Integra Godman VPV User manual

Codman®
VPV® System
EN – ENGLISH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
FR – FRANÇAIS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
DE – DEUTSCH. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22
NL – NEDERLANDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
IT – ITALIANO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
ES – ESPAÑOL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
PT (EU) – PORTUGUÊS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .62
DA – DANSK . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
SV – SVENSKA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
FI – SUOMI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
EL – ΕΛΛΗΝΙΚΑ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .102
HU – MAGYAR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112

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i
EN-ENGLISH
A. Program Unit
B. Transmitter Unit
FR-FRANÇAIS
A. Unité de programmation
B. Unité de transmission
DE-DEUTSCH
A. Programmiereinheit
B. Sender
NL-NEDERLANDS
A. Programmeereenheid
B. Zendereenheid
IT-ITALIANO
A. Programmatore
B. Trasmettitore
ES-ESPAÑOL
A. Unidad del programa
B. Unidad del transmisor
PT (EU)-PORTUGUÊS
A. Unidade de programação
B. Unidade do transmissor
DA-DANSK
A. Programenhed
B. Senderenhed
SV-SVENSKA
A. Programmeringsenhet
B. Sändarenhet
FI-SUOMI
A. ohjelmayksikkö
B. lähetinyksikkö
EL- ΕΛΛΗΝΙΚΑ
A. Μονάδα προγραμματισμού
B. Μονάδα μετάδοσης
HU-MAGYAR
A. programozó egység
B. adókészülék
1

ii
EN-ENGLISH
A. Liquid crystal display (LCD) screen
B. Mode selection key
C. Packaged valve mode icon and light
emitting diode (LED)
D. Implanted valve mode icon and LED
indicator lamp
E. A partial representation of the valve as
it appears when x-rayed
F. Pressure selection keys and their
corresponding LEDs
G. Receptacle for transmitter cord
H. Receptacle for power cord
I. Fuse holder
J. Power switch
FR-FRANÇAIS
A.
Écran d’affichage à cristaux liquides (LCD)
B. Touche de sélection du mode
C. Icône de mode de valve conditionnée
et diode électroluminescente (LED)
D. Icône de mode de valve implantée et
témoin lumineux LED
E. Une représentation partielle de la valve
telle qu’elle apparaît aux rayons X
F. Touches de sélection de pression et
leurs LED correspondantes
G. Prise pour le cordon de l’émetteur
H. Prise pour cordon d’alimentation
I. Porte-fusible
J. Interrupteur d’alimentation
DE-DEUTSCH
A. Flüssigkristallanzeige (LCD)
B. Modusauswahltaste
C. Symbol für Modus „Ventil verpackt“
und entsprechende Leuchtdiode (LED)
D. Symbol für Modus „Ventil implantiert“
und entsprechende LED
E. Teildarstellung des durchleuchteten
Ventils
F. Tasten zur Auswahl der gewünschten
Ventildruckeinstellung und
entsprechende LEDs
G. Anschlussbuchse für Senderkabel
H. Anschlussbuchse für Netzkabel
I. Sicherungshalter
J. Netzschalter
NL-NEDERLANDS
A. Lcd-beeldscherm
B. Moduskeuzeknop
C. Pictogram verpakte-klepmodus en led
D. Pictogram geïmplanteerde-klepmodus
en led-indicatorlampje
E. Een gedeeltelijke weergave van de
klep zoals die op een röntgenopname
te zien is
F. Drukkeuzeknoppen en hun
bijbehorende leds
G. Aansluitcontact voor zendersnoer
H. Aansluitcontact voor netsnoer
I. Zekeringhouder
J. Aan-uitschakelaar
IT-ITALIANO
A. Schermo con display a cristalli liquidi (LCD)
B. Tasto di selezione della modalità
C. Icona della modalità valvola confezionata e diodo
luminoso (LED)
D. Icona della modalità valvola impiantata e spia con LED
E. Rappresentazione parziale della valvola, come appare
ai raggi X
F. Tasti di selezione della pressione e LED corrispondenti
G. Presa per il cavo del trasmettitore
H. Presa per il cavo di alimentazione
I. Portafusibili
J. Interruttore di alimentazione
ES-ESPAÑOL
A. Pantalla de cristal líquido (LCD)
B. Tecla de selección de modo
C. Icono del modo de válvula envasada y diodo emisor
de luz (LED)
D.
Icono del modo de válvula implantada y luz indicadora LED
E. Una representación parcial de la válvula tal como
aparece cuando se toma una radiografía
F.
Teclas de selección de presión y sus correspondientes LED
G. Receptáculo del cable del transmisor
H. Receptáculo del cable de alimentación
I. Portafusibles
J. Interruptor de encendido
PT (EU)-PORTUGUÊS
A. Ecrã de cristal líquido (LCD)
B. Tecla de seleção de modo
C. Ícone de modo de válvula embalada e díodo de
emissão de luz (LED)
D.
Ícone de modo de válvula implantada e luz indicadora LED
E. Representação parcial da válvula, tal como é visível na
radiografia
F. Teclas de seleção de pressão e LEDs correspondentes
G. Recetáculo do cabo de transmissão
H. Recetáculo do cabo de alimentação
I. Suporte de fusíveis
J. Interruptor de alimentação
DA-DANSK
A. Display med flydende krystaller (LCD-skærm)
B. Tast til valg af tilstand
C. Ikon for tilstanden Emballeret ventil og lysemitterende
diode (LED)
D. Ikon for tilstanden Implanteret ventil og LED-
indikatorlampe
E. Delvis repræsentation af ventilen, som den ser ud ved
røntgengennemlysning
F. Trykindstillingstaster og tilhørende lysdioder
G. Stikkontakt til senderens el-ledning
H. Stikkontakt til el-ledning
I. Sikringsholder
J. Tænd/sluk-kontakt
SV-SVENSKA
A. Teckenfönster (LCD)
B. Lägesväljarknapp
C. Ikon för läget för förpackad ventil och indikatorlampa
D. Ikon för läget för implanterad ventil och
indikatorlampa
E. En delvis bild av ventilen som den ser ut när den röntgas
F. Tryckvalsknappar och deras motsvarande indikatorlampor
G. Uttag för sändarsladd
H. Uttag för nätsladd
I. Säkringshållare
J. Strömbrytare
FI-SUOMI
A. Nestekidenäyttö (LCD)
B. Tilan valintanäppäin
C. Pakatun venttiilin tilan kuvake ja valodiodi (LED)
D. Implantoidun venttiilin tilan kuvake ja LED-merkkivalo
E. Venttiili kuvattuna osittain sellaisena kuin se näkyy
röntgenkuvassa
F. Paineen valintanäppäimet ja niitä vastaavat merkkivalot
G. Lähettimen johdon liitin
H. Virtajohdon liitin
I. Sulakepidike
J. Virtakytkin
EL-ΕΛΛΗΝΙΚΑ
Α. Οθόνη υγρών κρυστάλλων (LCD)
Β. Πλήκτρο επιλογής τρόπου λειτουργίας
C. Εικονίδιο τρόπου λειτουργίας συσκευασμένης
βαλβίδας και φωτοδίοδος (LED)
D. Εικονίδιο τρόπου λειτουργίας εμφυτευμένης
βαλβίδας και ενδεικτική λυχνία LED
E. Μερική αναπαράσταση της βαλβίδας, όπως φαίνεται
στην ακτινογραφία
F. Πλήκτρα επιλογής πίεσης και οι αντίστοιχες λυχνίες
LED
G. Υποδοχή καλωδίου συσκευής μετάδοσης
Η. Υποδοχή καλωδίου ρεύματος
I. Ασφαλειοθήκη
J. Διακόπτης ρεύματος
HU-MAGYAR
A. Folyadékkristályos kijelző (liquid crystal display, LCD)
képernyő
B. Üzemmódválasztó gomb
C. Becsomagolt szelep üzemmód ikon és fénykibocsátó
dióda (LED)
D. Beültetett szelep üzemmód ikon és LED jelzőlámpa
E. A szelep részleges ábrázolása – így jelenik meg a
röntgenfelvételen
F. Nyomásválasztó gombok és a hozzájuk tartozó LED-ek
G. Az adókészülék vezetékének csatlakozóaljzata
H. A tápkábel csatlakozóaljzata
I. Biztosítéktartó
J. Tápkapcsoló
2

ii iii
EN-ENGLISH
A. Start button
B. Direction-of-flow arrow
C. Cord
D. Center rod
E. Feet (4 total)
FR-FRANÇAIS
A. Bouton Start (Démarrage)
B. Flèche de sens d’écoulement
C. Cordon
D. Tige centrale
E. Pieds (4 au total)
DE-DEUTSCH
A. START-Taste
B. Flussrichtungspfeil
C. Kabel
D. Mittelstab
E. Füße (insgesamt 4)
NL-NEDERLANDS
A. Startknop
B. Pijltje voor de stroomrichting
C. Snoer
D. Middenstaaf
E. Voet (vier in totaal)
IT-ITALIANO
A. Pulsante di avvio
B. Freccia della direzione del flusso
C. Cavo
D. Asta centrale
E. Piedini (4 in totale)
ES-ESPAÑOL
A. Botón de inicio
B. Flecha de dirección de flujo
C. Cable
D. Barra central
E. Pies (4 en total)
PT (EU)-PORTUGUÊS
A. Botão Iniciar
B. Seta de direção do fluxo
C. Cabo
D. Haste central
E. Pés (4 no total)
DA-DANSK
A. Start-knap
B. Pil for strømningsretning
C. Ledning
D. Midterstang
E. Fødder (4 i alt)
SV-SVENSKA
A. Startknapp
B. Pil för flödesriktning
C. Sladd
D. Mittstav
E. Fötter (totalt 4)
FI-SUOMI
A. Käynnistyspainike
B. Virtaussuunnan nuoli
C. Johto
D. Keskitanko
E. Jalat (4 kpl)
EL-ΕΛΛΗΝΙΚΑ
Α. Κουμπί Start (Έναρξη)
Β. Βέλος κατεύθυνσης ροής
C. Καλώδιο
D. Κεντρική ράβδος
Ε. Πόδια (4 συνολικά)
HU-MAGYAR
A. Start gomb
B. Az áramlás irányát jelző nyíl
C. Kábel
D. Középső rúd
E. Láb (összesen 4)
EN-ENGLISH
Adjusting a packaged valve
A. Programmable valve within sterile blister package
B. 4 Depressions in blister
C. Direction-of-flow arrows molded into blister
FR-FRANÇAIS
Réglage d’une valve conditionnée
A. Valve programmable en emballage thermoformé
stérile
B. 4 Dépressions de l’emballage thermoformé
C. Flèches de sens d’écoulement moulées dans
l’emballage thermoformé
DE-DEUTSCH
Einstellen eines verpackten Ventils
A. Programmierbares Ventil in steriler
Blisterverpackung
B. 4 Vertiefungen in der Blisterverpackung
C. In die Blisterverpackung eingeschmolzene
Flussrichtungspfeile
NL-NEDERLANDS
Een verpakte klep afstellen
A. Programmeerbare klep in steriele blisterverpakking
B. Vier uitsparingen in blister
C. Pijltjes voor de stroomrichting in de blister
IT-ITALIANO
Regolazione di una valvola confezionata
A.
Valvola programmabile in confezione sigillata sterile
B. 4 depressioni nella confezione sigillata
C. Frecce della direzione del flusso impresse nella
confezione sigillata
ES-ESPAÑOL
Ajuste de una válvula envasada
A. Válvula programable dentro del empaque de
blíster estéril
B. 4 Depresiones en el blíster
C.
Flechas de dirección de flujo moldeadas en el blíster
PT (EU)-PORTUGUÊS
Regulação da válvula embalada
A. Válvula programável no interior da embalagem
blister esterilizada
B. 4 reentrâncias na embalagem blister
C. Setas de direção do fluxo marcadas na
embalagem blister
DA-DANSK
Justering af en emballeret ventil
A. Programmerbar ventil inden for steril blisterpakning
B. 4 depression i blister
C. Pile for strømningsretning støbt i blister
SV-SVENSKA
Justera en förpackad ventil
A. Programmerbar ventil i steril blisterförpackning
B. 4 Urtag i blisterförpackning
C. Pilar för flödesriktning gjutna i blisterförpackningen
FI-SUOMI
Pakatun venttiilin säätäminen
A. Ohjelmoitava venttiili steriilissä kuplapakkauksessa
B. 4 syvennystä kuplapakkauksessa
C. Virtaussuunnan nuolet merkitty kuplapakkaukseen
EL-ΕΛΛΗΝΙΚΑ
Ρύθμιση συσκευασμένης βαλβίδας
A. Προγραμματιζόμενη βαλβίδα σε
αποστειρωμένη συσκευασία blister
Β. 4 εσοχές στη συσκευασία blister
C. Βέλη κατεύθυνσης ροής αποτυπωμένα στη
συσκευασία blister
HU-MAGYAR
Csomagolt szelep beállítása
A. Programozható szelep steril
buborékcsomagolásban
B. 4 mélyedés a buborékcsomagolásban
C. Az áramlás irányát jelző nyilak a
buborékcsomagolásba öntve
3 4

iv
EN-ENGLISH
Schematics of CODMAN® HAKIM® Programmable Valves
A. Inlet portion of valve
B. Direction of flow
FR-FRANÇAIS
Schémas des valves programmables CODMAN® HAKIM®
A. Portion d’entrée de la valve
B. Sens d’écoulement
DE-DEUTSCH
Schematische Darstellung der CODMAN® HAKIM® programmierbaren Ventile
A. Einlassbereich des Ventils
B. Flussrichtung
NL-NEDERLANDS
Schematische weergaven van CODMAN® HAKIM® programmeerbare kleppen
A. Inlaatgedeelte van klep
B. Stroomrichting
IT-ITALIANO
Diagrammi delle valvole programmabili CODMAN® HAKIM®
A. Porzione di ingresso della valvola
B. Direzione del flusso
ES-ESPAÑOL
Esquemas de las válvulas programables CODMAN® HAKIM®
A. Parte de entrada de la válvula
B. Dirección del flujo
PT (EU)-PORTUGUÊS
Esquema das válvulas programáveis CODMAN®HAKIM®
A. Parte de entrada da válvula
B. Direção do fluxo
DA-DANSK
Oversigter over CODMAN® HAKIM® programmerbare ventiler
A. Indløbsdel af ventil
B. Strømningsretning
SV-SVENSKA
Ritning över CODMAN® HAKIM® programmerbara ventiler
A. Inloppsdel av ventil
B. Flödesriktning
FI-SUOMI
Ohjelmoitavien CODMAN® HAKIM® -venttiilien kaaviot
A. Venttiilin sisääntulo-osa
B. Virran suunta
EL-ΕΛΛΗΝΙΚΑ
Σχεδιαγράμματα των προγραμματιζόμενων βαλβίδων CODMAN®
HAKIM®
Α. Τμήμα εισροής της βαλβίδας
Β. Κατεύθυνση ροής
HU-MAGYAR
A CODMAN® HAKIM® programozható szelepek sematikus ábrája
A. A szelep bemeneti szakasza
B. Az áramlás iránya
5
EN-ENGLISH
1. Cylindrical Valve
FR-FRANÇAIS
1. Valve cylindrique
DE-DEUTSCH
1. Zylindrisches Ventil
NL-NEDERLANDS
1. Cilindrische klep
IT-ITALIANO
1. Valvola cilindrica
ES-ESPAÑOL
1. Válvula cilíndrica
PT (EU)-PORTUGUÊS
1. Válvula cilíndrica
DA-DANSK
1. Cylindrisk ventil
SV-SVENSKA
1. Cylindrisk ventil
FI-SUOMI
1. Lieriömäinen venttiili
EL-ΕΛΛΗΝΙΚΑ
1. Κυλινδρική βαλβίδα
HU-MAGYAR
1. Hengeres szelep
EN-ENGLISH
2. Micro Valve
FR-FRANÇAIS
2. Micro-valve
DE-DEUTSCH
2. Mikroventil
NL-NEDERLANDS
2. Microklep
IT-ITALIANO
2. Micro-valvola
ES-ESPAÑOL
2. Microválvula
PT (EU)-PORTUGUÊS
2. Microválvula
DA-DANSK
2. Mikroventil
SV-SVENSKA
2. Mikroventil
FI-SUOMI
2. Mikroventtiili
EL-ΕΛΛΗΝΙΚΑ
2. Μικροβαλβίδα
HU-MAGYAR
2. Mikroszelep
EN-ENGLISH
3. Micro Valve with RICKHAM® Reservoir
FR-FRANÇAIS
3. Micro-valve avec réservoir RICKHAM®
DE-DEUTSCH
3. Mikroventil mit RICKHAM® Reservoir
NL-NEDERLANDS
3. Microklep met RICKHAM®-reservoir
IT-ITALIANO
3. Micro-valvola con serbatoio RICKHAM®
ES-ESPAÑOL
3. Microválvula con depósito RICKHAM®
PT (EU)-PORTUGUÊS
3. Microválvula com reservatório RICKHAM®
DA-DANSK
3. Mikroventil med RICKHAM®-beholder
SV-SVENSKA
3. Mikroventil med RICKHAM®-behållare
FI-SUOMI
3. Mikroventtiili ja RICKHAM®-säiliö
EL-ΕΛΛΗΝΙΚΑ
3. Μικροβαλβίδα με δεξαμενή RICKHAM®
HU-MAGYAR
3. Mikroszelep RICKHAM® tartállyal
EN-ENGLISH
4. Inline Valve with SHIPONGUARD® Device
FR-FRANÇAIS
4.
Vanne en ligne avec dispositif SHIPONGUARD®
DE-DEUTSCH
4. Inline-Ventil mit SHIPONGUARD® Gerät
NL-NEDERLANDS
4.
Inline-klep met SHIPONGUARD®-hulpmiddel
IT-ITALIANO
4.
Valvola in linea con dispositivo SHIPONGUARD®
ES-ESPAÑOL
4.
Válvula en línea con dispositivo SHIPONGUARD®
PT (EU)-PORTUGUÊS
4.
Válvula alinhada com dispositivo SHIPONGUARD®
DA-DANSK
4. Indbygget ventil med SHIPONGUARD®-enhed
SV-SVENSKA
4. Inline-ventil med SHIPONGUARD®-enhet
FI-SUOMI
4. Linjaventtiili ja SHIPONGUARD®-laite
EL-ΕΛΛΗΝΙΚΑ
4. Βαλβίδα σε σειρά με συσκευή SHIPONGUARD®
HU-MAGYAR
4. Hosszanti szelep SHIPONGUARD® eszközzel

iv v
EN-ENGLISH
Adjusting an implanted valve
(using implanted valve mode)
A. Patient’s scalp
B. Inlet portion of valve
C. Ultrasound gel on center rod of transmitter
D. Direction of flow
FR-FRANÇAIS
Réglage d’une valve implantée
(à l’aide du mode valve implantée)
A. Cuir chevelu du patient
B. Portion d’entrée de la valve
C. Gel échographique sur la tige centrale de
l’émetteur
D. Sens d’écoulement
DE-DEUTSCH
Einstellen eines implantierten Ventils
(unter Verwendung des Modus „Ventil
implantiert“)
A. Kopfhaut des Patienten
B. Einlassbereich des Ventils
C. Ultraschallgel auf dem Mittelstab des
Senders
D. Flussrichtung
NL-NEDERLANDS
Een geïmplanteerde klep afstellen
(door de geïmplanteerde-klepmodus te
gebruiken)
A. Hoofdhuid van patiënt
B. Inlaatgedeelte van klep
C. Contactgel op middenstaaf van zender
D. Stroomrichting
IT-ITALIANO
Regolazione di una valvola impiantata
(utilizzando la modalità valvola impiantata)
A. Cuoio capelluto del paziente
B. Porzione di ingresso della valvola
C. Gel per ultrasuoni sull’asta centrale
del trasmettitore
D. Direzione del flusso
ES-ESPAÑOL
Ajuste de una válvula implantada
(mediante el modo de válvula implantada)
A. Cuero cabelludo del paciente
B. Parte de entrada de la válvula
C. Gel para ultrasonido en la barra central
del transmisor
D. Dirección del flujo
PT (EU)-PORTUGUÊS
Regulação da válvula implantada
(utilizando o modo de válvula implantada)
A. Couro cabeludo do paciente
B. Parte de entrada da válvula
C. Gel ecográfico na haste central do
transmissor
D. Direção do fluxo
DA-DANSK
Justering af en implanteret ventil
(ved hjælp af tilstand med implanteret ventil)
A. Patientens hovedbund
B. Indløbsdel af ventil
C. Ultralydsgel på centerstang af senderen
D. Strømningsretning
SV-SVENSKA
Justera en implanterad ventil (med läget för
implanterad ventil)
A. Patientens skalp
B. Inloppsdel av ventil
C. Ultraljudsgel på sändarens mittstav
D. Flödesriktning
FI-SUOMI
Implantoidun venttiilin säätäminen
(implantoidun venttiilin tilan avulla)
A. Potilaan päänahka
B. Venttiilin sisääntulo-osa
C. Ultraäänigeeli lähettimen keskitangossa
D. Virran suunta
EL-ΕΛΛΗΝΙΚΑ
Ρύθμιση εμφυτευμένης βαλβίδας
(με χρήση του τρόπου λειτουργίας
εμφυτευμένης βαλβίδας)
Α. Δέρμα κρανίου του ασθενούς
Β. Τμήμα εισροής της βαλβίδας
C. Γέλη υπερήχων στην κεντρική ράβδο της
συσκευής μετάδοσης
D. Κατεύθυνση ροής
HU-MAGYAR
Beültetett szelep beállítása
(a beültetett szelep üzemmód alkalmazásával)
A. A beteg fejbőre
B. A szelep bemeneti szakasza
C. Ultrahanggél az adókészülék középső rúdján
D. Az áramlás iránya
6

vi
EN-ENGLISH
X-ray image of valve
A. White marker
B. Pressure indicator
C. Direction of flow (reference)
FR-FRANÇAIS
Cliché radiologique de la valve
A. Marqueur blanc
B. Indicateur de pression
C. Sens d’écoulement (référence)
DE-DEUTSCH
Röntgenbild eines Ventils
A. Weiße Markierung
B. Druckanzeiger
C. Flussrichtung (Referenz)
NL-NEDERLANDS
Röntgenbeeld van klep
A. Witte markering
B. Drukindicator
C. Stroomrichting (referentie)
IT-ITALIANO
Immagine a raggi X della valvola
A. Contrassegno bianco
B. Indicatore di pressione
C. Direzione del flusso (riferimento)
ES-ESPAÑOL
Imagen de rayos X de la válvula
A. Marcador blanco
B. Indicador de presión
C. Dirección del flujo (referencia)
PT (EU)-PORTUGUÊS
Imagem de radiografia da válvula
A. Marcador branco
B. Indicador de pressão
C. Direção de fluxo (referência)
DA-DANSK
Røntgenbillede af ventil
A. Hvid markør
B. Trykindikator
C. Strømningsretning (reference)
SV-SVENSKA
Röntgenbild av ventil
A. Vit markör
B. Tryckindikator
C. Flödesriktning (referens)
FI-SUOMI
Venttiilin röntgenkuva
A. Valkoinen markkeri
B. Paineosoitin
C. Virran suunta (viittaus)
EL-ΕΛΛΗΝΙΚΑ
Ακτινογραφική απεικόνιση της
βαλβίδας
A. Λευκός δείκτης
B. Δείκτης πίεσης
C. Κατεύθυνση ροής (αναφορά)
HU-MAGYAR
A szelep röntgenképe
A. Fehér jelölés
B. Nyomásjelző
C. Az áramlás iránya (hivatkozás)
EN-ENGLISH
Correlation of postions of the cam position (pressure) indicator to the
desired settings
FR-FRANÇAIS
Corrélation des positions de l’indicateur de position (pression) de la came
avec les réglages souhaités
DE-DEUTSCH
Zuordnung der Nockenposition des (Druck-)Anzeigers zu den
gewünschten Einstellungen
NL-NEDERLANDS
Correlatie tussen nokposities, (druk)indicator en de gewenste instellingen
IT-ITALIANO
Correlazione tra le ubicazioni dell’indicatore di posizione (pressione) della
camma alle impostazioni desiderate
ES-ESPAÑOL
Correlación de las posiciones del indicador de posición (presión) de la
leva en los ajustes deseados
PT (EU)-PORTUGUÊS
Correlação entre posições do indicador (de pressão) da posição do came
e as definições pretendidas
DA-DANSK
Korrelation mellem positioner af indikationen for knastposition (tryk) til
de ønskede indstillinger
SV-SVENSKA
Korrelation av positionerna för kampositionsindikatorn (tryck) med
önskade inställningar
FI-SUOMI
Ohjausnokan asennon (paine) osoittimen sijaintien vastaavuus haluttujen
asetusten kanssa
EL-ΕΛΛΗΝΙΚΑ
Συσχέτιση των θέσεων του δείκτη θέσης έκκεντρου (πίεση) με τις
επιθυμητές ρυθμίσεις
HU-MAGYAR
A bütyökpozíció (nyomásjelző) és a kívánt beállítások közötti összefüggés
7 8

vi vii
EN-ENGLISH
Pressure indicator, as seen on packaged valve
(magnified)
A. Cam position (pressure indicator, shown at “70” setting)
B. Cam
C. Flat spring
D. Direction of flow
FR-FRANÇAIS
Indicateur de pression, tel que sur la valve emballée
(agrandie)
A. Position de la came (indicateur de pression, représenté en
position « 70 »)
B. Came
C. Ressort plat
D. Sens d’écoulement
DE-DEUTSCH
Druckanzeiger, wie auf dem verpackten Ventil zu sehen
(vergrößert)
A. Nockenposition (Druckanzeiger bei Einstellung „70“)
B. Nockenscheibe
C. Federscheibe
D. Flussrichtung
NL-NEDERLANDS
Drukindicator, zoals weergegeven op verpakte klep
(vergroot)
A. Nokpositie (drukindicator, weergegeven bij “70”-instelling)
B. Nok
C. Platte veer
D. Stroomrichting
IT-ITALIANO
Indicatore di pressione sulla valvola confezionata
(ingrandito)
A. Posizione della camma (indicatore di pressione, mostrato
con l’impostazione “70”)
B. Camma
C. Molla piatta
D. Direzione del flusso
ES-ESPAÑOL
Indicador de presión, como se ve en la válvula envasada
(aumentada)
A. Posición de la leva (indicador de presión, como se
muestra en el ajuste “70”)
B. Leva
C. Resorte plano
D. Dirección del flujo
PT (EU)-PORTUGUÊS
Indicador de pressão, conforme visualizado na válvula embalada
(ampliada)
A. Posição do came (indicador de pressão, apresentado na
definição «70»)
B. Came
C. Mola plana
D. Direção do fluxo
DA-DANSK
Trykindikator, som set på emballeret ventil
(forstørret)
A. Knastposition (trykindikator, vist ved ”70”-indstilling)
B. Knast
C. Flad fjeder
D. Strømningsretning
SV-SVENSKA
Tryckindikator, som den ser ut på förpackad ventil
(förstorad)
A. Kamposition (tryckindikator, visad vid inställningen ”70”)
B. Kam
C. Platt fjäder
D. Flödesriktning
FI-SUOMI
Paineosoitin, kuten näkyvissä pakatussa venttiilissä
(suurennos)
A. Ohjausnokan asento (paineosoitin, kuvassa asetus “70”)
B. Ohjausnokka
C. Litteä jousi
D. Virran suunta
EL-ΕΛΛΗΝΙΚΑ
Δείκτης πίεσης, όπως φαίνεται στη συσκευασμένη
βαλβίδα (σε μεγέθυνση)
Α. Θέση έκκεντρου (δείκτης πίεσης, εμφανίζεται στη
ρύθμιση «70»)
Β. Έκκεντρο
C. Επίπεδο ελατήριο
D. Κατεύθυνση ροής
HU-MAGYAR
Nyomásjelző, ahogyan a csomagolt szelepen látható
(kinagyítva)
A. A bütyök helyzete (nyomásjelző, 70-re állítva látható)
B. Bütyök
C. Lapos rugó
D. Az áramlás iránya
9

2
EN – ENGLISH
IMPORTANT INFORMATION
Please Read Before Use
Indications
The CODMAN®VPV®System is indicated for use only with CODMAN®HAKIM®Programmable Valves in the treatment
of hydrocephalus when shunting cerebrospinal fluid from the ventricles of the brain. It is used to adjust the CODMAN
HAKIM Programmable Valve to the selected pressure and provides valve adjustment confirmation without the need for
radiographic imaging.
Contraindications
There are no known contraindications for the use of the CODMAN VPV System.
Product Description
The CODMAN VPV System (catalog no. 823192R) is comprised of the program unit, the transmitter unit, a 3m long power
cord, and ultrasound gel in a carrying case (see Figures 1 through 3).
Function and Intended Application
The CODMAN VPV System is intended for adjusting CODMAN HAKIM Programmable Valves in the treatment of
hydrocephalus.
The Program Unit
The program unit (Figure 2) is an electronic module that houses the power and control logic circuits. The front panel of
the program unit contains the following features:
A. Liquid crystal display (LCD) screen
B. Mode selection key
C. Packaged valve mode icon and light emitting diode (LED)
D. Implanted valve mode icon and LED indicator lamp
E. A partial representation of the valve as it appears when x-rayed
F. Pressure selection keys and their corresponding LEDs
G. Receptacle for transmitter cord
H. Receptacle for power cord
I. Fuse holder
J. Power switch
The pressure selection keys (F in Figure 2) range from 30 mm H2O to 200 mm H2O in increments of 10 mm H2O (from 294
Pascals [Pa] to 1960 Pa in increments of 98 Pa).
The Transmitter
The transmitter (Figure 3) connects to the program unit with a cord. The transmitter generates the electromagnetic field
that changes the setting of the valve.
Program Unit Mode Selection
The CODMAN VPV System has two modes of operation: packaged valve mode and implanted valve mode.
Packaged
Valve Icon
1. The Packaged Valve Mode
The packaged valve mode is used when adjusting the setting of a valve before implantation and
when adjusting the setting of a recently implanted valve when patient skin integrity requires a sterile
barrier. When the packaged valve mode is selected, the acoustic monitoring feature is not active.
Implanted
Valve Icon
2. The Implanted Valve Mode – with Acoustic Monitoring Feature
The implanted valve mode is used when adjusting the setting of a valve postoperatively when the
patient’s scalp is intact. When the implanted valve mode is selected, the acoustic monitoring feature is
active. See The Acoustic Monitoring Feature.
The Acoustic Monitoring Feature
When the implanted valve mode is selected, a sensor contained within the transmitter detects valve vibration as the
setting of the valve is changed. The program unit analyzes the valve vibration to determine instances of improper
placement of the transmitter or an inability to sense valve adjustment.
If confirmation of the valve adjustment is not displayed, the clinician may choose to perform the valve adjustment steps
again. No known adverse effects have been associated with multiple adjustment attempts. See Appendix E: Clinical Study
Summary for further information.
Reordering Information
Catalog No.Description
823192R CODMAN VPV System
Order replacement ultrasound gel from any supplier of good quality ultrasound gel.
Warnings and Precautions
CODMAN HAKIM Programmable Valves are supplied without a specific setting and must be adjusted prior to use.
Portable RF communication equipment (including peripherals such as antennas) should be used no closer than 30 cm
(12 inches) to any part of the VPV System, otherwise, degradation of the performance of this equipment could result.
Carefully read the instruction manual packaged with the CODMAN HAKIM Programmable Valve before implanting or
adjusting the valve.
Valve adjustment must be performed prior to implantation through the nonsterile outer package. Perform adjustments
postoperatively as needed.
Do not use the program unit in a magnetic resonance imaging (MRI) suite.
Electromagnetic interference and other types of interference generated by other equipment or medical devices might
affect the operation of the system.
Codman®
VPV® System

2 3
EN – ENGLISH
Do not allow the system to remain in environmental extremes.
After exposure to environmental extremes, such as those found in transport or storage, allow the system to reach room
temperature.
Do not adjust the setting of a packaged valve while the valve is located on a metal surface, such as a Mayo stand.
Cumulative changes to the valve setting greater than 40 mm H2O (392 Pa) within a 24-hour period are
not recommended.
Carefully monitor patients for the first 24 hours after the adjustment for any significant change in clinical condition.
Before use, check the program unit and transmitter connections (see Setting Up the VPV System).
Unauthorized modifications to the system may cause a malfunction that could result in serious patient injury or death.
Electrical shock hazard: Do not open the program unit or transmitter. Refer servicing to qualified service personnel. To
avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
Explosion hazard: Do not use the system in the presence of flammable material; i.e. anesthetics, solvents, cleaning
agents, and endogenous gases.
Do not sterilize the program unit or the transmitter, or immerse them in any liquid. Do not allow liquid to enter
the transmitter.
The use of accessories, transducers and/or cables other than those specified, with the exception of those sold by the
manufacturer as replacement parts for internal components, may result in increased emissions or decreased immunity of
the equipment or system.
The equipment or system should not be used adjacent to or stacked with other equipment and that if adjacent or
stacked use is necessary, the equipment or system should be observed to verify normal operation in the configuration in
which it will be used.
Setting Up the VPV System
Note: The program unit is designed to remain in the carrying case throughout all operations, if desired.
1. Insert the socket end of the program unit power cord into the receptacle at the upper right side of the program
unit top panel. Insert the plug end of the program unit power cord into the power supply.
2. Set the program unit power switch to ON. The LCD panel on the front of the program unit illuminates and displays
the following title screen for approximately 3 seconds:
CODMAN VPV
VERSION 1.01
Note: The software version number displayed may be different from the one shown above.
3. The LCD panel displays the following message:
IMPLANTED VALVE
PLEASE SELECT
PRESSURE
4. Proceed to Adjusting the Valve.
Adjusting the Valve
Valves can be adjusted using three methods:
• Packaged valve mode
• Implanted valve mode
• Packaged valve mode with an implanted valve
Valve Adjustment: Packaged Valve Mode
It is advisable to adjust the valve before it is implanted, both for ease of adjusting and to permit immediate visual confirmation
of the setting, refer to Appendix A: Confirming Valve Adjustment: Visually or by X-ray.
1. Follow Setting Up the VPV System to set up the equipment and turn on the power.
2. To select the packaged valve mode, press the mode selection key until the LED beneath the package valve mode
icon illuminates. The program unit beeps and the LCD panel displays the following message:
PACKAGED VALVE
PLEASE SELECT
PRESSURE
3. Press the appropriate pressure selection key on the front panel. The program unit beeps; the corresponding LED
illuminates and the lamps on the transmitter illuminate. At the same time, the display changes to:
PACKAGED VALVE
POSITION
TRANSMITTER HEAD
PRESS START
4. Refer to Figure 4. Point the arrow on the transmitter in the same direction as the arrow molded into the clear plastic
blister (the direction of flow). Place the transmitter’s feet in the four depressions in the blister package around the
inlet valve. Verify that the inlet portion of the valve is centered under the transmitter.
Note: Do not use ultrasound gel while in the packaged valve mode.
5. Press the start button of the transmitter. The program unit beeps and the display changes to read:
ADJUSTING VALVE
PLEASE WAIT
CAUTION: Do not move the transmitter during the adjustment.
6. During the adjustment, the pressure selection keys light sequentially and the program unit emits a series of clicks
until the selected setting command has been issued to the valve.
7. When the adjustment is complete (approximately 3 seconds), the program unit emits one long beep and the
display changes to:
ADJUSTMENT COMPLETE
PRESS A KEY
The valve setting can be confirmed visually or by x-ray. See Appendix A.

4
EN – ENGLISH
8. After you press any key, the display changes to the original message:
PACKAGED VALVE
PLEASE SELECT
PRESSURE
9. At the end of the adjustment session, turn off the power switch of the program unit and unplug the power cord
from the power source.
Valve Adjustment: Implanted Valve Mode
1. Follow Setting Up the VPV System to set up the equipment and turn on the power.
2. To select the implanted valve mode, press the mode selection until the LED beneath the implanted valve mode
icon illuminates. The program unit beeps and the LCD panel displays the following message:
IMPLANTED VALVE
PLEASE SELECT
PRESSURE
3. Press the appropriate pressure selection key on the front panel. The program unit beeps; the corresponding LED
illuminates and the lamps on the transmitter illuminate. At the same time, the display changes to:
IMPLANTED VALVE
POSITION
TRANSMITTER HEAD
PRESS START
4. Palpate the scalp to locate the shunt system and the implanted valve. Gently palpate the valve to locate the hard
inlet valve portion, approximately 10 mm long (see Figure 5 for valve schematics). A fluoroscopic screen can assist
in this process.
Note: It is not necessary to shave the scalp for this procedure.
5. Part any hair with the fingers. Apply a pea-sized amount of ultrasound gel, approximately 2 mm thick, to the
patient’s scalp directly over the valve inlet portion. When the center rod of the transmitter compresses the gel, the
gel’s diameter should be equal to or slightly larger than the diameter of the center rod. This will result in an air-
free connection between the scalp and the center rod of the transmitter.
Alternate method: apply ultrasound gel to the entire bottom surface of the center rod to a thickness of
approximately 2 mm.
CAUTION: Avoid contact between the gel and the feet of the transmitter. This can distort the acoustic signal
and cause a “REPEAT ADJUSTMENT” message to be displayed.
6. Before placing the transmitter on the scalp, ensure that the arrow on the transmitter housing is in line with the
direction of fluid flow through the shunt (Figure 6).
7. Place the transmitter on the scalp so the center rod is in the center of the ultrasound gel (directly over the hard
inlet portion of the valve) and the transmitter’s feet contact the patient’s scalp. The center rod may recede slightly
and the gel will compress.
CAUTION: Hold the transmitter in place until Step 10 is complete. Movement can interfere with the acoustic
monitoring process.
CAUTION: Eliminate or minimize ambient noise, such as talking, during the adjustment process. Excessive noise
can interfere with the acoustic monitoring process.
8. Press the transmitter’s start button. The program unit beeps once and the LCD display changes to:
ADJUSTING VALVE
PLEASE WAIT
9. During the adjustment, the pressure selection keys light sequentially and the program unit emits a series of clicks
until the selected setting command has been issued to the valve.
10. When the adjustment is complete (approximately 3 seconds), the program unit emits one long beep and the
display changes to:
ADJUSTMENT COMPLETE
PRESS A KEY
Note: If the acoustic monitoring feature did not receive an expected response, the program unit will emit three
beeps and one of the two screens below will be displayed. Refer to Troubleshooting and follow the instructions for
completing the adjustment.
REPEAT ADJUSTMENT
PRESS A KEY
– OR –
NO SIGNAL
REPEAT ADJUSTMENT
PRESS A KEY
11. After the “ADJUSTMENT COMPLETE” message is displayed and you press any key, the LCD panel changes to the
original message:
IMPLANTED VALVE
PLEASE SELECT
PRESSURE
12. Turn off the power switch of the program unit and unplug the power cord from the power source.
Valve Adjustment: Packaged Valve Mode With an Implanted Valve
To adjust a newly implanted valve, use a sterile drape to protect the patient from contact with the transmitter. Follow
the instructions below. Note: Select the Packaged Valve mode when a drape is used because the Implanted Valve mode
will likely result in a “REPEAT ADJUSTMENT” message due to the interference caused by the drape.
1. Follow Steps 1 through 9 of Valve Adjustment: Implanted Valve Mode, with the following exceptions.
a. select the packaged valve mode
b. use a sterile drape between patient and transmitter
c. DO NOT USE ultrasound gel
2. Follow Steps 7 through 9 of Valve Adjustment: Packaged Valve Mode to complete the adjustment.

4 5
EN – ENGLISH
Preventive Maintenance, Cleaning, and Disinfection
WARNING: Do not sterilize the program unit or the transmitter, or immerse them in any liquid. Do not allow liquid to
enter the transmitter.
With general care and handling, the program unit and transmitter are virtually maintenance free. The user must do the
following:
1. Check the equipment covers and interconnecting leads before each use. If damage is present, do not use; return
the equipment for service (see Service and Repair).
2. After each use and before storing, disconnect the program unit from the power supply and clean the program
unit, the transmitter feet, and the transmitter center rod with a damp cloth and mild detergent. Dry with a clean
cloth.
To disinfect, wipe down the entire system and cables with 70% isopropyl alcohol and a clean cloth.
If the equipment does not operate, return the system for service (see Service and Repair).

6
EN – ENGLISH
Troubleshooting
LCD displays the following message Cause Solution
REPEAT ADJUSTMENT
PRESS A KEY
The signal received was not sufficient to confirm the expected movement of the
valve. Possible causes include:
1. Incorrect placement of the transmitter
2. Too little gel used between the center rod and the patient
3. Noise present during adjustment
4. The valve did not move as expected
Press any key; repeat the adjustment sequence, including palpating the valve, verifying the amount of
ultrasound gel, and positioning the transmitter.
If the message continues to appear, an x-ray can be taken to confirm the changes made to the valve
setting.
If the setting has not been adjusted, perform appropriate intervention.
NO SIGNAL
REPEAT ADJUSTMENT
PRESS A KEY
No signal received to confirm the expected movement of the valve. Possible
causes include:
1. Incorrect placement of the transmitter
2. Too little gel used between the center rod and the patient OR the center rod
is not in contact with the patient
3. The valve did not move
4. The valve is too deeply implanted
5. Technical problem of the system
Press any key; repeat the adjustment sequence, including palpating the valve, verifying the amount of
ultrasound gel, and positioning the transmitter.
If the message continues to appear, an x-ray can be taken to confirm the changes made to the valve
setting.
If the setting has not been adjusted, perform appropriate intervention.
Persistent occurrence of this message might indicate a technical problem. Return for service.
EXCESS NOISE
REPEAT ADJUSTMENT
PRESS A KEY
Excessive environmental noise or vibration was detected. Possible sources include:
1. Movement of the transmitter or the patient during the adjustment sequence
2. Air conditioning equipment
3. Loud talking
Eliminate or remove sources of noise or vibration from the area. Press any key and repeat the adjustment
sequence.
OR
Use the packaged valve mode to adjust the valve. Follow the instructions in Adjusting the Valve; Packaged
Valve Mode With an Implanted Valve.
TRANSMITTER HEAD
COOLING
PLEASE WAIT
Transmitter has exceeded temperature limits. Possible causes include:
1. Exposure to high ambient temperature
2. Frequent use
Allow transmitter to cool. Refer to Appendix B: The Effect of Ambient Temperature on Valve Adjustment.
CAUTION: Remove the transmitter from contact with the patient while the message “TRANSMITTER
HEAD COOLING PLEASE WAIT” is displayed.
TRANSMITTER HEAD
DAMAGED
Transmitter was exposed to extreme heat or cold, or is damaged. Allow the transmitter to return to a temperature between 10 ºC and 35 ºC.
Continued occurrence of this message might indicate a technical problem; return for service.

6 7
EN – ENGLISH
LCD displays the following message Cause Solution
TRANSMITTER HEAD
DISCONNECTED
Transmitter is disconnected from the program unit. Reconnect the transmitter to the program unit.
Continued occurrence of this message might indicate a technical problem; return for service.
SENSOR ERROR
PRESS A KEY
Technical problem with the transmitter’s acoustic monitoring feature. Replace the transmitter.
OR
Use the packaged valve mode to adjust the valve. Press any key and follow the instructions in Adjusting the
Valve; Packaged Valve Mode With an Implanted Valve.
PLEASE WAIT
The program unit requires 10 seconds between valve adjustment cycles. If the message remains on the LCD longer than 10 seconds, return the system for service.
INCOMPLETE
ADJUSTMENT
REPEAT ADJUSTMENT
PRESS A KEY
Adjustment cycle did not complete due to power interruption. Verify connection to power source. Verify power source is within specification. Press any key and repeat
the adjustment.
Persistent occurrence of this message might indicate a technical problem. Return for service.
PROGRAMMER FAILURE
SERVICE REQUIRED
Technical problem with the program unit. Return for service.
NO LCD display; NO LED illumination
Power was not delivered to the program unit. 1. Ensure the correct type fuses are in place; replace if necessary
2. Check power cord connection; check that power switch is on
3. Check power supply integrity with a known functioning device
4. Return for service

8
EN – ENGLISH
Specifications
Electrical
Supply Voltage: 100–240 VAC
Range: 90–264 VAC (Autodetected)
Supply Frequency: 50/60 Hz
Supply Fuses: T5AL 250 VAC
Rated Input: 100–240 VAC 6.5 A
Mode of Operation: Continuous with intermient loading 30% maximum duty cycle
Environmental
Operating Temperature Range: +10 °C to +35 °C
Operating Humidity Range: 30% to 75% relative humidity, non-condensing
Operating Pressure Range: 700 hPa to 1060 hPa
Transport & Storage Temperature Range: –40 °C to +60 °C
Transport & Storage Humidity Range: 10% to 85% relative humidity, non-condensing
Transport & Storage Pressure Range: 500 hPa to 1060 hPa
Replacing the External Fuses
1. Turn the program unit power switch off.
2. Disconnect the program unit from the power supply.
3. The program unit’s fuse holder is located adjacent to the power switch on the rear of the top panel. Use a small
flat-head screwdriver to lift the lid of the fuse holder and pull the fuse holder from the chassis.
4. Remove each fuse by pulling it from its socket. Replace each fuse with a new fuse of the
appropriate specifications.
5. Reinsert the fuse holder in the program unit. Push the lid of the fuse holder in until the release snaps back into
position.
CAUTION: Replace each fuse with one of the correct specifications, as listed in Specifications.
Responsibility of the Manufacturer
Integra LifeSciences Corporation accepts responsibility for the effects of safety, reliability, and performance of the
equipment only if:
• Adjustments, modifications, and repairs are carried out by authorized personnel;
• The electrical installation of the relevant room complies with local regulations;
• The equipment is used in accordance with these instructions for use.
Safety Information
The CODMAN VPV System (catalog no. 823192R) complies with the requirements of
ANSI/AAMI ES60601-1:2005
CAN/CSA-C22.2 No. 60601-1:2008
IEC 60601-1 (2005) 3rd Edition
EN 60601-1 (2006) 3rd Edition
WARNING: Equipment not suitable for use in the presence of FLAMMABLE ANESTHETIC MIXTURE WITH AIR or WITH
OXYGEN or NITROUS OXIDE.
Service and Repair
Service and Repair
Please contact the nearest Service and Repair facility:
USA & Central/South America
Integra LifeSciences
5965 Pacific Center Blvd
Suite 705
San Diego, California 92121
Tel: [phone] Option 5
Fax: [phone]
Email: sdservicer[email protected]om
Canada
Integra Canada ULC – An Integra LifeSciences Company
2590 Bristol Circle, Unit 1
Oakville Ontario, Canada L6H 6Z7
Tel: [phone]
Fax: [phone]
Email: [e-mail]
Europe, Middle Each and Africa Service Center
Integra Neurosciences GmbH
Halskestrasse 9
Ratingen 40880, Germany
Tel: [phone]
Fax: [phone]
Email: [e-mail]
Asia Pacific Service Center
Integra NeuroSciences Pty. Ltd.
Unit 3, 24-30 Winterton Road
Clayton, Vic. 3168, Australia
Tel: [phone]
Fax: [phone]
Email: [e-mail]
Always include a repair purchase order number and a written description of the problem.
End of Useful Life
Dispose of the equipment in accordance with local ordinances.
PRODUCT INFORMATION DISCLOSURE
INTEGRA LIFESCIENCES CORPORATION (“INTEGRA”) HAS EXERCISED REASONABLE CARE IN THE SELECTION OF MATERIALS
AND THE MANUFACTURE OF THESE PRODUCTS. INTEGRA WARRANTS THAT THESE PRODUCTS SHALL CONFORM TO THE
PRODUCT LIMITED WARRANTY AS PROVIDED IN THE PRODUCT LABELING OR APPLICABLE PRODUCT CATALOG. THIS WARRANTY
IS EXCLUSIVE, AND INTEGRA DISCLAIMS ALL OTHER WARRANTIES, WHETHER EXPRESSED OR IMPLIED, INCLUDING BUT NOT
LIMITED TO, ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. INTEGRA SHALL
NOT BE LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIAL LOSS, DAMAGE, OR EXPENSE, DIRECTLY OR INDIRECTLY ARISING
FROM USE OF THESE PRODUCTS. INTEGRA NEITHER ASSUMES NOR AUTHORIZES ANY PERSON TO ASSUME ANY OTHER OR
ADDITIONAL LIABILITY OR RESPONSIBILITY IN CONNECTION WITH THESE PRODUCTS.
Appendix A: Confirming Valve Adjustment: Visually or by X-ray
Adjustment of the packaged valve can be confirmed visually or by x-ray. Adjustment of the implanted valve can be
confirmed by x-ray, if desired.
Figure 7 shows an x-ray of a CODMAN HAKIM Valve. The white marker on the valve indicates the right hand side of the
valve. The pressure indicator on the white ring indicates the chosen setting. If the valve were inverted, the white marker
would appear on the left side.

8 9
EN – ENGLISH
The positions of the pressure selection keys on the program unit’s front panel also correlate with the positions of the
pressure indicator on the valve, as seen when x-rayed (Figure 8). The figure shows the location of the pressure indicator
for each setting (30 through 200). When the valve is adjusted to 70, 120, or 170, the pressure indicator aligns with the “X”
in the center of the valve.
The position of the pressure indicator of a packaged valve can also be observed visually. Figure 9 shows a magnified view.
X-raying an Implanted Valve
Use an x-ray with intensifying TV screen, or an x-ray plate to confirm proper valve setting. Take care when positioning
the patient’s head so that:
• the nonimplanted side of the head rests on the plate (the implanted side is uppermost from the plate), and,
• the inlet valve is parallel to the x-ray plate.
Appendix B: The Effect of Ambient Temperature on Valve Adjustment
Ambient temperature affects the number of adjustment cycles that can be completed before the transmitter reaches the
temperature safety shut-off limit. It also has an effect on how quickly the transmitter will cool. In warm environments
(>30 ºC), the program unit reaches the temperature shut-off limit more quickly, and cools more slowly than in cooler
environments (<20 ºC).
Store the program unit and transmitter in a cool, dry location. Avoid storage in areas with high heat or high humidity.
“TRANSMITTER HEAD COOLING” Message
If repeated adjustment attempts cause the transmitter to become warm, the following LCD message indicates that the
temperature limit has been exceeded:
TRANSMITTER HEAD
COOLING
PLEASE WAIT
CAUTION: The temperature safety shut-off limit was chosen to ensure patient safety. Remove the transmitter from
contact with the patient while the message “TRANSMITTER HEAD COOLING PLEASE WAIT” is displayed.
When the transmitter has cooled, the program unit displays the following message:
IMPLANTED VALVE*
PLEASE SELECT
PRESSURE
*If the program unit is in the Packaged Valve mode, this line of the message will read “PACKAGED VALVE.”
Note: If the above message does not appear within one hour, return the transmitter for service.
Appendix C: Selecting the Language (Optional)
This optional command allows the user to choose one of 12 languages for the display of instructions and error messages.
The default language is English.
1. If the power is on, turn it off. Turn power on. The title screen (shown below) will display for 3 seconds.
CODMAN VPV
VERSION 1.01
While the title screen is displayed, press the “30” pressure selection key on the front panel.
The display changes to:
30 = ENGLISH
40 = DEUTSCH
50 = FRANÇAIS
MORE = 200
2. To select one of the languages displayed, press the appropriate pressure selection key. To view the next
three language choices, press the “200” pressure selection key until the desired language is displayed.
The available languages are:
• 30 = ENGLISH
• 40 = DEUTSCH
• 50 = FRANÇAIS
• 60 = ITALIANO
• 70 = ESPAÑOL
• 80 = PORTUGUÊS
• 90 =
• 100 = NEDERLANDS
• 110 = DANSK
• 120 = SVENSKA
• 130 = SUOMI
• 140 = ΕΛΛΗΝΙΚΑ
Note: A language can only be selected when it is shown on the display.
3. Successful selection of a language will result in the following display in the language chosen:
IMPLANTED VALVE
PLEASE SELECT
PRESSURE
Each time the power is turned on, the program unit automatically displays all information in the selected language.
To change the language again, turn the power off, then on again. Then immediately repeat the preceding procedure.
Appendix D: The Inverted Valve Adjustment Cycle (Optional)
An inverted valve can be diagnosed on x-ray: the white marker appears on the left side of the valve, instead of the right
side. When an inverted valve has been diagnosed, use the inverted valve adjustment cycle to adjust the valve to any of
the 18 settings. This optional command is in effect for one adjustment cycle only. Follow the steps below to enable this
feature.
1. If the program unit power is on, turn it off. Turn power on. The title screen (shown below) displays for 3 seconds.
CODMAN VPV
VERSION 1.01
While the title screen is displayed, press the “70” key on the program unit front panel. The display changes to:
ADJUST INVERTED
VALVE?
30 = YES 40 = NO
2. Press the “30” key to set the next adjustment cycle for an inverted valve, or press “40” to exit. When you press
“30,” the display changes to:
ADJUST INVERTED
VALVE?
PLEASE CONFIRM
80 = YES 40 = NO

10
EN – ENGLISH
3. To confirm that the next adjustment cycle is for an inverted valve, press “80”; or press “40” to cancel and exit.
When you press “80,” the display changes to:
IMPLANTED VALVE
INVERTED VALVE
PLEASE SELECT
PRESSURE
Proceed as usual, following the steps in Valve Adjustment: Implanted Valve Mode. At the end of the adjustment cycle, the
program unit returns to the normal adjustment cycle.
Appendix E: Clinical Study Summary
In a clinical study consisting of 172 subjects, 159 subjects had an x-ray taken with a blinded core lab consensus reading.
In these 159 subjects, 103 (65%) of the subjects received an “Adjustment Complete” message and 56 (35%) of the
subjects received a “Repeat Adjustment” message. Of the “Adjustment Complete” patients, 55% received an “Adjustment
Complete” message after the first attempt at reprogramming and 99% received the “Adjustment Complete” message
within the 5 attempts established in the study design.
Table 1 – Guidance and Manufacturer’s Declaration – Emissions
All ME Equipment and ME Systems
Guidance and Manufacturer’s Declaration - Emissions
The VPV Programmer is intended for use in the electromagnetic environment specified below. The customer or user of
the VPV Programmer should ensure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment – Guidance
RF Emissions
CISPR 11
Group 1 The VPV Programmer uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
RF Emissions
CISPR 11
Class A
Harmonics
IEC 61000-3-2
Class A
Flicker
IEC 61000-3-3
Complies
The VPV Programmer is suitable for use in all establishments, other than
domestic, and those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic purposes.
Table 2 – Guidance and Manufacturer’s Declaration – Immunity
All ME Equipment and ME Systems
Guidance and Manufacturer’s Declaration - Immunity
The VPV Programmer is intended for use in the electromagnetic environment specified below. The customer or user of
the VPV Programmer should ensure that it is used in such an environment.
Immunity Test IEC 60601
Test Level
Compliance
Level
Electromagnetic
Environment – Guidance
ESD
IEC 61000-4-2
+/- 8 kV contact
+/- 2 kV, +/- 4 kV, +/-
8 kV, - +/- 15 kV air
+/- 8 kV contact
+/- 2 kV, +/- 4 kV, +/-
8 kV, - +/- 15 kV air
Floors should be wood, concrete or
ceramic tile. If floors are synthetic, the
r/h should be at least 30%
EFT
IEC 61000-4-4
±2kV Mains
±1kV I/Os
±2kV Mains
±1kV I/Os
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
±1kV Differential
±2kV Common
±1kV Differential ±2kV
Common
Mains power quality should be that
of a typical commercial or hospital
environment.
Voltage Dips/
Dropout
IEC 61000-4-11
0 % UT; 0,5 cycle Út
0°, 45°, 90°, 135°, 180°,
225°, 270° and 315°
0% UT; 1 cycle at
0°×0 % UT; 25/30
cycles 0°
0% UT; for 5 seconds
0 % UT; 0,5 cycle Út
0°, 45°, 90°, 135°, 180°,
225°, 270° and 315°
0% UT; 1 cycle at
0°×0 % UT; 25/30
cycles 0°
0% UT; for 5 seconds
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the VPV
Programmer requires continued
operation during power mains
interruptions, it is recommended that
the VPV Programmer be powered from
an uninterruptible power supply or
battery.
Power Frequency
50/60Hz
Magnetic Field
IEC 61000-4-8
30 A/m 30 A/m Power frequency magnetic fields should
be that of a typical commercial or hospital
environment.

10 11
EN – ENGLISH
Table 3 – Guidance and Manufacturer’s Declaration – Immunity
ME Equipment and ME Systems that are NOT Life-supporting
Guidance and Manufacturer’s Declaration – Immunity
The VPV Programmer is intended for use in the electromagnetic environment specified below. The customer or user of
the VPV Programmer should ensure that it is used in such an environment.
Immunity Test IEC 60601
Test Level
Compliance
Level
Electromagnetic
Environment – Guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
(V1)=3Vrms
(E1)=3V/m
Portable and mobile communications
equipment should be separated from the VPV
Programmer by no less than the distances
calculated/listed below:
D=(3.5/V1)(√ P) 150kHz to 80MHz
D=(3.5/E1)(√ P) 80 to 800 MHz
D=(7/E1)(√ P) 800 MHz to 2.5 GHz
where P is the max power in watts and D is
the recommended separation distance in
meters.
Field strengths from fixed transmitters, as
determined by an electromagnetic site survey,
should be less than the compliance levels
(V1 and E1).
Interference may occur in the vicinity of
equipment containing a transmitter.
For RF Immunity Wireless Communication Equipment refer to test method per Table 9 of IEC60601-1-2 4th ed.
Table 4 – Recommended Separation Distances between portable and mobile RF
Communications equipment and the VPV Programmer
ME Equipment and ME Systems that are NOT Life-supporting
Recommended Separations Distances for the VPV Programmer
The VPV Programmer is intended for use in the electromagnetic environment in which radiated disturbances are
controlled. The customer or user of the VPV Programmer can help prevent electromagnetic interference by maintaining
a minimum distance between portable and mobile RF Communications Equipment and the VPV Programmer as
recommended below, according to the maximum output power of the communications equipment.
Max Output Power
(Watts)
Separation (m)
150 kHz to 80 MHz
D=(3.5/V1)(√ P)
Separation (m)
80 to 800MHz
D=(3.5/E1)(√ P)
Separation (m)
800 MHz to 2.5 GHz
D=(7/E1)(√ P)
0.01 0.116667 0.116667 0.233333
0.1 0.368932 0.368932 0.737865
11.166667 1.166667 2.333333
10 3.689324 3.689324 7.378648
100 11.66667 11.66667 23.33333

12
FR – FRANÇAIS
INFORMATIONS IMPORTANTES
Veuillez lire avant utilisation
Indications
Le système CODMAN®VPV®est indiqué uniquement avec les valves programmables CODMAN®HAKIM®dans le traitement
de l'hydrocéphalie lors de la dérivation du liquide céphalorachidien des ventricules du cerveau. Il est utilisé pour ajuster
la valve programmable CODMAN HAKIM à la pression sélectionnée et fournit une confirmation du réglage de la valve
sans nécessiter de radiographie.
Contre-indications
Il n'existe aucune contre-indication connue à l'utilisation du système CODMAN VPV.
Description du produit
Le système CODMAN VPV (réf. catalogue 823192R) se compose de l'unité de programmation, de l'émetteur, d'un cordon
d'alimentation de 3 m de long et d'un gel échographique dans une boîte de transport (voir les figures 1 à 3).
Fonction et application prévue
Le système CODMAN VPV est destiné à ajuster les valves programmables CODMAN HAKIM dans le traitement de
l'hydrocéphalie.
L'unité de programmation
L'unité de programmation (figure 2) est un module électronique qui contient les circuits logiques d'alimentation et de
commande. La face avant de l'unité de programmation présente les caractéristiques suivantes :
A. Écran d'affichage à cristaux liquides (LCD)
B. Touche de sélection du mode
C. Icône de mode de valve conditionnée et diode électroluminescente (LED)
D. Icône de mode de valve implantée et témoin lumineux LED
E. Une représentation partielle de la valve telle qu'elle apparaît aux rayons X
F. Touches de sélection de pression et leurs LED correspondantes
G. Prise pour le cordon de l'émetteur
H. Prise pour cordon d'alimentation
I. Porte-fusible
J. Interrupteur d'alimentation
Les touches de sélection de pression (F dans la figure 2) vont de 30 mm de H2O à 200 mm de H2O par incréments
de 10 mm de H2O (de 294 Pascals [Pa] à 1960 Pa par incréments de 98 Pa).
L'émetteur
L'émetteur (figure 3) se connecte à l'unité de programmation à l'aide d'un cordon. Le transmetteur génère le champ
électromagnétique qui modifie le réglage de la valve.
Sélection du mode d'unité de programmation
Le système CODMAN VPV a deux modes de fonctionnement : le mode valve conditionnée et le mode valve implantée.
Icône de valve
conditionnée
1. Le mode valve conditionnée
Le mode valve conditionnée permet d'ajuster le réglage d'une valve avant implantation et d'ajuster
le réglage d'une valve récemment implantée lorsque l'intégrité cutanée du patient nécessite une
barrière stérile. Lorsque le mode valve conditionnée est sélectionné, la fonction de surveillance
acoustique n'est pas active.
Icône de valve
implantée
2. Le mode valve implantée – avec fonction de surveillance acoustique
Le mode valve implantée permet d'ajuster le réglage d'une valve après intervention lorsque le cuir
chevelu du patient est intact. Lorsque le mode valve implantée est sélectionné, la fonction de
surveillance acoustique est active. Voir La fonction de surveillance acoustique.
La fonction de surveillance acoustique
Lorsque le mode valve implantée est sélectionné, un capteur contenu dans l'émetteur détecte les vibrations de la valve
dès que le réglage de la valve est modifié. L'unité de programmation analyse les vibrations de la valve pour déterminer
les cas de mauvais positionnement de l'émetteur ou d'incapacité à détecter le réglage de la valve.
Si la confirmation de l'ajustement de la valve ne s'affiche pas, le clinicien peut décider de reprendre les étapes d'ajustement
de la valve. Aucun effet indésirable connu n'a été associé à plusieurs tentatives d'ajustement. Voir Annexe E : Synthèse de
l'étude clinique pour de plus amples informations.
Informations sur les nouvelles commandes
Réf. catalogue Description
823192R Système CODMAN VPV
Commander un gel échographique de remplacement auprès de n'importe quel fournisseur de gel échographique de
bonne qualité.
Mises en garde et précautions
Les valves programmables CODMAN HAKIM sont fournies sans réglage spécifique et doivent être ajustées avant
utilisation.
Les équipements de communication RF portables (y compris les périphériques tels que les antennes) ne doivent
pas être utilisés à moins de 30cm (12 pouces) de toute partie du système VPV, faute de quoi la performance de ces
équipements pourrait se dégrader.
Lire attentivement le manuel d'instructions fourni avec la valve programmable CODMAN HAKIM avant d'implanter ou
de régler la valve.
Le réglage de la valve doit être effectué avant l'implantation à travers l'emballage externe non stérile. Effectuer les
réglages après l'intervention en cas de besoin.
Ne pas utiliser l'unité de programmation dans une salle d'imagerie par résonance magnétique (IRM).
Les interférences électromagnétiques et autres types d'interférences générées par d'autres équipements ou dispositifs
médicaux peuvent affecter le fonctionnement du système.
Codman®
Système VPV®