Specification Sheet Diana, System Operating Manual...5 Diana Hazardous Drug Compounding System, ICU...

Specification Sheet Diana, System Operating Manual Commodity No. DF-4941-EN Rev. 06 Date Prepared 11/19/2019 Artist: Made from: DF-4941-EN Rev. 05 Artwork: Supplied by ICU Medical. Artwork P/N: DF-4941-EN Artwork Revision: 05 (10/19) Page Count: The total Page count for printing DF-4941-EN is 94 Pages. Not including this spec sheet. Note: Spec sheet does not print. Inside front and back cover do not print. Refer to IS-014 for paper, ink and finishing specifications

Dian

a™

Compatible with:Diana Firmware SW_DS2000

Operator Software SW_DS2100

Remote Software SW_DS2200

User Manual v2.1.0Diana Compounding Workflow System

Diana Hazardous Drug Compounding System, ICU Medical, Inc.

2Diana Hazardous Drug Compounding System, ICU Medical, Inc. Diana Hazardous Drug Compounding System, ICU Medical, Inc.

List of Contents

Section 1 – Introduction ..................................................................................................................................... 5

1.1. Intended Use ......................................................................................................................................................... 51.2. Important Safety Instructions ............................................................................................................................. 51.3. Warnings and Precautions ..................................................................................................................................61.4. Regulatory Compliance ........................................................................................................................................71.5. List of Symbols Used on the Device .................................................................................................................. 71.6. Replaceable Parts .................................................................................................................................................9

Section 2 – General Operation Information ........................................................................................................ 9

2.1. Installation and Maintenance .............................................................................................................................92.2. Environmental Specifications .............................................................................................................................92.3 Performance Specifications ..................................................................................................................................

Section 3 – Diana System Overview ................................................................................................................. 10

3.1. System Components ..........................................................................................................................................103.2. Views of the Diana Syringe Pump Module ......................................................................................................11

Section 4 – Operator and Pharmacy Tablet ....................................................................................................... 13

4.1. Disposables ......................................................................................................................................................... 14

Section 5 – Operation ....................................................................................................................................... 15

5.1. Powering On the Devices .................................................................................................................................. 155.1.1. Powering On the Diana Compounding System ............................................................................................. 155.1.2. Powering On the Operator Tablet .................................................................................................................... 155.1.3. Powering On the Pharmacist Tablet ................................................................................................................ 16

5.2. Workflow of the System ..................................................................................................................................... 175.2. The Virtual Keyboard .......................................................................................................................................... 17

5.2.1. Manual Workflow ................................................................................................................................................ 175.2.2. Automated Workflow .........................................................................................................................................235.2.3. Validating a Transfer ..........................................................................................................................................355.2.4. Replacing Empty Input Container ................................................................................................................... 385.2.5. Interrupt Dispensing Process Using Stop...................................................................................................... 425.2.6 Resume After Stop ............................................................................................................................................. 425.2.7. Cancel the Delivery Process..............................................................................................................................43

Section 6 – Tool Settings .................................................................................................................................. 44

6.1. General ................................................................................................................................................................ 446.2. Settings Description .......................................................................................................................................... 46

6.2.1 Manage Order Printer Settings ....................................................................................................................... 466.2.2. Network Settings ............................................................................................................................................... 486.2.3. About This System Settings ............................................................................................................................. 496.2.4 Technician Tablet Settings ............................................................................................................................... 496.2.5. Require Pharmacist Picture Validation Settings ........................................................................................... 516.2.6. Compounding Machines Settings ................................................................................................................... 516.2.7. Create Drug Settings ..........................................................................................................................................536.2.8. Edit Drug Settings ...............................................................................................................................................55

3 Diana Hazardous Drug Compounding System, ICU Medical, Inc.

6.2.9. Substance Properties Settings .......................................................................................................................576.2.10 Review Preparations Settings ..........................................................................................................................576.2.11. Disposables Settings.........................................................................................................................................586.2.12. Substance Properties Settings ........................................................................................................................596.2.13 Manage Reconstitution Protocols Settings ................................................................................................. 60

7.0. Warranty and Service Information .................................................................................................................617.1. Limited Warranty ..............................................................................................................................................617.2. Service and Contact Information .................................................................................................................. 62

Appendix A: Cleaning and Disinfecting the Diana System ............................................................................... 63

Appendix B: Troubleshooting ........................................................................................................................... 64

Appendix C: Pairing Printer .............................................................................................................................. 65

Configuring a new printer (Operator and Remote Tablets) ................................................................................65Configuring a new USB only printer. ......................................................................................................................65Configuring a new Wi-Fi printer. ..............................................................................................................................65Printer Driver Instructions........................................................................................................................................ 69

Appendix D: Software Update Process ............................................................................................................. 72

1. Both Operator and Pharmacist Tablets ..........................................................................................................722. Operator tablet Only ...........................................................................................................................................74

Appendix E: Accuracy Verification Protocol ...................................................................................................... 75

Appendix F: Database Update Process ............................................................................................................. 76

Appendix G: Creating and Running a Reconstitution Protocol ......................................................................... 77

1. Reconstitution Protocol Creation .....................................................................................................................772. Running Reconstitution Protocol .....................................................................................................................81

Appendix H: Special Output Container Identification and Selection ................................................................ 84

1. CADD Cassette .................................................................................................................................................... 84

Appendix I: Specialty Substances List ............................................................................................................. 86

Appendix J: Barcode Scanner Configuration ..................................................................................................... 87


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1. Introduction

This manual provides the user with basic information for operating the Diana Automated Compounding System. It documents all the usable functions and explains how to use them. The device is supplied in a calibrated condition. Servicing must only be performed by the manufacturer.

1.1. Intended UseThe Diana Automated Compounding System is a modular system, which includes a syringe pump module for preparing and filling hazardous and non-hazardous drugs.

The Operator Software running on Windows 10 OS provides primary mechanism to control the Diana Automated Compounding System. A user can input order information, drug information, initiate a drug transfer, and print a label from this interface.

Optional Pharmacist Software running on Windows 10 OS provides the pharmacy the ability to remotely validate a completed order.

For convenience to the customer, the Operator Tablet PC, Pharmacist Tablet PC, Bar Code Scanner, and Label Printer can be purchased from ICU Medical.

The system can be connected to an input container or an output container.

The system must only be used with ICU Medical CH6000 and CL6000 disposables.

These parts are rigorously tested together to meet the accuracy requirements.

Patient order and drug information can be entered into the system for traceability.

1.2. Important Safety InstructionsThe operator must be properly trained in the use of the System. Please follow the information contained in this manual regarding its operation.

Always follow published guidelines relating to work protection and accident prevention, and ensure professional diligence at all times.

The System may not be resold or exported without the manufacturer’s written permission.

In order to prevent injury while the System is operating, ensure that fingers and other body parts do not come into contact with moving parts.


1.3. Warnings and Precautions

Safety

● Read this User Manual carefully before using the Diana Automated Compounding System.

● No modifications to the Diana Automated Compounding System are allowed. Do not modify in any way.

● The Diana Automated Compounding System does not contain any user-serviceable parts. To avoid injury or damage to the instrument, do not attempt to disassemble or service the instrument. Malfunctioning systems must be sent back to ICU Medical for repair.

● If damaged during operation, switch off immediately and disconnect from the power supply.

● If the Diana System has sharp edges, contact an ICU Medical representative immediately.

● Never connect directly to human beings or animals.

● To avoid the potential for cross contamination between drugs, use separate syringe cassettes units for every drug transfer. Syringe Cassette Units are single use only.

● Transport only by use of the handles.

● When using the Diana System with reconstituted vials, care should be taken to ensure the vials remain upright at all times and ensure vials are not over-pressurized prior to connecting to the Syringe Pump Module.

● The System should only be used with the manufacture-provided power cord.

● The Diana Automated Compounding System should only be connected to a properly grounded electrical supply outlet.

● Do not position the Diana Automated Compounding System such that access to the power cord connection is difficult.

● Avoid maximum weight (1 liter of water) allowed on side tray where output bag is held.

● Do not store or compound any materials within six inches from the left of the compounding module when the tray is installed on the unit.

Performance

● Avoid impacts and vibration that could result in a malfunction of the Diana Compounding System.

● The System is designed for use in laminar airflow boxes, Biological Safety Cabinets, Gloveboxes, Laminar Airflow Hoods and/or Safety work benches in clean rooms.

● The System is not suitable for use in mobile equipment.

Cleaning

● Avoid direct contact with liquids. If a spill occurs, quickly remove liquids and hazardous drugs in accordance with the facility protocol.

● Never immerse in liquids for cleaning purposes. Do not attempt to sterilize using mechanical or steam sterilization equipment.

● All maintenance of the Diana Automated Compounding System should be performed according to

the detailed instructions in this manual.


1.4. Regulatory ComplianceThe Diana System complies with the following standards:

1. The system shall be HIPAA compliant.2. The system shall be IEC 60601-1, 3rd Edition: General Requirements for Safety, compliant. For EU,

the IEC 60601-1 would be used in-lieu of IEC 61010-1.3. The system shall be IEC 60601-1-4, 3rd Edition: Programmable Electrical Medical Systems, compliant.4. The system shall be IEC 60601-1-6, 3rd Edition: Usability, compliant. This standard references IEC

62366-1:2015.5. The system shall be compliant with FCC 47 CFR Part 15, Electronic Code of Federal Regulations –

Radio Frequency Devices (802.11x wireless LAN [e.g. WiFi 2.4 GHz].6. The system shall be compliant with the guidance for the Content of Premarket Submissions for

Management of Cyber security in Medical Devices (Oct. 2, 2014).7. The system shall be compliant with ASTM D 4169, Standard Practices for Performance Testing of

Shipping Containers and Systems.8. The system shall comply with CSA 60601.1(Canada/US) or UL (refer to standard as IEC 60601-1)9. IEC 60601-1-2:2012 EMC Compliance10. IEC 62304:2006 Medical Device Software - software Life cycle processes

1.5. List of Symbols Used on the Device

Symbol Reference TitleISO 7010 M002 Refer to instruction

manual/booklet Symbol

IEC 60417-5032 Alternating current

ISO 7010 M005 Connect an earth terminal to the ground Symbol

ISO 7010 W001 Generic safety warning

ISO 7010 W012 High voltage warning

ISO 7010 W024 Fingers and other body parts do not come in contact with moving parts

ISO 3864-2 Warning (Triangle) Fingers and other body parts do not come in contact with moving parts

CSA 60601.1MCN: 252357


Symbol Reference TitleISO 15223-1: 2016 Manufacturer

ISO 15223-1: 2016 Serial number

47CFR, FCC Part 15 Subpart B, Class B Compliant with FCC Class B limits

IEEE 802.11 Device contains an RF transmitter

CSA 60601.1 IEC 60601-1 3rd Edition Compliance, safety, accountability

ISO 15223-1: 2016 Authorized European representative

EN 60529 Drip water protected

2012 / 19 / EU Waste electrical and electronic equipment directive

ISO 15223-1: 2016 Temperature limitation

ISO 15223-1: 2016 Humidity limitation

UN3481 Packaging Label for Lithium Battery

IP53


1.6. Replaceable Parts

Part Name ICU Part NumberPower cord; 10A/250VAC

LOCKING LINE CORD 3 COND US 6’

R1-16342

Tablet PC R1-16377

Label Printer R1-16396

Bar Code Scanner R1-16397

2. General Operation Information

2.1. Installation and Maintenance

NOTE: All maintenance and installation must be performed by an authorized ICU Medical representative.

All maintenance work should be completed by the manufacturer with the exception of routine cleaning.

2.2. Environmental Specifications

Operating Temperature +10°C to +40°COperating Humidity 0% to 60% (non-condensing)Operating Altitude 0 to 2000 meters above sea levelStorage Temperature 0°C to +60°CStorage Humidity 0% to 90% (non-condensing)Transportation Temperature 0°C to +60°CTransportation Humidity 0% to 60% (non-condensing)Dimensions 210 x 340 x 250 (mm)Weight 12.3 poundsElectrical Operating Power Range 100 – 240 V~

.8 – .4 A 50 – 60 Hz

Electrical Fuse

2.3 Performance Specifications

Minimum Fluid Delivery Volume 5mLMaximum Fluid Delivery Volume 1000 mLDelivered Volume Accuracy +- 5%Maximum Drug Left in Input Container 0.5mL


3. Diana System Overview3.1. System Components of the Diana System

1. The Diana System consists of multiple components that can communicate over a wireless communication protocol.

2. The components are a Syringe Pump Module, Operator Software, Pharmacist Software, Bar Code Scanner (Optional), and Label Printer (Optional).

3. Additional Syringe Pump Modules can be added to the system to ensure that each facility has the right mix of hardware to fit their needs.

1. Syringe Pump Module (SPM): The Diana Module consists of individual components and accepts commands that transfer fluid from the input container to the output container.

2. Operator Software: The Operator Software user interface running on Windows 10 OS provides primary mechanism to the user (typically a pharmacy technician) to control the SPM. A user can input order information, drug information, initiate a transfer, and print a label from this software..

3. Pharmacist Software: An optional Pharmacist Software user interface running on Windows 10 OS provides the pharmacy administrator a way to validate the transferred order preparation. A user can review order information, drug information, and preparation information, and print a verification label from this software.

4. Bar Code Scanner: The scanner is tethered to the tablet to scan bar codes on patient orders and input drug vials, which increases the efficiency and accuracy of data being entered into the Diana System.

5. Label Printer: A component that is connected through Bluetooth communication to the system that prints a label with information of the preparation that has been performed which can be placed on the output container. When the preparation has been verified on the Pharmacist Software, an updated label with verification information will then be printed on the label to be placed on the output container.


3.2. Views of the Diana Syringe Pump Module

1. Input Container- Typically a drug vial or IV bag. The input container is a fluid source with a compatible ICU Medical connector which, can be attached to the Diana Cassette prior to a transfer.

2. LED Status Lights- LED indicator lights (green and blue). GREEN - SPM is on and is currently selected by the Operator Software user interface. BLUE - SPM is powered on and is not selected by the Operator Software user interface.

3. Output Container- Typically an IV bag, syringe, ambulatory pump, or tubing set. The output container is a receptacle with a compatible ICU Medical connector, which can be attached to the Diana Cassette prior to a transfer.

4. Fluid Detection Sensor- The Fluid Detection Sensor detects the presence of air or fluid in the fluid path of the Diana Cassette.

5. Diana Cassette- The Diana Cassette is the main disposable for the SPM. The input and output containers are required to be attached to the cassette before a transfer.

6. Syringe Driver Pins- The Syringe Driver Pins are used to hold the Diana Cassette in place during a transfer.

7. Syringe Driver- The Syringe Driver is a movable arm that is calibrated to the Diana Cassette. Upon initiation of a transfer, the driver moves the syringe plunger back to the location that correlates to the volume of fluid in the syringe. For transfers over the maximum volume of the syringe barrel, the Syringe Driver will cycle through multiple transfers until the desired volume is reached.

8. Camera Window- The Camera Window is a clear window that provides a transparent barrier for the Diana Camera to have a clear view of the Diana Cassette.

9. Bag Holder- The Bag Holder is a tray in which the output container rests on before, during, and after a transfer.

Front of the Syringe Pump Module Left side of the Syringe Pump Module


10. Diana Handles- The Diana Handles are points in which a user can lift and transfer the Diana SPM.

11. Syringe Carriage- The Syringe Carriage is the main connection point of the Diana Cassette to the Diana SPM. It is vital to ensure the Diana Cassette is properly seated in the Syringe Carriage.

12. Power Plug- The Power Plug is used to connect the Diana SPM using the provided power cord.

13. Back Panel Label- The Back Panel Label provides an indication of regulatory compliances.

14. Power Switch- The Power Switch is used to turn the Diana SPM On or Off.

15. Wireless Antenna- The Wireless Antenna is used to enhance the communication of the Diana SPM to the other components of the system.

Right side of the Syringe Pump Module

3.2. Views of the Diana Syringe Pump Module Cont.

Back of the Syringe Pump Module


4. Operator and Pharmacist Tablet

1. Icon Tray- The Icon Tray consists of LED indicators for Power, Battery Life, Wi-Fi Connection, and Bluetooth Connection.

2. Power LED- The Power LED indicates when the device is powered on. When the LED is GREEN, the device is powered on.

3. Battery LED- The Battery LED indicates the battery status of the device. When the LED is GREEN, the device is using battery power. When the LED is RED, the battery is low and should be replaced. If the LED is off, the device is off.

4. WI-FI LED- The Wi-Fi LED indicates when the device is connected to Wi-Fi. When the LED is GREEN, the device is connected to Wi-Fi. When the LED is off, there is not a connection to the Wi-Fi.

5. Bluetooth LED- The Bluetooth LED indicates when the device is connected to Bluetooth. If the LED is off, there is not a connection to Bluetooth.

6. Charging Pins- The Charging Pins are used to charge the device when connected to the Docking Station.

7. Power Button- The Power Button is used to turn the Operator/Pharmacist Tablet on and off.

8. Camera and LED Module- The Camera and LED Module are used to take additional pictures of labels, input containers, patient orders, or other aspects of the transfer that can be photographed.

9. Mini USB Port- The Mini USB Port is used to connect the Tablet to other devices via a Mini USB Cable.

10. USB Port- The USB Port is used to connect the Tablet to other devices via a USB Cable.

11. Power Port- The Power Port is used to connect the Tablet to a power cord in cases where the Tablet cannot be connected to the Docking Station.

1 - 5 9 - 11

Front of the Tablet Back of the Tablet


4.1. Disposables

1. Input Port - The Input Port is a proprietary ICU Medical Connector that mates with a proprietary ICU Medical connector to establish a closed system during fluid transfer.

2. Output Port - The Output Port is a proprietary ICU Medical Connector that mates with a proprietary ICU Medical connector to establish a closed system during fluid transfer.

3. Cassette Stopcock - The Cassette Stopcock seats in the Syringe Carriage and is activated by the SPM to transfer fluid.

4. Cassette Handle - The Cassette Handle allows a user to easily insert the Cassette Stopcock into the Syringe Carriage.

5. Syringe Barrel - The Syringe Barrel is the cylindrical tube that houses fluid while the syringe is taking in and expelling fluid.

6. Syringe Plunger - The Syringe Plunger can be pulled and pushed inside the Syringe Barrel to take in and expel fluid.

7. Syringe Volume Markings - The Syringe Volume Markings are indications on the Syringe Barrel that indicate to the user the volume of fluid held in the syringe barrel.


5. Operation5.1. Powering On the Devices5.1.1. Powering On Diana Compounding System

5.1.2. Powering On Operator Tablet1. Power on the Operator Tablet.2. Once the Operator Tablet’s Windows 10 OS displays the login screen enter your site’s

password. If your system administrator has not changed it the default to ICU.3. From the Operator Tablet, launch the Software GUI by double-tapping the “Operator”

desktop shortcut. Once the user launches the Software GUI, the following screen will be displayed: Manual <TSG600537> Tab: Technician uses this tab to enter order information to the system and manually transfers the drug from input vial to output bag. The example screen shows the Manual TSG600537. Diana X Tab: Technician uses this tab to enter order information to the system and uses the Diana SPM to transfers the drug from input vial to output bag. The example screen shows the Diana 2 SPM.

1. Power on the Diana Compounding System by using the Power Switch on the back panel.

2. Diana LED indicators flashes blue continuously for a few seconds and then turn solid blue.


4. Select the Connected Diana system tab. The following screen will display:

5. Remove they syringe cassette unit, if any, and press OK. Once the initialization of the SPM is done, the following screen will display :

5.1.3. Powering On Pharmacist Tablet

1. Power on the Pharmacist Tablet.

2. Once the Remote Tablet’s Windows 10 OS displays the login screen enter your site’s password. If your system administrator has not changed it will default to ICU.

3. From the Pharmacist Tablet, launch the Software GUI by double-tapping the “Remote” desktop shortcut. Once the user launches the Software GUI, the following screen will be displayed:


5.2. Workflow Of The System

Once the system has been properly configured, follow the Section 5.1 to turn on the Diana System components.

The Virtual Keyboard

An important part of the Diana system settings is the virtual keyboard. Use of the virtual keyboard is not restricted to the several settings. It is also used for manual and automated deliveries and delivery validation.

The virtual keyboard is displayed when certain text boxes are touched or selected. These text boxes require some user input, such as entering an NDC (National Drug Code) or substance name. There are many uses for the virtual keyboard.

The virtual keyboard comes in 3 distinct types; an alphanumeric keyboard, a decimal numeric keypad and a hexadecimal numeric keypad. The numeric keypads are used when the input to the text box must be restricted to digits (either decimal or hexadecimal).

The Diana system provides the following workflows:

1. Manual Workflow2. Automated Workflow

5.2.1. Manual WorkflowThe Diana Operator Tablet allows the user to add order preparation information manually into the system.

NOTE: This worklfow can be used without the presence of a Diana Syringe Pump Module.

1. 2.195


5.2.1.2. Adding Order Information

1. Select the Manual tab.

2. Tap on the Order Number filed and enter/select/scan the information for Order Number, Drug Name and Volume.

NOTE: If the Order Number is not provided in the Patient Order Form enter 0 (Zero) for the Order Number.

3. Tap onscreen Enter button.

4. The Information entered will display.

5. Tap on Add icon to enter NDC, Lot Number, and Lot Expiration Date values.

6. The Add Vial Information screen will display.

7. Tap on the NDC field.


8. The following screen displays to enter/select/scan NDC, Lot Number, and Lot Expiration Date values.

9. Tap onscreen Enter button once the values are entered.

10. The software automatically opens the Camera Screen to take the picture of the input container.

NOTES:

a. User must take the picture of the input container; otherwise, the software prevents the transfer process.b. To take a picture of the vial, a user may utilize the tablet camera or the barcode scanner.

Take a picture of the label on the input vial which includes the NDC code, lot number, expiration date, drug name and concentration.c. To take a picture using tablet camera, focus towards the input vial label and press Capture

button.d. To take a picture using barcode scanner, focus towards the input vial label, press and hold

the scanner trigger button.

11.. The software captures the picture and displays on the screen.

12. To remove a picture, tap the Delete icon.


13. Tap the Save button to save the picture(s).

14. Added vial information is displayed on the screen.

15. The user may then withdraw the desired amount from the vial. Tap the Syringe Picture button to capture the volume of drawn back syringes.

16. Additional pictures can be taken by tapping the MISC button..

17 Tap the Complete button.

18. The verification screen will display with the entered information. .

19. Tap Photo button to take additional pictures.

20. Choose the Accept or Reject buttons to either accept the manual order or reject the order.


22. Tap on the Reason text area and enter the reason. Tap the Enter key.

23. The following screen will display. Tap the OK button

21. If the user rejects the order, the software provides a screen for the user to enter the reason for rejection.


24. A label will print, which should immediately be placed on the output container.

25. If the user accepts the order a label will print, which should immediately be placed on the output container.


5.2.2. Automated Workflow

The Diana Operator Tablet runs the Software Graphical User Interface (GUI) that interacts with the connected SPM, printer, and the barcode scanner. The software GUI utilizes an intuitive touchscreen approach for data entry.

5.2.2.1. Performing a Transfer

There is a two-step process involved to transfer a compound from the input container to the output container:

1. Entering Drug Name, Order Number and Transfer Volume

2. Entering Drug NDC Code, Lot Number and Lot Expiration Date

5.2.2.1.1. Entering the Drug Name, Order Number and Volume

There are two ways to enter the Drug Name, Order Number, and Volume of a mix from a patient order via the Operator Tablet GUI: Manually or using a Bar code Scanner.

1. Manually enter the Drug Name, Order Number and Volume from a patient order

A user can enter the drug name, order number, and desired volume to aid in error checking and reporting of the transfer. To utilize this function, follow the workflow below.

1. Ensure the Operator Tablet is communicating to the correct SPM. Select the SPM.

2. Touch on the text box Order Number text box.


3. An on-screen keyboard will then be displayed.

4. Use the onscreen keyboard to enter the Order Number from a patient order. NOTE: If the Order Number is not provided in the Patient Order Form enter 0 (Zero) for the Order Number.

5. Next, tap the Drug Name text box.

6. Use the on-screen keyboard to enter the drug name. As you enter the drug name, the software will attempt to automatically fill the rest of the drug name. Once you find the drug name, select the drug by tapping the desired drug.


8. Use the numeric keypad to enter the volume in milliliters of the transfer and tap the onscreen Enter key.

7. Next, tap the Volume text box and an onscreen numeric keypad will be displayed.

2. Use a barcode scanner to enter the Drug Name, Order Number, and Volume from a patient order

A user can also utilize a barcode scanner to enter the drug name, order number, and desired volume to make the process of data entry more efficient. To utilize this function, follow the workflow below

1. Ensure the Operator Tablet is communicating to the correct SPM. Select the SPM.


Checking Drug Name for Verification:

The Diana System software provides the ability to verify that the correct drug name has been entered or scanned before a transfer can take place. Once the desired drug name has been entered or scanned, the Diana System software will check the name of the drug against the list of drugs on the system.

When the incorrect drug has been entered or scanned, an indication will appear on the Operator Tablet GUI, requiring the user to cancel the request and enter new drug information.

5.2.2.1.2. Entering the Drug NDC, Lot Number and Lot Expiration Date

After the desired Drug Name, Order Number, and Volume entered, the Diana software requires the user to enter the Drug NDC (National Drug Code), Lot Number, and Lot Expiration Date values.

There are two ways to enter the drug information: Manually entering/selecting the Drug NDC ID or scanning the barcode of the Drug NDC (Input vial).

2. Use the bar code scanner and scan in the bar code from the patient order.

3. The Order Number, Drug Name, and Volume entries are automatically entered in the fields when user scans the bar code from the patient order.


1. Manually entering/selecting the Drug NDC

1. After entering the Order Number, Drug Name, and Volume, tap the NDC text box on the interface.

2. The corresponding NDC codes for the entered drug name will automatically populates for the user to select.

3. User can select the desired NDC code from the list.

2. Using the Barcode Scanner to enter the NDC code.

A user can utilize a barcode scanner to enter the NDC code to make the process of data entry more efficient. To utilize this function, follow the workflow below.

To utilize this feature, ensure that the drug vial has a barcode printed on the label that contains a unique NDC code.

1. After the desired Order Number, Drug Name, and Volume has been entered into the system, scan the Drug Vial Barcode.


Entering the Lot Number and Lot Expiration Date

1. After entering/scanning Drug NDC into the system, tap the Lot Number Text Box.

2. Locate the Lot Number on the Drug Vial and enter the Lot Number.

3. Tap the Month Text Box. Locate the Lot Expiration Date on the Drug Vial and enter the Lot Expiration month.

4. Tap the Year Text Box. Locate the Lot Expiration Date on the Drug Vial and enter the Lot Expiration Year.


5. Press on-screen keyboard Enter button.

6. The software automatically opens the Camera Screen to take the picture of the input container.

NOTE: a. User must take the picture of the input container; otherwise, the software prevents the transfer process. b. To take a picture of the vial, a user may utilize the tablet camera or the barcode scanner. c. To take a picture using tablet camera, focus towards the input vial label and press Capture button. d. To take a picture using barcode scanner, focus towards the input vial label, press and hold the scanner trigger button.

7. The software captures the picture and displays zoomed-in mode for the user to see the captured picture is clear enough to see the content of the input vial.

8. Tap the Close button.9. The captured picture displays on the screen.10. To remove a picture, tap the Delete button.11. Tap the Save button to save the picture(s).


12. The software notifies (flashing syringe cassette, input vial and output container) the user to connect the syringe cassette, input container, and output container to SPM.

13. Once the user connects the disposables to SPM, the following screen displays:

Checking the Drug NDC for Verification:

The Diana System software provides the ability to verify that the correct Drug NDC has been entered or scanned before a transfer can take place. Once the desired Drug NDC has been entered or scanned, the Diana System software will check the Drug NDC against the list of drug NDC’s on the system.


When the incorrect Drug NDC has been entered or scanned, the Operator Tablet GUI notifies the message to the user that NDC does not match with the drug.

Checking the Lot Expiration Date for Verification:

The Diana System software provides the ability to verify that the correct Lot Expiration Date has been entered before a transfer can take place. Once the Lot Expiration Date has been entered or scanned, the Diana System software will check the entered Lot Expiration Date.

When the incorrect Lot Expiration Date or Expired Date has been entered or scanned, an indication will appear on the Operator Tablet GUI, requiring the user to enter a new Lot Expiration Date.


5.2.2.1.3. Initiating a Transfer

Once the proper drug transfer information and pictures have been entered into the system, the system will now be in a state where it can begin a transfer.

1. To initiate a transfer, tap the Start Icon.

2. The Syringe Driver may draw a small volume of drug from the input vial and push it back into the input vial which will prime the disposables.

3. Once the fluid path has been primed, the SPM will then draw the desired amount of fluid into the disposable.

4. As the device is drawing fluid, the status bar (with a light blue color) on the Operator Tablet software GUI will begin to fill up, which provides a status to the user as to how far along the transfer is from being complete.


7. The Diana software provides the user the ability to zoom in on the pictures (to zoom in on the photo, tap the photo).

5. As the device is pushing fluid into the output container, the status bar will fill up (the light blue will fill up with a darker blue) accordingly. Additionally, a real-time indication of fluid transfer will be displayed on-screen providing the user with an indication of how much drug has been transferred into the bag.

6. Once the automated drug transfer process is completed, the Diana software GUI presents a validation screen to the user to accept or reject the transfer process.

8. User may take additional pictures by pressing the Photo button.

9. If the user accepts the transfer, a label will print, which should immediately be placed on the output container.


10. If the user rejects the transfer, the Diana software GUI presents a screen to the user to provide the reason for rejecting the transfer.

11. Tap OK button on the Reason for Order Rejection screen

12. Once the user provides the reason, a label will print, which should immediately be placed on the output container.


5.2.3. Validating a Transfer (Optional)

The Diana System has the option to incorporate a Pharmacist Tablet, which allows certain preparations (manual or automated) that require validation by a pharmacy administrator. The embedded camera inside the SPM can take pictures of the syringe in the pulled state before transferring into the output container and then send the transfer information along with the pictures of the transfer to the Operator Tablet. The Pharmacist Tablet software GUI will download the preparation, which includes the pictures taken by the operator and the SPM, and allows a pharmacist to verify the correct mixture took place without having to enter the clean room environment.

5.2.3.1. Validating a Transfer

Once a transfer for certain drugs has completed, the Pharmacist Tablet will display a transfer in the Pharmacist GUI with the patient order number on it

The pharmacist has options to approve or reject the transfer.

5.2.3.1.1. Approving a Transfer

1. Tap the transfer with the corresponding preparation order to be validated.

2. Review the information.

3. Review each picture and tap the green check mark icon to approve each picture.

4. For pictures which do not meet an approval standard, tap the red X Icon.

5. When all pictures have been reviewed, tap the Accept Icon on the screen.


6. Software present a Validation Screen for the user to sign the transfer.

7. Once the pharmacist approves the transfer, a label will print, which should immediately be placed on the output container.


5.2.3.1.2. Rejecting a Transfer

1. Tap the transfer with the corresponding preparation order to be validated.

2. Review the information.

3. Review each picture and tap the green check mark icon to approve each picture.

4. For pictures that do not meet an approval standard, tap the red X icon.

5. When all the pictures have been reviewed, tap the Reject icon on the screen.

6. The software presents a Reason for Order Rejection screen for the user to provide the reason.


7. Once the pharmacist rejects the transfer, a label will print, which should immediately be placed on the output container.

5.2.4. Replacing Empty Input Container

The Diana software notifies the user when an empty input container condition occurs. Follow the below steps to replace the empty input container..

1. When an empty input container condition occurs, the Diana software notifies the user..

2. The user may choose Reprime if the input container is not empty.

3. When user choose Reprime button the software notifies the user the below screen to notify the user to confirm the input and output containers are connected.


4. When user choose the Start button the software initiates the delivery process again.

5. When user choose the Cancel button the software takes the user to Empty Vial screen.

7. If the user wants to replace the input container, remove the empty input container, enter/ scan the new input container information.

6. The user may choose to finalize the delivery process by tapping the Finalize button. The SPM transfers the liquid from syringe cassette to the output container and the transfer completion screen displays to the user to accept or reject the transfer.


8. Press the onscreen keyboard Enter button.

9. The software automatically opens the Camera Screen to take the picture of the input container)

NOTE: User must take the picture of the input container; otherwise, the software prevents the transfer process. To take a picture of the vial, a user may utilize the tablet camera or the barcode scanner

10. Tap the Capture button. The software captures the picture and displays on the screen

11. To remove a picture, tap the Delete icon.

12. .Tap the Save button to save the picture(s).

13. Tap the OK button after entering the NDC, Lot Number, and Lot Expiration date.


14. The Diana software notifies the user to attach the drug input container.

16. Once the delivery process completes, the Diana software provides a verification screen to user to verify the information.

NOTE: The Diana software displays both input containers information on the verification screen.

15. The Diana software displays the following screen. Tap the Start icon again to continue the transfer process.


5.2.5. Interrupt Dispensing Process Using Stop

The compounding transfer process can be interrupted at any time by tapping the Stop key.

Once the user stops the transfer process, the Diana Software GUI presents options to the user to resume or cancel the delivery process.

5.2.6. Resume After Stop

After the Stop key has been selected, user may resume dispensing process when the compounding process is interrupted via Stop, the user can resume an interrupted compounding process without any errors by tapping the Start key.

Once the user resumes the process, the Diana Software GUI completes the drug transfer process and presents a validation screen to the user to accept or reject the transfer process.


5.2.7. Cancel the Delivery Process

Once the user stops the transfer process, the Diana Software GUI presents options to the user to resume or cancel the delivery process.

If the user cancels the delivery process, the Diana Software GUI completes the transfer process without transferring fluid from input container to the output container and presents a validation screen to the user to accept or reject the process.


6. Tool Settings6.1 General

Both the operator and the remote Diana 2.0 applications have user accessible settings. Some settings are available for both the remote and operator tablets, some are remote tablet only and others are operator tablet only. Some remote tablet only settings will be on the operator tablet if there is no pharmacist (i.e., remote) tablet in the system. Which settings are available is controlled by the tool settings configuration file. This file is created at installation time and is not changeable by the user.

Table below shows the tool settings available based on Diana 2.0 system configuration.

Tool Setting Name Operator Remote Operator Only (No Pharmacist)

About X X X

Review Preparations X X X

Create Drug X X

Edit Drug X X

Manage Order Printer X X X

Compounding Machines X X

Network Settings X X X

Disposable X X

Technician Tablets X

Require Pharmacist Picture Validation

X

Remote Validation X X

Substance Properties X X

Manage Reconstitution Protocols X X


Settings for the Diana Hazardous Drug Compounding System are displayed as a series of settings bars on the settings screen. The remote application startup screen displays the settigs.

Getting to the settings for the operator tablet requires an additional step. To display the settings screen for the operator tablet, the user has to touch or select the gear icon in the upper right hand corner of the operator main screen. Upon touching that gear icon, the operator settings screen is displayed.

Both the operator and the remote settings screens are scrollable. Since there can be more settings than are displayed, scrolling is necessary. To scroll, touch the screen in the settings area and drag up or down depending on the desired direction of scrolling.

The settings screen consists of several individual settings bars. Each setting bar has a description icon on the left of the bar, text in the middle that briefly explains what that setting is and a settings action icon on the right of the bar. The settings action icon is a white colored right facing arrow head against a blue background.

To launch any of the settings, touch the settings action icon of the desired settings bar.


6.2 Settings DescriptionMost settings screens have a Back icon . Touching or selecting this icon will return the display to settings screen.

6.2.1 Manage Order Printer Settings

The Media Access Control (MAC) address of the Zebra order printer that is part of the Diana Hazardous Drug Compounding System can be changed by the use of Manage Order Printer settings.

Touch the Manage Order Printer settings, the Printers settings screen is displayed.

The user will specify the label width and height for the labels that will be processed by this printer. Touching the label width or label height text box will cause the virtual numeric keypad to appear.

The user will select the printer from the available list of printers. Choose the printer by touching the printer down arrow button


The user has to enter the MAC address. MAC address of the printer has to be made known or the system will not be able to use the printer. To enter the new printer’s MAC address, touch the Printer Mac Address 6 boxes shown on the screen. Upon touching the screen, the screen displays a Hexadecimal keypad. The MAC address of the printer is 12 hexadecimal digits, typically expressed as 6 groups of 2 hexadecimal digits. A typical MAC address is 1A-2B-3C-4D-5E-6F. The dashes shown here are not part of the address but are shown for clarity.

Once all the information entered touch the onscreen enter key.

If the user selected the Delete button, the internal printer settings will be completely cleared, making it impossible for a printer to be used until a new MAC address is entered and accepted. If the Delete button is touched, the user will be asked to confirm this operation.

At this point, the user is free to accept the address by touching or selecting the Save button, and return to the main settings screen or return to the main settings screen without changing the printer MAC address by touching the Cancel button.

A restart of the operator or remote application is required after changing the printer MAC address.


6.2.2 Network Settings

The Diana Hazardous Drug Compounding System depends on a wireless local area network using the IEEE 802.11 protocols (commonly known as Wi-Fi) for communications between the Syringe Pump Modules (SPMs), the technician tablet (a.k.a. operator) and the pharmacist tablet (a. k. a. remote). The system can contain up to 3 SPMs per technician tablet. There may be many technician tablets however. Each SPM has a built-in Wi-Fi router, but only one Wi-Fi router can serve the Diana Hazardous Drug Compounding System. Should the SPM designated as the Wi-Fi router need to be replaced, or there is a compelling reason to change the Wi-Fi router to another SPM (or possibly a router not part of an SPM), this can be accomplished using Network Settings.

When touching the settings action icon of the Network settings, the Network Settings screen is displayed.

Three data items need to be entered here. The router serial number is the serial number of the SPM that will now be the Wi-Fi router for the system. The router Service Set ID (SSID) is that SSID of the SPM to be used as a router and password is the router’s Wireless Equivalent Privacy (WEP) key. The serial number, SSID and WEP key for the new router are listed in the documentation that came with the new SPM device. These data may also be on the SPM label.

To make changes to any of these three fields, touch one of the text boxes. Upon touching one of these text boxes, the Network Settings screen will change into its entry mode. Use the virtual keyboard to change the router serial number, SSID or password (WEP key). When complete, touch the keyboard return key.


The Network Settings screen is redisplayed, but the router serial number, SSID and password fields now have new values. To Accept these changes, touch the Save button. To reject these changes, touch the Cancel button. In either case, the Main Settings screen is displayed afterwards. To change a value, just touch one of the text boxes, and the keyboard will reappear.

NOTE: A restart of the operator or remote application is required after changing items on the Network Settings Screen.

6.2.3 About This System Settings

Touching or selecting the action icon of the About This System settings bar will display a screen that details the version and contents of the application. Unlike the other common settings, the operator and remote application display different screens when using this settings bar.

For operator, it will display the version of the operator software, the serial number of the operator tablet, SPM serial number and SPM system version. For remote, it will display the version of the remote software and the serial number of the remote tablet.

6.2.4 Technician Tablet Settings

he Diana Hazardous Drug Compounding System can have one or more technician (operator) tablets. The pharmacist tablet (remote tablet) must know about them in order to properly communicate and coordinate user defined drugs and to validate preparations.

The pharmacist tablet is configured at the factory to include all technician tablets associated with it, but over the lifetime of the system, the hosting clinic, hospital or pharmacy may add or replace some of the technician tablets. When that happens, the configuration of the pharmacist tablet must be updated. The way to do that is via the Technician Tablet settings.

When the user wants to change the configuration of several technician tablets in the system, touch or select the action icon on the Technician Tablet settings bar.


This screen has a tablet bar for each and every tablet the system currently knows about. A typical Tablet bar is shown.

To edit or delete the configuration of an existing tablet, touch the tablet action icon of the tablet bar associated with the target technician tablet. Touching this icon will display a popup menu near the tablet action icon.

If Edit is touched or selected, following screen is displayed, except that the screen says “Edit Tablet”, not “Add Tablet”. Enter the serial number of the tablet that is replacing the tablet being replaced and select the Save button to accept the change. Select the Cancel button to ignore the change.


If the delete action is selected, the target technician tablet’s entry into the remote tablet’s configuration is deleted and the tablet bar of that entry is removed from the display.

To add a new technician tablet, touch the button marked “Add Tablet” . Enter the serial number of the new tablet in the indicated space and select or touch the Save button. To reject the change, select or touch the Cancel button.

The remote tablet needs to be restarted after altering the technician tablets configuration.

6.2.5 Require Pharmacist Picture Validation Settings

For those preparations that require the validation of the supervising pharmacist, the images that are recorded for the syringe, vial and other miscellaneous images may be incorrect, inappropriate or may not need to be kept. The Diana Hazardous Drug Compounding System gives the pharmacist the option of being able to reject some of the images for a given preparation if the system setting of Require Image Validation is set.

In order to set this value, the user must touch or select the action icon of the Require Pharmacist Picture Validation settings bar. Select Yes to be able to individually validate each image or No to not be able to individually validate each image.

To accept the change, touch or select the Save button. To reject the change, touch or select the Cancel button.

6.2.6 Compounding Machines SettingsAt some time after the delivery of the Diana Hazardous Drug Compounding System, the owning clinic, hospital or pharmacy may elect to replace existing compounding machines (a. k. a. Syringe Pump Modules) or add new ones. When that happens, the internal configuration of the operator tablet must be updated to reflect this change. To accomplish this task, use the Compounding Machines settings.

To use the Compounding Machines settings, touch the action icon of the Compounding Machines settings bar.


On this screen, each and every compound machine (i.e., an SPM) is shown with a compounding machine bar.

To edit or delete the compounding machine configuration shown by the compounding machine status bar, select the action icon of that status bar. A popup menu indicating Edit or Delete will appear. To edit this configuration, select Edit. To change the serial number of this SPM, touch the serial number text box and the virtual keyboard will appear. Make the desired changes and select the keyboard return key. To accept the changes, select the Save button. To reject these changes, select the Cancel button.

To delete the configuration of a certain SPM, select the “Delete” option after touching the target SPM Compounding Machine bar’s action icon. Upon selecting “Delete”, the target configuration will be erased.

To add a new Compounding Machine, select the “Add Machine” button found in the upper right hand corner of the Compounding Machine Settings screen.

NOTE: By Selecting this icon, the screen will appear that will say “Add Compounding Machine”, not “Edit Compounding Machine”.

Add the serial number as was done when editing an SPM record. Select Save to accept the new SPM and Cancel to reject the new SPM.


6.2.7. Create Drug Settings

The Diana Hazardous Drug Compounding System comes with an extensive data base of existing drugs derived from the United States Food & Drug Administration (FDA) input. There are over 7600 different substances in that data base. These substances are available in many different concentrations for a total of over 76,000 different compounds. Given that a drug can be in various packages, the database has over 215,000 entries. The FDA updates this data source daily. ICU Medical, however, will update the internal database on a much slower schedule.

Regardless of that large number of drugs, there will be times when the hospital, clinic or pharmacy using the Diana system will need to compound substances not in the FDA database or existing substances in concentrations not yet listed. To allow for this possibility, the Diana Hazardous Drug Compound System allows for the creation of user defined drugs (UDDs).

To create a new UDD, touch or select the action icon of the Create Drug settings bar.

Note: All fields must be properly filled in before the user will be permitted to save this UDD.

The NDC field (i.e., National Drug Code) is a free form identifier for the UDD. FDA supplied NDCs have a specific format. To prevent a conflict with the contents of the FDA obtained drug data base, the string “_UD” is appended to the input of this text box. The Drug Name is also free form and can contain any of the characters in the virtual keyboard. It need not be unique. If this UDD requires remote validation from the supervising pharmacist, select the Remote Validation radio button. If not, select the No radio button.

The UDD to be created may be dispensed by the Diana SPM in amounts only greater than the specified Min Volume and not more than the specified Max Volume. The units for Min and Max volume are in ml’s. Touching the Chemolock Viscosity or Spiros Viscosity field will cause a popup to appear whose members are all the viscosity records defined for the specified connector type. The viscosity record defines how hard the SPM must push or pull the syringe in the SPM to account for the viscosity of this substance. Refer to section named “Viscosities Settings” for more about viscosity records.

The substance of the UDD is specified by filling in the Drug Name text box. Touching this text box will cause the virtual keyboard to appear and entering text into this text box will cause a popup to appear listing substances that start with the letters entered in the text box. For instance, if an “H” is entered into this text box, a scrollable list of known substances starting with “HADDOCK” will appear. To select a known substance, touch that substance. For a substance unknown to the system, keep typing until there are no more entries in the scrollable popup list. A record for that previously unknown substance will be created in the UserDefinedDrug data base upon saving of the UDD.


The concentration of the substance in the UDD is specified with 4 parameters; the magnitude of the mass and volume (the Mass and Volume text boxes) and the MassUnit and VolumeUnit combo boxes. Fill in the values of Mass and Volume using the virtual keyboard (will be a number pad for those boxes). To specify MassUnit or VolumeUnit, touch the desired combo box and select an item from the popup.

If Remote Validation is desired for this drug, select the Remote Validation radio button. If not, select the No radio button.

Note that the Save button is now visible. To save this drug, touch or select the Save button. Selecting Cancel will reject this UDD and return the user to the settings screen. Upon creating a drug, a notification will be sent to the operator tablet(s) if it was the remote tablet that created the drug.

Touch the notification icon and see the detailed information.


6.2.8. Edit Drug Settings

Since both User Defined Drugs and SPM specific items related to both FDA obtained and user defined drugs are part of the Diana Hazardous Drug Compound System, there needs to be way to edit these values. This is accomplished using the Edit Drugs settings. To get to this setting, touch or select the action icon of the Edit Drug Settings bar.

Touch the NDC text Box and using the virtual keyboard, enter the NDC of the drug that is wished to edit or delete. The NDC can be either a FDA supplied or user defined NDC.

To delete a User Defined drug, touch the Delete button after entering the NDC for that drug. If that drug exists, a confirmation screen will be displayed. If user selects Yes button, system deletes the drug NDC and the display will return to the main settings screen. If user selects No button, the display will return to the main settings screen without deleting the Drug NDC.


If the NDC entered in this screen does not exist and the Delete button is touched or selected, an error screen shown.

Upon touching or selecting the Edit Drug button, the edit drug screen will be displayed. The user an edit that drug or to select Cancel and return to the main settings screen.

Note: Only certain parts of the drug related to the performance of the Diana system may be edited for FDA obtained drugs. The only items that can be edited are:

• Viscosity Record

• Min Volume

• Max Volume

• Remote Validation

All parts of User Defined drugs can be edited except the Drug Identifier. When the items in Figure 6-32 are correct, touch or select the Save button. If the Cancel button is selected, all changes will be rolled back for this NDC.


6.2.9. Substance Property Settings

The various substances that are compounded into drugs in the FDA drug data base and in the User defined database are set to require (or not require) a Computerized Ambulatory Drug Delivery (CADD) receptacle or may (or may not) require remote validation. The Substance Properties Settings gives the user the ability to change these parameters at will.

To access the Substance Properties settings, touch the action icon of the Substance Properties settings bar. Upon touching that icon, below Substance Properties setting screen will appear.

Touch the substance text box on this screen and using the virtual keyboard, start entering the name of the substance that it is desired to modify. The system will supply a popup with substance(s) that start with the characters entered. Select from the popup or continue to type in this box.

When the desired substance name is entered, use the radio buttons to reassign remote validation or use of the CADD container. When done, press the Save button. The Save button will appear as soon as a legal legal substance is entered in the substance text box.

6.2.10. Review Preparations Settings

The Diana system keeps a record of each and every preparation attempted starting from manufacture. These records include dates, times, results and other relevant data. It also includes all imagery, whether of the syringe, the several vials or any of the miscellaneous images of the preparation. These preparations can be reviewed on the tablet using the Review Preparations setting.

To be able to review preparations, touch or select the action icon of the Review Preparations.


The Review Preparations screen has one or more preparations records in a scrollable list. Each row in this list is a record. The list can be sorted by order id, date, drug (i.e., substance and concentration) or status by touching or selecting the up/down arrow icon next to the title of each column in the list.

The following data is shown for each preparation: the order ID, the date of completion, the substance and concentration of the drug that was dispensed and the status of the preparation.

The rightmost column in this list is entitled action. Each record has two buttons in this column; the Print button and the Display button.

If the Display button for a certain preparation record is touched or selected, a screen that shows all of the images associated with this delivery, and other relevant information will be displayed. There may be one or more syringe pictures, depending on the amount of fluid delivered. There may be one or more vial pictures, 0 or more miscellaneous pictures, and a signature image, if this preparation was validated by the pharmacist.

Touching the Print button will print on the Diana System printer a label with a QR image and other relevant information for this preparation.

6.2.11. Disposables Settings

At the present time, the cassette (a. k. a. the syringe) of the syringe pump module, a part of the Diana Hazardous Drug Compound System, can be outfitted with two possible connectors (also known as disposables). These are termed “Chemolock” and “Spiros”. To change the current disposable type for the Diana system, select the action icon of the Disposable Settings bar. Select the radio button for either Chemolock or Spiros and select the Save button. The connector type will be updated for the Diana System and the GUI will transition back to the main screen. Selecting the Cancel button will also transition the GUI to the main screen.

Note: Selecting the Cancel button will also transition the GUI to the main screen.


6.2.12. Substance Properties Settings

The system comes preloaded with some FDA drugs set for remote validation. Please see Appendix J for this list. The user may override the default validation settings for any substance via the Substance Properties settings tool.

The following steps show how to change a Substance’s validation setting.

Touch the action icon of the Substance Properties settings bar

Enter the name of the substance to have its remote validation default behavior changed. As with many text entries in the Diana system, there will be a drop down list of substances that start with the character or characters entering in the box. Select the appropriate item.


When the the desired substance is selected, the current default remote validation behavior for that substance will be displayed via the radio buttons marked for “Remote Validation” to “Yes” or “No”. To change the behavior, select the radio button that isn’t currently selected and then select or touch the Save button. To not change anything, select or touch the Cancel button. After selecting the Save or Cancel button, the GUI will transition back to the main screen.

6.2.13. Manage Reconstitiution Protocol Settings

Refer to Appendix H for creating and running reconstitution protocols. Many pharmaceuticals are manufactured as powders and require reconstitution with a diluent before the pharmaceutical can be utilized. The Diana Hazardous Drug Compounding System can easily perform a reconstitution. The protocol that will be used for a particular pharmaceutical is called a reconstitution protocol. The several reconstitution protocols that are known to the Diana system can be managed with this settings bar.

To manage reconstitution protocols, touch the action icon of the Manage Reconstitution Protocols settings bar. Upon touching that action icon, picture below appears.

As is commonplace for many settings screens, the Manage Reconstitution Protocol settings screen has a back button, and add button and 0 or more bars, one for each known Manage Reconstitution protocol.

To add a reconstitution protocol, touch the “Add Reconstitution Protocol” button the screen below appears.

Fill out the screen in order to allow the Save button to appear (hidden until all items are filled in). The diluent compound text box upon entering a few letters will suggest compounds in a manner typical for the other settings screens. The same can be said for the Reconstituted Drug’s NDC.

To edit or delete a reconstitution protocol, touch the action icon for the settings bar of the desired Reconstitution protocol. To delete the protocol, select Delete from the pop-up.

To edit the reconstitution protocol, select Edit and the screen below appears.

All items except the reconstitution protocol name (in this figure it is RECON WATER) are editable. Make changes as it seems appropriate and select Save when done.


7. Warranty and Service Information

7.1. Limited Warranty

ICU Medical warrants the system to be free from defects in material and workmanship for one (1) year from the date of delivery, when operated in accordance with the User Manual. Sensors and accessories are warranted to be received in good condition, and ICU Medical agrees to accept return if found defective upon installation, provided that ICU Medical is notified within five (5) days from initial installation and the items not deemed ineligible for warranty under the conditions and exclusions from warranty listed in this manual. ICU Medical cannot honor warranty claims due to damages resulting from transport.

This warranty extends to the designated original purchasers of the equipment from ICU Medical and will not extend to any subsequent purchaser. This warranty shall not apply where: service is required due to purchaser’s failure to operate or maintain the equipment in a manner consistent with the specifications and guidelines set forth in the User Manual; service is required due to misuse or unauthorized service, unauthorized accessories or parts are used with the system; or where the equipment is found to be functioning within the published specifications.

This warranty includes repair or replacement of components that do not function as intended during the term of this warranty. Warranty components or assemblies shall be of equal or better quality than the component or assembly replaced. Such components replaced by ICU Medical become the property of ICU Medical.

This warranty is extended to original purchasers of the equipment from ICU Medical in lieu of all other warranties expressed or implied and all other obligations or liabilities on the part of ICU Medical, and no person, agent, or dealer is authorized to give any warranties or to assume any other liability on behalf of ICU Medical. For ICU Medical to properly administer the warranty, the purchaser must notify ICU Medical promptly after the occurrence or discovery of any alleged failure.


Disclaimer of Warranties:

THIS LIMITED WARRANTY IS PROVIDED IN LIEU OF ALL OTHER WARRANTIES, WHETHER EXPRESS OR IMPLIED, AND ICU MEDICAL HEREBY DISCLAIMS ALL OTHER WARRANTIES, INCLUDING WITHOUT LIMITATION IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR PARTICULAR PURPOSE AND NON-INFRINGEMENT.

Excluded from warranty coverage are damages resulting from:

● Incorrect connection of SPM or accessories.

● Unauthorized cleaning of the SPM or accessories.

● Transportation damages of any sort.

● Accident, fire, water, vandalism or causes other than ordinary usage.

● Misuse of the equipment or accessories.

● Disregard for the user manual instructions.

Limitation of Liability:

IN NO EVENT WILL ICU MEDICAL BE LIABLE FOR COSTS OF PROCUREMENT OF SUBSTITUTE PRODUCTS OR SERVICES, OR BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, OR CONSEQUENTIAL DAMAGES, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, ARISING OUT OF THIS WARRANTY, INCLUDING BUT NOT LIMITED TO LOSS OF ANTICIPATED PROFITS, EVEN IF ICU MEDICAL HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. THESE LIMITATIONS WILL APPLY NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY.

7.2. Service and Contact Information

For customer service, technical assistance, product return authorization and to order parts, accessories, or manuals contact ICU Medical Technical Support Operations nearest you:

ICU Medical, Inc.

951 Calle Amanecer

San Clemente, CA 92673

For Customer Service:

(866).829.9025

(949).366.2183


Appendix A: Cleaning and Disinfecting the Diana System

Do not attempt to sterilize or autoclave the Diana Automated Compounding System under any circumstances. All external parts are manufactured of stainless steel, aluminum, specially-coated aluminum, impact-proof polystyrene, or polyester.

Standard cleaning and disinfecting agents with an alcohol base can be used to clean and disinfect the device. DO NOT use radical-forming or peroxide-forming cleaning and disinfection agents or ketone based cleaning and disinfection agents. Do not directly spray onto or moisten the connector sockets on the rear wall of the device. NOTE: Connector sockets must be completely dry. For removing severe soiling, check solvent solubility of plastic and other device parts and labels before attempting to clean with any solvents.

In many cases, cleaning the device with a lukewarm soap solution is the simplest and most gentle cleaning method. Gentle wiping and spraying cleaning and disinfection agents is typically sufficient. The recommended cleaning and disinfecting protocol is provided below:

Step #1 – Wipe Device with 2% Sodium Hypochlorite (bleach) - Cleansing Solution

Ingredient Amount Amount

Bleach (5.25% sodium hypochlorite) 190.5ml 381ml

Sterile Water for Irrigation (pour bottle) 309.5 619ml

TOTAL VOLUME 500ml 1000ml

Step #2 – Wipe device with 1% Sodium Thiosulfate - Deactivating Solution

IngredientAmount Using

(Na Thiosulfate 10%)Amount Using

(Na Thiosulfate 25%)

Na Thiosulfate Inj. (10% or 25%) 50ml 20ml 40ml

Sterile Water for Irrigation (pour bottle) 450ml 480ml 960ml

TOTAL VOLUME 500ml 500ml 1000ml

Step #3 – Wipe with Sterile Water - Wipe all surfaces to remove any residual bleach or Na thiosulfate.

Step #4 – Wipe with Sterile Isopropyl Alcohol - Wipe all surfaces prior to use in compounding sterile products. Any remaining residue may be cleaned by using an alcohol swab, lint free towel soaked in isopropyl alcohol, or a soap solutions suitable for cleaning a biological safety cabinet.

Step #5 – (optional cleaning) repeat steps #3-#4 two times each, wiping in top-down motion and discarding towels, followed by a dry and clean towel wipe in between each step.


Appendix B: Troubleshooting

Description of Fault Remedy

Printer not printing properly Refer to Appendix C Pairing Printer section.

Air bubbles or vacuum forming in syringe

Replace the syringe cassette unit properly.

Connect the Input container properly.

Refer to Section 5 - Operation

Fluid seen dispensed back to input container instead of output container

Replace the syringe cassette unit properly.

Connect the Input and Output containers properly.

Refer to Section 5 - Operation

Operator Tablet Software Interface unable to connect the Syringe Pump Modulet

Refer to 5.1 Powering On the Devices section.

Pharmacist Tablet Software Interface unable to connect the Syringe Pump Module

Refer to 5.1 Powering On the Devices section.


Appendix C: Pairing Printer

Configuring a new Printer (Operator and Remote Tablets)

This section assumes the customer has ordered a replacement printer or additional printer and wishes to configure it for their system.

Configuring a new USB only printer

If the customer wishes to have their new printer made exclusively for one particular tablet, follow the instructions below:

1. Power on the printer and connect the printer to the tablet via USB.

2. In Windows, Go to Settings and on the Printers & Scanners section and make sure ZDesigner GX420t is listed as shown below, otherwise follow the steps in Printer Driver Instructions section, then return and proceed

3. After identifying that the printer is listed by Windows, select it to be your default printer. In addition, turn off the option of letting Windows manage my default printer.

4. To customize the dimensions of the printer label, look at the Printer Label Preferences

section.

Configuring a new Wi-Fi printer.

If the customer wishes to have their new printer be part of the wi-fi network, follow the instructions below:

1. Power on the printer and connect the printer to the tablet via USB. Even though we wish to configure the printer with wi-fi capability, the configuration must be done via USB.


2. In Windows, open the Zebra Setup Utilities application as shown below.

NOTE: If the ZDesigner printer is not listed, follow the steps in Printer Driver Instructions section, then return and proceed.

3. Select The Printer, then select the Configure Printer Connectivity option.

4. Select Wireless option and click Next.

5. Select DHCP.


6. In the following section, one must know the network ID that the rest of the system is configured too. In the following example, our system is already configured on D15, so we will Enter ESSID (SPM ESSID value [Example: D15]) and security mode is set to WPA-PSK/WPA2-PSK and click Next.

7. Unless the SPM password was changed, the default should be abcd1234 as the example shown below.

8. Click Next on Advanced wireless settings screen.


9. Click Next on Final stream screen.

10. Select Printer option and click Finish.

11. The printer should re initialize. After a few moments, the dashboard of the printer, shown below, should say Printer Ready and list an appropriate Signal Strength between 0-100, depending on the wi-fi signal. If the dashboard does not say either of these attributes, then it is not connected to the wi-fi of the network and the process must be repeated.

12. Once the printer is successfully on the wi-fi network, you may unplug the USB cable, it is no longer needed.


13. Launch the Diana Operator UI (Operator Tablet) or Diana Remote UI (Pharmacist Tablet).

14. Follow Section 6.2.1. Printers Settings to add printer to the UI.

15. Close the Diana UI.

16. Reboot the printer.

17. The printer should not be configured as a wi-fi printer for the application.

Printer Driver Instructions

This section is about adding the printer to Windows when it is not automatically detected.

1. Power on the printer and connect the printer to the tablet via USB.

2. In Windows, go to Settings and on the Printers & Scanners section as shown and click on Add a printer or scanner.

3. If the System fails to find an appropriate printer, click on The printer that I want isn’t listed.

4. On the Find a printer by other options window select Add a local printer or network printer with manual settings option and click Next button.


5. On the Choose a printer port window select Use an existing port option and select USB option form the list and click Next as shown below.

6. Select ZDesigner for Manufacturer and ZDesigner GX420t for Printers and click Next button.

7. Enter ZDesigner GX420t for printer name and click Next button.


8. Click Next button on Printer Sharing screen

9. Click Finish.

10. Go to Settings and on the Printers & scanners section make sure ZDesigner GX420t is listed.


Appendix D: Software Update Process 1. Both Operator and Pharmacist Tablets

1. Open the remote application from the Pharmacist Tablet.2. Open the operator application from the Operator Tablet.3. On the Pharmacist Tablet, insert the USB flash drive that has the software/firmware

update information.4. The system notifies the user the software update is ready to install on the tablets.

5. Tap the Continue button to start the upgrade process.

6. The system completes the upgrade process and closes the Remote UI and notifies the user with a message.


7. On all the Operator tablets, the system automatically detects the software upgrade process.

8. Tap Continue button to initiate the upgrade process.

9. The system completes the upgrade process and closes the Operator UI and notifies the user with a message.

10. Tap OK button.11. Restart the SPM.12. Restart the GUI on all Operator Tablets.13. Restart the GUI on the Pharmacist (Remote) tablet.14. From the Operator Tablet, select the About This System option from the Settings screen.15. Confirm the version information is updated.16. From the Operator Tablets, select the About This System option from the Settings screen.17. Confirm the version information is updated.


2. Operator tablet only

1. Open the operator application from the Operator Tablet.

2. On the Operator Tablet, insert the USB flash drive that has the software/firmware update information.

3. The system notifies the user the software update is ready to install on the tablets.

4. Tap the Continue button to start the upgrade process.

5. The system completes the upgrade process and closes the Operator UI and notifies the user with a message.

6. Tap OK button.

7. Reboot the SPM.

8. Restart the GUI on Operator Tablet.

9. From the Operator Tablet, select the About This System option from the Settings screen.

10. Confirm the version information is updated.


Appendix E: Accuracy Verification Protocol

1. Use 10mL input containers for this test.

2. Use 100mL output IV bag for this test.

3. Use new syringe cassette unit.

4. Place the empty output IV bag on scale.

5. Tare scale with empty IV bag (scale resolution should be to 0.000g)

6. Turn ON Diana Compounder.

7. Launch Operator Software UI.

8. Use the Water for Drug Name.

9. Perform a delivery of 5mL.

10. After dispensing is complete disconnect output IV bag.

11. Weigh the disconnected IV bag on previously tarred scale and record new weight.

12. Divide weight by 1 g/mL (density of water) to convert grams to mL’s.

13. Record mL’s after calculating density conversion.

14. Calculate % error.

Calculate % error = Measured Fluid dispensed mL’s – Programmed volume mL’s / Programmed volume mL’s * 100

15. Repeat 3 tests for 5 mL.

16. Repeat 4 tests for 10 mL and 20 mL (Use 100mL input containers for this test).


Appendix F: Database Update Process

The several data bases that are used by the Diana Hazardous Drug Compounding System can be updated by a process similar to the software update process. Unlike the software update process, the user must insert the USB flash drive that contains the database update package into each and every tablet.

1. If on the remote tablet, open the remote GUI. If on the operator tablet, open the operator GUI.

2. Insert the USB flash drive containing the database update package in the root of the flash drive into the USB port on the side of the tablet.

3. If the update package is correctly formatted, the screen shown below will appear.

4. Select Continue to commence the update process. A process screen will appear.

5. Upon completion of the update, the GUI will close.

6. Restart the GUI.


Appendix G: Creating and Running a Reconstitution Protocol

Several things must be done one time before a reconstitution protocol can be performed. First a reconstitution protocol must be created. A protocol defines the resulting drug and concentration after reconstitution and the diluent and amount to use. This reconstitution protocol can then be associated with one or more drugs through their Drug Identifier (usually an NDC).

1. Reconstitution Protocol Creation

1. Open the remote application from the Pharmacist Tablet.

2. Choose Create Drug option from the settings. The screen below displays.

3. Enter the information on the Create Drug screen. The information entered here is for example purpose only. Follow the hospital provided information.

Drug Identifier: 0069-3859-10-Rec_UD (_UD appends automatically)Drug Name: GEMCITABINE HYDROCHLORIDEMass: 38Mass Unit: mgVolume: 1Volume Unit: mL


Leave the other values as default values. See the picture below.

4. Tap the Save button.

5. Choose Edit Drug option from the settings. The screen below displays.

6. Enter 0069-3859-10 for the NDC and tap Edit Drug button. The screen below displays.


7. Tap Right Arrow for the Reconstitution Protocol option. The screen below displays.

8. Tap Add Reconstitution Protocol button. The screen below displays.

9. Enter the information on the Add Reconstitution Protocol screen. The information entered here is for example purpose only. Follow the hospital provided information.

Protocol Name: SODIUM CHLORIDEDiluent Compound: SODIUM CHLORIDE – 0.9 g/100 mLDiluent Volume: 50Reconstituted Drug’s NDC: 0069-3859-10_UDReconstituted Drug’s Expiration Time: 1 day 0 Hours 0 Minutes


10. Tap the Save button. The screen below displays.

11. Tap the Back button and tap the Save button on the Edit Drug screen. The remote application sends this information to operator application as a notifications.

12. Open the operator application from the Operator Tablet. The notification icon displayed.


13. Tap the notification icon. The screen below displays. Close the notifications screen.

2. Running Reconstitution Protocol

1. On the Operator application, select the connected SPM and scan the reconstitution protocol barcode.

Note: The reconstitution barcode is provided by the hospital. Example picture below.

2. Once the reconstitution protocol barcode scanned, the following screen displays to user to check the reconstitution protocol information.


3. If the reconstitution information is wrong, tap the Cancel button. System display the order screen.

4. If the reconstitution information is correct, tap OK button. The screen below displays.

5. Enter the Drug NDC details and Diluent NDC details and capture the input vial pictures.

6. Once all the information entered the Start button displays to start the reconstitution drug transfer process.

7. Tap the Start button to initiate the transfer process. The screens below displays during the transfer process.


8. Once the transfer process completes the system displays the verification screen to the user to confirm the transfer process. See the picture below.

9. On the verification screen tap the Accept or Reject button.

10. System prints the label as shown below .

11. User places the printed label on the Input Vial for future scans of NDC details.

12. When user scans the printed 2D barcode, the system puts the NDC details on the Order screen.


Appendix H: Special Output Container Identification and Selection

The Diana Hazardous Drug Compounding System supports quick removal of air and filling of CADD cassettes. In order to fill CADD cassettes, the drug’s to be put in CADDs must first be identified. This identification process is done through the Editing Drug tool..

1. CADD Cassette

1. On the Operator application, select the connected SPM and enter the order information. Once all the information entered on the Order Screen the screen below displays.

Note: Here we are using FLUOROURACIL—50 mg/1 mL

2. Select the appropriate patient container depending on the volume entered in the Order Screen. In this example 50 mL CADD Cassette selected.

3. Capture the input vial, output container pictures. System display the order screen.


4. Tap the Start button. First the system removes the air from the output container. Once the air removal process completes, the system transfers the drug from the input vial to output container.

5. Once the transfer process completes the system displays the verification screen to the user to confirm the transfer process. See the picture below.

6. On the verification screen tap the Accept or Reject button.


Appendix I: Specialty Substances List

1. The following list of substances that require remote validation

ABCIXIMAB ADO-TRASTUZUMAB EMTANSINE

ALEMTUZUMAB AZACITIDINE BASILIXIMAB

BELIMUMAB BENDAMUSTINE HYDROCHLORIDE

BEVACIZUMAB BLEOMYCIN SULFATE

BORTEZOMIB

BRENTUXIMAB VEDOTIN

CARBOPLATIN CARFILZOMIB CETUXIMAB CISPLATIN

CYCLOPHOSPHAMIDE CYTARABINE DACARBAZINE DACTINOMYCIN DAPTOMYCIN

DARATUMUMAB DECITABINE DINUTUXIMAB DOCETAXEL DOCETAXEL ANHYDROUS

DOXORUBICIN HYDROCHLORIDE

ECULIZUMAB ELOTUZUMAB EPIRUBICIN HYDROCHLORIDE

ERIBULIN MESYLATE

ETOPOSIDE ETOPOSIDE PHOSPHATE

FLUDARABINE PHOSPHATE

FLUOROURACIL GEMCITABINE HYDROCHLORIDE

GOLIMUMAB IDARUBICIN HYDROCHLORIDE

IDARUCIZUMAB IFOSFAMIDE INFLIXIMAB, LICENSE HOLDER UNSPECIFIED

IPILIMUMAB IRINOTECAN HYDROCHLORIDE

MELPHALAN HYDROCHLORIDE

METHOTREXATE METHOTREXATE SODIUM

MITOMYCIN MITOXANTRONE HYDROCHLORIDE

NATALIZUMAB NECITUMUMAB NELARABINE

NIVOLUMAB OBILTOXAXIMAB OBINUTUZUMAB OFATUMUMAB OXALIPLATIN

PACLITAXEL PANITUMUMAB PEGASPARGASE PEMBROLIZUMAB PEMETREXED DISODIUM HEPTAHYDRATE

PERTUZUMAB RAMUCIRUMAB RAXIBACUMAB RESLIZUMAB RITUXIMAB

SILTUXIMAB STREPTOZOCIN TOCILIZUMAB TOPOTECAN HYDROCHLORIDE

VEDOLIZUMAB

VINBLASTINE SULFATE VINCRISTINE SULFATE

VINORELBINE VINORELBINE TARTRATE

2. The following list of substances that requires use of a CADD cassette.

● FLUOROURACIL


Appendix J: Barcode Scanner Configuration (Operator Tablet Only)

1.1 Connect the Barcode Scanner into the Operator Tablet.

1.2 Scan the Set Factory Defaults barcode and wait for default install to complete

1.3. Place the scanner back into the docking station and wait 10 seconds after it beeps.

1.4. Pick up scanner and scan Symbol Native API (SNAPI) with Imaging Interface barcode. Wait 10 seconds.

1.5. Scan the below setup barcodes in sequence and wait for couple of seconds for the scanner to register the barcodes.


1.6. Restart the tablet.


DF-4941-EN Rev 06 (11/19)

Specification Sheet Diana, System Operating Manual...5 Diana Hazardous Drug Compounding System, ICU...

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