NEWTON IQ CYCLER Operator Manual Rev H

NEWTON IQ® CYCLER OPERATOR MANUAL Copyright  2000 - 2014, Fresenius Medical Care North America, All Rights Reserved.

EFFECTIVE

This document contains proprietary and confidential 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. NEWTON IQ, stay•safe, and Safe-Lock, PD Plus and IQcard are trademarks of Fresenius Medical Care Holdings, Inc. All other trademarks are the property of their respective owners. US Federal law restricts this device to sale only by or on the order of a physician. Frequency, duration, and parameters of treatment are to be determined by the prescribing physician. Indications for use: the Fresenius NEWTON IQ Cycler is indicated for acute and chronic peritoneal dialysis.

P/N 470203 Rev. H

i Printed : 07/21/2014 12:50 PM EDT

TABLE OF CONTENTS 1.

GETTING YOUR CYCLER READY ...1

EFFECTIVE

a. Receiving the Cycler ...1 b. Setting-Up the Cycler ...1 c. Cycler Stand Assembly Instructions ...2 d. Cycler Control Unit Setup ...3 2.

THE CYCLER FRONT PANEL ...7

3.

TYPES OF THERAPY ...9 a. PD Plus Therapy ...9 b. Continuous Cycling Peritoneal Dialysis (CCPD) ...9 c. Intermittent Peritoneal Dialysis (IPD) ...10 d. Tidal Peritoneal Dialysis (TPD) ...10

4.

SETTING THE CYCLER DATE AND TIME ...11

5.

TREATMENT SETTINGS AND OPTIONS ...12 a. Patient Weight (PT WEIGHT) ...13 b. Number of Fills (# FILLS)...13 c. Number of Pauses (# PAUSES) ...13 d. Pause Volume (PAUSE VOL) ...14 e. CCPD Volume (CCPDVOL) ...15 f. Last Fill Volume (LAST FILL) ...15 g. Total Volume (TOTAL VOL) ...16 h. Fill Time (FILL TIME)...16 i. Dwell Time (DWELL TIME) ...16 j. Drain Time (DRAIN TIME) ...16 k. Sleep Time (SLEEP TIME) ...17 l. Data Sheet (DATA SHEET) ...17 m. Patient Data (PATIENT DATA) ...18 n. Fast Fill/Drain (FAST FILL/DRAIN) ...18 o. Last Bag Alarm (LAST BAG ALARM) ...19 p. Prewarm Bags (PREWARM BAGS) ...20 q. RX Start Time (RX START TIME) ...20 r. Tidal Settings (TIDAL SETTINGS) ...21

ii

P/N 470203 Rev. H Printed : 07/21/2014 12:50 PM EDT

6.

ADDITIONAL OPTIONS ...22

EFFECTIVE

a. Screen Blanking (SCREEN BLANKING) ...23 b. Alarm Volume (ALARM VOLUME) ...23 c. Alarm Pitch (ALARM PITCH) ...23 d. Language (LANGUAGE) ...23 e. Allow > 3 Liters? (ALLOW>3 LITERS?) ...24 f. Weight Units (WEIGHT UNITS) ...24 g. IQcard Used? (IQCARD USED?) ...24 h. Add Diurnal UF? (ADD DIURNAL UF?) ...24 7.

USING THE PRESCRIPTION UPLOAD FEATURE ...25

8.

YOUR PERSONAL PRESCRIPTION ...26

9.

GETTING READY FOR YOUR TREATMENT ...27 a. Prepare cycler for use ...27 b. Tubing Set-Up...28 c. Connecting to the solution bags ...31 d. Tubing Flush and Prime ...32 e. Connecting to the Cycler – Leave your mask on. ...34

10. THE TREATMENT ...36 a. Treatment Phases (All Therapy Types) ...36 b. Using One PAUSE...38 c. Using Multiple PAUSES ...40 d. Connecting to the Cycler after more than one Pause Exchange: ...41 e. Interrupting the Treatment ...42 f. Bypassing...43 g. Moving the cycler During Your Treatment ...43 h. Completing the Treatment ...44 11. DISCONNECTING FROM THE CYCLER ...45 12. PATIENT DATA ENTRY FEATURE...46 13. SETTING UP FOR THE NEXT TREATMENT ...48 14. LOOKING AT YOUR TREATMENT RECORD ...49

P/N 470203 Rev. H

iii Printed : 07/21/2014 12:50 PM EDT

a. Cycle (CYC)...49 b. Fill (FILL) ...50 c. Drain (DRAIN) ...50 d. Ultrafiltration (UF) ...50 e. Total Cycler Dwell Time ...52

EFFECTIVE

15. ALARMS ...53 a. Both Cover Open...54 b. Cooling Alarm ...55 c. Drain Alarm ...56 d. Emptying Alarm...57 e. Fill Alarm ...58 f. Interrupt Too Long ...59 g. IQcard Batt Dead ...60 h. IQcard Batt Low ...60 i. IQcard Is In ...61 j. IQcard Not In ...62 k. IQcard Not Initialized ...63 l. IQcard Write Protected ...64 m. Last Bag Alarm ...65 n. Valve Cover Open...65 o. Mid-Drain Alarm ...66 p. Mid-Fill Alarm ...68 q. Not Flushing Alarm ...69 r. No Upload During Treatment ...70 s. Overfill Alarm ...70 t. Place Bags on Scale ...71 u. Priming Alarm ...72 v. Pump Error ...73 w. Pump Head Open ...74 x. Pump Leak Alarm ...74 y. Scale Alarm...75 z. Scale Error ...76 aa. Take Bags off Scale...77 bb. Treatment Setting Corrupted ...78 cc. Warming Alarm...79 dd. Zero Fill Volume Alarm ...80 16. ABANDON TREATMENT ALARMS ...82

iv

P/N 470203 Rev. H Printed : 07/21/2014 12:50 PM EDT

17. IN THE EVENT OF A POWER FAILURE ...84 18. DESCRIPTION ...85 19. GLOSSARY OF TERMS ...86 20. SPECIFICATIONS ...87 21. MAINTENANCE...88

EFFECTIVE

22. WARNINGS AND PRECAUTIONS ...89 23. LIMITED WARRANTY ...93

P/N 470203 Rev. H

v Printed : 07/21/2014 12:50 PM EDT

EFFECTIVE

THIS PAGE INTENTIONALLY LEFT BLANK

vi

P/N 470203 Rev. H Printed : 07/21/2014 12:50 PM EDT

1. GETTING YOUR CYCLER READY a. Receiving the Cycler The Cycler is delivered to you at your home. Everything needed for the Cycler is included in one box. It is best if you set up the Cycler Stand first. Once the Cycler Stand is set up, the Cycler Control Unit, Manifold Holder and Pump-to-Drain simply hook onto the Cycler Stand. b. Setting-Up the Cycler

EFFECTIVE

A complete list of Cycler parts needed for setup is as follows: 1. Operator Instructions 2. Newton IQ Procedure Card P/N 470210 3. Newton IQ Assembly Procedure Card P/N 470211 4. Stand Poles (upper pole and lower pole) 5. Cycler Stand Base 6. 2 Hitch Pins (locking pins) 7. Hanger Rod (for hanging Cycler Control Unit onto Cycler Stand) 8. 20-Liter Bag Organizer (used on top of the Cycler Heater/Scale) 9. Cycler Control Unit 10. Drain Hook (for Drain Bag) 11. Pump-to-Drain 12. Pump-to-Drain Hanger Bracket 13. Manifold holder (used on top of the cycler stand) OPERATOR INSTRUCTIONS

NEWTON IQ CYCLER

1 Printed : 07/21/2014 12:50 PM EDT

GETTING YOUR CYCLER READY (cont’d) c. Cycler Stand Assembly Instructions Hole for Hanger Rod

EFFECTIVE

Upper Pole

Pump-to-Drain Hanger Bracket

Upper Hitch Pin Lower Pole Lower Hitch Pin

1. Place the Lower Pole into the Cycler Stand Base. Make sure the holes in both the Lower Pole and the Cycler Stand Base are lined up so that the Lower Hitch Pin will go through both pieces to hold them together. 2. Press and hold the button on the end of the Lower Hitch Pin to flatten the locking bearings. Push the Lower Hitch Pin through the lined-up holes in the Lower Pole and the Cycler Stand Base. Let go of the button. This locks the Lower Hitch Pin in place. 3. Place the Upper Pole into the Lower Pole. Line up the holes in both poles. Slide the Pump-to-Drain Hanger Bracket over and down the Upper Pole. Line up the slot in the Pumpto-Drain Hanger Bracket with the Upper and Lower Pole holes and insert the Upper Hitch Pin through all three items. 4. Remove the Hanger Rod from the Cycler shipping box. Push the Hanger Rod through the upper holes at the top of the Upper Pole. The Hanger Rod should form a “T” with the Upper Pole. Cycler Stand Base

WARNING! The Cycler Stand could potentially tip over and cause injury if a Cycler and Stand is used in a tilted position or if moved without appropriate care. Never place objects under the Cycler Stand wheels to level the stand!

Hanger Rod

2

P/N 470203 Rev. H Printed : 07/21/2014 12:50 PM EDT

GETTING YOUR CYCLER READY (cont’d) d. Cycler Control Unit Setup 1. Pick up the Cycler by its bottom, front and back. Lift the Cycler out of its shipping box. CAUTION! Do not lift the Cycler by the Heater Tray/Scale. Doing this may damage the Cycler Scale.

EFFECTIVE

2. Remove the Cycler from its protective foam. There are two hooks on the back of the Cycler. These hooks are used to hang the Cycler onto the Cycler Stand. 3. Face the front of the Cycler Stand. Lift the Cycler and hook it on to the Cycler Hanger Rod. The front of the Cycler should be facing towards the front of the Cycler Stand when properly positioned.

Manifold Holder (hangs outside of Cycler hooks).

Cycler Hooks (Cycler hooks onto the Cycler Hanger Rod first, then Manifold Holder hangs on second.)

Make sure the Cycler Control Unit is positioned over the long legs of the base. Pump to Drain

Drain Hook FRONT VIEW

SIDE VIEW

3 Printed : 07/21/2014 12:50 PM EDT

GETTING YOUR CYCLER READY (cont’d) 4. Remove the Pump-to-Drain from its protective packaging. Straighten out the Pump-to-Drain cord. The Pump-to-Drain has hooks on one end that hang onto the Pump-to-Drain mounting bracket located at the middle of the Cycler Stand.

EFFECTIVE

5. Hook the Pump-to-Drain onto the Pump-to-Drain mounting bracket. You can position the Pump-to-Drain on either side of the Cycler Stand by changing the position of the Pump-to-Drain mounting bracket.

4

P/N 470203 Rev. H Printed : 07/21/2014 12:50 PM EDT

GETTING YOUR CYCLER READY (cont’d)

Manifold Holder

Heater Tray / Scale

EFFECTIVE

Heater Switch

Hanger Rod Pump-to-Drain plugs in here

Power Switch

Cycler Pole Electrical Plug

6. Plug the Pump-to-Drain cable connector into the port labeled “Pump to Drain” located on the back of the Cycler Control Unit. 7. Connect the Drain Hook to the Cycler Control Unit. The Drain Hook has a rounded single hook at one end that hooks into an eyehook on the bottom center of the Cycler Control Unit. 8. Connect the Manifold Holder to the Cycler stand. The Manifold Holder has two rounded hooks that hook onto the hanger rod. The Manifold Holder should extend above the cycler Heater Tray approximately 9 inches. 9. Place the clear plastic Bag Organizer on the cycler Control Unit Heater/Scale. The Bag Organizer fits firmly onto the heater with its edges up and the three cutouts for the Dialysis Solution outlet ports at the back of the cycler.

5 Printed : 07/21/2014 12:50 PM EDT

GETTING YOUR CYCLER READY (cont’d) WARNING! Check the Heater Tray and Bag Organizer to be sure they are free of obstructions and do not touch the top of the Cycler Cabinet  or the Stand Pole  (see figures below). Interference with the Heater Tray may result in inaccurate weighing of Dialysis Solution. Check again when all Solution bags are on the Scale.

EFFECTIVE

Check and make sure the Manifold Holder does not come in contact with the Bag Organizer, this may result in inaccurate weighing of Dialysis Solution. NOTE: Save the Cycler shipping box and the foam inserts in case the Cycler needs to be repacked.

CAUTION! The Newton IQ Cycler is a computer controlled electromechanical medical device. The Newton IQ Cycler should be installed in an appropriate environment (indoors) free from extremes of temperature and humidity. The cycler should not be placed near sources of contamination such as dirt, dust, or liquids. Failure to install the Newton IQ Cycler according to these guidelines may result in improper operation or early failure of the device or its components. CAUTION! Peritoneal dialysis solution should not be allowed to come into contact with the Pump-to-Drain assembly. Peritoneal dialysate leaves a dried salty residue that may be electrically conductive, leading to electrical shorts or corrosion of electrical or mechanical components. Mechanical components such as the valve heads or the cover may bind or corrode. 6

P/N 470203 Rev. H Printed : 07/21/2014 12:50 PM EDT

2.

THE CYCLER FRONT PANEL

EFFECTIVE

There is a display screen and five buttons on the front of the Cycler.

Messages for operating the Cycler are displayed on the screen. The five control buttons work as follows: The [START] button is used to move forward through the phases of a treatment. After an alarm, pressing [START] continues the treatment. During programming, pressing [START] takes you back to the TREATMENT screens. The [STOP] button mutes alarms. During the treatment set-up phase, pressing [STOP] allows you to repeat a tubing flush or patient line prime. During the treatment, pressing [STOP] interrupts the treatment. The [SELECT] button takes you to the SETTINGS screen. A programming cursor (in the shape of an arrow) is located on the SETTINGS screen, between the treatment Setting and the Setting’s value. The cursor normally points to the left towards the Settings. There are two ways to change a Setting as follows: 1.

For a Setting having only two values (for example, “YES” or “NO”, or “ON” or “OFF”), use the [UP] or [DOWN] arrows to move the cursor on the screen to the Setting that needs to be changed. When the cursor is next to the desired Setting, press [SELECT] to change the Setting between “YES” and “NO” or “ON” and “OFF”. 7 Printed : 07/21/2014 12:50 PM EDT

THE CYCLER FRONT PANEL (cont’d)

EFFECTIVE

2.

For a Setting having more than two values, use the [UP] or [DOWN] arrow to move the cursor on the screen to the Setting that needs to be changed. When the cursor is next to the desired Setting, press [SELECT] to point the cursor to the right towards the Setting Value. Next, use the [UP] or [DOWN] arrows to change the Setting Value as desired. After the Setting is programmed to the value you desire, press [SELECT] to “lock in” the new value. The cursor will now point to the left again.

The [UP] arrow and [DOWN] arrow buttons move the cursor on the screen to the Setting that needs to be changed. You use the [UP] arrow and the [DOWN] arrow to change Settings.

8

P/N 470203 Rev. H Printed : 07/21/2014 12:50 PM EDT

3. TYPES OF THERAPY Four types of prescribed therapy are available for use with the Newton IQ Cycler. The therapies can also be divided into two subtypes: Continuous Therapy and Intermittent Therapy. In Continuous Therapy, you always have at least 50% or more of your usual Fill Volume present in your peritoneum. In Intermittent Therapy you may either be empty or have only a very small amount of Dialysis Solution present in your peritoneum for certain time periods.

EFFECTIVE

Each therapy is prescribed for very specific reasons. The common factor in cycling therapy is that exchanges are done during the nighttime hours when you are usually in bed sleeping. The main differences in the therapy types are what happens during the day while you are awake, and with how the solution is delivered to you during the night. The four types of therapy are described below. a. PD Plus Therapy PD Plus Therapy is a continuous therapy in which one or more exchanges are received during the day from the Cycler, in addition to the nighttime exchanges. These daytime exchanges are called PAUSE exchanges. With PD Plus Therapy, you carry Dialysis Solution in your peritoneum during the day. This allows for continuous waste product and fluid removal. This type of therapy provides you with fresh Dialysis Solution from exchanges that take place nearly around-the-clock. b. Continuous Cycling Peritoneal Dialysis (CCPD) Continuous Cycling Peritoneal Dialysis (CCPD) is a Continuous Therapy. CCPD is the most common cycling therapy prescribed. With CCPD, you have Dialysis Solution in your peritoneum at all times but the exchanges are done only at night by the Cycler. You receive several exchanges while you sleep. The last thing that the Cycler will do is Fill you for the day. You do no other exchanges during the day. When you reconnect to the Cycler, you must first drain the dialysate that has been dwelling in you during the day. This type of therapy resembles a Continuous Ambulatory Peritoneal Dialysis (CAPD) schedule which is performed without a cycler, but with CCPD the exchanges are reversed. Three or more exchanges are done through the night, and one long exchange is done during the day. 9 Printed : 07/21/2014 12:50 PM EDT

TYPES OF THERAPY (cont’d) c. Intermittent Peritoneal Dialysis (IPD) Intermittent Peritoneal Dialysis (IPD), as its name suggests, is an Interrupted or Intermittent Therapy. With IPD, you will receive your exchanges every night from the Cycler while you are sleeping, but you will not have any Dialysis Solution in your peritoneum during the day while you are awake. IPD is also sometimes referred to as Nightly Intermittent Peritoneal Dialysis (NIPD).

EFFECTIVE

d. Tidal Peritoneal Dialysis (TPD) Tidal Peritoneal Dialysis differs from other Dialysis therapies in the way that Dialysis Solution is delivered to you during the nighttime. With TPD you are filled with a prescribed amount of solution, then only a portion is drained and refilled with each exchange. Depending on your prescription, you may end the treatment with a Fill or a Drain. Setting the different therapy types is done by programming the Newton IQ Cycler Settings and Options. Detailed instructions for programming the cycler for each of the four types of Peritoneal Dialysis therapies are on the following pages. Your physician should prescribe the therapy that is best for you.

10

P/N 470203 Rev. H Printed : 07/21/2014 12:50 PM EDT

4. SETTING THE CYCLER DATE AND TIME It is important to set the Cycler to the correct date and time if you want your PREWARMING and RX START TIME features to work on time. The Cycler is shipped with date and time set for the Pacific Time zone. You may need to reset the cycler for your specific time zone. To set the cycler date and time, you must enter the DIAGNOSTICS screen. To get to DIAGNOSTICS you must do the following:

EFFECTIVE

1. From the STANDBY screen (the first screen upon power-up), press and hold the [UP] and [DOWN] arrows at the same time for about 3 seconds and the DIAGNOSTICS screen will appear as follows:

START

STOP

A TO D ALARMS  CLOCK INPUTS OPTIONS

SELECT

2. With the arrow on the screen lined up with CLOCK, press [SELECT] and the CLOCK screen will appear as follows:

START

STOP

YEAR MONTH DATE HOUR MINUTE SECOND

2002

1 1 9 0 24

SELECT

Set the current date and time using this screen. To navigate the screen, use the up and down arrows. Press [SELECT] when you reach your choice. You will program the HOUR Setting using a 24-Hour system; for example, enter 00:00 for 12 AM (midnight), 12:00 for 12 PM (noon), and 18:00 for 6 PM, etc. The time will be shown by the cycler at the STANDBY screen using a 12-Hour system with AM and PM after the time (for example, 6:00 AM, 12:00 PM, etc.). You must press [SELECT] after you make a change to the date or time to save it. After you have updated the date and time at this screen, press [START] two times to return to the STANDBY screen. The date and time will be displayed in the lower right hand corner of this screen. 11 Printed : 07/21/2014 12:50 PM EDT

5. TREATMENT SETTINGS AND OPTIONS General treatment Settings and Options are programmed into the Newton IQ Cycler at the manufacturer. You must reprogram the Cycler Settings and Options for your personal prescription before you start your first treatment. Do the following to access the Settings and Options:

EFFECTIVE

NOTE: You may skip this section and refer to the “USING THE PRESCRIPTION UPLOAD FEATURE” of these Operator Instructions if you are told by your physician or dialysis nurse to use the Upload feature. 1. Turn on the Cycler using the POWER switch located on the back panel of the Cycler. After the Cycler performs its power-up self-test, it will display the STANDBY screen as follows:

START SELECT

01/01/02 9:00 AM

STOP

2. Press [START]. Instructions for programming or starting the treatment will appear.

START

PRESS SELECT TO PROGRAM SETTINGS. PRESS START TO BEGIN TREATMENT.

SELECT

STOP

3. Press [SELECT] to enter the SETTINGS/OPTIONS screen as follows:

START

STOP

DATA SHEETS PATIENT DATA PT WEIGHT 125 LBS # FILLS 5 # PAUSES 1 PAUSE VOLUME 3000

12

SELECT

P/N 470203 Rev. H Printed : 07/21/2014 12:50 PM EDT

TREATMENT SETTINGS AND OPTIONS (cont’d) Additional Settings and Options that are not displayed on the initial screen are available by pressing the [DOWN] arrow. Descriptions of the various Settings and Options follow. a. Patient Weight (PT WEIGHT)

EFFECTIVE

(Range is 0, and 20 – 500 lbs. or 0 and 9 – 227 kgs.) You may enter your initial weight here, in either pounds (lbs.) or kilograms (kgs.). Refer to the “ADDITIONAL OPTIONS” section of this manual to learn how to set the Cycler for recording your weight in either pounds or kilograms The Patient Weight value will automatically be updated after each treatment if your physician or dialysis nurse has you use the Patient Data Entry feature of the Cycler. Refer to the “PATIENT DATA ENTRY” section of these instructions to learn how to use the Patient Data Entry feature of the Cycler. b. Number of Fills (# FILLS) (Range is 1 – 20 Fills) The # FILLS is the number of times the peritoneum is filled will dialysate fluid. The # FILLS includes any programmed Pause volumes, CCPD volumes, and Last Fill volume. A Last Fill volume of zero is not counted in the number of Fills because no fill volume is delivered to the peritoneum. NOTE: This number is prescribed by your physician. c. Number of Pauses (# PAUSES) (Range is 0 – 5 Pauses) The # PAUSES indicates the number of PAUSES you are supposed to do during the treatment. A PAUSE is a special type of Dwell that allows you to Dwell while either connected or disconnected from the Cycler. It also differs from other Dwells because it is not a timed function; that is, you can PAUSE for as short or long as you would like.

13 Printed : 07/21/2014 12:50 PM EDT