English user manual
Contents
1. The pump will return to the infusion window or Press Information about the amount of delivered medicine will appear Press and hold a progressive bar will appear The dose will be cleared after its disappearance IO 001 04 3 WI 06 01V0 0 21 48 17 4 Pressure KVO In any time during the infusion process modifications of pressure level and KVO rate are possible Press MENU during infusion or during pause in infusion Select Pressure KVO and confirm After selecting this function the following parameters are available Occlusion pressure levels 1 6 press to change the level KVO 0 5 0 mlb Keep Vein Open the rate of the delivery of medicine to keep vein open when the infusion is stopped The resistance depends on the following factors e rate of infusion density of fluid inside diameter and the length of the extension line diameter of the needle usage of additional elements like antibacterial filters that increase resistance with increase of time of infusion e quality of used syringes The resistance is difficult to estimate and different at each case At the lowest pressure levels the alarm may occur despite the lack of occlusion In this case e change an antibacterial filter e change a pressure level for higher see above e change a syringe for a new one A syringe itself could cause a problem It is forbidden to prime the syringe again even with the same drug Because of the higher resista2. SYRINGE INFUSION PUMP USER S MANUAL MODEL S Please read these instructions carefully prior to using the device to ensure correct operation and to avoid patient injury In case of any doubts please contact an authorized MEDIMA representative or manufacturer directly WI 06 01V0 0 2148 WI 06 01V0 0 IO 001 04 3 CONTENS DW ZUJ ZN DO N R 90 90 90 90 90 N N BONE NE 10 10 1 10 2 10 3 10 4 11 12 13 14 13 16 16 1 16 2 16 3 16 4 16 5 16 6 17 1 17 2 17 3 17 4 17 5 17 6 17 7 17 8 PATIENT S SAFETY WARNINGS AND PRECAUTIONS 1221112211112111 6 DIFFERENCES BETWEEN MODELS aw ciotka Adi 7 MAINTENANCO AA EE E O OR O OP OZAWY 7 MANUFACTURER S RESPONSIBILITY sse 8 PUMPC ORSTRUCHON a AA 8 O NAA 9 ISI RCA A A A PR A A Wal SA 9 UNPACKIN God 10 PUMP INSTALEATION iure colina Deimos ia 10 Attaching the Pump to the IV Pole or Vertical Column sese eee eee eee 10 Mounting the pump into the docking station recommended 10 EDITING PARAMETERS conri a enters 11 Entering the Value of Numeric Parameters i e rate volume 11 Enternne MEAN CAE ZO 11 Permanent Resetting Of Parameters owo O A A 11 Change the Ty PEDESTAL A OOO A AO 11 SWITCHING THE PUMP ON sud it cen 12 INFUSION PROGRAMMING ml h sees eee 12 Infusion Rate Only way Diada iR A A 12 Rate and Volume of Infusion Way LID sss essen
3. More details at our website www medima com pl 28 48 WI 06 01V0 0 TO 001 04 3 1 Medima Drug Editor v 6 4 1 MEDIMA Sp z 0 0 me Drugs libraries list Demo mdd ADRENALINUM E ES c 3 K i E New library Y Open X Delete G Transfer 2 Trash Print m Save Hep b b b ED ZE Created Modified Created 8 29 2006 10 18 AM C DEMO LIB f 8 29 2006 8 29 2006 s a ug kg min v Infusion parameters Concentration P_Omem w Weight kg i ml h C DEMO LIB m Total dose J induction dose Library name DEMO LIB Y Bol po gt a Version Disable editing of limits in pumps C Disable editing of drugs in pumps No Drug name Inf mode Created 0 1 O ADRENALINUM Continuous 8 29 2006 ugk AMIODARONE s ATRACURIUM DOBUTAMINE DOLARGAN DOPAMINE EBRANTIL FENTANYL FUROSEMID M l CERME olo uja a a w h Bs Bs Bs en en Bs 21 CREATION OF USER S OWN LIST OF SYRINGES Parameters of many syringe types are calibrated in the pump Not all of them are used in each hospital To shorten the list Start programming of infusion parameters Using select displayed syringe type Press NO list of syringes will appear Press MENU Using select Create own list and confirm YES Using and select desired syringes to create own list Press ESC to finish To revert to the full list of
4. programmable default value 1000 ml h or less Rate depending on the used syringe Volume max 5 ml during primine the line pressure alarm is active Flow rate accuracy Mechanical accuracy of pumps is 0 5 according to Total accuracy of infusion including a syringe is 2 EN60601 2 24 Flow rate accuracy depends on the i i Maximal volume 0 5 ml for flow rate 2000 ml h infused during 0 2 ml for flow rate below 500 ml h malfunction 0 1 ml for flow rate below 100 ml h Ni MH 2000 mAh Battery life 20 hours 5 ml h Recharging time 5 hours 100 Foreseen for about 400 rechar Memory retention The memory of the unit will be retained for min 5 years when not powered Casing Material ABS Protection class IP22 according to EN60529 Dimensions 355 x 115 x 166 W x H x D excluding pole clamp Below 2 5 kg without power supply cord Password 13 46 79 42 48 WI 06 01 V0 0 TO 001 04 3 Event log capacity Minimal 2000 records of operation activities with date and time of event Power supply AC 100 240 V AC 15 10 50 60 Hz max ISVA 12 16 V DC max 1 A DC Type CF protection against defibrillation class I Operating conditions Temperature 5 C 40 C humidity maximum 90 Transport conditions Temperature 20 C 50 C humidity maximum 95 Communication ports e RS232C rate of transmission 38 kb e Infrared for communication with docking station Drug Names Library e Up to 120 drugs names Dr
5. very simple model operates in ml h ml min ml 24h ml h and in continuous infusion mode only Gives the possibility to enter and display up to 120 drug names Medima Model S1 This model allows infusion in ml h and in many other mass units like ng ug mg uU mU U kU umol mmol mol kg min h 24h and operates in many advanced modes continuous infusion infusion with profile and intermittent infusion Additionally allows recording drug library up 120 drugs but without limits on parameters Medima Model S2 Offers capabilities of model S1 and additionally enables to enter upper and lower soft and hard limits for all infusion parameters see p 19 3 page 26 Medima Model S PCA The pump is designed to improve management of acute post operative pain Syringe cover with lock and patient s bolus button is provided Additionally the pump offers capabilities of model S2 3 MAINTENANCE For correct and safe operation the manufacturer recommends to carry out a technical inspection every two years All maintenance work and repair should be done only by the personnel trained by the manufacturer In case of any doubts concerning correct pump operation the device should be removed from service and properly marked or secured as to prevent accidental use until the problem is resolved by an authorized MEDIMA representative or the manufacturer Before dispatching the pump to the maintenance workshop it should be cleaned and disinfect
6. Stored information is available during the infusion and when the pump is switched off The information about the current and previous infusions could be reviewed The following information is stored Infusion parameters Loading unloading a syringe Start stop of infusion Start pause and end of induction and bolus doses Each change of parameters during infusion All alarms including the moment of their muting by an operator Exceeding the value limits of infusion parameters model S2 Detailed information on review about infusion history is in p 22 1 page 30 17 6 Time date This function allows changing time and date of the internal clock Enter new data and confirm YES Press to close the window 17 7 Ward Name Entered Ward Name will display after choosing this function see p 22 4 9 Enter Ward Name page 35 e Press during infusion or during a pause in infusion e Using select Ward Name and confirm YES IO 001 04 3 WI 06 01 V0 0 23 48 17 8 Information This function allows reading information about the pump e Press MENU during infusion or during a pause in infusion e Using select Information and confirm YES The following will appear e Drug names Information about drug names name version creation date and modification date entered using DRUG EDITOR see p 20 5 page 28 e Pump Information about the pump see p 22 6 on page 36 e Statistics Statistical information about pump a
7. battery controller system e Battery test indicates status of battery discharge e Battery test eventlog enables to read results of four previous battery tests IO 001 04 3 WI 06 01V0 0 37 1 48 Battery test takes even up to 15 hours as it is controlled discharge of battery If the pump should be ready for patient transfer the battery test is not recommended The result of battery test below 80 requires battery replacement as it means that rapid decrease of battery capacity is expected and the pump could not work unless connected to the mains The indicator of battery charge status will not show proper values The following should be carried regularly e Control of power supply cable in case of insulation damages the power supply cable should be changed e Inspections according to service manual carried by qualified personnel e Cleaning and disinfection of outer pump surface see p 23 page 39 22 9 Service These features are for the personnel of technical department only and are secured by password e Press and hold MENU to select Service and confirm Enter password 159 0 and confirm YES select right function and confirm YES The following features are available e New battery Function of battery recharge with reset of battery controller It is recommended after batter replacement e Time to next Allows technical staff to plan next technical inspection One technical inspection can select period of time amou
8. created see p 21 page 29 IO 001 04 3 WI 06 01V0 0 11 48 9 SWITCHING THE PUMP ON e Ensure that the pump is not damaged In case of problems contact technical staff immediately Press 6 The pump will start AUTOTEST Two audible signals will sound Check screen for completeness of all pixels on the display Check if all control indicators on the keyboard are working After finishing the tests CONTINUE may appear on the display will clear all information about the course of the previous infusion dose or volume and time of infusion and allow continuing setting the parameters of new infusion YES allows to continue previous infusion dose volume and time of the previous infusion will not be cleared 10 INFUSION PROGRAMMING ml h After every change or entry of parameters check whether they are correct and the units are proper After switching the pump on the device goes to AUTOTEST and displays the parameters of the last infusion You can e Confirm each parameter pressing e Modify parameter entering new value and confirm pressing e Clear all displayed parameters and return basic infusion parameters in ml h e Press e Using select Clear parameters and confirm e Basic infusion parameters in ml h will appear 10 1 Infusion Rate Only way I e Ensure the type and size of syringe on display is accurate If not Use to find the name and the size of syringe Press list of syringes will appear Use to s
9. measurements were taken using BD PLASTIPAK 50 ml and standard extension set of 2 m IO 001 04 3 WI 06 01V0 0 45 48 34 DOCKING STATION The docking stations are recommended to save valuable space around the bedside DS2 for 2 pumps DS4 for 4 pumps DS6 for 6 pumps DSS for 8 pumps DS4E DS6E DS8E version with Ethernet They enable quick installation of pumps at the patient s bed and creation of sets required by actual therapy Power supply and communications ports are connected automatically after mounting a pump into the docking station In option there are communication modules that enable to connect a pump to the hospital information system We offer software that enables observation of infusion in the real time at any PC connected to LAN in the hospital ward It also gives a possibility to transfer a drug library and configuration to all pumps mounted into docking stations 46 48 WI 06 01V0 0 TO 001 04 3 IO 001 04 3 WI 06 01V0 0 471 48 ama 35 INFORMATION ABOUT MANUFACTURER MANUFACTURER REPRESENTATIVE MEDIMA Sp z 0 0 tel 48223132266 02 486 Warszawa fax 48223132269 Al Jerozolimskie 200 POLAND www medima com pl Serial Number Hospital Ward Name 36 DOCUMENT HISTORY Remarks Software Version on Issue 2 2005 10 001 04 1 2 9 2006 IO 001 04 2 V6 3 xx l 2 92000 10 001 042 V63xx IO 001 04 3 I SS ee A GAGA Ce 1011 48 48 W
10. select the parameter e Enter value and confirm e Press ESC to finish IO 001 04 3 WI 06 01 V0 0 33 48 22243 Limits There are e Max Rate 2000 ml h Limits max infusion rate e Max Bolus 2000 ml h Limits max bolus rate e Prime the line 1000 ml h Rate for priming e Using select the parameter e Enter value and confirm e Press ESC to finish 22 4 6 Alarm Options Alarm parameters description e Volume level Level of alarm loudness e Melody 1 9 Type of sound e Pre alarm time 5min Time to the SYRINGE EMPTY and INFUSION END 1 30 min e Occlusion pre YES NO Warning of pressure increase switch on off see p 18 alarm page 24 e Line disconnected YES NO Warning of pressure drop switch on off see p 18 page 24 Entering the value e Using select the parameter e Enter value and confirm e Press ESC to finish 22 4 7 Night Mode Options Night Mode allows tuning of alarm loudness and backlight brightness e Switch on YES NO Switch on Switch off of night mode e Volume level Level of alarm loudness e Melody 1 9 Type of sound e Start 22 00 Time of start of night mode e Finish 07 00 Time of finish of night mode 22 4 8 Security This function allows configuration of security options the list with the following parameters will appear 34 48 WI 06 01 V0 0 TO 001 04 3 e Switch on YES NO Activation or locking of all the security options e Drug library YES NO Locking of recording modification
11. 13 Rate and Time of Infusion way ID sss sese 14 Volume and Time of Infusion way IV sese 14 LOADING AS YRINGE st a aaa EEEE EE 15 PRIMING THE LINE START OF INFUSION cccssccssscssssescseccessnecsenceseeecees 16 UNLOADINGA SYRINGE ez iee a EErEE shales ieee da Lay 16 AUTO INFUSION Life and Health of Patient under Threat 1 17 FUNCTIONS AVAILABLE BEFORE THE START OF INFUSION 17 INFUSION za po c cantare Goko taneous E evel NATE 17 Quick Change of Infusion Rate without stopping the infusion 17 BOS b a OE 17 Review of Information about Infusion sss sese eee eee 18 Suspension and Restart of Infusion sese eee 19 EMpty SYM OSs ses seeds dd Awa AET ak 19 Ber EUS WO soi te cates A a A a 20 INFUSION MENU assistant 20 PP ABATE LCS etre teats cau es Ai cad 20 INS Wy ANIUSI NE seine Sa A aah 21 CI GE O ZEE 21 AS EEE ah aa WO 22 Event Os z ES W O A AA PO seca EC 23 Time datada ardid 23 Ward A NA 23 Informat oN AA A OOBE 24 IO 001 04 3 WI 06 01V0 0 3 48 17 8 1 Information about Drug Names Versions sese sese eee 24 IS ALARMS AA 24 19 ADDITIONAL POSSIBILITIES OF INFUSION programming 111 26 19 1 MENU parameters available during programming sss sees eee eee eee 26 19 2 Clear parameters come back to infusion in mlb sese 26 19 3 Options Additional Infusion Parameter sss 26 19 3 1 Total DOS oda oC Ob AC b jA
12. E 27 IS BOB e 27 19 3 3 Start TIME oh ad o A Eaa TESA AAA 27 207 DRUG NAMES ad 27 Dol Enter Drae NAME AAA ee a T E S e a A 27 20 27 Recall Drug NAME ado A a 28 20 3 Delete Drug Name az AO O OOOO EO AEG 28 20 4 Pump to Pump Drug Library Transfer sss sese 28 203 DRUGEDITOR SO Walt A O nik 28 21 CREATION OF USER S OWN LIST OF SYRINGES ee esoeuao saa ae eaaa acc ae 29 22 FUNCTIONS AVAILABLE WHEN THE PUMP IS SWITCHED OFF 30 9A AN ES ae AS 30 O A CA EO ok oO LO PORA A 32 223 MIME SS 32 22 4 Pump Configuration Abia AR kak Od 32 224 1 PAS WO diia di ad a lak aa odkad 33 224 2 Date FOMAL ada iran adikk alitas 33 Deas FONTAS se ee O a RAA W Ra otych 33 224A E ac Gia O AG 33 e LIMS E OO DARO O A AE 34 ZIAD Alarm OPUS Panik od not ota 34 22 Ake Night Mode OPUS as di ii 34 DDAR A US A EZ GR a A 34 220 Enter Ward Namoa akta Wraca b Ad GA REY 35 22 0 Wata Name wa e NN 35 22 6 5119219115 TT OZ A RA A zd AO OZ CKE 36 DON A A ER OE W Z OWA 36 A SUMA KA o A E AUY 36 LLO A awk A OO A O W AEP we Z ERA dy SAL 37 Bled IN A PO O AA OZ a 37 DS A AN 37 2202 A il e do de 38 D207 As A O OWOCOWA 38 22 9 2 Pump to Pump Drug Library Transfer sss sese eee 39 22 9 3 Pump to Pump Configuration Transfers sss sese eee 39 22 9 4 Clearing Drug Names Elba ma lac dna OR wl On dees 39 23 CLEANING AND DISINFECTION cua 39 24 INTERNAL BATTERY OPERATION A ORO 40 25 LONGER INTERRUPTION IN PUM
13. G THE LINE START OF INFUSION The pump enables to fulfil an extension line with medicine In order to do this e Press and hold lt lt lt a progressive bar will be displayed and after its disappearance the pump will start to prime the line until the button is released maximal volume is limited to 5 ml Ensure that there is no air in the extension line or in the syringe e Secure the extension set using the extension set hook 1 on the left side of casing to protect against accidental dislodging of syringe from the clamp e Connect the extension line to a patient Please note that the pump does not signal accidental removal of the needle from the vain Check the connection as much as possible or practical e Check the alarm operation press and hold XX audible signal will sound all controlled lamps on the keyboard will flash display will show ALARM e Press to start the infusion yellow lamp by START STOP button will flash flashing arrow in the upper right corner of display will indicate that the pump is in operation Never prime the line when a patient is connected to the line Filling the line is possible only before the start of infusion or when empty syringe is replaced Volume infused during priming the line is not added to the volume of infusion 13 UNLOADING A SYRINGE e Press to stop the infusion by safety valve e Isolate the extension line from the patient e Pull the syringe clamp down
14. I 06 01V0 0 IO 001 04 3
15. P OPERATION sese 40 4148 WI 06 01V0 0 IO 001 04 3 26 NURSE CALE CONNECTION io Ka Oc li 40 e CONNECTION LEAD Is AGE AA AAA AA AA 41 Doe INTERFACES 232 Ea a dat 41 2 ACCESSORIES at io 41 307 TECENICAL DATA 00 il TT 42 5h EIST TOFE SYRINGES aa dka Ka A O Ok kd da oe A 43 32 SREPEACEOPACPUSE sA ONA aaa Ak OO 44 33 GRAPHS OF INFUSION ACCURACY caia da 44 33 1 Start up curves and trumpet CUrYes esse eee iwo dA AOL AP w 44 33 2 Occlusion Reaction Time and Residual Bolg sss sss 45 de DOCKINGSTATION toda da OE wd YB 46 35 INFORMATION ABOUT MANUFACTURER 48 36 DOCUMENT HISTORY e aaa wid dia dake 48 IO 001 04 3 WI 06 01V0 0 5 48 1 PATIENT S SAFETY WARNINGS AND PRECAUTIONS Syringe infusion pumps are designed for the precise intravenous infusion feeding nutrition etc Decision concerning usage of the device can be made by the qualified healthcare professionals only Only syringes of volume name and type chosen in infusion parameters can be used Use of another syringe than specified in the pump even of the same volume may cause significant infusion errors and patient injury A list of recommended syringes is entered into the pump and is available during infusion programming These are three piece syringes with a rubber plunger and a Luer Lock end In case of any doubts concerning the used syringes infusion errors or pump operation immediately contact an authorized MEDIMA representative or the manufa
16. R software offers the same possibilities Option selection window with the infusion parameters e Press MENT e Using select Options and confirm YES A window with list of parameters will open e Total dose YES NO total dose enabled disabled e Bolus YES NO bolus enabled disabled e Start time YES NO start time enabled disabled e Using select a parameter and press to activate it or to deactivate it e Press ESC to revert to the parameters modified according to the chosen parameters options 26 48 WI 06 01V0 0 TO 001 04 3 19 3 1 Total Dose If this option is enabled disabled Total dose parameter will appear disappear on the display It is recommended to disable it if not required For the infusion in ml h Volume and Time will disappear and Total Dose for infusion in other units It should be remembered that if the above mentioned parameters are disabled or their volume not entered INFUSION END alarm will not occur Only SYRINGE EMPTY alarm will occur 19 3 2 Bolus If this option is enabled disabled Bolus parameter will appear disappear on the display It is recommended to disable it if not required It is very important because the delivery of bolus dose could be dangerous for a patient It is worth adding that the delivery of bolus dose can be also secured by a password see p 22 4 8 Security page 34 19 3 3 Start Time This function enables automatic start o
17. Ward Name IO 001 04 3 WI 06 01V0 0 35 48 22 6 Information This function allows reading information about the pump stored in the memory e Press and hold MENU e Using select Information and confirm YES The following will appear e Drug names Information about drug library name version creation date and modification date entered using DRUG EDITOR e Pump Pump data e Statistics Information about pump and battery working time e Using select desired function and confirm YES 22 6 1 Drug Names This information will appear only when the drug library was created and sent using MEDIMA DRUG EDITOR see p 20 5 page 28 The information is very important as it enables to check weather the drug library in the pump is the proper one the latest version and weather it was modified in the pump The following information will appear e Drug library name given in DRUG EDITOR software e Library version given in DRUG EDITOR software e Creation date in DRUG EDITOR software e Upload date from DRUG EDITOR software e Modify date in DRUG EDITOR software or in the pump e Drug changes locked preset in DRUG EDITOR software Use to review the information 22 6 2 Pump Here is information regarding pump identification e Serial number e Prod date e Pump type e Software Software version e g V6 3 1 e WD Watch dog version Use to review the information 36 48 WI 06 01V0 0 TO 001 04 3 22 6 3 Stati
18. amming parameters Pressing ESC will revert to infusion window It will happen automatically after 10 sec Entered changes do not reset volume dose counter and the infusion will be continued with the new parameters 17 2 New infusion New infusion function is available when the infusion is finished or stopped by pressing START STOP After selecting that function The infused volume counter will be reset and new infusion parameters programming option will be available Induction dose starts the infusion if it was previously programmed Start of new infusion according to new parameters or previous parameters e Press to stop the infusion Press MENU Using select New infusion and confirm YES Select enter and confirm new parameters Load a syringe prime the extension line connect the extension line to a patient and press START STOP OT ART STOP to stop the infusion Turn off the pump Turn on the pump CONTINUE Select enter and confirm new parameters Load a syringe prime the extension line connect the line to a patient and press 17 3 Clear Dose In any time during infusion the reset of volume dose of medicine is possible Infusion will be continued and induction dose will not be infused again Press MENU during infusion or during pause in infusion Select Clear dose Press and hold a progressive bar will appear and the dose will be cleared after its disappearance
19. and wait until the plunger grippers will release the syringe about 2 sec In case of any problems with the plunger grippers lock the syringe clamp move the syringe plunger and pull the syringe clamp again e Unload the syringe when the arm is moving e Unloading a syringe is possible only when pump is switched on or switched off but connected to the mains Never load and unload the syringe with the extension line connected to the patient Uncontrolled dangerous infusion or back flow may occur Use a safety valve in the patient s line for protection Every new connection of the extension set to the patient should be done after ensuring that there is no air in the line and in the syringe 16 48 WI 06 01 V0 0 TO 001 04 3 14 AUTO INFUSION Life and Health of Patient under Threat Auto infusion during drug delivery is one of the largest threats for patients life and health It appears when a syringe is above the patient s body and it is caused by gravitation Liquid in the infusion line beneath a syringe makes negative pressure which can cause an automatic plunger motion and uncontrolled infusion Its rate depends on e Height above patient s heart on which a syringe is held when the pump is mounted e Syringe diameter for small volume syringes the force of plunger movement caused by negative pressure is smaller probability of auto infusion is smaller The biggest danger is for 50 60ml syringes mostly used in the inf
20. arm occurs 1 2 COMM 3 4 NO Output normally open with COMM and closed during alarm 5 6 NC Output normally closed with COMM and open during alarm Use of original connection is recommended 40 48 WI 06 01V0 0 TO 001 04 3 27 CONNECTION LEAD 12V Use of DC12 V connection allows operating the pumps in ambulances Proper connection is signalized same as AC power connection 1 12V 2 12V 3 NC Use of original connection is recommended 28 INTERFACE RS232C Pumps are equipped with interface RS232C which enables e Transmission of contains of event log to the outside PC which allows review printing and archiving of data about the previous infusions To do this MEDIMA HISTORY FILE software is necessary which is not a standard delivery enclosure e Downloading a drug library to the pump s memory from MEDIMA DRUG EDIOR which is not a standard delivery enclosure Pump to pump drug library transfer see p 22 9 page 38 Pump to pump configuration transfer or from to PC Upgrade of the pump s software Visualization of the current infusion status RS232 cable with battery is required To visualize and archive information about infusion course it is recommended to use docking stations that enables to connect to hospital ward information system practically unlimited quantity of pumps via LAN Ethernet see p 34 Docking station page 46 Devices to transfer or receive digital data can be connected to p
21. ars The icon also shows battery charge status and its precise value can be read in Information after pressing Y1NFo see p 16 3 page 18 e Battery capacity will decrease in time Battery tests should be carried every 2 3 months after one year of its use and in case of capacity drop up to 80 the battery should be replaced e Battery status can also be evaluated from information about the number of recharges in the pump s statistics see p 22 6 2 page 36 The battery effective life time equals to 400 recharges After exceeding this number quick battery capacity degradation could be expected e Dueto configuration replacement of battery should be done only by the trained technical personnel e To achieve optimum operation ensure that the battery is fully recharged after full discharge periodically 25 LONGER INTERRUPTION IN PUMP OPERATION In case of expected interruptions in pump operation for longer period of time it is recommended e to clean an disinfect the device e to fully charge the battery e to recharge the battery regularly every 3 months or leave the pump connected to the electrical outlet 26 NURSE CALL CONNECTION Nurse call alarm connection provides the communication remote backup to the internal audible alarm Use of original connection lead is recommended The connection is not needed when the pump is mounted in the docking station Check the connection pressing 55 on the keyboard until test al
22. cturer directly The pumps should be properly marked and secured to prevent accidental use until the problem is resolved Connecting the extension set to the patient should be done after the syringe is loaded into the pump and the extension line is filled with fluid Otherwise uncontrolled infusion or back flow could occur and endanger the patient The extension set and the pump should be carefully checked for the presence of air as the pump does not have its own system of air detection in the extension line The replacement of syringe should be done after the extension set is isolated from the patient Every new connection to the patient should be done after checking for the presence of air in the line and the fixation of the syringe Uncontrolled flow of medicine may result if the syringe is removed from the pump before the extension set is properly isolated from the patient The pump should be mounted not higher than 70 cm above the patient heart as it may worsen the uniformity of infusion The most accurate pressure monitoring in the extension set is achieved when the pump is positioned close to the patient s heart level The pump should be operated within a safe distance from the patient so his accidental movements cannot stop the infusion The patient must be informed by the medical personnel that touching the pump keyboard by any unauthorised persons may cause a risk to his health or life If several pieces of infusion equipment are connec
23. d be plugged into a grounded electrical outlet only 8 EDITING PARAMETERS Use to select the parameter Start modification of the parameter by clearing the previous value pressing or entering it with numeric keys Each new value should be confirmed pressing YES If the entered value exceeds the allowed limits a window with the upper and lower limits will appear The window with the warning will close after pressing ESC or after 5 seconds Not all parameters have to be entered 8 1 Entering the Value of Numeric Parameters i e rate volume e Press or enter value with numeric keys confirm YES e Pressing clears last number e Pressing and holding allows you to change the unit of the parameter Use or press to select the proper units and confirm YES 8 2 Entering Time Press or enter value for hours Enter minutes after pressing or To start entering minutes omitting hours press f Press to finish Pressing clears last number and long holding the button clears all entered value 8 3 Permanent Resetting of Parameters If you want to clear the value of a parameter leave it without entering a value and press and then press 8 4 Change the Type of Syringe e Using select the type of syringe press NO a list of syringes will appear e Using select desired syringe type and confirm YES e During the syringe type selection MENU with additional functions is available user s own list of syringes can be simply
24. e danger to the patient s life For safety reason isolate the patient by closing the tap in the extension line Check if there is air in the syringe and if yes remove it e Ensure that the used syringe type and size are the same as on the display e Pull the syringe clamp 2 on display SYRINGE UNLOCKED e Set the plunger in the position x not Correct X Incorrect lt S A i V f position position N e Insert the syringe ensuring that the finger flanges are located between the casing and syringe flange clamp 3 and the syringe is properly located e Let go off the syringe clamp 2 CHECK SYRINGE on display means the syringe is improperly inserted or the type or size of syringe is incorrect Change the syringe or make a change in programming parameters To make a change in programming parameters press and hold MEND until a parameters window appears Ensure that the syringe plunger is correctly located If yes on display PRESS lt lt Check if the syringe plunger lies horizontally in the syringe axle Press lt lt lt the pump will move the arm and grippers will lock the syringe plunger Ensure that the grippers 4 are fully locked and the syringe plunger is secured otherwise danger of auto infusion will occur see p 14 page 17 Unloading a syringe is possible only when the pump is switched on or switched off but connected to the mains IO 001 04 3 WI 06 01 V0 0 15 48 12 PRIMIN
25. ed Original packaging is recommended to prevent possible damages during transport IO 001 04 3 WI 06 01V0 0 71 48 4 MANUFACTURER S RESPONSIBILITY The manufacturer is responsible for the safety reliability and correct operation of the pump on the condition that e Installation operation and modification are performed in accordance with the user s manual and manufacturer s instructions e Inspections and repairs are made be authorized personnel trained by MEDIMA e Technical inspections of devices are carried out every two years 3 PUMP CONSTRUCTION 1 Pump stem end 10 12V connector socket 2 Plunger grippers 11 RS232C socket 3 Syringe flange clamp 12 Alarm connector 4 Syringe clamp 13 Pole clamp 5 Extension set hook 14 Clamp knob 6 Keyboard 15 Battery cover 7 Display 16 Release button for the docking 8 Caring handle station 9 Mains socket 8 48 WI 06 01 V0 0 10 001 04 3 5 1 Keyboard Additional functions button Exit from MENU by ESC Internal functions can have additional options check by pressing MENT again Buttons used to select parameters or functions Review of the infusion parameters Button used to confirm value or information displayed Button used to reset or reject information displayed Numeric keys for entering parameters and names Button used to stop or exit selected window or entered data Starts stops infusion Infusion indicator yellow flashing Acou
26. ed volume dose of the total infusion is exceeded the pump will stop the infusion and END OF INFUSION will appear on the display BOLUS dose is included in the programmed dose of infusion It means that a patient will receive only such a dose of medicine that has been programmed regardless from the quantity of delivered bolus doses The total dose delivered to the patient can be read in information about infusion after pressing see p 16 3 Review of Information about Infusion page 18 16 3 Review of Information about Infusion Press e Review information using e Coming back to the infusion window after pressing ESC or automatically after 10 seconds 18 48 WI 06 01 V0 0 TO 001 04 3 During the infusion process the following information about infusion is available e nfused volume dose it can be cleared press and hold until a progressive bar disappears Time to the end of syringe Time to the end of infusion if programmed volume or time of infusion Time of infusion Battery charge status KVO rate 16 4 Suspension and Restart of Infusion To stop the infusion for longer period of time e Press START STOP to stop the infusion e Leave the syringe in the pump e Switch the pump off To restart the infusion e Switch the pump on again On display Continue press e Press START STOP to start the infusion all previous data and volume dose counter will be retained To remind about suspended i
27. elect the appropriate syringe and confirm e Enter infusion rate and confirm you can choose the following units ml h ml min ml 24h Press and hold until the units field starts flashing Pressing or select the proper units and confirm them e Clear infusion volume press and confirm 12 48 WI 06 01 V0 0 IO 001 04 3 e Enter clear or omit BOLUS parameters when displayed can be switched on off see p 19 3 Options Additional Infusion Parameters page 26 Press NO a window with bolus parameters will open Enter or clear bolus dose pressing and confirm pressing Enter time of bolus dose in seconds and confirm rate will be counted You can omit the time and enter the rate only e Using Y select Confirm and press a window with parameters will be closed e You can revert to the infusion parameters window Press and hold MENU until parameters appear or Press MENU Using select Parameters and confirm Using review or change parameters Press ESC to finish In addition in can programme an induction dose previously enabled see p 19 3 Options Additional Infusion Parameters page 26 programmed as the BOLUS function For this infusion the alarm INFUSION END would not occur because volume and time of infusion were not programmed Infusion would last until the syringe is empty or infusion is stopped 10 2 Rate and Volume of Infusion way ID e Ensure the type and size of s
28. epresent continuous flow versus operating time from the start of the infusion The in onset delivery is caused by different factors To reduce it always fill up the line after the syringe replacement for low flow rate use the syringe of a small capacity use possibly diluted drugs and higher rates Trumpet curves named for their characteristic shape display discrete data averaged over particular time period or observation windows Over long observation windows short term fluctuations have little effect on accuracy This graphs show how large of uniformity errors can be expected depending on half life of the drug and flow rate For drugs of shorter half life or for application were flow uniformity is a concern possibly diluted drugs and flow rates of 1 0 ml h or above and small syringe size are recommended Differences in factors such as size and plunger force in compatible syringes produced by the others manufacturers can cause variations in accuracy and trumpet curves as compared to those represented Additional curves for compatible syringes are available upon request Start up and trumpet curves may not be indicative of operation under negative pressure 44 48 WI 06 01 V0 0 IO 001 04 3 Tests taken using BD PLASTIPAK 50 ml syringe 20 Qilmifh Q r 1 00 40 Epl j ECO re 0 24 0 0 y 10 D 30 60 30 120 min D 10 20 30 40 min Start up Curve Trumpet Curve Nominal infusion rate r 1 0 ml h Ave
29. ery To obtain the information about the battery charge status and time of full recharge e Press and hold MENU e Using select Battery and confirm YES an information window will be displayed e Press ESC to finish 22 3 Time Date The proper time and date setting is necessary for proper information in the Event log e Press and hold MENT e Using select Time date and confirm YES e Using select Time and enter hours minutes and seconds e Short pressing will cancel last number and long pressing will cancel whole number e Press when entered time is the same as real time e Press to close the window or set date e Using select Date enter date and confirm see p 22 4 2 Date format page 33 e Short pressing will cancel last number and long pressing will cancel whole date e Press ESC to close the window 22 4 Pump Configuration Configuration Menu contains parameters which allow adapting the device to special user s needs To modify configuration e Press and hold e Select Configuration and confirm YES If the configuration of device was locked by password and pump would ask for password enter password and confirm YES If the password was forgotten read information in p 30 page 42 very carefully The following parameters will appear e Password Locks access to pump configuration and other options e Date Format dd mm yyyy mm dd yyyy yyyy mm dd e Contrast Display contrast setti
30. f infusion at programmed time After selecting this option an additional parameter time of infusion start will appear in the programming window This parameter can be omitted the infusion will start without the delay 20 DRUG NAMES Up to 100 drug names could be entered into memory and then displayed during the infusion 20 1 Enter Drug Name e Press MENU e Using select Drug names and confirm YES the list of drug names will appear e Press MENU e Using select Add name and confirm e Enter drug name using numeric keys like SMS in mobiles next pressing changes entered letter for e g to enter C you have to press Z three times enter of next sign available after 1 sec or after pressing next button short pressing cancels last sign and long pressing cancels whole name to enter space press 1 press to finish entering the name pressing will cancel entering the name and will revert to infusion parameters window If the entered name already exists the warning will appear IO 001 04 3 WI 06 01V0 0 27148 20 2 Recall Drug Name Press MENU Using select Drug names and confirm YES e Using select desired drug name and confirm YES instead of A the numerical keys can be used to chose the first letter from drug name 20 3 Delete Drug Name Press MENU e Using select Drug names and confirm YES e Using select desired drug name and confirm YES instead of the numerical key
31. fferent than mentioned above e Occurs every two minutes when the switched on device is left 2 min E E without the infusion MALFUNCTION e INFUSION STOPPED KVO also XXX SYRINGE EMPTY IO 001 04 3 WI 06 01V0 0 25 48 19 ADDITIONAL POSSIBILITIES OF INFUSION programming 19 1 MENU parameters available during programming During programming infusion parameters but before the infusion is started the following functions are available after pressing MENU that enable modification of the current infusion e Clear parameters Allows clearing all entered parameters and reverting to basic infusion in ml h e Drug names Drug names saved in the pump s memory see p 20 page 27 e Options Additional infusion parameters see p 19 3 page 26 19 2 Clear parameters come back to infusion in ml h After choosing this function all programmed infusion parameters will be cancelled and return to the basic continuous infusion in ml h will be available 19 3 Options Additional Infusion Parameters The additional parameters will appear after selection of below options There is no need to select and programme these parameters for each infusion they remain in the memory and they are used in following infusions They will be also saved in the pump s memory in each dosing protocol in the drug library each dosing procedure can have different options if enabled disabled before entering MEDIMA DRUG EDITO
32. g to the power supply In case of condensation on exterior of the device it should be left out for 4 to 8 hours until the casing surface is dry 7 PUMP INSTALLATION 7 1 Attaching the Pump to the IV Pole or Vertical Column 1 Unscrew the clamp knob 14 see the picture page 8 to fit it to the diameter of the IV pole 2 Put the IV pole inside the pole clamp 3 Screw on the clamp knob and ensure that the pump is securely fastened to the IV pole 4 Plug in the power cord Never attach the pump on the unstable IV stand Is it not recommended to use more than two pumps with one IV stand Do not mount the pump in a vertical position with the syringe pointing upwards as this could lead to an infusion of air which may be in the syringe 7 2 Mounting the pump into the docking station recommended 1 Hold the pump horizontally and push it into a free space in the docking station Ensure that the pump clicks and is fastened securely If the pump is not fixed properly display shows Improper fixing In such case push the pump firmly into the docking station 2 To release the pump from the docking station press release button 16 at the right side of casing and pull the pump forward see drawing page 8 10 48 WI 06 01 V0 0 IO 001 04 3 3 Check if the green mains indicator on the pump s keyboard is on if not check the docking station s power supply or the pump s fixation Both the pumps and docking station shoul
33. h change of parameters during infusion All alarms including also these with moment of their muting by operators Overridden limits values for infusion parameters Model S2 e Press and hold MENU e Select Event log and confirm e Using select required infusion and confirm a list of events for selected infusion will be displayed e Parameters of selected infusion could be reviewed Press once again MENT Select Drug parameters and press parameters of selected infusion will be displayed 30 48 WI 06 01V0 0 TO 001 04 3 e The required infusion can be found easily Press once again MENU Choose Search and press Y ES enter the date the pump will find and display the list of all infusions executed during that day For easy review and to keep records about the previous infusions event log could be transferred to the PC MEDIMA HISTORY FILE software enables presentation of all data infused volume and dose time of infusion number of boluses etc in a graphic or chart form MEDIMA HISTORY FILE software is not a standard delivery enclosure Contact an authorized MEDIMA representative or the manufacturer directly to obtain an information More details at our website www medima com pl Data stored in event log cannot be reset If the event log fills up the oldest information will be removed Event log capacity is about 2000 records It is difficult to estimate how many full infusions can be stored in
34. he pump 22 9 3 Pump to Pump Configuration Transfer To transfer configuration pump to pump act the same way as with drug library but select Send configuration instead of Send drugs 22 9 4 Clearing Drug Names Library In case of the suspicion of unauthorized drug library modification it is recommended to clear it and to retransfer it from another pump or from MEDIMA DRUG EDITOR software 23 CLEANING AND DISINFECTION Unload the syringe and switch the pump off e Disconnect the pump from the AC power supply e Wipe the surface over with the cloth dampened with warm water and detergent solution e After cleaning wipe the device with the dry cloth and wait until the surface is fully dried e Do not immerse the pump in any fluids as this may damage the pump and may cause electrical shock Only the external parts of the pump should be cleaned e Do not steam autoclave or ethylene oxides sterilise Disinfectants which could cause surface discoloration or degrade ABS are forbidden ITO 001 04 3 WI 06 01V0 0 39 48 24 INTERNAL BATTERY OPERATION e Internal rechargeable battery allows continued operation when the AC power is unavailable for example during patient transfer or AC failure e The battery recharges automatically after connection the pump to the AC power supply Infusion doesn t impact on battery charging speed e When operating on batteries a yellow lamp next to flashes and an icon on the display appe
35. n page 16 e Start the infusion pressing START STOP 17 INFUSION MENU During the infusion or during the brake in infusion the following functions are available after pressing MENU e Parameters Allows reviewing and modifying some of infusion parameters e New infusion Resetting the volume of medicine counter and allows to change all the infusion parameters Induction dose if it is programmed will start the infusion e Clear dose Enables to reset the counter of the delivered medicine during infusion or before the next one e Pressure KVO Enables change of the level of occlusion pressure and KVO e Event log Enables reviewing full history about previous infusions e Time date Enables changing time and date e Ward name Allows reviewing entered ward name e Information Information about the pump and the drug library downloaded from the MEDIMA DRUG EDITOR software name version creation date and modification date and about the total time of the pump s work 17 1 Parameters During infusion all programmed parameters can be reviewed and the following can be modified during the infusion course e Flow rate e Volume of infusion total dose e Bolus parameters To modify parameters during infusion or during pause in infusion e Press and hold MENU until a window with parameters appears Or 20 48 WI 06 01 V0 0 IO 001 04 3 e Press e select Parameters and confirm Review and modification like in progr
36. nce of high flow rates the pump automatically changes preset pressure level as follows e Above 500 ml h lowest level 2 e Above 1000 ml h lowest level 3 e Above 1500 ml h lowest level 4 This regards induction dose bolus normal infusion mode and priming the line The pump is equipped with ANTY BOLUS SYSTEM which enables the automatic reduction of residual bolus after occlusion release The excess of medicine accumulated in the extension line is removed by withdrawal of the syringe plunger The system also corrects the counter of delivered volume dose of medicine This function is activated automatically after muting OCCLUSION alarm 22 48 WI 06 01V0 0 TO 001 04 3 KVO This parameter determines the rate of the delivery of medicine to keep vein open in the following cases e Stop of infusion by pressing START STOP End of infusion e Empting a syringe there is always a residual amount of medicine in a syringe e Pause in intermittent infusion The KVO function is shown on the display by a blinking lettering and is active until a syringe is unloaded The KVO function can be programmed in the limits 0 5 0 ml h When the value 0 is entered or KVO values are cleared the function will be disabled When infusion rate is lower than KVO the infusion will not be stopped in the above mentioned cases 17 5 Event Log The pump records in the memory full history of infusion each alarm and all parameters with date and time
37. nd battery working time see p 22 6 page 36 17 8 1 Information about Drug Names Version This information appears only if a drug names have been downloaded to the pump using MEDIMA DRUG EDITOR see p 20 5 page 28 The information is very important as it enables to check weather the drug names in the pump are the proper ones the latest version and weather they were modified in the pump 18 ALARMS Alarms are indicated by e Audible sound with a descriptive message on the display e Blinking of the display flashing and a red lamp next to To silence the alarm press ff or e Doesn t stop the infusion Regards both DC 12V and AC power Doesn t stop the infusion BATTERY LOW Minimum 30 minutes of operation left After muting the sound the red lamp still flashes and the sound activates periodicall INFUSION STOPPED KVO also BATTERY EMPTY After muting the sound or after 3 minutes pump will switch off Restart of operation possible on AC power INFUSION STOPPED KVO also When the alarm is cancelled the pump moves the arm back OCCLUSION to reduce a residual bolus after occlusion release ANTI BOLUS SYSTEM The pump reduces infused volume counter Change the occlusion pressure level if needed see p 17 4 Pressure KVO S 24148 WI 06 01V0 0 TO 001 04 3 Doesn t stop the infusion HIGH PRESSURE Pre alarm at 75 of programmed pressure level enables personnel intervention before the infu
38. nfusion use the Timer function see p 22 7 Timer page 37 that starts alarm after expiry of the programmed time 16 5 Empty Syringe Just before a syringe is empty the pump will stop infusion and alarm will occur the volume remaining in the syringe can be although it s not recommended infused by restarting the infusion process press START STOP The syringe can be unloaded after turning the alarm off see p 13 page 16 exchanged for a full one and the infusion can be restarted without necessity of programming parameters Please observe all safety precautions when changing the syringe Volume dose counter will add volumes of all consecutive syringes A counter can be reset when needed see p 17 Infusion Menu page 20 Depending on the size of the syringe used for infusion the amount of medicine left in the syringe is as follows e 0 5 ml for syringes 50 and 30 ml e 0 25 ml for syringes 20 and 10 ml e 0 1ml for syringes 5ml Due to different types and volumes of syringes the volume remaining in the syringe can be different IO 001 04 3 WI 06 01V0 0 19 48 16 6 End of Infusion After infusing programmed volume of medicine pump will stop the infusion and alarm will sound displaying INFUSION END If you want to repeat the infusion with the same parameters e Change empty syringe for full one see p 13 Unloading a Syringe page 16 e Prime the extension line see p 12 Priming the Line Start of Infusio
39. ng e Default Values Typical parameters set after change of infusion mode e Limits Maximal limits for parameters e Alarm Options Alarm parameters e Night mode options Night Mode parameters e Security Security parameters e Enter Ward Name Possibility of entering hospital ward name for identification 32 48 WI 06 01V0 0 TO 001 04 3 Zoe Password The user can enter the password to lock pump configuration and other options see p 22 4 8 Security page 34 e Using select Password and confirm e Enter password and confirm e Enter password again and confirm e Incase of lose of password read carefully information in p 30 page 42 To cancel the password e Using select Password and confirm e Press and confirm e On display Password Cancelled The password and the serial number should be written on the last page of User s manual 22 42 Date Format e Using select Date Format e Press NO after every pressing the new format will appear e Selected format confirm 2243 Contrast Change of display contrast Select Contrast e Press to select proper contrast e Press to confirm e Press ESC to close the window ZZA Default Values Default values typical standard values that appear after the change of infusion mode e Bolus 500 ml h Bolus rate e Bolus time 15 sec Time of bolus dose delivery e Induction time 60 sec Time of induction dose delivery Entering parameters e Using
40. nt of infusions given volume and amount of battery recharges e Send drugs Allows sending drug library to other pump Requires a special cable see p 29 page 41 e Send configuration Allows sending configuration to the other pump for easy configuration of all the pumps at the ward in the same way Requires a special cable see p 29 page 41 e Delete drugs Allows clearing drug library for example when unauthorized modification is suspected 22 9 1 New Battery This function enables to charge a battery and to reset battery controller It is always necessary after battery replacement as the charge status of the new battery is unknown Battery controller is scaled to use with MEDIMA battery type Use of other than original battery can cause improper pump operation This can cause danger to a patient s life 38 48 WI 06 01V0 0 TO 001 04 3 22 9 2 Pump to Pump Drug Library Transfer To transfer a drug library pump to pump e Connect both pumps to the mains MEDIMA logo appears on display e Connect the pumps by special connection cord using RS232 sockets e Inthe pump with demo drug library e Press and hold MENU to select Service and confirm e Enter password 159 0 and confirm select function Send drugs and confirm YES both pumps will display information about sent received programs e Check whether sent drugs library is correct The previous drug library is cleared by the next one downloaded to t
41. occur IO 001 04 3 WI 06 01 V0 0 17 48 2 When volume dose of bolus are programmed pump will infuse the programmed volume of medicine and revert to standard infusion Press START STOP to stop the infusion of bolus and revert to standard infusion To start delivery of Bolus dose Press The window with the information about programmed bolus dose will appear If the value is proper press again Delivery of bolus dose will start If there is necessity of change the value enter new value and confirm YES Press lt lt lt to start delivery of bolus in changed value When bolus dose was not programmed or was cancelled press and hold lt lt lt and bolus will be delivered until the button is pressed All parameters of bolus dose time amp rate can be modified during the infusion Press and hold MEND until a window with parameters appears or Press MENU Select Parameters and confirm YES a window with parameters will appear Select Bolus and press a window with Bolus parameters will open Enter new parameters and confirm Coming back to the infusion window after pressing ESC If none of Bolus function parameters is programmed the function will not be available Delivery of bolus dose gives a signal through blinking of the blue lamp near the button lt lt lt and information about the delivered volume and dose will appear on the display If during delivery of bolus dose the programm
42. rage terror 0 24 Testing time 120 min Observation window 2 5 11 19 31 min Sampling time 30 s eo Gilmi h Q r 5 01 10 Epl 6 0 5 2 0 i 5 0 0 E ij a _ 101 z a p 0 30 60 90 120 min 0 10 20 30 40 min Start up Curve Trumpet Curve Nominal infusion rate r 5 0 ml h Average terror 0 25 Testing time 120 min Observation window 2 5 11 19 31 min Sampling time 30 s 33 2 Occlusion Reaction Time and Residual Bolus Pump reaction time for occlusion depends on many factors e Set pressure level the lower the level the sooner pump will signal occlusion in patient line e Flow rate the higher the rate the sooner the occlusion alarm will occur e Elasticity of extension line the thicker the walls of the extension line the sooner the occlusion alarm will occur e Length of extension line the longer line will increase reaction time for occlusion When occlusion occurs the extension line will expand due to the pressure and more fluid will be accumulated within The higher the pressure level set in the pump the thinner the walls of the extension line and the longer the extension line will become more fluid will be accumulated occurs at 1 ml h occurs at 5 ml h Anti Bolus System Anti Bolus System As can be observed the Anti Bolus System significantly reduces volume of fluid accumulated in the patient line This volume is subtracted from the total volume received by the patient These
43. reset and change of name of programs stored in pump memory Does not lock recalling and start of infusion based on program e Parameters YES NO Locking of parameters modification change e Date time YES NO Locking of date and time modification change e Infusion start YES NO Locking of start of infusion stop is not locked e Bolus start YES NO Locking of bolus dose delivery e Off YES NO Locking switching the pump off Enter password before using the functions secured by password If the password was forgotten read information in p 30 page 42 very carefully Setting security options e Pressing activate Security function e Using select desired security option and pressing YES activate it or lock it e Press ESC to exit security options In case of switching off all security options entered password will secure configuration parameters only Removal of the password results in unlocking pump configuration and switching off the Security function 22 4 9 Enter Ward Name For the easy identification of the owner of the pump there is a possibility to enter the ID number 16 signs or name including maximal four lines 20 signs each To process e Using select Enter Ward Name and confirm Enter or omit ID number Enter the name in selected line using numerical keys like SMS and Press YES to confirm entered name for selected line Press ESC to finish 22 5 Ward Name This function enables to read entered
44. s can be used to chose the first letter from drug name Press e Using select Delete name and confirm e Press ESC to exit 20 4 Pump to Pump Drug Library Transfer In case of big quantity of pumps at one hospital ward is very important all of them have the same drug names Manual entering of many drug names takes time and can cause errors In such a case entering all names to one pump and transferring to all others is recommended A function Send drugs see p 22 9 page 38 enables to transfer of data by interface RS232 A special connection cord is needed see p 29 page 41 Transfer of data between different models S S1 S2 S PCA is not allowed 20 5 DRUG EDITOR Software Drug names can be entered from the pump keyboard but it is easier to use MEDIMA DRUG EDITOR software and create a drug library in PC MEDIMA DRUG EDITOR software enables to create from simple to very sophisticated drugs protocols It is a very easy and useful tool which allows keeping records of the all versions of drug libraries and safe transfer to all pumps at the hospital ward For safety reason modification of all entered data can be disabled Although MEDIMA DRUG EDITOR software is designed for use with models S1 S2 and S PCA it can be used for creation of drug names for model S MEDIMA DRUG EDITOR software is not a standard delivery enclosure Contact an authorized MEDIMA representative or the manufacturer directly to obtain an information
45. sion is stopped Alarm needs activation see p 22 4 6 Alarm O page 34 INFUSION STOPED KVO also Rapid pressure drop it can occur when line is disconnected LINE during delivery fluids at high rates for e g bolus induction DISCONNECTED dose Alarm needs activation see p 22 4 6 Alarm Options page 34 Alarm will be activated only when the occlusion pressure is set above the 2 nd level INFUSION STOPED KVO active until the syringe unloaded Improper syringe fixation during the infusion It can be caused for example by too tight pulling of the extension line Doesn t stop the infusion 5 MIN TO Occurs when volume dose or infusion time is programmed INFUSION END Time can be programmed from 1 to 30 minutes see p 22 4 6 page 34 CHECK SYRINGE INFUSION STOPPED KVO active up to syringe INFUSION END unloading Occurs when volume dose or infusion time is programmed 5 MIN TO Doesn t stop the infusion SYRINGE Warning that the syringe will be empty soon Time can be EMPTY programmed from 1 to 30 minutes see p 22 4 6 Alarm options page 34 INFUSION STOPPED KVO active until the syringe unloaded Occurs just before a syringe is totally empty 0 5 ml for syringes 50 and 30 ml 0 25 ml for syringes 20 and 10 ml 0 1 ml for syringes 5 ml Possibility to delivery left drug quantity after switching the infusion on Due to different types and volumes of syringes the volume remaining in the syringe can be di
46. stic alarm reset button Longer pressing starts alarm tests Alarm red flashing Purge bolus button Bolus indicator blue flashing during bolus infusion Turn on turn off button To turn off press for 3 sec Power status indicator Green mains or 12V Yellow flashing battery 5 2 Display 1 Mode of infusion 7 Battery charge status 2 Infusion rate 8 Power status 3 Drug name 9 Chosen syringe type and size 4 Infusion rate in ml h 10 Infusion rate units 5 Infusion cycle number 11 Infusion pressure and chosen 6 Infusion status flashing during infusion occlusion level indicator IO 001 04 3 WI 06 01V0 0 9 48 6 UNPACKING Despite careful packaging the risk of transport damage cannot be entirely eliminated Upon delivery please check that nothing is missing and the device is not damaged In case of any problems please contact an authorized Medima representative or the manufacturer Complete set includes e Syringe pump model according to the order specification e AC power supplying cable e User s manual Prior the first use of the device plug the pump power cord into the electrical outlet to fully charge the battery Ensure that after connecting the mains the green led on the keyboard lights and the Medima logo appears on the display If the pumps were kept or transported in low temperature below O C it is recommended to leave them for a few hours at room temperature prior to connectin
47. stics You can find the following information here Pump e Inf counter Total number of infusion done by the device e Infused vol Total volume infused by the device e Working time Total working time Battery e Working time Total working time on battery e nstal date Battery installation date e Charge counter Total number of recharges see p 24 Internal Battery Operation page 40 Use to review the information 22 7 Timer Allows switching on the alarm after programmed time the pump remains switched off e Press and hold MENU e Using select Timer and confirm YES The following parameters will appear time left time left to the switch the alarm on time on time when the alarm will be switched on Enter one of the parameters the second will be calculated 22 8 Pump Tests This function enables starting basic pump tests e Press and hold MENU e Using select Tests and confirm YES e Using select a proper function and confirm YES For correct and safe operation the following tests should be carried regularly e Keyboard test checks proper keyboard operation e Display test checks damages of display e Alarmtest available also after pressing 3 during infusion e Clamp test checks operation of syringe diameter measuring system Compare result on display with the measurement taken with the slide calliper The error cannot exceed 0 8 mm e Batt controller test checks operation of
48. syringes after pressing select All syringes 10 001 04 3 WI 06 01V0 0 29 48 22 FUNCTIONS AVAILABLE WHEN THE PUMP IS SWITCHED OFF There are options available when the pump is switched off but connected to the power supply e Switch off the pump and connect a power supply cord MEDIMA logo will be displayed e Press and hold MENU a list of available options will be displayed e Event log Review of information about the previous infusions e Battery Information about battery charge status and time left to full battery recharge e Time Date Settings of time and date e Configuration Set of configuration parameters e Ward name Display of programmed ward name pump s identity e Information Information about the pump and drug library name version creation date and modification date entered using DRUG EDITOR software Timer Switch on of alarm after programmed time Tests Check of proper pump s operation e Service Features for hospital service department 22 1 Event Log The pump records in the memory full history of infusion each alarm and all parameters with date and time Stored information is available during the infusion and when the pump is switched off The information about the current and previous infusions could be reviewed The following information is stored Infusion parameters Loading unloading a syringe Start stop of infusion Start pause end of the delivery of induction and bolus doses Eac
49. ted together it is possible there may be mutual influence Please note that simultaneous administration of various medications in the same line may cause unwanted medical effects and affect patient safety or the efficiency of the treatment Information about possible interference between different medications should be obtained directly from their manufactures The pumps should be protected against infusion fluids spills Do not place containers with fluid directly above the pump Any spills should be cleaned immediately An explosion hazard exists if the instrument is used in the presence of flammable anaesthetics Locate the unit away from any hazardous sources 6 48 WI 06 01 V0 0 IO 001 04 3 EMO EN 60601 1 2 However measures should be taken to place the pumps a sufficient distance from equipment emitting a strong electromagnetic field i e x ray instruments electro surgical equipment defibrillators and cellular telephones If the pump is affected by this external interference it may stop the infusion and the alarm will sound If the pump is struck or dropped it should be removed from service for inspection by a qualified service engineer In case of any doubts please contact an authorized MEDIMA representative or the manufacturer directly The damaged device should be properly marked or secured as to prevent accidental use For power supply use grounded outlets only 2 DIFFERENCES BETWEEN MODELS Medima Model S A base
50. the memory as it depends on quantity of events during infusion alarms parameters etc MORPHINE 10 2 2006 11 40 29 AM PCA infusiuwi A A IS MORPHINE dh umc handay trick LS C7 Infuzian re T Ves Al ma rar Johny Keay Dra rar Walker free az niew cx Alame om KL Concentration 1 worl Deeege 2 moh Patient bows K l 408 24 NA Karre iis i FU bea 1 m PR G 2 m UN lire 8 Pete 720 rh 01 00 00 00 0300 04 00 DE 00 a 0700 y 0600 00 00 100 E Uoze mtivagt Umi Ce escage dose da 1905 10 Ti Lockout ma Piwi s dica Z Licoc rar 10 nz Dursbon 1n Induction dose Iken 2 m urz 10 L Rete 720 mh 1 WT GUL UAD OJRATIOW 3 UD Parhi geo w e Omand Crieziksu Zie conand Sy insga MIKU a boone 4 Parameters cangos mp iki 4 Tag and Trmwtszawy em 02 40 14 Cin bolus dese chances CAB FA In Is dices boa deme po Cin bolus cose changes DIA A K v v mn eee 1 MATT AAA 14 24 08 Un ba a dese changed n h mP DESNI A GSW RSP NAND WAI Aa USIU RRIT RPM WM GA USA Pit incu dos Been Lense S 2 s coke CE Wad asmanda amm S gt Aae 1 Complete infurinn Currrnt infusion mament Ta 104 850 104 4 Dan 37 81u1 57 1 nu Tazrmeds ra 50 Perr dh nz 30 Med derr de ne 87 Pas daranie w gt s7 Orka bks w 11 Sircelbchs ro 7 Zani 3 SO 2 Zara 16 13 26 Daan 07 00 10 wudlas 1022005 0 40 38 FPM IO 001 04 3 WI 06 01V0 0 31 48 22 2 Batt
51. tion you can programme the induction dose previously enabled see p 19 3 Options Additional Infusion Parameters page 26 programmed as the BOLUS function After infusing the calculated volume of medicine the pump will stop the infusion and the alarm INFUSION END will appear 10 4 Volume and Time of Infusion way IV e Ensure the type and size of syringe on display is accurate If not choose the correct one e Clear rate of infusion enter 0 or press and confirm YES e Enter volume of infusion and confirm YES e Enter time hours amp minutes and confirm YES the pump will calculate and show rate of infusion in ml h e Enter clear or omit BOLUS parameters e Using Y select Confirm and press the window with parameters will be closed e You can revert to the infusion parameters window see way I In addition you can programme an induction dose previously enabled see p 19 3 Options Additional Infusion Parameters page 26 programmed as the BOLUS function After infusing the programmed volume of medicine the pump will stop the infusion and the alarm INFUSION END will occur 14 48 WI 06 01V0 0 TO 001 04 3 11 LOADING A SYRINGE After proper entering infusion parameters the pump waits for a syringe to be loaded displaying INSERT SYRINGE Never load a syringe to the pump if the extension set is connected to a patient Uncontrolled infusion or back flow may occur and caus
52. ug names library can be transferred from pump to pump or from to PC using RS232C 31 LIST OF SYRINGES Below you will find the list of syringes appropriate for use in syringe pumps S S1 S2 and S PCA All the syringes are three part have a rubber plunger 6 Diprivan vitreous 50 ml Once 24 IO 001 04 3 WI 06 01V0 0 43 48 32 REPLACE OF AC FUSE If the pump is connected to the AC power supply and the display shows NO MAINS the fuse can be broken To replace it e Disconnect the AC power cord from the electric outlet e Open the drawer with the fuse replace for identical one and close the drawer e Connect the power cable and check if the green lamp on the keyboard next to will come on If not check the power supply cord and the outlet socket 33 GRAPHS OF INFUSION ACCURACY 33 1 Start up curves and trumpet curves In syringe infusion pumps the action of the pumping mechanism and variations in individual syringes cause short term fluctuations in rate accuracy Knowledge of system accuracy may be important when choosing parameters of infusion depending on the drugs being administered it solution and half life in patient body Below tests were performed in accordance with EN 60601 2 24 standards start up curves inform about the errors at the beginning of infusion depending on flow rate trumpet curves inform about the accuracy of fluid delivery over various time period Start up curves r
53. umps only by trained personnel They must meet requirements of EN60950 specification and the whole system should comply to EN60601 1 1 specification Connection of the pump which is at medical stand in a direct contact with a patient to PC is only possible by means of a special cable RS232 with isolation Contact an authorized MEDIMA representative or the manufacturer directly to obtain an information 29 ACCESSORIES Power supply cord 12 V Cable lead RS232 without isolation Cable lead RS232 with isolation Cable lead for pumps connection for drug library and configuration transfer Converter USB RS232 Docking station DS4 E Docking station DS6 E ZA G Lh RLN a ITO 001 04 3 WI 06 01V0 0 41 48 30 TECHNICAL DATA Flow rate 0 1 2000ml h for 50 ml syringe 0 1 1200 ml h for 30 ml syringe 0 1 1000 ml h for 20 ml syringe 0 1 600 ml h for 10 ml syringe 0 1 400 ml h Tor 5 ml syringe programmable by 0 1 ml h Volume of infusion 10 1 10 000 ml in 0 1ml increments up to 999 9 and above in 1 ml increments Time of infusion 1 min 200 hours in I min increments Bolus Volume from 0 1 ml up to syringe capacity in 0 1 ml increments Rate Minimal 2 x flow rate maximal 2000 ml h in 1 ml h increments Occlusion pressure 0 2 kgf cm2 bar 50 levels 0 4 kgf cm2 40 0 6 kgf cm2 30 0 8 kgf cm2 25 1 0 kgf cm2 25 1 2 kgf cm2 25 Priming the extension line 500 1500 ml h
54. usion For the typical syringe of the mentioned volume rise of syringe for the height of 70 cm above patient s heart causes plunger suction force about 0 5 kg and sudden auto infusion with the rate much higher than 1000ml h In order to minimize threat of auto infusion exchanging a syringe must be made extremely carefully after isolation of an extension line from a patient Isolation may include closing a tap in the patient line 15 FUNCTIONS AVAILABLE BEFORE THE START OF INFUSION After the confirmation of infusion parameters before the start of infusion and during the infusion the following functions are available after pressing for details see p 17 INFUSION MENU page 20 16 INFUSION Button starts stops the infusion 16 1 Quick Change of Infusion Rate without stopping the infusion e Enter new infusion rate with numerical keys you can start entering by pressing NO e Confirm YES leaving entered new value without confirmation will not change the rate 16 2 Bolus Bolus shock dose is a volume dose delivered with high flow rate to increase quickly the concentration of medicine in blood serum It can be delivered several times during infusion Depending on programmed bolus parameters it can be infused as follows 1 When volume dose of bolus is not programmed bolus will be infused until lt lt lt is pressed After infusing 1ml of medicine the infusion will be stopped for 2 seconds and short sound will
55. yringe on display is accurate If not choose the correct one e Enter infusion rate and confirm you can choose following units ml h ml min ml 24h e Enter volume of infusion and confirm YES the pump will calculate and show time of infusion e Enter clear or omit BOLUS parameters e Using M select Confirm and press a window with parameters will be closed e You can revert to the infusion parameters window see way I In addition you can programme an induction dose previously enabled see p 19 3 Options Additional Infusion Parameters page 26 programmed as the BOLUS function After infusing the programmed volume of medicine the pump will stop the infusion and the alarm INFUSION END will appear IO 001 04 3 WI 06 01 V0 0 13 48 10 3 Rate and Time of Infusion way III e Ensure the type and size of syringe on display is correct If not choose the appreciate one e Enter infusion rate and confirm you can choose following units ml h ml min ml 24h e Enter time hours amp minutes and confirm YES the pump will calculate and show volume of infusion Enter the hour number Enter minutes after pressing f or Y ES To enter minutes without hours press f Press to finish e Enter clear or omit BOLUS parameters e Using NM select Confirm and press the window with parameters will be closed e You can revert to the infusion parameters window see way I In addi
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