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

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Notes: ________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________

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How to Use this User’s Guide This User’s Guide is a reference for you to look up information about the Liberty Cycler. Start with the topic you are interested in, and look for it in the Table of Contents (see page 9) or in the Index (see page 238). 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 8), Glossary (see page 234), and Error Messages Tables (see page 197 and 204) 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.

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Contents Quick Search This page is a quick reminder where to find certain procedures or further instructions: Events Power Failure: 214 Troubleshooting Error Messages: 196 Incomplete Treatment: 16 Alarms (with no sound): 185 Defective cassette/tubing set: 97 Moisture in pump module: 149 Drain Complication: 204 Patient Line is Blocked: 207 Liberty Cycler Settings How to set weight (SI) units: 84 How to change the time/date: 86 How to set screen blanking: 86 How to adjust the alarm/key volume: 86 Treatment Setup How to use the IQdrive: 172 How to set your parameters: 50 Pre-Treatment checklist: 90 How to insert stay•safe PIN connector into stay•safe organizer: 98 Exchanges How to bypass: 166 How to do a STAT drain: 164 Drain times based on Fill volume: 212

Technical Support Number: 1 800 227-2572 8

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Table of Contents

My Treatment Parameters...2 How to Use this User’s Guide ...7 Contents Quick Search ...8 Introduction ... 12 Requirements ... 12 Indications for Use (Purpose of the Liberty cycler) ... 13 Contraindications (When this machine should not be used) ... 13 Peritoneal Dialysis Precautions ... 13 About This User’s Guide ... 14 Related Reading ... 15 Questions? Call Technical Support... 15 General Warnings ... 16 Meet Your Liberty Cycler ... 20 The Control Panel ... 24 The Status Bar ... 26 Touch Screen Buttons ... 28 Navigating With Screen-Buttons ... 30 The Pump Module ... 32 The Cassette and Tubing Set ... 36 The stay•safe Organizer ... 40 The Heater Tray ... 42 Setting up Your Liberty Cycler... 44 Entering Your Prescription ... 48 Setting Your Treatment Parameters ... 50 Select Therapy Tab ... 52 CCPD: Treatment-Based Settings ... 54 CCPD: Cycle-Based Settings ... 56 IPD: Treatment-Based Settings... 58 IPD: Cycle-Based Settings ... 60 PD+: Treatment-Based Settings ... 62 PD+: Cycle-Based Settings ... 64 Tidal: Treatment-Based Settings ... 66 Tidal: Cycle-Based Settings ... 70 Patient Settings Tab ... 74 Options Settings Tab ... 84 Liberty Cycler User’s Guide

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Hardware Settings Tab ... 86 Pre-Treatment Checklist... 90 Starting Your Treatment ... 92 Preparing... 96 Priming ... 110 Connecting Yourself ... 120 Exchanges ... 124 Exchange: Drain 0 ... 126 Exchange: Fill1 ... 128 Exchange: Pause ... 130 Exchange: Dwell ... 134 Ending Your Treatment ... 138 Your Treatment Summary ... 142 Power Down Cycler ... 150 Appendix ... 154 The My Records Screen-Button... 156 Using the STOP key ... 162 Using the STAT Drain ... 164 Bypassing an Exchange ... 166 Using the IQdrive (Optional) ... 172 Using the Wireless Modem (Optional) ... 178 Moving Your Liberty Cycler ... 180 Warnings and Alarms ... 184 Warning: The Help Button ... 190 Alarm: Red Status Bar ... 194 Troubleshooting ... 196 Error messages listed by code ... 197 Error messages listed alphabetically ... 204 Different People Drain Differently ... 212 Power Failure ... 214 Cleaning Your Cycler ... 220 Machine Specifications... 222 Manufacturer’s EMC Declaration ... 226 Product Improvement Policy ... 230 Warranty... 230 Glossary ... 234 Index ... 238

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Introduction & Overview

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Introduction Enjoy the freedom of the new Fresenius Medical Care Liberty 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 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 as well as fully trained and qualified to operate this machine. You and any other user must be able to tell between normal and abnormal operation.

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Indications for Use (Purpose of the Liberty cycler) The Fresenius Medical Care Liberty cycler is indicated for short term (acute) and long term (chronic) peritoneal dialysis.

The Liberty 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 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 Unsafe: Liberty Cycler must not to be used in an MR environment. Liberty 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. Not doing so can sometimes 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 cause low blood pressure (hypotension) or muscle cramping. Or it may pull too little Liberty Cycler User’s Guide

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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 Fresenius Medical Care Liberty cycler-it cannot replace formal training by your healthcare staff. It cannot provide or replace clinical advice.

This manual is specially designed for easy readability and understanding. It has illustrated procedures and step-by-step 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.

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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

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. MR unsafe: This symbol, on the back of your machine, means the machine must not be placed in an MR environment. Related Reading These documents have more information about your Fresenius Medical Care Liberty cycler:  Liberty Cycler Initiation of Treatment Procedure Card (P/N 480070)  Liberty Cycler Handi-Guide (P/N 480089)  Liberty Cycler Field Service Bulletins may be obtained from the Fresenius Medical Care website: www.FMCNA.com or contact your healthcare professional for more information.  Preventative Maintenance Requirements (09-PD-001)  Contact Fresenius Medical Care Quality Systems for information on test procedures to verify sterile items

Questions? Call Technical Support If you have any questions, please call Fresenius Medical Care Technical Support anytime at 1 800 227-2572.

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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: 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 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 the heater tray to be sure it is free of obstructions and does not touch the top of your cycler cabinet. Interference with the heater tray may result in inaccurate dialysate weighing and possibly result in patient injury. 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 tubings, small holes) before beginning treatment. 16

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Warning: Do not use damaged cassettes for your treatment or allow any liquid to drip in or on your machine. Spills from your treatment can lead to serious injury or death. If spills occur, you must contact Technical Support immediately 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 (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, and 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 164 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.

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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. 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. 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. If using a daytime dwell, please consult your health professional before bypassing Drain 0 since bypassing after a daytime dwell may result in reduced dialysis adequacy. Warning: Shock hazard. Do not remove Heater Tray. Refer servicing to qualified personnel. The electrical source must be single phase, three-conductor type at 120/250 VAC 50/60Hz. Your cycler needs a protective earth electrical ground connection. The outlet you use for your cycler must be checked and maintained for a good ground connection to protect you from risk of electrical shock. Warning: Shock hazard. The machine must be plugged directly into an electrical outlet; do not use extension cords or power strips. Do not use power cords other than those provided with your cycler. If you must connect your cycler to a 240V power source, contact Technical Support at 1 800 227-2572 for a power cord rated for 240V. Caution: Do not place your cycler near external heating or cooling sources like heaters or air conditioners. Caution: Your Liberty cycler contains an internal battery. This battery requires no periodic maintenance by the user and should not be replaced by the user. Caution: Your Liberty cycler is a computer controlled electromechanical medical device. It should be installed in an appropriate environment (indoors) free from extremes of temperature and humidity and reasonably protected from dust and dirt contamination or liquid splashes. Failure to install your Liberty cycler according to these guidelines may result in improper operation or early failure of the device or its parts. Caution: The maximum total weight on your cycler’s scale is 15 kg (33 lbs.) or three 5000 mL solution bags. Overloading the scale can cause damage to your cycler. 18

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Caution: Use only cycler tubing sets intended for the Fresenius Medical Care Liberty cycler. Caution: Use only your fingertips on the Touch Screen and cycler keys. Use of other objects, such as pens, may result in damage or premature failure. Caution: The cassette door is pressurized. Do not attempt to open the cassette door until your machine instructs you to do so. Caution: In order to prevent potentially hazardous conditions and ensure the safe operation of the Liberty Cycler, Radio Frequency Identification (RFID) Equipment must be kept at least 3 meters from the system while in operation. Note: Your machine’s operation involves fluids: accidental spills can occur. Spills can cause damage to carpeting and other surfaces. To contain such spills, your machine should be on a spill-tolerant surface. Clean up spills immediately. Note: This manual shows tubing set model 050-87212 which has two stay•safe patient connectors on the patient line. If you use a different tubing set, your healthcare staff is responsible for providing alternate instructions. Fresenius Medical Care manufactures tubing sets for use with the model Liberty cycler. The performance of tubing sets not manufactured by Fresenius Medical Care cannot be guaranteed by Fresenius Medical Care and are therefore the responsibility of the prescribing physician.

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Meet Your Liberty Cycler

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