Page 1
Babytherm 8004/8010
Infant Warmer System
Operating Instructions
D
1-214-94
Page 2
NOTICE
Proprietary Information
This document contains information in which Dräger, 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 Dräger, Inc.,
it is provided solely for the use intended.
Repairs/Modifications
Repairs on this device shall be performed only by DrägerService or its Authorized
Service Centers. Information about repairs can be obtained from Dräger or
Authorized Dealers. Dräger, 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, the name Babytherm and BabyLink are registered
trademarks of Drägerwerk Aktiengesellschaft.
ThermoView and ThermoMonitoring are trademarks of Drägerwerk
Aktiengesellschaft.
Dräger Medizintechnik GmbH 1997
All rights reserved, Subject to modifications
Operating Instructions Babytherm 8004/8010, 2. ed.
Page 3
Contents
Contents
Page
Important Safety Information READ THIS FIRST.4
Operator's Responsibility for Patient Safety............ 4
Limitation of Liability............................................... 4
Warranty................................................................ 5
Definitions.............................................................. 6
General WARNINGS and CAUTIONS................... 7
Precautions During Preparation.............................. 8
Precautions During Operation ................................8
Precautions During Care.......................................11
Precautions During Maintenance...........................11
Intended Use.......................................................12
Theory of Operation............................................ 13
Description of System Components...................... 14
Alarm System....................................................... 15
Operating Concept...............................................16
Preparation..........................................................18
Preparing Column Accessories.............................18
Preparing the Bed.................................................19
Attaching Ventilator Circuit Support Arm...............21
Supplies Storage Options ....................................21
Adjusting the Height (Option) ...............................21
Preparing for Intra-Hospital Patient Transport .......22
Page
Inspection and Maintenance............................... 52
Replacement of Parts............................................52
Preventive Maintenance Intervals.......................... 52
Troubleshooting.................................................. 53
General................................................................ 53
Radiant Heater......................................................53
Mattress Heater....................................................54
What's What........................................................ 55
Overview.............................................................. 55
Radiant Heater......................................................56
Controller............................................................. 57
Controller - Rear View.......................................... 59
Labels.................................................................. 60
Technical Data.....................................................61
Ordering Information...........................................65
Index ................................................................... 66
Testing Readiness for Operation ....................... 23
Before First Use................................................... 23
Before Each Use.................................................. 23
Operation ........................................................... 26
Precautions During Patient Care.......................... 26
Using the Radiant Heater .................................... 28
Setting Heater Output Manually .......................... 28
Using Skin Temperature Control ......................... 30
ThermoMonitoring ............................................... 35
Switching Radiant Heater Off................................36
Using Mattress Heater (Babytherm 8010) ........... 37
Notes on Heater Settings .................................... 40
Using Phototherapy (Available Option).................. 43
Configuration Mode.............................................. 44
Switching Lighting On/Off.................................... 48
Central Alarm....................................................... 48
Taking X-Rays ..................................................... 49
Shutting Down......................................................49
Care ....................................................................50
Disassembly......................................................... 50
Cleaning/Disinfecting/Sterilizing............................51
Before Next Use ................................................. 51
Operating Instructions Babytherm 8004/8010, 2. ed.
3
Page 4
Important Safety Information
Operator's Responsibility for Patient Safety
Limitation of Liability
Operator's Responsibility for Patient Safety
For correct and effective use of the product and in
order to avoid hazards it is mandatory to carefully
read and to observe all portions of this manual.
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, 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, Inc.
Limitation of Liability
Dräger, 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,
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, 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.
Dräger, 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.
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.
Operating Instructions Babytherm 8004/8010, 2. ed.
4
Page 5
Warranty
Important Safety Information
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, 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, Inc. holding the option. Dräger, Inc. is not
responsible for deterioration, wear, or abuse. In any
case, Dräger, Inc. will not be liable beyond the original
selling price.
Application of this warranty is subject to the following
conditions:
1. Dräger, 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 authorized
representative.
3. Examination by Dräger or its authorized
representative 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
authorized representative no later than two (2)
weeks following expiration of this warranty.
In order to assure complete protection under this
warranty, the Customer Registration Card and/or
Periodic Manufacturer's Service Record (if applicable)
must be returned to Dräger within ten (10) days of
receipt of the equipment.
The above is the sole warranty provided by Dräger, Inc.
No other warranty expressed or implied is intended.
Representatives of Dräger are not authorized to modify
the terms of this warranty.
Dräger, Inc., Telford, PA
Operating Instructions Babytherm 8004/8010, 2. ed.
5
Page 6
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 = 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 measures at regular
Maintenance intervals
Typing conventions in this manual
Display messages are printed in bold type, e. g:
Battery discharged
Controller keys are designated as »Key Name«, e.g.
»man.«
Operating Instructions Babytherm 8004/8010, 2. ed.
6
Page 7
General WARNINGS and CAUTIONS
Important Safety Information
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 specified
under "Intended Use" (see page 12). Observe
all WARNINGS and CAUTIONS as rendered
throughout this manual and on labels on the
equipment.
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 601.1, "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 !
Skin temperature control must not be used
with babies in shock. Because of reduced
peripheral blood flow the skin temperature of
these babies 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.
WARNING !
Do not use skin temperature control for
infants with a high temperature. Their skin
temperature is significantly higher than normal
so that controlling skin temperature would lead
to hypothermia. We recommend to set heater
output manually 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 used by persons with specific training and
experience in the use of the device.
WARNING !
Do not use cellular phones within 33 feet (10 m )
of the equipment.
Wireless phones may cause malfunction
in electromedical equipment.
Operating Instructions Babytherm 8004/8010, 2. ed.
CAUTION !
Maintenance
In case of malfunction of this device, contact
your local DrägerService or our Factory
Authorized Technical Service Center.
The device must be inspected and serviced
(preventive maintenance) by competent and
factory authorized technical service representatives at regular 2 year intervals. A record must
be kept on this preventive maintenance. We
recommend obtaining a service contract through
your vendor.
Maintenance or repair of the Babytherm
8004/8010 shall be performed only by Dräger
authorized technical service representatives.
7
Page 8
Important Safety Information
Precautions During Preparation
Precautions During Operation
Precautions During Preparation
WARNING !
Always select correct mattress type for
intended mode of operation (see page 20).
WARNING !
To maintain grounding integrity, connect only
to a "hospital grade" receptacle.
CAUTION !
Always verify that monitor shelves and other
accessories are securely attached.
Always observe the following load limits
per shelf: not to exceed 20 kg (44 lbs).
total load on both columns: max. 30 kg (66 lbs).
For items attached to column on swivel shelves,
do not exceed load of 5 kg on that column.
CAUTION !
Do not place any objects above or underneath
bassinet where they might be damaged when
height adjustments are made.
Precautions During Operation
WARNING !
Never leave patient unattended when
surrounding panels are down. Risk of patient
injury by infant falling out of the bassinet.
WARNING !
For lively and greater babies use side panels
of 23 cm height and additional inner panels.
Supervise the baby corresponding to its
liveliness.
WARNING !
When folding up surrounding panels, take
care not to pinch patient body parts, circuits,
or other items, such as sheets.
WARNING !
Continuous or intermittent audible alarms
require immediate operator attention to avert
or to prevent development of situations with
the possibility of patient injury.
CAUTION !
Never route patient circuits or lines over top of
panels – they may get pinched when folding up
panels or when installing cover.
CAUTION !
Always use circuits and patient lines with sufficient
length for secure connection at minimum and
maximum height.
CAUTION !
Always observe the load limit of 50 kg on the
electric height adjustment.
8
WARNING !
All accessories used must comply with
national safety standards for electromedical
equipment used in patient rooms
(e.g. IEC 601.1).
WARNING !
Patient Temperature Monitoring
Check the baby´s core temperature and skin
condition at regular intervals and adjust temperature setting to individual patient needs.
Core temperature of the baby must be
monitored particularly carefully during
phototherapy or while the radiant heater is
used in conjunction with mattress heater.
Skin temperature monitoring is no substitute
for core temperature checks since the two
parameters do not always closely correlate.
Operating Instructions Babytherm 8004/8010, 2. ed.
Page 9
Important Safety Information
Precautions During Operation
WARNING !
Mattress Heater
(Babytherm 8010 only)
When mattress heating is used, the gel mattress must be placed directly on the heated
tray surface.
The Dräger gel mattress (part no. 2M 20 827)
must not be used in any bassinets other than
the Babytherm. Heater plate temperatures
above 40 °C (104 °F) implicate the danger of
patient burns! Use of a gel mattress with
unheated bassinets will result in uncontrolled
patient cooling.
Always take into account warm-up time of the
mattress (approximately 1 hour) before
placing a patient in the bassinet.
Do not switch off Babytherm while a baby is
lying on the gel mattress as this will result in
uncontrolled cooling of patient .
WARNING !
Do not touch top of radiant heater or
protective screen.
Danger of burn injuries!
WARNING !
Do not use flammable detergents, or medications while radiant heater is in operation.
Fire hazard!
WARNING !
Never leave baby unattended while radiant
warmer is in operation!
Measure core temperature at regular intervals!
WARNING !
Do not put any medications or infusion
solutions in the heated area.
WARNING !
Skin temperature control must not be used
with babies in thermic shock. Because of
reduced peripheral blood flow the skin
temperature of these babies 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 (see page 28).
WARNING !
Do not use skin temperature control for
infants with a high temperature. Their skin
temperature is significantly higher than normal
so that controlling skin temperature would lead
to hypothermia. We recommend to set heater
output manually when caring for patients with
such conditions (see page 28).
WARNING !
Always operate phototherapy lights in combination with radiant heater. Otherwise risk of
hypothermia for the undressed infant.
Core temperature of the baby must be
monitored particularly carefully during
phototherapy because of the additional
transfer of thermal energy to the patient.
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 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
hood with the exception of devices
approved for use in explosive environments.
Operating Instructions Babytherm 8004/8010, 2. ed.
9
Page 10
Important Safety Information
Precautions During Operation
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 patient's
blood. Otherwise risk of hyperoxemia (eye
injuries with consequential blindness) or
hypoxemia (brain injuries).
– Monitor oxygen concentration at all times
during oxygen therapy.
WARNING !
Always verify that sensor probe is specified
and approved for use with Dräger Babytherm
Radiant Warmer 8004/8010.
WARNING !
The sensor probe must never be placed under
the baby. It would be measuring and attempting to control core temperature rather than
skin temperature.
WARNING !
Use temperature settings in the lower extended temperature range only on the order of a
physician. Watch patient particularly carefully!
WARNING !
Always use patient eye protection when using
phototherapy.
WARNING !
Always consider differentiated diagnosis for
patient so life sustaining measures are not
delayed.
WARNING !
Check the baby´s core temperature at regular
intervals. Phototherapy increases heat
transfer to patient.
Measure patient's bilirubin level at regular
intervals
WARNING !
Never use skin temperature probes for rectally
measuring core 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
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
patient.
Do not switch off Babytherm while a baby is
lying on the gel mattress as this will result in
uncontrolled cooling of patient.
CAUTION !
Remove from mattress all objects with sharp
edges. The gel mattress could be damaged!
Do not fold gel mattress!
CAUTION !
Do not place any objects above or underneath
bassinet where they might be damaged when
height adjustments are made.
Operating Instructions Babytherm 8004/8010, 2. ed.
10
Page 11
Important Safety Information
Precautions During Care
Precautions During Maintenance
Precautions During Care
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.
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. In this case, always
refer servicing to properly trained and factory
authorized service personnel.
CAUTION !
Do not expose Babytherm 8004/8010 to high
levels of ultraviolet radiation. This may cause
cracks in the PMMA (acrylic glass) parts.
CAUTION !
Do not launder mattresses in an automatic
washing machine. Do not autoclave mattresses.
CAUTION !
Only use detergents/disinfectants with a
ph value of 7 to 9 for phototherapy lenses.
Operating Instructions Babytherm 8004/8010, 2. ed.
11
Page 12
Intended Use
Intended Use
Babytherm 8004/8010 is an infant warmer system
intended as a therapeutic device providing warmth for
premature and full-term neonates and infants with a
weight up to16 lbs. It is intended for use in delivery
rooms, operating theatres, maternity and obstetric units,
neonatal wards, neonatal and paediatric intensive care
units. Both systems can be equipped with the optional
phototherapy system for treatment of hyperbilirubinemia.
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 601.1, "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.
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 used by persons with specific training and
experience in the use of the device.
Babytherm 8004 warms with a radiant heater providing
both "manual control" and "skin temperature control"
modes.
Babytherm 8010 warms with a radiant heater providing
both "manual control" and "skin temperature control"
modes as well as with a heated gel mattress.
Therapy and nursing uses:
– Resuscitation table
– Bassinet for use in normal and intensive care
– Patient re-warming and prevention of heat loss
– Thermal stabilizing of a patient with mattress heater
(Babytherm 8010, only)
– Gentle warming therapy using the combination of
radiant and mattress heater (Babytherm 8010, only)
– Cooling patients with high temperatures (mattress
temperature below body temperature;
Babytherm 8010, only)
– ThermoMonitoring by tummy-toe temperature meas-
urement for improved feedback of the thermal
condition of a patient
– Trendelenburg and reverse Trendelenburg
positioning
– Weaning of incubator patients to standard
(unheated) bassinet
– Oxygen and aerosol inhalation therapy
with appropriate accessories
– Phototherapy for lowering of patient blood bilirubin
levels (with phototherapy option)
– X-Ray assistance
Options
– Power column for electric height adjustment
– One or two (with power column installed) swivel
cabinets
– Double (inner) walls
– IV-pole
– Phototherapy
– Hood
– Swivel tray
Operating Instructions Babytherm 8004/8010, 2. ed.
12
Optional accessories
– Bronchial suction equipment
–O2-management accessories (flowmeter,
headhood, monitor)
– Interface for data output
Page 13
Overview
Babytherm 8004
D
10
°C
5
Skin °C manual
1
Skin
man.
Babytherm 8004
OK
Babytherm 8010
D
Skin °C manual Mattress°C
Check
Inop.
10
°C °C
5
1
Skin
man.
Operating Concept
Overview
Babytherm 8010
Check
>
38°C
<
Inop.
36°C
OK
Operating Instructions Babytherm 8004/8010, 2. ed.
13
Page 14
Theory of Operation
Description of System Components
Description of System Components
Babytherm consists of
– a mobile chassis with the attached infant bed
– a controller unit with operating panel
– a radiant heater, and
– a mattress heating system (Babytherm 8010 only)
Controller unit
The controller unit is located below the radiant warmer
between the two support columns at the head end of
the bed. The panel contains a membrane keypad and
display area. Integrated into the alphanumeric display
(2 x 40 characters) is a user guide for easier operation.
Radiant heater
The radiant warmer combines two infrared ceramic
heaters and 2 lights for illuminating the bed surface.
An integrated phototherapy light is optional.
The work light provides two settings, for daytime and
for nighttime lighting. The well balanced color spectrum
of the lamps used makes it easier to recognize diagnostically significant skin color nuances.
The radiant warmer can be operated in manual control
mode or skin temperature control mode.
"Manual" control mode provides fixed heater output
level settings from 1 through 10.
"Skin control" controls skin temperature according to a
preset value. Heater output is then automatically
controlled to patient needs.
Both modes of operation are monitored with check
routines and alarm schemes.
ThermoMonitoring
ThermoMonitoring is made possible with a secondary
skin temperature sensor. Skin temperatures taken
close to the body core and at the periphery (tummy-toe
temperature monitoring) are displayed on the controller
unit. They can be graphically represented on a PC via
optional serial interface (RS 232), using Dräger's
ThermoView software, improving diagnostic
possibilities.
Mattress heating
The Babytherm 8004/8010 features a mattress heating
system that uses conductive heat transfer to warm up
patients and to keep them warm.The system consists
of a gel mattress, an aluminum heating plate and an
electronic control and monitoring unit.
The gel mattress is made of a gel material with
excellent heat conducting properties, which won't dislocate even when the bed is tilted. The gel is enclosed
by a soft, skin compatible film.
The mattress molds itself to the body contours of the
patient lying on it, resulting in a large contact surface, a
property facilitating heat conduction to the patient and
avoiding pressure points (anti-decubitus effect). A cold
gel mattress, on the other hand, dissipates a patient's
thermal energy. The gel material has an excellent capacity for storing heat. When the power supply is disconnected (e.g. during a transport within the hospital), the
patient is kept warm for approximately 15 minutes if
sufficiently insulated (blanket, cover).
The aluminum heating plate consists of a 6 mm
(1/4 inch) thick aluminum plate and a heater element
attached below. It distributes heat evenly over the
entire bed area.
The mattress heater membrane keypad with its buttons
and display is located on the right-hand side of the
controller unit.
Mattress temperature is controlled according to the set
value entered. It adjusts in such a way that the set
temperature is reached (but not exceeded) in those
areas where the patient is in contact with the mattress.
System monitoring includes check routines and alarm
features.
Configuration mode
Configuration mode is a special operational mode of
the Babytherm 8004/8010 controller. In this mode,
information regarding software version and error log
cna be polled. The device can also be programmed
with user specific settings of skin temperature alarm
threshold, volume of audible alarms, as well as
language and contrast of the alphanumeric display. It
also serves to test the built-in nurse call and keys of the
operating panel.
Operating Instructions Babytherm 8004/8010, 2. ed.
14
Page 15
Phototherapy (available option)
Light from the halogen lamps contributes to photochemical breakdown of bilirubin in the skin.
Dräger halogen lights emit very effectively at wavelengths around 460 nm without the blue light often
associated with phototherapy. They therefore provide
for good skin color representation.
Phototherapy is switched on the main controller panel.
Modes of heater operation Babytherm 8004
– Operation of radiant heater with preset heater output:
Heater output is controlled in "manual" mode and
therapy is time-limited for higher heater output
settings.
– Operation of radiant heater in "skin control" mode:
Skin temperature is monitored and controlled.
Theory of Operation
Description of System Components
Modes of heater operation Babytherm 8010
– Operation of radiant heater with preset heater output:
Heater output is controlled in "manual" mode and
therapy time-limited for higher heater output settings.
– Operation of radiant heater in "skin control" mode:
Skin temperature is monitored and controlled.
– Mattress heater, independent of radiant heater:
Temperature of heating surface monitored and
controlled to maintain a preset temperature in the
contact area between infant and mattress.
Operating Instructions Babytherm 8004/8010, 2. ed.
15
Page 16
Theory of Operation
Alarm System
Alarm System
The Babytherm controller distinguishes three levels of
alarms.
High potential for patient risk
a continuous audible alarm (enunciator) that cannot be
silenced, for:
– device malfunction,
– power failure
an alarm tone sequence (loudspeaker) that can be
silenced in combination with flashing red LED, for:
– mattress heater sensor failure,
– mattress heater exceeding temperature limits,
– skin temperature sensor not connected during
skin control,
– sensor failure of tummy or toe skin temperature
sensor.
Medium potential for patient risk
an alarm tone sequence (can be silenced ) in
combination with flashing yellow LED, for:
– deviation between set and measured value for
skin or mattress temperature exceeding tolerance,
– 15-minute alarm (as a reminder to check core
temperature during manual mode with heater
levels higher than 3).
Low potential for patient risk
Display messages for:
– measured values out of measuring range,
– low battery voltage.
Any alarm that has not been acknowledged is indicated
by flashing red central alarm light on the radiant heater
unit.
The display shows a specific message for the alarm
activated.
NOTE: A new alarm being activated will always override
audible alarm silencing.
Operating Instructions Babytherm 8004/8010, 2. ed.
1
Central Alarm
1 Red light on radiant heater starts flashing simul-
taneously with any audible alarms.
Acknowledging the alarm will switch light off.
16
Page 17
Operating Concept
Theory of Operation
Operating Concept
D
➈
°C °C
Skin °C manual Mattress °C
Skin
man.
10
5
1
➇
➉
➆
Babytherm 8010
>
38°C
<
36°C
OK
Check
Inop.
➅
➄
➃
➂
➁
➀
Status LEDs
➀
Green LED continuously on during operation.
Red LED continuously on during power outages.
➁ »OK« key for confirming settings and to acknowledge
alarms.
NOTE: If the »OK« key is not pressed within
10 seconds after changing a setting, the previous
settings will remain in effect!
➂ Red indicator LED for "Inop." alarm.
➃ Key for testing LEDs, displays, enunciator, and
audible alarm.
➄ Key for silencing audible alarms.
➅ Visual display of alarms:
Warning = red LED, Caution = yellow LED.
➆ Text display, shows user messages and alerts.
➇ Babytherm 8010 only – display and keypad for
operating mattress heater:
top: display of measured mattress temperature;
bottom: display of set value for mattress temperature
with keys for setting;
to the right: indicator for operation in extended range
Operating Instructions Babytherm 8004/8010, 2. ed.
high (>38 °C), low (<36 °C).
➈ Display and keypad for radiant heater:
top: display for measured values of skin temperatures
close to core (tummy) and at periphery (toe);
bottom: Set value for skin temperature using keys for
changing set value and key for switching between
manual and skin temperature control mode. The
currently active mode is indicated by the respective
yellow LED;
Further to the right: bar graph for displaying heater
levels 1 through 10 for manual mode operation
Heater levels 1 to 3 = green bar elements,
Heater levels 4 to 10 = yellow bar elements,
and below, keys for setting heater levels.
➉ On/Off keys for switching:
work light,
night light,
phototherapy (available option)
radiant heater.
The respective yellow LEDs are lit during operation.
17
Page 18
Preparation
Preparing Column Accessories
Preparation
Preparing Column Accessories
Monitor shelf
Babytherm comes equipped with one monitor shelf.
Mounting rail elements (available option) to monitor shelf:
● Attach rail element to left and/or right of monitor shelf
with screws provided.
CAUTION !
Always verify that monitor shelves and other
accessories are securely attached.
Always observe the following load limits
per shelf: not to exceed 20 kg (44 lbs).
total load on both columns: max. 30 kg (66 lbs).
For items attached to column on swivel shelves,
do not exceed load of 5 kg on that column.
Compact rail
For placing smaller accessories, e.g. O2 flowmeter,
O2 monitor.
● Attach compact rail element to one of the columns
at a convenient height.
Instrument tray
For small instruments, maximum load capacity
3 kg (6.5 lbs).
● Put clamp of instrument tray on one of the columns
and tighten hand screw.
Recommended height: mattress level.
Operating Instructions Babytherm 8004/8010, 2. ed.
● Keep area clear for swiveling tray.
See above CAUTION for load limits to maintain a safe
level of stability against tipping over pursuant IEC
standards.
18
Page 19
Preparing the Bed
The bed is surrounded by two side panels and two end
panels, which can be opened independently of each
other. End panels have cutouts with U-grommets for
routing circuits and patient cables.
Installing surrounding panels
Preparation
Preparing the Bed
1 Insert lower pins on panel hinges into the left- and
right-hand slots in bassinet base.
● Position panel semi-upright.
2 Press panel down firmly, until pins lock into position at
the bottom of slots.
● Tilt panel fully upright and let it slide into locking
position.
● Install all four panels in the same fashion.
Verify that the panels are seated correctly!
To open:
● Lift panel all the way up, until upper pins on hinge
brackets are out of their guide slots, then fold down.
Installing inside panels
2
2
11
Use inside panels to protect the baby from falling out
when side panels are open.
● Insert pins in tapered holes and press down slightly
until the inside panel is firmly seated.
● Repeat for second inner panel.
WARNING !
For lively and greater babies use side panels
of 23 cm height and additional inner panels.
Supervise the baby corresponding to its
Operating Instructions Babytherm 8004/8010, 2. ed.
liveliness.
19
Page 20
Preparation
Preparing the Bassinet
Fitting a mattress
● Select mattress type:
– Operation with mattress heating
(Babytherm 8010 only):
Gel mattress 2M 20 827.
– Operation without mattress heating
(Babytherm 8004):
Foam rubber mattress 2M 21 012.
WARNING !
Always select correct mattress type for
intended mode of operation.
● Place the mattress in bassinet and cover it with a thin
sheet.
NOTE: Do not obstruct conductive heat transfer by
blankets or other insulating covers placed underneath the
patient.
Tilting the bed
1 Pull handle of locking mechanism toward front.
2 Push handle down = head-up position.
Pull handle up = head-down position.
● Release locking handle, the bed locks into position.
The bed can be tilted in increments of 0.5°.
Maximum tilt angles:
Trendelenburg position: 20°
Reverse Trendelenburg position: 15°
Preferred positions:
horizontal position,
10° Trendelenburg (head up) and
10° reverse Trendelenburg position (head down).
1
Operating Instructions Babytherm 8004/8010, 2. ed.
2
At max. tilt angle the mattress can slip from its position:
● In this case don't place sheet underneath the
mattress.
20
Page 21
Preparation
Attaching Ventilator Circuit Support Arm
Supplies Storage Options
Adjusting the Height (Option)
Attaching Ventilator Circuit Support Arm
● Insert flexible support arm into hole in the left side of
head panel and tighten with knurled screw.
Supplies Storage Options
Units with height adjustable column:
– swivel cabinet (available option) with 2 compartments
and 1 swivel tray
Units without electric height adjustment:
– 2 open compartments in the column (standard),
or
– 1 swivel cabinet with 2 compartments and
1 swivel tray (available option).
Adjusting the Height (Option)
1 Briefly depress right pedal.
The bassinet is raised.
2 Briefly depress left pedal.
The bassinet is lowered.
● Adjust to comfortable working height.
CAUTION !
Do not place any objects above or underneath
bassinet where they might be damaged when
height adjustments are made.
CAUTION !
Always use circuits and patient lines with sufficient
length for secure connection at minimum and
maximum height.
CAUTION !
Always observe the load limit of 50 kg on the
electric height adjustment.
Operating Instructions Babytherm 8004/8010, 2. ed.
1
2
21
Page 22
Preparation
Preparing for Intra-Hospital Patient Transport
Preparing for Intra-Hospital Patient Transport
● If height adjustment option is installed, lower bed to
lowest possible position.
● Swivel all cabinet trays inward.
● Swivel instrument tray inward.
● Detach or relocate any accessories protruding
sideways from the unit.
● Turn off heating systems and disconnect unit from
power.
For intra-hospital transport of a patient with
Babytherm 8004/8010:
Install cover (available accessory) to protect patients from
cold drafts:
1 Position cover on the end panels.
Side panels can still be opened when cover is
installed, end panels cannot be opened.
2 Verify inside temperature with thermometer mounted
inside the cover.
NOTE: When using cover, use 230 mm high side panels.
2
1
Operating Instructions Babytherm 8004/8010, 2. ed.
22
Page 23
Testing Readiness for Operation
Before First Use
● Verify that supplied voltage matches values
indicated on the rating plate next to the power cables.
WARNING !
To maintain grounding integrity, connect only
to a "hospital grade" receptacle.
● Connect both power plugs to power supply.
Testing Readiness for Operation
Before First Use
Before Each Use
Before Each Use
● Has the unit been disinfected?
● Are the surrounding panels locked securely into place,
and do they stay closed? Panel hardware is visible
above the bed surface.
● Are all panels free of cracks and sharp edges?
● Is the correct mattress in the bassinet?
Operation with mattress heater ➡ gel mattress,
operation without mattress heater ➡ foam rubber
mattress.
● Does the bed tilt properly and lock securely into
position?
● Does the electric height adjustment work properly?
● Is the thermometer in the cover (available option)?
● Are accessories and therapy equipment available and
in proper working order?
● Is gas supply available and sufficient for accessories
to be used?
● Are all circuits and patient lines installed securely and
properly?
CAUTION !
Never route patient circuits or lines over top of
panels – they may get pinched when folding up
panels or when installing cover.
Operating Instructions Babytherm 8004/8010, 2. ed.
23
Page 24
Testing Readiness for Operation
Before Each Use
Switching on and activating self test
● Press On/Off button, until it engages = ON.
Running a self test, Babytherm will now check
important functions.
1 The green »Power On«-LED is lit.
%$
2 After approximately 2 seconds, Babytherm displays
the radiant heater mode:
»man.« – no skin temperature probe connected
or
»Skin« – at least the yellow ("tummy") skin temperature probe is connected.
The respective LED is blinking.
3 The preconfigured set values are displayed.
4 If text message Battery discharged is showing and
5 yellow LED is lit, the rechargeable battery for power
failure alarm is being recharged. After approximately
30 minutes, the battery will be sufficiently recharged.
5 The yellow LED will be off.
6 If the red »Inop.« LED is lit = device malfunction,
see "Troubleshooting", page 53.
Testing LEDs, displays and audible alarm
7 Press k key.
8 Display shows message:
All displays on, horn on
All display elements remain on for about 2 seconds, all
LEDs are lit; the digital displays show 88.8
simultaneously with a continuous audible alarm from
the enunciator.
8 Display shows message:
All displays off, soft alarm on
All display elements remain dark for about 2 seconds,
simultaneously with an intermittent audible alarm.
This functional test may be performed also during
operation.
4
10
5
skin°C manual mattress.°C
3
skin
man.
1
3
2
8
10
5
skin°C manual mattress.°C
skin
man.
1
Babytherm 8010
°C
<
36°C
Babytherm 8010
°C
<
36°C
5
15min
6
1
Operating Instructions Babytherm 8004/8010, 2. ed.
15min
7
● Check at least once a day.
24
Page 25
Testing power failure alarm
● Disconnect power plug.
1 Red LED N will light simultaneously with continuous
audible alarm.
● Reconnect power.
Babytherm will continue to operate with values set
before power failure.
Testing Readiness for Operation
Before Each Use
Babytherm 8010
10
5
1
skin°C manual mattress.°C
skin
man.
°C
<
36°C
15min
Testing lights
2 Press key, bed surface is now lit by work light.
2 Press key again, work light will go off.
3 Press key, bed surface is now lit by night light.
3 Press key again, night light will go off.
23
1
Operating Instructions Babytherm 8004/8010, 2. ed.
25
Page 26
Operation
Precautions During Patient Care
Operation
Precautions During Patient Care
WARNING !
Never leave patient unattended when
surrounding panels are down. Risk of patient
injury by infant falling out of the bassinet.
WARNING !
When folding up surrounding panels, take
care not to pinch patient body parts, circuits,
or other items, such as sheets.
WARNING !
Continuous or intermittent audible alarms
require immediate operator attention to avert
or to prevent development 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 601.1).
Mattress heater
WARNING !
Mattress Heater
(Babytherm 8010 only)
When mattress heating is used, the gel mattress must be placed directly on the heated
tray surface.
The Dräger gel mattress (part no. 2M 20 827)
must not be used in any bassinets other than
the Babytherm. Heater plate temperatures
above 40 °C (104 °F) implicate the danger of
patient burns! Use of a gel mattress with
unheated bassinets will result
in uncontrolled patient cooling.
Always take into account warm-up time of
the mattress (approximately 1 hour) before
placing a patient in the bassinet.
Do not switch off Babytherm while a baby is
lying on the gel mattress as this will result in
uncontrolled cooling of patient .
Radiant heater
WARNING !
Do not touch top of radiant heater or
protective screen.
Danger of burn injuries!
Warmer Therapy
WARNING !
Patient Temperature Monitoring
Check the baby´s core temperature and skin
condition at regular intervals and adjust temperature setting to individual patient needs.
Core temperature of the baby must be
monitored particularly carefully during
phototherapy or while the radiant heater is
used in conjunction with mattress heater.
Skin temperature monitoring is no substitute
for core temperature checks since the two
parameters do not always closely correlate.
Always consider effects of additional sources of heat,
such as phototherapy lamps or radiant heaters. They
increase the heat directed to the patient. Avoid direct
sunlight!
26
WARNING !
Do not use flammable detergents or medications while radiant heater is in operation.
Fire hazard!
Operating Instructions Babytherm 8004/8010, 2. ed.
WARNING !
Never leave baby unattended while radiant
warmer is in operation!
WARNING !
Do not put any medications or infusion
solutions in the heated area.
Page 27
Operation
Precautions During Patient Care
Radiant heater
WARNING !
Skin temperature control must not be used
with babies in thermic shock. Because of
reduced peripheral blood flow the skin
temperature of these babies 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.
WARNING !
Do not use skin temperature control for
infants with a high temperature. Their skin
temperature is significantly higher than normal
so that controlling skin temperature would lead
to hypothermia. We recommend to set heater
output manually when caring for patients with
such conditions.
Phototherapy (available option)
WARNING !
Always operate phototherapy lights in combination with radiant heater. Otherwise risk of
hypothermia for the undressed infant.
Core temperature of the baby must be monitored particularly carefully during phototherapy because of the additional transfer of
thermal energy to the patient.
Oxygen therapy (with optional accessories)
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 slowly
– Do not operate Babytherm in the presence
of flammable anesthetics or diinfectants
– Do not use or store flammable liquids such
as alcohol, ether, or acetone inside the
Babytherm bassinet.
– Do not use electrical equipment inside
hood 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 patient's
blood. Otherwise risk of hyperoxemia (eye
injuries with consequential blindness) or
hypoxemia (brain injuries).
– Monitor oxygen concentration at all times
during oxygen therapy.
Operating Instructions Babytherm 8004/8010, 2. ed.
27
Page 28
Operation
Using the Radiant Heater
Setting Heater Output Manually
Using the Radiant Heater
After switching Babytherm on, it will suggest a mode of
operation for the radiant heater:
– no skin temperature probe connected = »man.«
(manual mode)
– at least the yellow "tummy" skin temperature probe is
connected = »Skin« (skin temperature control mode).
1 The respective yellow LED in the key is blinking.
Setting Heater Output Manually
10
5
1
skin°C manual mattress.°C
skin
man.
1
Babytherm 8010
°C
<
36°C
15min
For instance during short-term treatment, for infants in
thermic shock who should not be treated using skin
temperature control.
In manual mode, the radiant warmer provides preset
heater output, not linked to the body temperature of the
infant.
Output can be manually set between levels 1 and 10,
with setting 10 providing the maximum power output.
For more details see "Technical Data", page 61.
WARNING !
Never leave baby unattended while radiant
warmer is in operation!
Measure core temperature at regular intervals!
To enter manual mode when "Skin" mode is still on:
2 Press key, the yellow LED »man.« starts blinking.
3 The display shows message:
Set radiant heater level
Press OK-button to cancel.
4 Babytherm will offer the current calculated heater
output setting as default.
(After switching on, default heater level is 3.)
Each LED segment reflects a heater level increment:
1 through 3 = green LEDs
4 through 10 = yellow LEDs.
3
10
5
4
skin°C manual mattress.°C
skin
man.
2
1
6
Babytherm 8010
°C
<
36°C
5
Operating Instructions Babytherm 8004/8010, 2. ed.
15min
28
Page 29
1 Press »OK« key = confirm heater output at suggested
level.
Or
Operation
Setting Heater Output Manually
Babytherm 8010
2 press p or P key to select heater output level.
1 Press »OK« key = confirm heater output.
NOTE: If »OK« key is not pressed within approximately
10 seconds, the message will disappear and the previous
setting will remain in effect.
3 Display of newly selected heater output level.
4 Yellow LED in the key is now continuously lit,
" manual" mode is now active.
WARNING !
Measure core temperature at regular intervals!
As a reminder for the required monitoring of core
temperature, an audible alarm is generated every
14 minutes at heater levels 4 or higher.
5 Yellow LED starts blinking, and
● red central alarm light on the radiant heater starts
flashing.
6 display of set heater level starts blinking, and
7 text message appears:
15 min. patient temp check required.
Press OK-button to confirm.
NOTE: After 15 minutes (one minute from time of
message), the heater would shut off if alarm not
acknowledged.
● Check patient temperature.
10
5
3
skin°C manual mattress.°C
skin
man.
4
1
2
7
10
5
6
skin°C manual mattress.°C
skin
man.
1
°C
<
36°C
1
Babytherm 8010
°C
<
36°C
9
15min
15min
5
8
8 Press G key, its yellow LED will be lit continuously.
Or
9 press »OK« key.
The audible alarm will stop, the red central alarm light will
go off, and the heater will be switched on again (will
remain switched on).
NOTE: No reminder alarms are scheduled up to heater
level 3.
NOTE: A skin temperature probe that might be
connected simultaneously in manual mode will provide a
skin temperature reading. It will, however, not control
heater output.
Operating Instructions Babytherm 8004/8010, 2. ed.
29
Page 30
Operation
Using Skin Temperature Control
Using Skin Temperature Control
In this mode of operation, the infant's skin temperature is
controlled towards a set value using a temperature probe
attached to the skin. When the measured value for skin
temperature is lower than the set value, the radiant heater
operates at a high output level. Similarly, it works with
low output levels for high skin temperatures.
WARNING !
Skin temperature control must not be used
with babies in thermic shock. Because of
reduced peripheral blood flow the skin
temperature of these babies 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 (see page 28).
WARNING !
Do not use skin temperature control for
infants with a high temperature. Their skin
temperature is significantly higher than normal
so that controlling skin temperature would lead
to hypothermia. We recommend to set heater
output manually when caring for patients with
such conditions (see page 28).
For setting heater output manually, see page 28.
NOTE: Skin temperature should be the preferred
operating mode under normal conditions. Follow
Warnings and information on page 26.
Operating Instructions Babytherm 8004/8010, 2. ed.
30
Page 31
Connecting skin temperature sensor
When using a Dräger skin temperature sensor
(order separately, see "Ordering Information", page 65).
WARNING !
Always verify that sensor probe is specified
and approved for use with Dräger
Babytherm 8004/8010.
1 Plug yellow sensor connector into yellow jack.
2 Route sensor cable through one of the flexible
grommets onto bed surface.
3 Remove protective paper from adhesive pad and
place sensor probe on pad.
● Remove protective paper from other side and attach
sensor probe with adhesive pad to an appropriate
area of patient's skin.
Operation
Using Skin Temperature Control
NOTE: For replacement sensor pads, see "Ordering
Information", page 65.
When using a disposable temperature sensor:
If the infant is lying on his back:
● Place sensor on the abdomen in the liver region.
If the infant is lying on his stomach:
● Place sensor on the back, preferably in the kidney
region.
WARNING !
The sensor probe must never be placed under
the baby. It would be measuring and
attempting to control core temperature rather
than skin temperature.
WARNING !
Never use skin temperature probes for rectally
measuring core 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.
3
2
1
● Secure sensor cable with adhesive tape as
Operating Instructions Babytherm 8004/8010, 2. ed.
necessary to provide strain relief.
31
Page 32
Operation
Using Skin Temperature Control
WARNING !
When using skin temperature control mode,
check infant skin condition at regular intervals
and verify that skin temperature probe is
securely attached. A detached probe will
measure air temperature and the baby might
become overheated.
NOTE: Always allow skin temperature probe to adjust to
infant's skin temperature.
If a skin temperature probe is connected when switching
on:
1 Babytherm suggests "Skin" temperature mode,
yellow LED »Skin« in the key is blinking.
2 Display shows message:
Check skin sensor position
Press OK-button to confirm.
3 Press »OK« key.
4 Babytherm defaults to a set value of 36.5 °C or to the
most recently used set value, respectively.
3 Press »OK« key = accept set value.
Or
5 press p or P key to set desired value.
Set value is adjustable in 0.1 °C increments.
3 Press »OK« key = confirm set value.
4 New set value is displayed.
1 Yellow LED »Skin« is continuously lit,
"Skin temperature control mode" is active.
6 Measured values of skin temperature are displayed.
7 Display of heater output level changes according to
the current infant skin temperature and the set skin
temperature value.
If Babytherm was in "manual" mode:
1 Press key, the yellow LED »Skin« will start blinking.
Proceed as above.
2
10
6
7
4
skin°C manual mattress.°C
skin
man.
1
5
Babytherm 8010
°C
5
1
<
36°C
15min
3
Operating Instructions Babytherm 8004/8010, 2. ed.
NOTE: Always allow time for the system to reach steady
state! Deviations between set value for skin temperature
and measured values are normally eliminated within 5 to
15 min.
NOTE: An infant's skin temperature changes frequently,
for instance as a result of food intake or treatment
procedures. Deviations of a tenth of a degree are normal.
Therefore:
Only change set value for skin temperature if core temperature needs to be corrected.
32
Page 33
Exceeding the measuring range
If temperature is outside the measuring range
(15 °C to 42 °C):
● 3 dashes at the bottom of display = temperature
below 15 ºC,
● 3 dashes at the top of display = temperature
above 42 ºC.
● Refer to "Troubleshooting", page 54.
For temperatures below below 15 ºC the message
Skin temp. below range
is displayed.
For temperatures below above 42 ºC the message
Skin temp. above range
is displayed.
Operation
Using Skin Temperature Control
°C
°C
In case of a disconnected or defective sensor probe
1 Three blinking dashes in the center of display,
2 blinking red LED and audible alarm.
Additionally, flashing red central alarm light on the
radiant heater.
3 Display shows message:
Plug in skin temp. sensor
Press OK-button to acknowledge.
Or
Skin temp. sensor fault
Press OK-button to acknowledge.
Audible alarm starts after 10 seconds.
● Immediately connect sensor plug or replace sensor.
Audible alarm can be silenced and red central alarm light
be switched off for 10 minutes:
4 Press G key,
or
5 press »OK« key.
3
1
skin°C manual mattress.°C
6
skin
man.
10
5
1
Babytherm 8010
°C
<
36°C
2
4
15min
5
If the sensor problem cannot be remedied immediately:
6 Switch to "manual" mode.
Refer to "Setting Heater Output Manually", page 28.
Operating Instructions Babytherm 8004/8010, 2. ed.
33
Page 34
Operation
Using Skin Temperature Control
Deviations greater than ±0.5 °C between set and
measured value for skin temperature:
1 Display of skin temperature starts blinking.
2 Yellow LED starts blinking.
Additionally, flashing red central alarm light on the
radiant heater.
3 Display shows message:
Skin temp. deviation above 0.5 °C
Press OK-button to acknowledge.
The alarm threshold for skin temperature deviations may
be adjusted in configuration mode, see page 45.
The factory set default is ±0.5 °C.
Audible alarm can be silenced and red central alarm light
be switched off for 10 minutes:
4 Press G key.
or
5 press »OK« key.
2 Yellow LED stays continuously lit.
● Red central alarm light is switched off.
After skin temperature has returned to a value within
±0.5 °C of set temperature, the yellow LED, red central
alarm light, and audible alarm are turned off.
Prior to removing skin temperature probe temporarily,
switch to "manual" mode.
Refer to "Setting Heater Output Manually", page 28.
3
1
skin°C manual mattress.°C
skin
man.
10
5
1
Babytherm 8010
°C
<
36°C
2
4
15min
5
Skin temperature above 39 °C
6 Display of skin temperature starts blinking.
7 Red LED starts blinking, together with audible alarm.
Additionally, blinking red central alarm light on the
radiant heater.
8 Display shows message:
Skin temperature above 39 °C
Press OK-button to acknowledge.
7 Red LED is continuously lit.
In "manual Mode" the heater is switched off at this time.
Audible alarm can be silenced and red central alarm light
be switched off for 2 minutes:
9 Press G key.
or
10 press »OK« key.
When skin temperature has returned to measured values
below 39 °C, the alarm is automatically canceled.
34
8
6
skin°C manual mattress.°C
skin
man.
10
5
1
Babytherm 8010
°C
<
36°C
10
15min
7
9
Operating Instructions Babytherm 8004/8010, 2. ed.
Page 35
ThermoMonitoring
For improved feedback on thermal condition of a patient,
we recommend measuring both central and peripheral
skin temperatures (tummy-toe measurement).
Attaching peripheral skin temperature sensor
1 Plug white sensor connector into white jack.
Operation
ThermoMonitoring
2 Route sensor cable through one of the flexible
grommets onto bed surface.
3 Remove protective paper from adhesive pad and
place sensor probe on pad.
● Remove protective paper from other side and attach
sensor probe with adhesive pad to patient's
extremities, preferably to a foot.
● Secure with skin compatible adhesive tape.
Displaying peripheral temperature
4 Display of peripheral temperature is immediate with
connection of peripheral skin temperature sensor.
5 The foot symbol for peripheral skin temperature is
continuously lit.
If three dashes show in the display for peripheral skin
temperature, please refer to "Troubleshooting", page 53.
NOTE: The measured value of peripheral temperature
has no bearing on radiant warmer control. Both skin
temperatures can also be displayed or queried when
heater is operated in "manual" mode.
3
1
5
4
skin°C manual mattress.°C
skin
man.
10
5
1
2
<
36°C
Babytherm 8010
°C
15min
Data output via optional interface
Both temperatures can be presented in a graphical
format using the following optional accessories:
– BabyLink interface
– Interface cable MediCable
– Windows* PC with ThermoViewTM software.
For installation and operation, refer to the components'
respective operating instructions.
______
Operating Instructions Babytherm 8004/8010, 2. ed.
*Windows is a trademark of Microsoft Corporation
35
Page 36
Operation
Switching Radiant Heater Off
Switching Radiant Heater Off
1 Press key.
2 Display shows message:
Radiant heater OFF
Press OK-button to confirm.
3 Press »OK« key. Radiant heater is turned off.
1 Press key again = radiant heater can be turned on
again, see page 28.
2
10
5
1
skin°C manual mattress.°C
skin
man.
1
Babytherm 8010
°C
<
36°C
3
15min
36
Operating Instructions Babytherm 8004/8010, 2. ed.
Page 37
Using Mattress Heater (Babytherm 8010)
WARNING !
Always warm up mattress before placing
patient.
Do not switch off Babytherm while a baby is
lying on the gel mattress as this will result in
uncontrolled cooling of patient.
Allow approximately 1 hour for thorough warm-up.
Setting a mattress temperature
Temperature can be varied in increments of 0.1 ºC.
Setting temperature in the normal range
(36 °C to 38 °C):
1 Display of current set value for mattress temperature
2 Press P or p key
showing on the display.
3
Display shows message:
Set mattress temperature
Press OK-button to confirm.
If setting is not confirmed within 10 seconds, the
message will disappear and the previous setting will
remain in effect.
, until desired temperature is
Operation
Using Mattress Heater (Babytherm 8010)
3
10
5
1
skin°C manual mattress.°C
skin
man.
1
Babytherm 8010
°C
<
36°C
15min
2
4
4 Press »OK« key = confirm new set value.
1 Display of new set value of mattress temperature.
Extending upper limit of setting range:
5 Press P key, until
6 set value 38.0 ºC is displayed.
7
Display shows message:
Set mattress temperature
Confirm temp. above 38 ºC with OK.
8 Press »OK« key = release extended range.
9 Yellow display >38 ºC is now blinking.
5 Press P or p key
, until desired temperature is
showing on the display.
7
Display shows message:
Set mattress temperature
Press OK-button to confirm.
8 Press »OK« key = confirm new set value.
6 Display of new set value of mattress temperature.
7
10
5
6
skin°C manual mattress.°C
skin
man.
1
5
Babytherm 8010
°C
9
<
36°C
8
15min
Operating Instructions Babytherm 8004/8010, 2. ed.
9 Yellow display >38 ºC stays continuously lit.
37
Page 38
Operation
Using Mattress Heater (Babytherm 8010)
Extending lower limit of setting range:
WARNING !
Use temperature settings in the lower extended temperature range only on the order of a
physician. Watch patient particularly carefully!
1 Press p key, until
2 set value 36.0 ºC is displayed.
3
Display shows message:
Set mattress temperature
Confirm temp. below 36 ºC with OK.
4 Press »OK« key = release extended range.
5 Yellow display <36 ºC is now blinking
1 Press p or P key, until desired temperature is
showing on the display.
3
Display shows message:
Set mattress temperature
Press OK-button to confirm.
3
10
5
1
skin°C manual mattress.°C
skin
man.
1
2
Babytherm 8010
°C
<
36°C
5
15min
4
4 Press »OK« key = confirm new set value.
2 Display of new set value of mattress temperature.
5 Yellow display <36 ºC stays continously lit.
Temperature out of range
If the temperature is outside the measuring range of
5 °C to 45 °C:
– Three lines in the bottom of the display =
temperature is below 5 °C.
● Wait until mattress temperature reaches 5 ºC.
– Three lines in the top of the display =
temperature is above 45 °C.
● Wait until mattress temperature is below 45 ºC.
For temperatures below 5 ºC, the display message
Mattress temp. below 5 ºC will appear.
NOTE: These conditions may occur e.g. when Babytherm
had been stored in ambient conditions beyond the range
of 5 to 45 ºC (41 to 113 ºF).
°C
°C
Operating Instructions Babytherm 8004/8010, 2. ed.
38
Page 39
Deviation from set temperature
In case of deviations greater than ±1 °C between set
and measured mattress temperature values:
1 Yellow LED starts blinking.
2 Measured value of mattress temperature starts
blinking.
3 Display shows message:
Mattress temp. deviation >1 ºC
Press OK-button to acknowledge.
● Audible alarm starts, red central alarm light on radiant
heater starts flashing.
Audible alarm can be silenced for 10 minutes:
4 Press G key,
or
5 press »OK« key.
1 The yellow LED is now lit continuously.
● Red central alarm light is switched off.
When the mattress temperature reading has returned to a
value within ±1 °C of set temperature:
– Yellow LED, red central alarm light and audible alarm
are switched off.
Operation
Using Mattress Heater (Babytherm 8010)
3
10
5
1
skin°C manual mattress.°C
skin
man.
Babytherm 8010
°C
2
<
36°C
15min
5
1
4
After the mattress heater is initially switched on:
– Audible alarm is silenced for 1 hour (warm-up).
1 Yellow LED is lit continuously.
Mattress temperature above 40 °C
6 Red LED »40 °C« starts flashing.
7 Measured value of mattress temperature starts
blinking.
8 Display shows message:
Mattress temp. above 40 ºC
Press OK-button to acknowledge.
● Audible alarm starts, red central alarm light on radiant
heater starts blinking.
9 Press G key,
or
10 press »OK« key.
6 The red LED is now lit continuously.
● Red central alarm light is switched off.
NOTE: The alarm is canceled automatically when tempe-
Operating Instructions Babytherm 8004/8010, 2. ed.
rature has decreased to less than 0.5 ºC from set value.
8
10
5
1
skin°C manual mattress.°C
skin
man.
Babytherm 8010
°C
7
<
36°C
10
6
15 mi n
9
39
Page 40
Operation
Notes on Heater Settings
Notes on Heater Settings
Notes on settings for use of the mattress heater with and
without radiant heater.
Using radiant and mattress heater with a gel mattress
(Babyherm 8010)
Normal settings:
The patient's core temperature will, in the long run, adjust
to the mattress temperature. Therefore, set mattress
heater to a core temperature appropriate for the
particular patient, e.g. between 38.0 ºC and 38.3 ºC for
a premature and to 37 ºC for a term baby.
Set skin temperature to a value appropriate for the
particular patient, e.g. to 37 ºC for a premature and to
36.5 ºC for a term baby.
● To add warmth:
Set mattress temperature to desired skin temperature.
If necessary, set skin temperature to a slightly higher
value.
● To achieve a neutral heat balance:
Set mattress heater temperature to an infant core
temperature and skin control temperature to a skin
temperature that together define the Neutral Thermal
Zone for patient treated.
● To cool patient from below:
Set mattress temperature to desired core
temperature. If necessary, set skin temperature to a
slightly lower value.
40
Operating Instructions Babytherm 8004/8010, 2. ed.
Page 41
Mattress heater with gel mattress operated without
radiant heater (Babytherm 8010)
Normal settings:
The patient's core temperature will, in the long run, adjust
to the mattress temperature. Therefore, set mattress
heater to a core temperature appropriate for the
particular patient, e.g. between 38.0 ºC and 38.3 ºC for
a premature and to 37 ºC for a term baby.
WARNING !
Check the baby´s core temperature at regular
intervals and adjust temperature setting to
individual patient needs.
Operation
Notes on Heater Settings
● Always cover patients, and/or dress them.
NOTE: Do not obstruct conductive heat transfer by
blankets or other insulating covers placed underneath the
patient.
● To add warmth:
Set mattress temperatue to core temperature desired,
or slightly higher in order to accelerate warm-up.
● To cool patient:
set mattress temperature below current core
temperature, e.g. to 36 °C.
Operating Instructions Babytherm 8004/8010, 2. ed.
41
Page 42
Operation
Notes on Heater Settings
Using radiant heater only (Babytherm 8004)
WARNING !
Check the baby´s core temperature at regular
intervals and adjust temperature setting to
individual patient needs.
● Do not use bassinet covers. Otherwise, the radiant
heater will not have the intended effect. The acrylic
hood is not transparent for infared radiation from the
radiant heater.
● Do not cover or dress patient. Otherwise, the radiant
heater effect is impaired in an uncontrolled fashion.
Operating Instructions Babytherm 8004/8010, 2. ed.
42
Page 43
Using Phototherapy (Available Option)
WARNING !
Always use patient eye protection when using
phototherapy.
WARNING !
Always consider differentiated diagnosis for patient
so life sustaining measures are not delayed.
WARNING !
Check the baby´s core temperature at regular
intervals. Phototherapy increases heat transfer to
patient.
Measure patient's bilirubin level at regular intervals.
● Swivel radiant unit over patient. Phototherapy lights
must be positioned vertically above patient for full
effectiveness of the therapy.
Operation
Using Phototherapy (Availble Option)
Switching phototherapy lights on
1 Press key, yellow LED in the key starts blinking.
2 Display shows message:
Phototherapy: Use eye protection
Press OK-button to start XX:XX:XX.
XX:XX:XX = time from the first activation of phototherapy
for the baby up to the switch off of the complete
Babytherm or up to the reset of the counter.
3 Press »OK« key = phototherapy lights are switched
on.
2 Display shows for 5 seconds:
Phototherapy duration XX:XX:XX
1 Yellow LED in key is now continuously lit.
If radiant heater is operated in "manual" mode:
● Reduce heater output approximately 3 levels down
from setting used while phototherapy lights were off.
NOTE: Radiant heater output is adjusted automatically to
patient needs when operated in "Skin" mode.
To reset the babycounter phototherapy
1 Press key for 3 seconds,
2 Display shows:
Phototherapy duration XX:XX:XX
Press OK to reset the counter.
3 Press »OK« key = reset,
3 Display shows:
Phototherapy duration 00:00:0X
2
10
5
1
skin°C manual mattress.°C
skin
man.
1
Babytherm 8010
°C
<
36°C
3
15min
Switching phototherapy lights off
1 Press key
2 Display shows message
Phototherapy OFF
Press OK-button to confirm.
Operating Instructions Babytherm 8004/8010, 2. ed.
3 Press »OK« key = phototherapy lights switched off.
1 Yellow LED in key is now off.
43
Page 44
Operation
Configuration Mode
Configuration Mode
Possible Activities
Code Activity
c01 Displaying current software version
c02 Selecting skin temperature alarm threshold
c03 Adjusting speaker volume for alarms
c04 Hours of operation, phototherapy
c05 Testing control panel keys
c06 Testing nurse call
c07 Selecting language
c08 Adjusting display contrast
Err Error reporting
NOTE: The control panel keys and displays have a
different purpose/meaning than in radiant heater
operation mode!
1 Activate/cancel configuration mode
2 Information regarding current activity
3 Abbreviation of current activity
4 Code of current activity
5 Advance to / back to activity
6 Increase/decrease values for activity selected
7 Activate/leave error reporting mode
8 State changes within activities
9 Display setting for current activity
2
3
4
skin°C manual mattress.°C
9
7
skin
man.
5
10
6
Babytherm 8010
°C
5
1
<
36°C
15min
8
1
Activating configuration mode
1 Keep »OK«-button pressed for 3 seconds.
A brief alert sound is generated.
2 Display message:
Configuration mode
Press OK-button to start.
1 Press OK button again. A brief alert sound is
generated. Configuration mode is now active.
The device defaults to activity »c01« and displays the
current software version
Displaying the software version
1 Display message:
Configuration mode
Mode c01: Software version.
2 The current software version is displayed, e.g.: 1.00.
3 The current activity code c01 is displayed.
2
10
skin°C manual mattress.°C
skin
man.
1
2
10
3
skin°C manual mattress.°C
skin
man.
Babytherm 8010
°C
5
1
<
36°C
15min
1
Operating Instructions Babytherm 8004/8010, 2. ed.
Babytherm 8010
°C
5
1
<
36°C
15min
44
Page 45
Selecting skin temperature alarm threshold
1 Press P key briefly.
2 Display message:
Configuration mode
Mode c02: Max. skin temperature fault.
3 Abbreviation for this activity is displayed: SdE.
4 The current activity code is displayed: c02.
5 Display of set skin temperature alarm threshold where
no alarm is yet generated.
Factory default: 0.5.
6 Press keys P or p, until desired value is displayed.
Values from 0.3 to 1.0 °C selectable in 0.1 °C
increments.
2
3
4
skin°C manual mattress.°C
5
skin
man.
1
6
Operation
Configuration Mode
Babytherm 8010
10
5
1
°C
<
36°C
15min
Adjusting speaker volume for alarm tone sequences
1 Press P key briefly.
2 Display message:
Configuration mode
Mode c03: Soft alarm start volume.
3 Abbreviation for this activity is displayed: SSL.
4 The current activity code is displayed: c03.
5 Display of set speaker volume
Factory default: 2.
A brief audible alarm tone sequence is generated with
that volume.
6 Press keys P or p, until desired value is displayed.
Values from 1 to 8 selectable.
A brief audible alarm tone sequence is generated with
the new volume setting.
Displaying phototherapy hours of operation
1 Press P key briefly.
2 Display message:
Configuration mode
Mode c04: Time counter phototherapy.
3 Display of time of operation up to 1000 hours.
4 Press G key for 3 seconds. The counter is
reset to "0".
NOTE: This activity to be performed at time of photo-
therapy bulb exchange.
2
3
4
skin°C manual mattress.°C
5
skin
man.
1
6
2
3
skin°C manual mattress.°C
3
skin
man.
1
Babytherm 8010
10
5
1
10
5
1
°C
<
36°C
°C
<
36°C
15min
Babytherm 8010
15min
4
Operating Instructions Babytherm 8004/8010, 2. ed.
45
Page 46
Operation
Configuration Mode
Tasting control panel keys
1 Press P key briefly.
2 Display message:
Configuration mode
Mode c05: Keyboardtest (inactive).
3 Abbreviation for this activity is displayed: but.
4 The current activity code is displayed: c05.
5 Press key P or p, test is activated.
2 Display message:
Configuration mode
Mode c05: Keyboardtest (active).
● Press key to be tested.
6 A number sequence will appear in the display:
1. digit = number of keys pressed simultaneously,
2. and 3. digit = ID of key last pressed.
7 Keep G key pressed for 2 seconds to end the test.
3
4
skin°C manual mattress.°C
1
Key numbers:
skin°C manual mattress.°C
1
Babytherm 8010
°C
<
36°C
15min
7
6
skin
man.
2
10
5
1
5
Babytherm 8010
10
5
1
skin
45 67
3
2
man.
°C
<
36°C
15min
15
14
13
Testing nurse call
1 Press P key briefly.
2 Display message:
Configuration mode
Mode c06: Nurse call relay.
3 Abbreviation for this activity is displayed: Nuc.
4 The current activity code is displayed: c06.
5 Display showing 0 = nurse call relay open.
Display showing 1 = nurse call relay closed.
6 Press G key, the relay is switched.
7 Keep k key pressed for 4 seconds. The relay
becomes active.
An Inop-alarm is generated: red LED »Inop.« will light
up accompanied by a continuous audible alarm.
8
9
10
11 12
2
3
4
skin°C manual mattress.°C
5
skin
man.
1
Babytherm 8010
10
5
1
°C
<
36°C
15min
6
7
Operating Instructions Babytherm 8004/8010, 2. ed.
46
Page 47
Selecting language
1 Press P key briefly.
2 Display message:
Configuration mode
Mode c07: Display language –> English.
3 Abbreviation for this activity is displayed: LAN.
4 The current activity code is displayed: c07.
5 Number code of selected language is displayed.
Factory default for US: 2 = English.
6 Press keys P or p, until number code of desired
language appears in the display.
Available settings: 1 through 11.
Setting display contrast
1 Press P key briefly.
2 Display message:
Configuration mode
Mode c08: Display contrast.
3 Abbreviation for this activity is displayed: CON.
4 The current activity code is displayed: c08.
5 Display of contrast setting
Factory default: 128.
6 Press keys P or p, until desired contrast is
displayed.
Values from 1 to 255 selectable in increments of 1.
2
3
4
skin°C manual mattress.°C
5
skin
man.
1
6
2
3
4
skin°C manual mattress.°C
5
skin
man.
1
6
Operation
Configuration Mode
Babytherm 8010
10
5
1
10
5
1
°C
<
36°C
°C
<
36°C
15min
Babytherm 8010
15min
Reading error cache
1 Press key, error reporting is now active
2 Display message:
Configuration mode
Error memory.
3 Displaying error code: FXX.
4 Displaying: Err.
5 Frequency of error displayed here.
6 Pressing keys P or p will call up the next error
code.
7 Pressing k key will invoke the device self test.
8 Keeping G key pressed for 3 seconds will erase
error cache.
Return radiant heater to operation mode:
Operating Instructions Babytherm 8004/8010, 2. ed.
● Press »OK«-key.
2
3
4
skin°C manual mattress.°C
5
skin
man.
1
6
Babytherm 8010
10
5
1
°C
<
36°C
15min
8
7
47
Page 48
Operation
Switching Lighting On/Off
Central Alarm
Switching Lighting On/Off
1 Press key, bed surface is now illuminated by work
light.
1 Press key again, work light is switched off.
Babytherm 8010
2 Press key, bed surface is now illuminated by night
light.
2 Press key again, night light is switched off.
Central Alarm
3 The red central alarm light on the radiant heater unit
starts blinking with any alarm being activated.
It will be switched off after acknowledging alarms.
10
5
skin°C manual mattress.°C
skin
man.
1
2
1
°C
<
36°C
15min
3
48
Operating Instructions Babytherm 8004/8010, 2. ed.
Page 49
Taking X-Rays
Babytherm 8004
● Pull x-ray tray out from under mattress.
● Place x-ray cassette in the appropriate location on the
tray.
Place infant in center of mattress.
● Swivel radiant heater sideways. Heater will continue
warming patient.
● Place x-ray machine above bed surface.
● When x-ray procedure is finished, remove cassette
from tray end return tray.
● Swivel radiant heater back into its normal position.
Babytherm 8010
● Place x-ray film cartridge directly underneath patient.
● Swivel radiant heater sideways. Heater will continue
warming patient
● Place x-ray machine above bed surface.
● When x-ray procedure is finished, remove cassette
from under the patient.
● Swivel radiant heater back into its normal position.
Operation
Taking X-Rays
Shutting Down
Shutting Down
● Press On/Off button.
Green LED indicating operation will be switched off.
● Remove power plug from wall outlet.
Operating Instructions Babytherm 8004/8010, 2. ed.
%$
49
Page 50
Care
Disassembly
Cleaning / Disinfecting / Sterilizing
Care
The Babytherm 8004/8010 infant warmer system must
be thoroughly cleaned and disinfected after each patient,
or at least once a week. Perform any disinfection
procedures according to established hospital procedures
as well as to the following additional instructions.
WARNING !
Always follow accepted hospital procedures
for handling equipment contaminated with
body fluids.
For the cleaning and disinfecting of accessories, refer to
their respective operating instructions.
Disassembly
● Switch off all device(s), pull power plugs), and turn
off all pressurized oxygen and air if used.
WARNING !
Always disconnect power supply before
cleaning and disinfecting.
● Remove any ancillary patient care equipment from
unit.
Cleaning / Disinfecting / Sterilizing
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 PMMA (Plexiglas) parts.
To prevent any damage, we recommend that only detergents and disinfectants are used that are compatible with
the materials used in the bassinet and its components
and accessories, e.g. surface disinfectants on the basis
of
– aldehydes, or
– quarternary ammonium compounds
for disinfection procedures.
● Remove mattress from bed.
Always store mattress flat.
CAUTION !
Do not fold gel mattress!
● Take off flexible U-grommets.
50
Ensure that all disinfectants are registered with the U.S.
Environmental Protection Agency for use as intended.
Always follow the instruction labels specifically with
respect to prescribed concentrations and the necessary
exposure times.
Operating Instructions Babytherm 8004/8010, 2. ed.
Page 51
Care
Cleaning / Disinfecting / Sterilizing
Before Next Use
Cleaning and Disinfection Procedures
– bassinet, inside and outside
– surrounding panels, inside and outside
– bed surface
– Plexiglas
cover
– mattress;
– chassis, including attachments
● Remove visible impurities with a disposable cloth
wetted in a detergent.
● Wipe-disinfect surfaces.
● Wipe and dry with a clean, damp cloth.
CAUTION !
Do not launder mattresses in an automatic
washing machine. Do not autoclave mattresses.
– Silicone U-grommets
● Wash with a detergent and rinse with clear water.
● Bath disinfect parts. Then rinse in clear water and dry;
Before Next Use
● Reassemble components, refer to pages 18 through 22.
● Following wipe disinfection, operate unit for a few
hours without a patient, in order to eliminate any
disinfectant residues (at mattress temperature setting
of 37 °C).
Radiant heater in "manual" mode set to heater level 3.
Before a patient is placed in the Babytherm 8004/8010:
● Set up accessories for therapy as needed.
● Check operational readiness, see pages 23 to 25.
● Verify that mattress is sufficiently preheated.
or
● sterilize at 120 °C (248 °F).
– Phototherapy lenses
CAUTION !
Only use detergents/disinfectants with a
ph value of 7 to 9 for phototherapy lenses.
Operating Instructions Babytherm 8004/8010, 2. ed.
51
Page 52
Inspection and Maintenance
Replacement of Parts
Preventive Maintenance Intervals
Inspection and 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.
Replacement of Parts
Gel mattress Cover small cuts or other
damages in the film with
adhesive tape.
Silicone U-grommets Replace when brittle or sticky.
Temperature measuring Verify proper operation at time
system of preventive maintenance.
Lamps for work and Replace if defective by
night light factory trained technician.
Phototherapy lamps Replace complete set (6 bulbs)
if defective or after
1000 hours of operation
by factory trained technician.
Preventive Maintenance Intervals
Inspection and every twelve (12) months by
Preventive Maintenance factory trained technicians
WARNING !
Never operate the infant warmer system if it
has suffered physical damage or does not
seem to operate properly. In this case, always
refer servicing to properly trained and factory
authorized service personnel.
Operating Instructions Babytherm 8004/8010, 2. ed.
52
Page 53
General
Problem/Message Likely Causes Remedy
Troubleshooting
General
Mattress Heater
Red LED NN
continuous audible alarm.
Red LED »Inop.« lit,
continuous audible alarm.
NN
lit,
No power Check that Babytherm is plugged in.
Check that power is not interrupted
Call building maintenance.
Call DrägerService.
Device malfunction Call DrägerService.
Mattress Heater
Problem/Message Likely Causes Remedy
Yellow LED flashing,
Measured value display blinking,
message:
Mattress temp. deviation >1 °C,
audible alarm.
Red LED flashing,
Measured value display blinking,
message:
Mattress temp. above 40 ºC,
audible alarm.
Measured value of mattress
temperature has deviated from set
value by more than ±1 ºC.
Mattress temperature above 40 °C. When using in combination with
When using in combination with
radiant heater:
Reduce radiant heater output level.
radiant heater:
Reduce radiant heater output level.
Three upper segments blinking in
measured value display, message:
Mattress temp. sensor fault,
audible alarm.
Three upper segments blinking in
measured value display.
Three lower segments blinking in
measured value display, message:
Mattress temp. below 5 ºC.
Operating Instructions Babytherm 8004/8010, 2. ed.
Temperature sensors in heater
surface defective.
Mattress temperature above 45 °C.
Mattress temperature below 5 °C.
Call DrägerService.
Wait until temperature is
below 45 °C.
Wait until temperature is
above 5 °C.
53
Page 54
Troubleshooting
Radiant Heater
Radiant Heater
Problem/Message Likely Causes Remedy
Yellow LED flashing,
Measured value display blinking,
message:
Skin temp. deviation > x.x °C,
audible alarm.
Red LED flashing,
three middle segments blinking in
measured value display, message:
Plug in skin temp. sensor,
audible alarm.
Red LED flashing,
three middle segments blinking in
measured value display, message:
Skin temp. sensor fault,
audible alarm.
Red LED flashing,
blinking display of measured value,
message:
Skin temperature above 39 ºC,
audible alarm.
Measured value of skin temperature
has deviated from set value by more
than ± 0.5 ºC.
Skin temperature probe not
connected
or
Defective sensor.
Defective sensor. Switch to »Manual« operating mode,
Skin temperature >39 °C. Check that skin temperature sensor
When measured value is below set
value: Check that skin temperature
probe is positioned correctly.
When measured value is above set
value: Check core temperature
immediately!
Check plug connector and jack.
Switch to »Manual« operating mode,
replace sensor, then switch back to
"Skin" mode.
replace sensor, then switch back to
"Skin" mode.
is properly attached.
Check whether external heat sources
are warming infant (e.g. sun light,
phototherapy).
Three upper segments blinking in
measured value display, message:
Skin temp. above range.
Three lower segments blinking in
measured value display, message:
Skin temp. below range.
Three upper segments blinking in
measured value display, message:
Peripheral temp. above range.
Three lower segments blinking in
measured value display, message:
Peripheral temp. below range.
Red LED flashing,
three middle segments blinking in
measured value display, message:
Peripheral temp. sensor fault,
audible alarm.
54
Skin temperature >42 °C.
Skin temperature <15 °C.
Peripheral (toe) temperature >42 °C.
Peripheral (toe) temperature <15 °C.
Defective sensor. Replace sensor.
Check that skin temperature sensor
is properly attached.
Check that skin temperature sensor
is properly attached.
Operating Instructions Babytherm 8004/8010, 2. ed.
Page 55
Overview
24
23
22
21
What's What
Overview
1
20
19
18
17
16
15
14
13
12
11
1 Radiant heater
2 End panel
3 Side panel
4 Inner panels (2 each, available option)
5 Handle with inner unlocking bar for tilting the
bassinet
6 Bassinet mounted rail with hook for drainage
canisters (available option)
7 Swivel cabinet (option)
8 Chassis with casters, 2 of which can be locked
9 Height adjustable column (available option)
10 Foot controls, for height adjustable column (9)
11 Height adjustment warning label
12 Main WARNING/CAUTION label
13 Skin temperature sensor connection:
top jack, yellow – measuring and controlling
"tummy" skin temperature,
bottom jack, white – measuring peripheral ("toe")
Operating Instructions Babytherm 8004/8010, 2. ed.
skin temperature
2
3
4
5
6
7
10 9 8
14 Grounding pin
15 Identification and rating plate
16 Accessory mounting rail
17 Bed assembly
18 Gel mattress for use with mattress heater;
Foam rubber mattress for use without mattress
heater
19 Silicone U-grommets, (3 each)
20 Warning label "Never leave baby unattended..."
21 Support columns with monitor shelf and two side
rail
22 X-Ray tray on the back side, Babytherm 8004 only
(without illustration)
23 Controller with operating panel
24 Swivel joint for radiant heater (± 90º)
55
Page 56
What's What
Radiant Heater
Radiant Heater
1
2
5
1 Handle
2 Central alarm light, flashes if an alarms needs
to be acknowledged
3 Ceramic heater elements
4 Lighting (work light, night light)
5 Phototherapy lights (6)
5433
Operating Instructions Babytherm 8004/8010, 2. ed.
56
Page 57
Controller
What's What
Controller – Babytherm 8004/8010
10
°C °C
Skin °C manual Mattress °C
Skin
man.
11
12
13
10
5
1
14
9
8
Babytherm 8010
7
6
5
>
38°C
<
36°C
OK
Check
Inop.
4
3
2
1
1 Operation indicators:
Green LED lit for operation..
Red LED lit during power failure
2 »OK« key for confirming settings and to acknowledge
alarms.
NOTE: If the »OK« key is not pressed within
10 seconds after changing a setting, the previous
settings will remain in effect!
3 Red LED »Inop.«;
indicates device malfunction.
4 Key for testing LEDs, displays, speaker, and audible
alarms.
5 Key for silencing audible alarms for 10 minutes.
6 Yellow alarm LED;
flashes for Caution level alarm,
stays lit when audible alarm has been silenced.
7 Red alarm LED;
flashes for Warning level alarm.
8 Text display, shows messages and prompts user to
acknowledge/confirm.
9 Display and keypad for operating mattress heater
10 Display and keypad for operating radiant heater
11 On/Off key for daytime (work) lighting;
yellow LED in key is lit during operation.
12 On/Off key for nighttime lighting;
yellow LED in key is lit during operation.
13 On/Off key for radiant heater;
yellow LED in key is lit during operation.
14 On/Off key for phototherapy lights (available option);
yellow LED in key is lit during operation.
Operating Instructions Babytherm 8004/8010, 2. ed.
57
Page 58
What's What
Controller – Babytherm 8004/8010
Display and keypad for radiant heater
11.1 Display of measured value for "tummy" skin
temperature
11.2 Foot symbol for peripheral ("toe") temperature;
is lit when peripheral skin temperature sensor is
connected.
11.3 Display of measured value for "toe" skin
temperature; only while peripheral skin
temperature sensor is connected.
11.4 Display of radiant heater output level;
level 1 through 3: green
level 1 through 3: yellow
11.5 Keys to set radiant heater output levels
11.6 Keys to switch between operating modes
»man.« (manual heater control) and »Skin« (skin
temperature control);
yellow LED stays lit for the respective mode.
11.7 Keys for setting value for skin temperature
11.8 Display of skin temperature set value
11.1 11.2 11.3 11.4
°C
skin °C manual
skin
man.
10
5
1
11.8 11.7 11.6 11.5
Display and keypad for mattress heater
(Babytherm 8010 only)
10.1 Display of measured mattress temperature
10.2 Indicator for upper extended range >38 °C
10.3 Indicator for lower extended range <36 °C
10.4 Keys for setting value for mattress temperature
10.5 Display of mattress temperature set value
10.1 10.2
°C
>
38°C
<
Mattress °C
36°C
10.5 10.4 10.3
Operating Instructions Babytherm 8004/8010, 2. ed.
OK
58
Page 59
Controller – Rear View
What's What
Controller – Rear View
1
2
3
6
1 Input ports for connecting nurse call of up to three
devices in the work place (connections for central
alarm).
2 Output port for connecting to paging, nurse call
systems (connection for central alarm).
3 RS 232 interface (modem), available option
4 RS 232 interface (BabyLink), available option
5 Controller power switch
% = OFF, $ = ON.
6 Cover panel
4
5
%$
Operating Instructions Babytherm 8004/8010, 2. ed.
59
Page 60
WARNING !
DANGER OF PATIENT INJURY
NEVER LEAVE BABY UNATTENDED WHEN
SURROUNDING PANELS ARE DOWN
CAUTION !
KEEP SPACE KEEP SPACE
BELOW ABOVE
CABINET BASSINET
CLEAR WHEN CLEAR WHEN
LOWERING RAISING
What's What
DANGER !
RISK OF EXPLOSION IF USED IN THE PRESENCE OF FLAMMABLE ANESTHETICS
WARNING !
DISCONNECT SUPPLY BEFORE SERVICING
REPAIRS ON THIS EQUIPMENT TO BE PERFORMED ONLY BY
DrägerService OR ITS AUTHORIZED SERVICE CENTERS
CAUTION !
TO MAINTAIN GROUNDING INTEGRITY, CONNECT ONLY TO A
"HOSPITAL GRADE" RECEPTACLE
TO REDUCE RISK OF ELECTRIC SHOCK, DO NOT REMOVE COVER
FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO
SALE BY OR ON THE ORDER OF A PHYSICIAN
Dräger, Inc.
Critical Care Systems
3136 Quarry Rd
Telford, PA 18969
Tel: (215) 721-6910
Fax: (215) 721-6915
Babytherm
Typ
Fabr. Nr.
V
A
Hz 50/60
Made in Germany
Dräger Medizintechnik GmbH, Lübeck
WARNING !
DISCONNECT BOTH SUPPLIES BEFORE SERVICING
Labels
Labels
1 Main WARNING/CAUTION label
WARNING !
DO NOT SWITCH OFF BABYTHERM WHILE A BABY IS LYING ON THE
GEL MATTRESS AS THIS WILL RESULT IN COOLING OF THE PATIENT
WARNING !
CHECK BABY'S TEMPERATURE AND SKIN
CONDITION AT REGULAR INTERVALS AND ADJUST
TEMPERATURE SETTING TO INDIVIDUAL PATIENT NEEDS
WARNING !
USE FOAM RUBBER MATTRESS WHEN THE HEATING
MATTRESS IS COLD. GEL MATTRESS WILL COOL THE INFANT IF
MATTRESS HEATER IS SWITCHED OFF
WARNING !
FOR ACTIVE AND BIGGER BABIES USE SIDE PANELS OF
23 CM HEIGHT AND ADDITIONAL INNER PANELS.
MAKE SURE TO MONITOR AVTIVE BABIES APPROPRIATELY
2 Side panel WARNING labels (2x)
3 Servicing WARNING labels (2x)
4 Height adjustment CAUTION labels
5 ID label, Dräger Inc. (Importer)
6 ID label, Dräger Medizintechnik GmbH Lübeck
60
Operating Instructions Babytherm 8004/8010, 2. ed.
Page 61
Technical Data
Ambient conditions
For operation:
Temperature 20 °C to 30 °C (68 °F to 104 °F)
Atmospheric pressure 900 hPa to 1060 hPa
Relative humidity 0 to 75 %, no condensation
Air velocity in climate rooms max. 0.3 m/s
For storage and transport:
Temperature –20 °C to 60 °C (–4 °F to 140 °F)
Atmospheric pressure 500 hPa to 1060 hPa
Relative humidity 0 to 90 %, no condensation
Radiant heater
Output (irradiance) at 80 cm distance
from heater
Heater level 3 10 mW/cm
Heater level 10 30 mW/cm
2
2
Technical Data
Lights 120 V
23 W for work light, 7 W for night light
Minimum distance required between
top of radiant heater and ceiling >50 cm (20 inches)
Skin temperature measurement
Sensor Use only original Dräger sensors
(see "Ordering Information", page 65)
Measurement range 15 °C to 42 °C
Accuracy ±0.1°C
Accuracy of entire measurement system ±0.2 °C
Setting range 35 °C to 37.5 °C
Mattress heater (Babytherm 8010 only)
Temperature measurement:
Measurement range 5 °C to 45 °C
Accuracy ±0.5 °C between 20 and 42 ºC
±2 ºC otherwise
Setting range 30 °C to 38.5 °C
Height adjustment (available option)
Height adjustment range 295 mm
Specified operation Intermittent operation
Operating Instructions Babytherm 8004/8010, 2. ed.
(Maximum operating time of 1 min must be followed
by 60 min period for cooling.)
61
Page 62
Technical Data
Phototherapy (available option)
Lamps Halogen 12 V / 50 W (6 needed)
Lighting angle 24º
Irradiance at 80 cm distance from light 9.5 W/m
source and for useable area
of 400 x 200 mm
2
Area on mattress with specified intensity
Relative intensity light spectrum
400
200
Relative spectral intensity
Wavelength
Operational data
Line voltage 120 V; 50/60 Hz
Power consumption
Radiant heater 600 W
Mattress heater (Babytherm 8010) 160 W
Infrared light 30 W
Phototherapy light 440 W
Main Fuses M 15 A UL 198 G, (two)
Electric column (available option)
Power consumption 560 W
Fuses for electric column T 6.3 A L 250 V; IEC 127-2/III (two)
62
Operating Instructions Babytherm 8004/8010, 2. ed.
Page 63
Technical Data
D
Electrical protection class
Skin temperature sensor Type BF
Heating surface of mattress Type BF
I
m
m
Safety standards IEC 601-1
IEC 601-2-35 Part 2 (for mattress heater)
IEC 601-2-21 (for radiant heater)
Electromagnetic compatibility Tested pursuant IEC 601-1-2
Interfaces (available options)
All interface signals are electrically isolated from any components in contact with patient.
Isolation test voltage is 1.5 kV.
BabyLink interface RS 232
Output voltage pursuant RS-232-C
Monitor cable (part no. 83 06 488)
Wiring scheme
Babytherm 8004/8010
Pin
5
2
3
9 pin Sub D
connector
GND GND
RxD TxD
TxD RxD
Connector housing
Monitor
Pin
5
3
2
9 pin Sub
connector
Modem interface RS 232
Connection of external modem for service
purposes
Wiring scheme
Both RS 232 interfaces and central alarm input are not electrically isolated from one another.
Operating Instructions Babytherm 8004/8010, 2. ed.
Pin
5
2
3
7
8
GND
RxD
TxD
RTS
CTS
63
Page 64
Technical Data
Central alarm
Output for connection to paging systems (nurse call)
Operation voltage max. 24 V
Current max. 250 mA
Power max. 3 W
Electrically isolated relais contact
Input Connection of nurse call output of up to 3 devices.
(For each alarm forwarded by any of these devices to
Babytherm 804/8010, the red central alarm light will light.)
5
3
1
Electrically isolated relais contact
2
3
Dimensions
Length x Width 1315 x 750 mm (51,8 x 29,5 inches)
Overall height
unit without height adjustment 1960 mm (77.2 inches)
unit with electric column 1885 to 2180 mm (74.2 to 85.8 inches)
Working height of the bed surface
without height adjustment 1025 mm (40.4 inches)
unit with electric column 885 to 1180 mm (34,8 to 46,5 inches)
Bed size 750 x 490 mm (29,5 x 19,3 inches)
Tilting of bed adjustable in small increments
maximum of 20 °C down
maximum of 15 °C up
Height of surrounding panels 150 mm (5,9 inches )or
230 mm (9,1 inches, recommended for use with cover)
Height of inside panels 70 mm (2,8 inches)
Weight (with one cabinet)
unit without height adjustment
with mattress heater (8010) 133 kg
without mattress heater (8004) 120 kg
unit with height adjustment
with mattress heater (8010) 120 kg
without mattress heater (8004) 110 kg
64
Operating Instructions Babytherm 8004/8010, 2. ed.
Page 65
Ordering Information
Name and Description Part No.
Babytherm 8010, 120 V FR 00 120
with mattress heater and
skin temperature control
Babytherm 8004, 120 V FR 00 114
with skin temperature control and
X-Ray tray
To be specified with order:
– Set of side panels, height 230 mm or
set of side panels, height 150 mm
– 2 inner panels or
no inner panels
– Height adjustable column or
fixed column
– Without swivel cabinet or
with one swivel cabinet or
with two swivel cabinets
(models with electric column only)
– Phototherapy lights integrated into
radiant heater
Name and Description Part No.
Accessories
Cover 2M 21 030
Cover prop 2M 21 342
Infusion bottle holder 2M 16 520
Patient circuit support arm 2M 21 191
Instrument tray 2M 21 186
Compact rail, addl. 2M 85337
Cable clips (bag of 4) G 13 171
Monitor shelf, addl. 2M 21 161
Patient circuit support 2M 85 239
Replacement parts / Consumables
Foam rubber mattress 2M 21 012
Gel mattress 2M 20 827
Mattress cover sheet 2M 21 272
Skin temperature sensor, yellow
(box of 10) 2M 21 916
Skin temperature sensor, white
(box of 10) 2M 21 915
Options (for retrofitting)
Set of side panels, height 230 mm 2M 21 034
Set of side panels, height 150 mm 2M 21 032
Inner panel, height 70 mm 2M 20 936
Swivel cabinet 2M 20 638
Cabinet installation hardware 2M 20 868
Interface kit 2M 30 268
Kit phototherapy 2M 30 313
Replacement adhesive pads
(box of 100) 2M 21 734
Halogen lamp 12 V, 50 W 2M 30 084
Lamp for work light 2M 30 160
Lamp for night light 2M 30 161
Silicone U-grommet 2M 20 434
Service documentation on request
Operating Instructions Babytherm 8004/8010, 2. ed.
65
Page 66
Index
Alarms
mattress heater.............................................38 - 39
skin temperature control............................... 32 - 33
radiant heater...................................................... 29
Alarm system.............................................................16
Ambient conditions.................................................... 61
Before next use.........................................................51
Bed
preparing.............................................................19
tilting................................................................... 20
Care......................................................................... 50
Central alarm.............................................................16
Checking, heater readiness for operation...................23
Cleaning....................................................................50
Column, preparing.....................................................18
Compact rail..............................................................18
Configuration mode...................................................44
Cover........................................................................22
Description............................................................... 14
Disassembly.............................................................. 50
Disinfection............................................................... 50
First Use................................................................... 23
Gel mattress....................................................... 20, 26
warm up time.................................................26, 37
Heater output, setting................................................24
Intended use............................................................. 12
Labels.......................................................................60
Lighting
switching on........................................................ 48
checking..............................................................25
Peripheral sensor, connecting................................... 35
Power failure alarm, checking.................................... 25
Precautions
during preparation................................................. 8
during operation.................................................... 8
during care.......................................................... 11
during maintenance............................................. 11
Preparing accessories.........................................18, 21
Preparation........................................................ 18 - 23
Radiant heater, using.......................................... 28 -29
Recommendations, for warmer therapy...............40 - 42
Sensor defect............................................... 33, 53, 54
Sensor plug........................................................ 33, 53
Settings
skin temperature control...................................... 32
mattress heater.............................................37 - 38
Set value range, extending, for mattress heater..........38
Skin temperature control, using.......................... 30 - 34
Skin temperature sensor, connecting.........................31
Steady state.............................................................. 32
Switching off............................................................. 49
Technical data...........................................................61
Temperature, peripheral............................................ 35
Temperature settings.................................................40
Testing readiness for operation............................16, 18
Theory of operation................................................... 13
ThermoMonitoring..................................................... 35
Tilting bed................................................................. 20
Tipping, safety against............................................... 20
Transport, intra-hospital............................................. 22
Troubleshooting.........................................................53
Warmer therapy................................................. 40 - 42
WARNINGS and CAUTIONS, General....................... 7
What's what.......................................................56 - 60
Maintenance, preventive intervals.............................. 47
Mattress heater, using........................................37 - 39
Mattress types...........................................................20
Monitor shelf............................................................. 18
Operating concept.................................................... 16
Ordering information..................................................65
66
X-rays, taking............................................................49
Operating Instructions Babytherm 8004/8010, 2. ed.
Page 67
Operating Instructions Babytherm 8004/8010, 2. ed.
67
Page 68
These Instructions for Use apply only to
Babytherm 8004 or
Babytherm 8010
with Serial No.:
If no Serial No. has been filled in by
Dräger these Instructions for Use are
provided for general information only and
are not intended for use with any specific
machine or device.
Manufactured by
Dräger Medizintechnik GmbH
Germany
H Moislinger Allee 53 – 55
D-23542 Lübeck
T (4 51) 8 82 - 0
X 26 80 70
FAX (4 51) 8 82-20 80
90 28 625 - GA 6132.300 enUS
Dräger Medizintechnik GmbH
2nd edition - January 1997
Subject to alteration
Distributed by
Dräger Medical, Inc.
H 3136 Quarry Road
Telford, PA 18969
T 215-721-6910
FAX 215-721-6915
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