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Grasby Omnifuse PCA

1. WARNING For safe operation of the pump the syringe must 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 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 24 25 26 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 operat
2. 4 11 Le fo fo N a Q gt fe t fe cz D 7 gt fe e gt Q Warnings Graseby Medical Ltd Repeated warnings Error message On screen information Short message on screen _ ml TO END The syringe is nearly empty LESS THAN __ ml TO END There is now less than _ ml to the end of the infusion AC MAINS The mains power supply has AC MAINS FAILURE FAILURE been disconnected The pump is now running on battery BACKUP The backup battery should be BACKUP BATTERY LOW BATTERY replaced The current date time may be lost BATTERY The pump cannot be used on BATTERY FAULT Do not FAULTY battery use on battery COMMS The remote connection to the COMMUNICATIONS FAILURE pump has been broken FAILURE HANDSET An unexpected Handset failure HANDSET failure FAILURE has been detected Investigate reason for this HANDSET LED Handset LED failure has been Handset LED failure detected Investigate reason for this HANDSET Handset SWITCH failure has Handset SWITCH failure SWITCH been detected Investigate reason for this KVO Infusion ended Pump now NOW RUNNING AT KVO running in KVO mode at _ RATE __ LIMIT The number of bad demands BAD DEMAND LIMIT EXCEEDED allowed within the lockout EXCEEDED period has been exceeded Investigate reason for this LOW BATTERY The pump batteries are low LOW BATTERY Connect to Please connect pump toa m
3. During an infusion you can change syringes For example you could change an empty syringe with a full one The replacement syringe must be the same brand and size as the original syringe brand and size that were confirmed at the start of the infusion Suspend the infusion by pressing Stop then carry out the instructions for How to unload a syringe page 2 17 and How to load a syringe page 2 16 If you try to replace a syringe with a different brand or size you will see an invalid syringe message INVALID SYRINGE Please replace the syringe You will not be able to restart the infusion until you load a syringe of the same brand and size as the original Please read Warnings and Cautions concerning syringes on page 2 15 2 14 Omnifuse PCA Instruction Manual Graseby Medical Ltd Loading and unloading a syringe Warnings and Cautions concerning syringes Please read these warnings and cautions before following the instructions in any of these sections 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 To avoid syphoning of the syringe co
4. 24 For details on how to create a protocol which appears on the Protocol menu for use in a clinical area see the Omnifuse PCA Technical User Manual Programming without protocols If no protocols are in use the pump does not display a protocol menu but shows the first programming step once the syringe is loaded The programming steps are the same as those described in the section on the USER PROGRAMMED option For details see User Programmed infusions page 3 24 Omnifuse PCA Instruction Manual D E S D i ou lt O A d V d je Q 3 E gt Q Programming the Omnifuse PCA Graseby Medical Ltd Overview of how the pump works with a protocol Because a protocol is always devised for a specific clinical application the Omnifuse PCA is not supplied with any pre defined protocols by Graseby Medical Ltd This section explains the general principles of using protocols Switch on and load syringe When you switch on a pump with protocols in use it carries out its self tests and then asks you to complete the syringe loading sequence When loading the syringe ensure that the line from the syringe leaves the pump through the channel so it will not be trapped when you shut the cover Select a protocol The menu of protocols is displayed once you have loaded the syringe The menu will contain only the protocols that have been set up for this pump There may be
5. To adjust the alarm volume Press and hold the Alarm Silence key and at the same time press the 1 2 or 3 key on the keypad As you press a number the pump demonstrates the volume of the alarm at your chosen level The last number you press sets the volume that the pump will use for the alarm until set to a different volume 2 12 Omnifuse PCA Instruction Manual Graseby Medical Ltd Loading and unloading a syringe Loading and unloading a syringe The pump is designed to make loading a syringe a one handed operation There are three components that secure the syringe The syringe ear slot The barrel clamp The pusher The syringe is placed in the trough at the front of the pump The ear or flange of the syringe should be placed into the syringe ear slot The barrel clamp is lowered by hand onto the syringe The sections on the following pages provide full details on loading unloading a syringe Please note that Warnings relating to syringe loading and unloading are listed on page 2 15 Syringe position Syringe placed in trough Syringe ear slot GM151 4004GB A When to load the syringe When you turn the pump on you see the screen below unless a syringe is already loaded PUMP STOPPED LOAD SYRINGE Or press SKIP to load syringe later If a syringe is already loaded you will only be asked to confirm the brand and size When to skip loading
6. 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 injury 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 Omnif
7. lo N a 2 cS i Ee fe D 2 gt fe fe gt Q Warnings Graseby Medical Ltd Error message On screen information Action HANDSET Handset SWITCH and LED Switch off the pump press the FAILURE failures have been detected handset connector firmly into the The infusion has not been socket then switch on again If started the message appears again the pump must be checked by a qualified technician HANDSET A handset failure has been Press the handset connector NOT FOUND detected The infusion has firmly into the socket then try to not been started The failure start the infusion If the message may indicate a faulty appears again the pump must be handset or simply that the checked by a qualified handset is not connected technician HISTORY The infusion cannot be Wait for the download to end or DOWNLOAD started whilst a history press stop if the pump should not download is in progress be downloading history INVALID The start stop date or time Re enter the date and time for DATE TIME you entered is incorrect the History display Please correct INVALID The password entered for If you know the correct PASSWORD Clinician Override was password re enter it invalid INVALID RATE The bolus rate is invalid Check the settings you have Please adjust the bolus time entered for the bolus Re enter or dose the duration size of dose as the
8. 3 5 Using the Omnifuse Sleep mode Waking the pump up When you are ready to connect the pump to the patient and start the infusion you must wake the pump up ASLEEP STANDARD ACULT Drug Concentration 1 4 mg ml PCA Bolus Dose 1 4 m9 PCA Dose Time STAT Lockout Period 66 85 hhinn CONFIRM Select item CONFIRM or press Stor STANDARD ADULT PLL PCA Bolus Dose 1 0 ma Close cover before starting infusion PURGE SLEEP REWIEW Graseby Medical Ltd The WAKE ME hotspot is already highlighted Press the Command wheel to wake the pump and exit from Sleep mode The pump takes you directly to the Review screen for the infusion that was programmed earlier If you need to change settings at this point highlight a setting and press the Command wheel When the settings are correct turn the Command wheel to highlight CONFIRM and press the Command wheel to display the Infusion start screen 3 14 Omnifuse PCA Instruction Manual Graseby Medical Ltd Giving a clinician override bolus Giving a clinician override bolus The Omnifuse PCA has a Clinician s Override Bolus feature used to give an additional bolus dose between lockout periods or if additional analgesia is required for example before a clinical procedure The Clinician bolus screen is only accessible using a password STANDARD ADULT ON STANDBY a PCA available in 03 187 mmiss
9. Equivalent Rate i 200 A Paih Background rate 0 0 m9 h Good Demands 8 PAGE UP PAGE DOWN Grarh Information Bad Demands Bo Alarms 0 PAGE UFP PAGE DOWN Graseby Medical Ltd 5 To view the text screen associated with the graph select the Info icon i This displays a page of text relating to the infusion 6 Press the Command wheel to HOLD the screen for one minute so that you can read the first page of details 7 Select PAGE DOWN to see the following pages PAGE DOWN shows the final page of information PAGE UP takes you to previous pages 8 When you have finished select the Return icon to go back to the graph screen or RETURN to leave the Graphics display and return to the infusion screen 3 20 Omnifuse PCA Instruction Manual Graseby Medical Ltd PCA Charting PCA Charting The Omnifuse PCA offers a Charting Once you have entered the scores from feature which you can use to record the the CHART hotspot you can view a patient s pain and or nausea and condensed score chart from the pump s sedation scores on the pump GRAPH hotspot or the full data using the Omnifuse Drug Protocol Management System Entering pain nausea and sedation scores You can enter patient chart scores when the infusion is running or suspended STANDARD ADULT PLL 1 Turn the Command wheel to highlight the CHART hotspot and ON STANDBY z Brees tie E E PCA available in 03 1
10. 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 Omnifuse PCA Instruction Manual Care and Maintenance Graseby Medical Ltd Removing and replacing the lockable cover You should only remove the lockable cover from the pump for cleaning To remove the lockable cover 1 Unlock the cover and open it fully 2 Load a syringe so that the pusher block is out of the way 3 Pull the cover at the right hand side until it flexes sufficiently to allow it to slide over the small boss on the end of the pump case Flex cover in this direction GM151_2026GB D Small boss Initially you may find that you need to exert some force 4 When the cover is free of the boss pull it towards you then move it to the left to release it from the other end of the case To replace the lockable cover after cleaning 1 Locate the left hand end of the cover in the hole in the left hand end of the pump case where the infusion line leaves the syringe trough Pull the right hand end of the cover and flex it until it can slide over the small boss on the right hand end of the pump case 2 22 Omnifuse PCA Instr
11. on the pump screen or transferred to a PC to be analysed in more detail c 2 pm S m e Omnifuse PCA Instruction Manual 5i P al fe 2 oO 5 Introduction to the Omnifuse PCA Graseby Medical Ltd Performance Below is a summary of PCA features of the pump and the relevant parameter range At the back of this manual is a detailed specification covering all aspects of the pump performance Pump feature Range Dose Range Dose Duration Clinician Override Dose Range Loading Dose Range Background Dose Rate Range Background Rate Ranges with bolus Background Rate Range no boluses Bolus Rate Range Bolus Duration Range timed Dose Limit Range by Mass Dose Limit Range by Volume Dose Limit Range by Demands Dose Limit Period 0 1 ug mcg 99 9mg 5 seconds 99 59 minutes 0 1 ug mcg 99 9 mg 0 1 ug meg 99 9 mg 0 1 ug meg hour 500 mg hour 0 1 20 ml hour 0 1 800 ml hour 0 1 800 ml hour 1 second 99 hours 99 mins 0 1 u mcg 99 9 mg 1 1 1 999 9 ml 999 demands 8 hours or infusion time User interface The screen and controls on the pump are easy to use All the information for programming and running infusions is shown on the LCD screen Liquid Crystal Display Next to the screen is a multi function Command wheel which you turn and press to select items and enter information The pump ha
12. 3 15 5 E E ie 5 e i ou lt 6 ou Giving a clinician override bolus Graseby Medical Ltd 4 Ifthe settings are applicable for the STANDARD ADULT Piha Polus PEE ae Tive patient start the bolus 8 5 mg 288 mivh BBB mis Press and hold the Command wheel for one second the bolus Press and hold wheel to start bolus will be delivered automatically 5 If you need to stop before the whole STANDARD ADULT PALI Infusing Clinician Bolus dose has been delivered press the G J 2 mg Command wheel 8 5 MJ 268 ml h BAI miS At the end of the bolus the running STOP BOLUS screen is displayed d V d oO Ke o 3 E gt Ko 3 16 Omnifuse PCA Instruction Manual Graseby Medical Ltd PCA Infusion Graph features PCA Infusion Graph features The GRAPH hotspot shows the PCA infusion profile on a graph and provides additional text information about the infusion If the CHART feature is in use you can see pain nausea and sedation scores on graphs see PCA Charting page 3 21 Time period for graphs The graphs show data up to 24 hours old If the infusion lasts longer than one day the oldest data is lost As the infusion proceeds the displayed time period changes to show either the last hour the last four hours the last 10 hours or the last 24 hours If the infusion lasts for more than an hour you can examine the profile for each hour
13. 4 sounds 2 12 Asleep patient 3 21 pump 3 13 Background infusion 3 25 Background rate 3 28 graph annotation 3 18 Bad demand graph annotation 3 18 Battery charging time S 1 disposal S 8 icon 2 10 level 2 8 recharging 2 7 type S 1 Battery life 2 8 Beeps adjusting the level 2 12 Before 2 5 Bolus clinician 3 15 graph annotation 3 18 occlusion pressure during 3 11 occlusion release S 5 patient 3 3 PCA dose 3 5 rate range S 2 totals 3 6 Button patient dose demand 2 3 C Carrying the pump 2 19 CE marking S 8 Change brand of syringe 2 18 Change syringe during an infusion 2 14 Chart enter patient scores 3 21 Charting 3 3 Clamp pump to pole 2 19 Cleaning the pump 2 21 Clinician bolus 3 3 3 15 graph annotation 3 18 Command wheel 2 4 Communications port 1 3 Connect handset to pump 2 3 Continuous infusion 3 25 Cover removing 2 22 Cumulative total reset 3 6 D Demands 3 25 Design standards S 8 Dimensions of pump S 1 Disinfectants 2 21 Disposal of batteries S 8 Dose clinician bolus 3 15 limit 3 25 loading 3 26 PCA bolus 3 27 viewing totals 3 6 Dose limit period 3 24 Dose units 3 24 Drug concentration 3 24 Drug concentration units 3 24 Omnifuse PCA Instruction Manual Graseby Medical Ltd E Electrical safety S 8 Embolism avoiding 3 10 F Fixed protocol 3 2 4 7 Flo Safer S 6 Fluid ingress S 8 G Good demands total 3 6 Graph annotation 3 18 icons 2 10 3 17 information
14. Af Flow ml hour Rate Flow ml hour w Time minutes 0 0 20 40 60 80 100 120 GM151_2102GB A Omnifuse PCA Pump Specification 9 Standards Graseby Medical Ltd Trumpet curves dp Braun Omnifix 50ml syringe 0 1ml hr 150cm extension O 15 Maximum O rs 101 oO x 5 s5 overall mean error 3 o o S 5 12 3 4 5 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 2 2 5 Observation Window minutes Mean error 6 21 104 Minimum 154 TA Braun Omnifix 50ml syringe 1ml hr 150cm extension E s 5 Maximum o o overall mean error 9 9 SS 5 1 2 3 4S 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 o S Minimum 5 4 Observation Window minutes Mean error 0 44 10 J i a Braun Omnifix 50ml syringe 5ml hr 150cm extension O 54 overall mean error A Maximum D s E 5 o SSS SSS SSS 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 5 i A Minimum Observation Window minutes Mean error 0 39 10 4 GM151_2101GB A Specification 10 Omnifuse PCA Pump Graseby Medical Ltd Index A AC power supply 10 1 Accessories S 6 Administration sets 2 14 Alarm format of screen message 4 1 graph annotation 3 18 LED 2 4 2 11 occlusion level setting 3 12 occlusion pressure 3 11 Silence key 2
15. If the syringe is not yet ready or if someone else is preparing the syringe while you program the pump you can skip loading The SKIP hotspot allows you to go ahead with programming the pump and load the syringe later on Please read Warnings and Cautions concerning syringes on page 2 15 Omnifuse PCA Instruction Manual 2 13 Loading and unloading a syringe Graseby Medical Ltd Syringe brand and size When you load a syringe into the trough and close the barrel clamp the pump displays The name of the previously loaded syringe brand and The size of the syringe it currently detects For example PUMP STOPPED Syringe size and brand Meee 20m Press wheel to change selection CONFIRM The pump can sense the size of syringe you have loaded but it cannot sense the brand Instead it remembers the brand of syringe used last time then checks the sizes listed for that brand against the size of the syringe sensed If the pump finds that the size is not compatible with the brand it displays a warning on the message line Brand does not match detected size If you see this message you must select the correct brand Syringes supported by the Omnifuse are listed in the Specification at the back of the manual It is essential that you check the syringe brand displayed by the pump and make sure that it corresponds to the one you have loaded Replacing a syringe during an infusion
16. Start the programmed Background infusion Omnifuse PCA Instruction Manual Graseby Medical Ltd PCA infusion features The Omnifuse PCA pump has features which you may use before an infusion Patient totals You can reset the cumulative totals for a patient before or during an infusion see page 3 6 Purge line Using the Purge feature on an Omnifuse PCA pump ensures that the start up time is reduced to the shortest possible time This is described on page 3 10 Occlusion alarm setting Before starting the infusion you should check that the occlusion alarm level is suitable for the patient see page 3 12 Sleep mode Once you have programmed the pump you can use the Sleep feature to leave the pump switched on and ready to be started when necessary For details see page 3 18 Programming the Omnifuse PCA The Omnifuse PCA pump has features which you may use during an infusion Lockable cover During the infusion the cover must be kept locked shut If the cover is opened when the pump is running the alarm will sound If you need to open the cover when the pump is infusing first suspend the infusion with the Stop key Once you have suspended the infusion for any reason you must open and shut the lockable cover before you can restart the pump PCA Bolus patient s handset To administer a PCA bolus the patient presses the button on the handset Clinician bolus The pump can
17. THIS HOUR THIS SHIFT RESET RETURN Total delivered since reset 10 Oma 10 0m1 gt 18 demands 18 good Totals reset at 13 29 03 02 03 THIS HOUR THIS SHIFT RETURM STANDARD ADULT PLL PCA Bolus Dose 1 0 m9 Close cover before starting infusion PURGE SLEEP REVIEW 2 On the total screen you can see e Cumulative total volume and mass Number of good and bad demands since the last manual reset Time and date of the last reset Hotspots leading to the other types of total THIS HOUR and THIS SHIFT see page 3 8 3 To reset the total highlight RESET then press the Command wheel Wait for a moment to return to the Infusion Start screen D S D i A lt 8 A Omnifuse PCA Instruction Manual d V d A fa Q o 3 5 PCA Totaliser Graseby Medical Ltd Hourly total and Shift total Hourly totals and Shift totals work in a similar way The shifts must be defined and programmed into the pump for a specific clinical environment and may be switched off or changed with the Configuration menu or Graseby Medical Technician s PC software see the Omnifuse PCA Technical User Manual The Hourly and Shift totals are reset automatically at the start of each infusion Total delivered since reset 10 0m9 10 Bm gt 18 demands 18 Jood Totals reset at 13 29 03702703 eee THIS SHIFT HOLD Total delivered this hou
18. a 150 cm line part number 0128 0122 Note Values are for a 50 ml syringe Values are reduced for smaller syringes Omnifuse PCA Pump Specification 5 w D fa O S R oO 5 Specificatioins Graseby Medical Ltd Accessories Flo Safer extension sets Length Part number PCA set with anti syphon valve non return valveand 150 cm 0128 0121 J loop 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 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 PCA Pump Graseby Medical Ltd Specificatioins Supported syringe brands and sizes Brand Size 2 3 5 10 20 30 50 60 BD Plastipak BD Precise Braun Euroject c fo Ez i 2 no Braun Om
19. ee ar aie eee eee 3 18 Viewing a PCA infusion profile graph and text ceeceeseeseeseeeeeneeteeeeeneeeees 3 19 PCA Charting eaa reran a aaae ea oara advan ceeeenseetetdesectetedendceyedeeeseone 3 21 Entering pain nausea and sedation Scores ssessesesssesseserrressrrnnreesrere nene 3 21 Viewing pain nausea and Sedation graphS sssssssiserriersisssrieerirerrreerrrssren 3 23 User Programmed infusions 1cccccsseeceeeeeneeseeeeeneeeseeeeeneeseeeeeneeeseeeeene 3 24 Program Mg S ODS ae el E T EAE E EAER 3 24 User programming screens isiisssessieseeinerninrinsstnainnnniranernncrnnanrinacnnacaneennnnenn 3 26 Reviewing User Programmed settings eceeeeseeeeseeeeeeneeeeeneeeeeneeteenaeereaes 3 29 Starting a User Programmed infusion ccecceeeeeeeeeeeeeeeeeeeeeeeeeteeeeeaeeeneeeaaee 3 30 Ending an infusionen E ia ga eee 3 31 ii Omnifuse PCA Instruction Manual Graseby Medical Ltd Chapter 4 Troubleshooting ITO CTIONN aiie eaae te cenemety ee stb cea ees cutee ey e 4 1 Format of Omnifuse PCA Alarms and Warnings c ceecceeseeeeeeeeeeeseeeeeeeaes 4 1 O How to handle Alarms ooo eeeeeeeeneeeeeneeeeeneeeeeeeeseaneeseaeeeeeaaeeeesaeeeeeaeeeseneeeeaes 4 1 E How to handle Warnings sssseiseniesrnerniernictinerranernunrnianetnacnnnncnnaninnnnnanennaac nna 4 2 How to handle System faults 2 00 ceceeeceeeeeeeeeeeeeeseeeeeaeeeeeseaeeeaeeeeeeseaeeseeeeneeend 4 3 fe AN ANIM S E E E E E E
20. for the protocol so you can check that the settings are correct for the patient 2 To continue highlight CONFIRM and press the Command wheel 3 The Infusion Start screen is displayed showing the PCA Bolus Dose but before starting the infusion you could now e Select TOTAL to check or reset the cumulative total see page 3 6 Select PURGE to Purge the line as described on page 3 10 Select the pressure icon GL to change the Occlusion Alarm level see page 3 12 Select SLEEP to leave the pump Asleep until you want to use it see page 3 18 Select REVIEW to go back to the Review screen 4 To start the infusion close and lock the cover then press Start The screen displays ON STANDBY ready for the patient to press the handset to deliver a bolus Omnifuse PCA Instruction Manual D z E D le i a lt O o d V d fe Ke o 3 E gt Q PCA Totaliser Graseby Medical Ltd PCA Totaliser The Omnifuse PCA pump has a Totaliser feature This shows three separate types of total Cumulative total Hourly total e Shift total The totaliser also shows the number of good and bad demands made since the last reset Note Cumulative and Hourly totals are always available Shift totals are shown in the example screens here but may not be in use on your pump How to view and reset the cumulative total The cumulative
21. 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 service 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 e 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 PCA Pump Graseby Medical Ltd Standards Startup curves 0 35 Braun Omnifix 50ml syringe 0 1ml hr 150cm extension 0 3 0 25 Rate 0 2 c f S 2 2 Flow ml hour Mi AA E Time minutes 0 20 40 60 80 100 120 12 Braun Omnifix 50ml syringe 1ml hr 150cm extension 1 yey ria VV V VVV AMA HAA PNA PP AH Flow ml hour 0 8 5 Rate 0 6 4 0 44 Flow ml hour 0 24 Time minutes 0 r r r r r r I 20 40 60 80 100 120 024 Braun Omnifix 50ml syringe 5ml hr 150cm extension 5 y
22. just one or up to fifty protocols Enter the required parameters When you select a protocol the pump displays either the review screen or the first parameter if the protocol requires one Many of the parameters for an infusion will be set up as part of the protocol The pump removes the majority of programming steps and only asks you to enter the minimum information it requires Review all the infusion parameters When you have entered any parameters required by the protocol or if there are no parameters required the pump will display the Review screen This shows all the infusion parameters for you to check those you have entered and also the ones that are part of the protocol You may be able to change some of these values depending on how the protocol has been designed Parameters can be Fixed so you cannot make changes Limited so you can make changes within a certain range specified in the protocol or Fully changeable so you can alter them within the pump limits The parameters must be confirmed before you can start the infusion Start the infusion Close and lock the cover before starting the infusion When you press Start the infusion begins and the pump displays the name of the protocol on the screen The pump operates according to your confirmed protocol It may Go ON STANDBY waiting for a PCA demand from the patient Begin to deliver the programmed Loading Dose or
23. of liquid in the line can be measured only approximately at the syringe plunger Omnifuse pressure levels You set the occlusion alarm in levels There may be up to five levels ranging from Level 1 low to Level 5 high The lower you set the alarm level the faster the response time will be toa potential problem with the infusion line For example if Level 1 is selected then as soon as pressure in the line begins to build up the alarm will sound The occlusion alarm is slower to sound if Level 5 has been selected The Occlusion Levels menu shows the levels available and the approximate pressure for the alarm to sound for each level Please Select Occlusion Level Current Pressure reading 2 2 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 Occlusion alarm lock level In some clinical areas it may not be safe for the occlusion alarm to be set to a high level In this case a technician can configure the pump so that the menu only shows the levels that are acceptable Please Select Occlusion Level LEVEL 1 188 mmHg LEVEL 2 t 388 mmHg LEVEL 3 6 S mmHg Current Pressure reading 0 0 This example screen shows how the screen would look with the Occlusion Alarm Lock level set to 3 For fu
24. or when necessary from its own rechargeable backup batteries The pump has been designed to be simple to use with a minimum of physical controls Most actions are performed by choosing options from the screen with the Command wheel which you turn and then press There is a keypad for entry of numerical data for stopping and starting the pump and for switching it on and off Carefully read the entire contents of this manual before using the pump Cg a Safety and security Many safety features are incorporated into the Omnifuse PCA pump Self test routines run each time the pump is switched on to check it is working correctly Continual checks are also made while the pump is running especially during an infusion A wide range of audible and visual alarms and warnings including the LCD screen flashing e Each infusion setting must be reviewed and confirmed before an infusion can start e Occlusion pressure is monitored as a standard feature The dry side pressure level is displayed while the pump is running The occlusion alarm level setting is adjustable but may be locked to restrict the upper level if required e A lockable cover and security software controls access to the syringe The pump can only be programmed if the cover is open and an infusion can only be started when the cover is shut Ahistory of the last 3000 of the pump s events or actions stamped with the date and time can be viewed
25. syringe brand and size are correct press the Command wheel to CONFIRM Press and hold the blue Load key Keep positive pressure on the key while the screen shows this message When the pusher is properly engaged with the syringe plunger the pump beeps When the pump displays this message release the Load key G The pump will display the next screen in the programming sequence Please read Warnings and Cautions concerning syringes on page 2 15 2 18 Omnifuse PCA Instruction Manual Graseby Medical Ltd Care and Maintenance Care and Maintenance This section explains the everyday care of described in the Omnifuse PCA Technical the Omnifuse pump It does not cover User Manual and the Omnifuse Service technical pump maintenance which is Manual Carrying the pump The Omnifuse pump has a carrying handle which you should always use to carry the pump safely Carrying handle 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 GM151 4301GB A Positioning the pump for use When you position the pump in a location Fitted into an Omnistack pump suitable for the patient make sure it is stacking system which can hold up to four Omnifuse pumps The Clamped to an IV Infusion pole Omnistack must be used with the or Graseby wheelbase or a suitable pylon See the Omnistack Instr
26. 3 20 infusion profile 3 17 3 19 pain nausea sedation scores 3 23 PCA infusion profile 3 17 summary of types available 3 3 zooming 3 19 H Handset 2 3 error message 4 8 Help icon 2 10 3 17 Hourly total 3 8 Icons 2 10 Indicators 2 11 Info icon 2 10 3 17 3 20 Infusion profile graph 3 17 text 3 19 Infusion start screen 3 5 IPX4 S 8 IV Pole 2 19 K Keypad 2 4 KVO rate 4 9 L LCD S 1 LEDs 2 4 2 11 keypad 2 4 patient handset 2 3 Limit PCA dose 3 25 Load key 2 4 Load syringe 2 16 Loading dose 3 24 Lockable cover 2 1 close cover message 3 29 during infusion 3 3 Locking pole clamp 2 20 Lockout period 3 24 handset LED 2 3 set duration 3 27 time remaining 3 30 Mains indicator LED 2 11 Mains lead retainer 2 7 Mains supply 2 7 S 1 Maintenance 2 21 Mass units programming ranges S 3 Maximum infusion rate S 2 Monitoring battery 2 7 occlusion pressure 3 12 N Nausea score graph 3 23 recording 3 21 Near empty infusion indicator 2 11 warning message 4 12 O Occlusion alarm 2 12 alarm lock level 3 11 approx alarm pressures 3 11 icon 2 10 pressure and alarms 3 11 Omnistack 2 19 On standby 3 5 Override Bolus 3 15 Index 2 Omnifuse PCA Instruction Manual Graseby Medical Ltd P Pain score graph 3 23 recording 3 21 Parameters 3 2 Patient bolus 3 3 handset 2 3 PCA Bolus dose 3 24 Bolus rate 3 27 charting 3 21 Dose time 3 24 graph of infusion 3 19 totals 3 6 PCA Bolus
27. 3 3 enter dose amount 3 27 infusion start screen 3 5 totals 3 6 Pole clamp locking 2 19 standard 2 19 Power battery 2 7 power up tests 2 5 supply S 1 Previous hour total 3 9 Programming a PCA infusion 3 1 Programming steps 3 24 Protocol fixed 3 2 4 7 saving 3 24 selecting 3 4 Purge how to purge line 3 10 rate range S 2 volume 3 10 warning message 3 10 R Recharging batteries 2 7 Remove syringe 2 17 Review program settings 3 5 RS232 interface 1 3 S Safety features 1 1 Scores pain nausea sedation 3 21 viewing on graph 3 23 Screen icons 2 10 Sedation score recording 3 21 3 23 Set up User Programmed infusion 3 24 Shift total 3 8 Size of pump S 1 of syringes S 6 Sleep mode 3 13 Sound adjusting the level 2 12 alarms and warnings 2 12 Standards S 8 Standby 3 5 Start infusion 3 5 Startup curves S 9 S 10 Switching on off 2 5 Syringe brand changing 2 18 brands supported S 6 change shown on graph 3 18 how to load 2 16 2 17 Load key 2 4 removing when switched off 2 17 replacing during an infusion 2 14 size rate increments S 2 T Total hourly 3 8 previous hour 3 9 shift 3 8 Totaliser 3 6 Trumpet curves S 9 S 10 U User interface 1 2 USER PROGRAMMED 3 24 User programmed infusion 3 24 Omnifuse PCA Instruction Manual Index 3 Graseby Medical Ltd V Volume alarm adjusting 2 12 W Wake me 3 14 Warnings format of screen message 4 1 one off 4 6 repeated 4 2 Weight pump
28. 87 mmiss CWolume infused since reset 16 0mg C BOLUS GRAFH TOTAL Score range in use G 10 2 The first score entry screen Enter Pain Score appears showing the last recorded score All the score entry screens Patient asleers C Cancel Exit work the same way Press wheel to accert value Enter the score requested on the screen using the numeric keypad or by turning the Command wheel Press the Command wheel to accept The scores can be in the range 0 3 0 10 or 0 100 Press the Decimal point key on the keypad to enter if the patient is asleep e E E i 5 e i ou lt x 6 ou In the example here a combined at rest movement pain score is requested If the pump is set up to Note Charting may be turned off on record separate scores for pain at a pump If the pump is set up so that rest and pain on movement it will Charting is available the CHART ask you to enter pain scores on two hotspot will be displayed screens Omnifuse PCA Instruction Manual 3 21 PCA Charting Graseby Medical Ltd Score range in use 10 3 When displayed enter the score on Enter Nausea Score the Nausea screen and press the Command wheel Patient asleep C Cancel z Exit Press wheel to accert value Score range in use 1a 4 Complete the Sedation screen in the Enter Sedation Score same way Patient asleep C Cancel Z Exit Press wheel to accert v
29. CWolume infused since reset 14 4mg GRAPH CHART TOTAL Please enter Password Press wheel to confirm Password ALLOW BOLUS The Dose Limit set for this infusion has already been exceeded wont inue with Clinician Override olus WB v o STANDARD ADULT olus settings anm Dose Rate Time 35 m1 200 ml h 8889 mis Press wheel to accert value When the infusion is started the C BOLUS hotspot appears However the Clinician bolus can be turned off on a pump In this case the C BOLUS hotspot does not appear For details on how to enable the Clinician override bolus feature and how to set the password for accessing the Clinician Bolus screen see the Omnifuse PCA Technical User Manual To give a Clinician bolus 1 Turn the Command wheel to highlight C BOLUS then press the Command wheel 2 Enter the password for accessing the Clinician bolus feature then press the Command wheel to accept If the Dose Limit has been exceeded this screen is displayed Press the Command wheel to confirm that you wish to continue with the bolus 3 Enter the dose using the Command wheel or the numeric keypad The pump displays the time required to deliver the bolus Press the Command wheel to accept You can adjust the Dose Rate or Time Highlight the field press the Command wheel and then enter the correct value using the keypad or Command wheel Omnifuse PCA Instruction Manual
30. E A 4 4 WarniinGS t iei0 s 2veccetis et ct ete eek dance tees eek A 4 6 One Off WarninGS seimi eld he ah aes ch eh ya toedraai Na iaae 4 6 Repeated Warnings 2 4200se a dee tii a a a eiei 4 12 Specification SPOCIHICAtI ONS veriee AA E E E S 1 Standard S a raea Aae a apa aa a a N aa r eaaa daana ta rasata aaas S 8 eelan ORTA EEE T S 9 PPUMPORCUIVOS irisan eaa ae E ai E G aaar Eai S 10 Omnifuse PCA Instruction Manual iii U9 U09 Graseby Medical Ltd Omnifuse PCA Instruction Manual Chapter 1 Introduction Introduction to the Omnifuse PCA PC software options Omnistack pump stacking system Page 1 4 5 Graseby Medical Ltd Introduction to the Omnifuse PCA Introduction to the Omnifuse PCA The Omnifuse PCA pump is designed for Patient Controlled Analgesia and is supplied with a patient handset and lockable cover It has a purple Command wheel LCD surround and keypad The features on the Omnifuse PCA pump can be tailored to suit individual hospital and clinical requirements The pump can be programmed for a patient bolus with or without a loading dose or background infusion A clinician s override bolus is also available The clear messages on the screen guide you through an intuitive programming and running sequence with further information available from on screen help explaining how to use a feature or follow a prompt The Omnifuse PCA pump can be run directly from the AC mains supply
31. GRASEBY omnifuse PCA Syringe Pump NY x struction Manual 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 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 os 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 covers all aspects of using the Omnifuse PCA pump Warnings and Cautions This gives a list of Warnings and Cautions which you must be aware of before using the pump These are repeated on the relevant pages in the m
32. Graseby Medical Ltd Graph annotation The graph shows boluses bad demands any background rate and alarms or syringe changes Boluses on the graph The PCA boluses that have occurred during the period are displayed as vertical lines on the graph They show the time of the bolus and the size of the dose C above a vertical line marks a clinician override bolus If there is a loading dose the graph shows it as a vertical line at the start of the infusion Bad demands A bad demand is shown as a v thin downward arrow If the patient has made g multiple bad demandes in a short period the graph shows a thick downward arrow Background rate If there is a background infusion the graph shows this as a thick horizontal line marking the dose with the rate displayed at the top of the screen Annotations on graphs Letters are used on a graph to indicate special events at the time they occurred A alarm S syringe change 3 18 Omnifuse PCA Instruction Manual Graseby Medical Ltd PCA Infusion Graph features Viewing a PCA infusion profile graph and text On an Omnifuse PCA pump you can view the progress of the infusion as a graph The GRAPH hotspot appears on the screen when you begin the infusion and is available until you press and hold Stop to end the infusion STANDARD ALULT PLL ON STANDBY g PCA available in 03137 mmiss Wolume infused since reset 16 8mg C BOLUS AA CHAR
33. LED goes out and the battery icon is shown on the screen when the pump is running on batteries The pump will display a warning message approximately 30 minutes before battery power runs out When the pump is reconnected to the main supply or mains power resumes the pump automatically switches back to the AC mains supply Note When the pump is being used on battery an independent battery monitor is active This provides an additional check on the battery condition If the pump s alarm sounds but no message is displayed on the screen the independent battery monitor has detected a problem The alarm cannot be silenced and the pump cannot be used It must be taken to a qualified technician for repair Omnifuse PCA Instruction Manual Switching the pump on and off Graseby Medical Ltd Recharging the batteries While the pump is switched off you should leave it connected to the AC mains supply so that the batteries are always kept fully charged Recharging can take up to 10 hours if the batteries are completely flat While the pump is running on the mains supply the battery icon is displayed to show that the batteries are being charged The battery icon disappears once the batteries are fully charged Battery life As arough guide an Omnifuse pump can operate on battery power for up to 10 hours at a continuous infusion rate of 5 ml h with the batteries starting from fully charged This p
34. RGE see page 3 10 Change the Occlusion Alarm level see page 3 12 Select SLEEP see page 3 13 Select REVIEW to go back to the Review screen User Programmed ON STANDBY PCA Available now Volume infused since reset 4 8mg C BOLUS GRAPH CHART of User Programmed P Infusing Loading Dose O F M9 verwer bose 1 8 mo 1 8 milo Volume infused since reset By ml GRAPH CHART eck User Programmed P Background Ratei 8 5 ml h PCA Available now Volume infused since reset 8 1 ml GRAFH CHART TOTAL eck When you have confirmed the settings and carried out all pre infusion checks Close and lock the cover then press Start What happens depends on whether you have specified a Loading Dose or Background Rate If neither Loading Dose or Background Rate is specified the pump goes ON STANDBY waiting for the patient to press the button on their handset If you have specified a Loading dose when you press Start this screen is displayed and the Loading dose is delivered After the Loading Dose the pump goes ON STANDBY with a timer on the screen counting down to show how much of the Lockout period remains Alternatively it begins the continuous background infusion if one is specified If you have specified a Background Rate when you press Start the pump begins a continuous background infusion The screen shows when a PCA bolus is availa
35. S 1 Wrist strap 2 3 Index 4 Omnifuse PCA 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 PartNo 0153 0082 C January 2004 smiths 2004 Graseby Medical Ltd Smiths Medical A part of Smiths Group plc
36. Select Occlusion Level 3 Turn the Command wheel to LEVEL 1 198 mmHg highlight the level at which you ie E Eee a want the occlusion level alarm to LENEL 4 sound LEWEL 5 1254 mmHg Current Pressure reading 2 2 4 Press the Command wheel to set the level and exit from the Occlusion Level screen The pressure icon now shows the new level Gul 5 Close and lock the cover then press Bs Start to resume or start the gt infusion U a Monitoring the pressure 3 While the pumpis infusing the icon PLL To monitor infusion pressure check SJ shows the selected occlusion alarm level where the alarm level has been set and Ye anda visual guide to the current infusion see how close the actual pressure is to it pressure The line on the icon here Llu shows that the alarm is set at Level 3 The pressure level will normally fluctuate as the infusion progresses If If the pressure rises the pressure icon you notice that it is steadily moving fills from left to right In the icon below closer to the alarm level you should the alarm is set at Level 5 check the patient and line immediately LI LI Ai i to find out why 3 12 Omnifuse PCA Instruction Manual Graseby Medical Ltd Using the Omnifuse Sleep mode Using the Omnifuse Sleep mode You may want to program the pump ready for an infusion but connect it to the patient and start the infusion later For example you may pr
37. T TOTAL Use wheel to select Graphics screen PCA Infusion profile Pain profile Nausea Sedation profile mg Pe 4 B C H eri a0 t 13700 i400 15 00 16800 Zoom window na Pe 4 a6 i esi B G m 13700 14 00 15 00 16100 mg 1 2 0 6 C fal t ae 13 30 13 45 14 00 14 15 Turn the Command wheel to highlight the GRAPH hotspot and press the Command wheel If Charting is in use on the pump you will see this menu Turn the Command wheel to highlight PCA Infusion Profile then press the Command wheel The PCA infusion profile graph will look something like this Select the Hold icon amp to keep the graph on the screen The Hold icon is replaced by the Return icon el Select the Zoom icon 4 to display the Zoom window Turn the Command wheel to move the window left or right along the graph until it is positioned over the hour that you want to examine Press the Command wheel to display the selected hour in greater detail To leave the graph select the Return icon fe Omnifuse PCA Instruction Manual 3 19 to E E yl ton 5 fe i ou lt x 6 ou d V d Ke o 3 3 gt Ko PCA Infusion Graph features Grarh Information Protocol ST Syringe AI Start time 118 Duration 1 Ad Uol delivered 16 PAGE LP PAGE DOWN ARD ay 38702703 i m Grarh Information Hass delivered iG 25 a PCA Dose
38. age On screen information Short message on screen BATTERIES Please connect pump to a mains URGENT BATTERIES DEAD supply immediately The pump EXHAUSTED will automatically switch off CLAMP The syringe clamp was opened CLAMP OPENED OPENED during an infusion The infusion has been suspended COMMS The remote connection to the COMMUNICATIONS FAILURE pump has been broken FAILURE CONTROL External controller terminated CONTROL TERMINATED FINISHED control whilst infusing COVER The cover was opened during an COVER OPENED OPENED infusion The infusion has been suspended DOSE The Dose Limit set for the DOSE LIMIT EXCEEDED EXCEEDED infusion has been exceeded The infusion has been suspended FAULTY A handset failure has been HANDSET NOT HANDSET detected This may indicate a CONNECTED faulty handset or simply the handset is not connected LOAD NOT The syringe loading operation did SYRINGE LOADING NOT COMPLETE not complete within the time COMPLETED IN TIME allowed Open and close the barrel clamp then try loading the syringe again Omnifuse PCA Instruction Manual Graseby Medical Ltd Alarms Error message On screen information Short message on screen OBSTRUCTION The syringe load unload has been OBSTRUCTION stopped as an obstruction has been detected Please remove the obstruction and press LOAD to continue the load unload OCCLUSION The infusion has been suspended OCCLUSION See He
39. ains mains supply supply as soon as possible 4 12 Omnifuse PCA Instruction Manual Graseby Medical Ltd Warnings Error message On screen information Short message on screen NOT INFUSING The pump is not infusing NOT INFUSING Please set up and start the infusion or switch the pump off PUMP TOO The internal temperature of the PUMP TOO COLD COLD pump is lower than expected Please move pump to a warmer environment PUMP TOO HOT The internal temperature of the PUMP TOO HOT pump is higher than expected Please move pump to a cooler environment SOUNDER No sound can be detected SOUNDER FAILURE FAILURE Remove pump from service as soon as possible SWITCH and Handset SWITCH and LED Handset LED and SWITCH LED failures have been detected failure Investigate reason for this VOLUME LOW There is insufficient fluid VOLUME INSUFFICIENT remaining in the syringe to deliver another complete bolus dose FOR NEXT BOLUS Omnifuse PCA Instruction Manual 4 13 D i O lt N 2 fa H Warnings Graseby Medical Ltd j te 23 iv 2 gt fe Ko 4 14 Omnifuse PCA Instruction Manual Specification Standards Page Specificatioins 1 Standards 8 Graseby Medical Ltd Specificatioins Specificatioins j G Weight 3 5 kg approx e Dimensions 384 mm x 170 mm x 92 mm not inc
40. alue STANDARD ADULT P Ls 5 When you have entered all the scores the pump automatically ON STANDBY returns to the infusion screen gee ee 2i e caval 16 0m9 You can view the scores that have been C BOLUS GRAPH TOTAL entered for the patient on a graph see page 3 28 d V d oO Ke o 3 E gt Ko 3 22 Omnifuse PCA Instruction Manual Graseby Medical Ltd PCA Charting Viewing pain nausea and sedation graphs On an Omnifuse PCA pump with the CHART feature in use for recording the patient s nausea pain and sedation scores you can view the data as graphs from the GRAPH hotspot STANDARD ADULT ON STANDBY PCA available in 08 187 mmiss Wolume infused since reset 16 8mg FEL Use wheel to select Grarhics screen PCA Infusion Profile Pain Profile Nausea Sedation Profile Combined rain scores Ome Ton 15 00 16 00 17 00 18 00 nausea sedation Omen om 15 00 16 00 17 00 18 00 Turn the Command wheel to highlight the GRAPH hotspot and press the Command wheel On the menu turn the Command wheel to highlight Pain or Nausea Sedation then press the Command wheel When the graph is displayed select the Hold icon fl to keep the graph on the screen The Hold icon amp is replaced by the Return icon ial The Pain profile graph shows the pain score plotted on a graph You may see two lines pain at
41. ammed sequence is shown on the next page Programming steps The programming steps can include any of the following parameters Parameter Description Dose units For example mg Drug concentration units For example mg ml Drug concentration For example 1 mg ml The size of dose to be delivered as soon as you press Start to begin the infusion Loading dose d V d The size of the dose that will be delivered when the patient presses the button on the patient handset PCA Bolus dose The period over which the PCA Bolus dose should be delivered this sets the infusion rate for example 1ml delivered in 18 seconds sets the rate to 200 ml h PCA Dose time e Q 3 3 gt Q The period the pump will wait between one PCA bolus and the next Any demands made during this period are recorded on the pump as Bad demands Lockout period Can be set between 1 and 8 hours or the duration of the infusion see the Omnifuse PCA Technical User Manual Dose limit period 3 24 Omnifuse PCA Instruction Manual Graseby Medical Ltd User Programmed infusions Parameter Description Dose limit Maximum amount which can be delivered to the patient within the infusion Demands Can be specified instead of a dose limit this is the maximum number of demands the patient can make within the specified dose limit period Background infusion The rate the pump will infu
42. anual Table of Contents Use the table of contents to see the structure of the manual and the headings in the order in which they appear Chapter 1 Introduction This introduces the Omnifuse PCA pump It provides a high level description of the features of the pump Chapter 2 Basics This chapter covers the external features of the pump and contains detailed explanations of the techniques for using the pump for example switching on loading or changing a syringe and operating the patient handset It also covers the care and maintenance of the pump Chapter 3 PCA Programming This chapter describes how to program the Omnifuse PCA pump It explains how to use the special pump features designed for the PCA environment Chapier 4 Troubleshooting This chapter gives you a list of the warnings and alarms that may be displayed by the Omnifuse and tells you how to handle them Specifications and Standards This lists the specifications for the Omnifuse PCA pump and the standards with which it complies a 5d 2 D Index At the end of the manual is an index which provides an alphabetical list of key words and cross references these to the relevant pages in the manual Omnifuse PCA Instruction Manual vo ped O o s Si e 1 Graseby Medical Ltd Warnings Cautions Warnings Warnings tell you about dangerous conditions that
43. art at 9 45 to commence an infusion and checked the totals at 10 15 THIS HOUR would show you the amount delivered since 10 00 The PREVIOUS hotspot would appear on the screen PREVIOUS would show the volume if used between 9 45 and 10 00 TOTAL would return you to the cumulative total screen Omnifuse PCA Instruction Manual 3 9 Le E g 5 i a lt 1S a d V d oO Q o 3 E gt co Purging the line Graseby Medical Ltd Purging the line The purging of the line may have been completed before loading the syringe However purging with the PURGE facility on the Omnifuse pump ensures that the start up time is reduced to the shortest possible time STANDARD ADULT FEL PCA Bolus Dose 1 0 mg Fress wheel to select Purge SLEEP REVIEW TOTAL P aul Ensure that the line is isconnected from the Patient Press and hold wheel to Purge line RETURN Purging line P Gaul 0 2 ml 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 The volume of fluid contained in the connecting tubing is a residual amount and will not be infused Hence this extra volume of fluid must be allowed for when initially filling the syringe and purging the system Under delivery of medication can cause complications resulti
44. be saved in the pump 2 Do not use the pump It must not be used again until it has been checked by a technician System fault at switch on The system fault screen described opposite appears if a component fails at switch on or at any other time The following screen would be displayed only if a fault is discovered at switch on GRASEBY m Omnifuse Series If you see this screen you can press the Command wheel to display a help screen showing further information Do not use the pump It must not be used again until it has been checked by a technician If the pump sounds a continuous alarm with no message When the pump is being used on battery an independent battery monitor is active This provides an additional check on the battery condition If the pump s alarm sounds but no message is displayed on the screen the independent battery monitor has detected a problem The alarm cannot be silenced and the pump cannot be used It must be taken to a qualified technician for repair Omnifuse PCA Instruction Manual D E lo m G 3 i ma ml fe 0 7 gt fe e p Q Alarms Graseby Medical Ltd Alarms The pump sounds a continuous alarm and the screen flashes red when any of these messages are displayed You must press Alarm Silence to clear the alarm For more details see How to handle Alarms page 4 1 Error mess
45. ble The PCA Available now message shown in this example appears if a PCA Bolus dose has been programmed 3 30 Omnifuse PCA Instruction Manual Graseby Medical Ltd User Programmed infusions Ending an infusion To end an infusion Press and hold Stop you must keep it pressed for at least two seconds If you only press the Stop key briefly the infusion will be suspended and can be restarted if you open and shut the cover and press the Start key D E S D Sen a lt a Omnifuse PCA Instruction Manual 3 31 User Programmed infusions Graseby Medical Ltd d V d oO Ko 3 E Ko 3 32 Omnifuse PCA Instruction Manual Chapter 4 Troubleshooting Page Introduction 1 Alarms a Warnings 6 Graseby Medical Ltd Introduction This chapter offers troubleshooting advice if the pump sounds the alarm It covers all the alarms and warnings that may be displayed on the Omnifuse PCA screen to notify you of an operating or equipment problem Introduction The chapter also covers System Faults which sound the alarm but can only be resolved by a technician see page 4 3 Format of Omnifuse PCA Alarms and Warnings Omnifuse PCA alarms and warnings are displayed on the screen in a standard format The error message is displayed in large letters at the top of the screen Below this on screen information tells you how to clear
46. could lead to death or serious injury to the user or patient that can occur if you do not obey all of the instructions in this manual 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 resulting in patient injury or death WARNING To avoid incorrect or inappropriate configuration of the pump the Configuration menu 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 anaesthetic mixtures with air oxygen or nitrous oxide The use of the device in presence of such mixtures 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 deat
47. cover must be unlocked and opened before you can program a PCA infusion then shut and locked before you can The cover must be shut and locked with restart the infusion This is to ensure a key before the infusion starts The that the infusion can only be started by cover should only be removed for an authorised person who has the key to cleaning see Removing and replacing the the cover lockable cover page 2 22 Lockable cover Omnifuse PCA Instruction Manual 2 1 Parts of the Omnifuse PCA pump Front of the pump Syringe pusher Graseby Medical Ltd Moves automatically during syringe unload or under control of the Load key when loading Keypad Cannot be moved by hand Command wheel LCD screen Displays information about pump s activities Slot for syringe ear Barrel clamp Closed by hand to secure the syringe barrel and measure its size Syringe position Syringe placed ta trough Syringe ear in slot GM151 4302GB A Plunger sensor Detects position of syringe Syringe plunger clamp Automatically clamps the plunger on the syringe to complete the syringe loading process 2 2 Omnifuse PCA Instruction Manual Graseby Medical Ltd Parts of the Omnifuse PCA pump PCA Handset The Omnifuse PCA patient handset is Cable and wrist strap designed to be comfortable and easy to use The handset is connected to the pump by a purple cable which ma
48. d Alarm indicator flashes when the pump sounds the alarm Omnifuse PCA Instruction Manual 2 11 Omnifuse screen icons and indicators Graseby Medical Ltd Sounds on the Omnifuse This table describes the sounds that you may hear from the Omnifuse pump and tells you what action is required if you hear them For more details on pump warnings and alarms see Troubleshooting Chapter 4 Sound Occurs when What you should do Beep You press a key or the If the beep is too soft or too loud call Command wheel a technician to change it for you via the Key Beep Volume parameter in the Configuration menu Double beep The pump requires Read the message on the screen your attention then carry out the suggested action Alarm The pump has Read the message on the screen discovered an operating then press the Alarm Silence key problem for example and carry out the suggested the syringe is empty or action there is an occlusion Continuous The pump has detected Read the message on the screen System Alarm an internal error Pressing Alarm Silence will have no effect Switch off the pump and hand it over to a qualified technician for servicing Setting the alarm volume The volume of the alarm on the Omnifuse can be set to one of three levels e 1 Soft 2 Medium 3 Loud Provided the pump is not infusing and the cover is open you can adjust the volume to suit the operating environment
49. dication resulting in patient 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 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 Omnifuse PCA Instruction Manual 2 15 Loading and unloading a syringe Graseby Medical Ltd How to load a syringe PUMP STOPPED LOAD SYRINGE Or press SKIP to load syringe later PUMP STOPPED Syringe size and brand BD PLASTIPAK 20ml Please CONFIRM or change PUMP STOPPED PRESS LOAD KEY Press and hold LOAD key PUMP STOPPED SYRINGE LOADING Keer LOAD key pressed PUMP STOPPED SYRINGE LOADED Please release LOAD key Ensure that the line to the patient is clamped or disconnected Switch on the pump if it is switched off Lift up the barrel clamp if it is closed you will see this message Place the syringe in the trough The syringe ear must fit into the slot Lower the barrel clamp by hand The screen shows the size of syringe the pump has detected and the brand of syringe used last time Press the Command wheel to CONFIRM that the syringe brand and size are correct To change brand see How to change the brand of syri
50. e correctly leading to 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 2 2 O 2 5 S _ S Omnifuse PCA Instruction Manual o 2 Q 2 Sac o ee oO gt 7 Graseby Medical Ltd Cautions Cautions tell you about dangerous conditions that may occur and cause damage to the pump if you do not obey all of the instructions in this manual 1 CAUTION Refer all service repair and calibrations only to qualified technical personnel Unauthorised modifications to the pump must not be carried out 2 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 3 CAUTION Do not attempt to move the pump s pusher by hand Always use the syringe Load key to move the pusher Failure to observe this caution may cause mechanical damage to the pump 4 CAUTION Never carry the pump except by the handle Failur
51. e syringe is loaded the pump shows a menu of one or more protocols 2 Turn the Command wheel to highlight the protocol you want to use then press the Command wheel The pump displays the first screen in the programming sequence for the protocol On the following pages you can see an example of what happens if you choose a fixed protocol If the menu includes the USER PROGRAMMED option as shown on the example screen here you can create a PCA infusion for a particular patient see page 3 24 Omnifuse PCA Instruction Manual Graseby Medical Ltd Programming the Omnifuse PCA Reviewing settings and starting the infusion Most protocols will lead directly to the Review screen In this example a fixed protocol has been set up for a clinical environment where the pump will be used to administer a STANDARD ADULT PCA prescription for Morphine STANDARD ADULT Drug Concentration PCA Bolus Dose PCA Dose Time 1 4 mg ml 1 4 mg TAT 5 Lockout Period Baas hh mm CONFIRM STANDARD ADULT PCA Bolus Dose 1 0 m9 Close cover before starting infusion PURGE SLEEP REVIEW STANDARD ADULT ON STANDBY PCA Available now Wolume infused since reset 18 fmg C BOLUS GRAPH CHART FLL The drug is supplied in a concentration of 1 mg ml of infusate and the PCA Bolus dose is 1 mg The lockout time between doses is 5 minutes 1 The pump displays the Review screen
52. e that needs to appropriate be cleared BRAND The pump can only be used The screen displays the name of LOCKED with this brand of syringe the only brand of syringe which can be used with this particular pump If this is not correct return the pump to the technician CONC The entered or derived drug Check the settings you have INVALID concentration is too high programmed against the low The screen indicates patient s prescription the max min concentration allowed CONFIG When Dose Limit is set to Only appears when a technician INVALID DEMANDS the Dose Limit configures the pump for use see Period must be set to Omnifuse PCA Technical User INFUSION Manual CONFIRM The infusion programming Select REVIEW to check change REVIEW sequence has not been the infusion parameters and completed Ensure that all CONFIRM them You can then infusion parameters have press start been confirmed COVER This option cannot be Press Stop to suspend the LOCKED selected when the cover is infusion before unlocking the locked cover Omnifuse PCA Instruction Manual Graseby Medical Ltd Warnings Error message On screen information Action COVER The infusion cannot be Shut the cover and lock to secure UNLOCKED started with the cover open it before pressing Start or unlocked DOSE The Dose Limit set for the Press Stop to silence the EXCEEDED infusion has been exceeded alarm Check the p
53. e 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 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 CAUTION Failure to use the mains lead retainer means that the pump may be accidentally disconnected from the mains Omnifuse PCA Instruction Manual Graseby Medical Ltd Contents Chapter 1 Introduction F Introduction to the Omnifuse PCA ss ssesssssssessesseseessessesessssseseessessees 1 1 E PC Software Options ccccsscccsseeeeeseecesseeeeeseeeeeseeeeeneeseseeeeeeesneesseneeenseeeess 1 4 Omnistack pump stacking system s sssssnsonsusnnnnonnnnnnnnnnnnnnnnnnnr ennenen nenene 1 4 8 Chapter 2 Basics Parts of the Omnifuse PCA PUMP eccceseceesteeeeeeeeeeseee
54. eeeeeeeensnaeeneeeeeeas 2 1 Rearotine pump maonar a ni dardania ei aaa 2 1 Lockable cover cits 40h ee ee A 2 1 Front ofthe PUMP treintena an ap ended eee ee 2 2 PCA Handset wcctneiia innit Abani a a a iad dean 2 3 The Command wheel keypad and LEDS eeecceeeceeeeeeeeeeeeeeeeeeteaeeeeeeeeeeteas 2 4 Switching the pump ON AN off s eccceeeeeeseeeeeneeeeeeeeeeeeneeeeeeeeeeeeseeeeeneas 2 5 Switching on and power up tests 00 eecceeeceseeeeeeeseeeeeeeeeeeeteeeseeeseeeeeeeeeeeeeeee 2 5 SWItCHING OM e224 See 2 se EAE E T 2 6 Using the pump ON batteries 20 0 ee eeeeeeeeneeeeeneeeeeaeeeeeeeeeeseeeeeeeeeesnneeeeneees 2 7 Recharging the batteries ecccescseeeseceeseeeeenenceeeneeeseseeenesenseeseneeseseeeeenenens 2 8 Omnifuse screen icons and indicators ccceeeeeeeesseeesseseeeeeeeeeeens 2 9 ICONS ON the PUMP SCIEON sssri ocsi a n ane i Na 2 9 Sree ICONS han Ai as ali RA ee ig a Ea eas 2 10 P mpiindicatorS sas obs certs aen a a s a 2 11 Sounds on the Omnifuse eee eeeeeeeeeeeeeeeeeeeee tees tt ntttnestnttntnestnstnntnnennsennn nne 2 12 Setting the alarm volume cccecceeeeeeseeceseeseeeeeeeeeseeeeeceaeeeseesaeeseaeeeeeseeeteatend 2 12 Loading and unloading a syringe ccccceseeeeeeeeeseeeeeeeensneeeeeeenseeeeeeeenees 2 13 When to load the syringe 0 eeeceeeneeeeeeneeeeneeeeeneeeeeneeseaeeeeeaeeeseneeteneeeeseneeee 2 13 Syringe brand ANd SIZE erae aee aerae aaa aa Aa E aaa AAEE EAE EER sana
55. eeeeteteeeeeeeeeeeeeee 3 2 PCA infusion features rinsi enat E EA T e 3 3 Selecting a PCA protocol assitatu es iaia e cane eee ne 3 4 Reviewing settings and starting the infusion s sssseseeseriesessrirerrrerrrrsrrresnes 3 5 PCA TotaliSe ny scjsc cca ccese cock ctu ep entvet ected ea seats ae ta Taaa a ae aeaa enters te raataa 3 6 How to view and reset the cumulative total cece eee eee eeee eee eeees 3 6 Hourly total and Shift total nsss esiaine 3 8 Purging the Ne siceccccccseceteccccececteccece ec ctseeened esd cceeasc edeveteesessseseentesseeenseesis 3 10 Occlusion pressure and alarms scccsseeeeeseeseeeeeeseeeesseeeeeeeeeensneeeeneees 3 11 How to set or change the occlusion alarm level ccccccccceeeeeeeeeeeeeeeeeeees 3 12 Monitoring the pressure 0 eeeeeeseeeeeneeeeseeeeeeeeeeeaeeeseneeeseaeeeeeaeeeseaeeeseneeeeeaes 3 12 Using the Omnifuse Sleep mode ccssccssseceeeeeeeseseeeeseeeeesseeseeseeeeeeeees 3 13 Using SLEEP mode ieioea eea an ated 3 13 While the pump iS asleep 0 eee eeeeeeeeneeeeeaeeeeeneeeeeaeeeeeneeteeeeensaeeeseneeeseaeees 3 13 Waking the pump tUp sex hiis 2b tr hee ees Peles tia Me aati ana EEE wtih 3 14 Giving a clinician Override bolus cccescccesteeeeeeeeeeseseeeneeeeeseeeeeeneeeeeneas 3 15 PCA Infusion Graph features ccseccccsecessseeseseeeeeseeeseeeneeeesseeseeneeeeeseees 3 17 Graph ICONS kriste ad Aa a ee LR es 3 17 Graph annotation yet tence eer ndtes
56. eel If the relevant hotspot is not highlighted turn the Command wheel to highlight it then press the Command wheel When you press the wheel the pump will carry out the command In this example if you press the Command wheel with SKIP highlighted the pump will skip the syringe load process Icons on the pump screen This example screen shows where the Omnifuse screen icons may appear during an infusion PCA Bolus Dose 1 0 mg aH PURGE SLEEP REWTEW There are additional icons that appear on graph screens The table on page 2 10 explains all the icons that may appear Omnifuse PCA Instruction Manual Omnifuse screen icons and indicators Graseby Medical Ltd Screen icons Icon Name Description B Info Displays settings and parameters for the current infusion Help Displays a screen of help information relating to the current state of the pump nm Occlusion Level The position of the vertical line shows the level at which the occlusion alarm pressure has been set from Level 1 on the left to Level 5 on the right When the pump is running the icon fills from left to right to show the current pressure You use this icon to change the alarm pressure level see How to set or change the occlusion alarm level page 3 12 M Battery level This is displayed as a static icon when the pump is running on batteries or as a flashing icon when the pump is con
57. emove the syringe from the trough INFUSION SUSPENDED Please close the barrel clamr To discontinue unloading If you did not intend to unload the syringe 1 At Step 5 above turn the Command wheel to select NO The pump asks you to close the barrel clamp 2 Close the barrel clamp close and relock the cover Press Start to resume the infusion Please read Warnings and Cautions concerning syringes on page 2 15 Omnifuse PCA Instruction Manual 2 17 Loading and unloading a syringe Graseby Medical Ltd How to change the brand of syringe If the syringe brand and size displayed are not correct when you load the syringe follow the steps shown here PUMP STOPPED Syringe size and brand eee eae 20m Press wheel to change selection CONFIRM Use wheel to select syringe brand FRESENIUS INS PUMPJET JMS MONOJECT NIPRO PUMP STOPPED Syringe size and brand JMS 20ml Please CONFIRM or change PUMP STOPPED PRESS LOAD KEY Press and hold LOAD key PUMP STOPPED SYRINGE LOADING Keer LOAD key Pressed PUMP STOPPED SYRINGE LOADED Please release LOAD key Turn the Command wheel to highlight the syringe brand then press the Command wheel to change the selection The screen shows a menu of syringe brands Turn the wheel to highlight the correct brand then press the Command wheel to select it When the
58. eriod includes four syringe load unload cycles To ensure that the batteries perform as specified they must always be fully charged The batteries must not be left partially charged for extended periods for example when the pump is in store 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 2 8 Omnifuse PCA Instruction Manual Graseby Medical Ltd Omnifuse screen icons and indicators Omnifuse screen icons and indicators Moving around the screen To move around on the screen you turn the Command wheel in either direction The highlighting shows you where you are PUMP STOPPED LOAD SYRINGE Or press SKIP to load syringe later Message line Hotspot Icon As well as the main command on the screen you can see The message line Hotspots Icons Message line This gives you more details about the command on the screen or shows the status of the infusion or shows you a warning or alarm message reminder Hotspots A hotspot is an action word on the bottom line of the screen The hotspots you can see are relevant to whatever the pump is doing The most common hotspot is CONFIRM In many cases the hotspot you need is automatically highlighted on the screen so you can just press the Command wh
59. es see Using the pump on batteries page 2 7 Switching on and power up tests To switch on press On Off The initial screen shows GRASEBY omnifuse pca The pump continues with its self test PERFORMING SELF TEST PUMP SZH l234567 SZU VERSION 8 3 8 0 PUMP ID 5620456 LOCATION PRIMROSE WARD The Pump ID and Location shown on this screen are set up in the Technician menu described in the Omnifuse PCA Technical User Manual 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 Service due message The pump checks its service due date at the end of the power up tests If a service is due you will see a message for example SERVICE DUE NOW Please contact vour local Service Derartuent mr The pump can still be used To continue with your setup simply press the Command wheel If however you wish the pump to be serviced switch off The pump will display the service due message when you next switch it on Faulty pump If the pump discovers a fault during the power up tests it displays a message Do not use the pump but return it to a qualified service engineer For more details see Troubleshooting Chapter 4 WARNING Do not use a faulty pump If the pump detects a fault a continuous alarm will sound and the screen will dis
60. ese warnings are displayed on the screen for three seconds You must follow the instructions on the screen before you can start the infusion For example if an infusion is suspended and you press the Start the pump displays this message OPEN CLOSE COVER The cover must be opened and closed before the infusion can be restarted After three seconds this screen is replaced and the message line displays a short warning message STANDARD ADULT PEL SUSPENDED ren and close cover before restarting C BOLUS GRAPH CHART HISTORY Short warning message If the pump displays a warning 1 Read the message 2 Carry out the action suggested on the screen Omnifuse PCA Instruction Manual Graseby Medical Ltd Introduction How to handle System faults The pump carries out a self test when it is switched on and continually monitors all internal components while it is in use If it detects an error with one of the components the pump sounds a continuous alarm and displays a System Fault screen with a fault number and a message for example SYSTEM FAULT 23 OST Keyboard failure Please do not use the Pume Turn the Pume off and return it for servicing If the pump displays a system fault with a number 1 The Alarm Silence key has no effect You must switch off the pump to silence the alarm You do not need to note the fault number since this will
61. fuse PCA Technical User Manual PASSWORD The entered password isthe Only appears when the ERROR same as one of the other technician is configuring the passwords All passwords pump see Omnifuse PCA must be different Please Technical User Manual enter another password PASSWORD Entered passwords do not Only appears when the MISMATCH match The password has technician is configuring the not been changed pump see Omnifuse PCA Technical User Manual POWER Handset POWER failure The pump must be checked by a FAILURE has been detected The qualified technician infusion has not been started The failure may indicate a cable connector fault PROTOCOL An error occurred whilst You should consider having the ERROR trying to load the selected pump checked by a technician protocol Please select since all protocols available another protocol or select should load successfully USER PROGRAMMED if that is available fe S RATE The default bolus rate has The maximum bolus rate is D REDUCED been reduced to the restricted by the size of the 72 maximum allowed by the loaded syringe If the maximum z loaded syringe and bolus rate is not suitable for the o configured maximum bolus prescription you must use a 5 rate larger syringe Q 4 10 Omnifuse PCA Instruction Manual Graseby Medical Ltd Warnings Error message On screen information Action RATE INVALID The background rate entered is too high for the Check the
62. h 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 correct 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
63. he rate and size of the dose and the lockout time between doses depends on the drug protocol or programmed infusion in use on the pump The pump s maximum PCA bolus rate is 800 ml h In addition to the PCA bolus the Omnifuse PCA can be configured to offer a Clinician Bolus You need to use a special password to access this feature which overrides the PCA lockout time The dose and rate for the clinician bolus shown on the screen are the same as the PCA bolus but can be altered if necessary before giving the bolus The PCA pump can also be programmed to deliver a loading dose when required Charts Pain nausea and sedation scoring You can use the Omnifuse PCA to collect patient monitoring scores regarding pain nausea and sedation This information can then be viewed as a chart on the screen or transferred to a PC for viewing Protocols The Protocol feature is an integral part of the Omnifuse PCA It ensures the safe programming and use of the Omnifuse for a PCA environment Before the pump is used the hospital community protocols relevant to the clinical area can be configured in the pump This is done using the Omnifuse Drug Protocol Management System Depending on the clinical area there may be just one protocol reflecting a specific drug regime or there may be a choice of protocols For example a protocol can be loaded into the pump so it can be used for the administration of 1 mg of analgesia with a l
64. i ea 2 14 Replacing a syringe during an infusion ssessesseerieerrrseirssrrrsrireerrrerinnsrrnens 2 14 Warnings and Cautions Concerning Syringes essesseeeeeeeereerrsereereerrerrsns 2 15 Howto load a Syringe ssnstinin nnr n n E E 2 16 Howto unload a Syringe sen soiien a ata andthe 2 17 How to change the brand of syringe eee eeseseeenseeeeneeeeeneeeseneeeeenaeerenneereaeees 2 18 Care and Maintenance s cccesseeeseeeeeeeeeeeseeeeeneeeeeeneaeseseeeeeeseesesneeeeeenes 2 19 Carrying the PUMP atens nann uprana a e eie ed e ain 2 19 Positioning the pump for use ooo eeeeeeceeeeeeeeeeeeeeeeeeeeeeeeeeeeaeeeeeeseaeesieeteeeeeaeesas 2 19 Using the pole clamp isscicsseciesicccesed a aa aaraa e dE aa aa aaia 2 20 Omnifuse PCA Instruction Manual i U9 U09 Graseby Medical Ltd Locking pole claMp ssi aciee aati add caved ae ere ee 2 20 Cleaning and care Of the PUMP eceeeeeeeeeeeeeeeeteeeeeaeeeeeeteaeeeeeseeeeeaeeeeaeeeaees 2 21 Removing and replacing the lockable cover eseeeeeeeeseeeeeneeeteneeteenntereaes 2 22 Chapter 3 PCA Programming Programming the Omnifuse PCA cc ccssseeeseeeeeeeesesnneeeeeeeeeenneeeneeees 3 1 Programming with Protocols ecceeesceeeeseeeeeneeeeeneeeseneeeeeseeeesaeeeeneeeeseaeeteaes 3 1 Programming without Protocols eee eeseeeeeneeeeeneeeteneeeeeseeeseneeseneeeeeneteneaes 3 1 Overview of how the pump works with a protocol eeeeeceee
65. ime and Rate Press the Command wheel to accept 9 Enter the Lockout Period and press the Command wheel to accept 10 Select the Dose Limit period Scroll the screen to see all the options from 1 hour to 8 hours Highlight the period required and press the Command wheel to accept Omnifuse PCA Instruction Manual to l E E 5 e i a lt 6 a d V d oO Ke o 3 E gt Ko User Programmed infusions User Programmed Dose Limit 38mg Press wheel to accept value PGi User Programmed Dose Limit Demand s gt Press wheel to accept value FEL User Programmed Background Rate ma h Infusion Rate ml h Press wheel to accept value P Gi 11 12 Graseby Medical Ltd Enter the total Dose Limit within the period specified This is the total amount of the drug that may be administered including PCA bolus doses any Clinician Bolus or Loading Dose and continuous background infusion if there is one Alternatively the pump may be configured so you enter the Dose Limit as a number of demandes that are allowed over the infusion Enter the Background Rate which can be left at 0 0 This is the final parameter When you press the Command wheel the pump will display the Review screen 3 28 Omnifuse PCA Instruction Manual Graseby Medical Ltd User Programmed infusions Reviewing User Programmed se
66. in greater detail by zooming in on it as described below Example PCA infusion profile graph This example shows the graphics icons PCA bolus and clinician bolus doses that appear on an infusion profile graph mg i 1 2 4 B Cc H Pas aa 13 00 i4ioo 15 00 16100 The icons are described in the table below all other items are described in Graph annotation page 3 18 Graph icons To allow more room for the graph all the hotspots have been turned into icons Icon Name Description i Info Displays settings and parameters for the current infusion Help Displays a screen of help information relating to the current state of the pump a Hold Select to hold the screen display for one minute While the screen is on hold the icon changes to the Return icon below Return This is displayed when the pump is holding the Graph screen Select this icon to return to the running screen or previous graph screen You can also use it to return to the full profile when you have zoomed in on a particular hour of a long infusion Eri Zoom This is displayed during infusions longer than one hour when the graph display can be zoomed to show more detail for a particular hour Use the Return icon to go back to the full profile Omnifuse PCA Instruction Manual 3 17 e z E g D i a lt a d V d Ke o 3 3 gt Ko PCA Infusion Graph features
67. ll details on how to lock the occlusion alarm level see the Omnifuse PCA Technical User Manual Note If necessary the pump raises the occlusion alarm level temporarily during a Patient PCA or Clinician bolus to avoid a nuisance occlusion alarm At the end of the bolus the alarm level automatically returns to the selected level To find out how to change the occlusion level and monitor the occlusion pressure during an infusion see page 3 12 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 patient injury or death Omnifuse PCA Instruction Manual 3 11 e z E g D ti lt Occlusion pressure and alarms Graseby Medical Ltd How to set or change the occlusion alarm level You can only set or change the occlusion alarm level if the cover is open 1 Ifthe PCA infusion has started press Stop to suspend it then unlock and open the cover Please Select Ocolusion Level 2 Turn the Command wheel to LEVEL 1 188 mmHg highlight the pressure icon L and press the Command wheel to LEVEL 4 756 mmHg display the Occlusion Level menu LEVEL 5 1258 mmHg Current Pressure reading 2 2 Please
68. ll feel a positive click Command wheel 9 2 ee z 90000 POOR On Off yy Start key Stop key Keypad Next to the Command wheel is the keypad where you will find the On Off key Start key Green Stop key Red The numeric keypad is for entering numbers It includes a Cancel key and Decimal point key On the right of the keypad is Alarm Silence key Red Syringe Load key Blue wi LED Decimal point key Graseby Medical Ltd keypad and LEDs Turn the wheel in either direction to highlight items on the screen such as hotspots Press the wheel to select accept or confirm the parameters or action wa LED Alarm LED Alarm Silence key Syringe Load Cancel key GM151 4002GB A LEDs The pump has three LEDs Infusion LED This is green or amber It is lit or flashes when an infusion is running For full details see Pump indicators page 2 11 Mains LED This is yellow It is lit when the pump is connected to the AC mains supply and goes out if the pump is operating on batteries Alarm LED This flashes red when the pump is sounding the alarm Omnifuse PCA Instruction Manual Graseby Medical Ltd Switching the pump on and off Switching the pump on and off Before you switch the pump on visually check for damage to any part of the pump or its connectors Plug it in to an AC mains supply if possible If necessary the pump can be run on its internal batteri
69. lp Please remove cause of occlusion and re start POWER Handset POWER failure hasbeen HANDSET POWER FAILURE detected This may indicate a FAILURE faulty POWER supply or the POWER line itself is faulty SYRINGE The infusion has been suspended SYRINGE EMPTY See EMPTY Please load a new syringe or end Help this infusion SYRINGE The syringe has been disturbed SYRINGE TAMPERING TAMPERING Open and close the barrel clamp DETECTED then try loading the syringe again SWITCH The handset switch has been HANDSET SWITCH FAILURE pressed for longer than 30 PRESSED FOR TOO seconds This may indicate a LONG problem with the switch The infusion has been suspended Le fo N 2 2 gt fe t Omnifuse PCA Instruction Manual 4 5 fe D 2 gt fe fe gt Q Warnings Graseby Medical Ltd Warnings There are two lists of warnings in this section One off warnings and Repeated warnings For more information these types of warning and details on what to do if the pump displays a warning see How to handle Warnings page 4 2 One off warnings Error message On screen information Action ALARM STATE The previous alarm has not When this warning message been cleared Clear alarm disappears from the screen read condition press ALARM the short message line It will tell SILENCE or press STOPas you the alarm stat
70. luding pole S clamp S Orientation Horizontal either mounted on a pole or flat on a Di stable horizontal surface 7p 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 More than 12 months Operating temperature 5 to 40 C Storage temperature 20 to 55 C Relative humidity 20 to 90 non condensing Atmospheric pressure 700 1060 millibars Options Locking pole clamp Alarm volume Louder than 65 dBA at 1 metre at maximum volume Power supply AC power supply 100 240 V at 50 60 Hz 50 W Battery type Set of three Cyclon sealed lead acid batteries Battery operating time 10 hours at 5 ml h Battery charge time 10 hours Backup battery Single 3 V Lithium battery Omnifuse PCA Pump Specification 1 Specificatioins Graseby Medical Ltd Infusion flow rates Range 0 1 to 800 ml h dependent on syringe size Accuracy 2 not including syringe variability 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 w D fa y 9 S faj 5 Bolus accuracy 5 with a Braun Omnifix 50 ml syringe and 150 cm extension set measured over 25 1ml boluses KVO rate Between 0 05 ml h and 2 ml h Pu
71. mnistack powered from a single mains inlet The Omnistack can be clamped to the Graseby wheelbase or to a suitable pylon The Omnistack must not be used with a standard IV pole For full details on how to use the Omnistack see the Omnistack Instruction Manual The part numbers for the Omnistack stacking system are listed in the Accessories section of the Specification at the back of this manual Note An Omnifuse PCA pump fitted with the optional Locking Pole Clamp cannot be mounted in an Omnistack stacking system Omnifuse PCA Instruction Manual 1 5 c 2 S m xe ie i 5 Omnistack pump stacking system Graseby Medical Ltd 5 ie Q p oO gt Omnifuse PCA Instruction Manual Chapter 2 Basics Page Parts of the Omnifuse PCA pump 1 Switching the pump on and off 5 Omnifuse screen icons and indicators 9 Loading and unloading a syringe 13 Care and Maintenance 19 Graseby Medical Ltd Parts of the Omnifuse PCA pump Parts of the Omnifuse PCA pump Rear of the pump AC mains connector Pole PCA socket clamp Used to connect Optical interface port Carrying handle PCA handset between arms of pole clamp Used to carry pump RS232 port safely with one hand Used to connect GM151 4303GB A to a computer Lockable cover The PCA pump is fitted with a lockable If an infusion is started then suspended cover which must be opened using a key the
72. nected to the AC mains supply and the batteries are charging m Hold Graph This appears when the pump is displaying the Graph screen Select this icon to hold the screen While the screen is on hold the icon changes to the return icon shown below Return Graph This is displayed when the pump is holding the Graph screen Select this icon to return to the running screen or previous graph screen EFi Zoom Graph This is displayed during long infusions when the graph display can be zoomed to show more detail for a particular hour 2 10 Omnifuse PCA Instruction Manual Graseby Medical Ltd Pump indicators There are three LEDs or indicators on the front of the pump positioned above the numeric keypad Mains indicator Infusion indicator Alarm indicator Seen 2 e000 g Infusion indicator The Infusion indicator shows whether or not the pump is infusing and changes colour when the syringe is nearly empty See details in the table below Infusion LED Shows Flashing Medication being delivered Slow Pump on Standby after flashing delivering a dose Steady Infusion suspended Stop key was pressed LED Colour Shows Green Syringe is full Amber Syringe is nearly empty Omnifuse screen icons and indicators Mains indicator The yellow Mains indicator is lit when the pump is connected to the AC mains supply Alarm indicator The re
73. ng in patient injury or death The purge rate is set by a technician in the range 50 800 ml h Details of how to do this are in the Omnifuse PCA Technical User Manual 1 Highlight the PURGE hotspot and press the Command wheel 2 The pump displays a warning to ensure that the line is not connected to the patient The PURGE hotspot is highlighted Press and hold the Command wheel to purge the line 3 As the pump purges the volume that has been purged through the line will be displayed You may release the Command wheel at any time and the purge will stop The pump automatically stops purging when it reaches 2 ml on the screen 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 3 10 Omnifuse PCA Instruction Manual Graseby Medical Ltd Occlusion pressure and alarms Occlusion pressure and alarms Infusion pressure is detected by a sensor inside the pusher block as it presses against the syringe plunger The actual pressure in the infusion line depends on a number of factors such as the viscosity of the liquid the stiction of the syringe plunger the bore of the line and the height of the pump relative to the patient These variables mean that the pressure
74. nge Select the Dose units and press the Command wheel to accept When you press the Command wheel to accept you move on to the next step Select the Drug concentration units and press the Command wheel to accept Enter the Drug concentration using the numeric keypad or the Command wheel and press the Command wheel to accept Enter the Loading Dose and press the Command wheel to accept 3 26 Omnifuse PCA Instruction Manual Graseby Medical Ltd Lockout Period BB 85 hh mm Press wheel to accert value User Programmed el A Dose P Gla ma ar 1 8m13 Press wheel to accert value User Programmed bose Tine Rate PLL mmi SS 208 mlh Fress wheel to accert value User Programmed PCA Dose Time Rate ai 0 18 mmiss 264 mlh Please CONFIRM tor change User Programmed PLL Select Dose Limit Period 2 Hours 3 Hours 4 Hours 5 Hours Select Dose Limit Period 4 Hours 5 Hours 6 Hours t Hours User Programmed infusions 6 Enter the PCA Bolus Dose and press the Command wheel to accept You do not see the next two screens if the PCA Dose Duration is set to STAT For full details see the Configuration Menu section in the Omnifuse PCA Technical User Manual 7 Enter the rate for the PCA bolus by entering the PCA Dose Time As you adjust the time the rate is altered automatically Press the Command wheel to accept 8 Confirm the PCA Dose T
75. nge page 2 18 Press and hold the blue Load key G Keep positive pressure on the Load key 4 while the screen shows this message Release the Load key when the the pump beeps and displays this message The pump will display the next screen in the programming sequence Please read Warnings and Cautions concerning syringes on page 2 15 2 16 Omnifuse PCA Instruction Manual Graseby Medical Ltd Loading and unloading a syringe How to unload a syringe If the pump is switched off with a syringe still in place you do not need to turn it on lift the barrel clamp and gently remove the syringe from the trough INFUSION SUSPENDED UNLOAD SYRINGE WES NO INFUSION SUSPENDED REMOVE SYRINGE If the pump is switched on the infusion must be suspended or the pump must be stopped before you try to unload a syringe 1 Press Stop If you press the key briefly the screen displays SUSPENDED or if you press and hold Stop PUMP STOPPED 2 Ifinfusate is still present in the syringe clamp the patient line before proceeding 3 Unlock and open the cover 4 Lift up the barrel clamp by hand The pump recognises that you have lifted the clamp and asks you to confirm that you wish to remove the syringe 5 Confirm YES by pressing the Command wheel The pusher will automatically release the syringe plunger and retract 6 When you see this message r
76. nifix Braun Perfusor Codan Faulding Pharmaject Fresenius Injectomat IMS Pumpjet JMS Monoject Nipro Terumo TOP Zeneca PFS Pre filled syringe Note The syringes shown 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 50m1 Symbols Symbol Meaning y Identifies the Potential Equalisation Terminal located on the body of 4 the pole clamp The applied part is Type CF The pump should be operated from an AC power source Omnifuse PCA Pump Specification 7 2 x D fa O S oO 5 Standards Standards Graseby Medical Ltd Electrical iy safety Classified as Internally Powered Equipment Class 1 Type CF insulation on all inputs Fluid ingress protection IPX4 Splash proof 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
77. ns The pump has an RS232 serial cable connector with PC interface protocol This is used for configuring the pump from a PC used to transfer the pump history to a PC and is also used to control the pump externally PC software options With a PC linked to the pump by RS232 cable you can transfer information between the pump and PC Two software packages are available on CD ROM from Graseby Medical Ltd for use with the Omnifuse PCA pump Omnifuse Drug Protocol Management System The Protocol support software package is used to design and create Protocols and download them for use on the Omnifuse PCA Graseby Omnifuse Technician PC Software This software package is required for technical maintenance and servicing an Omnifuse PCA pump as well as pump configuration The Technician PC software is used to e Perform service tests and calibration on the pump Set parameters and enable or disable options that would otherwise be changed using the pump s own Configuration menu Download and examine the pump s history database Keep a service database for pumps Store configurations and settings from the pump and restore them later Omnifuse PCA Instruction Manual Graseby Medical Ltd Omnistack pump stacking system Omnistack pump stacking system The Omnistack is a multi pump stacking system designed for mounting Omnifuse syringe pumps Up to four Omnifuse pumps can be mounted on an O
78. ntents 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 For safe operation of the pump the syringe must 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 CAUTION Do not attempt to move the pump s pusher by hand Always use the syringe Load key to move the pusher Failure to observe this caution may cause mechanical damage to the pump How to load a syringe page 2 16 How to unload a syringe page 2 17 e How to change the brand of syringe page 2 18 WARNING The supported syringes are single use only and the administration set should be changed according to the manufacturers instructions A new syringe and administration set must be used for a new patient Failure to observe this warning may lead to compromised performance of the pump resulting in patient injury or death 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 me
79. ockout time of 5 minutes When the pump is switched on for use this protocol will be available and all the user in the clinical area needs to do to set up the pump for a patient is to load the syringe select the protocol and confirm the parameters displayed on the screen c 2 gt So ie The Omnifuse PCA can also offer a User Programmed option to enable the pain specialist to enter one off infusion settings suitable for a particular patient Omnifuse PCA Instruction Manual gt fe 2 oO 5 Introduction to the Omnifuse PCA Graseby Medical Ltd Mass Units The Omnifuse PCA can be set up to allow the clinical user to enter a dose of medication expressed as a mass rather than a volume to be infused over a period of time Graphics The pump can display a graph to show the profile of the infusion the pain nausea and sedation scores entered for the patient Locking pole clamp An optional locking pole clamp can be used with the Omnifuse PCA Once locked onto an IV pole the pump can only be moved by an authorised person with a key Power The Omnifuse PCA is normally run from the AC mains supply However it switches automatically to internal rechargeable batteries in the event of a power cut or if it is disconnected from the mains On fully charged batteries the pump may be run for up to 10 hours depending on the infusion rate External communicatio
80. offer a Clinician bolus facility which is accessed using a password This can be used to override the lock out period and give a specified dose before the next PCA Patient bolus is available For details on how to give a Clinician bolus see page 3 15 Charting and Graphs During an infusion details of the patient s pain nausea and sedation scores can be collected and stored on the pump The information can then be viewed as a graph on the screen e For details on how to record the patient s scores see page 3 21 For details on how to view the patient s pain nausea and sedation data on a graph see page 3 23 Omnifuse PCA Instruction Manual D S D LS ou lt O ou d V d fe Ke o 3 E gt co Programming the Omnifuse PCA Graseby Medical Ltd Selecting a PCA protocol The protocols available on the pump have been set up for the clinical environment so you can choose one that is suitable for your patient Select protocol or USER PROGRAMMED USER PROGRAMMED STANDARD ADULT Note This menu is only shown on pumps that have been set up with protocols You do not see this screen on pumps that have been set up without protocols see Programming without protocols page 3 1 The screen here shows an example of how a previously named protocol may used 1 Switch on the pump and load the syringe see Basics Chapter 2 As soon as th
81. ogram a pump while the patient is in theatre so it is ready to use when the patient arrives in the recovery area In this case you should program the pump then use the Omnifuse s special SLEEP mode In this mode the pump can be left switched on and ready to start when required Using SLEEP mode To put the pump into sleep mode STANDARD ADULT PCA Bolus Dose 1 0 mg Press wheel to select SLEEP mode PURGE REWTEW TOTAL ASLEEP 1 Program the infusion and confirm all the infusion parameters The Infusion Start screen will display the SLEEP hotspot Turn the Command wheel to highlight SLEEP 2 Press the Command wheel The pump displays this message The pump will stay ASLEEP until you press the Command wheel to wake it up see page 3 14 While the pump is asleep While it is asleep the pump does not sound the Not Infusing alarm All the other alarms for example the low battery alarm or syringe tampering alarm will still sound to warn you about conditions on the pump You can load or change a syringe when the pump is asleep without waking it up for example if the syringe is not available but you want to set the pump up The screen shows the usual syringe loading messages then displays the ASLEEP screen once the loading is completed Omnifuse PCA Instruction Manual 3 13 e E E ie 5 fe j ou lt x 6 ou d V d E e Q o 3
82. p is locked in place on a pole it can only be moved by an authorised person who has the pole clamp key 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 operator or the patient As a result the operator or patient may suffer direct injury or the Omnifuse pump may fail to operate correctly leading to patient injury or death 2 20 Omnifuse PCA Instruction Manual Graseby Medical Ltd Care and Maintenance Cleaning and care of the pump Cleaning the pump The Omnifuse pump is designed to be water resistant against accidental spillages but not waterproof You should therefore clean the casing and outer surfaces of the pump using a damp cloth or if necessary a cloth dampened with a mild solution of washing up liquid Clean the pump as follows 1 Remove the lockable cover as described on page 2 22 and clean the cover 2 Wipe over the exterior surfaces of the pump paying particular attention to the barrel clamp and the syringe ear slot To clean beneath the syringe pusher block switch on the pump and load an empty syringe so that the block moves left 3 When cleaning is complete di
83. play 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 Omnifuse PCA Instruction Manual Switching the pump on and off Power up tests completed When the power up tests are complete the screen shows the first of the syringe loading instructions For example PUMP STOPPED LOAD SYRINGE r Press SKIP to load syringe later The pump is now ready for you to load the syringe as described on page 2 13 Graseby Medical Ltd Switching off Before you can switch off the pump must be stopped If an infusion is running Press and hold the Stop key The screen displays PUMP STOPPED To switch off the pump Press the On Off key and hold it down for two seconds As the pump switches off the screen displays Switching off Please waiter Ensure that the mains surely is connected and switched on to keer batteries fully charged Ensure that the pump is connected to the AC mains to keep the batteries charged and ready for use next time Omnifuse PCA Instruction Manual Graseby Medical Ltd Switching the pump on and off Using the pump on batteries In everyday use the Omnifuse pump should be connected to a suitable AC mains supply not used on batteries Thi
84. r 1 ma 1 m1 gt 1 demands 1 good Since 22 68 03702703 PREVIOUS TOTAL Total delivered this shift 3 Bma 3 Gm1 gt 3 demands 3 good Since 20 68 03702703 PREVIOUS TOTAL They are accessed from the THIS HOUR and THIS SHIFT hotspots on the Cumulative Total screen Note The Hourly totals are always available but Shift Totals can be turned off on a pump In this case the SHIFT TOTAL hotspot does not appear on the Cumulative total screen See the Omnifuse PCA Technical User Manual 1 On the Cumulative total screen turn the Command wheel to highlight THIS HOUR or THIS SHIFT then press the Command wheel THIS HOUR displays a screen showing the total infused in the current hour THIS SHIFT shows the total delivered since the start of this shift For longer infusions you will see a PREVIOUS hotspot You can add together THIS HOUR or THIS SHIFT and PREVIOUS figures to find out the total volume infused since the start of the infusion see next page 2 To return to the Cumulative total screen highlight TOTAL and press the Command wheel To go back to the ON STANDBY or running screen leave the keypad untouched for a few moments Omnifuse PCA Instruction Manual Graseby Medical Ltd PCA Totaliser Understanding the hourly total To understand THIS HOUR and PREVIOUS totals look at this diagram 10 00 PREVIOUS THIS HOUR Start time Time now 9 45 10 15 If you pressed St
85. ramming ranges by infusion unit Background Rate set when PCA Bolus dose is zero Unit Range Increment ml h 0 1 to 800 0 1 up to 100 1 above 100 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 Infusion pressure Maximuminfusion Note pressure 1250 mmHg 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 Specification 4 Omnifuse PCA Pump Graseby Medical Ltd Specificatioins Occlusion sensing pressure levels Approximate S pressure Alarm level Note 180 mmHg Level 1 These values are approximate and are lt 300 mmHg Levet the pressure at the front face of the Oo syringe plunger The values also assume Di 500 mmHg Level 3 an ideal syringe with no stiction and a 7p 750 mmHg Level 4 low infusion rate 1250 mmHg Level 5 Occlusion sensing time to occlusion Alarm level and Number of minutes Bolus on occlusion release infusion rate to occlusion Level 1 1 ml h 15 Less than 0 1 ml Level 1 5mlh 2 5 Level 5 1ml h More than 100 Less than 1 0 ml Level 5 5mlh 21 Note Values are approximate and are determined using the method described in EN 60601 2 24 clause 51 6b using a Monoject 50 ml syringe and
86. rescription to The infusion has been see if Dose Limit has been suspended Stop infusion to entered correctly End infusion clear alarm condition reprogram and restart DOSE INVALID The derived dose volume is Check the settings you have too high low The maximum programmed against the minimum dose allowed is _ patient s prescription DRUG MASS The drug mass is too high Check the settings you have INVALID low The Maximum programmed against the minimum drug mass patient s prescription allowed is _ DRUG VOL The drug volume is too high Check the settings you have INVALID low The Maximum programmed against the minimum drug volume patient s prescription allowed is _ DURATION The lockout period is too Check the prescription and re INVALID long short The maximum enter the lockout period dose or minimum allowed is _ bolus duration The infusion dose or bolus duration is too short long The minimum maximum duration allowed is _ EAR NOT The syringe ear has notbeen Load the syringe again and place CLAMPED clamped Please reload the the syringe ear or flange in the syringe checking the syringe ear slot syringe ear is correctly located FIXED This parameter or the You cannot change the selected PROTOCOL whole protocol is fixed and parameter in this protocol cannot be altered Accept this protocol parameter as it is select a different protocol or choose USER PROGRAMMED Omnifuse PCA Instruction Manual D E
87. rest and pain on movement or one combined line depending on how you recorded pain scores Nausea and Sedation are plotted as two lines on the chart if you select the Nausea sedation graph On both charts when the score is recorded as patient is asleep the chart shows a thick horizontal line On the Pain and Nausea Sedation graphs you can select the Zoom icon 4 to display the Zoom window Use this to define a period you wish to view in more detail The zoom feature works as described for the Infusion Profile graph described on page 3 19 Omnifuse PCA Instruction Manual to E E i 5 fe i ou lt x 6 ou User Programmed infusions Graseby Medical Ltd User Programmed infusions The Omnifuse PCA pump can be used for a variety of PCA infusions which are normally set up in the pump as Protocols The pump can also be set up to display the programming steps instead of using a pre defined protocol If the pump has been set up for use If you program an infusion this way you cannot save the settings as a named protocol to appear on the menu To save a named protocol in the pump you must use the Omnifuse Drug Protocol Management System see the Omnifuse PCA Technical User Manual An example showing all the screens without any protocols or if you choose the USER PROGRAMMED option from the Protocol menu you can enter a User Programmed infusion available in a user progr
88. rge 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 Specification 2 Omnifuse PCA Pump Graseby Medical Ltd Programming ranges PCA Bolus programming ranges by infusion unit Specificatioins Unit Range Increment ml 0 1 to 99 9 0 1 mg kg 0 1 to 99 9 0 1 ug kg 0 1 to 999 0 1 up to 100 1 above 100 ng kg 0 1 to 999 0 1 up to 100 1 above 100 mg 0 1 to 99 9 0 1 ug 0 1 to 999 0 1 up to 100 1 above 100 ng 0 1 to 999 0 1 up to 100 1 above 100 Background infusion rate programming ranges by infusion unit Background Rate set and PCA Bolus dose not zero Unit Range Increment ml h 0 1 to 20 0 1 up to 100 1 above 100 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 Omnifuse PCA Pump Specification 3 c O Ez AS O 2 wn 2 ke D fa O S E fa 5 Specificatioins Graseby Medical Ltd Continuous infusion rate prog
89. s a numeric keypad for entry of data such as bolus dose An Infusion LED flashes to show that the pump is infusing and changes colour if the syringe nears empty A yellow LED is lit when the pump is connected to the AC mains supply While you program the pump and during an infusion the screen shows instructions on a message line Help and information icons lead to more detailed information Status icons show the battery level and occlusion pressure level A special feature lets you program the pump ready for an infusion then leave it asleep until it is needed The pump totaliser shows totals for the infusion and totals since last reset A shift totals feature is also available 1 2 Omnifuse PCA Instruction Manual Graseby Medical Ltd Introduction to the Omnifuse PCA Administration sets Graseby medical have a wide range of Flo Safer administration sets that may be used for specific infusion therapies These are listed in the Specification at the end of this manual Syringes On the Omnifuse PCA the syringe can be loaded as a one handed operation Syringes of 2 ml to 60 ml capacity can be used with the pump The syringe type and size are confirmed as the first step in programming an infusion The syringe types available on the pump s menu depend on which have been configured for use Bolus The Omnifuse PCA pump offers a PCA bolus activated by a press on the patient s handset T
90. s way the batteries are kept fully charged available for use in an emergency The yellow Mains LED is only lit when the pump is connected to the AC mains supply The battery icon is shown on the screen when the pump is running on batteries The battery icon is displayed when the pump is connected to the AC mains supply to show that the batteries are being charged When the batteries are charged the icon disappears Pump with patient in transit If a mains supply is unavailable for example if the pump is infusing a patient in transit you can start or continue an infusion with the pump running on batteries Mains lead retainer The mains lead is held in the pump with a retainer This is so that it cannot be pulled out accidentally CAUTION Failure to use the mains lead retainer means that the pump may be accidentally disconnected from the mains 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 Mains supply failure If the AC mains supply fails or if the pump is disconnected from the mains it automatically switches to its internal batteries If the pump is infusing the infusion continues without interruption This message is displayed AC MAINS FAILURE The mains Power surely has been disconnected The Pume is now running on battery The yellow Mains
91. se continuously The pump starts the background infusion as soon as you press Start and continues in between patient boluses If the patient requires a continuous infusion of analgesia for example because they cannot press the button on the handset this parameter can be used with the PCA Bolus dose set to zero If the PCA bolus dose is set to zero the background rate may be programmed up to 800 ml h depending on the size of the syringe see the Specification for details dD S d A lt 1S ou Omnifuse PCA Instruction Manual 3 25 d V d iL fa Q o 3 E 5 User Programmed infusions Graseby Medical Ltd User programming screens The following pages show all the available parameters that may appear in a user programming sequence Select Protocol or USER PROGRANNED USER PROGRAMMED STANDARD ADULT Please select dose units i na mgka Please select drug conc units User Programmed Drug Concentration P Du 1 8 ma m1 Press wheel to accert value User Programmed Loading Dose gnm 0 0 mg Dose B ml Press wheel to accert value If a Protocol menu is displayed select USER PROGRAMMED When you press the Command wheel the first user programmed parameter is displayed on the screen If no protocols are in use on the pump the Dose units screen is displayed once you have loaded the syri
92. setting you have made loaded syringe The for the Background infusion rate maximum rate allowed is _ against the patient s Phe device orentered prescription If this is correct infusion rate is too high low YU must use a larger syringe The screen indicates the max min rate allowed The bolus rate is too high low The maximum minimum allowed is _ SCORE The entered score is too Re enter the patient s pain INVALID high The maximum allowed sedation or nausea score within is _ the range displayed SWITCH Handset SWITCH failure The pump must be checked by a FAILURE has been detected The qualified technician infusion has not been started The failure may indicate a cable connector fault SYRINGE Syringe brands cannot be Only appears when a technician LOADED enabled or disabled whilst a configures the pump for use see syringe is loaded Unload Omnifuse PCA Technical User syringe first Manual TIME INVALID The entered time is invalid Enter the correct time using the Only times in the range 24 hour clock Remember to 00 00 to 24 00 may be enter 4 00 as 04 00 entered VOLUME The infusion volume is too Check the setting you have made INVALID high low The maximum against the patient s minimum volume allowed prescription is_ WEIGHT The patient weight is too Check the patient s weight INVALID high low The Maximum against the weight you have minimum patient weight allowed is _ entered Omnifuse PCA Instruction Manual
93. settings you have entered resulted in a rate that is too fast INVALID Please replace the syringe You must use a syringe of the SYRINGE same brand and size if you need to replace a syringe during an infusion INVALID TIME The bolus duration is Check the settings you have invalid Please adjust the bolus dose or rate entered for the bolus Re enter the infusion rate size of dose as the settings you have entered resulted in a duration that is too short or long Omnifuse PCA Instruction Manual Graseby Medical Ltd Warnings Error message On screen information Action KVO RATE The configured KVO rate is For your information only you do REDUCED greater than the infusion not need to take any action as the rate or the background rate automatic adjustment means the The KVO rate has been infusion will start reduced to an appropriate value LED FAILURE Handset LED failure has The pump must be checked by a been detected The infusion qualified technician has not been started The failure may indicate a faulty LED or a cable connector fault LOAD FAILED The syringe load sequence Check around the syringe and has failed Try load the pusher for any obstruction sequence again ensuring Remove and reload the syringe that the mechanism is not If the problem persists get the obstructed in any way pump checked by a qualified technician LOAD Try load sequence again The pump has sensed that
94. sinfect the pump using a suitable disinfectant solution and remove any disinfectant residue by wiping with a clean damp cloth 4 After cleaning and disinfection remove the syringe and replace the lockable cover 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 CAUTION Do not use cleaning and disinfecting agents other than the approved ones specified here Disinfectants Disinfect the casing of the pump either with a cloth dampened in a solution of sodium hypochlorite 0 2 or with alcohol wipes intended for disinfecting equipment A suitable disinfectant solution can be made by diluting sodium hypochlorite with water to give a solution of 0 1 available chlorine Preferably use a freshly made solution and do not use one which is more than 24 hours old Maintenance Other than cleaning and disinfection the Omnifuse pump requires no maintenance to be carried out at ward level In particular it does not require lubrication and indeed any lubricant containing an organic solvent may damage the plastic of the pump casing If you consider that the pump needs further attention after you have cleaned and disinfected it return it to a qualified engineer for servicing CAUTION The pump must not be immersed
95. tches the pump The patient presses the button to and can be distinguished from any other demand a PCA bolus dose cables The handset is supplied with a wrist strap Connection to pump You can connect the handset before or Sleeve on plug after switching the pump on To connect the handset to the pump Cable Push the plug on the cable firmly into the socket on the left hand side hi d of the pump Once correctly ug to connect j to pump connected the handset is locked in a was the socket SS To remove the handset from the pump Grasp the sleeve on the plug Pull gently to release the lock and disconnect the handset GM151 4308GB B Green light Patient demand button and handset light Button Around the button used by the patient to demand a PCA dose the handset has two LEDs that when lit give a green light The pump can be set to switch the light on and off in one of three ways The light is on when the PCA dose is available but goes off during the bolus and stays off during the lockout period On all the time so the handset is easy to locate even in the dark Off all the time awis1 4s00G8 A Omnifuse PCA Instruction Manual 2 3 Parts of the Omnifuse PCA pump The Command wheel Command wheel You enter commands into the pump with a multi function Command wheel You can turn the wheel freely either clockwise or counter clockwise If you press the wheel down you wi
96. the FAILURE ensuring that the syringe plunger is not where it mechanism is notobstructed should be Remove the syringe in any way and that the and check it Reload the syringe syringe has not been over filled LIMIT INVALID The Dose Limit value Check the prescription to find entered is too high low the dose limit specified for this Maximum minimum value patient and re enter is _ NO SYRINGE None of the standard Only appears when a technician syringe brands are enabled configures the pump for use see At least one should be Omnifuse PCA Technical User enabled Select and change Manual at least one brand to ENABLED NO RECORDS No history records exist Check the range of dates you FOUND between the dates specified have entered Please select alternative dates or exit history Omnifuse PCA Instruction Manual dD i fo fo N g 2 gt fe im Warnings Graseby Medical Ltd Error message On screen information Action OPEN CLOSE The cover must be opened After changing a setting open COVER and closed before the and shut the cover then press infusion can be restarted Start PASSWORD The Clinician Override Only appears when the CHANGE password has been changed technician is configuring the pump see Omnifuse PCA Technical User Manual PASSWORD The Configuration password Only appears when the CHANGE has been changed technician is configuring the pump see Omni
97. the error This is an example of an alarm screen OBSTRUCTION The syringe load unload has been stopped as an obstruction has been detected ease remove the obstruction and Press LOAD to recommence the load unload Lists of all alarms start on page 4 4and warnings start on page 4 6 How to handle Alarms The pump sounds the alarm for conditions that require immediate attention The LCD display flashes red and displays a message If a PCA infusion has been started it is suspended Examples of conditions causing an alarm are An operating problem for example an occlusion has been detected or the syringe is empty This is the Occlusion alarm screen OCCLUSION The infusion has been susrended Please remove cause of occlusion and re start An external problem has occurred for example the syringe load process has failed because the pusher has detected an obstruction See a full list of Alarm messages on page 4 4 If the pump sounds the alarm The screen always displays a message explaining what has caused the alarm 1 Read the message 2 Press Alarm Silence amp to silence the alarm and clear the message 3 Check the patient and clear the problem which caused the alarm 4 Restart the infusion Omnifuse PCA Instruction Manual Le fo fo L N A 2 gt fe fe pl 2 gt fe fe gt Q Introd
98. total is displayed on the message line when the pump is running and can be viewed or reset from the TOTAL hotspot To view the cumulative total at any time highlight the TOTAL hotspot and press the Command wheel You can reset the cumulative total Before you start the infusion for example if the programmed infusion is for a new patient as described in the steps below STANDARD ADULT PCA Bolus Dose 1 0 ma Close cover before starting infusion PURGE SLEEP REVIEW Total delivered since reset 1 8ma 18 m1 gt 14 demands 18 good Totals reset at 13 29 03702703 THIS HOUR THIS SHIFT RESET HOLD After the infusion has started In this case you must suspend the infusion and unlock and open the cover before following the steps below Close and lock the cover before you restart the infusion This example shows how to reset the totals if the pump is not infusing or if the infusion is suspended 1 On the Infusion Start screen highlight the TOTAL hotspot then press the Command wheel The Total delivered since the last reset is displayed The totals will be displayed on the screen for five seconds To view the total for longer highlight the HOLD hotspot and press the Command wheel Omnifuse PCA Instruction Manual Graseby Medical Ltd PCA Totaliser Total delivered since reset 18 0ma 1 m1 gt 18 demands 18 good Totals reset at 13 29 037 02 03
99. ttings User Programmed 1 86 mg ml 8 8 mg 1 4 ma PCA Dose Time BHI18 mmiss Lockout Period Beas hh mm Select item CONFIRM or Press Stor Drug Concentration Loading Dose PCA Bolus Dose User Programmed Dose Limit Period Dose Limit Background Rate 8 8 mah CONFIRM Select item CONFIRM or Press Stor User Programmed PCA Bolus Dose 1 0 m9 Close cover before starting infusion PURGE SLEEP REVIEW User Programmed P Loading Dose 1 0 m9 Close cover before starting infusion SLEEP REVIEW oH User Programmed Back9round Rate 0 5ml7h Close cover before starting infusion PURGE SLEEP REVIEW P al On the Review screen you can check the prescription Make any changes by highlighting a setting and pressing the Command wheel Turn the Command wheel to scroll through the parameters At the end of the parameters highlight CONFIRM and press the Command wheel The Infusion Start screen is displayed This will show the PCA Bolus Dose or the Loading Dose or the Background Rate Omnifuse PCA Instruction Manual to l E E 5 e i a lt 6 a d V d iL fa Q o 3 E 5 User Programmed infusions Graseby Medical Ltd Starting a User Programmed infusion Before starting the infusion you should carry out pre infusion checks as required Select TOTAL see page 3 6 Select PU
100. uction Graseby Medical Ltd How to handle Warnings Warnings are displayed for conditions that require attention but are not urgent problems The alarm does not sound instead the pump sounds a double beep If the PCA infusion has been started it continues There are two types of warning repeated and one off which are explained here A list of warnings starts on page 4 6 Repeated warnings The pump displays the error message and on screen information briefly then shows the running screen with the short message on the message line The error message and running screen alternate until you take action to resolve the warning condition For example if you leave the pump running on battery power and the batteries become depleted you will see the warning message LOW BATTERY The pume batteries are low Please connect PUMP to a mains SuPPly as soon as Possible After three seconds this screen is replaced with the running screen where the message line displays a short message STANDARD ADULT Poo DON STANDBY PCA Available now LOW BATTERY Connect to mains surrly C BOLUS GRAPH CHART k TOTAL Short warning message The message is repeated until you connect the pump to a mains supply or end the infusion and switch off One off warnings Warnings may be displayed while you are programming the PCA infusion or before the infusion is started or when it is suspended Th
101. uction e Ona stable horizontal surface such Manual for full details as a table where it cannot slide or slip The surface should be at least If the pump is fitted with a locking pole 500mm x 250mm to accommodate the clamp this must be used to secure it to an pump IV pole or Omnifuse PCA Instruction Manual 2 19 Care and Maintenance Graseby Medical Ltd Using the pole clamp The Omnifuse pump is fitted with a pole clamp designed to hold the pump at a 45 angle against an IV infusion pole GM151_2016GB D This angle makes it easy for you to read the screen and also gives you good access to the keypad and Command wheel To clamp the pump to an IV pole 1 Close and lock the cover Open the clamp screw so that the clamp is open wide enough to slip onto the pole 2 Hold the pump with both hands and position it with the pole between the jaws of the clamp 3 Supporting the pump underneath with one hand tighten the clamp screw with the other hand until the pump is securely fixed to the pole The rear of the pump looks like this with the pole clamp correctly fixed to a pole GM151_2025GB D Locking pole clamp The pump may be fitted with a locking pole clamp with its own key If so it must be used to secure the pump to an IV pole Note The Omnifuse PCA with locking pole clamp must be clamped to an IV stand It cannot be used on a flat surface or in an Omnistack Once the pum
102. uction Manual Chapter 3 PCA Programming Page Programming the Omnifuse PCA 1 PCA Totaliser 6 Purging the line 10 Occlusion pressure and alarms 11 Using the Omnifuse Sleep mode 13 Giving a clinician override bolus 15 PCA Infusion Graph features 17 PCA Charting 21 User Programmed infusions 24 Graseby Medical Ltd Programming the Omnifuse PCA Programming the Omnifuse PCA The Omnifuse PCA pump is supplied with Protocol software so in the clinical environment you can choose to deliver analgesia according to a pre defined protocol If no pre defined protocols are in use the pump displays the programming steps instead Programming with protocols Protocols are usually designed to deliver a prescription for a named drug although there may be more than one protocol designed for a drug that is used in more than one way Up to fifty named protocols can be stored in the Omnifuse Before the pump is used in the clinical area it is set up with specific protocols The available protocols are displayed on a Protocol menu once the syringe has been loaded For details see Selecting a PCA protocol page 3 4 USER PROGRAMMED The protocol menu may include an extra USER PROGRAMMED option which you can use to set up a PCA infusion by entering all the parameters You cannot use this facility to store a protocol For details on how to use the USER PROGRAMMED option for a User Programmed one off infusion see page 3
103. use PCA Instruction Manual Graseby Medical Ltd 16 17 18 19 20 21 22 23 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 patient 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 eath 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

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