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ICU Medical Diana DS1000, User Manual, Page: 7 / 60

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ICU Medical Diana DS1000 User Manual Download Page 7

Diana Peristaltic Pump, ICU Medical 

 

Page 7 

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 

 

Summary of Contents for Diana DS1000

Page 1: ...Diana Peristaltic Pump DS1000 User Manual DF 4369 EN Rev 03 09 2020...

Page 2: ...3 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...

Page 3: ...y 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...

Page 4: ...tions 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...

Page 5: ...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 S...

Page 6: ...mage 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 manufact...

Page 7: ...nating 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 Cer...

Page 8: ...he 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 5...

Page 9: ...ected 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 P...

Page 10: ...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 Repl...

Page 11: ...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 whi...

Page 12: ...ered 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...

Page 13: ...d 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...

Page 14: ...avy 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 Do...

Page 15: ...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 t...

Page 16: ...r 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 c...

Page 17: ...7 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 dep...

Page 18: ...uick 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 c...

Page 19: ...e 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 us...

Page 20: ...on 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 b...

Page 21: ...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...

Page 22: ...s subset of transfers On the Drug Set Up screen select the volume of the source container User can enter the volume or select a predetermined container size Enter Lot number and Lot Expiration Date of...

Page 23: ...arts to prime the tubing set If Skip Prime is selected the tubing set will not be primed system will be return to the Calibrate screen Note In order to properly calibrate the unit ensure the tubing se...

Page 24: ...ainer must be detached from the tubing set during the Weighing Process Failure to do so will results in inaccurate calibrations Ensure destination container is reconnected to the tubing set before pre...

Page 25: ...ght vs measured weight 6 If the measured weight entered is not compliant with facility s guidelines a recalibration may be performed Note By pressing Calibrate the unit will adjust its calibration set...

Page 26: ...a discrepancy between expected and measured weight is within 10 30 range Pressing Yes button confirms the user s entry and completes the calibration process Pressing No button returns user to Prime p...

Page 27: ...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 3 Once...

Page 28: ...rclockwise rotation is activated by default 3 7 Batch Mode A user can also use batch mode for compounding multiple containers doses at a time User can specify a set interval time to wait between the t...

Page 29: ...10 syringes the Number of Containers would be 10 Note Maximum number of containers is 999 Interval Time This number specifies the time in seconds the unit will wait to initiate next transfer Example...

Page 30: ...umber on the unit will update accordingly The user will be alerted with a countdown on the top right of how many seconds are left until the next transfer is automatically initiated 3 8 Power Off When...

Page 31: ...updates to speed volume and allows user to view software version Date and Time Allows updates to the date and time Scale Calibration Check Features is not used Advanced settings Allows updates to drug...

Page 32: ...pump speed 20 while the slowest flow rate is equal to pump speed 1 The speed is measured in mL min Default speed settings are show in the table below Note Precise pump speed is not user configurable d...

Page 33: ...d of 9 3 Press the Add button to select the specific name of the speed The speed setting will be updated once the name is selected 4 User will now be able to see the selected speed name when performin...

Page 34: ...w the version of software components as well as unit serial number 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...

Page 35: ...is setting is not implemented 4 1 5 User Logout 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...

Page 36: ...Diana Peristaltic Pump ICU Medical Page 36 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...

Page 37: ...ttings of the system This menu is available only to authorized user 4 4 1 Edit Drug 1 Select Edit Drug in the Advanced Settings menu User can search drugs by NDC or a drug name To search by NDC select...

Page 38: ...ers the drug name characters system will suggest the name to autofill If required drug does not exist in unit s database then user will need to add the new drug to the database To add new drug select...

Page 39: ...rug Existing Drug 3 If a specific gravity is entered outside the value range defined in the system 0 95 1 30 the Specific Gravity field is highlighted in red If the user continues and presses the Save...

Page 40: ...Diana Peristaltic Pump ICU Medical 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...

Page 41: ...be displayed This menu allows a user to switch the language 1 Select Language in the Advanced Settings menu 2 Select the desired language by pressing on the corresponding gray square Press Save to se...

Page 42: ...User Management in the Advance Settings section To create a new user Press Add User Enter the username password and rights permissions level Press Save Note The administrator can choose between two a...

Page 43: ...ser 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...

Page 44: ...d each time the unit has been powered on 4 4 8 Require Drug Info The peristaltic pump allows a user to require the presence of drug information before compounding will begin This aids in the proper do...

Page 45: ...in the Advanced Settings section 2 Toggling between and x will allow the change of specific gravity or not 4 4 10 Complete Screen Display Interval in Seconds A timer can be set for how long the displa...

Page 46: ...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 Devel...

Page 47: ...to 1 mL and less than 5 mL 10 for volumes greater than or equal to 0 5 mL and less than 1 mL Diana Peristaltic Pump accuracy with Dextrose 10 Lipids at a fluid specific speed using ICU Medical Lipids...

Page 48: ...t and locate the above symbol where the lithium ion battery holder is located 3 Remove the old battery if any 4 Insert the new battery into the unit with positive Symbol side facing up Note Incorrect...

Page 49: ...To ensure proper temperature maintenance a maximum limit of duty cycle transfer volume and internal temperature has been placed in the unit software Once the unit has reached one of these limits a war...

Page 50: ...Time 8 Hours Maximum transfer volume 240 Liters Max Temperature Limit 55 C Recommended Cool Down Period 30 minutes Note Some metal parts may be warm after heavy use of the unit The user should not us...

Page 51: ...se back pressure or lower speed Tubing was not installed correctly Consistently inaccurate filling Use the calibration function Inaccurate filling not repeatable varies for example due to unequal back...

Page 52: ...mponents replaced by ICU Medical become the property of ICU Medical This warranty is extended to original purchasers of the equipment from ICU Medical in lieu of all other warranties expressed or impl...

Page 53: ...tact 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 C...

Page 54: ...to applying a disinfectant Cleaning and disinfecting shall occur before the pump is in use Use lint free cloths or swabs only Do not use abrasive materials Clean the areas of Diana Peristaltic Pump t...

Page 55: ...tubing set 9 Press Start to initiate transfer 10 Disconnect container from Tubing Set 11 Place on scale 12 Assess accuracy of the unit With Graduated Cylinder 1 Use new Tubing Set 2 Ensure Tubing Set...

Page 56: ...recognized by the system Drug Database The Drug Database update allows a user to mass load information for a given drug such as specific gravity and minimum or maximum volume transfers This provides...

Page 57: ...staltic Pump utilizing the adapter cable The following screen shows up automatically 3 Select the aspect of the software that requires an update by tapping the desired selection Software components th...

Page 58: ...ng the update a confirmation message that the update has been successfully completed will appear Note For non firmware updates completion message will stay on the screen for a few seconds afterwards t...

Page 59: ...Diana Peristaltic Pump ICU Medical Page 59 Completion Screen during firmware update Completion screen during database update...

Page 60: ...Diana Peristaltic Pump ICU Medical Page 60...

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