RP/VARD

RP/VARD
Patient line with double safety valve
Study of the patient line
with double level safety line
RP/VARD : Study of the patient line with double level safety line

Introduction
For Patient Line safety, it is necessary to be careful about the risk of contamination.
This is the main function of this type of device.
Tests were carried out to confirm the results of our previous trial. Since
then (1996), MEDEX Biomedical has produced and commercialised over
1 million patient lines without any incidents calling into question the safety
of the device. The production methods, some of which are 100 % controlled,
have not changed. The statistical use of the figures collected confirms
the mastery of the performance. EC marking guarantees compliance with
the specifications.
In 4 batches tested, we varied the mechanical characteristics of 2 silicon
disks. The difference in the results, while remaining within the expected
performance, should be linked to this parameter.
The test conditions are severe when compared with normal use: size of
the compounds, 3 hour maintenance, ...
The mass of 2-Deoxy-D-[1-3H] glucose is 164 Daltons, that is 274 10-24
grams and the size is 7 Angströms or 0.7 nanometers.
By way of comparison, one of the smallest polioviruses measures 20 nanometres.
The safety of the valve itself is not called into question.
However, the improvements result from changes in the device produced
to reduce the risk of infection resulting from contamination during handling
of the patient line.
We have centred our efforts on this point so as to provide a device that
increases safety even more.
Annecy le Vieux, 3 October 2000.
10 bis, rue du Pré Paillard
74940 ANNECY LE VIEUX
FRANCE
tel : +33 (0)4 50 64 14 64
fax : +33 (0)4 50 64 14 68
www.medexbio.com

A.D.E.B.I.O.P.H.A.R.M.
Equipe de recherche n° 75
Directeur : OG EKINDJIAN
STUDY OF THE EFFICACY OF THE PATIENT
LINE
WITH DOUBLE LEVEL SAFETY VALVE
COMMERCIALISED BY MEDEX BIOMEDICAL
REPORT DRAWN UP BY
P. JAFFRAY and O.G. EKINDJIAN
SEPTEMBER 2000
ASSOCIATION POUR LE DEVELOPPEMENT ET L’ETUDE
DES TECHNIQUES BIOLOGIQUES ET PHARMACEUTIQUES
Siège social 4 avenue de l’Observatoire - Paris 6ème
Association sans but lucratif déclarée conformément à la loi du 01 juillet 1901
SIRET 775664121 0016 - Code APE 731Z
CEE n° FR 11775664121
Association agréée au titre du Crédit d’impôt en faveur de la recherche

.. Purpose
To assess the efficacy of the valves equipping RP/VARD patient lines
manufactured by MEDEX (cf. Estimate for the trial of 24 July 1999).
For this purpose, a radio-labelled structural analogue of glucose,
a compound with a very low molecular weight (164 daltons) that is
hydrosoluble and very diffusible, will be used.
.. Materials and Methods
.Materials expertised
.Marker used
- 4 batches of patient lines with valves where the silicon has the following
characteristics (data provided by MEDEX on 26 April 2000)
Batch 401 : supplier R, process and characteristics 1
Batch 402 : supplier R, process and characteristics 2
Batch 403 : supplier G, process and characteristics 3
Batch 404 : supplier G, process and characteristics 4
- 2-Deoxy-D-[1-3H] glucose 1.00 mCi – 37.0 Mbq
Code number: TRK383, Batch number B146
Amersham Pharmacia Biotech. Buchinghamshire England HP7 9NA
- Buffered aqueous solution (phosphate buffer, pH 7.4)
.Assay method
Activity of 2-Deoxy-D-[1-3H] glucose measured by ß radiation count.

.. Experimental protocol and expression of the results
These tests use part of the protocol previously employed (refer to 1995
report).
The protocol consists of :
. 3 successive injections of 3 ml of buffered aqueous solution
from the upstream line of the valve and filling of the entire line at
the time of the last injection.
. Suction of the aqueous solution contained in the downstream
part of the line and replacement of this solution with a buffered
aqueous solution containing the glucose analogue labelled with
tritium (2-Deoxy-D-[1-3H] glucose).
Closing of both ends of the line with parafilm.
Placement of the lines, with the downstream end on top (Fig. 1),
on a holder for 3 hours at room temperature (+24 °C).
. Suction of the aqueous solution contained in the upstream part
of the line and the aqueous solution containing the labelled ana
logue contained in the downstream part of the line.
. Measurement of the radioactivity in each of these solutions.
The total volume of each of these solutions is identical, that is
200 µl.
The natural radioactivity of the lines, the buffered solution and
the counting equipment is determined.
. Drawing up a report
A report:
Radioactivity of the solution upstream / radioactivity of the solu
tion downstream is determined for each valve.
It indicates the efficacy of the “barrier” function of the line.

Upstream
Valve
Downstream
.. Figure 1 : the line during the experiment
Line filled with aqueous solution in the
upstream-downstream position
Downstream
Valve
Upstream
Time at + 25°C
Line filled with aqueous solution and
solution containing the marker in
downstream-upstream position

.. Results and discussion
The results for each line batch are presented in the following tables:
Patient line :
BATCH 401
Value expressed in
ppm
Average value in ppm
per line
Control
line upstream
Control
line downstream
Experimental line
upstream
Experimental line
downstream
9 9 75 943000
11 9 68 984000
15 7 70 1012000
8 8 58 988000
9 11 67 991000
10,4 8,8 67,6 983600
Mean value of background noise : 9,6
Mean value of treated line corrected by background noise : 58
Report : Mean value corrected upstream/Mean value line treated downstream : 5,89 10 -5
Each table includes the values of the control line counts (filled only with buffered aqueous solution) and
those of the experimental lines (filled only with buffered aqueous solution in the upstream part and buffered
solution containing the glucose analogue in the downstream part).
The values are provided in ppm (pulses per minute).
The mean values of the five valves per batch and per test are indicated.
The mean value of the “background noise” of the method used to measure the radioactivity is subtracted
from the mean value of the “experimental” lines.

Patient line :
BATCH 402
Value expressed in
ppm
Average value in ppm
per line
Control
line upstream
Control
line downstream
Experimental line
upstream
Experimental line
downstream
8 8 75 897000
7 7 59 876000
9 7 37 919000
6 8 79 901000
7 6 68 895000
7,4 7,2 63,6 897600
Mean value of background noise : 7,3
Mean value of treated line corrected by background noise : 56,3
Report : Mean value corrected upstream/Mean value line treated downstream : 6,27 10 -5
Patient line :
BATCH 403
Value expressed in
ppm
Average value in ppm
per line
Control
line upstream
Control
line downstream
Experimental line
upstream
Experimental line
downstream
7 6 29 951000
7 6 24 900000
9 8 41 922000
7 9 62 939000
13 7 29 850000
8,6 7,2 37 912400
Mean value of background noise : 7,9
Mean value of treated line corrected by background noise : 29,1
Report : Mean value corrected upstream/Mean value line treated downstream : 3,19 10 -5

Patient line :
BATCH 404
Value expressed in
ppm
Average value in ppm
per line
Control
line upstream
Control
line downstream
Experimental line
upstream
Experimental line
downstream
7 7 14 931000
8 14 43 931000
7 7 22 914000
8 6 39 942000
8 8 43 866000
7,6 8,4 32,2 916800
Mean value of background noise : 8
Mean value of treated line corrected by background noise : 24,2
Report : Mean value corrected upstream/Mean value line treated downstream : 2,64 10 -5
In each batch studied, the repeatability of the measurements on 5 lines per test is good in
both the control and the experimental series.
For each batch, the ratios of the corrected upstream value over the mean value of the experimental
downstream lines ranges from 2.64 10-5 to 6.27 10-5, attesting to a slight difference in
behaviour between the line batches. The efficacy of the “barrier” in batches 403 and 404 is similar
and higher.
.. Conclusion
The very low radioactivity found after 3 hours of contact at room temperature attests to a
very high “barrier” effect of the double level safety valve found in the patient line with respect to a
compound with a very low molecular weight that is very diffusible in an aqueous medium. In fact, in
the experimental conditions used for batches 403 and 404, an average of less than 30 ppm, is found
in the upstream part compared with over 900 000 in the downstream part.
However, the “barrier” effect is not absolute since radioactivity about 3 to 4 times
the background noise of the measurement method is detected.

DATA SHEETS ON THE DEVICES

FIK150
FIK150/C
FIK/SP/140
FIK/PI/150/C
DFIK/I/S
DFIK/PI/S
DFIK/PI/PS
DFIK/I/PS
RP/VARD/20 - RP/VARD/35
Principe de raccordement
Connecting principle
Verbindungssystem
Principios de conexión
KSB25
KSB50
KSB/PI
2
Metodo di raccordo
Aansluitingsprincipes
Princípio de conexão
KSB/I/S
KSB/I5/S
KSB/PI/S
Dispositif d’injection de produit de contraste
Contrast media disposable
Injektions-systemen für Kontrastmittel
Dispositivos de inyección de productos de contraste
Dispositivi di iniezione di mezzi di contrasto
Injectiesysteem van contrastmiddel
Dispositivos de injecção para meios de contraste
Raccord patient avec double valve à seuil de sécurité (brevet MEDEX)
Patient line with a double level safety valve (MEDEX patent)
Patientenschlauch mit 2-fach sicherheitsventil (MEDEX-Patent)
Prolongador con doble válvula antirretorno (patente MEDEX)
Raccordo paziente con doppia valvola a soglia di sicurezza (brevetto MEDEX)
Patiënten-tussenstuk met dubbele veiligheidsklep (patent MEDEX)
Prolongador com dupla válvula de segurança (patente MEDEX)
REF MEDEX : RP/VARD/20
RP/VARD/35
USAGE UNIQUE
A changer impérativement entre chaque patient.
SINGLE USE
This device must be imperatively changed for each person receiving contrast.
EINMAL-GEBRAUCH
Dieses Produkt ist nur zur einmaligen Anwendung bestimmt und muss nach jedem Patienten
gewechselt werden.
UN SOLO USO
Es vital que este dispositivo se cambie por cada paciente que reciba contraste.
MONOUSO
Sostituire tassativamente per ogni paziente.
EENMALIG GEBRUIK
Voor elke patiënt moet een nieuwe aansluiting gebruikt worden.
UTILIZACAO ÚNICA
O dispositivo médico deve ser obrigatoriamente substituido em cada paciente.
Catheter
Catheter
Katheter
Catéter
Catetere
Catheter
Catheter
0 4 5 9
REV061004

* 1 PSI # 7 kPa
** Essais réalisés avec une substance
radio-marquée très diffusible
3 H-2-déoxy-D-glucose, molécule
de très faible masse moléculaire
(164 daltons).
* 1 PSI # 7 kPa
** Tests done with a very diffusable
radiomarked substance 3 H-2deoxy-D-glucose
molecule with a
very low molecular mass (164 daltons).
* 1 PSI # 7 kPa
** Teste durchgeführt mit einer sehr
ausbreitenden radio-markierten 3
H-2-Deoxy-D-Glucose-Substanz,
Molekül mit sehr niedriger Molekularmasse
(164 Daltons).
* 1 PSI # 7 kPa
** Pruebas realizadas con una sustancia
radiomarcada de alta difusión
3 H-2-desoxi-D-glucosa, molécula
de masa molecular muy baja (164
daltons).
* 1 PSI # 7 kPa
** Studi realizzati con una sostanza
radio-marcata ad elevata fiffusione
3 H-2-deoxy-D-glucosio, con massa
molecolare molto bassa (164 daltons).
* 1 PSI # 7 kPa
** Testen uitgevoerd met een zeer
goed diffunderende radiogemarkeerde
substantie 3 H-2-deoxy-Dglucose,
een molecule met zeer
lage moleculaire massa (164 daltons).
* 1 PSI # 7 kPa
** Ensaios realizados com uma
substância radiomarcada de elevada
difusão 3H-2-desoxi-D-glucose,
molécula de massa molecular muito
baixa (164 daltons).
2 USAGE UNIQUE
A utiliser avec tous types de
dispositifs d’injection de produit
de contraste.
2 SINGLE USE
Can be used with every contrast
media disposable.
2 EINMAL-GEBRAUCH
Anwendbar bei allen Injektionssystemen
für Kontrastmittel.
2 UN SOLO USO
Utilizar con todo tipo de dispositivos
de inyección de productos
de contraste.
2 MONOUSO
Utilizzabile con tutti i tipi di dispositivi
di iniezione di mezzi di
contrasto.
2 EENMALIG GEBRUIK
Te gebruiken met elke type van
contrastmiddel injector.
2 UTILIZACAO ÚNICA
A utilizar com todos os tipos de
dispositivos de injecção para
meios de contraste.
Instructions
particulières :
Use specifications : Hinweise :
Especificaciones de uso:
Istruzioni
particolari :
Speciale
instructies :
Instruções
particulares :
Vérifier l’intégrité du protecteur
avant usage.
Ensure sterile package is intact
before use.
Vor Gebrauch ist sicherzustellen,
dass die sterile Verpackung
unbeschädigt ist.
Comprobar la integridad del
protector de esterilidad antes
del uso.
Verificare l’integrità della confezione
prima dell’uso.
Vóór gebruik controleren of
het steriliteitsdopje ongeschonden
is.
Verificar a integridade da embalagem
antes de usar.
Caractéristiques :
RP/VARD/ 20 35
Volume (ml) 0,8 1,4
Longueur (cm) 20 35
Pression max. (kPa*) 2100 2100
Seuil ouverture (kPa*) 25 25
Conditionnement (U) 100 100
Stérile ETO
Characteristics :
RP/VARD/ 20 35
Volume (ml) 0,8 1,4
Length (cm) 20 35
Max. pressure (kPa*) 2100 2100
Open pressure (kPa*) 25 25
Packaging (U) 100 100
ETO sterilised
Technische Daten :
RP/VARD/ 20 35
Volumen (ml) 0,8 1,4
Länge (cm) 20 35
Max. Druck (kPa*) 2100 2100
Offenes Ventil (kPa*) 25 25
Verpackung (Stück) 100 100
Sterilisiert mit ETO
Características :
RP/VARD/ 20 35
Volumen (ml) 0,8 1,4
Longitud (cm) 20 35
Presión max (kPa*) 2100 2100
Límite de apertura (kPa*) 25 25
Acondicionamiento (U) 100 100
Esteril ETO
Dans le sens passant, la valve
autorise le passage du liquide
pour une pression amont supérieure
à 25 kPa (3,5 PSI)*. Elle
est hermétique dans le sens
inverse (probabilité de passage
des molécules < 10-6 )**.
La sécurité attribuée à ce type
de valve, dites «double valve à
seuil de sécurité», dépend essentiellement
de sa conception
(brevet MEDEX).
In use the valve allows fluid to
pass at a pressure above 25
kPa (3.5 PSI)*. It is a one-way
safety valve (possibility of molecular
reflux < 10-6 )**. The name
given to these valves «double
level safety valves» refers to
its unique structure (MEDEX
patent).
RACCORD PATIENT AVEC
DOUBLE VALVE A SEUIL DE
SECURITE
PATIENT LINE WITH DOUBLE
LEVEL SAFETY VALVE
PATIENTEN ANSCHLUßS-
TUCK MIT DOPPELTEM ANTI-
RÜCKFLUSS SICHERHEITS-
VENTIL
Während der Anwendung lässt
das Ventil Flüssigkeit durch bei
einem Druck von über 25 kPa
(3,5 PSI)*. In die Gegenrichtung
ist es hermetisch (Möglichkeit
von Molekulendurchfluss < 10- 6 )**. Die Benennung «Anschlußstück
mit doppeltem Anti-Rückfluss
Sicherheitsventil» bezieht
sich auf die einmalige Struktur
(MEDEX-Patent).
En el sentido de circulación, la
válvula permite el paso del líquido
para una presión de entrada
superior a 25 kPa (3,5 PSI)*. En
el sentido inverso, la válvula es
hermética (probalidad de paso
de las moleculas < 10-6 )**. La
seguridad atribuida a este tipo
de válvula, llamada «doble válvula
de seguridad» depende
esencialmente de su diseño
(patente MEDEX).
La valvola permette il passaggio
del liquido in una sola direzione,
per pressione a monte superiore
a 25 kPa (3,5 PSi)*. Essa
è ermetica nel senso inverso
(probabilità di passaggio delle
molecole < 10-6 )**. La sicurezza
attribuita a questo tipo di valvole,
definite «doppia valvola con
sistema di sicurezza», dipende
essenzialmente dalle sue caratteristiche
tecniche (brevetto
MEDEX).
Caratteristiche :
RP/VARD/ 20 35
Volume (ml) 0,8 1,4
Lunghezza (cm) 20 35
Pressione mas.(kPa*) 2100 2100
Soglia apertura (kPa*) 25 25
Confezione (Pz) 100 100
Sterilizzato ETO
Eigenschappen :
RP/VARD/ 20 35
Volume (ml) 0,8 1,4
Lengte (cm) 20 35
Max. druk (kPa*) 2100 2100
Open klep (kPa*) 25 25
Verpakking (E) 100 100
ETO Gesteriliseerd
Características :
RP/VARD/ 20 35
Volume (ml) 0,8 1,4
Comprimento (cm) 20 35
Pressão max.(kPa*) 2100 2100
Pressão pressure (kPa*) 25 25
Acodicionamento (U) 100 100
Esterilizado com ETO
Bij gebruik laat de klep vloeistof
door vanaf een druk van 25 kPa
(3,5 PSI)*. Ze sluit hermetisch in
de tegengestelde richting (kans
op doorgang van molecules <
10-6 )**. De naam «tussenstuk
met dubbele anti-terugslag veiligheidsklep»
verwijst naar zijn
unieke vormgeving (patent ME-
DEX).
A utilização da válvula, no sentido
da circulação, permite a passagem
do fluído com uma pressão
de entrada superior a 25 kPa (3,5
PSI)*. No sentido inverso, a válvula
é hermética.(probabilidade
de passagem de moléculas<
10-6 )**. A segurança atribuída a
este tipo de válvula, designada
"dupla válvula de segurança",
depende essencialmente da sua
concepção (patente MEDEX).
LINEA DE CONEXION AL
PACIENTE CON DOBLE
VALVULA DE SEGURIDAD
RACCORDO PAZIENTE CON
DOPPIA VALVOLA A SISTEMA
DI SICUREZZA
PATIENT TUSSENSTUK MET
DUBBELE ANTI-REFLUX
VEILIGHEIDSKLEP
PROLONGADOR COM DUPLA
VALVULA DE SEGURANÇA
FR
EN DE
ES IT NL PT
10 bis, rue du Pré Paillard
74940 ANNECY LE VIEUX
FRANCE
tel : +33 (0)4 50 64 14 64
fax : +33 (0)4 50 64 14 68
www.medexbio.com
Notice d’utilisation
User notice
Gebrauchsanweisung
Instrucciones de uso
Istruzioni d’uso
0 4 5 9
Gebruiksaanwijzing
Folheto de instruções
RP/VARD/20 - RP/VARD/35

medex biomedical
10 bis, rue du pre paillard
74940 annecy le vieux (FRANCE)
tel : +33 (0)4 50 64 14 64
fax : +33 (0)4 50 64 14 68
www.medexbio.com
AUTOMATIC INJECTORS
FOR CONTRAST MEDIA DELIVERY
LOW AND HIGH PRESSURE
SYRINGES AND BAGS
MEDICAL DISPOSABLES