Medtronic 95185-001 Instructions for Use

Bio-Probe™

Blood Flow Monitoring System: Transducer, Disposable Insert Blutflussüberwachungssystem: Messumformer, Einwegeinsatz Système de contrôle du débit sanguin : capteur, raccord jetable Sistema di monitoraggio del flusso ematico: trasduttore, inserto monouso Flowbewakingssysteem: transducer, wegwerp-insert

TX50, TX50P, DP38, DP38P, CB2980POLY, CB4627, DP38T, DP38PT, BBDP38, BBDP38P

DP38T, DP38PT: These devices are not CE-marked. These devices are not available for distribution in the European Union and associated countries.

TX50, TX50P, DP38, DP38P, CB2980POLY, CB4627, BBDP38, BBDP38P: These devices are CE-marked.

DP38T, DP38PT: Diese Produkte haben keine CE-Kennzeichnung. Diese Produkte sind nicht für den Vertrieb in der Europäischen Union und zugehörigen Ländern erhältlich.

TX50, TX50P, DP38, DP38P, CB2980POLY, CB4627, BBDP38, BBDP38P: Diese Produkte haben eine CE-Kennzeichnung.

DP38T, DP38PT : ces appareils ne comportent pas le marquage CE. Ces appareils ne sont pas disponibles pour la distribution dans l'Union européenne et les pays associés.

TX50, TX50P, DP38, DP38P, CB2980POLY, CB4627, BBDP38, BBDP38P : ces appareils ne comportent pas le marquage CE.

DP38T, DP38PT: questi dispositivi non sono dotati di marchio CE. Questi dispositivi non sono disponibili per la distribuzione nell'Unione Europea e nei relativi Paesi.

TX50, TX50P, DP38, DP38P, CB2980POLY, CB4627, BBDP38, BBDP38P: questi dispositivi sono dotati di marchio CE.

DP38T, DP38PT: Deze producten hebben geen CE-markering. Deze producten zijn niet verkijgbaar in de Europese Unie en geassocieerde landen.

TX50, TX50P, DP38, DP38P, CB2980POLY, CB4627, BBDP38, BBDP38P: Deze producten hebben geen CE-markering.

Operator Manual • Benutzerhandbuch • Manuel de l'utilisateur • Manuale dell’operatore • Gebruikershandleiding

Caution: Federal law (USA) restricts this device to sale by or on the order of

a physician.

Trademarks may be registered and are the property of their respective owners. Marken sind eventuell eingetragen und sind das Eigentum ihrer jeweiligen Inhaber. Les marques commerciales peuvent être déposées et appartiennent à leurs propriétaires respectifs. I marchi di fabbrica possono essere registrati e sono di proprietà dei rispettivi titolari. Handelsmerken kunnen zijn geregistreerd en zijn het eigendom van de desbetreffende eigenaren.

Explanation of symbols on product or packaging / Erläuterung der auf dem Produkt oder der Verpackung angebrachten Symbole / Explication des symboles indiqués sur le produit ou l'emballage / Spiegazione dei simboli presenti sul prodotto o sulla confezione / Verklaring van de symbolen op het product of de verpakking

Refer to the appropriate product to see which symbols apply. / Auf den Produkten sind nur die für das jeweilige Produkt gültigen Symbole angebracht. / Se référer au produit approprié pour savoir quels symboles s'appliquent. / Fare riferimento al prodotto specifico per individuare i simboli che lo riguardano. / Controleer het desbetreffende product om te zien welke symbolen van toepassing zijn.

Do not use if package is damaged / Nicht verwenden, wenn die Verpackung beschädigt ist / Ne pas utiliser si l'emballage est endommagé / Non utilizzare se l'imballaggio non è integro / Niet gebruiken als de verpakking beschadigd is

Open here / Hier öffnen / Ouvrir ici / Aprire qui / Hier openen

Nonpyrogenic fluid path / Pyrogenfreier Flüssigkeitsweg / Trajet des fluides apyrogène / Percorso per il liquido apirogeno / Niet-pyrogeen vloeistoftraject

Do not reuse / Nicht wiederverwenden / Ne pas réutiliser / Non riutilizzare / Niet opnieuw gebruiken

Do not sterilize / Nicht sterilisieren / Ne pas stériliser / Non sterilizzare / Niet steriliseren

Do not use alcohol or alcohol-based fluids on any surface of this device / Weder Alkohol noch Flüssigkeiten auf Alkoholbasis dürfen mit irgendeiner Oberfläche dieses Geräts in Berührung kommen / Ne pas utiliser d'alcool ou de liquides à base d'alcool sur les surfaces de cet appareil / Non utilizzare alcol né detergenti a base di alcol su alcuna superficie di questo dispositivo / Geen alcohol of vloeistoffen op basis van alcohol op het oppervlak van dit product gebruiken

Do not immerse / Nicht in Flüssigkeit tauchen / Ne pas immerger / Non immergere / Niet onderdompelen

This direction for fluid path / Diese Richtung für den Flüssigkeitsweg / Trajet des fluides dans cette direction / Direzione del percorso del liquido / Richting van de vloeistoftraject

Sterilized using ethylene oxide / Mit Ethylenoxid sterilisiert / Stérilisé à l'oxyde d’éthylène / Sterilizzato a ossido di etilene / Gesteriliseerd met ethyleenoxide

Consult instructions for use / Gebrauchsanweisung beachten / Consulter le mode d'emploi / Consultare le istruzioni per l'uso / Zie gebruiksaanwijzing

Authorized representative in the European Community / Autorisierter Repräsentant in der Europäischen Gemeinschaft / Représentant agréé dans la Communauté européenne / Rappresentante autorizzato nella Comunità europea / Geautoriseerd vertegenwoordiger in de Europese Gemeenschap

Date of manufacture / Herstellungsdatum / Date de fabrication / Data di fabbricazione / Productiedatum

Manufacturer / Hersteller / Fabricant / Fabbricante / Fabrikant

Manufactured in / Hergestellt in / Lieu de fabrication / Fabbricato in / Vervaardigd in

Do not resterilize / Nicht resterilisieren / Ne pas restériliser / Non risterilizzare / Niet opnieuw steriliseren

Upper limit of temperature / Obere Temperaturgrenze / Limite supérieure de température / Limite superiore di temperatura / Maximale temperatuur

Temperature limit / Temperaturbereich / Limite de température / Limiti di temperatura / Temperatuurbereik

Use-by date / Verwendbar bis / Date de péremption / Utilizzare entro / Uiterste gebruiksdatum

Lot number / Chargennummer / Numéro de lot / Numero di lotto / Partijnummer

Serial number / Seriennummer / Numéro de série / Numero di serie / Serienummer

Quantity / Menge / Quantité / Quantità / Aantal

Catalog number / Katalognummer / Numéro de référence / Numero di catalogo / Catalogusnummer

Type CF applied part / Anwendungsteil vom Typ CF / Pièce appliquée de type CF / Parte applicata di tipo CF / Toegepast onderdeel type CF

For US audiences only / Gilt nur für Leser in den USA / Ne s'applique qu'aux États-Unis / Esclusivamente per il mercato statunitense / Alleen van toepassing voor de VS

Conformité Européenne (European Conformity). This symbol means that the device fully complies with European Council Directive MDD: 93/42/EEC. / Conformité Européenne (Europäische Konformität). Dieses Symbol besagt, dass das Gerät allen Vorschriften der europäischen Richtlinie 93/42/EWG für Medizinprodukte entspricht. / Conformité Européenne. Ce symbole signifie que l’appareil est entièrement conforme à la Directive européenne MDD : 93/42/CEE. / Conformité Européenne (Conformità europea). Questo simbolo indica che il dispositivo è conforme alla Direttiva del Consiglio europeo MDD 93/42/CEE. / Conformité Européenne (Europese Conformiteit). Dit symbool betekent dat het product volledig voldoet aan de Europese Richtlijn MDD 93/42/EEG.

Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. See http://recycling.medtronic.com for instructions on proper disposal of this product. / Dieses Produkt darf nicht mit dem Restmüll/Hausmüll entsorgt werden. Bei der Entsorgung dieses Produkts sind die einschlägigen Vorschriften zu beachten. Anweisungen zur korrekten Entsorgung dieses Produkts finden Sie auf unserer Webseite unter http://recycling.medtronic.com. / Ne pas mettre ce produit au rebut dans une décharge municipale ne pratiquant pas le tri des déchets. Respecter la réglementation locale en vigueur en la matière. Consulter le site http://recycling.medtronic.com pour obtenir des instructions sur la mise au rebut adéquate de ce produit. / Non eliminare questo prodotto insieme ai rifiuti solidi urbani non differenziati. Attenersi alle normative in vigore per il corretto smaltimento. Per istruzioni sul corretto smaltimento del prodotto, consultare il sito web http://recycling.medtronic.com. / Niet met het gewone huisvuil wegwerpen. Werp dit product weg volgens de lokale afvalverwerkingsregels. Zie http://recycling.medtronic.com voor instructies voor de juiste afvoer van dit product.

Humidity limitation / Luftfeuchtigkeitsbereich / Limite d'humidité / Limiti di umidità / Vochtigheidsbereik

Table of Contents

1. About the Bio-Probe™ blood flow monitoring system 4

1.1. Indications for use 4

1.2. Contraindications 4

1.3. Description 4

1.4. Package contents 5

1.5. Instrument inspection 5

1.6. Environmental limits 5

1.7. Compatibility with the Bio-Console™ extracorporeal blood pumping console 5

1.8. Compatibility of transducers with disposable inserts 5

1.9. Adverse effects 6

1.10. Warnings and precautions 6

2. Assembling 6

3. Emergency 10

4. Troubleshooting 12

5. Cleaning 13

6. Servicing 14

7. Equipment limited warranty 14

8. Limited warranty 15

9. Equipment limited warranty 16

10. Limited warranty 17

1. About the Bio-Probe™ blood flow monitoring system

Before using this system, read these instructions.

1.1. Indications for use

The Bio-Probe™ blood flow monitoring system is to be used with an appropriate model Bio-Console™ extracorporeal blood pumping console to measure directly the blood flow in the extracorporeal perfusion circuit.

1.2. Contraindications

Use the device only as indicated.

1.3. Description

The Bio-Probe blood flow monitoring system consists of a flow transducer and a sterile, single-use insert. A transducer mount may be used.

The TX50 and TX50P transducer models are reusable. The arrow on the transducer cover indicates the correct direction of fluid flow, and the color of the arrow indicates whether the transducer should be used with an adult or pediatric patient:

■

Model TX50: The adult transducer has a gray arrow on the cover and a black cable.

■

Model TX50P: The pediatric transducer has a blue arrow on the cover and a blue cable.

The disposable inserts are available uncoated or with a biocompatible coating. Contact your Medtronic customer service representative for more information.

The disposable inserts are sterilized using ethylene oxide. The transducer may be placed on a transducer mount and attached to a pole during a perfusion procedure or

when storing the transducer. Instructions for using the transducer mount are described in the operator manual for the appropriate model of the Bio-Console extracorporeal blood pumping console.

4 Instructions for Use English

1.4. Package contents

Included in the package is an operator manual and either an adult transducer (Model TX50) or a pediatric transducer (Model TX50P).

The disposable insert is not included but is a necessary part of the Bio-Probe blood flow monitoring system.

1.5. Instrument inspection

This section provides a list of inspection checks on the Bio-Probe blood flow monitoring system for technical personnel trained and skilled in all device functions. Users must read and understand this manual completely before operating the Bio-Probe blood flow monitoring system and performing these checks. Operating functions of this device should be checked before use as stated in this manual. Device instrument inspection, as described in this section, should be checked at least once per 12 months.

In all events, should problems occur, contact your Medtronic service representative. The following checks should be made:

■

Visual inspection

■

Inscriptions, information and warning signs properly and completely fixed

■

Mechanical damage to the device, accessories and all other cables

1.6. Environmental limits

Operating temperature (TX50, TX50P) 18°C to 33°C (64°F to 92°F) Operating humidity (TX50, TX50P) 30% to 75% R.H. noncondensing Storage temperatures

■

TX50, TX50P

■

DP38, DP38P, DP38T, DP38PT, BBDP38,

-34°C to 66°C (-29°F to 150°F)

-34°C to 50°C (-29°F to 122°F)

BBDP38P

■

CB2980POLY, CB4627

-34°C to 40°C (-29°F to 104°F)

Storage Humidity (TX50, TX50P) 15% to 95% R.H. noncondensing

1.7. Compatibility with the Bio-Console™ extracorporeal blood pumping console

Before using the Bio-Probe blood flow monitoring system, ensure that you have the appropriate transducer for the console being used. Refer to the appropriate console operator manual for additional information.

1.7.1. Models 550 and 560

These console models were designed for the transducer Models TX50 and TX50P.

1.8. Compatibility of transducers with disposable inserts

Refer to the Bio-Probe disposable insert instructions for use for additional information pertaining to coatings.

Table 1.

Use with transducer Model TX50 (adult)

Use with transducer Model TX50P (pediatric)

Uncoated insert DP38 DP38P Cortiva™ BioActive Surface insert CB2980POLY CB4627

Trillium™ Biosurface coated insert Balance™ Biosurface coated insert

Technology licensed under agreement from BioInteractions, Limited, United Kingdom.

DP38T DP38PT

BBDP38 BBDP38P

Instructions for Use English 5

1.9. Adverse effects

The following adverse effects are associated with the use of the Bio-Probe blood flow monitoring system: blood loss, coagulopathy, excessive blood component activation/thrombogenicity, hemolytic anemia, hypotension, infection, ischemia, neurological dysfunction, and organ dysfunction.

1.10. Warnings and precautions Read all warnings, precautions, and instructions for use carefully prior to use. Failure to read and follow all

instructions, or failure to observe all stated warnings, could cause serious injury or death to the patient.

1.10.1. Warnings

■

Before using this system, read the operator manual for the appropriate model of the Bio-Console extracorporeal blood pumping console.

■

A standby transducer should be available during perfusion. If the transducer must be replaced during a procedure, follow the instructions in the Emergency section.

1.10.2. Precautions

■

The disposable inserts were designed for single patient use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device, which could result in patient injury, illness, or death.

■

If it is necessary to lubricate the insert while attaching the tubing, use only sterile water or saline. Do not use alcohol-based fluids on the disposable insert.

■

Before opening the package of the insert, carefully inspect the packaging. If the package is damaged or opened, or if the insert appears damaged, do not use the insert. Return the insert to your local Medtronic representative.

■

Inspect the transducer, cable, and cable connector for mechanical damage. If damage is found, use a standby transducer and contact a qualified Medtronic service technician.

■

Only use the transducers with their compatible disposable inserts (see Table 1). If the incorrect disposable insert is used, the transducer may become damaged.

■

Handle the transducers with care. Avoid sharp bends, kinks, or twists, or other stresses on the transducer cable. Hold and carry the transducer gently; do not carry the transducer by the cable. Do not use scalpels, hemostats, tubing clamps, or other surgical tools on the transducer or its cable.

■

For optimal flow accuracy, attach a primed Bio-Probe blood flow monitoring system to the console.

■

Verify that the pins of the transducer are straight and clean.

■

Ensure that the disposable insert pins contact the transducer pins (underneath the transducer cover).

■

Dispose of the devices in accordance with local hospital, administrative, and other government policies.

2. Assembling

Before placing a patient on cardiopulmonary bypass, connect an assembled and primed Bio-Probe blood flow monitoring system to the console. Refer to the appropriate Bio-Console extracorporeal blood pumping console operator manual for instructions about turning on the console and attaching the Bio-Probe blood flow monitoring system to the console.

Caution: Before assembling the system, ensure that an adult disposable insert is used only with the adult transducer Model TX50. If a pediatric disposable insert is used, the adult transducer may be damaged when the transducer cover is closed. See Table 1.

6 Instructions for Use English

1. Adult

2. Pediatric

Figure 1

1. Using sterile technique, remove the disposable insert from its sterile package.

Note: The pin spacing between the adult disposable insert differs from that of the pediatric insert.

Figure 2

2. Connect the arterial line to one side of the disposable insert.

Caution: Use only sterile saline or sterile water to lubricate the tubing and the insert. Do not use alcohol or alcohol-related solutions.

Instructions for Use English 7

Figure 3

3. Maintaining sterile technique, connect at least 15 cm (6 in) of tubing to the other side of the disposable insert (a) and to the outlet of the centrifugal blood pump (b).

Figure 4

4. Push the transducer cover open and align the disposable insert with the fluid flow direction on the transducer cover.

Note: If the transducer is aligned incorrectly with the fluid path, a negative flow value will be displayed on the console.

8 Instructions for Use English

Figure 5

5. Firmly push the insert into the transducer.

Figure 6

6. Push the transducer cover closed until the latch engages.

Instructions for Use English 9

Figure 7

The Bio-Probe blood flow monitoring system is assembled. Refer to the Bio-Console extracorporeal blood pumping console operator manual for instructions about attaching the transducer, priming the circuit (with a balanced electrolyte or normal saline solution), and zeroing the transducer.

3. Emergency

Should the transducer stop functioning, replace it with the standby tranducer:

1. Disconnect the nonfunctioning transducer from the console and connect the standby transducer to the console.

2. Remove the disposable insert with attached tubing from the nonfunctioning transducer.

Figure 8

3. Push open the transducer cover of the standby transducer. Align the disposable insert with the fluid flow direction on the transducer cover of the functioning transducer.

10 Instructions for Use English

Note: If the transducer is aligned incorrectly with the fluid path, a negative flow value will be displayed on the console.

Figure 9

4. Firmly push the insert into the standby transducer.

Figure 10

5. Push the transducer cover closed until the latch engages.

Instructions for Use English 11

Figure 11

The Bio-Probe blood flow monitoring system is now reassembled with the standby transducer. Refer to the BioConsole extracorporeal blood pumping operator manual for instructions about zeroing the transducer.

4. Troubleshooting

Condition Cause Corrective Action

Flashing digital display

The priming solution is not a balanced electrolyte or normal saline.

The contact between the pins of the disposable insert and the pins under the transducer cover is disrupted.

The pins under the transducer cover are misaligned.

The transducer cable is not connected properly.

A cautery unit, lamp, or other ambient electrical current is interfering.

The disposable insert pins or the pins inside the transducer cover are wet.

Use a balanced electrolyte or normal saline as the priming solution.

Ensure that the transducer cover (over the disposable insert) is securely closed.

Verify proper pin contact between the transducer and the disposable insert.

Verify that the transducer pins are free from dirt or fluid.

Use the correct size of disposable insert for this transducer model number.

Ensure that the transducer cable is connected into the console.

Check the transducer cable for breakage. Determine the cause and eliminate it, if pos-

sible. Dry the pins.

12 Instructions for Use English

Condition Cause Corrective Action

Negative flow meter reading with a known positive pump output or flow

Other problems Unknown Consult with a qualified Medtronic service

The transducer is reversed in the flow path. (Notice the arrow on the transducer cover.)

The flow display was not zeroed correctly. Refer to the zeroing or balancing procedure

Open the transducer cover, lift out the disposable insert, turn the transducer (or disposable insert) 180°, place the disposable insert back under the transducer cover, and rezero the transducer.

for the flow transducer in the appropriate operator manual for the Bio-Console extracorporeal blood pumping console.

technician.

5. Cleaning

The transducer will perform more efficiently and last longer if it is cleaned and stored as described:

1. After a perfusion procedure, push open the transducer cover and discard the disposable insert. Caution: The disposable insert should never be resterilized or reused.

Figure 12

2. Clean the transducer, transducer pins (underneath the transducer cover), and cable by wiping them with a cloth moistened with water and mild soap. Avoid strong or abrasive cleaners. Wipe off the soap using a cloth or sponge moistened with clear water.

Note: Do not immerse any part of the transducer, cable, or cable connector.

Instructions for Use English 13

Figure 13

Note: The transducer does not require sterilization.

3. Dry the transducer, transducer pins, and cable with a cloth.

4. Ensure that the pins underneath the transducer cover are straight. If a pin is not straight, notify a qualified Medtronic service technician.

5. To store the transducer, either place it on the transducer mount or unplug the transducer and place it in its protective plastic case.

Instructions for using the transducer mount are described in the operator manual for the appropriate model of the Bio-Console extracorporeal blood pumping console.

6. Servicing

If the transducer is damaged, contact the Medtronic Customer Service Department. You must receive authorization from Medtronic before returning a transducer for repair.

Note: Do not repair the transducer; the warranty will be voided. Medtronic maintains a professional staff of consultants to provide technical consultation for product users. To

find answers for a question or to schedule product training, contact your local Medtronic service representative.

7. Equipment limited warranty

The following limited warranty 1 applies to United States customers only:

A. This LIMITED WARRANTY provides the following assurance to the purchaser of the Medtronic Models

TX50 and TX50P flow transducers for the Bio-Probe blood flow monitoring system, hereafter referred to as the “Transducer”:

(1) Should the Transducer fail to function within normal tolerances due to a defect in materials or

workmanship within a period of 1 year, commencing with the delivery of the Transducer to the purchaser, Medtronic will at its option: (a) repair or replace any part or parts of the Transducer; (b) issue a credit to the purchaser equal to the purchase price, as defined in Subsection A(2), against the

This Limited Warranty is provided by Medtronic, 710 Medtronic Parkway, Minneapolis, MN 55432. It applies only in the United States. Areas outside the United States should contact their local Medtronic representative for exact terms of the Limited Warranty.

14 Instructions for Use English

purchase of the replacement Transducer; or (c) provide a functionally comparable replacement Transducer at no charge.

(2) As used herein, purchase price shall mean the lesser of the net invoiced price of the original, current

functionally comparable, or replacement Transducer.

B. To qualify for the repair, replacement or credit set forth in Section A, the following conditions must be met:

(1) The Transducer must be returned to Medtronic within 30 days after discovery of the defect. (Medtronic

may, at its option, repair the Transducer on site).

(2) The Transducer must not have been repaired or altered outside of Medtronic’s factory in any way which,

in the judgment of Medtronic, affects its stability and reliability. The Transducer must not have been subjected to misuse, abuse, or accident.

C. This LIMITED WARRANTY is limited to its express terms. In particular:

(1) Except as expressly provided by this LIMITED WARRANTY, MEDTRONIC IS NOT RESPONSIBLE

FOR ANY DIRECT, INCIDENTAL, OR CONSEQUENTIAL DAMAGES BASED ON ANY DEFECT, FAILURE, OR MALFUNCTION OF THE TRANSDUCER, WHETHER THE CLAIM IS BASED ON WARRANTY, CONTRACT, TORT, OR OTHERWISE.

(2) This LIMITED WARRANTY is made only to the purchaser of the Transducer. AS TO ALL OTHERS,

MEDTRONIC MAKES NO WARRANTY, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE WHETHER ARISING FROM STATUTE, COMMON LAW, CUSTOM OR OTHERWISE. NO EXPRESS OR IMPLIED WARRANTY TO THE PATIENT SHALL EXTEND BEYOND THE PERIOD SPECIFIED IN A(1) ABOVE. THIS LIMITED WARRANTY SHALL BE THE EXCLUSIVE REMEDY AVAILABLE TO ANY PERSON.

(3) The exclusions and limitations set out above are not intended to, and should not be construed so as to,

contravene mandatory provisions of applicable law. If any part or term of this LIMITED WARRANTY is held to be illegal, unenforceable, or in conflict with applicable law by a court of competent jurisdiction, the validity of the remaining portions of the LIMITED WARRANTY shall not be affected, and all rights and obligations shall be construed and enforced as if this LIMITED WARRANTY did not contain the particular part or term held to be invalid. This LIMITED WARRANTY gives the purchaser specific legal rights. The purchaser may also have other rights which vary from state to state.

(4) No person has any authority to bind Medtronic to any representation, condition, or warranty except this

LIMITED WARRANTY.

8. Limited warranty

(FOR SINGLE-USE PRODUCT) The following limited warranty 2 applies to United States customers only:

A. This LIMITED WARRANTY provides the following assurance to the patient who receives the Medtronic Bio-

Probe disposable inserts for the Bio-Probe blood flow monitoring system, hereafter referred to as the “Product”:

(1) Should the Product fail to function within normal tolerances due to a defect in materials or workmanship

prior to its use-by date, Medtronic will at its option: (a) issue a credit to the purchaser equal to the purchase price, as defined in Subsection A(2), against the purchase of the replacement Product; or (b) provide a functionally comparable replacement Product at no charge.

(2) As used herein, purchase price shall mean the lesser of the net invoiced price of the original, or current

functionally comparable, or replacement Product.

B. To qualify for the LIMITED WARRANTY, these conditions must be met:

(1) The Product must be used prior to its use-by date.

This Limited Warranty is provided by Medtronic, 710 Medtronic Parkway, Minneapolis, MN 55432. Areas outside the United States should contact their local Medtronic representative for exact terms of the Limited Warranty.

Instructions for Use English 15

(2) The unused portion of the Product must be returned to Medtronic and shall be the property of

Medtronic. (3) The Product must not have been altered or subjected to misuse, abuse, or accident. (4) The Product must be used in accordance with the labeling and instructions for use provided with the

Product.

C. This LIMITED WARRANTY is limited to its express terms. In particular:

(1) Except as expressly provided by this LIMITED WARRANTY, MEDTRONIC IS NOT RESPONSIBLE

FOR ANY DIRECT, INCIDENTAL, OR CONSEQUENTIAL DAMAGES BASED ON ANY DEFECT,

FAILURE, OR MALFUNCTION OF THE PRODUCT, WHETHER THE CLAIM IS BASED ON

WARRANTY, CONTRACT, TORT, OR OTHERWISE. (2) This LIMITED WARRANTY is made only to the patient in whom the Product was used. AS TO ALL

OTHERS, MEDTRONIC MAKES NO WARRANTY, EXPRESS OR IMPLIED, INCLUDING, BUT NOT

LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY, OR FITNESS FOR A

PARTICULAR PURPOSE WHETHER ARISING FROM STATUTE, COMMON LAW, CUSTOM, OR

OTHERWISE. NO EXPRESS OR IMPLIED WARRANTY TO THE PATIENT SHALL EXTEND BEYOND

THE PERIOD SPECIFIED IN A(1) ABOVE. THIS LIMITED WARRANTY SHALL BE THE EXCLUSIVE

REMEDY AVAILABLE TO ANY PERSON. (3) The exclusions and limitations set out above are not intended to, and should not be construed so as to,

contravene mandatory provisions of applicable law. If any part or term of this LIMITED WARRANTY is

held to be illegal, unenforceable, or in conflict with applicable law by a court of competent jurisdiction,

the validity of the remaining portions of the LIMITED WARRANTY shall not be affected, and all rights

and obligations shall be construed and enforced as if this LIMITED WARRANTY did not contain the

particular part or term held to be invalid. This LIMITED WARRANTY gives the patient specific legal

rights. The patient may also have other rights which vary from state to state. (4) No person has any authority to bind Medtronic to any representation, condition, or warranty except this

LIMITED WARRANTY.

9. Equipment limited warranty

(FOR REPAIRABLE EXTERNAL EQUIPMENT/OUTSIDE THE US) The following limited warranty 3 applies to customers outside the United States:

A. This LIMITED WARRANTY provides the following assurance to the purchaser of the Medtronic Models

TX50 and TX50P flow transducers for the Bio-Probe blood flow monitoring system, hereafter referred to as the “Transducer”, that should the Transducer fail to function within normal tolerances due to a defect in materials or workmanship within a period of one 1 year, commencing with the delivery of the Transducer to the purchaser, Medtronic will at its option: (a) repair or replace any defective part or parts of the Transducer; (b) issue a credit equal to the original Transducer purchase price (but not to exceed the value of the replacement Transducer), against the purchase of replacement Transducer; or (c) provide functionally comparable replacement Transducer at no charge.

B. To qualify for this repair, replacement, or credit, the following conditions must be met:

(1) The Transducer must be returned to Medtronic within 60 days after discovery of the defect. (Medtronic

may, at its option, repair the Transducer on site). (2) The Transducer must not have been repaired or altered by someone other than Medtronic in any way

which, in the judgment of Medtronic, affects it stability and reliability. (3) The Transducer must not have been subjected to misuse, abuse, or accident.

16 Instructions for Use English

C. This LIMITED WARRANTY is limited to its express terms. In particular, Medtronic is not responsible for any

incidental or consequential damages based on any use, defect, or failure of the Transducer, whether the claim is based on warranty, contract, tort, or otherwise.

D. The exclusions and limitations set out above are not intended to, and should not be construed so as to,

contravene mandatory provisions of applicable law. If any part or term of this LIMITED WARRANTY is held by any court of competent jurisdiction to be illegal, unenforceable, or in conflict with applicable law, the validity of the remaining portion of the LIMITED WARRANTY shall not be affected, and all rights and obligations shall be construed and enforced as if this LIMITED WARRANTY did not contain the particular part or term held to be invalid.

10. Limited warranty

(FOR SINGLE-USE PRODUCT/OUTSIDE THE US) The following limited warranty 4 applies to customers outside the US:

A. This LIMITED WARRANTY provides assurance for the purchaser who receives the Medtronic Bio-Probe

disposable inserts for the Bio-Probe blood flow monitoring system, hereafter referred to as the “Product”, that should the Product fail to function to specification, Medtronic will issue a credit, equal to the original Product purchase price (but not to exceed the value of the replacement Product) against the purchase of any Medtronic replacement Product used for that patient. THE WARNINGS CONTAINED IN THE PRODUCT LABELING ARE CONSIDERED AN INTEGRAL PART OF THIS LIMITED WARRANTY. CONTACT YOUR LOCAL MEDTRONIC REPRESENTATIVE TO OBTAIN INFORMATION ON HOW TO PROCESS A CLAIM UNDER THIS LIMITED WARRANTY.

B. To qualify for the LIMITED WARRANTY, these conditions must be met:

(1) The Product must be used prior to its use-by date. (2) The Product must be returned to Medtronic within 60 days after use and shall be the property of

Medtronic. (3) The Product may not have been used for any other patient.

C. This LIMITED WARRANTY is limited to its express terms. In particular:

(1) In no event shall any replacement credit be granted where there is evidence of improper handling,

improper implantation, or material alteration of the replaced Product. (2) Medtronic is not responsible for any incidental or consequential damages based on any use, defect, or

failure of the Product, whether the claim is based on warranty, contract, tort, or otherwise.

D. The exclusions and limitations set out above are not intended to, and should not be construed so as to,

Instructions for Use English 17

Inhaltsverzeichnis

1. Das Bio-Probe™ Blutflussüberwachungssystem 18

1.1. Indikationen 18

1.2. Kontraindikationen 18

1.3. Beschreibung 18

1.4. Verpackungsinhalt 19

1.5. Inspektion des Instruments 19

1.6. Umgebungsbedingungen 19

1.7. Kompatibilität mit der extrakorporalen Bio-Console™ Blutpumpenkonsole 19

1.8. Kompatibilität der Messumformer mit Einwegeinsätzen 19

1.9. Unerwünschte Nebenwirkungen 20

1.10. Warnhinweise und Vorsichtsmaßnahmen 20

2. Montage 21

3. Verhalten in Notfällen 24

4. Problemlösung 27

5. Reinigung 27

6. Wartung 29

7. Garantieerklärung für das Produkt 29

8. Garantieerklärung 30

1. Das Bio-Probe™ Blutflussüberwachungssystem

Lesen Sie diese Anleitung vor der Verwendung des Systems sorgfältig durch.

1.1. Indikationen

Das Bio-Probe™ Blutflussüberwachungssystem wird mit einem geeigneten Modell der extrakorporalen BioConsole™ Blutpumpenkonsole für die direkte Messung des Blutflusses im extrakorporalen Perfusionskreislauf eingesetzt.

1.2. Kontraindikationen

Verwenden Sie das Gerät nur gemäß den Indikationen.

1.3. Beschreibung

Das Bio-Probe Blutflussüberwachungssystem besteht aus einem Flussmessumformer und einem sterilen Einwegeinsatz. Die Verwendung eines Messumformerhalters ist zulässig.

Die Messumformer Modell TX50 und Modell TX50P sind wiederverwendbar. Der Pfeil auf der Messumformerabdeckung zeigt die korrekte Richtung des Flüssigkeitsflusses an, und an der Farbe des Pfeils ist zu erkennen, ob der Messumformer für die Verwendung bei erwachsenen oder bei pädiatrischen Patienten vorgesehen ist:

■

Modell TX50: Der Messumformer für Erwachsene hat einen grauen Pfeil auf der Abdeckung und ein schwarzes Kabel.

■

Modell TX50P: Der pädiatrische Messumformer hat einen blauen Pfeil auf der Abdeckung und ein blaues Kabel.

Die Einwegeinsätze sind unbeschichtet oder mit einer biokompatiblen Beschichtung erhältlich. Weitere Informationen erhalten Sie von Ihrem Medtronic Kundendienst.

Die Einwegeinsätze sind mit Ethylenoxid sterilisiert. Der Messumformer kann in einen Messumformerhalter eingesetzt und für den Perfusionseingriff oder zur

Aufbewahrung an einem Ständer angebracht werden. Gebrauchshinweise für den Messumformerhalter sind

18 Gebrauchsanweisung Deutsch

dem Benutzerhandbuch für das entsprechende Modell der extrakorporalen Bio-Console Blutpumpenkonsole zu entnehmen.

1.4. Verpackungsinhalt

Die Verpackung enthält ein Benutzerhandbuch und einen Messumformer für Erwachsene (Modell TX50) oder einen pädiatrischen Messumformer (Modell TX50P).

Der Einwegeinsatz liegt nicht bei, wird jedoch für die Nutzung des Bio-Probe Blutflussüberwachungssystems zwingend benötigt.

1.5. Inspektion des Instruments

Dieser Abschnitt enthält eine Übersicht über die Prüfungen, die im Rahmen der Inspektion des Bio-Probe Blutflussüberwachungssystems durch geschulte und mit allen Funktionen des Geräts vertraute Techniker durchzuführen sind. Sie müssen dieses Handbuch vollständig durchgelesen und verstanden haben, bevor Sie das Bio-Probe Blutflussüberwachungssystem in Betrieb nehmen und diese Prüfungen durchführen. Vor der Verwendung müssen die Betriebsfunktionen des Geräts wie in diesem Handbuch ausgeführt überprüft werden. Die in diesem Abschnitt beschriebene Inspektion des Geräts sollte mindestens alle 12 Monate durchgeführt werden.

Wenden Sie sich beim Auftreten von Problemen jeglicher Art an den für Sie zuständigen Medtronic Kundendienst-Repräsentanten.

Die nachfolgenden Prüfungen sollten durchgeführt werden:

■

Sichtprüfung

■

korrekt und vollständig angebrachte Aufschriften, Informationen und Warnhinweise

■

mechanische Beschädigungen des Geräts, der Zubehörteile sowie aller weiteren Kabel

1.6. Umgebungsbedingungen

Betriebstemperatur (TX50, TX50P) 18 °C bis 33 °C (64 °F bis 92 °F) Luftfeuchtigkeit bei Betrieb (TX50, TX50P) 30 % bis 75 % rel. LF., nicht kondensierend Lagerungstemperatur

■

TX50, TX50P

■

DP38, DP38P, DP38T, DP38PT, BBDP38, BBDP38P

■

CB2980POLY, CB4627

Luftfeuchtigkeit bei Lagerung (TX50, TX50P) 15 % bis 95 % rel. LF., nicht kondensierend

1.7. Kompatibilität mit der extrakorporalen Bio-Console™ Blutpumpenkonsole

Bevor Sie das Bio-Probe Blutflussüberwachungssystem verwenden, achten Sie darauf, dass Sie den passenden Messumformer für die verwendete Konsole haben. Nähere Informationen finden Sie in dem Benutzerhandbuch der verwendeten Konsole.

1.7.1. Modell 550 und 560

Diese Konsolenmodelle wurden für die Messumformer Modell TX50 und Modell TX50P konzipiert.

1.8. Kompatibilität der Messumformer mit Einwegeinsätzen

Weitere Informationen zur Beschichtung sind der Gebrauchsanweisung des jeweiligen Bio-Probe Einwegeinsatzes zu entnehmen.

-34 °C bis 66 °C (-29 °F bis 150 °F)

-34 °C bis 50 °C (-29 °F bis 122 °F)

-34 °C bis 40 °C (-29 °F bis 104 °F)

Gebrauchsanweisung Deutsch 19

Tabelle 1.

Verwendung mit Messumformer Modell TX50 (erwachsene Patienten)

Verwendung mit Messumformer Modell TX50P (pädiatrische Patienten)

Unbeschichteter Einsatz DP38 DP38P Einsatz mit bioaktiver Cortiva™ Ober-

CB2980POLY CB4627

fläche Mit Trillium™ Biosurface beschichteter

Einsatz Mit Balance™ Biosurface beschichteter

Einsatz

Die Verwendung dieser Technologie unterliegt einer Lizenzvereinbarung mit BioInteractions, Limited, Großbritannien.

DP38T DP38PT

BBDP38 BBDP38P

1.9. Unerwünschte Nebenwirkungen

Die folgenden unerwünschten Nebenwirkungen können im Zusammenhang mit der Verwendung des Bio-Probe Blutflussüberwachungssystems auftreten: Blutverlust, Koagulopathie, übermäßige Aktivierung der Blutkomponenten/Thrombogenität, hämolytische Anämie, Hypotonie, Infektion, Ischämie, neurologische Fehlfunktionen und Organfunktionsstörungen.

1.10. Warnhinweise und Vorsichtsmaßnahmen

Lesen Sie sich vor Gebrauch alle Warnhinweise, Vorsichtsmaßnahmen und Anweisungen aufmerksam durch.

Werden nicht alle Anweisungen und Warnhinweise gelesen und befolgt, kann dies zu ernsthaften Verletzungen oder zum Tod des Patienten führen.

1.10.1. Warnhinweise

■

Bevor Sie dieses System verwenden, lesen Sie bitte das Benutzerhandbuch für das entsprechende Modell der extrakorporalen Bio-Console Blutpumpenkonsole durch.

■

Während der Perfusion muss ein Ersatz-Messumformer bereitgehalten werden. Wenn der Messumformer während eines Eingriffs ausgetauscht werden muss, befolgen Sie die Anweisungen im Abschnitt „Verhalten in Notfällen“.

1.10.2. Vorsichtsmaßnahmen

■

Die Einwegeinsätze sind nur auf die Verwendung bei einem einzigen Patienten ausgelegt. Das Produkt darf nicht wiederverwendet, wiederaufbereitet oder resterilisiert werden. Wiederverwendung, Aufbereitung oder Resterilisation können die strukturelle Integrität des Geräts beeinträchtigen und/oder unter Umständen eine Kontamination des Geräts bewirken, die wiederum zu Verletzung, Erkrankung oder zum Tod des Patienten führen kann.

■

Muss der Einsatz für das Anschließen der Schläuche gleitfähig gemacht werden, darf hierfür nur steriles Wasser oder sterile Kochsalzlösung verwendet werden. Keine alkoholhaltigen Flüssigkeiten an den Einwegeinsatz gelangen lassen.

■

Vor dem Öffnen der Verpackung des Einsatzes die Verpackung sorgfältig inspizieren. Verwenden Sie den Einsatz nicht, wenn die Verpackung beschädigt oder geöffnet ist oder der Einsatz beschädigt zu sein scheint. Senden Sie den Einsatz an den für Sie zuständigen Medtronic Repräsentanten zurück.

■

Überprüfen Sie den Messumformer, das Kabel und den Kabelstecker auf mechanische Beschädigungen. Wenn eine Beschädigung festgestellt wird, verwenden Sie einen Ersatz-Messumformer und wenden Sie sich an einen qualifizierten Medtronic Servicetechniker.

■

Die Messumformer nur mit den für sie vorgesehenen kompatiblen Einwegeinsätzen (siehe Tabelle 1) verwenden. Wenn der falsche Einwegeinsatz verwendet wird, kann der Messumformer beschädigt werden.

20 Gebrauchsanweisung Deutsch

+ 50 hidden pages

Medtronic 95185-001 Instructions for Use

Specifications and Main Features

Frequently Asked Questions

User Manual