Dräger Babyleo TN500 User manual

Instructions for use
Babyleo TN500
WARNING
To properly use this medical device,
read and comply with these
instructions for use.
IncuWarmer
Software 1.0n

2 Instructions for use Babyleo TN500 SW 1.0n
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Instructions for use Babyleo TN500 SW 1.0n 3
Contents
Contents
1 Information about this document ........................................................... 6
1.1 Typographical conventions ............................................................. 6
1.2 Use of terms ................................................................................... 6
1.3 Illustrations...................................................................................... 6
1.4 Trademarks..................................................................................... 7
2 Safety-related information ...................................................................... 8
2.1 Intended use ................................................................................... 8
2.2 Indications....................................................................................... 8
2.3 Contraindications ............................................................................ 8
2.4 Environments of use ....................................................................... 8
2.5 Essential performance characteristics ............................................ 9
2.6 Target groups ................................................................................. 9
2.7 Information on safety instructions and precautionary statements... 10
2.8 Basic safety instructions ................................................................. 11
2.9 Electrical safety............................................................................... 13
2.10 Use of oxygen................................................................................. 14
2.11 Explosion protection ....................................................................... 15
2.12 Mechanical safety ........................................................................... 15
2.13 Thermal radiation and fire prevention ............................................. 18
2.14 Therapy and applications................................................................ 19
2.15 Safety during cleaning and service................................................. 22
2.16 Safety instructions for accessories ................................................. 23
3 Product description ................................................................................. 24
3.1 Structure and function..................................................................... 24
3.2 Screen views .................................................................................. 32
3.3 Range of functions.......................................................................... 41
4 Operating concept ................................................................................... 45
4.1 Display unit ..................................................................................... 45
4.2 Adjusting the device height............................................................. 48
4.3 Adjusting the mattress tray ............................................................. 49
4.4 Hood ............................................................................................... 51
4.5 Hand ports and access panels ....................................................... 52
4.6 Locking and unlocking functions..................................................... 55
5 Assembly and preparation ...................................................................... 56
5.1 Maximum load ................................................................................ 56
5.2 Nurse call........................................................................................ 57
5.3 Adjusting the gas cylinder holder and connecting the oxygen
cylinder 58
5.4 Establishing potential equalization.................................................. 62
5.5 MEDIBUS connection for data transfer........................................... 62

4 Instructions for use Babyleo TN500 SW 1.0n
Contents
6 Operation .................................................................................................. 63
6.1 Checking for operational readiness ................................................ 63
6.2 Switching on the device .................................................................. 64
6.3 Switching off the device .................................................................. 67
6.4 Operating modes ............................................................................ 68
6.5 Incubator operation......................................................................... 69
6.6 Radiant warmer operation .............................................................. 71
6.7 Transition ........................................................................................ 74
6.8 Skin temperature mode .................................................................. 77
6.9 Air temperature mode ..................................................................... 85
6.10 Manual mode .................................................................................. 91
6.11 Humidity.......................................................................................... 94
6.12 Oxygen (option) .............................................................................. 96
6.13 Heated mattress (option) ................................................................ 100
6.14 Kangaroo mode .............................................................................. 104
6.15 Tolerate cooling (option) ................................................................. 109
6.16 Warm-up (option)............................................................................ 111
6.17 Weaning (option) ............................................................................ 113
6.18 Scale (option).................................................................................. 116
6.19 Taking x-rays .................................................................................. 122
6.20 Developmental care (option)........................................................... 124
7 Alarms....................................................................................................... 127
7.1 Alarm priorities and alarm signals................................................... 127
7.2 Suppressing and delaying the alarm signal .................................... 127
7.3 Dismissing the alarm message....................................................... 130
7.4 Viewing the alarm history................................................................ 130
8 Configuration ........................................................................................... 131
8.1 Entering patient data....................................................................... 131
8.2 Transferring data to another device................................................ 134
8.3 Displaying trends and data ............................................................. 137
8.4 System setup .................................................................................. 142
9Transfer..................................................................................................... 150
9.1 Intrahospital patient transfer with switched off warming therapy .... 150
10 Troubleshooting....................................................................................... 153
10.1 Alarm – Cause – Remedy............................................................... 153
10.2 Power failure alarm......................................................................... 161
10.3 Adjustment of device height not possible ....................................... 162
10.4 Adjustment of mattress tray not possible........................................ 162
10.5 Fault during weighing...................................................................... 162
10.6 Fault with the oxygen supply .......................................................... 163
10.7 Removing liquid from the heating plate .......................................... 164
11 Reprocessing ........................................................................................... 166
11.1 Automatic humidifier cleaning......................................................... 166
11.2 Dismantling ..................................................................................... 167
11.3 Information on reprocessing ........................................................... 171

Instructions for use Babyleo TN500 SW 1.0n 5
Contents
11.4 Classification for reprocessing........................................................ 172
11.5 Recommendations for reprocessing ............................................... 172
11.6 Surface disinfection with cleaning................................................... 174
11.7 Additional reprocessing measures.................................................. 176
11.8 After reprocessing........................................................................... 176
12 Service ...................................................................................................... 180
12.1 Overview......................................................................................... 180
12.2 Inspection ....................................................................................... 180
12.3 Maintenance ................................................................................... 184
12.4 Replacing the filter cloth for patient air in the sensor wall............... 185
12.5 Repair ............................................................................................. 185
12.6 Activating applications .................................................................... 185
13 Disposal .................................................................................................... 187
13.1 Disposing of the device................................................................... 187
14 Technical data .......................................................................................... 188
14.1 Ambient conditions ......................................................................... 188
14.2 Operating data ................................................................................ 188
14.3 Performance characteristics ........................................................... 189
14.4 Measured value display .................................................................. 190
14.5 Materials ......................................................................................... 192
14.6 Data exchange and interfaces ........................................................ 192
14.7 Device combinations....................................................................... 194
14.8 Connections to IT networks ............................................................ 194
14.9 EMC Declaration............................................................................. 196
14.10 Open-source software .................................................................... 199
15 Annex ........................................................................................................ 200
15.1 Description of skin temperature regulation ..................................... 200
15.2 Further information on heated mattress (option) ............................ 201
15.3 Automatic selftest ........................................................................... 202
15.4 Delay of the alarm condition ........................................................... 203
15.5 Schematic representation of alarm and information tones ............. 203
15.6 Interfaces ........................................................................................ 204
15.7 Abbreviations .................................................................................. 205
15.8 Symbols .......................................................................................... 206
15.9 Symbol in the software ................................................................... 209
15.10 Product labels ................................................................................. 210
16 Password .................................................................................................. 213
16.1 Configuration password for Babyleo TN500 Software 1.0n............ 213
Index.......................................................................................................... 215

6 Instructions for use Babyleo TN500 SW 1.0n
Information about this document
1 Information about this document
1.1 Typographical conventions
1.2 Use of terms
Dräger uses the term "accessory" not only for accessories in the sense of
IEC 60601-1, but also for consumable parts, removable parts and attached parts.
1.3 Illustrations
Depending on the configuration, the products and screen content shown in this
document may differ from the actual on-site products.
Text Texts printed in bold and italics indicate device labels and screen texts.
1Numbers indicate the individual action steps of a sequence of actions. The
numbering restarts with 1 for each new sequence of actions.
(1) Numbers in parentheses refer to elements in illustrations.
Numbers in illustrations are shown within a circle and indicate elements to
which reference is made in the text.
►This triangle is used in safety instructions and precautionary statements to
indicate possible ways of avoiding the risk.
–Dashes indicate lists.
> The "greater than" symbol indicates the navigation path in a dialog window.
This symbol indicates information which makes it easier to use the product.
This arrow indicates the result of a process step.
✓This check mark indicates the result of a process sequence.
1

Instructions for use Babyleo TN500 SW 1.0n 7
Information about this document
1.4 Trademarks
Trademarks owned by Dräger
The trademarks are registered in the following countries:
Trademarks owned by third-party manufacturers
Trademark Country
Babyleo®Germany, Australia, Switzerland, China, EU, Japan,
Korea, Mexico, New Zealand, Russia, Singapore, USA
Infinity®EU, USA, China, Brazil, Australia, India
IncuWarmer®EU
DrägerService®Germany, USA
MEDIBUS.X®EU, USA
Oxycell®EU, USA
KangarooMode®EU, USA
ThermoMonitoring®Germany, France, USA
Trademark Trademark owner
Actichlor®Ecolab
Incidin®Ecolab
BruTab6S®Brulin
Buraton®Schülke & Mayr
Mikrozid®Schülke & Mayr
Perform®Schülke & Mayr
acryl-des®Schülke & Mayr
Descogen®Antiseptica
Dismozon®BODE Chemie
Dispatch®Clorox
Klorsept®Medentech
Oxycide®Ecolab USA
Virkon®DuPont
Neodisher®Chemische Fabrik Dr. Weigert
ODU MEDI-SNAP®ODU

8 Instructions for use Babyleo TN500 SW 1.0n
Safety-related information
2 Safety-related information
2.1 Intended use
The IncuWarmer Babyleo TN500 is intended for use with premature babies and
neonates and can be used as both an incubator and a radiant warmer. When the
product is switched between incubator and radiant warmer operation, patients
continue to be kept warm during the transition. The device provides a thermally
regulated environment for patients with a body weight of up to 5 kg (11 lbs) and a
height of up to 55 cm (22 in). The device can be operated as either a closed care
unit or an open care unit. As a closed care unit, Babyleo TN500 is an incubator.
Neonates are kept warm in the patient compartment with humidifiable air, which can
be enriched with oxygen (option). As an open care unit, Babyleo TN500 is a radiant
warmer.
2.2 Indications
The IncuWarmer Babyleo TN500 provides controlled ambient conditions for
premature babies and neonates. The following parameters are regulated, according
to the intended use:
–Temperature
–Humidity
–Oxygen (option)
2.3 Contraindications
Do not use Babyleo TN500 outside the specified environments of use.
2.4 Environments of use
Babyleo TN500 provides controlled ambient conditions for premature babies and
neonates in a hospital. Babyleo TN500 is intended for use in the following
environments:
–Labor and delivery units
–Labor and delivery rooms
–Neonatal intensive care units
–Operating rooms
Babyleo TN500 is intended for use in the following environments where some of the
functions described under intended use are restricted (no active warming therapy,
humidification, and oxygen enrichment). For further information, see the following
chapter: ''Intrahospital patient transfer with switched off warming
therapy'' (page 150)
–During intrahospital patient transfer
Babyleo TN500 is not intended for use in the following environments:
–Home use
–Transport vehicles, e.g., ambulances, airplanes, or helicopters
–MRI environment

Instructions for use Babyleo TN500 SW 1.0n 9
Safety-related information
2.5 Essential performance characteristics
Provided that the essential performance characteristics are functioning correctly,
the product can be used for its intended purpose. The product has the following
essential performance characteristics:
–Skin temperature regulation in incubator operation
The measured central skin temperature is compared with the set value for the
skin temperature and adjusted accordingly, or an alarm is triggered.
–Air temperature regulation in incubator operation
The measured air temperature in the patient compartment is compared with the
set value for the air temperature and adjusted accordingly, or an alarm is
triggered.
–Skin temperature regulation in radiant warmer operation
The measured central skin temperature is compared with the set value for the
skin temperature and adjusted accordingly, or an alarm is triggered.
2.6 Target groups
2.6.1 Definition of target groups
The target groups may only carry out the following activities if they meet the
necessary requirements. For further information, see the following chapter: ''Basic
safety instructions'' (page 11)
2.6.1.1 Users
Users are clinical personnel such as doctors and nursing staff trained in
neonatology.
2.6.1.2 Reprocessing personnel
2.6.1.3 Service personnel
Service personnel are, e.g., hospital technicians trained in servicing the device.
Activity Requirement
Use of the product in accordance with
the intended use
Specialist medical knowledge in neonatol-
ogy
Knowledge of currently known risks and
benefits of warming therapy
Activity Requirement
Reprocessing Specialist knowledge in the reprocessing of
medical devices
Activity Requirement
Installation Specialist knowledge in electrical engineer-
ing and mechanics
Experience in the servicing of medical
devices
Basic service work (inspection, main-
tenance according to the "Mainte-
nance" chapter)

10 Instructions for use Babyleo TN500 SW 1.0n
Safety-related information
2.6.1.4 Specialized service personnel
Dräger recommends arranging a service contract with DrägerService.
2.6.1.5 Installation personnel
Installation personnel are, e.g., hospital technicians who have not received training
for this device.
2.7 Information on safety instructions and precautionary
statements
Safety instructions and precautionary statements warn of risks and give instructions
for the safe use of the product. Failure to observe them may lead to personal injury
or property damage.
2.7.1 Safety instructions
This document contains sections with safety instructions which warn of risks. The
type of risk and the consequences of non-compliance are described in each safety
instruction.
2.7.2 Precautionary statements
Precautionary statements relate to action steps and warn of risks that may arise
when executing the action steps. Precautionary statements precede the action
steps.
The following warning signs and signal words indicate precautionary statements
and differentiate the possible consequences of non-compliance.
Activity Requirement
Installation Specialist knowledge in electrical engineer-
ing and mechanics
Experience in the servicing of medical
devices
Experience in complex service work on this
product
Basic and complex service work
(inspection, maintenance, repair)
Activity Requirement
Assembly and installation Specialist knowledge in electrical engineer-
ing and mechanics
Experience in the assembly and installation
of medical devices
Warning sign Signal word Consequences of non-compliance
WARNING May result in death or serious injury.
CAUTION May result in moderate or minor injury.
NOTICE May result in property damage.

Instructions for use Babyleo TN500 SW 1.0n 11
Safety-related information
2.8 Basic safety instructions
2.8.1 Instructions for use
Failure to use the product in accordance with the information contained in these
instructions for use may result in personal injury and property damage.
►Follow these instructions for use and those for any products used in conjunction
with this product.
►Only use this product for the purpose specified in ''Intended use''.
►Keep these instructions for use close to hand.
The instructions for use do not contain any information on the following points:
–Risks that are obvious to users
–Consequences of obvious improper use of the product
–Potentially negative effects on patients with different underlying diseases
2.8.2 Symbols and product labels
Failure to observe symbols and product labels may result in personal injury and
property damage.
►Observe the symbols and product labels.
2.8.3 Monitoring the patient's condition
Monitoring of a patient's condition can range from direct observation to electronic
monitoring by means of medical devices. The patient may be put at risk if his or her
condition is not adequately monitored.
►Monitor the patient's condition by suitable means and at appropriate intervals.
2.8.4 Duties of the operating organization
The tasks described in this document specify the requirements which have to be
met by each respective target group. If the respective target group is not
appropriately qualified, personal injury and property damage may result.
The operating organization of this product must ensure the following:
►The target group has the required qualifications (e.g., has undergone specialist
training or acquired specialist knowledge through experience)
►The target group has been trained to perform the task.
►The target group has read the sections of these instructions for use relating to
the activity concerned and noted the safety instructions and precautionary
statements they contain.

12 Instructions for use Babyleo TN500 SW 1.0n
Safety-related information
2.8.5 Operation of the device by persons outside the defined target
groups
The device is not intended for use by non-specialists (persons not defined as target
group). Responsibility for use of the device that is inconsistent with its intended use,
particularly by non-specialists, lies with the operating organization. If the operating
organization nevertheless allows non-specialists to interact with the device,
appropriate instruction and supervision must be provided.
If non-specialists (e.g., visitors) are given access to the device, the following
precautions must be taken:
►Non-specialists must be informed that unauthorized interactions may lead to
injury.
►Select the Family screen view or lock the user interface to prevent device
settings from being changed unintentionally.
►Lock the height adjustment and the bed-tilt mechanism to prevent them from
being activated unintentionally.
2.8.6 Modifications to the product
Modifications to the product may lead to malfunctions, which in turn may result in
personal injury and property damage.
►Do not modify this product.
2.8.7 Alarms
Failure to notice alarm signals may put the patient at risk.
►Check that 2 acoustic signals sound and the alarm light shows yellow and red
when the device is switched on.
►Set the alarm volume so that alarm signals can be heard.
►Be aware that only high- and medium-priority alarms trigger the nurse call.
►Take note of alarms directly on the device. Be aware that using the nurse call
does not unconditionally guarantee that alarms will be transmitted.
►Make sure that the alarm system has not been rendered ineffective by setting
the alarm limits to extreme values or deactivated by switching off the alarms.
►Adjust the basic alarm settings on devices to the needs of the patient.
2.8.8 Service port
Only use the service port on the device for servicing purposes. Any other use may
lead to malfunctions, which in turn may result in personal injury.
►Do not use the service port (RJ45) to connect the device to the IT network.

Instructions for use Babyleo TN500 SW 1.0n 13
Safety-related information
2.9 Electrical safety
2.9.1 Electric shock
Under the housing there are conducting components which may cause an electric
shock. To avoid the risk of personal injury and property damage, the following
preventive measures must be taken:
►The housing must only be opened by the target groups authorized to perform the
respective service measure.
►Disconnect the mains plug before opening the housing.
►Do not simultaneously touch the connectors of the interfaces and the patient.
►To prevent condensate formation and the resulting failure of electronic
components, do not switch on the device for 3 hours after sudden temperature
changes (e.g., after storage in unheated rooms).
►Only connect the device to grounded power sockets.
►Do not connect the device by means of a power socket strip.
►Only connect USB mass storage devices that are included in the list of approved
accessories to the USB port.
►Do not connect any accessory operating on mains voltage to the USB port.
►Only connect devices to the audio port, COM port, USB port and service port
that comply with the requirements set out in the standards and specifications
listed in the technical data. For further information, see the following chapter:
''Technical data'' (page 188).
►Do not place containers containing more than 1 liter of liquid in or on the device.
►Do not allow any liquids to penetrate into the device.
2.9.2 Electromagnetic compatibility (EMC)
Medical electrical equipment is subject to special precautionary measures
concerning electromagnetic compatibility. The EMC information must be observed
during installation and commissioning. For further information, see the following
section: ''EMC Declaration'' (page 196).
Portable and mobile radio frequency communication equipment can affect medical
electrical equipment.
To avoid the risk of malfunctions, the following measures must be taken and the
personnel concerned must be trained accordingly:
►Observe the ESD protective measures. Such protective measures may include
wearing antistatic clothing and shoes, touching a potential equalization pin
before and during connection of the pins, or using electrically insulating and
antistatic gloves.
►Comply with the requirements for an electromagnetic environment. For further
information, see the following chapter: ''Electromagnetic
environment'' (page 197).

14 Instructions for use Babyleo TN500 SW 1.0n
Safety-related information
Electromagnetic fields may disrupt the function of the device, putting the patient at
risk. Electromagnetic fields are generated by, for example:
–Cellular phones
–Radio-frequency surgical equipment
–Defibrillators
–Shortwave therapy equipment
►Observe the separation distances. For further information, see the following
chapter: ''Recommended safety clearances for portable and mobile high-
frequency communication equipment'' (page 199).
2.10 Use of oxygen
2.10.1 Oxygen cylinders
If oxygen cylinders or devices containing oxygen are installed in the vicinity of the
ventilation slot, oxygen may get into the device at the power supply unit. In the
event of sparking at the power supply unit there is an increased risk of fire, which
may lead to personal injury and property damage.
►Position oxygen cylinders and devices containing oxygen on that side of the
device without the ventilation slot.
2.10.2 Oxygen cylinder valves
The use of unauthorized or poorly maintained oxygen cylinder valves presents an
increased risk of fire, which may lead to personal injury and property damage.
►Do not use unauthorized oxygen cylinder valves.
►Make sure that oxygen connectors and oxygen seals are kept free from oil and
dust at all times. Always open oxygen cylinder valves slowly.
2.10.3 Oxygen supply
The health of patients can be endangered if they are provided with too much or not
enough oxygen. If O2is supplied externally, there is also a risk of fire.
►If the device is switched off, do not supply any O2from an external source. Do
not leave behind any oxygen-supplying accessories (e.g., O2hood, nasal
prongs) in the patient compartment.
►Measure and monitor the oxygen concentration in the patient compartment.
►Make sure that the oxygen concentration in the patient compartment is always
below 65 %.
►Always monitor the oxygen concentration in the patient's blood, e.g., using blood
gas analysis and a pulse oxymeter.
►Make sure that the O2settings are correct.
►Check the amount of O2supplied via an external O2hood.
►Always monitor the additional O2supply via the central gas supply, an oxygen
cylinder or an O2hood.
►Be aware that Babyleo TN500 displays no alarms in the case of an external
oxygen supply, e.g., via an O2hood.
►In the patient compartment use only electrical devices that are approved for use
in an oxygen-enriched atmosphere.

Instructions for use Babyleo TN500 SW 1.0n 15
Safety-related information
2.10.4 Oxygen sensors
The air in the patient compartment can be enriched with oxygen (option). The
oxygen concentration in the patient compartment is measured by O2sensors.
The user must adjust the O2sensors regularly. If the O2sensors are not adjusted,
the measurement uncertainty of the oxygen concentration may be increased. The
patient may then receive too much or too little oxygen. The health of the patient
may be endangered.
►Always monitor the oxygen concentration in the patient's blood, e.g., using blood
gas analysis and a pulse oxymeter.
►Adjust the O2sensors at least every 2 weeks under Special procedures... >
Oxygen.
►Measure and monitor the oxygen concentration in the patient compartment.
2.11 Explosion protection
2.11.1 Flammable gases
In the presence of oxygen concentrations greater than 25 Vol%, combustible or
explosive gas mixtures, there is an increased risk of explosion and fire, which may
lead to personal injury and property damage.
►Do not operate the device in areas where oxygen concentrations greater than
25 Vol%, combustible or explosive gas mixtures are likely to occur.
►Do not operate the device in areas where combustible solvents or explosive
anesthetic agents are used.
►Do not use combustible solvents or explosive anesthetic agents in the device.
Even small residues of these agents may react with oxygen to cause a fire.
2.11.2 Unauthorized gases
The use of compressed gases that are not approved for medical purposes may
adversely affect the function of the device and put the patient's health at risk.
►Only use compressed gases that are approved for medical purposes.
►Only use compressed gases that are dry and free from dust and oil.
2.12 Mechanical safety
2.12.1 Tipping over of the device
Excessive weight loading or a change in the center of gravity may cause the device
to tip over, injuring the patient, users, and bystanders. The device and accessories
may also be damaged due to the tip over.
►Do not place the device on inclined surfaces and avoid lateral loading by
pushing, resting, or leaning against the side.
►Observe the maximum load for all shelves, drawers, and holding devices.
►Do not exceed the maximum load of the x-ray tray.
►During transfer make sure that the device does not tip over due to incorrect
alignment of accessories on the duct rail.

16 Instructions for use Babyleo TN500 SW 1.0n
Safety-related information
2.12.2 Trapping of body parts
The careless execution of functions or the accidental triggering of functions by
untrained persons may cause injury to the patient, users or third parties. Hands,
feet, and other body parts may become trapped and crushed. There is also a risk of
injury from incorrectly mounted accessories. The illustration below shows the
special hazard areas.
Fig. 1 Special hazard areas during operation
28227
No. Location where there is a risk of injury
1Between the hood arm and the housing of the radiant warmer and between
the hood frame and the front of the radiant warmer (e.g., when opening and
closing the hood)
2On the accessories of the side duct rails when closing the hood or lowering
the hood arm
3Between the hood and the side panels (especially on the sensor wall)
4On the sensor wall between the bed support and the inside of the device
(e.g., when lowering or tilting the mattress tray)
5On the long side of the bed support between the mattress tray and the inside
of the device (e.g., when lowering or tilting the mattress tray)
6Between the compressed gas cylinder and accessories fixed to the duct rail
(e.g., when lowering the device)
7Between the trolley and the power cable connection (e.g., when lowering the
device)
8Between the trolley and the drawer (e.g., when lowering the device)
5
4
6
8
9
2
3
7
10
1

Instructions for use Babyleo TN500 SW 1.0n 17
Safety-related information
Before moving device components, take the following precautions:
►Make sure that there is no-one else in the hazard area.
►Make sure that no body parts become trapped.
2.12.3 Risk of patient falling out
If the access panels or the hand ports are open or the mattress tray has been pulled
out, there is a risk of the patient falling out.
►Make sure that the side and front access panels are correctly locked.
►Monitor the patient at all times when the access panels or hand ports are open
or the mattress tray is pulled out.
2.12.4 Unintended movement of the trolley
If the locking brakes are not engaged, the trolley may move on inclined surfaces,
causing injury to the patient and bystanders.
►In stationary operation, engage all the locking brakes on the trolley and check
that they are working properly.
2.12.5 Falling objects
Objects placed on the hood may fall off, injuring the patient.
►Remove all objects before opening the hood.
2.12.6 Wear and material fatigue
Wear and material fatigue on the components may lead to device malfunctions and
other faults. There is a risk of injury.
►Check the device and reusable products for signs of wear (e.g., cracks,
deformation, discoloration, or detachment) and replace if necessary.
►Perform service measures at the specified intervals.
►Replace the fan impeller when damaged.
►Check that the side access panels, the front access panel, and the hand ports
lock securely, and repair if necessary.
9On the front between the bed support and the inside of the device (e.g., when
lowering or tilting the mattress tray)
10 When closing the hand ports, when closing one of the two side access pan-
els or the front access panel.
No. Location where there is a risk of injury

18 Instructions for use Babyleo TN500 SW 1.0n
Safety-related information
2.13 Thermal radiation and fire prevention
2.13.1 Radiant warmer
Thermal radiation from the radiant warmer may cause increased water loss, skin
burns, and eye damage in the patient.
►Do not leave the patient unattended during radiant warmer operation.
2.13.2 Fire prevention
Objects placed on the housing of the radiant warmer or on the protective grid may
melt or fall off, injuring the patient. There is a risk of fire.
►Do not place objects (e.g., towels) or combustible materials over the housing of
the radiant warmer or hang them in front of the protective grid.
►Do not obstruct the ventilation slots on the radiant warmer and do not cover
them with combustible materials.
►In radiant warmer operation remove the hood cover and ensure a safety
clearance of 20 cm (8 in) between the top edge of the radiant warmer and the
ceiling.
Fig. 2 Radiant warmer protective grid
The radiant warmer may heat up objects in the beam path close to the radiant
warmer to such an extent that touching the objects causes burns. In addition, the
objects may ignite and cause a fire.
►Do not permanently locate objects (e.g., examination lights) in the beam path of
the radiant warmer.
►Allow the objects to cool down before touching, to avoid burns.
►Before pivoting accessories (e.g., examination lights) out of the beam path of the
radiant warmer, take precautions to prevent burns.
2.13.3 Additional heat sources
The temperature in the patient compartment may rise to dangerous levels due to
direct sunlight or other external heat sources (e.g., phototherapy devices). The
patient may become overheated.
►When additional heat sources (e.g., solar radiation, examination lights, or
phototherapy lights) are active, make sure that the temperature in the patient
compartment remains non-critical.
►Check the patient's body core temperature at regular intervals.
30230

Instructions for use Babyleo TN500 SW 1.0n 19
Safety-related information
2.13.4 Air flow in the warm air duct
If the warm air duct in the device becomes blocked or covered, thermoregulation is
disrupted. The hot air flow may reach the patient directly, causing burns.
►Do not block or cover the warm air duct (1) and do not deflect the hot air flow to
the patient using objects (e.g., blankets).
The warm air duct passes through the air ducts of the X-ray flap. The convective
heater directs the warm air through the air ducts of the X-ray flap into the patient
compartment.
Fig. 3 Air ducts of the X-ray flap
2.14 Therapy and applications
2.14.1 Ambient conditions
If the permissible ambient conditions are not complied with, the values set for
humidity and temperature in the patient compartment may not be achieved. The
patient may be put at risk.
►Be aware of and comply with the permissible ambient conditions. For further
information, see the following chapter: ''Technical data'' (page 188)
2.14.2 Therapy settings
If the therapy settings are unsuitable for the patient, the patient may be put at risk.
►Before starting therapy, check the therapy settings carefully. Adjust the therapy
settings to the needs of the patient, e.g., after transferring patient data to a new
device, after transferring data via a USB port, after changing the operating
mode, when using the default settings.
►Measure the body core temperature at regular intervals using a separate
thermometer.
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20 Instructions for use Babyleo TN500 SW 1.0n
Safety-related information
2.14.3 Increased CO2concentration in the patient compartment
If the device does not have the "Tolerate cooling" option, it must be switched off to
cool down. When the device is switched off, an inadequate supply of fresh air may
result in an increase in CO2in the patient compartment. This may put the patient at
risk.
►Ensure that the patient has an adequate supply of fresh air when the device is
switched off (e.g., by opening a hand port or a side panel).
2.14.4 Skin temperature sensors
Incorrect use of the skin temperature sensors may result in hypothermia or
hyperthermia. Reused skin temperature sensors may transmit pathogens or may be
defective and result in incorrect measurements. The patient is put at risk.
►Only use skin temperature sensors approved for the device.
►The skin temperature sensors are disposable products: Do not reuse,
reprocess, or sterilize.
►Incorrect interpretation of the values may result in hypothermia or hyperthermia.
►Do not use the skin temperature sensor as a clinical thermometer and do not
use it to measure rectal temperature.
►Use dry skin temperature sensors only.
►Use covers recommended by Dräger only, e.g., ThermoPad sensor covers or
similar covers with aluminum film.
►Check the position of the skin temperature sensors at regular intervals.
►Place the yellow skin temperature sensor in the liver or kidney region only.
►Place the white skin temperature sensor on the foot or hand only.
►Do not place the skin temperature sensors under the patient.
►The device cannot distinguish between an increase in body core temperature
when the skin is cold (e.g., with a fever) and a low body core temperature (e.g.,
with hypothermia). Do not use skin temperature mode in cases of fever or
shock.
►If skin temperature sensors are connected, do not use radio-frequency surgical
equipment, endocardial catheters, or defibrillators.
2.14.5 Air temperature in the device
The following situations may lead to hypothermia or hyperthermia in the patient:
–The hand ports or access panels are left open.
–The mattress tray or x-ray tray is left pulled out.
►Only open the hand ports or access panels temporarily and only for as long as is
necessary.
►Only pull out the mattress tray or x-ray tray temporarily and only for as long as is
necessary.