Page 1 Quest Medical, Inc.
Page 2 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.
Page 3: Table Of Contents
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 904384 Rev M – 04/2023 Quest Medical, Inc.
Page 4 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.
Page 5 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.
Page 6 MPS 3 System – Table of Contents 11.4.5.Delivery Temperature Reads More Than 5° Above Water Temperature 36 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...
Page 7: Introduction
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.
Page 8: About This Operations Manual
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...
Page 9: Symbols Used In This Operations Manual
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.
Page 10: Terminology / Abbreviations
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...
Page 11 MPS 3 System – Introduction Term Definition / Description TTBD Time to be Delivered...
Page 12 MPS 3 System – Introduction...
Page 13: System Overview
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.
Page 14 MPS 3 System – System Overview (Under mount) Figure 1: MPS 3 Console Overview Item Name Function MPS 3 Console Push Button Switch Sleep (OFF) / Wake (ON) MPS 3 Door Contain Blood/Crystalloid Cassette Heat Exchanger (HEX) Locking Knob Secure Heat Exchanger...
Page 15 Air In Line Sensor Detect Air in Delivery Line Mounting Feet (4X) Facilitate Mounting Front Handle (under mount) Facilitate Transport Figure 2: MPS 3 Console Rear Panel Item Name Function Circulation System Drain Port Drain Circulation System Water Outlet Port...
Page 16 MPS 3 System – System Overview Retrograde Ext. Pressure Connector Monitor External Retrograde Pressure Transducer Console to Controller Comm Port Connect Console to Controller Cable Medical Air Inlet Connect Medical Air to Console Ground Equalization Plug Ground Console Main Power Switch...
Page 17: Mps 3 Controller
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.
Page 18 MPS 3 System – System Overview Figure 3: MPS 3 Controller Overview Item Name Function MPS 3 Controller Touchscreen Display Monitor / Select / Set Parameters Set Knob Scroll Through Parameters USB Port Connect USB Drive Flow Control Knob Start / Stop Cardioplegia Delivery...
Page 19 MPS 3 System – System Overview Figure 4: MPS 3 Controller Rear Panel Item Name Function Type A USB Port Expansion Port Type B USB Port Service Connection or Electronic Data Management System Communication Cable Port Connect Console to Controller Communication...
Page 20: Mps 3 Disposables
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.
Page 21 Fill / Refill / Deliver Additive to HEX Heat Exchanger (HEX) Regulate Temperature of Cardioplegia Blood Source Line Connect Blood Source to MPS 3 Circuit Vent Line Extension Connect Vent Line to Reservoir Blood Delivery Extension Line Line to Table...
Page 22 MPS 3 System – System Overview Arrest Agent Delivery Line Fill / Refill / Deliver Arrest Agent to HEX Arrest Agent Cartridge Deliver Arrest Agent...
Page 23: System Specifications And Performance
MPS 3 System – System Specifications and Performance 3. System Specifications and Performance 3.1. Console Specifications MPS 3 Console Classification of Installation Stationary Mode of Operation Continuous Ingress Protection Marking Console: IPX1 Battery: IPX5 AC Mains Supply Voltage 100-120 V...
Page 24 – System Specifications and Performance MPS 3 Console Arrest Delivery Concentration 0 mEq/L to 40 mEq/L Additive Delivery Concentration 0 ml/L to 50 ml/L System Pressure 0 mmHg to 750 mmHg Delivery Temperature Control Range Cold, 15°C to 39°C...
Page 25: Controller Specifications
MPS 3 System – System Specifications and Performance 3.2. Controller Specifications MPS 3 Controller Dimensions Width: 12.5" Depth: 4.5" Height: 7.5" Weight 10 lbs. DC Supply Voltage 24 VDC Communication ports Isolated USB Host port – 2 Ports (USB •...
Page 26: Mps 3 Disposables Specifications
– System Specifications and Performance 3.3. MPS 3 Disposables Specifications Blood Blood Extension Normal Mode Low Volume Part Number Source Source Line Priming Mode Priming Line Line ID Length Volume Volume Length Delivery Sets with 10 Core Heat Exchangers 1/4”...
Page 27: Glossary Of Symbols And Labels
MPS 3 System – System Specifications and Performance 3.4. Glossary of Symbols and Labels 3.4.1. Console and Controller Symbols and Markings Symbol Description Antegrade External Pressure Transducer Cable Connection ANTEGRADE Port Retrograde External Pressure Transducer Cable Connection RETROGRADE Port Medical Air...
Page 28: Delivery Set And Optional Accessories Symbols And Markings
stem – System Specifications and Performance Symbol Description The Minimum Temperature Limit. The Maximum Temperature Limit. The acceptable Upper and Lower Limits of relative humidity for transport and storage. The acceptable Upper and Lower Limits of atmospheric pressure for transport and storage. Dispose all electrical and electronic equipment to a safe and responsible collection, recycling and recovery agency.
Page 29 MPS 3 System – System Specifications and Performance Symbol Description Accompanying documents shall be consulted before use of equipment or accessories Do not use if package is damaged Do not resterilize Single use only Non-pyrogenic May contain phthalates - DEHP Caution: Federal (U.S.A.) law restricts this device to sale by...
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Page 31: Warnings And Cautions
USE ONLY QUEST MEDICAL AUTHORIZED SERVICE TECHNICIANS. Quest Medical, • Inc. cannot assure safe operation of the MPS 3 System if it is serviced by anyone other than an authorized service technician. Unauthorized service voids all warranties. Use of the device is restricted to professionally trained personnel in accordance with the •...
Page 32 Ensure use of MPS 3 System only with proper functioning equipment in the OR. Use of • malfunctioning equipment could be a potential fire hazard. The MPS 3 System is able to interface with a heater cooler unit to warm or cool • cardioplegia and/or blood. The heater cooler’s water quality must be maintained per manufacturer recommendation.
Page 33 Water quality in the MPS 3 must be maintained per the recommendations in Section 12.1. • DO NOT connect a heater cooler unit to the MPS 3 Console that has not been properly disinfected per the recommendations in Section 12.1.3.
Page 34: Installation And Setup Cautions
The operator should ensure that the MPS 3 Controller is securely attached and positioned • in optimum viewing angle. Avoid OPERATOR INJURY. If the MPS 3 Controller is mounted to a vertical pole on the • HLM via a mounting arm, ensure that the Controller is secure on its arm and all arm tensioners are tight enough to prevent movement.
Page 35 Water quality in the MPS 3 must be maintained per the recommendations in Section 12.1. DO NOT connect a heater cooler unit to the MPS 3 Console that has not been properly disinfected per the recommendations in Section 12.1.3.
Page 36: System Warnings And Cautions
Call a Quest authorized service technician if the MPS 3 System is exhibiting electrical malfunctions. Observe all alarm codes and messages. Do not use the MPS 3 System in the event of a •...
Page 37 Quest Medical customer support. Ensure that external port covers are closed when not in use. • DO NOT CONNECT anything to the MPS 3 USB port that is not approved by Quest • Medical. Use the Quest provided USB memory device solely for the MPS 3. DO NOT USE this •...
Page 38: Disposable Circuit Priming And Delivery Cautions
DO NOT LOAD cassette/cartridges if the pistons are in the forward position. Cycle the • power to reset the pistons. If the pistons do not retract, STOP THE MPS 3 System and call Quest Medical Technical Support. If the pump piston is not fully retracted, there may be an unintentional bolus delivery during the onset flow.
Page 39: Priming
• contamination is a risk after more than 12 hours. Close the door before using the MPS 3 System. The door must be closed to • operate the MPS 3 System. However, DO NOT force to open or close the doors.
Page 40: Cardioplegia Delivery
The operator is responsible for maintaining safe operating flow rates. • The ECG connection on the MPS 3 System is only an activity monitor and is • NOT A MAIN MONITORING DEVICE. Any decisions in care should be made by a main monitor and not the MPS 3 System display.
Page 41: System Cleaning
DO NOT immerse unit in any kind of ultrasonic bath, disinfectant, cleaning solution, or any • kind of liquid. Do not spray liquids directly onto the MPS 3 System and prevent liquids from entering the Console and Controller as this may short-circuit the internal electronics and can cause potential hazard for operator and/or patient.
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Page 43: System Installation
MPS 3 System – System Installation 5. System Installation This section contains the steps to install the MPS 3 System. The following steps explain how to unpack the components, verify the components list, install the system, and perform the initial setup of the MPS 3 System.
Page 44: Unpacking The Mps 3 System
If the accessories are visibly damaged, DO NOT unpack the components. Contact Quest Medical Customer Service. 4. Remove the top layers of foam packaging to uncover the MPS 3 inner box. 5. With the help of an assistant, remove the inner box from the shipping box by lifting it from the handles on the side of the inner box.
Page 45: Unpacking The Mps 3 Console
MPS 3 System – System Installation 3. Remove the top layer of foam packaging to uncover the MPS 3 Controller. 4. Remove the Controller from the shipping box by lifting it from the underside of the module. Discard the two foam pieces. DO NOT lift the Controller using the Set / Flow Control Knobs.
Page 46: Unpacking The Mps 3 Disposables
Contact Quest Medical Customer Service. Remove the USB memory stick and set aside. 10. Use care when transporting your MPS 3 System to its point of use. 5.2.3. Unpacking the MPS 3 Disposables The MPS 3 Delivery Sets and optional accessories are packaged and shipped separately from the MPS 3 System.
Page 47: System Components
MPS 3 System – System Installation 5.3. System Components The following components are required for installation and initial system setup. Component P/N Description Reference Image MPS 3 Console 5301000 100 – 120V, 50/60 Hz MPS 3 Console 5302000 200 – 240V, 50/60 Hz...
Page 48 MPS 3 System – System Installation Component P/N Description Reference Image 5001002 MPS Hypothermic Reservoir Holder MPS 3 Power Cord 530NA16 North America MPS 3 Operator’s Manual 5301010-EN English 5301010-FR French MPS 3 and MPS 3 ND 5301035-EN Troubleshooting Manual - English...
Page 49: System Accessories
MPS 3 Medical Air Adaptor Kit 5301023 MPS 3 Console Pole Mount 5301025 MPS 3 Console Adapter MPS 3 Console to Controller 513PWCC10 Communication Cable 513UDMS MPS 3 USB UDMS Cable 513USCC MPS 3 RS232 EDMS Cable 513UECG MPS 3 Controller In to ECG Out...
Page 50 MPS 3 System – System Installation Component P/N Description Reference Image MPS 3 Antegrade (Aortic Root) 511800A Transducer Interface Cable MPS 3 Retrograde (Coronary Sinus) 511800R Transducer Interface Cable 5301016 MPS 3 Blood Bypass Tubing...
Page 51: Installing The Mps 3 System
This can be accomplished by mounting the MPS 3 Console on the base of the HLM or on a Quest Medical supplied MPS 3 Console Pole Mount. The MPS 3 Console should be placed in a location that is convenient for safe and effective operation.
Page 52 MPS 3 Console. Figure 6: Lift Console with Handles 5. Carefully lower the MPS 3 Console on to the HLM base. Verify that the console is secure in the installation location. 6. Connect the Power Cord to the AC Connector on the back of the MPS 3 Console.
Page 53 MPS 3 Console Pole Mount Adapter per the instructions provided with the accessory. 3. Using a Philips screwdriver, remove one of the feet on the MPS 3 Console and replace it with the locking foot provided with the MPS 3 Pole Mount Adapter.
Page 54 Pole Mount Adapter and all four feet are securely in the cups. Use the Locking Pin on the Pole Mount Adapter to secure the locking foot on the MPS 3 Console. Verify that the console is secure in the installation location.
Page 55 MPS 3 System – System Installation 9. Connect the Power Cord to the AC Connector on the back of the MPS 3 Console. The Power Cord should be inserted through the Strain Relief clamp by unscrewing the clamp and running the power cord through the clamp. This will help prevent accidentally unplugging the power cord.
Page 56: Installing The Mps 3 Hypothermic Reservoir
MPS 3 System – System Installation 5.5.2. Installing the MPS 3 Hypothermic Reservoir If the cold water source to be used with the MPS 3 System is the Quest Medical Hypothermic Reservoir, the reservoir should be placed in a location that is easily accessible for the operator to fill, refill, and add ice and drain, as required.
Page 57 MPS 3 System – System Installation If the cold water source to be used with the MPS 3 System is the Quest Medical Hypothermic Reservoir, please follow these steps to install the Hypothermic Reservoir. 1. Consult the HLM Operation Instructions prior to attempting to install the MPS 3 Hypothermic Reservoir to ensure the Reservoir can be safely installed.
Page 58 MPS 3 System – System Installation 5. Insert the Reservoir into the Bracket so that the water ports face the opening on the Bracket to allow for tubes be installed. Figure 15: Insert Reservoir into Bracket 6. The position of the Reservoir may be adjusted using the lever handle on the top of the bracket.
Page 59 MPS 3 System – System Installation 7. Install the ½” Tubing supplied with the Hose Kit to the Reservoir Inlet and Outlet and secure the tubing with a hose clamp. Route the tubing of the Reservoir Inlet up through the bracket.
Page 60 MPS 3 System – System Installation...
Page 61 MPS 3 System – System Installation 12. Connect the Hansen fittings to the Console Inlet and Outlet ports. Connect the Reservoir Outlet tubing to the Console Inlet. Connect the Reservoir Inlet tubing to the Console Outlet. Figure 19: Connect Reservoir Tubing to Console...
Page 62: Installing The Mps 3 Controller
The location should also allow for minor adjustments to the Controller position to accommodate viewing angles and reach for all operators who may operate the device. The MPS 3 Controller must be installed on a vertical pole of the Heart Lung Machine for proper operation.
Page 63 To install the MPS 3 Controller using the Telescoping Mounting Arm (P/ N 5303008) on the HLM Pole, follow these steps: 1. Consult the HLM Operation Instructions prior to attempting to install the MPS 3 Controller to ensure the Controller can be safely installed.
Page 64 MPS 3 System – System Installation Figure 21: Tighten Pole Clamp to Secure Mounting Arm...
Page 65 MPS 3 System – System Installation 5. To install the MPS 3 Controller, align the quick disconnect mounting adapter on the back of the Controller with the mating connector on the Telescoping Mounting Arm. Carefully slide the Controller onto the Pole Mounting Arm. The quick release adapter should click into place when properly secure.
Page 66 MPS 3 System – System Installation 7. The Pole Mounting Arm length can be adjusted by lifting the telescoping clamp and extending the arm to the desired length. If the telescoping clamp needs to be tightened or loosed, simply adjust the hex nut on the mechanism with a 3/16”...
Page 67 To install the MPS 3 Controller using the Articulating Mounting Arm (P/ N 5303007) on the HLM Pole, follow these steps: 1. Consult the HLM Operation Instructions prior to attempting to install the MPS 3 Controller to ensure the Controller can be safely installed.
Page 68 This Way Up Figure 25: Tighten Pole Clamp to Secure Mounting Arm 5. To install the MPS 3 Controller, align the quick disconnect mounting adapter on the back of the Controller with the mating connector on the Articulating Mounting Arm. Carefully slide the Controller onto the Articulating Mounting Arm.
Page 69 MPS 3 System – System Installation 7. The Articulating Mounting Arm configuration can be changed by holding onto the Controller, loosening the quick release knob and adjusting the mounting arm to the desired configuration. Lock the configuration into place by tightening the quick release knob.
Page 70: Connecting A Heater Cooler Unit To The Mps 3 System
5.5.4. Connecting a Heater Cooler Unit to the MPS 3 System If the cold/warm water source to be used with the MPS 3 System is a third party Heater Cooler Unit (HCU), the HCU must supply an adequate water flow rate (greater than 1.25 gpm) and water temperatures (0 –...
Page 71 MPS 3 System – System Installation If the cold water source to be used with the MPS 3 System is a third party Heater Cooler Unit (HCU), please follow these steps to connect the HCU to the MPS 3 System.
Page 72 MPS 3 System – System Installation 5. Connect the Hansen fittings to the Console Inlet and Outlet ports. Connect the HCU Outlet tubing to the Console Inlet. Connect the HCU Inlet tubing to the Console Outlet. Figure 29: Connect Reservoir Tubing to Console...
Page 73: Priming The Circulation System
Prior to first use of the MPS 3 System, follow the disinfection procedure outlined in Section 12.1.3. The MPS 3 water circulation system must be fully primed and purged of all air prior to use to ensure full functionality of the system. Failure to do may result in loss of temperature control, inadequate cooling, and inability to perform leak tests during priming and may result in premature wear or damage to the equipment.
Page 74 MPS 3 System – System Installation 7. It takes approximately 24 seconds to complete the H2O Prime. A countdown timer is displayed during the process. The process can be stopped and resumed. 8. Verify that water flow is established by checking the inlet of the hypothermic reservoir during the priming sequence.
Page 75 HCU has variable speed settings, ensure it is set to tis maximum flow mode. The pressure and flow from the HCU should automatically purge the air from the MPS 3 System. If a bypass loop is being used in conjunction with the HCU, clamp the loop during the H2O Circulation System prime to maximize water pressure into the MPS 3 System.
Page 76: Installing The Optional Accessories
The MPS 3 System has pneumatic compressors to drive the pneumatic power, but the MPS 3 Console is equipped with a Medical Air Inlet. This can be used to attach a Medical Air Supply to the inlet to bypass the internal compressors for quieter operation or in the event of compressor failure.
Page 77 MPS 3 System – System Installation To connect the Medical Air Supply to the MPS 3 System, please follow the following steps. 1. Verify that the Medical Air Supply has a pressure not exceeding 55psi. High pressures may damage the MPS 3 System.
Page 78: Connecting To The Electronic Data Management System (Edms)
System. Ensure that all fingers are free from pinch / crush hazards while connecting the EDMS Cable. To connect the EDMS Cable to the MPS 3 System, please follow the following steps. 1. Verify that the EDMS is compatible with the MPS 3 System.
Page 79: Connecting The Electrocardiogram (Ecg) Cable
To connect the ECG Cable to the MPS 3 System, please follow the following steps. 1. Verify that the ECG is compatible with the MPS 3 System. The ECG port of the MPS 3 System is designed to be used with a ¼” Phono ECG cable.
Page 80: Connecting The External Antegrade And Retrograde Pressure Cables
The MPS 3 System may be connected to external Antegrade or Retrograde Pressure Transducers, if desired. These pressure transducers can be used to measure the pressure in the Aortic Root or Coronary Sinus to be displayed on the MPS 3 Controller display. The sterile, single use Pressure Transducers can be purchased as optional disposable accessories.
Page 81 To connect the External Antegrade or Retrograde Pressure Cables to the MPS 3 System, please follow the following steps. 1. Connect the External Antegrade Pressure Cable to the rear panel of the MPS 3 Console in the Antegrade Pressure Connector. The Antegrade Pressure Cable and Pressure Connector are color coded red to help guide proper connections.
Page 82: Mps 3 Startup
Controller paired as a System by matching Serial Numbers (located on the Console and Controller rear labels). Please refer to section 11.3 for instructions on how to start up the MPS 3 System in a Console or Controller emergency change out scenario.
Page 83 To power on the MPS 3 System, follow the steps outlined below: 1. Turn main power switch on the rear panel of the MPS 3 Console to the ON position. The push button switch on the front of the MPS 3 Console will be illuminated in orange to verify the main power switch is in the ON position.
Page 84 MPS 3 System – Startup 3. After the system is powered on, the MPS 3 Controller will display the startup screen. The startup screen will indicate the MPS 3 System is powered on and System Diagnostics is being performed. Alarm messages will be displayed on the startup screen should an error be encountered during System Diagnostics.
Page 85 MPS 3 System – Startup 4. Once System Diagnostics has completed successfully, the selection screen will illuminate the following options: RESUME CASE (Section 9.2) • NEW CASE (Section 9.1) • PROTOCOL MANAGER (Section 9.3) • MENU (Section 9.4) • Figure 40: Selection Screen...
Page 86: System Settings
MPS 3 System – Startup 6.2. System Settings When the MPS 3 System is powered on for the first time, it is recommended that the operator adjust the System Settings to the desired preference. The following parameters may be changed in the Settings menu.
Page 87 MPS 3 System – Startup 2. The settings menu is displayed on 3 pages. To cycle through pages, use the arrow buttons near the page numbers. Figure 42: Settings Menu, Page 1 3. To change Delivery Line Type, select the selection button and choose single or double.
Page 88 MPS 3 System – Startup Figure 43: Settings Menu, Page 2 8. To select Language, select the selection button and choose the desired language. 9. To set the Arrest Source Limit, select the selection button and choose the desired units.
Page 89 MPS 3 System – Startup 14. Once the desired settings are configured, select DONE to return to the Selection Screen. 15. Select the back arrow in the lower left corner to exit the settings menu at any time.
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Page 91: Graphical User Interface (Gui) Overview
Overview 7. Graphical User Interface (GUI) Overview The MPS 3 Controller utilizes a Graphical User Interface (GUI) to allow the operator to set parameters, start / stop cardioplegia delivery and monitor delivery parameters. The interface is intuitive in operation, but this section will detail the layout of the interface for further clarification.
Page 92 stem – Graphical User Interface (GUI) Overview Icon Name Description The Flow Rate (1) displays the current flow rate. A Flow Rate and dynamic vertical flow bar displays the flow range Range and dynamically represents the current flow rate value with respect to the flow limits. The System Pressure (2) is always displayed.
Page 93 MPS 3 System – Graphical User Interface (GUI) Overview Icon Name Description Blood-to- The B:C (10) displays the Blood-to-Crystalloid Ratio Crystalloid Ratio setting and the Crystalloid Name. The volume and Crystalloid remaining displays the volume of fluid remaining in Volume the crystalloid bag.
Page 94 stem – Graphical User Interface (GUI) Overview Icon Name Description The Delivery Pressure Chart (21) is a real-time chart Delivery Pressure showing 16 second dynamic delivery pressure Chart history. Only displayed in Chart view The Stopwatch Timer (22) counts up every second Stopwatch Timer when the timer is started and halts when the timer is stopped...
Page 95: Home Screen Views
MPS 3 System – Graphical User Interface (GUI) Overview 7.2. Home Screen Views The Home Screen provides the operator with the buttons and views that allows the operator the flexibility to view and modify the parameters while delivering Cardioplegia to the patient.
Page 96: Changing Case Parameters During Delivery
2. The Low Vol button is only active if the current flow rate is 0 ml/min. Selecting the Low Vol button will put the MPS 3 System in a flow mode where it pumps with a reduced stroke volume. The maximum flow rate is limited to 200 ml/min.
Page 97 MPS 3 System – Graphical User Interface (GUI) Overview Target pressure is reached. Auto-Start is disabled for Ante-External Pressure, Retro, Simulgrade, and Graft mode.
Page 98: Delivery Pressure Settings
stem – Graphical User Interface (GUI) Overview 7.3.2. Delivery Pressure Settings The System pressure is always displayed. If the pressure source is selected as external, the corresponding external Antegrade or Retrograde pressure is displayed, and the System pressure is displayed with the ‘Sys’ label. Figure 49: Delivery Pressure The upper and lower pressure limits are always displayed.
Page 99 MPS 3 System – Graphical User Interface (GUI) Overview Figure 51: Retro Pressure Settings Figure 52: Graft Only Pressure Settings...
Page 100 stem – Graphical User Interface (GUI) Overview 3. The following table summarizes the pressure limits for Antegrade, Retrograde, and Graft Only modes. All are settable in increments of 1. The lower pressure limit maximum will be limited to 20mmHg less than the current upper pressure limit setting.
Page 101: Time
MPS 3 System – Graphical User Interface (GUI) Overview 7.3.3. Time The Time displays the On / Off time for the pump. The ‘On Time’ displays when the dose is delivering and ‘Off Time’ is displayed when not delivering. The Stopwatch Timer will be displayed in the ‘On Time’...
Page 102 stem – Graphical User Interface (GUI) Overview 7.3.3.1. Ischemic Timer The Ischemic Timer gives the operator the ability to be notified when a set period of non-delivery has elapsed. This notification is provided by an audible tone and by flashing the timer display. There are two different timers that can be set: The Initial Timer and the Repeat Timer.
Page 103: Volume
MPS 3 System – Graphical User Interface (GUI) Overview 7.3.4. Volume The Incremental Volume displays the total Cardioplegia volume (blood + crystalloid + arrest + additive) delivered during the current ‘On’ Time. When flow is stopped, the Incremental Volume display shall continue showing the incremental volume. If flow is resumed before Off Time displays, the Incremental Volume continues counting from the previous value.
Page 104 stem – Graphical User Interface (GUI) Overview 4. Set the VTBD and TTBD values. Button VTBD TTBD Delivers the set volume for a Delivers for the set duration for One Time single dose a single dose Delivers the set volume for Delivers for the set duration for every dose until the operator every dose until the operator...
Page 105 MPS 3 System – Graphical User Interface (GUI) Overview 7.3.4.2. Volume Summary / Delivery Summary The Total, Blood, Crystalloid, Arrest, Additive, Antegrade, Retrograde, Simulgrade, and Graft Only volume counters shall be tracked and dynamically displayed to the operator. Use the Reset Volumes button to reset all the counters to zero.
Page 106 stem – Graphical User Interface (GUI) Overview The Delivery Summary button is used to display the summary of all delivered components to the patient. First the total non-blood volume is displayed. This is the sum of Crystalloid + Arrest Agent + Additive Volume delivered. Next, the total Potassium delivered to the patient is displayed.
Page 107: Arrest Agent (K+)
Overview 7.3.5. Arrest Agent (K+) The MPS 3 System offers the capability to set two arrest agent delivery concentrations as High K+ and Low K+. The High/Low K+ button allows the operator to change between the two concentrations and also, when highlighted, indicates which concentration is displayed.
Page 108: Additive
Refill and Purge, Refer to Section 8.3. 7.3.6. Additive The MPS 3 System offers the capability to select the name of the Additive and to set the delivery concentration. The Additive concentration range is between 0 ml/L to 50 ml/L.
Page 109: Blood : Crystalloid
To refill or purge the Additive, select the Refill or Purge button. For more information about Refill and Purge, refer to Section: 8.4. 7.3.7. Blood : Crystalloid The MPS 3 System offers the capability to deliver blood and crystalloid in various ratios. The available options are: •...
Page 110 stem – Graphical User Interface (GUI) Overview 1. To set Blood : Crystalloid settings, select on the Home Screen. The B:C Settings screen is displayed. Figure 62: B:C Settings Screen Figure 63: Blood : Cryst Ratio Selection 2. Select the Blood : Cryst Ratio value. A numeric keypad with commonly used ratios is displayed to set the ratio.
Page 111: Temperature
Prime or Recirc processes. 7.3.8. Temperature The MPS 3 System offers the capability to set the temperature of the cardioplegia solution delivered to the patient. The delivery temperature as measured in the heat exchanger and the H2O temperature as measured in the water circuit path are displayed.
Page 112: Function Buttons
stem – Graphical User Interface (GUI) Overview 5. The Drain Hex button may be used at the end of the case to drain the water in the heat exchanger to prevent dripping during removal. H2O Circ has to be turned off to enable the Drain Hex button. 6.
Page 113: Vent
The operator can purge air from the bubble trap by selecting the Vent button. The MPS 3 System opens the vent valve instead of the delivery valve. Any air that is trapped in the heat exchanger bubble trap can now be purged via the vent line. The MPS 3 controls ratios and temperature but does not deliver Arrest or Additive drugs in Vent mode.
Page 114: Ecg
– Graphical User Interface (GUI) Overview 7.4.2. ECG To view the ECG trace, connect the Controller to the ECG Monitor using the MPS 3 ECG cable. Follow your ECG monitor manufacturer’s instructions for connection and configuration. Refer to Section 5.6.3 for connection instructions to the MPS 3 Controller.
Page 115: Ecg Events
MPS 3 System – Graphical User Interface (GUI) Overview 7.4.1. ECG Events Selecting the ECG chart displays the ECG Event screen. An ECG cable does not have to be connected to the Controller to enter the ECG Event screen or to record events.
Page 116 stem – Graphical User Interface (GUI) Overview Figure 68: Hot Shot Detection Confirmation Screen Figure 69: Heart Restart Method Selection Screen Figure 70: Cross Clamp (left), Arrested (center) and Rhythm (right) Buttons...
Page 117: Hold Volume
MPS 3 System – Graphical User Interface (GUI) Overview 7.4.2. Hold Volume The Hold Vol button indicates the Hold Volume mode is active / inactive. When activated the Hold Vol icon flashes yellow. The incremental volume stops counting and the Off timer starts counting (even if flow > 0). The Air inline sensor is deactivated.
Page 118 stem – Graphical User Interface (GUI) Overview Figure 73: Graft Only Screen Select the Graft Only button to exit Graft Only Mode and to change the route label and pressure limits to ‘Ante+Graft,’ ‘Retro+Graft,’ or ‘Simul+Graft.’ Select the Graft icon button to exit ‘Ante+Graft,’ ‘Retro+Graft,’ ‘Simul+Graft,’ or ‘Graft Only’ modes.
Page 119: Menu
MPS 3 System – Graphical User Interface (GUI) Overview 7.4.4. Menu The Menu displays the menu options, where operator can select and adjust the parameters in Settings, H2O Circ, Device Info, Additive, Crystalloid, Personnel, Error Report, Case History, or File Transfer sub-menu options. Long press the Menu button to directly enter page 2 of the Case Report screen.
Page 120: Protocol
stem – Graphical User Interface (GUI) Overview 7.4.5. Protocol The Protocol icon button displays the protocol name, if a protocol asides from Defaults is launched. An asterisk ‘*’ next to the name indicates that one or more parameters have been modified from the original saved Protocol when launched. Operator can modify the protocol parameters by selecting the protocol name or they can select a new protocol from the existing protocol list.
Page 121: Delivery Routes
MPS 3 System – Graphical User Interface (GUI) Overview 7.4.6. Delivery Routes Cardioplegia can be delivered in the following three delivery valve modes: • Antegrade • Retrograde • Simulgrade The currently active delivery route is shown in yellow: Figure 77: Antegrade (left), Retrograde (center), and Simulgrade (right) Delivery Routes To change delivery routes, pressure limits, and dose route labels from Antegrade to Retrograde, or vice versa, short press the route in grey.
Page 122: Auto Mode And Auto-Start Mode
Auto mode is selected or when target pressure is reached. The MPS 3 System exits auto mode when the Auto or Stop button is pressed or the flow is adjusted using the flow knob.
Page 123 MPS 3 System – Graphical User Interface (GUI) Overview Figure 80: Auto Mode Screen...
Page 124: Mps 3 Disposable Installation
MPS 3 System – Disposable Installation 8. MPS 3 Disposable Installation This section details the instructions for installing the MPS 3 Delivery Set and optional accessories for use with the MPS 3 System. Only genuine Quest disposable components, including delivery sets and extension lines, can be used with the MPS System to ensure the intended system performance and reliability.
Page 125: Installing The Heat Exchanger
MPS 3 System – Disposable Installation 8.1.1. Installing the Heat Exchanger Turn the MPS 3 Console power switch off and then on to ensure the pump pistons are retracted. Open the door to reveal the pumping chambers. DO NOT LOAD cassette if the pistons are in the forward position (convex).
Page 126 MPS 3 Console. Figure 82: MPS 3 Locking Knob Engagement Route the vent line through the vent valve on the MPS 3 Console by pressing down on the vent valve manual operation button. Ensure tubing is not overstressed or kinked upon installation.
Page 127: Installing The Blood / Crystalloid Cassette
DO NOT LOAD cassette if the pistons are in the forward position (convex). Cycle the power to reset the pistons. If the pistons do not retract, STOP THE MPS 3 CONSOLE and call for service. If the pump pistons are not fully retracted, there may be unintentional delivery during the onset.
Page 128: Connecting The Delivery Set To The Extracorporeal Circuit
MPS 3 System – Disposable Installation The blood source line is connected to the blood inlet tubing. Route the tubing along the top of the MPS 3 Console using the tubing clamps on the Console. Blood Source Crystalloid Source Figure 85: MPS 3 B / C Cassette Source Lines...
Page 129 (A). To open the valve, press down firmly on the manual button and hold while inserting the tubing. (see step 8 from section 8.1.1) Figure 86: MPS 3 Air in Line Sensor Engagement FULLY INSERT the tubing through the air in line detector for proper MPS 3 Console operation.
Page 130: Installing And Filling The Arrest Agent Cartridge
8.1.4. Installing and Filling the Arrest Agent Cartridge DO NOT USE an arrest agent (potassium chloride) concentration other than 2 mEq/ml. The MPS 3 System is designed to operate with an arrest agent concentration of 2 mEq/ml. Using an arrest agent concentration other than 2 mEq/ml will result in inaccurate delivery concentrations and may cause patient injury.
Page 131 MPS 3 System – Disposable Installation 3. With printing facing to the right, align the two flanges on the Arrest Cartridge with the matching features on the Arrest Pump on the MPS 3 Console. Figure 89: Align the Cartridge 4. Insert the Arrest Cartridge into the Arrest Pump and turn clockwise 90° to lock into the pump.
Page 132 MPS 3 System – Disposable Installation 5. Connect the Yellow stopcock Arrest Cartridge Delivery Line with the non-standard luer fitting attaching to the Arrest cartridge and the check valve fitting to the heat exchanger. Figure 91: Arrest Delivery Line Connections 6.
Page 133 MPS 3 System – Disposable Installation 7. Carefully fill the Arrest Cartridge by moving the solution from the filling syringe to the Arrest Cartridge. Figure 93: Cartridge filling 8. For best results, ensure that the Arrest Cartridge is free of air by aspirating with the filling syringe.
Page 134: Installing And Filling The Additive Cartridge
2. Remove the plunger by unscrewing it in a counterclockwise motion Figure 95: Plunger Removal 3. With printing facing to the right, align the two flanges on the Additive Cartridge with the matching features on the Additive Pump on the MPS 3 Console.
Page 135 MPS 3 System – Disposable Installation Figure 96: Align the Additive Cartridge...
Page 136 MPS 3 System – Disposable Installation 4. Insert the additive Cartridge into the Additive Pump and turn clockwise 90° to lock into the pump. Figure 97: Secure Additive Cartridge to Console 5. Connect the green stopcock Additive Cartridge Delivery Line with the standard luer fitting attaching to the Additive cartridge and the check valve fitting to the heat exchanger.
Page 137 MPS 3 System – Disposable Installation 7. Carefully fill the Additive Cartridge by moving the solution from the filling syringe to the Cartridge. Figure 99: Cartridge filling 8. For best results, ensure that the Additive Cartridge is free of air by aspirating with the filling syringe.
Page 138: Priming And Recirculation
Prior to delivering cardioplegia, the delivery set must be primed to remove all air in the delivery set and the drug cartridges. After the disposable is loaded, the MPS 3 System is powered on, and case parameters have been entered, the MPS 3 System is ready to perform the priming sequence. On completion of prime the operator has the option to recirculate fluid through the Vent Valve.
Page 139 MPS 3 System – Disposable Installation 2. Select the Start Prime button on the Prime screen, and the Auto Prime sequence will initiate. Figure 101: Auto Prime Sequence Initiated During the Auto Prime process, the following operations are performed: Source line fill •...
Page 140 When the Auto Prime sequence is complete, the operator has the option to recirculate through the delivery set by adjusting the flow knob. During recirculation mode (Recirc) the MPS 3 System switches to all blood mode and recirculates the solution through the vent valve to the cardiotomy reservoir.
Page 141: Refill Arrest Agent
The purge button will be disabled while refilling the arrest agent. The MPS 3 System allows the operator to refill the arrest agent cartridge at any time. To refill the arrest agent: Select icon on the Home Screen.
Page 142: Purging The Arrest Agent Cartridge Line
The purge button will be disabled while refilling the arrest agent. The MPS 3 System allows the operator to refill the additive cartridge at any time. To refill the additive cartridge: 1. Select icon on the Home Screen.
Page 143: Purging The Additive Cartridge Line
MPS 3 System – Disposable Installation The additive pump is automatically turned Off when the cartridge is empty and the following alarm is displayed: “Additive cartridge is empty Additive pump is Off” When the cartridge is refilled, the pump is automatically turned on.
Page 144: Replacing The Crystalloid Bag
8.6. Replacing the Crystalloid Bag If crystalloid is being used for cardioplegia delivery, a Crystalloid Volume Remaining must be entered. The MPS 3 System uses this value to calculate the volume remaining in the crystalloid bag and reminds the operator of a low volume condition.
Page 145: Removing The Delivery Set
If using a heater cooler, turn the heater cooler unit off and drain all water from the MPS 3 Console. If the heater cooler has a water removal feature, perform this function prior to shutting off the heater cooler.
Page 146 MPS 3 System – Disposable Installation Figure 104: Delivery Set Removed from the MPS 3 Console This page intentionally left blank...
Page 147: Mps 3 System Functional Use
MPS 3 System – Functional Use 9. MPS 3 System Functional Use This section details higher level functionality of the MPS 3 System. To power on the MPS 3 System refer to Section 6.1. Figure 105: Selection Screen 9.1. New Case Setup The New Case Setup screen allows the operator to select case parameters to be used in setting up the new case.
Page 148: Defaults
MPS 3 System – Functional Use Figure 106: New Case Setup 9.1.1. Defaults Defaults allows the operator to setup the new case parameter using the default values set in the Protocol Manager. The default values are saved in memory and displayed for editing or conformation during the setup sequence.
Page 149 MPS 3 System – Functional Use Figure 108: New Case Parameters, Page 2 Figure 109: New Case Parameters, Page 3...
Page 150 MPS 3 System – Functional Use Figure 110: New Case Parameters, Page 4 Figure 111: New Case Parameters, Page 5...
Page 151 MPS 3 System – Functional Use Figure 112: New Case Parameters, Page 6 Figure 113: New Case Parameters, Page 7...
Page 152 MPS 3 System – Functional Use Figure 114: New Case Setup Parameters, Page 8...
Page 153 MPS 3 System – Functional Use The following table summarizes the New Case parameters that can be set by the operator during each new case setup. Factory Item Parameter Name Description Range Default Value Minimum Maximum Value Value High arrest agent...
Page 154 MPS 3 System – Functional Use Factory Item Parameter Name Description Range Default Value Ante Ext Ante Ext Upper Pressure upper Limit limit Ante Sys Ante Sys Upper Pressure upper Limit limit Ante Ext Ante Ext Lower Pressure lower Limit...
Page 155 MPS 3 System – Functional Use Factory Item Parameter Name Description Range Default Value TTBT Time (min) TTBD time 1:00 15:00 4:00 TTBD Mode TTBD mode Once, Always, Off Initial Ischemic Initial Ischemic Timer (min) Time Repeat Ischemic Repeat Time for...
Page 156: Using An Existing Protocol
MPS 3 System – Functional Use 9.1.2. Using an Existing Protocol New Case Setup Using an Existing Protocol allows the operator to select an existing protocol from a list of previously saved protocols. The saved protocol feature can standardize cardioplegia delivery parameters and shorten set-up time. The operator can customize the protocol in setting up the current case.
Page 157: Resuming An Existing Case
MPS 3 System – Functional Use 9.2. Resuming an Existing Case When a previous case is resumed, the MPS 3 System displays the Home Screen using the parameters set in the previous case. The Resume Case button becomes disabled if the operator returns to the Selection Screen after confirming a protocol in New Case Setup or if the different controller option is selected on Alarm 315.
Page 158 MPS 3 System – Functional Use Figure 118: Create Protocol Screen 3. Select an option and the Protocol Name screen displays where the new protocol name may be entered. Figure 119: Protocol Naming Screen...
Page 159 MPS 3 System – Functional Use 4. Enter the protocol name and select the Done button to save the protocol name. The maximum character length for the protocol name is 14 alpha-numeric characters. All parameters can be reviewed and edited.
Page 160: Interfacing With Menu
MPS 3 System – Functional Use 9.4. Interfacing with Menu The following options can be accessed within the Menu. Figure 121: Menu Screen 9.4.1. Settings For details regarding the Settings menu, refer to Section 6.2. 9.4.2. H2O Circ The H2O Prime and H2O Clean options are available within the: Menu  H2O Circ Menu option.
Page 161 The process can be stopped and resumed. Figure 123: H2O Prime Sequence To run the H2O Cleaning Cycle, select the H2O Clean tab and select Start. See Section 12.5 for details on how to clean the MPS 3 System circulation system. Figure 124: H2O Clean Menu...
Page 162: Device Info
MPS 3 System – Functional Use 9.4.3. Device Info Device Info contains MPS 3 System information required for service personnel. Figure 125: Device Info Screen Pressing the Save button will save the device information to an external USB memory when connected.
Page 163: File Transfer
Select Menu  File Transfer Case History  Quest Internal Memory to view the list of all Case Records available on the MPS 3 System up to a max of 225 cases. Select cases and use the delete button to delete them. Select 1 case and use the View button to view the Case details.
Page 164 MPS 3 System – Functional Use Figure 127: File Transfer – Case History – Internal Memory Select Menu  File Transfer Case History  USB to view the list of all Case Records available on the USB memory. Select cases and use the delete button to delete them.
Page 165: Case History
MPS 3 System – Functional Use 9.4.5. Case History The Case History function allows the operator to view the list of 225 most recent case records. These records are identified by the case start date and time, for example [21 JUN 2020 13:15].
Page 166 MPS 3 System – Functional Use The dose history displays in a table where each row or record corresponds to a dose. If while flowing during a case the operator changes Delivery Route (Ante/Retro/Simul), selects Arrested/ Rhythm/Hotshot, Graft On/Off, Graft Only, or Graft Label a New Dose is created.
Page 167 MPS 3 System – Functional Use Figure 130: Dose History Screen...
Page 168 MPS 3 System – Functional Use 9.4.5.1. Editing Graft Label To edit the Graft label: 1. Select the Graft Label cell and a Graft label screen displays as shown below: Figure 131: Graft Label Screen 2. The operator may label or re-label a Dose by selecting from two different lists to label the Graft;...
Page 169 MPS 3 System – Functional Use 9.4.5.2. Dose Record View When a dose is selected, the corresponding pressure, flow and external pressure data is displayed on three separate graphs. A single dose is limited to a maximum of four hours (looped data). The data corresponding to the...
Page 170 MPS 3 System – Functional Use 9.4.5.3. Case Report The Case Report contains all Patient and Procedure details in one place. To view the Case Report: 1. Select Menu  Case History  Case  Case Report. The Case Report screen 1 of 4 is displayed.
Page 171 MPS 3 System – Functional Use Figure 133: Case Report 1 of 4 Figure 134: Case Report: Procedure View...
Page 172 MPS 3 System – Functional Use Figure 135: Case Report: Procedure: CABG View The fields in Case Report screen 2 of 4 are explained below. Glucose values in the alternate units are auto populated in the corresponding fields. Cross-Clamp Time (min): This field displays the XClamp Time as recorded in the ECG Setting screen.
Page 173 MPS 3 System – Functional Use Arrest Dose Pressure (mmHg): This field displays the average system pressure during the dose the Arrest button was selected on the ECG Setting screen. Subsequent Arrest Dose Pressures are displayed if multiple Arrest Doses are recorded in the ECG Event Screen.
Page 174 MPS 3 System – Functional Use Highest Glucose on CPB (mmol/L): Use this field to record the highest Glucose concentration in mmol/L while on CPB. Last Glucose CPB (mg/dl): Use this field to record the last Glucose concentration in mg/dl while on CPB.
Page 175 MPS 3 System – Functional Use Figure 136: Case Report 2 of 4...
Page 176 MPS 3 System – Functional Use The fields in Case Report screen 3 of 4 are explained below. TEE Score: Enter the TEE (Transesophageal Echocardiogram) score with range 0 - 9. PRBC: Enter PRBC (Packed Red Blood Cells) given with range 0 – 9 Units.
Page 177: Additive List
MPS 3 System – Functional Use 9.4.6. Additive List The Additive List contains a list of Additives created by the operator. Items in the list can be added, deleted, or edited. To add an item to the Additive list: 1. In Selection Screen, select Menu  Additives. The Additive List screen is displayed.
Page 178 MPS 3 System – Functional Use...
Page 179 3. All the fields in the Additive Template have to be filled to match the Additive solution being used. The ‘per L cdpg’ (quantity of component delivered per liter of cardioplegia) and ‘Total Volume’ fields are calculated by the MPS 3 based on the provided information. A component can be deleted by selecting the component’s name and then selecting Delete Row.
Page 180: Crystalloid List
MPS 3 System – Functional Use 9.4.7. Crystalloid List The Crystalloid List contains a list of Crystalloid solutions created by the operator. Items in the list can be added, deleted or edited. To add an item to the Crystalloid list: 1.
Page 181 3. All the fields in the Crystalloid Template have to be filled to match the Crystalloid solution being used. The ‘per L cdpg’ and ‘Crystalloid Volume’ fields are calculated by the MPS 3 based on the provided information. A component can be deleted by selecting the component’s name and then selecting Delete Row.
Page 182: Component List
MPS 3 System – Functional Use 9.4.8. Component List The Component List contains a list of up to 6 custom Components created by the operator. The Component List already has 9 reserved Component names (KCL, Mag Sulfate, Lido 1%, Lido 2%, Mannit 20%, Adenosine, NaHCO , Mannit 25% and Insulin).
Page 183: Personnel
MPS 3 System – Functional Use 9.4.9. Personnel The Personnel List allows the customization of personnel in the account. This includes the Surgeon, Anesthesiologist and Perfusionist Lists. All Personnel entries (Surgeon, Anesthesiologist & Perfusionist) are automatically sorted alphabetically based on the first letter of the name as entered.
Page 184: Error Report
MPS 3 System – Functional Use Figure 147: Anesthesiologist List Figure 148: Perfusionist List 9.4.10.Error Report The Error Report menu option lists all the Errors on the device in Chronological order along with time stamp and Error code. This list helps Service personnel to identify and troubleshoot an error condition on your device.
Page 185 MPS 3 System – Functional Use Figure 149: Error Report...
Page 186: Trainer Mode
MPS 3 Controller without having to load a disposable onto the Console. To enter Trainer Mode, select Trainer and confirm Yes on the dialogue box. The MPS 3 System will restart and an orange border will be displayed around the screen to alert operators they are in Trainer Mode and the Console is no longer responding to commands from the Controller.
Page 187 MPS 3 System – Functional Use Figure 150: Entering Simulator Mode Warning Figure 151: Simulator Mode...
Page 188: Shut Down And Restart
Shut Down on the dialogue box. To completely shut down the MPS 3 System, turn main power switch on the rear panel of the MPS 3 Console to the OFF position. To restart the MPS 3 System from Standby mode, select and hold the push button switch on the front of the MPS 3 Console until the indicator light turns blue.
Page 189: Data Transfer
MPS 3 System – Functional Use 9.5. Data Transfer Data transfer allows the operator to copy the information from MPS 3 System to external storage media. The operator is able to copy the information related to: Protocols, Additives, Crystalloids, Components, Personnel •...
Page 190: Alarm Overview
Alarms and errors are the notifications to the operator to ensure safe and proper function of the MPS 3 System. The alarm message states the alarm or error code, a brief description of the alarm, and prompts for clearing the alarm. All Alarms are recorded in the Alarm Report and may be accessed from the Menu option.
Page 191: Medium Priority Alarms
MPS 3 System – Alarm Overview 10.2.Medium Priority Alarms Medium priority alarms require acknowledgement by the operator without halting fluid delivery. Medium priority alarms are announced in a yellow message window and a repeating audible tone. When a medium priority alarm is displayed, the flow knob and all buttons remain active.
Page 192: Troubleshooting
Doing so may void the product warranty. 11.2.MPS 3 Blood Bypass Tubing The MPS 3 Blood Bypass Tubing (REF 5301016) is only for use as a back-up with the MPS 3 System to continue fluid delivery in the event of complete battery depletion after AC power failure or if the System becomes unusable even after following the corrective action and troubleshooting suggestions in Sections 11.3 and 11.4.
Page 193: Error Code List And Solutions
MPS 3 System – Troubleshooting 11.3.Error Code List and Solutions The following table list error codes, the displayed message, and recommended corrective action. The error code can be seen just below the Caution or Warning symbol in the message window. A chronological listing of all Error codes on the device can be accessed by selecting the Error Report button from the Menu screen.
Page 194 MPS 3 System – Troubleshooting Alarm Code Message Display Corrective Action Door Open detected * Open and Close door Close door and press RETEST * Select ignore if operator feels (Press IGNORE only if faulty sensor) door is securely even when...
Page 195 MPS 3 System – Troubleshooting Alarm Code Message Display Corrective Action * Manually actuate delivery and vent valves several times Delivery Valve failed diagnostics * Clean valves if dirty * Restart System RESTART CONFIRM * Call service after multiple occurrences...
Page 196 MPS 3 System – Troubleshooting Alarm Code Message Display Corrective Action System Config mismatch Error * Restart System Call Service 28, 29 * Call service after multiple occurrences SHUTDOWN RESTART Fluid Level sensor test failure * Continue with case while...
Page 197 MPS 3 System – Troubleshooting Alarm Code Message Display Corrective Action * Check heat exchanger to ensureensure it is secured Delivery Set pressure test error tightly with the locking knob Check circuit and * Manually actuate the delivery Delivery/Vent valves and vent valves &...
Page 198 MPS 3 System – Troubleshooting Alarm Code Message Display Corrective Action * Select USE SYSTEM External Retrograde sensor not detected * Retest and if multiple failures are observed, disconnect the USE SYSTEM RETEST cable and try again * Contact service after multiple...
Page 199 MPS 3 System – Troubleshooting Alarm Code Message Display Corrective Action * Check the source line Excessive Blood source pressure pressure Check Blood source * Restart and resume case, if the problem persists CONFIRM * Contact service after multiple occurrences...
Page 200 MPS 3 System – Troubleshooting Alarm Code Message Display Corrective Action Air detected in delivery Line IGNORE CONFIRM * Check delivery line to ensure it is fully inserted in sensor When IGNORE is selected: * If sensor is ignored, manually...
Page 201 MPS 3 System – Troubleshooting Alarm Code Message Display Corrective Action * Check Crystalloid inlet line for Inadequate Crystalloid fill clamps, kinks, or occlusions 61, 62 Check Source * Raise the Crystalloid bag or CONFIRM use a pressure cuff * Check Blood inlet line for...
Page 202 MPS 3 System – Troubleshooting Alarm Code Message Display Corrective Action Door is open * Close the door Close door to continue * Select shutdown to turn System off SHUTDOWN System FPGA Error * Restart System 75, 76 * Call service after multiple...
Page 203 MPS 3 System – Troubleshooting Alarm Code Message Display Corrective Action * Choose DISABLE if Arrest delivery is no longer needed for Arrest cartridge is empty or absent procedure Fill Arrest cartridge, press RETEST DISABLE RETEST * Refill Arrest Cartridge and...
Page 204 MPS 3 System – Troubleshooting Alarm Code Message Display Corrective Action * Check arrest delivery line for clamps, kinks, or occlusions * Check cartridge for occlusions/ leaks Arrest under-delivery detected * Check stopcock position Check cartridge and circuit * If problem persists, replace...
Page 205 MPS 3 System – Troubleshooting Alarm Code Message Display Corrective Action * Choose CONFIRM if Additive delivery is no longer needed for Additive cartridge is empty or absent procedure Additive pump is Off REFILL CONFIRM * Select REFILL and refill...
Page 206 MPS 3 System – Troubleshooting Alarm Code Message Display Corrective Action * Select CONFIRM to turn Arrest pump off and continue procedure Arrest pump error Arrest pump is Off CONFIRM RETEST * Select RETEST to turn Arrest pump on and continue...
Page 207 MPS 3 System – Troubleshooting Alarm Code Message Display Corrective Action * Continue without temperature control H2O temperature sensor error H2O temperature will not be displayed Heaters Disabled * Restart and resume case CONFIRM * Call service after multiple occurrences...
Page 208 CONFIRM cooler unit, then partially clamping/reducing the tubing size or installing pressure relief check valve will increase flow into the MPS 3 H2O Circulation System. * Try to prime/re-prime circulation system * If system will still not prime properly, remove heat...
Page 209 CONFIRM clamping/reducing the tubing size of the bypass loop or installing pressure relief check valve in line will increase flow into the MPS 3 H2O Circulation System. * Try to prime/re-prime circulation system * If system will still not prime...
Page 210 MPS 3 System – Troubleshooting Alarm Code Message Display Corrective Action Heater diagnostics started May take up to 100 seconds * Wait for heater diagnostics to complete CONFIRM Pneumatic pressure sensor error * Restart System Service required * Call service after multiple...
Page 211 MPS 3 System – Troubleshooting Alarm Code Message Display Corrective Action System Communication Error * Manually Restart System * Call service after multiple Manual Restart Required occurrences System Error * Restart System * Call service after multiple SHUTDOWN RESTART occurrences...
Page 212 MPS 3 System – Troubleshooting Alarm Code Message Display Corrective Action * Safe to use. Drug pump is fully Drug pump LED fail functional. Only the LED may be Contact Service after this Case compromised. * Call service after multiple...
Page 213 MPS 3 System – Troubleshooting Alarm Code Message Display Corrective Action Elevated internal temperature detected * Check fans and air inlets for Check for obstructed air flow obstructions Maintenance required * Restart System * Contact service after multiple CONFIRM occurrences...
Page 214 MPS 3 System – Troubleshooting Alarm Code Message Display Corrective Action Battery capacity at 50% * Reconnect AC power. If power LCD has been dimmed to conserve power loss did not occur, check power cord, outlet, or circuit breaker CONFIRM Battery capacity at 25% * Reconnect AC power.
Page 215 MPS 3 System – Troubleshooting Alarm Code Message Display Corrective Action Air detected in delivery line. Flow continues * Check delivery line to ensure it Manually check for air is fully inserted in sensor * If sensor is ignored, manually...
Page 216 MPS 3 System – Troubleshooting Alarm Code Message Display Corrective Action Arrest pump Home Sensor fail * Select RETEST Arrest pump is disabled * If error still persists, restart system and try again * Contact service after multiple occurrences CONFIRM...
Page 217 MPS 3 System – Troubleshooting Alarm Code Message Display Corrective Action * Select RETEST to retry. * Check Additive Cartridge to verify it is properly installed and Additive pump piston sensor error fully secured to the Additive Verify Additive cartridge installation...
Page 218 MPS 3 System – Troubleshooting Alarm Code Message Display Corrective Action System Error * Restart System * Call service after multiple SHUTDOWN RESTART occurrences 209, 210, 211, 212, Data Logging Error * Continue as normal. 213, 214, Consult Service after this case...
Page 219 MPS 3 System – Troubleshooting Alarm Code Message Display Corrective Action * Continue as normal Battery Error Consult service after this case * Restart and resume case CONFIRM * Call service after multiple occurrences * Continue as normal. Board Board Temperature sensor Fail...
Page 220 MPS 3 System – Troubleshooting Alarm Code Message Display Corrective Action * Check Additive Cartridge to verify it is properly installed and Additive pump piston sensor error fully secured to the Arrest pump Verify Additive cartridge installation * If the cartridge was secure, try...
Page 221 MPS 3 System – Troubleshooting Alarm Code Message Display Corrective Action UI Internal Error * Restart System Call Service * Call service after multiple occurrences SHUTDOWN RESTART Elevated internal UI temperature * Ensure the device has Check for obstructed air flow...
Page 222 MPS 3 System – Troubleshooting Alarm Code Message Display Corrective Action File Access Failure * Continue as normal. * Call service after multiple CONFIRM occurrences System Data Error * Restart system * Call service after multiple alarms SHUTDOWN RESTART Memory Access Failure...
Page 223 MPS 3 System – Troubleshooting Alarm Code Message Display Corrective Action * Continue as normal. Case Case Data Error Data is not essential to Reset to Defaults operation. * Call service after multiple CONFIRM occurrences Delivered volume Data Error * Continue as normal. Check...
Page 224 MPS 3 System – Troubleshooting Alarm Code Message Display Corrective Action * May not be able to adjust Unable to set System Audio level audio volume level. * Call service after multiple CONFIRM occurrences Low Arrest volume < 10 ml...
Page 225 MPS 3 System – Troubleshooting Alarm Code Message Display Corrective Action * Select SWAP to continue Different Console-Controller pair detected Press SHUTDOWN and reconnect original Press SWAP if intended * Select SHUTDOWN to power off system and re-connect SWAP SHUTDOWN...
Page 226: Further Troubleshooting
MPS 3 System – Troubleshooting 11.4.Further Troubleshooting This section describes how to troubleshoot issues that may not be found in the previous table. These tips and guidelines have been developed from operator feedback and experiences. 11.4.1.Delivery Line Occlusion/Max Overpressure Alarms Check for any clamps accidentally left on the delivery tubing or kinks present in •...
Page 227: Delivery Temperature Reads More Than 5° Above Water Temperature
Ensure the Hypothermic Reservoir has water filled to the drain port. Elevate the Hypothermic Reservoir above the MPS 3 System so that the outlet port of the reservoir is above the heat exchanger. Check the water lines to ensure they are properly connected to the correct inlet and outlet ports Check the water lines to ensure they are not kinked or blocked.
Page 228 MPS 3 System – Troubleshooting Verify that the locking knob is in the correct orientation to secure the 10 • convolution or 16 convolution heat exchanger. Refer to section 8.1.1.1 for full details.
Page 229: Inadequate Fill Alarms/Delay In Delivery
In order to use the Drain HEX functionality, the system must be in cold mode • and the circulation pump must be turned off. If a heater-cooler unit is being used with the MPS 3 System, the heater-cooler • unit flow must be turned off prior to using the Drain HEX functionality.
Page 230: Console Or Controller Swap Out
MPS 3 System – Troubleshooting 11.5.Console or Controller Swap Out It is recommended to change out the MPS 3 Console or MPS 3 Controller only if the MPS 3 System becomes unusable after following the corrective actions and troubleshooting suggestions in Sections 11.3 and 11.4.
Page 231 MPS 3 System – Troubleshooting...
Page 232 MPS 3 System – Troubleshooting Figure 157: Alarm 314 Figure 158: Alarm 315...
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Page 234 MPS 3 System – Troubleshooting...
Page 235: System Maintenance
MPS 3 System – System Maintenance 12. System Maintenance This section details important procedures and practices to maintain the MPS 3 System to ensure proper function. Only Quest Medical Service personnel or trained technicians and operators should attempt to perform maintenance on the MPS 3 System.
Page 236: Mps 3 Surface Cleaning And Disinfection
Sensor as this may cause higher than actual Delivery Temperature displays. Reference Figure 1 for Delivery Temperature Sensor location. 1. Shutdown the system and unplug the power cord to the MPS 3 Console prior to cleaning. 2. Open the door to the console.
Page 237 1. Wring excess solution from CaviWipes® and gently wipe the external surfaces of the MPS 3 System until all surfaces are clean. 2. Spray CaviCide® onto the external surfaces of the MPS 3 System. Ensure the device remains visibly wet for 2 minutes and ensure to pay attention to areas which are difficult to access.
Page 238: Delivery And Vent Valve Cleaning
MPS 3 System – System Maintenance 12.1.2.Delivery and Vent Valve Cleaning The MPS 3 Console Delivery and Vent Valves consist of a mechanism to open and close the valves during normal operation. This mechanism is designed to last for years, but it must be free from debris and buildup to function properly. The manual override button on top of each valve can be used to test the actuation of each valve.
Page 239: Water Circulation System Cleaning
AND possible patient injury. Use Minncare HD to clean and disinfect the MPS 3 console water circulation system. Follow all manufacturer’s recommendations for preparation, storage, and disposal of disinfection solution.
Page 240 MPS 3 System – System Maintenance 12.1.3.1.Water Circulation System Draining 1. Skip steps 2 and 3 if you are preparing for initial device setup or using a device that has been previously drained (e.g. for storage). 2. Inspect the hoses for discoloration or cloudiness, which may indicate bacterial growth.
Page 241 The MPS 3 water circulation system includes the pump, heater, water reservoirs, fittings, warm / cold valve, temperature sensors, and all interconnected tubing. 1. If it is not already, connect the Hypothermic Reservoir to the MPS 3. Connect the hypothermic reservoir outlet tubing to the MPS 3 inlet fitting. Connect the hypothermic reservoir inlet tubing to the MPS 3 outlet fitting.
Page 242 MPS 3 System – System Maintenance Figure 162: H2O Circ- Clean When the Start button is selected, the cleaning instructions along with the time remaining shall be shown. The MPS circulates the disinfectant solution through the warm and cold water paths for 15 minutes and indicates when the cleaning process is complete.
Page 243 MPS 3 System – System Maintenance 2. Fill the hypothermic reservoir with 3 liters of sterile water or tap water filtered with a 0.22 micron filter. Place hypothermic reservoir lid on the reservoir. 3. Manually purge the circulation system of air (Section 5.5.5).
Page 244: System Controller Cleaning
25 ml of 3% Hydrogen Peroxide to the Hypothermic Reservoir and circulate to inhibit microbial growth. After each use of the MPS 3 System, drain the Hypothermic Reservoir to its drain spout, add an additional 25 ml of 3% hydrogen peroxide, to compensate for dilution of melted ice, and circulate to ensure distribution throughout the water circulation system.
Page 245: Storage Instructions
MPS 3 System – System Maintenance 12.2. Storage Instructions The MPS 3 console that is not in use should be properly cleaned, drained, and stored in a cool, dry location protected from freezing temperatures, see 3.1 Storage Environment. 12.3. Preventative Maintenance Quest Medical Inc.
Page 246 MPS 3 System – System Maintenance 2. The Service Menu is password protected. The technician must enter the correct password to view the Service screen. Figure 163: Service - Passcode Screen 3. Select the Data Logs button to view all the log files available in the system. The operator can select just one or last 10 or last 20 or last 30 or all of the available logs;...
Page 247 MPS 3 System – System Maintenance Figure 165: Data Logs Screen...
Page 248 MPS 3 System – System Maintenance 4. Select the Self Diagnostics button to display the Diagnostics screen. After completion of diagnostics the test result can be copied to the memory. Figure 166: Self Diagnostics Screen 5. Select System Maintenance to view the maintenance screen. The next scheduled Maintenance due date is displayed.
Page 249: Service
This warranty runs to the original purchaser of an MPS 3 console only. If the defect has been caused by those events to which this warranty does not apply, as stated herein above, Quest will repair the defective product, upon receipt of approval of purchaser, at Quest Medical then current charges.
Page 250: Unscheduled Services
A written estimate of the service is provided upon request. Loaner devices are available upon request. Rental fees may apply. For MPS 3 Systems that are out of warranty, a variety of Service Contracts and MPS technical training programs are available. To learn about our Service Contract Options, contact the MPS Service Coordinator line at 1 (888) 510-7623.
Page 251 MPS 3 System – Service incident occurred. To report serious incidents to Quest Medical, send an email to custserv@questmedical.com or call +1 (800) 627-0226.
Page 252 MPS 3 System – Service...
Page 253: Part Numbers And Accessories List
MPS 3 USB UDMS Cable 513USCC MPS 3 RS232 EDMS Cable 513UECG MPS 3 Controller In to ECG Out 5301010-EN Operations Manual - English 5301010-FR Operations Manual - French 5301035-EN MPS 3 and MPS 3 ND Troubleshooting Manual - English...
Page 254: Power Cords
MPS 3 System – Part Numbers and Accessories 15.1.1.Power Cords Part Number REF Country/Region Wall Receptacle Connection 530NA16 North America NEMA 5-15 HG...
Page 255: Mps 3 Delivery Sets
MPS 3 System – Part Numbers and Accessories 15.2.MPS 3 Delivery Sets MPS 3 Delivery Sets with 10 Convolution Heat Exchanger Drug Part Number Blood Source Blood Source Extension Line Cartridges Line ID Line Length Length Included 1/4” 42” 72”...
Page 256 MPS 3 System – Part Numbers and Accessories...
Page 257: Mps 3 Disposables Optional Accessories
MPS 3 System – Part Numbers and Accessories 15.3.MPS 3 Disposables Optional Accessories Part Number Description 5003104 Arrest Agent Cartridge 5003105 Additive Cartridge 5053106 Arrest Agent Delivery Line 5053107 Additive Delivery Line 5001106 3/16” x 10 ft. (120”) Extension Line...
Page 258 MPS 3 System – Part Numbers and Accessories...
Page 259 MPS 3 System – Part Numbers and Accessories...
Page 261: Appendix
17. Appendix 17.1.Electromagnetic Environment Recommendations The MPS 3 System complies with all requirements for electromagnetic compatibility according to the IEC 60601-1-2 4th edition, which applies to the basic safety and essential performance of Medical Equipment (ME) equipment and ME systems in the presence of electromagnetic disturbances.
Page 262: Electromagnetic Emission
MPS 3 System – Appendix device behavior which may be caused by such radiation. The MPS 3 System is intended for use in the electromagnetic environment specified in the tables below. 17.1.1.Electromagnetic Emission Guidance and Manufacturer’s Declaration – Electromagnetic Emissions.
Page 263 0% UT; 70% 25/30 Cycles is recommended that the 61000-4-11 (50/60Hz) product be powered from an uninterruptible power supply or a battery. MPS 3 system 0% UT; 0% 250/300 Cycles is equipped with backup (50/60Hz) (5s) battery.
Page 264 If the measured field strength in the location in which the MPS 3 System are used exceeds the applicable RF compliance level above, the MPS 3 System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the MPS 3 System.
Page 265: Recommended Separation Distance
Guidance and Manufacturer’s Declaration – Recommended Separation Distance The MPS 3 System is intended for use in an environment in which radiated RF disturbances are controlled. The customer or the operator of the device can help prevent electromagnetic interference by...
Page 266: Mps® 3 Aortic Root And Coronary Sinus Transducer Interface Cable
1. Connect transducer end of MPS 3 interface cable to the disposable transducer cable connector. 2. Plug the MPS 3 Aortic Root and/or Coronary Sinus interface cable connector into the red antegrade or blue retrograde port, respectively, on back of the MPS 3 console.
Page 267: Mps® 3 Bypass Tubing Instructions For Use
Indication For Use The MPS 3 Blood Bypass Tubing is only for use as a back-up with the Quest MPS 3 Console to continue fluid delivery in the event of complete battery depletion or if the MPS 3 Console becomes unusable. The Blood Bypass Tubing, when used in conjunction with the MPS Console and Delivery Set, is intended for use by perfusionists and surgeons trained in the delivery of cardioplegia solutions to the myocardium during open heart surgery.
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