1.0

Introduction ................................................................................................................. 5
Intended Use ............................................................................................................................ 5
Important Safety Instructions .................................................................................................. 5
Warnings and Precautions ....................................................................................................... 6
List of Symbols Used on the Instrument .................................................................................. 8

1.4.1
2.0

List of Symbols on the Back of the Instrument ......................................................................... 9
Diana Peristaltic Pump Overview ...............................................................................10
Installation ............................................................................................................................. 10
Equipment Description .......................................................................................................... 11

Diana Peristaltic Pump, ICU Medical

Page 2Graphic User Interface (GUI).................................................................................................. 13
Data Entry .............................................................................................................................. 14
Consumables .......................................................................................................................... 15
2.5.1

Tubing Set Overview............................................................................................................... 15

2.5.2

Tubing Set Information and Compatibility.............................................................................. 16

3.0

Operating the Diana Peristaltic Pump ........................................................................17
Tubing Set Installation / Removal .......................................................................................... 17Power On ............................................................................................................................... 19
Drug Set Up ............................................................................................................................ 20

3.3.1

Changing the Specific Gravity ................................................................................................. 21

3.3.2

Entering the Container Volume .............................................................................................. 24
Priming ................................................................................................................................... 25

3.4.1

Priming to Container .............................................................................................................. 25

3.4.2

Circle Priming ......................................................................................................................... 27
Calibration .............................................................................................................................. 28

3.5.1

Warnings During Calibration Process ..................................................................................... 31
Basic Set Up and Transfer ...................................................................................................... 32
Forward / Reverse Transfer ................................................................................................... 34
Batch Mode ............................................................................................................................ 35
Power Off ............................................................................................................................... 37

4.0

Settings......................................................................................................................38
Customization ........................................................................................................................ 38

4.1.1

Custom Speed Settings ........................................................................................................... 39

4.1.2

Version Information ............................................................................................................... 41

4.1.3

Volume ................................................................................................................................... 42

4.1.4

User Login............................................................................................................................... 42

4.1.5

Adjust Priming Volume ........................................................................................................... 43

4.1.6

Activate / Deactivate User Login ............................................................................................ 44
Date and Time ........................................................................................................................ 48
Advanced Settings.................................................................................................................. 49

4.3.1

Rotating passcode .................................................................................................................. 49

4.3.2

Edit Drug................................................................................................................................. 50

4.3.3

Language ................................................................................................................................ 54

4.3.4

User Management.................................................................................................................. 55

4.3.5

User Login at Startup .............................................................................................................. 57

4.3.6

Require Drug Information ...................................................................................................... 57

4.3.7

Change Specific Gravity in the Drug Screen ........................................................................... 58

4.3.8

Complete Screen Display Interval in Seconds ......................................................................... 59

4.3.9

Logfiles ................................................................................................................................... 60

Diana Peristaltic Pump, ICU Medical

Page 3

Technical Services .................................................................................................................. 61
Developer ............................................................................................................................... 61
5.0

Specifications, Maintenance and Troubleshooting .....................................................62
Accuracy Specifications .......................................................................................................... 62

5.1.1

Envionmental Specifications................................................................................................... 62
Pulsating Battery Indicator .................................................................................................... 63
Fuse Replacement .................................................................................................................. 64
Tubing Replacement .............................................................................................................. 64
Temperature Warning ........................................................................................................... 65
General Troubleshooting ....................................................................................................... 66

6.0

Unit Software Update .................................................................................................67
Duty Cycle .............................................................................................................................. 71

7.0

Transport ...................................................................................................................72

8.0

Database Error ..........................................................................................................72
List of Database Errors ........................................................................................................... 72

9.0

Service and Contact Information ................................................................................74

10.0

Warranty and Service Information ..............................................................................75
Limited Warranty ................................................................................................................... 75

Appendix A: Cleaning and Disinfection of the Diana Systems .........................................................76
Appendix B: Accuracy Verification Protocol.................................................................................77
Appendix C: Volumetric Calibration ...........................................................................................78

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Page 4

1.0 Introduction
Intended Use
The Diana Peristaltic Pump is an automated pharmacy compounding system and it is intended to be
used in a healthcare facility to dispense a specified quantity of liquid from a set of source containers
into a destination container. For the purposes of this manual, a liquid is a substance that flows freely
but is of constant volume, having a consistency like that of water or oil.
Intended users/operators of the System are Pharmacists and Pharmacy Technicians. The operator
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 as-needed basis, recurring training is not required to operate thisunit.

Important Safety Instructions
The operator must be properly trained in the use of the System. Please follow the information
contained in this manual regarding its operation.
Always follow published guidelines relating to work protection and accident prevention, and ensure
professional diligence at all times.

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Warnings and Precautions


Read this User Manual carefully before using the Diana Peristaltic Pump.



DO NOT connect unit directly to humans.

No modifications to the Diana Peristaltic Pump are allowed. Do not modify in any way, otherwise there is a possibilityof operator injury, impairments or damage to the unit.

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



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



DO NOT place the compounder on an unstable surface.



To avoid the potential for cross-contamination between drugs, replace the tubing set when a new drug is to becompounded.

When using the Diana Peristaltic Pump to transfer liquid to rigid containers such as vials or bottles, care should betaken to ensure the containers remain upright at all times and ensure containers are not over-pressurized prior toconnecting to the Diana Peristaltic Pump.

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



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



The Diana Peristaltic Pump should only be connected to a properly grounded electrical supply outlet. User shouldrefer to the requirements for medical electrical systems in the current edition of IEC 60601-1 for proper use.



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

Position the Diana Peristaltic Pump to assure asy access to its power plug (so that it can be disconnected fromelectrical supply in the event of an emergency).



The tubing set fluid path is sterile (sterilized using irradiation) and non-pyrogenic in unopened and undamaged
packaging. Use aseptic techniques with tubing set when removing caps, spiking diluent containers, and making
connections to luer adapter.



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



The dispensing set should be changed within 24-hours due to touch contamination.



DO NOT re-sterilize or reuse the tubing set. Re-sterilizing or reusing may cause damage to the tubing.



Change the tubing set prior to each change of liquid to avoid drug incompatibility and/or transferring the incorrectvolume.



DO NOT USE Diana Peristaltic Pump to compound hazardous drugs and medications (for example acids, ethers andother chemicals known to be incompatible with silicone tubing). The system is designed only for non-hazardous
liquids.



Refer to tubing set label for important use information.



DO NOT USE for intravenous administration or other routes of direct patient delivery.

Calibrate the system each time the tubing set is changed. Only the intended direction needs to be calibrated.
Calibrate again if direction is changed. The system retains calibration for both directions to allow repeated switchingof direction without recalibrating. Either direction can be recalibrated as often as desired.



Calibration should always be performed with the liquid intended to transfer because the tubing set should bechanged prior to each change of liquid.

Accurate specific gravity configuration is essential for gravimetric accuracy. Accuracy reported by the system isdirectly related to the accuracy of the specific gravity used for the liquid to be transferred.

For highest accuracy, calibration should be performed using a container similar to the one intended for transfer andat a volume similar to the intended transfer volume.

Calibration may need to be performed when there is a change in pump speed, use of needles, use of in-line filters,
filling containers that create back pressure such as elastomeric or microbore tubing, or a significant change indesired volume.

Use of tubing set that are not compatible with the Diana Peristaltic Pump may adversely affect volume accuracy,
pump reliability and performance. See Compatible Tubing Sets section for more details.



DO NOT operate the system without the roller cover in place as injury may occur. If the roller cover is bent or
damaged contact ICU Service for repair.

The power cord must be connected to a properly grounded hospital grade 120V receptacle for proper pump
performance and safety.

Liquid ingress inside the pump may cause damage and impact performance. Clean spills immediately.

RECOMMENDED: Use Heavy Duty “BX01”, “BX02”, or “BX03” tubing when filling ambulatory pumps or other hard to
fill containers.

Diana Peristaltic Pump, ICU Medical

Page 6



Pump operation must be monitored at the beginning of each cycle and at intervals during the cycle to ensure the
Diana Peristaltic Pump is operating within acceptable limits (out of limits conditions displayed during use). Use thecalibration function to achieve specified accuracy (see Calibration Process section for more details).



Verify pump accuracy performance before use to ensure It meets facility protocols.



Do not operate the pump if at any point the roller assembly is rotating while the lid is open. In such an event,
unplug the pump, discontinue operation, and contact ICU Medical service center for repairs.

Save the original box and packaging. In the event that the pump needs to be sent in for servicing, return the Diana
Peristaltic 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 be provided.

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



DO NOT use the Diana Peristaltic Pump continuously for more than 8 hours or 240 liters. Upon reaching this limit,
allow the system to rest for 30 minutes before additional use.



DO NOT use the same tubing set for more than 60 liters, overuse may result in damage to the tubing set and spill of
the liquid.

Some metal parts might be warm when in use. The user should allow the unit to cool down prior to moving ortransporting the unit.

Consider the drug manufacturer's labeling and USP compounding guidelines when performing compounding.

Ensure Diana Peristaltic Pump is placed on a stable surface. If applicable, allow Biomedical Engineering to confirm
electrical requirements are met.

At the end of service life, dispose of pump, accessories, and consumables by contacting ICU Medical for further
information.



During storage and use, avoid impacts and vibration which could result in a malfunction of the Diana Peristaltic
Pump.



The System is designed for use in Biological Safety Cabinets, Laminar Airflow Hoods and/or Safety Work benches inclean rooms in a healthcare setting.



Do not insert any foreign objects into the unit ports and openings.



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



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

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



The System is not suitable for use in mobile equipment.

Some metal parts may be warm after heavy use of the unit. The user should not use the unit for 30 minutes before
transportation to allow the metal parts to cool.

Verify Diana Peristaltic Pump accuracy performance before use to ensure it meets facility protocols – see section 5.1
for details.

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Page 7

List of Symbols Used on the Instrument
This instrument is compliant with the symbols mentioned below.
SymbolReference
IEC 60417 – 5010

“ON”/ ”OFF” (push-push)

ISO 7010 - M002

Refer to instruction manual/booklet Symbol

IEC 60417 - 5032

Alternating current

ISO 7010 - M005

Connect an earth terminal to the groundISO 7010 - W001

General warning sign

ISO 7010 - W012

Warning; electricity

ISO 7000 - 3082

Manufacturer

ISO 7000 - 2498

Serial number

CSA

Certification markISO 15223-1: 2016
(Symbol 5.1.2)

IP33

Description

IEC 60529

Authorised European representative
Ingress protection

IEC 60417 - 6414

WEEE; waste electrical and electronicequipment; crossed- out wheeled bin

ISO 7000 - 0632

Temperature limit

ISO 7000 - 2620

Humidity limitation

Diana Peristaltic Pump, ICU Medical

Page 8

1.4.1 List of Symbols on the Back of the Instrument
The graphics below show the back panel of the instrument. The callouts indicate the location ofvarious connectors and switches for the Diana Peristaltic Pump.

SymbolReference

Description

IEC 60417, Reference
Number: 5016

Indicates the fuse is held inside the housing

IEC 60417, Reference
Number: 5534

ISO 7000-3650

Diana Peristaltic Pump, ICU Medical

Page 9

Indicates plug to be used to Power onsystem.
Indicates socket to be used for USB Update
port2.0 Diana Peristaltic Pump Overview
Installation
To install the unit, place the unit onto a stable surface. Plug the ICU supplied power cord into theback of the unit and then into an electrical outlet.
Note: The Diana Peristaltic Pump should only be connected to a properly grounded electricalsupply outlet. Users should refer to the requirements for medical electrical systems in thecurrent edition of IEC 60601-1 for proper use.
Once the system is plugged in, press the circular on/off switch located on the front of the
instrument.
We recommend the system be sent to ICU medical Service once a year for inspection andmaintenance.
All maintenance and installation must be performed by an authorized ICU Medical representative.
All maintenance work should be completed by the manufacturer with the exception of routine
cleaning.

Diana Peristaltic Pump, ICU Medical

Page 10Equipment Description
The Diana Peristaltic Pump is an automated pharmacy compounding unit controlled by softwareand is intended to be used in a healthcare facility by Pharmacists and Pharmacy Technicians todispense a specified quantity of liquid from a set of source containers into a destination container.
The pictures below show the Diana Peristaltic Pump with the major components labeled andreference the table that follows. Descriptions of the components can be found in Table 1 following
the pictures.

3

Views of the Diana Peristaltic Pump Module

2

1

Diana Peristaltic Pump, ICU Medical

Page 11

Back of the pump

6

7
4

8

5
10

Reference
12

Component
Power Button
Tubing Detection Sensor

9

Table 1
Description
Power ON/OFF Button.
The Tubing Detection Sensor detects the presence and proper
placement of the tubing set.
Protective cover, must be closed while unit is actively
pumping
Replaceable fuses, used to protect electrical equipment

3

Flap

4

Fuses

5

Power Inlet

6

Printer Port

7

USB Port

8

Scanner Port

The USB port is for use by ICU Medical authorized personnel
to service Diana Peristaltic Pump.
User can use it for to export or import files with a USB Stick.
The ports not used by the system. They are plugged by a cap.

9Foot Pedal Port

The ports not used by the system. They are plugged by a cap.

10

Scale Port

The ports not used by the system. They are plugged by a cap.

Diana Peristaltic Pump, ICU Medical

The Power Inlet is used to connect the Diana Peristaltic Pump
to the electrical outlet using the provided power cord.
The ports not used by the system. They are plugged by a cap.

Page 12Graphic User Interface (GUI)The user interface of the Peristaltic Pump has been designed so that there are three tabs at the
top of the screen (Drug Set Up, Set Up, Compound) where a user can navigate to a specificworkflow.
The figure below show the user interface screen on the Diana Peristaltic Pump with key items
labeled. Descriptions of the these key items can be found in Table 2 following the figure.
7 Set Up Tab
11 Toolbar
1 Drug Set Up Tab

8 Compound Tab

2 Drug Name
10 Drug Name Input
3 Drug ID
4 Lot Number

9 Specific Gravity Field

5 Lot Expiration Date

Reference
1

Component
Drug Set Up
Tab

2

Drug Name

3

Drug ID

4

Lot Number

5

Lot Expiration
Date
Container
Volume6
7

Set Up Tab

Diana Peristaltic Pump, ICU Medical

6 Container Volume

Table 2
Description
This tab is the first screen to be displayed and allows a user
to assign drug information to a container. This information
will then be used to generate a compounding log andlabelling for future use.
Enter the drug which is used in preparation. Most common
drugs will show up on the right side of the menu.
Identification Number associated with the Drug Name will
display on screen.
Enter lot number of the drug. This information can then be
retrieved in compounding reports.
The expiration date for the drug. (MM/YYYY)
The amount of liquid (in mL) in the source container. This isused to ensure that there is enough liquid to fill thedestination containers.
Allows a user to provide the amount of volume (in mL) tobe transferred. Within this tab, a user can also change thespeed of transfer (mL/min). Once this information isentered, a user can tap “Start” to initiate a transfer.

Page 13Reference
8Component
Compound Tab

9Specific Gravity
Field

10

Drug Name
Input

11

Toolbar

Description
Provides user a visual confirmation that the system istransferring liquid.
Note: This tab is only functional during a transfer.
Displays entered Specific Gravity of chosen drug.
Note: The default specific gravity is set to 1.0 g. The specificgravity of a drug can be changed by the user on the Drug
Set Up screen or in Edit Drug settings page. Edit Drugsettings require an operator to be an authorized user in the"Advanced Settings”.
Provides the user a list of recently used drug names forquick input into the drug compounding log. A user can tap
the drug name for quick data entry.
Provides the user access to the settings

Data Entry

Enter the numeric value andpress “Enter”

Diana Peristaltic Pump, ICU MedicalEnter the alphanumericvalue and press “Enter”

Page 14Enter the date and press“Enter”

Consumables
2.5.1 Tubing Set Overview
The following accessories/consumables are not included with the Diana Peristaltic Pump. They
must be ordered separately. Contact an ICU representative for assistance in ordering.
The picture below shows the tubing set with key features labeled. Descriptions of the these key
features can be found in Table 3 following the picture.

1

2

3

The tubing set is to be used in conjunction with the Diana Peristaltic Pump. The set consistsof an input port, output port, and tubing set handle.
Table 3
Reference Component

Description

1

Input Port2

Output Port3

Tubing Set
HandleThe Input Port is a proprietary ICU Medical Connector that mates with aproprietary ICU Medical connector to establish a closed system duringliquid transfer.
The Output Port is a proprietary ICU Medical Connector that mates witha proprietary ICU Medical connector to establish a closed system duringliquid transfer.
The Tubing Set Handle allows a user to easily place the tubing set into
the Tubing Detection Sensor. Ensure the red clip is on the top of the
Tubing Detection Sensor.

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Page 15

2.5.2 Tubing Set Information and Compatibility
ICU Medical recommends that only compatible tubing sets tested by the manufacturer be used
for compounding.
ICU Medical Item
Part Number
BX01
BX02
BX03
LPA01
PA01
PA01LL
PA02
PA03

Description
Single Lead Heavy Duty Tubing Set
Dual Lead Heavy Duty Tubing Set
Triple Lead Heavy Duty Tubing Set
Single Lead Tubing for use w/Lipids
Single Lead Tubing Set
Single Lead Tubing Set- w/Double Luer
Double Lead Tubing Set
Triple Lead Tubing Set

The following components are compatible with ICU Medical Tubing Sets:
Component Type
SpirosClave
16-gauge needle
18-gauge needle
0.2-micron filter
0.5-micron filter
Elastomeric pump
CADD cassette

Diana Peristaltic Pump, ICU Medical

Page 16

3.0

Operating the Diana Peristaltic Pump
Tubing Set Installation / Removal

The following section describes how the user of the Diana Peristaltic Pump Module properly inserts
and removes the tubing set unto the unit.
Note: Incorrect insertion of the tubing set may damage the unit.
1.

The Diana Peristaltic Pump should be placed with the display view facing the user.

2.

Before opening, inspect the tubing set package. If packaging is not intact, discard it and use a new set.

3.

Using aseptic technique, open the package and remove the tubing set.

4.

Locate the embossed "arrow" pointing downwards on the handle of the tubing set. Locate a "red clip" behind thehandle.

Diana Peristaltic Pump, ICU Medical

Page 17

5.

Turn the roller head by hand to insert the white clip into the roller pump. Hand turn the roller head until the tubing set
is secure around the perimeter of the roller head.

Note: Ensure there is no kinking of the tube.
When removing the tubing set, it is recommended to clamp the lines to prevent spillage.
6.
7.
8.

When ready to remove the tubing set, pull white clip upwards.
Turn the rollers by hand while removing the tubing.
Pull red clip upwards and remove the tubing set from the roller pump.

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Page 18

Power On
Press the Power Button on the front of the unit (lower right) to turn it on.

When the pump has been started, a welcome screen is displayed (see below).

Diana Peristaltic Pump, ICU Medical

Page 19

Next, a series of alerts will display, depending on the state of the unit (see below):

No Tubing Set Detected

Tubing Set Detected

Flap is Open

Satisfying the unit command or answering the questions will bring the user to the home screen.

Drug Set Up
Enter the drug information by selecting the Drug Name text field and entering the data.
The drug must exist in the database. Additionally, the unit has a “quick feature” list on the right that
defaults to the most commonly transferred drugs.

The “Next” button will only be activated if all fields are filled out.
Note: User must enter a specific gravity for the selected fluid in the Specific Gravity field
before proceeding, see “Changing the Specific Gravity” section 3.3.1 for more details.
Note: User must enter the input container volume in the Container Volume field before
proceeding, see “Entering the Container Volume” section 3.3.2 for more details.
Press the “Next” button. The next step is to start the priming and calibration process.

Diana Peristaltic Pump, ICU Medical

Page 20

3.3.1 Changing the Specific Gravity
The specific gravity of a drug can be changed by the user on the Drug Set Up tab. Changes tothis option require a user permission to be enabled by the authorized user in the "Advanced
Settings."
Note: The default specific gravity for most drugs is set to 1.0 g.
1.

The default specific gravity is set to 1.0g for most fluids. User will see a blue square with ayellow triangle containing an exclamation mark (see below) - this means that the specificgravity can be changed by the user to a different value. When user clicks on the specificgravity field a warning message will appear advising that user is about to change thespecific gravity for that particular drug (see below).

Note: If user presses “Cancel”, system will return to the Drug Set up screen with the specificgravity selected at the default of 1.0 g.

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Page 21

2.

Press "Continue" to change the specific gravity of the selected drug by manually entering
using the keyboard. Then press the "Enter" button.

Note: User will receive a warning message after the modified specific gravity is entered. User
must acknowledge the message by pressing the "Save" button. The changed specific gravity isthen permanently saved into the database.

Note: When the Cancel button is pressed, the Peristaltic Pump returns to the drug Set Up
screen. The specific gravity has not been changed.

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Page 22

3.

Saved changes to the specific gravity in the database will appear in gray font and a notification
stating that “specific gravity changed by user” will display above the drug name.

4.

If the user selects a drug from the database where the specific gravity has already beenchanged, the button is grayed out and cannot be changed on the Drug Set Up screen. The
specific gravity can only be changed or adjusted by the authorized user in the Advanced
Settings.

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Page 23

3.3.2 Entering the Container Volume
The user must enter, in the Container Volume field, the volume of liquid has been attached to thesystem in the source container. The system will track the volume that has been removed fromthe source container during use. The system will provide a warning message (see below) to theuser when the unit predicts that the source container will be empty based on the previous subsetof transfers.
On the Drug Set Up screen, select the volume of the source container. User can manually enterthe volume or select a predetermined container size. Enter Lot number and Lot Expiration Date of
the new source container. Press “Continue”.

The system will automatically stop once the source container is empty with no air within the set.

A new source container volume can be entered if additional transfers are necessary.

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Page 24

Priming
Priming is typically performed into a disposable container that will be used for priming andcalibration and then destroyed. In this process, air primed out of the tubing and any excess liquid istransferred to the priming container. See the “Priming to Container” section of this manual.
In certain circumstances, it may be useful to prime the tubing using a modified method known as
Circle Priming. See the “Circle Priming” section of this document.

3.4.1 Priming to Container
Note: In order to properly calibrate the unit, ensure the tubing set is properly primed
following these instructions. Failure to do so may result in incorrect liquid volumes beingtransferred.
1. If not already connected, connect the input (proximal) end of the tubing set to a source
container.
If a multi-lead tubing set is used, connect each of the input (proximal) ends of the tubing
set to a source container. For Circle Priming, see the “Circle Priming” section of thisdocument.
2. If not already connected, connect the receiving (distal) end of the tubing set to a
destination container.
Note: Make sure that the receiving (distal) end of the tubing set is connected to a
destination container.
3. The unit prompts the user if the tubing set needs to be primed. Press "Prime" and the unit
automatically starts to prime the tubing set.
Note: There may be a few seconds delay between pressing “Prime” and the unit
starting.
4. Visually confirm priming was successful, then disconnect the destination container fromthe tubing set.

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Page 25

If Skip Prime is selected, the tubing set will not be primed, system will return to the Calibrate
screen.

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Page 26

3.4.2 Circle Priming
In certain circumstances, it may be useful to prime the tubing using a modified method known as“Circle Priming”. In this process, air primed out of the tubing and any excess liquid is transferredback to the source container.
Note: In order to properly calibrate the unit, ensure the tubing set is properly primed following
these instructions. Failure to do so may result in incorrect liquid volumes being transferred
1. If not already connected, connect the input (proximal) end of the tubing set to a source
container.
If a multi-lead tubing set is used, connect each of the input (proximal) ends of the tubing
set to a source container.
2. For circle priming, if not already connected, connect the receiving (distal) end of the tubing
set to a separate port on the source container.
Note: Make sure that the receiving (distal) end of the tubing set is connected to thesource container.
Note: If a multi-lead tubing set is used, make sure that the source container
connected to the receiving (distal) end of the tubing has sufficient capacity to safely
receive the full priming volume.
3. The unit prompts the user if the tubing set needs to be primed.
Press "Prime" and the unit automatically starts to prime the tubing set.
Note: There may be a few seconds delay between pressing “Prime” and the unit
starting.
4. Visually confirm priming was successful then disconnect the receiving (distal) end of thetubing set from the source container.

If Skip Prime is selected, the tubing set will not be primed, system will be return to the
Calibrate screen.

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Page 27

Calibration
The unit allows a user to choose the liquid type and volume with which to calibrate the system. The
liquid type can be selected in the Set Up Tab. It is recommended to calibrate the machine after
change of the tubing set, desired volume, destination container, or when the unit has transferredover 60,000 mL from all liquid transfers. Because the tubing set should be replaced when a new drug
is to be compounded, it should be calibrated with the drug you intend to tranfer.
Note: For highest accuracy, calibration should be performed using a container similar to theone intended for transfer and at a volume similar to the intended transfer volume.
The calibration process of the Peristaltic Pump can be performed using a separate third-party scale,referred to here as an external scale. Accurate specific gravity configuration is essential for
gravimetric accuracy.
Note: Accuracy performance obtained by the system is directly related to the accuracy of thespecific gravity used for the liquid to be transferred.
Calibration is typically performed into the same disposable container that was used for priming,then the container should be destroyed. In certain circumstances, it may be useful to prime thetubing using a modified method known as Circle Priming.
If circle priming is performed, a separate disposable container should be be used for calibration thendestroyed.
1. Enter Calibration Volume and identify the speed.

Note: The transfer speed will be based on the volume and viscosity of the liquid. To adjust
the speed of the pump, tap the arrows on either side.
2. If not already placed, place the destination container (calibration container) on the scale.
Note: To ensure proper calibration, , it is recommended to detach the destination
container from the tubing set during the Weighing Process. Failure to do so may result ininaccurate calibrations. Ensure destination container is reconnected to the tubing set
before proceeding and pressing “Start”.

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3. Tare the external scale.
4. Press “Start” to initiate the transfer.
Note: There may be a few seconds delay between pressing “Start” and the unit starting.

5. After the calibration transfer is complete, enter the weight measured by an external scale
into the screen as shown below. After entering the weight, press “Accept”.

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6. After a successful calibration, the unit will display a confirmation that calibration has been
completed and the user will be directed to the Set Up menu.

Note: Pressing “Accept’ will update the calibration of the unit to account for theover/underfill of the transfer as indicated on the screen (difference between specified
volume/weight vs measured weight).
7. Disconnect the calibration container from the tubing set.
8. If the measured weight entered is not compliant with facility’s guidelines, a recalibration
may be performed and the calibration transfer repeated.

Note: By pressing Recalibrate, the unit will adjust its calibration setting based on theprevious transfer and then a new calibration process begins to ensure accurancy

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3.5.1 Warnings During Calibration Process
The following warnings can be encountered during an incorrect calibration process.

The first warning message of “Wrong Calibration!” is displayed when the discrepancy between
the expected and the measured weight is more than 30%. Pressing the “OK” returns user toPrime part of the workflow.
Repeat the priming and calibration to ensure the accuracy of the unit.
The second warning message of “Calibration out of regulatr range!” is displayed when thediscrepancy between expected and measured weight is within 10-30% range.
Pressing "Yes" button confirms the user's entry and completes the calibration process. Pressing"No" button returns user to Prime part of the workflow.

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Basic Set Up and Transfer
Upon proper calibration, the unit allows a desired volume to be transferred and the speed to be
set up before initiating a transfer.
1. If not already connected, connect the input (proximal) end of the tubing set to a source
container.
2. If not already connected, connect the receiving (distal) end of the tubing set to a
destination container.
3. Enter Volume to be transferred and select the speed. Press “Next” to confirm the transfer
process.

Note: Pressing “Next” without entering a volume will enable the “Infinite Transfer” mode. Pump
will indicate that “Infinite Transfer” mode is about to be initiated, volume number will change toan infinity symbol (See below). Infinite mode will continue until the user manually stops thetransfer.

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4. Unit will move to the Compound tab screen.
After confirming that entered information is accurate, press “Start” to initiate transfer.
The unit will begin liquid transfer and the progress bar will indicate the status of thetransfer. The volumetric measurement will provide an indication of what has beentransferred into the bag. Pressing “Stop” will interrupt the transfer.

Note: There may be a few seconds delay between pressing “Start” and the unit starting.

5. Once the transfer is complete, the system displays the “Compounding Completed”
message. The system will automatically return to the Set Up screen (the duration of“Compounding Completed” message display is configurable in the Advanced Settings).

6. Disconnect the Tubing Set and place the destination container on the External Scale forweighing. Check the weight and verify that the correct volume is transferred.
7. After compounding is complete, follow facility’s medication handling protocol andprocedures.

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Forward / Reverse Transfer
When on the Set Up tab, the user can manually change the forward or reverse (right/left)
rotation of the pump. This setting allows residual liquids to be returned to the source
container.
Note: Forward rotation (counterclockwise rotation) is activated by default.
Note: The Calibration is only accurate for the direction you use at the Calibration Step.
Both Forward and Reverse directions should be calibrated separately to achieve specified
accuracy.

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Batch Mode
For compounding multiple destination containers/doses, batch mode can be used. User can
specify a set interval time to wait between the transfers, allowing a user to efficiently batch-fill
multiple destination containers (e.g. vials).
1. From the Set Up screen, press “Batch” to set the number of (destination) Containers andInterval Time.

Note: The minimum interval time between the individual fillings is set to a default of 2 seconds.

OptionDescription

Number of Containers This number specifies the quantity of destination containers planned tobe filled. For example, if the machine is to fill 10 syringes, the Number ofContainers would be 10.
Note: Maximum number of destination containers is 999.
Interval Time

This number specifies the time (in seconds) the unit will wait to initiate
next transfer.
Example: If the interval time is set to 5 seconds, the unit will perform atransfer then wait 5 seconds before automatically initiating next transfer.
Note: Minimum time delay between transfers is 2 seconds, maximum is
180 seconds.

Quality Control Check

This number specifies which transfer (in order) should be used for aweighing check to ensure that unit calibration is still valid.

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2. Press “Accept” to continue.

Note: When batch settings are entered, the number of destination containers to be filled andthe interval/pause times between the individual fillings appear on the display of the unit.

3. If not already connected, connect the input (proximal) end of the tubing set to a source
container. For Circle Priming, see the “Circle Priming” section of this document.
4. If not already connected, connect the receiving (distal) end of the tubing set to a destination
container.
5. Press “Start” to begin batching. As each destination container is filled, the Container number
on the unit will update accordingly. The user will be alerted with a countdown on the top
right of how many seconds are left until the next transfer is automatically initiated.
Note: There may be a few seconds delay between pressing “Start” and the unit starting.

Diana Peristaltic Pump, ICU Medical

Page 36Power Off
When user is done with compounding processes, the unit can be turned off. Press the Power
Button on the front of the unit to turn it off.

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4.0 Settings
1. Click on

for Settings located in the top right of toolbar. The Menu Screen will appear.

The settings menu as described below, provides the user access to the basic settings of theunit.
OptionCustomization

Description
Allows updates to speed and volume and also allows user
to view software version

Date and Time

Allows updates to the date and time

Scale Calibration Check

This feature is not used

Advanced settings

Allows updates to drug listings, language options, andnetwork connections. (password-protected)

Technical Service

Allows access to technical settings (password-protected).
This option is reserved for ICU Medical personnel.

DeveloperThis is a settings screen for Administrators only

Customization
The Customization tab allows the user to modify settings that are user-controllable.

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4.1.1 Custom Speed Settings
The user of Diana Peristaltic Pump can modify the speed settings of the pump in the Customization
tab. The unit allows the user to select up to 20 different speed settings. Unique named identifiers
can be created and matched to a specific speed setting (e.g., the highest flow rate is equal to pumpspeed 20, while the slowest flow rate is equal to pump speed 1). The speed is measured in mL/min.
Default speed settings are show in the table below.
Speed
Slow (3)Normal (9)Fast (14)mL/min165
440700

Note: Precise pump speed is not user-configurable during compounding; only named identified
presets are available.
1. In the menu setting, select “Customization” and then the menu item "Cusom Speed
Settings".

2. A window will appear with the customization options for the Diana Peristaltic pump stored
in the system. In the next steps, the user can change the name of the speed settings. Speedsettings can be activated or deactivated for the user to see during liquid transfer.
Note: After a start-up, the pump defaults to a normal speed of 9.

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3. Press the “Add” button to select a specific name of a speed. The speed setting will be
updated once the name is selected.

4. User will now be able to see the selected speed name when performing a liquid transferfrom the Set Up screen. The user can press left/right arrows to change the speed.

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4.1.2 Version Information
The user and ICU Medical personnel can view the version of software components as well as
unit.

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4.1.3 Volume
With this setting, the user can adjust the sound volume. User can select a desired volume byclicking the desired position on the scale, the slide will move accordingly. To test the current
volume, press the Test button.

4.1.4 User Login

The default setting on the Diana Peristaltic Pump system does not require user login upon
power on. The user login settings can be updated by an authorized user. Once activated, theuser is prompted to enter the user name and password when the system is turned on. Userlogin settings can be updated within the Advanced Settings menu (see section 4.3 of thismanual).

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4.1.5 Adjust Priming Volume
The User can manually adjust the volume for priming the tubing set. If User Management (seesection 4.3.4 of this manual for details on User Management) is not activated, the user could findthe menu item “Adjust Priming volume” on the first page of the Customization. If the user
management is activated, the user could find the menu item “Adjust priming volume” on thesecond page of the customization.
1. When User Management is not activated, choose the menu item “Adjust priming volume”
from the first page of the customization menu. Press the displayed field and enter the volume
by using the keyboard. Confirm the entered volume by pressing the “save” button.

2.

If the User Management is activated, the user could find the menu item “Adjust priming
volume” on the second Page of the customization.

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4.1.6 Activate / Deactivate User Login
The User Login can be activated or deactivated in the advanced settings of the Diana Peristaltic
Pump system by the authorized user.
1.

Start the PPM module by pressing the on / off button and you will see the following
screen after some seconds.

2. Open up the Flap and insert the tubing set clip into the slot. Rotate the roller head so thatthe tubing is wrapped around the motor. (See Section 3.1 for detailed instruction for
installing the tubing set)
3. After the system has booted up, the query appears, asking if a new tubing set has been
inserted. Choose between "yes" and "no".
To remove the tubing set from the pump, lift the white clip out of the insert and unwrap thetubing set from the Rotor.

Note: if you choose between "yes" or "no" you will get different start screens. See chapter 5.2.

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4. Press the Next button. Now you reach the calibration menu. Press the button at the top
right of the touchscreen to access the settings and then select the advanced settings.

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5. Enter the pin code for this area. The pin code will be sent to you by the ICU Medical
service staff. Once pin is entered, you are in the menu sub-item of the advanced settings.

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6. Please scroll down by pressing the "Page Down" button and select "User Login at Startup"
to enable it.

Note: Once the green check mark is selected by the authorized user, the System must be
rebooted before the user login will appear.

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Date and TimeThe user can update the date and time in the Diana Peristaltic Pump on the first page of theSettings Menu.
1. Enter the current date and/or time and press set

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Advanced Settings
The Advanced Settings will allow the user to adjust various settings of the system. This menu isavailable only to authorized user and has a rotating passcode.

4.3.1 Rotating passcodeThe rotating passcode is composed of three different components and must be recalculated by
the user every day. The Requirements are: the Serial Number of the Diana Peristaltic Pump
system, the current date (this is the rotating part) and the value for assigned to the the Advanced
Settings options. The value assigned for Advanced Settings is 3.
1. The first component for choosing the rotating passcode is the current date. (the first 5 digitsof the date).
2. The second component is the last digit of the serial number of the Diana Peristaltic Pump
system.
3. The third and last component is the value for the setting area (3 -> for the Advanced
settings).

The date (first 5 digits of the date)
Serial Number of the PPM(Last digit of the serial number)

Below is an example of how the rotating password is calculated. To get the correct password, theuser has to add the three components consisting of Serial Number, X and Y together.
Passcode: Base PIN + X + Y
Base PINFirst 5 digits of the dateX
Y

Last digit of the serial number of the unit
Value for setting area (3 -> Advanced)

Example for calculating the passcode:
The digits which are marked in red are the digits that must be used in the rotaing passcode.
Date:
05/28/2021
Serialnumber of the used PPM: R10001NCY888
Value setting area:
3 (Advanced settings)
The Passcode for the Advanced setting area is: 05282 + 8 + 3 = 05293 (this is the correct passcode).

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4.3.2 Edit Drug
1. Select “Edit Drug” in the Advanced Settings menu.

Users can search drugs by NDC or a drug name.
To search by NDC, select NDC option. Enter the NDC code and press “Enter”.

Note: As user enters NDC number, system will suggest the NDC number to autofill.

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To search by name, select Name. Enter the name and press “Enter”.

Note: As user enters the drug name characters, system will suggest the name to autofill.
If required drug does not exist in unit’s database, then user will need to add the new drug tothe database. To add new drug, select “Add New Drug”. Enter the new drug information andpress “Enter”.

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2. Once the drug is identified, add missing information if required, and verify the correct informationis entered in the designated fields and press “Save”.

New Drug

Existing Drug

3. If a specific gravity is entered outside the value range defined in the system (0.95-1.30), the"Specific Gravity" field is highlighted in red. If the user continues and presses the “Save” button, awarning message appears which must be confirmed by pressing the "Ok" button. User will not beable to proceed further if correct Specific Gravity is not entered.

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4. Enter a specific weight in the range 0.9 – 1.30 g and then press "Save". System will return to initial
Edit Drug screen.

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4.3.3 Language
The Diana Peristaltic Pump has multiple interface languages that can be displayed. This menu
allows a user to switch the language.
1. Select Language in the Advanced Settings menu.

2. Select the Language by pressing on the gray square next to the desired choice. Press Saveto set the new language.

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4.3.4 User Management
The administrator of this function can create individual users and assign users various
permissions.
1. Select User Management in the Advance Settings section.

To create a new user:
Press “Add User”. Enter the username, password, and rights (permissions level). Press “Save”.

Note: The administrator can choose between two access rights (Standard and Advanced) and assign
this to the user. Only an advanced user has the ability to add new users to the system.

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To modify a user:
Select an existing user and press “Modify” button. Once done with changes press “Save’.

To delete a user:
Select an existing user and press “Delete” button. The user will be removed from the User
Accounts list.

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4.3.5 User Login at Startup
The authorized user can require a user login on the unit.
1. Select “User Login at Startup” in the Advanced Settings section.

2. Toggling between () and ( x ) will require the system to either require User Login at Startup
or not.
Note: When the green check mark is set by the authorized user, the user login will be required
each time the unit is powered on.

4.3.6 Require Drug Information
The peristaltic pump allows a user to require the presence of drug information before
compounding will begin. This aids in the proper documentation of the liquid being transferred.
Note: By default, Drug Info is set to “Not Require Drug Information”.
1. Select “Require Drug Info” in the advanced Setting section.

Drug Information is NOT required

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4.3.7 Change Specific Gravity in the Drug Screen
The authorized user can decide whether the specific gravity of a drug can be changed in the
Drug Set Up screen.
1. Select Change Specific Gravity in Drug Screen in the Advanced Settings section.

2. Toggling between () and (x) will allow the change of specific gravity or not.

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4.3.8 Complete Screen Display Interval in Seconds
A timer can be set for how long the display of the finished filling operation should be
displayed.
Note: This time adjustment can only be done after an authorized user enters the password toaccess the Advanced Setting menu
1.

Find the field below the “Complete Screen Display Interval in Seconds” in the Advanced
Settings section.

2. Using the "+" and "-" buttons, adjust the desired time-out interval. The interval can be set
between 0 and 60 seconds.

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4.3.9 Logfiles

Insert USB stick into adapter
Note: USB stick and adapter must be requested from ICU Service personnelInsert adapter into Peristaltic Pump USB port
Select desired option (Last 7 days, Last 30 days, Last 60 days, Archive)
Remove USB and adapter from pump after “Finished” message is displayed on unit
Note: “Archive” will save all available log files

Note: System will display progress until log files are transferred to the USB stick

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Technical Services“Technical Service” Menu Item is for ICU Medical authorized personnel only.

Developer“Developer” Menu Item is for ICU Medical authorized personnel only.

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5.0 Specifications, Maintenance and Troubleshooting
All maintenance must be performed by an authorized ICU Medical representative except forroutine cleaning and specifically excluded activities.
ICU Medical recommends sending the unit to ICU Medical Service department once a year for
inspection and maintenance. Please contact your local ICU Medical representative or ICU
Medical Service department for instructions.

Accuracy Specifications
Note: Verify Diana Peristaltic Pump accuracy performance before use to ensure it meets facility
protocols.
Diana Peristaltic Pump accuracy with Water/Isopropyl Alcohol at a Slow-speed setting using ICU
Medical Luer-based components, 16G needle, 18G needle:+/- 1% for volumes greater than or equal to 10 mL+/- 2% for volumes greater than or equal to 5 mL and less than 10 mL+/- 4% for volumes greater than or equal to 1 mL and less than 5 mL+/- 10% for volumes greater than or equal to 0.5 mL and less than 1 mL
Diana Peristaltic Pump accuracy with Dextrose 10%/Lipids at a viscosity-specific speed using ICU
Medical Lipids tubing set (Luer-based):+/- 10% for volumes greater than or equal to 5 mL
Diana Peristaltic Pump can provide a sustained transfer rate (measured with Water) using ICU
Medical tubing set:
0.7 L/min with Luer-based sets
0.6 L/min with 16G needle
0.2 L/min with 18G needle

5.1.1 Envionmental Specifications
Reference
Operating Temperature
Operating Humidity
Operating Altitude
Storage Temperature
Storage Humidity
Storage Altitude
Transportation Temperature
Transportation Humidity
Transportation Altitude
Physical Dimensions
WeightDiana Peristaltic Pump, ICU Medical

Specification+10°C to +40°C
15% to 60% (non-condensing)
0 to 2000 meters above sea level
0°C to +60°C
15% to 85% (non-condensing)
0 to 2,000 meters above sea level
0°C to +60°C
15% to 85% (non-condensing)
0 to 2,000 meters above sea level
5.7 in x 9.8 in x 8.6 in (145 mm x 249
mm x 218 mm)
11.2 pounds (5.09 kg)

Page 62Electrical Operating Power Range

100 – 240 V AC
0.8 – 0.4 A
50 – 60 Hz

Electrical Fuse

Pulsating Battery Indicator
The pulsating battery indicator is a safety reminder to the user that the Peristaltic Pump Module
has to returned to ICU Medical Service Team. The 3 Volt battery which is installed isn’t providing
the required power and has to be replaced.

If the battery has to be changed
this icon starts flashing at top of
display

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Fuse Replacement

The Peristaltic Pump uses two fuses located in the rear of the unit; fuses are a part of the Power
Inlet (See Section 2.2 for illustration of location). Service on the fuses can be performed by theend-user (end-user buys the fuses from local hardware/electrical store). Fuse type to be used is
ceramic fuse model number T2AH250V. Incorrect insertion of the fuses may result in no power tothe unit.
1. Make sure the unit is powered-off and power cord is unplugged.
2. Using flat head screwdriver, remove the fuse holder from the Power Inlet by turning the fuseholder in a counterclockwise direction.
3. Remove the old fuse(s) from the holder and replace with new fuse(s). It is recommended toreplace both fuses at the same time.
4. Re-insert fuse holder back into Power Inlet and rotate the fuse holder in a clockwise direction
gently until it stops. Be careful when threading the fuse holder back into the unit to to avoid
damage to the fuse holder or Power Inlet.

Tubing Replacement

The system will display the warning shown below if a tubing set has compounded more than
60L of fluid. When the user replaces the tubing set, the workflow may continue.

Note: This warning will continue to be displayed even if the unit is turned off and then on again.
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Temperature Warning
In rare instances, the Diana Peristaltic Pump may indicate that the system is overheating. A
common source of this issue is heavy use of the unit in short periods of time. To ensure proper
temperature maintenance, a maximum limit of duty cycle, transfer volume and internal
temperature has been placed in the unit software. Once the unit has reached one of these limits,a warning is displayed to the user.

The unit will be required to remain idle during the cooling phase. The unit will be ready for use
after end of the cooling off period and the duty cycle will revert to the original state.
Note: During cooling off period, a user cannot operate the unit.
In some instances, the unit will instruct the user to power off the unit. The warning remains forthe duration of the cooling process on the unit's display. Once the warning on the display is gone,
the unit can be used again for further filling activities.
Run Time Variable
Maximum Run Time
Maximum transfer volume
Max Temperature Limit
Recommended Cool Down
PeriodSetting
8 Hours
240 Liters
55° C
30 minutes

Note: Some metal parts may be warm after heavy use of the unit. The user should not use theunit for 30 minutes before transportation to allow the metal parts to cool.

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General Troubleshooting
Description of Fault

Silicone tubing herniates orballoons and prevents
pumping of liquid

Tubing kicks out of thepump

Consistently inaccurate
filling

Possible Causes

Solution

Using output containers
with back-pressure (likeambulatory pumps orelastomeric pumps)

Use Heavy Duty tubing (BX series)

Using smaller than 16 G
needleSwitch to 16 G needle or reduce the speed ofthe pump to reduce the back pressure

Using inline filter

Reduce speed to reduce back pressure

Too much back pressure forthe speed (use of needles,
filters or filling units)

Decrease back pressure or lower speed

Tubing was not installed
correctly

Remove tubing and re-install

Incorrect calibration

Use the calibration function

Inaccurate filling, notrepeatable (varies)

Lower the speed
Decrease back pressure (use larger needle orremove filter)

Does not pump and makes
loud grinding noise

Lower the speed of the unit
Use “BX” series tubing

Pump display is dark

Check Power Cord and ensure connection

Unit providing alert tochange compounding set
Compounding set (tubingset) has been used totransfer 60 liters.

Replace tubing set.

System malfunction.

Please contact ICU Medical TechnicalSupport.

Database Error Messages

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6.0 Unit Software Update
The folder “drp / update" can be found on the USB stick to update the Diana Peristaltic Pump.
Note: USB stick and adapter must be requested from ICU Service personnel
After the system has booted up, the prefabricated USB stick is plugged into the USB interface of thesystem (you will need the enclosed adapter cable). A selection window opens automatically. The
window will allow the user to select which components should be updated. It is possible to perform acomplete system update or the user selects the appropriate components to be updated.
If the drug database and / or the FDA database is updated, the user will receive a short message(green message) on the display after a successful update and the system automatically restarts. If thesystem update is also checked, a new window opens with a progress bar and with an indication ofwhich file is currently being updated.
After the update has been successfully transferred, the system will restart and return to the setup
screen.
Note: Prerequisite for the system restart is that no new firmware or Kernel is included in thesystem update. ICU Personnel will provide further instructions if firmware or Kernel updates are
required
1. Turn on the system and wait for the system to completely power on.

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2. Insert the USB stick with the update on it into the designated port on the back of the roller
pump (adapter cable required). The selection window will open automatically.

3. Follow instruction provided by ICU Medical service personnel and make the selection ofwhich components need to be updated.

Note: Components marked with a red cross cannot be updated because they are notavailable on the USB stick.
4. Then press the "Next" button to start the update.

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5. Once the system is updated, the following message will be displayed:

A progress bar indicates how far the update has progressed and which file iscurrently being updated.

Note: This message is displayed to the user only if a firmware update is performed toprevent the system from being turned off by the user while the update is in progress.

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6. After completing the update (if no firmware update has been made), the user will receive
a confirmation message that the update has been successfully completed. Then thesystem automatically restarts.

7. If a firmware update is executed, the user receives a message and the system must be
restarted manually by pressing the on / off button. Switch the system off. Wait someseconds before you restart.

9. After a successful update and restart of the system, the user can start with his workflow as
usual.

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Duty Cycle
The maximum duty cycle of the unit is 8 hours. After 8 hours of continuous usage the system must beallowed to cool down for 30 minutes. The system cannot be used during this cooling-off period. The
system is completely ready for use after expiration of the cooling-off period and the duty cycle will
reset back to 8 hours.

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7.0 Transport
Please note that some metal parts may be warm after heavy use of the unit. The user should not use
the unit for 30 minutes before transportation to allow the metal parts to cool. However, the unit
should remain switched on during the cooling phase.

8.0 Database Error
This database error occurs when the Diana peristaltic pump module cannot read the database. The
number in brackets indicates the error. You will find the error designation in the following list (see8.1.1). If this error occurs, please contact a service technician immediately.

The database error listed here can occur while the system is running, but writing to the database(e.g. creating a new medicine) cannot be performed. However, the user can confirm this error
message by pressing the "OK" key and then follow up with the usual workflow. If you receive thiserror message, please contact a service employee in order to be able to correct this database error as
quickly as possible.

List of Database Errors
Displayed error
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Description of the error
Page 72

#define SQLITE_ERROR

1 /* Generic error */#define SQLITE_INTERNAL

2 /* Internal logic error in SQLite */#define SQLITE_PERM

3 /* Access permission denied */#define SQLITE_ABORT

4 /* Callback routine requested an abort */#define SQLITE_BUSY

5 /* The database file is locked */#define SQLITE_LOCKED

6 /* A table in the database is locked */#define SQLITE_NOMEM

7 /* A malloc() failed */#define SQLITE_READONLY

8 /* Attempt to write a readonly database */#define SQLITE_INTERRUPT

9 /* Operation terminated by sqlite3_interrupt()*/#define SQLITE_IOERR

10 /* Some kind of disk I/O error occurred */#define SQLITE_CORRUPT

11 /* The database disk image is malformed */#define SQLITE_NOTFOUND

12 /* Unknown opcode in sqlite3_file_control() */#define SQLITE_FULL

13 /* Insertion failed because database is full */#define SQLITE_CANTOPEN

14 /* Unable to open the database file */#define SQLITE_PROTOCOL

15 /* Database lock protocol error */#define SQLITE_EMPTY

16 /* Internal use only */#define SQLITE_SCHEMA

17 /* The database schema changed */#define SQLITE_TOOBIG

18 /* String or BLOB exceeds size limit */#define SQLITE_CONSTRAINT

19 /* Abort due to constraint violation */#define SQLITE_MISMATCH

20 /* Data type mismatch */#define SQLITE_MISUSE

21 /* Library used incorrectly */#define SQLITE_NOLFS

22 /* Uses OS features not supported on host */#define SQLITE_AUTH

23 /* Authorization denied */#define SQLITE_FORMAT

24 /* Not used */#define SQLITE_RANGE

25 /* 2nd parameter to sqlite3_bind out of range */#define SQLITE_NOTADB

26 /* File opened that is not a database file */#define SQLITE_NOTICE

27 /* Notifications from sqlite3_log() */#define SQLITE_WARNING

28 /* Warnings from sqlite3_log() */Diana Peristaltic Pump, ICU Medical

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

ICU Medical, Inc.
951 Calle Amanecer
San Clemente, CA 92673(866).829.9025(949).366.2183

ICU Medical Germany GmbH
Altenaer Str. 136
58513 Lüdenscheid
Phone: +49 2351 9548 26
Fax: +49 2351 9548 20

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10.0

Warranty and Service Information
Limited Warranty

ICU Medical warrants the system to be free from defects in material and workmanship for one (1)year from the date of delivery, when operated in accordance with the User Manual. Sensors andaccessories 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 frominitial installation and the items not deemed ineligible for warranty under the conditions andexclusions from warranty listed in this manual. ICU Medical cannot honor warranty claims due todamages resulting from transport.
This warranty extends to the designated original purchasers of the equipment from ICU Medical andwill not extend to any subsequent purchaser. This warranty shall not apply where: service is required
due to purchaser’s failure to operate or maintain the equipment in a manner consistent with thespecifications and guidelines set forth in the User Manual; service is required due to misuse or
unauthorized service, unauthorized accessories or parts are used with the system; or where theequipment is found to be functioning within the published specifications. This warranty includes
repair or replacement of components that do not function as intended during the term of thiswarranty. Warranty components or assemblies shall be of equal or better quality than thecomponent or assembly replaced. Such components replaced by ICU Medical become the propertyof ICU Medical.
This warranty is extended to original purchasers of the equipment from ICU Medical in lieu of allother warranties expressed or implied and all other obligations or liabilities on the part of ICU
Medical, and no person, agent, or dealer is authorized to give any warranties or to assume any otherliability on behalf of ICU Medical. For ICU Medical to properly administer the warranty, the purchaser
must notify ICU Medical promptly after the occurrence or discovery of any alleged failure.

Disclaimer of Warranties:

THIS LIMITED WARRANTY IS PROVIDED IN LIEU OF ALL OTHER WARRANTIES, WHETHER EXPRESS OR
IMPLIED, AND ICU MEDICAL HEREBY DISCLAIMS ALL OTHER WARRANTIES, INCLUDING WITHOUT
LIMITATION IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR PARTICULAR PURPOSE AND
NON-INFRINGEMENT.
Excluded from warranty coverage are damages resulting from: Incorrect connection of Peristaltic Pump or accessories.
 Unauthorized cleaning of the Peristaltic 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 SUBSTITUTEPRODUCTS OR SERVICES, OR BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, OR
CONSEQUENTIAL DAMAGES, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, ARISING OUT OF
THIS WARRANTY, INCLUDING BUT NOT LIMITED TO LOSS OF ANTICIPATED PROFITS, EVEN IF ICU
MEDICAL HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. THESE LIMITATIONS WILLAPPLY NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY.

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Appendix A: Cleaning and Disinfection of the Diana Systems
Switch off the power supply of the Peristaltic Pump. Spilled liquid and drops must be wiped promptly
to avoid intrusion into the pump. Use only lint-free cloths or swabs with cleaning and disinfection
solutions. Use no abrasives. Also clean the Diana peristaltic pump under the stainless steel plate,including rollers when the system is turned off.
In the following you find the recommended cleaning and disinfection Protocol:
Step 1 - Wipe the pump with 2% sodium hypochlorite (bleach) - Cleaning solution
Ingredient

Lot

Lot

Bleach (5.25% sodium hypochlorite)

190.5 ml

381 mlSterile water for rinsing (pour bottle)

309.5 ml

619 mlTOTAL VOLUME

500 ml1000 ml

Step 2 - Wipe the pump with 1% sodium thiosulfate off - Disable solution

Ingredient

Amount when using

Amount when using(Sodium thiosulfate 10%)

(Sodium thiosulfate 25%)

Sodium thiosulfate inj. (10% or 25%)

50 ml

20 ml

40 ml

Sterile water for rinsing (pour bottle)

450 ml

480 ml

960 mlTOTAL VOLUME

500 ml500 ml1000 ml

Step 3 - Wipe the pump with sterile water - wipe all surfaces to remove residues of bleach or sodium
thiosulfate.
Step 4 - With sterile isopropanol wipe - wipe all surfaces prior to using the system for compoundingof sterile products. Remaining residue can be removed with a sterile isopropanol wipe or lint-freesterile swab soaked with sterile water or sterile isopropanol.

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Appendix B: Accuracy Verification Protocol
A standalone scale is recommended to perform this protocol. If a scale is not available, a graduatedcylinder can be used.
With Standalone Scale:
1. Use new Tubing Set
2. Ensure Tubing Set is fully primed and properly calibrated
3. Identify the specific gravity of the liquid being tested
4. Use at least 150 mL output empty container for this test
5. Enter 100 mL and press Next
6. Without connecting the tubing set to the bag, place the empty container on scale
7. Tare scale with empty container
8. Attach the empty container Tubing Set
9. Press Start to initiate transfer
10. Remove Tubing Set
11. Enter the weight if the specific gravity is correct
12. Enter the actual volume into the Diana Peristaltic Module
13. Press Calibrate
With Graduated Cylinder:
1. Use new Tubing Set
2. Ensure Tubing Set is fully primed and properly calibrated
3. Use at least 150 mL output empty container for this test
4. Enter 100 mL and press Next
5. Place the distal end of the tubing set inside the graduated cylinder so that liquid will passed
into the cylinder
6. Press Start to initiate transfer
7. Remove Tubing Set
8. Identify the volume transferred
9. Enter the actual weight into the Diana Peristaltic Module
Note: Find the actual weight by multiply the volume inside Cylinder by the specific gravity of
the liquid
10. Press Calibrate

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Appendix C: Volumetric Calibration
The user can perform a volumetric calibration of the Diana Peristaltic Pump if no scale is available.
Note: The calibration process of the Peristaltic Pump is designed for and recommended to be
performed using an external scale or the optional attached scale. Accuracy specifications are basedon gravimetric calibration. Performing calibration without a scale, such as with an IV syringe,
introduces additional variations. For IV syringes, these variations include–but are not limited to–thevolumetric accuracy of the syringe, the “to deliver” intent of syringe markings and the “to contain”
interpretation during syringe-based calibration, the compressibility of air in the syringe and thesyringe plunger seal, the surface area of the syringe plunger seal, and the kinetic and static friction of
the syringe plunger seal within the syringe barrel.
1. Turn the unit on.
2. Prepare source container and install tubing during initialization, if desired, for faster
workflow.
a. Heavy duty tubing (BX series) is recommended for high-backpressure processes such as
filling elastomeric pumps or filling at high speeds against high restrictions like 18G or
20G needles. Tubing should be replaced after 60 L of liquid transfer in either direction.
3. Resolve any alerts.
a. Always select “Yes” for “Is this a new set?” unless you intend to continue compounding
without recalibrating. If you plan to calibrate, select “No.” Failure to do so may cause
the software to crash during priming or calibration in certain versions up to andincluding 2.0.0.5. The remainder of these instructions assume the user has selected“Yes.”b.

The unit will display the Drug Set Up screen.

4. Attach source container.
5. For a “No Drug Info” setup, leave Drug Name blank on Drug Set Up page, and Press the“Next” button.
a. If preferred, select a Drug Name which is configured for 1.00 g/ml Specific Gravity.
b.

When using a syringe-based visual calibration process, always use 1.00g/ml Specific
Gravity regardless of the actual specific gravity of the liquid to be transferred.

6. If desired, enter the volume of solution in the source container as “Container Volume.”a. This is optional. Leaving the Container Volume at 0.0 ml will inactivate the “Source
container is empty” alert. If a Container Volume is entered, the unit will alert “Source
container is empty” when the unit predicts the source container will be empty based on
the previous transfers.
7. Press the “Next” button.
a. These instructions assume the user has selected “Yes” when prompted “Is this a new
set?” The unit will display the Priming screen in the Calibration tab.
8. Make sure that the receiving (distal) end of the tubing set is connected to a destination
container.
9. Press the “Prime” button.
a. The unit displays the priming progress screenb.

After priming, the unit will display the Calibration screen in the Calibration tab.

10. Attach a new, empty 50 ml syringe.
a. Smaller syringes exhibit higher backpressure. A 50 ml syringe is recommended.
11. If desired, adjust the calibration volume.
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Page 7812. If desired, adjust the speed.
a. Each Diana Peristaltic Pump is validated to provide accuracy of ± 1% with water at Slowspeed setting with no restriction nor back pressure for volumes greater than or equal to
10 ml. Different liquid characteristics, speeds, restrictions, and back-pressures may exhibit
different results. Verify Diana Peristaltic Pump accuracy performance before use to ensure
it meets expectations when used according to facility protocols.
b.

Default speed can be set per Drug Name in Settings.

13. Press “Start.”a. The unit displays the calibration transfer progress screenb.

After calibration transfer, the unit will display the Enter Measured Volume screen.

14. Visually determine the volume of liquid transferred to the 50 ml syringe.
15. Enter the determined volume as “Measured Weight.”
a. The system is designed for calibration with an external scale. Syringe-based visualcalibration requires defining Specific Gravity as 1.00 grams per milliliter and entering thedetermined volume as a weight in grams.
16. Press “Accept.”
a. The unit displays the Enter Transfer Volume screen in the Set Up tab
17. Continue with transfer as described in the Manual.

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