ROTAFLOW SYSTEM WITH ICU KIT Ver 1.0 User Manual

Copyright All rights reserved. No part of this publication may be duplicated, adapted or translated without prior written permission, except within the framework of the copyright laws. © Copyright MAQUET Cardiopulmonary AG Subject to technical changes Owing to our policy of continuous product development, the illustrations and technical data contained in this User’s Manual may differ slightly from the current version of the device. Manufacturer MAQUET Cardiopulmonary AG Hechinger Strasse 38 72145 Hirrlingen, Germany Telephone:+49 (0) 7478 921-0 Fax: +49 (0) 7478 921-100 [email protected] www.maquet.com

ROTAFLOW with ICU Kit | User’s Manual | English | 1.0 Copyright MAQUET Cardiopulmonary AG, Hirrlingen

| ROTAFLOW with ICU Kit | Table of Contents | 3 |

TABLE OF CONTENTS PART 1 GENERAL

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5 7 9 14

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15 16 21 21

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23 23 23 25 25 26 27 29 30

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31 31 33 34 35 36 36 38

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39

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39 39 41 43 44

PART 6 CLEANING AND DISINFECTION AFTER EACH USE

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45

PART 7 MAINTENANCE AND SERVICE

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46 46 46

1.1 Safety 1.2 Precautions 1.3 Abbreviations

PART 2 SYSTEM COMPONENTS 2.1 ROTAFLOW Console with ICU Kit 2.2 ROTAFLOW Drive 2.3 ROTAFLOW Emergency Drive

PART 3 CONNECTION AND INSTALLATION 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8

Operation as a stand-alone device: Connect ROTAFLOW Console Operation on a heart-lung machine: Install ROTAFLOW Console Install ROTAFLOW Drive Install ROTAFLOW Emergency Drive Operation as a stand-alone device: Install level sensor Connect tubes Switch on ROTAFLOW Console, Self-test Removal

PART 4 OPERATION 4.1 4.2 4.3 4.4 4.5 4.6 4.7

Modes Selecting settings Priming and Zero Calibration Checks before usage Flow regulation “STAND AL” mode: Interventions Modes “ART” and “ART PULS”: Interventions

PART 5 SAFETY 5.1 Modes “ART” and “ART PULS”: Communication error with heart-lung machine 5.2 Battery operation 5.3 Replacing ultrasonic contact cream 5.4 Disconnection from a heart-lung machine during operation 5.5 Using Emergency Drive

7.1 Maintenance 7.2 Service

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PART 8 ACCESSORIES

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47

PART 9 MESSAGES

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49 49 49

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53 53 54 55 55

9.1 Messages during self-test 9.2 Error messages

PART 10 TECHNICAL DATA 10.1 General 10.2 ROTAFLOW Console 10.3 ROTAFLOW Drive 10.4 ROTAFLOW Emergency Drive

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1

GENERAL The MAQUET ROTAFLOW system is a centrifugal pump, which is designed for use in an extracorporeal perfusion circuit to pump blood during cardiopulmonary bypass interventions and for permanent extracorporeal pulmonary or cardiovascular support. The ROTAFLOW System can be used for stand-alone operation, on a MAQUET heart-lung machine console, as part of the ELS System or part of the PLS System. This User’s Manual describes the ROTAFLOW Console with ICU Kit. Please also take note of the documents supplied for the other components of the system. User’s Manual applies to ROTAFLOW Console with ICU Kit This User’s Manual always refers to the ROTAFLOW Console with ICU Kit, even if the suffix “with ICU Kit” is not explicitly mentioned. The ROTAFLOW Console with ICU Kit is identified at the rear with a label stating “Upgrade ICU” (Ö 2.1.5 “ICU Kit”, page 20). „ See below for features of the ROTAFLOW System The flow can be kept constant independently of the pressure. Air bubbles in the circuit can be detected to prevent any ingress in the patient. It is possible to detect and regulate the fluid level (blood) in a reservoir if it is too low. Under normal conditions and with fully charged, new batteries, the system can be operated for at least 1.5 hours with the battery back-up. „ Other features with operation on a MAQUET heart-lung machine The system provides for a more physiological, optimized, pulsatile pumping action, which is internally triggered and controlled by the patient’s own ECG. The pressure level can be monitored and regulated. Most of the functions required during surgery can be managed using the system control panel of the heart-lung machine. Useful signals and data are displayed. A complete perfusion report can be recorded for subsequent analysis and printout using JOCAP XL online. „ Use in ELS System The ROTAFLOW Console with ICU Kit can be used as a component of the ELS System. The ELS System is used for extended respiratory and/or circulatory

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support. It is approved for transportation in air and ground vehicles (mobile intensive care units and ambulances). The ELS System is made up of the following components: – ELS Set (disposable products) – Holder for ELS System (Mobile ELS Holder, Mobile RFC Holder, ELS Wall Holder (optional), ELS Base Plate (optional)) – ROTAFLOW Console with ICU Kit – ROTAFLOW Drive During transport the ROTAFLOW Console is mounted on the Mobile RFC Holder. The ROTAFLOW Drive is installed on the Mobile ELS Holder. „ Use in PLS System The ROTAFLOW Console with ICU Kit can be used as a component of the PLS System. The PLS System is used for extended respiratory and/or circulatory support. The PLS System is made up of the following components: – PLS Set (disposable products) – Holder for PLS System (Mobile HLM Holder, Holder for PLS System (rotating), Holder for PLS System (fixed)) – ROTAFLOW Console with ICU Kit – ROTAFLOW Drive

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1.1

SAFETY

1.1.1

SYMBOLS ON ROTAFLOW CONSOLE Important: Refer to the accompanying documents.

Refer to the User’s Manual.

IEC 60601-1 classification: Type B applied part

Alternating current

Protection class in accordance with IEC 60529: Protection against ingress of dust and splashing water Date of manufacture: Year in which the device was made

Separate collection of electric and electronic devices in accordance with Directive 2002/96/EC: Do not dispose of the device with normal domestic waste. Keep separate from domestic waste and dispose of in an environmentally safe way in compliance with local regulations. The device meets the requirements of Council Directive 93/42/EEC concerning medical devices. Equipotential bonding

1.1.2

SYMBOLS OF CONTROLS AND DISPLAY ELEMENTS Intervention LED “Level Monitoring”

Intervention LED “Bubble Monitoring”

Intervention LED “Pressure Monitoring”

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Select button

Set button

“Audio off” button

“Level override” button

“Bubble override” button

“Zero adjustment” button

“Clamp” button

Rotary pressure knob

“External power” lamp

“Battery operation” lamp

“Battery charging” lamp

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1.1.3

SYMBOLS ON ROTAFLOW DRIVE Do not turn upside down.

1.1.4

SPECIAL INSTRUCTIONS These special instructions are used in the User’s Manual. Please bear them in mind. WARNING! Risk of serious personal injury! This is an instruction or procedure which must be observed to avoid injury to the user, patient or other persons. ATTENTION! Risk of damage to equipment! This is an instruction or procedure which must be observed to avoid the device being damaged. Note Important or explanatory information.

1.2

PRECAUTIONS Note Please read the User’s Manual carefully before using the device! WARNING! „ Use the system and accessories in accordance with the User’s Manual and tried and tested medical practice. It is the responsibility of qualified staff to ensure that the system is used, tested and maintained in accordance with all updates of the product specification and User’s Manual. „ Do not connect equipment which does not form part of this system. „ During an operation, only use devices and equipment which are functioning perfectly. „ Adjust the extracorporeal circulation properly and check it before starting operation. „ The system may be operated only by qualified staff. „ The system should only be used under supervision. The system must be continuously monitored by qualified staff to ensure patient safety. Clinical procedures and methods are the responsibility of the physician.

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WARNING! „ Do not use the system near escaping flammable or combustible gases. „ During longer procedures, it is possible that the ultrasonic contact cream might dry out, which can impair the results of the flow meter. For this reason, the ultrasonic contact cream must be renewed every 48 hours or as soon as the error message [SIG!] appears. „ Do not use the ROTAFLOW System in suction mode. „ The ROTAFLOW System should only be used with a valve or other adequate systems or methods (e.g., two tube clamps) preventing a reverse flow. „ If the pump stops during an operation, the blood flow will be interrupted and supply to the patient will cease. Please ensure that the cause of the interruption to the pump is remedied as quickly as possible and that the pump is started up again promptly. „ Make sure that there is no contact between high-frequency measuring equipment and the measuring system or tubes, as this may cause the flow indicator to malfunction. „ Do not touch the patient and the external interfaces of the device at the same time. „ Do not touch the plugs of the ROTAFLOW Console as electrostatic charging and moisture may cause damage. „ Bear in mind that the ROTAFLOW Console weighs approx. 15 kg. ATTENTION! „ Switch off the mains power switch at the rear of the ROTAFLOW Console before maintenance or cleaning. „ Ask MAQUET about the most environmentally friendly method of disposing of parts. 1.2.1

CLAMPING THE TUBE WARNING! „ First of all disable the flow regulation (Ö 4.5 “Flow regulation”, page 36). „ Clamp the tube to prevent a reverse flow. „ Immediately turn the flow regulator to zero to prevent hemolysis. „ When opening the tube clamp, simultaneously increase the speed. Do not open the tube clamp at a high speed to prevent magnetic uncoupling.

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1.2.2

MAGNETIC UNCOUPLING WARNING! Magnetic uncoupling can be identified by a decrease in the flow rate and a humming sound. If magnetic uncoupling occurs, proceed as follows: „ Disable the flow regulation immediately (Ö 4.5 “Flow regulation”, page 36). „ Clamp the tube to prevent a reverse flow. „ Turn the speed to zero. „ Once the ROTAFLOW Centrifugal Pump stops, increase the speed and open the tube clamp simultaneously. If magnetic uncoupling occurs again, use the ROTAFLOW Emergency Drive. If it continues to occur, install a new ROTAFLOW Centrifugal Pump.

1.2.3

EXTERNAL DEVICES WARNING! „ If you are using the ROTAFLOW System with other medical devices, check the total leakage currents. „ Check that all devices comply with IEC 60601-1. „ Check that all devices connected to the digital interface of the ROTAFLOW System satisfy the IEC specifications (IEC 60950 for data processing equipment located more than 1.5 meters from the operating table and IEC 60601 for data processing equipment within 1.5 meters of other medical devices).

1.2.4

MEMBRANE OXYGENATOR Variations in pressure in a microporous membrane oxygenator (following an abrupt fall in the arterial flow) may cause gas microemboli if the blood pressure falls below the gas pressure. WARNING! „ Monitor the pressure in the arterial tube system. „ Adjust the pump so that the pressure in the blood flow through the oxygenator is always higher than the gas pressure.

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1.2.5

LEVEL AND BUBBLE MONITORING WARNING! Mortal danger to patients from gas emboli „ Install the bubble and level monitoring system according to the instructions. „ Always test the function of the bubble and level monitoring system using fluid together with the oxygenator and reservoir before each use. „ A bubble stop malfunction may occur with initially imperfect mixing of blood and priming liquid due to a difference in the acoustic properties of the fluids. „ The arterial filter is no substitute for the function of the bubble and level monitoring system. Use more than one system. The responsibility for taking precautions still lies with the user. „ If you use the ROTAFLOW System without a bubble or level monitoring system, ensure patient safety with other adequate systems or methods.

1.2.6

BEFORE AND DURING TRANSPORT APPLICATION WARNING! Risk from accidental changes in flow For flow regulators without a rotary pressure function there is the risk of the knob being turned accidentally, which changes the flow. It is therefore only permitted to use the ROTAFLOW Console with ICU Kit for transport applications. WARNING! Danger if warning signals are not heard In noisy environments, there is the risk that acoustic warning signals emitted by the ROTAFLOW Console may not be heard. You should therefore position the ROTAFLOW Console so that you can see the displays and any optical warning signals at all times. ATTENTION! „ Comply with national transportation regulations. „ Also follow the instructions supplied with other components of the ELS System. „ The person responsible for configuring the system as a whole must ensure that the complete system is permissible. „ Only use the ELS System in ground and air vehicles which have their own oxygen supply and own power supply which is suitable for the ROTAFLOW Console.

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WARNING! Risk of decannulation and mechanical damage When changing the mode of transport, repositioning the patient or moving the patient outside the mode of transport, there is a risk of decannulation and mechanical damage caused by strain on the tubes or impacts. The greatest care should thus be exercised when carrying out these measures. „ Take care in confined spaces, such as doorways and elevators. „ Do not allow tubes or cables to hang down. „ Ensure that there is no strain on tubes or cables. „ Avoid mechanical impacts and knocks. „ Avoid kinking tubes or cables. „ Do not drop any of the components. WARNING! Risk of power failure An inadequate power supply may put the ROTAFLOW Console out of service. Please therefore note: „ Always start work with the battery of the ROTAFLOW Console fully charged. „ Use the power supply of the vehicle or hospital whenever possible so as to conserve the battery. „ Take the ROTAFLOW Emergency Drive with you when transporting the patient. Keep it at the ready for stop-gap operation in the event of pump failure. ATTENTION! „ All components must be installed so that they can be monitored and operated by the user during transportation. There must also be sufficient space to use the ROTAFLOW Emergency Drive. „ Take at least two tube clamps with you when transporting the patient. Keep them at the ready for clamping tubes in the event of leakage. „ All components must be attached to the holders provided for this purpose and properly secured (ROTAFLOW Console on Mobile RFC Holder, ROTAFLOW Drive on Mobile ELS Holder). „ For transportation in aircraft, the Mobile ELS Holder and Mobile RFC Holder must be attached to the floor rails or to the ELS Base Plate and securely fastened. If the ELS Base Plate is used, it must be attached to the aircraft floor rails and securely fastened. „ For transportation in ground vehicles, the Mobile ELS Holder and Mobile RFC Holder must be attached to the ELS Wall Holder and securely fastened. „ During transportation, ensure that the correct ambient conditions are maintained for all components.

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ATTENTION! „ Protect components from moisture. WARNING! When installing and using the ELS Set, follow the instructions supplied. Recommendation: Use speed regulation in aircraft. Extreme electromagnetic radiation may occur during transportation in aircraft – possibly impairing flow regulation. It is therefore recommended to use speed regulation during transportation in aircraft and not flow regulation. 1.2.7

USE OF PORTABLE MULTIPLE SOCKET OUTLETS WARNING! „ Only use the portable multiple socket outlets supplied with the system to supply power to equipment forming part of the system. „ Follow the instructions supplied with the multiple socket outlet. „ Do not put portable multiple socket outlets down on the ground. Make sure that people cannot trip over portable multiple socket outlets or cables. „ Do not connect additional portable multiple socket outlets or extension cords to the system. „ Comply with the maximum load given for the portable multiple socket outlet (Ö Instructions supplied with multiple socket outlet).

1.3

ABBREVIATIONS HLIM

Upper speed limit (“High limit”)

LLIM

Lower speed limit (“Low limit”)

FLIM

Lower flow limit (“Flow limit”)

HLM

Heart-lung machine

rpm

Revolutions per minute

LPM l/min

Liters per minute

ART ART PULS STAND AL FREE

Ö 4.1 “Modes”, page 31

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2

SYSTEM COMPONENTS

ROTAFLOW Console with ICU Kit

ROTAFLOW Drive

ROTAFLOW Emergency Drive

ROTAFLOW Centrifugal Pump

Capacitive level sensor with level sensor pad

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2.1

ROTAFLOW CONSOLE WITH ICU KIT

2.1.1

FRONT

[1]

On/off switch with cover

Ö 3.7 “Switch on ROTAFLOW Console, Self-test”, page 29

[2]

“External power” lamp (green)

The “External power” lamp lights up when the ROTAFLOW Console is connected to an external power supply.

[3]

“Battery operation” lamp (orange) The “Battery operation” lamp lights up when the internal battery is in use (Ö 5.2 “Battery operation”, page 39)

[4]

“Battery charging” lamp (orange) The “Battery charging” lamp lights up when the battery is being charged. It extinguishes once the battery is fully charged.

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2.1.2

FRONT PANEL

[1]

Intervention LEDs (only in modes “ART” and “ART PULS”)

The intervention LEDs indicate the interventions selected (Ö 4.7 “Modes “ART” and “ART PULS”: Interventions”, page 38). „ The intervention LED flashes whenever monitoring is switched off during operation or when a fault occurs.

[2]

Speed display

This display shows the speed in rpm (revs per minute).

[3]

Flow display

This display shows the flow in l/min (liters per minute).

[4]

Flow regulator

You can use the flow regulator (rotary pressure knob) to adjust the speed or flow (with flow regulation connected). To do so, press on the knob, turn and then release.

[5]

Speed scale

The scale is provided as a guide should the speed display fail.

[6]

Select button

The select button is used to select the required setting or value (Ö 4.2 “Selecting settings”, page 33)

[7]

Status display

This display shows messages about the status of the ROTAFLOW System (Ö 9 “Messages”, page 49)

[8]

Set button

The set button is used to confirm the setting or value selected (Ö 4.2 “Selecting settings”, page 33).

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[9]

“Audio off” button

The “Audio off” button is used to switch off the acoustic alarm temporarily. „ The button flashes when the acoustic alarm is switched off. „ The acoustic alarm is automatically switched back on if a new alarm condition occurs.

[10]

“Level override” button (only in “STAND AL” mode)

The “Level override” button is used to switch level monitoring off and on in “STAND AL” mode (Ö 4.6.2 ““STAND AL” mode: Level monitoring”, page 37). „ To switch level monitoring off, press the button for at least 3 seconds. „ The button flashes when level monitoring is switched off.

[11]

“Bubble override” button (only in “STAND AL” mode)

The “Bubble override” button can be used to reset the bubble sensor after a bubble intervention and switch bubble monitoring on and off (Ö 4.6.1 ““STAND AL” mode: Bubble monitoring”, page 37). „ To reset the bubble sensor after a bubble intervention, press the button briefly (less than 3 seconds). „ To switch bubble monitoring off, press the button for at least 3 seconds. „ The button flashes when bubble monitoring is switched off.

[12]

“LPM Mode” button

Use the “LPM Mode” button to switch flow regulation Ö 4.5 “Flow regulation”, page 36 on and off. „ The button lights up when flow regulation is switched on.

[13]

“Zero adjustment” button

The “Zero adjustment” button can be used to calibrate flow measurement to zero (Ö 4.3 “Priming and Zero Calibration”, page 34).

[14]

“Clamp” button

You can use the “Clamp” button to confirm that suitable systems or methods are available (e.g., two tube clamps) to prevent a reverse flow (Ö 3.7 “Switch on ROTAFLOW Console, Self-test”, page 29).

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2.1.3

REAR

[1] Battery cover [2] “CLS” socket (for level sensor) [3] “RFD Master” socket (for ROTAFLOW Drive) [4] Not used [5] Mains power switch [6] Power socket [7] Holder for ROTAFLOW Drive [8] Rating plate [9] Not used [10] RS232 port (serial output interface e.g., for JOCAP XL) [11] Grounding connection (equipotential bonding) [12] Cover for RS232 port

2.1.4

UNDERSIDE

For operation on a MAQUET heartlung machine: [1] Plug [2] Protective plug cap [3] Securing mechanism for protective cover [4] Openings for holding pins of heartlung machine console

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2.1.5

ICU KIT The ICU Kit equips the ROTAFLOW Console with the following components: „ Cover for on/off switch „ Rotary pressure knob for flow regulation „ Special mains power switch (rear) „ EMC filter (in housing) The ROTAFLOW Console with ICU Kit is identified at the rear with a label stating “Upgrade ICU” [1].

ROTAFLOW with ICU Kit | User’s Manual | English | 1.0 Copyright MAQUET Cardiopulmonary AG, Hirrlingen