Quest Engineering MPS 3 User manual

Quest Medical, Inc.

Quest Medical - MPS®3 System
©2021 by Quest Medical, Inc. All Rights Reserved. MPS® 3 is a registered trademark of
Quest Medical, Inc. Quest™ is a trademark of Quest Medical, Inc. Printed in U.S.A.
No part of this document may be reproduced, stored, or transmitted in any form or by
any means electronic, mechanical, photocopied, recorded, or otherwise without the prior
written permission of Quest Medical, Inc.
This device is not designed, sold, or intended for use except as indicated. All Operations
Manual instructions must be followed. In no event shall Quest be responsible for
failures, errors, or other liabilities resulting from customer’s noncompliance with the
procedures and precautions outlined herein.
The MPS 3 System and MPS 3 sterile disposables are covered under one or more of
the following U.S. Patents: 7,842,003 and 8,475,138. Also covered by pending U.S. and
International Patents and Patent applications.
Operations Manual
904384 REV M – 04/2023
Manufactured by:
Quest Medical, Inc.
One Allentown Pkwy
Allen, TX 75002-4211
U.S.A.
Phone: [phone] or [phone]
www.questmedical.com
Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a
physician.
Read this Operations Manual prior to operating the MPS 3 System. The
attending clinician is solely responsible for the setup and use of this System.
Only genuine Quest Medical Disposable components, including MPS 3 Delivery
Sets and optional accessories, can be used with the MPS 3 System to ensure
the intended system performance and reliability.
Accompanying documents shall be consulted before use of equipment or
accessories.

MPS 3 System – Table of Contents
Table of Contents
1. Introduction ..........................................................................................................................................1
1.1. About This Operations Manual ........................................................................................2
1.2. Indication for Use.............................................................................................................2
1.3. Contraindications.............................................................................................................2
1.4. Symbols Used in this Operations Manual........................................................................3
1.5. Terminology / Abbreviations.............................................................................................4
2. System Overview .................................................................................................................................1
2.1. MPS 3 Console................................................................................................................1
2.2. MPS 3 Controller .............................................................................................................5
2.3. MPS 3 Disposables .........................................................................................................8
3. System Specifications and Performance ..........................................................................................1
3.1. Console Specifications ....................................................................................................1
3.2. Controller Specifications..................................................................................................3
3.3. MPS 3 Disposables Specifications ..................................................................................4
3.4. Glossary of Symbols and Labels .....................................................................................5
3.4.1. Console and Controller Symbols and Markings ......................................5
3.4.2. Delivery Set and Optional Accessories Symbols and Markings ..............6
4. Warnings and Cautions .......................................................................................................................1
4.1. General Warnings and Precautions.................................................................................1
4.2. Installation and Setup Cautions.......................................................................................4
4.3. System Warnings and Cautions ......................................................................................6
4.4. Disposable Circuit Priming and Delivery Cautions ..........................................................8
4.4.1. Priming ....................................................................................................9
4.4.2. Cardioplegia Delivery ............................................................................10
4.5. System Cleaning............................................................................................................11
4.6. System Alarms...............................................................................................................11
5. System Installation ..............................................................................................................................1
5.1. Installation Introduction....................................................................................................1
5.2. Unpacking the MPS 3 System.........................................................................................2
5.2.1. Unpacking the MPS 3 Controller .............................................................2
5.2.2. Unpacking the MPS 3 Console................................................................3
5.2.3. Unpacking the MPS 3 Disposables .........................................................4
5.3. System Components .......................................................................................................5
5.4. System Accessories ........................................................................................................7
5.5. Installing the MPS 3 System............................................................................................9
5.5.1. Installing the MPS 3 Console ..................................................................9
5.5.2. Installing the MPS 3 Hypothermic Reservoir .........................................14
5.5.3. Installing the MPS 3 Controller ..............................................................20
5.5.4. Connecting a Heater Cooler Unit to the MPS 3 System........................28
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MPS 3 System – Table of Contents
5.5.5. Priming the Circulation System .............................................................31
5.6. Installing the Optional Accessories................................................................................34
5.6.1. Connecting Medical Air..........................................................................34
5.6.2. Connecting to the Electronic Data Management System (EDMS) ........36
5.6.3. Connecting the Electrocardiogram (ECG) Cable...................................37
5.6.4. Connecting the External Antegrade and Retrograde Pressure Cables .38
6. MPS 3 Startup.......................................................................................................................................1
6.1. System Power On............................................................................................................1
6.2. System Settings...............................................................................................................5
7. Graphical User Interface (GUI) Overview...........................................................................................1
7.1. Home Screen Overview...................................................................................................1
7.2. Home Screen Views ........................................................................................................5
7.3. Changing Case Parameters During Delivery...................................................................6
7.3.1. Flow Settings ...........................................................................................6
7.3.2. Delivery Pressure Settings ......................................................................8
7.3.3. Time .......................................................................................................11
7.3.4. Volume...................................................................................................13
7.3.5. Arrest Agent (K+) ...................................................................................17
7.3.6. Additive..................................................................................................18
7.3.7. Blood : Crystalloid..................................................................................19
7.3.8. Temperature ..........................................................................................21
7.4. Function Buttons............................................................................................................22
7.4.1. Vent .......................................................................................................23
7.4.2. ECG.......................................................................................................24
7.4.1. ECG Events.....................................................................................................................25
7.4.2. Hold Volume ..........................................................................................27
7.4.3. Graft.......................................................................................................27
7.4.4. Menu......................................................................................................29
7.4.5. Protocol .................................................................................................30
7.4.6. Delivery Routes .....................................................................................31
7.4.7. Home .....................................................................................................31
7.4.8. Auto Mode and Auto-Start Mode ...........................................................32
8. MPS 3 Disposable Installation ............................................................................................................1
8.1. Installing the MPS 3 Delivery Set ....................................................................................1
8.1.1. Installing the Heat Exchanger..................................................................2
8.1.2. Installing the Blood / Crystalloid Cassette ...............................................4
8.1.3. Connecting the Delivery Set to the Extracorporeal Circuit ......................5
8.1.4. Installing and Filling the Arrest Agent Cartridge.......................................7
8.1.5. Installing and Filling the Additive Cartridge............................................11
8.2. Priming and Recirculation..............................................................................................15
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MPS 3 System – Table of Contents
8.3. Refill Arrest Agent ..........................................................................................................18
8.3.1. Purging the Arrest Agent Cartridge Line ................................................19
8.4. Refill Additive .................................................................................................................19
8.4.1. Purging the Additive Cartridge Line .......................................................20
8.5. Auto Prime for Disabled Arrest and Additive Pumps .....................................................20
8.6. Replacing the Crystalloid Bag .......................................................................................21
8.7. Removing the Delivery Set ............................................................................................22
9. MPS 3 System Functional Use............................................................................................................1
9.1. New Case Setup..............................................................................................................1
9.1.1. Defaults ...................................................................................................2
9.1.2. Using an Existing Protocol.....................................................................10
9.2. Resuming an Existing Case...........................................................................................11
9.3. Using MPS 3 Protocol Manager ....................................................................................11
9.4. Interfacing with Menu ....................................................................................................14
9.4.1. Settings..................................................................................................14
9.4.2. H2O Circ................................................................................................14
9.4.3. Device Info.............................................................................................16
9.4.4. File Transfer...........................................................................................17
9.4.5. Case History ..........................................................................................19
9.4.6. Additive List ...........................................................................................31
9.4.7. Crystalloid List .......................................................................................34
9.4.8. Component List .....................................................................................36
9.4.9. Personnel ..............................................................................................37
9.4.10.Error Report...........................................................................................38
9.4.11.Trainer Mode .........................................................................................40
9.4.12.Shut Down and Restart .........................................................................42
9.5. Data Transfer.................................................................................................................43
10. Alarm Overview ....................................................................................................................................1
10.1. High Priority Alarms ................................................................................................................1
10.2.Medium Priority Alarms....................................................................................................2
10.3.Informational Signals.......................................................................................................2
11. Troubleshooting ...................................................................................................................................1
11.1. General troubleshooting ..................................................................................................1
11.2. MPS 3 Blood Bypass Tubing ...........................................................................................1
11.3. Error Code List and Solutions..........................................................................................2
11.4. Further Troubleshooting ................................................................................................35
11.4.1.Delivery Line Occlusion/Max Overpressure Alarms ..............................35
11.4.2.Arrest & Additive Alarms ........................................................................35
11.4.3.Bubble Trap Errors ................................................................................35
11.4.4.System and Internal Error Alarms (Non-Recoverable Alarms) ..............35
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MPS 3 System – Table of Contents
mps
11.4.5.Delivery Temperature Reads More Than 5° Above Water Temperature36
11.4.6.Delivery/Vent Valves Errors ...................................................................36
11.4.7.Low/No Water Flow in Circulation System.............................................36
11.4.8.Cannot Close the Door ..........................................................................36
11.4.9.Cannot Install Heat Exchanger..............................................................36
11.4.10.Inadequate Fill Alarms/Delay in Delivery .............................................38
11.4.11.Battery Not Charged/Charging While Not in Use.................................38
11.4.12.Air in Delivery Line...............................................................................38
11.4.13.Circulation System Not Heating...........................................................38
11.4.14.Cannot Drain HEX ...............................................................................38
11.5. Console or Controller Swap Out....................................................................................39
12. System Maintenance............................................................................................................................1
12.1.Cleaning ..........................................................................................................................1
12.1.1.MPS 3 Surface Cleaning and Disinfection ..............................................2
12.1.2.Delivery and Vent Valve Cleaning ...........................................................4
12.1.3.Water Circulation System Cleaning.........................................................5
12.1.4.System Controller Cleaning...................................................................10
12.2.Storage Instructions.......................................................................................................11
12.3.Preventative Maintenance .............................................................................................11
12.4.System Service..............................................................................................................11
13. Service ..................................................................................................................................................1
13.1.Warranty Service .............................................................................................................1
13.2.Unscheduled Services ...................................................................................................................2
15. Part Numbers and Accessories List...................................................................................................1
15.1.Accessories List SKUs ....................................................................................................1
15.1.1.Power Cords............................................................................................2
15.2.MPS 3 Delivery Sets........................................................................................................3
15.3.MPS 3 Disposables Optional Accessories.......................................................................5
17. Appendix...............................................................................................................................................1
17.1.Electromagnetic Environment Recommendations...........................................................1
17.1.1.Electromagnetic Emission .......................................................................2
17.1.2.Electromagnetic Immunity .......................................................................2
17.1.3.Recommended Separation Distance.......................................................5
17.2. MPS® 3 Aortic Root and Coronary Sinus Transducer Interface Cable.................................6
17.3.MPS® 3 Bypass Tubing Instructions for Use ..................................................................7
Quest Medical, Inc. 904384 Rev M – 04/2023iv

MPS 3 System – Introduction
1. Introduction
Quest Medical, Inc. recognizes the need for increased flexibility in cardioplegia
delivery. The Quest Medical MPS 3 System enables a variety of intraoperative
myocardial protection protocols using Microplegia™ exclusively available through
the MPS 3 System technology. The MPS 3 System provides complete control over
several elements of myocardial protection, including composition, distribution,
temperature, and safety.
The MPS 3 System is the latest addition to the MPS line of Quest Myocardial
Protection Systems, which have been the market leader for over 20 years and
completed over 1 million cases worldwide.
The MPS 3 System sets the standard for state-of-the-art cardioplegia delivery and
myocardial protection. The system allows operators to customize cardioplegia
solutions by varying blood/crystalloid ratios, drug delivery, flow and pressure
regulation, and temperature control. The new touchscreen controller delivers all
critical information to the perfusionist and allows for full control of cardioplegia
delivery. Increased functionality and flexibility will allow operators to improve
patient care with individualized protocols with specific drug compositions and
concentrations to provide optimum myocardial protection.
The MPS 3 System has also been updated to a smaller, modular design to better
fit the diverse landscape of heart-lung machine setups. This allows the MPS 3
System to be fully integrated with the heart-lung machine and allow for ideal
cardioplegia circuit setup, while keeping the controls easily within reach for
convenience. The same pumping technology that has been a staple for the Quest
Medical MPS Systems has been dramatically enhanced to increase performance,
advance safety, and improve quality. Case setup and delivery set installation have
been simplified to allow for quick and easy setup. The MPS 3 System sets a
standard in cardioplegia delivery systems.
The Operations Manual is to be used for the installation, operation, and
maintenance of the MPS 3 System. While the system has been designed to be
intuitive in operation, the Operations Manual is an essential aid for the safe and
effective use of the MPS 3 System.
Prior to operation, please carefully read these instructions in detail.
Thank you for investing in Quest Medical, Inc.
1

MPS 3 System – Introduction
1.1. About This Operations Manual
This Operations Manual describes the MPS 3, Myocardial Protection
System. It details the MPS 3 System overview, installation, basic operating
principles, setting case parameters, navigating the graphical user interface,
and system maintenance. This manual is intended for use by perfusionists
trained in delivering cardioplegia solution to the myocardium during
cardiopulmonary bypass surgery. It is also intended for biomedical
technicians and staff trained to install, service, and troubleshoot this
equipment. Please read the Operations Manual prior to operating the MPS 3
System.
1.2. Indication for Use
The Quest Medical MPS 3 Myocardial Protection System, consisting of the
MPS 3 Console, the MPS 3 Controller, and the MPS 3 Disposables (MPS 3
Delivery Set and optional accessories) together is intended for use by
perfusionists and physicians to deliver whole blood (from any arterial source)
and/or cardioplegia solutions to the heart during open-heart surgery on either
an arrested or beating heart for use up to six hours in duration.
1.3. Contraindications
The MPS 3 System should not be used on patients unable to tolerate
extracorporeal circulation.
2

MPS 3 System – Introduction
1.4. Symbols Used in this Operations Manual
The symbols used in these instructions are intended to help the operator find specific
information and provide attention to critical information. Understanding the meaning and use
of these symbols is important to avoid injury to the patient / operator or unintended damage
to the MPS 3 System.
Symbol
Description
Accompanying documents shall be consulted before use of equipment or
accessories.
Please read before using this device, symbol is used to alert you to
potential Personal Injuries Hazards & Cautions, understand all safety
messages that follow this symbol to avoid injury to the operator and/or
patient.
Consult instructions for use.
Electronic instructions for use.
Additional notes for information, suggestions and comments.
Caution: Federal (U.S.A.) law restricts this device to sale by or on
the order of a physician.
Catalog Number
3

MPS 3 System – Introduction
1.5. Terminology / Abbreviations
This Operations Manual may contain terminology and abbreviations relevant to the
indication for use and use environment. Please refer to the table below for definitions and/or
descriptions of those terms.
Term
Definition / Description
Normal Use
Expected normal use pattern for device.
Cardioplegia
The fluid solution, typically comprised of blood mixed with drugs,
delivered to the myocardium with the intention to arrest or revive
the heart.
Simulgrade
The ability to deliver Antegrade and Retrograde cardioplegia
simultaneously.
Perfusionist
A medical professional responsible for extracorporeal oxygenation
of the blood during open-heart surgery and for the operation and
maintenance of equipment often including a heart-lung machine.
Priming Volume
The minimum volume of priming solution remaining after air is
purged from an initially sterile set prior to use.
System Pressure
The pressure sensed in the bubble trap of the heat exchanger.
Delivery Pressure
The pressure sensed at the delivery site using an external pressure
sensor. When an external sensor is not used, delivery pressure is
the same as System Pressure.
Flow Rate
The rate of delivery of the cardioplegia solution expressed in units
of ml/min.
Chamber Pressure
The pressure sensed in the left and right chambers of the pump.
Delivery
Temperature
The temperature of the delivery fluid sensed in the bubble trap of
the heat exchanger.
B/C Pump
Blood / Crystalloid pumping mechanism (does not include arrest or
additive pumps).
CCW
Counterclockwise
CPB
Cardiopulmonary Bypass
ECG
Electrocardiogram
EDMS
Electronic Data Management System
EMC
Electromagnetic Compatibility
GUI
Graphical User Interface
HCU
Heater Cooler Unit
Hgb
Hemoglobin
HLM
Heart-Lung Machine
MPS
Myocardial Protection System
VTBD
Volume to be Delivered
4

MPS 3 System – Introduction
TTBD
Time to be Delivered
Term
Definition / Description
5

MPS 3 System – Introduction
6

MPS 3 System – System Overview
2. System Overview
The MPS 3 System consists of the MPS 3 Console, MPS 3 Controller, and the MPS 3
Disposables (MPS 3 Delivery Set and optional accessories). The primary function of the MPS 3
System is to aid the perfusionist in cardioplegia delivery to the patient during Cardiopulmonary
Bypass Surgery.
The MPS 3 Console, in conjunction with the MPS 3 Disposables, combines blood from the heart-
lung machine and crystalloid from the IV-bag in a specified ratio and then adds in the drug (Arrest
Agent or Additive). The electro-mechanical MPS 3 Console incorporates a blood/crystalloid pump,
temperature controllable water circulation system, pressure and temperature monitors, a sensor
interface with the MPS 3 Delivery Set, an Arrest Agent pump, an Additive pump, and ultra-sonic air
detection sensors. The system monitors and controls the blood-crystalloid ratio, drug
concentration, flow rate, pressure, temperature, and delivery route of the cardioplegia solution
delivered to the patient.
The MPS 3 System is a software-controlled system with a touchscreen, graphical user interface
MPS 3 Controller. The MPS 3 Controller can be positioned remotely from the MPS 3 Console on
any vertical pole of the Heart Lung Machine via the mounting arm, affording flexibility in equipment
setup to achieve the most desirable circuit setup. The MPS 3 Controller is utilized by the operator
to select all parameters, initiate/stop cardioplegia delivery, monitor delivery parameters, and view/
save relevant case information and data.
2.1. MPS 3 Console
The MPS 3 Console combines the Blood and Crystalloid solution to a proportion set by the
operator and adds the arrest agent or additive drug to the solution. This delivery solution is
then passed through the heat exchanger, where the temperature of the delivery fluid is set by
the operator and regulated by the MPS 3 Console water circulation system. The delivery fluid
is monitored for delivery pressure, temperature, and air bubbles before it is delivered to a
patient, at the desired flow rate.
1

MPS 3 System – System Overview
Figure 1: MPS 3 Console Overview
Item
Name
Function
1
MPS 3 Console
2
Push Button Switch
Sleep (OFF) / Wake (ON)
3
MPS 3 Door
Contain Blood/Crystalloid Cassette
4
Heat Exchanger (HEX) Locking Knob
Secure Heat Exchanger
5
Temperature Sensors
Monitor Delivery Temperature
6
Pressure Transducer
Monitor System Pressure
7
Fluid Level Sensor
Monitor Air in Heat Exchanger
8
Vent Valve
Control Vent Delivery / Expel Air from HEX
9
Retrograde Valve
Control Retrograde Delivery
10
Additive Pump (Green)
Control Additive Delivery
2
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
(Under mount)

MPS 3 System – System Overview
Figure 2: MPS 3 Console Rear Panel
11
Arrest Agent Pump (Yellow)
Control Arrest Agent Delivery
12
Antegrade Valve
Control Antegrade Delivery
13
Air In Line Sensor
Detect Air in Delivery Line
14
Mounting Feet (4X)
Facilitate Mounting
15
Front Handle (under mount)
Facilitate Transport
Item
Name
Function
16
Circulation System Drain Port
Drain Circulation System
17
Water Outlet Port
Water Outlet to Cold Water Source
18
Water Inlet Port
Water Inlet from Cold Water Source
19
Cooling Fans (2X)
Maintain Internal Temperature
20
Rear Handle
Facilitate Transport
21
Antegrade Ext. Pressure Connector
Monitor External Antegrade Pressure Transducer
3
16
17
18
19
20
21
22
23
24
25
26
27
28
29

MPS 3 System – System Overview
22
Retrograde Ext. Pressure Connector
Monitor External Retrograde Pressure Transducer
23
Console to Controller Comm Port
Connect Console to Controller Cable
24
Medical Air Inlet
Connect Medical Air to Console
25
Ground Equalization Plug
Ground Console
26
Main Power Switch
AC Mains Power Switch
27
Power Plug Socket
Connect AC Mains Power Plug
28
Power Cable Strain Relief
Secure Power Cable
29
Drip Pan Drain Port (under mount)
Drain Drip Pan
4

MPS 3 System – System Overview
2.2. MPS 3 Controller
The MPS 3 Controller is used to select and set cardioplegia parameters including blood/
crystalloid ratio, drug concentrations, flow rate, pressure limits, and delivery temperature
among others. The MPS 3 Controller is controlled by the operator to start and stop
cardioplegia delivery via the touchscreen interface or the flow knob on the front of the MPS 3
Controller. The MPS 3 Controller interfaces with the MPS 3 Console through the Console to
Controller Communicable Cable attached on the back of both modules. Power is supplied to
the MPS 3 Controller through the Console to Controller Communication Cable.
The MPS 3 Controller allows the operator to perform the following functions:
•Start / Stop Cardioplegia Delivery
•Set, View, and Control System Parameters (Pressure, Volume, Flow Rate, and
Temperature)
•View / Address Alarm Notifications
•Toggle System Settings
•View Case Logs / Dose Data
•View ECG Trace
•Protocol Management
•Monitor System Status / Diagnostics
5

MPS 3 System – System Overview
Figure 3: MPS 3 Controller Overview
Item
Name
Function
30
MPS 3 Controller
31
Touchscreen Display
Monitor / Select / Set Parameters
32
Set Knob
Scroll Through Parameters
33
USB Port
Connect USB Drive
34
Flow Control Knob
Start / Stop Cardioplegia Delivery
6
30
31
32
33
34

MPS 3 System – System Overview
Figure 4: MPS 3 Controller Rear Panel
Item
Name
Function
35
Type A USB Port
Expansion Port
36
Type B USB Port
Service Connection or Electronic Data Management
System
37
Communication Cable Port
Connect Console to Controller Communication
Cable
38
Analog ECG Port
Connect Analog ECG Cable
39
RS-232 Port
Connect Electronic Data Management System
40
Controller Mounting Bracket
Connect to Controller Mounting Arm
7
35
36
37
39
38
40

MPS 3 System – System Overview
2.3. MPS 3 Disposables
The MPS 3 Disposables (MPS 3 Delivery Sets and optional accessories) are designed to
work in conjunction with the MPS 3 Console. The MPS 3 Delivery Sets are sterile, single use
disposables which consist of a blood/crystalloid cassette, heat exchanger, blood/crystalloid
source lines, delivery extension line, and appropriate tubing and luer fittings to complete the
cardioplegia circuit. Arrest Agent and Additive Cartridges may be included with the Delivery
Set or may be purchased separately to allow for pharmacy filling. A full list of MPS 3 Delivery
Sets and optional accessories can be found in Section 14.2.
8