Enraf-Nonius IR Radiator TGS 3.2/6.2 User manual

Brand: Enraf-Nonius

Model: IR Radiator TGS 3.2/6.2

Type: User manual

Operating Manual

Index 3-EN

Page 1 of 13

Issue date: 2017-01-06

Infrared spots

TGS 3.2 and TGS 6.2

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

START UP ................................................................................................................................................. 6

10.1

WITCHING

-O

N OF THE

EVICE

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

10.2

ETTING OF THE

IMER

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

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

REGULAR TASKS ................................................................................................................................... 7

12.1

EGULAR

AFETY

HECKS

...................................................................................................................... 7

12.2

IMIT

ALUES FOR THE

NNUAL

AFETY

HECK

................................................................................... 7

12.3

ARE AND

AINTENANCE

....................................................................................................................... 7

12.4

URFACE

ISINFECTION

........................................................................................................................... 7

REPLACEMENT OF DEFECTIVE INFRARED LAMPS .................................................................. 8

SERVICE ................................................................................................................................................... 8

LIMITED GUARANTEE ........................................................................................................................ 9

MANUFACTURER .................................................................................................................................. 9

TECHNICAL DATA .............................................................................................................................. 10

17.1

ECHNICAL

ATA

.................................................................................................................................. 10

17.2

TANDARDS AND

IRECTIVES

............................................................................................................... 10

17.3

LECTRICAL

AFETY

LASSIFICATION

.................................................................................................. 12

INFRARED RADIATION ..................................................................................................................... 12

INSTALLATION CHECKLIST ........................................................................................................... 13

Operating Manual

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Page 2 of 13

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.

2 General Information

The infrared spots 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 can be maintained 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

manufacturer in original. It is the base for the limited warranty.

The infrared spot may only be handled and positioned by its sidebars.

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Attention: The surfaces of the device will be hot during operation!

3 Appropriation

The infrared spots TGS 3.2 and TGS 6.2 are 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 pain

• Muscular rigidity and ankylosis (exception: acutely inflamed processes)

• Circulatory disorder

• Deep-rooted/engrained disorders of the lumbar spine

• Hematoma

• Preparation of other therapeutic actions, i.e. massages

• Treatment of chronic inflammations beyond an acute attack

3.2 Contraindications

• Severe heart diseases

• Acute inflammations

• Coagulopathy

• Thrombosis

• Severe diabetes mellitus

• Thyrotoxic crisis

• Terminal renal insufficiency

• Hemolytic anemia

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4 Power Supply

The standard power supply for infrared spots TGS 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 TGS from the power supply:

• For a complete disconnection of a wall mounted or stand based infrared

spot TGS 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 TGS has to

be performed and documented.

6 Environmental Conditions

6.1 Storage

The infrared spots TGS have 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 spots TGS 3.2 and TGS 6.2 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 spots TGS 3.2 and

TGS 6.2:

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 instruction of the producer has to be followed.

8 Infrared Lamps

The following therapeutic infrared reflector lamps are standard for TGS:

• Philips Infrared, PAR 38, 150 W, 230 V, E 27

The following replacement lamps are allowed:

• Philips Infrared, PAR 38, 150 W, 230 V, E 27

• Osram Theratherm, PAR 38, 150 W, 230 V, E 27

Other lamps, especially lamps for veterinary purposes, are not allowed!

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 300 hours. The

supervision of the operating time is subject to the user.

Please follow the advices in chapter 13: Replacement of Defective Infrared Lamps.

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 TGS 3.2 or TGS 6.2 the operating manual has

to be read carefully. It has to be kept nearby the device. Before operating the

TGS 3.2 or TGS 6.2, 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.

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Attention: The minimum distance between device and patient is 60 cm!

Caution: Danger of burning!

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!

Before every operation all lamps have to be checked for their firm fit in the socket

and their centric position in the cover plate. If necessary, the lamps have to be fixed

or their position has to be adjusted manually.

10 Start Up

10.1 Switching-On of the Device

The infrared spots TGS 3.2 and TGS 6.2 are switched on by the main switch, which

is located on the switch board of the device (picture). 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 spots TGS 3.2 and TGS 6.2 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). The treatment

period is started by pressing the button “START/STOP”. The running of the timer is

indicated by the blinking of the colon in the display. Pressing the “START/STOP”

button before the running out of the timer interrupts the treatment (indicated by the

permanent glowing of the colon). Pressing the “START/STOP” 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, which can be stopped by pressing any button on the

timer.

Main switch

Separate switches

- +

START/STOP

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The timer of the TGS 3.2 or TGS 6.2 is equipped with a repeat-function. After the

expiring of the treatment period (indicated by an acoustic signal), press the

“START/STOP” button twice. The acoustic signal stops and the display shows the

previous time setting. Press the “START/STOP” button again and a new treatment

period starts.

11 Safety Installation

In case of a short cut or on overload the infrared spot TGS is disconnected from the

power supply by two device fuses. They are located on the up side of the device.

Before replacing a fuse, the power plug of the infrared spot has to be pulled. Blown

fuses may only be replaced by fuses of exactly the same type (see chapter 17.1:

Technical Data).

12 Regular Tasks

12.1 Regular Safety Checks

For the infrared spots TGS 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 spots the national rules and guidelines

concerning the operation of devices in health care facilities have to be obeyed.

The Infrared spots TGS 3.2 and TGS 6.2 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

has been disconnected. The high surface temperature of the infrared

lamps during and after the treatment may cause serious burning.

Before replacing a defective infrared lamp the safety grid has to be removed by

unscrewing the fixing screws. Defective infrared lamps may only be replaced by

infrared lamps of the same type, size and power (see chapter 17.1 Technical Data

)

After the replacement the safety grid has to be fixed again. Operation of the device

without safety grid is not permitted.

Note: Infrared lamps are wear parts. They are not subject to guarantee!

14 Service

Apart from regular cleaning infrared spots TGS 3.2 and TGS 6.2 are maintenance-

free, if it is verifiably mounted and operated according to this manual. 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 repairs.

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15 Limited Guarantee

The function of this device is guaranteed by Enraf-Nonius BV, The Netherlands, 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, The Netherlands 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!

16 Manufacturer

The

Infrared spots TGS 3.2 and TGS 6.2 are manufactured for Enraf-Nonius BV by:

Heuser Apparatebau GmbH

Am Schlagbaum 10

42781 Haan

Germany

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17 Technical Data

17.1 Technical Data

TGS 3.2

TGS 6.2

Art.nr. 3441.801 3441.802

Power supply * 220-240V / 50/60Hz 220-240V / 50/60Hz

Number of lamps 3 6

Heating capacity per light bulb 150 W 150 W

Max. heating capacity 450 W 900 W

Lamps individually switchable Yes Yes

Timer Max. 60 min. Max. 60 min

Device fuses

IEC 60127-2/4 DIN VDE 820

6,3x32 5 A

fast acting 6,3x32 5 A

fast acting

Overall dimensions (LxWxH) 710x330x160 mm 710x490x160 mm

Net weight 10,4 kg 9,8 kg

Shipping weight 13 kg 13,3 kg

Packing dimensions (LxWxH) 820 x 480 x 465 mm 820 x 620 x 465 mm

Medical Device Class Class IIa Class IIa

power supplied via the support system (optional)

17.2 Standards and Directives

All infrared spots TGS comply with the safety requirements of the following

standards, laws and directives:

• German Medical Devices Act

• MDD 93/42/EWG, 2007 – Medical Device Directive

• 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

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Guidelines and manufacturer’s declaration - electromagnetic immunity

The infrared spots TGS 3.2 and TGS 6.2 are intended for use in the electromagnetic environment specified

below. The customer or the user should ensure that the infrared spots TGS 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 TGS is used exceeds the applicable RF compliance level above, the

infrared spots TGS 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

TGS.

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 TGS 3.2 and TGS 6.2

Infrared spots TGS 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 TGS 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.

17.3 Electrical Safety Classification

The infrared spots TGS are 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 manufacturer of the

infrared lamp)

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19 Installation Checklist

Product Serial Number Date of Installation

Infrared spot TGS

Date, Signature

of the

Technician

Was the stand installed according to the

Operating 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 TGS 3.2 or

TGS 6.2 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 IR Radiator TGS 3.2/6.2 User manual

Enraf-Nonius IR Radiator TGS 3.2/6.2 User manual

Enraf-Nonius IR Radiator TGS 3.2/6.2 User manual

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