Dräger caleo User manual

WARNING
To properly use this medical device, read
and comply with these instructions for use.
Neonatal Incubator
Software 2.n
Instructions for Use
Caleo®

2
Operating Instructions Caleo, Software 2.n
NOTICE
Proprietary Information
This document contains information in which Dräger claims proprietary rights.
The information may not be reproduced in whole or in part except as authorized
in writing by Dräger. This information is the property of Dräger, it is provided
solely for the use intended.
Repairs/Modifications
Repairs on this device should be performed by DrägerService, its
Authorized Service Organizations or properly trained technicians.
Information about repairs can be obtained from Draeger or Authorized Service
Organizations. Dräger, its subsidiaries and affiliates are not responsible for injury
to persons or damage to property arising directly or indirectly from unauthorized
repairs or modifications to this device. Furthermore, any unauthorized repairs or
modifications could void any warranty extended by Dräger.
This document is provided for customer information only, and will not be
updated or exchanged without customer request.
Trademarks
The Dräger name and logo are registered trademarks of Dräger.
Caleo, Twincubator, Kangaroo Mode, and ThermoMonitoring are registered
trademarks of Dräger.
BabyLink, Caleo Calmcapsule, Caleo CleanSwitch, Caleo SoftBed,
Caleo JumboPorts, ThermoPad, and ThermoTrace are trademarks of Dräger.
© 2000 - 2012 Dräger Medical GmbH
All rights reserved, Subject to modifications

How to use these Operating Instructions
The headline ...
specifies the subject of the main chapter
to help you find your way around quickly.
The page body ...
contains instructions for use of the device
in a combination of text and illustrations. The information is
translated directly into sequences of activities showing the user
how to use the device.
The left-hand column ...
contains text
explaining the device and guiding the user directly to its uses
through concise, ergonomically arranged instructions.
zBullet points refer to individual actions.
1numbers refer both to illustrations and the sequence of
action when several steps are required to complete a task.
The right-hand column ...
contains illustrations
as a visual reference to the text, guiding the user to locate
parts of the unit itself. Elements mentioned in the text are
highlighted. Unnecessary details are omitted. Rendering of
screen displays guide the user and allow to reconfirm actions
performed.
147
Preparation
35
Installing Accessories
Moving the control unit to the opposite side
for 38 mm pole
1Loosen clamping screw to remove control unit. (Support
control unit to prevent it from dropping once clamping screw
is loosened.)
2Loosen clamping screw to remove holder.
Upon delivery, the control unit is attached to the 38 mm dia.
tube of 310 mm length (38/310 pole).
This tube is secured for transport with a screw attachment.
If required, the tube can be detached (recommendation: ask for
assistance from qualified technical personnel):
3Remove both caps from the tube. Insert a screwdriver into
the holes and release the tube.
To install control unit on the adjacent side:
lSlide holder over the other pole.
2Tighten clamping screw to fix holder in position.
lSet control unit to the desired working height
1Tighten clamping screw to secure control unit to the holder.
Mounting the control unit on the handle side
lInstall basic pole (2M 50 680), see page 37.
lScrew in the extension pole 38/600 (2M 50 691) or pole 38/
310 (2M 50 688).
lRe-install the control unit as specified in the Assembly
Instructions.
CAUTION !
When mounting control unit to its pole, ensure that there is
sufficient space to swivel the control unit.
(see "Tilting the bed", page 50).
CAUTION !
Only qualified technical personnel may move the control unit
from the wall side to handle side or vice versa.
CAUTION !
Do not remove cable to the control unit from the cable guides
on the basic pole.
Make sure there is sufficient space to swivel and tilt the unit.
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Operating Instructions Caleo, Software 2.n
5
5
Contents
Important Safety Information 7
Intended Use 19
What’s What 21
Operating Concept 29
Preparation 31
Checking Readiness For Operation 54
Operation 59
Care 117
Maintenance 136
Maintenance intervals 136
Troubleshooting 141
Theory of Operation 149
Glossary 163
Technical Data 165
Ordering Information 171

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7
Operating Instructions Caleo, Software 2.n
Important Safety Information — Intended Use
Important Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Operator's Responsibility for Patient Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Summary of WARNINGS and CAUTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Restrictions of Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Important Safety Information
8
Operating Instructions Caleo, Software 2.n
Operator's Responsibility for Patient Safety
Definitions
Important Safety Information
Operator's Responsibility for Patient Safety
The design of the equipment, the accompanying literature, and
the labeling on the equipment take into consideration that the
purchase and use of the equipment are restricted to trained
professionals, and that certain inherent characteristics of the
equipment are known to the trained operator. Instructions,
warnings, and caution statements are limited, therefore, largely
to the specifics of the Dräger design.
This publication excludes references to various hazards which
are obvious to a medical professional and operator of this
equipment, to the consequences of product misuse, and to
potentially adverse effects in patients with abnormal conditions.
Product modification or misuse can be dangerous. Draeger
disclaims all liability for the consequences of product alter-
ations or modifications, as well as for the consequences which
might result from the combination of this product with other
products whether supplied by Dräger or by other manufac-
turers if such a combination is not endorsed by Dräger.
Patient monitoring
The operators of this infant incubator system must recognize
their responsibility for choosing appropriate safety monitoring
that supplies adequate information on equipment performance
and patient condition. Patient safety may be achieved through
a wide variety of different means ranging from electronic
surveillance of equipment performance and patient condition to
simple, direct observation of clinical signs. Responsibility for
the selection of the best level of patient monitoring lies solely
with the equipment operator.
Distributed in the USA by:
3135 Quarry Road, Telford PA 18969
WARNING !
Strictly follow these Instructions for Use
Any use of the product requires full understanding and
strict observation of all portions of these instructions.
This equipment is only to be used for the purpose
specified under "Intended Use" (see page 19).
Observe all WARNINGS and CAUTIONS as rendered
throughout this manual and on labels on the equipment.
Definitions
NOTE: A NOTE provides additional information intended to
avoid inconveniences during operation.
Definition of target groups
Users, maintenance personnel and professionals are defined
as the target groups for this medicine device.
These target groups were trained to handle the medical device
and have the necessary specialized knowledge and training,
the necessary know how to use, install, prepare, maintain or
repair the medical device.
Dräger points out that only the defined target groups should
use, install, prepare, maintain or repair the medical device.
User
Users are persons who may use the medical device in accor-
dance with its intended purpose.
Maintenance personnel
Maintenance personnel are persons who are responsible to the
owner or operator for the maintenance of the medical device.
Maintenance personnel are persons who install, prepare or
maintain the medical device in working condition.
Professionals
Professionals are persons who may perform repair jobs or
complex maintenance jobs on the medical device.
Typing conventions in this manual
Display messages are printed as »message«, e. g:
»confirm new mode with rotary knob«
Controller keys are designated as »Key Name«, e.g. »man.«
indicates a reference to the operating manual on the
incubator, e.g. for a control element.
Symbols
Please refer to "Glossary" on page 163 for explanations.
Labels on the equipment
Please refer to "Labels" on page 25.
WARNING !
A WARNING statement provides important information
about a potentially hazardous situation which, if not
avoided, could result in death or serious injury.
CAUTION !
A CAUTION statement provides important information about
a potentially hazardous situation which, if not avoided, may
result in minor or moderate injury to the user or patient or in
damage to the equipment or other property.

Important Safety Information
9
Operating Instructions Caleo, Software 2.n
Summary of WARNINGS and CAUTIONS
Summary of WARNINGS and CAUTIONS
WARNING !
Strictly follow these Instructions for Use
Any use of the product requires full understanding and
strict observation of all portions of these instructions.
This equipment is only to be used for the purpose
specified under "Intended Use" (see page 19).
Observe all WARNINGS and CAUTIONS as rendered
throughout this manual and on labels on the equipment.
WARNING !
This device may only be used by properly trained
personnel under the supervision of qualified medical
personnel familiar with the currently known risks and
benefits of using an infant incubator.
WARNING !
Dräger cannot warrant or endorse the safe performance
of third party accessories for use with the Caleo
incubator system.
Only use accessories that are qualified to the required
specifications for an intended use in an oxygen enriched
environment.
WARNING !
This device is to be used only in rooms with line power
installations complying with national safety standards
for hospital patient rooms (e.g., IEC/EN 60601-1 "Medical
Electrical Equipment - General Requirements For
Safety").
To maintain grounding integrity, connect only to a
"hospital grade" receptacle.
Always disconnect supply before servicing.
WARNING !
DANGER, risk of explosion if used in the presence of
flammable anesthetics.
This device is neither approved nor certified for use in
areas where combustible or explosive gas mixtures are
likely.
WARNING !
The use of this device requires continuous supervision
of the infant by trained nursing personnel in order to
ensure immediate corrective action in situations with a
risk of patient injury.
CAUTION !
Restriction of Distribution
Federal Law (U.S.) restricts this device to sale by or on the
order of a physician.
CAUTION !
Device for use in health care facilities only and exclusively by
persons with specific training and experience in its use.
CAUTION !
Maintenance
The device must be inspected and serviced at regular 1 year
intervals. A record must be kept on this preventive
maintenance. We recommend obtaining a service contract
with DrägerService.
For repairs of the Caleo incubators we recommend that you
contact DrägerService.

Important Safety Information
10
Operating Instructions Caleo, Software 2.n
Precautions During Preparation
WARNING !
Always observe all precautions against fire hazards from
oxygen (see page 61).
WARNING !
Never leave infant unattended when access doors or
access ports are open to avoid any risk of an infant
falling out of an incubator.
WARNING !
Always ensure that access port catches are securely
engaged in order to avoid any risk of an infant falling out
of an incubator.
WARNING !
When opening and closing front door, avoid pinching or
jamming hoses and cables in the attached double wall.
WARNING !
Always ensure that both knobs of the large access doors
are engaged in position in order to avoid any risk of an
infant falling out of an incubator.
The red catch behind each knob must no longer be
visible!
WARNING !
The attached double wall must be positioned parallel to
the front door otherwise the ducted flow of warm air will
be interrupted!
WARNING !
When opening and closing side doors, avoid pinching or
jamming hoses and cables in the attached double wall.
WARNING !
Always ensure that both knobs of the side doors are
engaged in position in order to avoid any risk of an infant
falling out of an incubator.
The red catch behind each knob must no longer be
visible!
WARNING !
Always observe the maximum load of the infant bed
(5 kg, 11 lbs).
WARNING !
Never leave infant unattended when the bed has been
pulled out to avoid any risk of an infant falling out of an
incubator.
WARNING !
Do not lean on the bed when it is pulled out. Equipment
damage with risk of patient injury may result.
WARNING !
Always ensure that the bed is pushed all the way in!
Otherwise the ducted flow of warm air will be interrupted,
and the infant may be warmed or cooled excessively.
WARNING !
Do not use the X-ray drawer as a writing support or as a
bed for the infant. Risk of equipment damage or patient
injury.
WARNING !
Always ensure that the x-ray drawer is pushed all the
way in! Otherwise the ducted flow of warm air will be
interrupted, and the infant may be warmed or cooled
excessively.
WARNING !
Make sure that the installed hoses are routed freely and
safely.
WARNING !
Do not reach between incubator housing and housing
support while tilting the bassinet. Risk of injury!

Important Safety Information
11
Operating Instructions Caleo, Software 2.n
WARNING !
Use only authentic, originally sealed OEM bags
containing sterilized distilled or demineralized water.
Do not use any additives for water intended for
humidifying the incubator.
Do not use infusion solution bag for the humidification
system.
WARNING !
Output of the integrated power strip is not monitored!
Do not connect life support devices which do not have
their own power failure alarm.
Do not exceed the maximum permissible power input
for connected accessories
(all 4 sockets together: max. 2 A).
Do not exceed the maximum permissible total leakage
current. For the leakage current of Caleo without socket
strip see "Technical Data", page 166.
WARNING!
Installation of the nurse call kit should only be performed
by DrägerService or factory trained and authorized
service personnel.
WARNING!
Connect nurse call to a central hospital alarm system
only while Caleo is properly grounded via its power cable
and a grounded wall outlet or via the grounding pin on
the rear panel of the control unit.
Otherwise, the risk of electric shock cannot be safely
excluded.
WARNING!
Only alarm messages with a high risk potential or
serious device faults are transmitted via nurse call.
WARNING!
Connection of a nurse call does not relieve staff of their
duty to check patient data at regular intervals.
zScreen displays must be checked regularly.
WARNING!
A fault in any of the components in the link between
nurse call and central hospital alarm system (e.g. in the
electronics for nurse call in Caleo, in the Caleo power
supply, or in the enunciator of the central hospital alarm
system, etc.) may result in failure of the nurse call.
WARNING!
The system must meet the requirements about medical
electrical equipment in accordance to IEC/EN 60601-1-1
and IEC/EN 60601-1-2.
WARNING!
Connect external devices to the interfaces only while
Caleo is properly grounded via its power cable and a
grounded wall outlet or via the grounding pin on the rear
panel of the control unit.
Otherwise, the risk of electric shock cannot be safely
excluded.
WARNING!
All data that are transmitted via medical devices are for
information only and should not be used as the sole
basis for clinical decisions.
WARNING !
Do not use a power outlet strip for supplying power to
the Caleo incubator!
Connecting the incubator via a power outlet strip may, in
case of failure of the protective earth conductor, cause
patient leakage currents to rise above permitted limits
with a risk of electric shock to the patient.
WARNING!
The Caleo incubator is ready for operation only when all
checks have been performed successfully.

Important Safety Information
12
Operating Instructions Caleo, Software 2.n
CAUTION !
Always verify that monitor shelves and other accessories are
securely attached.
Always observe the following limits:
Maximum overall load must not exceed 66 kg (145.5 lbs)
(see page 170).
For items attached to column on swivel shelves, do not
exceed load of 3 kg (6.6 lbs).
When installing accessories, please note:
zAccessory equipment must not collide with the unit when
adjusting tilt angle and height of Caleo.
zAccessory equipment on the handle side does not move
with the main unit during height adjustment of Caleo
(Handle side, see page 170).
CAUTION !
Maximum loads for
– pole 38 mm/600 is 10 kg (22 lbs).
– pole 38 mm/310 is 10 kg (22 lbs).
– pole 25 mm/600 is 3 kg (6.6 lbs).
Max. distance between loads and pole: 150 mm (6 inches).
CAUTION !
When mounting control unit to its pole, ensure that there is
sufficient space to swivel the control unit (see "Tilting the
bed", page 48).
CAUTION !
Only qualified technical personnel may move the control unit
from the wall side to handle side or vice versa.
CAUTION !
Do not remove cable to the control unit from the cable guides
on the basic pole.
Make sure there is sufficient space to swivel and tilt the unit.
CAUTION !
Maximum load per hook is 3 kg (6.6 lbs).
CAUTION !
Maximum load for swivel tray is 3 kg (6.6 lbs).
Ensure sufficient space for swiveling!
CAUTION !
Maximum load for compact rail clamp is 5 kg (11 lbs).
CAUTION !
Do not install incubator controller on telescoping column.
CAUTION !
Maximum load for base pole is 10 kg (22 lbs).
Max. distance between loads and pole: 150 mm (6 inches).
CAUTION !
Maximum load for instrument tray is 2 kg (4.4 lbs).
CAUTION !
Maximum loads for pole extensions
– 38 mm/600 is 5 kg (11 lbs).
– 38 mm/310 is 5 kg (11 lbs).
– 25 mm/600 is 3 kg (6.6 lbs).
Max. distance between loads and pole: 150 mm (6 inches).
CAUTION !
Maximum load for notebook holder is 3 kg (6.6 lbs).
CAUTION !
Maximum load for monitor shelf is 20 kg (44 lbs).
Do not exceed the maximum installation height.
Vertical distance between monitor shelf and stand must not
exceed 20 cm (7.8 inches) on the wall side and 100 cm
(39 inches) on the handle side (see page 170).
CAUTION !
Always check that connecting O2supply hose is of sufficient
length when using independent O2flowmeter, allowing for the
height adjustments of the bassinet.
CAUTION !
The permissible O2inlet pressure is between 300 and
600 kPa (43.5 and 87 psi).
CAUTION !
Maximum load for drawer is 7 kg (15 lbs).
CAUTION !
Always take care not to damage sensor unit inside the
incubator when manipulating canopy !

Important Safety Information
13
Operating Instructions Caleo, Software 2.n
Precautions During Operation
CAUTION !
Cables and hoses must be sufficiently long to avoid kinking,
tear or pinching when adjusting the incubator height!
Do not store anything underneath the drawer.
CAUTION !
The castor with direction lock does not have a brake.
To secure Caleo, apply the brakes on all 3 castors with
brakes.
CAUTION !
Cables and hoses must be carefully routed to avoid kinking,
tear or pinching when adjusting the incubator tilt angle!
CAUTION !
Exclusively use sterilized distilled or demineralized water
for humidifying the incubator!
WARNING !
Make sure that all hoses and cables are routed correctly
and safely without obstruction! Otherwise:
Risk of extubation! Danger of disconnection!
WARNING !
Never leave infant unattended when the canopy, double
walls, front door, or access ports are open, when the bed
has been pulled out, or when access grommets have
been removed. Risk of patient injury.
Under these conditions, watch patient carefully to
prevent any possibility of an infant falling out of the
incubator.
WARNING !
Always observe the maximum load of the patient bed
(5 kg, 11 lbs).
Do not lean on or apply weight to the bed when it has
been pulled out.
WARNING !
Avoid additional external heat sources, such as direct
sunlight, spot lamps, and electric pads or blankets.
They cause the air temperature inside the incubator to
increase in an uncontrolled fashion.
WARNING !
The infant’s central temperature must be regularly
monitored with an independent thermometer.
WARNING !
It is the responsibility of the attending physicians to
draw conclusions from the measured skin temperature.
WARNING !
Do not use skin temperature control mode for infants in
shock, as their skin temperature is much lower than
normal. Skin temperature control would increase the
incubator air temperature too much, resulting in the risk
of overheating the infant.
We recommend operating the Caleo incubator in air
temperature control mode when caring for patients with
such conditions – see page 65.
WARNING !
Do not use skin temperature control mode for infants
with a fever, since their skin temperature is much higher
than normal. Using skin temperature control would
reduce the incubator air temperature too much, resulting
in the risk of hypothermia.
WARNING !
Skin temperature control mode must not be used on
twins, since Caleo controls only the temperature for one
infant. Risk of hypothermia or overheating. Always use
air temperature control mode when caring for twins.
WARNING !
Do not confuse skin sensor probe positions on the
infant’s body! The yellow skin temperature sensor (T1) is
used for skin temperature control. Inappropriate
positioning of this sensor could lead to overheating of
the infant.

Important Safety Information
14
Operating Instructions Caleo, Software 2.n
WARNING !
Do not place any blankets or sheets over the hot air vent.
The temperature control system would be disrupted,
causing a risk of overheating or burn if air from the hot
air vent is channeled directly to the infant.
WARNING!
Cleaning mode may only be used while Caleo is not
occupied by a patient.
After use, allow Caleo to cool down before dismantling.
Risk of burns when touching the heater!
WARNING !
During a power failure, the lack of fresh air supply may
cause an elevated CO2 concentration inside the patient
capsule. Risk of CO2 poisoning.
WARNING !
Beware of cross-infections when treating twins!
WARNING !
Fire hazards from oxygen !
– No open flames or cigarettes! Textiles, plastics, and
oils readily ignite in an oxygen enriched atmosphere
and burn with great intensity.
– Keep oxygen valves, connections, and seals free from
oil and grease.
– Open valves on O2 cylinders slowly.
– Do not operate Caleo in the presence of flammable
anesthetics or disinfectants. Risk of explosion!
– Do not use or store flammable liquids such as alcohol,
ether, or acetone inside the Caleo incubator.
– Do not use electrical equipment inside the patient
capsule unless this equipment is expressly designed
for use in environments that present an explosion
hazard.
WARNING !
Due to the physiological risks from O2, it is mandatory to
monitor O2 concentrations continuously during the
administration of O2, either using the integrated
O2measurement and control system or an independent
O2 analyzer.
WARNING !
Always take into consideration the physiological risks
from the administration of oxygen.
Elevated oxygen concentrations inside the incubator
may only be used by or on the order of a physician.
Oxygen is classed as a drug.
It is absolutely essential that such oxygen therapy be
selected and controlled on the basis of the arterially
measured oxygen partial pressure in the infant's blood
(SaO2 or SpO2). This is the only way to minimize the risk
of both hyperoxemia (with potential for damage to the
eyes by retrolental fibroplasia) and hypoxemia (which
might contribute to intraventricular hemorrhage and
damage to the infant’s brain).
WARNING !
Medicated aerosols and similar substances must not be
nebulized in the infant capsule.
The mist of nebulized substances may impair the proper
function of the incubator.
WARNING !
When using Kangaroo Mode, central temperature of the
infant, who is outside the controlled climate of the
incubator, must be monitored constantly.
Particular attention must be paid to critical care patients’
vital parameters, especially a critical O2 partial pressure.
Ensure that all cables and hoses are routed correctly and
safely.
WARNING !
Infant temperature must be monitored with particular
care during phototherapy. Absorption of light through
the infant's skin will supply heat to the patient which may
increase central temperature.
WARNING !
During phototherapy, the supply of fluids to the infant
must be increased, e.g. by parenteral infusion, to
compensate for the increased water loss.
WARNING !
Never cover phototherapy lamp or incubator canopy with
the intention to boost the phototherapeutic effect. A heat
build-up will likely result with the danger of overheating
the infant, because the incubator cannot be adequately
cooled with ambient air under these conditions.

Important Safety Information
15
Operating Instructions Caleo, Software 2.n
WARNING !
Always use eye protection for the infant when using
phototherapy.
WARNING !
Ensure that the ventilator circuit and all other cables,
hoses and tubing are routed correctly and safely.
Danger of extubation and disconnection!
Hoses and/or cables are at risk of being trapped when
tilting the Caleo, adjusting the height, and when opening
and closing the front door.
WARNING !
Cleaning mode must only be used when Caleo is empty.
After use, allow Caleo to cool down before dismantling.
Risk of burns when touching the heater!
WARNING !
Caleo is to be used only in rooms with line power
installations that comply with national safety standards
for hospital patient rooms (e.g., IEC/EN 60601-1 "Medical
Electrical Equipment - General Requirements For
Safety").
To maintain grounding integrity, connect only to a
"hospital grade" receptacle.
Always disconnect supply before servicing.
WARNING !
Do not use a power outlet strip for supplying power to
the Caleo incubator!
Connecting the incubator via a power outlet strip may, in
case of failure of the protective earth conductor, cause
patient leakage currents to rise above permitted limits
with a risk of electric shock to the patient.
WARNING!
Cleaning mode may only be used while Caleo is not
occupied by a patient.
WARNING!
Risk of burns upon contact with the heater!
Do not disassemble Caleo while in cleaning mode.
WARNING!
Always adjust audible alarm volume to a level that
ensures the operator will be alerted when alarms occur.
Failure to identify and correct alarm situations may
result in patient injury.
WARNING !
While alarm suppression is active, the operator of the
incubator must still assume responsibility for proper
patient care and safety in the event of an alarm.
Failure to identify and correct alarm situations may
result in patient injury.
WARNING !
Only use auxiliary electromedical equipment which
complies with national safety standards for hospital
patient rooms (e.g., IEC/EN 60601-1 "Medical Electrical
Equipment - General Requirements For Safety", UL 544).
When using the integrated power strip to connect
auxiliary devices, always observe total leakage current
and current consumption limits!
(See "Technical Data", page 166.)
WARNING !
The output of the integrated power strip is not
monitored!
Do not connect life support devices which do not have
their own power failure alarm.
WARNING !
Regularly measure infant temperature!
Do not leave canopy open for any length of time, other-
wise the air temperature inside the incubator will drop.
WARNING !
When the extended setpoint range for air temperature is
used, the infant’s temperature must be continuously
monitored.
WARNING !
Monitor infant constantly when canopy, doors, or access
ports are open, to ensure infant cannot fall out of the
incubator.

Important Safety Information
16
Operating Instructions Caleo, Software 2.n
WARNING !
Always verify that temperature sensors are specified and
approved for use with Dräger Caleo.
Disposable sensors must not be cleaned for re-use.
If used more than once, the necessary measurement
precision cannot be guaranteed.
WARNING !
Do not use skin temperature sensor (yellow) or
peripheral temperature sensor (white) to measure rectal
(central) temperature!
Do not locate sensor under the infant, otherwise
measurement and control would be performed with
reference to infant central temperature instead of skin
temperature.
WARNING !
Regularly check that skin temperature sensor is properly
attached to the infant's skin! A skin temperature probe
that has fallen off would be measuring air temperature
with a risk of overheating the infant (although the air
temperature would not rise above 39 oC).
WARNING !
When the extended setpoint range for skin temperature
is used, particular care must be taken to monitor infant
temperature.
WARNING !
As long as 3 dashes remain on screen while the
incubator is operated in skin temperature control mode,
Caleo will not heat. Infant may become hypothermic.
WARNING !
Always keep in mind the physiological risks and fire
hazards associated with the use of high O2 concentra-
tions.
Precautions During Care
CAUTION !
When fitting accessories, please note:
zThe accessory equipment must not collide with the unit
when adjusting the tilt angle and height of Caleo.
zThe accessory equipment on the handle side will not move
with the main unit during height adjustment of Caleo
(page 170).
Always observe maximum loads to avoid danger of unit
tipping over.
CAUTION !
Use caution when moving the incubator over uneven
surfaces, e.g. rough pavement outside the hospital or into an
elevator, as castors may become damaged or dislodged.
CAUTION !
Never cover the sensor unit or hang anything from the open-
ings in the sensor unit. Keep these openings free from dirt.
CAUTION !
Only use phototherapy units supplied with their own stand.
Do not place phototherapy devices directly on Caleo canopy,
as they may slip when the bed tilt is activated.
WARNING !
Always follow accepted hospital procedures for handling
equipment contaminated with body fluids.
WARNING !
Always disconnect power supply before cleaning and
disinfecting.
WARNING !
Risk of burns from heater!
When the incubator is closed, the heater is still hot
enough to inflict serious burns for a long time after
switching off (70 oC = 158 oF after 1 hour).
WARNING !
Always disconnect all supplies before disassembly.

Important Safety Information
17
Operating Instructions Caleo, Software 2.n
WARNING !
Risk of burns upon contact with the heater.
Allow Caleo to cool down before further disassembly.
WARNING !
The incubator is ready for operation only when all
checks have been carried out successfully.
WARNING !
Always ensure that both knobs of the large access doors
are engaged in position in order to avoid any risk of an
infant falling out of an incubator.
The red catch behind each knob must no longer be
visible!
WARNING !
The attached double wall must be positioned parallel to
the front door otherwise the ducted flow of warm air will
be interrupted!
WARNING !
Always ensure that both knobs of the side doors are
engaged in position in order to avoid any risk of an infant
falling out of an incubator.
The red catch behind each knob must no longer be
visible!
WARNING !
Always ensure that the bed is pushed all the way in!
Otherwise the ducted flow of warm air will be interrupted,
and the infant may be warmed or cooled excessively.
CAUTION !
Even accessories designed to be reused after cleaning have
a limited life. For example, due to a number of factors
connected with handling and preparation, disinfectant
residues can attack the material more intensely during
autoclaving; increased wear can occur and service life can be
markedly shortened. Accordingly, these parts and
accessories must be replaced when any external signs of
wear – such as cracks, deformation, discoloration, peeling,
etc., – become apparant.
Precautions During Maintenance
CAUTION !
Certain components of the Caleo incubator consist of
materials that are sensitive to certain organic solvents
sometimes used for cleaning and disinfecting (e.g., alcohols,
phenols, halogen releasing compounds, oxygen releasing
compounds, strong organic acids, etc.). Exposure to such
substances may cause damage that is not always
immediately recognized. Sterilization of the incubator or
components with ethylene oxide (EtO) or disinfection with
formaldehyde is also not recommended.
CAUTION !
U-grommets cannot be autoclaved at 134 oC (273 oF).
CAUTION !
Take care not to damage the sensor unit when removing
patient bed.
CAUTION !
Do not allow any moisture to enter the sensor unit.
Do not disinfect sensor unit by immersion or spraying.
Sensor damage may result.
CAUTION !
Do not allow any moisture to enter the control unit.
Do not disinfect control unit by immersion or spraying.
Equipment damage may result.
CAUTION !
Ensure that only recommended cleaning agents and
disinfectants are used!
The acrylic and Makrolon material may develop stress cracks
if other agents, such as alcohol, are used.
Do not use UV radiation on the incubator. This also may
cause cracks in the acrylic parts.
WARNING !
To avoid any risk of infection, clean and disinfect
incubator and accessories before any maintenance
according to established hospital procedures – this
applies also when returning units or parts for repair.

Important Safety Information
18
Operating Instructions Caleo, Software 2.n
WARNING !
In order to avoid risk of electric shock, always
disconnect power supply before starting any
maintenance procedures.
WARNING !
Never operate the Caleo incubator, if it has suffered
physical damage or does not seem to operate properly.
We recommend that you contact DrägerService for main-
tenance service for the Caleo incubator.
WARNING !
Treatment of batteries and O2 sensors
– Do not throw into fire! Risk of explosion.
– Do not force open! Cells contain corrosive acid that
may cause caustic burns.
– Do not attempt to recharge battery. Risk of explosion.
CAUTION !
For disposal of batteries and O2sensors follow all local, state,
and federal legislation with respect to environmental protec-
tion.
CAUTION !
The device must be inspected and serviced at regular 1 year
intervals. A record must be kept on this preventive
maintenance. We recommend obtaining a service contract
with DrägerService.
For repairs of the Caleo incubators we recommend that you
contact DrägerService.

Intended Use
19
Operating Instructions Caleo, Software 2.n
Applications
Restrictions of Use
Intended Use
Applications
Caleo®is an infant incubator system for premature babies and
sick infants up to a body weight of 5 kg (11 lbs) or a body
length of 55 cm (22 inches), providing a controlled environment
of warmth, humidity*, and elevated O2concentration* in the
patient area. The total body weight when treating twins is
limited to 5 kg (11 lbs).
Caleo is intended for use in clinical environments where
premature babies or infants are treated who require a
controlled climatic environment.
Options for nursing and therapy:
– Convective heat therapy through control of incubator air
temperature or infant skin temperature
– Humidification of the incubator air
–O
2therapy through controlled elevation of the O2
concentration in the patient environment
– Nursery and intensive care via access ports or two large
access doors
– Pivoting bed for raising and lowering the infant’s head
(Trendelenburg and anti-Trendelenburg position)
With monitoring for:
– Air temperature
– Skin temperature
– Relative humidity
–O
2concentration
– Weight*
WARNING !
This device may only be used by properly trained
personnel under the supervision of qualified medical
personnel familiar with the currently known risks and
benefits of using an infant incubator.
* Available option
WARNING !
Dräger cannot warrant or endorse the safe performance
of third party accessories for use with the Caleo
incubator system.
Only use accessories that are qualified to the required
specifications for an intended use in an oxygen enriched
environment.
Restrictions of Use
CAUTION !
Restriction of Distribution
Federal Law (U.S.) restricts this device to sale by or on the
order of a physician.
CAUTION !
Device for use in health care facilities only and exclusively by
persons with specific training and experience in its use.
WARNING !
This device is to be used only in rooms with line power
installations complying with national safety standards
for hospital patient rooms (e.g., IEC/EN 60601-1 "Medical
Electrical Equipment - General Requirements For
Safety").
To maintain grounding integrity, connect only to a
"hospital grade" receptacle.
Always disconnect supply before servicing.
WARNING !
DANGER, risk of explosion if used in the presence of
flammable anesthetics.
This device is neither approved nor certified for use in
areas where combustible or explosive gas mixtures are
likely.
WARNING !
The use of this device requires continuous supervision
of the infant by trained nursing personnel in order to
ensure immediate corrective action in situations with a
risk of patient injury.

Intended Use
20
Operating Instructions Caleo, Software 2.n
Restrictions of Use
WARNING !
General information on electromagnetic compatibility
(EMC) according to the international EMC standard
IEC 60601-1-2
Medical electrical equipment needs special precautions
regarding electromagnetic compatibility (EMC) and needs to
be installed and put into service according to the EMC
information provided in the technical documentation available
from DrägerService upon request.
Portable and mobile RF communications equipment can
affect medical electrical equipment.
Pins of connectors identified with the ESD
warning symbol shall not be touched and not be
connected unless ESD precautionary
procedures are used. Such precautionary
procedures may include antistatic clothing and
shoes, the touch of a ground stud before and during
connecting the pins or the use of electrically isolating and
antistatic gloves. All staff involved in the above shall receive
instruction in these procedures.