Dräger Babytherm 8004 Betriebsanleitung

To all operators and users

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

our market and product monitaring we have become aware

a case

which

a Babytherm 8004 without patient was operated

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

reached. As a result

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

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.

the alarm

not

acknowledged, the radiantwarmer will

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

the Babytherm instructions for use. We attribute this

to the fact that it might not

practicable to replace the heating element after 10,000

operating hours. We have therefore converted this value into a period

2 years, which

can

measured more easily.

lf your heating elements have been in operation for more than 2 years, please

replace them.

Drägerwerk

& Co. KGaA

islinger Allee 53-55

23558 Lübeck, Germany

Postal address:

23542 Lübeck, Germany

TeL

+49

451

882.{)

Fax +49

451

882-2080

[email protected]

www.draeger.com

VAT

DE135082211

Bank information: Company headquarters: Lübeck

Commerzbank

AG,

Lübeck Commercial register:

IBAN:

DE95 2304 0022 0014 6795 00 Municipal Court

lübeck

HRB 7903

Swift Code: COBA

230 General partner: Drägerwerk Verwaltungs

Sparkasse

Lübeck

IBAN:

DE15 2305

0101

0001

0711

17 Company headquarters: Lübeck

Swift code: NOLADE21SPL Commercial

reg

ister:

Municipal Court Lübeck HRB 7395

Chairman of the Executi

Board

for

Drägerwerk

. KGaA

and

Drägerwerk Verwaltungs

Prof. Dr. Nikolaus Schweickart

Executive Board:

Siefan Dräger (Chairman)

Rainer

Klug

Gert-Hartwig Lescow

Dr. Reiner Piske

Anton Schrofner

ilräger

Page

2/2

you have any questions regarding orders, please contact your local Dräger

representative.

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.

amended our instructions for use by the attached supplement, which contains

corresponding notes and warnings.

Piease add the supplement

all instructions for use

the Babytherm 8004/8010

and inform any possible users

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

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: helen.glass@draeger.com

Tel.: 01442 292870

Fax: 01442 240327

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

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