Liberty Select Cyclers Users Guide Rev A

Liberty Select Cycler User’s Guide © Copyright 2019 Fresenius Medical Care-All Rights Reserved This document contains proprietary information of Fresenius USA, Inc. d/b/a Fresenius Medical Care North America and its affiliates (“Fresenius Medical Care”). The contents of this document may not be disclosed to third parties, copied, or duplicated in any form, in whole or in part, without the prior written permission of Fresenius Medical Care. Fresenius Medical Care, the triangle logo, stay•safe, Liberty and Liberty Select are trademarks of Fresenius Medical Care Holdings, Inc., or its affiliated companies. All other trademarks are the property of their respective owners. This document is for software version 2.9.0 (Liberty Select Cycler). The Liberty® Select Cycler is manufactured by: Fresenius USA, Inc. 4040 Nelson Ave Concord, CA 94520 Caution: Federal (US) law restricts this device to sale only by or on the order of a physician. Caution: Frequency, duration, and treatment settings are to be determined by the prescribing physician. Indications for Use: The Fresenius Liberty Select Cycler is indicated for acute and chronic peritoneal dialysis.

Liberty Select Cycler User’s Guide

P/N 480145 Rev A

1

How to Use this User’s Guide This User’s Guide is a reference for you to look up information about the Liberty Select Cycler. Start with the topic you are interested in, and look for it in the Table of Contents (see page 4) or in the Index (see page 266). The Table of Contents is detailed enough that you should be able to find most topics. If not, refer to the Index for further details. Please note that the Contents Quick Search (see page 3), Glossary (see page 262), and Error Messages Tables (see page 221 and 230) also contain similar information, but presented in a slightly different way. The goal of the User’s Guide is to help you find the information you need quickly and easily.. The User’s Guide is developed as a reference and guidance for information for all of your automated peritoneal dialysis (APD) treatments. The order of the topics presented here is the same order you will follow as you set up your treatment.

2

P/N 480145 Rev A

Liberty Select Cycler User’s Guide

Contents Quick Search This page is a quick reminder where to find certain procedures or further instructions: Events Power Failure: 242 Troubleshooting Error Messages: 218 Incomplete Treatment: 17 Alarms (with no sound): 207 Defective cassette/tubing set: 105 Moisture in pump module: 169 Drain Complication: 231 Patient Line is Blocked: 233 Liberty Select Cycler Settings How to set weight (SI) units: 86 How to change the time/date: 94 How to set screen blanking: 94 How to adjust the alarm/key volume: 94 Treatment Setup How to use the IQdrive: 194 How to set your parameters: 52 Pre-Treatment checklist: 98 How to insert stay•safe PIN connector into stay•safe organizer: 106 Exchanges How to bypass: 186 How to do a STAT drain: 184 Drain times based on Fill volume: 240

Technical Support Number: 1-800-227-2572 Liberty Select Cycler User’s Guide

P/N 480145 Rev A

3

Table of Contents How to Use this User’s Guide ...2 Contents Quick Search ...3 My Treatment Settings ...6 Introduction ... 12 Requirements ... 12 Purpose of the Liberty Select Cycler... 12 Contraindications (When this machine should not be used) ... 13 Peritoneal Dialysis Precautions ... 13 About This User’s Guide ... 14 Peritoneal Cycler Preventive Maintenance: ... 16 Related Reading ... 16 For Technical Questions ... 16 For Medical or Clinical Questions ... 16 General Warnings ... 17 Meet Your Liberty Select Cycler ... 22 The Control Panel ... 26 The Status Bar ... 28 Touch Screen Buttons ... 30 Navigating With Screen-Buttons ... 32 The Pump Module ... 34 The Cassette and Tubing Set ... 38 The stay•safe Organizer ... 42 The Heater Tray ... 44 Setting up Your Liberty Select Cycler ... 46 Entering Your Prescription ... 50 Entering Your Treatment Settings... 52 Select Therapy Tab ... 54 CCPD: Treatment-Based Settings ... 56 CCPD: Cycle-Based Settings ... 58 IPD: Treatment-Based Settings... 60 IPD: Cycle-Based Settings ... 62 PD+: Treatment-Based Settings ... 64 PD+: Cycle-Based Settings ... 66 Tidal: Treatment-Based Settings ... 68 Tidal: Cycle-Based Settings ... 72 Patient Settings Tab ... 76 Options Settings Tab ... 86 Hardware Settings Tab ... 94 Pre-Treatment Checklist... 98 4

P/N 480145 Rev A

Liberty Select Cycler User’s Guide

Starting Your Treatment ... 100 Preparing... 104 Priming ... 122 Ready for Treatment - Connecting Yourself ... 132 Exchanges ... 136 Exchange: Drain 0 ... 138 Exchange: Fill1 ... 140 Exchange: Pause ... 142 Exchange: Dwell ... 148 Additional Drain Option ... 150 Ending Your Treatment ... 154 Your Treatment Summary ... 162 Power Down Cycler ... 170 Appendix ... 174 The My Records Screen-Button... 176 Using the STOP key ... 182 Using the STAT Drain ... 184 Bypassing a Phase ... 186 Using the IQdrive (Optional) ... 194 Using the Wireless Modem (Optional) ... 200 Moving Your Liberty Select Cycler ... 202 Warnings and Alarms ... 206 Warnings and Alarms (continued) ... 208 Warning: The Help Button ... 212 Alarm: Red Status Bar ... 216 Troubleshooting ... 218 Error messages listed by code ... 221 Error messages listed alphabetically ... 230 Different People Drain Differently ... 240 Power Failure ... 242 Cleaning Your Cycler ... 248 Machine Specifications... 250 Manufacturer’s EMC Declaration ... 254 Product Improvement Policy ... 258 Warranty... 258 Glossary ... 262 Index ... 266

Liberty Select Cycler User’s Guide

P/N 480145 Rev A

5

My Treatment Settings Use this page for your treatment values as prescribed by your doctor or practitioner. Use only one of these prescriptions for your treatment.

6

P/N 480145 Rev A

Liberty Select Cycler User’s Guide

Liberty Select Cycler User’s Guide

P/N 480145 Rev A

7

8

P/N 480145 Rev A

Liberty Select Cycler User’s Guide

Liberty Select Cycler User’s Guide

P/N 480145 Rev A

9

Notes: ________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________

10

P/N 480145 Rev A

Liberty Select Cycler User’s Guide

Introduction & Overview

Liberty Select Cycler User’s Guide

P/N 480145 Rev A

11

Introduction Enjoy the freedom that the Liberty Select Cycler offers you. We at Fresenius Medical Care know that life on peritoneal dialysis may be complicated, but we have worked hard to make it simpler. Your Liberty Select Cycler is light, portable, and easy to operate. It has an easy to load cassette and simple touch screen menus to guide you through setup and treatment procedures. Carefully following your doctor or practitioner’s instructions, you have the convenience and freedom of peritoneal dialysis at your fingertips. Be sure to read and follow all instructions and warnings listed in the User’s Guide. Requirements

Operators like you must be trained on the Liberty Select Cycler to perform peritoneal dialysis under the direction of a physician. In addition, each operator should be: 

Knowledgeable of peritoneal dialysis procedures and how they affect the body



Well-practiced in aseptic techniques and other peritoneal dialysis procedures



Very familiar with the contents of this User’s Guide as well as fully trained and qualified to operate this machine. You and any other user must be able to identify between normal and abnormal operation.

Purpose of the Liberty Select Cycler

The Liberty Select Cycler is indicated for short term (acute) and long term (chronic) peritoneal dialysis. The Liberty Select Cycler can provide the following therapies:  Continuous Cycling Peritoneal Dialysis (CCPD)  Intermittent Peritoneal Dialysis (IPD)  Peritoneal Dialysis Plus (PD+)  Tidal Peritoneal Dialysis (TPD) 12

P/N 480145 Rev A

Liberty Select Cycler User’s Guide

Contraindications (When this machine should not be used)

CAPD and CCPD are effective and attractive choices for many ESRD patients; however, no one dialysis therapy is right for all patients. The following health problems may prevent you from using the Liberty Select Cycler: 

Leaks across the inside of your body’s lining (Transdiaphramatic leakage)  A destructive metabolism (hypercatabolism)  Too little peritoneal membrane surface area  Multiple abdominal surgeries This is a guideline only. Your doctor or practitioner must make the final decision whether the Liberty Select Cycler is appropriate for you. MR (Magnetic Resonance) Unsafe: Liberty Select Cycler must not to be used in an MR environment. Liberty Select Cycler may pose unacceptable risks to the patient, medical staff or other persons within the MR environment. Peritoneal Dialysis Precautions

Your doctor or practitioner has prescribed peritoneal dialysis (PD) for you. There are risks to PD, but your doctor feels it is better to perform PD than not. Here are some things you and your doctor or practitioner should consider: You must perform PD treatments according to the prescription given to you by your physician and the manufacturer’s instructions. Not doing so may result in harm. Abdominal pain, bleeding, infected peritoneal membrane (peritonitis), and a blocked catheter extension set can cause problems with your treatment. Some dialysate solutions are stronger (higher percentage of dextrose) than others at removing fluids. It is important to use the right dialysate solution for your needs: the wrong dialysate solution may pull too much fluid (hypovolemia/ dehydration) out of your body and may cause low blood pressure (hypotension) or muscle cramping. Or it may pull too little fluid (hypervolemia/overhydration) and may cause high blood pressure (hypertension) or swelling (edema). You must continue to remove the right amount of fluid from your body. Liberty Select Cycler User’s Guide

P/N 480145 Rev A

13

You and your PD nurse must work together to monitor your body weight and blood chemistry levels. You must pay close attention to how you feel and report any changes to your PD nurse. This may help prevent such complications as congestive heart failure, volume depletion, overfill of solution, shock, and inadequate therapy. Follow your prescription and instructions to reduce the risk of these problems that could result in serious complications. Care partners should carefully monitor patients for the above signs and symptoms. About This User’s Guide

This User’s Guide is a reference for properly trained home users of the Liberty Select Cycler-it does not replace formal training by your PD nurse. It cannot provide or replace clinical advice. This User’s Guide is specially designed for easy readability and understanding. It has illustrated procedures and stepby-step instructions. Follow your machine’s on-screen instructions. Use this User’s Guide as a guide for your machine’s screens. You should read the entire User’s Guide before beginning your treatment. Take note of attention boxes, explained below: Attention Boxes Warning: This symbol warns against an action or situation that could hurt you. If you do not follow these instructions, it can lead to serious injury or death.

Shock Hazard: This symbol means you could get a severe electrical shock if you use the equipment wrong. Caution: This symbol means you will damage your machine if you do not follow instructions. Note: This symbol means there is extra information about machine features. Notes have helpful information and tips. They may also show instructions for unique cases. 14

P/N 480145 Rev A

Liberty Select Cycler User’s Guide

Other Important Symbols Degree of protection against electric shock: Type BF

Symbol for Alternating Current (AC). Symbol for a Protective ground terminal. This symbol with the finger pinch in the background means to keep fingers clear of any moving parts. ON: This symbol, at the top of the switch on the back of your machine, means the switch is in the ON position. OFF: This symbol, at the bottom of the switch on the back of your machine, means the switch is in the OFF position. This symbol stands for the USB port located on the back of the machine. This port is where you connect your IQdrive. This symbol stands for the RS232 Serial Port Connection on the cycler’s rear panel (for modem only). This symbol on the back of your cycler means to consult the operating instructions for proper use of the equipment. MR (Magnetic Resonance) unsafe: This symbol, on the back of your machine, means the machine must not be placed in an MR environment. This symbol on the back of your cycler indicates that Interference may occur in the vicinity of the machine.

Liberty Select Cycler User’s Guide

P/N 480145 Rev A

15

Peritoneal Cycler Preventive Maintenance:

All Fresenius Medical Care Peritoneal Cyclers are designed to detect drifting calibrations and mechanical failures through an extensive self-check built into the machine. This check is done each time the machine is powered on. Functional parameters are also continuously monitored throughout the treatment. The only required maintenance is surface cleaning as stated in the User’s Guide. If problems do occur, in most cases Fresenius Medical Care will replace the cycler within 1 working day and, if applicable, arrange to pick up the used cycler. The replacement policy applies only to those cyclers that remain the property of Fresenius Medical Care North America. History files on these devices are maintained by Fresenius Medical Care North America. Related Reading

These documents have more information about your Liberty Select Cycler: 

Liberty Select Cycler Initiating Treatment Procedure Card



Liberty Select Cycler Handi-Guide



Liberty Select Cycler Field Service Bulletins may be obtained from the Fresenius Medical Care website: www.FMCNA.com or contact your healthcare professional for more information.

For Technical Questions

If you have any questions, please call a Fresenius Medical Care Technical Support Representative anytime at 1-800227-2572. For Medical or Clinical Questions

Call your home therapy nurse or on-call nurse.

16

P/N 480145 Rev A

Liberty Select Cycler User’s Guide

General Warnings Read all the warnings before beginning your treatment. Additional warning statements for each topic are found throughout the User’s Guide.

Warning: Read this entire User’s Guide before beginning your treatment. You must be familiar with how to use your machine and with the features of this User’s Guide. If you do not follow these instructions to install and maintain this equipment, it may cause serious injury or death. Warning: Protective measures MUST be taken to prevent backup in the drain line. When connecting the drain line, ensure that an air gap is maintained between the drain line and the drain. Warning: Your doctor or practitioner must prescribe your entire treatment. If you use incorrect values, it may cause serious injury or death. Do not use example values shown in machine pictures. Warning: In the event of an incomplete treatment, call your doctor, practitioner, or PD nurse. Warning: Check for proper functioning of your machine before beginning your treatment. Alarm failure or unidentified problems could lead to serious health risks. Warning: Keep fingers clear of moving parts. Warning: The Liberty Select Cycler is not sterile equipment. Only the interior of the tubing sets are sterilized. You must use aseptic technique (masking and hand washing) as directed by your PD nurse to prevent infection. Infections may cause serious injury or death. Warning: Explosion Hazard. Do not use in the presence of flammable substances like anesthetics. Warning: Check that all tubing is free from kinks or damage (scratches, loose tubing, small holes) before beginning treatment. Liberty Select Cycler User’s Guide

P/N 480145 Rev A

17

Warning: Do not use damaged cassettes for your treatment. Damaged cassettes can lead to leaks, contamination, and infection. Warning: Do not allow any liquid to drip in or on your machine. Spills from your treatment can lead to serious injury or death. If spills occur, immediately contact a Fresenius Medical Care Technical Support Representative at 1-800-227-2572. Do not attempt to clean or disinfect leaks inside your cycler. Warning: You must clean your machine to prevent contamination and infection. Warning: Do not use devices emitting strong electromagnetic radiation such as portable phones, radio equipment (walkie-talkies, etc.), radio transmitters, and like equipment near your machine. Improper operation may result. Digital phones may be conditionally allowed. Discontinue use of any device if any interference is noted, such as false pressure readings that disappear when the external signal is removed. Warning: You must keep your machine away from pets, pests and children to prevent contamination and infection. Warning: Use caution when handling the cycler tubing set as it may cause strangulation. Warning: The power cord, tubing set and drain line(s) can be a trip hazard and may result in falls. Warning: If the fluid in the drain line appears cloudy, contact your PD nurse because this could be an early sign of infection.

18

P/N 480145 Rev A

Liberty Select Cycler User’s Guide

Warning: Increased Intraperitoneal Volume (IIPV), commonly known as Overfill, is when you have too much fluid in your abdomen. IIPV/overfill may result in serious injury or death from conditions such as: abdominal wall and/or diaphragmatic hernias, hydrothorax, heart problems including chest pain and heart failure, high blood pressure, pulmonary edema, decreased pulmonary function and pericardial effusion. Patients and care partners should watch for the potential signs of IIPV. These include:  Difficulty breathing  Vomiting or spitting up  Feeling full, bloated, or overfilled after treatment  Abdominal pain or discomfort  Expanded or tense abdomen  Chest pain  Increased blood pressure  Change in mental status  Leakage of fluid from the PD catheter extension exit site. If you experience any of these symptoms or feel a large, painful build-up of pressure during your fill, do not finish your fill cycle. Press the STOP key and immediately initiate a STAT Drain or perform a manual drain as instructed by your PD nurse. See page 184 for more information on how to use the STAT Drain feature. Once the fluid is completely drained from your abdomen, call your doctor, practitioner, or PD nurse. Warning: If you have no Last Fill programmed on your cycler and you did a manual Fill during the day, your cycler does not know that you must drain additional fluid from the abdomen. If your catheter extension set line then gets kinked during Drain 0 and the draining stops, your cycler may advance to Fill 1 before you have finished draining your abdomen. This may cause an overfill situation which may lead to serious injury or death. Always make sure that you have drained enough during Drain 0 when your cycler starts Fill 1. Drain 0 may be bypassed under certain circumstances. Please consult your PD nurse before bypassing Drain 0. See page 186 for more information.

Liberty Select Cycler User’s Guide

P/N 480145 Rev A

19