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ICU Medical Diana DS1000 User Manual

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

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Summary of Contents for ICU Medical Diana DS1000

  • Page 1 ™ Diana Peristaltic Pump DS1000 User Manual DF-4369-EN Rev 03 (09/2020)

  • Page 2: Table Of Contents

    Forward / Reverse Transfer ......................28 3.7. Batch Mode ..........................28 3.8. Power Off ............................. 30 Settings ..............................31 4.1. Customization ..........................32 4.1.1. Custom Speed Settings ......................32 4.1.2. Version Information ......................34 4.1.3. Volume..........................34 Diana Peristaltic Pump, ICU Medical Page 2...
  • Page 3 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 Diana Peristaltic Pump, ICU Medical Page 3...

  • Page 4: Introduction

    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.
  • Page 5 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...
  • Page 6 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.

  • Page 7: List Of Symbols Used On The Unit

    European authorized representative 5.1.2) IP33 IEC 60529 Ingress protection WEEE; waste electrical and electronic IEC 60417 - 6414 equipment; crossed-out wheeled bin ISO 7000 - 0632 Temperature limit ISO 7000 - 2620 Humidity limitation Diana Peristaltic Pump, ICU Medical Page 7...

  • Page 8: 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 Diana Peristaltic Pump, ICU Medical Page 8...

  • Page 9: Diana Peristaltic Pump Overview

    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. Diana Peristaltic Pump, ICU Medical Page 9...
  • Page 10 Reference Component Description Power Button Power ON/OFF Button. Tubing Detection Sensor The Tubing Detection Sensor detects the presence and proper placement of the tubing set. Fuses Replaceable fuses, used to protect electrical equipment. Diana Peristaltic Pump, ICU Medical Page 10...

  • Page 11: Graphic User Interface (Gui)

    The Power Inlet is used to connect the Diana Peristaltic Pump to the electrical outlet using the provided power cord. USB Port The USB port is for use by ICU Medical authorized personnel to service Diana Peristaltic Pump. Inactive Ports The ports not used by the system.

  • Page 12: Data Entry

    Toolbar Provides the user access to the settings 2.4. Data Entry Enter the numeric value and Enter the alphanumeric Enter the date and press press “Enter” value and press “Enter” “Enter” Diana Peristaltic Pump, ICU Medical Page 12...

  • Page 13: Consumables

    Reference Component Description 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. 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.

  • Page 14: Tubing Set Information And Compatibility

    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 Description Part Number BX01 Single Lead Heavy Duty Tubing Set BX02 Dual Lead Heavy Duty Tubing Set...

  • Page 15: Operating The Diana Peristaltic Pump Module

    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. Diana Peristaltic Pump, ICU Medical Page 15...
  • Page 16 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. Diana Peristaltic Pump, ICU Medical Page 16...

  • Page 17: 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): Diana Peristaltic Pump, ICU Medical Page 17...

  • Page 18: Drug Set Up

    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. Diana Peristaltic Pump, ICU Medical Page 18...

  • Page 19: Changing The Specific Gravity

    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. Diana Peristaltic Pump, ICU Medical Page 19...
  • Page 20 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. Diana Peristaltic Pump, ICU Medical Page 20...
  • Page 21 4. If the user selects a drug from the database where the specific gravity has already been changed, the button is grayed out and cannot be changed on the Drug Set Up screen. The specific weight can only be changed or adjusted by any authorized user in the Advanced Settings. Diana Peristaltic Pump, ICU Medical Page 21...

  • Page 22: Container Mode

    30,000 mL from all fluid transfers. The fluid type can be selected in the Set Up Tab. Diana Peristaltic Pump, ICU Medical Page 22...

  • Page 23: Priming And Calibration Process

    Failure to do so may result in incorrect fluid volumes being transferred. Note: Make sure that the receiving (distal) end of the tubing set is connected to a destination container. 2. Enter Calibration Volume and identify the speed. Diana Peristaltic Pump, ICU Medical Page 23...
  • Page 24 4. Enter the weight measured by an external scale into the screen as seen below. If the measured weight is acceptable, press “Accept”. 5. After a successful calibration, the unit will display a confirmation that calibration has been completed and the user will be directed to the Set Up menu. Diana Peristaltic Pump, ICU Medical Page 24...

  • Page 25: Warnings During Calibration Process

    By pressing Calibrate, the unit will adjust its calibration settings based on the previous transfer, however, a new calibration process begins to ensure accuracy. 3.4.2. Warnings during Calibration Process The following warnings can be encountered during an incorrect calibration process. Diana Peristaltic Pump, ICU Medical Page 25...

  • Page 26: Basic Set Up And Transfer

    Upon proper calibration, the unit allows a desired volume to be transferred and the speed to be set up before initiating a transfer. 1. Enter Volume to be transferred and select the speed. Press “Next” to confirm the transfer process. Diana Peristaltic Pump, ICU Medical Page 26...
  • Page 27 4. Disconnect the Tubing Set and place the destination container on the External Scale for weighing. Check the weight and verify that the correct volume is transferred. 5. After compounding is complete follow facility’s medication handling protocol and procedures. Diana Peristaltic Pump, ICU Medical Page 27...

  • Page 28: Forward / Reverse Transfer

    1. From the Set Up screen, press “Batch” to set the Number of Containers and Interval Time. Note: The minimum interval time between the individual fillings is set to a default of 2 seconds. Diana Peristaltic Pump, ICU Medical Page 28...
  • Page 29 2. Press “Accept” to continue. Note: When batch settings are entered, the number of containers to be filled and the interval/pause times between the individual fillings appear on the display of the unit. Diana Peristaltic Pump, ICU Medical Page 29...

  • Page 30: Power Off

    3.8. Power Off When user is done with compounding processes, the unit can be turned off. Press the Power Button on the front of the unit to turn it off. Diana Peristaltic Pump, ICU Medical Page 30...

  • Page 31: Settings

    Allows updates to drug listings, language options, and network connections. (password-protected) Technical Service Allows access to technical settings (password-protected). This option is reserved for ICU Medical personnel. Developer This is a settings screen for Administrators only Diana Peristaltic Pump, ICU Medical...

  • Page 32: Customization

    2. A window will appear with the customization options for the Diana Peristaltic Pump peristaltic pump stored in the system. In the next steps, user can change the name of the speed settings. Speed settings can be activated or deactivated for user to see during fluid transfer. Diana Peristaltic Pump, ICU Medical Page 32...
  • Page 33 4. User will now be able to see the selected speed name when performing a fluid transfer from the Set Up screen. The user can press left/right arrows to change the speed. Diana Peristaltic Pump, ICU Medical Page 33...

  • Page 34: Version Information

    4.1.2. Version Information The user and ICU Medical personnel can view the version of software components as well as unit serial number. SN: R10001NCY005 4.1.3. Volume With this setting, the user can adjust the sound volume. User can select a desired volume by clicking the desired position on the scale, the slide will move accordingly.

  • Page 35: Scale Off

    Follow these steps to log off the current active user from the system. 1. Press User Logout to log out of the system. 2. The User Logout icon will disappear indicating that no user is currently logged into the system. Diana Peristaltic Pump, ICU Medical Page 35...

  • Page 36: Date And Time

    4.2. Date and Time The user can update the date and time in the Diana Peristaltic Pump. 1. Enter the current date and/or time and press set. Diana Peristaltic Pump, ICU Medical Page 36...

  • Page 37: Scale Calibration Check

    To search by NDC, select NDC option. Enter the NDC code and press “Enter”. Note: As user enters NDC number, system will suggest the NDC number to autofill. To search by name, select Name. Enter the name and press “Enter”. Diana Peristaltic Pump, ICU Medical Page 37...
  • Page 38 If required drug does not exist in unit’s database, then user will need to add the new drug to the database. To add new drug, select “Add New Drug”. Enter the new drug information and press “Enter”. Diana Peristaltic Pump, ICU Medical Page 38...
  • Page 39 "Specific Gravity" field is highlighted in red. If the user continues and presses the “Save” button, a warning message appears which must be confirmed by pressing the "Ok" button. User will not be able to proceed further if correct Specific Gravity is not entered. Diana Peristaltic Pump, ICU Medical Page 39...
  • Page 40 4. Enter a specific weight in the range 0.9 – 1.30 g and then press "Save". System will return to initial Edit Drug screen. Diana Peristaltic Pump, ICU Medical Page 40...

  • Page 41: Language

    2. Select the desired language by pressing on the corresponding gray square. Press “Save” to set the new language. 4.4.3. Custom Label Settings This setting cannot be changed. 4.4.4. Print Setup This setting cannot be changed. Diana Peristaltic Pump, ICU Medical Page 41...

  • Page 42: Network Connections

    Only an advanced user has the ability to add new users to the system. To modify a user. Select an existing user and press “Modify” button. Once done with changes press “Save’. Diana Peristaltic Pump, ICU Medical Page 42...

  • Page 43: User Login At Startup

    Select an existing user and press “Delete” button. The user should be removed from the User Accounts list. 4.4.7. User Login at Startup The authorized user can require a user login on the unit. 1. Select “User Login at Startup” in the Advanced Settings section. Diana Peristaltic Pump, ICU Medical Page 43...

  • Page 44: Require Drug Info

    This aids in the proper documentation of the drug or fluid being used. Note: By default, Drug Info is set to not Require Drug Information. 1. Select “Require Drug Info” in the Advanced Settings section. Drug Information is NOT required Drug Information is required Diana Peristaltic Pump, ICU Medical Page 44...

  • Page 45: Change Specific Gravity In The Drug Screen

    Select “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. Diana Peristaltic Pump, ICU Medical Page 45...

  • Page 46: Logfiles

    This setting cannot be changed. 4.4.12. Scale Deviation Borders This setting cannot be changed. 4.5. Technical Services Technical Services is for ICU Medical authorized personnel only. 4.6. Developer Developer setting is for ICU Medical authorized personnel only. Diana Peristaltic Pump, ICU Medical Page 46...

  • Page 47: Specifications, Maintenance And Troubleshooting

    All maintenance must be performed by an authorized ICU Medical representative except for routeine cleaning and soecifically excluded activities. ICU Medical recommends sending the unit to ICU Medical Service department once a year for inspection and maintenance. 5.1. Accuracy Specifications...

  • Page 48: Lithium-Ion Coin Battery Replacement

    5.3. Lithium-Ion Coin Battery Replacement Peristaltic Pump 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 a damage of the unit.

  • Page 49: Temperature Warning

    In some instances, the unit will instruct the user to power off the unit. The warning remains for the duration of the cooling process on the unit's display. Once the warning on the display is gone, the unit can be used again for further filling activities. Diana Peristaltic Pump, ICU Medical Page 49...
  • Page 50 30 minutes Note: Some metal parts may be warm after heavy use of the unit. The user should not use the unit for 30 minutes before transportation to allow the metal parts to cool. Diana Peristaltic Pump, ICU Medical Page 50...

  • Page 51: General Troubleshooting

    Pump display is dark Unit providing alert to change compounding set Compounding set has been used to transfer 60 liters. Replace compounding set. Database Error Messages System malfunction. Please contact ICU Medical Technical Support. Diana Peristaltic Pump, ICU Medical Page 51...

  • Page 52: Warranty And Service Information

    6. Warranty and Service Information 6.1. Limited Warranty ICU Medical warrants the system to be free from defects in material and workmanship for one (1) year from the date of delivery, when operated in accordance with the User Manual. Sensors and accessories...

  • Page 53: Service And Contact Information

    6.2. Service and Contact Information For customer service, technical assistance, product return authorization and to order parts, accessories, or manuals contact ICU Medical Technical Support Operations: ICU Medical, Inc. 951 Calle Amanecer San Clemente, CA 92673 (866).829.9025 (949).366.2183 Diana Peristaltic Pump, ICU Medical...

  • Page 54: Appendix A: Cleaning And Disinfection Of The Diana Peristaltic Pump

    Step. 2 – wipe the appliance with isopropyl alcohol (60-95%) with low-shedding wipes or swabs - wipe all surfaces prior to the start of compounding activities. Allow to dry before fluid transfer begins. Diana Peristaltic Pump, ICU Medical Page 54...

  • Page 55: Appendix B: Accuracy Verification Protocol

    9. Assess accuracy of the unit. Note: For transfers that do not meet the accuracy criteria published in the manual, please repeat the accuracy assessment two additional times. If issue persists, please contact ICU Medical. Diana Peristaltic Pump, ICU Medical Page 55...

  • Page 56: Appendix C: Unit Software Update

    Note: Tool is designed to be used only by ICU Medical trained personnel or other qualified technicians. Please contact ICU Medical for details. Updating the Software Note: These steps are for ICU Medical personnel only.
  • Page 57 Software components that will be updated will show as a checked box , while components that will not be updated will show as a box with an X, 4. Press the "Next" button to start the update. Diana Peristaltic Pump, ICU Medical Page 57...
  • Page 58 For non-firmware updates, completion message will stay on the screen for a few seconds, afterwards the unit will restart automatically. For firmware updates, completion message will stay on indefinitely, USB adapter cable must be removed, and unit must be restarted manually. Diana Peristaltic Pump, ICU Medical Page 58...
  • Page 59 Completion screen during database update Completion Screen during firmware update Diana Peristaltic Pump, ICU Medical Page 59...
  • Page 60 Diana Peristaltic Pump, ICU Medical Page 60...

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