pads
properly positioned?
Is the therapeutic time too
long?
Do the electrode pads rmly
stick to the skin?
Are the electrode pads too
dry?
Are the electrode pads dirty?Please clean the electrode
Are the surface of the
electrode pads scratched?
Correctly load the
batteries.
Remove the transparent
protection lm over the
electrode pad.
Firmly stick the electrode pad
to the skin.
Separate the electrode pad
and stick them to the skin gain.
pad.
dial to regulate it.
Change the position of the
electrode pad.
Control it within 10 - 15
minutes a time.
Please rmly stick the
electrode pad to the skin.
Please gently wipe them up
with wet cloth and then use
them again.
pad.
Please replace them with new
electrode pad.
Power sources cut
o in the therapeutic
process.
Have the electrode pads come
o the skin?
Are the wires disconnected?Turn o the power and
Have the batteries been
exhausted?
Turn o the power and stick
the electrode pad rmly to
the skin.
properly connect the wire.
Please replace them with new
ones.
10 | Maintenance
• Do not drop this device subject it to strong impact.
• Avoid high temperature and direct sunlight. Do not immerse the device in
water.
• If this device is stored near freezing, allow it to acclimate to room
temperature before use.
• Do not attempt to disassemble this device.
• If you do not use the device for a long time, please remove the batteries. .
• If the device becomes dirty, please clean it with a soft dry cloth. Do not use
any abrasive or volatile cleaners.
• No component can be maintained by user in the device.
The circuit diagrams, compon ent part lists, descriptio ns, or other information
which will assist the user‘s appropriately qualied technical personnel to
repair those parts of equipment which are designated as repairable can be
supplied by the manufacturer.
• In order to ensure that the electrodes adhere as long as possible, they
should be cleaned carefully with a damp, lint-free cloth.
• After use, stick the electrodes onto the backing lm.
• Electrode Pads are designed to be replaceable, so when the electrodes do
not adhere rmly, you must replace electrode-pads.
11 | Explanation of symbols
Symbol for «Consult Operation Guide»
GB
Symbol for «WARNING!»
Symbol for «TYPE BF applied parts»
29
Environment Protection - Waste electrical products should not be disposed of with household waste. Please recycle where facilities exist.
Check with your local Authority or retailer for recycling advice.
Symbol for «Manufacturer»
Symbol for «Date of manufacture»
GB
Symbol for «Keep dry»
Symbol for »Serial number«
0483
Complies with 93/42/EEC requirements
12 | Warranty
The guarantee period is 24 months from the date of purchase and covers all
manufacturers’ errors in material and quality. This guarantee only applies if the
instructions for use have been followed and becomes ineective if force has
been applied to the appliance or it has been used in any but the correct and
proper manner, or if it has been serviced by any unauthorised person.
Dear Customer,
In case you prodect does not function as you expected please do not reurn
immediately. Perhaps our hotline (+49-69-954061-24) can be of assistance
If you are still not satised, you have the possibility to return products under
40 € value free of charge within the BRD. We require your address. This you
may provide to the above listed telephonic Hotline or by e-mail to: technik@
hydas.de. Prepare the package for shipping and include the reciept and description of the problem. Please be aware of the fact that collect packages
may not be accepted.
Leitlinien und Herstellererklärung zur elektromagnetischen Strahlung
Der Artikel 4508 ist für die Verwendung in einer Umgebung mit den nachstehend denierten elektromagnetischen Eigenschaften vorgesehen. Der Kunde oder der Benutzer
des Artikels hat sich zu vergewissern, dass er in einer solchen Umgebung eingesetzt wird.
RF Emissionen CISPR 11Klasse BArtikel 4508 ist für den Einsatz in allen RäumÜberschwingungsströme
IEC 61000-3-2
Spannungsänderungen/
Spannungsschwankungen IEC 61000-3-3
Für alle ME EQUIPMENT und ME SYSTEME
Leitlinien und Herstellererklärung zur elektromagnetischen Störfestigkeit
Der Artikel 4508 ist für die Verwendung in einer Umgebung mit den nachstehend denierten elektromagnetischen Eigenschaften vorgesehen. Der Kunde oder der Benutzer
des Artikels hat sich zu vergewissern, dass er in einer solchen Umgebung eingesetzt wird.
Störfestigkeit
gegen schnelle
transiente
elektrische
Störgrößen
IEC 61000-4-4
Gruppe 1Das 4508 verwendet RF-Energie ausschließ-
Nicht
zutreend
Nicht
zutreend
Leistungstest
IEC 60601
± 6 kV Kontakt
± 8 kV Luftentladung
± 2 kV für
Stromversorgungsleitungen
lich für den internen Betrieb. Folglich sind
seine RF-Emissionen sehr schwach und es
besteht keine Gefahr, dass sie Interferenzen
mit einem danebenstehenden
Elektrogerät erzeugen.
lichkeiten geeignet, inkl. Privaträumen und
an Orten, wo er direkt an das öentliche Niederspannungs-Stromversorgungsnetz, das
Wohngebäude versorgt, angeschlossen wird.
Compliance
level
± 6 kV Kontakt
± 8 kV Luftentladung
Nicht
zutreend batteriebetriebenes
Gerät
Elektromagnetische
Umgebung - Empfehlungen
Die Böden müssen aus Holz,
Beton oder Keramikiesen
sein. Falls die Böden mit synthetischem Material ausgelegt
sind, muss die relative Feuchtigkeit bei einem Minimum
von 30% liegen.
Nicht zutreend
Stoßspannungen
IEC 61000-4-5
Spannungseinbrüche,
Kurzzeitunterbrechungen und
± 1 kV line(s) to
line(s)
<5% Ut
(Spannungseinbruch >95% Ut)
in 0.5 Zyklus
Nicht
zutreend
Nicht
zutreend
Nicht zutreend
Nicht zutreend
Spannungsschwankungen
bei
ankommenden
Stromversor-
Felder mit der Spannung des
Stromnetzes müssen die
Pegeleigenschaften eines
durchschnittlichen Ortes in
einer typischen Büro- oder
Krankenhausumgebung
haben.
MERKE: UT ist die Spannung des Wechselstromnetzes vor Anwendung des Leistungstests.
Leitlinien und Herstellererklärung zur elektromagnetischen Strahlung
Der Artikel 4508 ist für die Verwendung in einer Umgebung mit den nachstehend denierten elektromagnetischen Eigenschaften vorgesehen. Der Kunde oder der Benutzer
des Artikels hat sich zu vergewissern, dass er in einer solchen Umgebung eingesetzt wird.
Funkstörfestig-
keitstest
Abgestrahlte
RF-Energie
IEC 61000-4-3
Leistungstest
IEC 60601
3 V/m
80 MHz bis 2.5
GHz
RichtwerteElektromagnetische
Umgebung - Empfehlungen
3 V/mTragbare und mobile RF-Kommuni-
kationsgeräte dürfen nur in einem
Abstand zum Gerät und seinem
Zubehör benutzt werden, der mindestens dem empfohlenen und mit
der Formel für die Senderfrequenz
berechneten Abstand entspricht.
Empfohlener Abstand:
80 MHz to 800 MHz
800 MHz to 2,5 GHz
Wonach P der Leistungspegel der
Maximalspannung des Senders in
Watt (W) ist, der in den
technischen Spezikationen des
Herstellers angegeben ist, und
demzufolge d der empfohlene
Abstand in Metern (m).
Die Feldstärke der festen RF-Sender,
wie durch eine elektromagnetische
Untersuchung
unter dem Richtwert liegen, der in
jeder Frequenzbandbreite
a
festgelegt, muss
b
liegt.
Störsignale können in der Nähe
jedes Gerätes mit dem folgenden
Symbol auftreten:
ANMERKUNG 1: Von 80 MHz bis 800 MHz wird die Hochfrequenzamplitude verwendet.
ANMERKUNG 2: Diese Richtwerte können in bestimmten Situationen nicht angemessen
sein. Die elektromagnetische Ausbreitung wird durch Absorption und Reexion von
Gebäuden, Gegenständen und Menschen beeinusst.
a
: Die Feldstärken der Signale aus festen Sendern, wie Basisstationen eines Funktelefons
(Mobil-oder schnurloses Telefon) und eines mobilen Radios, Amateurfunkradios,
AM- und FM-Radio-und TV-Signalen, sind nicht exakt vorherzubestimmen. Eine Analyse
der elektromagnetischen Umgebung des Ortes ist zu erwägen, um die elektromagnetische Umgebung, die von festen RF-Sendern ausgeht, berechnen zu können. Wenn die
Stärke des in der Umgebung des Compex Performance gemessenen Feldes den oben
angegebenen RF-Richtwert überschreitet, ist die korrekte Funktionsweise des Compex
Performance zu überprüfen.
b
: Oberhalb der Frequenzamplitude von 150 kHz bis 80 MHz muss die Feldstärke
weniger als 3 V/m betragen.
Empfohlener Abstand zwischen einem tragbaren und mobilen
RF Telekommunikationsgerät und dem 4508.
Das 4508 wurde für eine elektromagnetische Umgebung entwickelt, in der ausgestrahlte RF-Turbulenzen kontrolliert werden. Käufer oder Benutzer des 4508 können
zur Verhütung elektromagnetischer Störsignale beitragen, indem sie den in der nachfolgenden Tabelle mit den empfohlenen Richtwerten angegebenen Mindestabstand
zwischen den tragbaren und mobilen RF-Kommunikationsgeräten (Sender) und
dem 4508 und die maximale elektrische Leistung des Telekommunikationsgeräts
berücksichtigen.
Max. elektrische
Leistung des
Senders
W
Abstand gemäß Frequenz des Senders mCISPR 11
150 kHz bis 80 MHz
d = 1,2√P
80 MHz bis 800 MHz
d = 1,2√P
800 MHz bis 2,5 GHz
d = 2,3√P
0,010.120.120.23
0,10.380.380.73
11.21.22.3
103.83.87.3
100121223
Falls die maximale elektrische Leistung eines Senders nicht in der nachstehenden
Tabelle aufgeführt ist, kann der empfohlene Mindestabstand in Metern (m) mit der
Formel für die Senderfrequenz berechnet werden. wonach P dem vom Hersteller
angegebenen maximalen elektronischen Leistungspegel des Senders in Watt (W)
entspricht.
ANMERKUNG 1: Von 80 MHz bis 800 MHz wird die Hochfrequenzamplitude verwendet.
ANMERKUNG 2: Diese Richtwerte können in bestimmten Situationen nicht angemessen
sein. Die elektromagnetische Übertragung wird durch Absorption und Reexion von
Gebäuden, Gegenständen und Personen verändert.
ELECTROMAGNETIC COMPATIBILITY INFORMATION
For all ME EQUIPMENT and ME SYSTEMS
Guidance and manufacture’s declaration - electromagnetic emissions
The 4508 is intended for use in the electromagnetic environment specied below.
The customer or the user of the 4508 should assure that it is used in such an environ-
Emissions testCompliance
RF emissions
CISPR 11
RF emissions CISPR 11Class B
Harmonic emissions
IEC 61000-3-2
Voltage uctuations/
icker emissions IEC
61000-3-3
applicable
applicable
For all ME EQUIPMENT and ME SYSTEMS
Guidance and manufacturer’s declaration - electromagnetic immunity
The 4508 is intended for use in the electromagnetic environment specied below.
The customer or the user of the 4508 should assure that it is used in such an environ-
IMMUNITY testIEC 60601 test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
level
± 6 kV contact
± 8 kV air
±2 kV for power
supply lines
ment.
The 4508 uses RF energy only for its inter-
Group 1
Not
Not
nal function. Therefore, its RF
emissions are very low and are not likely to
cause any interference in nearby electronic equipment
The 4508 is suitable for use in all
establishments other than domestic and
those directly connected to the public
low-voltage power supply network that
supplies buildings
used for domestic purposes.
ment.
Compliance
level
± 6 kV contact
± 8 kV air
not applicable not applicable
Electromagnetic
environment-guidance
Electromagnetic
environment-guidance
Floors should be wood,
concrete or ceramic tile. If
oors are covered with
synthetic material, the relative
humidity should be at least
30 %.
(For INTERNALLY POWERED
ME EQUIPMENT)
Surge
IEC 61000-4-5
± 1 kV line(s) to
line(s)
not applicable not applicable
(For INTERNALLY POWERED
ME EQUIPMENT)
Voltage dips,
short interruptions and
<5% UT
(>95% dip in
UT) for 0.5 cycle
not applicable not applicable
(For INTERNALLY POWERED
ME EQUIPMENT)
voltage variations
on power supply
input lines
IEC 61000-4-11
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
Power frequency
(50Hz/60Hz)
magnetic eld
IEC 61000-4-8
3 A/m3 A/mPower frequency magnetic
elds should be at levels cha-
racteristic of a typical location
in a typical commercial or
hospital environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacturer‘s declaration - electromagnetic immunity
The 4508 is intended for use in the electromagnetic environment specied below.
The customer or the user of the 4508 should assure that it is used in such an environ-
IMMUNITY test IEC 60601 test
level
Radiated RF
IEC 61000-4-3
3 V/m 80 MHz
to 2.5 GHz
ment.
Compliance
level
Electromagnetic
environment-guidance
3 V/mPortable and mobile RF commu-
nications equipment should be
used no closer to any part of the
4508, including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter. Recommended separation distance:
80 MHz to 800 MHz
800 MHz to 2,5 GHz
Where P is the maximum output
power rating of the transmitter in
watts (W) according to the transmitter manufacturer and d is the
recommended separation distance
in meters (m).
Field strengths from xed RF
transmitters, as determined by an
electromagnetic site survey,
be less than the compliance level in
each frequency range.
a
should
b
Interference may occur in the
vicinity of equipment.
Marked with the following symbol:
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 aected by absorption and reection from structures, objects and people.
a
: Field strengths from xed transmitters, such as base stations for radio (cellular/cord-
less) 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 the
4508 is used exceeds the applicable RF compliance level above, the 4508 should be
observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the 4508.
b
: Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than
[V1] V/m.
For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING
portable and mobile RF communications equipment and the 4508
The 4508 is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the 4508 can help prevent
electromagnetic interference by maintaining a minimum distance between portable
and mobile RF communications equipment (transmitters) and the 4508 as recommended below, according to the maximum output power of the communications
equipment.
Rated maximum
output power of
transmitter
W
0,010.120.120.23
0,10.380.380.73
11.21.22.3
103.83.87.3
100121223
For transmitters rated at a maximum output power not listed above, the
recommended separation distance d in meters (m) can be determined 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 aected by absorption and reection from structures, objects and people.
Recommended separation distances between
Separation distance according to frequency of transmitter