Authorized European Representative Fuse Distributeur agréé pour l’Europe Bevollmächtigter Vertreter in der Europäischen Gemeinschaft Gemachtigde vertegenwoordiger in de Europese Unie Rappresentante autorizzato per l’Europa Representante autorizado en Europa Representante Europeu Autorizado Autoriseret europæisk repræsentant Auktoriserad europeisk representant Valtuutettu edustaja Euroopassa Hivatalos európai képvisel Εξουσιοδοτημένος αντιπρόσωπος στην Ευρώπη Fusible Sicherung Zekering Fusibile Fusible Fusível Sikring Säkring Sulake Biztosíték Ασφάλεια Prescription device only (USA) Disponible uniquement sur ordonnance (États-Unis) Verschreibungspflichtiges Produkt (USA) Alleen op medisch voorschrift (VS) Dispositivo solo su prescrizione (USA) Dispositivo para uso bajo prescripción solamente (EE.UU.) Dispositivo vendido unicamente mediante receita médica (EUA) Kun receptpligtig anordning (USA) Receptbelagt (USA) Mise en garde Achtung Voorzichtig Attenzione Precaución Atenção Forsigtig Försiktighet! Huomautus Figyelem! Προσοχή Ainoastaan lääkärin määräyksestä (USA) Kizárólag orvosi rendelvényre kiadható eszköz (USA) Συσκευή για την οποία απαιτείται συνταγή (ΗΠΑ) HAKIM® Programmer and Transmitter (catalog no. 823190R) Caution Instruction Manual Please Read Before Use Consult instructions for use Made in Voir la notice d’utilisation Gebrauchsanweisung beachten Raadpleeg de gebruiksaanwijzing Consultare le Istruzioni per l’uso Vea las instrucciones de uso Consulte as instruções de utilização Se brugsanvisningen Se bruksanvisningen Lue käyttöohjeet Olvassa el a használati útmutatót Συμβουλευτείτε τις οδηγίες χρήσης Fabriqué en Hergestellt in Geproduceerd in Prodotto in Hecho en Produzido em Produceret i Tillverkad i Valmistusmaa Készült Κατασκευάζεται Alternating Current Type BF – Equipment with an electrical path to the patient, not including direct cardiac application Type BF – Équipement relié au patient par un fil électrique, sans application cardiaque directe Typ BF – Gerät mit elektrischem Kontakt zum Patienten; keine direkte Herzanwendung Type BF – Apparatuur met een elektrische verbinding naar de patiënt, directe verbinding naar het hart niet inbegrepen Tipo BF – Apparecchiatura con un percorso elettrico al paziente, esclusa applicazione cardiaca diretta Tipo BF – Equipo con circuito eléctrico al paciente, no incluye aplicación cardiaca directa Tipo BF – Equipamento ligado ao paciente por um fio eléctrico, não incluindo aplicação cardíaca directa Type BF – Udstyr med elektrisk bane til patienten, inkluderer ikke direkte anvendelse på hjerte Typ BF – Utrustning med en elektrisk bana till patienten, men som inte omfattar direkt tillämpning på hjärtat Tyyppi BF – Laitteessa on sähköreitti potilaaseen, lukuun ottamatta suoria kardiologiasovelluksia BF típus – a beteghez elektromos áramot vezető készülék, a szívre közvetlen nem használatos Τύπος BF – Συσκευή με ηλεκτρική οδό προς τον ασθενή, που δεν περιλαμβάνει άμεση καρδιακή εφαρμογή * Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, MA 02767-0350 USA 800 225 0460 +1 508 828 3000 Continuous with intermittent loading Continuous with intermittent loading Continu avec charge intermittente Dauerbetrieb mit periodischer Aufladung Continu bedrijf met intermitterende belasting Continuo con caricamento intermittente Continuo con carga intermitente Contínuo com carga intermitente Kontinuert med intermitterende belastning Kontinuerligt med periodisk laddning Jatkuva toiminta ja jaksoittainen kuormitus Folyamatos, intermittens terhelés Συνεχής, με διαλείπουσα φόρτιση Codman A division of Johnson & Johnson Medical Ltd. Pinewood Campus, Nine Mile Ride, Wokingham RG40 3EW United Kingdom * Medos International SÀRL Chemin-Blanc 38, 2400 Le Locle, Switzerland +41 (0)32 934 8000 *For recognized manufacturer, refer to product label. *Pour le fabricant reconnu, consulter l’étiquette du produit. *Dem Produktetikett ist der anerkannte Hersteller zu entnehmen. *Raadpleeg het etiket op het product voor informatie over de erkende fabrikant. *Per il produttore riconosciuto, fare riferimento all’etichetta del prodotto. *Para el fabricante reconocido, refiérase a la etiqueta del producto. *Para conhecer o fabricante reconhecido, consulte a etiqueta do produto. *Se produktets etiket for at få oplysninger om anerkendt producent. *Information om produktens tillverkare finns på förpackningen. *Katso valmistajan tiedot tuotteen pakkausmerkinnöistä. *A gyártóval kapcsolatos információkat lásd a termék címkéjén. *Για πληροφορίες σχετικά με τον αναγνωρισμένο κατασκευαστή, ανατρέξτε στην ετικέτα του προϊόντος. 208527-001_B_UG.indd 1-3 Courant alternatif Wechselstrom Wisselstroom Corrente alternata Corriente alterna Corrente alterna Vekselstrøm Växelström Vaihtovirta Váltóáram Εναλλασσόμενο ρεύμα LCN 208527-001/B © 2006-2017 DePuy Synthes. All rights reserved. Revised 02/17 30.08.17 13:17 ENGLISH Programming the Valve HAKIM Programmer and Transmitter LCN 208527-001/B Programmer Information Programming must be performed prior to implantation through nonsterile outer package. Perform programming postoperatively as needed. IMPORTANT INFORMATION Please Read Before Use The programmer control panel (see Figure 1) features a display panel and a representation of the programmable portion of the valve as it appears when x-rayed. This representation also incorporates the 18 pressure selection buttons. Eighteen LEDs, corresponding to the position of the valve pressure indicator when viewed on x-ray, confirm the pressure setting chosen. HAKIM® Programmer and Transmitter The HAKIM Programmer and Transmitter were designed and developed in conjunction with Carlos Hakim, Ph.D. and Salomon Hakim, M.D. Transmitter Information The transmitter (Figure 2) incorporates an illuminated center hole and directional arrows to aid in proper positioning over the valve. It connects to the programming unit via a pronged plug and is activated by a start button. X-rayed Valve Information (Figures 3 & 4) The white marker on the valve indicates the right hand side of the valve. The pressure indicator on the white ring indicates the chosen pressure setting. Description The programming system consists of two parts: the programmer and the transmitter. There is a direct correlation between the position of the pressure selector buttons on the programming unit’s control panel and the positions of the pressure indicator on the valve as seen when x-rayed. Note that when the valve is programmed to 70, 120, or 170, the pressure indicator aligns with the “X” in the center of the valve. The programmer (Figure 1) is an electronic module that houses the power and control circuits. The control panel on the front of the programmer features a programming information display panel and a representation of the programmable portion of the valve as it appears when x-rayed. The control panel also contains the buttons used to program the pressure setting of the valve and choose the language for the display. The pressure settings range from 30 mm H2O to 200 mm H2O in increments of 10 mm H2O (from 294 Pa to 1960 Pa in increments of 98 Pa). After depressing the desired pressure selector button, a blue LED lights in the programmer, corresponding exactly with the position of the pressure indicator on the valve. The transmitter then emits a sequentially coded electromagnetic signal. The stepper motor of the valve detects the signal and rotates the cam assembly, which in turn adjusts the tension of the spring to the selected pressure setting. The transmitter (Figure 2) provides the programming signal to the valve. Reordering Information Catalog No. Description 823190R Programmer Initialization and Language Selection Procedure Programmer, complete, 100–240 VAC supplied with carrying case, transmitter and cord. Not sterile. Before first use of the programmer on a valve, perform the following steps to set up the programmer for operation and to set the display language. Indications and Usage 1. Verify that the correct fuse is installed in the programmer for the power supply voltage to be used: The HAKIM Programmer and Transmitter are designed for use only with CODMAN® HAKIM Programmable Valves in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. Supply Voltage 100/120 VAC 220/240 VAC Precautions CODMAN HAKIM Programmable Valves are supplied without a specific programmed pressure setting and must be programmed prior to use. Fuse Type T5AL 5 x 20 mm T2AL 5 x 20 mm 2. Insert the plug from the transmitter into the receptacle at the back of the programmer. Carefully read the instruction manual packaged with the CODMAN HAKIM Programmable Valve before programming or implanting the valve. Electrical and electronic equipment. Return waste to collection system or treatment and recycling facilities. Applicable in the EU. Follow decontamination instructions before return. Équipement électrique et électronique. Renvoyez les déchets à l’organisme de collecte ou à une installation de traitement et de recyclage. Applicable dans l’UE. Suivez les instructions de décontamination avant le renvoi. Elektrische und elektronische Geräte. Abfallstoffe an ein Auffangsystem oder an eine Abfallverwertungs- bzw. Recyclinganlage zurückgeben. Für Geräte in der EU. Vor Rückgabe alle entsprechenden Dekontaminierungsanweisungen beachten. Elektrische en elektronische apparatuur. Voer afval af volgens het verzamelsysteem en recyclefaciliteiten. Van toepassing in de EU. Volg de ontsmettingsrichtlijnen voordat afvoer plaatsvindt. Apparecchiature elettriche ed elettroniche. Inviare i rifiuti ad un sistema di raccolta o a strutture di trattamento e riciclaggio. Applicabile nella UE. Prima della restituzione, seguire le istruzioni per la decontaminazione. Equipo eléctrico y electrónico. Devuelva los desechos a un sistema de recogida o a una planta de tratamiento y reciclaje. Aplicable en la UE. Siga las instrucciones de descontaminación antes de devolver los desechos. Equipamento eléctrico e electrónico. Os resíduos devem ser enviados para o sistema de recolha ou estações de tratamento e reciclagem. Aplicável na U.E. Siga as instruções de descontaminação antes de proceder ao envio. Elektrisk og elektronisk udstyr. Affald skal afleveres på et indsamlingssted eller en genbrugsstation. Gældende i EU. Følg anvisningen i dekontaminering inden affald afleveres. Elektrisk och elektronisk utrustning. Återlämna till insamlingsstation eller till hanterings- och återvinningsanläggningar. Gäller i EU. Följ anvisningarna för dekontaminering före återlämning. Sähköiset ja elektroniset laitteet. Palauta jätteet keräysjärjestelmään tai käsittely- ja kierrätyskeskukseen. Koskee EU:n aluetta. Noudata puhdistusohjeita ennen palautusta. Elektromos és elektronikus berendezés. A hulladékokat juttassa el egy begyűjtő rendszerbe vagy egy hulladékkezelő és -újrahasznosító létesítménybe. Az Európai Unióra vonatkozik. A hulladékok visszajuttatása előtt kövesse a dekontaminációra vonatkozó utasításokat. Ηλεκτρικός και ηλεκτρονικός εξοπλισμός. Απορρίψτε τα άχρηστα υλικά σε σύστημα συλλογής ή σε εγκαταστάσεις κατεργασίας και ανακύκλωσης άχρηστων υλικών. Ισχύει για την EE. Ακολουθήστε τις οδηγίες απολύμανσης πριν από τη διάθεση των άχρηστων υλικών. P mm H2O Pressure in mm of H2O Pression en mm H2O Druck in mm von H2O Druk in mm H2O Pressione in mm di H2O Presión en mm de H2O Pressão em mm de H2O Tryk i mm H2O Tryck i mm H2O Paine ilmaistuna yksikössä mm H2O P mm of H2O Πίεση σε mm H2O Class II Equipment Équipement de la classe II Gerät der Klasse II Klasse II Apparecchiatura della classe II Equipo clase II Equipamento classe II Klasse II Klass II Luokka II II-es osztályú készülék Τάξη II Quantity Quantité Menge Aantal Quantità Cantidad Quantidade Antal Kvantitet Määrä Mennyiség Ποσότητα Refer to Instructions for Use Voir les instructions d’utilisation Gebrauchsanweisung beachten Raadpleeg de gebruiksaanwijzing Fare riferimento alle istruzioni per l’uso Refiérase a las instrucciones de uso Ver instruções de utilização Se brugsanvisningen Se bruksanvisningen Katso käyttöohjeet Lásd a Használati útmutatót Ανατρέξτε στις Οδηγίες χρήσης 3. Plug the socket end of the programmer power cord into the receptacle on the programmer. Insert the plug end of the power cord into an appropriate power source. Do not use the programmer in a magnetic resonance imaging (MRI) suite. Do not allow the programmer or the transmitter to remain in environmental extremes. 4. Set the rear panel programmer power switch to ON. After completing the self test procedure, the LCD panel on the front of the programmer will illuminate and display the following title screen: The HAKIM Programmer must be used by a trained medical professional in a healthcare setting. After exposure to environmental extremes, such as those found in transport or storage, allow the programmer and the transmitter to come to room temperature before operating. CODMAN HAKIM PROGRAMMER VER 5.0 Do not program the valve on a metal surface, such as a Mayo stand. Note: The software version number displayed may be different than the one shown above. While becoming familiar with valve programming, it is recommended that the pressure setting of the implanted valve be changed in increments of no more than 40 mm H2O (392 Pa) in a 24-hour period. Patients whose pressure setting has been changed must be carefully monitored during the first 24 hours postprogramming. It is recommended that x-rays be taken to confirm the changes made to valve pressure setting. 5. As soon as the message above is displayed, press the “30” pressure selection button on the front panel. The display will change to: LANGUAGE 30 = ENGLISH MORE = 200 Before use, check the programmer and transmitter connections, settings, and function (see “Preimplantation Programming Familiarization Procedure” in this manual). Unauthorized modifications to the programmer or the transmitter can cause a malfunction that could result in serious patient injury or death. Electrical shock hazard: Do not open the programmer or transmitter. Refer servicing to qualified service personnel. Explosion hazard: Do not use the programmer in the presence of flammable material; i.e., anesthetics, solvents, cleaning agents, and endogenous gases. Before turning on the programmer, verify that the correct fuse is installed. Do not move the transmitter during programming. Do not sterilize the programmer or the transmitter or immerse them in any liquid. Do not stack Hakim Programmer with other equipment to avoid interference. 2 208527-001_B_UG.indd 4-6 30.08.17 13:17
