Diana Peristaltic Pump™ User Manual
DS1000

IFU0000620 (01, 2024-04)

For use with Software
Release V2.2 Only

Change History
Part Number

Description of Change

IFU0000620 (01, 2024-04)

Initial Release

Contents

Contents
Chapter 1 Introduction .................................................................................................................................................................. 5
1.1 Intended Use...................................................................................................................................................................... 5
1.2 Important Safety Instructions ............................................................................................................................................. 5
1.3 Warnings and Cautions ...................................................................................................................................................... 5
1.3.1 General ....................................................................................................................................................................... 5
1.3.2 Liquids Handling ......................................................................................................................................................... 6
1.3.3 Power Supply ............................................................................................................................................................. 6
1.3.4 Tubing and Dispensing Sets ....................................................................................................................................... 6
1.3.5 Drug Database ........................................................................................................................................................... 7
1.3.6 Calibration .................................................................................................................................................................. 7
1.3.7 System Operation ....................................................................................................................................................... 8
1.3.8 Service and Maintenance ........................................................................................................................................... 8
1.3.9 Storage and Disposal ................................................................................................................................................. 8
1.3.10 Cleaning ................................................................................................................................................................... 9
1.4 Symbols ............................................................................................................................................................................. 9
1.4.1 Labeling Symbols Glossary ........................................................................................................................................ 9
1.4.2 List of Symbols on the Back of the Pump Unit .......................................................................................................... 12
1.5 Conventions ..................................................................................................................................................................... 13
1.5.1 Illustrations, Screen Displays, and Software Messages ........................................................................................... 14
Chapter 2 Diana Peristaltic Pump System Overview ................................................................................................................. 15
2.1 Diana Peristaltic Pump Description .................................................................................................................................. 15
2.1.1 Diana Peristaltic Pump Hardware Version ................................................................................................................ 17
2.2 Diana Peristaltic Pump Unit (DS1000) Installation ........................................................................................................... 17
2.3 Diana Peristaltic Pump Unit Graphic User Interface (GUI)............................................................................................... 18
2.3.1 Guidance Text ........................................................................................................................................................... 19
2.3.2 Touch Screen Usage ................................................................................................................................................ 19
2.3.3 Data Entry ................................................................................................................................................................. 20
2.4 Tubing Set ........................................................................................................................................................................ 20
2.4.1 Tubing Set Overview................................................................................................................................................. 20
2.4.2 Tubing Set Information and Compatibility ................................................................................................................. 21
2.5 Foot Pedal Kit (DS1040) .................................................................................................................................................. 22
2.6 USB Adapter (DS1050) .................................................................................................................................................... 23
Chapter 3 Operating the Diana Peristaltic Pump ....................................................................................................................... 24
3.1 Overview .......................................................................................................................................................................... 24
3.2 Tubing Set Installation / Removal .................................................................................................................................... 24
3.2.1 Tubing Set Installation .............................................................................................................................................. 25
3.2.2 Tubing Set Removal ................................................................................................................................................. 27
3.3 Power On ......................................................................................................................................................................... 28
3.4 Tubing Preparation – Recommended for Heavy Duty Tubing .......................................................................................... 29
3.5 Drug Set Up ..................................................................................................................................................................... 31
3.5.1 Entering Drug Name and Drug ID............................................................................................................................. 32
3.5.2 Enter Lot Number ..................................................................................................................................................... 35
3.5.3 Enter Lot Expiration Date.......................................................................................................................................... 36
3.5.4 Enter Specific Gravity ............................................................................................................................................... 37
Diana Peristaltic Pump User Manual1

Contents
3.5.5 Enter Source Volume ................................................................................................................................................ 38
3.5.6 Accept Drug Information ........................................................................................................................................... 40
3.5.7 No Drug Information ................................................................................................................................................. 40
3.5.8 Changing the Specific Gravity .................................................................................................................................. 41
3.5.9 Source Container Volume Tracking .......................................................................................................................... 43
3.6 Tubing Connections ......................................................................................................................................................... 43
3.7 Priming ............................................................................................................................................................................. 44
3.7.1 Circle Priming ........................................................................................................................................................... 45
3.8 Calibration ........................................................................................................................................................................ 46
3.8.1 Gravimetric Calibration with External Scale .............................................................................................................. 46
3.8.2 Volumetric Calibration ............................................................................................................................................... 50
3.8.3 Warnings During Calibration ..................................................................................................................................... 53
3.8.4 Recalibration ............................................................................................................................................................. 54
3.9 Set Up and Transfer ......................................................................................................................................................... 55
3.10 Infinite Transfer Mode .................................................................................................................................................... 56
3.11 Batch Mode .................................................................................................................................................................... 59
3.11.1 Using Batch Mode................................................................................................................................................... 61
3.12 Power Off ....................................................................................................................................................................... 63
Chapter 4 Settings ..................................................................................................................................................................... 64
4.1 Customization .................................................................................................................................................................. 66
4.1.1 Custom Speed Settings ............................................................................................................................................ 66
4.1.2 Version Information ................................................................................................................................................... 69
4.1.3 Volume...................................................................................................................................................................... 70
4.1.4 Scale Option ............................................................................................................................................................. 70
4.1.5 Volumetric Calibration Enable................................................................................................................................... 71
4.1.6 Reprint Label Screen Enable .................................................................................................................................... 71
4.1.7 Adjust Priming Volume .............................................................................................................................................. 72
4.1.8 User Logout .............................................................................................................................................................. 73
4.1.9 User Login ................................................................................................................................................................ 73
4.2 Date and Time ................................................................................................................................................................. 73
4.3 Scale Check ..................................................................................................................................................................... 74
4.4 Advanced Settings ........................................................................................................................................................... 74
4.4.1 Rotating Passcode.................................................................................................................................................... 75
4.4.2 Edit Drug................................................................................................................................................................... 76
4.4.3 Language.................................................................................................................................................................. 80
4.4.4 Custom Label Settings.............................................................................................................................................. 81
4.4.5 Print Setup ................................................................................................................................................................ 82
4.4.6 User Management .................................................................................................................................................... 82
4.4.7 User Login at Startup ................................................................................................................................................ 88
4.4.8 Require Drug Information ......................................................................................................................................... 88
4.4.9 Change Specific Gravity in the Drug Screen ............................................................................................................ 89
4.4.10 Complete Screen Display Interval in Seconds ........................................................................................................ 89
4.4.11 Logfiles ................................................................................................................................................................... 91
4.4.12 Scale Deviation Borders ......................................................................................................................................... 92
4.5 Technical Services ........................................................................................................................................................... 92
4.6 Developer......................................................................................................................................................................... 93
Chapter 5 Specifications, Maintenance and Troubleshooting .................................................................................................... 94
5.1 Accuracy Specifications ................................................................................................................................................... 94
5.2 Environmental Specifications ........................................................................................................................................... 95
Diana Peristaltic Pump User Manual2

Contents
5.3 Lithium-Ion Coin Battery Replacement ............................................................................................................................ 96
5.4 Fuse Replacement ........................................................................................................................................................... 97
5.5 Tubing Replacement ........................................................................................................................................................ 98
5.6 Temperature Warning....................................................................................................................................................... 98
5.7 Duty Cycle........................................................................................................................................................................ 99
5.8 General Troubleshooting................................................................................................................................................ 100
Chapter 6 Pump Unit Software Update .................................................................................................................................... 102
Chapter 7 Transport ................................................................................................................................................................. 106
Chapter 8 Database Error ........................................................................................................................................................ 107
8.1 List of Database Errors .................................................................................................................................................. 108
Chapter 9 Service and Contact Information ............................................................................................................................. 110
Chapter 10 Warranty and Service Information ......................................................................................................................... 111
10.1 Limited Warranty .......................................................................................................................................................... 111
10.1.1 Disclaimer of Warranties ....................................................................................................................................... 111
10.1.2 Limitation of Liability ............................................................................................................................................. 111
Appendix A: Cleaning and Disinfection of the Diana Peristaltic Pump ..................................................................................... 112
Cleaning and Disinfection of Diana Peristaltic Pump Accessories ....................................................................................... 113
Foot Pedal Kit: ................................................................................................................................................................. 113
Appendix B: Accuracy Verification Protocol .............................................................................................................................. 114

Diana Peristaltic Pump User Manual3

Contents

Table of Figures
Figure 1: Back Panel .................................................................................................................................................................. 12
Figure 2: Diana Peristaltic Pump Unit ........................................................................................................................................ 15
Figure 3: Front and Sides ........................................................................................................................................................... 15
Figure 4: Back of the Pump Unit ................................................................................................................................................ 16
Figure 5: Hardware Version........................................................................................................................................................ 17
Figure 6: UI Components ........................................................................................................................................................... 18
Figure 7: Guidance Text ............................................................................................................................................................. 19
Figure 8: Data Entry ................................................................................................................................................................... 20
Figure 9: Tubing Set ................................................................................................................................................................... 20
Figure 10: Foot Pedal ................................................................................................................................................................. 22
Figure 11: USB Adapter (DS1050) ............................................................................................................................................. 23
Figure 12: General Workflow of the Diana PPM System............................................................................................................ 24
Figure 13: Required Fields ......................................................................................................................................................... 31
Figure 14: Specific Gravity Warning ........................................................................................................................................... 37
Figure 15: Changing the Specific Gravity ................................................................................................................................... 41
Figure 16: Calibration out of regular range Accept? ................................................................................................................... 53
Figure 17: Wrong Calibration Please Repeat ............................................................................................................................. 54
Figure 18: Power Off .................................................................................................................................................................. 63
Figure 19: Settings ..................................................................................................................................................................... 64
Figure 20: Advanced Settings .................................................................................................................................................... 65
Figure 21: Customization ........................................................................................................................................................... 66
Figure 22: Version Information ................................................................................................................................................... 69
Figure 23: Scale Option ............................................................................................................................................................. 70
Figure 24: Volumetric Calibration Enable ................................................................................................................................... 71
Figure 25: Reprint Label Screen Enable .................................................................................................................................... 71
Figure 26: User Logout .............................................................................................................................................................. 73
Figure 27: Date and Time........................................................................................................................................................... 73
Figure 28: Scale Check .............................................................................................................................................................. 74
Figure 29: Advanced Settings .................................................................................................................................................... 74
Figure 30: Rotating Passcode .................................................................................................................................................... 75
Figure 31: Custom Label Settings .............................................................................................................................................. 81
Figure 32: Print Setup ................................................................................................................................................................ 82
Figure 33: Scale Deviation Borders............................................................................................................................................ 92
Figure 34: Technical Service ...................................................................................................................................................... 92
Figure 35: Developer .................................................................................................................................................................. 93
Figure 36: Lithium-Ion Coin Battery Replacement ..................................................................................................................... 96
Figure 37: Fuse Replacement .................................................................................................................................................... 97
Figure 38: Tubing Replacement ................................................................................................................................................. 98
Figure 39: Temperature Warning - Pause Transfers................................................................................................................... 98
Figure 40: Temperature Warning - Power Off System ................................................................................................................ 99
Figure 41: Database Error (14) ................................................................................................................................................ 107
Figure 42: Database Error (5) .................................................................................................................................................. 107

Diana Peristaltic Pump User Manual4Introduction

Chapter 1 Introduction
1.1 Intended Use
The Diana PPM system is intended for use by healthcare professionals allowed by law to perform manual pharmaceuticalreconstitution, admixture, or compounding.
The Diana PPM system is not intended to screen, monitor, treat, diagnose, or prevent any specific condition or disease.
In this manual, the meaning of liquid refers to a substance that flows freely, but it is of constant volume, having a consistency
like water or oil.
The Diana Peristaltic Pump is designed for use in laminar airflow boxes, biological safety cabinets, gloveboxes, laminar airflow
hoods and/or safety work benches in clean rooms.
The Diana Peristaltic Pump is intended for use by pharmacists, pharmacy technicians, doctors, and nurses who are properly
trained to use this system. Please follow the information contained in this manual as a self-paced training guide before
operating the system for the first time. Refer to this manual as a reference guide when needed. Frequent training is not
required to use this system.
The Diana Peristaltic Pump System (often referred to as “System” throughout the User Manual) consists of:●●●●

Diana Peristaltic Pump Unit (Required) (often referred to as just the “pump unit” throughout the User Manual)
Tubing Set (Required)This User Manual (Required)Foot Pedal Kit (Optional)

1.2 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.
The pharmacist or pharmacy technician must wear Personal Protective Equipment (PPE) when operating the System, andadhere to facility protocols and standards for operating compounding equipment.
Always follow published guidelines related to work protection and accident prevention and ensure professional diligence.

1.3 Warnings and Cautions
Read this User Manual carefully before using the Diana Peristaltic Pump. For safe operation of the Diana Peristaltic Pump,
refer to the Warnings, Cautions, and recommendations in the following sections.

1.3.1 General●

DO NOT connect the System directly to humans.

●

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

●

DO NOT USE for biological tissue, cells, or body fluids.

●

DO NOT operate the System in the presence of flammable substances, including anesthetics.

●

No modifications to the System are allowed. Do not modify in any way, otherwise there is apossibility of operator injury, impairments, or damage to the System.

Important: The Diana Peristaltic Pump does not contain any user-serviceable parts.
Diana Peristaltic Pump User Manual5Introduction●

To avoid injury or damage to the System, DO NOT attempt to disassemble or service the System.
Malfunctioning Systems must be sent back to ICU Medical for repair.

●If the pump unit is damaged during operation, switch off immediately and disconnect from thepower supply.

●

If the pump unit has observable sharp edges, contact an ICU Medical representative immediately.

●

DO NOT place the compounder on an unstable surface.

1.3.2 Liquids Handling●

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

●

When using the pump unit to transfer liquid to rigid containers such as vials or bottles, care should
be taken to ensure the containers always remain upright and ensure containers are not overpressurized prior to connecting to the pump unit.

●

Liquid ingress inside the System components may cause damage and impact performance. Clean
spills immediately.

1.3.3 Power Supply
Important: The pump unit should only be connected to a properly grounded electrical supply outlet.
Important: User should refer to the requirements for medical electrical systems in the current edition of IEC 60601-1 forproper use.
●

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

●

The pump unit should only be used with the manufacture-provided power cord (ICU Kit Number
DS1902, ICU Part Number: 826-11518-403).

●

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

●

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

●

Position the pump unit to assure easy access to its power plug (so that it can be disconnected fromelectrical supply in the event of an emergency).

1.3.4 Tubing and Dispensing Sets
Important: 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 toluer adapter.

Note:

●

DO NOT use tubing set if the sterile packaging has signs of damage. If the tubing set’s sterile
packaging is damaged, 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 thetubing.

●Change the tubing set prior to each change of liquid to avoid drug incompatibility and/ortransferring the incorrect volume.

Refer to tubing set label for important use information.

Diana Peristaltic Pump User Manual6Introduction●

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.

1.3.5 Drug Database●

The System includes a pre-loaded default drug list, the drugs listed are a sub-set of the full FDA
drug database. The System drug list includes only drug name and NDC code from the FDA drug
database.

●

The System default drug list was chosen based on selecting drugs that match the intended use of
the System (includes the key words in the "route" field: "EPIDURAL", "HEMODIALYSIS", "INTRA","PARENTERAL", "SUBCUTANEOUS", "SUBMUCOSAL"). If a drug is not in the database provided it
can be added using the "Add Drug" functionality. See Section Edit Drug for details on how to use
the “Add Drug” feature.

●

Follow manufacturer and facility protocols for any drug added to the database.

●Specific Gravity is set by default to 1.0 for all drugs in the pre-loaded drug list. This default specificgravity value does NOT represent actual drug specific gravity and MUST be updated by the user
before the specific gravity can be used to accurately correlate weight and volume for each drug. See
Section Changing the Specific Gravity for details about how default verses user entered specificgravity values are represented within the System. See Section Changing the Specific Gravity fordetails about how to update the default specific gravity values for drugs.

●

Default drug list is not translated when System language is changed from English (drug names
remain in English).

Important: Accurate specific gravity configuration is essential for gravimetric accuracy. Accuracy reported by the System isdirectly related to the accuracy of the specific gravity entered by the user for the liquid to be transferred.
●

DO NOT use gravimetric calibration process unless confident that the specific gravity has been
accurately entered for the fluid being transferred.

1.3.6 Calibration●

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

●

Calibrate the pump unit each time the tubing set is changed. Only the intended direction needs to becalibrated. Calibrate again if direction is changed. The System retains calibration for both directions
to allow repeated switching of direction without recalibrating. Either direction can be recalibrated asoften as desired.

●

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

Important: 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.
Important: For highest accuracy, calibration should be performed using a container similar to the one intended for transfer
and at a volume similar to the intended transfer volume.
Important: The pump unit must be used in conjunction with ICU Medical Transfer Tubing Sets. These sets have been
specifically designed to ensure accuracy and decrease user variability. The set contains a bar connector which fits into a sloton the pump unit. The slot keeps the tubing seated properly and decreases user variability in the tubing installation.

Diana Peristaltic Pump User Manual7

Introduction

1.3.7 System Operation●

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

●

The system shall not be connected to hospital networks.

Important: Use Heavy Duty “BX01”, “BX02”, or “BX03” tubing when filling containers used with ambulatory pumps or otherhard to fill containers.
Important: Pump unit operation must be monitored at the beginning of each cycle and at intervals during the cycle to ensure
the pump unit is operating within acceptable limits (out of limits conditions displayed during use). Use the calibration function
to achieve specified accuracy (see the Calibration section for more details).
●

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

●

Do not operate the pump unit 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.

1.3.8 Service and MaintenanceImportant: Save the original box and packaging. If the System 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 ashipping box to be provided.
●

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

●

DO NOT use the pump unit continuously for more than 8 hours or 240 liters. Upon reaching thislimit, allow the System to rest for 30 minutes before additional use.

●

Some metal parts might be warm when in use. The user should allow the pump unit to cool downprior to moving or transporting it.

●

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

●

Ensure the System is placed on a stable surface. If applicable, allow Biomedical Engineering toconfirm electrical requirements are met.

●

The System is not suitable for use in mobile equipment.

●

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

●

Verify pump unit accuracy performance before use to ensure it meets facility protocols – Accuracy
Specifications for details.

●

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

1.3.9 Storage and Disposal
Important: At the end of service life, please contact ICU Medical for further directions on how to properly dispose the systemcomponents and consumables.
During storage and use, avoid impacts and vibration which could result in a malfunction of the System.
●

When storing the System, ensure the location is in compliance with the Storage Temperature,
Humidity, and Altitude listed in Table 12.

Diana Peristaltic Pump User Manual8Introduction●

The System is designed to be used in Biological Safety Cabinets, Laminar Airflow Hoods and/or
Safety Work benches in clean rooms in a healthcare setting.

1.3.10 Cleaning●

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

●

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

●

All cleaning of the System should be performed according to the detailed instructions in thismanual.

1.4 Symbols
1.4.1 Labeling Symbols Glossary
This section describes the symbols used in the labeling for the Diana Peristaltic Pump System. The System complies with thesymbols mentioned below.
Table 1: Symbols Glossary

SymbolDiana Peristaltic Pump User Manual

Reference

Description

IEC 60417 – 5010

“ON”/ “OFF” (push-push)

ISO 7010 - M002

Follow Instructions for Use

IEC 60417 – 5032

Alternating current

9Introduction

SymbolReference

Description

IEC 60417-5019

Connect an earth terminal to the groundISO 7010 - W001

General warning sign

ISO 7010 - W012

Warning; electricity

ISO 7000 – 3082

Manufacturer

ISO 15223-1:2021
Symbol 5.1.1
ISO 7000 – 2498

Serial number

ISO 15223-1:2021
Symbol 5.1.7
CSA

Diana Peristaltic Pump User Manual

Canadian Standards Association
Certification mark indicates that the
product has been tested against
applicable North American standards
requirements.

10

Introduction

SymbolReference

Description

ISO 15223-1: 2021 Symbol 5.1.2

Authorized European Representative

IEC 60529

Ingress protection (protected against
solid foreign objects 2.5 mm diameter orgreater and spraying water)

IEC 60417 – 6414

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

Directive 2012/19/EU
ANNEX IX Symbol
ISO 7000 – 0632

Temperature limit

ISO 15223-1:2021
Symbol 5.3.7
ISO 7000 – 2620

Humidity limitation

ISO 15223-1:2021
Symbol 5.3.8

Diana Peristaltic Pump User Manual11Introduction

1.4.2 List of Symbols on the Back of the Pump Unit
Figure 1 shows the back panel of the instrument and the location of various connectors and switches for the pump unit.
Table 2 provides depiction, references, and description of the symbols on the back.

Figure 1: Back Panel

Diana Peristaltic Pump User Manual12Introduction
Table 2: Back Symbols
SymbolDescription

Reference

Indicates the fuse is held inside thehousing.

IEC 60417, Reference Number: 5016

Indicates plug to be used to Power on
the pump unit.

IEC 60417, Reference Number: 5534

Indicates socket to be used for USB
Update port.

ISO 7000-365ar0

Indicates socket for connecting theFoot Pedal Kit.

EC 60417, Reference Number: 6378

Indicates socket for connecting thePrinter Kit (Accessory not included in
the current version of the system).

IEC 60417, Reference Number: 5851

Indicates socket for connecting the
Scanner Kit (Accessory not included in
the current version of the system).

N/A

Indicates socket for connecting the
Scale Kit (Accessory not included in
the current version of the system).

IEC 60417, Reference Number: 0143

1.5 Conventions
This section describes the conventions used throughout this manual, as follows:
Table 3: Conventions
Convention

Application

ExampleItalic, bold, blue

Reference to a section, figure, or table

Table 1

Initial Caps lowercase

Screen displays, modes and…will enable the Infinite Transfer
mode

device labels (as appropriate)
Bold

Button, Icons, or messages names.
Emphasis

Pressing the Yes button confirms
the user's entry.

Red

Warnings and Cautions

WARNING: INCORRECTINSERTION OF THE TUBING SET
MAY DAMAGE THE PUMP UNIT.

Diana Peristaltic Pump User Manual13Introduction

1.5.1 Illustrations, Screen Displays, and Software Messages
Illustrations and screen examples in this manual are graphic depictions, not exact representations of the product.

Diana Peristaltic Pump User Manual14Diana Peristaltic Pump System Overview

Chapter 2 Diana Peristaltic Pump System Overview
The Diana Peristaltic Pump System consists of the Diana Peristaltic Pump Unit (Required), the Tubing Set (Required) and theFoot Pedal Kit (Optional).

2.1 Diana Peristaltic Pump Description
The Diana Peristaltic Pump (Figure 2) is a software-controlled automated pharmacy-compounding system intended for use ina healthcare facility by Pharmacists and Pharmacy Technicians to dispense a specified quantity of liquid from a set of source
containers into a destination container.

Figure 2: Diana Peristaltic Pump Unit
Figure 3 and Figure 4 show the pump unit with the major components labeled and reference in Table 4.

Figure 3: Front and Sides
Diana Peristaltic Pump User Manual

15Diana Peristaltic Pump System Overview

Figure 4: Back of the Pump Unit
Table 4: Pump Unit Components
Reference

Component

Description

1

Power Button

Power ON/OFF Button

2

Tubing Detection
Sensor

Detects the presence and proper placement of the tubing set.

3

Flap

The flap protective cover must be closed while the pump unit is actively pumping.

4

Fuses

Protect the electrical equipment

5Power Inlet

Connects the pump unit to the electrical outlet using the provided power cord.

6

Printer PortThis port is not used by the system, plugged by cap.

7

USB Port

For use by ICU Medical authorized personnel to service the System.
The user can export or import files with a USB drive.

8

Scanner PortThis port is not used by the system.

9

Foot Pedal Port

Connects the optional Foot Pedal Kit accessory.

10

Scale PortThis port is not used by the system, plugged by cap.

Diana Peristaltic Pump User Manual16Diana Peristaltic Pump System Overview

2.1.1 Diana Peristaltic Pump Hardware Version
There are two versions of the Diana Peristaltic Pump hardware that are in the field: 2.1 and 2.2. The version of hardware caneasily be distinguished by looking at the label on the back panel of the Pump Unit, note the elements outlined in Red in Figure
5. There are no differences in how the released software runs on each version of hardware.

Figure 5: Hardware Version

2.2 Diana Peristaltic Pump Unit (DS1000) Installation
To install the pump unit:
1. Place the pump unit onto a stable surface.
2. Plug the power cord supplied by ICU Medical into the back of the pump.
3. Plug the power cord into an electrical outlet.
Important: Only connect the pump unit to a properly grounded electrical supply outlet. Refer to the requirements for medical
electrical systems in the current edition of IEC 60601-1 for proper use.
4. Once the System is plugged in, press the circular on/off switch located on the front of the pump unit.
Important: We recommend the System be sent to ICU Medical Service once a year for inspection and maintenance.
Important: An authorized ICU Medical representative must perform all maintenance.
Important: The manufacturer must complete all maintenance work except for routine cleaning.

Diana Peristaltic Pump User Manual17Diana Peristaltic Pump System Overview

2.3 Diana Peristaltic Pump Unit Graphic User Interface (GUI)The user interface of the pump unit features three tabs at the top of the screen (Drug Set Up, Set Up, Compound) that allow
navigation to specific workflows. Figure 6 shows the labeled user interface and Table 5 lists the labeled components.

Figure 6: UI Components
Table 5: User Interface Components
Reference

Component

Description

1

Drug Set Up Tab

First screen to be displayed and allows users to assign drug information to a container,
which generates a compounding log and labeling for future use.

2

Drug NameEnter the drug to be used. Most common drugs will show up on the right side of the
menu.

3

Drug ID

Identification number associated with the Drug Name that displays on screen

4

Lot NumberEnter the lot number of the drug.

5

Lot Expiration
Date

6

Source Volume

This information can then be retrieved in compounding reports.
The expiration date for the drug (MM/YYYY)
The amount of liquid (mL) in the source container, used to ensure that there is enoughliquid to fill the destination container. Default value is “off”, which turns off the source
container volume tracking.

Diana Peristaltic Pump User Manual18Diana Peristaltic Pump System Overview
Reference
7

Component
Set Up Tab

Description
Allows a user to provide the amount of volume (mL) to be transferred and change thetransfer speed (mL/min).
Once this information is entered, press “Start” to initiate a transfer.

8

Compound Tab

Provides a visual confirmation that the pump unit is transferring liquid.
Note:

9

This tab is only functional during a transfer.

Specific Gravity
Field

Displays entered Specific Gravity of chosen drug.

10

Drug Name Input

A list of the most recent 3 drugs that were added or changed in the database. Pressing
will fill the Drug Set Up tabs with data from the drug database for that drug.

11

Settings

Provides the user access to the settings.

Note:

The default specific gravity is set to 1.0 g. The specific gravity of a drug can bechanged on the Drug Set Up screen or Edit Drug settings page. Edit Drugsettings require an operator to be an authorized user in Advanced Settings.

2.3.1 Guidance Text
The System provides guidance for priming, calibration, set up, and compounding in a grey bar near the top of the screen as
shown in Figure 7.

Figure 7: Guidance Text

2.3.2 Touch Screen Usage
The touch screen is not like those used for tablets and mobile phones; it is designed for use in a lab environment with gloved
hands. Firmly select and enter values.

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2.3.3 Data Entry
Enter numeric or alphanumeric values and dates by using the keypad as shown in Figure 8.

Figure 8: Data Entry

2.4 Tubing Set
2.4.1 Tubing Set Overview
Important: The following consumables are not included with the System. They must be ordered separately. Contact an ICU
representative for assistance.
The tubing set, which consists of an input port, output port, and tubing set handle, is for use in conjunction with the pump unit.
Figure 9 shows the tubing set and Table 6 describes the labeled components.

Figure 9: Tubing Set

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Table 6: Tubing Set Components
Reference

Component

Description

1

Input Port

An IV spike used for bags or bottles (excepting PA01LL which has a luer lock connector
on the input port)2

Output PortA luer lock connector

3

Tubing Set Handle

Allows the easy placement of the tubing set into the Tubing Detection Sensor
Ensure the red clip is on the top of the Tubing Detection Sensor.

2.4.2 Tubing Set Information and Compatibility
ICU Medical recommends that only compatible tubing sets tested by the manufacturer should be used for compounding.
Table 7: Tubing Set Description and Compatibility
ICU Medical Item Part Number

Description

Heavy Duty Tubing Sets
BX01

Single Lead Heavy Duty Tubing Set

BX01LL

Single Lead Heavy Duty Tubing Set – w/ Double Luer

BX02

Dual Lead Heavy Duty Tubing Set

BX03

Triple Lead Heavy Duty Tubing Set

Normal Tubing Sets
LPA01

Single Lead Tubing for use w/Lipids

PA01

Single Lead Tubing Set

PA02

Dual Lead Tubing Set

PA03

Triple Lead Tubing Set

PA01LL

Single Lead Tubing Set- w/Double Luer

Note:

The pump unit must be used in conjunction with ICU Medical Transfer Tubing Sets which have been specificallydesigned to ensure accuracy and decrease user variability. The set contains a bar connector which fits into a slot on
the pump unit. The slot keeps the tubing seated properly and decreases user variability in the tubing installation.

Important: Use a Heavy Duty “BX01”, “BX02”, or “BX03” tubing when filling containers used with ambulatory pumps or otherhard to fill containers.

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The following table lists the components that are compatible with ICU Medical Tubing Sets:
Table 8: Component Type Compatibility
Component Type
SpirosClave
16-gauge needle
18-gauge needle
0.2-micron filter
0.5-micron filter
Elastomeric pump
CADD cassette

2.5 Foot Pedal Kit (DS1040)
To use:1. Insert the Connector into “Foot Pedal Port” on the back of the pump unit. Screw it in.
2. Place the Foot Pedal on the ground with the hinge away from the user.
3. Step on the front of the Foot Pedal to activate it.
The Foot Pedal (Figure 10) can be used instead of pressing the touch screen during Transfer, Batch Mode, and Infinite
Transfer Mode operations. For example, pressing “Next”, “Start”, “Stop”, “Continue”, or “Pause” on the touch screen can also
be done by activating the Foot Pedal. This provides a hand free alternative to manipulate input containers, output containers,
and tubing during transfers.
Note:

Do NOT use the Foot Pedal on a wet floor.

Figure 10: Foot Pedal

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2.6 USB Adapter (DS1050)
To install:
1. Line up the groove on the 4 pin USB Adapter Connector with the guide pin on the USB Port on the back of the pumpunit.
2. Insert the 4 pin USB Adapter Connector into the USB Port.
3. Turn housing until the USB Adapter Connector is securely tightened into the USB Port.
4. Once installed the USB Adapter provides a standard USB Socket for connection of approved accessories.
Note:

Only install passive USB storage devices (such as USB Sticks) into the USB connector.

See Logfiles for instructions on how to use an attached USB storage device to download system logs from the pump unit.
See Pump Unit Software Update for instructions on how to use an attached USB storage device to update the software anddrug database in the pump unit.

Figure 11: USB Adapter (DS1050)

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Chapter 3 Operating the Diana Peristaltic Pump
3.1 Overview
Before operating the system, the components must be installed, and the settings configured. For details regarding installation,
see Chapter 2: Diana Peristaltic Pump System Overview. Chapter 4: Settings describes how the System settings canbe customized to the procedures and policies of the user’s lab and organization.
Figure 12 provides an overview of the overall workflow of the system:

Figure 12: General Workflow of the Diana PPM System
When replacing the tubing set or changing drugs, complete steps 1 through 4. Once those steps are completed, the user cancomplete multiple Fluid Transfers (step 5), until they need to change the tubing set of the drug. Understanding this workflow
reduces the chance of errors during usage of the system. The rest of this chapter provides more detail about the Diana
Peristaltic Pump System workflow, what options are available, and why you might choose certain options.

3.2 Tubing Set Installation / Removal
The following section describes how to properly install and remove the tubing set into the pump unit.
WARNING: INCORRECT INSERTION OF THE TUBING SET MAY DAMAGE THE PUMP UNIT.
Important: Before opening, inspect the tubing set package. If packaging is not intact, discard it and use a new set.
Important: Use an aseptic technique to open the package and remove the tubing set.

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3.2.1 Tubing Set Installation
1. Place the pump unit with the display view facing the user.

2. Locate the embossed arrow pointing downwards on the handle of the tubing set.

3. Locate the red clip behind the handle.

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4. Insert the handle into the slot in the roller head, aligning the red clip with the red arrow.

5. Align the white handle of the tubing set as shown below.

6. Press down the white handle until fully engaged into the pump unit.

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7. Engage a roller onto the tubing and then continue turning the roller head until the tubing set is secure around theperimeter of all the roller heads.

8. Installation is complete when the tubing is positioned between the roller head and surrounding pump unit wall.

9. Ensure there is no kinking of the tubing set.

3.2.2 Tubing Set Removal
Note:

When removing the tubing set, it is recommended to clamp the lines to prevent spillage.

When ready to remove the tubing set:
1. Lift upward on the white handle of the tubing set to remove it from the pump unit.
2. While turning the rollers by hand, pull up on the white handle to disengage the tubing.
3. Remove the tubing set from the pump unit roller.

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

2. When the pump unit has been started, a welcome screen is displayed.

3. Next, a series of alerts will display, depending on the state of the pump unit.

4. Follow the on-screen commands or answer the questions to access the home screen.

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3.4 Tubing Preparation – Recommended for Heavy Duty Tubing
When using heavy duty tubing (BX01, BX01LL, BX02, or BX03) with the PPM, it is recommended to prepare the tubing set
before fluid priming to assist in normalizing tubing set performance prior to pump calibration.
1. Install the tubing set – See Tubing Set Installation for a description of how to install a new tubing set.
Note:

Do not remove the protective caps from either end of the tubing set.

Note:

In some situations, failure to perform these steps could cause the roller head to not turn and could
contribute to inaccuracy during fluid transfers.

2. Close the lid.
3. Leave Drug Information empty, set Source Volume to off, and press Next.

4. Without connecting the input container, start Tubing Preparation by pressing Prime.

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5. Press Re-prime to return to Priming screen.

6. Press Prime to do additional Tubing Preparation.

7. Repeat steps 5 and 6 two additional times to complete Tubing Preparation.
8. Press “No Drug Info” to return to Drug Set Up to enter Drug Information and connect your tubing to input andoutput containers to start your transfer.

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3.5 Drug Set Up
The Drug Set Up screen provides the System with details about the drug. On this screen, the user enters Drug Information thesystem needs to track.
●
●
●
●
●

Drug Name
Drug ID
Lot Number
Lot Expiration Date
Specific Gravity

When the user enters the Drug Information, the system records the drug used for compounding in the system logs. The user
also needs to decide if they want the system to track Source Volume. This section describes how to set the system to track
Drug Information and Source Volume.
Note:

When entering Drug Information, all fields must be filled in before the Next button appears.

Note:

For all required drug information (Figure 13), field labels are red, and fields have a red border until the information isentered.

Figure 13: Required Fields
See No Drug Information to compound without the system keeping track of Drug Information. See Source Container
Volume Tracking to compound without the system keeping track of Input Container Volume.

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3.5.1 Entering Drug Name and Drug ID
Each Drug Name has an associated Drug ID. There are three ways to enter the Drug Name and the Drug ID: enter the Drug
Name field, enter the Drug ID field, or select the drug from the Quick Feature list.
Note:

The drug must exist in the database.

Option 1: Enter the Drug Name●●●

Select the Drug Name field.
Start typing the name of the drug. Autocomplete options for drugs in the database appear below your entry.
Select the drug and press Enter. The Drug Name and corresponding Drug ID are filled in.

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Option 2: Enter the Drug ID●●●

Select the Drug ID field.
Start typing the ID for the drug.
Select the ID and press Enter.

The Drug Name and corresponding Drug ID are filled in.

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Option 3: Select Preset
The circled presets capture the last 3 drugs that were added or changed in the database. Pressing one of the blue entries will
fill in its corresponding Drug Name and Drug ID.

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3.5.2 Enter Lot Number
1. Select the Lot Number field.
2. Enter the lot number from the input container in the Lot Number field and press Enter.

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3.5.3 Enter Lot Expiration Date
1. Select the Lot Expiration Date field.
2. Select the Lot Expiration Date using the Month and Year picker. Select Year, then select Month and press Enter.

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3.5.4 Enter Specific Gravity
1. Enter a specific gravity for the selected fluid in the Specific Gravity field. See Changing the Specific Gravity formore details on how to set Specific Gravity.
Note:

Specific Gravity is set by default to 1.0 for all drugs in the default drug list. The default specific gravity value
does NOT represent actual drug specific gravity and must be updated before the specific gravity can beused to accurately correlate weight and volume for each drug.

Important: A yellow warning triangle (Figure 14) is displayed next to the Specific Gravity field for all drugs that have default
value and need updating prior to accurately represent the given fluid properties. The yellow warning triangle disappears after
specific gravity has been updated by the user.

Figure 14: Specific Gravity Warning

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3.5.5 Enter Source Volume
The default value for Source Volume is “off”. This indicates that the user wants to monitor the source container volume
independently.
1. Select the Source Volume field.
There are two options:Enter a value for Source Volume. The system will track how much fluid has been removed from the Source
Container and will inform the user when it becomes empty. Then, the system will ask for information about the
replacement Source Container once it is empty. Enter the Source Container volume in the Source Volume fieldand press Enter.

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

If the user wishes to keep track of the Source Container Volume on their own, enter “off” for Source Volume andpress Enter.

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3.5.6 Accept Drug Information
1. Press the Next button.
Note:

The Next button is only available if all fields are filled out.

3.5.7 No Drug Information
The Drug Set Up screen defaults to No Drug Information and Source Volume “off”. If the user has entered Drug Information
and/or Source Volume and wishes to clear that:
1. Press.

2. Pressto continue with transfer.

Note:

Users can control whether entering Drug Information is required through the setting Require Drug Information.

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3.5.8 Changing the Specific Gravity
The specific gravity of a drug can be changed on the Drug Set Up screen if a user has been granted permission by anauthorized user in Advanced Settings.
Important: Specific Gravity is set by default to 1.0 for all drugs in the default drug list, which does NOT represent actual drug
specific gravity and must be updated by the user before the specific gravity can be used to accurately correlate weight andvolume for each drug.
When access is granted, a blue square with a yellow triangle containing an exclamation mark (Figure 15) appears indicating
the current value is the default and the user can change the specific gravity to a different value.

Figure 15: Changing the Specific Gravity
Important: A yellow warning triangle appears next to the Specific Gravity field for all drugs that have default value and must
be updated to accurately represent the given fluid properties. The yellow warning triangle disappears after specific gravity has
been updated by the user.

3.5.8.1 To change the specific gravity:
1. Press the Specific Gravity field.
A warning message about the change in the specific gravity appears.
Press Continue to change the specific gravity of the selected drug using the keyboard.
Press Cancel to return to the default Drug Set Up screen (Specific gravity 1.0 g).

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2. Enter the desired Specific Gravity using the keypad, press the Enter button to save the new value.
A warning message about the change in the Specific Gravity appears.
Press Save to store the changed Specific Gravity value into the database.
Press Cancel and the Specific Gravity will not be saved.

3. Once the specific gravity has been changed, the button is greyed 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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3.5.9 Source Container Volume Tracking
When the Source Volume is entered on the Drug Set Up screen, the system tracks the volume removed from the Source
Container (including priming, calibration, and transfer steps). When the System predicts that the Source Container is empty, it
displays the following warning message:

The System displays the details of the new Source Container to enter.

3.6 Tubing Connections
Prior to performing Priming, Calibration, and Fluid Transfer, the tubing must be connected to the appropriate input and output
containers. Compatible tubing sets come in options with 1, 2, and 3 source leads (each equipped with clamps). Whenconnecting source containers:
1.
2.
3.
4.
Note:

Install the tubing set (see Tubing Set Installation).
Close all source lead clamps.
Spike and hang source containers.
Once all source leads are connected to source containers, open all source lead clamps.
If using a bifurcated or trifurcated set with fewer than the maximum number of source containers, unused leads muststill be primed to avoid introducing air intermittently during use. Open only the clamp(s) on connected source lead(s).

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Prime unused source leads one at a time by raising the spike above the level of fluid in the source containers,
opening the clamp, allowing fluid to fill the tubing up to the clamp (clamp can be moved down to reduce priming
volume of unused source lead) then closing the clamp.

3.7 Priming
Priming means to fill the tubing set with fluid. Fluid is pumped from the input container into the tubing until it is filled with fluidand no air remains. Priming is typically performed into a disposable container that will be used for priming and calibration andthen destroyed.
See the Circle Priming section of this document for a description of when it might be useful to do a technique called “Circle
Priming” and how to do it.
Note:

To properly calibrate the pump unit, ensure the tubing set is properly primed following these instructions. Failure to doso may result in an incorrect transfer of liquid volumes.

To prime:
1. If not already connected, connect the input (proximal) end of the tubing set to a source container. If a multi-leadtubing set is used, connect each of the input (proximal) ends of the tubing set to a source container.
Note:

For Circle Priming, see the Circle Priming section of this document.

2. If not already connected, connect the receiving (distal) end of the tubing set to a destination container.
3. Press Prime and the pump unit automatically starts to prime the tubing set.
Note:

There may be a delay of a few seconds between pressing Prime and the pump unit starting.

4. Visually confirm priming was successful, then disconnect the destination container from the tubing set.

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

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Note:

The Skip Prime option will not be available (see screen shot shown below) if the user has indicated that they areusing a new tubing set. Priming is always required for new tubing sets prior to proceeding to calibration or transfer.

3.7.1 Circle Priming
When using the Circle Priming process, air primed out of the tubing and any excess liquid is transferred back to the source
container. This provides the following advantages: conserves excess drug used during normal priming, prevents the drug
used for priming from air contact, and eliminates the need for a priming container.
Note:

To properly calibrate the pump unit, ensure the tubing set is properly primed following these instructions. Failure to doso may result in an incorrect transfer of liquid volumes.

To Circle Prime:
1.
Note:

Connect the input end of the tubing set to a source container.
If a multi-lead tubing set is used, connect each of the input ends of the tubing set to a source container.

2. Connect the output end of the tubing set to a separate port on the source container.
Note:

If a multi-lead tubing set is used, make sure that the source container connected to the output end of the tubing has
sufficient capacity to safely receive the full priming volume.

3. Press Prime and the pump unit automatically starts to prime the tubing set.
Note:

There may be a few seconds delay between pressing “Prime” and the pump unit starting.

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4. Visually confirm priming was successful, then disconnect the receiving (distal) end of the tubing set from the source
container.

3.8 Calibration
The System allows a user to choose the drug and volume with which to calibrate the System. The drug can be selected in the
Drug Set-Up Tab. It is recommended to calibrate the pump unit after change of the drug, tubing set, desired volume, or
destination container. Because the tubing set should be replaced when a new drug is to be compounded, it should becalibrated with the drug the user intends to transfer.
Note:

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

Calibration is typically performed into the same disposable container that was used for priming, then the container should bedestroyed.
Note:

If circle priming is performed, a separate disposable container should be used for calibration then destroyed. See
Circle Priming for a description of how to perform Circle Priming.

There are two ways that calibration can be performed:
●
●
Note:

Gravimetric Calibration with External Scale
Volumetric Calibration

It is important to determine which method the facility will use for calibration and carefully read and follow thedirections and guidance below for the method that you choose.

3.8.1 Gravimetric Calibration with External Scale
The calibration process of the pump unit can be performed using a separate third-party scale, referred 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 the specific gravity used for theliquid to be transferred.
DO NOT use the gravimetric calibration process unless confident that the specific gravity has been
accurately entered for the fluid being transferred.

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To calibrate the pump unit:
1. Enter the Calibration Volume and Speed.

Note:

The transfer speed should be selected based on the volume, output container type, connector type, and viscosity of
the liquid. To adjust the speed of the pump unit, press the arrows on either side.

2. If not already placed, place the destination container (calibration container) on the external 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 in inaccurate calibrations.

3. Tare the external scale.
4. Remove the destination container from the external scale and reattach it to the tubing set.

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5. Press Start to initiate the transfer.
Note:

There may be a few seconds delay between pressing Start and the pump unit starting.

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6. After the calibration transfer is complete, enter the weight measured by an external scale into the screen as shown
below. To use the entered weight to update the pump unit calibration, press Adjust.

Note:Pressing Adjust will update the calibration of the pump unit to account for the over/underfill of the transfer as
indicated on the screen (difference between specified volume/weight vs measured weight).

Note:

If the measured weight is significantly different than the expected weight, the System will display a warning before
allowing the pump unit calibration to be updated. See the Warnings During Calibration section of this manual for
details.

Note:

See Recalibration section of this manual for steps to follow if the user does NOT want to use the entered weight toupdate the pump unit calibration.

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7. After a successful calibration, the pump unit will display a Calibration completed message. At this point, calibration iscompleted and the user will be directed to the Set Up menu.

3.8.2 Volumetric Calibration
When a scale is not available, the System supports volumetric calibration. Volumetric calibration is an option that is selected in
the Settings menu. It is a one-time setting that is done when the user decides which calibration protocol they want to use forthe facility.
Note:

Volumetric Calibration is set to On by default.

Note:

When performing volumetric calibration, the user should use an output container with accurate graduated volume
markings (example: syringe or graduated cylinder).

To turn On the Volumetric Calibration feature, select Settings, then Customization, then press the On button next to theVolumetric Calibration text.

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When Volumetric Calibration is On, the System will ask for a volume instead of a weight at the end of the calibration steps.
1. Enter Calibration Volume.
2. Select Speed.
3. Press Start.

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4. Enter volume transferred as indicated on the output container.
5. To use the entered volume to update the pump unit calibration, press Adjust.

Note:Pressing Adjust will update the calibration of the pump unit to account for the over/underfill of the transfer as
indicated on the screen (difference between specified volume vs measured volume).

Note:

If the measured volume is significantly different than the expected volume, the System will display a warning before
allowing the pump unit calibration to be updated. See the Warnings During Calibration section of this manual for
details.

Note:

See Recalibration section of this manual for steps to follow if the user does NOT want to use the entered volume to
update the pump unit calibration.

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After a successful calibration, the user will be directed to the Set Up menu.

3.8.3 Warnings During Calibration
The following warnings will be displayed during gravimetric and volumetric calibration if the difference between the expected
and measured weight/volume is higher than expected.
The first warning message of “Calibration out of regular range Accept?” (Figure 16) is displayed when the discrepancy
between expected and measured weight is greater than 20%. When the user receives this message, it is an opportunity toconsider whether the calibration operation was performed correctly.

Figure 16: Calibration out of regular range Accept?
Pressing the Yes button confirms the user’s entry and completes the calibration process. Pressing on the No button returns
the user to Prime part of the workflow. Repeat the priming and calibration to ensure the accuracy of the pump unit.

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The second warning message of “Wrong Calibration Please Repeat” (Figure 17) is displayed when the discrepancy
between the expected and the measured weight is large enough to suggest something went wrong with the calibration.

Figure 17: Wrong Calibration Please Repeat
Press the OK button to return to the Prime part of the workflow. Repeat the priming and calibration processes to ensure theaccuracy of the pump unit.

3.8.4 Recalibration
If the Measured Weight or Volume entered is not compliant with facility’s guidelines, a recalibration may be performed, and thecalibration transfer process repeated. Press the Back button to go through the calibration process again.

Note:

By Pressing Back, the pump unit calibration will NOT be updated based on the previous transfer and the System willallow the user to repeat the calibration steps again.

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3.9 Set Up and Transfer
Upon proper calibration, the System allows a desired volume to be transferred and the desired 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.
4. Press Next to confirm the transfer settings.

5. After confirming that the entered information is accurate, press Start to initiate transfer. The pump unit will begin
liquid transfer and the progress bar will indicate the status of the transfer. The volumetric measurement will provide
an indication of what has been transferred into the bag. Pressing Stop will interrupt the transfer.

Note:

There may be a few seconds delay between pressing Start and the pump unit starting.

Note:

If the optional Foot Pedal Kit is installed, pressing the Foot Pedal can be used to “Start” a transfer, or “Stop” atransfer in progress.

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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.

3.10 Infinite Transfer Mode
In Infinite Transfer Mode, the user has direct control of when fluid transfer is started and stopped. To enter this mode:
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. Select Infinity Mode by pressing the infinity symbol on the Set Up screen or selecting Infinity when entering
Volume.

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4. Press Next to confirm the transfer settings.

The user is now in Infinite Transfer Mode.
5. Press Start to start transfer.

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6. Press Stop to stop the transfer.

7. Press Continue to resume transfer or press Cancel to exit Infinite Transfer mode.

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3.11 Batch Mode
Batch mode can be used for compounding multiple destination containers/doses. The user can confirm the transfer accuracy
using their own equipment and methods. When specifying the details of Batch Mode, the user will fill in the Number ofContainers and the Interval Time.
Table 9: Batch Mode Settings
OptionDescription

Number ofContainers

The number of destination containers that the user wants to fill.

Interval Time

This number specifies the time (in seconds) the System will wait after completing the current transfer
before initiating the next transfer.

The maximum value that can be entered is 999.

Interval time can have values from 2 to 180 seconds and Manual.
When the interval is set to Manual, the pump will stop after each transfer and the user must press Start
to proceed with the next transfer in the batch. See details below this table on how to select “Manual”
for Interval Time.

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Selecting Manual for Interval can be accomplished in two ways:
1. To select the option manual in the Interval Time field, press ‘-‘ until the number 2 is reached; then, press ‘-‘ one lasttime, and the option manual will be available for selection.

2. Select the Interval Time field, on the keypad screen select ‘m’ and press Enter.

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3.11.1 Using Batch Mode
1. Connect the input (proximal) end of the tubing set to a source container.
2. From the Set-Up screen, select Volume and Speed as you would normally do for a transfer.

3. Press Batch to set the number of (destination) Containers and Interval Time.

Note:

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

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4. Press Next on the Set Up screen, and then Start on the Compound screen to start the batch transfers.

When the transfer is complete, a countdown on the top right of the screen will alert the user about how many
seconds are left until the next transfer is automatically initiated.
Note:

If you are interrupted or need more time to switch output containers, press Pause or Stop.

5. When each transfer is complete and during the timer countdown, connect the receiving (distal) end of the tubing set
to the next destination container.
Note:

There may be a few seconds delay between pressing Start and the pump unit starting.

Diana Peristaltic Pump User Manual62

Operating the Diana Peristaltic Pump
When all transfers in the batch are complete, the following screen appears:

3.12 Power Off
When the user is done with compounding processes, the pump unit can be turned off. Press the Power button on the front of
the pump unit to turn it off (Figure 18).

Figure 18: Power Off

Diana Peristaltic Pump User Manual

63

Settings

Chapter 4 Settings
To access the Settings Menu, press on the Settings Icon ( )located in the top right of the toolbar (Figure 19). The Settings
Menu will be displayed. Any menu items that are greyed out are not available.

Figure 19: Settings
Important: The Settings icon cannot be accessed until a tubing set is installed and the flap is closed.
The following table describes the settings menu:
Table 10: Settings Menu

OptionDescription

Customization

Allows updates to speed, volume options, and the user to view software version.

Date and Time

Allows updates to the date and time.

Scale Calibration Check

Allows user to perform Scale Kit calibration checks.

Advanced Settings

Allows updates to drug listings, language options, and network connections.
(Password-protected).

Technical Service

ICU Medical Personnel only.

Developer

ICU Medical Personnel only.

Diana Peristaltic Pump User Manual64Settings
The following is a map of the Settings Menu structure (Figure 20). Each Setting is described in detail in the following sections.
Press Customization to enter the Customization Menus. Press Advanced Settings to enter the Advanced Settings Menus.
Use Page Up and Page Down buttons to move between pages in the Customization and Advanced Settings Menus.

Figure 20: Advanced Settings

Diana Peristaltic Pump User Manual65

Settings

4.1 Customization
Press on the Customization tab to modify settings that are user controllable. A window will display the customization options
for the System as shown in Figure 21.
The available Customization settings are: Custom Speed Settings, Version Information, Volume, Volumetric Calibration
Enable, and Adjust Priming Volume, and User Logout (If the user management is activated).

Figure 21: Customization

4.1.1 Custom Speed Settings
The user of the System can modify the name or activation status of the speed settings of the pump unit in the Customization
tab.
The System has 10 speed settings, and it allows the user to set each speed as Active or Inactive. The speed is measured in
mL/min. Default speed settings are shown in the table below.
Table 11: Default Speed Settings
NumberDefault Name

mL/min*1

Minimum

75

2

Slow

150

3

Normal450

4Luer Max700

516G Thick375

6

16G Max

500

7

18G Thick100

8

18G Max

350

9Elastomeric

200

Diana Peristaltic Pump User Manual

Backdraw (mL)

0.5

0.5

0.5

66

Settings
Number10

Default Name
CADD

mL/min*Backdraw (mL)

200

*Note: The pump unit speed is not user-configurable; only named identified presets are available.
To Customize the speed settings:
1. In the Customization settings menu, press on the Custom Speed Settings option.

2. Change the name or activation status of a speed setting by pressing the number next to the name.

Note:

Active speed settings are shown with Blue shaded number next to the speed name.

Diana Peristaltic Pump User Manual67

Settings
3. Select a Speed Name to change it. Press the blue button to Activate or Deactivate the speed setting.
Press Save to confirm the changes.

Note:

At installation, the pump unit defaults to setting 3 “Normal” (450 mL/min) for all drugs.

Note:

If the setting 3 “Normal” (450 mL/min) is deactivated, the next active speed will be used as the default.

Note:

The user will be able to select activated speed settings, using the names the user customized, for calibration andfluid transfers. The user can press the left/right arrows to change the speed.

Diana Peristaltic Pump User Manual68Settings

4.1.2 Version Information
Press on Version Information setting to see the pump unit software component versions, see Figure 22.

Figure 22: Version Information

Diana Peristaltic Pump User Manual69

Settings

4.1.3 Volume
1. Press on the Volume setting to adjust the sound volume. The user can select a desired volume by clicking thedesired position on the bar, the slide will move accordingly.
2. To test the current volume, press the Test button.

4.1.4 Scale Option
There is no option for a connected scale in this System version. This option is marked “Scale Option Disabled” and cannot
be turned on or off, see Figure 23.

Figure 23: Scale Option

Diana Peristaltic Pump User Manual70

Settings

4.1.5 Volumetric Calibration Enable
When using the System without a scale, the user has the option of Enabling Volumetric Calibration. This will allow the user tocalibrate without a scale, and the calibration interface will ask for a volume in ml when reading the calibration results. Find theVolumetric Calibration setting on the Customization Menu (Figure 24). To enable this option press On. If later an External
Scale is incorporated into the workflow, go to this screen and press Off.

Figure 24: Volumetric Calibration Enable
Note:

Volumetric Calibration is set to On by default.

4.1.6 Reprint Label Screen Enable
Printer is not an available option in this System version. Reprint Label Screen is a disabled option and cannot be turned on
or off, see Figure 25.

Figure 25: Reprint Label Screen Enable

Diana Peristaltic Pump User Manual71Settings

4.1.7 Adjust Priming Volume
The User can manually adjust the volume for priming the tubing set. This setting is on the second page of the Customization
Menu. Press the text to Adjust Priming Volume.

Select the current Priming Volume value. After entering the new value, press Save.

Diana Peristaltic Pump User Manual72

Settings

4.1.8 User Logout
If User login at startup is enabled in Advanced Settings, the user will be required to login when the System is powered on.
That will add User Logout as a selection on the second page of the Customization Menu. Press User Logout to logout of the
System. The System will then show the User Login screen so the next user can Login as shown in Figure 26.

Figure 26: User Logout

4.1.9 User Login
The default setting on the pump unit does not require user login upon power on. The user login settings can be updated by anauthorized user. Once activated, the user is prompted to enter the username and password when the System is turned
on. User login settings can be updated within the Advanced Settings menu (see User Login at Startup).

4.2 Date and TimeThe user can update the date and time in the pump unit on the first page of the Settings Menu. Enter the current date and/ortime and press Set as in Figure 27:

Figure 27: Date and Time

Diana Peristaltic Pump User Manual73Settings

4.3 Scale Check
The Scale Check feature (Figure 28) allows the user to check the function of the connected Scale Kit by weighing a test
weight of known mass. Connected scale is not available in this version, so this option is greyed out and not selectable.

Figure 28: Scale Check

4.4 Advanced Settings
The Advanced Settings will allow the user to adjust various settings of the System. There are three pages of Advanced
Settings as shown in Figure 29. These menus are available only to authorized users by entering the Rotating Passcode(see below for details).

Figure 29: Advanced Settings

Diana Peristaltic Pump User Manual74

Settings

4.4.1 Rotating PasscodeThe rotating passcode is composed of three different components (Figure 30) and must be recalculated by the user every
day.
●
●
●

The first component is the current date, the first 5 digits of the date.
The second component is the last digit of the serial number of the pump unit.
The third component is the value for the setting area (3 -> for the Advanced settings).

Figure 30: Rotating Passcode
Below is an example of how the rotating password is calculated. To get the correct password, the user must add the threecomponents consisting of Serial Number, X and Y together.
Passcode: Base PIN + X + Y
Base PINFirst 5 digits of the dateX

Last digit of the serial number of the pumpunit

Y

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 rotating passcode.
Date

05/28/2021

Serial number 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).

Diana Peristaltic Pump User Manual75

Settings

4.4.2 Edit Drug
1. Select Edit Drug in the Advanced Settings menu.

The user can search drugs by NDC or Name (drug name).
2. To search by NDC, select NDC option. Enter the NDC code and press Enter.
Note:

As user enters the NDC number, System will suggest the NDC number to autofill.

Diana Peristaltic Pump User Manual76

Settings
3. To search by name, select Name. Enter the name and press Enter.

Note:

As user enters the drug name characters, the System will suggest the name to autofill.

If the required drug does not exist in pump unit’s database, then the user will need to add the new drug to the database.
4. To add new drug, press on Add New Drug. Enter the new drug information and press Enter.

Note:

Drug Name and NDC are required fields to save a new drug. Save button will not appear until a Drug Name and
NDC are entered.
a.

Drug Name Specificationsi.

May be a combination of alphanumeric characters.

ii.
Up to 100 characters allowed, but using less than 20 characters is recommended forreadability on the device.
iii.
entered.

The recommendation is to include name and concentration as part of Drug Name

Diana Peristaltic Pump User Manual77

Settings

b.

Note:

NDC Specificationsi.

May be a combination of alphanumeric characters.

ii.

The recommendation is to use numbers only.

System search functions may not properly identify NDCs that utilize letters or special characters.
iii.

May not enter NDC that is already saved in the database.

iv.
Up to 100 characters allowed, but using less than 20 characters is recommended forreadability on the device.
v.

The recommendation is to adhere to FDA standard formats for 10-digit numeric NDCs.

5. Once the user identifies the drug, add missing information if required.
6. Verify the correct information is entered in the designated fields and press Save.

Diana Peristaltic Pump User Manual78

Settings
If a specific gravity is entered outside the value range defined in the System (0.70-1.60), the text “Specific Gravity”
will be displayed in red. If the user continues and presses the Save button, a warning message appears. Pressing Ok
acknowledges the warning and returns the user to the previous screen to correct the Specific Gravity entry.

7. Enter a specific weight in the range 0.70 – 1.60 g and then press Save. The System will return to the initial Edit Drug
screen.

Diana Peristaltic Pump User Manual79Settings

4.4.3 Language
The pump unit user interface can be displayed in multiple languages. The Language menu allows the user to switch thelanguage.
To Select Language:
1. Go to Advanced Settings menu and press on Language.

2. Press the gray square next to the desired choice to select the Language.

Diana Peristaltic Pump User Manual

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Settings
3. Press Save to set the new language.

4.4.4 Custom Label Settings
Printer is not an available option in this version. Custom Label Settings (Figure 31) is a disabled option.

Figure 31: Custom Label Settings

Diana Peristaltic Pump User Manual81Settings

4.4.5 Print Setup
Printer is not an available option in this version. Print Setup (Figure 32) is a disabled option.

Figure 32: Print Setup

4.4.6 User Management
User Management involves the creation of individual or group accounts for the people on the team. When an account iscreated, it can have two levels of permission:●●Standard (Access to Customization, Date and Time, and Scale Check)
Advanced (Access to Customization, Date and Time, Scale Check, and Advanced Settings)

To support the creation of accounts, the system comes with a default account named “User Manager.” It is recommended that
accounts be managed through the “User Manager” account. The “User Manager” account has the Technical level of
permissions. To access the “User Manager” account:
1. Select Settings.

Diana Peristaltic Pump User Manual82

Settings
2. Select Advanced Settings.

3. Enter Advanced Settings Passcode.

4. Select Page Down.

Diana Peristaltic Pump User Manual

83

Settings
5. Select User Login at Startup.

6. Confirm “User Login at Startup” is set.

7. Power cycle the pump unit. Press down the arrow on "Select User" and choose User Manager.

Diana Peristaltic Pump User Manual84

Settings
8. Enter passcode for User Manager (“43210”).

The “User Manager” is now logged in. After logging in, the screen shown below will display. The “User Manager”
has Advanced permissions which enable access to the Advanced Setting menu items without entering a passcode.

The “User Manager” can now create additional accounts.

Diana Peristaltic Pump User Manual

85

Settings
To create a user:
The following steps create a user named “Technician 1” with Standard rights and Password “11111” as an example.
Note:

The User Manager can choose between Standard or Advanced Rights (Permission Levels).

1. Press on User Management in the Advance Settings section.

2. Press on Add User.
3. Enter “Technician 1” as User Name and Password “11111”
4. Retype the password to confirm it.
5. Select Standard for Rights.
6. Press Save.

Diana Peristaltic Pump User Manual86Settings
To modify a user:
1. Select an existing user and press Modify.

Modify allows the Password and/or Rights for a User to be changed.
2. Once changes are made, press Save.

Diana Peristaltic Pump User Manual

87

Settings
To delete a user:
Select an existing user and press Delete. The user is removed from the User Accounts list.

4.4.7 User Login at Startup
The authorized user can require a user login on the pump unit.
To Login at Startup:
1. Press on User Login at Startup in the Advanced Settings section.

When the green check mark is set by the authorized user, the user login will be required each time the pump unit is poweredon.

4.4.8 Require Drug Information
The System 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.

Diana Peristaltic Pump User Manual88

Settings
To enable the Require Drug Information option:
1. Press Require Drug Info in the Advanced Setting section.
2. Press on red box to enable the option. A Green checkmark will be displayed.

4.4.9 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. Press on Change Specific Gravity in Drug Screen in the Advanced Settings section.

2. Toggle between () and (x) to change the Specific Gravity or not.

4.4.10 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 to access the Advanced
Setting menu.

Diana Peristaltic Pump User Manual89

Settings
To adjust the Complete Screen Display Interval in Seconds:
1. Go to 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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90

Settings

4.4.11 Logfiles
1. Insert an USB stick into the adapter.
Note:

See section USB Adapter (DS1050) for detailed description of adapter.

2.
3.
4.
5.

Insert the adapter into the pump unit USB port.
Select desired option (Last 7 days, Last 30 days, Last 60 days, Archive).
Wait for the “Finished” message to be displayed on the pump unit.
Remove the USB and adapter from pump unit.

Note:

Log file saved in CSV (Commas Separated Value) format.

Note:

Archive will save all available log files.

Note:

System will display progress until log files are all transferred to the USB stick.

Diana Peristaltic Pump User Manual91Settings

4.4.12 Scale Deviation Borders
Connected Scale is not available in this version. Scale Deviation Borders (Figure 33) is a disabled option, it only applies
when there is a Connected Scale.

Figure 33: Scale Deviation Borders

4.5 Technical Services
Technical Service menu item (Figure 34) is for ICU Medical authorized personnel only.

Figure 34: Technical Service

Diana Peristaltic Pump User Manual92

Settings

4.6 Developer
Developer Menu item (Figure 35) is for ICU Medical authorized personnel only.

Figure 35: Developer

Diana Peristaltic Pump User Manual93Specifications, Maintenance and Troubleshooting

Chapter 5 Specifications, Maintenance and Troubleshooting
All maintenance must be performed by an authorized ICU Medical representative except for routine cleaning and specifically
excluded activities.
ICU Medical recommends sending the pump unit to ICU Medical Service department once a year for inspection andmaintenance. Please contact the local ICU Medical representative or ICU Medical Service department for instructions.

5.1 Accuracy Specifications
Important: Verify pump unit accuracy performance before use to ensure it meets facility protocols.
●

Pump unit accuracy with Water/Isopropyl Alcohol at a Slow-speed setting using ICU Medical Luer-based
components, 16G needle, or 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●

Pump unit accuracy with Lipids at a viscosity-specific speed using ICU Medical Lipids tubing set (Luer-based):+/- 10% for volumes greater than or equal to 5 mL●

The pump unit can provide a sustained transfer rate (measured with Water) using ICU Medical tubing set:

700 mL/min (“Fast” default speed) with Luer-based sets
560 mL/min with 16G needle
150 mL/min (“Slow” default speed) with 18G needle

Diana Peristaltic Pump User Manual94Specifications, Maintenance and Troubleshooting

5.2 Environmental Specifications
Table 12: Environmental Specifications

ReferenceSpecification

Operating Temperature+10°C to +40°C

Operating Humidity

15% to 60% (non-condensing)Operating Altitude

0 to 2000 meters above sea level

Storage Temperature

0°C to +60°C

Storage Humidity

15% to 85% (non-condensing)

Storage Altitude

0 to 2,000 meters above sea level

Transportation Temperature

0°C to +60°C

Transportation Humidity

15% to 85% (non-condensing)Transportation Altitude

0 to 2,000 meters above sea level

Physical Dimensions

5.7 in x 9.8 in x 8.6 in (145 mm x 249 mm x 218 mm)

Weight11.2 pounds (5.09 kg)

Electrical Operating Power Range

100 – 240 V AC
0.8 A – 0.4 A
50 – 60 Hz

Electrical Fuse

Diana Peristaltic Pump User Manual95Specifications, Maintenance and Troubleshooting

5.3 Lithium-Ion Coin Battery Replacement
Important: The pump unit relies on a 3-volt Lithium battery (CR2032). Service on the battery is recommended to be done only
by an authorized ICU Medical Representative. Incorrect insertion of the Lithium-ion battery may result in damage of the pumpunit.
Battery location can be identified by this symbol in this pump unit.
The battery indicator (36.

) will appear on the front panel when the lithium-Ion coin battery requires service as shown in Figure

Figure 36: Lithium-Ion Coin Battery Replacement

Diana Peristaltic Pump User Manual96Specifications, Maintenance and Troubleshooting

5.4 Fuse Replacement
The pump unit uses two fuses located in the rear of the pump unit (Figure 37); fuses are a part of the Power Inlet (See Diana
Peristaltic Pump Description for illustration of location).

Figure 37: Fuse Replacement
Service on the fuses can be performed by the end-user (end-user buys the fuses from local hardware/electrical store).
The Fuse type to be used is ceramic fuse model number T2AH250V.
Important: Incorrect insertion of the fuses may result in no power to the pump unit.
To replace the fuse:
1. Make sure the pump unit is powered-off and the power cord is unplugged.
2. Use a flat head screwdriver to remove the fuse holder from the Power Inlet by turning the fuse holder in acounterclockwise direction.
3. Remove the old fuse(s) from the holder and replace them with new fuse(s). It is recommended to replace 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 pump unit to avoid damaging the fuse holder or Power Inlet.

Diana Peristaltic Pump User Manual97Specifications, Maintenance and Troubleshooting

5.5 Tubing Replacement
The System will display the warning shown in Figure 38 if a tubing set has compounded more than 60L of fluid. When theuser replaces the tubing set, the workflow may continue.

Figure 38: Tubing Replacement
Note:

This warning will continue to be displayed even if the pump unit is turned off and then on again.

5.6 Temperature Warning
The Pump Unit contains temperature sensors that are monitored to determine when the fans should be turned on to cool theunit. The system also has a maximum temperature limit. When the system approaches its limit, the warning shown in Figure
39 will appear.
Note:

When the warning notification appears, it is recommended to stop using the unit for 30 minutes.

Figure 39: Temperature Warning - Pause Transfers

Diana Peristaltic Pump User Manual98Specifications, Maintenance and Troubleshooting
When the system temperature exceeds the maximum temperature limit, the warning shown in Figure 40 will be displayed.
When the warning notification appears, it is recommended to shut off the pump unit for 30 minutes before using it again.

Figure 40: Temperature Warning - Power Off System
When these warnings occur, please check that the vents on the bottom of the pump unit are not blocked and that there issufficient air flow around the unit. Also, ensure the system is operated in an environment that is within the Operating
Temperature, Pressure, and Humidity limits listed in Environmental Specifications. If the warnings persist, contact ICU Medical
Service for assistance.
Table 13: Temperature Limits

Run Time Variable

Setting

Max Temperature Limit

55° C

Recommended Cool Down Period

30 minutes

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

5.7 Duty Cycle
For best performance of your system, it is recommended to allow the Pump Unit a 30-minute cooldown period after:●●

8 hours of continuous fluid transfer
Pumping 240 liters of fluid

The Pump Unit can remain on but should not be actively transferring fluid during the 30-minute cooldown period.

Diana Peristaltic Pump User Manual99Specifications, Maintenance and Troubleshooting

5.8 General Troubleshooting
Table 14: General Troubleshooting

Description of Fault
Silicone tubing herniates orballoons and prevents
pumping of liquid

Tubing kicks out of the pumpunit

Possible Causes

Solution

Using output containers with back-pressure Use Heavy Duty tubing (BX series)(like containers used with ambulatory
pumps or elastomeric pumps)
Using smaller than 16 G needle

Switch to 16 G needle or reduce thespeed of the pump unit to reduce theback pressure

Using inline filter

Reduce speed to reduce back pressure

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

Decrease back pressure or lower speed

Tubing was not installed correctly

Remove tubing and re-install

Consistently inaccurate filling Incorrect calibration

Use the calibration function

Inaccurate filling, notrepeatable (varies)

Lower the speed

Does not pump and makes
loud grinding noise

Decrease back pressure (use larger
needle or remove filter)
Lower the speed of the pump unit
Use “BX” series tubing
Check Power Cord and ensure
connection

Pump unit display is dark
The pump unit providing alert
to change compounding set

Diana Peristaltic Pump User Manual

Compounding set (tubing set) has beenused to transfer 60 liters.

Replace tubing set.

100

Specifications, Maintenance and Troubleshooting

Description of Fault
Database Error Messages

Diana Peristaltic Pump User Manual

Possible Causes
System malfunction

Solution
Please contact ICU Medical TechnicalSupport.

101

Pump Unit Software Update

Chapter 6 Pump Unit Software Update
Note:

The USB stick and adapter must be requested from ICU Service personnel.

The folder drp / update can be found on the USB stick to update the pump unit software.
After the pump unit has booted up, the prefabricated USB stick is plugged into the USB interface of the pump unit (the user
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 a complete pump unit update, or the user selects the appropriatecomponents to be updated.
If the drug database and / or the FDA database is updated, the user will receive a short message (green message) on thedisplay after a successful update and the pump unit automatically restarts. If the pump unit update is also checked, a new
window opens with a progress bar and with an indication of which file is currently being updated.
After the update has been successfully transferred, the pump unit will restart and return to the setup screen.
Note:

Prerequisite for the pump unit restart is that no new firmware or Kernel is included in the pump unit update. ICU
Personnel will provide further instructions if firmware or Kernel updates are required.

1. Turn on the pump unit and wait for it to completely power on.

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

Diana Peristaltic Pump User Manual102

Pump Unit Software Update
3. Follow instructions provided by ICU Medical service personnel, and make the selection of which components need to
be updated.

Note:

Components marked with a red cross cannot be updated because they are not available on the USB stick.

4. Then press the Next button to start the update.

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

Diana Peristaltic Pump User Manual103

Pump Unit Software Update
6. A progress bar indicates how far the update has progressed and which file is currently being updated.

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

7. After completing the update (if no firmware update has been made), the user will receive a confirmation message thatthe update has been successfully completed. Then the pump unit automatically restarts.

Diana Peristaltic Pump User Manual104

Pump Unit Software Update
8. If a firmware update is executed, the user receives a message, and the pump unit must be restarted manually bypressing the On / Off button. Switch the pump unit off. Wait some seconds before the user restarts.

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

Diana Peristaltic Pump User Manual105Transport

Chapter 7 Transport
Please note that some metal parts may be warm after heavy use of the pump unit. The user should not use the pump unit for
30 minutes before transportation to allow the metal parts to cool. However, the pump unit should remain switched on during
the cooling phase.

Diana Peristaltic Pump User Manual106Database Error

Chapter 8 Database Error
This database error occurs when the pump unit software cannot read the database. The number in brackets indicates theerror (Figure 41). The user will find the error designation in the following list (see List of Database Errors). If this error
occurs, please contact a service technician immediately.

Figure 41: Database Error (14)The database error shown in Figure 42 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 thenfollow up with the usual workflow. If the user receives this error message, please contact a service employee to be able tocorrect this database error as quickly as possible.

Figure 42: Database Error (5)Diana Peristaltic Pump User Manual107Database Error

8.1 List of Database Errors
Table 15: Database Errors

Displayed error

Description of the error#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 read only 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 */Diana Peristaltic Pump User Manual108Database Error

Displayed error

Description of the error#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 User Manual109

Service and Contact Information

Chapter 9 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 the user:

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

Diana Peristaltic Pump User Manual

110Warranty and Service Information

Chapter 10 Warranty and Service Information
10.1 Limited Warranty
ICU Medical warrants the System to be free from defects in material and workmanship for one (1) year from the date ofdelivery, when operated in accordance with the User Manual. Sensors and accessories are warranted to be received in goodcondition, and ICU Medical agrees to accept return if found defective upon installation, provided that ICU Medical is notified
within five (5) days from initial installation and the items not deemed ineligible for warranty under the conditions and exclusions
from warranty listed in this manual. ICU Medical cannot honor warranty claims due to damages resulting from transport.
This warranty extends to the designated original purchasers of the equipment from ICU Medical and will not extend to any
subsequent purchaser. This warranty shall not apply where: service is required due to purchaser’s failure to operate or
maintain the equipment in a manner consistent with the specifications and guidelines set forth in the User Manual; service isrequired 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 ofcomponents that do not function as intended during the term of this warranty. Warranty components or assemblies shall be ofequal or better quality than the component or assembly replaced. Such components replaced by ICU Medical become theproperty of ICU Medical.
This warranty is extended to original purchasers of the equipment from ICU Medical in lieu of all other warranties expressed or
implied and all other obligations or liabilities on the part of ICU Medical, and no person, agent, or dealer is authorized to give
any warranties or to assume any other liability on behalf of ICU Medical. For ICU Medical to properly administer the warranty,
the purchaser must notify ICU Medical promptly after the occurrence or discovery of any alleged failure.

10.1.1 Disclaimer of Warranties
THIS LIMITED WARRANTY IS PROVIDED IN LIEU OF ALL OTHER WARRANTIES, WHETHER EXPRESS OR IMPLIED,AND ICU MEDICAL HEREBY DISCLAIMS ALL OTHER WARRANTIES, INCLUDING WITHOUT LIMITATION IMPLIEDWARRANTIES OF MERCHANTABILITY, FITNESS FOR PARTICULAR PURPOSE AND NON-INFRINGEMENT.
Excluded from warranty coverage are damages resulting from:
Incorrect connection of Diana Peristaltic Pump unit or accessories.
Unauthorized cleaning of the Diana Peristaltic Pump unit or accessories.
Transportation damages of any sort.
Accident, fire, water, vandalism or causes other than ordinary usage.
Misuse of the equipment or accessories.
Disregard the user manual instructions.

10.1.2 Limitation of Liability
IN NO EVENT WILL ICU MEDICAL BE LIABLE FOR COSTS OF PROCUREMENT OF SUBSTITUTE PRODUCTS ORSERVICES, 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 SUCHDAMAGES. THESE LIMITATIONS WILL APPLY NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OF ANY
LIMITED REMEDY.

Diana Peristaltic Pump User Manual111Appendix A: Cleaning and Disinfection of the Diana Peristaltic Pump

Appendix A: Cleaning and Disinfection of the Diana Peristaltic
Pump
Switch off the power supply of the pump unit. Spilled liquid and drops must be wiped promptly to avoid ingress into the pumpunit. Use only lint-free cloths or swabs with cleaning and disinfection solutions. Do not use abrasives. Also clean the pump unit
under the stainless-steel plate, including rollers when the System is turned off.

Following is a list of approved cleaning, decontamination, and disinfection agents approved for use with the System.
Table 16: Approved cleaning, decontamination, and disinfection agents for the pump unit
Agent

Concentrations (water solutions)

Isopropyl Alcohol

Equal or less than 70.0% w/w

Peracetic Acid

Equal or less than 2.0% w/w

Hydrogen Peroxide

Equal or less than 7.5% w/w

SurfaceSafe

See Agent product labeling

HD CleanSee Agent product labeling

Peridox RTU

See Agent product labelingContec TB-1 3300

See Agent product labeling

PREempt

See Agent product labeling

Note:

If the facility uses cleaning, decontamination, and disinfection agents not included on this list, please contact ICU
Medical.

Diana Peristaltic Pump User Manual112Appendix A: Cleaning and Disinfection of the Diana Peristaltic Pump

Cleaning and Disinfection of Diana Peristaltic Pump Accessories
Foot Pedal Kit:
The Foot pedal is made from Nylon plastic material; thus, it is suggested to clean it with an isopropanol wipe and sterile water
only.

Diana Peristaltic Pump User Manual113Appendix B: Accuracy Verification Protocol

Appendix B: Accuracy Verification Protocol
A standalone scale is recommended to perform this protocol. If a scale is not available, a graduated cylinder can be used.
With Standalone Scale
After a new tubing set is installed, primed, and calibrated, the user may do an accuracy verification at any point.
To do an accuracy verification test with Standalone Scale:
1.
2.
3.
4.

Install empty calibration container.
Ensure the Volumetric Calibration setting is turned OFF.
Select the Calibrate Tab.
Follow the directions in Gravimetric Calibration with External Scale section.

With Graduated Cylinder (If no scale available)
After a new tubing set is installed, primed, and calibrated, the user may do an accuracy verification at any point.
To do an accuracy verification test with Graduated Cylinder:
1.
2.
3.
4.
5.
6.

Disconnect the output container and put distal end of tubing into a graduated cylinder of at least 150 mL size.
Ensure the Volumetric Calibration setting is turned ON.
Select the Calibrate Tab.
Follow the directions in the Volumetric Calibration section of the User Manual (use 100 mL as volume to transfer).
Remove the tubing set from the Graduated Cylinder.
Read the volume in the Graduated Cylinder and enter it as instructed.

Diana Peristaltic Pump User Manual114