Dräger Medical Babytherm 8004 User manual

MT-292-98
Operating Instructions
Babytherm 8004/8010
Open Care Infant Warmer System
WARNING:
For a full understanding of the
performance characteristics of this
equipment, the user should carefully
read this manual before operating.

2
Operating Instructions Babytherm 8004/8010, 4th ed.
NOTICE
Proprietary Information
This document contains information in which Dräger Medical, Inc. 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 Medical, Inc., it is provided solely for the use intended.
Repairs/Modifications
Repairs on this device shall be performed only by DrägerService or factory
authorized technical service personnel. Information about repairs can be
obtained from Dräger or Authorized Dealers. Dräger 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. Further-
more, any unauthorized repairs or modifications void any warranty extended
by Dräger Medical Inc.
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 Drägerwerk
Aktiengesellschaft.
Babytherm, BabyLink, and ThermoMonitoring are trademarks of
Drägerwerk Aktiengesellschaft.
© Dräger Medical AG & Co. KGaA 2001 . . . 2003
All rights reserved, Subject to modifications

Operating Instructions Babytherm 8004/8010, 4th ed.
Contents
Important Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . 4
Operator's Responsibility for Patient Safety . . . . . . . . . . . . . . 4
Limitation of Liability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Summary of WARNINGS and CAUTIONS . . . . . . . . . . . . . . . 7
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Restrictions of Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Theory of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Description of System Components . . . . . . . . . . . . . . . . . . . 17
Alarm System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Operating Concept . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Preparing Pole Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . 20
X-ray Tray . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Preparing the Bed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Bed Canopy (Available Accessory) . . . . . . . . . . . . . . . . . . . . 24
Attaching Ventilator Circuit Support Arm . . . . . . . . . . . . . . . 24
Drainage Canister Hook . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Accessories for Oxygen Therapy . . . . . . . . . . . . . . . . . . . . . . 25
Storage Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Preparing for Intra-Hospital Patient Transport . . . . . . . . . . . 26
Testing Readiness for Operation . . . . . . . . . . . . . . . . . . . . . 27
Before First Time Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Before Each Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Precautions During Infant Care . . . . . . . . . . . . . . . . . . . . . . 31
Adjusting the Height (Available Option) . . . . . . . . . . . . . . . . 34
Switching On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Manual Heater Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Using Skin Temperature Control . . . . . . . . . . . . . . . . . . . . . . 37
ThermoMonitoring™ Technique . . . . . . . . . . . . . . . . . . . . . . . 43
Switching Radiant Warmer Off . . . . . . . . . . . . . . . . . . . . . . . . 44
Using Heated Gel Mattress (Babytherm 8010) . . . . . . . . . . 44
Notes on Heater Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Using the Bed Canopy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Using Phototherapy (Available Option) . . . . . . . . . . . . . . . . . 53
Switching Lighting On/Off . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Central Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Oxygen Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Suction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Taking X-Rays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Shutting Down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Activating Configuration Modes . . . . . . . . . . . . . . . . . . . . . . . 59
Using Configuration Modes . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Equipment Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Disassembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Cleaning / Disinfecting / Sterilizing . . . . . . . . . . . . . . . . . . . . 64
Before Next Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Inspection and Maintenance . . . . . . . . . . . . . . . . . . . . . . 66
Replacement of Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Preventive Maintenance Intervals . . . . . . . . . . . . . . . . . . . . . . 66
Disposing of the Babytherm . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
General System Failures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Mattress Heater (Babytherm 8010) . . . . . . . . . . . . . . . . . . . . 67
Radiant Heater . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
What’s What . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Radiant Warmer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Controller . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Controller - Rear View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Ordering Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
Parts List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Activating Configuration Modes . . . . . . . . . . . . . . . . . . . . . . . 59
Using Configuration Modes . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Equipment Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Disassembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Cleaning / Disinfecting / Sterilizing . . . . . . . . . . . . . . . . . . . . 64
Before Next Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Inspection and Maintenance . . . . . . . . . . . . . . . . . . . . . . 66
Replacement of Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Preventive Maintenance Intervals . . . . . . . . . . . . . . . . . . . . . . 66
Disposing of the Babytherm . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
General System Failures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Mattress Heater (Babytherm 8010) . . . . . . . . . . . . . . . . . . . . 67
Radiant Heater . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
What’s What . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Radiant Warmer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Controller . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Controller - Rear View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Ordering Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
Parts List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

Important Safety Information
4
Operating Instructions Babytherm 8004/8010, 4th ed.
Operator's Responsibility for Patient Safety
Limitation of Liability
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.
Dräger 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 Dräger Medical, Inc.
Patient monitoring
The operators of the infant warmer 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.
The responsibility for the selection of the best level of patient
monitoring lies solely with the equipment operator.
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.
The equipment is only to be used for the purpose
specified under “Intended Use” on page 14.
Observe all WARNINGS and CAUTIONS as rendered
throughout this manual and on labels on the equipment.
Limitation of Liability
Dräger 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 Dräger 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 Dräger
Medical, Inc. and regardless of the form of action
(including, without limitation, breach of warranty, negligence,
strict liability, or otherwise).
THE STATED WARRANTlES ARE IN LlEU OF ALL OTHER
WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING,
WITHOUT LIMITATION, WARRANTlES OF
MERCHANTABILITY, FITNESS FOR ANY PARTICULAR
PURPOSE, OR NONINFRINGEMENT.
Dräger 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.

Important Safety Information
5
Operating Instructions Babytherm 8004/8010, 4th ed.
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:
1. The defect shall be a result of workmanship or material.
Defects caused by misuse, mishandling, tampering, or by
modifications not authorized by Dräger 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 Dräger
Medical, Inc. holding the option. Dräger Medical, Inc. is not
responsible for deterioration, wear, or abuse. In any case,
Dräger Medical, Inc. will not be liable beyond the original
selling price.
Dräger Medical, Inc. is not responsible for normal
deterioration, wear, or abuse. In any event, Dräger Medical,
Inc. will not be liable beyond the original selling price of said
items. This warranty applies only if the following conditions are
met:
1. Dräger Medical, Inc. or its qualified representative is
promptly notified, in writing, upon detection of the defective
material or equipment.
2. Examination by Dräger Medical, Inc. or its qualified
representative confirms that the defect is covered by the terms
of this warranty.
The exclusive remedy in the event of breach of this warranty
shall be limited to repair or replacement of, or credit for, the
product, equipment or parts. Dräger Medical, Inc. alone shall
choose which of these options is appropriate.
The above is the sole warranty provided by Dräger Medical,
Inc. This warranty is in lieu of all other warranties, written or
oral, statutory, express or implied, including without limita-
tion the warranty of merchantability, fitness for a particular
purpose or non-infringement of patent, trademark, or copy-
right.
Dräger Medical, Inc., Telford, PA

Important Safety Information
6
Operating Instructions Babytherm 8004/8010, 4th ed.
Definitions
Definitions
NOTE: A NOTE provides additional information intended to
avoid inconveniences during operation.
Typing conventions in this manual
Display messages are printed as »message«, e. g:
»battery charge low«
Controller keys are designated in bold print, e.g.
man.
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.
Inspection examination of actual condition
Service measures to maintain specified condition
Repair measures to restore specified condition
Maintenance inspection, service, and repair, where
necessary
Preventive
Maintenance
Maintenance measures at regular
intervals

Important Safety Information
7
Operating Instructions Babytherm 8004/8010, 4th ed.
Summary of WARNINGS and CAUTIONS
Summary of WARNINGS and CAUTIONS
General WARNINGS and CAUTIONS
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.
The equipment is only to be used for the purpose speci-
fied under "Intended Use" (see page 12). Observe all
WARNINGS and CAUTIONS as rendered throughout this
manual and on labels on the equipment.
WARNING !
Babytherm 8004/8010 must only be used by properly
trained clinical and nursing staff under the supervision of
a qualified physician familiar with the currently known
risks and benefits of using an infant warmer.
WARNING !
Dräger cannot warrant or endorse the safe performance
of third party accessories for use with the Babytherm
8004/8010 infant warmer 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, "Safety
of Medical Equipment").
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!
Electrical connections to equipment which is not listed in
these Operating Instructions should only be made follo-
wing consultations with the respective manufacturers or a
qualified expert.
WARNING !
General information regarding electromagnetic compati-
bility (EMC) in accordance with the international EMC
standard IEC 60601-1-2: 2001
Electrical medical devices are subject to special precautio-
nary measures with respect to electromagnetic compatibility
(EMC) and must be installed and commissioned in accor-
dance with the EMC information provided in the technical
documentation available on request from DrägerService.
Portable and mobile HF communication devices can
affect electrical medical devices.
Do not touch the pins on plugs carrying ESD
warnings and do not establish connections
between these plugs without taking protec-
tive measures against ESD. Such measures
include wearing antistatic clothing and shoes,
holding an earthing bolt before and during connection, or
wearing electro-insulating or antistatic gloves. The staff
concerned should receive training in respect of these
ESD protective measures.
WARNING !
Do not use mobile phones within 33 feet (10 m) of the
device.
Mobile phones can cause interference to electrical and elec-
tronic medical devices, thereby putting patients at risk.
*
*Dräger medical devices comply with the interference immunity
requirements of the specific standards for the products or
EN 60601-1-2 (IEC 60601-1-2). However, depending on the design
of the mobile phone and situation of use, field strengths may occur
in the immediate environment of a mobile phone that exceed the
limits of the standards quoted and therefore cause interference.
WARNING !
It is the responsibility of the physician to draw conclu-
sions from any skin temperature measurements taken.
WARNING !
Skin temperature control must not be used with infants in
shock. Because of reduced peripheral blood flow the skin
temperature of these infants occasionally lies well below
the core body temperature. Using a skin temperature
control system could lead to overheating. We recommend
to set heater output manually when caring for patients
with such conditions.

Important Safety Information
8
Operating Instructions Babytherm 8004/8010, 4th ed.
Summary of WARNINGS and CAUTIONS
Precautions during preparation
WARNING !
Always check infant temperature at least at the intervals
of the timed alarm when using radiant heater in manual
mode.
WARNING !
Do not use skin temperature control for infants with a
fever. Their skin temperature is significantly higher than
normal so that controlling skin temperature would lead to
hypothermia. We recommend to set heater output manu-
ally when caring for patients with such conditions.
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.
Device for use only in health care facilities and only by
persons with specific training and experience in the use of
the device.
WARNING !
Stability
To ensure continued protection against tipping over,
do not place unit on a slope of more than 10°.
Always observe load restrictions on indivual shelves/
poles as well as maximum combined load capacities.
WARNING !
For active infants use side panels of 230 mm (9 inch)
height.
Inner panels must be used with all patients, regardless of
whether (outer) side panels are open or closed!
Otherwise the patient could fall out!
Supervise active and older infants particularly closely.
WARNING !
Always select correct mattress type for intended mode of
operation, i.e. foam mattress for use without mattress
heater, gel mattress for use with matress heater
(Babytherm 8010 only).
Precautions during operation
WARNING !
To minimize the tendency of a mattress to slip at
maximum tilt, do not use sheets that would cover
mattress fully from the underside.
Use Dräger fitted mattress cover sheet (2M 21 272)
WARNING !
When preparing accessories for oxygen therapy, observe
all precautions against fire hazards from oxygen as
described in "Operation", page 56.
WARNING !
Use of the radiant warmer can cause an unnoticed
increase in the infant’s water loss.
WARNING !
Monitor oxygen concentration at all times during oxygen
therapy with an independent oxygen analyzer and take
the necessary precautions against the physiological risk
associated with the administration of oxygen, see
"Operation", page 56.
CAUTION !
Always verify that monitor shelves and other accessories are
securely attached.
Always observe the following load limits per shelf:
max. 20 kg (44 lbs),
total load on both poles: max. 30 kg (66 lbs).
For items attached to pole on swivel shelves, do not exceed
load of 5 kg on that pole.
CAUTION !
Do not use the x-ray tray in the extended position to write on.
Do not place objects other than x-ray plate on tray.
Do not lean on the tray. Risk of damage.
WARNING !
Never leave infant unattended when surrounding panels
are down. Risk of patient injury! Infant may fall out of the
bassinet.

Important Safety Information
9
Operating Instructions Babytherm 8004/8010, 4th ed.
Summary of WARNINGS and CAUTIONS
WARNING !
When operating surrounding panels, take care not to
pinch patient body parts, circuits, or other items, such as
bedding sheets.
WARNING !
Side panels must be securely locked in position and the
panel hardware must be visible above the surface of the
bed.
Inner panels must be used with all patients, regardless of
whether the side panels are open or closed.
With lively and/or older infants, 230 mm (9 inch) high
side panels should be used.
WARNING !
Continuous or intermittent audible alarms require imme-
diate operator attention to avert or to prevent develop-
ment of situations with the possibility of patient injury.
WARNING !
All accessories used must comply with national safety
standards for electromedical equipment used in patient
rooms (e.g. IEC/EN 60601.1).
WARNING !
Infant Temperature Monitoring
Check infant temperature and skin condition at regular
intervals as prescribed by hospital protocol and adjust
temperature setting to individual patient needs.
Infant temperature must be closely monitored during
phototherapy or while the radiant heater is used in
conjunction with mattress heater.
Watch out for exposure to sunlight.
WARNING !
Mattress Heater
(Babytherm 8010 only)
When mattress heating is used, the gel mattress must be
placed directly on the heated tray surface.
Do not use Dräger gel mattress (part no. 2M 20 827) in
any bassinets other than the Babytherm 8010. Use of a
gel mattress with unheated bassinets will result in uncon-
trolled cooling of infant.
Do not use a foam mattress with Babytherm 8010.
Heater plate temperatures above 40 oC (104 oF) impli-
cate the danger of patient burns when Babytherm 8010
is operated without the specified gel mattress.
Always take into account warm-up time of the mattress.
Wait approximately 1 hour before placing an infant in the
bassinet.
Do not switch off Babytherm while an infant is lying on the
gel mattress as this will result in uncontrolled cooling of
infant.
WARNING !
Do not touch top of radiant warmer or protective screen.
Danger of burn injuries!
WARNING !
Do not place any objects on top of the radiant warmer.
Impeding ventilation may create a fire hazard!
WARNING !
When operating the radiant warmer while the bed is tilted,
closely monitor parts of the infant’s body that are closer
to the heater. They will receive more heat.
WARNING !
Do not use flammable cleaning agents or medications
while radiant heater is in operation.
Fire hazard!
WARNING !
Do not put any medications or infusion solutions in the
heated area.

Important Safety Information
10
Operating Instructions Babytherm 8004/8010, 4th ed.
Summary of WARNINGS and CAUTIONS
WARNING !
Always check infant temperature at least at the intervals
of the timed alarm when using radiant warmer in manual
mode.
WARNING !
Do not use skin temperature control for infants in a state
of shock!
Skin temperature of these infants is much lower than
normal. Infants would be overheated using the automatic
skin temperature control. For infants in a state of shock,
set heater output to »man.« and measure infant tempera-
ture every 15 minutes.
WARNING !
Do not use skin temperature control for infants with a
fever. Their skin temperature is significantly higher than
normal. Using automatic skin temperature control would
lead to hypothermia. For infants with a high temperature,
set heater output to »man.« and measure infant tempera-
ture every 15 minutes.
WARNING !
Always use eye protection for the infant when using
phototherapy. Check regularly that the eye protection is
correctly positioned.
WARNING !
Always consider all aspects of an infant’s diffferentiated
diagnosis to ensure that no life-saving measures are
delayed.
Regularly measure the patient’s bilirubin level. Beware of
possible toxic effects of bilirubin photoisomers.
WARNING !
Always operate phototherapy lights in combination with
radiant warmer. Otherwise risk of hypothermia for the
undressed infant can occur.
Infant temperature must be closely monitored during
phototherapy because of the additional transfer of heat to
the infant.
Do not use reflective foil to boost the effect of photother-
apy. A dangerous rise of the infant temperature can occur
when using reflective foil.
WARNING !
Phototherapy can upset the the patient’s water balance.
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 !
Direct eye contact with the radiation source for an
extended period of time should be avoided when in use.
Protect patients in the immediate vicinity of the photother-
apy device from the radiation emitted, e.g. by using gog-
gles and shields.
Users should avoid remaining in the area of irradiation for
extended periods due to the risk of sunburn.
WARNING !
Fire Hazards from oxygen!
— 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 slowly.
— Do not operate Babytherm in the presence of
flammable anesthetics or disinfectants.
— Do not use or store flammable liquids such as alcohol,
ether, or acetone inside the Babytherm bassinet.
— Do not use electrical equipment inside canopy with the
exception of devices approved for use in explosive
environments.
WARNING !
Physiological risks of oxygen!
— Oxygen therapy only on the order of a physician.
— Elevated oxygen concentrations must be selected on
the basis of arterially measured oxygen partial
pressure in the infant's blood. Otherwise risk of
hyperoxemia (eye injuries with consequential blind-
ness) or hypoxemia (brain injuries) can occur.
— Monitor oxygen concentration at all times during
oxygen therapy using an independent oxygen analyzer.
WARNING !
Always monitor closely infant temperature when
bed canopy is in use.

Important Safety Information
11
Operating Instructions Babytherm 8004/8010, 4th ed.
Summary of WARNINGS and CAUTIONS
WARNING !
Never leave Babytherm unattended with the side panels
open. Risk of patient injury can occur! Infant may fall out
of the bassinet.
WARNING !
Do not perform any infant care or therapy while configur-
ing the system, because normal equipment functions
(e.g. temperature measurement, alarms) are disabled.
WARNING !
Always verify that sensor probe is specified and approved
for use with Dräger Babytherm 8004/8010.
WARNING !
Do not place sensor probe underneath the infant.
The measured value for skin temperature would become
distorted by the mattress.
WARNING !
Never use skin temperature probes for rectally measuring
infant temperature.
Specifically, never use skin temperature probe rectally for
skin temperature control as this would measure and use
core instead of skin temperature for control.
WARNING !
When using skin temperature control mode, check infant
skin condition at regular intervals as prescribed by hospi-
tal protocol and verify that skin temperature probe is
securely attached. A detached probe will measure air
temperature and the baby might become overheated.
WARNING !
Always warm up mattress before placing infant.
Do not switch off Babytherm while a baby is lying on the
gel mattress. Risk of hypothermia.
WARNING !
Check infant temperature at regular intervals as
prescribed by hospital protocol and adjust temperature
setting to individual patient needs.
WARNING !
Do not use a gel mattress with Babytherm 8004.
The unheated gel mattress would cool the infant.
Risk of hypothermia can occur!
WARNING !
Always consider all aspects of an infant’s diffferentiated
diagnosis to ensure that no life-saving measures are
delayed.
Regularly measure the patient’s bilirubin level.
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 leave infant unattended while radiant warmer is in
operation.
Measure infant temperature at regular intervals as
prescribed by hospital protocol.
CAUTION !
Keep gel mattress clear of sharp objects. Risk of damage
can occur!
Do not fold or kink gel mattress. Roll up for transport.
CAUTION !
Do not place any objects above or underneath bassinet
where they might be damaged when height adjustments are
made.
CAUTION !
Always use cables with sufficient length for secure
connection at minimum and maximum height.
CAUTION !
Always observe the load limit of 50 kg (110 lbs) when electric
height adjustment option is installed.
CAUTION !
Do not use the x-ray tray in the extended position to write on.
Do not place objects other than x-ray plate.
Do not lean on the tray. Risk of damage.

Important Safety Information
12
Operating Instructions Babytherm 8004/8010, 4th ed.
Summary of WARNINGS and CAUTIONS
Precautions during equipment care
CAUTION !
When using external phototherapy devices, keep in mind that
the maximum load on the bed canopy is11 kg (24 lbs).
WARNING !
Always follow accepted hospital procedures for handling
equipment contaminated with body fluids.
WARNING !
Always disconnect power supply before cleaning and
disinfecting.
CAUTION !
Do not fold gel mattress.
CAUTION !
Certain components of the bassinet 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 bassinet itself with ethylene oxide (EtO) is
also not recommended.
CAUTION !
Do not expose Babytherm 8004/8010 to high levels of
ultraviolet radiation. This may cause cracks in the acrylic
glass components.
CAUTION !
Only use detergents/disinfectants with a ph value of 7 to 9
for phototherapy lenses.
Precautions during maintenance
WARNING !
To avoid any risk of infection, clean and disinfect bassinet
and accessories before any maintenance according to
established hospital procedures – this applies also when
returning units or parts for repair.
WARNING !
Maintenance work on the Babytherm 8004/8010 may be
performed by trained and factory authorized staff only.
WARNING !
Always disconnect power supply before servicing.
WARNING !
Never operate the infant warmer system if it has suffered
physical damage or does not seem to operate properly.
We recommend that you contact DrägerService for
maintenance service of the Babytherm 8004/8010.
WARNING !
When servicing the device, always use replacement parts
that are qualified to Dräger standards.
Dräger cannot warrant or endorse the safe performance
of third party replacement parts for use with Babytherm
infant warmers.
CAUTION !
Maintenance
The device must be inspected and serviced at regular
intervals. A record must be kept on this preventive
maintenance. We recommend obtaining a service contract
with DrägerService through your vendor.
For repairs of the device we recommend that you contact
DrägerService.

13
Operating Instructions Babytherm 8004/8010, 4th ed.
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Intended Use
14
Operating Instructions Babytherm 8004/8010, 4th ed.
Applications
Intended Use
Applications
Babytherm 8004/8010 is an open care infant warmer system
for warming premature babies, neonates and infants with a
body weight of up to 8 kg (17.6 lbs).
The device is intended for use in delivery rooms, operating
rooms, maternity and obstetric units, neonatal and pediatric
wards, neonatal and pediatric intensive care units.
Therapy and nursing uses
— As resuscitation table and in birthing rooms, obstetric units,
and NICUs
— As infant warmer bassinet during normal and intensive care
—Forinfantre-warmingandcompensation of heat loss
— For thermal stabilizing of infants with mattress heater
(Babytherm 8010 only)
— For gentle warming therapy using the combination of
radiant and mattress heater
— Cooling infants with fever (temperature of mattress below
infant body temperature, Babytherm 8010 only)
— With adjustable bed tilt for treatment of infants in
Trendelenburg and reverse Trendelenburg position
— For weaning infants from incubators
—ForO
2and nebulizer therapy (with appropriate
accessories)
— For lowering an infant’s bilirubin levels when using the
phototherapy option
Babytherm 8004 heating features
— Radiant warmer operation with a preset warmer output:
Radiant warmer output is set in manual mode, and therapy
time at higher warmer output levels is monitored with a
timed alarm.
— Radiant warmer operation with infant temperature control
("baby control mode"): Infant skin temperature is
automatically monitored and controlled.
WARNING !
Babytherm 8004/8010 must only be used by properly
trained clinical and nursing staff under the supervision of
a qualified physician familiar with the currently known
risks and benefits of using an infant warmer.
Babytherm 8010 heating features
— Radiant warmer operation with a preset warmer output:
The radiant warmer output is set in manual mode, and
therapy time at the higher warmer output levels is
monitored.
— Radiant warmer operation with skin temperature control
(baby control mode): Skin temperature is automatically
monitored and controlled.
— Heated gel mattress, operating independently of the radiant
warmer:
Temperature of the heating pads is automatically monitored
and adjusted to attain and maintain a preselected tempera-
ture at the contact surface between infant and mattress.
Options
—Heightadjustment
— One or two swivel cabinets
— Side panels (150 mm or 230 mm, (5.9 or 9.1 inches))
— IV-pole
— Phototherapy
— Bed canopy
— Swivel tray
— RS 232 interface
Frequently used third party accessories
— Bronchial aspirator
—O
2flowmeter
—O2distributor
—O2distributor with cylinder connection
—O2analyzer
—O2hood
WARNING !
Dräger cannot warrant or endorse the safe performance
of third party accessories for use with the Babytherm
8004/8010 infant warmer system.
Only use accessories that meet the required specifi-
cations for an intended use in an oxygen enriched
environment.

Intended Use
15
Operating Instructions Babytherm 8004/8010, 4th ed.
Restrictions of Use
Restrictions of Use
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 is for use only in health care facilities and only by
persons with specific training and experience in the use of
the device.
WARNING !
This device is to be used only in rooms with properly
grounded 3-wire hospital grade outlets complying with
national safety standards for hospital patient rooms
(e.g., IEC/EN 60601.1, "Safety of Medical Equipment").
To maintain grounding integrity, connect only to a
"hospital grade" receptacle. Always disconnect supply
before servicing.
WARNING !
DANGER! risk of explosion exists if this device is 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 !
Do not use mobile phones within 33 feet (10 m) of the
device.
Mobile phones can cause interference to electrical and
electronic medical devices, therefore placing patients at
risk.*
* Dräger medical devices comply with the interference immunity
requirements of the specific standards for the products or
EN 60601-1-2 (IEC 60601-1-2). However, depending on the design
of the mobile phone and situation of use, field strengths may occur
in the immediate environment of a mobile phone that exceed the
limits of the standards quoted and therefore cause interference.

Theory of Operation
16
Operating Instructions Babytherm 8004/8010, 4th ed.
Overview
Theory of Operation
Overview
20 15 10 5 0 5 10 15 20
Check
Inop.
Babytherm 8004
OK
1
5
10
C
skin
man.
skin C manual
D
Check
Inop.
Babytherm 8010
OK
1
5
10
>38 C
<36 C
C C
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skin C manual matress C
D
Babytherm 8004 Babytherm 8010

Theory of Operation
17
Operating Instructions Babytherm 8004/8010, 4th ed.
Description of System Components
Description of System Components
Babytherm consists of:
— a mobile chassis with infant bassinet
— a control unit with operating panel
— a radiant heater
— a heated gel mattress (Babytherm 8010 only)
Control unit
The control unit is located below the radiant warmer and
between the two support poles at the head end of the bed.
The control panel contains a membrane keypad and integral
alphanumeric display (2 x 40 characters) providing user
guidance for easier operation.
Radiant warmer
The radiant warmer combines two infrared ceramic heaters
and two examination lights for illuminating the bed surface.
The bed surface lighting can be adjusted as a examination
light and for night lighting. The well balanced color spectrum
of the lamps facilitates recognition of diagnostically significant
skin color nuances.
The radiant warmer can be operated in manual control or skin
temperature control mode. In manual mode, fixed warmer
output levels of 1 to 10 are set.
In "skin temperature control" mode, the patient’s skin
temperature is continuously adjusted towards a preselected
optimum setting.
In this mode, the radiant warmer output level is automatically
adjusted to the needs of the patient.
Both modes of operation are monitored by self-check routines
and alarms.
ThermoMonitoring™ technique (available option)
ThermoMonitoring is made possible with a secondary skin
temperature sensor. Abdominal/central and peripheral skin
temperature readings (tummy-toe temperature monitoring) are
displayed on the controller. They can be graphically
represented using the optional interface (RS 232) and
a monitor. This option improves the diagnostic capabilities
of the system.
Phototherapy (available option)
Light from the halogen lamps contributes to photo-chemical
breakdown of bilirubin in the skin. Dräger halogen lights are
particularly effective at wavelengths around 460 nm.
Phototherapy is switched on/off from the main controller
operating panel.
Heated gel mattress (Babytherm 8010)
The mattress heater system consists of the following
components:
gel mattress, aluminium heating plate, and controller.
The gel mattress consists of a highly heat-conductive gel that
does not "run" or move even when the bed is tilted. The gel is
surrounded by a film of soft skin-like material.
The mattress molds itself to the body contours of the patient
laying on it, thereby providing a large contact surface that
transfers warmth to the patient and avoids pressure points.
When the gel mattress is cold, warmth is transferred from the
patient to the mattress.
The gel has good heat storage properties. If the AC power
supply is interrupted, e.g. during in-hospital transport, the
patient will be kept warm for about 15 minutes, provided that
insulation is sufficient (blanket, bed canopy).
The heating system consists of a thick aluminium plate and a
heating element below the plate. This system ensures that heat
is distributed evenly over the entire bed surface.
The control and display panel for the heated gel mattress is
located on the right-hand side of the controller.
Mattress temperature is adjusted with reference to a
temperature setpoint entered by the user. The set temperature
is only reached in areas where the patient is in contact with the
mattress.
System monitoring includes self-check routines and alarms.
Configuration modes
Configuration modes are special operational modes of the
Babytherm 8004/8010 controller. In these modes, information
regarding the current software version and error log can be
checked. The device can also be configured with user specific
settings for skin temperature alarm threshold, volume of
audible alarms, as well as language and display contrast.
A configuration mode can also test the built-in nurse call and
keys of the operating panel.

Theory of Operation
18
Operating Instructions Babytherm 8004/8010, 4th ed.
Alarm System
Alarm System
The Babytherm controller distinguishes three alarm levels.
Warning (high potential risk)
Continuous audible alarm that cannot be silenced in case of:
— device failure
— power failure
Alarm tone sequence that may be silenced in combination with
a blinking red LED for:
— mattress heater sensor failure
— mattress heater exceeding temperature limits
— skin temperature sensor not connected while operating in
skin temperature control mode
— failure of a skin temperature sensor
— skin temperature above 39 oC (102.2 °F)
Caution (medium potential risk)
Alarm tone sequence (may be silenced) in combination with a
blinking yellow LED for:
— deviation between setpoint and measured value of skin or
mattress temperature exceeding tolerance
— 15-minute alarm (as a reminder to check core temperature
at least every 15 minutes with heater levels higher than 4,
during manual mode)
Message (low potential risk)
Display messages for:
— measured values out of measuring range
— low battery voltage
Any alarm that has not been acknowledged is indicated by the
flashing red central alarm light on the radiant heater unit.
The alphanumeric display shows a specific message for the
active alarm.
NOTE: A new alarm being activated will always override
audible alarm silencing.
0
91 29 457092 29 457093 29 457

Theory of Operation
19
Operating Instructions Babytherm 8004/8010, 4th ed.
Operating Concept
Operating Concept
➀ON/OFF indicator:
The green LED is lit when the unit is ON.
The red LED is lit following a power failure.
➁OK button confirms advisory messages and settings.
If the OK button is not pressed within 10 seconds of
entering a new setting, the previous settings remain active.
➂Inop alarm display.
➃Button for checking the LEDs, displays, enunciator, and
audible alarm.
➄Button for silencing audible alarms.
➅Visual display for alarms:
Warning = red LED. Caution = yellow LED.
➆Text display: shows advisory messages for the user.
➇Babytherm 8010 only – display and keypad for the heated
gel mattress:
top: display for the measured mattress temperature.
bottom: display for the set mattress temperature, with
buttons for setting the desired temperature.
094 29 458
Check
Inop.
Babytherm 8010
OK
1
5
10
>38 C
<36 C
C C
skin
man.
skin C manual mattress. C
➀
➁
➂
➃
➄
➅
➆
➇
➈
➉
right: indicators for operation in extended setting range –
high (> 38 °C / 100.4 °F) or low (< 36 °C / 96.8 °F).
➈Display and keypad for the radiant warmer:
top: display for the measured value of the core and peri-
pheral skin temperature.
bottom: display for the set skin temperature with buttons for
setting the desired value and a toggle button for selecting
"man." (manual control mode) or "skin" (skin temperature
control) mode.
The active mode is indicated by the relevant yellow LED.
right: display of heater output levels 1 to 10, for manual
operation of the radiant warmer.
Heater levels 1 to 3 = green LEDs
Heater levels 4 to 10 = yellow LEDs
buttons for selecting the desired increment.
➉On/Off buttons for:
Examination light
Night light
Phototherapy (available option)
Radiant warmer
Each of these buttons has a yellow LED that is lit when the
respective function is switched on.