Dräger Babytherm 8004 Supplement Manual

To all operators and users of
Babytherm 8004/8010 open care units
for premature and newborn patients
lmportant safety notice!l!
Babytherm 8004/8010
open care units for premature and newborn patients
Dear Madam/Sir,
Dräaer
June 2016
As part of our market and product monitaring we have become aware of a case in which
a Babytherm 8004 without patient was operated in skin temperature mode with skin
temperature sensor to prepare it for use. ln skin temperature mode, the radiant warmer
output is controlled automatically until the set skin temperature is reached. As a result of
operating the temperature sensor without patient contact, the radiant warmer was
operated continuously at a high output Ievel. During this forced continuous operation
under high thermal Ioad, the heating element aged faster. Apart became detached from
the heating element and fell onto the mattress tray \1\fhere a towel caught fire.
Do not operate the device in skin temperature mode with temperature sensor
without patient contactl
To preheat the device, you can use the manual mode up to Ievel 3 as there is no active
time Iimit. At Ievel 4 or above, there will be regular alarms. lf the alarm is not
acknowledged, the radiantwarmer will be automatically switched off. For further details,
please refer to the Babytherm 8004/8010 instructions for use.
Additionally, our analyses have shown that the heating elements are not replaced at
regular intervals as recommended in the Babytherm instructions for use. We attribute this
to the fact that it might not be practicable to replace the heating element after 10,000
operating hours. We have therefore converted this value into a period of 2 years, which
can be measured more easily.
lf your heating elements have been in operation for more than 2 years, please
replace them.
Drägerwerk AG & Co. KGaA
Moislinger Allee 53-55
23558 Lübeck, Germany
Postal address:
23542 Lübeck, Germany
TeL +49 451 882.{)
Fax +49 451 882-2080
info@draeger.com
www.draeger.com
VAT ID DE135082211
Bank information : Company headquarters: Lübeck
Commerzbank AG, Lübeck Commercial register:
IBAN: DE95 2304 0022 0014 6795 00 Municipal Court lübeck HRB 7903 HL
Swift Code: COBA OE FF 230 General partner: Drägerwerk Verwaltungs
Sparkasse zu Lübeck AG
IBAN: DE15 2305 0101 0001 0711 17 Company headquarters: Lübeck
Swift code : NOLADE21SPL Commercial register:
Municipal Court Lübeck HRB 7395 HL
Chairman of the Executive Board
for
Drägerwerk AG & Co. KGaA and
Drägerwerk Verwaltungs AG:
Prof. Dr. Nikolaus Schweickart
Executive Board:
Siefan Dräger (Chairman)
Rainer Klug
Gert-Hartwig Lescow
Dr. Reiner Piske
Anton Schrofner