caleo_neonatal_incubator_sw_2-n_instructions_for_us.pdf
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D
M E D I C A L
Caleo®
Neonatal Incubator
MT-292-98
Operating Instructions
Software 2.n
Page 2
NOTICE
Proprietary Information
This document contains information in which Draeger Medical, Inc. claimed
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
Draeger Medical, Inc., it is provided solely for the use intended.
Repairs/Modifications
Repairs on this device shall be performed only by DraegerService or Factory
Authorized Service Centers. Information about repairs can be obtained from
Dräger or Authorized Dealers. Draeger Medical, Inc. will not be responsible
for injury to persons or damage to property arising directly or indirectly out of
unauthorized repairs or modifications to this device. Furthermore, any
unauthorized repairs or modifications void any warranty extended by Dräger.
This document is provided for your information only. It will not be exchanged
or updated without request.
Trademarks
The Dräger name and logo are registered trademarks of Dräger.
Caleo, and Caleo Twincubator are registered trademarks of Dräger.
BabyLink, Caleo Calmcapsule, Caleo CleanSwitch, Caleo SoftBed, Caleo
JumboPorts, KangarooMode, ThermoMonitoring, ThermoPad, and ThermoTrace are trademarks of Dräger.
© Dräger Medical AG & Co. KGaA, 2002
All rights reserved, Subject to modifications
Operating Instructions Caleo, Software 2.n
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How to use these Operating Instructions
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.
Preparation
Installing Accessories
Accessory poles
Screw on
pole 38 mm/600 (2M 50 691) or alternatively
pole 38 mm/310 (2M 50 688) or alternatively
pole 25 mm/600 (2M 50 689).
● Remove cover plate from the frame base.
● Screw pole fully into the frame base and tighten firmly.
Check that it is securely hold in position.
CAUTION !
Max. distance between loads and pole: 150 mm (6 inches).
Moving the control unit to the opposite side
for pole, 38 mm
1 Loosen the clamping screw to remove control unit.
(Support control unit to prevent it from dropping once
clamping screw is loosened).
2 Loosen the clamping screw to remove holder.
● Move holder to the other pole and set to the desired
working height.
2 Tighten clamping screw to fix holder in position.
1 Tighten clamping screw to secure control unit to the holder.
1
2
02437572
The left-hand column ...
contains text
explaining the device and guiding the user directly to its uses
through concise, ergonomically arranged instructions.
● Bullet points refer to individual actions.
1 numbers refer both to illustrations and the sequence of
action when several steps are required to complete a task.
22837570
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).
Infusion support attachment (2M 21 514)
for pole, 38 mm
CAUTION !
Maximum load per hook is 3 kg (6.6 lbs).
● Place pole clamp of the IV support on the upright mounting
support.
● Secure IV support by tightening the clamp knob.
01037570
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.
Operating Instructions Caleo, Software 2.n
14737572
31
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Operating Instructions Caleo, Software 2.n
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Contents
Operating Instructions Caleo, Software 2.n
Important Safety Information
7
Intended Use
20
What's What
21
Operating Concept
27
Preparation
29
Checking Readiness For Operation
48
Operation
53
Care
109
Maintenance
124
Troubleshooting
127
Theory of Operation
135
Glossary
149
Technical Data
151
Ordering Information
157
Index
161
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Operating Instructions Caleo, Software 2.n
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Page 7
Important Safety Information — Intended Use
Contents
Important Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Operator's Responsibility for Patient Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Limitation of Liability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Summary of WARNINGS and CAUTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Operating Instructions Caleo, Software 2.n
Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Restrictions of Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
7
Page 8
Important Safety Information
Operator's Responsibility for Patient Safety
Important Safety Information
Operator's Responsibility for Patient Safety
WARNING !
Strictly follow this Operator's Instruction Manual
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 12).
Observe all WARNINGS and CAUTIONS as rendered
throughout this manual and on labels on the equipment.
The design of this equipment, the accompanying literature,
and the labeling on the equipment take into consideration that
the purchase and use of this 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 Medical, Inc. disclaims all liability for the
consequences of product alterations 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 manufacturers if such a
combination is not endorsed by Draeger Medical, Inc.
8
Draeger Medical, Inc.'s liability, whether arising out of or
related to manufacture and sale of the goods, their installation,
demonstration, sales representation, use, performance, or
otherwise, including any liability based upon Draeger Medical,
Inc.'s Product Warranty, is subject to and limited to the
exclusive terms and conditions as set forth, whether based
upon breach of warranty or any other cause of action
whatsoever, regardless of any fault attributable to Draeger
Medical, Inc. and regardless of the form of action (including,
without limitation, breach of warranty, negligence, strict
liability, or otherwise).
THE STATED EXPRESSED WARRANTlES ARE IN LlEU OF
ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED,
INCLUDING, WITHOUT LIMITATION, WARRANTlES OF
MERCHANTABILITY, FITNESS FOR ANY PARTICULAR
PURPOSE, OR NONINFRINGEMENT.
Draeger Medical, Inc. shall not be liable for, nor shall buyer be
entitled to recover any special incidental, or consequential
damages or for any liability incurred by buyer to any third party
in any way arising out of or relating to the goods.
Operating Instructions Caleo, Software 2.n
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.
Limitation of Liability
Page 9
Important Safety Information
Warranty
Warranty
All Dräger products are guaranteed to be free of defects for a
period of one year from date of delivery.
The following are exceptions to this warranty:
Application of this warranty is subject to the following
conditions:
1. The defect shall be a result of workmanship or material.
Defects caused by misuse, mishandling, tampering, or by
modifications not authorized by Draeger Medical, Inc. or its
representatives are not covered.
2. Rubber and plastic components and materials are
warranted to be free of defects at time of delivery.
Any product which proves to be defective in workmanship or
material will be replaced, credited, or repaired with Draeger
Medical, Inc. holding the option. Draeger Medical, Inc. is not
responsible for deterioration, wear, or abuse. In any case,
Draeger Medical, Inc. will not be liable beyond the original
selling price.
1. Draeger Medical, Inc. or its authorized representative must
be promptly notified, in writing, upon detection of the defective
material or equipment.
2. Defective material or equipment must be returned,
shipping prepaid, to Dräger or its factory authorized service
center.
3. Examination by Dräger or its factory authorized service
center must confirm that the defect is covered by the terms of
this warranty.
4. Notification in writing, of defective material or equipment
must be received by Dräger or its factory authorized service
center no later than two (2) weeks following expiration of this
warranty.
The above is the sole warranty provided by Draeger Medical,
Inc.
No other warranty expressed or implied is intended.
Representatives of Dräger are not authorized to modify the
terms of this warranty.
Operating Instructions Caleo, Software 2.n
Draeger Medical, Inc., Telford, PA
9
Page 10
Important Safety Information
Definitions
Definitions
WARNING !
A WARNING statement refers to conditions with a possibility of personal injury if disregarded.
CAUTION !
A CAUTION statement designates the possibility of damage
to equipment if disregarded.
NOTE: A NOTE provides additional information intended to
avoid inconveniences during operation.
Inspection
Service
Repair
Maintenance
=
=
=
=
examination of actual condition
measures to maintain specified condition
measures to restore specified condition
inspection, service, and repair, where
necessary
Preventive
= Maintenance measures at regular
Maintenance
intervals
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.
Operating Instructions Caleo, Software 2.n
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Page 11
Important Safety Information
Summary of WARNINGS and CAUTIONS
Summary of WARNINGS and CAUTIONS
WARNING !
WARNING !
Strictly follow this Operator's Instruction Manual
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 12).
Observe all WARNINGS and CAUTIONS as rendered
throughout this manual and on labels on the equipment.
The use of this device requires continuous supervision of
the infant by trained nursing personnel in order to avoid
immediate corrective action in situations with a risk of
patient injury.
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 601.1, "Safety of
Medical Equipment").
To maintain grounding integrity, connect only to a
"hospital grade" receptacle.
Always disconnect supply before servicing.
WARNING!
Mobile telephones must not be used within 10 meters
(33 feet) of the incubator. Mobile telephones can interfere with the function of electromedical equipment and
therefore endanger the patient!
CAUTION !
Restriction of Distribution
Federal Law and Regulations in the United States and
Canada restrict this device to sale by or on the order of a
physician.
This device for use only in health care facilities and to be
used only by persons with specific training and experience in
the use of the device.
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 DraegerService through your vendor.
For repairs of the Caleo incubators we recommend that you
contact DraegerService.
Operating Instructions Caleo, Software 2.n
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.
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Page 12
Important Safety Information
Summary of WARNINGS and CAUTIONS
Precautions During Preparation
WARNING !
Always observe all precautions against fire hazards from
oxygen (see page 55).
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 !
Never leave infant unattended when access doors or
hand ports are open 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 !
WARNING !
Always ensure that hand port catches are securely
engaged in order to avoid any risk of an infant falling out
of an incubator.
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 !
WARNING !
When opening and closing front door, avoid pinching or
jamming hoses and cables in the attached double wall.
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 !
WARNING !
Always ensure that both knobs of the 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!
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 !
WARNING !
When opening and closing side doors, avoid pinching or
jamming hoses and cables in the attached double wall.
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).
12
WARNING !
Do not use any additives for water intended for
humidifying the incubator.
WARNING !
Use only unopened original bags containing pure and
sterile distilled water.
Do not use any additives for water intended for
humidifying the incubator.
Water bags for humidifaction must not be confused with
infusion solutions!
Operating Instructions Caleo, Software 2.n
WARNING !
Do not reach between incubator housing and housing
support while tilting the bassinet. Risk of injury!
Page 13
Important Safety Information
Summary of WARNINGS and CAUTIONS
WARNING !
Connections to the integrated power strip should only be
made by factory trained and authorized technical service
personnel.
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. 2A).
Do not exceed the maximum permissible total leakage
current. For the leakage current of Caleo without socket
strip (see "Technical Data", page 152).
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.
CAUTION !
When mounting control unit to its pole, ensure that there is
sufficient space to swivel the control unit
(see "Tilting the bed", page 45).
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 !
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 swivelling!
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).
Operating Instructions Caleo, Software 2.n
CAUTION !
Maximum loads for pole extensions
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 155).
For items attached to column on swivel shelves,
do not exceed load of 3 kg (6.6 lbs).
— 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).
When fitting accessories, please note:
● The accessory equipment must not collide with the unit
when adjusting the tilt angle and height of Caleo®.
● The accessory equipment on the handle side does not
move with the main unit during height adjustment of
Caleo® (Handle side, see page 155).
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Page 14
Important Safety Information
Summary of WARNINGS and CAUTIONS
Precautions During Operation
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 Seite 155).
WARNING !
Make sure that all hoses and cables are routed correctly
and safely without obstruction! Otherwise:
Risk of extubation! Danger of disconnection!
WARNING !
CAUTION !
Always check that connecting O2 supply hose is of sufficient
length when using independent O2 flowmeter, allowing for
the height adjustments of the bassinet.
CAUTION !
The permissible gas pressure is between 300 and 500 kPa
(43.5 and 73 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 !
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 !
Cables and hoses must be carefully routed to avoid kinking,
tear or pinching when adjusting the incubator tilt angle!
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 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 59.
14
Operating Instructions Caleo, Software 2.n
CAUTION !
[ Exclusively use sterile distilled or demineralized water for
humidifying the incubator!
Never leave infant unattended when the canopy, double
walls, front door, or hand ports are open, when the bed
has been pulled out or when access grommets have been
removed. Risk of patient injury. Infant may fall out of the
incubator.
Page 15
Important Safety Information
Summary of WARNINGS and CAUTIONS
WARNING !
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.
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.
— Use the original Caleo® air filter (MX 17 015) only!
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.
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 channelled directly to the infant.
WARNING!
Operating Instructions Caleo, Software 2.n
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 !
Due to the physiological risks from O2, it is mandatory to
monitor O2 concentrations continuously during the
administration of O2, either using the integrated O2
measurement 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.
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.
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 patient capsule.
The mist of nebulized substances may impair the proper
function of the incubator.
15
Page 16
Important Safety Information
Summary of WARNINGS and CAUTIONS
WARNING !
WARNING !
When using Kangaroo Mode, the 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.
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 601.1, "Safety of
Medical Equipment").
To maintain grounding integrity, connect only to a
"hospital grade" receptacle.
Always disconnect supply before servicing.
WARNING !
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.
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 !
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!
Cleaning mode may only be used while Caleo is not occupied by a patient.
WARNING !
Never cover phototherapy lamp or incubator canopy with
cloths, aluminium foil or other materials 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.
WARNING !
Always use eye protection for the infant when using
phototherapy.
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.
16
Risk of burns upon contact with the heater!
Do not disassemble Caleo while in cleaning mode.
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 601.1, "Safety of Medical
Equipment", 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 152.)
Operating Instructions Caleo, Software 2.n
WARNING !
WARNING!
Page 17
Important Safety Information
Summary of WARNINGS and CAUTIONS
WARNING !
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.
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 !
Mobile telephones must not be used within 10 meters
(33 feet) of the incubator. Mobile telephones can
interfere with the functioning of electromedical
equipment and therefore endanger the patient.
WARNING !
When the extended setpoint range for skin temperature is
used, particular care must be taken to monitor infant
temperature.
WARNING !
Regularly measure infant temperature!
Do not leave canopy open for any length of time, otherwise the air temperature inside the incubator will drop.
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 !
When the extended setpoint range for air temperature is
used, particular care must be taken to monitor infant
temperature.
WARNING !
Monitor infant constantly when canopy, doors, or hand
ports are open, to ensure infant cannot fall out of the
incubator.
WARNING !
Operating Instructions Caleo, Software 2.n
Always verify that skin temperature sensor probe is
specified and approved for use with Dräger Caleo.
WARNING !
Do not use skin temperature sensors 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 !
Always keep in mind the physiological risks and fire
hazards associated with the use of high O2 concentrations.
CAUTION !
When fitting accessories, please note:
● The accessory equipment must not collide with the unit
when adjusting the tilt angle and height of Caleo®.
● The accessory equipment on the handle side must not
move with the main unit during height adjustment of
Caleo® (page 155).
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
openings in the sensor unit. Keep these openings free from
dirt.
CAUTION !
Only use phototherapy units supplied with their own stand.
Do not put phototherapy devices directly on Caleo canopy.
17
Page 18
Important Safety Information
Summary of WARNINGS and CAUTIONS
Precautions During Care
WARNING !
WARNING !
Always follow accepted hospital procedures for handling
equipment contaminated with body fluids.
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 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 !
[ Use only Caleo® air intake filter (MX 17 015).
Fire hazard.
WARNING !
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 !
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.
Always disconnect all supplies before disassembly.
CAUTION !
U-grommets cannot be autoclaved at 134 oC (273 oF).
WARNING !
Risk of burns upon contact with the heater.
Allow Caleo to cool down before further disassembly.
CAUTION !
Take care not to damage the sensor unit when removing
patient bed.
WARNING !
The incubator is ready for operation only when all checks
have been carried out successfully.
WARNING !
Always ensure that both knobs of the 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!
18
CAUTION !
Do not allow any moisture to enter the control panel.
Do not disinfect control panel by immersion or spraying.
Equipment damage may result.
Operating Instructions Caleo, Software 2.n
CAUTION !
Do not allow any moisture to enter the sensor unit.
Do not disinfect sensor unit by immersion or spraying.
Sensor damage may result.
Page 19
Important Safety Information
Summary of WARNINGS and CAUTIONS
Precautions During Maintenance
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.
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 DraegerService for
maintenance 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.
Operating Instructions Caleo, Software 2.n
CAUTION !
For disposal of batteries and O2 sensors follow all local,
state, and federal legislation with respect to environmental
protection.
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 DraegerService through your vendor.
For repairs of the Caleo incubators we recommend that you
contact DraegerService.
19
Page 20
Intended Use
Applications
Restrictions of Use
Intended Use
Restrictions of Use
CAUTION !
Restriction of Distribution
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.
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 O2
concentration* 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
— O2 therapy through controlled elevation of the O2 concentration in the patient environment
— Nursery and intensive care via hand ports or two large
access doors
— Pivoting bed for raising and lowering the infant’s head
(Trendelenburg and anti-Trendelenburg position)
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 !
Mobile telephones must not be used within 10 meters
(33 feet) of the incubator. Mobile telephones can
interfere with the function of electromedical equipment
and therefore endanger the patient!*
*
Dräger medical equipment conforms to the interference immunity
requirements laid down in product-specific standards or in
EN 60601-1-2 (IEC 60601-1-2). However, depending on the design
of a mobile phone and the use situation, field strengths exceeding
the values laid down in the specified standards may be generated
in the immediate vicinity of mobile phones, thereby causing
interference and malfunctions.
Operating Instructions Caleo, Software 2.n
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.
20
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 601.1, "Safety of
Medical Equipment").
To maintain grounding integrity, connect only to a
"hospital grade" receptacle.
Always disconnect supply before servicing.
WARNING!
WARNING !
Available option
WARNING !
The use of this device requires continuous supervision of
the infant by trained nursing personnel in order to avoid
immediate corrective action in situations with a risk of
patient injury.
With monitoring for:
— Air temperature
— Skin temperature
— Relative humidity
— O2 concentration
— Weight*
*
Federal Law and Regulations in the United States and
Canada restrict this device to sale by or on the order of a
physician.
This device for use only in health care facilities and to be
used only by persons with specific training and experience in
the use of the device.
Page 21
What’s What / Operating Concept
Contents
What’s What / Operating Concept
Contents
What's What . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Front View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Side View, Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Top View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
22
23
23
24
Operating Concept . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Operating Instructions Caleo, Software 2.n
Control Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
21
Page 22
What's What
Front View
What's What
Front View
1
2
3
4
5
6
7
8
9
10
11
12
13
14
Canopy
Hand port
Front door
Transport handle
Bassinet frame
Drawer (2M 50 565)*
Castors
Pedals for height adjustment*
Height adjustable column*/ bassinet mount
Connection for water heater (luer lock)*
X-ray drawer / slide-out bed
Display
Control unit
Upright mounting support
13
12
14
1
2
3
4
11
10
5
6
9
8
22
Available option
Operating Instructions Caleo, Software 2.n
*
8
11137572
7
Page 23
What's What
Side View, Connections
Side View, Connections
1
2
3
4
5
6
7
8
9
10
11
Central alarm light
Sensor unit, temperature sensor connections
Line power connection
On/off switch
Air intake filter (MX 17 015)
O2 connection for O2 control*
Water container (2M 50 040)*
Twin access U-grommets (2M 50 385)
Side door
U-grommets (2M 50 412)
Feeding grommet, hood (2M 50 352)
10
11
1
2
9
8
3
4
7
11237572
6
5
Top View
12
12
12
*
13
13
22337572
Operating Instructions Caleo, Software 2.n
12 Leveling guides
13 Heating air vents
Available option
23
Page 24
What's What
Labels
Labels
1
Connections for skin
temperature sensors,
page 64
T1
1
T2
∑ 2 A max.
T 2 H 250V IEC127-2/V
M10A UL 198G
auxiliary power strip,
page 47,
Technical Data,
page 152
Type designation for
fuses for auxiliary
power strip
Type designation
for system fuses
Equipotential
bonding
On/off switch,
page 58
ID/rating plate
NRTL/C
REF 2M50555
SN
V~
A
Hz
ARXX–0000
120
8,3
60
5
2
4
6
3
24437572
2
2M50555ARXX–0000
Made in Germany
Dräger
Medizintechnik GmbH
23542 Lübeck, Germany
2000
Use the original Caleo air filter only!
Risk of fire!
3
7
8
9
10
11
12
300 kPa min.
500 kPa max.
2000
2001
2002
2003
2004
2005
Filter label,
exchange filter
monthly, see
page 112
page 36
O2
5
24
Aquadest
page 46
Operating Instructions Caleo, Software 2.n
4
1
31 2
3
4
5
6
Page 25
What's What
Labels
6
Caleo Infant Incubator
Quick Reference
For detailed information, always refer
to Caleo Operating Manual !
Before use, check device according to
Instructions in Operating Manual.
Air
Switch on device (rear side of mobile
stand).
Skin
Select control mode by pressing button.
Adjust settings with rotary dial knob.
Confirm settings by pressing dial knob.
See text messages in case of alarm.
DANGER!
Risk of explosion if used in the presence of flammable
anesthetics.
WARNING - FIRE HAZARD!
Keep all sources of ignition out of the room in which the
incubator is located.
Higher risk of ignition and fire in air enriched with oxygen.
All oxygen valves, connections and seals must be kept
free of oil and grease.
Open valves slowly.
Do not use any electrical equipment inside the incubator
other than equipment or instruments expressly designed
and approved for use inside incubators.
WARNING!
Disconnect supply before servicing.
Repairs on this equipment to be performed by DraegerService or factory trained and authorized personnel only.
CAUTION!
Opening of covers by DraegerService or factory trained
and authorized personnel only.
To maintain grounding integrity connect only a 'hospital
grade' power outlet.
Federal (US) Law restricts this device to sale by or on the
order of a physician.
Operating Instructions Caleo, Software 2.n
WARNING!
Danger of patient injury: never leave infant unattended
when doors or handports are open.
WARNING!
Check infant temperature and skin condition at regular
intervals and adjust temperature setting to individual
patient needs.
Check incubator temperature, incubator function, and
temperature sensor attachment at regular intervals.
Improper attachment or location of the temperature
sensor may cause cooling or overheating of the patient.
WARNING!
External radiant heat sources such as radiant heaters or
sunlight may increase incubator air temperature above the
set level
WARNING!
Never block or obstruct air vents! Risk of burning!
Draeger Medical, Inc.
3136 Quarry Road
Telford, PA 18969
25