Operating Manual
Index 3-EN
Page 1 of 13
Issue date: 2017-01-06
Infrared spots
TGS 3.2 and TGS 6.2
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
START 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 ................................................................................................................................... 7
12.1
R
EGULAR
S
AFETY
C
HECKS
...................................................................................................................... 7
12.2
L
IMIT
V
ALUES FOR THE
A
NNUAL
S
AFETY
C
HECK
................................................................................... 7
12.3
C
ARE AND
M
AINTENANCE
....................................................................................................................... 7
12.4
S
URFACE
D
ISINFECTION
........................................................................................................................... 7
13
REPLACEMENT OF DEFECTIVE INFRARED LAMPS .................................................................. 8
14
SERVICE ................................................................................................................................................... 8
15
LIMITED GUARANTEE ........................................................................................................................ 9
16
MANUFACTURER .................................................................................................................................. 9
17
TECHNICAL DATA .............................................................................................................................. 10
17.1
T
ECHNICAL
D
ATA
.................................................................................................................................. 10
17.2
S
TANDARDS AND
D
IRECTIVES
............................................................................................................... 10
17.3
E
LECTRICAL
S
AFETY
C
LASSIFICATION
.................................................................................................. 12
18
INFRARED RADIATION ..................................................................................................................... 12
19
INSTALLATION CHECKLIST ........................................................................................................... 13
Operating Manual
Index 3-EN
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.
Operating Manual
Index 3-EN
Page 3 of 13
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
Operating Manual
Index 3-EN
Page 4 of 13
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!
Operating Manual
Index 3-EN
Page 5 of 13
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.
Operating Manual
Index 3-EN
Page 6 of 13
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
Separate switches
- +
START/STOP
Operating Manual
Index 3-EN
Page 7 of 13
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
Operating Manual
Index 3-EN
Page 8 of 13
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.
.
Operating Manual
Index 3-EN
Page 9 of 13
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
Operating Manual
Index 3-EN
Page 10 of 13
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
Operating Manual
Index 3-EN
Page 11 of 13
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.
Operating Manual
Index 3-EN
Page 12 of 13
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)
Operating Manual
Index 3-EN
Page 13 of 13
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
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 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, ______________________________________
/