Operating Manual
Index 4-EN
Page 1 of 15
Issue date: 2017-01-06
Infrared spot IRS
Content
1
SAFETY SYMBOLS .................................................................................................................................... 2
2
GENERAL INFORMATION ...................................................................................................................... 2
3
APPROPRIATION ....................................................................................................................................... 3
3.1
I
NDICATIONS
............................................................................................................................................ 3
3.2
C
ONTRAINDICATIONS
.............................................................................................................................. 3
4
POWER SUPPLY ......................................................................................................................................... 4
5
OPERATIONAL SAFETY .......................................................................................................................... 4
6
ENVIRONMENTAL CONDITIONS .......................................................................................................... 4
6.1
S
TORAGE
................................................................................................................................................. 4
6.2
O
PERATING
C
ONDITIONS
......................................................................................................................... 4
7
ACCESSORIES ............................................................................................................................................ 5
8
INFRARED LAMPS ..................................................................................................................................... 5
9
BEFORE THE USE ...................................................................................................................................... 5
10
STARTING UP ......................................................................................................................................... 6
10.1
S
WITCHING
-O
N OF THE
D
EVICE
............................................................................................................... 6
10.2
S
ETTING OF THE
T
IMER
............................................................................................................................ 6
11
SAFETY INSTALLATION ..................................................................................................................... 7
12
REGULAR TASKS ................................................................................................................................... 8
12.1
R
EGULAR
S
AFETY
C
HECKS
...................................................................................................................... 8
12.2
L
IMIT
V
ALUES FOR THE
A
NNUAL
S
AFETY
C
HECK
................................................................................... 8
12.3
C
ARE AND
M
AINTENANCE
....................................................................................................................... 8
12.4
S
URFACE
D
ISINFECTION
........................................................................................................................... 8
13
REPLACEMENT OF DEFECTIVE INFRARED LAMPS .................................................................. 9
14
SERVICE ................................................................................................................................................. 10
15
LIMITED GUARANTEE ...................................................................................................................... 10
16
MANUFACTURER ................................................................................................................................ 11
17
TECHNICAL DATA .............................................................................................................................. 11
17.1
T
ECHNICAL
D
ATA
.................................................................................................................................. 11
17.2
P
HOTOBIOLOGICAL
S
AFETY
................................................................................................................... 11
17.3
S
TANDARDS AND
D
IRECTIVES
............................................................................................................... 14
17.4
E
LECTRICAL
S
AFETY
C
LASSIFICATION
.................................................................................................. 14
18
INFRARED RADIATION ..................................................................................................................... 14
19
INSTALLATION CHECKLIST ........................................................................................................... 15
Operating Manual
Index 4-EN
Page 2 of 15
1 Safety Symbols
This symbol indicates a possible risk of danger. Read this manual
carefully and follow all safety advices that are marked by this sign.
This symbol indicates that a minimum distance of
60 cm between patient and infrared spot has to be
kept as well as between infrared spot and any other
surfaces. The patient may not touch, handle or
operate the device.
Ignoring this safety symbol bears risk for the
patient, the operator or other persons as well as risk
for the real values surrounding the equipment.
This symbol warns to open the enclosure of the infrared
spot while it is connected to the power supply. Ignoring
this safety symbol bears risk for the patient, the
operator or other persons as well as risk for the real
values surrounding the equipment.
This symbol indicates that optic radiation emanates from this
device.
This symbol indicates that the surfaces of the infrared spot are hot
during operation and a certain time afterwards. Ignoring this safety
symbol bears the risk of burning.
2 General Information
The infrared spot IRS may be opened and serviced by trained personnel only. When
the device is mounted or dismounted to a stand, wall- or ceiling-arm, the jib has to be
secured and relieved. Otherwise there will be danger caused be the arm or jib
swiveling upward. The installation manual of the stand, wall- or ceiling-arm has to be
followed strictly. The stand, wall- or ceiling-arm has to be fastened in a way that the
minimum distance of 60 cm between device and patient as well as between device
and any other surface is feasible in every possible position.
The installation has to be documented on the installation checklist enclosed to this
manual. This checklist, signed by both user and mechanic has to be sent to the
Operating Manual
Index 4-EN
Page 3 of 15
manufacturer in original. It is the base for the limited warranty. Operation without
returned checklist is not permitted.
The infrared spot may only be handled and positioned by its sidebars.
Attention: The surfaces of the device will be hot during operation!
3 Appropriation
The infrared spot IRS is intended to treat patients with infrared light according to a
doctors or therapists prescription. The indications and contraindications listed below
have to be respected. The device may only be operated by therapeutically qualified
personnel. The patient may not touch, handle or operate the device. The use for
other purposes, especially the treatment of babies and infants, is not permitted. If not
prescribed otherwise, the maximum time for a therapy is 30 minutes.
3.1 Indications
• Acute or chronic muscle pains
• Muscle or joint stiffness (except acutely inflamed processes)
• Vascular disorders
• Deep-seated pains in the lumbar spine
• Hematomas
• Preparation of therapeutic measures, e.g. massages
• Treatment of chronic inflammations (except acutely inflamed processes)
3.2 Contraindications
• Serious heart diseases
• Acute inflammations
• Coagulopathies
• Thrombosis
• Serious diabetes mellitus
• Thyreotoxic crisis
• Terminal kidney failure
• Hemolytic anemia
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Index 4-EN
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4 Power Supply
The standard power supply for infrared spot IRS is 220-240V / 50/60Hz.
The fuse is 16 A maximum. A residual current protective device has to be installed.
Attention:
• To avoid an electric shock the device may only be connected to a power
supply system that is equipped with a protective earth conductor.
• Complete disconnection of the infrared spot IRS from the power supply:
• For a complete disconnection of a wall mounted or stand based infrared
spot IRS from the power supply the plug has to be pulled out of the socket.
Unobstructed access to the socket has to be ensured, so that in case of
an emergency the plug may be pulled immediately.
• The plug may never be pulled by the cable but only by the grip area. The plug
may never be touched with wet hands.
5 Operational Safety
The operating company is obliged to establish operational safety for the user of this
device. All legal requirements regarding operational safety have to be obeyed.
According to legal standards an annual safety check of the infrared spot IRS has to
be performed and documented.
6 Environmental Conditions
6.1 Storage
The infrared spot IRS has to be stored under the following conditions:
Storage temperature: -20 °C - +70 °C
Maximum relative humidity: 75 %, no condensation
Barometric pressure: 500-1060 hPa
6.2 Operating Conditions
Storage temperature: 0 °C - +40 °C
Maximum relative humidity: 75 %, no condensation
Barometric pressure: 500-1060 hPa
The infrared spot IRS may only be used under dry conditions. All kinds of moisture
have to be kept away from the devices. The use in explosive surroundings is not
permitted. Cleaning with damp or wet media is not permitted. During operation a
minimum distance of 60 cm between infrared spot and patient as well as infrared
spot and any other surface has to be maintained.
The infrared spot has to be kept under supervision during the whole operating time.
Operation without supervision, e.g. by using a time switch, is not permitted!
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7 Accessories
Following (optional) accessories are available for the infrared spot IRS:
Name Art. Nr.
Mobile stand SST 3441.821
Mobile stand SSU 3441.822
Mobile stand SSV 3441.823
Wall arm HWA 3441.824
The use of other accessories is not permitted. Operation with non-approved
accessory will lead to the loss of warranty claim. When using accessories, the
operating instructions of the manufacturer have to be observed.
8 Infrared Lamps
The standard infrared lamps are therapeutic Infrared-Halogen-Lamps, 200 W, 230 V,
R7s. Defective infrared lamps may only be replaced, when the device has cooled
down to room temperature and the power supply is disconnected or the fuse is
switched off. According to the manufacturers declaration the average useful life is
500 hours. After completing the life cycle, the lamps have to be replaced, whether
they function or not. The supervision of the operating time is subject to the user.
Please follow the advices in chapter 13: Replacement of Defective Infrared Lamps.
Replacement lamps are not available on the free market. They have to be ordered
from Enraf-Nonius BV via your local distributor.
Please note that Infrared lamps are wear parts. They are not subject to guarantee!
9 Before the Use
Before the first use of the infrared spot IRS the Operating Manual has to be read
carefully. It has to be kept nearby the device. Before operating the infrared spot IRS,
the therapist has to make sure that the patient does not touch the device.
Furthermore the therapist has to check that the height adjustment of the wall-arm or
stand is fixed.
Attention: The minimum distance between device and patient is 60 cm!
Caution: Danger of burning!
The installation has to be documented on the installation checklist enclosed to this
manual. This checklist, signed by both user and mechanic has to be sent to the
manufacturer in original. It is the base for the limited warranty
.
The ventilation slots may in no way be covered or blocked. If the ventilation is not
sufficient there is a risk of overheating. This might cause danger for patient and/or
device. Operation without supervision, e.g. by using a time switch, is not permitted!
The warning signs on the device have to be followed with every use of the device!
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10 Starting Up
10.1 Switching-On of the Device
The infrared spot IRS is switched on by the main switch, which is located below the
control panel (picture 1). The main switch indicates function by a green glowing. The
device is now ready for use. The number of the infrared lamps in use is determined
by the separate switches.
10.2 Setting of the Timer
Attention: The infrared spot IRS may only be operated by authorized,
trained personnel. False positioning of the device, e.g. too little
distance between device and patient or too long treatment may cause
serious burning.
The treatment period is set by pressing the button or (picture 1). The treatment
period is started by pressing the button “Start”. Pressing the “Start” button before the
running out of the timer interrupts the treatment. Pressing the “Start” button again
continues the treatment. The number of infrared lamps in use can be varied during
the treatment by the separate switches. The expiring of the treatment period is
indicated by an acoustic signal and the display shows the previous time setting.
Picture 1
Main switch
Start / Stop
Plus
Minus
Separate switchesTime display
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11 Safety Installation
In case of a short cut or on overload the infrared spot IRS is disconnected from the
power supply by two device fuses (Picture 2).
Before replacing a fuse the power plug of the infrared spot has to be pulled. After
loosening the three fixing screws the lamp cover may be swayed open (s. chapter 13:
Replacement of Defective Infrared Lamps). Blown fuses may only be replaced by
fuses of exactly the same type (see chapter 17.1 Technical Data). If this safety
installation was activated, contact the service of your dealer or the manufacturer
before you operate the infrared spot again!
Device fuses
Picture 2
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Page 8 of 15
12 Regular Tasks
12.1 Regular Safety Checks
For the infrared spot IRS an annual safety check has to be performed and
documented.
12.2 Limit Values for the Annual Safety Check
Measurement Limit Value
Protective earth conductor resistance < 0,2 Ω
Insulating resistance > 2,0 MΩ
Enclosure leakage current < 100 µA
Earth leakage current < 0,5 mA
If any of the measured values exceeds the limit value, the device has to be put out of
service immediately!
12.3 Care and Maintenance
For care and maintenance of the infrared spot IRS the national rules and guidelines
concerning the operation of devices in health care facilities have to be obeyed.
The Infrared spot IRS may only be cleaned with a moist, lint-free cloth. Liquid
remnants (cleaning agents, water) have to be removed immediately. Before cleaning,
the power supply has to be disconnected and the device has to have cooled down to
room temperature.
12.4 Surface Disinfection
Recommended surface disinfectants:
• Biguamed Perfekt N, Hersteller Desomed –Dr. Trippen GmbH
• Cleanisept Wipes, Hersteller Dr. Schumacher GmbH
• Incidin Plus, Hersteller Ecolab Deutschland GmbH
• Mikrozid AF liquid, Hersteller Schülke & Mayr GmbH
• TPH protect, Schülke & Mayr GmbH
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13 Replacement of Defective Infrared Lamps
Attention: Defective infrared lamps may only be replaced, when the
device has cooled down to room temperature and the power supply is
disconnected. The high surface temperature of the infrared lamps
during and after the treatment may cause serious burning.
Defective infrared lamps may only be replaced by infrared lamps of the
same type, size and power (see chapter 17.1 Technical Data
)
.
Before replacing a defective infrared lamp the fixing screws of the lamp cover
(picture 3) have to be loosened to sway the cover open.
Attention: Take hold of the lamp only by its flat ends! Oil and grease
remnants in the area of the glass bulb may burn and lead to bursting of
the lamp!
To remove a defective lamp seize it by one of its flat ends and push towards the
opposite bulb socket until the lamp may be swayed out of the first socket (picture 4).
Remove the lamp. To mount a new lamp, proceed in reversed order. Insert the end
of the lamp with slight pressure on the metallic tip of the bulb socket. Sway the lamp
into the opposite socket and loosen the pressure until the lamp clicks into place.
Sway back the lamp cover and fix it with the screws. Operating the infrared spot
without lamp cover is not permitted!
Note: Infrared lamps are wear parts. They are not subject to guarantee!
Picture 3
Fixing screws
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14 Service
Apart from regular cleaning the infrared spot IRS is maintenance-free. In case of a
defect the repairing has to be executed by a qualified person. If the repairing can’t be
done locally the device may be sent to Enraf-Nonius BV, The Netherlands for service
and repair.
.
15 Limited Guarantee
The function of this device is guaranteed by Enraf-Nonius BV, if it is verifiably
mounted and operated according to this manual.
The guarantee time is twelve months after the delivery to the dealer.
The guarantee is limited to repair or exchange to a new device; the decision is up to
Enraf-Nonius BV exclusively. Please keep the original packaging for the time of
guarantee. Guarantee will only be granted, if the device is sent back in original
packaging. Damages caused by insufficient wrapping will be charged to the
dispatcher.
Further compensations are not included in this limited guarantee.
Note: Infrared lamps are wear parts. They are not subject to guarantee!
Picture 4
Seizing
Direction
of
pressure
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16 Manufacturer
The infrared spot IRS is manufactured for Enraf-Nonius BV by:
Heuser Apparatebau GmbH
Am Schlagbaum 10
42781 Haan
Germany
17 Technical Data
17.1 Technical Data
Infrared spot IRS Art.nr. 3441.804
Power supply * 220-240V / 50/60Hz
Number of lamps 3
Heating capacity per lamp 200 W
Max. heating capacity 600 W
Lamps individually switchable Yes
Timer Max. 99 min.
Device fuses 6,3x32 fast acting
5,0 A
IEC 60127-2/4 • DIN VDE 0820
Overall dimensions (LxWxH) 700 x 395 x 145 mm
Net weight 12,0 kg
Shipping weight 14,5 kg
Packing dimensions (LxWxH) 815 x 500 x 500 mm
Medical Device Class Class IIa
*
Power supplied via the support system (optional)
17.2 Photobiological Safety
The photobiological safety of the infrared spot IRS is testified according to the
following standard:
DIN EN 62471; VDE 0837-471:2009-03:2009-03:
Photobiologische Sicherheit von Lampen und Lampensystemen (IEC 62471:2006,
modifiziert; Deutsche Fassung EN 62471:2008
Therefore no additional protective action is required.
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Guidelines and manufacturer’s declaration - electromagnetic immunity
The infrared spots IRS are intended for use in the electromagnetic environment specified below. The customer or
the user should ensure that the infrared spot IRS are used in the specified environment.
Immunity test IEC 60601
test level
Immunity
compliance
level
Electromagnetic environment
guidelines
Conducted RF
IEC 61000-4-6
Conducted RF
IEC 61000-4-3
3 Vrms
150kHz 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 the infrared spot TGS (incl.
cables) than the recommended
separation distance calculated from the
equation applicable to the frequency of
the transmitter.
Recommended separation distance:
d = 1,17√
d = 1,17√ 80 MHz to 800 MHz
d = 2,34√ 800 MHz to 2,5 GHz
were 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 (a), should be below the
compliance level in each frequency range
(b).
Interference may occur in the vicinity of
equipment marked with the following
symbol:
Notes:
1) At 80 MHz and 800 MHz the separation distance for the higher frequency range applies.
2) These guidelines may not apply in all situations. Electromagnetic radiation is affected by absorption and
reflection of structures, objects and people.
a) Field strengths from fixed transmitters, such as base stations for wireless (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast, cannot be
predicted in theory with any accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be carried out. If the measured field strength of the
location in which the infrared spot IRS is used exceeds the applicable RF compliance level above, the
infrared spot IRS should be monitored to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as reorienting or relocating the infrared spot IRS.
b) Over the frequency range of 150 kHz to 80 MHz the field strengths should be less than 3 V/m.
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Recommended separation distances between portable and mobile RF communications equipment and
the infrared spots IRS
The Infrared spots IRS are intended for use in an electromagnetic environment in which radiated RF
interferences are controlled. The customer or the user can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and
the infrared spots IRS as recommended below, according to the maximum output power of the communications
equipment.
Rated maximum output
of transmitter
[
[[
[W]
]]
]
Separation distance according to frequency of transmitter
[
[[
[m]
]]
]
150 kHz to 80 MHz
d = 1,17
√
80 MHz to 500 MHz
d = 1,17
√
800 MHz to 2,5 GHz
d = 2,34
√
0,01 0,12 0,12 0,23
0,1 0,37 0,37 0,74
1 1,17 1,17 2,34
10 3,69 3,69 7,40
100 11,70 11,70 23,40
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
meters [m] can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts [W] according to the transmitter manufacturer.
Notes:
1) At 80 MHz and 800 MHz the separation distance for the higher frequency range applies.
2) These guidelines may not apply in all situations. Electromagnetic radiation is affected by absorption and
reflection of structures, objects and people.
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17.3 Standards and Directives
The Infrared spots IRS comply with the safety requirements of the following
standards, laws and directives:
• German Medical Devices Act
• MDD 93/42/EWG, 2007 – Medical Device Directive
• Classification: Medical Device Class IIa
• DIN EN 60601-1: 2007 – Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance
• DIN EN 60601-1-2: 2007 – Medical electrical equipment –
Part 1-2: General requirements for basic safety and essential performance –
Collateral standard: Electromagnetic compatibility – Requirements and tests
Therefore no additional protective action is required.
17.4 Electrical Safety Classification
The infrared spot IRS is class 1 equipment. To avoid an electric shock the device
may only be connected to a power supply system that is equipped with a protective
earth conductor.
Degree of enclosure protection IP 22
18 Infrared Radiation
Shortwave infrared radiation (declaration according to the infrared lamp
manufacturer)
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19 Installation Checklist
Product Serial Number Date of Installation
Infrared spot IRS
Date, Signature
of the
Technician
Was the stand installed according to user´s
manual?
yes
no
not applicable
Was the wall- or ceiling-arm mounted
according to the Operating Manual of the
manufacturer using appropriate installation
material?
yes
no
not applicable
Is the spring inside the wall- or ceiling-arm
adjusted to the weight of the device?
yes
no
not applicable
Can the minimum safety distance of 60 cm
between device and patient be maintained? yes
no
Does the electric installation have a residual
current protective device? yes
no
Does the residual current protective device
work properly? yes
no
Is the power supply fused with 16 A
maximum? yes
no
If any of the questions above is answered with „no“, the operation of the device is not
permitted! In case of defects or harm due to incorrect installation all guarantee will be
declined!
Date, signature of the user, ______________________________________
/
