ICU Medical Diana User manual

Effective
icumedtcal
humanconnections
Diana™
Hazardous Drug Compounding System User Manual v1.3.x
Compatible with:
Diana Firmware v5.3x
Diana Display v5.3x
Needlefree > Easy to Use > Less Waste > Lower Cost
ICU Medical, Inc. Document Number: DF-4925-EN Rev: 02
Effective Date: 01 Aug 2016 Printed By: Date/Time:
Confidential and proprietary information. Do not reproduce without written permission from ICU Medical. Users must ensure that they are using the most current released
rev of this document.

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Diana Hazardous Drug Compounding System, ICU Medical, Inc.
List of Contents
Description and Intended Use............................................................................................................................3
Cautions and Warnings ......................................................................................................................................5
Regulatory Compliance.......................................................................................................................................6
General Operation Information...........................................................................................................................6
What to do in case of damage..................................................................................................................................................... 7
Views of the System...........................................................................................................................................8
Front and Rear of the System.......................................................................................................................................................8
Touchscreen Key Panel .................................................................................................................................................................9
Print Parameters........................................................................................................................................................................... 12
Setting up the System ..................................................................................................................................................................13
Operation of the System ..............................................................................................................................................................13
External Accessories.................................................................................................................................................................... 14
Connecting the External Liquid Sensor .................................................................................................................................... 14
Powering the System On............................................................................................................................................................. 14
Installing Disposables for Channel One................................................................................................................................... 16
Insertion of the 50 ml syringe into the syringe pump unit ................................................................................................... 19
Technical Data Specifications...........................................................................................................................38
Appendix A: Diana System Manager Software ................................................................................................39
Appendix B: Cleaning and Disinfecting the Diana System .............................................................................. 41
Appendix C: List of Symbols Used on the Device............................................................................................42
Appendix D: Troubleshooting...........................................................................................................................43
2
ICU Medical, Inc. Document Number: DF-4925-EN Rev: 02
Effective Date: 01 Aug 2016 Printed By: Date/Time:
Confidential and proprietary information. Do not reproduce without written permission from ICU Medical. Users must ensure that they are using the most current released
rev of this document.

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Diana Hazardous Drug Compounding System, ICU Medical, Inc.
3
Introduction
This manual provides the user with basic information for operating the System. It documents all the usable
functions and explains how to use them. The device is supplied in a calibrated condition. Servicing must only
be performed by the manufacturer.
Because of continuing product improvements, prices and specications are subject of change without
notice. Changes to this manual, either in response to user input or to continuing product improvements, are
accomplished through reissue. If in the normal use of this manual, errors, omissions, or incorrect data are
noted, please contact ICU Medical, Inc. Customer Service or your local ICU Medical representative.
Description and Intended Use
The Diana Hazardous Drug Compounding System is a controller-regulated device which includes syringe
pump units for preparing and lling hazardous drugs. Compatible vials, elastomeric pumps, and bags can
be used as receiving containers. Desired Volumes can be selected for compounding. The central device
contains a touchscreen display for entering data and for controlling the functions of the System. Entered
data, and the status of the System are displayed as plain text or in diagrams.
It is important to follow the safety instructions to ensure proper functionality. Please refer to the Technical
Data Specication Section of the manual for information on accuracy ranges for each channel of the device
as they dier from the operating range of the device.
Preparation volumes in the range of 5 ml to 999.9 ml have been tested under dierent conditions. Please
refer to the Technical Data Specication section in this manual for the accuracy range of the device before
use. ICU Medical cannot ensure the accuracy of preparations under 5 ml.
In order to ensure system performance within the accuracy range provided herein, it is recommended that
you initially test the accuracy of each drug at the clinical volumes before use.
Diana System Version Compatibility
Diana System, Model CH5300 and CL5300 (also known as ASN223 and ASN223CL in some countries), v1.3.x
is compatible with:
●Diana Firmware v5.3x
●Diana Display v5.3x
●Diana Serial Switch v5.3x
TheDianaSystemModelCH5300andCL5300areassembledbyICUMedicalInc.atitsfacilities4455AthertonDr.,
Salt Lake City, Utah, U.S.A.
The Diana System Model ASN223 and ASN223CL are assembled by Neo Care GmbH D-58513 Ludenscheid
Altenaer Str. 136, Germany. Neo Care is a wholly owned subsidiary of ICU Medical Inc.
Trademarks: ICU Medical, ICU Medical human connections, Diana, Clave, MicroClave, Y-Clave, and Spiros
are trademarks of ICU Medical Inc. Clave, MicroClave, Y-Clave, ChemoLock and Spiros are registered in the
United States patent and trademark oce.
ICU Medical, Inc. Document Number: DF-4925-EN Rev: 02
Effective Date: 01 Aug 2016 Printed By: Date/Time:
Confidential and proprietary information. Do not reproduce without written permission from ICU Medical. Users must ensure that they are using the most current released
rev of this document.

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Diana Hazardous Drug Compounding System, ICU Medical, Inc.
Customer Service
All functions of the System were checked before shipment.
For customer service, technical assistance, product return authorization and to order parts, accessories, or
manuals contact ICU Medical Technical Support Operations nearest you:
U.S. & Canada
ICU Medical, Inc.
1-866-829-9025
1-949-366-2183
ICU Medical Europe
Italy
1-866-829-9025
1-949-366-2183
ICU Medical - NeoCare
Germany
1-866-829-9025
1-949-366-2183
Medikus GmbH
Austria
1-866-829-9025
1-949-366-2183
Other Locations
Record your local ICU Medical or distributor contact information here:
Name: ______________________________________________
Phone: ______________________________________________
Email: ______________________________________________
4
ICU Medical, Inc. Document Number: DF-4925-EN Rev: 02
Effective Date: 01 Aug 2016 Printed By: Date/Time:
Confidential and proprietary information. Do not reproduce without written permission from ICU Medical. Users must ensure that they are using the most current released
rev of this document.

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Diana Hazardous Drug Compounding System, ICU Medical, Inc.
5
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General Safety Instructions
The operator must be properly trained in the use of the System. Please follow the information contained in
this manual regarding function of the System.
Always follow published guidelines relating to work protection and accident prevention, and ensure
professional diligence at all times.
The System may not be resold or exported without the manufacturer’s written permission.
In order to prevent injury while the System is operating, ensure that ngers and other body parts do not
come into contact with moving parts.
Cautions and Warnings
●The system should only be used with the manufacturer provided power cords.
●Avoid impacts and vibration.
●Do not attempt to alter the System in any way.
●Transport only by use of the handle.
●Avoid direct contact with liquids. If a spill occurs, quickly remove liquids and hazardous drugs in
accordance with the facility protocol.
●Never immerse in liquids for cleaning purposes. Do not attempt to sterilize using mechanical or steam
sterilization equipment.
●If damaged during operation, switch o immediately and disconnect from the power supply.
●Ensure drug vial temperature is within 8-12oCof room temperature to minimize occurrence of condensation
on cassette during compounding. Remove the required vials from the refrigerator and allow them to reach
room temperature (about 30 minutes) prior to compounding to minimize occurrence of condensation on
cassette.
●When using the Diana system with reconstituted vials, care should be taken to ensure the vial remains
upright at all times and ensure vials are not over-pressurized prior to connecting to Channel One cassette.
●WARNING: Never connect directly to human beings or animals.
●WARNING: To avoid potential for cross contamination between drugs, only use cassettes and preparation
sets for the same drug preparations and transfers.
●WARNING: Use new, sterile cassettes and adapters only. This reduces cross contamination of drugs and
fluids, including but not limited to: penicillin and related agents, mutagenic agents, drugs with narrow
therapeutic indexes, and high-potency drugs. Also reduces the severity of the associated clinical hazards
that can result from contaminated and non-sterile fluid pathways.
ICU Medical, Inc. Document Number: DF-4925-EN Rev: 02
Effective Date: 01 Aug 2016 Printed By: Date/Time:
Confidential and proprietary information. Do not reproduce without written permission from ICU Medical. Users must ensure that they are using the most current released
rev of this document.

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Diana Hazardous Drug Compounding System, ICU Medical, Inc.
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Regulatory Compliance
The Diana System complies with the following standards:
●IEC 601-1:1988+A1:1991+A2:1995 Medical electrical equipment – Part 1: General requirements for Safety.
●IEC 601-1-4:1996 +A1:1999 Medical electrical equipment – Part 1: General requirements for Safety,
Collateral Standard: Programmable Electrical Medical Systems (PEMS).
●IEC 60601-1-2, 3rd Edition: 2007 Medical Device EMC/EMI Compliance – Class A.
●CE mark meeting the applicable European Community EC directives
●The Diana System CH5300 and CL5300 are CSA certied for US and Canada,
General Operation Information
Before powering the system on, make sure the power cord is correctly connected back of the Diana unit and
the wall outlet (110/220 Vac). Aer powering the device o, wait 10 seconds before powering on.
For three-phase electrical power system compatibility, connect the system to a center-tapped single phase
branch of the electrical power service.
The start, stop and pause functions can be operated remotely by means of an additional foot-operated
switch.
An established protocol should be developed to clean the System with commercially available cleaning and
disinfection agents (see Appendix B: Cleaning and Disinfecting the Diana System).
Prime all disposables prior to using for drug compounding and patient preparation. Verify all connections
and consumables are secure. The System is only compatible with ICU Medical supplied accessories and
disposables. Do not use alternative disposables as this can aect the calibration, and fail to support accurate
compounding and appropriate operation. Discard all Diana diluents sets, cassettes and syringe assembly
units and all Oncology disposables within 24 hours of opening a sterile package unless otherwise specied
in the specic product’s user manual or directions for use.
6
ICU Medical, Inc. Document Number: DF-4925-EN Rev: 02
Effective Date: 01 Aug 2016 Printed By: Date/Time:
Confidential and proprietary information. Do not reproduce without written permission from ICU Medical. Users must ensure that they are using the most current released
rev of this document.

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Diana Hazardous Drug Compounding System, ICU Medical, Inc.
7
Installation and Maintenance
The Diana system does not allow for any user installation or maintenance. All maintenance and installation
must be performed by an authorized ICU Medical representative.
Before leaving the factory, every device is calibrated by the manufacturer and then veried to meet all
specications. All maintenance work should be completed by the manufacturer with the exception of routine
cleaning. Customers should perform routine accuracy verication checks using the protocol described
in Appendix E: Accuracy Verication Check Test Protocol and contact the manufacturer if any errors are
observed outside the system specications.
Customer should contact ICU Medical if any recalibration or maintenance is required. At minimum, customer
should contact ICU Medical at least once per year to help determine if maintenance and calibration services
are required.
What to do in case of damage
If the device is damaged during operation, or if the mains cable is damaged, switch the device o immediately
and disconnect it from the power supply (socket).
Environmental Operating Conditions
Operating Temperature: +10°C to +40°C
Storage Temperature: 0°C to +60°C
Relative Humidity: 20% to 90% (Non-condensing)
The System is designed for use in laminar airflow boxes and/or safety work benches in clean rooms.
The System is not suitable for use in mobile equipment.
ICU Medical, Inc. Document Number: DF-4925-EN Rev: 02
Effective Date: 01 Aug 2016 Printed By: Date/Time:
Confidential and proprietary information. Do not reproduce without written permission from ICU Medical. Users must ensure that they are using the most current released
rev of this document.

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Diana Hazardous Drug Compounding System, ICU Medical, Inc.
D CD
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Views of the System
Views of the system throughout this manual highlight the use of a Diana Cassette with Spiros. Other versions
of the Diana Cassette are also available. Please refer to the Diana Cassette Directions for Use for additional
instruction.
The specication plate and the system interface for accessories and add-on devices are tted on the back
of the device (see illustration Front and Rear of the System). The on/o switch and the touchscreen display
panel used for all System operations are tted on the front of the device.
Installation of the external accessories on the device’s central unit must only be carried out when
the device is powered off.
Front and Rear of the System
1. 2 x 2AT fuses
2. Main power cord
3. Connection for foot pedal accessory
4. Connection to serial interface module for label printer and scanner
5. Connection for external liquid sensor
6. Touch function display
7. Power switch
8
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Effective Date: 01 Aug 2016 Printed By: Date/Time:
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rev of this document.

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Diana Hazardous Drug Compounding System, ICU Medical, Inc.
9
d : 0ml
al : 0ml
Operation of the System
Touchscreen Key Panel
Diana utilizes an intuitive touchscreen approach for data entry. The programming screen is the default
screen. Users are prompted to select a channel and scan an order number and/or a medication before
programming volumes.
Channel Selection Active Channel Start Order
Illustration 1 - Programming screen
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Diana Hazardous Drug Compounding System, ICU Medical, Inc.
MenuButton
Accessing Standard Parameters
To access the standard parameter page select Menu button shown in the display below. Access to the
standard parameters page is only possible when channel one is selected and active channel displays
CHAN 1 and the programmed volume (Desired ml) shows 0 ml. The standard parameters are inaccessible
when channel two is active.
Illustration 2 - Access standard parameters page by selecting Menu Button on programming screen
10
ICU Medical, Inc. Document Number: DF-4925-EN Rev: 02
Effective Date: 01 Aug 2016 Printed By: Date/Time:
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Diana Hazardous Drug Compounding System, ICU Medical, Inc.
11
Exit
Display:5.34
Firmware:5.34
Adjusting System and Syringe Speed Parameters
Selecting Menu when CHAN 1 is active takes you to the Standard Parameters page, as shown in
Illustration 3 -below. In this window you can change the beep from on to o as well as the brightness level
Diana oers the ability to change speed in the main Programming Screen, however, you can also change
the speed for both channels in the Standard Parameters menu. To change speed, select channel 1 for the
20 ml syringe pump motor or channel 2 for the 50 ml syringe pump motor. Now you can select Normal,
Moderate, or Fast speeds by selecting these values in the Parameter section. For viscous solutions and
drugs (e.g. Paclitaxel) use Normal speed. To change the number of labels that are printed out with upon
delivery completion, increase/decrease the number next to the Labels parameter. Leave this window with
Exit, and the changed values are stored.
Syringe Channel
Syringe Speed
Illustration 3 - Standard parameters
Use of Moderate and Fast Speed should be reserved to non-viscous drugs and fluids.
Use Normal speed only when using viscous solutions and drugs (e.g. Paclitaxel).
Use Normal speed only when using multi-vial solutions (e.g. Methotrexate).
Use Normal speed when using the Genie vial access device equipped with a check valve.
ICU Medical, Inc. Document Number: DF-4925-EN Rev: 02
Effective Date: 01 Aug 2016 Printed By: Date/Time:
Confidential and proprietary information. Do not reproduce without written permission from ICU Medical. Users must ensure that they are using the most current released
rev of this document.

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Diana Hazardous Drug Compounding System, ICU Medical, Inc.
Print Parameters
Users may change the Printer date/time, number of printed labels and print a test label by accessing the
Print Parameters page. To access this page, select the Menu button and then the Printer button in the
Standard Parameters menu. The Print Parameters screen will display as shown below in Illustration 4.
Illustration 4 - Print parameters
First, ensure Diana is connected to the printer. To test if the connection works, select ‘P’ on the Print Label
feature. Use the 12 or 24 hour clock to set the clock function accordingly, and use the hour, minute, and
second functions to set the time. Likewise, use the day, month and year functions to set the calendar date.
To save the date, select ‘S’ to Set Data. Diana must be able to communicate to the printer to save the new
settings on the printer.
To print a test label, select ‘P’ on the Print Label feature. If the changes were saved you should see those
changes reflected in the label printed.
Mode 1 enables the Diana print feature. If Mode is selected to 0, then the Diana print feature is disabled. To
re-enable printing, change Mode 0 to Mode 1. If printing is disabled aer making this change, please check
the connection or reset the baud rate on the printer using the Diana System Manager.
Other features:
●12 or 24 h: mode of which kind of clock
●Set Date: Push Sto transfer this data to setup printer
●Set Autosense: Push Ato activate sensor in printer to detect when print labels have run out.
●Print label: Push Pfor to print one test label
●Labels: Push “+” or “-“ to adjust the number of labels printed at the completion of a workflow sequence.
►Diana can print up to 5 labels upon the completion of a compound.
12
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Diana Hazardous Drug Compounding System, ICU Medical, Inc.
13
Setting up the System
●How to connect the cables to Diana
●Barcode & Scanner
Operation of the System
All the components required for operation are integrated in the base unit.
The touch panel allows the operator to communicate with the System. The operator enters commands via
the keypad, and the System acknowledges this by means of plain text in the display.
Aer powering the System on, the device rst carries out a self-test. If an error is found during the self-test,
the operator sees an error message. If the error is found to be in one of the two compounding channels,
the relevant channel is displayed so that the operator can, if appropriate, remove the cause of the problem.
Readiness for operation is only displayed aer the self-test has recognized that the device is functioning
correctly.
I '
• II I ZebraPrinter
SerialCable
=-,-:-::-------------,
Cable
~'-= t
4,~
Diana MotorolaScanner SerialCable
MiniPowerCord
InterfaceModule
InterfaceModulePowerCord
MotorolaPowerCord
DianaPowerCord
PowerOutlet
ICU Medical, Inc. Document Number: DF-4925-EN Rev: 02
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Diana Hazardous Drug Compounding System, ICU Medical, Inc.
External Accessories
Connection of the external accessories (e.g. foot pedal, external liquid sensor, serial interface module,
scanner and printer) must only be performed when the device is powered o and the mains switch is not
illuminated.
Connecting the External Liquid Sensor
During compounding with Channel 2, always use the external liquid sensor which is supplied with the System.
It monitors the level of liquid in the drip chamber of the diluent supply line and automatically interrupts the
compounding process before air is pushed into the receiving container.
The sensor must be connected to the FLC connector on the back of the device for correct operation. Insert
the FLC connector into the receptacle on the rear of the System and hand-tighten, using the screws on the
connector.
Liquid sensors in channel 1 are embedded into the Diana System. No further action is required to use.
Powering the System On
Before powering the System on, check to ensure that all the external connection devices and main power
cord are secure.
When rebooting the system the user should wait 10 seconds before turning the Diana back ON to allow the
device to properly initialize.
14
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Diana Hazardous Drug Compounding System, ICU Medical, Inc.
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Connecting the Channel One Cassette to the syringe
●Use only the sterile and approved ICU Medical components with the Diana System and remove any air
gap in the provided syringe before making the connection to the cassette.
●Screw the syringe all the way to the cassette collar to create a secure tting and correct syringe-cassette
length as shown in illustrations 5 and 6 below.
●Eliminate any visible gap between the syringe luer end and cassette collar as shown in Illustration 7.
Cassette Collar
Cassette Flow Chamber
Illustration 5 - Cassette-Syringe Connection Illustration 6 – Connected Cassette
Remove any air gap in syringe barrel before connecting the syringe to the cassette.
Eliminate any
visible gap
Illustration 7 - Eliminate any visible gaps
Eliminate any visible gap between the cassette collar and syringe luer end.
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Diana Hazardous Drug Compounding System, ICU Medical, Inc.
Installing Disposables for Channel One
When assembling the disposable items, follow this sequence:
1. Uncap syringe and remove any air gap in syringe barrel
2. Connect cassette flow chamber to the 20 ml syringe
3. Verify a secure and no gap “luer-to-collar” connection between the syringe and the cassette
4. Insert the assembled cassette and syringe unit into the syringe pump unit
5. Prepare the receiving container
6. Prepare the vial from which fluid is to be transferred
7. Connect the vial to the cassette in Channel
8. Connect the receiving container to the cassette
16
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Diana Hazardous Drug Compounding System, ICU Medical, Inc.
17
Insertion of the Syringe Cassette Unit
Illustration 8 – Cassette assembly insertion Illustration 9 – Cassette insertion
As shown in illustrations 8 and 9, push the syringe/cassette assembly unit in the direction of the arrows into
the groove. When inserting the unit, ensure that the cassette engages fully, and a ‘click’ sound will be heard.
In addition, verify the correct seat of the syringe piston in the lower holder of the pump unit. Fix the piston
by turning the knurled screw lightly - do not over-tighten.
Knurled screw should be in unscrewed position before inserting and removing the syringe/cassette
assembly unit.
Do not over-tighten knurled screw.
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Diana Hazardous Drug Compounding System, ICU Medical, Inc.
Priming Section
When using new cassettes in Channel 1, Diana will detect the lack of fluid and ask if a new cassette has
been inserted. If so, select “Yes, Start Priming” and Diana will automatically prime the cassette before
administering a fluid transfer.
Preparation of the Receiving Container
The following receiving containers can be used with the System:
Infusion bag
Semi-rigid plastic bottle
Elastomeric pump
All the containers listed above need to be connected to the System disposables by means of the Clave®/
MicroClave®/Y-Clave®/ChemoLock® Connector to ensure functionality. For correct handling of the device
used with the receiving container, please refer to the Directions for Use included in each package.
Preparation of the Drug Vial
Access the drug vial using an approved Vial Access Device according to the Directions for Use.
Connection of the Drug Vial and Receiving Container to the System
Attach the vial and receiving container to the cassette by utilizing the ChemoClave or ChemoLock Closed
System. See Cassette Directions for Use for additional instruction.
Ensure drug vial temperature is within 8-12oC of room temperature to minimize occurrence of
condensation on cassette during compounding. Remove the required vials from the refrigerator
and allow them to reach room temperature (about 30 minutes) prior to compounding to minimize
occurrence of condensation on cassette.
Illustration 10 – Connected receiving container
18
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Diana Hazardous Drug Compounding System, ICU Medical, Inc.
19
Installing Diluent Set for Channel Two
When assembling the disposable items, follow this sequence:
1. Prime the diluent set prior to use.
2. Insert the 50 ml syringe into the syringe pump carriage.
3. Connect to the solution container, or use the spike to access.
4. Suspend the solution container.
Ensure the diluent set fluid lines are not twisted or occluded before operating the Diana System.
Priming Channel Two
Channel Two must be hand primed before using. To hand prime, connect the diluent set to a source
fluid container and receiving container and remove the syringe from the syringe pump carriage. Manually
draw 20 ml fluid into the syringe from the source container. Hold the syringe vertically with the syringe facing
upwards to allow air bubbles to escape though the syringe luer tting. Press the liquid out from the syringe
into the receiving container and dispose of the priming liquid waste. When the tubes and syringe are de-
aerated, reinsert the syringe into the Channel Two syringe pump carriage. Discard priming fluid volume and
if needed receiving container.
Insertion of the 50 ml syringe into the syringe pump unit
Align the groove of the syringe with the carriage and rst insert to the rear, then press the front end into the
mounting. Fix the syringe in position by means of the knurled screw. Fix the piston by turning the knurled
screw lightly - do not over-tighten.
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Diana Hazardous Drug Compounding System, ICU Medical, Inc.
Drip Chamber and External Liquid Sensor Placement
The Channel Two drip chamber and the external liquid sensor help ensure consistent fluid flow and no air-
in-line occurs between the source container and receiving container during dispensing.
As shown below in Illustration 11, ll the drip chamber to the top with fluid - minimizing the air gap - by
squeezing the chamber when connected to the source container. Aer the drip chamber is full, slide the
external liquid sensor as far up the drip chamber walls until snug and secure in place.
Illustration 11- Proper sensor placement
Fill the drip chamber to the top with fluid minimizing the air gap.
Slide the external liquid sensor as far up the drip chamber walls as possible.
20
ICU Medical, Inc. Document Number: DF-4925-EN Rev: 02
Effective Date: 01 Aug 2016 Printed By: Date/Time:
Confidential and proprietary information. Do not reproduce without written permission from ICU Medical. Users must ensure that they are using the most current released
rev of this document.