Preoperative Valve Test; Re-Implantation; Safety Measures; Compatibility With Diagnostic Procedures - MIETHKE paediSHUNTASSISTANT Mode D'emploi

| InstructIons for use
GB

PREOPERaTIvE valvE TEST

isotonic sterile sodium chloride solution
Fig. 6: Patency test
The paediSHUNTASSISTANT/SHUNTASSIS-
TANT can be filled most gently by aspiration
through a sterile, single-use syringe attached to
the distal end of the catheter. The proximal end
of the valve is immersed in a sterile, physiologi-
cal saline solution. The valve is patent if fluid can
be extracted in this way (see fig. 6).
Caution: Pressure admission through the
single-use syringe should be avoided, both
at the proximal and the distal end.
Contaminations in the solution used for the
test can impair the product's performance.
InTERaCTIOnS wITH PROduCTS fROM
OTHER ManufaCTuRERS
The paediSHUNTASSISTANT/SHUNTASSI-
STANT should not be used under any circum-
stances in conjunction with hydrostatic valves,
as this can bring about an unphysiologically
high ventricular pressure. hydrostatic valves
allow for changes in hydrostatic pressure in the
drainage system caused by changes in positi-
on. If in doubt, please contact the medical pro-
duct consultants at christoph Miethke Gmbh
& cO. kG.

RE-IMPlanTaTIOn

Under no circumstances should products that
have had previously been implanted in a patient
be subsequently re-implanted in another, as a
validated decontamination process will com-
promise the functionality of the valve.
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SafETy MEaSuRES

The patients must be carefully monitored after
the implantation. reddened skin and tension in
the area of the drainage tissue could indicate
infections at the shunt system. Symptoms such
as headache, dizzy spells, mental confusion or
vomiting are common occurrences in cases of
shunt dysfunction. Such symptoms, as well as
shunt system leakage, necessitate the imme-
diate replacement of the shunt component re-
sponsible, or of the entire shunt system.
COMPaTIBIlITy wITH dIaGnOSTIC
PROCEduRES
MrI examinations with field strengths of up to
3.0 tesla and cT examinations can be carried
without endangering or impairing the function-
ality of the shunt.
The paediSHUNTASSISTANT/SHUNTASSIS-
TANT is Mr conditional (ASTM-f2503-08). All
components are visible via X-ray. The provided
catheters are MrI Safe. reservoires, deflectors
and connectors are MrI conditional (ASTM-
f2503-08).

POSTOPERaTIvE valvE TEST

The paediSHUNTASSISTANT/SHUNTASSIS-
TANT has been designed as a safe and reliable
unit even without the provision of a pumping
device. however, there are ways of testing the
unit if a shunt system with a prechamber or a
borehole reservoir is used. Valve tests can be
carried out by flushing or pressure measure-
ments.

funCTIOnal SafETy

The valves have been designed for long-term
reliable and precise operation. Still, it cannot be
excluded that the shunt system needs to be re-
placed for technical or medical reasons.
The valve and the valve system are able to
resist positive and negativ pressure up to 200
cmh
O during and after implantation.
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STERIlISaTIOn

The products are sterilized with steam under
closely monitored conditions. The double wrap-
ping in sterile bags ensures sterility for a period
of five years. The expiry date is printed on the
wrapping of each individual product. Products
taken from a damaged wrapping must not be
used under any circumstances.

RESTERIlISaTIOn

The functional safety and reliability of resterilized
products cannot be guaranteed, therefore re-
sterilisation is not recommended.

REquIREMEnTS Of THE Mdd 93/42/EEC

The Mdd calls for the comprehensive docu-
mentation of the whereabouts of medical pro-
ducts that are applied in human beings, es-
pecially the whereabouts of implants. for this
reason, the individual identification numbers
of any implanted valves are to be noted in pa-
tients' records, so that in the event of any in-
quiries, the implant can be traced without any
difficulties. each valve is outfitted with a sticker
for this purpose.

nOTE On THE InSTRuCTIOnS fOR uSE

The descriptions and explanations given in this
document are based on the clinical experience
available to date. It is for the surgeon to deci-
de if surgical procedures should be changed
according to his or her experience and to sur-
gical practice.
InstructIons for use |

MEdICal PROduCTS COnSulTanT

In compliance with the requirements of the eu-
ropean law Mdd 93/42/eec, christoph Miethke
Gmbh&co. kG names medical pro duct con-
sultants as the individuals to be addressed with
all queries concerning the products:
dipl.-Ing. christoph Miethke
dipl.-Ing. roland Schulz
christoph Miethke Gmbh & co. kG
Ulanenweg 2
d-14469 Potsdam · Germany
Phone: +49(0) 7000 6438453 or
Phone: +49(0) 331 620 83 0
fax: +49(0) 331 620 83 40
e-mail: info@miethke.com
Please address any enquiries to:
AeScUlAP AG
Am Aesculap Platz
d-78532 Tuttlingen · Germany
Phone: +49 (0) 7461 95-0
fax: +49 (0) 7461 95-26 00
e-mail: information@aesculap.de
Service address in the US
AeScUlAP Inc.
Attn. AeScUlAP Technical Services
615 lambert Pointe road
hazelwood, MO, 63042
AeScUlAP repair hotline
Phone: +1 (800) 214-3392
fax: +1 (314) 895-4420
distributor in the US/ contact in canada
AeScUlAP Inc.
3773 corporate Parkway
center Valley, PA 18034
Phone: +1-800-282-9000
www.aesculapusa.com
GB
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