HPAC Cell CalibrationStation Operator Guide

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Parata Systems, LLC. All rights reserved. No part of this documentation or the associated productmay be reproduced, processed, duplicated or published in any form by photocopying, microfilming,reprinting or other process, in particular electronic means, without the written agreement of ParataSystems, LLC.

Trademarks

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Refer to www.parata.com/patents-and-trademarks/ for patents owned by Parata Systems, LLC.

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Use, duplication or disclosure by the U.S. government is subject to the restrictions set forth in theParata Systems, LLC Agreement and as provided in DFARS 227.7202-1(a), 227.7202-3(a) and227.7202-4 (1998 ed., revised June 21, 2005), DFARS 252.227-7013(b)(3) and (c) (NOV 1995,revised January 23, 2006), FAR 12.212(a) (1995), FAR 52.227-19, or FAR 52.227-14 (ALT III), asapplicable. Unpublished rights are reserved under the copyright laws of the United States.

Disclaimer

The information contained herein is considered accurate at the time of publication. Parata Systems,LLC reserves the right to make changes to the documentation or associated product at any timewithout notice.

Safety and alerts

Warning:

Pressing an E(mergency) Stop button immediately halts all robotic activity. You must release the E-Stop button for the Parata Express unit to resume normal operation.

The E-Stop button is provided as a safety mechanism; it is not a general-purpose stop button. Itshould be pressed only when there is a safety concern, such as prior to reaching inside the ParataExpress unit.

Warning: Be extremely careful when clearing jammed caps from the capping mechanism(located below the cap bins). The blades that hold the cap are sharp.

Warning:

Make sure the drug in the cell is the correct replacement for the NDC you are entering.

Warning: If this is a hazardous drug, please be advised that Parata does not recommenddispensing hazardous drugs with Parata Express.

Warning:

Be extremely careful of sharp edges when performing maintenance on the unit.

Warning:

The robotic arm can cause serious injury! Do not stick your hand into the “envelope” of the ParataExpress unit (for example, through an empty cell location or the conveyor end opening to retrieve adropped vial) without first pressing an E-Stop.

Warning:

Advanced Diagnostics provides access to machine sensors and actuators which can cause harm to theoperator or system if exercised improperly.

CAUTION:

After replenishing a cell, make sure the cell door is closed to prevent the contents from exiting.

CAUTION: Reducing pressure may lead to unrecognized counting errors.

CAUTION: Relocating cells containing pill inventory, if not done properly, can result in pillsflooding the agitation chamber.

CAUTION: If the Express’ cells are mapped and you run Load Cell Layout, the currentconfiguration for all cells is cleared, and replaced with the cell configuration data from the XML fileyou loaded.

CAUTION: To avoid damaging the print head, do not attempt to clean the print head withanything other than a Cleaning Card.

CAUTION: Caps produced by other manufacturers may cause problems with the Expresscapping system. Do not attempt to operate the Express with unapproved cap types or sizes. Also,keep the cap bins free of foreign objects.

CAUTION: Using vials produced by another vial manufacturer may impede proper function ofthe system. Do not attempt to operate the Express with unapproved vial types or sizes. Also, keep thevial bins free of foreign objects.

CAUTION: The circuit breaker in the unit’s Power Entry Module (PEM) is for emergency useonly. Do not use it to power down the Express. Doing so can damage the PC.

CAUTION: Do not allow the print head to snap closed.

CAUTION: When opening a cap bin door, do not use the prescription drop-off shelves forleverage by pressing against them with your thumbs. Doing so may unseat or break a drop-off shelf.

CAUTION: When opening the small vial bin door, do not use the prescription drop-off shelvesfor leverage by pressing against them with your thumbs. Doing so may unseat or break a drop-offshelf.

Part I. HPAC Cell Calibration Station Operator's Guide...............................................................1

Chapter 1. Overview....................................................................................................................2

Chapter 2. Components...............................................................................................................3

Chapter 3. Installation.................................................................................................................4

Chapter 4. Working with Cells.................................................................................................. 6

Chapter 5. Calibrating Cells.......................................................................................................9

Chapter 6. Validating the cell's calibration settings...............................................................12

Chapter 7. Guidelines for cell optimization............................................................................ 16

Chapter 8. Troubleshooting...................................................................................................... 18

Chapter 9. Maintenance............................................................................................................ 19

Inspect Mist Separator......................................................................................................... 19

Replace the cell cradle assembly.........................................................................................20

Replace Mist Separator Filter.............................................................................................. 23

Part I. HPAC Cell Calibration Station Operator'sGuide

This document describes how to use a Cell Calibration Station.

HPAC Cell Calibration Station - Operator's GuideThis document describes how to use a Cell Calibration Station.

Chapter 1. Overview

Parata’s HPAC Cell Calibration Station provides an external, standalone, precision testingenvironment for validating cell calibration settings and testing pilldispensing efficiency for drugsmaintained in Parata automation. The Calibration Station accommodates two cell types—standardcells and super cells. It is connected to the house high-pressure air system. You use the CalibrationStation to help determine or verify cell settings.

After you have added pill inventory to the cell, you use the touch screen to enter a desired pillquantity to dispense. Because the station also is used to optimize cell settings, note that the count canbe correct without the cell being optimized to achieve an efficient dispense rate.

Chapter 2. Components

Chapter 3. Installation

System requirements

Power

• 120VAC/60Hz/15A service

External air

The Calibration Station utilizes compressed air to count pills. As the station does not contain acompressor, it requires a connection to the pharmacy high-pressure air system. To meet operatingrequirements and protect the integrity of the drugs being counted, the following requirements must bemet:

• External air should be regulated down to 90 psi before entering the Calibration Station.• The external air should maintain a minimum flow rate of 6.5 cfm.• The external air should have a dew point less than or equal to 40 degrees F at 80-90 psi.• The external air should be oil free and meet the cleanliness requirements of ISO 8583.1 Class

3.3.2.• External air must be plumbed in with 5/16" OD tubing.

Installing the Calibration Station

This section describes how to unpack and set up the Calibration Station.

1. Uncrate the unit.a. Remove the four (4) screws in the top of the crate and remove the top.

b. Remove the power cord and any other peripherals and set them aside.c. Lift out the foam packing material.

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d. With assistance, lift the Calibration Station out of the crate. One person should grasp thecradle plate of the unit and the other should lift the main part of the station.

e. Place the unit on a sturdy counter or table with access to power and external airconnections.

CAUTION: Do NOT lift the unit by any plastic parts.

2. Set up and inspect the unit.a. Connect the power cord to the side of the test stand and plug the other end into the wall

outlet.b. Attach the line from the external air connection to the intake fitting on the back panel of the

Calibration Station.

Note: This is a quick-connect pressure fitting. Insert the tube all the way into thefitting and pull back to lock it in place. To release the tube, push the orange collar intoward the fitting.

c. Verify that the external air pressure is 90 psi.

Chapter 4. Working with Cells

This section describes how to remove a cell from and insert a cell into the Calibration Station—aprocedure similar to inserting/ removing cells from Parata automation. It also includes the procedurefor unlocking the cell door.

CAUTION: Both the cell network board and cell connector board are equipped with inlinefuses. To avoid damaging these boards, please make sure to turn off the 2 Amp breaker (illustration)before disconnecting any cables from them.

Inserting cells into the Calibration Station

Follow these steps to insert a cell:

1. Angle the cell slightly downward (about 20°) to align the cradle rails within the rail guides onthe cell.

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CAUTION: Holding the cradle rails against the cell will help guide the cell into position(illustration).

2. Guide the cell into position until you meet resistance.3. Press the cell firmly until you hear a “click,” signifying that the cell is properly inserted. The

click occurs when the cell ears (one on each side of the cell) engage the clips on the ends of thecradles.

Removing cells from the Calibration Station

1. Pull the cell release latch outward and lift the cell upward at a slight (about 20°) angle.

2. Slide the cell out of its slot, supporting it from the bottom with your free hand.

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Unlocking cells

Parata automation can include locking cells which contain a locking mechanism designed to preventan operator from accidently opening the wrong cell during replenishment and return-to-stockprocesses.

To open the cell door, the system must send a command to the cell to direct the locking cell’ssolenoid to retract. The cell calibration application contains a button for this purpose.

Clicking the UNLOCK DOOR button in the calibration application retracts the solenoid that locksthe door. The solenoid will remain retracted for 5 seconds.

Chapter 5. Calibrating Cells

The cell calibration steps in this section apply to both standard and super cells. The basic steps are:

1. Determine the cell parameters for the drug.2. Manually adjust the cell width/height throats and baffle.3. Set the pressure in the product software.4. Enter the throat width, throat height and baffle settings in the product software.5. Add the drug to the MDL, if necessary. Refer to the appropriate automation product

documentation.6. Replace a defective cell, if necessary. Refer to the appropriate automation product

documentation.7. Set up the new cell. Refer to the appropriate automation product documentation.

Determining parameters for a new drug cell

The first step in the cell calibration process is to determine the cell parameters for the drug.Cell parameters may be stored in an MDL in the Host System or may be included with the druginformation in the Calibration Tool in the Parata Customer Portal.

The Customer Portal also includes a Calibration Request form you can use to request parametersettings, request that a drug be added to the database, and report issues with recommended cellparameters.

If no recommended settings are available, you will need to use the cell calibration charts to determinethe parameters.

Note: The calibration charts are in the Cell Settings Tool (P/N 201-1464).

To determine the cell parameters for a new drug, follow these steps:

1. If applicable, follow the appropriate Parata automation product process to determine if the drugparameters already are stored in the MDL.

2. If applicable, obtain the parameters from the Parata Customer Portal.a. Obtain a Cell Calibration Worksheet from the Cell Troubleshooting and Calibration Guide.b. Sign into www.Parata.com.c. Click on Login button in the top right.

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d. Enter your User ID and Password in the Login fields and click the Login button.

e. Under Home, click the Drug Management Tile, then click the Add or Manage Drugs inAutomation Tile.

f. In the Product Selection box, select your automation product from the drop-down list (inthis example, the Parata MAX is selected), then click CONTINUE.

g. Enter the NDC number and click SEARCH.

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h. Click SELECT next to the desired NDC. An expanded description of the NDC will open,showing HPAC Cell setting values.

• If the drug has recommended settings in the Settings Tested section, note the Height,Width, Pressure and Baffle values on a Cell Calibration Worksheet. The Height andWidth values pertain to the nozzle throat. If the drug is not in the Calibration Tool ordoes not have recommended settings:

◦ Use the cell calibration charts in the Cell Settings Tool (P/N 201-1464) todetermine the parameters.

OR

◦ Submit a request for Parata to add the drug or settings to the Calibration Tool(Parata Drug Database).

3. To submit a request for Parata to add a drug or settings:a. Click on Calibration Request under the search field, after trying to search for settings.

b. In the subject field, please use the following format: New Drug, Drug Name, Strength,MAX

• Fill out the Drug Name, NDC, Manufacturer, and Distributor fields.• Enter the reason for the request in the Description field. If applicable, you can also

enter the cell settings you are currently using.c. Submit Request when finished.

Chapter 6. Validating the cell's calibration settings

After manually setting the nozzle height, nozzle width and baffle height on the cell, insert the cellinto the Calibration Station to validate the settings.

• Your primary objective is to establish consistency in the cell’s pill-counting accuracy for thedrug it will contain.

• The secondary objective is to ensure that the settings also provide an efficient dispense rate.

To validate cell settings using the Calibration Station, follow this procedure:

1. Make sure the 120 VAC power cord and the external air supply are connected to the CalibrationStation.

2. Apply power by pressing the main power switch, located on the right side of the unit.

3. If the station’s PC is shut down, apply power to the PC using the switch on the top of thecabinet.

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4. Once Windows has loaded on the monitor, doubleclick the desktop shortcut to the HPAC CellCalibration Station software.

Note: As the station initializes, the following window appears:

• If you already have inserted a cell into the cradle and the cell’s firmware is outdated, thestation automatically updates the firmware before continuing.

• A firmware update also will occur if any other circuit, such as the cell network board orcell connector board, has been replaced.

5. If prompted, insert the cell you are testing into the cradle.• Once you have inserted the cell, the cell state comes online and you are prompted to select

the desired pill count and EPR pressure.

Note: If the inserted cell has an outdated firmware version, the cell’s LED blinks red. (Theactual firmware update will occur later.) The red blinking LED indicates that the cell is in “BootMode,” waiting for a firmware update.

6. Before entering a pill count, place a container under the cell to catch dispensed pills. Thiscontainer should have sufficient volume to capture the cell’s pill inventory, and its openingshould be positioned very close to the cell nozzle to avoid spillage.

7. If necessary, replenish the cell.

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• If you have inserted a locking cell in the station’s cradle, the UNLOCK DOOR buttonbecomes active. Touch the UNLOCK DOOR button to unlock the cell door. The cell doorremains unlocked for 5 seconds only.

8. Using the Requested Pill Count drop-down list, select the desired pill count.• To count the cell’s current inventory (all the pills it contains), select Cell Inventory.• To enter a value directly, select User Input to display a numeric keypad, which you can use

to enter the desired pill count value.9. Using the Requested EPR drop-down list, select the desired EPR pressure.

10. Touch the BEGIN COUNT button to start the counting process.

11. Observe the cell during the fill process to determine whether the pills are agitating properly, andwhether the dispense time is optimal.

• During the count process, the EPR pressure is displayed on the station’s front panel.

Note: After a successful count has occurred, the following data is displayed:• Cell Count: The number of pills counted.• Requested Cnt: The value entered in the Requested Pill Count field.• Jam Retries: The number of times the cell tried to clear a jam; maximum consecutive

number = 8.• Count Time: How long the system took to dispense the pills. The time count starts when

the dispense command is received.

• If you selected the value “Cell Inventory” on the Requested Pill Count drop-down list, onlythe actual pill count is displayed.

• Also on a “Cell Inventory” fill, you are prompted to check the cell to verify that all pillswere dispensed.

12. Remove the cell to verify that all pills were dispensed.• If pills remain in the cell, reinsert the cell and touch the CONTINUE COUNT button.

You can repeat this process until the cell’s inventory is depleted—there is no limit to the

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number of attempts to empty the cell. Press the FINISH button to display the total numberof pills in the cell.

Note: Errors occurring during the counting process are displayed.

13. Touch the TEST ANOTHER? or EXIT PROGRAM button to continue.• Touching the SAVE TRACE button stores a trace file containing information regarding the

current status of the cell and/or Calibration Station. This file is useful when troubleshootingissues with the cell or Calibration Station.

Chapter 7. Guidelines for cell optimization

After a successful fill, determine if the cell calibration settings should be modified to optimize thedispense rate. This is accomplished by reviewing the dispense performance values. After each fill,the software displays values in the Count Rate, Cell Count, Jam Retries and Count Time fields.

• Count Rate: The number of pills dispensed per second.• Cell Count: The total number of pills counted.• Jam Retries: The number of times the cell tried to clear a jam.• Count Time: The time the system took to dispense the pills. The time count begins when the

dispense command is received.

In a successful fill, the Cell Count field value is the number of pills requested. The Count Timeindicates the time required for the dispense. The values in the Count Rate and Jam Retries fieldscan be used to determine whether the cell settings should be modified. The goal is to adjust the cellsettings so that each fill is successful, there are zero (or very few) jam retries and the count rate is ashigh as possible.

When adjusting the cell settings, it is important to change only one setting at a time. Test each settingto determine if it improved dispensing performance. You may have to adjust the settings severaltimes during this process.

Always begin by adjusting the baffle. Adjust the nozzle throat settings next, then the pressure.

Jam Retries

A value in this field indicates that the agitation chamber may be slightly starved or flooded; the bafflesetting is not so off-target that it is causing over- or under-dispenses—but it can be improved.

• If the chamber is starved, adjust the baffle up one setting and rerun the fill. Repeat this processuntil the retry value is zero or as low as possible.

• If the chamber is flooded, adjust the baffle down one setting and rerun the fill. Repeat thisprocess until the retry value is zero or as low as possible.

Count Rate

The count rate depends on the size and type of pill being dispensed. This rate can be improved bymodifying the baffle setting, changing the nozzle throat width or height, or adjusting the pressuresetting. It is important to ensure that changes made improve this rate do not affect the Jam Retriesvalues.

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When adjusting the settings to improve the count rate, make changes in the order listed below. Makeone change at a time, and test the setting:

1. Modify the baffle setting.2. Adjust the nozzle throat width.

Note: Be careful not to make it so large that multiple pills are dispensed at the same time.

3. Adjust the nozzle throat height.

Note: Be careful not to make it so large that multiple pills are dispensed at the same time.

4. If the rate is still not optimal after you adjust the baffle and throat, adjust the pressure setting.

Note: Raising the air pressure is not the preferred solution, as it may affect other countingperformance functions. Also, a pressure setting that is too high can break pills.

Chapter 8. Troubleshooting

Cell seating issues

If a known good cell fails to be recognized by the Calibration Station, the cell connector board orcradle may be defective. The entire cell cradle assembly can be replaced. See Maintenance andcalibration schedule, below.

Air leak

If an air leak is noticed when a known good cell is inserted into the cell cradle, the high pressurefitting may be defective. The entire cell cradle assembly can be replaced. See Maintenance andcalibration schedule, below.

Chapter 9. Maintenance

Daily• Verify that the external air pressure is 90 psi. Check the pressure on the gauge for

the house air connection.

Weekly• Inspect Mist Separator (page 19)

As needed• Replace the cell cradle assembly (page 20)

Annually• Verify: EPR calibration

Every 2 years• Replace Mist Separator Filter (page 23)

Inspect Mist Separator

1. Check the mist separator.

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a. With air connected to the unit, check the separator for air leaks. If there is a hissing sound,the filter should be replaced.

b. Inspect the filter. If there is debris in the filter bowl or the filter is yellow or discolored, thefilter should be replaced.

c. While air pressure is present, press the red button on the bottom of the mist separator. Thiswill remove any moisture.

2. Check the filter element in the super mist separator.a. With air connected to the unit, check the separator for air leaks. If there is a hissing sound,

the filter should be replaced.b. Inspect the filter. If there is debris in the filter bowl or the filter is yellow or discolored, the

filter should be replaced.

Replace the cell cradle assembly

The cell cradle assembly includes the air manifold assembly, the cell connector board and the cradleitself, as illustrated below.

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The top cradle is a complete, working assembly that can be used to replace a defective assemblyin the lower position. The defective assembly can be used safely in the top position, because it isrequired only to support super cells. However, once you have placed a defective assembly in the topposition, you will need to obtain a spare assembly for future repairs.

To replace the cell cradle assembly, follow these steps:

1. Remove power from the cell network and connector boards by turning off the breaker next tothe lower cell cradle.

2. ONLY AFTER THE BREAKER HAS BEEN TURNED OFF, unplug the ribbon cable fromthe cell connector board.

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3. Shut off the high-pressure air supply to the unit.

4. Press the red button on the bottom of the mist separator to bleed the air lines.

5. Disconnect the air hose from the quick-disconnect elbow fitting. Push the orange collar intoward the fitting to release the tube.

6. Use a 5/32” Allen wrench to remove the four (4) button-head screws that secure the cradleassembly to the frame.

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7. Gently squeeze the cradle fingers together to clear the aluminum stiffeners while pulling theentire assembly away from the frame.

Note: You may have to wiggle the assembly to remove it from the 2 dowel-locating pins.

8. If you are using the top cradle assembly as a replacement, use a 5/32” Allen wrench to removethe four (4) button-head screws that secure the assembly to the frame.

9. Place the new (or top) cradle assembly in the lower cradle position on the cradle plate andsecure it with the four (4) screws you removed in step 6.

10. Connect the air tubing to the quick-disconnect elbow fitting. Insert the tube all the way into thefitting and pull back to lock it in place.

11. Connect the ribbon cable to the connector board.12. Turn on the breaker switch next to the lower cell cradle.13. Open the high-pressure air supply to the unit.14. If you used the top cradle assembly as the replacement unit, install the defective assembly in the

top position.

Note: This is a good time to acquire a replacement assembly for future use.

Replace Mist Separator Filter

1. Power down the Calibration Station.2. Shut off the high-pressure air supply to the unit.

3. Locate the mist separator on the back of the Calibration Station. This is the smaller separator onthe right.

4. Press the red button on the bottom of the mist separator to bleed the air lines.

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5. Pull down on the lock, then push the cover up and rotate it 1/8-turn to the left.6. Pull the cover down, being careful not to lose the O-ring.

7. Unscrew the filter and dispose of it according to pharmacy policy.8. Place the new filter in the mist separator and turn it clockwise to screw it into place.9. Ensure the O-ring is in place; then place the cover on the separator with the space between the

double marks on the cover lined up with the center line on the front of the separator. Turn thecover clockwise until the lock snaps into place.

10. Turn on the high-pressure air supply to the unit.

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11. Power on the Calibration Station.