Liberty PDx Users Guide Rev B

Liberty PDx Cycler User’s Guide © Copyright 2014, 2016, 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, and Liberty are trademarks of Fresenius Medical Care Holdings, Inc., and/or its affiliated companies. All other trademarks are the property of their respective owners. This document is for software version 1.0.0. The Liberty® PDx 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 Liberty PDx Cycler is indicated for acute and chronic peritoneal dialysis.

Liberty PDx Cycler User’s Guide

P/N 480054 Rev B

1

How to Use this User’s Guide This User’s Guide is a reference for you to look up information about the Liberty PDx Cycler. Start with the topic you are interested in, and look for it in the Table of Contents or in the Index (see page 250). 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, Glossary (see page 246), and Error Messages Tables (see page 204 and 213) also contain similar information, but presented in a slightly different way. The User’s Guide’s goal is to create many different ways for you to quickly and easily get the information.

2

P/N 480054 Rev B

Liberty PDx Cycler User’s Guide

Contents Quick Search This page is a quick reminder where to find certain frequently used procedures or further instructions: Treatment Issues Power Failure: 224 Troubleshooting Error Messages: 202 Incomplete Treatment: 18 Alarms (with no sound): 191 Defective cassette/tubing set: 101 Moisture in pump module: 155 Drain Complication: 213 Patient Line is Blocked: 216 Liberty PDx Cycler Settings How to set weight (SI) units: 88 How to change the time/date: 90 How to set screen blanking: 90 How to adjust the alarm/key volume: 90 Treatment Setup How to use the IQdrive: 178 How to program your settings: 54 Pre-Treatment checklist: 94 How to insert trigger into stay•safe patient connector: 102 Exchanges How to bypass: 172 How to do a STAT drain: 170 Drain times based on fill volume: 222

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

P/N 480054 Rev B

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 PDx Cycler ... 13 Contraindications (When this machine should not be used) ... 13 Peritoneal Dialysis Precautions ... 13 About This User’s Guide ... 14 Related Reading ... 16 Questions? Call Technical Support... 16 General Warnings ... 18 Meet Your Liberty PDx Cycler ... 24 The Control Panel ... 28 The Status Bar ... 30 Touch Screen Buttons ... 32 Navigating With Screen-Buttons ... 34 The Pump Module ... 36 The Cassette and Tubing Set ... 40 The stay•safe Organizer ... 44 The Heater Tray ... 46 Setting up Your Liberty PDx Cycler ... 48 Entering Your Prescription ... 52 Setting Your Treatment Settings ... 54 Select Therapy Tab ... 56 CCPD: Treatment Based Settings... 58 CCPD: Cycle Based Settings ... 60 IPD: Treatment Based Settings ... 62 IPD: Cycle Based Settings ... 64 PD+: Treatment Based Settings ... 66 PD+: Cycle Based Settings ... 68 Tidal: Treatment Based Settings ... 70 Tidal: Cycle Based Settings ... 74 Patient Settings Tab ... 78 Options Settings Tab ... 88 Hardware Settings Tab ... 90 4

P/N 480054 Rev B

Liberty PDx Cycler User’s Guide

Pre-Treatment Checklist ... 94 Starting Your Treatment ... 96 Preparing... 100 Preparing (Continued) ... 102 Performing Flush ... 114 Priming ... 116 Connecting Yourself ... 126 Exchanges ... 130 Exchange: Drain 0 ... 132 Exchange: Fill 1 ... 134 Exchange: Pause ... 136 Exchange: Dwell ... 140 Ending Your Treatment ... 144 Your Treatment Summary ... 148 Power Down Cycler ... 156 Appendix ... 160 The My Records Screen-Button ... 162 Using the STOP key ... 168 Using the STAT Drain ... 170 Bypassing an Exchange ... 172 Using the IQdrive (Optional) ... 178 Using the Wireless Modem (Optional) ... 184 Moving Your Liberty PDx Cycler ... 186 Warnings and Alarms ... 190 Warning: The Help Button ... 196 Alarm: Red Status Bar ... 200 Troubleshooting ... 202 Error messages listed by code ... 204 Error messages listed alphabetically ... 213 Different People Drain Differently ... 222 Power Failure ... 224 Power Fail Recovery ... 226 Cleaning Your Cycler ... 232 Machine Specifications... 234 Manufacturer’s EMC Declaration ... 238 Product Improvement Policy ... 242 Warranty... 242 Glossary ... 246 Index ... 250

Liberty PDx Cycler User’s Guide

P/N 480054 Rev B

5

My Treatment Settings Use this page for your treatment values as prescribed by your doctor. Use only one of these prescription cards for your treatment.

6

P/N 480054 Rev B

Liberty PDx Cycler User’s Guide

Liberty PDx Cycler User’s Guide

P/N 480054 Rev B

7

8

P/N 480054 Rev B

Liberty PDx Cycler User’s Guide

Liberty PDx Cycler User’s Guide

P/N 480054 Rev B

9

Notes: ________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________

10

P/N 480054 Rev B

Liberty PDx Cycler User’s Guide

Introduction & Overview

Liberty PDx Cycler User’s Guide

P/N 480054 Rev B

11

Introduction Enjoy the freedom of the Liberty PDx Cycler. 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 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’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 manual. Requirements Operators of your Liberty PDx Cycler machine must be trained 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 manual  Fully trained and qualified to operate this machine. You and any other user must be able to tell between normal and abnormal operation. 

12

P/N 480054 Rev B

Liberty PDx Cycler User’s Guide

Purpose of the Liberty PDx Cycler The Liberty PDx Cycler is indicated for short term (acute) and long term (chronic) peritoneal dialysis.

The Liberty PDx Cycler can provide the following therapies: continuous cycling peritoneal dialysis (CCPD), intermittent peritoneal dialysis (IPD), peritoneal dialysis plus (PD+), and tidal peritoneal dialysis (TPD). 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 likely prevent or impair you from using the Liberty PDx 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 must make the final decision whether or not any medical device is appropriate for you. MR (Magnetic Resonance) Unsafe: Liberty PDx Cycler must not to be used in an MR environment. Liberty PDx Cycler may pose unacceptable risks to the patient, medical staff or other persons within the MR environment. Peritoneal Dialysis Precautions Your doctor 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 your doctor should consider:

You must perform PD treatments according to the prescription given to you by your physician and the manufacturer’s instructions. By not doing so, it may result in harm. Abdominal pain, bleeding, infected peritoneal membrane (peritonitis), and a blocked catheter 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 Liberty PDx Cycler User’s Guide

P/N 480054 Rev B

13

body and cause low blood pressure (hypotension) or muscle cramping. Or it may pull too little fluid (hypervolemia) and cause high blood pressure (hypertension) or swelling (edema). You must continue to correctly remove fluid from your body. You and your PD Nurse must work together to monitor your weight and blood chemistry levels. You must pay close attention to how you feel and report any changes to your PD Nurse. This will help prevent such complications as congestive heart failure, volume depletion, overfill of solution, shock, and inadequate therapy. Follow your doctor’s prescription and instructions to reduce the risk of these problems that could result in serious complications. Caregivers 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 PDx Cycler-it cannot replace formal training by your PD Nurse. It cannot provide or replace clinical advice.

This manual is specially designed for easy readability and understanding. It has illustrated procedures and step-bystep instructions. Follow your machine’s on-screen instructions. Use this manual only 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.

14

P/N 480054 Rev B

Liberty PDx Cycler User’s Guide

Note: This symbol means there is extra information about machine features. Notes have helpful information. They may also show instructions for unique cases. Other Important Symbols Degree of protection against electric shock: Type BF

Symbol for Alternating Current (AC). This symbol indicates the machine is classified as Class II equipment. 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 which allows connections to an 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 PDx Cycler User’s Guide

P/N 480054 Rev B

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. Our history on these machines indicates that the only required maintenance is surface cleaning as stated in the Users Guide.

If problems do occur, in most cases Fresenius Medical Care will either replace or repair the cycler within 1 working day and if applicable, make arrangements to pick up the used cycler. The replacement policy applies only to those cyclers that remain the property of Fresenius USA, Inc. History files on these devices are maintained by Fresenius USA, Inc. Related Reading These documents have more information about your Liberty PDx Cycler:  Liberty PDx Cycler Initiation of Treatment Procedure Card (P/N 480055)  Liberty PDx Cycler Handi-Guide (P/N 480056)  Liberty PDx Cycler Field Service Bulletins may be obtained from the Fresenius Medical Care website: www.FMCNA.com or contact your healthcare professional for more information. Questions? Call Technical Support If you have any questions, please call Fresenius Medical Care Technical Support anytime at 1-800-227-2572.

16

P/N 480054 Rev B

Liberty PDx Cycler User’s Guide

This Page is Intentionally Blank

Liberty PDx Cycler User’s Guide

P/N 480054 Rev B

17

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

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 manual. 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 back syphonage of the outflow path. Ensure that when connecting the drain line that an adequate air gap is maintained between the dialyzing solution circuit and the drain. Warning: Your doctor 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 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 PDx 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: Check that all tubing is free from kinks or damage (scratches, loose tubings, small holes) before beginning treatment.

18

P/N 480054 Rev B

Liberty PDx Cycler User’s Guide

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 Technical Support at 1-800227-2572. 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 (walkietalkies, 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: 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 caregivers 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 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 as instructed by your PD Nurse. See page 170 for more information on how to use the STAT drain feature. Once the fluid is completely drained from your abdomen, call your doctor or PD Nurse. Liberty PDx Cycler User’s Guide

P/N 480054 Rev B

19