Nufer Medical CERATHERM 600-3 User manual

14.171.C_GA_Ceratherm_600_3_EN.docx
CERATHERM 600-3
Radiant Heater
Instruction Manual
FOR THE OPERATORS AND THOSE RESPONSIBLE FOR THE CARE
AND MAINTENANCE OF THIS UNIT:
•Read through this instruction manual thoroughly before using the
unit.
•Keep this instruction manual in a place where it can be referred to
whenever needed.

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Instruction Manual CERATHERM 600-3
Contents
1. INTRODUCTION............................................................................................................. 4
1.1 G ENERAL ....................................................................................................................4
1.2 P URPOSE ....................................................................................................................4
1.3 E LECTROMAGNETIC E MISSIONS AND E LECTROMAGNETIC C OMPATIBILITY .........................4
1.4 S COPE OF D ELIVERY ...................................................................................................5
1.5 M AINTENANCE P ROCEDURE .........................................................................................5
1.6 S UPPORT ....................................................................................................................5
2. DEFINITIONS AND SYMBOLS ...................................................................................... 6
2.1 D EFINITIONS ...............................................................................................................6
2.2 S YMBOLS ....................................................................................................................6
3. SAFETY GUIDELINES ................................................................................................... 9
4. GENERAL DESCRIPTION ........................................................................................... 13
5. ASSEMBLY .................................................................................................................. 13
5.1 M INIMUM C LEARANCE ................................................................................................13
6. PRODUCT DESCRIPTION ........................................................................................... 14
6.1 D ESCRIPTION OF P ARTS .............................................................................................15
7. OPERATION ................................................................................................................. 17
7.1 M ASTER SWITCH ........................................................................................................17
7.2 C ONTROL E LEMENTS ON THE F RONT ...........................................................................18
8. COMMISSIONING ........................................................................................................ 19
8.1 A DJUSTING THE H EAT O UTPUT ...................................................................................19
8.2 P RACTICAL E XAMPLES OF O UTPUT L EVEL S ETTINGS ....................................................20
8.3 C HECKING THE S ET O UTPUT ......................................................................................20
8.4 A LARM M ONITORING ..................................................................................................20
9. LED LIGHTING ............................................................................................................. 21
9.1 O PERATION ...............................................................................................................21
9.2 C HANGING THE B RIGHTNESS V ALUES ..........................................................................21
10. TROUBLESHOOTING .................................................................................................. 22
11. TESTING THE CONTROL ELEMENTS........................................................................ 23
12. CLEANING/DISINFECTION ......................................................................................... 24
12.1 G ENERAL INFORMATION .............................................................................................24
13. WARRANTY ................................................................................................................. 25
13.1 W ARRANTY P ERIOD ...................................................................................................25
13.2 W ARRANTY R ESTRICTIONS .........................................................................................25
14. DISPOSING OF THE UNIT ........................................................................................... 25
15. SPECIFICATIONS*....................................................................................................... 26

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Instruction Manual CERATHERM 600-3
16. ACCESSORIES ............................................................................................................ 27
16.1 W ALL MOUNT , FIXED , NON - PIVOTING ( OPTIONAL ) .....................................................................................27
16.2 W ALL MOUNT WITH DOUBLE - JOINT ARM ( OPTIONAL ) .................................................................................28
16.3 W ALL MOUNT WITH DOUBLE - JOINT ARM , LONG , WITH HEIGHT ADJUSTMENT ( OPTIONAL )..............................28
16.4 C EILING MOUNT WITH DOUBLE - JOINT ARM , LONG , WITH HEIGHT ADJUSTMENT ( OPTIONAL )...........................29
16.5 M OBILE STAND , WITH HEIGHT ADJUSTMENT ( OPTIONAL )............................................................................29
17. REPAIR REQUEST FORM ........................................................................................... 31

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Instruction Manual CERATHERM 600-3
1. Introduction
1.1 General
This instruction manual describes the intended use, operation, specifications, care and
maintenance of the CERATHERM 600-3 radiant heater.
Read through this instruction manual carefully and familiarise yourself with the content before
operating the CERATHERM 600-3. To ensure that the unit is used safely, follow the
operating guidelines and explanations that are given in this instruction manual. The
CERATHERM 600-3 must only be operated by persons who have been properly trained and
instructed, under the supervision of a skilled medical specialist who is familiar with the
currently known risks and benefits of using a radiant heater.
NUFER MEDICAL is in no way responsible for errors or accidents that are the result of non-
compliance with the instructions on operation, care, maintenance and any other content
given in this instruction manual. The same applies for repair work performed on the unit if
such work is performed by unauthorised persons or if unapproved original components are
used.
The CERATHERM 600-3 must only be used for its intended purpose as per chapter 1.2 of
this instruction manual.
Keep this instruction manual in a place where it can be referred to whenever needed. In the
event of technical problems or malfunctions, please inform your local NUFER MEDICAL
sales partner immediately. If you do not understand the content of this instruction manual,
contact your local NUFER MEDICAL sales partner for more information.
1.2 Purpose
The CERATHERM 600-3 radiant heater is designed to preheat examination and baby
changing tables and to maintain the body temperature of new-borns, children and adults.
1.3 Electromagnetic Emissions and Electromagnetic Compatibility
The CERATHERM 600-3 radiant heater meets all the requirements of the EN 60601-1-2
industrial standard.
Accordingly, the unit’s electromagnetic emissions are very low and cannot impair the
functioning of electronic equipment located in the immediate vicinity.
Ensure that any electronic equipment that is used in the vicinity of the CERATHERM 600-3
radiant heater also meets the requirements of EN 60601-1-2 . Equipment with electromagnetic
emissions that are too high can impair the radiant heater’s ability to function safely.
Do not use any wireless communication devices within 5 metres of the radiant heater. The
mains power supply to which the CERATHERM 600-3 radiant heater is connected must meet
the legal and technical requirements for a hospital or clinic mains power supply in terms of
dielectric strength, frequency stability and pulse spikes etc. Ensure that the radiant heater is
not exposed to electrostatic discharge.

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Instruction Manual CERATHERM 600-3
1.4 Scope of Delivery
The CERATHERM 600-3 radiant heater is supplied with a mains cable, instruction manual
and declaration of conformity. Approved accessories are described in chapter 16.
1.5 Maintenance Procedure
No particular maintenance is required for the CERATHERM 600-3 radiant heater, except for
the annual safety check described in chapter 20 of the CERATHERM 600-3 service manual.
The unit does not have any special wear parts.
1.6 Support
Maintenance for the CERATHERM 600-3 radiant heater must only be performed by persons
who have been authorised by NUFER MEDICAL or the local trained sales partner. If repair
work is required, the unit must be returned to the NUFER MEDICAL sales partner located in
your country, along with a completed ‘Repair Request Form’ (see chapter 17). Further
information is available from the customer service department of:
NUFER MEDICAL AG
Morgenstrasse 148
CH-3018 Bern / Switzerland
Tel. [phone]
Fax [phone]
[email protected]
www.nufer-medical.ch

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Instruction Manual CERATHERM 600-3
2. Definitions and Symbols
2.1 Definitions
Please take time to familiarise yourself with the definitions given below before you use the
radiant heater. The following expressions are used in this instruction manual:
Expression Symbol Description
Warning:
This expression is used in the text to draw your attention to
hazardous conditions in connection to the operation, cleaning
or maintenance of the unit if there is a risk of injury or death
for the operator or the patient.
Caution:
This expression is used in the text to draw your attention to a
process that must be followed exactly to avoid injury to the
user or patient, or damage to the unit.
Note:
This expression is used in the text to draw your attention to
processes or conditions that you could otherwise overlook or
misunderstand.
2.2 Symbols
Please take time to familiarise yourself with the symbols given below before you use the
radiant heater. This lists includes all the symbols that are displayed on the unit to aid
operation or as a warning or note:
Symbol Explanation
Ensure that the instruction manual is observed.
Text with
border

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Instruction Manual CERATHERM 600-3
Dangerous voltage.
Warning sign: Refer to the relevant section of the instruction manual for
further information.
Warning sign: Hot surfaces -> Risk of burns.
Warning sign: Ensure that there is a clearance of at least 80 cm
between the reclining surface and the bottom edge of the heater head.
There must be a clearance of at least 50 cm between the ceiling/false
ceiling and the top edge of the heater head -> Risk of fire and risk of
burns.
Warning sign: Do not reach into the heater head -> Risk of burns.
Warning sign: Do not place any objects on the protective grille
-> Risk of fire.

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Instruction Manual CERATHERM 600-3
Operation: Switches unit on and off (observe chap. 8)
Display: The unit’s operating mode (observe chap. 8)
Operation: Alarm confirmation (observe chap. 8)
Display: Alarm (observe chap. 8 and safety guidelines in chap. 2)
Operation: Preset heat level 1 (20% output)
Display: Heat level 1 active
Operation: Preset heat level 2 (50% output)
Display: Heat level 2 active
Operation: Preset heat level 3 (75% output)
Display: Heat level 3 active
Operation: Preset heat level 4 (98% output)
Display: Heat level 4 active
Display: Heating active (observe chap. 8.3)
Operation: Lighting 20% on/off (observe chap. 9)
Display: None
Operation: Lighting 100% on/off (observe chap. 9)
Display: None
Operation: Master switch (supply voltage on/off, see chap. 7)
Display: Mains supply on
Potential equalisation connection.
If the unit is used in a room that corresponds to Category 3 or 4 under
Swiss Low-Voltage Installation Standard NIN / 7.10, this connection must
be connected to the room’s potential equalisation connection.
1
2
3
4

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Instruction Manual CERATHERM 600-3
0123
The unit meets the requirements of EU Directive 93/42/EEC/Annex II.
Monitoring is provided by TÜV SÜD Product Service GmbH, 80339
München.
The unit must be disposed of in accordance with EU Directive
2002/96/EC. Get in touch with your allocated NUFER MEDICAL sales
partner.
3. Safety guidelines
Please ensure that the following safety guidelines are observed. The guidelines must be
observed during the installation and use of the radiant heater:
The radiant heater must only be connected to a power socket with a
protective earth connection.
Connection values of the power socket:
230 V AC +/−10%, 50–60 Hz, 6 A.
The unit is fitted with a ceramic heater that is sensitive to knocks and blows.
Ensure that the unit is not exposed to any strong knocks or blows.
Ensure that the wall mount is fastened into solid masonry and that suitable
wall-plug screws are used. Lightweight walls must be appropriately reinforced
in the wall-mount area. The client’s specialist personnel are responsible
for the secure fastening of the radiant heater.
-> Risk to user and patient safety.
Parts must neither be removed from or attached to the radiant heater and no
other modifications must be made -> Risk to user and patient safety.
Ensure that there is a clearance of at least 80 cm between the reclining
surface and the bottom edge of the heater head; there must be a clearance of
at least 50 cm between the ceiling/false ceiling and the top edge of the heater
head -> Risk of fire, risk to user and patient safety.

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Instruction Manual CERATHERM 600-3
The radiant heater may increase patient water loss unnoticeably. It is vital that
the patient is constantly monitored by the care staff -> Risk to patient safety.
Changing the underlay (using dark cloths, heating pads etc.) can result in
higher temperatures on the reclining surface and affect the patient’s body
temperature -> Risk to patient safety.
Do not touch the patient and the radiant heater simultaneously. Possible
potential differences between the unit and the care surface may place patient
safety at risk.
The radiant heater always functions as a manual radiant heater. No patient
information is transmitted to the unit during use. The care personnel are
therefore responsible for the patient’s condition at all times.
Ensure that no liquids enter the unit. If liquids do enter the inside of the unit,
shut the unit down immediately and have it checked by an authorised
person and repaired as required. A safety check must be performed before the
unit can be used again.
The radiant heater is fitted with an LED bulb to light up the care surface / the
patient’s body. Ensure that neither user nor patient look directly into the bulb.
External conditions can affect the radiant heater’s performance. Do not
operate the unit at temperatures below +5°C or over +30°C. The relative
humidity should not exceed 90%. Ensure that no condensation forms on the
unit.
External conditions (such as temperature and drafts) and other equipment in
the vicinity (e.g. phototherapy equipment) can affect the patient’s body
temperature.

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Instruction Manual CERATHERM 600-3
Ensure that the radiant heater is positioned above the centre of the care
surface. Do not operate the radiant heater at a right angle to the care
surface.
The radiant heater must only be used in a horizontal position with heat
radiating downwards -> Risk of fire, risk to user and patient safety.
The radiant heater must not be used in environments that are at risk of fire
or explosion, i.e. in the immediate vicinity of anaesthetic gases or other highly
flammable gases, liquids or materials -> Risk of fire or risk of explosion.
The openings in the housing on the top side of the heater head must be kept
clear at all times to guarantee sufficient air circulation. Do not lay any cloths,
objects or flammable substances on the topside of the heater head -> Risk of
fire.
Never touch the protective grille on the top of the unit or the reflector and
heater on the underside of the unit when the heater head is in use.
-> Risk of burns, risk to user safety.
The radiant heater must only be operated by persons who have been properly
trained and instructed, under the supervision of a skilled medical specialist
who is familiar with the currently known risks and benefits of using a radiant
heater -> Risk to user and patient safety.
The patient must never be left unattended beneath the radiant heater while it
is switched on -> Risk to patient safety.
It is vital that care staff independently monitor the patient’s temperature
-> Risk to patient safety.

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Instruction Manual CERATHERM 600-3
When the housing of the heater head is removed, there is a risk of electric
shock. The unit’s mains cable must always be disconnected before the
housing of the heater head is opened.
When the heater head has been on for 15 minutes, an acoustic and visual
alarm is activated. The alarm can be delayed for a further 15 minutes by
pressing the button.
When the radiant heater is being used above infant incubators or heating beds,
it must be ensured that there is sufficient clearance between the bottom edge
of the heater head and any heat-sensitive materials such as Plexiglas or
acrylic glass. Ensure that there is at least 80 cm clearance at all times. Set the
heat output no higher than level 3 (75%).
The radiant heater must only be operated with original accessories that
NUFER MEDICAL has expressly approved for use with the CERATHERM 600-
3. Observe the relevant information in chapter 16.
In the event of a technical alarm shut the unit down immediately and
have it checked by an authorised person and repaired as required. A safety
check must be performed before the unit can be used again.
Before any cleaning or disinfection is performed, ensure that the unit is shut
down and disconnected from the mains supply. Observe the relevant
information in chapter 12.
Repair and maintenance work must only be performed on the radiant heater by
authorised personnel. Only components that NUFER MEDICAL has expressly
approved for use with the CERATHERM 600-3 may be used.
After the unit is decommissioned, it must be disposed of correctly in
accordance with EU Directive 2002/96/EC. Get in touch with your allocated
NUFER MEDICAL sales partner.

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Instruction Manual CERATHERM 600-3
4. General Description
The built-in ceramic heater has very good radiation properties and generates invisible
infrared radiation of around 3 µm. This radiation spectrum is absorbed very effectively by the
skin and causes no harm to the patient’s eyes.
5. Assembly
5.1 Minimum Clearance
After you have removed the packaging, compare the
unit data on the specification plate with the electrical
connection data. Electricity is supplied via a 220–
240 V AC 50/60 Hz mains socket with a connection
value of 6 A.
Ensure that the wall- and ceiling mount (fixed or
mobile) is fastened into solid masonry (brickwork,
sand-lime brick or concrete) and that suitable wall-
plug screws are used.
Mount the heater head:
•with a clearance of at least 80 cm and no more
than 100 cm between the reclining surface and
the bottom edge of the heater head.
•with a clearance of at least 50 cm between the
ceiling/false ceiling and the top edge of the
heater head.
Figure 1
Ensure that there is always a clearance of at least 80 cm between the
reclining surface and the bottom edge of the heater head.
Ensure that there is always a clearance of at least 50 cm between the
ceiling/false ceiling and the top edge of the heater head.
The thickness of the underlay must also be taken into account.
Neglecting to do so may result in burns or fire.
Min.50 cm.

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Instruction Manual CERATHERM 600-3
6. Product description
The CERATHERM 600-3 radiant heater has four programmable heat output levels, which
can be selected directly by pressing the buttons [heat level 1-4].
The default settings for the heat levels are 20, 50, 75 and 98%. All levels can be adjusted by
a specialist upon request (within certain limits, e.g. safety level no larger than 20%).
All heat outputs above the safety level are monitored with a 15-minute reminder alarm. This
alarm is intended as an aid for the user only; it does not relieve the user of a duty to
supervise the patient.
An indicator lamp is built in to monitor actual heat output.
The patient is lit by a modern high-power LED lamp, which has the following advantages over
a halogen lamp:
•More natural colour temperature (4000°K)
•No UV- or IR-radiation component
•Longer service life
•Lower energy consumption
Observe the relevant information in chapter 15 (Lighting)!
The light can be set to one of two brightness levels (default setting: 20% and 100%). These
values can be set by a specialist in 10% increments.
The lighting switches on and off gradually, i.e. with a smooth transition, so it has a less
disruptive impact on the patient.
In standby mode, the lighting has an automatic shut-off function. If the lighting is switched on
and no lighting button has been pressed for 20 minutes, the lighting switches off
automatically. This function can be disabled as required.
The installed software version can be displayed as necessary.
The setting of the relevant parameters is described in chapters 18 and 19 of the
CERATHERM 600-3 service manual.

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Instruction Manual CERATHERM 600-3
6.1 Description of Parts
Underside:
Figure 2
No.
Designation Function
12 Reflector Radiates heat
13 Hand grip Adjusts the radiant heater
14 LED light Lights the patient -> Observe the relevant information in chapter 15!
15 Ceramic heating element Generates heat
Table 1
12
15
14
13

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Instruction Manual CERATHERM 600-3
Topside:
Figure 3
No.
Designation Function
16 Heater head mount Fastens the heater head to the ceiling/wall and trolley
17 Specification plate Displays serial number, mains connection, fuse data and various
symbols
18 Unit socket Connects to 220–240 V / 50 Hz power supply
19 Fuses Main fuses 2 × 3.15 AT
20 Potential equalisation connection Connects to room’s potential connection (room categories 3 and 4)
21 Protective grille Functions as heat guard and provides ventilation
Table 2
21
16
17
18
20
19

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Instruction Manual CERATHERM 600-3
7. Operation
Operation of the CERATHERM 600-3 radiant heater has been kept deliberately
straightforward. Use of the unit is largely self-explanatory.
7.1 Master switch
The unit’s ON/OFF switch is located on the rear side. This is normally switched on at all
times. The heater head itself is switched on/off with ON/OFF button [7] on the front side. If
this button is used to switch off the unit, it switches to energy-saving standby mode.
Note
If the unit is switched off at
the mains switch while it is not in standby
mode (i.e. while heat level 1–4 is active), the mains failure alarm sounds.
The unit cannot differentiate between mains failure and being switched off
in such a case. Pressing alarm confirmation button [6] during a mains
failure alarm silences the buzzer. The alarm LED will continue to flash until
the supply voltage returns or the energy storage unit is empty (min. 15
min).
Figure 4
No. Designation Function
1 Master switch Disconnects the radiant heater from the mains supply
22 Fuse holder Contains two 3.15 AT microfuses (20 × 5 mm)
Table 3
1
22

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Instruction Manual CERATHERM 600-3
7.2 Control Elements on the Front
1 2 3 4
CERATHERM 600-3
Figure 5
No.
Designation
Function
2 Illuminated button: Heat level 1 Sets heat level 1 with 20%
1
3 Illuminated button: Heat level 2 Sets heat level 2 with 50%
4 Illuminated button: Heat level 3 Sets heat level 3 with 75%
5 Illuminated button: Heat level 4 Sets heat level 4 with 98%
2
6 Illuminated button: Alarm
confirmation Resets an alarm
7 Illuminated button: ON/OFF On: Level 1 is activated / Off: Heater head on standby
8 Button: LED 20% Switches LED lighting on and off, at 20%
9 Button: LED 100% Switches LED lighting on and off, at 100%
10 LED: Heat output indicator Displays the heat output via differing blink rates
11 Warning: Read manual. Read through the manual before commissioning.
Table 4
Button illumination:
•Buttons 2–7 are illuminated.
•Buttons 8 and 9 are not illuminated.
Note
When the buttons are referred to in the text below, the number will be
given in square brackets [ ].
1
Given output corresponds to default settings.
2
Cannot be any higher than 98% because of the internal hardware monitoring circuit.
[2]
[3]
[4]
[5]
[6]
[7]
[8]
[9]
[10]
[11]

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Instruction Manual CERATHERM 600-3
1234
CERATHERM 600-3
8. Commissioning
When the radiant heater is switched on via the mains switch on the rear side, the unit is
initially in standby mode.
1. If you require additional light, switch on the LED lamp with a low [8] or high [9]
brightness level.
2. Switch on the heater head by pressing on/off button [7]. The heat output is
automatically set to heat level 1 (20%) to keep the reclining surface warm. (The
reclining surface is pre-warmed after roughly 5–10 minutes.)
3. If greater output is desired as per table 4, select one of the heat levels 2–4 directly
[3,4,5]. The yellow heat output indicator LED [10] displays whether the radiant heater
is providing the desired output.
4. If heat level 2, 3 or 4 is selected, a reminder alarm will sound after 15 minutes. If this
alarm is not confirmed with alarm button [6] within 8 seconds, output is reduced to the
safety level (20%) for safety reasons. If the alarm is confirmed within 8 seconds, the
heater will operate for a further 15 minutes, at the previous heat output.
5. The heater head can be switched to standby mode by pressing the green on/off button
[7].
6. Once the controls have been set to standby mode via on/off button [7] on the front, the
unit can be fully shut down by pressing mains switch [1] on the rear side.
8.1 Adjusting the Heat Output
Figure 6
[2]
[3]
[4]
[5]
[10]

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Instruction Manual CERATHERM 600-3
1
2
3
4
The four-level controls allow heat output to be perfectly adjusted to suit particular
requirements. The following standard values are set by default:
Level 1 = 20% Level 2 = 50 % Level 3 = 75 % Level 4 = 98 %
Note
The safety level (level 1) can be set no higher than 20%.
For technical reasons, level 4 cannot be set above 98%.
The heat output of the individual levels 1–4 can be customised for particular applications by
authorised maintenance staff, for example:
Level 1 = max. 20% Level 2 = 40% Level 3 = 60% Level 4 = 80%
8.2 Practical Examples of Output Level Settings
Level 1: e.g. for pre-heating the reclining surface or keeping it warm, and for continuous operation
Phase 2: e.g. for normal operation for a baby changing or examination table
Phase 3: e.g. for additional heat during resuscitation, in the delivery room or operating
theatre
Phase 4: e.g. for increased heating requirements in the operating theatre, for anaesthesia
or in the recovery room
8.3 Checking the Set Output
The set output is displayed via heat output indicator LED [10]. The LED signals the activation
of the heating element. If the LED is flashing, the heater is active. If the LED is dark, the heat
element is switched off. One heat period corresponds to roughly 2 seconds. If a 50% output
has been selected, for example, the LED lights up for roughly 1 second and is out for roughly
1 second. The LED lights up longer as output increases.
8.4 Alarm Monitoring
If the unit has been set to a heat output above level 1 for 15 minutes, a reminder alarm is
activated. The alarm signal is both acoustic (buzzer sounds in five short intervals) and visual
(alarm LED flashes red).
If alarm confirmation button [6] is pressed within 8 seconds of the alarm beginning, the alarm
is deactivated for the next 15 minutes and the heater head continues operation at the
previous heat output. If no alarm confirmation is given within this 8-second period, heat
output is reduced to 20% for safety reasons. The red alarm LED displays this status visually
until the heater head is either switched off with on/off button [7] or the alarm is confirmed with