ROTAFLOW CENTRIFUGAL PUMP Instructions for Use G-018-08-01

These instructions for use are intended for all personnel who will handle the ­RotaFlow Centrifugal Pump and should be read and understood before the use of the product.

Please note instructions for use · Gebrauchsanweisung beachten · Respecter le mode d’emploi · Fare riferimento alle istruzioni per l’uso · Consultar las instrucciones de uso · Observar as instruções de uso · Proszę zapoznać się z instrukcją użycia 请注意使用说明书

Not intended for re-use, must not be resterilized! · Nicht zur Wiederverwendung, nicht resterilisieren · Produit á usage unique, ne pas réutiliser, ne pas restériliser · Non riutilizzare, non risterilizzare · No reutilizar, no reesterilizar

Sterilization with ethylene oxide · Sterilisation mit Ethylenoxid · Stérilisation á l’oxyde d’ethlène · Sterilizzazione con assido di etilene · Esterilizacíon con óxido de etileno · Esterilização com óxido de etilene · Sterylizowano tlenkiem etylenu

Expiration date · Verwendbar bis · Date limite d’utilisation · Data di scadenza · Fecha de caducidad · Válido até · Data ważności

不可重复使用，不可重复灭菌！

使用截止日期

采用环氧乙烷灭菌

Date of manufacture · Herstellungsdatum · Date de fabrication · Data di fabbricazione · Data de fabricação · Data de fabricação · Data produkcji 生产日期

LOT

Batch designation · Chargenbezeichnung · Numéro de fabrication · Numero di lotto · Identificación del lote · Designação do lote · Oznaczenie serii

指定批号

REF

Order number · Bestellnumber · Référence · Codice di Ordinazione · Referencia · Número de referência · Numer zamówienia 订货号

Storage Temparature · Lagertemperatur · Stockage recommandée · Stoccaggio consigliata · Almacenamiento recommendada · Armazenamento recomendada · Temperatur przechowywania 存储温度

Nonpyrogenic · Pyrogenfrei · Apyrogène · Apirogeno · Apirógeno ·Pirogênios ·Niepirogenny

无致热原

Note: “US Federal law restricts this device to sale by or on the order of a physician.”



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English... Page ­RotaFlow Centrifugal Pump 1.

Description

The centrifugal pump has a spinning rotor with flow channels which imparts rotary motion to the incoming blood, directing it through a spiral housing to the outflow port.

2. Indications The RF 32 Centrifugal Pump is intended for use in an extracorporeal circulation during a cardiopulmonary bypass within the framework of surgical procedures, or in circulatory support. The RF 32 pumps blood within the flow rate range as described.

3.

Contraindications

Possible side effects include, but are not limited to: mechanical failure, hemolysis and thromboembolic phenomena. These are potential side effects with all extracorporeal blood systems. The centrifugal pump is contraindicated to use as a suction device.

4.

Warnings and Precautions

Potential side effects include, for instance, infections, haemolysis and embolisms. Side effects associated with extractorporeal circulation in general may also occur, e.g. post perfusion syndrome and organ damage. • Observe expiration date! •

Do not use if sterile pouch is inadvertently opened or damaged.

•

Check system for completeness. (refer to picture 1)

• Use aseptic techniques, when attaching the appropriate tubing to the inlet and outlet of the ­RotaFlow centrifugal blood pump. • Avoid contact of anaesthetic fluids (e.g. isoflurane, ethrane etc.) and alcoholic solutions with any surface of the centrifugal pump. Such contact could cause damage to the product. The operational safety is not guaranteed anymore and the manufacture´s liability is out of the question. •  Insure that the pump and circuit has been debubbled and primed properly prior to beginning support. • Attach tubing in such a manner as to prevent kinks or any restrictions that may alter flow. • Make sure the complete system is watertight. •

Do not hit or strike the ­RotaFlow centrifugal blood pump with hard materials.

•

To prevent a backflow (drainage) of patient blood, the pump must operate at a minimum speed or the tube must be clamped. The minimum speed is that at which the patient and line pressure are overcome.



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Please note the following when clamping the tube: •

First, deactivate the flow regulation (refer to Section 4.3, Flow Regulation, ­RotaFlow System Operating Instructions).

•

Reduce the pump speed to the minimum speed before clamping the tube, then turn the flow regulator to zero to prevent hemolysis.

• When the pump is stopped, both the venous and arterial lines should be clamped. Inspect the arterial line for air bubbles that may arise as the result of retrograde flow. Remove any air bubbles detected. To restart the pump, again set it for the minimum speed so that both the patient and line pressure are overcome. Then remove the tube clamps. Never remove the clamps when the pump is operating at high speed otherwise the pump may magnetically de-couple. • While running the arterial line has to be monitored because the centrifugal pump, like all other centrifugal pumps, is able to pump air. The perfusion has to be stopped if air is detected. Gas embolism may cause severe health injuries. • It is intended that systemic anticoagulation is utilised while this device is in use. Anticoagulation levels should be determined by the physician based on risks and benefits to the patient. If the outlet tubing is clamped the pump should not run for a long time to prevent the blood from being damaged. •

Frequent patient and device monitoring is recommended.

• Apply ultrasonic grease at both sides of the pump outlet to ensure ideal functioning of the flow measuring system and the bubble detector. • If there are abnormal noises or blood is leaking the pump has to be changed. •

The adapter has to be cleaned and disinfected with a alcoholic moistened cloth, periodically.

5. Packaging and Storage The product is provided sterile and non-pyrogenic, each product packed in an aseptic pouch. Sterility is maintained as long as the package remains unopened and undamaged. Please observe the expiration date on the respective package. The product should be stored in its cardboard box in a cool, dry and dark place as heat and sunlight may cause package degradation over time. Recommended storage temperature: Max. +10 °C – +30 °C (+50 °F – +86 °F).

6. Specifications Centrifugal pump: Model Number:

RF-32

Priming Volume (approx.ml): 32 Inlet/Outlet I.D. (mm) (inches):

9.5 (3/8)

Max. rated pressure (mmHg):

750 (refer to Flow - Pressure Diagram)

Flow rates (l/min):

0 – 10



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The centrifugal pump consists out of the following materials: housing:

polycarbonate

rotor:

polycarbonate

connector:

polycarbonate

callote:

polyethylene

ball:

Sapphire

magnet:

neodymium

in.- and outlet caps 3/8"

HDPE

Adapter for the centrifugal pump RF-32 Model Number: MA-32 for BIO-Console from manufacture Medtronic.

7.

Duration of application

The ­R otaFlow Centrifugal Pump must be replaced after 4 days at the latest. Assess patient condition before replacing pump. The use of Bioline Coating on the ­R otaFlow Centrifugal Pump makes it possible to extend application to a period of 14 days if operated on a ­RotaFlow Console RFC 20-970 with the RFD 20-973 Drive Unit. Important: Check the ­R otaFlow Centrifugal Pump frequently for changes such as signs of coagulation, cracks and leaks. Perform a continuous visual inspection by illuminating the ­RotaFlow with a lamp. “If in doubt, replace the centrifugal pump.”

8. Installation When using the ­RotaFlow Centrifugal Pump in the PLS Permanent Life Support System, it must not be driven by the Biomedicus Console (Medtronic) using the Adapter MA-32. To run the RF 32 in the PLS System, always use only the ­RotaFlow Console RFC 20-970 with the corresponding RFD 20-973 Drive Unit. The ­R otaFlow centrifugal pump is for use exclusively with the following systems. Centrifugal pump: • ­

RotaFlow RF-32

Centrifugal pump consoles: • ­

RotaFlow console RFC 20-970

•

Bio-Console (Medtronic) in combination with adapter MA-32 and the RF-32

As an alternative, the centrifugal pump console “Bio-Console” from Medronic may, assuming it has 93/42 EEC approval, be used in conjunction with the appropriate magnetic adapter (MA-32). Important: The instructions for use provided for the console in use must be read carefully.



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Measuring systems when using Bio-Console (Medtronic): •

Flowprobe FP-32E

•

Transducer TX 50 (Medtronic) PVUMFU USBOTEVDFS 'MPX1SPCF TJOHMF
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 Mount the adapter as shown in picture 1. After pressing the metal latch fix the pump onto the adapter. Make sure the rim of the pump is underneath the metal rim of the adapter. Note: The user information of all products being used should be read carefully! Important: Make sure the outer edge of the ­RotaFlow is inserted below the guide nose of the adapter. The lid of the flow sample can still be closed if it is inserted incorrectly. However, the ­RotaFlow will then emit abnormal noises.

9.

Disposal

Disposable: Single use only. Do not reuse this disposable product as resterilization after use may compromise the biocompatibility and functional integrity of this product. Dispose of this device according to hospital procedure for contaminated materials.



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10. Performance Data ì0ERFORMANCEì$ATA

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11. Warranty and Liability Limitations MAQUET Cardiopulmonary AG warrants that this product conforms to the legal requirements, in particular those set forth in the EU Guidelines for Medical Products, 93/42/EWG. Therefore, in case this product exhibits faults that can be directly attributed to material or processing errors that occurred during its manufacture or packaging (“faults”), and said faults appeared prior to the expiration date (UBD), MAQUET Cardiopulmonary AG will, at its discretion, replace the product



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a) With one of equal construction, or: b) With one exhibiting the identical function. All the following conditions must be met in order to make claims within the context of this warranty: a)

The product must not have been employed after its UBD.

b)

The fault did not initially occur after the UBD.

c) If the product in question is a disposable product or is a product which MAQUET Cardiopulmonary AG designates as being for single use, the fault must be detected at the first use. d)

The fault was immediately reported to MAQUET Cardiopulmonary AG or its representative.

e)

The faulty product was forwarded to MAQUET Cardiopulmonary AG or its representative immediately after the fault was reported.

This warranty in no way limits and applies in conjunction with any and all regulations governing warranties on the part of the seller and the product liability laws. For the remainder, this warranty applies only to the extent defined above. Additional claims arising from this warranty are excluded. This warranty as well as the cited legal claims apply in place of, and to the exclusion of, all other warranties, either verbal or written, or express or implicit on the part of MAQUET Cardiopulmonary AG. None of our representatives or employees are empowered to reach differing agreements. Due to numerous factors such as shipping, storage, and handling on the part of the user, all of which lie outside the control of MAQUET Cardiopulmonary AG, MAQUET Cardiopulmonary AG is not liable, in particular, for damages of any type resulting directly or indirectly from the product or its employment unless said damages can be shown to be the result of a failure on the part of the product. In particular, MAQUET Cardiopulmonary AG assumes no liability for damages resulting from resterilization or reuse of products approved for single use only, or which MAQUET Cardiopulmonary AG designates as being for single use.

All rights reserved © 2007, MAQUET Cardiopulmonary AG

G-018/08/01 Art. No. 04243



® MAQUET is registered trademark of MAQUET GmbH & Co. KG Copyright by MAQUET Cardiopulmonary AG, Hirrlingen · We reserve the right to make technical and construction changes.

Maquet Cardiopulmonary AG Hechinger Straße 38 D-72145 Hirrlingen, Germany Phone: +49 (0) 7478 921-0 Fax: +49 (0) 7478 921-100 [email protected] www.maquet.com

GETINGE GROUP is a leading global provider of equip­ ment and systems that contribute to quality enhan­ cement and cost efficiency within healthcare and life sciences. Equipment, services and technologies are supplied under the brands ARJO for patient hygiene, patient handling and wound care, GETINGE for infection control and prevention within healthcare and life science and MAQUET for Surgical Workplaces, Cardiovascular and Critical Care.