PrisMax Operators Manual Ver 2.xx Rev B June 2019

PrisMax Operator's Manual

Program version: 2.XX Order number: AW8035

2Trademarks PrisMax and Baxter are trademarks of Baxter International Inc Legal Manufacturer

Baxter Healthcare SA 8010 Zurich Switzerland

AW8035 Rev B JUN2019 Program version: 2.XX

Table of contents - 3

PrisMax overview

5

Powering on/off | User interface | System configuration | Cleaning | Maintenance and testing

PrisMax operating instructions

39

Selecting the treatment | Connecting sets and fluids | Priming and connecting the patient | Running the treatment | Stopping the treatment

Alarms and troubleshooting

91

Alarms | Troubleshooting

General information

171

About the general information | Warnings, cautions and notes | Indication for use | Contraindications | Keywords used in this manual | Responsibility and disclaimer | Symbols | Color coding | Certification marks | Installation, service and transport | Disposal

Therapies

193

About the therapies | Abbreviations | Pressure handling (all therapies) | Continuous Renal Replacement Therapies (CRRT) | Therapeutic Plasma Exchange (TPE)

Device description

233

Control unit functions | Flow path management | Fluid management | Air management | Anticoagulation | Components | Control unit | Power control panel | Pumps | Left side panel and drip tray | Pressure sensors and deaeration chamber holder | Pinch valves, return clamp and detectors | Front scales | Miscellaneous components | Back panel | Remote screen viewing | On device training AW8035 Rev B JUN2019 Program version: 2.XX

4 - Table of contents

Sets and accessories

267

Disposable sets | Blood warmers | Auto Effluent (AE) accessory | Other accessories

Specifications

285

Environmental | Physical | Hardware | Medical device classification | Scales | Power | Electrical safety | External interfaces | Compliance | Settings | Displayed data | Syringe | Flow rates and accuracy | Alarm notification | Access line pressure sensor | Return line pressure sensor | Filter pressure sensor | Effluent line pressure sensor | Absolute atmospheric pressure sensor | Air Bubble Detector (ABD) | Blood Leak Detector (BLD) - Effluent | Disposable set specifications | History data | Service specifications | Guidelines and manufacturer’s declaration of electromagnetic emissions and immunity | Disposable set life | Supported blood warmers | Logged data | Syringe pump accuracy

Glossary Glossary (alphabetically sorted)

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PrisMax overview - 5

Chapter 1

PrisMax overview Powering on/off

7

User interface

9

Using the touchscreen ... 9 Toolbar ... 11

System configuration

21

About system configuration ... 21 Display ... 22 Sound ... 23 Advanced settings (site experts and administrator users only) ... 24 Cybersecurity ... 28

Cleaning

31

About cleaning ... 31 Cleaning the Blood Leak Detector (BLD) ... 33 Cleaning the touchscreen ... 33

Maintenance and testing Self tests ... 34 Preventive Maintenance (PM) ... 35 Blood Leak Detector (BLD) normalization ... 36 Pressure pod reposition procedures ... 37 AW8035 Rev B JUN2019 Program version: 2.XX

34

6 - PrisMax overview

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PrisMax overview - 7

PrisMax overview Powering on/off WARNING! After turning on the control unit, verify that the red status light is lit, and the speaker is activated during the start-up sequence. In case of malfunction, turn off the control unit, unplug the control unit, and call service. NOTE! The intended operator position during PrisMax operation is by the patient or at the front of the control unit. Follow these steps to turn the control unit on ( "Power control panel", page 8): 1. Connect the system power cord to AC power. The AC power indicator will illuminate green. 2. Press the green On/Standby button. The status light at the top of the display turns green, and the Power-on Screen appears. 1. If the system passes the Power-On-Self-Test (POST) the Start screen ( "Start screen", page 9) appears. If a POST failure is displayed, reset the system. If the POST failure continues, call service. To power off, press and hold the On/Standby button until the screen turns off. 3. If a filter set, solutions, or bags are already connected to the system, tap the End button, and follow the onscreen instructions to remove the components.

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8 - PrisMax overview

Figure Power control panel 1. On/Standby button: Turns the PrisMax system on or places it in standby. When the system is on, the display and all electronics are on. Press and hold to go into standby. When the system is in standby, all electronics are off, except for power supply and battery charging. To completely remove power from the system, disconnect the AC plug from the wall when the device is in standby.

2. Power indicator (green): Alternating current (AC) or battery power connected to the system. On: system running on AC. Off: no AC. Flashing: running on battery or battery charging during standby mode.

3. Stop button: Stops all motors and closes the return clamp. This provides an independent way to stop the device if the screen fails.

4. Stop indicator (yellow): Control unit is stopped (all pumps stopped).

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Figure Start screen

User interface Using the touchscreen The PrisMax system uses two types of screens: the Procedure screens and the Operations screen. The Procedure screens guide the operator through the starting and stopping of a therapy. The Operations screen is the home screen used during therapy. Any other information is displayed as pop-up windows on the screen. The toolbar is always visible at the top of the screen. Procedure screen See "Procedure screen", page 10, that shows the layout and key elements of a Procedure screen.

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10 - PrisMax overview

Figure Procedure screen 1. Toolbar buttons, see "About the toolbar", page 11.

2. Procedure steps in suggested order. The active steps are shown in full color, while inactive steps are dimmed. A check mark shows that a step is complete.

3. Advisory information for the current step, if any.

4. Text and illustration about the current step. The illustration shows the completed step and not the current status.

5. Available actions. Active buttons are in full color, and inactive buttons are dimmed. Tap to perform an action.

6. Help screen tap to display a help screen for the current step, if available.

Operations screen See "Operations screen", page 11, that shows the layout and key elements of the Operations screen. The screen appears during therapy.

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Figure Operations screen 1. Toolbar buttons. See "About the toolbar", page 11.

2. Animated set illustration.

3. Current pressure measurements and limits.

4. Treatment status information.

5. Message center showing the most recent alarms and events.

Toolbar About the toolbar The toolbar can include the following (not all buttons appear in every situation):

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12 - PrisMax overview Table Toolbar Current operating mode and therapy. The title of the button changes between Setup, Therapy, END, B-Recirc and S-Recirc depending on the operating mode of the PrisMax system. Tap to view prescription summary. Allows the operator to change patient weight and Hct.

Only shown if an active alarm is minimized. The color of the warning triangle is based on the priority of the alarm that is minimized. Tap to view the alarm window.

Only shown if an alarm is currently overridden/alarm off. Tap to view a list of overridden alarms. It is possible to clear all overrides from this screen.

Tap to select a history data display (Prescription, Dose, PFR, Events, Pressures, Temperatures). See "History", page 14, for more information.

Tap to select a system tool, such as normalize blood leak detector (BLD) or adjust deaeration chamber. See "Tools overview", page 15, for more information.

Tap to configure the system (display brightness, sound level, or system information). See "About system configuration", page 21, for more information.

Tap to lock the screen. Protects against inadvertent screen selections and allows cleaning. See "Lock", page 20, for more information.

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PrisMax overview - 13

Tap to view general help information.

Current date, time, and power source.

System running on AC power, battery fully charged.

System running on AC power, battery not fully charged.

System running on battery power.

System running on battery power, low battery charge.

System running on AC power, battery not charging.

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14 - PrisMax overview

During Setup, tapping the button cancels the setup procedure. During therapy, tap to stop control unit. Stops all motors and closes the return clamp. Select one of the options from the pop-up window (resume treatment, discard set, blood recirculation, or saline recirculation). The button changes title from CANCEL to STOP to END depending on the operating mode of the PrisMax system.

Tap to take a screenshot. This button is only available if previously selected from the Tools menu.

History

The PrisMax system continuously stores and updates the control unit conditions and operating data. Tap the History button to view the History screen. See "History screen",page 15. The History button is active during Therapy or End mode. It is also active in Setup mode if continuing treatment on the same patient.

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Figure History screen History includes I/O data, events, and graphs related to pressures. The I/O data includes the current period and the cumulative fluid removal volumes during treatments. All events during Setup and Therapy are stored in the order of occurrence in a treatment file. Each event includes a description, time, and date. Graphs of the operating pressures are accessible from the Pressure History screen. Saving history data The PrisMax system saves the history data for each treatment as a treatment file. The system stores up to 400 MB of treatment files data. If the memory is full, the oldest treatment file is replaced with the new treatment file. The history data can only be accessed while in Service mode. Tools overview

Tap the Tools button to select a system tool from the pop-up window ( "Tools window", page 16). AW8035 Rev B JUN2019 Program version: 2.XX

16 - PrisMax overview

Figure Tools window Normalize Blood Leak Detector (BLD) WARNING! Fluid in effluent line must be verified to be free of blood before normalizing the blood leak detector. The Normalize Blood Leak Detector (BLD) tool normalizes the detector signal to a value that indicates that no blood is present in the effluent line. The system automatically normalizes the blood leak detector when priming is complete. Use this tool to normalize the blood leak detector if the effluent line is removed and then replaced during treatment. Adjust deaeration chamber NOTE! Increasing the fluid level in the deaeration chamber draws the excess air into the monitor line and out through the return line pressure port. The PrisMax system automatically monitors and adjusts the fluid level in the deaeration chamber. This tool is available only during therapy and after prime has completed and provides the means to adjust the level that the auto adjustment uses as a target level. Disabling the auto liquid level adjustment for the deaeration chamber allows for manual

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adjustment of the level, but fluid leveling will no longer be automatic and subject to flow rate factors. The fluid level can vary because of events during the treatment. For example, changing a solution bag can introduce a small amount of air into the set. A fluid level that is too high increases the risk of wetting the return line fluid barrier. A wet fluid barrier blocks the return line, causing the loss of return pressure monitoring. A fluid level that is too low can cause an alarm because of air bubbles going from the deaeration chamber to the Air Bubble Detector (ABD).

Figure Recommended fluid level Sometimes a significant amount of foam can form at the top of the deaeration chamber. If the foam reaches the fluid barrier, it can interfere with the return pressure monitoring and cause alarms. The automatic liquid level function is able to detect foam and will make the appropriate adjustments to try and avoid reaching the fluid barrier. Increasing the post-replacement infusion rate may reduce the amount of foam. Initiate self test The PrisMax system automatically does a complete self test ten minutes after the treatment begins and then every two hours after that. If an alarm goes off at the scheduled start of a periodic self test, the periodic self test may be delayed. AW8035 Rev B JUN2019 Program version: 2.XX

18 - PrisMax overview The software handles some alarms differently during the self test. Some alarm limits temporarily change or are disabled during the self test. The self test checks the functionality of the following components: • Automatic Reposition System (ARPS) pump • Blood Leak Detector (BLD) • Discharge ring guide • Liquid Level Sensor (LLS) • Pressure sensors • Return clamp

Initiating a self test To start a full self test, or an individual test, do the following: 1. Tap the Tools button. 2. Tap Self Test. 3. Tap Run All Self Tests, or tap an individual test. The status of the self test is displayed when the Self Test window is open. See "Self test window", page 19.

An advisory message shows during the self test in the message center, and the pressure alarm bars turn grey. If any part of the self test fails, an alarm message shows the problem and suggests corrective action. This is available only during therapy.

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Figure Self test window Test connectivity This tool verifies the function of the control unit back panel connectors by sending a test alarm and toggling the nurse call relay. The Test Connectivity window ( "Test connectivity window", page 19) shows the current port settings. Tap the Alarm button to generate a test alarm.

Figure Test connectivity window AW8035 Rev B JUN2019 Program version: 2.XX