Sterilization - Decontamination Of Polaris® Valves And Valve Kits; Cleaning - Decontamination Of The Polaris® Adjustment Kit; 10. Instructions; Choice Of Valve Model - Sophysa POLARIS SPV-140 Gebrauchsanweisung

8. Sterilization – Decontamination
of Polaris® Valves and Valve Kits
The Polaris® valves and valve kits are packed individually in double peel-off , sterile,
pyrogen-free packaging, sterilized with ethylene oxide.
W :
ARNINGS
D
O NOT USE THE VALVES OR VALVE KITS IF THE STERILE PACKAGING IS OPEN OR DAMAGED
.
EXPIRATION DATE HAS PASSED
V
ALVES AND VALVE KITS ARE SINGLE USE DEVICES
/ .
AND OR EXPLANTATION
N :
OTE
S
OPHYSA CANNOT BE HELD RESPONSIBLE FOR THE PERFORMANCE OF ANY PRODUCT THAT HAS BEEN
- / - ,
RE STERILIZED AND OR RE USED NOR FOR ANY COMPLICATIONS WHICH MIGHT RESULT FROM THIS
9. Cleaning – Decontamination
of the Polaris® Adjustment Kit
The various components of the Polaris® adjustment kit are not sterile and must not
be sterilized.
However, if there is a low risk of infection, decontamination of the Polaris® adjustment
kit may be performed by manual disinfection followed by a fi nal rinse.
Disinfection is best performed by applying a disinfectant, using material (swab)
impregnated with a standardized solution of a broad spectrum disinfectant
(bactericide, tuberculicide (mycobactericide), fungicide and virucide) in accordance
with the recommendations of the manufacturer.
This disinfection must be followed by a meticulous fi nal rinse, again using material
(swab), with an appropriate type of water, followed by drying.
The cleaning/disinfection should be performed in accordance with standard hospital
procedures.
P :
RECAUTIONS
D
O NOT STERILIZE OR IMMERSE THE ADJUSTMENT KIT COMPONENTS
I
RREVERSIBLE ALTERATIONS TO THE MARKINGS
M
DEMAGNETIZATION OF THE AGNET RISK RENDERING THE ADJUSTMENT DEVICE UNUSABLE
O
NLY USE STANDARD DISINFECTANT SOLUTIONS IN ACCORDANCE WITH THE METHODS VALIDATED FOR
THE DECONTAMINATION OF COMPONENTS OF THE
N -
ON ADHERENCE TO STANDARD DECONTAMINATION RULES COULD INDUCE A RISK OF MICROBIAL
.
CONTAMINATION

10. Instructions

Choice of valve model

The choice of Polaris® adjustable pressure valve model is left to the neurosurgeon and
depends upon the clinical needs of the patient.
P :
RECAUTIONS
D -
O NOT USE PRE CONNECTED VALVE KITS
- .
FOR VENTRICULO ATRIAL SHUNTS
T
HERE COULD BE IMPLANTATION DIFFICULTIES RELATING TO THE SHUNT LENGTH ADAPTATION AT
.
THE ATRIUM
U SPVA ( )
SE AN ANTECHAMBER TYPE MODEL
SPV
OR ONE OF THE MODELS COMBINED WITH A VENTRICULAR CATHETER WITH RESERVOIR IF
THE PLAN IS TO USE THE SHUNT SYSTEM TO CHECK THE PATENCY OF THE SHUNT
.
OR FOR INJECTIONS
. D - -
O NOT RE STERILIZE OR RE USE AFTER UNPACKING
.
,
DISTORTION OF THE PLASTIC PARTS AND
P ® .
OLARIS ADJUSTMENT KIT
( -
VALVES WITH PRE ATTACHED DISTAL CATHETER
, SPVB ( )
AN BURR HOLE RESERVOIR TYPE MODEL
,
TO SAMPLE THE
Adjustment of a Polaris® valve BEFORE IMPLANTATION:
selection of operating pressure
Before opening the packaging that guarantees the sterility of the valve, it is necessary
to adjust the valve rotor in the position which corresponds to the pressure chosen for
the implantation by the surgeon depending upon the needs of the patient.
NOTE:
,
I
OR IF THE
F A VALVE IS PRE
WHEN ADJUSTING TAKE INTO ACCOUNT THE FACT TAT THE
THE VALVE OPERATING PRESSURE
The sterile packaging is designed to allow adjustment of the valve through the blister
packaging, using a Polaris® adjustment kit.
P :
RECAUTIONS
.
C
HANGING THE VALVE PRESSURE MUST ONLY BE DONE BY A NEUROSURGEON
.
PERSON
D
O NOT UNPACK OR IMPLANT THE VALVE WITHOUT PREVIOUSLY ADJUSTING IT TO THE OPERATING
PRESSURE ESTIMATED TO BE THE MOST APPROPRIATE FOR THE PATIENT
T
HE OPERATION SCAR AND
PAINFUL AND INACCURATE
.
IT IMPOSSIBLE
W :
ARNING
T
HE ADJUSTMENT KIT MUST NOT BE USED IN THE OPERATIVE FIELD
,
BE STERILIZED USING IT DURING THE OPERATION WOULD CAUSE A HIGH RISK OF INFECTION FOR
.
THE PATIENT
1) Identifi cation of the valve model
Identify the reference and/or the pressure range of the Polaris® valve to be adjusted:
Refer to the labeling on the package.
/
OR
.
Figure 8: Details of the blister pack of a Polaris® SPV valve set to the highest pressure
(for this example)
2) Choice of Locator Reading Area
)
Use the Locator on which the pressure values for valve models with standard
calibration are engraved: 30-200mmH
For a "special pressure" valve model (10-140, 50-300 or 80-400mmH
fi x the reading ring, which corresponds to the valve model, onto the Locator,
,
positioning the two holes in the ring on the two pins on the Locator.
CSF
W :
ARNING
D P
O NOT USE A OLARIS
MAKING SURE THAT THE PRESSURE RANGE SHOWN ON THE
10
- S X®
CONNECTED TO A IPHON GRAVITATIONAL ANTI
S
IPHON
.
/ -
OR POST OPERATIVE EDEMA CAN MAKE POSITIONING THE
. T
HIS COULD THEN CAUSE DIFFICULTIES IN ADJUSTMENT OR EVEN MAKE
O.
2
®
ADJUSTMENT KIT WITHOUT PREVIOUSLY IDENTIFYING THE VALVE MODEL AND
L
OCATOR CORRESPONDS TO THIS MODEL
- .,
SIPHON DEVICE
X® 200 H O
ADDS UP TO MM TO
2
,
OR OTHER QUALIFIED
.
L
OCATOR
. A
S THE ADJUSTMENT KIT CANNOT
O),
2
.