Baxter HomeChoice PRO APD System User Manual

Baxter HomeChoice PRO APD System

Introduction to HomeChoice APD Systems

• Baxter’s HomeChoice and HomeChoice PRO APD Systems are designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients. Their Fill volumes can range from 60 mL to 3000 mL. HomeChoice and HomeChoice PRO APD Systems are intended to be operated by:
  • Home patients whose physicians have prescribed this system. Patients, or their caregivers, must have received adequate training to use the system.
  • Clinicians who are using the system for patients under their care and under a prescription. Clinicians must have received adequate training to use the system.
• Since Drain and volume requirements vary among patients, both the HomeChoice and HomeChoice PRO APD Systems software have a choice of modes, either Standard Mode or Low Fill Mode. The dialysis center selects the Fill mode for the patient before therapy begins.

Introduction to Peritoneal Dialysis

Peritoneal Dialysis (PD) is a procedure that cleans and filters the blood. Peritoneal dialysis rids the body of unwanted waste and excess fluid, helps to control blood pressure, and maintains the proper balance of chemicals such as potassium, sodium, and bicarbonate in the body. This process of cleansing the blood uses the body’s own peritoneal membrane as a filter. See Figure 5-1.

1. Peritoneal Cavity
2. Catheter
3. Peritoneal Membrane

The basic steps of PD are the following:

1. Peritoneal dialysis usually begins with an initial drain to remove existing fluid from the peritoneal cavity.
2. The peritoneal cavity is filled with fresh dialysis solution. Solution enters through a catheter that has been surgically placed through the wall of the abdomen and into the peritoneal cavity.

Continuous Ambulatory Peritoneal Dialysis (CAPD)

• With CAPD, the blood is always being cleaned. Dialysis exchanges are done manually three to five times a day. This type of peritoneal dialysis does not use an automatic cycler. This method can be used to continue your treatments if you are unable to use your cycler; for example, during a power failure.

Automated Peritoneal Dialysis (APD)

• All peritoneal dialysis techniques that use a cycler to perform exchanges are referred to as Automated Peritoneal Dialysis (APD). APD exchanges are usually referred to as cycles. Each cycle consists of three (3) phases:
  • Fill phase
  • Dwell phase
  • Drain phase
• Treatment settings, such as the amount of solution to be infused and the length of time the solution remains in the peritoneal cavity, are programmed on the cycler. The cycler then automatically performs the treatment. In APD, the treatment settings can be modified to meet the needs of each patient.
• There are four (4) types of APD therapy:
  • Continuous Cycling Peritoneal Dialysis/Intermittent Peritoneal Dialysis (CCPD/IPD)
  • Tidal Peritoneal Dialysis (TPD)
  • Hi-Dose Continuous Cycling Peritoneal Dialysis (Hi-Dose CCPD)
  • Hi-Dose Tidal Peritoneal Dialysis (Hi-Dose TPD)

HomeChoice APD Systems Functions

• The HomeChoice and HomeChoice PRO APD Systems perform peritoneal dialysis by directing the flow of fluid between the solution bags, the cassette, your peritoneal cavity, and your drain option.
• Once you have connected all solution bags and your drain option, and have connected yourself to the disposable set, you have created a fluid circuit. The system manages your PD by the following methods:
  • With the cassette loaded in the cycler, the system is able to draw fluid into the cassette chambers by opening and closing the correct combination of valves on the cassette.

Fluid Pathways: Drain, Fill, and Dwell

Fluid pathways change during the therapy. They are pictured below for the three (3) main phases of therapy.

1. DRAIN
   • During the Drain phase, the system pulls fluid from your peritoneal cavity to the disposable cassette where it is measured. The fluid is then sent to the drain option. This process is repeated until the system determines you are empty. The system calculates the UF volume for each Drain cycle.
2. FILL
   • During the Fill phase, the system pulls fluid from the heater bag to the disposable cassette where it is measured. The fluid is then delivered to your
     peritoneal cavity. This process is repeated until the programmed Fill Volume has been delivered to your peritoneal cavity.
3. DWELL
   • During the Dwell phase, the system pulls fluid from the supply bags to the disposable cassette where it is measured. This fluid is then delivered to the heater bag to replenish the solution that was used during the previous Fill phase. This is done to warm the fluid in the heater bag to prepare for the next Fill phase.

Situations When Fluid Lines are Not Controlled

There are three (3) situations during the use of the system when the fluid lines are not clamped by the internal occluder (behind the door of the cycler) or not closed by the valves in the cassette. All lines should be clamped when any of the following situations take place:

• When the door is open.
• During treatment setup when LOAD THE SET appears on the display screen.
• At the end of treatment when REMOVE THE SET appears on the display screen.

During these three situations, the system does not have control of the valves and fluid pathways. Therefore, the solution can move freely between pathways. This can result in an increased intraperitoneal volume (IIPV) situation.

HomeChoice APD Systems Description

There are two models of Baxter HomeChoice APD System cyclers described in this guide:

• HomeChoice PRO APD System cycler
• HomeChoice APD System cycler

The HomeChoice PRO APD System Cycler

1. Heater Pan
2. Silver Heater Sensor Button
3. Bag Stops
4. Serial Number
5. Occluder (behind Door)
6. Door
7. Handle (shown in locked position)
8. Control Panel
9. PRO Card Port

1. Power Entry
2. J1 – Service Port
3. J2 – Modem Port
4. Power Cord
5. On/Off Switch

1. Display Screen
2. Control Panel
3. GO Button
4. STOP Button
5. ENTER Button
6. UP/DOWN Buttons

Disposable Sets

Disposable sets have one of two types of connections:

• Luer
• Spike

The following disposable sets are available with either connection type:

• Automated PD Set with Cassette – 4 Prong
• Integrated APD Set
• Low Recirculation Volume APD Set with Cassette

Your dialysis center determines which type of disposable set and connection you use.

Luer Disposable Set

1. Organizer
2. Effluent Sampling Site
3. Cassette
4. Lines

1. Patient Line
2. Final Line (Blue Clamp)
3. Supply Lines (White Clamps)
4. Heater Line (Red Clamp)
5. Drain Line
6. Luer Connectors

Environmental Conditions

Operating Conditions

The HomeChoice and HomeChoice PRO APD Systems are designed for use in these conditions:

• Temperature between 59°F to 96.8°F (15°C to 36°C)
• Humidity between 15% and 85%
• Altitude of –1,100 ft to +10,000 ft (–340 m to +3,050 m)

Use While Traveling

The system is designed to be portable and to allow you to travel. To be sure that your therapies continue smoothly, contact your dialysis center about the following:

• When you will not be taking your supplies with you, arrange with your dialysis center well in advance of your trip. Your solution and disposable sets can be delivered to you at your destination.
• If you are traveling out of the region where you live, inquire about any emergency contact information that you will need.
• If you are traveling to another country, the solution bag connection method may be different. Your dialysis center can provide you with information about any differences in supplies and connection methods.
• Some regions of the world use different voltage levels, frequencies, and plug shapes. Ask your dialysis center about the use of approved plug adaptors. Also ask about step-up or step-down isolation transformers with a minimum rating of 500 watts (continuous). Use an isolation transformer in countries with the same voltage as the U.S. if there is any doubt about the proper grounding of an electrical outlet.

Setup and Check-out

Check-out

1. Check the cycler for external damage. See 5.5, HomeChoice APD Systems Description, on page 5-8 for a description of the system and its components.
2. Verify that a power cord was included in the box.
3. If you see any damage on the cycler or the cord is missing, contact Baxter Technical Assistance. See 2.2, Numbers to Call for Assistance, on page 2-1.

Set Up the HomeChoice APD System

Place the HomeChoice/HomeChoice PRO APD System cycler on a stable, clean, flat surface (table or nightstand) in a well-lighted area. The table should be large enough to hold the cycler and all of the solution bags. Make sure a three-prong grounded outlet is nearby. See 7.3, Grounding Instructions, on page 7-4 for warnings concerning the three-prong outlet. Be sure the cycler is placed at the same height as you when you are lying in bed.

• To decrease the flow rate during Drain, raise the cycler by approximately 6 inches (15 cm).
• To increase the flow rate during Drain, lower the cycler by approximately 6 inches (15 cm).

Operating Instructions –PRO Card and Modem

Introduction

• Your HomeChoice PRO APD System has a computerized data transfer feature – the PRO Card. During your initial training, your dialysis nurse or physician showed you a small electronic data card that fits into your system. The PRO Card holds treatment information and is used by your dialysis center to automatically set up your therapy. The PRO Card also records information about each treatment.
• The PRO Card holds at least two months of treatment information. This feature provides information to your dialysis center to help improve your therapy. You might also use a modem and a phone line to transfer PRO Card information to the dialysis center. See 8.4, Install the Modem Option, on page 8-14.

Using the PRO Card

• At the time of your initial training, your physician gave you a PRO Card. The PRO Card contains your personal therapy settings prescribed for you by your physician. Just insert your PRO Card into your HomeChoice PRO APD System. Treatment results from your therapy are recorded to the PRO Card. This data provides your physician with important information about your therapy.

Care and Handling of the PRO Card

The PRO Card is compact and durable. It is designed to be carried to and from your dialysis center visits. It must remain inserted in the HomeChoice PRO APD System all other times. Please follow these guidelines for handling your PRO Card:

• Make sure that the main power switch of the HomeChoice PRO APD System is OFF before you insert or remove the PRO Card.
• Do not use excessive force when you insert or remove the PRO Card from the port. The PRO Card slides easily into the PRO Card port.
• Do not insert anything other than your PRO Card into the PRO Card port.
• Do not bend the PRO Card.
• Always store the PRO Card in its case to transport it.
• Keep the PRO Card away from magnets.

Confirm Your PRO Card

• When you return from a visit to your dialysis center with a new or reprogrammed PRO Card, you must verify that you have the correct card. The following steps help you to confirm your name and patient ID.

HomeChoice PRO APD System Prompts

• The HomeChoice PRO APD System records information needed by your physician, such as your weight, blood pressure, and day or manual exchanges. The system displays daily messages to prompt you to enter this information. Three buttons are used to enter data: ENTER, (up arrow), and (down arrow). The data entry menu only appears when you turn on the HomeChoice PRO APD System. Shown below are the basic steps for entering data in the entry prompts. The setting shown for each entry is zero (0) until you enter your data.

Definitions of Data Entry Prompts

• Table 8-1 and Table 8-2 list all the prompts available on the HomeChoice PRO APD System. See Basic steps for entering data on page 8-7.
• Table 8-1. Definitions of Data Entry Prompts

Remove Your PRO Card

• When you visit your doctor or dialysis center, you are usually asked to bring the PRO Card with you. Follow the steps below to remove your PRO Card.

Steps to Remove Your PRO Card

1. Turn off the HomeChoice PRO APD System.
2. Slide the PRO Card gently out of the slot.
   • NOTE: Do not bend the PRO Card.
3. Place the PRO Card in its case.

Technical Data

Physical Specifications

System Performance

Electromagnetic Compatibility

Low Fill Mode Drain Logic

• The Minimum Drain Volume and the Minimum Drain Time settings must both be met for the system to advance to the Fill phase when Slow Flow or No Flow occurs. Some LOW DRAIN VOLUME alarms that could occur due to Slow Flow or No Flow are suppressed if the Minimum Drain Time is not met. Table 19-5 compares the Standard Fill Mode Drain Logic with the Low Fill Mode Drain Logic.
• A single pump stroke volume of fluid is pushed back to the patient when a Drain ends due to No Flow to verify that the patient line is not occluded. The next Fill begins at this volume.
• Table 19-5. Drain Logic Options
  

  FLOW CONDITION	VOLUME OF FLUID DRAINED when Flow Condition Occurs
  Standard Fill Mode Drain Logic	Minimum Drain Volume HAS NOT been reached	Minimum Drain Volume HAS been reached
  Slow Flow Below 50 mL/min	LOW DRAIN VOLUME alarm will sound.	Automatically moves on to Fill mode with 100% of Fill Volume being delivered.
  No Flow* Below 12 mL/min	LOW DRAIN VOLUME alarm will sound.	Automatically moves on to Fill mode with 100% of Fill Volume being delivered.
  Low Fill Mode Drain Logic	Minimum Drain Volume HAS NOT been reached	Minimum Drain Volume HAS been reached
  Slow Flow Below 15 mL/min	If Minimum Drain Time has not elapsed, no alarm will sound. If Minimum Drain Time has elapsed, LOW DRAIN VOLUME alarm will sound.	If Minimum Drain Time has elapsed, moves on to Fill mode with 100% of Fill Volume being delivered.
  No Flow* Below 3 mL/min	LOW DRAIN VOLUME alarm will sound.	If Minimum Drain Time has not elapsed, the Drain will continue with no alarm, unless 100% of the Fill Volume has been drained, in which case it moves on to Fill mode. If Minimum Drain Time has elapsed, move on to Fill mode with 100% of Fill Volume being delivered.

Unscheduled Replenish

• If the heater bag empties before the end of the Fill phase, the system will usually, but not always, transfer the solution from the supply bags to the heater bag in order to complete the Fill phase. This is an unscheduled replenishment because the heater bag ran dry unexpectedly during the Fill.
• Table 19-6. Unscheduled Replenish Logic
  

  Fill Descriptions	Unscheduled Replenish
  Day Fill 1	Volume Delivered < 90% of Fill Volume
  Day Fill 2 and up	Volume Delivered < 100% of Fill Volume
  Fill 1 of n	Volume Delivered < 90% of Fill Volume
  Fill 2 thru n-1	Volume Delivered < 100% of Fill Volume
  Fill n	Volume Delivered < 75% of Fill Volume
  Last Fill	Volume Delivered < 75% of Fill Volume

Determining Maximum Fill Volume

• Table 19-7 on page 19-15 allows you to determine the highest Fill Volume that should be programmed for a given dry weight. This information allows you to
  verify that the entered Fill Volume is not accidentally programmed too high for you or a caregiver’s patient. In fact, most patients require a Fill Volume that is much lower than the values listed in this table.
• Table 19-7. Determining Maximum Fill Volume

Prepare for Therapy

1. Gather your supplies.
   • 1 – Solution Bags
   • 2 – Drain Option
   • 3 – Disposable Set
   • 4 – Disconnect Cap(s)
   • 5 – Face Mask(s)
     • Patient Line Extension, if needed (not pictured)
   • Check solution bags for SEAL:
     • Strength
     • Expiration Date
     • Amount
     • Leaks
2. Place a solution bag on the heater pan.
3. Turn on the cycler.
   • Press the On/Off switch to the ON position.
   • Observe that the characters on the display screen turn on and then off for several seconds.
   • The current mode (STANDARD MODE or LOW FILL MODE) appears for a few seconds.
   • When the system is ready, PRESS GO TO START appears
4. Prepare your drain option.
   • For Drain Bag: close the clamp on the line with the blue pull ring.
   • For Drain Line Extension: leave the line clamp open. When a drain line extension is used instead of a drain bag, you must leave a space between the
     end of the drain line and any fluid in the drain or container.
5. Press GO when you are ready to begin.
   • LOAD THE SET appears
6. Place the organizer.
   • Place the long slot of the organizer over the hook at the top of the door
7. Prepare your drain option.
   • Drain Bag: close clamp on the short tube to prevent leakage.
   • Drain Line Extension: remove tip protectors from both ends of the drain.
8. Attach your drain option.
9. Open all drain clamps.
10. Put on face mask and wash and dry your hands thoroughly
11. Connect bags.
    • Connect the line with the RED clamp to the heater bag.
    • Connect the line with the BLUE clamp to the Last Fill bag.
    • Connect the lines with the white clamps to additional solution bags, if needed
12. Check connections and open clamps.
    • Open clamps only on lines connected to solution bags.
    • Make sure the patient line is in the left slot of the organizer.
    • Open the clamp on the patient line.
13. Priming complete.
    • When priming is complete, the display screen alternates between CONNECT YOURSELF and CHECK PATIENT LINE
14. Press GO.
    • DISCONNECT YOURSELF appears on the display screen.
15. Open the door.
16. Remove and discard the disposable set.

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Baxter HomeChoice PRO APD System-FAQs