Diana™ Compounding Workflow System
User Manual
DS2900

IFU0000481 (01, 2022-10)

For use with Release V3.0

Diana™

Compounding Workflow System

Contents
1.

Introduction ............................................................................................................................7
1.1

Intended Use ................................................................................................................................. 7

1.2

General Guidelines ........................................................................................................................ 7

1.3

Important Safety Precautions ........................................................................................................ 7

1.4

Glossary of Symbols .................................................................................................................... 10

1.5

List of Symbols Used on the Operator and/or Pharmacist User Interface ................................... 12

1.6

Replaceable Parts ........................................................................................................................ 15
General Operation Information .............................................................................................16

2.
2.1.

Implementation and Maintenance .............................................................................................. 16

2.2.

Environmental Specifications ...................................................................................................... 16

2.3.

Performance Specifications ......................................................................................................... 16
Diana Compounding Workflow System Overview ...................................................................18

3.
3.1.

Components of the Diana Compounding Workflow System ........................................................ 18

3.2.

Views of the Diana Syringe Pump ................................................................................................ 20

3.3.

Operator and Pharmacy Tablet .................................................................................................... 22

3.4.

Bag Tray Assembly Instructions ................................................................................................... 23

3.5.

Tablet Stand Kit Assembly Instructions ....................................................................................... 27

3.6.

Diana Cassette............................................................................................................................. 30

3.6.1. Cassette Installation .................................................................................................................... 31
3.7.

Compatible Input and Output Connections ................................................................................. 35

3.8.

SurfaceGo™ Tablets Settings ...................................................................................................... 35
Operation .............................................................................................................................36

4.
4.1.

Powering On the Devices............................................................................................................. 36

4.1.1.

Powering ON the Diana Syringe Pump .............................................................................. 36

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4.1.2.

First Time Use of the Operator Tablet ............................................................................... 37

4.1.3.

First Time Use of the Pharmacist Tablet ........................................................................... 43

4.1.4 Sessions on Operator and Pharmacist Tablet Applications .................................................. 44
4.2.

Shutting Down the components of the Diana Compounding Workflow System.......................... 48

4.2.1.

Powering OFF the Diana Syringe Pump ............................................................................. 48

4.2.2.

Powering OFF the Tablets .................................................................................................. 49

4.3.

Workflow of the System ............................................................................................................. 51

4.3.1.

Manual Workflow................................................................................................................ 51

4.3.2.

Automated Workflow.......................................................................................................... 62

4.3.3.

Validating a Transfer .......................................................................................................... 80

4.3.4.

Replacing the Empty Input Container ............................................................................... 87

4.3.5.

Interrupt Dispensing Process Using Stop ......................................................................... 94

4.3.6.

Resume After Stop.............................................................................................................. 95

4.3.7.

Cancel/Finalize the Delivery Process ................................................................................ 96

4.3.8.

Quit the Delivery Process ................................................................................................... 97

4.3.9.

The Virtual Keyboard........................................................................................................ 100

Tool Settings ...................................................................................................................... 101

5.
5.1.

Label Printer Setting .................................................................................................................. 103

5.2.

About This System Setting ......................................................................................................... 103

5.3.

Operator Tablets Setting............................................................................................................ 105

5.3.1.

Add New Operator Tablet ................................................................................................ 105

5.3.2.

Replace Existing Operator Tablet .................................................................................... 108

5.3.3.

Remove Operator Tablet .................................................................................................. 111

5.4.

Diana Syringe Pumps Setting .................................................................................................... 112

5.5.

Drugs Setting ............................................................................................................................. 113

5.5.1.

Create Drug ....................................................................................................................... 113

5.5.2.

Edit Drug ........................................................................................................................... 128

5.5.3.

Disable Drug ..................................................................................................................... 130

5.5.4.

Delete Drug ....................................................................................................................... 130

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5.6.

Ingredient CADD And Pharmacist Validation Setting ................................................................. 132

5.7.

Review Complete Preparations and Review Active Preparations Setting .................................. 136

5.8.

Export Report Setting................................................................................................................. 137

5.9.

Export Logs Setting.................................................................................................................... 140

5.10.

Ingredient Viscosity Setting ....................................................................................................... 141

5.11.

Manage Drug Volume Bounds Setting ...................................................................................... 146

5.12.

Manage Users Setting ............................................................................................................... 147

5.12.1.

Add New User ................................................................................................................... 147

5.12.2.

Edit Existing User ............................................................................................................. 150

5.12.3.

Disable or Enable User or Reset Password ..................................................................... 152

5.13.

Change Password Setting .......................................................................................................... 153

5.14.

Import SSL Certificates .............................................................................................................. 155

5.15.

System Settings Setting ............................................................................................................. 155

5.15.1.

Photo Display Time in Seconds ....................................................................................... 156

5.15.2.

Drug Server IP Address .................................................................................................... 158

5.15.3.

Camera Usage .................................................................................................................. 158

5.15.4.

Print Labels ....................................................................................................................... 159

5.15.5.

Require Container Picture ................................................................................................ 160

5.15.6.

Validate All Images .......................................................................................................... 161

5.15.7.

Session Timeout In Minutes ............................................................................................ 162

5.15.8.

Export Configuration Files ............................................................................................... 164

Warranty and Service Information ....................................................................................... 165

6.
6.1.

Limited Warranty ....................................................................................................................... 165

6.2.

Service and Contact Information ............................................................................................... 167

Appendix A: Cleaning and Disinfection of the Diana Automated Compounding System .................. 168
Appendix B: Troubleshooting and Maintenance ............................................................................. 170
Fuse Replacement ................................................................................................................................. 176
Appendix C: Accuracy Verification Protocol .................................................................................... 178
Appendix D: Making a Reconstituted Drug ..................................................................................... 179
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1.

Adding Reconstitution Protocol to a Drug ................................................................................. 179

2.

Making a Reconstitution Drug ................................................................................................... 184

Appendix E: Special Output Container Identification and Selection ................................................ 193
1.

CADD Cassette ........................................................................................................................... 193

Appendix F: Specialty Substances List ........................................................................................... 201

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Change History
Part Number
IFU0000481(01,2022-10)

Description of Change
Initial Release

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1. Introduction
1.1

Intended Use

The Diana™ Compounding Workflow System is a modular system which includes the Diana™ Syringe
Pump (SPM). The SPM is intended to be used in a healthcare facility or approved 503B outsourcing
facility. Use is to be supervised by a pharmacist and performed by pharmacy technicians trained in sterilecompounding and the use of the system to dispense a specified quantity of hazardous and nonhazardous drugs from a set of source containers into a destination container or containers.
The SPM device is supplied in a calibrated condition. Servicing must only be performed by ICU Medical or
its authorized agents.
Note: The system is NOT intended to screen, monitor, treat, diagnose, or prevent any specificcondition or disease
Note: The system has no patient contact.

1.2

General Guidelines
Intended users/operators of the system are pharmacists and pharmacy technicians. The user
must be properly trained in the use of the system. Please follow the information contained in thismanual as a self-paced training guide prior to operating the unit for the first time. Refer to thismanual as a reference guide on an as-needed basis. Users should have the ability to read andunderstand English, and should have reading vision of 20/32 or better
The pharmacist or pharmacy technician must wear Personal Protective Equipment (PPE) when
operating the system and adhere to facility protocols and standards for operating compounding
equipment.
Always follow published guidelines relating to work protection and accident prevention andensure professional diligence at all times.

1.3

Important Safety Precautions•

Read this User Manual carefully before using the Diana Syringe Pump System.

•

DO NOT connect the unit directly to humans or animals.

•

The Diana Syringe Pump System is designed for use in laminar airflow boxes, biological safetycabinets, gloveboxes, laminar airflow hoods and/or safety work benches in clean rooms.

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Hazardous drug preparation should only be performed in containment primary engineering
controls such as biological safety cabinets.
•

The Diana Syringe Pump System should be installed in HIPAA compliant facilities.

•

No modifications to the Diana Syringe Pump System are allowed. Do not modify in any way,otherwise there is a possibility of operator injury, impairment or damage to the unit.

•

The Diana Syringe Pump 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 the unit is damaged during operation, switch off immediately and disconnect from the power
supply.

•If the Diana Syringe Pump System has observable sharp edges, contact an ICU Medical
representative immediately.

•

Do not place the Diana Syringe Pump on an unstable surface.

•

Place the system components (including the syringe pump, tablets, printer, and scanner) on alevel, clean, dry surface. Ensure space between components to allow appropriate air flow.

•

The Bag Tray Assembly is designed to hold only one output container at a time.

•

Do not use the Compounding System if enclosure is cracked or otherwise compromised.

•

To avoid the potential for cross contamination between drugs, replace the Diana Cassette when a
new medication is to be compounded. Also replace the Diana Cassette if the same Cassette has
been installed on the machine for 24 hours.

•

When using the Diana Syringe Pump System for reconstituting vials, care should be taken to
ensure the vials remain upright at all times and ensure vials are not over-pressurized prior toconnecting to the Syringe Pump.
The Diana system does not measure the total volume of the output container , therefore the user
is responsible to ensure that final volume of fluid in the output container after transfer will bewithin the volume range deemed acceptable by the output container manufacturer.
If using a length of tubing between the outlet of the Diana Cassette outlet and the output
container, the tubing must be primed prior to connection to the Diana Cassette on the Syringe
Pump
The Diana system only requires the user to input year and month of the drug expiration. DO NOT
rely on the Diana system to warn users about drugs that expire prior to the end of the expiration
month (example: July 2022 = July 31, 2022).
The System should only be used with the manufacture-provided power cord (ICU Kit Number
DS1902 , ICU Part Number: 826-11518-403).

•

•

•

•
•

If power cord is damaged, stop using the system and unplug the cord from the power source.

•

The Diana Syringe Pump System should only be connected to a properly grounded electricalsupply outlet.

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Avoid routing the power cord across the floor where it can create a tripping hazard.

•

Position the Diana Syringe Pump to provide easy access to its power plug (so that it can be
disconnected from electrical supply in the event of an emergency).

•

DO NOT use the Diana Cassette set if the sterile packaging has signs of damage. If the Diana
Cassette’s sterile packaging is damaged, replace it with a new one and discard the damaged one.

•

Replace Diana Cassette after 10 preparations.

•

Note: Follow the Diana Cassette labeling instructions.

•

The maximum weight allowed on the bag tray or IV rod is 1.0kg (2.2lb).

•

When the Diana Syringe Pump System is installed below a vertical flow HEPA filter, the area below
the adjustable tray does not receive first air. Do not expose critical sites below the tray. Vial
stoppers and needle ports exposed below the tray should be disinfected before accessing.

•Transport the Diana Syringe Pump only by use of its handles.

•

At the end of service life, dispose of the syringe pump, accessories, and consumables bycontacting ICU Medical for further information.

•

During storage and use, avoid impacts and vibrations which could result in a malfunction of the
Diana Syringe Pump System.

•

Do not insert any body parts or foreign objects into the Diana Syringe Pump ports or openings.

•

The System is not suitable for use in mobile equipment such as an ambulance.

•

Avoid direct contact with liquids. If a spill occurs, quickly remove spilled liquids in accordancewith the facility protocol.

•

Follow facility procedures for the disposal of batteries, electronic components, Diana Cassettes,
tubing, and container bags.

•

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

•

All cleaning of the Diana Syringe Pump System should be performed according to the detailed
instructions in this manual.

•Service performed by persons other than ICU Medical or its authorized agents may cause thewarranty to be voided, at the discretion of ICU Medical.

•

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

•

Do not operate Compounding System in the presence of flammable substances, including
anesthetics.

•

Save the original Diana Syringe Pump System box and packaging. In the event that it needs to besent in for servicing, return the Diana Syringe Pump in its original packaging. If the original box
cannot be located, contact ICU Medical at 800-824-7890 and ask for a shipping box to beprovided.

Diana Compounding Workflow System, ICU Medical, Inc.

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•Portable and mobile RF communications equipment, such as cellular telephones, 2-way radios,Bluetooth™ devices, microwave ovens, in close proximity to the Diana Compounding Workflow
System may affect wireless and wired communications and/or the operation of the system.

•

External Radio Frequency Interference (RFI) or electromagnetic radiation may affect the safe
operation of the Diana Compounding Workflow System. Ensure it is not being affected byelectromagnetic interference from other devices being used in the vicinity of the Diana
Compounding Workflow System.

•

1.4

If hardware is not supplied by ICU Medical, we strongly recommend the use of virus checking
software on the web server hardware that will be designated to host the Diana Web Server
software and databases. However, we suggest you consider ignoring scanning directories where
the datafiles reside or to ignore MDF and LDF type files. Updates or changes to the antivirus
software after installation could affect the Diana Web Server application’s performance. Pleasecontact the ICU Medical Technical Support Center for information or assistance.

Glossary of Symbols
SymbolReference

Description

ISO 7010 M002

Follow Instructions For Use

IEC 60417-5032

Alternating Current

ISO 7010 W001

Generic Safety Warning

ISO 7010 W012

High Voltage Warning

ISO 7010 W024

Fingers and other body parts do not comeinto contact with moving parts

ISO 3864-2 Warning (Triangle)

Fingers and other body parts do not comeinto contact with moving parts

15223-1 Fourth edition 2021-07
Ref # 5.1.1

Manufacturer

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Symbol

Reference

Description

ISO 15223-1: 2016
Ref # 5.1.7

Serial Number

IEC 60417-5019

Connect an earth terminal to the groundIEC 60417 - 5534

Power plug

47CFR, FCC Part 15 Subpart B,
Class B

Compliant with FCC Class B limits

IEEE 802.11ac-2013

Device Contains an RF Transmitter

CSA 60601.1 IEC 60601-1 3rd
EditionCompliance, Safety, Accountability

15223-1 Fourth edition 2021-07
Ref # 5.1.2

Authorized European Representative

EN 60529: 2018

Protected from limited dust ingress &Protected from water spray less than 60
degrees from vertical.

Directive 2012 / 19 / EU

Waste Electrical and Electronic Equipment
Directive

ISO 15223-1: 2016
Ref # 5.3.7

Temperature limitation

ISO 15223-1: 2016
Ref # 5.3.8

Humidity limitation

UN3481

Packaging Label for Lithium Battery

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Symbol

Reference
ISO 15223-1: 2016
Ref # 5.4.2

1.5

Description
Single use item marked

List of Symbols Used on the Operator and/or Pharmacist User Interface
SymbolDescription
ICU Medical Logo. The user can tap the logo toaccess closing the application.

Manual Tab when the tab is selected and is notselected.

Automated Tab when the tab is selected and is
not selected.

Syringe Cassette is not connected to the
Syringe Pump. Blinking icon means connect
the Syringe Cassette to the Syringe Pump when
the order is ready for processing.
Input Vial is not connected to the Syringe
Pump. Blinking icon means connect the Input
Vial to the Syringe Pump when the order isready for processing.
Output Container is not connected to the
Syringe Pump. Blinking icon means connect
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Symbol

Description
the Output Container to the Syringe Pump
when the order is ready for processing.

Barcode Scanner is not connected.

Label Printer is not connected.
Operator lost communication to the Web
Server.
SPM camera is not working.
Logged In User. The user may press this icon
to logout from the UI.
Setting Icon. User may press this icon to accessthe configured settings of the application.
User may press this photo button to take apicture using the tablet camera or connectedbarcode scanner.
The user may press this icon to delete thecaptured picture.
Pop-up for the user to edit or delete theinformation.
Automated tab when the Syringe Pump is
performing the delivery. (“12340006”
represents the Syringe Pump Serial Number)
Automated tab when the Syringe Pump is
stopped during the delivery.
Automated tab when the Syringe Pump has
encountered an unrecoverable error.
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Symbol

Description
Automated tab when the Syringe Pump is notconnected to the system.
Automated tab when the Syringe Pump isrebooted.
Order is waiting on the Operator application for
the Pharmacist to validate the completed
preparation.
Displaying amount of liquid Delivered andSpecified for the order on the
Verification/Validation screen.

f

Displaying the Order on the Pharmacist Tablet
for validation.

Signature screens for the pharmacist when
accepting the preparation.

Navigate Ascending/Descending lists up anddown.
Navigate Ascending/Descending lists up anddown.
Action icon to access the setting in the setting
screen.
Down arrow to select an option/value from thelist.

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Symbol

Description

Select or Deselect an option.

User may press this button to add/show thereconstitution protocol information on the Drug
screen.

1.6

Replaceable Parts

Part Name
Diana Compounding Workflow System

ICU Part Number
DS2900

Diana Syringe Pump

DS2000

Diana Workflow Management System

DS2100

Diana Workflow Management Software

DS2110

Diana Operator Tablet

DS2120

Diana Pharmacist Tablet

DS2130

Diana Tablet Stand Kit

DS2140

Diana Tablet Case

DS2141

Diana Tablet StandDS2142

Diana USB Bar Code Scanner Kit
Diana USB Bar Code ScannerDS2150DS2151

Diana USB C to USB A Adapter

DS2152

Diana USB Bar Code Scanner Cable

DS2153

Diana Wi-Fi Printer Kit
Label Printer Paper Roll (Case)

DS2160
DS2161

Diana Webserver

DS2810

Diana Router

DS2820

Diana Power Cord

DS2010

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2. General Operation Information
2.1. Implementation and Maintenance
NOTE: All software and hardware iImplementation should be performed by an authorized ICU Medical
representative or authorized agent. All maintenance work shall be completed by the manufacturer withthe exception of routine cleaning (See Appendix A for details).

2.2. Environmental Specifications
Operating Temperature+10°C to +40°C (50°F to 104°F)

Operating Humidity

0% to 60% (Non-condensing)Operating Altitude

0 to 2000 meters (6562 feet) above sea level

Operating Light

30 to 1600 Lux

Storage Temperature

0°C to +60°C (32°F to 140°F)

Storage Humidity

0% to 90% (Non-condensing)

Storage Altitude

0 to 2000 meters (6562 feet) above sea level

Transportation Temperature

0°C to +60°C (32°F to 140°F)

Transportation Altitude

0 to 5000 meters (16405 feet) above sea level

Transportation Humidity

0% to 60% (Non-condensing)

Dimensions

21 x 34 x 25 (cm)8.27 x 13.38 x 9.84 (inch)

Weight5.6 kg (12.3 lbs)

Electrical Operating Power Range

100 – 240 V~
0.8 – 0.4 A
50 – 60 Hz

Electrical Fuse

Note: Operate the unit within the environmental specifications listed in the above table to ensure proper
operation.

2.3. Performance Specifications
Minimum Fluid Delivery Volume

1 mL

Maximum Fluid Delivery Volume

1000 mL

Delivered Volume Accuracy of water from 5ml to 1000ml+- 5%

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Note: Fluid viscosity can affect system accuracy, see section 5.10 for details on making system
adjustments to account for fluid viscosity

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3. Diana Compounding Workflow System Overview
3.1.

Components of the Diana Compounding Workflow System

The Diana Compounding Workflow System consists of multiple components that can communicate over a
Wi-Fi network. The components are:• Syringe Pump
• Operator Tablet• Pharmacist Tablet• Web Server• Bar Code Scanner• Printer
Additional Operator Tablets and Syringe Pumps can be added to the system to ensure that each facility has
the right mix of hardware to fit their needs. Up to three Syringe Pumps can be configured to the same
Operator Tablet. One Pharmacist Tablet can be associated with up to three Operator Tablets. Shown below
is a system diagram of the Diana Compounding Workflow System.

Term

Definition

Order Data

Data that describe the preparation to be compounded; e.g., order number, drug id,
drug volume, etc.

Compounding Data

Data that describe the status and record of the compounding process; e.g., NDC,
timestamps, approvals, etc.

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Term

Definition

Machine Data

Specific commands and parameters the Syringe Pump uses; e.g., carriage pushingand pulling speeds, transfer volumes, start and stop commands, sensor status, etc.

PhotosPhotographs. Images captured by the Scanner, Operator Tablet, and/or Syringe
Pump.

Component

Description

Syringe Pump

The component of the system that accepts commands that transfer fluid from the
input container to the output container.

Operator Tablet

A tablet that has a software user interface running on Windows 10 OS, which
provides the primary mechanism to the user (typically a pharmacy technician) tocontrol the Diana Syringe Pump. A user can input order and drug information; initiate
and verify a transfer; and print a label.

Pharmacist Tablet

A tablet that has a software user interface running on Windows 10 OS, which
provides the user (typically a pharmacist) a way to validate the transferred orderpreparation. A user can review order, drug, and preparation information, and print averification label.

Web Server

An essential component in the Diana ecosystem. It serves as the mediator between
the remote SQL Server databases and the other components that require access todata, i.e. the Diana Syringe Pump, Operator, and Pharmacist software.

Bar Code Scanner

The scanner is tethered to the Operator Tablet to scan bar codes on input drug vials
and take pictures, which increases the efficiency and accuracy of data being enteredinto the Diana System.

Printer

A component that is connected through wireless communication to the system thatprints 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.
Note: Due to size limitations of the printed labels, labels printed for preparations
that use 14 or more unique vials in a single preparation may have missing
information on the label. Printed label information is for reference only.

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3.2.

Views of the Diana Syringe Pump

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Item #

Component

Definition/Explanation

1.

Input Container

Typically a drug vial or IV bag. The input container is a fluid source with acompatible 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

The Diana Syringe Pump is on and is currently selected by the Operator
Software user interface.

BLUE

The Diana Syringe Pump is powered on and is not selected by the Operator
Software user interface

3.

Output Container

Typically an IV bag, CADD Cassette, empty sterile container, or vials. 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

Detects the presence of air or fluid in the fluid path of the Diana Cassette.

5.

Camera Window

A clear window that provides a transparent barrier for the Diana Camera tohave a clear view of the Diana Cassette.

6.

Syringe Driver Pins

Used to hold the Diana Cassette in place during a transfer.

7.

Syringe Driver

A movable holder that is calibrated to the Diana Cassette. Upon initiation ofa 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 throughmultiple transfers until the desired volume is reached.

8.

Diana Cassette

Diana Cassette.

9.

Bag Holder

A tray on which the output container rests before, during, and after atransfer. The holder must be attached to the left cleat (as shown in the

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pictures above, Item 16). The tray has three positions available depending on
the output container/adapter combination and operator preference. The Bag
Holder can be used either with a Pin or IV Rod configuration. In the case of
the IV Rod use, it can be adjusted up or down according to the IV bag size
used.

3.3.

10.

HandleHandles used to lift and move the Diana Syringe Pump.

11.

Syringe Carriage

The main connection point of the Diana Cassette to the Diana Syringe Pump.
It is vital to ensure the Diana Cassette is properly seated in the syringe
carriage.

12.

Power Plug

Used to connect the Diana Syringe Pump using the provided power cord.

13.

Back Panel Label

Provides an indication of regulatory compliance. Provides details likemanufacturer address, model number, IP53 rating, voltage rating, and serial
number.

14.

Power Switch

Used to turn the Diana Syringe Pump On or Off.

15.

Wireless Antenna

Used to enhance the communication of the Diana Syringe Pump to the othercomponents of the system.

16.

Cleat

Used to connect the bag holder to the Diana Syringe Pump.

Operator and Pharmacy Tablet

Item #

Component

Definition/Explanation

1.

Power Button

Used to turn the Operator/Pharmacist Tablets on and off.

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2.

Volume Buttons

Used to increase/decrease the tablet volume sound.

3.

Front Camera

Used to take additional pictures of labels, input containers, patient orders, orother aspects of the transfer that can be photographed.

4.

Studio Mics

Microphone to capture the sound.

5.

Headphone Jack

Input for the headsets, earphones or headphones.

6.

USB-C Port

Industry-standard connector for connecting USB Cables.

7.

Kickstand

Tablet Stand.

8.

Power Port

Used to connect the Tablet to a power cord.

9.

microSD Card Reader

microSD card reader for transferring data.

10.

Back Camera

Used to take additional pictures of labels, input containers, patient orders, orother aspects of the transfer that can be photographed.

3.4.

Bag Tray Assembly Instructions

The Diana Syringe Pump comes with a Bag Tray Assembly consisting of a bag tray that can be assembled
using either the provided Pin or Rod. The Rod may be used for holding the output containers during thetransfer process. The Bag Tray Assembly instructions are below.
1.

Remove the bag tray items from the box.

2.

Insert the Screw in the Tray Arm, do not tighten.

3.

Place the Tray Arm into the Hinge and insert either the Pin or the Rod in the hole. Note theorientation of the components. Light pressure on the Tray Arm, applied towards the Hinge, may
be required to assist the insertion. If using the Rod, the Screw may be tightened to help support
containers weiging more than 250 grams.

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4.

Connect the Bag Tray to the Syringe Pump, by attaching the bag tray Hinge to the left front cleat(see BLUE arrow below) by sliding the slot (see BLUE arrow below) in the Hinge over the cleat.

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5.

Push down on the Hinge until the cleat is no longer visible, this will seat the Hinge firmly on thecleat. To remove the hinge, tap from below and lift up.

6.

The Tray Arm can be swiveled in 3 positions.

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7.

To change the Pin with the Rod or vice versa, the Tray Arm has to be placed in a perpendicular
position and the screw loosened. Then the Pin must be pushed from below (blue arrow) andpush on the Tray Arm in the direction shown below (red arrow) to release the spring pressure
from internal retaining pins while pulling the Pin or the Rod out. While pushing on the Tray Arm
towards the Hinge (red arrow), pull the Pin or Rod up and out. For a better grip on the top of thePin, fist push the Pin up from below (blue arrow). Follow steps mentioned earlier to insert thedesired component.

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3.5.

Tablet Stand Kit Assembly Instructions

Tablets have an optional Tablet Stand Kit. The Tablet Stand Kit assembly instructions are below.
1.

The Tablet Stand Kit has these 3 components.

2.

Install the Case onto the tablet. See business.otterproducts.com/pro-pack for guidance, your case is a
Defender Series case.

3.

Attach the Gooseneck to the Suction Cup Base by screwing it into the cup's nut. Make it finger tight by hand
only.

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4.

Bend the Gooseneck so the square points toward the user and the arrows on the square are pointing up.

5.

On the back of the tablet case, there is a square frame that needs to be hooked on the top of the basesquare. Push the tablet down to lock (click) in place. The tablet can be rotated and attached on any side.

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6.

To attach the Suction cup to a surface, the orange plunger (See image in “1.” above) needs to be pushed a
few times until the suction cup adheres to it. To remove – pull one of the rubber tabs on the lip of thesuction cup.

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3.6.

Diana Cassette

Item #

Component

Definition/Explanation

1.

Input Port

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

2.

Output PortThe Output Port is a proprietary ICU Medical Connector that mates with aproprietary 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
Diana Syringe Pump 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 ispulling in and expelling fluid.

6.

Syringe Plunger

The Syringe Plunger can be pulled and pushed inside the Syringe Barrel to pullin and expel fluid.

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7.

Syringe
Graduated
Volume Markings

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

ICU Medical recommends that only compatible cassettes tested by the manufacturer be used forcompounding.
ICU Medical Part Number

Description

CL6000

Diana Cassette with Two Bonded ChemoLockTM

CL6000-5

Diana Cassette with Two Bonded ChemoLock™ Adaptors, 5 Units

3.6.1. Cassette Installation
3.6.1.1.

Make sure that the Diana Syringe Cassette package is not damaged. DO NOT use

the Diana Cassette set if the sterile packaging has signs of damage.

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3.6.1.2.

Open package and remove Diana Syringe Cassette. Make sure that the stop cockposition is angled half way between the two ChemoLock connectors (see image below). If thestop cock is not in the correct position or any other defect or damage is seen on the Diana Syringe
Cassette, do not use the cassette and dispose of it.

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3.6.1.3.

Slide the Syringe Cassette into the Diana Compounder making sure the Syringe

Cassette is securely in place. The bottom of the syringe piston should be placed into the bracket
at the bottom of the compounder during the installation process.

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3.6.1.4.

To Connect Drug Vial (Input Container) to Syringe Cassette: Invert vial containing

the Chemolock vial access device to the vertical Chemolock connector on the Syringe Cassette.
Note: The Diana compounder is designed to detect air bubbles in the fluid beingtransferred. If air is detected in the fluid, the Diana compounder will prompt the user to
use the reprime feature on the device to reprime the cassette. During the reprime
workflow, the Diana compounder will automatically reduce the pull speed of the Diana
compounder (to reduce the introduction of cavitation in the fluid). Use of input
containers or access devices with restrictive flow paths may cause cavitation, thus theuser may need to utilize the reprime function the cassette Diana compounder to reduce
the operating speed of the device. See section 6.3.4 for more information on reprime.
3.6.1.5.

To Connect Output Container to Syringe Cassette: Connect Output Container

containing the Chemolock spike to the horizontal Chemolock connector on the Syringe Cassette.

Note: After 10 preparations of the Diana Cassette, the Operator Tablet will display the below warning
message that can be cleared by replacing it with a new unused Diana Cassette.

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3.7.

Compatible Input and Output Connections

The Diana Syringe Cassette has integrated ChemoLock injectors for the input and output connection
locations. Only ICU Medical ChemoLock components should be used to attach the input and output
containers to the Diana Syringe Cassette.
System users should utilize the appropriate ChemoLock component based on the specifics of thetransfer they will be performing.

3.8.

SurfaceGo™ Tablets Settings

Refer to Microsoft SurfaceGo user manual for details about adjusting tablet settings
Latest user manual can be found at https://support.microsoft.com

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4. Operation
4.1.

Powering On the Devices
In order to communicate with all the components of the Diana system, the user must complete
these steps in the following order.
Note(s): Make sure the Wi-Fi Router is Powered ON and the Diana Web Service is running on
the Host Web Server System prior to turning on the Diana system components.

4.1.1. Powering ON the Diana Syringe Pump
1.

Power ON the Diana Syringe Pump using the Power Switch on the back panel.

2. During Power ON, Diana Syringe Pump LED indicators flash blue and green continuously for a few
seconds and then turn solid blue.

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4.1.2. First Time Use of the Operator Tablet
1.

Power on the Operator Tablet by pressing the tablet’s power button.

2. Operator Tablet automatically logs in to Diana User system account and displays the Operator
application Login page.
Note: If the below screen is not displayed, contact ICU Service personnel for assistance.

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3. Enter the User ID and Password values.
Note: Contact system administrator for the User credentials. See section 6.12 “Manage User
Settings” for details on how the system administrator can set-up User credentials.

Note: If the entered User ID and Password values are incorrect, the following message displays.
Contact system administrator if the user is unable to login with provided username and password.

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4. If the user is logging on to the system for the first time, the Operator application asks the user tochange the default password. Change the default password.
Note: Password values must consist of printable characters, cannot start or end with awhitespace character, and must contain at least one numeric character, one symbol character,and one upper-case text character. Password length must be between 8 and 21 characters.

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5. After the successful login the Order Entry Page for the Manual Tab of the XX is displayed.

Manual <Operator Tablet Serial Number> Tab: The user uses this tab to enter order information
to the system and manually transfers the drug from input vial to output container without using
the Diana syringe pump. The technician can use the Manual workflow without using the Diana
Syringe Pump. The example screen above shows the Manual Operator 021220701751.
Diana <Syringe Pump Serial Number> Tab: The user uses this tab to enter order information to
the system and uses the Diana Syringe Pump to transfer the drug from input vial to output
container. The example screen above shows the Diana 6 (“6” is the serial number for the Diana
Syringe Pump).

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6. To proceed to Syringe Pump Module initialization: Select the connected Diana <Syringe Pump
Serial Number> tab to display the Order Entry Page for the Diana Syringe Pump . The following
screen is displayed.

Note: Each time the Diana Syringe Pump is power cycled, if the user selected the Diana
Automated tab, the Operator tablet software displays an initialization message. If there aredisposables (Diana Cassette, input vial and/or output container) connected to the Diana Syringe
Pump, the following screen displays.

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If no disposables are connected the following screen displays. Remove the disposables if
connected. Press the OK button once all disposables are disconnected.

The system then initializes its moving parts to a home position. Once the initialization of the
Diana Syringe Pump is done, the Order Details screen will display (see screen below).

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4.1.3. First Time Use of the Pharmacist Tablet
1.

Power on the Pharmacist Tablet by pressing the tablet’s power button.

2. Pharmacist Tablet automatically login to Diana User system account and display the Pharmacist
application Login page.
Note: If the below screen is not displayed, contact ICU Service personnel for assistance.

3. Enter the User ID and Password values.

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4. Once login successful the Pharmacist application displays the Application Home Screen. (seebelow).

4.1.4 Sessions on Operator and Pharmacist Tablet Applications
By default, the sessions on the Operator and Pharmacist Tablet Application are set to require log
out and log back in every 48 hours. The user will automatically be logged out of the Operator andPharmacist Tablet Applications after 48 hours of use. After logging back into the application, theuser can continue using the system.

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Page 44The user can log out of the Application at any time during use by using the Log Out icon (circled in
red below).

The warning message below will be displayed on the Application screen 1-minute before
automatic log out. The system will automatically log out the user 1-minute after this message isdisplayed.

Note: If a preparation is in process when session log out is required, the SPM will pause thepreparation. Once the user logs back into the Operator Application, the user can continue thepreparation by pressing the Start icon on the Application.
The user can change the session timeout from 10 minutes to 2880 minutes. To change thesession timing, follow the steps below.
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1.

Click theicon in the upper right-hand corner of the Operator Or Pharmacist
Tablet Application. This will open the application settings screen.

2. Select “System Settings” (circled in RED below)

3. Use the touch screen on the tablet to scroll to the bottom of the page (swipe up
on the touch screen) to expose the entry box for “Session Timeout in Minutes”(circled in RED below)

4. Update the time to match your desired time. Minimum time 10 minutes,
maximum time 2880 minutes.

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5. Click the Save icon on the bottom of the tablet screen (circled in RED below)

6. For changes to take effect, please restart the Webserver first. Then close andreopen the Operator and Pharmacist Applications. And lastly, power cycle theSyringe Pump Unit.

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4.2.

Shutting Down the components of the Diana Compounding Workflow System

4.2.1. Powering OFF the Diana Syringe Pump
Power OFF the Diana Syringe Pump using the Power Switch on the back panel.

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4.2.2. Powering OFF the Tablets
When the Operator or Phamacist application is opened follow the instructions to shutdown the
Operator or Phamacist Tablet.
Make sure the user logged into the Operator or Pharmacist application. Tap on the Operator or
Pharmacist application icumedical logo (top left corner). Operator or Pharmacist application
displays the Close Program message to the user.

Operator Application Screen

Pharmacist Application Screen
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Tap Power Off button to power OFF the Operator tablet or tap Close to close the program without
powering off the tablet.

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4.3.

Workflow of the System

The Diana System provides the following workflows:

1. Manual Workflow
2. Automated Workflow
4.3.1. Manual Workflow
The Diana Operator Tablet user interface allows the user to add order preparation information
manually into the Diana Compounding System. The user then manually compounds the desired
medication(s) with the ordered amount and volume of medication(s) and diluent(s).
Note: This workflow can be used without the presence of a Diana Syringe Pump.
1.

Select the Manual tab.

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2. Tap on the Order Number text box and enter the Order Number.
Note: If the Order Number is not provided in the Patient Order Form, enter zero for the Order
Number.

Note: The down arrow key (circled in green below) can be pressed to minimize the keyboard and exit
this entry screen.
Note: The right side displayed drug list (circled in red below) is a list of recently used drugs. This list
will update as the user does preparations using the system.

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3. Next, tap the Drug Name text box. Use the on-screen keyboard to enter the drug name. As you typein the drug name, the software will automatically display the drug names in the system databasestarting with the typed letters. Once you find the drug name, select the drug by tapping the desired
drug. If the user does not find the desired drug in the drop down menu, please refer to section 5.5 ofthis manual for details about creating a new drug.
Note: The user can select the drug on the right side (blue background) displayed drug list.
Note: The drug name and concentrations are derived from the FDA database. Users must ensure they
select the correct drug from the list.

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

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5. Use the numeric keypad to enter the volume (mL) of the medication to be transferred and tap theonscreen Enter key.
The user may enter a value from 1 to 1000 mL. The system will accept
values with up to two decimal places (example: 25.55 mL).

6. The drug information entered will display on the Order screen.

Note: “Delete Vial Info” button will clear the entered information below the Drug Vial 1 heading
Note: “Delete All” button will clear the all information entered on the order entry page

7. Next, to enter the input drug information, Enter Drug Vial 1 information by tapping on the NDC text
box. The following screen displays for the user to select the desired NDC ID from the list. Selectavailable NDC ID. The software will automatically display the NDC IDs in the system database. If the
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user does not find the desired drug NDC in the drop down menu, please refer to section 5.5 of thismanual for details about creating a new drug.
Note: The user can use the connected barcode scanner to scan the NDC barcode from the input
vial. To scan the input barcode, focus on the input vial label barcode, then press and hold thescanner trigger button.

8. Tap on Lot Number text box. The following screen displays for the user to enter the lot number ofthe input vial. Lot number must be alpha-numeric and must be 20 characters or less.
Note: If there are previously added Lot Numbers for the selected NDC, the software automaticallydisplays a list of available Lot Numbers in the system for the user to select the Lot Number.

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9. Add Expiration Date: Tap on Month text box. The following screen displays for the user to enter the
Expiration Month of the input vial.

10. Tap on Year text box. The following screen displays for the user to enter the Expiration Year of the
input vial.
Note: If the user selects previously added Lot Number for the selected NDC, the software enters theMonth and Year values automatically. The user can change the Month and Year values.

11. Tap onscreen Enterbutton once the values are entered/selected.

12. The software automatically displays the Document the input container label screen to allow theuser to take a picture of the input container.
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Notes:a. The user must take a picture of the input container; otherwise, the software prevents thetransfer process.
Note: This feature can be disabled. Refer to the System Settings section.
b. To take a picture of the vial, a user may utilize the tablet camera or the barcode scanner. Take apicture 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 on the input vial label, and press Capture button.
d. To take a picture using the barcode scanner, focus on the input vial label, then press and holdthe scanner trigger button.

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

14. Tap the Close button.
Note: The zoomed-in picture will automatically close within the configured time (in seconds) if theuser does not tap the Close button. Refer to the System Settings section for setting up the Photo
Display Time in Seconds time.
15. The software displays the captured picture on the screen. To remove a picture, tap the Delete icon
next to the captured picture. Tap the OK button to save the picture(s).

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16. Added vial information is displayed on the screen. The user may add additional Vials to the order bypressing the Add Vial button (follow the above steps for Adding NDC information). Tap theComplete button.

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

18. The user may then withdraw the desired amount of fluid from the vial. Tap the Photo button tocapture the volume drawn to syringes.
19. Review the pictures on the verification screen by selecting the green check mark under each picture.
Note: The UI interface displays the Accept button only when all the pictures are reviewed by theuser. This feature can be disabled. Check in the System Settings section.
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Page 5920. Choose the Accept or Reject buttons to either accept or reject the manual order.

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

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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.

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

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Page 6125. If the user accepts the order, a label will print, which should immediately be placed on the output
container.

Note: Due to size limitations of the printed labels, labels printed for preparations that use 14 or moreunique vials in a single preparation may have missing information on the label. Printed label information
is for reference only.
26. Once the verification is done, the UI displays the Manual Order Details screen.

4.3.2. Automated Workflow
The Diana Operator application allows the user to transfer the fluid from the input vial to output
container by using the connected Diana Syringe Pump.
1.

Ensure the Operator application is communicating to the correct Diana Syringe Pump. Select the
Diana Syringe Pump.

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2. Tap on the Order Number text box and enter/select the information for Order Number, DrugName, and Volume.
Note: If the Order Number is not provided in the Patient Order Form, enter 0 (Zero) for the Order
Number.

3. Next, tap the Drug Name text box. Use the on-screen keyboard to enter the drug name. As you enter
the drug name, the software will automatically display the drug names starting with the typed letters.
Once you find the drug name, select the drug by tapping the desired drug.
Note: The user can select the drug on the right side displayed drug list.

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

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

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6. The information entered is displayed.

7. Tap on the NDC text box. The following screen allows the user to select the available NDC ID fromthe list. Select an available NDC ID.
Note: The user can use the connected barcode scanner to scan the NDC barcode from the input
vial.

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8. Tap on Lot Number text box. The following screen allows the user to enter the lot number of the
input vial.
Note: If there are previously added Lot Numbers for the selected NDC, the software automaticallydisplays a list of available Lot Numbers in the system for the user to select the Lot Number.

9. Tap on Month text box. The following screen allows the user to enter the Expiration Month of the
input vial.

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Page 6610. Tap on Year text box. The following screen allows the user to enter the Expiration Year of the input
vial.
Note: If the user selects a previously added Lot Number for the selected NDC, the software enters
the Month and Year values automatically. The user can change the Month and Year values.

11. Tap onscreen Enterbutton once the values are entered/selected.

12. The software automatically opens the Document the input container label screen to take thepicture of the input container.
Notes:
a. The user must take a picture of the input container; otherwise, the software prevents thetransfer process.
Note: This feature can be disabled. Check in the System Settings section.
b. To take a picture of the vial, a user may utilize the tablet camera or the barcode scanner. Takea 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 the tablet camera, focus on the input vial label and press the Capture
button.
d. To take a picture using the barcode scanner, focus on the input vial label, press and hold thescanner trigger button.

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Page 6713. The software captures the picture and displays zoomed-in mode for the user to verify the captured
picture is clear enough to see the content of the input vial.

14. Tap the Close button.
Note: The zoomed-in picture will automatically close within the configured time (in seconds) if theuser does not tap the Close button.

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Page 6815. The captured picture displays on the screen. To remove a picture, tap the Delete icon next to thecaptured picture. Tap the OK button to save the picture(s).

16. Added NDC information is displayed on the screen.
17. The software notifies (flashing Diana Cassette, input vial and output container icons on the toolbar) the user to connect the Diana Cassette, input vial, and output container to the Diana Syringe
Pump.

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18. Once the user connects the disposables to the Diana Syringe Pump, the following screen displays:

Note: 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.
Note: The Diana system does NOT monitor output container size, therefore the user is responsible
to ensure that volume of fluid delivered into the output container is within the volume range deemed
acceptable by the output container manufacturer
19. To initiate a transfer, tap the Start button. The Syringe Driver may draw a small volume of drug fromthe input vial and push it back into the input vial which will prime the disposables.

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20. Once the fluid path has been primed, the Diana Syringe Pump will then draw the desired amount of
fluid into the Diana Cassette. As the device is drawing fluid, the status bar (with a light blue color)on the Operator tablet will begin to fill. This provides a status to the user as to how far the transfer
is from being complete.

21. 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.
22. Once the automated drug transfer process is completed, the Diana software GUI presents averification screen to the user to accept or reject the transfer process.

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Page 7123. The Diana software provides the user the ability to zoom in on the pictures (to zoom in on the photo,tap the photo).

24. The user may take additional pictures by pressing the Photo button.

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25. Review the pictures on the verification screen by selecting the green check mark under each
picture.
Note: The UI interface displays the Accept button only when all the pictures are verified by theuser. This feature can be disabled. Check in the System Settings section.

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

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Page 7327. If the user rejects the transfer, the Diana software GUI presents a screen to the user to provide thereason for rejecting the transfer.

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Page 7428. Tap OK button on the Reason for Order Rejection screen.

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

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4.3.2.1.

Checking Drug Name for Verification
The Diana System software provides the ability to verify that the correct drug name has been entered
before a transfer can take place. Once the desired drug name has been entered, the Diana System
software will check the name of the drug against the list of drugs in the system database.
When the incorrect drug has been entered, an indication is displayed on the Operator application
requiring the user to enter new drug information.

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4.3.2.2.

Checking the Drug NDC for Verification
The Diana System software provides the ability to verify that the correct Drug NDC has been enteredor 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 format has been entered or scanned, the Operator application displays
a message to the user that the entered/scanned NDC is not a valid format.
Note: The Lot Number and Lot Expiration values also need to be entered prior to the operator
software verifying if the NDC information is correct or not.

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When the entered/scanned Drug NDC is in the correct format, but it is not associated with theentered Drug Name, the Operator application displays a New Drug screen for the user to add thedrug information. The User can create a new Drug NDC for the Drug Name or select the option tocancel the drug creation.

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4.3.2.3.

Checking the Lot Expiration Date for Verification
The Operator application provides the ability to verify that the correct Lot Expiration Date has beenentered before a transfer can take place. Once the Lot Expiration Date has been entered , theOperator application will check the entered Lot Expiration Date.
When an incorrect Lot Expiration Date or Expired Date has been entered, an indication is displayedon the Operator application, requiring the user to enter a new Lot Expiration Date.

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4.3.3. Validating a Transfer
The Diana System has a Pharmacist Application that runs on the Pharmacist Tablet, allows
preparations (manual or automated) to be validated by a pharmacy administrator. For the automatedtransfers the embedded camera inside the Diana Syringe Pump take pictures of the syringe in thepulled state before transferring into the output container and then send the transfer information alongwith the pictures of the transfer to the Operator Application. The Pharmacist Application will
download the preparation, which includes the pictures taken by the operator application and the
Diana Syringe Pump, and allows a pharmacist to verify the correct mixture took place without having
to enter the clean room environment.
Once a transfer for certain drugs has been completed from the Operator application, the Pharmacist
Application 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.

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4.3.3.1.
1.

Approving a Transfer

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

2. Review the information. Review each picture and tap the green check mark icon to approveeach picture.

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Page 813. When all the pictures have been reviewed, the Accept button will display.
Note: Displaying Accept button without validating the pictures can be possible when the
Validate All Images settings is set to Red (Disabled) in the System Settings.

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4. Touch the Accept button on the screen.

5. The software presents a Signature screen for the user to sign the transfer.

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6. Once the pharmacist approves the transfer, a label will print, which should immediately beplaced on the output container.

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4.3.3.2.

Rejecting a Transfer

1. Tap the transfer with the corresponding preparation order to be validated.
2. Review the information.
3. Tap the Reject icon on the screen.

4. The software presents a Reason for Order Rejection screen for the user to provide the reason.
Tap Reason area and enter the rejection reason. Tap on-screen Enter key and then tap OK
button.

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5. Once the pharmacist rejects the transfer, a label will print, which should immediately be placedon the output container.

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4.3.4. Replacing the Empty Input Container
The Diana operator application notifies the user when an empty input container condition occurs. Follow
the steps below to replace the empty input container.
1.

When an empty input container condition occurs, the Diana operator application notifies the user.

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2. To replace the empty input container, proceed to Step 3 in this section.
a. User can choose Reprime (See above picture) if the input container is not empty.
b. The user may choose to finalize the delivery process by tapping the Finish Delivery (Seeabove picture) button.
Follow the steps below to Finalize the order without replacing the Empty Input Vial:i.

The Diana Opeator application notifies the user to confirm the Finalize transfer process.
The User can press the Cancel button to be taken back to the Empty Vial screen. Tap OK
button to finalize the transfer process.

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ii.

The Diana Syringe Pump transfers the liquid from Diana Cassette to the output container
and the verification screen displays to the user to accept or reject the transfer.
Note: Accept button displays when the user reviews and select the checkmarks under the
pictures.

3. If the user wants to replace the input container, remove the empty input container. The following
screen will display.
Note: Reprime button is not displayed once the user removes the empty input container.

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4. Enter/scan the new input container information. After entering the information, tap the onscreen
keyboard Enter button.

5. The software automatically opens the Camera Screen to take a picture of the input container.
Note: The User must take the picture of the input container; otherwise, the software prevents thetransfer process from progressing. To take a picture of the input container, a user may utilize thetablet camera or the barcode scanner.
6. Tap the Capture button. The operator application captures the picture and displays it on the screen.
Note: The Capture button displays when the picture taking option is either Tablet Front or Tablet Rearin the System Settings. If the picture taking option is Scanner Video, only OK button displays.
7. To delete a picture, tap the Delete icon.

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8. Tap the OK button to save the picture(s).

9. The Diana operator application prompts the user to attach the drug input container (blinking input
container on the tool bar. See picture below).

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Page 9110. Connect the new input container to the Diana Cassette. The Diana operator application displays thefollowing screen. Tap the Start button to continue the transfer process.

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Note: The Diana operator application displays each input container’s information on the verification
screen.

12. Review the pictures and Accept or Reject the preparation.

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4.3.5. Interrupt Dispensing Process Using Stop
The compounding transfer process can be interrupted at any time by tapping the Stop button.

Once the user stops the transfer process, the Diana Operator application GUI presents options to the User
to resume by pressing the Start button or finalize the delivery process by pressing the Finalize button orquit the delivery process by pressing the Quit button.

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4.3.6. Resume After Stop
After the Stop button has been selected, the user can resume an interrupted compounding process without
any errors by tapping the Start button.

Once the user resumes the process; the Diana Operator application completes the drug transfer process
and presents a verification screen to the user to accept or reject the transfer process.

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4.3.7. Cancel/Finalize the Delivery Process
Once the user stops the transfer process, the Diana Operator application presents options to the user to
finalize the delivery process.

If the user finalizes the delivery process, the Diana Operator application prompts the user to confirm
finalizing the delivery process.

If the user taps the Yes button, the Diana Operator application GUI completes transferring the liquid fromthe Diana Cassette to the output container and presents a verification screen to the user to accept or reject
the process.
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Note: The Accept button displays when the user reviews and select the checkmarks under the pictures.

4.3.8. Quit the Delivery Process
Once the user stops the transfer process, the Diana Operator application presents options to the user
to quit the delivery process.

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the disposables, press OK, SPM goes through an initialization as if it were power cycled.

The user can tap the Cancel button to cancel the quitting process. If the user wants to quit the transfer
process, the user has to remove the disposables from the compunder. The operator application enables
the OK button.

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If the user taps the OK button, the Diana Compounder starts reinitialization process.

Once the reinitialization of the compounder completes, the Diana Operator application presents averification screen to the user to accept or reject the process.
Note: The Accept button displays when the user reviews and select the checkmarks under the pictures.

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4.3.9. The Virtual Keyboard
An important part of the Diana Software User Interface is the virtual keyboard. The virtual keyboard isdisplayed when certain text boxes are touched or selected. These text boxes require some user input,
such as entering an NDC (National Drug Code) or medication name. There are many uses for the virtual
keyboard.
The virtual keyboard comes in two types: an alphanumeric keyboard and a numeric-only keypad. The
numeric keypad is used when the input to the text box is restricted to numeric digits.

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5. Tool Settings
Both the Diana Operator and the Pharmacist applications have user accessible settings. Some settings areavailable for both the Pharmacist and Operator applications, some are Pharmacist application only andsome are Operator application only. Which settings are available is controlled by the tool settings
configuration file. This file is created at implementation time and is not changeable by the user.
The table below shows the tool settings available on Diana Compounding Workflow System.
Tool Setting Name
About This System
Review Complete Preparations
Review Active Preparations
Drugs
System Settings
Import SSL Certificates
Manage Drug Volume Bounds
Export Report
Export Logs
Label PrinterDiana Syringe Pumps
Manage Users
Change Password
Operator Tablets
Ingredient CADD And Pharmacist Validation
Ingredient Viscosity Setting

Operator Pharmacist
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x

Settings on the Operator and Phamacist applications are displayed as a series of settings bars on thesettings screen. The Pharmacist application startup screen displays the settings.

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Getting to the settings for the Operator application, requires an additional step. To display the settings
screen for the Operator application, the user must touch the gear icon in the upper right-hand corner of
the Operator application main screen.

Both the Operator and the Pharmacist application settings screens are scrollable.

There can be moresettings than can be displayed at one time. Scrolling of the settings is simple; touch the screen in thesettings 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 descriptive icon on
the left of the bar, text in the middle that briefly describes the associated setting and a settings action iconon the right of the bar. The settings action icon is a white colored right facing arrowhead against a blue
background.
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To launch any of the settings, touch the settings action icon of the desired settings bar.

Most settings screens have a Back button. Touching or selecting this button will return thedisplay to the main settings screen.

5.1.

Label Printer Setting

Contact ICU Service representative to assist in configuring printer.
Note: Due to size limitations of the printed labels, labels printed for preparations that use 14 or more uniquevials in a single preparation may have missing information on the label. Printed label information is forreference only.

5.2.

About This System Setting

Touching the action icon of the About This System settings bar will display a screen that details the version
and contents of the application.
1.

Tap the Settings Icon

2. Tap the About This System setting action icon

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The following information for the Operator and Pharmacist applications is displayed.
Operator:•

Tablet Serial Number•••

Operator Application Version
Diana Syringe Pump Serial Number
Diana Syringe Pump System Version and Installed Date

Pharmacist:••

Tablet Serial Number
Pharmacist Software Version

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5.3.

Operator Tablets Setting

The Diana Hazardous Drug Compounding System can have one or more operator tablets. The Pharmacist
application (Pharmacist tablet) must know about them in order to properly communicate and coordinate
user defined drugs and to validate preparations.
The Pharmacist application is configured at the factory to include all operator tablets associated with it, but
over the lifetime of the system, the hosting clinic, hospital or pharmacy may add or replace some of theoperator tablets. When that happens, the configuration of the Pharmacist application must be updated via
the Operator Tablets setting.
This Operator Tablets setting option allows the user to do the following:1.

Add New Operator Tablet

2. Replace Existing Operator Tablet
3. Remove Operator Tablet

5.3.1. Add New Operator Tablet
1.

Tap Settings Icon

2. Tap Operator Tablets setting action icon

3. Manage Tablets screen is displayed

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4. Tap the Add Tablet button in the Manage Tablets screen

5. Enter the Operator Tablet serial number in the Add Tablet pop-up window

6. Tap the Save button
Note: Tapping the Cancel button will return to the Manage Tablets screen without adding a new
Operator Tablet to the system
7. Tap the Yes button on the Save Tablet Settings confirmation page
Note: Tapping the No button will return to the Add Tablet pop-up window
8. Tap the Ok button on the Restart Required confirmation message pop-up window

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9. Restart the Operator application

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1.

Tap the Settings Icon

2. Tap the Operator Tablets setting action icon

3. The Manage Tablets screen is displayed
4. Tap the action icon for the existing Operator tablet bar
5. A pop-up menu indicating Edit and Delete is displayed

6. To replace the Operator tablet, tap Edit

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7. Change the Operator tablet serial number in the Edit Tablet pop-up window

8. Tap the Save button
Note: Tapping the Cancel button will return to the Edit Tablet screen without editing the existing
Operator tablet serial number
9. Tap the Yes button on the Save Tablet Settings confirmation page
Note: Tapping the No button will return to the Edit Tablet pop-up window
10. Tap the Ok button on the Restart Required confirmation message pop-up window

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1.

Tap the Settings Icon

2. Tap the Operator Tablets setting action icon
3. The Manage Tablets screen is displayed

4. Tap the action icon for the existing Operator tablet bar
5. A pop-up menu indicating Edit and Delete is displayed

6. To remove the Operator tablet, tap the Delete button
7. Tap the Yes button on the Delete Tablet confirmation pop-up window
Note: Tapping No button will return to the Manage Tablets screen pop-up

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8. Restart the Operator application

5.4.

Diana Syringe Pumps Setting

Contact ICU Service representative to assist in configuring Syringe Pumps.

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5.5.

Drugs Setting

Since both user defined, and FDA defined drugs are part of the Diana Automated Compounding System,
the Drugs setting allows the user to do the following:
1.

Create Drug

2. Edit Drug
3. Delete Drug5.5.1. Create Drug
The System allows the user to create new user defined drugs and/or drug concentrations in to thesystem.
If the user wants to add a new drug (Drug ID aka NDC code) to an existing drug ingredient, follow thesection 5.5.1.1 Create New Drug ID section.
If the user wants to create a custom drug (Drug ID, custom drug name and concentration) follow thesection 5.5.1.2 Create Custom Drugs section.
If the user wants to create a custom, user definable mass and volume values (Drug ID and newconcentration to an existing Drug Ingredient) for the drug follow the section 5.5.1.3 Create Custom
Mass Volume For a Drug section.
NDC Codes (Drug IDs) are printed on medication containers. They consist of three pieces: Labeler Code,Package Code, and Product Code as shown in the example below.

In the instructions that follow, the Labeler Code, Package Code, and Product Code values shown are
just examples. Use the specific values for your drug.

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5.5.1.1.
1.

Create Drug ID for a drug missing from the Library
On the Pharmacist application tap the Settings icon

2. Tap the Drugs setting action icon

3. The Enter NDC window is displayed

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4. Tap the Create Drug button and the Create New Drug screen is displayed

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5. Tap the Labeler field and enter the values for Labeler, Product and Add New Package codes
and then tap on-screen enter key
Note: Need to tap on each field to enter the values

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6. Tap the Add button. Entered new Package value is added to the Packaging dropdown list

7. Tap the Active Ingredient field and type the first letter of the desired ingredient, and a list ofingredients starting with that letter will be displayed. Select the Ingredient from the list. The
Application automatically enters the values for the following:a. Active Ingredientb. Mass value and Mass units
c. Volume value and Volume units

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8. Tap on-screen enter key

9. Choose the following if necessary for the NDC
a. Select or Deselect Can use CADD?

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b. Select or Deselect Pharmacist Validation?
Note: Scroll down to see the CADD and Pharmacist Validation options

10. Tap the Show Protocol+ button if the new drug requires Reconstitution Protocols
Note: Refer to the Making a Reconstituted Drug section to view instructions for adding a
Reconstitution protocol to a drug
11. Tap the Save button to add the new drug to the drug library or tap Cancel to cancel the new
drug creation
12. Tap the Yes button on the Save Drug confirmation page
Note: Tapping the No button will return to the Create New Drug screen

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Create Custom Drugs (e.g., investigational drug)

1. From the Pharmacist application, select the Settings icon.
2. Select Drugs option and on the Enter NDC screen tap Create Drug button.

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3. On the Create New Drug screen enter the following for the National Drug Code section andtap the Add button. Verify that the package is added to the Packaging list.
Labeler -> 1111 (example; do not use an existing labeler code)
Product -> 2222 (example)
Add a New Package -> 01 (example)
Note: Labeler, Product, and Packge values must be entered for the newly created drug or it
not be usable by the Diana system.

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4. Tap on the Active Ingredient field and by using on-screen keyboard enter, for example,
CustomDrug. Notice that Pharmacist application notifies “Did not find an Ingredientmatch. Saving form will create new Ingredient” banner message to the user.

5. Enter/Select the following values and tap on-screen Enter key once the values areentered/selected.
Mass-> 100 (example)
Mass Units->mg (example)
Volume-> 100 (example)
Volume Units-> mL (example)
Viscosity-> NORMAL VISCOSITY (example)

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6. Tap the Save button on the Create New Drug screen. Press Yes on the Save Drug message.

7. Pharmacist application displays the settings home screen after user manually adds thecustom drug and diluent information into the Drug Library.

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Create Custom Concentration For a Drug (e.g., special dilution)

1. From the Pharmacist application, select the Settings icon.
2. Select Drugs option and on the Enter NDC screen tap Create Drug button.

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3. On the Create New Drug screen enter the following for the National Drug Code section
and tap the Add button. Verify that the package is added to the Packaging list.
Labeler -> 8888 (example; do not use an existing labeler code)
Product -> 9999 (example)
Add a New Package -> 01 (example)
Note: Labeler, Product, and Packge values must be entered for the newly created drug or it
not be usable by the Diana system.

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4. Tap on the Active Ingredient field and by using on-screen keyboard enter, for example,
TestDrug, and select TestDrug 100.0 mg / 100.0 mL.

5.

Verify that after selecting the compound, the Mass, Volume and Units values areautomatically filled based on the selected Active Ingredient option.

6. Tap the Mass filed and change the value to 200.00. Verify that Pharmacist application
notifies “Did not find an Compound match. Saving from will create new Compound forIngredient” banner message to the user.
Note: The values entered here in this manual is for example purpose only.

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7.

Tap on-screen Enter button and verify that the updated Mass volume is displayed.

8. Tap the Save button on the Create New Drug screen.

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9. Press Yes on the Save Drug message and verify that the Pharmacist application displays
the settings home screen after user manually adds the custom drug and diluent
information into the Drug Library.

5.5.2. Edit Drug
The System allows the user to update an existing drug concentration in the system.
Note: The System allows the user to update the following only:•

Adding new package•

Select/Deselect Pharmacist Validation?

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1.

•

Select/Deselect Can use CADD?

•

Add Reconstitution Protocol

On the Pharmacist application tap the Settings Icon

2. Tap the Drugs setting action icon
3. On the Enter NDC pop-up window, tap the NDC field and enter the existing NDC ID and tap the
Edit Drug button. Drug details screen displays

4. Enter/select the values for the following:a. Add a new package
b. Select or deselect Can use CADD?
c. Select or deselect Pharmacist Validation?

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5. Tap the Show Protocol+ if the new drug requires Reconstitution Protocols
6. Tap the Save button to update the drug information or tap Cancel to cancel the drug update

5.5.3. Disable Drug
See Ingredient CADD And Pharmacist Validation Setting

5.5.4. Delete Drug
The System allows the user to delete an existing user created drug from the system.
Note: The System does not allow to delete any FDA drugs.
1.

On the Pharmacist application tap the Settings Icon

2. Tap the Drugs setting action icon
3. On the Enter NDC pop-up window, tap the NDC field and enter the existing NDC ID and tap the
Delete Drug button

4. The System displays the confirmation screen for the user to confirm the delete with Yes or No
option5. Tap Yes to delete the drug

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6. Tap No to cancel drug deletion

Note: If the NDC entered does not exist and the Delete button is touched, an error screen isdisplayed.

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5.6.

Ingredient CADD And Pharmacist Validation Setting

The various ingredients in the drug database can be enabled/disabled, set to require/not require a
medication cassette container (e.g. CADDTM) and set to require/not require Pharmacist validation. The
Ingredient CADD And Pharmacist Validation setting allows the user to search for ingredients andchange their associated values.
1.

On the Pharmacist application tap the Settings Icon

2. Tap the Ingredient CADD And Pharmacist Validation setting action icon

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3. The Ingredient Properties screen is displayed

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4. Tap the Search Ingredient text box and begin typing the ingredient name.
Note: The system will display a drop-down list of ingredients that start with the character orcharacters entered in the text box. Select the desired item.

5. Check or uncheck the Use CADD Container field.
6. Check or uncheck the Pharmacist Validation field

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7. Check or uncheck the Enabled field

8. Tap the Save button
Note: Tapping the Cancel button will return to the Settings screen without changing the Ingredient
properties
9. Tap the Yes button on the Save Ingredients Settings confirmation page
Note: Tapping the No button will return to the Ingredient Properties screen

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5.7.

Review Complete Preparations and Review Active Preparations Setting

The Diana system keeps a record of every preparation created, starting from manufacture. These records
include dates, times, results, images and other relevant data. These preparations can be reviewed on theapplication using the Review Complete Preparations setting.
Review Active Preparations contains the preparations that are currently active on the system. Active
preparations are either in the SPM Transferring or Compounding Drug or Need Operator Validation or
Need Pharmacist Validation states.
Review Active Preparations on the Operator application displays preparations in SPM Transferring or
Compounding Drug or Need Operator Validation state.
Review Active Preparations on the Pharmacist application displays preparations in SPM Transferring or
Compounding Drug or Need Operator Validation or Need Pharmacist Validation state.
To review preparations, touch the action icon of the Review Complete Preparations or Review Active
Preparations bars.

The Review Complete Preparations screen has one or more preparation records in a scrollable list. Eachrow in this list is a record. The list can be sorted in ascending or descending order by Order ID, Date, Drug(i.e., substance and concentration) or Status by touching the up/down arrow icon next to the title of eachcolumn in the list.
The following data is shown for each preparation: the order ID, the date of completion, the substance andconcentration of the drug that was dispensed and the status of the preparation.

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The rightmost column in this list is entitled Action. Each record has two buttons in this column; one is thePrint button, and the other is the Display button.
If the Display button for a preparation record is touched, a screen that displays all of the images associatedwith 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, zero or more
miscellaneous pictures, and a signature image if the preparation was validated by the pharmacist.

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

5.8.

Export Report Setting

The Export Report setting allows the user to export all delivery/preparation information stored in the system
to an external drive. Export Report setting is available in both Operator and Pharmacist applications.
1.

Insert USB flash drive into the tablet’s USB port

2. Tap the Settings Icon

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3. Tap the Export Report setting action icon

4. The Select Destination Drive for Export Report pop-up window is displayed

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5. In the Select Destination Drive for Export Report pop-up window, enter the Report Folder nameNote: The Report Folder name should be a folder name on the root of the inserted USB drive. If
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6. Tap the Accept button
Notes:
a. Tapping the Cancel button will return to the Settings screenb. If the USB flash drive was not inserted, the No USB Drive pop-up window will be displayed.
Tap the OK button will return to the Select Destination Drive for Export Report pop-up
window

5.9.

Export Logs Setting

The Export Logs setting allows the user to export the Operator or Pharmacist log files.
1.

Insert a USB flash drive into the tablet’s USB port

2. Tap the Export Logs setting action icon

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3. The Export Logs pop-up window is displayed

4. In the Export Logs pop-up window, tap the Save button
Note: Tapping the Cancel button will return to the Settings screen
5. Application displays successful export notification to the user

5.10. Ingredient Viscosity Setting
The viscosity of the drugs which can be compounded with the Diana Automated Compounding System canbe based on water, various alcohols, and various oils or lipids. Each of these has a different viscosity. The
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Diana Syringe Pump must know the viscosity of the drug solution or suspension being dispensed or it may
not function correctly. Most drugs can use the “Normal” setting, but the user may find improved system
performance by updating the viscosity setting to “High” for fluids with high viscosities.
Note: System settings are defaulted to “Normal” for all drugs in the default database

The Diana Pharmacist application allows the user to change the viscosity setting for the drugs.
1. Tap the Setting Icon
2. Tap the Ingredient Viscosity Setting action icon

3. The Ingredient Viscosity Setting setting screen is displayed

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4. Tap the Search Compound text box and type the compound nameNote: The system will display a drop-down list of ingredients which start with the character orcharacters entered in the box. Select the desired item

5. Select an Ingredient Compound
6. The Modify Compound Viscosity pop-up window will be displayed
7. Choose the Viscosity for the Ingredient from the drop down list

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8. Tap the Update button
Note: Tapping the Cancel button on the Modify Compound Viscosity pop-up window will returnto the Ingredient Viscosity Setting setting screen without changing the viscosity for the compound

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9. Tap the Save button on the Ingredient Viscosity Setting screen
Note: Tapping the Cancel button on the Ingredient Viscosity setting screen will return to the
Settings screen without changing the viscosity for the compound

10. Tap the OK button on the Success confirmation page

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5.11.

Manage Drug Volume Bounds Setting

The Manage Drug Volume Bounds setting allows the user to set the Minimum and Maximum drugvolumes in milliliters the system will allow the user to transfer.
1.

Tap the Settings Icon

2. Tap the Manage Drug Volume Bounds setting action icon

3. The Drug Volume Bounds setting screen is displayed

4. Change the desired Minimum or Maximum volume based on the site preference
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Note: The volume bounds should be in between 1 mL and 1000 mL.
5. Tap the Save button
Note: Tapping the Cancel button on the Drug Volume Bounds setting screen will return to
the Settings screen without changing the values
6. Tap the Yes button on the Save Drug Volume Bounds confirmation pop-up window
Note: Tapping the No button on the Save Drug Volume Bounds confirmation pop-up window
will return to the Drug Volume Bounds setting screen

5.12. Manage Users Setting
The Manage Users setting in the Pharmacist application allows the administrator to manage users of thesystem.
This option allows the administrator to do the following:1.

Add New User

2. Edit Existing User
3. Disable or Enable User or Reset Password

5.12.1. Add New User
1.

Tap the Settings Icon

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2. Tap the Manage Users setting action icon

3. The Manage Users screen is displayed

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4. Tap the Add user button. The Add User screen is displayed

5. Enter values for all the fields and select appropriate roles for the user
Note: Password values must consist of printable characters, cannot start or end with a whitespacecharacter, and must contain at least one numeric character, one symbol character, and one uppercase text character. Password length must be between 8 and 21 characters.

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6. Tap the Save button
Note: Tapping the Cancel button will return to the Manage Users screen without adding a new user
to the system

5.12.2. Edit Existing User
1.

Tap the Settings Icon

2. Tap the Manage Users setting action icon
3. The Manage Users screen is displayed
4. Tap the action icon for the existing user bar

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5. A pop-up menu indicating Edit, Enable/Disable and Reset Password is displayed

6. To edit the user, tap the Edit button
7. Change the values for the user in the Edit User pop-up window

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8. Tap the Save button
Note: Tapping the Cancel button will return to the Manage Users screen without editing theexisting user values

5.12.3. Disable or Enable User or Reset Password
1.

Tap the Manage Users setting action icon

2. The Manage Users screen is displayed
3. Tap the action icon for the existing user bar
4. A pop-up menu indicating Edit, Enable/Disable and Reset Password is displayed

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5. To disable the user, tap Disable
6. To enable the user, tap Enable
7. To reset the user password, tap Reset Password
8. Tap the OK button on the Manage Users Password Reset successfully message

5.13. Change Password Setting
The Change Password setting in the Operator application allows the logged-in user to reset their password.
1.

Tap the Settings Icon

2. Tap the Change Password setting action icon

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3. The Change Password screen is displayed
4. Enter the new password
Note: Password values must consist of printable characters, cannot start or end with awhitespace character, and must contain at least one numeric character, one symbol character,and one upper-case text character. Password length must be between 8 and 21 characters.

5. Tap the Save button
Note: Tapping the Cancel button will return to the Settings screen without resetting the
password

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5.14. Import SSL Certificates
Contact ICU Service representative to configure this setting.

5.15. System Settings SettingThis setting allows the user to enter/select or enable/disable different options for the system. Scroll down
to see all the System Settings options.
These are the settings available:•

Photo Display Time in Seconds•

Drug Server IP Address•

Camera Usage•

Print Labels•

Require Container Picture•

Validate All Images•

Session Timeout In Minutes•

Export Configuration Files

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5.15.1. Photo Display Time in Seconds
1.

This setting allows the user to configure the default photo display time for pictures taken of the
input vial or syringe during order preparation. This setting also applies to the photos taken
while on the verification and validation screens.

2. Tap the Settings icon and tap the System Settings setting action icon

3. Tap the Photo Display Time in Seconds field

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4. Enter time in seconds

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5. Tap the Save button to save the changes or the Cancel button to cancel the changes

5.15.2. Drug Server IP AddressThis shows the IP address of the Drug Server. Contact ICU Service representative to configure this setting.

5.15.3. Camera Usage
This setting allows the user to select which camera the Operator and Pharmacist applications uses to takepictures of the input vial or syringe during order preparation. This setting also applies to the pictures
taken on the Verification and Validation screens.
Note: Pharmacist application does not have the barcode scanner configured, so the Scanner Video
option is automatically disabled.
1.

Tap the Settings Icon and tap the System Settings setting action icon

2. Select one of the following options below:
a. Tablet Front
b. Tablet Rearc. Scanner Video

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3. Tap the Save button to save the changes or the Cancel button to cancel the changes

5.15.4. Print Labels
This setting allows the user to enable or disable automatic printing of the order completion label when
the user accepts or rejects an order on the Verification or Validation screens.
1.

Tap the Settings Icon and tap the System Settings setting action icon

2. Select/Deselect the Print Labels option

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3. Tap the Save button to save the changes or the Cancel button to cancel the changes

5.15.5. Require Container PictureThis setting allows the user to enable or disable the requirement to take input vial or Diana Cassette
pictures in the Order Details screen before starting the preparation process.
1.

Tap the Settings Icon and tap the System Settings setting action icon

2. Select/Deselect the Require Container Picture option

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3. Tap the Save button to save the changes or the Cancel button to cancel the changes

5.15.6. Validate All Images
This setting allows the user to enable or disable the requirement to validate the images on the
Verification or Validation screens.
1.

Tap the Settings Icon and tap the System Settings setting action icon

2. Select/Deselect the Validate All Images option

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3. Tap the Save button to save the changes or the Cancel button to cancel the changes

5.15.7. Session Timeout In Minutes
This setting allows the user to configure the user inactive session timeout in minutes.
1.

Tap the Settings Icon and tap the System Settings setting action icon

2. Tap the Session Timeout In Minutes field
3. Change the time

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4. Tap the Save button to save the changes or the Cancel button to cancel the changes

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5.15.8. Export Configuration Files
This setting allows the user to export the current operator/pharmacist tablet configuration files to an
external USB drive.
1.

Tap the Settings Icon and tap the System Settings setting action icon

2. Tap the Export Configuration Files button
Note: If the external USB is not connected to the tablet, the application displays N/A next tothe Export Configuration Files button. If the external USB is connected to the tablet, theapplication displays the USB drive letter next to the Export Configuration Files button
3. 100% complete green bar is displayed after successful export of the configuration files

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6. Warranty and Service Information
6.1.

Limited Warranty

ICU Medical warrants the system to be free from defects in material and workmanship for one (1) year fromthe 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.

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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 topurchaser’s failure to operate or maintain the equipment in a manner consistent with the specifications andguidelines 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 befunctioning within the published specifications.
This warranty includes repair or replacement of components that do not function as intended during theterm of this warranty. Warranty components or assemblies shall be of equal or better quality than thecomponent 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 otherwarranties 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 IMPLIEDWARRANTIES OF MERCHANTABILITY, FITNESS FOR PARTICULAR PURPOSE AND NON-INFRINGEMENT.
Excluded from warranty coverage are damages resulting from:
•
•
•
•
•
•

Incorrect connection of the Diana Syringe Pump or accessories.
Unauthorized cleaning of the Diana Syringe Pump 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, INCLUDINGBUT 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.

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6.2.

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:

ICU Medical, Inc.
951 Calle Amanecer
San Clemente, CA 92673(866).829.9025
https://www.icumed.com

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Appendix A: Cleaning and Disinfection of the Diana AutomatedCompounding System
Switch off the Diana Syringe Pump and remove the Power cord from the Diana Syringe Pump.
The operator must wear proper protective equipment (PPE) when operating the System and adhere tofacility protocols and standards for operating compounding equipment.
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-coatedaluminum, impact-proof polystyrene, or polyester.
Standard cleaning and disinfecting agents with an alcohol base can be used to clean and disinfect thedevice. DO NOT use radical-forming or peroxide-forming cleaning and disinfection agents or ketone
based cleaning and disinfection agents unless listed below. Do not directly spray onto or moisten theconnector sockets on the rear wall of the device. For removing severe soiling, check solvent solubility ofplastic and other device parts and labels before attempting to clean with any solvents.
Approved cleaning and disinfection agents:
Agent

Isopropyl Alcohol
Sodium Hypochlorite (bleach)
Peracetic Acid
Hydrogen Peroxide
SurfaceSafe
HD Clean
Peridox RTU
Contec TB-1 3300

Concentrations (water solutions)
Equal or less than 70.0% w/w
Equal or less than 2.0% w/w
Equal or less than 2.0% w/w
Equal or less than 7.5% w/w
See Agent product labelingSee Agent product labelingSee Agent product labelingSee Agent product labeling

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

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

AmountAmountBleach (5.25% sodium hypochlorite)

190.5 mL

381 mL

Sterile Water for Irrigation (pour bottle)

309.5 mL

619 mL

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TOTAL VOLUME

500 mL

1000 mL

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

Amount Using(Na Thiosulfate 10%)Amount Using(Na Thiosulfate 25%)

Na Thiosulfate Inj. (10% or 25%)

50 mL

20 mL

40 mL

Sterile Water for Irrigation (pour bottle)

450 mL

480 mL

960 mLTOTAL VOLUME

500 mL

500 mL

1000 mL

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 solution suitable for cleaning a biological safety cabinet.
Step #5 – (optional cleaning) repeat steps 3 and4 two times each once per day from debris, wiping in
top-down motion and discarding towels, followed by a dry and clean towel wipe in between each step.
Carefully clean the sensors, syringe plunger pins, syringe carrier plunger, and stopcock holder (See picture
below).

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Appendix B: Troubleshooting and Maintenance
Description of Fault

RemedyIP address configuration message

Operator or Pharmacist tablet lost communication to the
Web Server. Make sure that the Webserver computer is On
and is connected to the configured Wi-Fi router. Restart thetablet and if the message reappears contact ICU service
personnel.

Drug name is invalid or not found

Make sure that the entered drug name is correct.

Invalid character entry

Make sure that the entered value does not contain any
special characters other than specified in the error message.

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Invalid NDC entry

Make sure that the entered/scanned drug ID (NDC) iscorrect.

Incorrect Month entry

Make sure that the entered Month is correct.

Expired Date entry

Make sure that the entered the date value is not expired.
Check the date on the input vial. If it is expired discard the
input vial and use a new unexpired input vial.

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Insert New Disposable error

Make sure that a new Diana Cassette (disposable) is
installed on the Syringe Pump before proceeding with thedrug transfer process

Motor movements error

Examine the Syringe pump for any obstruction in the syringe
carrier. Remove any obstructions found. Remove any
attached disposables from the Syringe Pump. Restart the
Syringe Pump.

Previous application shutdown was not graceful

Tap the Close button and restart the application.

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SPM restarted error message during the delivery
process

Remove the disposables from the SPM, press OK. The
previous delivery status will be in Discontinue state.

Login error

Make sure that the entered User ID and Password arecorrect.

Password entry error while setting up the user
password

Make sure that the entered password is in correct format.

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Account Locked

If the account locked message is due to 5 consecutive failed
login attempts. The user account should be unlocked by an
Administrator from the Pharmacist application.

Unauthorized access error

Make sure the user has the right access privileges.

Displaying amount of liquid Delivered and Specified for theorder on the Verification/Validation screen.
If the UI displays Delivered Box in Green, that means thedelivered volume is within the range.
If the UI displays Delivered Box in Red, that means thedelivered volume is not within the range.
User will either Accept or Reject the delivery based on thedelivered volume
Display of SPM camera disconnected Icon on thetool bar

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Restart the Diana Syringe Pump. If the icon still displays,
contact ICU service personnel.

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Display of Barcode scanner not connected Icon on
the tool bar

Barcode Scanner is not connected. Make sure that thebarcode is connected to the Operator tablet properly. If theicon still displays, contact ICU service personnel.

Display of Printer not connected Icon on the tool bar

Label Printer is not connected. Make sure that the printer isturned on. If the icon still displays, contact ICU service
personnel.

Display of Wi-Fi not connected Icon on the tool bar

Operator lost communication to the Web Server. Make surethat the Webserver computer is On and is connected to theconfigured Wi-Fi router. If the icon still displays, contact ICU
service personnel.

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Fuse Replacement
Diana Syringe Pump uses two fuses located in the rear of the unit; fuses are a part of the power inlet
module. Service on the fuses can be done by the end-user (end-user buy the fuses from local
hardware/electrical store). Incorrect insertion of the fuses may result in no power to the unit.
1.

Procure proper fuses (two per pump): F2.5A 250V, 5x20mm

2. Make sure the unit is powered-off and power cord is unplugged.
3. Using flat head screwdriver remove the power switch holder from power inlet module, by pulling
the power switch holder carefully.
4. Remove the old fuse(s) from the power switch holder and replace with new fuse(s). It is
recommended to replace both fuses at the same time.
5. Reinsert power switch holder back into power inlet module by gently pushing inside until it stops.

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Appendix C: Accuracy Verification Protocol
1. Use 10 mL input containers for this test.
2. Use a 100 mL output IV bag for this test.
3. Use a new Diana Cassette.
4. Place the empty output IV bag on a scale.
5. Tare scale with empty IV bag (scale readability and repeatability should be to 0.001g)
6. Turn ON the Diana Syringe Pump.
7. Launch the Operator software.
8. Use the Water substances for Drug Name.
9. Perform a delivery of 5 mL.
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 100 mL input containers for this test).

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Appendix D: Making a Reconstituted Drug
A reconstitution protocol must be created for a drug. A reconstitution protocol defines the resulting drug
and concentration after reconstitution and specifies 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. Adding Reconstitution Protocol to a Drug
1. Open the Pharmacist application from the Pharmacist Tablet.
2. Choose the Drugs option from the settings. The screen below is displayed.

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3. On the Enter NDC screen, enter the Drug ID for which the reconstitution protocol is being
created.
Note: If the Drug ID needs to be added to the Drugs database, refer to the Drugs settings
section to create a new Drug ID.

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4. Tap Edit Drug from the Enter NDC screen. The Drug details screen is displayed.

5. Scroll down the screen to see the Show Protocol+ button.

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6. Tap the Show Protocol+ button. Information related to Reconstitution Protocol for the drug isdisplayed.

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7. Add the information for Diluent Volume, Diluent and Reconstituted Drug sections.
Important Note: Follow the hospital instructions for adding the information for Diluent andReconstituted Drug sections. The information in this section is for example purposes only.

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8. Once all the information is entered, tap the Save button.
9. Tap the Yes button on the Save Drug confirmation dialog.

2. Making a Reconstitution Drug
Note: If using a length of tubing between the outlet of the Diana Cassette outlet and theoutput container, the tubing must be primed prior to connection to the Diana Cassette on the
Syringe Pump

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1.

On the Operator application, select the connected Diana Syringe Pump.

2. For the Drug Name enter/select the Reconstituted drug name.
3. Enter the Order Number and enter a value for the Volume.

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4. Tap the NDC field and select the NDC ID for which the reconstitution protocol was added.
Note: The user must select the correct NDC ID in order to perform a reconstitution for the drug.

5. Enter the Lot Number and Lot Expiration details using keyboard and press Enter key.

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6. The Reconstitution Protocol Detected message is displayed. Tapping the OK button allows
the user to perform the Reconstitution.
Note:The user can choose the Cancel button to perform a normal delivery.

7. Tap the OK button on the confirmation message to proceed. Information related toReconstitution Protocol is displayed.

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8. Scroll down to see the Drug Vial 1 section, to add the drug vial.

9. Tap the NDC field on the Drug Vial 1 section and select the NDC ID, enter the Lot Number and
Lot Expiration details.

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Page 18810. The Document the input container label screen is displayed to allow the user to takepictures. Capture the input vial pictures and tap the OK button.

11. Insert the Diana Cassette and connect the input vial and output container.

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12. Process the order by tapping the Start icon.

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13. The System starts processing the order and displays the verification screen once the transfer
process completes.

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Page 19114. On the verification screen, review the pictures and the Reconstituted drug information andAccept/Reject the preparation.

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Appendix E: Special Output Container Identification and Selection
The Diana Automated Compounding System supports special output containers that require removal of
air before transferring fluid into it. The drugs that needs special output containers are identified in the
drug database through the Ingredient CADD And Pharmacist Validation tool setting.

1. CADD Cassette1.

On the Operator application, select the connected Diana Syringe Pump and enter the orderdetails. Once the information is entered on the Order Screen the following pop-up screen isdisplayed.
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.

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In this example 50 mL CADD Cassette selected.
3. Tap the NDC field,enter the NDC details and tap on the virtual keyboard Enter key.

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4. On the Document the input container label window, capture the input vial and tap the OK
button. The System displays the order screen.

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5. Connect the disposables and tap the Start button.

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6. The Operator application displays a Removing Air notification asking the user to remove input
vial and attach the input spike with empty bag to the input adapter. Remove the Input Vial andthen connect the input spike with empty bag and tap OK button.

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7. The system removes the air from the output container and displays the Air Removal Complete
notification. Remove the input spike and waste bag and attach the input vial. Tap the OK
button.

8. Tap the Start button to start the transfer process. The Diana Syringe Pump starts transferring
the drug from the input vial to the output container.

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9. Once the transfer process completes the system displays the verification screen for the user toconfirm the transfer process. See the screens below. Review the pictures on the verification
screen and tap the Accept or Reject button.

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Appendix F: Specialty Substances List
1.

The following list of substances are set by default to requiring Pharmacist validation.

CHLORAMBUCILDOCETAXELPERTUZUMAB

LISINOPRILMETHOTREXATEPASIREOTIDEGANCICLOVIRHYDROXYUREAMETHYLTESTOSTERONELOMUSTINE

DEFERIPRONE

PROGESTERONECLONAZEPAMOXCARBAZEPINEDACTINOMYCIN

MEDROXYPROGESTERONE ACETATEACITRETIN

NILOTINIB

MECHLORETHAMINECYCLOSPORINECIDOFOVIRNELARABINEVALGANCICLOVIRRIFAMPIN

VANDETANIB

BRENTUXIMAB VEDOTIN

BELINOSTATMISOPROSTOLOXYTOCIN

BOSENTANDINOPROSTONEESTRADIOLTHIOGUANINECARBAMAZEPINEFLOXURIDINETESTOSTERONEMITOMYCINCAPECITABINETHALIDOMIDETRETINOINOXALIPLATINCISPLATINIMATINIBAMBRISENTAN

DECITABINESPIRONOLACTONETEMSIROLIMUS

VIGABATRINROMIDEPSINNEVIRAPINEAPOMORPHINE

DUTASTERIDECARBOPLATIN

LIRAGLUTIDE

TRAMETINIBTOPIRAMATEETOPOSIDECABERGOLINEIXABEPILONEAFATINIBMYCOPHENOLIC ACID

COLCHICINEGEMCITABINERIOCIGUATFLUCONAZOLEPHENYTOIN

VEMURAFENIBRISPERIDONETHIOTEPAENTECAVIRZIPRASIDONEFLUTAMIDE

PEMETREXEDDRONEDARONEPALIFERMINBEXAROTENE

CLADRIBINEMYCOPHENOLATE MOFETILDAUNORUBICINFINASTERIDECARMUSTINEMETHIMAZOLESORAFENIBAZATHIOPRINEFULVESTRANTCYTARABINERASAGILINEPROPYLTHIOURACILENZALUTAMIDEERLOTINIBGEMTUZUMAB OZOGAMICIN

PALIPERIDONELEUPROLIDEIFOSFAMIDEDACARBAZINEPACLITAXELCLOFARABINEMERCAPTOPURINE

DOXORUBICINVALRUBICINRIBAVIRIN

ALITRETINOIN

DEGARELIXTEMOZOLOMIDEBUSULFAN

MITOTANEREGORAFENIBDEXRAZOXANEEXEMESTANEDIETHYLSTILBESTROLOSPEMIFENEFLUOROURACILVORICONAZOLECETRORELIXABACAVIRCARBIDOPATEMAZEPAM

BOSUTINIB

TOPOTECAN

CHLORAMPHENICOLESTROPIPATELEFLUNOMIDEVISMODEGIB

ANASTROZOLEPOMALIDOMIDECRIZOTINIBPENTETATE CALCIUM TRISODIUM

SIROLIMUS

EVEROLIMUS

CABAZITAXELADO-TRASTUZUMAB EMTANSINEPENTOSTATINTERIFLUNOMIDEFINGOLIMOD

TRIPTORELINBORTEZOMIBZIDOVUDINEPLERIXAFORFLUDARABINEMIFEPRISTONE

BLEOMYCINDABRAFENIBPRALATREXATEFLUOXYMESTERONEIDARUBICIN

AXITINIB

MACITENTANLENALIDOMIDEAZACITIDINEVORINOSTATCYCLOPHOSPHAMIDELETROZOLE

MELPHALANDASATINIB

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2. FLUOROURACIL is configured by default to support use of a CADD cassette.

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