ROTAFLOW CENTRIFUGAL PUMP Instructions for Use Nov 2014

| ROTAFLOW Centrifugal Pump ﴾RF-32﴿ | 7 |

ROTAFLOW Centrifugal Pump (RF-32) 1

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Description

The ROTAFLOW Centrifugal Pump (RF-32) is a non-occlusive pump. It has a quick rotating rotor with flow channels which accelerate the incoming blood. The resulting pressure causes the blood to be pumped through a spiral housing to the outlet. The RF-32 may only be used in combination with the following active medical products: n

ROTAFLOW Drive with the ROTAFLOW Console or the ROTAFLOW Emergency Drive or

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Magnet adapter MA-32 in conjunction with the Bio-Console® 550 if this complies with the Medical Device Directive 93/42/EEC.

Observe the corresponding Instructions for Use for the active medical products.

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Blood inlet Flow direction indicator Measuring cell Blood outlet Rotor Fixing ring

The device may only be operated by qualified medical staff experienced in extracorporeal circulation. The device is intended to be used in a clinical environment. Within the specified flow rate, the device can be used for all patients irrespective of age, body weight and gender. Observe the corresponding Instructions for Use for coated products. n

BIOLINE Coating, G-034 or

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SOFTLINE Coating, G-114

The maximum duration of use is 4 days.

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Intended Use

The ROTAFLOW Centrifugal Pump (RF-32) is intended to maintain the blood flow during extracorporeal circulation.

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Indication

Within the specified flow rate the devcie can be used as pump during cardiopulmonary bypass procedures or for extracorporeal circulatory support. Instructions for Use | 2.0 | G-018 | 05

| 8 | ROTAFLOW Centrifugal Pump ﴾RF-32﴿ |

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Contraindications

No contraindications are known if the device is used for the intended use and in accordance with the stated operating conditions. The ROTAFLOW Centrifugal Pump (RF-32) with BIOLINE Coating (heparin-albumin- coating) must not be used in the treatment of: n

Patients with known hypersensitivity to heparin (heparin allergy);

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Patients currently suffering from, or with a history of, type II heparin-induced thrombocytopenia (HIT).

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Warnings and Precautions

5.1 n

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Basic Safety Instructions Failure to comply with the intended use can result in serious injuries or death. –

Only use the product in accordance with these Instructions for Use.

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Read the Instructions for Use completely before using the product.

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Observe all information on the product.

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Also follow the Instructions for Use for additional components used.

A lack of knowledge on use of the product can result in serious injuries to or death of the patient. –

The product may only be operated and monitored by qualified medical staff.

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The product may only be operated by staff specially trained in the field of extracorporeal circulation.

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The physician in charge of treatment is responsible for the procedure and correct use of the product.

The use of non-sterile or defective products can result in infection of the patient, user and third parties. –

Only use the product if it is sterile.

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Do not use the product if it or the sterile packaging is damaged.

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Observe the use-by date on the packaging.

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Always observe strict asepsis when handling the product.

Resterilization can damage the product. This can lead to inadequate patient support and infection of the patient, user and third parties. –

Do not resterilize the product.

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Do not use resterilized products.

The materials used can trigger allergic reactions. –

Explain the possible consequences to patients before use.

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| ROTAFLOW Centrifugal Pump ﴾RF-32﴿ | 9 |

5.2

Safety Instructions for the Extracorporeal Circulation

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Implementing an extracorporeal circulation can cause the associated side effects in the patient, such as infections, hemolysis, embolisms, post-perfusion syndrome and organ damage.

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Undetected bubbles or too low a liquid level in the reservoir can cause air embolisms in the patient.

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Monitor the patient regularly for possible side effects.

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Use level sensors and bubble detectors.

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Activate level detection and bubble detection on the console.

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If the level or bubble detection should not function correctly, monitor the extracorporeal circulation visually.

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Use the ultrasonic contact cream for the flow/bubble sensor as specified in the accessories for the ROTAFLOW Console.

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Apply the ultrasonic contact cream all around the measuring cell in order to ensure the measuring function for flow and bubble detection.

No anticoagulation or insufficient anticoagulation causes occlusion of the extracorporeal circulation and the patient circuit. This can lead to inadequate patient support, hemolysis or thrombus formation in the patient. –

Weigh the benefits of extracorporeal circulation against the risk of systemic anticoagulation.

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Use anticoagulants; e.g. heparin or argatroban.

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Check the effect of anticoagulants at regular intervals by measuring the ACT (activated clotting time). The ACT should not fall below 450 s.

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Particles may enter the tube circuit due to ambient conditions and shear forces during assembly. This can lead to infections and inadequate patient support.

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The detachment of unsecured tube connections can lead to blood loss and air embolisms in the patient.

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Use an arterial filter.

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Check that tube connections are correctly and securely fastened.

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Secure all tube connections in the tube system with hose ties.

Instable and incorrectly connected components can lead to blood loss and air embolisms in the patient. –

Use the correct tube sizes for the components.

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Check that all the components and devices attached are securely connected.

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Fix all the products used securely.

Mechanical forces may act on the components during the application. This can lead to blood loss, embolisms and inadequate patient support. –

Secure all connections.

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Avoid excessive tension and check the integrity and leak-tightness of the components immediately.

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Avoid intra-hospital transportation Instructions for Use | 2.0 | G-018 | 05

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| 10 | ROTAFLOW Centrifugal Pump ﴾RF-32﴿ |

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Ensure that the tubes are not kinked.

Signs of coagulation, damage or leaks on the product may occur during use. This can lead to blood loss, embolisms and inadequate patient support. –

Subject the product used and the tubing system to visual inspections on an ongoing basis.

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Inspect the product and the tubing system with a lamp.

5.3

Safety Instructions for Centrifugal Pump

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Centrifugal pumps are non-occlusive blood pumps; arterial backflow can occur if the pump stops. This leads to hemodynamic instability in the patient.

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The centrifugal pump can create a high negative pressure on the venous side. This can lead to gas bubbles forming and increased hemolysis in the patient.

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Clamp off the arterial side in the event of a pump stop.

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Avoid high speed coupled with minimal flow.

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Monitor the negative pressure on the venous side.

Air bubbles in the centrifugal pump reduce the hemodynamic performance of the centrifugal pump. Larger air bubbles can be transformed into stable microbubbles. These can lead to air embolisms in the patient. –

Prevent air from entering the centrifugal pump.

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Stop the pump and remove the air that has entered the centrifugal pump.

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Operating the centrifugal pump without liquid damages the rotor bearing. The product is not fully functional, which may lead to reduced pump performance and thus endanger the patient.

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Leaks or scratching noises in the ROTAFLOW Centrifugal Pump can be a sign that it is malfunctioning. Malfunctioning can lead to inadequate patient support.

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Start the centrifugal pump only when it has been primed.

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Always keep a replacement centrifugal pump at the ready.

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Listen for scratching noises when priming the system.

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Replace the centrifugal pump if you hear scratching noises.

Contact with solvents such as alcohol, ether, acetone, and liquid inhalation anesthetics (e.g. isoflurane, Ethrane, enflurane) can damage the device. Its functionality is no longer guaranteed and the manufacturer will not accept liability under any circumstances. –

Do not allow solvents to come into contact with the interior or exterior of the device.

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The centrifugal pump should not be used as a suction pump.

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Do not use this product in the vicinity of MRI devices.

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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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To restart the centrifugal 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 centrifugal pump is operating at high speed otherwise the centrifugal pump may magnetically decouple.

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Product Information

6.1

Technical Data

Product version Blood flow Centrifugal pump speed Priming volume Blood inlet/blood outlet Maximum pressure Materials Pump housing, rotor, connector Step bearing Bearing ball Magnet 3/8" caps Packaging: n Sterile pouch n Insert n Multi­unit box

6.2

RF­32 0 … 10 l/min 0 ­ 5000 rpm Approx. 32 ml 3/8" (9.53 mm) 750 mmHg (⇨ "Performance Data", page 181)

Polycarbonate (PC) Polyethylene (PE/TPE) Sapphire Neodymium­iron­boron HDPE Polyethylene, Tyvek Styrofoam Cardboard, corrugated cardboard

Packaging and Storage

The device is delivered sterile and non-pyrogenic. Sterility remains assured as long as the packaging is not opened or damaged and the use-by date has not expired. The device must be stored in a cool, dark and dry place until used. Prescribed storage temperature: +10°C ... +30°C (+50°F ... +86°F)

Instructions for Use | 2.0 | G-018 | 05

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| 12 | ROTAFLOW Centrifugal Pump ﴾RF-32﴿ |

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Application

7.1

Preparation and Installation WARNING! Damage to the product or packaging. A non-sterile or defective product can result in patient infections. ▪

Perform a careful visual inspection of the sterile packaging before use. Pay particular attention to moisture, openings and soiling.

▪

Perform a careful visual inspection of the product before use. In particular, ensure there is no damage to the material, cracks, burrs or fissures.

1

Open the sterile packaging and connect the inlet tube to the blood inlet.

2

Connect the outlet tube to the blood outlet.

3

Secure the tube connections with hose ties.

7.1.1 Notes for Use on the Bio-Console® 550 Notes on use were prepared taking the ROTAFLOW Drive and the ROTAFLOW Emergency Drive into account. Observe the Bio-Console® 550 Instructions for Use to ensure safe application and for information on how to proceed in the event of an emergency. Measurement system when using the Bio-Console® 550 (Medtronic): The following is required to use the Bio-Console® 550 measurement system: n

FLOWPROBE FP-32 E or a suitable flow probe from Medtronic

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TX 50 transducer from Medtronic 1 2 3 4 5 6 7 8

Outlet Adapter Centrifugal pump Inlet Transducer FLOWPROBE disposable insert Metal lever Console

Fig. 1

1

Position the adapter on the console as shown in Fig. 1.

2

After pressing the metal lever, insert the centrifugal pump in the adapter and ensure that is fixed precisely.

3

Lock the metal lever into place. CAUTION! Read the FLOWPROBE Instructions for Use and the Instructions for Use for the products used carefully.

Instructions for Use | 2.0 | G-018 | 05

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7.2

Priming the System

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WARNING! Leaks and damage on the product. Can lead to infections, blood loss and embolisms in the patient. ▪

Check the product for leaks during priming.

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Do not use the product if there are any leaks.

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Do not use the product if the surface of the measuring cell is damaged.

1 2 3 4 5 6

Blood outlet Measuring cell Locking device Blood inlet Locating lug ROTAFLOW Drive

1

Prime the centrifugal pump by means of gravity via the tubing system.

2

Apply ultrasonic contact cream to both sides of the measuring cell. Both sides must be completely covered with the ultrasonic contact cream.

3

Insert the centrifugal pump into the ROTAFLOW Drive.

4

NOTICE! Ensure that the fixing ring is positioned below the locating lug of the drive. The locking device can still be closed even if the centrifugal pump is inserted incorrectly, however the pump then produces abnormal noises. Close the locking device.

5

Start the console with a flow of 3-4 l/min to recirculate.

6

WARNING! Do not use hard objects, as they may damage the components. This can lead to embolisms and infections. Tap the tubing system and the centrifugal pump with your hand to remove any gas bubbles still present in the system.

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With the pump stopped, clamp the tube at the centrifugal pump outlet.

8

Calibrate the flow measurement to zero (⇨ ROTAFLOW System Instructions for Use).

Instructions for Use | 2.0 | G-018 | 05

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7.3

Starting Perfusion WARNING! Tube system which has not been completely de-aired. Risk of embolisms in the patient. ▪

Make sure that the tube system has been completely de-aired before starting perfusion.

1

WARNING! The ROTAFLOW System used must be fully functional to ensure patient safety. Before connection to the patient, perform the specified function tests and checklists for the ROTAFLOW Console used.

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Connect the patient.

3

Start extracorporeal circulation as per the clinical requirements.

4

Set the alarm limits and the operating mode on the ROTAFLOW Console in accordance with clinical requirements.

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Emergency Procedures

8.1

Replacing the Centrifugal Pump WARNING! Signs of coagulation in the components used. Inadequate patient support. ▪

Always adhere to strict aseptic procedures when replacing the product.

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Maintain perfusion until the replacement component or the replacement tubing set is ready for use.

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Always have a replacement tubing set or replacements for the components used readily available.

1

Prime the replacement centrifugal pump or the entire tubing system.

2

Once the replacement centrifugal pump or the replacement tubing system is ready for use, stop extracorporeal circulation.

3

If you replace the centrifugal pump, clamp the arterial and venous tubes, using one clamp for each. Put 2 clamps on both the blood inlet and blood outlet tube of the RF-32.

4

If you wish to replace the entire tubing system, put 2 clamps on each of the arterial and venous tubes close to the patient about 10 cm apart.

5

Remove the faulty centrifugal pump or the entire tubing system.

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Connect the replacement centrifugal pump or the replacement tubing system.

7

Ensure that there is no air in the tubing system and start extracorporeal circulation.

8

Secure the tube connections with hose ties.

Instructions for Use | 2.0 | G-018 | 05

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8.2

Using ROTAFLOW Emergency Drive

If the power supply fails or the drive is faulty, the centrifugal pump must be operated manually using an emergency drive. When using the Bio-Console, use the emergency drive available. Follow the instructions in the respective Instructions for Use. 1

Close the arterial and the venous tube clamps.

2

Take the centrifugal pump out of the ROTAFLOW Drive.

3

Insert the Centrifugal Pump into the ROTAFLOW Emergency Drive.

4

Unfold the handle of the hand crank.

5

Turn the hand crank clockwise. Ensure that you can see the LED speed indicator at all times. ▶

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9

The LED speed indicator shows the speed.

When the speed is sufficiently high, open both tube clamps.

Disposal and Service

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Dispose of the product according to the applicable regulations for contaminated products and the packaging as per the national regulations.

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If you have any questions or problems, or if you experience any malfunctions, please consult your local MAQUET representative or contact MAQUET Cardiopulmonary AG directly.

Instructions for Use | 2.0 | G-018 | 05

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| ROTAFLOW Centrifugal Pump ﴾RF-32﴿ | 181 |

Performance Data

Pressure [mmHg]

ROTAFLOW RF-32

Blood flow [l/min]

Instructions for Use | 2.0 | G-018 | 05

® MAQUET Registered Trademark · Order No. 70000.4243 · G-018 · Version 05 · NONUS · 2014-11

Please visit our website www.maquet.com

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