Enclosure 3_Blister Packager Specs.pdf

Central Pharmacy Blister Packager Operator's Guide CG-01036 Rev-A

Central Pharmacy Blister Packager Operator's Guide

About Omnicell For more information about legal notices, see www.omnicell.com.

Contact Omnicell Omnicell, Inc. • 590 E. Middlefield Road • Mountain View, CA 94043 • (650) 251-6100 •http://www.omnicell.com

Copyright and Trademarks This guide and accompanying software and/or hardware described in it are protected under copyright laws and may not be reproduced, adapted, or translated, wholly or in part, without the express written consent of Omnicell, Inc. The same proprietary and copyright notices must be attached to any permitted copies as were attached to the original documents.

This guide is CONFIDENTIAL and designed only for Omnicell personnel, designated representatives, and customers.

© 2021 Omnicell, Inc. All rights reserved. Periodically, check myomnicell.com for updates to this material.

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© 2021 Omnicell, Inc. 2 http://www.omnicell.com

Contents Use this information to set up, operate, maintain, and troubleshoot the Central Pharmacy Blister Packager.

Central Pharmacy Blister Packager Safety and Information Symbols in this Guide The Role of an Operator Locating the Blister Packager Specifications and Requirements Lifting the Blister Packager Contacting Omnicell Support

Safety Overview Who Should Operate the Blister Packager Precautions Machine Safety Machine Safety Labels Guards and Devices

Power Switch Seal Station Guard Fill Station Air Supply

Lockout and Restart Procedures Lock Out the Blister Packager Restart the Blister Packager

System Components and Controls Control Center

Main Power Switch Seal Station Controls Temperature Control Fill Station Controls

Air Pressure Regulator Adjust the Air Pressure

Setting Up the Blister Packager The Seal Station The Carrier Platen The Fill Station

Plates Hopper Brushes

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Operating the Blister Packager Operate the Blister Packager Using the Hopper Hand Pack Medications on the Blister Packager

Maintaining the Blister Packager Daily Maintenance

Using PeridoxRTU Cleaning Solution Clean Blister Packager

Weekly Maintenance Drain the Air Pressure Regulator

Replacing Fuses Replace a Fuse

Troubleshooting Blister or Medication has been Directly Sealed to the Heater Plate

Open the Sealer Clean the Sealer

Common Causes of Heat Seal Failure Breaking In Fill Station Brushes

Appendix A: Plate Gauges

Appendix B: Product Drop Chart

Appendix C: Maintenance Checklist

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Central Pharmacy Blister Packager Use this information to operate the Central Pharmacy Blister Packager (blister packager), a semi-automated medication packaging system.

The blister packager fills blisters for selected medications and seals a foil over the blister with information about the packaged medication. This guide describes how to operate the packager to create medication blister packages.

Important: Using the blister packager for any other task than the intended purpose above can lead to injury.

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Safety and Information Symbols in this Guide Use the following safety and information symbols throughout this guide.

Symbol Definition

Important: Indicates important information that requires your attention regarding the current topic. It might also be used to alert against unsafe practices.

Caution: Indicates a potentially hazardous situation which, if not avoided, could result in minor or moderate injury.

WARNING: Indicates a potentially hazardous situation which, if not avoided, could result in serious injury or death, or severe damage to the equipment.

The Role of an Operator This information describes the blister packager operator's role at a high level.

The packaging system fills blisters with the selected medications. The operator maintains medication inventory, assembles each blister package, and ensures each package is properly sealed and labeled.

As a blister packager operator, you will:

● Ensure that the environment and power supply requirements below are met.

● Select and install the correct sequence of the plates for the Fill Station.

● Select and install the proper brushes for the Fill Station.

● Load the blister packager with the required medications and packaging material.

● Ensure you have an understanding of all hazardous drugs and their risk assessment:

○ Ensure that any oral solid hazardous drug has had an appropriate internal pharmacy risk assessment before considering using in the packaging machine.

○ Ensure no antineoplastic oral solid agent (Table 1 of the NIOSH list) will be used in the packaging machine.

● Ensure medication blisters are properly filled.

● Ensure each blister package is correctly labeled.

● Perform routine system maintenance.

● Perform system troubleshooting.

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Locating the Blister Packager When selecting a location for the blister packager, be sure to meet the space, power, and air supply line requirements to ensure proper setup of this machine.

● The blister packager weighs approximately 50kg (110lb) and measures 96cm (37.8in) wide, 71cm (28in) deep, and has a maximum height of 84cm (33in).

Important: See Lifting the Blister Packager before attempting to move the blister packager.

● In addition to the machine, consider a work area approximately 50-100cm (20-39in) to the left of the machine to allow the storage of newly-packaged blisters.

● To the right of the blister packager, allow approximately 1m (3ft) for a dust extractor, along with the blisters to be filled.

● Above the machine, allow approximately 1m (3ft) clearance for the brush motor arm in the up position.

● Underneath the workbench, provide room for the space plates, a spare box, and an air compressor for the blister packager, if needed.

● The machine requires the proper electrical outlet with a protective earth pin.

● 115-120 VAC, 10 Amp max., with the power cord within easy reach of the operator. Use the supplied power cord with the pin configuration that matches the wall outlet and is the correct cord for your country. The supplied cord provides protective earth grounding.

All the power cords meet the following requirements:

○ Country-specific plug with a protective earth pin.

○ IEC 60320 C-13 connector.

○ Conductor size of combination 18/3 AWG or 3x1.0mm2, 10 Amp, 250V.

○ Jacket of SJTO or H05VV-F, 105o C, PVC.

○ International Color Coded conductors.

○ Length not to exceed 2.5m (8ft).

WARNING

Electrical shock or fire

Using a different power cord can result in injury from electrical shock or fire. Do not use a detachable main power cord with inadequate safety ratings.

● The machine also requires an air supply capable of producing 0.689 - 0.792 MPa.

● The dimensions of the inside air fittings size is 1/4-inch.

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Specifications and Requirements The following table lists the blister packager's location specifications and requirements.

Location Indoor use only

Space (W × D × H) 96cm × 71cm × 84cm (38in × 28in × 33in)

Power Supply 115-120 VAC 50/60 Hz

10 Amp max.

Supplied country-specific power cord

Weight 50kg (110lb)

Environment Altitude: up to 2000m (6560ft)

Temperature: 5°C to 40°C (41°F to 104°F)

Humidity: 80% for temperatures up to 31°C (88°F), 50% for temperatures from 32°C to 40°C (89°F to 104°F)

±10% Main supply fluctuations

Transient Overvoltage Category II with Temporary Overvoltages

Lifting the Blister Packager Use the following instructions for lifting the blister packager.

About this task The blister packager weighs approximately 50kg (110lb) and measures 96cm (37.8in) wide, 71cm (28in) deep, and has a maximum height of 84cm (33in).

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Procedure

1. Always use a team of two to four people to lift the blister packager or move it into place.

Ideally, team lifters should be of approximately the same size.

Important: One lifter should be responsible for controlling the action and ensuring proper coordination. If one lifter shifts the load, lifts too soon, or lowers it improperly, one of the lifters on the team may be injured.

Tip: When equipment is available, you should use it to lift and carry heavy objects. Loaders, forklifts, hoists, etc. are made for this purpose.

2. Always wear gloves and long sleeves, to protect your hands and arms from sharp corners on the machine.

3. Position the lifting team at the machine corners, as shown in the following figures.

(1) Front left corner (3) Back left corner

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(2) Front right corner (4) Back right corner

When lifting with a team of two, position the lifters diagonally from each other. Lift from the front right and back left corners, or lift from the front left and back right corners.

4. Follow these basic guidelines for safe lifting and handling:

a) Check that there is enough space for movement, and that the footing is good.

b) Make sure that you have good balance.

Your feet should be shoulder-width apart, with one foot beside and the other foot behind the object that you are lifting.

c) Bend at the knees and don't stoop.

Keep your back straight, but not vertical. (There is a difference. Tucking in the chin straightens the back.)

d) Grip the load with the palms of your hands and your fingers.

The palm grip is much more secure. Tuck in your chin again to make certain your back is straight before starting to lift.

e) Carefully lift the corners and frame bars from the bottom of machines.

f) Use your body weight to start the load moving, then lift by pushing up with your legs.

This makes full use of the strongest set of muscles.

g) Keep your arms and elbows close to your body while lifting.

h) Carry the load close to your body.

Don't twist your body while carrying the load. To change direction, shift your foot position and turn your whole body.

i) Watch where you are going!

j) To lower the object, bend your knees.

Don't stoop. To deposit the load on a bench or shelf, place it on the edge and push it into position. Make sure your hands and feet are clear when placing the load.

DO NOT:

k) Use your back muscles to do lifting.

l) Try to lift an item that is too heavy.

m) Twist your body while carrying an object.

n) Attempt team lifting without proper coordination.

5. Place the machine on a sturdy workbench at operator standing level (87cm [34in] countertop height) with room to accommodate the device and ancillary products.

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Contacting Omnicell Support Use the following information to contact Omnicell Support.

Order Consumables at myOmnicell.com

1. Go to myomnicell.com and select the Shop tab.

2. Central Pharmacy Blister Packager items can be found under Central Pharmacy

Packaging > Medication Packaging. Or, you can search for a product's SKU number.

For US-based customers, call

● CPM/Carousel customers: 1-800-910-2220

● XR2 customers: 1-800-700-8737 (Option 4, then 1)

● Consumables: 1-800-845-0053.

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Safety Overview Before operating the blister packager, review the safety information in this chapter.

● Who should operate the blister packager

● Precautions

● Machine safety labels

● Machine safety

● Safety guards and devices

● Lockout and restart procedures

Who Should Operate the Blister Packager Do not attempt to operate the blister packager unless you have taken product training.

Go to myOmnicell.com Training page to view the e-learning courses, videos, classroom trainings, and virtual trainings for Omnicell products.

CAUTION

One operator only

The blister packager is designed to be used by a single operator only.

Precautions Follow all safety precautions.

WARNING

Do not attempt to operate or perform any maintenance on this equipment until you have followed all safety precautions.

Only authorized and trained personnel should operate the machine.

Note the following precautions while operating the blister packager:

● Unauthorized modification of the blister packager is strictly prohibited.

● Only use parts provided by Omnicell when replacing blister packager components.

Omnicell will not be liable for failure if unauthorized parts are used.

● Avoid wearing loose or baggy clothing to avoid snagging on moving equipment parts.

● Tie back long loose hair to avoid snagging on moving equipment parts.

● Wear gloves when handling medications to avoid contact with medication.

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● Wear gloves when cleaning machine parts to avoid contact with any cleaning agents (70% isopropyl alcohol; PeridoxRTU solution).

Machine Safety Review the following machine safety hazards.

The following components of the blister packager are potentially hazardous to operators:

● Brush Motor Housing - Use caution when raising or lowering the brush motor arm. When the arm is lifted, the motor will automatically shut off. The rear of the arm's moving parts present a pinching hazard.

The safety latch in the back of the brush motor arm should always be engaged when the brush motor arm is in the upright position to prevent crushing or pinching hazards.

● Brush Holders and Shroud - The rotating parts in this area present a snag and pulling potential. Keep hands, loose clothing, and long hair away from the moving parts.

● Carrier Platen - The carrier platen presents a potential for pinched fingers. Always use the handle to move the carrier platen.

● Seal Station - The platen presents a crushing and burn hazard. Avoid inserting your hand or fingers under the platen.

● Control Center - Electric shock hazard. Never touch any components behind the control center panel.

● Air Pressure Regulator - (in the back) Compressed air hazards could include excessive pressure, flying objects, mechanical failure, fires, explosions, and dangerous noise levels.

Machine Safety Labels Machine safety labels are affixed to the packager to alert users to various items.

Symbol Definition

Read the Operator's Guide before operating this machine.

Replace all machine guards before operating the machine.

Burning hazard - hot surface on and around this area.

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Symbol Definition

Electrical shock hazard.

Crush or pinch hazard.

Alerts you to a potential danger of moving parts causing snagging and pulling of loose clothing, jewelry or long hair when machine is in operation.

Alerts you to a potential danger of moving parts can cause serious injury. Keep hand or fingers away. Disconnect and lockout power before servicing.

Guards and Devices The packager has guards and devices designed to protect operators from moving components and electrical or burn hazards.

Power Switch

Located on the far left of the control center on the front of the blister packager, the power switch shuts down all electrical components including the brush motor and heating element in the Seal Station.

Power Switch (in OFF position)

Important: Turning the power switch to OFF immediately returns the seal plate to the up position and immediately stops the brush motor.

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Seal Station Guard

The guards are protective covers that helps prevent accidental contact with the heat sealer in the Seal Station.

WARNING

Burn hazard; crush or pinch hazard

Due to the temperature and crush or pinch hazard of the seal area, keep all hands, fingers, and objects clear.

Heat Sealer Guards and Warnings

(1) Burn Warning, front (2) Crush Warning, front

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Heat Sealer Crush, Guard, and Pinch Zone Warnings (left and right sides)

(1) Crush Warning, left side (4) Guard Warning, right side

(2) Burn Warning, left side (5) Burn Warning, right side

(3) Guard Warning, left side (6) Crush Warning, right side

Fill Station

Rotating brushes and other moving parts in this area represent a potential for serious injury.

The brush motor will turn off once it is locked in the upright position. Before performing any maintenance, see Lockout and Restart Procedures.

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Fill Station Parts and Warnings

(1) Warning Labels

(2) Rotating Moving Parts

(3) Rotating Parts

WARNING

Follow all safety precautions

Do not attempt to operate or perform any maintenance on this equipment unless you have been instructed on its proper operation and safety precautions.

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Air Supply

Disengaging the quick disconnect located at the air pressure regulator will shut off all air pressure in the machine.

Air Supply Disengage

Important: When the air supply is disengaged, the seal plate will drift down to the seal position.

Lockout and Restart Procedures Lockout and restart procedures must be performed before any maintenance work is done on the blister packager.

Lock Out the Blister Packager

Use the following steps to lock out the blister packager.

Procedure

1. Announce the upcoming lockout to the other personnel that use the blister packager.

2. Turn the power switch on the control center to OFF.

3. Disconnect the air hose at the air pressure regulator.

4. Disconnect the power cord from the A/C outlet.

Restart the Blister Packager

Use the following steps to restart the blister packager.

Procedure

1. When maintenance or other tasks are complete, clear the blister packager of personnel before restarting the machine.

2. Reconnect the blister packager power cord to the A/C outlet.

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3. Reconnect the air hose at the air pressure regulator.

4. Turn the power switch on the control center to the 2 SEC ON position.

5. Announce to other personnel that the blister packager is back on.

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System Components and Controls This information outlines the blister packager components along with the various controls and their correct parameter settings.

Blister Packager System Components (brush motor arm in lowered position)

(1) Control Center (6) Brush Motor Arm (elevated)

(2) Seal Station (7) Hopper

(3) Product Box (8) Plate Riser

(4) Air Pressure Regulator (9) Clean-out Tray

(5) Brush Shut Off Sensor (on backside)

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Control Center The blister packager's control center is located on the front of the system below the platen carrier and controls the Seal Station and the Fill Station areas.

Control Center

(1) Power and Seal Timer Knob (4) Brush Speed Dial

(2) Sealer Button (5) Filler Button

(3) Temperature Control (6) Brush Motor Switch

Main Power Switch

This information describes the blister packager's main power switch.

Turning this switch on provides power to all electrical components, including the Seal Station, temperature control setting, and Fill Station. The power switch also controls the sealing time choices (2 seconds or 4 seconds).

Power Switch (OFF position)

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Seal Station Controls

The seal timer knob enables the operator to select the appropriate sealing time based on type of cards being filled - 2 seconds for unit dose cards with foil, or 4 seconds for punch cards.

The actual sealing of the card in the Seal Station takes place when the operator presses the sealer button.

Important: The sealer button is not enabled until the carrier platen is under the seal station and makes contact.

Seal Station Controls

(1) Seal Timer Knob (2) Sealer Button

Temperature Control

The LED Digital Display shows the current temperature of the sealer.

The control also enables the operator to adjust the temperature setting. The factory setting is fixed at 315°F (157°C) for optimum sealing.

Important: Keep the temperature setting between 285 to 315°F for sealing.

Never set the temperature higher than 315°F.

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Temperature Control

(1) Current Temperature (3) Temperature Up

(2) Temperature Down

To change the temperature, hold the * button and press the Temperature Down or

Temperature Up buttons.

Important: When changing the temperature setting, note that the heat sealer will take time to adjust to heat up or cool down to the new setting.

Fill Station Controls

The brush motor switch turns the motor driving the brushes on and off.

The brush speed dial sets the rotating speed of the brushes. Pressing the Filler button electronically activates the delivery plate, dropping the medication in the Fill Station into the card blisters.

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Fill Station Controls

(1) Brush Speed Dial

(2) Filler Button

(3) Brush Motor Switch

Air Pressure Regulator The air pressure regulator is factory set at 0.689 MPa (100 psi) for optimum sealing pressure.

Important: The air fittings size for the blister packager is 1/4-inch inside dimensions.

Air Pressure Regulator

(1) Pressure Adjustment Knob (2) Pressure Gauge

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Important: The compressor must provide a minimum of 0.55 MPa (80 psi) at all times.

Adjust the Air Pressure

Use the following information to adjust the blister packager's air pressure.

Procedure

1. Lift the pressure adjustment knob from the locked position, which is approximately

3mm (1/8 inch).

2. Turn the knob to adjust the pressure:

a) To increase pressure - turn the knob clockwise

b) To decrease pressure - turn the know counter-clockwise

3. Set the pressure to the recommended value of 0.689 MPa (100 psi).

4. Press the adjustment knob down to the locked position.

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Setting Up the Blister Packager The blister packager uses an automated Fill Station with an adjustable speed, an easy-to-change combination of brushes, and a three-plate filling system.

WARNING

Follow safety precautions

Do not attempt to operate the blister packager unless you have been trained by Omnicell personnel in the blister packager operation and safety precautions.

Before setting up the blister packager follow the guidelines for locating the device. See Locating the Blister Packager. All operators should follow and understand the Safety Overview. Once the machine is safely located and the electrical and air outlet are installed, the device can be set up for use.

The Seal Station The operator uses the seal timer knob to control the duration of each sealing, and the sealer button to engage the Seal Station.

Both of these controls are located on the control center (see Seal Station Controls).

Important: Use 2 seconds when sealing with foil.

Once the blister packager is turned on and the air supply is connected, the operator must perform the following actions:

● Set the air pressure regulator to 0.689 MPa (100 psi), per factory setting. See Air Pressure Regulator.

● Set the temperature control to 315°F (157°C). This is a factory setting - the Seal Station should reach this temperature approximately 15 minutes after the packager is turned on.

See Temperature Control.

Important: If blisters are melting, adjust the temperature control to a lower temperature. If blisters are not sealing, adjust the temperature control to a higher temperature.

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The Carrier Platen The carrier platen must be loaded with the correct combination of blisters and foil.

The operator will move the platen to the Fill Station (right), then to the Seal Station (left) for sealing.

Carrier Platen

The Fill Station The Fill Station uses a three-plate system along with a set of brushes.

The operator will choose a combination of plates for the different medications being packaged.

The operator will also decide on a combination of brushes during the set-up process, the proper device settings, and the height for brushes and plates required to successfully fill the blister with the desired medication.

Once the combination of plates, brushes, and device settings proves to be effective in the processing of the packaging of blisters, the operator can maintain a log for each medication for future use. See Appendix B: Product Drop Chart.

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Plates

The Fill Station uses three different types of functional plates: Bottom Plate (BP), Center Plate (CP), and Top Plate (TP).

Each plate has a unique function and comes in a variety of thicknesses and configurations for different medication sizes and shapes. The plates must be applied in a specific order to properly fill blisters. The plates are marked in a manner that identifies their type and use.

Fill Station Plates

(1) Bottom Plate (BP)

(2) Center Plate (CP)

(3) Top Plate (TP)

All plates have a designation to identify them at least by type and dosage. The following is an example of a typical center plate.

Typical Plate Designation

(1) Type of Plate (4) Cavity Size

(2) Dosage (5) Cavity Shape

(3) Cavity Shape

● Type of Plate - Options are BP (Bottom Plate), CP (Center Plate), and TP (Top Plate).

● Dosage - Indicates the number of dosage openings are available for the blister fill.

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● Cavity Shape - Indicates the shape of the openings in the plate. Options are T (Tablets -round), C (Capsules - oblong), and V (Ovals - elliptical).

● Cavity Size - Indicates the size of the openings in the plate. The value can range from 03 (extra small) to 70 (extra extra large).

● Thickness - Indicates the thickness of the plate. The value can range from A (thin) to G (thick).

Bottom Plate

This is the first plate to be placed in the main frame below the brushes, near the bottom of the Fill Station.

It is stationary and functions as the guide or funnel for the medication to drop into the blister.

It also acts as an offset bridge to prevent medication from dropping prematurely during the fill process.

Three bottom plates are delivered with the machine. The bottom plate fits in only one way and has a ridge to indicate how it fits in to the main frame.

Bottom Plate

Center Plate

The center plate is placed over the bottom plate and has slots on the sides to fit into the tall guide pins at the bottom of the Fill Station.

It will be longer than the bottom plate or top plate, and has a small hole to fit into the front push pin at the bottom of the Fill Station. The center plate comes in three different cavity shapes: Round, Oblong, and Elliptical.

The thickness of the center plate must be the same or slightly less than the resting medication.

The cavity size should be large enough to accommodate the medication without allowing a second medication access to the cavity. The operator can adjust the center plate positioning by using the plate riser located on the right front side of the Fill Station. Turning the handle counter-clockwise will raise the center plate; turning the handle clockwise will lower the center plate. The plate should be adjusted so the medication lays just below the plate surface.

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Important: If the center plate is set too low, the medication will be above the surface and will be damaged during the fill process. If the center plate is set too high, a second medication could wiggle between plates or fall into the cavity. Sweep a straight edge across the surface to indicate proper height adjustment.

Center Plate, positioned on Front Push Pin and Tall Guide Pins

(1) Center Plate

(2) Front Push Pin

(3) Tall Guide Pins

Top Plate

This last plate is placed on top in the same guide pins as the center plate.

The number of cavities must match with the blister being packaged. The inside cavities of this plate are unique as they are beveled to allow the medications to easily drop in. The larger end of the holes should always be face up.

Important: The metal plate should be used when there are issues with static at a site.

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Top Plate

Hopper

Once the Bottom Plate, Center Plate, and Top Plate have all been placed on the bottom of the Fill Station, the operator can put the hopper in place by aligning it inside the four tall guide pins.

Hopper in Place in the Fill Station

(1) Hopper (2) Front Guide Pins

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Brushes

The blister packager uses three brushes as part of the filling process.

The brushes are color coded to differentiate their rigidity:

● Soft - white handle with blue bristles

● Medium - blue handle

● Stiff - white handle

For most applications, starting with three medium brushes will be adequate. In the case of large or heavy medications, use the stiff brushes to help the filling process. In the case of very fragile or light medications, use the soft brushes to help deter breakage.

When attaching the brush to the holders, one side contains an untapped hole for inserting the thumbscrews. The other side is threaded to receive and hold the brushes. Insert the screw through the unthreaded side.

Brush Holder Thumb Screws

(1) Smooth Side

Once the brushes are attached, lower the brush motor arm. The motor arm will rest on the top end of the adjustment knob. Turn the black star knob in the middle of the brush assembly to lower or raise the brushes so they gently touch the top plate.

Important: Adjust the brushes accordingly: if the brushes are too high, medications cannot be moved to drop into the holes; if the brushes are too low, the brushes can sweep the medications out of the holes.

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Rotating Brushes

The blister packager is now ready to package medications.

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Operating the Blister Packager The blister packager has three main components that the operator will use - the Seal Station, System Controls and the Fill Station.

This section discusses how to operate the device to fill and package medications using the hopper or by hand packing medications.

WARNING

Follow all safety precautions

Be sure to follow these instructions on the proper use of the blister packager.

Operator safety can be compromised if the machine is used in a manner not specified by the manufacturer.

Blister Packager

Operate the Blister Packager Using the Hopper Use the following information to operate the blister packager using the hopper.

Procedure

1. Set up the plates in the Fill Station to properly accommodate the medication and the blisters you need to fill. (See Plates and Appendix A: Plate Gauges for more information on plate selection.)

2. Turn on the blister packager to the 2 seconds seal timer setting and wait for the Temperature Control to show the maximum operating temperature of 315°F (157°C) -about 15 minutes after you turn the power on.

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3. Add medication to the hopper.

Start with ¼ full to prevent spilling over. A small spare amount of the current medication can be put into the container sitting on top of the Seal Station for any missed fills during packaging.

4. Lower the brushes into the hopper by using the handle on the front of the brush motor arm.

5. Adjust the speed of the brushes using the brush speed dial.

Start at a slower speed and observe how the medication is rotating and filling into the top plate. Changing the brush speed or using a different combination of brushes will produce different results.

Important: The medication should move freely with the brushes. The medication should fill into the top plate and should not be swept out of the plate cavity, or swept out over the sides of the hopper.

6. With the carrier platen between the Seal and Fill Stations, insert the correct style of blister into the Card Platen Carrier with orange rubber for sealing.

7. Confirm that the seal timer knob is set to 2 (2 seconds).

8. Using the black round carrier handle, slide the platen to the right, fully underneath the

Fill Station.

9. On the first fill, carefully push the center plate inward using the handle.

The operator should feel a slight resistance caused by the spring mechanism associated with fill-automatic solenoid. For any other strong resistance, the operator should inspect for the cause (e.g., more than one medication in a cavity or a center plate adjustment is needed. Modify the setup to address any concerns.

10. Once the operator is satisfied with the first fill, he or she can press the filler button on the control center to repeat the fill.

11. The operator will slide the carrier platen with the filled blister to the center position.

12. Check the blister for proper filling and dosage.

Any missing medication can be filled manually from the small container on top of the Seal Station. Any blister cavities with more than 1 medication or with broken medications can be removed and corrected.

13. The operator must inspect the blisters before placing the foil on the carrier platen with the screws through the holes on the side of the foil to hold it in place on the blister for sealing.

14. Push the carrier platen with the closed blister fully under the Seal Station to the left.

15. Press the sealer button on the control center to seal the blister.

16. Move the platen to the center position and remove the blister.

17. When packing the same medication, insert new blister and repeat steps 8-16.

Note: When there is not a full blister, the foil will print starting in the upper left corner and print down vertically, then move to the next column. Partial sheets should be packed manually and medications placed only in the blisters that will have labels on the foil.

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Results If a different medication is being used, see Setting Up the Blister Packager before proceeding.

Hand Pack Medications on the Blister Packager Use the following information when hand packing medications on the blister packager.

Procedure

1. Turn on the blister packager to the 2 seconds seal timer setting.

2. Place a blister in the Card Platen Carrier with orange rubber.

3. Place a medication in each blister.

4. Lay foil on with the holes lined up with pins to hold the foil in place.

5. Slide the Card Platen Carrier to the left under the heat sealer.

6. Press the sealer button.

7. Slide the Card Platen Carrier to center and remove the blister.

Note: When there is not a full blister, the foil will print starting in the upper left corner and print down vertically, then move to the next column.

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Maintaining the Blister Packager Before performing any maintenance activities of the blister packager, follow the steps in Lockout and Restart Procedures.

CAUTION

Dust from medication can adversely affect blister packager operation. Regular cleaning ensures optimal and efficient machine operation. Follow the cleaning procedures as determined in your facility's internal risk assessment for when and how to clean.

Do not attempt to operate or perform any maintenance on this equipment until you have followed all safety precautions. Only authorized and trained personnel should operate this machine

When cleaning the blister packager, proper personal protective equipment (PPE) must be used to ensure employee safety.

Use proper ventilation when cleaning the blister packager and its associated parts.

If you have any questions, contact your supervisor before doing any operation, work, or maintenance on this equipment.

Important: If packing hazardous medications, use PeridoxRTU sporicidal disinfectant/cleaner and Contec SterileSorb dry wipes made by Contec Healthcare when cleaning the blister packager (www.contechealthcare.com).

To protect the machine hardware and ensure proper disinfecting and cleaning, follow the manufacturer's recommended cleaning procedures.

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Daily Maintenance The blister packager requires daily cleaning of its various components to ensure optimal and efficient machine operation.

Using PeridoxRTU Cleaning Solution

After a pharmacy does their internal risk assessment for hazardous medications and decides to use the packager for non-chemotherapeutic hazardous drugs, the pharmacy should clean the machine using PeridoxRTU sporicidal disinfectant /cleaner and Contec SterileSorb dry wipes.

Important: Use PeridoxRTU sporicidal disinfectant/cleaner and Contec SterileSorb dry wipes made by Contec Healthcare when cleaning the blister packager (www.contechealthcare.com). To protect the machine hardware and ensure proper disinfecting and cleaning, follow the manufacturer's recommended cleaning procedures. Always follow proper safety data sheet (SDS) requirements when using and disposing of cleaning materials.

Recommended wipes:

● Dry Wipes: Contec SterileSorb Wipes

● Wet Wipes: 70% Alcohol Wipes

● Contact Contec Healthcare for more information

(www.contechealthcare.com).

CAUTION

When cleaning the blister packager, proper personal protective equipment (PPE) must be used to ensure employee safety.

Use proper ventilation when cleaning the blister packager and its associated parts.

Cleaning Guidelines

1. Use the manufacturer's recommended dry wipe to remove excess pill debris/dust from blister packager surface.

2. Saturate the dry wipe with PeridoxRTU solution.

3. Clean the surface with the saturated wipe, utilizing overlapping, unidirectional strokes.

4. The saturated wipe may be reused for the next step. Discard contaminated wipes in a manner consistent with facility guidelines and federal and state regulations.

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5. Repeat steps 2-4.

6. For disinfection, leave the surface wet with PeridoxRTU for at least 3 minutes.

7. Wipe surface with a new 70% alcohol damp wipe.

8. Allow all parts to air dry completely before using on the next packing.

Clean Blister Packager

Use the following steps daily to clean the blister packager.

Before you begin

Tip: Follow these tips for proper cleaning:

Do: Use a medical-grade vacuum cleaner.

Follow PPE guidelines.

Follow proper disposal guidelines.

Don't: Spray any kind of cleaning solution directly on device.

Use any oral solid antineoplastic agent listed in Table 1 of the NIOSH list of hazardous drugs.

Procedure Minimum Daily Cleaning Suggestions:

1. Turn the Seal Timer Control to the OFF position on the blister packager.

2. Select an option based on the medication type being packed:

a) If packing nonhazardous medications, clean the main body of the device, plates used for filling, hopper metal ring, bin to catch meds under the hopper, and brushes with 70% alcohol. Clean the polycarbonate hood and the orange rubber on the Card Platen Carrier with water only.

b) If the pharmacy, after doing the appropriate risk-assessment for hazardous drugs, decides to repackage specific hazardous drugs, it is recommended the machine be cleaned with PeridoxRTU wipes to clean the main body of the device, the plates used for filling, hopper metal ring, bin to catch meds under the hopper, brushes, the polycarbonate hood, and the Card Platen Carrier after each use. See Using PeridoxRTU Cleaning Solution.

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3. Make sure items are completely dry before using on the next packing.

Weekly Maintenance The operator must drain the air pressure regulator on a weekly basis to ensure proper operation of the blister packager.

Drain the Air Pressure Regulator

Procedure

1. Turn the Seal Timer Control to the OFF position on the blister packager.

2. Unplug the blister packager power cord from the outlet.

3. Place a container below the air pressure regulator bowl.

4. Press the nipple on the bottom to discharge any condensation/moisture into the container.

Air Pressure Regulator

(1) Air Regulator Nipple

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Replacing Fuses The blister packager fuses can be found on the back of the blister packager, near the power cord.

Important: Always turn the power OFF and unplug the blister packager before performing fuse maintenance.

Blister Packager Fuses

Each fuse is different, so make sure you replace the defective fuse with the correct fuse type:

Fuse Number Fuse Type

FU110 2A L 250V

FU210 1A L 250V

FU302 1A L 250V

FU120 8A L 250V

FU220 1A L 250V

Inside the power plug:

FU100 T10A H 250V

FU101 T10A H 250V

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Replace a Fuse

Use the following steps to replace the blister packager fuses.

Procedure

1. Screw the cap off by turning it counter-clockwise.

2. Remove the old fuse and then insert a replacement fuse of the correct fuse type.

3. Screw the cap back on by turning it clockwise.

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Troubleshooting Reference this section for common issues and how to troubleshoot them.

If your issue persists, call Omnicell Technical Support. See Contacting Omnicell Support.

Blister or Medication has been Directly Sealed to the Heater Plate The material should be removed as soon as possible from the heating plate.

See Lockout and Restart Procedures. The device must be turned off and locked out before proceeding.

WARNING

Pinch and burn hazards

Use caution around the sealer area due to the burn and pinch hazards. When removing material from the seal plate, use a brass wire brush or a non-metallic spatula.

Accessing the Heat Sealer

(1) Removable Product Box

(2) Handle

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(3) Hex Head Screw

Open the Sealer

Use the following instructions to open the heat sealer.

Procedure

1. Remove the product box before opening the sealer.

2. Remove the hex head screw and washer with the supplied 9/16" wrench to release the heat seal.

3. Use the black handle to lift the platen to the upright position to reveal the heating plate.

Revealing the Heating Plate

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Clean the Sealer

Only clean the heat sealer when there is any blister or medication material directly adhered to the heating plate.

Before you begin

WARNING

Pinch and burn hazards

Use caution around the sealer area due to the burn and pinch hazards. When removing material from the seal plate, use a brass wire brush or a non-metallic spatula.

Procedure

1. The sealer should be open and hot.

2. Lay down a paper towel or a piece of cardboard to catch falling debris from the heat plate.

3. Use a brass brush or non-metallic spatula to remove any debris from the heat plate.

4. Remove any debris from the table.

5. Lower the heat sealer back into position.

6. Replace the hex head screw and washer.

7. Remove all tools and verify that nothing is left on the main table.

8. Restart the blister packager.

9. Verify that it reaches its operating temperature of 157°C (315°F).

10. Seal three or four empty blisters to ensure that the sealer is free of any debris.

11. Continue packaging medication.

Common Causes of Heat Seal Failure Following are some of the common causes of heat seal failure:

● A blister was not seated in the platen properly.

● A blister was stuck to the heat seal plate.

● Plastic debris is stuck to the plate.

● The temperature is too low or too high.

● Two blisters are in the same package.

● Air pressure is set too low.

● Seal timer is set incorrectly for the blister and foil being sealed.

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Breaking In Fill Station Brushes For new machines or machines using replacement brushes, we recommended that you run the new brushes in the Fill Station for an hour prior to their use in packaging medication.

The brushes generally have a 1-hour break-in time. During that first hour of use, some bristles may fall out of a brush, until the brush has been sufficiently agitated.

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Appendix A: Plate Gauges Operators should be aware that the tablet and capsule consistency will greatly affect performance.

The Plate Gauge is a guide to help match plate combinations to medications. Proper filling and dispensing still require the knowledge and skill of an experienced operator to make correct adjustments to the brush speed and filling volume.

There are three (3) types of holes or medication cavities on Center Plates (CP):

● T (Tablets) Round- plates for round medication or capsules dropped on the edge.

● C (Capsules) Oblong- plates for oblong shaped or tablets dropped on the edge.

● V (Ovals) Elliptical- plates for elongated and caplet shapes.

Plate Gauge

Use the Plate Gauges to help select the best fit for the center plate for filling applications.

● Classify the medication by shape (tablet, oval or capsule).

● Determine size the medication via the closest hole size.

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● Determine the height using the THICKNESS key on the Plate Gauge.

Measuring Pill Height and Thickness

● V(OVAL) Center Plate chosen based on shape of medication - CP32V.

● Best hole size on V(OVAL) Center plate is #60 = CP32V60.

● Thickness of center plate D is best fit for filling.

● Choose center plate C - CP32V60C. This plate will be raised at the Fill Station before putting on the Top Plate.

Important: Once the operator decides on flat or vertical orientation, the medication should rest slightly above the Center Plate (approximately 1mm [1/8 inch]) when determining the correct thickness of the proper center plate.

See Plates for instructions on reading the plate designation.

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Appendix B: Product Drop Chart Use this chart to record the combination of plates, brushes, and device settings that prove to be effective in processing specific medications in the packaging of blisters.

Record this information for each medication for future use.

Product Strength MFG Format BP CP TP Thick

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Product Strength MFG Format BP CP TP Thick

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Appendix C: Maintenance Checklist Use this checklist to track the daily, weekly, and as needed maintenance performed on the blister packager.

Copy or reprint this checklist as often as needed to maintain your records.

TASKS Date/ Initials

Date/ Initials

Date/ Initials

Date/ Initials

Date/ Initials

Date/ Initials

Date/ Initials

Daily Maintenance

Perform the lockout and restart procedures.

Clean the main body.

Clean all fill plates.

Clean the polycarbonate shroud.

Weekly Maintenance

Drain the air pressure regulator.

As Needed

Replace fuses.

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