HomeChoice SmartCare Module 3 Training for Software ver 10.4 Participants Workbook April 2011

Table of Contents Learning Objectives ...2 Topics Covered in this Module ...3 Chapter 1: Software Update Overview ...4 Chapter 2: HomeChoice System Settings ...7 Nurse’s Menu ...9 Change Program...12 Make Adjustments ...16 Chapter 3: Therapy Execution ...21 Prepare for Therapy ...23 Perform Therapy ...27 End Therapy ...40 Chapter 4: Clinical Software ...46 Learning Objectives Revisited ...53 Increased Intraperitoneal Volume (IIPV) ...54

Module 3: Training for the HomeChoice SmartCare (version 10.4) Software Participant’s Workbook 1

• Explain the reasons for changing the HomeChoice software • List the software updates for therapy programming in HomeChoice system settings Module 3-Learning Objectives After completing this training,

• Identify software updates encountered when preparing and performing therapy

you will be able to:

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• Explain the HomeChoice SmartCare changes that affect the use of Baxter’s Clinical application software, PD Link Module 3: Training for the HomeChoice Smartcare Software. software Baxter International Inc. August 2010.

Module 3-Learning Objectives After completing this module, you will be able to: 

Explain the reasons for changing the HomeChoice software



List the software updates for therapy programming in HomeChoice system settings



Identify software updates encountered when preparing and performing therapy



Explain the HomeChoice SmartCare changes that affect the use of Baxter’s Clinical application software, PD Link software

Background: Information for this module is based on the Patient At-Home Guide (PAHG), document #07-19-63-293 (July 28, 2010) and the Trainer’s Guide (TG) document #07-19-63-294 (August 6, 2010). To find the information in these guides, refer to specific page numbers that appear in brackets and italics below the slide notes. Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician or other licensed practitioner. For safe and proper use of this device, refer to the device Operator's Manual.

Module 3: Training for the HomeChoice SmartCare (version 10.4) Software Participant’s Workbook 2

Topics Covered in This Module • Chapter 1: Software Update Overview • Chapter 2: HomeChoice System Settings • Chapter 3: Therapy Execution • Chapter 4: Clinical Software

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Module 3: Training for the HomeChoice SmartCare Software. Baxter International Inc. April 2011.

Topics Covered in This Module In order to accomplish the stated Module 3 learning objectives, this training session will be organized into 4 chapters. The following topics will be covered in this module: 

Chapter 1: Software Update Overview



Chapter 2: HomeChoice System Settings



Chapter 3: Therapy Execution



Chapter 4: Clinical Software

Module 3: Training for the HomeChoice SmartCare (version 10.4) Software Participant’s Workbook 3

• State the benefits provided by HomeChoice SmartCare • List the software updates within both the programming and therapy execution arms of the HomeChoice structure Chapter 1 Introduction- Learning Objectives After completing this training, you will be able to:

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Module 3: Training for the HomeChoice Smartcare Software. Baxter International Inc. August 2010.

Chapter 1 Introduction-Learning Objectives After completing Chapter 1 of this module, you will be able to: 

State the benefits provided by HomeChoice SmartCare



List the software updates within both the programming and therapy execution arms of the HomeChoice structure

Module 3: Training for the HomeChoice SmartCare (version 10.4) Software Participant’s Workbook 4

Benefits of HomeChoice SmartCare Software Updates • HomeChoice SmartCare software updates reduce the likelihood of inappropriate therapy parameters. • Improves patient safety during APD • Reduces the risk of increased intraperitoneal volume (IIPV) 5

Module 3: Training for the HomeChoice SmartCare Software. Baxter International Inc. August 2010.

Benefits of HomeChoice SmartCare Updates There are several benefits of software enhancements that have been made in the HomeChoice SmartCare software upgrade. HomeChoice SmartCare enhancements were designed to reduce the likelihood of inappropriate therapy parameters. Also, HomeChoice SmartCare updates were created to enhance patient safety during automated peritoneal dialysis. In this module you will learn several ways in which the HomeChoice SmartCare software reduces the risk of overfill situations, referred to as increased intraperitoneal volume (IIPV). [PAHG pp 3-3–3-5, 4-2, 16-10–16-11]

Module 3: Training for the HomeChoice SmartCare (version 10.4) Software Participant’s Workbook 5

The HomeChoice SmartCare Changes PROGRAMMING

THERAPY EXECUTION

NURSE’S MENU

PREPARE FOR THERAPY

1- Reset Weight

1- Reload the Set

2- Tidal Full Drains

2- Connect Bags

CHANGE PROGRAM

3- VERIFY I-DRAIN Prompt

1- Check Fill Volume

PERFORM THERAPY

2- Check Patient Weight

1- I-Drain Bypass

3- Tidal Volume

2- Slow Flow Drain Alarm

4- Tidal Total UF

3- Partial Fill Volume

5- Tidal Full Drains Every

END THERAPY

6- Weight Units

1- Low UF

7- Patient Weight

2- High Drain

MAKE ADJUSTMENTS 1- I-Drain Alarm 6

Module 3: Training for the HomeChoice SmartCare Software. Baxter International Inc. April 2011.

2- Last Manual Drain

The HomeChoice SmartCare Changes There are two categories of HomeChoice SmartCare software updates: programming and therapy. Therefore, we will discuss HomeChoice SmartCare software updates according to the two sides of the HomeChoice structure. Within the programming arm of the structure, we will discuss changes to the Nurse’s Menu, change program, and how to make adjustments. Changes to the Nurse’s Menu include updates to Reset Weight and Tidal Full Drains. Updates to Change Program will affect weight settings and Tidal allowable ranges. Changes to Make Adjustments will affect the I-DRAIN ALARM and the Last Manual Drain. In the Therapy arm, we will discuss updates that are encountered when preparing for therapy, when performing therapy, and when completing therapy. Changes that affect the Prepare for Therapy stage include Reload the Set, Connect Bags, and Verify I-DRAIN Prompt. Changes that affect the Perform Therapy stage include the I-Drain Bypass, Slow Flow Drain Alarm, and Partial Fill Volume. Updates to the End Therapy stage include the Low UF and High Drain features.

Module 3: Training for the HomeChoice SmartCare (version 10.4) Software Participant’s Workbook 6

Chapter 2 HomeChoice System Settings • Nurse’s Menu • Change Program • Make Adjustments

Module 3: Training for the HomeChoice SmartCare Software. Baxter International Inc. August 2010.

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Chapter 2 Therapy Programming Chapter 2 covers HomeChoice SmartCare system setting updates. The three areas of Therapy Programming are: 

Nurse’s Menu



Change Program



Make Adjustments

Module 3: Training for the HomeChoice SmartCare (version 10.4) Software Participant’s Workbook 7

• Identify the new RESET WEIGHT prompt • Explain the CHECK WEIGHT/VOLUME changes

Chapter 2 HomeChoice System Settings- Learning Objectives After completing this training, you will be able to:

• Identify Tidal therapy programming defaults and allowable ranges • Describe changes to the Initial Drain alarm settings • Explain Last Manual Drain/UF Target programming

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Module 3: Training for the HomeChoice Smartcare Software. Baxter International Inc. August 2010.

Chapter 2 HomeChoice System Settings-Learning Objectives After completing this chapter, you will be able to: 

Identify the new RESET WEIGHT prompt



Explain the CHECK WEIGHT/VOLUME changes



Identify Tidal therapy programming defaults and allowable ranges



Describe changes to the Initial Drain alarm settings



Explain Last Manual Drain/UF Target programming

Module 3: Training for the HomeChoice SmartCare (version 10.4) Software Participant’s Workbook 8

Chapter 2 HomeChoice System Settings Nurse’s Menu Change Program Make Adjustments

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Module 3: Training for the HomeChoice SmartCare Software. Baxter International Inc. August 2010.

Chapter 2 HomeChoice System Settings-Nurse’s Menu The first area of discussion within Chapter 2 will be on the updates encountered within the Nurse's Menu section of the HomeChoice system settings.

Module 3: Training for the HomeChoice SmartCare (version 10.4) Software Participant’s Workbook 9

RESET WEIGHT Option The first change is that all users (Std. and PRO) must enter their weight at least once (kg or lb). This Patient Weight setting is used to validate that the programmed therapy settings for Fill Volume (Day, Nite, Last) do not exceed the maximum allowable settings for the patient’s dry weight. For more detail on how to select the proper patient weight, refer to page 13 of this workbook. Another new patient weight feature is the RESET WEIGHT option. The RESET WEIGHT default setting is NO. When the RESET WEIGHT setting is NO, the patient needs to enter his or her weight only once for a given HomeChoice Cycler unit. However, when the RESET WEIGHT is set to YES in the Nurse’s menu, a weight must be entered every time a patient performs a therapy with the HomeChoice device.

Question: Why is it recommended to have the RESET WEIGHT option set to YES in hospital and clinical settings? ________________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________

Module 3: Training for the HomeChoice SmartCare (version 10.4) Software Participant’s Workbook 10

Tidal Full Drains Updates Because Baxter recommends enabling the Tidal Full Drains safety feature to help prevent UF accumulation, HomeChoice SmartCare software is updated so that the default setting is YES. This encourages the user to program one or more full drains in the middle of tidal therapy to reduce the risk of IIPV. The range of allowable frequency settings has not changed. Tidal Full Drains allows the patient to drain completely after the programmed number of cycles. Every 3 cycles is the default. Currently, Tidal Full Drain is set to YES for Low Fill Mode. [PAHG p 8-6 and 8-12; TG pp 1-8, 10-5, 13-47]

Module 3: Training for the HomeChoice SmartCare (version 10.4) Software Participant’s Workbook 11

Chapter 2 HomeChoice System Settings Nurse’s Menu

Change Program Make Adjustments

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Module 3: Training for the HomeChoice SmartCare Software. Baxter International Inc. August 2010.

Chapter 2 HomeChoice System Settings-Change Program The next section of this chapter will discuss the updates encountered within the Change Program section of the HomeChoice system settings.

Module 3: Training for the HomeChoice SmartCare (version 10.4) Software Participant’s Workbook 12

CHECK WEIGHT/VOLUME-Program Change NOW: Messages Related to Weight setting

CHECK PATIENT WEIGHT CHECK FILL VOLUME CHECK NITE FILL VOL CHECK DAY FILL VOL CHECK LAST FILL VOL 13

Module 3: Training for the HomeChoice SmartCare Software. Baxter International Inc. August 2010.

CHECK WEIGHT/VOLUME-Program Change The fill volumes for each cycle are based on the programmed patient weight. If one or more fill volume parameters are too high for the programmed weight, the patient receives a CHECK VOLUME message/alarm. Table 16-7, found in the PAHG, can be used to find the maximum fill volume for a given patient weight. For example, Table 16-7 indicates that for a 110 lb (50 kg) patient, the recommended fill volume is 2200 mL. If a patient weight was entered as 110 lb (50 kg) and Fill Volume had been set at 2500 mL, the device would display CHECK FILL VOLUME. There is also an audible alarm. Note that if the patient’s weight is not listed within Table 16-7, then the user should choose the maximum fill volume listed in the row indicated for the next lower weight. For example, if the patient’s weight is 140 lbs, choose 136 lb (62 kg) to determine the maximum fill volume. CHECK PATIENT WEIGHT will appear if the user attempts to accept the default value (1KG / 2 Lb). If this occurs, the patient should call their nurse for proper programming of the cycler. The messages related to Weight setting occur during programming [PAHG pp 16-18–16-19; TG pp 1-7, 12-13, 12-23, A-15]

Module 3: Training for the HomeChoice SmartCare (version 10.4) Software Participant’s Workbook 13

Tidal Therapy Programming-Programming Change WAS

TIDAL VOLUME:

%

NOW

TOTAL UF:

ML

TIDAL VOLUME:

%

TOTAL UF:

ML

Standard mode

5%

Default Values

0 mL

95%

Default Values

(Standard & Low Fill modes)

5%–95%

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Allowable Ranges

0 mL – 10,000 mL

1000 mL Low Fill mode

400mL 40%–95%

Allowable Ranges

10 mL – 10,000 mL

Module 3: Training for the HomeChoice SmartCare Software. Baxter International Inc. August 2010.

Tidal Therapy Programming-Programming Change Software changes specific to Tidal therapy include changes to the default values and allowable ranges for programmed values. Total UF must now be programmed to at least 10 mL; 0 mL is no longer a valid setting. The minimum value for Tidal Volume Percent has been increased from 5% to 40%. For example, if set at 40%, 40% of the fill volume would be removed. Tidal therapies of 535% are no longer valid. When therapy is changed from CCPD to Tidal, the Total UF value reverts to the default value. If the Total UF volume is set too low, the UF volume can gradually accumulate with each successive therapy cycle. This increases the risk of IIPV. The higher default value helps prevent UF from accumulating. Similarly, a higher default Tidal Volume Percent is similar to CCPD, which carries a lower risk of IIPV. [PAHG pp 3-4, 16-25–16-26; TG pp 1-8, 13-44–13-45]

Module 3: Training for the HomeChoice SmartCare (version 10.4) Software Participant’s Workbook 14

Tidal Full Drains Updates-Programming Change Because Baxter recommends enabling the Tidal Full Drains safety feature to help prevent UF accumulation, HomeChoice SmartCare is updated so that the default setting is YES. This encourages the user to program one or more full drains in the middle of tidal therapy to reduce the risk of IIPV. The FULL DRAINS EVERY allowable frequency settings have not changed. However, the FULL DRAINS EVERY default is now every 3 Tidal Full Drains. [PAHG 16–26; TG pp 1-8, 13-47] Background: Baxter recommends using Tidal Full Drains to prevent overfills or excess drainage of the peritoneal cavity if the Total UF was not estimated correctly.

Module 3: Training for the HomeChoice SmartCare (version 10.4) Software Participant’s Workbook 15

Chapter 2 HomeChoice System Settings Nurse’s Menu Change Program

Make Adjustments

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Module 3: Training for the HomeChoice SmartCare Software. Baxter International Inc. August 2010.

Chapter 2 Therapy Programming-Make Adjustments This chapter will conclude with a discussion of updates encountered within the Make Adjustments level of HomeChoice system settings.

Module 3: Training for the HomeChoice SmartCare (version 10.4) Software Participant’s Workbook 16

Initial Drain Alarm-Programming Change • Initial Drain (I-Drain): drain that occurs at the beginning of each therapy WAS NOW

Static Default I-Drain Setting • Standard Mode • Low Fill Mode

1400 mL (--) illegal value

Auto Adjust Default I-Drain Setting

70% of Last Fill volume or current setting

Standard & Low Fill modes

whichever is higher drain volume

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Module 3: Training for the HomeChoice SmartCare Software. Baxter International Inc. August 2010.

Initial Drain Alarm-Programming Change The Initial Drain (I-Drain) is the fluid drained from the peritoneal cavity at the beginning of each therapy, before the first Day or Night fill. The new HomeChoice SmartCare software has updated the permitted parameters that a patient can use to program the Initial Drain, or I-Drain setting. In the previous software version, the default I-Drain settings were 1400 mL for the standard fill mode and (--) for the low fill mode. In HomeChoice Smartcare software, the cycler starts with the same defaults as the previous software version, however whenever a user makes a change to the Last Fill Volume, the I-Drain alarm setting will automatically reset to 70% of the new Last Fill volume setting, or remain at the existing setting, whichever is the higher drain volume. This new default applies to both standard and low fill modes The I-Drain alarm volume still has the same allowable ranges as shown for the two fill modes. For Dry Day patients, use 0-30mL as the I-Drain alarm volume. If the I-Drain alarm is set to OFF, the Initial Drain phase ends and the Fill Phase begins as soon as a No Flow condition exists. Therefore, the I-Drain alarm should not be set to OFF. However, the I-Drain alarm Volume can be set to 0 mL. Regardless of how the alarm is set (ON/OFF), the cycler will always begin therapy with an initial drain. To program the I-Drain alarm, press ENTER to access the MAKE ADJUSTMENTS menu. Press ▼ until I-DRAIN ALARM appears and then press ENTER. When the volume digits blink, press ▲ or ▼ to change the setting and then press ENTER to save the desired I-DRAIN ALARM volume. Once the blinking stops, press ▼ to the next option or STOP to exit Make Adjustments. [PAHG p 4-3;TG pp 1-7, 10-4, 12-22, 13-30] Question: Can someone identify an alarm message one might expect to occur as the result of setting the IDrain alarm to OFF in the Standard Fill mode? _____________________________________________________________________________________ _____________________________________________________________________________________

Module 3: Training for the HomeChoice SmartCare (version 10.4) Software Participant’s Workbook 17

Last Manual Drain-Programming Change

WAS

LAST MANUAL DRAIN : N

NOW

LAST MANUAL DRAIN : Y UF TARGET: 0 ML ALARM: NO

disabled 18

enabled

Module 3: Training for the HomeChoice SmartCare Software. Baxter International Inc. August 2010.

Last Manual Drain-Programming Change The Last Manual Drain setting allows the patient a final opportunity to fully drain before the Last Fill Volume is delivered. Using the Last Manual Drain and setting the UF Target appropriately reduces the risk of an incomplete last drain and IIPV. In HomeChoice SmartCare software, the Last Manual Drain default is YES. When the LAST MANUAL DRAIN: Y, and the UF Target is not met, the system beeps continuously. A LOW UF alarm appears on the display screen. When the ALARM: NO is selected, and the UF Target is not met, only the LOW UF alarm appears on the display screen. The system will not alarm audibly. It will wait for the patient to wake up and finish draining. At that time, the patient can change his/her position and initiate a Manual Drain. A good starting point for setting the UF target is 70% of your expected Total UF. Table 16-9 [PAHG 16-23 and 16-24] can be used to calculate the UF Target based on the expected UF. If the UF Target is left to zero (0), patients who have negative ultrafiltration will get a LOW UF alarm just before delivering the last fill. No alarm occurs if patient met the UF target that was set. In the previous software version, the Last Manual Drain feature is disabled, which also disables the UF Target.

[PAHG pp 9-12, 9-14–9-15; TG pp 1-8, 10-4, 13-13 Table 13–5: Tidal Total UF and Last Manual Drain UF Target Volume Setting based upon % of Expected UF Volume, 13-44]

Module 3: Training for the HomeChoice SmartCare (version 10.4) Software Participant’s Workbook 18

Summary: HomeChoice System Settings • New RESET WEIGHT prompt • New allowable ranges for Tidal therapy parameters • Tidal Full Drains - same default enabled for both Standard and Low Fill modes • I-Drain defaults to 70% of the last fill volume or the current setting, whichever is the higher drain volume • New features alert users that they must perform the Last Manual Drain to complete therapy 19

Module 3: Training for the HomeChoice SmartCare Software. Baxter International Inc. August 2010.

Summary: HomeChoice System Settings This chapter covered the following HomeChoice SmartCare updates: 

New RESET WEIGHT prompt



New allowable ranges for Tidal therapy parameters



Tidal Full Drains - same default enabled for both Standard and Low Fill modes



I-Drain defaults to 70% of the last fill volume or the current setting, whichever is the higher drain volume



New features alert users that they must perform the Last Manual Drain to complete therapy

Module 3: Training for the HomeChoice SmartCare (version 10.4) Software Participant’s Workbook 19