Dräger Babytherm 8004 Owner's 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
Mo islinger Allee 53-55
23558 Lübeck, Germany
Postal address:
23542 Lübeck, Germany
TeL [phone].{)
Fax [phone]
[email protected]
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 reg ister:
Municipal Court Lübeck HRB 7395 HL
Chairman of the Executi ve 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

ilräger
Page 2/2
lf you have any questions regarding orders, please contact your local Dräger
representative.
lf you have concluded a service contract with us, your responsible Dräger
service technician will check the age of your heating elements at the next opportunity
and replace them if necessary.
We amended our instructions for use by the attached supplement, which contains
corresponding notes and warnings.
Piease add the supplement
to all instructions for use of the Babytherm 8004/8010
and inform any possible users in your facility about it.
We regret any inconvenience this information may cause but consider it necessary as a
preventive measure to increase patient and user safety.
Piease feel free to contact your local Dräger representative if you have any questions.
Yours faithfully,
Ci~el~
Oliver Möller
Post Market Surveillance
Quality and Regulatory Affairs
Attachment:
lnken Schroeter
Product Management Life Support Systems
Thermoregulation
Supplement to the instructions for use of your Babytherm 8004/8010

To enable us to monitor the effectiveness of this communication, we request that you sign
and return (email or post) the 'Confirmation of Receipt' as below.
Important Safety Notice
Failure of radiant heaters due to overload
and ageing
Please list affected devices below:-
Part
Number
Device
Machine ID
Serial Number
Hospital Name: ________________________________
Contact Name: _______________________________
Signature:__________________________________
Date: _____________________________
Should you have any questions, please contact:-
Quality Department
Draeger Medical UK Limited
The Willows, Mark Road
Hemel Hempstead
Hertfordshire HP2 7BW
E-mail: [e-mail]
Tel.: [phone]
Fax: [phone]

Babytherm 8004/8010
WARNING
To properly use this medical device,
read and comply with these Instruc-
tions for Use.
de Ergänzung, Seite 2
en Supplement, page 4
fr Supplément, page 6
es Suplemento, página 8
it Foglio informativo, pagina 10
pt_ib Documento suplementar, página 12
nl Aanvullingsdocument, pagina 14
da Supplement, side 16
no Vedlegg, side 18
sv Tilläggsinformation, sida 20
fi Lisälehti, sivu 22
pl Suplement, strona 26
cs Dodatek, strana 28
sk Dodatok, strana 30
hu Kiegészítődokumentum, 32. oldal
ro Supliment, pagina 34
sr Dodatak, stranica 36
bg Допълнение, стр.38
tr Ek, Sayfa 40
zh 增补 , 第42 页
ko 부록 , 44 참조
ja 補足文書 , 46 ページ

4 Supplement Babytherm 8004/8010
English
Supplement Babytherm 8004/8010 en English
Supplement to the instructions for use
Babytherm 8004/8010 with part number: 9029458,
edition: 12 – 2015-01 and earlier
Babytherm 8004/8010 (NAWI scale option) with
part number: 9052336, edition: 3 – 2015-01 and
earlier
zKeep this supplement with the instructions for
use of the medical device.
This supplement updates the information of the
instructions for use in the following chapters:
For your safety and that of your patients
Maintenance intervals (in Supplement 9054794 named Maintenance)
Safety checks
Safety checks are not a substitute for maintenance,
which includes the preventive replacement of
wearing parts, as specified by the manufacturer.
1Check the accompanying documents:
– The latest version of the instructions for use is
available
2Perform a functional test of the following
features according to the instructions for use:
– Height adjustment
– The flaps close securely
3Check that the device combination is in perfect
condition:
– All labels are complete and legible
– There is no visible damage
– Fuses which are accessible from the outside
are in compliance with the specified values
– Check the condition of the two heater elements,
paying particular attention to signs of thermal
overload.
4Check if the medical device is completely
equipped as described in the instructions for
use.
WARNING
Risk of overheating of the radiant warmer
If the radiant warmer is operated continuously
at high output, for example, in skin tempera-
ture mode with a temperature sensor and
without a patient, the life span of the infrared
radiator may be shortened.
Do not operate the device in skin temperature
mode with a temperature sensor connected
and without a patient.

Supplement Babytherm 8004/8010 5
English
5Check the electrical safety according to
IEC 62353.
6Check the safety features:
– Mains power supply failure alarm
– LEDs, display, alarm tone
Table of maintenance intervals
Technical data
WARNING
Risk due to faulty infrared radiators
The heater elements are designed for safe op-
eration within the specified maintenance inter-
vals. Failure to observe the specified mainte-
nance intervals or using the device contrary to
its intended use poses a risk to patient safety.
Observe the specified maintenance intervals.
Component Interval Task Personnel responsible
Heating element/infra-
red radiator
After 2 years
or 5000 oper-
ating hours
Exchange in pairs Experts
Radiant warmer
Radiant power between the bed and the radiant
warmer1)
1) measured according to IEC 60601-2-21
Heater level 3 max. 10 mW/cm2
Heater level 10 max. 30 mW/cm2