Enraf-Nonius Halogen IR Radiator IRS User manual

Brand: Enraf-Nonius

Model: Halogen IR Radiator IRS

Type: User manual

Operating Manual

Index 4-EN

Page 1 of 15

Issue date: 2017-01-06

Infrared spot IRS

Content

SAFETY SYMBOLS .................................................................................................................................... 2

GENERAL INFORMATION ...................................................................................................................... 2

APPROPRIATION ....................................................................................................................................... 3

3.1

NDICATIONS

............................................................................................................................................ 3

3.2

ONTRAINDICATIONS

.............................................................................................................................. 3

POWER SUPPLY ......................................................................................................................................... 4

OPERATIONAL SAFETY .......................................................................................................................... 4

ENVIRONMENTAL CONDITIONS .......................................................................................................... 4

6.1

TORAGE

................................................................................................................................................. 4

6.2

PERATING

ONDITIONS

......................................................................................................................... 4

ACCESSORIES ............................................................................................................................................ 5

INFRARED LAMPS ..................................................................................................................................... 5

BEFORE THE USE ...................................................................................................................................... 5

STARTING UP ......................................................................................................................................... 6

10.1

WITCHING

-O

N OF THE

EVICE

............................................................................................................... 6

10.2

ETTING OF THE

IMER

............................................................................................................................ 6

SAFETY INSTALLATION ..................................................................................................................... 7

REGULAR TASKS ................................................................................................................................... 8

12.1

EGULAR

AFETY

HECKS

...................................................................................................................... 8

12.2

IMIT

ALUES FOR THE

NNUAL

AFETY

HECK

................................................................................... 8

12.3

ARE AND

AINTENANCE

....................................................................................................................... 8

12.4

URFACE

ISINFECTION

........................................................................................................................... 8

REPLACEMENT OF DEFECTIVE INFRARED LAMPS .................................................................. 9

SERVICE ................................................................................................................................................. 10

LIMITED GUARANTEE ...................................................................................................................... 10

MANUFACTURER ................................................................................................................................ 11

TECHNICAL DATA .............................................................................................................................. 11

17.1

ECHNICAL

ATA

.................................................................................................................................. 11

17.2

HOTOBIOLOGICAL

AFETY

................................................................................................................... 11

17.3

TANDARDS AND

IRECTIVES

............................................................................................................... 14

17.4

LECTRICAL

AFETY

LASSIFICATION

.................................................................................................. 14

INFRARED RADIATION ..................................................................................................................... 14

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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Page 4 of 15

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!

Operating Manual

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Page 5 of 15

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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Index 4-EN

Page 7 of 15

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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Index 4-EN

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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Index 4-EN

Page 10 of 15

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

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.

Operating Manual

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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.

Operating Manual

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Page 13 of 15

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.

Operating Manual

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Page 14 of 15

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

not applicable

Was the wall- or ceiling-arm mounted

according to the Operating Manual of the

manufacturer using appropriate installation

material?

yes

not applicable

Is the spring inside the wall- or ceiling-arm

adjusted to the weight of the device?

yes

not applicable

Can the minimum safety distance of 60 cm

between device and patient be maintained? yes

Does the electric installation have a residual

current protective device? yes

Does the residual current protective device

work properly? yes

Is the power supply fused with 16 A

maximum? yes

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, ______________________________________

Enraf-Nonius Halogen IR Radiator IRS User manual

Enraf-Nonius Halogen IR Radiator IRS User manual

Enraf-Nonius Halogen IR Radiator IRS User manual

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