Omnifuse Technical User Manual
Contents
1. D lt 9 e Ax 3 D e c 6 o C Q US csl te 3 3 E Configuration menu Graseby Medical Ltd Displayed Values Default Parameter Comments Notes Baud rate 9600 19200 This sets the rate at which the pump communicates with a PC or printer via the RS232 serial port If this value is changed exit the Configuration menu switch the pump off and then on again for the change to become effective Serial port configuration can only be changed via the pump s Configuration menu Set the parameter on the pump first and then ensure that the equivalent setting in the device connected to the RS232 port is the same Config Mode 55555 password See Changing the Configuration password on page 16 Changing the Configuration password This allows the password for entry to the Configuration menu to be changed The default password is 55555 To change the password 1 Access the Configuration menu as described on page 10 2 Select Config Mode password and press the Command wheel 4 Type in the new password again and press the Command wheel to confirm PASSWORD CHANGE The Configuration Password has been changed Please enter Password Press wheel to confirm Password 3 Type in the new password and press the Command wheel The change is briefly confirmed before returning to the Configuration men2. Range 0 1 to 800 ml h dependent on syringe size Accuracy 2 measured over the 2nd hour of an infusion at 1 ml h and at 5 ml h with a Braun Omnifix 50 ml syringe and 150 cm extension set Bolus accuracy 5 with a Braun Omnifix 50 ml syringe and 150 cm extension set measured over 25 boluses of 1 ml each KVO rate Between 0 05 ml h and 2 ml h Purge rate 50 100 200 400 800 ml h upper limit dependent on syringe size Bolus rate 0 1 to 800 ml h upper limit dependent on syringe size in increments of 0 1 ml h up to 100 ml h 1 ml h above 100 ml h Maximum infusion flow rates Syringe Size ml Flow Rate ml h 2 50 ml h 3 50 ml h 5 100 ml h 10 200 ml h 20 400 ml h 25 400 ml h 30 600 ml h 50 60 800 ml h Omnifuse Instruction Manual Specification 3 c O o o o 2 o Graseby Medical Ltd Programming ranges Continuous infusion rate programming ranges by infusion unit Unit Range Increment ml h 0 1 to 800 0 1 up to 100 1 above 100 ml min 0 01 to 13 0 0 01 up to 10 0 1 above 10 mg kg h 0 1 to 99 9 0 1 ug kg h 1 to 999 1 ng kg h 1 to 999 1 mg h 0 1 to 500 0 1 up to 100 1 above 100 ug h 0 1 to 999 0 1 up to 100 1 above 100 ng h 0 1 to 999 0 1 up to 100 1 above 100 mg kg min 0 01 to 99 9 0 01 up to 10 0 1 above 10 ug kg min 0 1 to 999 0 1 up to 100 1 above 100 ng kg min
3. Disabled Infusion in ng min Enabled Disabled Drug conc entry User mix Pre mix Omnifuse Technical User Manual 13 5 E lt fe e A 5 D e E 6 o C Q 3 Q 0 Q 3 3 2 Configuration menu Graseby Medical Ltd Displayed Parameter Values Default Comments Notes Use Drug Protocols Yes No Menu of protocols is displayed to the user after syringe loading If set to No the pump displays the programming steps instead User Programming Enabled Disabled Effective only when Use Drug Protocols is set to YES Enabled a User Programming option appears on the Drug Protocol menu for step by step programming Disabled user must choose a pre loaded protocol Occlusion Lock Level NO LOCK Level 1 Level 2 Level 3 Level 4 Level 5 Limits the occlusion alarm levels which are available to the pump user In line pressure sens Enabled Disabled Must be enabled to use the in line pressure sensor In line alarm limit 1 999 mmHg Maximum setting user can enter for the in line occlusion alarm when in line pressure sensing is enabled Lockable cover Security No Security Infusion cannot start unless cover is locked keypad is locked once infusion is started View Shift Totals Enabled Disabled Shift Start Times Shift 1 00 00 24 00 Shift 2 00 00 24 00 Shift 3 2 00 00 24 00
4. 1 to 999 1 mg min 0 01 to 50 0 0 01 up to 10 0 1 above 10 ug min 0 01 to 99 9 0 01 up to 10 0 1 above 10 ng min 1 00 to 99 9 0 01 up to 10 0 1 above 10 Infusion pressure Maximum 1250 mmHg infusion pressure Note This value is approximate and is the pressure at the front face of the syringe plunger It also assumes an ideal syringe with no stiction and a low infusion rate LH o e o ES fe 5 Specification 4 Omnifuse Instruction Manual Graseby Medical Ltd Occlusion sensing pressure levels Alarm levels Approximate pressure in mmHg Level 1 180 Level 2 300 Level 3 500 Level 4 750 Level 5 1250 Note Approximate pressure at the front face of the syringe plunger assuming an ideal syringe with no stiction and a low infusion rate Occlusion sensing time to occlusion Alarm level and Number of minutes to Bolus on occlusion release infusion rate occlusion Level 1 Q 1 ml h 15 Less than 0 1 ml Level 1 5 ml h 2 5 Level 5 Q 1 ml h More than 100 Less than 1 0 ml Level 5 5 ml h 21 Note Values are approximate and are determined using the method described in EN 60601 2 24 clause 51 6b using a Braun Omnifix 50 ml syringe and a 150 cm line part number 0128 0122 Note Values are for a 50 ml syringe Values are reduced for smaller syringes c 9 e o o 2 o Omnifuse Instruction Manual Specification 5 LH o e o o ES G
5. Default all 00 00 Allows setting of up to three shift start times Time changes between BST and GMT are not automatic SLEEP mode Enabled Disabled Enables the ASLEEP function Nurse call back time 30 Seconds 1 min 2 mins 3 mins 4 mins 5 mins This sets the interval after which the NOT INFUSING repeated warning is displayed 14 Omnifuse Technical User Manual Graseby Medical Ltd Configuration menu Displayed Values Default Comments Notes Parameter History See History on page 17 Display contrast 0 low to 20 high default 10 Display brightness 0 dim to 20 bright If set gt 10 when operating on battery the pump uses brightness level 10 Brightness returns to configured level if pump is connected to AC mains supply Key beep volume 0 off to 10 loud default 7 Key beep Yes No Bolus beep Yes No Red LCD flash on Yes No If No is chosen the display alarm remains green during an alarm Operating alarm sound Alarm 1 Alarm 2 Alarm 3 Alarm 4 Alarm 5 Each of the five alarm tones can be reviewed by pressing the Alarm Silence key A when this feature is selected Back light on time 30 seconds 1 5mins 2 mins 2 5mins 3 mins When the pump is powered by the internal batteries the display backlight goes out if the pump has not been touched during the selected time Omnifuse Technical User Manual 15
6. EY fe 2 Q en fe Introduction Graseby Medical Ltd Omnifuse pump variants The standard Omnifuse is not fitted with an In line occlusion sensor or Lockable cover For environments where In line occlusion sensing or a Lockable cover are required three Omnifuse pump variants are available The variants may be specified when the pump is purchased or a standard pump can be returned to Graseby Medical and upgraded to one of the variants The three variants are Omnifuse with In line Occlusion Sensing Omnifuse with Lockable Cover Omnifuse with In line Occlusion Sensing and Lockable Cover In line Occlusion Sensing For clinical applications where occlusion pressure needs to be monitored very precisely for example in a Neonatal unit the pump should be ordered with an in line occlusion sensor This is used with a special extension set which includes a pressure sensing disc to monitor occlusion pressure in the infusion line while the pump is infusing If required an infusion can be started without the in line sensor in which case the pump reverts to the standard dry side occlusion sensing With In line sensing in use the pump can display a graph showing the changes in pressure during an infusion Lockable Cover The Lockable cover pump variant may be used in clinical areas where it is necessary to prevent the syringe from being removed and to prevent any change to the flow rate
7. Enter the five digit password As each digit is entered an asterisk is displayed 5 Press the Command wheel to accept the password and return to the menu Correct a mistake using Cancel menu Technician password The default password is 44444 If the correct password has not been entered after three attempts the pump will return to the LOAD SYRINGE screen The password can be changed using the Change password parameter see Changing the Technician password on page 22 If a password is forgotten it can be retrieved using the Graseby Omnifuse Technician PC software 18 Omnifuse Technical User Manual Graseby Medical Ltd Technician menu Using the Technician menu When the Technician menu is entered the list of parameters is displayed Use wheel to select Tech Parameter Total volume infused 426 Battery voltage Battery usage CRC Primary Software ver Press STOP to return The screen displays mainly technical information about the pump but a few parameters can be changed Use the Command wheel to scroll through the list of parameters The parameters their possible values and how to use them are described on the following pages Exit the Technician menu Press the Stop key to return to the LOAD SYRINGE screen Omnifuse Technical User Manual 19 E D E 2 S 9 Techn yoo D 5 3 e 2 E Technician menu Graseby Medical L
8. Service Recall setting of none 6 12 months The user is advised when the current date in the pump exceeds the last service date plus the service recall period 20 Omnifuse Technical User Manual Graseby Medical Ltd Technician menu Displayed Parameter Description Date Pump Serviced Displays the date the pump was most recently serviced in dd mm yyyy format Service Due Message Select to view text displayed when the service interval if set expires The message can be changed using the Graseby Omnifuse Technician PC software Inf Param Defaults If Disabled the pump uses saved parameters from the previous infusion on power up or programming sequence restart as normal If Enabled infusion parameters will always be reset zero forcing the user to re program the infusion parameters Syringe Brands Displays a list of brands that can be individually Enabled or Disabled At least one brand must be enabled at any time Press to return to the Technician menu Syringe Dimensions Displays dimensions of the custom syringe in the pump after being defined via the Graseby Omnifuse Technician PC software If a custom syringe has not been defined the parameter will not appear in the menu Pump Id The pump identifier up to 20 characters see page 24 Ward Location The pump s location up to 20 characters see page 25 History Download Create a PC file of the p
9. be correctly loaded Ensure that the syringe plunger is properly aligned before closing the barrel clamp Failure to do so may result in inaccurate delivery resulting in patient injury or death WARNING Ensure that your fingers are not in the path of the pusher during syringe loading or unloading Failure to do so may result in user injury 23 24 25 26 27 28 Warnings Cautions WARNING To avoid syphoning of the syringe contents free flow ensure that the syringe is correctly loaded into the pump that the syringe plunger is properly engaged by the pump s pusher block and that the pump is placed not more than 80cm above the infusion Site Syphoning can result in over infusion leading to patient injury or death WARNING To avoid over infusion do not purge the infusion line when the administration set is connected to the patient Over infusion of medication can result in patient injury or death WARNING To avoid the pump becoming detached from an IV pole always make sure that the pump is securely fixed to the pole Always check the security and stability of the assembly with the pump mounted If no IV pole is used make sure that the pump is completely stable on a horizontal surface Failure to observe this warning may cause damage to the Omnifuse pump and harm the user or the patient As a result the user or patient may suffer direct injury or the Omnifuse pump may fail to operate correctly leading t
10. for the infusion The Lockable cover prevents physical access to the syringe except by an authorised person with a key The cover can be used with or without the Omnifuse s Security software This prevents accidental changes to the infusion rate or access to the bolus feature once the infusion is started In line Occlusion Sensing and Lockable Cover The Omnifuse is also available as a pump fitted with both the In line sensor and the Lockable cover Omnifuse Technical User Manual Graseby Medical Ltd Setup Setup When the pump is first unpacked the following assembly and acceptance tasks may be completed as required Contents of the box When first opened the box should contain Omnifuse syringe pump Manuals Instruction Manual Technical User Manual Quick Reference Guide Mains lead which must be fitted to the pump so that it meets the IPX4 fluid ingress rating requirement Mains lead retainer and screw See Visual checks and assembly on page 4 for fitting instructions Additional items for pump options Two keys are supplied with an Omnifuse which has a Lockable cover ACD containing Omnifuse Drug Protocol Management System 0153 0084 is supplied if Drug Protocol software has been ordered When the pump is unpacked Complete the visual checks to ensure that no damage has occurred during transit Note Do not attempt to use the pump ifitis visibly damaged
11. out CAUTION When turning the pump on if screens similar to those illustrated are not displayed do not use the pump and send the pump to authorised service personnel CAUTION Do not attempt to move the pump s pusher by hand Always use the syringe Load key 2i to move the pusher Failure to observe this caution may cause mechanical damage to the pump CAUTION Never carry the pump except by the handle Failure to do so may result in damage to the case or you may drop the pump and cause it internal damage CAUTION Do not use cleaning and disinfecting agents other than the approved ones specified here CAUTION The pump must not be immersed in any liquids or exposed to strong organic solvents Wipe off spills immediately and do not allow fluid or residues to remain on the pump Additionally the pump is not designed to be autoclaved steam sterilised EtO sterilised or subjected to temperatures in excess of 45 C 113 F Failure to observe this caution may cause serious damage to the pump CAUTION Failure to use the mains lead retainer means that the pump may be accidentally disconnected from the mains supply CAUTION Users should bear in mind that the syringe ear clamp is for location only and may not be powerful enough to hold the syringe in place against the powerful negative back pressures that may be encountered in certain clinical applications Omnifuse Technical User Manual Graseby Medical Ltd Conte
12. the time shown enter 1036 An invalid time resets all the values to zero 3 To accept the displayed time press the Command wheel 4 To return to the Technician menu highlight OK and press the Command wheel Note Time changes between GMT and BST are not automatic o E 2 S 9 Techn Omnifuse Technical User Manual 23 yoo 2 D 5 3 e Technician menu Graseby Medical Ltd Pump Id The pump Id is displayed during startup It should be a unique combination of letters and numbers up to a maximum of 20 characters 1 Select Pump Id on the Technician menu PUHP ID 56204568 Use wheel to change rarameter value 2 Enter or change characters by turning the Command wheel To enter letters turn the Command wheel clockwise To enter numbers turn the wheel anti clockwise to scroll through 0 to 9 3 Press the Command wheel to store a character and move on to the next 4 To correct an entry press the Cancel key C on the keypad This erases the character and moves the cursor back one space 5 When all the required characters have been entered press Stop p The new Pump ld is stored and the screen returned to the Technician menu The Id will be displayed next time the pump is switched on Location 1 Select Ward Location on the Technician menu LOCATION Use wheel to change Parameter value 2 Enter or change cha
13. 10 hours During charging the battery icon appears at the left of the display PUMP STOPPED 8 LOAD SYRINGE Or press SKIP to load syringe later When the batteries are fully charged the icon disappears The battery icon is displayed when the pump operates from the batteries Pump configuration When the tests have been successfully completed the pump must be configured before clinical use For details of enabling or disabling features see Accessing the Configuration menu on page 10 To enter or change the Pump Id and or Ward Location see Technician parameters on page 20 It is recommended that the default passwords should be changed See Changing the Configuration password on page 16 and Changing the Technician password on page 22 If Drug protocols are to be loaded onto the pump see Protocols on page 25 Omnifuse Technical User Manual o 7 o LE is Q rT o o lt C 2 gt ce en cd o Q 3 3 2 Configuration menu Graseby Medical Ltd Configuration menu The Configuration menu is used to enable or disable parameters and set values for parameters that affect the pump operation It is protected by an access code and password To restore default factory Configuration menu settings use the Graseby Omnifuse Technician PC software part number 0151 0266 Accessing the Configuration menu To access the Configuration me
14. GRASEBY omnifuse Syringe Pump z Published by Graseby Medical Limited All possible care has been taken in the preparation of this publication but Graseby Medical Limited accepts no liability for any inaccuracies that may be found Graseby Medical reserves the right to make changes without notice both to this publication and to the product which it describes Copyright 9 2004 Graseby Medical Limited No part of this publication may be reproduced transmitted transcribed or stored in a retrieval system or translated into any human or computer language in any form or by any means without the prior permission of Graseby Medical Limited GRASEBY MEDICAL LIMITED Colonial Way Watford Hertfordshire United Kingdom WD24 4LG Telephone 44 0 1923 246434 Facsimile 44 0 1923 231595 http www smiths medical com Registered in England Company number 995550 Trademarks and acknowledgements Graseby Smiths omnifuse omnistack ZF and Flo Safer are all trademarks of the Smiths Group ple All other trademarks are acknowledged as the property of their respective owners Graseby Medical Ltd Using this manual This manual contains technical information to enable authorised personnel to configure an Omnifuse pump The manual includes the following sections Warnings and Cautions This gives a list of Warnings and Cautions which you must be aware of before using the pump These ar
15. Intermite start delay Disabled Circadian rhythm Disabled Infusion in ml min Disabled Infusion in ma ka h Disabled Press STOP to return For a full list see Configuration parameters on page 12 Change a setting or value 1 Turn the Command wheel and scroll up or down the menu until the required parameter is highlighted Press the Command wheel Turn the Command wheel until the required value is selected 4 Press the Command wheel to set the new value c GU E G G DG A 3 j e Le o Omnifuse Technical User Manual 11 C LS gt ES Q o i S 3 3 2 Configuration menu Graseby Medical Ltd Configuration parameters The following table shows the Configuration parameters with preset values and default settings in bold in the order that they are listed on the pump Notes The pump may further limit infusion bolus and purge rates depending on syringe size Displayed Parameter Values Default Comments Notes Maximum Infusion rate 50 100 200 400 800 ml h Maximum Bolus rate 50 100 200 400 800 ml hour Purge rate 50 100 200 400 or 800 ml h KVO rate O off then 0 05 to This configures the minimal 2ml hour Default 0 1 ml hr Adjustable in 0 01 ml steps between 0 05 and 0 1 Adjustable in 0 1 ml steps between 0 1 and 2 0 flow rate to which the pump will switch when the syri
16. Stop date 5 Check the period you have chosen to display then press the Command wheel to select OK 6 There is a brief delay while the pump retrieves the history The time and date for each event is displayed on the bottom line of the screen when the event is highlighted 7 Turn the Command wheel to scroll through the events 8 To exit from the Pump History event list press Stop twice to return to the Configuration menu Omnifuse Technical User Manual 17 3 G GU E G G A 3 _ Le o yoo D 5 3 e Technician menu Graseby Medical Ltd Technician menu The Technician menu provides access to technical information about the pump It can also be used to define the pump date time Id and location which appears when the pump powers up The Technician menu is protected by an access code and password Access the Technician To access the Technician menu 1 Unlock and open the cover and ensure that there is no syringe in the pump 2 Switch on the pump and wait until the screen displays PUMP STOPPED LOAD SYRINGE Or_ press SKIP to load syringe later Note The Technician menu can only be accessed from the LOAD SYRINGE screen when the cover is open 3 Simultaneously press keys 8 2 and and release them when the password screen is displayed Please enter rassword Press wheel to confirm Password 4
17. aun Omnifix 50ml syringe 0 1ml hr 150cm extension 154 Maximum 104 gt L s5 overall mean error o o S S 12 34 5 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 2 5 Observation Window minutes Mean error 6 2196 104 Minimum 454 TA Braun Omnifix 50ml syringe 1ml hr 150cm extension E lt 5 Maximum E o o overall mean error B 9 SS S 5 1 2 3 4S 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 28 24 25 26 27 28 29 30 31 o E Minimum 54 Observation Window minutes Mean error 0 44 0 a o E 104 Braun Omnifix 50ml syringe 5ml hr 150cm extension 2 x e 9 54 overall mean error 2 Maximum o S 3 5 o RAMUS 5 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 a 54 i Minimum Observation Window minutes Mean error 0 39 95 40 4 GM151_2101GB A Specification 10 Omnifuse Instruction Manual For further information please contact your local distributor or Graseby Medical direct on 44 0 1923 246434 GRASEBY CE Graseby Medical Ltd Colonial Way Watford Herts UK WD24 4LG Telephone 44 0 1923 246434 Facsimile 44 0 1923 231595 http www smiths medical com Part No 0151 0840 C January 2004 smiths 2004 Graseby Medical Ltd Smiths Medical A part of Smiths Group plc
18. e repeated on the relevant pages in the manual Setup Explains how to carry out initial checks describes all the functions that are tested on power up and outlines the acceptance tasks that may be carried out Note For complete operating instructions refer to the Omnifuse Instruction Manual part number 0151 0839 Configuration menu Covers all the parameters in the Configuration menu and explains how to set configuration and clinician passwords Describes how to access pump history Technician menu Describes the Technician menu giving step by step instructions for setting the technician password pump date and time and the Pump Id and Location Specifications and Standards This lists the specifications for the Omnifuse pump and the standards with which it complies Omnifuse Technical User Manual L E a E 97 N Cc u E e O 3 D S E Warnings Cautions Graseby Medical Ltd Warnings Cautions Warnings Warnings details dangerous conditions that could lead to death or serious injury to the user or patient that can occur if the instructions in this manual are not obeyed 1 WARNING To avoid over or under infusion always verify that the brand and size of the loaded syringe are the same as the brand and size displayed on the screen before starting an infusion Failure to do so may result in an inaccurate delivery of medication result
19. e and the following screen is displayed PUMP STOPPED LOAD SYRINGE Or press SKIP to load syringe later Omnifuse Technical User Manual Setup Graseby Medical Ltd Fault checklist If the pump identifies a faulty component a system fault screen is displayed for example SYSTEM FRULT 23 OST Keyboard failure Please do nat use the pump Turn the PUMPE off and return it for servicing Ifthe LEDs do not follow the prescribed sequence a LED may be defective or there may be a more serious fault Ifthe screen display does not follow the prescribed sequence the LCD is defective or there may be a more serious fault Ifthe sounder sequence is not followed the sounder may be defective or there may be a more serious fault If the pump is under warranty press the On Off key to switch off and return the pump to the supplier Omnifuse Technical User Manual Graseby Medical Ltd Acceptance tests Acceptance tests The following tests must be completed on Faulty units should be returned new pumps on delivery and pumps returned from Graseby Medical Ltd after repair service or upgrade Test Method Correct result 1 0 Mechanical Before applying No visible damage inspection power ensure that the case and exposed parts are not damaged 2 0 Electrical Using a test voltageof The insulation must exceed safety test 500V DC measurethe 200 Mohm ins
20. echnical User Manual Graseby Medical Ltd Introduction Introduction This manual is designed to provide technical details regarding the Omnifuse pump It covers tasks such as pump configuration and acceptance testing It supplements the Omnifuse Instruction Manual part number 0151 0839 which is for use by regular pump users Who should read this manual The reader must be trained and familiar with the use of the Omnifuse pump and its options and have appropriate experience of the technical aspects of syringe pumps This ensures that the effects of any change made to the pump set up using the Configuration and Technician menus are fully understood For step by step instructions on how to use the features described in this manual please read the Omnifuse Instruction Manual This manual should be read by people who need to configure the pump A member of a biomedical engineering department who is configuring the pump for use in a particular environment A technician servicing a pump A clinician deciding how a pump should be configured for specialised use All users of the Graseby Omnifuse Technician PC Software since the Configuration and Technician menu options described here can also be set up via that software A member of a team setting up protocols for use of a pump in a particular environment go E S gt o LS A rm Omnifuse Technical User Manual D d
21. ect Failure to do so may result in compromised function of the product patient injury or death WARNING Failure to follow the Maintenance Procedures described in Chapter 2 of the Omnifuse Service Manual may result in compromised function of the product and lead to patient injury or death 10 11 12 13 14 15 WARNING It is essential that clinical staff remain within visual and audible range of the pump so that they can respond promptly to critical alarms Failure to respond promptly to an alarm may result in patient injury or death WARNING The user should ensure that the performance offered by the pump is fit for the intended purpose Failure to do so may result in compromised function of the product patient injury or death WARNING When the pump is carrying out an infusion to ensure that electrical safety is maintained only items of equipment that conform to EN60950 are to be connected to the RS232 connector situated at the base of the pump otherwise patient safety may be compromised WARNING While Graseby Medical Limited have taken all reasonable steps to ensure that the pump operates correctly while under remote control it is the responsibility of the person who designs and implements the controlling device to ensure that the resulting system pump and controlling device is fit for its intended purpose Failure to do so may result in compromised function of the product patient injury or user inj
22. fe Graseby Medical Ltd Accessories Flo Safer extension sets Length Part number Syringe extension sets 150 cm 0128 0122 200 cm 0128 0198 Syringe extension sets with anti syphon valve 150 cm 0128 0253 200 cm 0128 0254 Syringe extension set with pressure sensing disc 150 cm 0130 0041 Polyethylene lined syringe extension sets with anti 150 cm 0128 0257 syphon valve 200cm 0128 0258 Low priming volume syringe extension set with anti 100 cm 0128 0259 syphon valve Epidural syringe extension sets with anti syphon 150 cm 0128 0261 valve Yellow 200cm 0128 0262 Epidural syringe extension sets Yellow 150 cm 0128 0263 200 cm 0128 0264 Software Part number Graseby Omnifuse Technician PC software 0151 0266 Omnifuse Drug Protocol Management System 0153 0084 Omnistack Part number Omnifuse pump stacking system 0156 0001 Wheelbase 0156 0096 Pole assembly for wheelbase Long 0156 0097 Short 0156 0098 Specification 6 Omnifuse Instruction Manual Graseby Medical Ltd Supported syringe brands and sizes Brand Size 2 3 5 10 20 30 50 60 Brand Size 2 3 5 10 20 30 50 60 BD Plastipak BD Precise Braun Euroject Braun Omnifix Braun Perfusor Codan Faulding Pharmaject Fresenius Injectomat IMS Pumpjet JMS Monoject Nipro Terumo TOP Pre filled syringe Note The syringes s
23. g manufacturers These include variations in the syringe barrel diameter syringe stiction Barrel diameters Syringe barrel diameter error results in under or over infusing by an amount proportionate to any difference between the real syringe diameter and the nominal diameter which is the figure provided by the syringe manufacturer and registered in the pump s memory Syringe stiction Syringe stiction is a condition where the syringe plunger travels in a start and stop manner down the barrel This is caused by static friction between the syringe bung and the inside of the barrel This error results in alternate over and under infusing of drugs over a short period Syringe stiction may also result in small under 0 5 ml doses being less than expected when delivered 26 Omnifuse Technical User Manual Specification Standards Page Specification 1 Standards 8 Graseby Medical Ltd Specification Weight 3 5 kg approx Dimensions 384 mm x 170 mm x 92 mm not including pole clamp Orientation Horizontal either mounted on a pole or flat on a stable horizontal surface Display LCD super twist with viewable area of approximately 105 mm x 32 mm Green backlight when connected to AC mains supply and for up to 3 minutes configurable following a key press when operating on battery Backlight flashes red during an alarm unless configured Off Data retention time M
24. he change is briefly confirmed on the Password Change screen before returning to the Technician menu D 5 3 e 22 Omnifuse Technical User Manual Graseby Medical Ltd Technician menu Pump date 1 Select the Date parameter on the Technician menu to display the date on the pump Please adjust date 11 62 2683 Select date field to adjust value CANCEL 2 Turn and press the Command wheel The time will be boxed For small date changes Turn the Command wheel to display the correct date then press the Command wheel For large date corrections use the keypad As you enter numbers the date builds up from right to left across the display For example to enter the date shown enter 11022003 An invalid date resets all the values to Zero 3 To accept the displayed date press the Command wheel 4 To return to the Technician menu highlight OK and press the Command wheel Pump time 1 Select the Time parameter on the Technician menu to display the time on the pump Flease adjust time 10 36 hh mm Press wheel to accert value CANCEL 2 Turn and press the Command wheel The time will be boxed For small time changes Turn the Command wheel to display the correct time then press the Command wheel For large time corrections use the keypad As you enter numbers the time builds up from right to left across the display For example to enter
25. hown in the Supported syringe brands and sizes table are supported by Omnifuse with their critical dimensions but may not achieve the stated accuracy due to syringe variability with the exception of the Braun Omnifix 50ml Symbols E 9 E E o o 2 o Symbol Meaning v Identifies the Potential Equalisation Terminal located on the body of i the pole clamp The applied part is Type CF The pump should be operated from an AC power source Omnifuse Instruction Manual Specification 7 o o e o zh o 8 fe 5 Standards Standards Graseby Medical Ltd Electrical Kd safety Classified as Internally Powered Equipment Class 1 Type CF insulation on all inputs Fluid ingress protection IPX4 Splash proof C CE marking 0473 The CE mark demonstrates that the pump conforms to the requirements of European Council Directive 93 42 EEC concerning medical devices The number 0473 identifies the Notified Body under which the Quality Systems operated within Graseby Medical Ltd are assessed Design standards EN60601 1 EN60601 1 2 EN60601 1 4 EN60601 2 24 et Disposal When the time comes to dispose of the pump its batteries or any of its accessories do so in the best way to minimise any negative impact on the environment You may be able to use recycling or disposal schemes To find out about these contact your local waste disposal ser
26. ient injury or death WARNING Use only the syringes and administration sets listed in Specifications and Standards at the end of this manual Failure to do so may result in an inaccurate delivery Graseby Medical does not guarantee performance of the pump if syringes other than those listed are used Incorrect function or performance of the pump can cause complications resulting in patient injury or death WARNING When using the In line Occlusion Sensing option use only a Graseby Medical or Graseby Medical approved extension set part number 0130 0041 Graseby Medical does not guarantee performance of the pump if unapproved extension sets are used Failure to observe this warning may lead to compromised performance of the pump resulting in patient injury or death WARNING The volume of fluid contained in the connecting tubing is a residual amount and will not be infused Allowance must be made for this extra volume of fluid when initially filling the syringe and purging the system Under delivery of medication can cause complications resulting in patient injury or death WARNING To avoid patient embolism ensure that the patient tubing is purged of all air bubbles before administering any medication The pump provides a purge facility to assist with this process The presence of air within the medication can result in complications leading to patient injury or death WARNING For safe operation of the pump the syringe must
27. ing in patient injury or death WARNING To avoid incorrect or inappropriate configuration of the pump the Configuration must only be selected by qualified persons or authorised personnel Incorrect pump configuration could lead to inappropriate infusion resulting in patient injury or death WARNING This equipment is not suitable for use in the presence of flammable anaesthetics oxygen enriched or explosive atmospheres The use of the device in such atmospheres may lead to explosion or fire WARNING To avoid possible malfunction of the pump do not expose the pump to X rays gamma rays or ionizing radiation or to the RF interference or strong electric magnetic fields emitted for example by diathermy equipment or mobile telephones If the pump is used in the presence of or in combination with Magnetic Resonance Imaging MRI machines it must be protected from the magnetic field emitted by such equipment Malfunction of the pump can cause incorrect infusion or loss of infusion resulting in patient injury or death WARNING Operation of the pump outside the temperature limits defined in the specification may result in erroneous operation Ensure that the temperature is within the specified limits Failure to do so may result in patient injury or death WARNING In order to ensure that the intended infusion is performed data must be entered correctly Before confirming any displayed data the user should ensure that it is corr
28. l User Manual Graseby Medical Ltd Setup Switch on and power up function test Before switching on 1 Fit the mains lead retainer and RS232 cover as shown on page 4 2 Connect the pump to the AC mains supply 3 Ensure that the mains LED illuminates This diagram shows the position of the LEDs illuminated during the power up tests Infusion Mains LED LED Alarm On Off LED Yooo06 GM 1 Eu Switching on 1 Press the On Off key on the pump 2 Observe the screens listen for the beeps and confirm the following sequence The green infusion yellow AC mains supply and red alarm LEDs illuminate The pump beeps and briefly displays the red opening screen After a few seconds the red screen shows the serial number and software version PERFORMING SELF TEST PUMP SZH 01234567 Sz VERSION 8 5 8 0 GRASEBY omnifuse While this screen is displayed the pump completes the Power On Self Tests POST When the tests are complete the pump beeps again and the screen changes to the normal display colour The red alarm LED is extinguished and the infusion LED changes from green to amber and is then extinguished The Pump Id and Location screen is displayed PUMP ID 5620456 LOCATION PRIMROSE WARD See Pump Id on page 24 for step by step instructions on how to change the text After a few seconds the pump beeps twic
29. ng the protocol through the data to be entered The required dialogue screens are dynamically generated based on choices made as parameters are entered A protocol may be as simple as a drug name but will usually define the infusion mode and values for the infusion parameters relevant to that infusion mode It is possible to either define the limits between which each parameter can be adjusted or to set the parameter to a single fixed value that cannot be altered by the user of the pump Name only protocols require that the user of the pump has to enter all the infusion parameters prior to running an infusion All other protocols define both configuration and infusion parameters required for that infusion The exception is Patient Weight which cannot be stored in a protocol as weight is patient dependent However the protocol can contain an upper and lower limit for this to ensure that the entered weight is appropriate for the infusion being programmed Omnifuse Technical User Manual 25 x G o io e LS ou o lt cus 2 Ke 2 3 o gt Le Syringe performance Graseby Medical Ltd Syringe performance The accuracy of infusions depends ultimately on the accurate performance of the pump and the precision of the syringe barrel diameter Syringe variations can therefore contribute significantly to errors in drug delivery However syringe performance varies widely amon
30. nge near empty state ends Near empty type Time based Volume based Near empty point Time based 1 2 3 5 10 minutes Volume based AUTO 0 2 0 5 1 2 3 5 10ml AUTO means the pump calculates the near empty point on the basis of the size of syringe detected 12 Omnifuse Technical User Manual Graseby Medical Ltd Configuration menu Displayed Values Default Comments Notes Parameter Ratechange running Enabled Disabled Allows infusion rate to be altered when an infusion is running Bolus Enabled Disabled BOLUS hotspot available Bolus preset Enabled Disabled Preset bolus available as well as hands on bolus Preset volume mode Enabled Disabled Preset time mode Enabled Disabled Intermittent mode Enabled Disabled Appear on Configuration menu when Extra Infusion Modes Intermit start delay Enabled Disabled option installed on pump Circadian rhythm Enabled Disabled Infusion in ml min Enabled Disabled Infusion in mg kg h Enabled Disabled Infusion in mg kg min Enabled Disabled Infusion in ug kg h Enabled Disabled Infusion in ug kg min Enabled Disabled Infusion in ng kg h Enabled Disabled Infusion in ng kg min Enabled Disabled Infusion in mg h Enabled Disabled Infusion in mg min Enabled Disabled Infusion in ug h Enabled Disabled Infusion in ug min Enabled Disabled Infusion in ng h Enabled
31. nts Contents Rs 6 eri o sarreria TET 1 Who should read this manual seene eee ee eee eee eee 1 Omnifuse pump variants see eee ee ee eee eee 2 a E EE 3 Contents of the bok 4 uice A xen idni iii 3 Visual checks and assembly sse een 4 Switch on and power up function test sss see eee ee eee eee 5 Acceptance tests lees eese essen nennen nennen annnm 7 Configuration menu lt gt sszss252222c2sa25 yasa 69225 2o 2252425 raodanas as 92 snnt n 2025 nans a dedain 10 Accessing the Configuration menu see ee ee eee ee ee eee eee ee eee 10 Configuration parameters sese eee ee eee ee eree 12 Changing the Configuration password see eee ee eee ee eee eee eee ee 16 HiStOLy cost ORE am IUS 17 Technician menu sucs EEEE 18 Access the Technician menu sese 18 Technician parameters esses entente trennt nennen nnne 20 Changing the Technician password see eee eee eee ee eee eee 22 P mgp date c ith eer hc deni epus 23 PUMP UME eoe ret Ri ge HEU et D o De tois Pr eae eod 23 Putnp Id iiit E REED AE 24 Location ELE 24 PrOtOCOINS e 25 Syringe performance ssni eiaeaeno aaen aapna rantein ener nennen nana nennt nnn 26 iz m S 1 GC Te Ts oec TT eundi ELILAieceniee S 7 ECOL E S 8 Tr mpetCcUEVes eie cence cedar E S 9 Omnifuse Technical User Manual U9 U09 Contents Graseby Medical Ltd Omnifuse T
32. nu 1 Unlock and open the cover 2 Switch on the pump and wait until the screen displays this screen PUMP STOPPED LOAD SYRINGE d Or press SKIP to load syringe later Note The Configuration menu can only be accessed when the cover is open 3 Simultaneously press keys 7 9 and 1 and release them when the password screen is displayed Please enter Password Press wheel to confirm rassword 4 Enter the five digit password As each digit is entered an asterisk is displayed 5 Press the Command wheel to accept the password and enter the Configuration menu To correct an error press Cancel C and re enter the password Configuration password The default password is 55555 If the correct password has not been entered after three attempts the pump will return to the LOAD SYRINGE screen The password can be changed using the Config Mode password parameter see Changing the Configuration password on page 16 If a password is forgotten it can be retrieved using the Graseby Omnifuse Technician PC software 10 Omnifuse Technical User Manual Graseby Medical Ltd Configuration menu Using the Configuration menu Exit the Configuration menu When the correct Configuration Press the Stop key to return to the password is entered the list of original screen configuration parameters is displayed Use wheel to select Config Parameter Intermittent made Disabled
33. o patient injury or death WARNING Following a significant liquid spill onto the pump it should be wiped dry and inspected by service personnel before being returned to service Failure to do so may result in compromised functioning of the pump leading to patient or user injury or death WARNING To avoid syphoning of the syringe contents free flow ensure that the patient line is clamped before loading or unloading the syringe Syphoning can result in over infusion leading to patient injury or death WARNING When the Omnifuse pump is fitted with a lockable cover the cover and associated security software should always be used in accordance with local protocol The lockable cover protects the syringe and its contents from tampering the security software ensures that the infusion parameters are not interfered with Failure to use the security software together with the lockable cover could result in an inaccurate delivery leading to patient injury or death Omnifuse Technical User Manual L E E p E 97 GC ni 5 e p f D 3 D Warnings Cautions Graseby Medical Ltd Cautions Cautions details dangerous conditions that may occur and cause damage to the pump if the instructions in this manual are not obeyed 1 CAUTION Refer all service repair and calibrations only to qualified technical personnel Unauthorised modifications to the pump must not be carried
34. ore than 12 months Operating temperature 5 to 40 C Storage temperature 20 to 55 C Relative humidity 20 to 90 non condensing operating Atmospheric pressure 700 1060 millibars operating Alarm volume Louder than 65 dBA at 1 metre at maximum volume Software options Extra Infusion modes and Mass Units Drug Protocols Graphics Remote Control 2 e 0 G Q o Omnifuse Instruction Manual Specification 1 Graseby Medical Ltd Pump variants Description Part numbers Omnifuse Syringe Pump UK and Ireland Model 0159 0001 Australian Model 0159 0740 Canadian English Model 0159 0711 Omnifuse with In line Occlusion Sensing UK and Ireland Model 0152 0001 Australian Model 0152 0740 Canadian English Model 0152 0711 Omnifuse with Lockable Cover UK and Ireland Model 0157 0001 Australian Model 0157 0740 Canadian English Model 0157 0711 Omnifuse with In line Occlusion Sensing and Lockable Cover UK and Ireland Model 0158 0001 Australian Model 0158 0740 Canadian English Model 0158 0711 Power supply 92 E 25 AC power supply 100 240 V at 50 60 Hz 50 W 9 Battery type Set of three Cyclon sealed lead acid batteries mp G Battery operating time 10 hours at 5 ml h 3 Battery charge time 10 hours Backup battery Single 3 V lithium battery Specification 2 Omnifuse Instruction Manual Graseby Medical Ltd Infusion flow rates
35. racters by turning the Command wheel To enter letters turn the Command wheel clockwise To enter numbers turn the wheel anti clockwise to scroll through 0 to 9 3 Press the Command wheel to store a character and move on to the next 4 To correct an entry press the Cancel key C on the keypad This erases the character and moves the cursor back one space 5 When all the required characters have been entered press Stop The new Location is stored and the screen returned to the Technician menu The location will be displayed next time the pump is switched on 24 Omnifuse Technical User Manual Graseby Medical Ltd Protocols Protocols Drug Protocols provide a way of pre programming some or all of the parameters required for an infusion into the pump Protocols can only be added removed or altered by an authorised person using the Omnifuse Drug Protocol Management System part number 0153 0084 Protocols are created and stored on a PC or network as a collection and then down loaded to a pump A collection may contain up to fifty protocols which is the maximum number that can be down loaded to a pump An individual protocol can be used in several collections A collection can be down loaded to several pumps so that each ward or department will have a standard set of protocols available on all pumps The parameters are entered via an interactive dialogue that guides the person defini
36. rt the infusion see Ensure that as the infusion failure 4 3 runs the infusion LED flashes green Remove or switch off the external AC mains supply Ensure that the alarm sounds intermittently and the message AC MAINS FAILURE is displayed but the pump continues to run on the internal batteries Ensure that the screen returns to the Infusion screen and that the message AC MAINS FAILURE appears on it Check that the error screen is displayed periodically with a double beep Reconnect the AC supply Ensure that the yellow AC mains LED illuminates and that the error message is no longer displayed Press the Stop key Ensure that the green Infusion LED shows steady and that the Infusion screen shows the infusion status Omnifuse Technical User Manual Graseby Medical Ltd Acceptance tests Test Method Correct result Press the Start key Run the infusion until the Near Empty Point is reached Check that the infusion LED now flashes amber Press and release the Stop key The amber LED ceases to flash but remains illuminated Press and hold the Stop key The amber LED is no longer illuminated Press and hold the On The display goes blank and the Off key for about yellow AC mains LED remains three seconds illuminated Battery charging Before using the pump for clinical purposes plug it into the AC mains supply and charge it for at least
37. td Technician parameters The following table shows the Technician It also shows adjustable parameters in menu parameters in the order in which bold for example date time Pump Id they appear on the pump s display Ward Location The display shows fixed information Parameters can be adjusted using the checks and tests for example battery Graseby Omnifuse Technician PC usage software Displayed Parameter Description Total volume infused Shows the total volume infused by the pump since manufacture Battery voltage Shows the battery voltage in millivolts Battery usage When selected displays the number of times the pump has been run on battery power for durations of ess than 1 hour between 1 and 4 hours between 4 and 10 hours over 10 hours Select the RETURN hotspot to return to the Technician menu CRC The Cyclic Redundancy Check for the main pump software This is used to check that the software has not been corrupted Primary Software ver Displays the version of the primary software loaded into the pump Secondary Software ver Displays the version of the secondary software loaded into the pump Date View or change the pump date in dd mm yyyy format see page 23 Time View or change the pump time between 00 00 and 23 59 in hh mm format Time changes between GMT and BST are not automatic see page 24 Service Recall Period Displays current
38. u 16 Omnifuse Technical User Manual Graseby Medical Ltd History A record of pump actions during a selected period may be examined by selecting History on the Configuration menu Up to 3000 events with dates and times may be reviewed If the number of events exceeds 3000 the earliest events are progressively overwritten History display Start 1B 46 Stop Baise Press STOP to return 10 0472003 1170572003 History display Start B2 88J 16704720603 Stop B8 52 110572002 Press wheel to accert value History display Start 2100 1370372003 Stor 19 100 22704 2003 Press ST P to return Retrieving History 1 a PUMP HISTORY SYRINGE CONFIRMED OCCLUSION LEVEL CHANGED El INFUSION SUSPENDED 14 26 83 Wed 26 Mar 2663 Configuration menu You can download more history details to a PC to view save or print using the Graseby Omnifuse Technician PC software This aids diagnosis during servicing and provides a permanent record of the pump s history 1 Select History on the menu and press the Command wheel The History display screen appears To exit without viewing any events press Stop 2 Turn the Command wheel clockwise to highlight the Start time and press the wheel 3 Turn the Command wheel or use the keypad to alter the start time then press the wheel to accept 4 Repeat steps 3 and 4 to set the Start date Stop time and
39. ulation resistance between the mains inlet and exposed metal parts 3 0 Initial power With the AC mains Ensure that the following events on supply not connected occur in the order shown press On Off 69 Asingle beep sounds All three LEDs illuminate The LCD display turns RED The screen displays PERFORMING SELF TEST Asingle beep sounds and all LEDs extinguish The infusion LED briefly 7 illuminates amber D The screen displays LOAD 2 SYRINGE D e 3 1 Connect AC mains The yellow AC mains supply s supply LED illuminates eg S 4 0 Keyboard Press and hold the On The display goes blank and the 5 tests AC Off key for about yellow AC LED remains lt connected three seconds illuminated Omnifuse Technical User Manual 7 gt O O o pmb E o o aem o e o Acceptance tests Graseby Medical Ltd Test Method Correct result 4 1 Keyboard Press the As 3 0 tests AC On Off key connected 4 2 Press all the keys on Ensure that the Lockable cover the numeric keypadin is open and that a brief beep turn press the On Off sounds as each key is pressed key very briefly 4 3 Command Using the Command Check that the Command wheel wheel checks wheel program a test can change the operation of the infusion with a BD pump and that it can confirm Plastipak syringe selections fitted and select a rate of 99 9 ml hr 5 0 AC mains Sta
40. ump history Refer to the Omnifuse Service manual part number 0151 0700 Change Password Select to change Technician password see page 22 E o E o Techn Fcal Calibration value for use by Graseby Medical Msf Calibration value for use by Graseby Medical Pcal Calibration value for use by Graseby Medical Asf Calibration value for use by Graseby Medical Cont Alarm freq Calibration value for use by Graseby Medical Omnifuse Technical User Manual 21 Technician menu Graseby Medical Ltd Displayed Parameter Description Alarm Tone Freq 1 Calibration value for use by Graseby Medical Alarm Tone Freq 2 Calibration value for use by Graseby Medical Alarm Volume Displayed on the menu but set by the user via the keypad to volume 1 quietest to 2 or 3 loudest The default setting is 3 R1 to R6 Calibration values for use by Graseby Medical Main PCB rev Power PCB rev Not used Syringe PCB rev In line PCB rev Changing the Technician password The password that is used to access the Technician menu can be changed as follows 1 Access the Technician menu as described on page 18 2 Select Change password and press the Command wheel Please enter Password Press wheel to confirm Password yoo 3 Type in the new password and press the Command wheel 4 Type in the new password again and press the Command wheel to confirm T
41. ury WARNING Do not use a faulty pump If the pump detects a fault a continuous alarm will sound and the screen will display a System Fault message If this happens switch the pump off disconnect it from the mains and take it to a suitably qualified engineer Incorrect performance of the pump can cause complications resulting in patient injury or death WARNING Failure to use the mains lead supplied with the pump will compromise the pump s ability to resist fluid ingress resulting in possible user or patient injury or death WARNING Correct management of battery charging is essential to ensure that the pump can operate on batteries for the time specified Failure to do so may lead to impaired functioning of the pump resulting in patient injury or death WARNING The occlusion alarm level must be checked before starting an infusion to ensure that it is appropriate for that infusion Failure to do so may result in an unacceptably slow time to occlusion alarm resulting in patient injury or death Omnifuse Technical User Manual Graseby Medical Ltd 16 17 18 19 20 21 22 WARNING If an occlusion alarm occurs immediately clamp the line to eliminate the possibility of a bolus being delivered to the patient Then inspect the fluid pathway for kinks clogged catheter etc in order to remove the occlusion prior to restarting the infusion An unintentional bolus of medication can result in pat
42. vice Separate any other parts of the equipment where arrangements can be made for their recovery either by recycling or energy recovery The only pump components which are potentially harmful enough to require separate disposal according to manufacturer s instructions or local regulations are Main batteries lead acid Back up battery on main PCB lithium LCD display contains harmful chemicals and may explode if incinerated Note Existing national or local regulations concerning waste disposal must take precedence over the above advice Patents Applied for Specification 8 Omnifuse Instruction Manual Graseby Medical Ltd Startup curves Standards 0 35 5 Braun Omnifix 50ml syringe 0 1ml hr 150cm extension 0 34 0 25 4 Rate o2 3 0154 0 1 I i Flow ml hour Time minutes 0 20 40 60 80 100 120 12 Braun Omnifix 50ml syringe 1ml hr 150cm extension 0 84 o o Flow ml hour o Fa 0 2 Flow ml hour Time minutes 20 0 2 7 40 60 80 100 Braun Omnifix 50ml syringe 5ml hr 150cm extension 120 Rate Flow ml hour w 0 T Flow ml hour Time minutes 0 20 GM151_21026B A 40 60 80 100 120 Omnifuse Instruction Manual Specification 9 E 9 a iS o o Qo Standards Graseby Medical Ltd Trumpet curves Br
43. when unpacked Contact your Graseby Medical distributor J 9 0090 A9 00000 GM151_2027GB E Omnifuse Technical User Manual Setup Graseby Medical Ltd Visual checks and assembly Check that the items in Contents of the box on page 3 are present and correct Check the pump case for any signs of damage Peel the protective cover from the LCD screen and check that there is no damage to the screen TT required record the serial number which is shown on the label on the base of the pump Socket cover A cover is provided to protect the RS232 socket This pushes over the socket and is held in place by friction Cou RS232 Cover GM151 2023GB C Fit mains lead retainer The pump is supplied with a separate mains lead A mains lead retainer is also provided to prevent the lead from being accidentally or deliberately pulled out of the pump socket When it is fitted the lead cannot be removed without unscrewing the retainer Mains lead C Mains lead retainer Mains lead retainer Alternative GM151 2007GB E version WARNING Failure to use the mains lead supplied with the pump will compromise the pump s ability to resist fluid ingress resulting in possible user or patient injury or death CAUTION Failure to use the mains lead retainer means that the pump may be accidentally disconnected from the mains supply Omnifuse Technica
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