Module 3 Training for the HomeChoice SmartCare (version 10.4) Software Participant s
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 1
Explain the reasons for changing the HomeChoice software List the software updates for therapy programming in HomeChoice system settings 2 Module 3 Learning Objectives After completing this training, you will be able to: Module 3: Training for the HomeChoice Smartcare Software. Baxter International Inc. August 2010. 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 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. 2
Topics Covered in This Module Chapter 1: Software Update Overview Chapter 2: HomeChoice System Settings Chapter 3: Therapy Execution Chapter 4: Clinical Software 3 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 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: 4 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 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 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] 5
The HomeChoice SmartCare Changes 6 PROGRAMMING NURSE S MENU 1- Reset Weight 2- Tidal Full Drains CHANGE PROGRAM 1- Check Fill Volume 2- Check Patient Weight 3- Tidal Volume 4- Tidal Total UF 5- Tidal Full Drains Every 6- Weight Units 7- Patient Weight MAKE ADJUSTMENTS 1- I-Drain Alarm 2- Last Manual Drain Baxter International Inc. April 2011. THERAPY EXECUTION PREPARE FOR THERAPY 1- Reload the Set 2- Connect Bags 3- VERIFY I-DRAIN Prompt PERFORM THERAPY 1- I-Drain Bypass 2- Slow Flow Drain Alarm 3- Partial Fill Volume END THERAPY 1- Low UF 2- High 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. 6
Chapter 2 HomeChoice System Settings Nurse s Menu Change Program Make Adjustments 7 Baxter International Inc. August 2010. 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 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 8 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 8
Chapter 2 HomeChoice System Settings Nurse s Menu Change Program Make Adjustments 9 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. 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? 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] 11
Chapter 2 HomeChoice System Settings Nurse s Menu Change Program Make Adjustments 12 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. 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 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] 13
Tidal Therapy Programming Programming Change WAS NOW TIDAL VOLUME: % TOTAL UF: ML TIDAL VOLUME: % TOTAL UF: ML 5% Default Values 0 ml (Standard & Low Fill modes) 95% Default Values Standard mode 1000 ml Low Fill mode 400mL 5% 95% Allowable 0 ml Ranges 10,000 ml 40% 95% Allowable 10 ml Ranges 10,000 ml 14 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 5-35% 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] 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. 15
Chapter 2 HomeChoice System Settings Nurse s Menu Change Program Make Adjustments 16 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. 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 1400 ml Low Fill Mode (--) illegal value Auto Adjust Default I-Drain Setting 70% of Last Fill volume or current setting whichever is higher drain volume Standard & Low Fill modes 17 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 I- Drain alarm to OFF in the Standard Fill mode? 17
Last Manual Drain Programming Change WAS NOW LAST MANUAL DRAIN : N LAST MANUAL DRAIN : Y UF TARGET: 0 ML ALARM: NO disabled enabled 18 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] 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 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 19
Assessment: Therapy Programming When would you enable the RESET WEIGHT feature? Why is a valid I-Drain alarm setting important? What Tidal parameters have new allowable ranges? Do both fill modes have the Tidal Full Drains default set to YES? Why have Last Manual Drain updates been made? 20 Baxter International Inc. August 2010. Assessment: Therapy Programming Question: When would you enable the RESET WEIGHT feature? Question: Why is a valid I-Drain alarm setting important? Question: What Tidal parameters have new allowable ranges? Question: Do both fill modes have the Tidal Full Drains default set to YES? Question: Why have Last Manual Drain updates been made? 20
Chapter 3 Therapy Execution Chapter 3 covers Therapy Execution updates to the HomeChoice SmartCare software. The three areas of Therapy Execution are: Prepare for Therapy Perform Therapy End Therapy 21
Describe the new alternating messages for CONNECT BAGS and RELOAD THE SET prompts Describe the updates that prevent inappropriate drain bypass Explain the partial fill volume changes Chapter 3 Therapy Execution Learning Objectives After completing this training, you will be able to: List the Manual Drain/ Low UF updates Identify the conditions that trigger a HIGH DRAIN alarm 22 Module 3: Training for the HomeChoice Smartcare Software. Baxter International Inc. August 2010. Explain the meaning of the three numbers that follow HIGH DRAIN on the display Chapter 3 Therapy Execution Learning Objectives After completing this chapter you will be able to: Describe the new alternating messages for CONNECT BAGS and RELOAD THE SET prompts Describe the updates that prevent inappropriate drain bypass Explain the partial fill volume changes List the Manual Drain/Low UF updates Identify the conditions that trigger a HIGH DRAIN alarm Explain the meaning of the three numbers that follow HIGH DRAIN on the display 22
Chapter 3 Therapy Execution Prepare for Therapy The first section of Chapter 3 will discuss updates encountered within the Prepare for Therapy stage of Therapy Execution. 23
Reload Set Display Change WAS NOW RELOAD THE SET CLOSE ALL CLAMPS alternating RELOAD THE SET 24 Baxter International Inc. April 2011. If the messages above appear: 1- Press STOP to mute the alarm 2- Close all clamps and reload the cassette 3- Press GO to begin the priming 4- Display reads OPEN THE CLAMPS alternating with CONNECT BAGS Reload Set Display Change The first update has to do with the RELOAD THE SET messages that alert the user that there is a problem sealing the cassette into the device. With the previous software version the unit displayed a RELOAD THE SET message. However, the new HomeChoice SmartCare software will display alternating CLOSE ALL CLAMPS and RELOAD THE SET messages. This enhancement is to prevent free flow of fluid. When this messaging occurs, press STOP to silence the alarm. After closing the clamps, the cassette should be removed from the device and reloaded in order to continue the priming procedure. An OPEN CLAMPS message will be displayed after reloading the cassette to ensure the cassette sealing test works properly. Question: Please identify the common triggers of the CLOSE ALL CLAMPS/RELOAD THE SET messaging? Question: Please state procedures that will help prevent triggering the CLOSE ALL CLAMPS/RELOAD THE SET messaging? 24
Connect Bags Message after loading the set and just before priming WAS NOW CONNECT BAGS CONNECT BAGS alternating OPEN THE CLAMPS 25 Baxter International Inc. August 2010. Connect Bags The second of these software updates has to do with new CONNECT BAGS messages that occur after loading the set, just before priming begins. The previous software version displayed a CONNECT BAGS message. However, the new HomeChoice SmartCare software will display alternating CONNECT BAGS and OPEN THE CLAMPS messages. It is important to note that only the clamps on the supply lines used should be opened. [PAHG p 10-16; TG p 1-9] 25
VERIFY I-DRAIN Prompt While the I-Drain settings are programmed prior to therapy, the VERIFY I-DRAIN prompt occurs before the start of the Initial Drain. During therapy, the VERIFY I-DRAIN prompt will alert the user if the I-Drain alarm setting is OFF or if the I-Drain alarm volume is too low. In the previous software, the VERIFY I-DRAIN prompt appeared if the I-Drain alarm volume was <25% of the Last Fill, Day Fill, or Night Fill. In HomeChoice SmartCare software, the minimum I-Drain alarm volume has increased; the I-Drain alarm volume must now be at least 70% of the Last Fill Volume setting or at least 25% of Day or Night Fill volume to avoid the VERIFY I-DRAIN Prompt. For example if the Last Fill Volume was 2000 ml, the I-Drain alarm volume must be at least 1400 ml, or 70% to avoid the VERIFY I-DRAIN Prompt. [PAHG pp 15-35 15-36; TG p 1-8] 26
Chapter 3 Therapy Execution Perform Therapy The next section of Chapter 3 will discuss updates encountered within the Perform Therapy level of Therapy Execution. 27
Initial Drain Bypass WAS NOW BYPASS Initial Drain could be bypassed any time. Will automatically move on to Fill 1 when criteria are met LOW DRAIN VOLUME BYPASS Initial Drain CAN NOT be bypassed unless a LOW DRAIN VOLUME alarm first occurs. Will still automatically move on to Fill 1 when criteria are met 28 Baxter International Inc. August 2010. Initial Drain Bypass The device will automatically move on to Fill 1 when the amount drained exceeds the I-Drain alarm value AND flow rates slow or stop. (ie, without receiving a LOW DRAIN VOLUME alarm). Previously, the Initial Drain phase could be bypassed anytime the patient wished. Now, the I-Drain alarm cannot be bypassed if the flow rate of the drain fluid is still higher than the Slow Flow rate. In addition, the new software requires that the LOW DRAIN VOLUME alarm must occur before the user is given the option to bypass the Initial Drain. The LOW DRAIN VOLUME alarm sounds when the volume of fluid drained is less than the expected volume. If the LOW DRAIN VOLUME alarm sounds frequently, the I-Drain alarm volume may be set too high. Reminder: A LOW DRAIN VOLUME alarm occurs because: 1. The volume set for Initial Drain Volume alarm has not yet been met AND 2. The flow rates have slowed or stopped, at times due to physiological issues. The patient should evaluate the current volume drained. The patient should see if the volume drained is the expected amount, and act accordingly. See section 15.3.8 of the HomeChoice Patient At-Home Guide for more information on troubleshooting this alarm. Note: (Standard Mode) Low Flow -> 50mL/min (Low Fill Mode) Low Flow -> 15mL/min [PAHG pp 14-43, 15-17, 15-43 15-45, 15-50; TG pp 1-8, 13-6] 28
Reasons to Not Bypass Initial Drain 29 Bypassing Initial Drain with fluid remaining is a significant contributor to IIPV The cycler sets the estimated patient volume and UF calculation to zero at the end of Initial Drain Fluid not drained during Initial Drain may be drained in subsequent cycles and counted as night UF, misleading the physician about the effectiveness of therapy HomeChoice SmartCare does not permit Initial Drain bypass while fluid is still draining well Baxter International Inc. April 2011. Reasons to Not Bypass Initial Drain It is important to understand when it is and is not appropriate to bypass a LOW DRAIN VOLUME alarm during Initial Drain. It is also important to know the significance of performing this bypass. It is appropriate to bypass a LOW DRAIN VOLUME alarm during Initial Drain when the patient and nurse are confident that the patient is empty. For example, it is appropriate if the patient performed an off cycler drain and did not adjust the I-Drain alarm. It is not appropriate to bypass a LOW DRAIN VOLUME alarm during Initial Drain when the patient and nurse do not believe the patient is empty. For example, it is not appropriate if the patient becomes impatient and wants to progress quicker through the therapy. Significance of Performing Initial Drain Bypass At the end of Initial Drain (either when the patient drained at least the volume specified by I- Drain Alarm or after bypassing a LOW DRAIN VOLUME alarm), the cycler sets the estimated patient volume and UF calculation to zero. It then proceeds to Fill 1 and delivers the specified fill volume. Any fluid still remaining in the peritoneal cavity at the end of Initial Drain will be added too. If the residual volume is significant, this poses a risk of IIPV. Additionally, the residual fluid may be drained out in subsequent cycles and counted as night UF. This may mislead the physician about the effectiveness of therapy as they may believe that the residual fluid is UF when in fact it is not. [PAHG pp 9-9] 29
Alternatives to Bypassing Initial Drain Change position and check the patient line for kinks, and then continue draining Re-evaluate the I-Drain alarm setting Evaluate cycler placement height Recommended cycler position is at the same height as the patient s supine position Lower the cycler position by 6 inches (15 cm) below the patient s supine position to increase suction during drain Assess the patient for fibrin blockage Consider possibility that the catheter migrated 30 Baxter International Inc. April 2011. Alternatives to Bypassing Initial Drain The alternatives listed are techniques to correct a LOW DRAIN VOLUME alarm. If the alarm is not frequent, it is possible that it is caused by fluid that has pocketed away from the catheter. A partially kinked patient line is also a possibility. These causes can be corrected by the patient repositioning and checking for kinks in the patient line, and then continuing to drain. If the alarm continues during therapy or occurs regularly over multiple therapies, The I- Drain alarm value and cycler placement height should be re-evaluated. The patient should also be assessed for fibrin blockage. The possibility of catheter migration should also be considered. Lowering the cycler position will increase suction and may improve draining. However, this increased suction may result in increased pain-on-drain. [PAHG pp 15-17, 15-50] 30
Recommendations for Dry Day Patients What you should do: Set I-Drain alarm to 0 (zero) ml Estimated time to move to Fill 1 is approximately 2 minutes What you should not do: Set I-Drain Alarm value too high or OFF May result in a Low Drain Volume alarm Estimated time in Initial Drain may increase up to 10 minutes Pressing Stop/Go during Initial Drain Results in additional time spent in Initial Drain Closing and opening the clamps May result in a Check Patient Line alarm The HomeChoice can tell the difference between empty peritoneum and a clamped patient line 31 Baxter International Inc. April 2011. Recommendations for Dry Day Patients A Dry Day may be the result of the patient not performing a Last Fill or manually draining without refilling prior to the next treatment. If the volume drained during Initial Drain has not exceeded the I-Drain alarm, the HomeChoice will spend up to an additional 10 minutes attempting to drain the fluid before displaying a LOW DRAIN VOLUME alarm. What you should do: Set I-Drain alarm to 0 (zero) ml Estimated time to move to Fill 1 is approximately 2 minutes What you should not do: Set I-Drain alarm value too high or OFF This may result in a LOW DRAIN VOLUME alarm Also, estimated time in Initial Drain may increase up to 10 minutes Press Stop/Go during Initial Drain This results in additional time spent in Initial Drain Close and open the clamps This may result in a Check Patient Line alarm The HomeChoice can tell the difference between an empty peritoneum and a clamped patient line [PAHG pp 9-11] 31
Recommendations for Pain-on-Drain 32 Prescribe a Low Reserve Volume Tidal therapy Evaluate Tidal Full Drains therapy parameters Confirm cycler placement height Recommended position is at the same height as the patient s supine position Cycler may be placed higher to reduce suction during drain Maximum allowed cycler height is 12 in (30 cm) above the patient s supine position PD catheter position may contribute to pain-ondrain Baxter International Inc. April 2011. Recommendations for Pain-on-Drain Baxter is aware that some patients experience pain during the drain phase. Often this is the reason patients are prescribed a Low Reserve Volume Tidal therapy. The HomeChoice SmartCare change to not allow the Initial Drain to be bypassed is a significant impact on patients who experience pain on drain. This change was introduced to reduce the likelihood of an IIPV (overfill) from occurring due to the inappropriate use of Bypass to cancel Initial Drain. Setting TIDAL FULL DRAINS (Nurse s Menu) to YES and setting FULL DRAINS EVERY (Change Program Menu) to drain the patient to empty during one or more times during tidal therapy may also contribute to pain on drain. Enabling these features mitigate the risk of IIPV as a result of UF accumulation during the tidal therapy. The patient s typical ultrafiltration should be well understood and properly programmed (Total UF parameter) before disabling these features. Increasing the cycler height relative to the patient will decrease the flow rates during drain. This results in decreased suction and potentially reduces pain. It is possible that pain on drain is a result of PD catheter position. [PAHG pp 9-10, pp 6-2] 32
Recommendations for Pain-on-Drain Cont. Set an appropriate I-Drain alarm to satisfy Initial Drain requirements and to move on to Fill 1 Set I-Drain alarm to the estimated volume in the peritoneal cavity 70% of the Last Fill Volume is the recommended starting point Dry Day patients should set I-Drain alarm to 0 ml Do not set I-Drain alarm to an unreasonably high value. This may increase the time in Initial Drain The goal is not to get a Low Drain Volume alarm and then bypass, but rather to have a thorough drain 33 Baxter International Inc. April 2011. Recommendations for Pain-on-Drain - Continued Set an appropriate I-Drain alarm to satisfy Initial Drain requirements and to move on to Fill 1 Set I-Drain alarm to the estimated volume in the peritoneal cavity 70% of the Last Fill Volume is the recommended starting point Dry Day patients should set I-Drain alarm to 0 ml Do not set I-Drain alarm to an unreasonably high value. This may increase the time during the Initial Drain phase. The goal is not to get a Low Drain Volume alarm and then bypass, but rather to have a thorough drain. See page 16-21, Determining Initial Drain Alarm Volume Settings in The HomeChoice and HomeChoice PRO APD Systems Patient At-Home Guide. [PAHG pp 9-10, 16-21] 33
I-Drain Bypass/Low Drain Alarm Different Screens WAS NOW LOW DRAIN VOLUME Press STOP Press DRAIN VOLUME: ML Press TOTAL UF: ML Press BYPASS LOW DRAIN VOLUME Press STOP Press DRAIN VOLUME: ML Press I-DRAIN ALARM: ML Press DRAIN NOT FINISHED Press BYPASS new 29 Baxter International Inc. August 2010. I-DRAIN Bypass/Low Drain Alarm Different Screens If the LOW DRAIN VOLUME alarm sounds, the patient can press STOP and use the down arrow to compare the amount of fluid already drained during this phase (DRAIN VOLUME) with the minimum expected drain volume (I-DRAIN ALARM). This information can be used to determine how close he or she is to draining the programmed I-Drain alarm volume. If the patient decides that it is safe to move to the first fill phase, he or she may press the down arrow twice. The patient is first reminded that the I-Drain was not completed before reaching the BYPASS screen. The Total UF screen does not appear during initial drain because it was always zero. Note: Patients should never bypass an alarm or drain without first discussing with their clinicians. [PAHG p 15-44] 34
Drain Phases A negative UF condition will now cause the NEGATIVE UF alarm to sound at the end of each cycle, even if the entire target drain volume was met for that particular cycle. This is an extremely rare occurrence with HomeChoice SmartCare software. Background: A negative UF condition occurs when the cumulative amount drained during a therapy session is less than the cumulative amount filled. [TG pp 1-9, 12-8] 35
Drain Phases Drain bypass increases risk of IIPV Additional safety parameters to discourage drain bypass WAS NOW DRAIN NOT FINISHED message displayed for Initial Drain only DRAIN NOT FINISHED message displayed for OTHER drain phases 31 Baxter International Inc. August 2010. Drain Phases Like the Initial Drain, other drain phases can also be bypassed. However, bypassing a drain phase can leave fluid in the peritoneal cavity. Remember: A drain bypass indicates that the peritoneal cavity is empty, and can cause a full fill to be delivered in addition to the residual peritoneal fluid, resulting in IIPV. Software changes have been made to discourage bypassing drain phases. The HomeChoice Cycler now displays the DRAIN NOT FINISHED message for all bypassed drain phases. This alerts the user that the minimum drain amount has not been reached. [PAHG pp 15-46 15-47; TG p 1-8] 36
Drain Bypass To bypass a drain phase, the patient can press STOP and use the down arrow to compare the amount of fluid already drained during this phase (DRAIN VOLUME) with the minimum expected drain volume (MIN DRAIN VOL) for CCPD or (TIDAL DRAIN) for TPD to determine how close he or she is to draining the minimum volume expected by the device. The cumulative amount of ultrafiltrate drained during therapy is updated throughout the drain phase, and is displayed as CURRENT UF in HomeChoice SmartCare software. This is different than TOTAL UF, which was previously displayed because total UF was only updated at the end of the previous drain cycle. The patient can use this information to determine whether sufficient drainage has taken place. If the volume drained is less than the minimum expected drain volume, a DRAIN NOT FINISHED message appears next. Alternatively, a CAUTION: NEGATIVE UF alarm may appear. Patients should be instructed that the DRAIN NOT FINISHED and CAUTION: NEGATIVE UF alarms should be bypassed only with the advice of a clinician at the dialysis center. If the patient s clinician decides that it is safe to move to the fill phase, he or she can press the down arrow again for the BYPASS option. [PAHG pp 15-46 15-49, 15-54] 37
Partial Fill Volume Changes After bypassing a CAUTION: NEGATIVE UF alarm, the next fill will be a partial fill. WAS NOW Device delivers FULL fill after bypass of CAUTION: NEGATIVE UF alarm Device delivers PARTIAL fill after alarm bypass of CAUTION: NEGATIVE UF alarm Negative UF Alarm Threshold: 50% of Fill Volume 33 Baxter International Inc. January 2011. Partial Fill Volume Changes Important software updates have been made for situations when bypass of a drain step has occurred. In the previous software version, the HomeChoice Cycler delivered a full fill volume more often after a bypassed drain. With HomeChoice SmartCare software, if negative UF conditions exist, then the device delivers a partial volume based on the estimated amount left in the peritoneal cavity. Remember: A Negative UF condition occurs when the cumulative amount drained during a therapy session is less than the cumulative amount filled by more than 50% or the programmed negative UF setting (Low Fill mode). Negative UF limit for standard mode is fixed at 50%. It is a configurable value for Low Fill Mode (20 60%, defaulting to 50%) [PAHG 3 5, 15 56, 16 14, 16 15] [TG pp 1-8, 13-25 13-26, 13-32 13-33, 13-49] 38
Drain Phases Note that a SLOW FLOW DRAIN alarm cannot be bypassed with the new HomeChoice SmartCare software. This is because the SLOW FLOW DRAIN alarm indicates that a line may be kinked or partially obstructed, and this should be corrected before therapy is continued. [PAHG 15 22] 39
Chapter 3 Therapy Execution End Therapy The final section of Chapter 3 will discuss updates encountered at the End of Therapy. 40
LOW UF The Last Manual Drain default is now set to YES. Therefore, a Low UF alarm will appear if the UF Target has not been achieved before the Last Fill is delivered. With the LOW UF ALARM: YES, the device beeps continuously to alert the patient to perform the manual drain. With the LOW UF ALARM: NO, the device is silent but displays the Low UF message. The system will stop therapy until a last Manual Drain is performed or the Low UF message is bypassed. This may delay a patient s therapy ending. If a UF Target is not set, the patient will be prompted for a value. 0 is an illegal value. [PAHG p 1-8; TG p 13-44] 41
HIGH DRAIN/CALL PD NURSE A high drain is a drain volume much higher than expected. Specifically, it means that the drain volume was more than 200% of the maximum programmed fill volume for Standard mode or more than 190% of the maximum programmed fill volume for Low Fill mode. This situation suggests that IIPV may have occurred during the previous therapy. If the device measures a large drain volume at any point in the therapy, HomeChoice SmartCare software will display HIGH DRAIN XYZ and CALL PD NURSE warning messages. The messages can appear at the end of the current treatment or, if the system shuts down early, at the beginning of the next treatment. The patient should be instructed to: Press STOP to mute the alarm Contact the PD nurse first Contact Baxter Technical Assistance if the alarm continues [PAHG pp 15-5 15-6; TG p 13-38] 42
HIGH DRAIN XYZ indicates when the high drain occurred HIGH DRAIN X YZ First Digit Last 2 Digits 0 = Day Drain Day drain cycle # 1 = Night Drain Night drain cycle # 2 = Manual Drain Manual Drain # Example #1: HIGH DRAIN 105: 1: Night Drain 05: Fifth Cycle Example #2: HIGH DRAIN 2: 0: Day Drain 02: Second Cycle (the leading zeros are not displayed) Assess patient therapy to PREVENT future occurrences 43 Baxter International Inc. April 2011. HIGH DRAIN The three numbers that follow HIGH DRAIN indicate when the device detected the large drain volume. The first number indicates whether it was a programmed day or a night drain (0 for day and 1 for night) or a manual drain (2). The last two numbers indicate the cycle number or manual drain number. For example, HIGH DRAIN 105 indicates that an unusually large drain volume was detected during the fifth cycle of night therapy. Leading zeros will not be displayed. Additional examples are below: HIGH DRAIN 9: Day drain, ninth cycle HIGH DRAIN 101: Night drain, first cycle HIGH DRAIN 203: Manual drain, third cycle Question: What would you ask your patient if he/she calls with the HIGH DRAIN message? Remember: Manual Drain is in reference to a cycler-assisted Manual Drain. This is not referring to an off-cycler manual drain. [TG pp 1-8, 13-38] 43
Summary: Therapy Execution New alternating CONNECT BAGS/OPEN THE CLAMPS and CLOSE ALL CLAMPS/RELOAD THE SET messaging Additional information provided to the user before BYPASS screen (e.g. LOW DRAIN VOLUME, CURRENT UF: XXX ML) A partial Fill is delivered when bypassing a LOW DRAIN VOLUME alarm and there is a Negative UF condition The LOW UF feature prompts the user to perform a Manual Drain to complete therapy when the UF Target was not met The HIGH DRAIN alarm will be displayed if there is an unusually large drain volume 44 Baxter International Inc. April 2011. Summary: Therapy Execution This chapter covered the following HomeChoice SmartCare updates: New alternating CONNECT BAGS/OPEN THE CLAMPS and CLOSE ALL CLAMPS/RELOAD THE SET messaging Additional information provided to the user before BYPASS screen (e.g. LOW DRAIN VOLUME, CURRENT UF: XXX ML) A partial Fill is delivered when bypassing a LOW DRAIN VOLUME alarm and there is a NEGATIVE UF condition The LOW UF feature prompts the user to perform a Manual Drain to complete therapy when the UF Target was not met. The HIGH DRAIN alarm will be displayed if there is an unusually large drain volume. 44
Assessment: Therapy Execution What is the reason for the new alternating messages for CONNECT BAGS and RELOAD THE SET prompts? What is the purpose of not allowing an I-Drain bypass without first receiving a LOW DRAIN VOLUME alarm? How does the way the new software handles a partial filling after a bypass help the patient? Why have Last Manual Drain updates been made? What do the numbers 0, 1, and 2 signify when displayed during a HIGH DRAIN alarm? 45 Baxter International Inc. April 2011. Assessment: Therapy Execution Question: What is the reason for the new alternating messages for CONNECT BAGS and RELOAD THE SET prompts? Question: What is the purpose of not allowing an I-Drain bypass without first receiving a LOW DRAIN VOLUME alarm? Question: How does the way the new software handles a partial filling after a bypass help the patient? Question: Why have Last Manual Drain updates been made? Question: What do the numbers 0, 1, and 2 signify when displayed during a HIGH DRAIN alarm? 45
Chapter 4 Clinical Software Learning Objectives After completing Chapter 4 you will be able to: Identify RESET WEIGHT programming changes Identify software updates that may trigger the PROGRAM NOT VALID prompt Explain the PROGRAM NOT VALID message Explain the risk of failure to reprogram the prescription after the PROGRAM NOT VALID prompt appears 46
RESET WEIGHT Programming Updates PD Link Software Can NOT program the following new HomeChoice SmartCare software parameters onto PRO card : RESET WEIGHT Weight Units Used for fill volume validation Patient Weight HomeChoice PRO System Manual programming of new Weight Settings RESET WEIGHT: YES AND PD Link weight prompt: ENABLED Patient to Enter Weight twice. 47 Baxter International Inc. April 2011. RESET WEIGHT Programming Updates A new prompt in the Nurse s Menu will remind you to check the RESET WEIGHT option of shared devices. However, PD Link Software will not be able to program the RESET WEIGHT parameter onto the PRO card. The RESET WEIGHT parameter must be changed manually. Patients who use HomeChoice PRO to recored daily weight information for the clinician may be prompted to enter the weight value twice during startup if the RESET WEIGHT option is YES and the PD Link Software weight prompt is enabled. The weight entered at the PATIENT WEIGHT prompt is not written to the PRO card and will not be recorded for PD Link Software. The HomeChoice SmartCare software RESET WEIGHT prompt is used to validate that your Day Fill, Night Fill and Last Fill Volumes do not exceed recommended Fill Volumes. This weight information is not available to the Clinical Software. [PAHG p 1-14; TG p 12-13] 47
PROGRAM NOT VALID Appears if prescription on PRO card is not accepted Previously valid values for Tidal Volume % and Tidal Total UF, still allowable in PD Link Software, will be rejected by HomeChoice SmartCare software if outside new allowable ranges. PROGRAM NOT VALID 43 Baxter International Inc. August 2010. PROGRAM NOT VALID PD Link Software still accepts previous settings, so a patient may see the PROGRAM NOT VALID message after inserting the PRO card. This is because the new HomeChoice SmartCare software may reject previously valid prescriptions that are still allowable in PD Link software. If this occurs, the system will attempt to use the therapy parameters stored on the cycler instead of the PRO card. If no therapy parameters are stored, the default settings are used; however, the default settings are not a valid complete therapy and must be changed. Appropriate programming of the PRO card prevents this from occurring. [PAHG p 7-14; TG p 3-3] 48
PROGRAM NOT VALID If a PROGRAM NOT VALID message appears: Do NOT press GO! Instruct patient to call their PD Nurse Pressing GO at the PROGRAM NOT VALID screen without changing prescription may result in running an unintended therapy. 49 Baxter International Inc. April 2011. PROGRAM NOT VALID If a PROGRAM NOT VALID message does appear, do NOT proceed without reviewing and changing the prescription settings. System will attempt to use Last valid therapy parameters stored on the cycler, if any, or Default settings, which are not a complete valid therapy Be aware that the PROGRAM NOT VALID is a different error message from INVALID PRO CARD. [PAHG p 7-14; TG p 3-3] 49
Defaults & Allowable Ranges PD LINK SOFTWARE HOMECHOICE SMARTCARE SETTING DEFAULT RANGE DEFAULT RANGE ALL THERAPIES WEIGHT UNITS: N/A N/A KG KG / LB PATIENT WEIGHT: N/A N/A 1 KG 1-990 KG 2-990 LB I-DRAIN ALARM: 1400 ML OFF, 0 3500 LARGER OF OFF, 0 3500 STD MODE STD MODE 1400 ML OR STD MODE -- ML OFF, 0 1500 70% OF LAST FILL OFF, 0 1500 INVALID LOW FILL STD MODE LOW FILL VALUE MODE -- ML MODE LOW FILL INVALID VALUE OR MODE 70% OF LAST FILL LOW FILL MODE TIDAL LAST MANUAL DRAIN: OFF ON / OFF ON ON / OFF TIDAL VOL: 5% 5% - 95% 95% 40% - 95% TOTAL UF: 0 ML 0-10,000 ML 1,000 ML 10-10,000 ML STD MODE 400 ML LOW FILL MODE TIDAL FULL DRAINS: NO YES/NO YES YES/NO FULL DRAINS EVERY: 1 1-99 3 1-99 PD Link Software will not reflect new HomeChoice ranges or defaults 45 Baxter International Inc. August 2010. Defaults & Allowable Ranges While there are new defaults and allowable ranges in HomeChoice SmartCare software, PD Link software continues to allow previous settings. One example of this is with Tidal Full Drains. Tidal Full Drains are enabled by default in Low Fill mode; this setting cannot be changed. However, in Standard mode, the Tidal Full Drain setting default is still NO. If the setting isn t changed to YES, PRO cards will allow full drains only at the Initial Drain and at the end of therapy. If Tidal Full Drains are enabled, but you don t change the default frequency of 1, HomeChoice SmartCare software will perform full drains every cycle, which is equivalent to a normal CCPD therapy. PD Link Software ranges highlighted in the Red Box are values that may be rejected by HomeChoice SmartCare software if they are outside the new allowable ranges. Be aware that the HIGH DRAIN/CALL PD NURSE alarm message will not be visible in PD Link software. [TG pp 3-3, B-6] 50
Summary: Clinical Software PD Link Software has not changed New RESET WEIGHT, weight units, and PATIENT WEIGHT prompts can NOT be programmed in PD Link Software and not saved on a PRO card PROGRAM NOT VALID messages may occur because PD Link Software still accepts previous settings There are many changes to defaults and allowable ranges which are NOT reflected in PD Link Software New HIGH DRAIN message (Chapter 3) will not be visible in PD Link Software 46 Baxter International Inc. August 2010. Summary: Clinical Software This chapter covered the following issues regarding how HomeChoice SmartCare software updates may impact the use of clinical software with this device: PD Link Software has not changed New RESET WEIGHT, WEIGHT UNITS, and PATIENT WEIGHT prompts can NOT be programmed PD Link Software and not saved on a PRO card PROGRAM NOT VALID messages may occur because PD Link Software still accepts previous settings There are many changes to defaults and allowable ranges which are NOT reflected in PD Link Software New HIGH DRAIN message (Chapter 3) will not be visible in PD Link Software 51
Assessment: Clinical Software What are the patient weight updates affecting clinical software usage? Why would a PROGRAM NOT VALID prompt occur? What Tidal therapy drain update could result in an unintended CCPD therapy if the old default is not changed? 52 Baxter International Inc. April 2011. Assessment: Clinical Software Question: What are the patient weight updates that affect clinical software usage? Question: Why would a PROGRAM NOT VALID prompt occur? Question: What Tidal therapy drain update could result in an unintended CCPD therapy if the old default parameter is not changed? 52
Explain the reasons for changing the HomeChoice SmartCare software List the software updates for therapy programming Module 3 Learning Objectives Now that we have completed this training, let s review our learning objectives: Identify software updates encountered when preparing and performing therapy Explain the HomeChoice SmartCare software changes that affect the use of PD Link Software 48 Module 3: Training for the HomeChoice Smartcare Software. Baxter International Inc. August 2010. Module 3 Learning Objectives Revisited After completion of this training, review the answers to the following Module 3 learning objectives: Objective: Explain the reasons for changing the HomeChoice SmartCare software. (Refer back to slide 5) Objective: List the software updates for therapy programming. (Refer back to slide 19) Objective: Identify software updates encountered when preparing and performing therapy. (Refer back to slide 39) Objective: Explain the HomeChoice SmartCare software changes that affect the use of PD Link Software. (Refer back to slide 46) 53
Increased Intraperitoneal Volume (IIPV) If you suspect your patient has IIPV, please tell your patient or patient caregiver to do the following: 1. Press STOP immediately, then press the down arrow and initiate a Manual Drain; the Manual Drain procedure is located in the HomeChoice Patient At-Home Guide 2. Once the fluid has completely drained from the abdomen, call the patient s dialysis center or nephrologist 3. In addition, call the patient s dialysis center or nephrologist immediately if the patient has complaints, signs, or symptoms of IIPV 4. For assistance in performing the above steps, call the Baxter Global Technical Services group, available 24 hours a day, 7 days a week at 1-800-553-6898 5. A patient who cannot reach his/her dialysis center, nephrologist, or Baxter Global Technical Services and is experiencing IIPV symptoms should call 911 immediately or go to the nearest emergency room 49 Baxter International Inc. August 2010. Increased Intraperitoneal Volume (IIPV) If you suspect your patient has IIPV, it is important to tell your patient or patient caregiver to Press STOP immediately. Next, he/she should press the down arrow and initiate a Manual Drain; the Manual Drain procedure is located in the HomeChoice Patient At-Home Guide. Once the fluid has completely drained from the abdomen, the patient should call his/her dialysis center or nephrologist. In addition, the patient should call his/her dialysis center or nephrologist immediately if he/she has complaints, signs, or symptoms of IIPV. For assistance in performing the above steps, the patient can call the Baxter Global Technical Services group, available 24 hours a day, 7 days a week at 1-800-553-6898. A patient who cannot reach his/her dialysis center, nephrologist, or Baxter Global Technical Services and is experiencing IIPV symptoms should call 911 immediately or go to the nearest emergency room [PAHG p 3-6] Baxter, HomeChoice, HomeChoice SmartCare and PD Link are trademarks of Baxter International Inc. AL10340A 4/11 54