Dräger Babytherm 8000 LDR User manual

Babytherm® 8000 LDR
Warming Bed
Instructions for Use

i
NOTICE
Proprietary Information
This document contains information in which Dräger 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;
it is provided solely for the use intended.
Repairs/Modifications
Repairs on this device shall be performed only by DrägerService, a division
of North American Dräger (NAD), or its Authorized Service Centers.
Information about repairs can be obtained from Dräger or Authorized
Dealers. NAD or Dräger 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 and the name Babytherm® are registered
trademarks of Dräger Medizintechnik GmbH.
© North American Dräger 1998
All rights reserved. Subject to modifications.

ii

iii
Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
Operator's Responsibility for Infant Safety . . . . . . . . . . . . . . . . . 1
Limitation of Liability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Definitions and Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
General WARNINGS and CAUTIONS . . . . . . . . . . . . . . . . . . . . 5
Precautions During Preparation . . . . . . . . . . . . . . . . . . . . . . . . . 6
Precautions During Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Precautions During Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Precautions During Maintenance . . . . . . . . . . . . . . . . . . . . . . . . 7
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Mattress Heating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
Storage of Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Installing Side Panels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Opening Side Panels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Installing Canopy (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Selecting a Mattress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Tilting the Bed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Tests of Readiness for Operation . . . . . . . . . . . . . . . . . . . . . . . . 13
Preuse Checkout Procedure . . . . . . . . . . . . . . . . . . . . . . . . . 13
General Precautions During Infant Care . . . . . . . . . . . . . . . . . 14
Heat Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
Warnings and Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Heater Safety Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Mattress Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Mattress Heater Control Panel . . . . . . . . . . . . . . . . . . . . . . . . . 16
Mattress Heater Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Control Systems Self-Test . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Control Systems Operator Test . . . . . . . . . . . . . . . . . . . . . . 20
Heater Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Operation without Concurrent Use of a Radiant Warmer . . . . 22
Oxygen Therapy with Canopy . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Operator Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Adjusting Mattress Temperature . . . . . . . . . . . . . . . . . . . . . . . 23
Heater Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Power-Down Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Using the Canopy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Operation with Concurrent Use of a Radiant Warmer . . . . . . . 31
Cleaning/Disinfecting/Sterilizing . . . . . . . . . . . . . . . . . . . . .33
Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Disassembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Cleaning and Disinfection Procedures . . . . . . . . . . . . . . . . . . . . 33
Before Next Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

iv
Contents
Inspection and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . .35
Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Repair and Replacement of Parts . . . . . . . . . . . . . . . . . . . . 35
Preventive Maintenance Intervals . . . . . . . . . . . . . . . . . . . . 35
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36
Mattress Heater . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37
Operator Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Warning - Fire Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Caution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Danger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Warning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39
Ambient conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Electrical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Ordering Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41
Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42

1
Introduction
Introduction
Operator's Responsibility for Infant Safety
For correct and effective use of the product and in order to minimize
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 infants with abnormal conditions. Product
modification or misuse can be dangerous. Dräger 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.
The operators of the heated bassinet system must recognize their
responsibility for choosing appropriate safety monitoring that supplies
adequate information on equipment performance and infant condition.
Infant safety may be achieved through a wide variety of different means
ranging from electronic surveillance of equipment performance and infant
condition to simple, direct observation of clinical signs. The responsibility
for the selection of the best level of infant monitoring lies solely with the
equipment user.
Limitation of Liability
Dräger'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'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
and regardless of the form of action (including, without limitation, breach of
warranty, negligence, strict liability, or otherwise).

2
Introduction
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 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.
Limited Warranty
All Dräger products are guaranteed to be free of defects in material and
workmanship for a period of one year from date of delivery.
The following are exceptions to this warranty:
1. Defects caused by misuse, mishandling, tampering, or by modifications
not authorized by Dräger or its representatives are not covered.
2. All consumable and disposable products are guaranteed to be free from
defects upon shipment only.
Any product which proves to be defective in workmanship or material will
be replaced, credited, or repaired with Dräger holding the option. Dräger is
not responsible for deterioration, wear, or abuse. In any case, Dräger will
not be liable beyond the original selling price.
This warranty is rendered void and Dräger shall not be held liable for
condition as resultant from:
1. Damage to the unit is incurred as a result of mishandling.
2. The customer fails to maintain the unit in a proper manner.
3. The customer uses any parts, accessories or fittings not specified or sold
by Dräger.
4. Sale or service is not performed by an authorized service/dealer.
Application of this warranty is subject to the following conditions:
1. Dräger or its authorized representative must be promptly notified, in
writing, upon detection of the defective material or equipment.
2. Contact Dräger Customer Service at 1-800-4DRAGER for a Return
Authorization Number.
3. Defective material or equipment must be returned, shipping prepaid, to
Dräger or its authorized representative.
4. Examination by Dräger or its authorized representative must confirm
that the defect is covered by the terms of this warranty.

3
Introduction
5. 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.
The above is the sole warranty provided by Dräger. No other warranty
expressed or implied is intended. Representatives of Dräger are not
authorized to modify the terms of this warranty.
Dräger, Telford, PA

4
Introduction
Definitions and Symbols
Warnin
g
sA WARNING statement refers to conditions with a possibility of personal
injury or death if disregarded.
Cautions A CAUTION statement designates the possibility of damage to equipment
or improper operation if disregarded.
Notes A NOTE provides additional information intended to clarify apparently
contradictory or confusing situations.
Terminolo
g
y
Typing conventions in this manual:
LED messages are printed in bold type:
Example: SEt
Symbols
Inspection examination of actual condition
Service measures to maintain specified condition
Repair measures to restore specified condition
Maintenance inspection, service, and repair, where
necessary
Preventive
Maintenance
Maintenance measures at regular
intervals
CAUTION:
ATTENTION:
Refer to accompanyin
g
documents before
operatin
g
equipment.
Consulter les documents ci-joints avant de faire
fonctionner l’appareil.
Denotes IEC601-1 type of applied part.
Protective earth symbol.
!

5
Introduction
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." 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 infant rooms. To maintain grounding integrity,
connect only to a "hospital grade" receptacle. Always
disconnect power before servicing.
Warning: Do not use in the presence of flammable anesthetics. Turn off
and disconnect oxygen supply when performing cleaning and
service. Keep matches, lighted cigarettes, and all other
sources of ignition out of the room in which the Babytherm is
located. Small quantities of flammable agents, such as ethyls
and alcohol, can cause a fire in connection with oxygen left in
the Babytherm in the presence of ignition sources.
Warning: Do not use cellular phones or similar wireless communication
equipment within 33 feet (10 m) of the Babytherm 8000 LDR.
Wireless phones may cause malfunction in electromedical
equipment.
Caution: Restriction of Distribution: Federal Law restricts this device
to sale by or on the order of a physician.
Caution: Maintenance: In case of malfunction of this device, contact
your local DrägerServiceSM technician or our Factory
Authorized Technical Service Center. The device must be
inspected by competent and factory authorized technical
service representatives at regular intervals. A record must be
kept on this preventive maintenance. Maintenance or repair
of the Babytherm 8000 LDR shall be performed only by
Dräger authorized technical service representatives.
Warning: Never operate the heated bassinet 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.

6
Introduction
Precautions During Preparation
Warning: Use of gel mattress when mattress heater is switched off will
result in infant becoming hypothermic. Use foam rubber
mattress when mattress heater is not in use for extended
periods (> 15 min.).
Caution: Never route infant circuits or lines over top of panels – they
may get pinched when folding up panels or when installing
cover.
Precautions During Operation
Warning: To prevent infant fall, do not leave infant unattended when
any panels are down. All panels must be erect and secure
during transport to prevent infant fall.
Warning: When folding up surrounding panels, take care not to pinch
infant body parts, circuits, or other items, such as sheets.
Warning: Temperature Monitoring: Check the infant’s temperature and
skin condition at regular intervals and adjust temperature
setting to individual infant needs. Infant temperature must
be monitored particularly carefully during phototherapy or
while a radiant warmer is used in conjunction with the
Babytherm heated bassinet.
Warning: Mattress Heater: When mattress heating is used, the gel
mattress must be placed directly on the heated tray surface.
Always take into account warm-up time of the mattress
(approximately 1 hour) before placing an infant in the
bassinet.
Warning: To minimize infant overheating, always consider effect of
additional heat sources, such as phototherapy lamps or
radiant warmers. They increase the heat directed to the
infant. Avoid direct sunlight.
Warning: Do not obstruct conductive heat transfer by placing
additional blankets or other insulating covers underneath the
infant.
Warning: Set temperatures in the lower extended temperature range
only on the order of a physician. Check the infant's
temperature and skin condition at regular intervals.
Warning: Check the infant's temperature and skin condition at regular
intervals.

7
Introduction
Warning: Always use a proper fitting thin sheet (Part No. 2M21272).
Do not fold the sheet under the gel mattress more than 3". To
prevent infant fall in Trendelenberg or reverse Trendelenberg
position always use proper fitting mattress sheet.
Warning: When used with an infant radiant warmer, check its
operator’s manual for directions of the correct heat level and
distance to the infant.
Warning: Use of radiant warmers may increase insensible water loss.
Measures to maintain desired fluid levels should be
considered.
Warning: Use of Radiant Warmer: Use of the Dräger RH600 warmer is
recommended. Dräger cannot warrant or endorse the safe
performance of third party radiant warmers for use with the
Babytherm 8000 LDR. Specifically, combinations with
radiant warmers that are not intended for use with heated
bassinets bear risks of excessive overall heat transfer to the
infant.
Caution: Remove from mattress all objects with sharp edges. Do not
fold gel mattress. The gel mattress may become damaged.
Precautions During Care
Warning: Always follow accepted hospital procedures for handling
equipment contaminated with body fluids.
Warning: Always disconnect AC line cord before cleaning and
disinfecting.
Caution: Do not launder mattress in an automatic washing machine.
Do not autoclave mattress.
Precautions During Maintenance
Warning: To minimize the 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 8000 LDR may be
performed by trained and factory authorized staff only.
Warning: Never operate the heated bassinet 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.

8
Introduction
Intended Use
Babytherm 8000 LDR is a heated bassinet intended as a therapeutic device
providing warmth, with or without the use of a canopy, for premature and
full-term neonates and infants up to 16 lbs.

9
Description
Description
Mattress Heating
The Babytherm 8000 LDR features a mattress heating system that uses
conductive heat to warm up infants and to keep them warm.
The system consists of a gel mattress, a heating plate and an electronic
control and monitoring unit. The gel is enclosed by a soft, skin compatible
film.
The mattress molds itself to the body contours of the infant lying on it,
resulting in a large contact surface, a property that helps promote thermal
heat transfer to the infant and minimizes pressure points. A cold gel
mattress, on the other hand, dissipates infant thermal energy. The gel
material has an excellent capacity for storing heat. When the power supply
is disconnected (e. g. during transport within the hospital), the infant is
kept warm for approximately 15 minutes if sufficiently insulated (blanket,
cover).
The heating plate consists of an aluminum plate with a heater element
attached to its under side. It distributes heat evenly over the entire bed
area.
The control and monitoring unit is located under the heating plate and faces
the side most frequently accessed by caregivers.
The micro-processor controlled system continuously monitors the status of
the electronic temperature control and alarm system, and alerts the user if
any faults are detected.
Features
With its ergonomic design including:
• foldable side panels for increased access to the infant
• tilting bed for Trendelenberg and reverse Trendelenberg position
• pop-up side table – integrated hand rail
• cable management system
• storage space in the cabinet
• 5 inch diameter castors, two with locks
• optional canopy
it serves an important function for newborn babies from the first minute
after birth until discharge to home.

10
Description

11
Preparation
Preparation
Storage of Supplies
Always observe the stated weight limits when placing items on the shelf.
Installing Side Panels
The bassinet 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 infant cables.
Figure 1. Installation of Side Panel
1. Insert lower pins on panel hinges into the left- and right-hand slots in
bassinet base.
2. Position panel semi-upright.
3. Press panel down firmly, until pins lock into position at the bottom of
slots.
• Tilt panel fully upright and let it drop into locking position.
4. Install all four panels in the same fashion.
5. Verify the panels are seated correctly.
DI0001
SIDE
PANEL
HINGE

12
Preparation
OpeningSide
Panels To open Babytherm side panels:
1. Lift panel all the way up, until upper pins on hinge brackets are out of
their guide slots.
2. Fold down.
Installing Canopy (OPTIONAL)
Place canopy over side and end panels so that the flanges on the canopy
interlock with the end panel cutouts.
Selecting a Mattress
1. Select mattress type:
• Operation with mattress heating:
Gel mattress (Part No. 2M20827) [PROVIDED].
• Operation without mattress heating:
Foam rubber mattress (Part No. 2M21012) [OPTIONAL].
2. Place the mattress in bassinet and cover it with a thin sheet.
Warning: Always use a proper fitting thin sheet (Part No. 2M21272)
[PROVIDED]. Do not fold the sheet under the gel mattress
more than 3". To prevent infant fall in Trendelenberg or
reverse Trendelenberg position always use proper fitting
mattress sheet.
Warning: Do not obstruct conductive heat transfer by placing
additional blankets or other insulating covers placed
underneath the infant.
Warning: Use of gel mattress when mattress heater is switched off will
result in infant becoming hypothermic. Use foam rubber
mattress when mattress heater is not in use for extended
periods (> 15 min.).
Tilting the Bed
The bed can be locked in three positions: head up, level, or feet up.
1. Pull handle of locking mechanism up.
2. Tilt the bed as desired.
Tilt angles:
• Trendelenberg position: 10°
• Reverse Trendelenberg position: 10°
3. Release locking handle, the bed locks into position.

13
Preparation
Tests of Readiness for Operation
1. Verify that supplied voltage agrees with the values indicated on the
rating plate next to the power cable.
2. Inspect the power plug and power cord for signs of wear.
3. Inspect gel mattress and infant area for signs of damage.
Preuse
Checkout
Procedure
Prior to each use:
1. Disinfect the Babytherm per institutional procedures.
2. Lock the side and end panels securely into place.
3. Verify that all panels are free of cracks and sharp edges.
4. Verify that the correct mattress is in the bassinet.
• Operation with mattress heater ⇒ gel mattress,
• Operation without mattress heater ⇒ foam rubber mattress.
5. Check the bed tilt positions and lock securely into required angle.
6. Verify that all patient lines and circuits are securely and properly
installed.
Caution: Never route infant circuits or lines over top of panels – they
may get pinched when folding up panels or when installing
cover.
7. Verify that the storage doors and the pop-up table are working properly.
8. Verify that the two locking casters function properly.
9. Lay gel mattress flat on the heating plate.
10. Connect plug to properly grounded, hospital grade power outlet.
11. Press button.
a. all LEDs illuminate for approximately 2 seconds
b. numeric displays show 88.8
c. an audible alarm is generated
d. displays and LEDs extinguish
e. the audible alarm is silent
f. after 2 seconds, actual temperature is displayed.
Note: This function check is possible during operation without affecting
any of the settings.
12. Contact your DrägerService authorized service/dealer in case of failure.
Check

14
Preparation
General Precautions During Infant Care
Warning: To prevent infant fall, do not leave infant unattended when
any panels are down. All panels must be erect and secure
during transport to prevent infant fall.
• Check that all 4 panels are closed and locked securely into
place.
Warning: To allow for adequate air flow while canopy is in use, do not
obstruct openings around side panels of the bassinet.