Drager Babytherm 8000 WB User manual
Babytherm 8000 WB
Heated Bassinet
Operating Instructions
Operating Instructions Babytherm 8000 WB
1-214-94
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 and the name Babytherm are registered trademarks
of Drägerwerk Aktiengesellschaft.
Dräger, Inc. 1994
All rights reserved, Subject to modifications
Operating Instructions Babytherm 8000 WB
Contents
Contents
Page
Introduction 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................................. 10
Precautions During Maintenance...........................10
Intended Use.......................................................11
Description.......................................................... 11
Preparation..........................................................12
Adjusting the Height ....................................... 12
Storage of Supplies ........................................12
Attaching Infusion Bottle Holder.......................12
Installing Surrounding Panels ..........................13
Fitting a Mattress ............................................14
Tilting the Bed ................................................ 15
Tests of Readiness for Operation ...................... 16
General Precautions During Patient Care ..........17
Page
Care ....................................................................30
Disassembly.................................................... 30
Cleaning/Disinfecting/Sterilizing.......................31
Before Next Use ............................................ 31
Inspection and Maintenance............................... 32
Replacement of Parts...................................... 32
Preventive Maintenance Intervals..................... 32
Troubleshooting.................................................. 33
Mattress Heater...............................................33
Electric Height Adjustment (Option).................33
What's What........................................................ 34
Overview......................................................... 34
Mattress Heater Control Panel.........................35
Labels.............................................................36
Technical Data.....................................................38
Ordering Information...........................................40
Index ...................................................................41
Notes .................................................................. 42
Heat Therapy ..................................................... 17
Heater Safety Precautions ............................. 17
Mattress Heating ........................................... 17
Checking Heater Readiness for Operation.......18
Heater Operation ........................................... 22
Alarms ........................................................... 24
Shut-Down .................................................... 24
Notes on Mattress Heater Settings ................ 25
Operation with Concurrent Use of a
Radiant Heater .............................................. 26
Taking X-Rays .................................................... 29
Operating Instructions Babytherm 8000 WB
3
Introduction Operator's Responsibility for Patient Safety
Limitation of Liability
Introduction
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.
The operators of the heated bassinet 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.
4
Operating Instructions Babytherm 8000 WB
Warranty
Warranty
Introduction
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.
Operating Instructions Babytherm 8000 WB
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., Chantilly, VA
5
Introduction 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
LED messages are printed in bold type, e. g:
SEt
Operating Instructions Babytherm 8000 WB
6
General WARNINGS and
CAUTIONS
General WARNINGS and CAUTIONS
Introduction
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 11). 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.
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.
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 8000 WB
shall be performed only by Dräger authorized
technical service representatives.
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 8000 WB
7
Introduction Precautions During
Preparation
Precautions During
Operation
Precautions During Preparation
WARNING !
Always select correct mattress type for intended
mode of operation (see page 14)
CAUTION !
Do not place any objects above or underneath
bassinet where they might be damaged when height
adjustments are made.
CAUTION !
Never route patient circuits or lines over top of
panels – they may get pinched when folding up
panels or when installing cover.
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 !
When folding up surrounding panels, take care
not to pinch patient body parts, circuits, or other
items, such as sheets.
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 a radiant warmer is used
in conjunction with the Babytherm heated
bassinet (see pages 26 - 28).
Skin temperature monitoring is no substitute for
core temperature checks since the two
parameters do not always closely correlate.
WARNING !
Mattress Heater
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 8000 WB. 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 patient cooling.
Always take into acount warm-up time of the
mattress (approximately 1 hour) before placing
a patient in the bassinet.
Do not switch off mattress heater while a baby is
lying on the gel mattress as this will result in
cooling patient .
Operating Instructions Babytherm 8000 WB
8
Precautions During Operation
(cont'd)
Introduction
WARNING !
Do not switch off mattress heater while a baby is
lying on the gel mattress as this will result in
cooling patient .
WARNING !
Use foam rubber mattress when the mattress
heater is switched off. Gel mattress will cool the
infant if mattress is switched off.
WARNING !
Do not obstruct conductive heat transfer by
blankets or other insulating covers placed
underneath the patient.
WARNING !
Set temperatures in the lower extended
temperature range only on the order of a
physician. Check the baby's temperature and
skin condition at regular intervals
WARNING !
Dräger, Inc. cannot warrant or endorse the safe
performance of third party radiant heaters for
use with the Babytherm 8000 WB. Specifically,
combinations with radiant warmers that are not
intended for use with heated bassinets bear
risks of excessive overall heat transfer to the patient.
We recommend contacting the manufacturers/
distributors of third party radiant heater units
regarding compliance of their product with
heated bassinets before attempting to use them
in conjunction with the Babytherm 8000 WB.
The following notes on settings of Babytherm
8000 in the presence of radiant heaters are
intended as guidelines only and cannot take into
consideration the specifics of individual radiant
heater designs.
WARNING !
When used with an infant radiant warmer check
its operators manual for directions of the correct
heat level and distance to the baby.
WARNING !
Check the baby's temperature and skin
condition at regular intervals
Operating Instructions Babytherm 8000 WB
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.
9
Introduction 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 expose Babytherm 8000 WB to high level of
ultraviolet radiation. It may cause cracks in the
PMMA (perspex) parts.
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 com-pounds,
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 !
Preventive Maintenance work on the Babytherm
8000 WB may be performed by trained and
factory authorized staff only.
WARNING !
Always disconnect supply before servicing.
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.
CAUTION !
Do not launder mattresses in an automatic washing
machine. Do not autoclave mattresses
10
Operating Instructions Babytherm 8000 WB
Intended Use
Description
Intended Use
Babytherm 8000 WB is a heated bassinet intended as a
therapeutic device providing warmth for premature and
full-term neonates and infants with a weight up to 16 lbs.
Description
Mattress heating
The Babytherm 8000 WB 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 consists 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 that helps conducting heat to the patient and
avoids pressure points (anti-decubitus effect). A cold gel
mattress, on the other hand, dissipates patient 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.
Operating Instructions Babytherm 8000 WB
The control and monitoring unit is located under the
heating plate. The membrane keypad with its buttons and
displays faces the side most frequently accessed by
caregivers. Temperature is set by the user and adjusts in
such a way that the set temperature is just reached in
those areas where the patient contacts the mattress.
System monitoring includes check routines and alarm
features.
Features
With its ergonomic design including:
– foldable side panels for easy care.
– a tilting bed for Trendelenburg and
Reverse Trendelenburg position
and options such as:
– electric height adjustment
– swivel cabinet
– infusion bottle holder
it serves an important function during a patient's
transition from incubator to standard (unheated) bassinet.
11
Preparation Adjusting the Height
Storage of Supplies
Attaching Infusion Bottle Holder
Preparation
Adjusting the Height (Option)
Before operating the Babytherm 8000 WB, always check
electric height adjustment:
● Connect power supply.
WARNING !
To maintain grounding integrity, connect only to
a "hospital grade" receptacle.
1 Depress right pedal.
The bassinet is raised.
2 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.
Storage of Supplies
Units with electric height adjustment:
– swivel cabinet (option) with 2 compartments and
1 swivel tray
Units without electric height adjustment:
– 2 open compartments in the column (standard),
– 1 swivel cabinet (option) with 2 compartments and
1 swivel tray.
Attaching Infusion Bottle Holder
1 2
21
Operating Instructions Babytherm 8000 WB
● Mount bottle holder to side rail. Secure rail clamp.
12
Installing Surrounding Panels
Installing Inside Panels
Installing Surrounding 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 patient cables.
Preparation
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 drop into locking
position.
● Install all four panels in the same fashion.
Verify 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.
22
11
Installing Inside Panels
Use inside panels to protect the baby from falling out
when side panel is open.
● Insert pins in tapered holes and press down slightly
until the inside panel is firmly seated.
● Repeat for second inner panel.
Operating Instructions Babytherm 8000 WB
13
Preparation Fitting a Mattress
Installing Cover
Fitting a Mattress
● Select mattress type:
– Operation with mattress heating:
Gel mattress 2 M 20 827.
– Operation without mattress heating:
Foam rubber mattress 2 M 21 012.
WARNING !
Always fit correct mattress type for intended
mode of operation.
● Place the mattress in bassinet and cover it with a
cloth.
14
Operating Instructions Babytherm 8000 WB
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