ICU Medical Diana DS1000 User manual

Diana™ Peristaltic Pump
DS1000
User Manual
DF-4369-EN Rev 03 (09/2020)

Diana Peristaltic Pump, ICU Medical Page 2
Contents
1. Introduction............................................................................................................................................4
1.1. Intended Use ..................................................................................................................................4
1.2. General Guidelines .........................................................................................................................4
1.3. Important Safety Instructions.........................................................................................................4
1.4. List of Symbols Used on the Unit....................................................................................................7
1.5. List of Symbols Used on the Back of the Unit.................................................................................8
2. Diana Peristaltic Pump Overview ...........................................................................................................9
2.1. Installation......................................................................................................................................9
2.2. Diana Peristaltic Pump Module......................................................................................................9
2.3. Graphic User Interface (GUI)....................................................................................................... 11
2.4. Data Entry.................................................................................................................................... 12
2.5. Consumables ............................................................................................................................... 13
2.5.1. Tubing Set Overview............................................................................................................ 13
2.5.2. Tubing Set Information and Compatibility .......................................................................... 14
3. Operating the Diana Peristaltic Pump Module.................................................................................... 15
3.1. Tubing Set Installation / Removal................................................................................................ 15
3.2. Power On..................................................................................................................................... 17
3.3. Drug Set Up.................................................................................................................................. 18
3.3.1. Changing The Specific Gravity ............................................................................................. 19
3.3.2. Container Mode................................................................................................................... 22
3.4. Priming / Calibration Process ...................................................................................................... 22
3.4.1. Priming and calibration process .......................................................................................... 23
3.4.2. Warnings during Calibration Process .................................................................................. 25
3.5. Basic Set Up and Transfer............................................................................................................ 26
3.6. Forward / Reverse Transfer......................................................................................................... 28
3.7. Batch Mode ................................................................................................................................. 28
3.8. Power Off..................................................................................................................................... 30
4. Settings................................................................................................................................................ 31
4.1. Customization.............................................................................................................................. 32
4.1.1. Custom Speed Settings........................................................................................................ 32
4.1.2. Version Information ............................................................................................................ 34
4.1.3. Volume................................................................................................................................. 34

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4.1.4. Scale off ............................................................................................................................... 35
4.1.5. User Logout ......................................................................................................................... 35
4.2. Date and Time ............................................................................................................................. 36
4.3. Scale Calibration Check ............................................................................................................... 37
4.4. Advanced Settings ....................................................................................................................... 37
4.4.1. Edit Drug.............................................................................................................................. 37
4.4.2. Language.............................................................................................................................. 41
4.4.3. Custom Label Settings ......................................................................................................... 41
4.4.4. Print Setup........................................................................................................................... 41
4.4.5. Network Connections.......................................................................................................... 42
4.4.6. User Management............................................................................................................... 42
4.4.7. User Login at Startup........................................................................................................... 43
4.4.8. Require Drug Info ................................................................................................................ 44
4.4.9. Change Specific Gravity in the Drug Screen ........................................................................ 45
4.4.10. Complete Screen Display Interval in Seconds ..................................................................... 45
4.4.11. Logfiles................................................................................................................................. 46
4.4.12. Scale Deviation Borders....................................................................................................... 46
4.5. Technical Services........................................................................................................................ 46
4.6. Developer .................................................................................................................................... 46
5. Specifications, Maintenance and Troubleshooting............................................................................. 47
5.1. Accuracy Specifications ............................................................................................................... 47
5.2. Environmental Specification........................................................................................................ 47
5.3. Lithium-Ion Coin Battery Replacement ....................................................................................... 48
5.4. Fuse Replacement ....................................................................................................................... 48
5.5. Temperature Warning................................................................................................................. 49
5.6. General Troubleshooting............................................................................................................. 51
6. Warranty and Service Information...................................................................................................... 52
6.1. Limited Warranty......................................................................................................................... 52
6.2. Service and Contact Information................................................................................................. 53
Appendix A: Cleaning and Disinfection of the Diana Peristaltic Pump ....................................................... 54
Appendix B: Accuracy Verification Protocol................................................................................................ 55
Appendix C: Unit Software Update ............................................................................................................. 56
Updating the Software ............................................................................................................................ 56

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1. Introduction
1.1. Intended Use
The Diana Peristaltic Pump is an automated pharmacy compounding unit and is intended to be used in
a healthcare facility to dispense a specified quantity of fluid from a set of source containers into a
destination container. It can be used independently as a standalone unit or as a module of the Diana
Pharmacy Workflow System.
1.2. General Guidelines
Intended users/operators of the System are Pharmacists and Pharmacy Technicians. The operator must
be properly trained in the use of the System. Please follow the information contained in this manual as a
self-paced training guide prior to operating the unit for the first time. Refer to this manual as a reference
guide on as-needed basis, recurring training is not required to operate this unit.
The operator must wear proper protective equipment (PPE) when operating the System and adhere to
facility protocols and standards for operating compounding equipment.
Always follow published guidelines relating to work protection and accident prevention and ensure
professional diligence at all times.
1.3. Important Safety Instructions
•Read this User Manual before using the Diana Peristaltic Pump.
•DO NOT connect unit directly to humans.
•No modifications to the Diana Peristaltic Pump are allowed. Do not modify in any way, otherwise
there is a possibility of operator injury, impairment or damage to the unit.
•The Diana Peristaltic Pump does not contain any user-serviceable parts. To avoid injury or
damage to the instrument, do not attempt to disassemble or service the instrument.
Malfunctioning systems must be sent back to ICU Medical for repair.
•If unit is damaged during operation, switch off immediately and disconnect from the power
supply.
•If the Diana Peristaltic Pump has observable sharp edges, contact an ICU Medical representative
immediately.
•Do not place the compounder on an unstable surface.
•To avoid the potential for cross-contamination between drugs, replace the tubing set when a
new drug is to be compounded.
•When using the Diana Peristaltic Pump to reconstitute lyophilized powder medications, care
should be taken to ensure the vials remain upright at all times and ensure vials are not over-
pressurized prior to connecting to the Diana Peristaltic Pump.
•The System should only be used with the manufacture-provided power cord (ICU Kit Number
DS1902, ICU Part Number: 826-11518-403).
•If power cord is damaged, stop using the system and unplug the cord from power source.

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•The Diana Peristaltic Pump should only be connected to a properly grounded electrical supply
outlet. Users should refer to the requirements for medical electrical systems in the current
edition of IEC 60601-1 for proper use.
•Position the Diana Peristaltic Pump in such a way that limits any hazard to user from excess
power cord and makes for easy access to the power cord outlet.
•Ensure that access to the mains plug is not blocked while using the compounder (so that it can
be disconnected from electrical supply in the event of an emergency).
•Tubing set fluid path is sterile (sterilized using irradiation) and non-pyrogenic in unopened and
undamaged package. Use aseptic techniques with tubing set when removing caps, spiking diluent
containers and making connections to luer adapter.
•DO NOT use tubing set if sterile packaging has signs of damage. If tubing set’s sterile packaging is
damaged, replace the set with a new one and discard of the damaged set.
•The dispensing set should be changed within 24-hours due to touch contamination.
•DO NOT re-sterilize or reuse the tubing set. Re-sterilizing or reusing may cause damage to the
tubing.
•Change the tubing set prior to each change of drug or fluid to avoid drug incompatibility and/or
compounding the incorrect volume.
•DO NOT USE Diana Peristaltic Pump to compound hazardous drugs and medications (for example
acids, ethers and other chemicals known to be incompatible with silicone tubing). System is
designed only for non-hazardous drugs such as Water, 0.9% Sodium Chloride/Saline, Dextrose
10%, Lipids.
•Refer to tubing set label for important use information.
•DO NOT USE Diana Peristaltic Pump for intravenous drug administration or other routes of direct
patient delivery.
•Calibration may need to be performed when there is a change in drug/fluid viscosity or pump
speed, use of needles, use of in-line filters, filling containers that create back pressure such as
elastomeric or microbore tubing, or a significant change in desired volume.
•Use of tubing sets that are not compatible with the Diana Peristaltic Pump may adversely affect
volume accuracy, pump reliability and performance. See Compatible Tubing Sets section for
more details.
•DO NOT load or unload the tubing set with the power on or operate the pump without the roller
cover in place as injury may occur.
•The power cord must be connected to a properly grounded hospital grade 120V receptacle for
proper pump performance and safety.
•Fluid ingress inside the pump may cause damage and impact performance. Clean spills
immediately.
•If needed, use ICU Medical Heavy Duty “BX01”, “BX02”, or “BX03” tubing sets when filling
ambulatory pumps or other hard to fill containers.
•Pump operation must be monitored at the beginning of each cycle and at intervals during the
cycle to ensure the Diana Peristaltic Pump is operating within acceptable limits (out of limits

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conditions displayed during use). Use calibration function to achieve accuracy (see Calibration
Process section for more details).
•Verify pump accuracy performance before use to ensure it meets facility protocols.
•Do not operate the pump if at any point the roller assembly is rotating while the lid is open. In
such an event, unplug the pump, discontinue operation, and contact ICU Medical service center
for repairs.
•Save the original Diana Peristaltic Pump box and packaging. In the event that the pump needs to
be sent in for servicing, return the Diana Peristaltic Pump in its original packaging. If the original
box cannot be located, contact ICU Medical at 800-824-7890 and ask for a shipping box to be
provided.
•Service performed by persons other than ICU Medical or its authorized agents may cause the
warranty to be voided, at the discretion of ICU Medical.
•Do not use the Diana Peristaltic Pump continuously for more than 8 hours or 240 liters. Upon
reaching this limit, allow the unit to idle for 30 minutes before additional use.
•Do not use the same tubing set for more than 60 liters, overuse may result in damage to the
tubing set and spill of the fluid.
•Some metal parts might be warm when in use. The user should allow the unit to cool down prior
to moving or transporting the unit.
•Consider the drug manufacturer's labeling and USP compounding guidelines when performing
compounding.
•The Diana Peristaltic Pump is an independent system that does not require the configuration of
any additional units.
•Ensure Diana Peristaltic Pump is placed on a stable surface. If applicable, allow Biomedical
Engineering confirm electrical requirements are met.
•At the end of service life, dispose of pump, accessories, and consumables by contacting ICU
Medical for further information.
•During storage and use, avoid impacts and vibrations which could result in a malfunction of the
Diana Peristaltic Pump.
•The System is designed for use in Biological Safety Cabinets, Laminar Airflow Hoods and/or
Safety Work Benches in clean rooms in a healthcare setting.
•Do not insert any foreign objects into the unit ports and openings.
•Avoid direct contact with liquids. If a spill occurs, quickly remove liquids in accordance with
facility protocols.
•Never immerse in liquids for cleaning purposes. Do not attempt to sterilize using mechanical or
steam sterilization equipment.
•All cleaning of the Diana Peristaltic Pump should be performed according to the detailed
instructions in this manual.

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1.4. List of Symbols Used on the Unit
This unit is compliant with the symbols mentioned below.
Symbol
Reference
Description
IEC 60417 - 5010
"ON"/ "OFF" (push-push)
ISO 7010 - M002
Refer to instruction manual/booklet
IEC 60417 - 5032
Alternating current
ISO 7010 - M005
Connect an earth terminal to the ground
ISO 7010 - W001
General warning sign
ISO 7010 - W012
Warning; electricity
ISO 7000 - 3082
Manufacturer
ISO 7000 - 2498
Serial number
CSA
Certification mark
ISO 15223 - 1:2016 (Symbol
5.1.2)
European authorized representative
IP33
IEC 60529
Ingress protection
IEC 60417 - 6414
WEEE; waste electrical and electronic
equipment; crossed-out wheeled bin
ISO 7000 - 0632
Temperature limit
ISO 7000 - 2620
Humidity limitation

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1.5. List of Symbols Used on the Back of the Unit
The graphic below shows the back panel of the Unit. The callouts indicate the location of various
connectors and switches for the Diana Peristaltic Pump.
Symbol
Reference
Description
IEC 60417 - 5016
Fuse
IEC 60417 - 5534
Power plug
ISO 7000 - 3650
Universal Serial Bus (USB), port/plug

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2. Diana Peristaltic Pump Overview
2.
2.1. Installation
To install the unit, place the unit onto a stable surface. Plug the ICU supplied power cord into the
back of the unit and then into an electrical outlet.
Note:The Diana Peristaltic Pump should only be connected to a properly grounded electrical
supply outlet. Users should refer to the requirements for medical electrical systems in the
current edition of IEC 60601-1 for proper use.
2.2. Diana Peristaltic Pump Module
The Diana Peristaltic Pump is an automated pharmacy compounding unit controlled by software
and is intended to be used in a healthcare facility by Pharmacists and Pharmacy Technicians to
dispense a specified quantity of fluid from a set of source containers into a destination
container.

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Views of the Diana Peristaltic Pump Module
Reference
Component
Description
1
Power Button
Power ON/OFF Button.
2
Tubing Detection Sensor
The Tubing Detection Sensor detects the presence and proper
placement of the tubing set.
3
Fuses
Replaceable fuses, used to protect electrical equipment.
5
4
1
2
6
3
Back of the pump

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4
Power Inlet
The Power Inlet is used to connect the Diana Peristaltic Pump
to the electrical outlet using the provided power cord.
4
USB Port
The USB port is for use by ICU Medical authorized personnel
to service Diana Peristaltic Pump.
5
Inactive Ports
The ports not used by the system. They are plugged by a cap.
2.3. Graphic User Interface (GUI)
The user interface of the Peristaltic Pump has been designed so that there are three tabs at the
top of the screen (Drug Set Up, Set Up, Compound) where a user can navigate to a specific
workflow.
Reference
Component
Description
1
Drug Set Up
Tab
This tab is the first screen to be displayed and allows a user to
assign drug information to a container. This information will
then be used to generate a compounding log and labelling for
future use.
2
Drug Name
Enter the drug which is used in preparation. Most common
drugs will show up on the right side of the menu.
3
Drug ID
Identification Number associated with the drug will display on
screen.
4
Lot Number
Enter lot number of the drug. This information can then be
retrieved in compounding reports.
5
Lot Expiration
Date
The expiration date for the drug.
6
Container
Volume
The amount of fluid (in mL) in the source container. This is
used to ensure that there is enough fluid to fill the destination
containers.
1 Drug Set Up Tab
2 Drug Name
3 Drug ID
4 Lot Number
5 Lot Expiration Date
6 Container Volume
7 Set Up Tab
9 Specific Gravity Field
10 Drug Name Input
11 Toolbar
8 Compound Tab

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7
Set Up Tab
Allows a user to provide the amount of volume (in mL) to be
transferred. Within this tab, a user can also change the speed
of transfer. Once this information is entered, a user can tap
“Start” to initiate a transfer.
8
Compound Tab
Provides user a visual confirmation that the system is
transferring fluid.
Note: This tab is only functional during a transfer.
9
Specific Gravity
Field
Displays entered Specific Gravity of chosen drug.
Note: The default specific gravity is set to 1.0 g. The specific
gravity of a drug can be changed by the user on the Drug Set
Up screen or in Edit Drug settings page. Edit Drug settings
require an operator to be an authorized user in the "Advanced
Settings”.
10
Drug Name
Input
Provides the user a list of recently used drug names for quick
input into the drug compounding log. A user can tap the drug
name for quick data entry.
11
Toolbar
Provides the user access to the settings
2.4. Data Entry
Enter the alphanumeric
value and press “Enter”
Enter the date and press
“Enter”
Enter the numeric value and
press “Enter”

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2.5. Consumables
2.5.1. Tubing Set Overview
The following accessories/consumables are not included with the Diana Peristaltic Pump. They
must be ordered separately. Contact an ICU representative for assistance in ordering.
The tubing set is to be used in conjunction with the Diana Peristaltic Pump. The set consists of an
input port, output port, and tubing set handle.
Reference
Component
Description
1
Input Port
The Input Port is a proprietary ICU Medical Connector that mates with a
proprietary ICU Medical connector to establish a closed system during
fluid transfer.
2
Output Port
The Output Port is a proprietary ICU Medical Connector that mates with
a proprietary ICU Medical connector to establish a closed system during
fluid transfer.
3
Tubing Set
Handle
The Tubing Set Handle allows a user to easily place the tubing set into
the Tubing Detection Sensor. Ensure the red clip is on the top of the
Tubing Detection Sensor.
2
1
3

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2.5.2. Tubing Set Information and Compatibility
ICU Medical recommends that only compatible tubing sets tested by the manufacturer be used for
compounding.
ICU Medical Item
Part Number
Description
BX01
Single Lead Heavy Duty Tubing Set
BX02
Dual Lead Heavy Duty Tubing Set
BX03
Triple Lead Heavy Duty Tubing Set
LPA01
Single Lead Tubing for use w/Lipids
PA01
Single Lead Tubing Set
PA01LL
Single Lead Tubing Set- w/Double Luer
PA02
Double Lead Tubing Set
PA03
Triple Lead Tubing Set
Following components are compatible with ICU Medical Tubing Sets:
Component Type
Spiros
Clave
16-gauge needle
18-gauge needle
0.2-micron filter
0.5-micron filter
Elastomeric pump
CADD cassette

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3. Operating the Diana Peristaltic Pump Module
3.1. Tubing Set Installation / Removal
The following section describes how the user of the Diana Peristaltic Pump Module properly inserts the
tubing set into the unit.
Note: Incorrect insertion of the tubing set may damage the unit.
1. The Diana Peristaltic Pump should be placed with the display view facing the user.
2. Before opening, inspect the tubing set package. If packaging is not intact, discard it and use a
new set.
3. Using aseptic technique, open the package and remove the tubing set.
4. Locate the embossed "arrow" pointing downwards on the handle of the tubing set. Locate a "red
clip" behind the handle.
5. Insert the tubing set with the "arrow" pointing downward as seen below. Push the red clip
downwards into the recess provided until a "snap-in” sound is heard.

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6. Turn the rollers by hand to insert the white clip into the roller pump. Hand turn the roller until the
tubing set is secure around the roller pump.
Note: Ensure there is no kinking of the tube.
When removing the tubing set, it is recommended to clamp the lines to prevent spillage.
1. Pull white clip upwards.
2. Turn the rollers by hand while removing the tubing.
3. Pull red clip upwards and remove the tubing set from the roller pump.

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3.2. Power On
Press the Power Button on the front of the unit (lower right) to turn it on.
When the pump has been started, a welcome screen is displayed (see below).
Next, a series of alerts will display, depending on the state of the unit (see below):

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Satisfying the unit command or answering the questions will bring the user to the home screen.
3.3. Drug Set Up
Enter the drug information by selecting the Drug Name text field and entering the data. The drug
must exist in the database. Additionally, the unit has a “quick feature” list on the right that
defaults to the most commonly transferred drugs.
Note: The unit has a setting to require medication information entry to allow the transfer to be
initiated. The user can edit this setting in the Drug Menu Settings screen.
Note: The “Next”button will be activated if all fields are filled out.
Note: User can also configure the Container Volume prior to performing the transfer, see
“Container Mode” section for more details.
Flap is Open
No Tubing Set Detected
Tubing Set Detected

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Press the “Next" button. The next step is to start the priming and calibration process.
3.3.1. Changing The Specific Gravity
The specific gravity of a drug can be changed by the user on the drug menu screen. Changes to
this option require a user permission to be enabled by the authorized user in the "Advanced
Settings."
Note: The default specific gravity for most drugs is set to 1.0 g.
1. If user selects a drug from the database, the default specific gravity is set to 1.0 g. User will
see a blue square with a yellow triangle containing an exclamation mark (see below), this
means that the specific gravity can be changed by the user to a different value. When user
clicks on the specific gravity field a warning message will appear advising that user is about to
change the specific gravity for that particular drug (see below).
Note: If user presses “Cancel”, system will return to the Drug Set up screen with the specific
gravity selected at the default of 1.0 g.
2. Press "Continue" to change the specific gravity of the selected drug by manually entering using
the keypad. Then press the "Enter" button.

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Note: User will receive a warning message after the modified specific gravity is entered. User
must acknowledge the message by pressing the "Save" button. The changed specific gravity is
then permanently saved into the database.
Note: When the Cancel button is pressed, the Peristaltic Pump returns to the Drug Set Up screen.
The specific gravity has not been changed.
3. Saved changes to the specific gravity in the database will appear in gray font and a notification
stating that “specific gravity changed by user” will display above the drug name.