RAUMEDIC DATALOGGER User manual

zwo-685 en Rev. 00 / 2023-03-22 Page 1 of 2
Instructions for use
Transducercable
DATALOGGER
Read the instructions for use carefully before
using the medical device!
1 General descri tion
The DATALOGGER t ansduce cable (length 2.00 m) is used to
display invasive blood p essu e values on Raumedic monito
systems.
The co esponding t ansduce cable DATALOGGER fo each
connection type can be found in Section
9 Transducer connection ty es.
2 Notes
2.1 O erating instructions
Afte connecting the t ansduce to a Raumedic device using the
DATALOGGER t ansduce cable, assign the t ansduce to the
measu ement location. Follow the t ansduce manufactu e ’s
inst uctions fo use when ze oing. Use the “conventional ze oing”
option on the Raumedic device.
2.2 Precautionary measures
 This p oduct may only be used by t ained specialist pe sonnel.
 Befo e each use, a visual check of the cable and plug
connecto s must be ca ied out to ensu e that they a e clean
and f ee of damage. Do not use in the event of damage o
malfunction.
 Avoid bending o kinking the cable significantly.
 P otect cables f om st ong UV adiation.
 Connecto s must only be used in the intended sockets. Be
mindful of the mechanical coding on the connecto s and
sockets.
 Do not unsc ew the connecto s.
 The Redel connecto (8-pin ci cula connecto ) is equipped
with a push-pull locking system, which p events the connecto
f om being eleased when pulling on the cable. When
disconnecting the connection, only g asp the connecto in the
immediate vicinity of the socket (on the connecto pa t with the
two a ow symbols).
 Follow the inst uctions fo use fo the t ansduce s and
Raumedic devices.

3 Connecting the transducer cable to
Raumedic devices
The DATALOGGER t ansduce cable makes it possible to connect
selected exte nal t ansduce s (see Section 9 Transducer
connection types) to the p essu e inputs on Raumedic devices
(MPR 1 DATALOGGER, MPR2 logO DATALOGGER,
Neu oSma t logO). Inse t the Redel connecto into an available
p essu e input socket (yellow colou coding). The embossed
a ows indicate the co ect connection position.
Example: P essu e input socket on Neu oSma t logO
Afte that, conduct a functional check of the enti e measu ing chain
as desc ibed in the inst uctions fo use fo the Raumedic device in
question.
4 Safety information
If liquid accidentally uns inside the cable connecto , do not
use the cable.
If only the oute cable insulation has been moistened, wipe
the moistu e away with a d y cloth befo e using the cable.
In the event of a malfunction, check the individual
components of the measu ing chain and eplace them as
needed.
A functional measu ing chain is a p e equisite fo usage. If
the p oblem cannot be localised, contact the
manufactu e /supplie immediately.
5 Cleaning
Cables can be cleaned with a cloth and lukewa m soapy wate and
disinfected with 70% isop opanol solution. Wipe the cables d y
with a cloth befo e use.
 Disconnect all plug connections befo e cleaning the cables.
 Do not imme se the cable in liquid.
 Do not clean the cable ult asonically.
6 Sterilisation
Do not ste ilise o autoclave the cable.
7 Information and warning symbols
on the label
Warning
symbol Meaning
Keep d y
Keep away f om sunlight
Consult inst uctions fo use
Item numbe
Only g asp the connecto he e!
Do not pull on the g ommet o the cable!

zwo-685 en Rev. 00 / 2023-03-22 Page 2 of 2
In the US, fede al law specifies that this
inst ument may only be sold to and
p esc ibed by physicians.
Se ial numbe
Manufactu e
Date of manufactu e
CE ma k
Follow disposal inst uctions. Do not dispose
of old devices as household waste.
Quantity
Medical device
Unique Device Identification
8 Dis osal
Defective o unused p oducts may be etu ned
to the manufactu e fo disposal.
Follow disposal inst uctions. Ensu e p ope
disposal.
9 Transducer connection ty es
Ty e
Transducercable DATALOGGER Smiths Medical
Item number 094908-001
Transducercable DATALOGGER Combitrans
Item number 096664-001
Transducercable DATALOGGER Medex MX 960
Item number 095974-001
Ty e
Transducercable DATALOGGER Becton Dickinson
Item number 096046-001
Transducercable DATALOGGER Edwards TRUWAVE
Item number 096036-001
10 Liability and warranty notice
Check functional testing. Raumedic neithe explicitly no implicitly
assumes any liability, no offe s any wa anty o gua antee, fo this
p oduct’s suitability fo any pu pose beyond what is desc ibed in
these inst uctions fo use. The same applies to additional
p ocessing of this item and its use in the manufactu e of othe
p oducts. Raumedic wa anty conditions apply exclusively.
Pursuant to the Euro ean Medical Device Regulation
(2017/745), Raumedic AG is obliged to state the following:
All se ious adve se events that occu in connection with the
p oduct a e to be epo ted to Raumedic AG and to the competent
autho ity in the membe state in which the use and/o the patient
is located.
Note:
Se ious incidents a e defined as the death of a patient, use o
othe pe son o the tempo a y o pe manent se ious dete io ation
in the health of a patient, use o othe pe son. It does not matte
whethe these occu ed o could occu . The exact definition can
be found in Regulation (EU) 2017/745 A ticle 2 (65).
The contact details of the competent autho ity of
you membe state can be found on the Inte net
using the sea ch te ms “Com etent Authorities
for Medical Devices EU”.
Manufacturer: Raumedic AG, He mann-Staudinge -St . 2,
95233 Helmb echts, Ge many
www. aumedic.com mailto:neu omonito ing@ aumedic.com