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Aitecs 10S & 12S Syringe Pump Operator`s - Med-E

1. code 237 Factory Function name Enables disables default REE ae ee RE 2 Notes Plus Plus Pro VTBI programming of volume to be infused x y el y VOLUME OVER programming of VTBI over time y a y TIME A INFUSION RATE programming of infusion rate upper LIMIT XXXX ml h _ limit 1500 ml h y y O MANUAL BOLUS manual bolus infusion y y 2 AUTOMATIC BOLUS delivery of preprogrammed bolus x q J g 2 volume BOLUS RATE programming of bolus rate y y y PROGRAMMING E 36 SEP 10S PLUS SEP 12S PLUS SP 12S PRO PUMP MANUAL BOLUS RATE rogramming of bolus rate upper LIMITXXXX ml h limit i A 1500 miaj y y y i 40 80 120 kPa programming occlusion pressure level 40 80 120 x x 4 for 50 60 and 100 ml syringes kPa 30 60 90 kPa RATE mg ug h programming of infusion rate in mass x x J i units RATE programming of infusion rate in mg ug kg h min mg kg h ug kg h mg kg min G X y y ug kg min CALCULATION OF alculation of concentration from CONCENTRATION Entered drug mass and diluent X y y volume TOTAL VOLUME displaying of total infused volume DISPLAY V y y IAUTOSAVE saving of settings and total infused x y y J volume after switching the pump off IDRUG NAME display of drug name x J y d DISPLAY TITRATION programming of infusion rate without x y y J stopping the infusion STANDBY programming of standby time x y y
2. Ese START STOP JA H v Jla lla 30 SEP 0 Stop X X ml XX mi h or Total infused XX ml 2 Press the C key 10S PLUS SEP 12S PLUS SP 12S PRO PUMP MANUAL The appropriate question is displayed CLEAR infused volume or CLEAR total infused volume 3 Press the YES key and the corresponding parameter value is cleared Locking and unlocking keypad Viewing date and time Keypad lock feature is enabled disabled through the setup menu When keypad lock feature enabled in setup menu 1 After infusion parameters have been set and the infusion started or following the bolus infusion or after parameter change the following message is displayed Lock keypad Press YES NO To enable the keypad lock function press the YES key Press the NO key if the keypad lock is not required NOTE The keypad is locked automatically if none of keys is pressed in response to above message within 10 sec 2 In order to disable keypad lock if enabled first press the F key when message Keypad LOCKED ENTER to unlock is displayed press the ENTER key 3 In order to enable keypad lock if disabled first press the F key when message Keypad UNLOCKED ENTER to lock is displayed press the ENTER key Date and time can be selected for temporary viewing by means of
3. Wn TO PUMP 12V supply Nurse Call connection connection N 3 g 58 Connection Data Ground GND Normally Closed NC Common COM Normally Open NO NOTE Use standard D Type 9 Pin connectors the internal batteries are not fully charged when operating from 12VDC When operating pump from 12 VDC permanently recharge the internal batteries connect pump to the MAINS after 1 week of operation SEP 10S PLUS SEP 12S PLUS SP 12S PRO 55 PUMP MANUAL 12 WARRANTY AND SERVICE INFORMATION Warranty Service Information 56 The Manufacturer warrants that pump is free from defects in material and workmanship under normal use and service for a period of 12 months after the purchase date The Manufacturer or its authorised representative takes obligation to carry out the warranty repair of the pump or to replace the pump with an operational one in case the Manufacturer or its authorised representative determines that the cause of the pump s failure was related to the manufacturing process Ifthe customer finds a defect in the pump during the Warranty period he must report it and inform the Manufacturer or its authorised representative within 30 days A pump sent for testing repair or replacement shall be submitted to the Manufacturer or its authorised representative in its original or equivalent packaging The pump is sent for repair and back at customer
4. NOTES 1 When you insert a syringe having a diameter not complying with any syringe installed the following message is displayed ILLEGAL SYRINGE Change SYRINGE 2 When you insert a syringe of different type brand or size than used previously the following message is displayed CHECK SYRINGE syringe size and brand If inserted syringe size and brand are the same as displayed press the YES key or the ENTER key Otherwise press the PROG key and select different syringe type or check the correctness of syringe insertion 3 User can minimize syringe list through setup menu in accordance with the chapter 6 13 Lift the syringe clamp to its upper position 14 Turn the syringe clamp counter clockwise by 90 15 Remove the syringe Air can be removed from the extension set after syringe is inserted and brand confirmed before entering the STOP mode before pressing the YES key when the message SEP 10S PLUS SEP 12S PLUS SP 12S PRO 21 PUMP MANUAL 22 Total XXX ml Ready to run is displayed In order to remove air from the extension set press the BOLUS key The following message is displayed PURGE press BOLUS ENNE The syringe extension set should not be connected to the patient during air removal SEP 10S PLUS SEP 12S PLUS SP 12S PRO PUMP MANUAL Recommended Syringes 5 ml optional 10 ml 20 ml 30 ml 50 60 ml 100 ml BD PLASTIPA
5. Wipe off spills immediately Do not allow fluid or residues to remain on the pump Caution must be exercised in the selection of drugs intended to be delivered via any infusion pump If the drug contained in the syringe will be exposed to extreme environmental conditions for prolonged time periods IT IS IMPORTANT TO SELECT DRUGS THAT WILL NOT CHANGE PHARMACOLOGICALLY UPON SUCH EXPOSURE Epidural administration of drugs other than those indicated for epidural use could result in serious injury to the patient Epidural administration of anesthetics is limited to short term infusion not to exceed 96 hours with indwelling catheters specifically indicated for short term anesthetic epidural drug delivery Epidural administration of analgesics is limited to use with indwelling catheters specifically indicated for either short term or long term analgesic epidural drug delivery e To prevent infusion of drugs not indicated for epidural use do not use IV administration sets incorporating injection sites during epidural delivery e Clearly distinguish pumps used for epidural drug delivery from pumps used for other routes of administration As with all medical electronic equipment care must be exercised to avoid exposing this device to powerful sources of electromagnetic interference This device design has been tested to current European standards and guidelines for medical devices The device was not found to be affected adversely by
6. AE 0 99 La Pe 0 35 aod Epmin Epmin 407 6 04 2 11 19 31 al 2 14 18 31 SEP 10S PLUS SEP 12S PLUS SP 12S PRO 47 PUMP MANUAL Maximum Infusion Pressure Generated The maximum infusion pressure prior to alarm activation is 145 kPa Alarm Delay at Occlusion Time to Alarm activation max Occlusion alarm Rate pressure level low 40 kPa 15 kPa low 30 kPa 15 kPa high 120 kPa 25 kPa high 90 kPa 20 kPa Low 1 h 20 min 1h E High 2h 1 h 40 min Low 15 min 10 min sn High 25 min 20 min Bolus Volume at Occlusion Rate Occlusion alarm pressure level Bolus volume max Low 0 3 ml lA High 0 5 ml Automatic Bolus volume accuracy The information in the following table represents laboratory testing conducted per Sub Clause 50 106 of IEC 60601 2 24 Part 2 Set val Deviation pies Mean Maximum positive Maximum negative 0 1 ml 0 6 2 0 4 0 1 ml 0 5 12 0 2 20 ml 0 3 14 0 3 48 SEP 10S PLUS SEP 12S PLUS SP 12S PRO PUMP MANUAL 10 GUIDANCE AND MANUFACTURER S DECLARATION ON ELECTROMAGNETIC EMISSIONS Electromagnetic Compatibility Statement This statement and the information provided in the following tables are required by IEC 60601 1 2 2001 The tables can be used to identify what EMC electromagnetic compatibility standards SEP 10S Plus SEP 12S Plus SP 12S Pro syringe p
7. infusion and after few seconds E nE VEE ARIPA stop it Set standby time to 3 min and wait until it is elapsed Use BD Plastipak 50 ml syringe Pull out syringe plunger to the X min PREALARM aa nearma iecit miesi CANCEL ko value of 20 ml Launch the i infusion and wait until alarm is generated Loaded syringe having a Load BD Plastipak 50 ml syringe ILLEGAL SYRINGE diameter not complying with asi proper synge Slowly lift up the syringe barrel Change SYRINGE any syringe from the pump clamp until message is indicated syringe library on the display CLAMP The syringe barrel clamp has Close the clamp and resume While infusion is in progress lift OPENED been opened during infusion the infusion up the syringe barrel clamp Load syringe barrel without plunger Insert fixture between the PLUNGER The syringe plunger has been Check the correctness of grippers to keep them in plunger NOT FITTED displaced during infusion syringe position inserted position Launch infusion and after few seconds pull the fixture out of grippers Remove the pump from ERROR XX The pump has detected an service and have the pump XX error code internal malfunction checked by qualified personnel Audible signal accompanying these messages is an intermittent one The purpose of the function KOR Keep Open Rate is to continue infusion of very small amount of drug after the end of infusion SEP 10S PLUS SE
8. the F key and scroll keys in STOP mode and during infusion Turning off on the display backlight night mode Display backlight can be turned off on using the C1 key When running from the internal battery display backlight is turned off automatically SEP 10S PLUS SEP 12S PLUS SP 12S PRO 31 PUMP MANUAL 5 ADVANCED FEATURES Drug protocols optional in SEP 12S Plus and SP 12S Pro unavailable in SEP 10S Plus There is a possibility to configure 5 profiles with up to 10 steps each Profile scheme can be custom configured for various applications i e it is possible to set or disable if unnecessary induction dose and pause time after it program each step rate in different units and duration set post profile rate The profile mode can be used for Propofol Dobutamine Remifentanil and other drugs infusion requiring special drug administration schemes using the best hospital practice Parameters used to configure drug oo Creating drug protocol 32 Drug name Dose mode ml h mg h mg min mg kg h mg kg min ug h ug min ug kg h ug kg min Concentration mg ml g ml Maximum patient weight Induction Loading dose Initial bolus mg ug kg mg ug ml Duration Step count 0 10 Rate N ml h mg h mg min mg kg h mg kg min ug h ug min ug kg h ug kg min Time N Post profile mode To create drug name with protocol enter Drug Set code 147 Drug name T Press the PROG key the follow
9. 17 P 150 KHz TO 80 IEC 61000 4 6 MHz outside ISM bands 10 Vrms 10 Vrms d L2NP 150 kHz to 80 MHz in ISM bands Radiated RF 10 V m 10 V m d 1 2 P 80 MHz to 800 MHz d 2 3 P 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol A NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz gt The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz are intended to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas For this reason an additional factor of 10 3 is used in calculating the recommended separation distance for transm
10. and name see Section Loading the syringe NOTES 1 If the following message is displayed SEP 10S PLUS SEP 12S PLUS SP 12S PRO PUMP MANUAL Switching pump off Loading the syringe NO MAINS Check power cord after pressing the ON OFF key it means the pump is not connected to the mains Either connect the pump to the mains or confirm by pressing the C key that the pump will be powered with the internal battery 2 If the message VERY LOW BATTERY is displayed after pressing the ON OFF key when the pump is connected to the mains then switch it off by pressing the ON OFF key once more and wait for approximately 15 min to allow the internal battery to charge Then the pump will be prepared for syringe insertion and infusion parameter programming The internal battery may be charged permanently because it is protected against overcharging In order to have the battery fully charged keep the pump constantly connected to the mains The pump is switched off by keeping the ON OFF key pressed for 3 sec 1 Lift the syringe clamp to its upper position 2 Turn the Me clamp counter clockwise by 90 3 Pressing the key move the syringe driver arm to the right to the distance needed for syringe insertion Insert the filled syringe into the pump when the following message is displayed Insert SYRINGE into SLOTS SEP 10S PLUS SEP 12S PLUS SP 12S PRO 19 PUMP MANUAL 4 Ins
11. in Bolus mode XXX Bolus rate 3 If you want to inject Bolus manually press and keep the BOLUS key depressed Infusion is performed at the Bolus rate until BOLUS key is released and is accompanied by short beeps Review of programmed parameters Q a Aves PROG ENTER oD oft aay mr E Gs a Gae Programmed parameters may be reviewed during the infusion or after stopping it 1 Press the F key 2 Select the following message by the scrolling keys SETTINGS REVIEW or SETTINGS 3 Press the ENTER key 4 It is possible to review all the programmed parameters by pressing the scroll up key 5 It is possible to exit REVIEW mode by pressing the C key Change of programmed parameters Programmed parameters may be modified only when the a infusion is stopped Infusion rate can be changed Titration during infusion as well as in the stop mode NO oD 06 ad mie mg 0 El START STOP on BOLUS oF O 444 H 718 415 la 9 6 3 ws 1 Press the F key SEP 10S PLUS SEP 12S PLUS SP 12S PRO 2 Select the following message using the scroll keys SETTINGS 3 Press the ENTER key 4 Select the parameter to be modified by the scroll keys 5 Press the PROG key Enter or select the new value of the parameter
12. or missing parts and that connectors and accessories are undamaged Recharge by plugging into mains power outlet Check that the MAINS LED is illuminated during this time Perform as required but recommended every 24 months Entire device Schedule operational checkout by qualified biomedical personnel or authorised service representative Battery Operation Overview Storage The device can be battery operated in emergency situations and for temporary portable applications When operating on battery the Battery LED lights Battery Charging The battery is charging whenever the device is plugged into mains outlet regardless of whether the device is on or off If the pump is not used for a long time the battery should be charged at least once in a 2 months In general the more often a battery is discharged and recharged the sooner it will need to be replaced Notify a authorised service person for replacement Batteries should only be replaced by authorized service personnel Battery Disposal Battery should be disposed of as outlined by the local country regulation It is recommended that the device remain plugged in during storage to maintain the battery at full charge Do not store the device with the key ON and the device unplugged When unpackaged ensure the product is stored in a clean and dry SEP 10S PLUS SEP 12S PLUS SP 12S PRO 41 PUMP MANUAL Test routines Repair 42 20 95 RH no
13. see chapter 3 6 Confirm the new value of the parameter by pressing the ENTER key PUMP MANUAL 29 NOTES 1 Itis possible to change following parameters Infusion rate Bolus rate Bolus dose VTBI Occlusion pressure level 2 Another way to change parameters in the stop mode is as follows Open and close the syringe clamp When the message 9 9 9 Continue infusion is displayed press the NO key 3 Ifkeypad locked first unlock the keypad to change the parameters Standby mode can be activated if such feature is enabled in setup menu 1 Stop the infusion by pressing the START STOP key OFF O 2 Press the ENTER key Standby mode lA ves proc enter 7 8 9 0 om oma s P e Fr galle o Jap 11213 5 Q START la STOP The following message is displayed STANDBY Duration min 3 Enter the pause duration using the numeric keys 4 Confirm the pause duration by pressing the ENTER key The following message is displayed STANDBY Rest XX XX XX X XX XX time remaining to the end of pause 5 Press the C key to cancel the pause Clearing infused drug volume total infused volume available only when infusion is stopped PROG ENTI ES 1 Select the parameter to be cleared with the scroll keys mic mg a oD OF lt lt F 7 8 9 als 6
14. several devices into a single infusion system can have substantial influence on the accuracy of the infusion rate at least for one of these devices In such situations the operation of devices using gravitational forces can be unstable or impossible at all The syringe should be disposed of in an appropriate manner considering the nature of the residual fluid that may be contained within in accordance with the hospital disposal practices Though the factory supplied configuration settings are suitable for most therapies the operator and hospital professionals should verify that the pump settings are appropriate for the clinical application Do not use hard or sharp objects on the keypad Be sure to PURGE THE SYSTEM OF ALL AIR BEFORE ADMINISTERING ANY MEDICATION Failure to follow this normal infusion procedure could precipitate serious consequences Remember that the volume of fluid contained in the connecting tubing is a residual amount and cannot be infused Allow for this extra volume of fluid when initially filling the syringe SEP 10S PLUS SEP 12S PLUS SP 12S PRO 11 PUMP MANUAL Cautions 12 WARNING WARNING CAUTION CAUTION CAUTION must be employed to assure that the pump is in good working order before putting it into use If the pump is being operated on battery power alone ensure that the battery has been charged as described in this manual Verify all program data before pressing START
15. the valid version of the system standard IEC 60601 1 1 If in doubt consult manufacturer s service department Refer to the Service Manual for further information regarding the RS232 interface The assessment for suitability of any software used in the clinical environment to receive data from syringe pump lies with the user of the equipment When infusing through a central line catheter Viltechmeda recommends using sets with a Luer lock adaptor Follow the cleaning schedule and methods defined under Chapter 8 Maintenance and Storage to ensure proper maintenance of the device Do not clean disinfect or sterilise any part of the device by autoclaving or with ethylene oxide gas Doing so may damage the device and void the warranty Only external parts of the device should be disinfected Do not use the following chemicals on the device as they will damage the front panel acetone acetoaldehyde ammonia benzene hydroxytoluene methylene chloride and ozone Do not use cleaners containing n alkyl dimethyl ethylbenzyl ammonium chloride unless they appear in the list of recommended cleaners in chapter 8 When attaching the pump to an IV pole or other mounting locations ensure it has been securely clamped Ensure device is mounted where main body is easily accessible and syringe can be installed in the loading mechanism without stretching or kinking the tubing To avoid personal injury ensure that the IV pole is stable and
16. these susceptibility tests and will perform safely The device s emissions also were found to be acceptable Using the pump near operating equipment which radiate high energy radio frequencies such as electrosurgical cauterising equipment two way radios or cellular telephones may cause false alarm conditions If this happens reposition the pump away from the source of interference or turn off the pump This unit emits a certain level of electromagnetic radiation which is within the levels specified by IEC 60601 2 24 and IEC 60601 1 2 SEP 10S PLUS SEP 12S PLUS SP 12S PRO PUMP MANUAL CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION The RS232 is a standard optional SEP 10S Plus feature on the syringe pump Connection to the computer while pump is connected to the patient is prohibited Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC standards e g IEC 950 for data processing equipment and IEC 60601 1 for medical equipment Furthermore all configurations shall comply with the valid version of the system standard IEC 60601 1 1 Everybody who connects additional equipment to the signal output configures a medical system and is therefore responsible that the system complies with the requirements of
17. E AND STORAGE cccscsssssssessescsscssessesensesceseseesesseesenenscsseeesseseeuseseeseusesceseuseseeseseasessesessessesess 40 Cleaning OVENVIC WS A E E aha 40 Preventive MAMANI A a a A gh ans 41 B ttery Oper tion A A A A RR becsbivesiadeapaise s a ieas 4 OLA rt o O dd o dd al DO et dao 4 TeSt HOULINES 0 A A A A A ERENT EEEE EERE a estes 42 RA A as 42 9 TECHNICAL SPECIFICATIONS sii cecsessecceccste casvessedcecossenstcesbesssecesusseteseedsestenoscececdasteadeseutnsussessedseseukesocsesddecenensecee 43 4 SEP 10S PLUS SEP 12S PLUS SP 12S PRO PUMP MANUAL Volumetric Accuracy Of the SYSten ccccecccccsccssesssssecsscesessessecseesecsceesceseesessecseesecsceeenseesesecseesecaasecesaeeeeesecsesseeneeerentes 45 Startup Graph Description ii AAA A AA esta A AA 45 How Trumpet Curve Graphs are Interpreted c cccccccccscsscesssesceseeseuesseeecseeeecseesccessceaecsesseceeeecasesenseeseeaeeeveeenteeten 46 How Trumpet Curves Can Be Used pirrer ai iE ETa a eA EEE A EEA a A E EEEE Ea 46 Startup and Trumpet Curves paa aeeai Eea da AE Sa a Eein artia Eea idas aate 47 Influences of Back Pressure at SMM iaa a atten ya as Geis E a e iaa 47 Maximum Infusion Pressure Generated cccccccccsccecsecceecssesssesecuseeseesesseesecesecseesceseeseesecsesseceseecseeseeseeseesesieeeeeneeeren 48 Alarm Delay at Ocelusion serieei val stead saci bus esa gu ceeds isis 48 Bolus VOlUMEGE OCCIUSION A te an pbc usited ease dud A aae a a e aE ia 48 Automatic B
18. K BD PRECISE BD PrecisG BD PERFUSOR BD USA MONOJECT Kendall OMNIFIX BBraun Lie PERFUSOR BBraun IVAC INJECTOMAT Fresenius TERUMO Europe TERUMO USA NIPRO LLL JMS KD JECT Ill Ez LLL ELVIONY EXELMED DIMES L Lie Lie DISPOMED PolfaBol PolfaLub JANPOL HAYAT PERF HAYAT 10 20 50 MAYBOD YAS WEIHAI XINHUA HONGDA HUI CHUN L jejeje L jejejejeje 2 a AAA AAA AA A Lie YAZD Le Lie 2 POMAT MEDIZ SHIFA Lil INFUJECT PENTAFERTE ONCE MK BG USC DISPO VAN VITTA ROMSONS Lei LL e V MED 2222222 NOTE The Manufacturer of the pump can change the syringe list including syringes of new brands or removing the included ones The list of syringe brands is dependant on the software version of the pump Only use approved and pressure proved syringes with Luer lock connections and lines SEP 10S PLUS SEP 12S PLUS SP 12S PRO PUMP MANUAL 23 3 PROGRAMMING OF INFUSION PARAMETERS Selecting drug name All parameters can be programmed after syringe is loaded and syringe make confirmed When all the parameters are programmed and infusion started pump keypad can be locked Previously programmed parameters are reviewed using the scrolling up down keys It is necess
19. O PUMP MANUAL 13 ACCESSORIES Description Part Number Headboard footboard mounting B6302003 clamp Clamp for mounting in ambulance cars required by EN B6090003 1789 1999 A1 2003 RS 232 cable B6650007 12VDC cable B6650008 Mains splitter MS 04 B2087019 gt a gt e 3o IV stand 1 235 e a 6 o Clamp for Draeger bar mounting B6302019 01 Nurse Call cable B6650009 Model Serial No Delivery date Quality inspector SEP 10S PLUS SEP 12S PLUS SP 12S PRO PUMP MANUAL 57
20. P 12S PLUS SP 12S PRO PUMP MANUAL 39 8 MAINTENANCE AND STORAGE MANO The pump has to be switched off and must be unplugged from the line for cleaning MIME Do not clean disinfect or sterilise any part of the device by autoclaving or with ethylene oxide gas Doing so may damage the device and void the warranty Only external parts of the device should be disinfected ey enie am Do not use the following chemicals on the device as they will damage the front panel acetone acetoaldehyde ammonia benzene hydroxytoluene methylene chloride and ozone Do not use cleaners containing n alkyl dimethyl ethylbenzyl ammonium chloride unless they appear in the list of recommended cleaners overleaf Weieng Keep the syringe pump clean and dry mer enne am After cleaning check for the absence of liquid in the mains Cleaning Overview 40 inlet The presence of liquid can cause shortening of the contacts Clean the mains inlet using a dry pad of gauze and only then reconnect the pump to the mains The exterior of the device may be cleaned with a soft cloth sparingly dampened with any of the cleaners listed below Do not spray cleaners directly into the syringe mechanism the area where the power cord enters the device or the interface connectors Do not use hard instruments for cleaning Follow the manufacturer s dilution instructions for concentrated cleaners Always clean disinfect the device after each use For a
21. ROG key Following message will be displayed Modify protocol Press the YES key to start modifying protocol as described above Pressing the NO key allows to add new drug name to library Infusion of drug with protocol Drug protocol review Infusion of drug protocol can be started after confirmation of loaded syringe selection drug name with ko symbol setting patient weight if rate units based on patient weight programming of bolus rate and or dose if enabled in set up menu and setting the occlusion level User is able to change rate and duration of the current step of the drug profile during infusion Use the scroll keys to review current parameters during infusion NOTES 1 Having achieved the required therapeutic level it is possible to terminate the profile by pressing the STOP key The following message will appear End Profile YES NO 1 1 Press the YES key If you press the START key afterwards infusion will be continued with the rate profile was terminated at until syringe is emptied 1 2 Press the NO key If you press the START key afterwards infusion will be continued from the point profile was terminated 2 To stop the Induction Loading dose Initial bolus during their delivery and switch to the first step execution press the STOP key and afterwards the START To review drug protocol parameters press the F key available only having selected and confirmed drug name The following
22. SEP 10S Plus SEP 125 Plus SP 125 Pro SYRINGE INFUSION PUMPS gv aifecs Prior to using this pump read this manual carefully to fully understand the pump s functionality and to ensure safe and proper operation Document history Original issue BN037047EN September 2006 firmware version SPP02 Revision 1 0 BN037047EN P01 November 2006 firmware version SPP02 Revision 2 0 BN037047EN P02 March 2007 firmware version SPP03 2 SEP 10S PLUS SEP 12S PLUS SP 12S PRO PUMP MANUAL CONTENTS DOCUMENTO A iii 2 CONTENTS AAA E E O E E E 3 Compliance artista 6 Material Specifications oeh eeina E NN 7 Hazardous components to be separated at the end Of life ccccccccsccecesesseesecsseesceseeseesesseeeeeeecneeeeceseessesenseeseeeeeesaes 7 INTRODUCTION cares ccscusccccctscseseetveassetsnceeseusvccesuste coacsesautecansetssceesestesceccste consessvecevestseccsestesdestesestsvesdecsesestsdcnuts duscenenseesses 8 OVErvI Woo ia 8 PUMP DESIDIA AAA ee a Ee A eee ee a Dae a a 8 Serial Number Descriptions ia iii di dais dis 8 Tems supphed With pump Scott 9 Operational Warnings and Cautions sinisiin eei e r en aaie 9 SVM DOL MCP ULI A E seen sa ano EREE EEE EEEE EE EE E E 10 WANNE S ae EER ENE E ii de TEA 11 CAU A O e da 12 NOLES Dra tl eds helada Mb e eet ea bre at sd asa 14 1 PUMP DESCRIPTION poriniti toia A TA TA A EL SE E A T A 15 Front view of SEP I0S Plus ssccczcscces css Aosulevizasstcvtuseses suzssatiotaistsevannistge
23. US SEP 12S PLUS SP 12S PRO 43 PUMP MANUAL Infusion rate in mass units 0 01 to 9 99 ug mg h ug mg kg h min in 0 01 ug mg h ug mg kg h min steps 10 0 to 99 9 ug mg h ug mg kg h min in 0 1 ug mg h ug mg kg h min steps 100 to 999 ug mg h ug mg kg h min in 1 ug mg h ug mg kg h min steps Bolus doses 0 1 to 99 9 ml in 0 1 ml steps 0 1 to 99 9 ml in 0 1 ml steps 0 01 to 9 99 ug mg ug mg kg in 0 01 18 mg ug mg kg steps 10 0 to 99 9 pg mg ug mg kg in 0 1 1g mg ug mg kg steps 100 to 999 ug mg ug mg kg in 1 g mg ug mg kg steps no automatic bolus Battery charging time Patient weight 0 4 to 99 9 kg in 0 1 kg steps 100 to 200 kg in 1 kg steps Mounting table top operation universal pole clamp Draeger bar optional Mains splitter optional AC power supply 220 230 VAC 10 50 60 Hz or 115 VAC optional 10 50 60 Hz External DC power supply 12 VDC Battery Battery type NiMH 9 6 V 1300 mAh Battery operation 8h 5 ml h Up to 24 hours to 100 charge Power consumption 10 VA max Fuses T80 mA L250 V for 220 230 VAC T160 mA L250 V for 115 VAC Protection against current leakage Type CF equipment Protection against electrical shocks Class II Protection against splashing liquid IPX4 splashing water protected CE 0408 Council Directive 93 42 EEC 14 June 1993 concerning medical devices E
24. abled in setup menu Programming drug concentration only in SEP 12S Plus and SP 12S Pro Select the message Concentration on the display 1 Press the PROG key 2 Select the required drug concentration measurement unit using the ml lt omg key 3 Enter the required value of drug concentration using the numerical keypad 4 Confirm drug concentration by pressing the ENTER key NOTES 1 In order to have drug concentration calculated from entered drug mass and diluent volume select the message Calculate concentration using the ml omg key Press the YES key Enter drug mass and diluent volume analogously to concentration programming above 2 Drug concentration can be programmed only if infusion rate is set in mass units 3 Drug concentration value can not be set to 0 Programming patient s weight only in SEP 12S Plus and SP 12S Pro Select the message Patient weight on the display 1 Press the PROG key 2 Enter the patient weight using the numerical keypad 3 Press the ENTER key to confirm the selected patient weight NOTE The programmed patient s weight shall not exceed the value of 200 kg Programming infusion rate or volume over time Select the message Infusion rate on the display 1 Press the PROG key SEP 10S PLUS SEP 12S PLUS SP 12S PRO 25 PUMP MANUAL 2 Enter the required value of infusion rate using the numerical keypad 3 Press t
25. an help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and syringe pump as recommended below according to the maximum output power of the communications equipment Rated Separation distance according to frequency of transmitter maximum m output power of transmitter 150 kHz to 80 MHz 150 kHz to 80 MHz 80 MHz to 800 800 MHz to 2 5 Ww outside ISM bands in ISM bands MHz GHz d 1 17 P d 1 2NP d 1 2P d 2 3NP NOTE 1 At 80 MHz and 800 MHz the separation distance of the higher frequency range applies NOTE 2 The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz NOTE 3 An additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas NOTE 4 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 54 11 DRAWING OF CABLES FOR MULTIFUNCTIONAL CONNECTOR MFC TO PC TO PUMP RS232 connection YYYY
26. ary to confirm all the parameters To confirm the parameter press the ENTER key or the scrolling up key Only then the pump will switch to STOP mode 9 In order to modify the selected parameter press the PROG key Enter the parameter value using the numerical keys and press the ENTER key to confirm it Using the ml lt omg during programming of parameter value it is possible to select the required measurement unit only in SEP 12S Plus and SP 12S Pro When the parameter has no numerical value then select the required message by means of the scroll keys and confirm it by pressing the ENTER key To cancel newly entered selected value and restore previous value press the PROG 1 After syringe is inserted and brand confirmed press the PROG key 2 Select the required drug name by the scrolling keys 3 Press the ENTER key to confirm selected drug name NOTES 1 If you don t want the drug name to be displayed select NONE from the drug list and press ENTER 2 You can enter new drug name to the list in accordance with instruction given in the chapter 6 of this manual Selecting dose mode only in SEP 12S Plus and SP 12S Pro 24 Select the message Dose mode 1 Press the PROG key 2 Select the required infusion rate unit by pressing the mlomg key 3 Press the Enter key to confirm the selected dose mode SEP 10S PLUS SEP 12S PLUS SP 12S PRO PUMP MANUAL NOTE Available only ifmass units en
27. d in such an environment Emission test Compliance Electromagnetic environment guidance RF emissions Group 1 Syringe pump uses RF energy only for its CISPR 11 internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B Syringe pump is suitable for use in all CISPR 11 establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions Class A IEC 61000 3 2 Voltage fluctuations flicker Complies emissions IEC 61000 3 3 Table 2 Guidance and manufacturer s declaration electromagnetic immunity Syringe pump is intended for use in the electromagnetic environment specified below The customer or the user of syringe pump should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV contact 1 Floors should be wood concrete or ceramic tile If the floors are covered with synthetic material the relative humidity should be at least 30 8 kV air 15 kV air 1 Electrical fast 2 kV for power 2 kV for power Mains power quality should be that of a typical transient burst supply
28. deviation reflects the M mean percentage error smallest sampling intervals or observation windows As the sizes Percentage error min of the sampling intervals increase in minutes the deviations in Observation interval flow from the programmed delivery rate are reduced as the Trumpet Graph Example deviations are spread out over the longer periods of time This results in the narrowing of the trumpet curve giving a more realistic representation of the device s average flow rate accuracy over longer intervals of time For example if you were to look at the maximum and minimum percentage error points corresponding to the 5 minute interval point on the Observation Interval axis you would be looking at the average flow variance for any 5 minute period throughout the infusion Similarly if you were to look at the 60 minute interval point on the Observation Interval axis you would be looking at the average flow variance for any 60 minute period throughout the infusion How Trumpet Curves Can Be Used Trumpet curves can be important sources of information for the medical professional who must decide whether a certain infusion pump can be used with a particular drug For example when delivering a drug with a short half life very small deviations in flow over the course of an infusion would be desirable to ensure that the deviations in plasma level also remained small The device s ability to deliver very closely to the programmed rate
29. device that has been in an Isolation Area select those agents from the list below that both clean and disinfect While the product design safeguards against fluid spillage if fluid enters the pump contact your dealer or manufacturer s servicing department for assistance This should be done immediately to minimise any potential difficulties with the solutions pooling and drying on the mechanism Recommended cleaners Before using a cleaner on the pump it should be tested on a small area beforehand A solution of 3 hydrogen peroxide Soapy water Ethyl alcohol SEP 10S PLUS SEP 12S PLUS SP 12S PRO PUMP MANUAL Preventive Maintenance The table below contains a schedule of basic maintenance tasks that should be performed on the device If the device cannot be cleaned using the basic methods described earlier or components are missing or damaged discontinue use and notify the appropriate authorised service personnel Check Action Perform as required but recommended after every use Housings Clean housing and front panel as recommended in the cleaning instructions in this section Check for cracks and large dents Labels Clean as recommended in the cleaning instructions Check for scratches cuts or obliterated words Power cord Verify that the power cord is undamaged over the entire length of the cord and the moulded plug Rear housing accessory Battery Verify that there are no loose
30. e syringe pump be powered from an uninterruptible power supply or a battery User should always have battery installed per Operators Manual sec sec 2 Power frequency 3 A m 3 A m Power frequency magnetic characteristic of a typical 50 60 Hz location in a typical commercial or hospital magnetic field environment IEC 61000 4 8 400 A m 1 The pump functions normally when exposed to power frequency magnetic fields of 400 A m Note 1 Syringe pump was designed to meet the requirements of EN 60601 1 2 2001 and IEC 60601 2 24 1998 Note 2 Pump automatically transfers to battery operation if there is a loss of main power SEP 10S PLUS SEP 12S PLUS SP 12S PRO 51 PUMP MANUAL Table 3 Guidance and manufacturer s declaration electromagnetic immunity for LIFE SUPPORTING EQUIPMENT and SYSTEMS Syringe pump is intended for use in the electromagnetic environment specified below The customer or the user of syringe pump should assure that it is used in such an environment IEC 61000 4 3 80 MHz to 2 5 GHz Immunity test IEC 60601 Compliance Electromagnetic environment guidance test level level Portable and mobile RF communications equipment should be used no closer to any part of syringe pump including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms 3 Vrms d 1
31. eesensesseesecseesecseescacecseeaecseeseceveeeneseseeaeeseeaeseseeneeeren 26 SEP 10S PLUS SEP 12S PLUS SP 12S PRO 3 PUMP MANUAL Programming bolus TALE RA AA A AAA A A A a aa een A 26 Prosramming bolus dose 2 A A A a A an a eek 27 Programming occlusion pressure level ccccccccccccsccsssescesseseesseeecnseescesesseesecesecseescsecseeaecseseceseeceeesesseeseeeeeeeeeneeeren 27 4 INFUSI N ssssssscocsssstsosesssntetenesssusestesensoostsassensesesseorensssoosess oseosessesoustsasseosesesseasuss osootesseseusiss opeeresossoasuss iseeresoesossesesseorases 28 Starting and stopping INJUSTO arado e abia etica 28 BOLUS COSC injection 2 A A A AA A A EEE E one 28 Review of programmed parameters cccccccsccsceescevseseesceseeecsseeecuseescsecseesecseeecseeseceeseesecseeseceseeenseeseeseeseeaesneeeeensetend 29 Change of programmed parameters ceccccccccceeccecesseeecueeeeeeeecseescuseeseesecseeecsseeecseeseesecseeseseeeecateeseesecieeeeneeeeeneeeree 29 Standby modesina a AS AS le AS Soles th IE E RS 30 Clearing infused drug volume total infused VOIUME Q cccccccssesseeeceseesesseeeecuseeecuseescesesseesecseeecnteeseesenseeseeseeseeaeeatees 30 Locking and unlocking Keypad cccccccccccscssssssseveesecnseeesseeeceeeecceesccesseesecseeecseeececeeseesecseeeceseeeaeseseeseeseeaesneveeeneeeren 31 Viewing date ANEMIA ali 31 Turning off on the display backlight night mode cccccccceeceeteescesesseeseeseeeecseeecseescesesseesecueseecaseesensen
32. ements of the standards EN ISO 9001 2000 and EN ISO 13485 2003 Devices SEP 10S Plus SEP 12S Plus SP 12S Pro hereinafter the pump Manufacturer Viltechmeda 125 Kalvariju Str 08221 Vilnius Lithuania 6 SEP 10S PLUS SEP 12S PLUS SP 12S PRO PUMP MANUAL Material Specifications Steel Stainless Steel Copper Aluminium Bronze Brass Polyamide PA6 PA Polycarbonate PC Composition of Polycarbonate and ABS PC ABS Battery NIMH Hazardous components to be separated at the end of life Battery NIMH Printed circuit boards containing brominated flame retardant TBBA 79 94 7 and lead Electrolyte capacitors AC power lead SEP 10S PLUS SEP 12S PLUS SP 12S PRO PUMP MANUAL INTRODUCTION Overview Pump description Serial Number Description VILTECHMEDA 125 Kalvariju Str 08221 Vilnius Lithuania Tel 370 5 2776745 2737508 Fax 370 5 2763867 E mail faktor aitecs com The pump is designed to meet the fluid and drug delivery requirements of today s changing clinical environment The pump is indicated for infusion via intravenous IV intra arterial IA epidural or subcutaneous routes of administration Infusion rates are programmable from 0 1 to 1500 ml h The pump accepts wide range single use syringes with volumes from 10 to 100 ml optional 5 ml The pump can be custom configured to select key features that meet specific requirements The selected option
33. ert the syringe push button into the syringe driver arm slot to the depth to ensure minimal distance between the syringe barrel and the pump body 5 Holding the syringe by hand keep pressing the BOLUS key until the syringe finger grips will fit into the corresponding pump slot 6 By pressing the syringe barrel and push button down insert fully the syringe finger grips and push button into corresponding pump slots The cylindrical syringe barrel shall lay on the pump body with no gap Axes of the syringe barrel and its plunger shall be on the same line The following message is displayed Close CLAMP 7 Turn the syringe clamp clockwise by 90 8 Lower the syringe clamp onto the syringe barrel The syringe size sensor determines the syringe size automatically The following message is displayed Syringe XX ml syringe brand name where XX syringe size D 9 If the syringe size and brand are correct press the ENTER key Q KES enoa 10 Otherwise press the PROG key ala 11 Select the required syringe name with the scrolling keys oD oB aa 12 Confirm the selected syringe name and size selected by mo Lam UH 0 pressing the ENTER key mer ennie em Use of syringes not pre programmed or incorrect insertion of the syringe increase patient s risk 20 SEP 10S PLUS SEP 12S PLUS SP 12S PRO PUMP MANUAL Syringe removal
34. expense Ifno defect is found during testing the Manufacturer or its authorised representative reserves the right to submit the invoice to the customer for the work carried out This Warranty is not applicable to pumps with damaged seal or when failure was caused by violations of requirements of this Operation Manual by mains voltage non conformity to the requirements of IEC by spills of liquids by mechanical damages caused by shocks or a pump being dropped by pump damages caused during transportation or when packaging is damaged For service and repair contact manufacturer Viltechmeda 125 Kalvariju Str 08221 Vilnius Lithuania Tel 370 5 2776 745 2737 508 2737 506 Fax 370 5 2763 867 E mail service aitecs com Shipping costs for all units returned to Viltechmeda shall be paid for by the customer The unit must be packed in its original container or in another Viltechmeda approved container that will provide adequate protection during shipment To ensure prompt return a Viltechmeda s authorised dealer must be notified before shipping any unit for repair When calling for service please be prepared to provide model and serial number of the unit A brief written description of the problem should be attached to the instrument when it is returned for service Viltechmeda will not be responsible for unauthorised returns or for units damaged in shipment due to improper packing SEP 10S PLUS SEP 12S PLUS SP 12S PR
35. g of this parameter by means of the C key or by switching the pump off XX programmed infusion rate 1 Press the START STOP key Segments of the X44 4H indicator begin to flash sequentially 2 You may review the following parameters using the scroll keys drug name XXX ml h XXX infusion rate VTBI XX ml TIME XX XX XX X Volume to be infused XX XX XX time remaining to the end of VTBI Infused X X ml Total XX ml X X amount of drug infused during current session XX total infused amount of drug 3 Press the START STOP key when you wish to stop the infusion Segments of the X44 4H indicator stop flashing and the rightmost segment only is left on Bolus may be injected during infusion only 0 1 Press the BOLUS key The following message is displayed a AYES PROG emer 7 8 9 om oa lin FI 4 6 al 1 2 3 02 on START BOLUS OFF O STOP 444 28 BOLUS Press YES BOLUS SEP 10S PLUS SEP 12S PLUS SP 12S PRO PUMP MANUAL NOTE While the keypad lock is active bolus injection is prevented To inject bolus first unlock the keypad 2 If you want to inject the programmed Bolus dose press the YES key During Bolus performance the following message is displayed BOLUS X X ml XXX ml h X X amount of drug injected
36. he Enter key to confirm the selected infusion rate NOTE In order to have infusion rate calculated from entered volume to be infused VTBI value and time press the F key during infusion rate programming i e after pressing the PROG key The following message is displayed Volume over time Press the YES key Enter VTBI value and Time analogously to infusion rate programming above Programming volume to be infused VTBI Programming bolus rate Select the message VTBI on the display 1 Press the PROG key 2 Enter VTBI value using the numerical keypad 3 Press the ENTER key to confirm VTBI value NOTE To reset previously entered value and execute the infusion without the preset VTBI set the VTBI value to 0 Select the message BOLUS rate on the display 1 Press the PROG key 2 Enter the required value of Bolus rate with the numeric keypad When Bolus function is not required the Bolus rate value will be set to zero 3 Press the ENTER key to confirm the selected Bolus rate NOTE Bolus rate can be programmed only if BOLUS RATE PROGRAMMING feature enabled in Setup menu see chapter 6 26 SEP 10S PLUS SEP 12S PLUS SP 12S PRO PUMP MANUAL Programming bolus dose Select the message BOLUS dose on the display 1 Press the PROG key 2 Select the required Bolus dose measurement unit using the mlomg key only in SEP 12S Plus and SP 12S P
37. ing message is displayed Replace drug name Press the YES key to edit selected drug name or the NO key and afterwards the YES key in response to message to add drug name Add drug name Enter the new drug name using keys in accordance with the table shown in chapter 6 Having entered required drug name press the F key to place ko symbol at the end of drug name a symbol initiates programming of protocol Confirm the new drug name by pressing the ENTER key SEP 10S PLUS SEP 12S PLUS SP 12S PRO PUMP MANUAL Dose mode Press the PROG key Select the required rate units using the ml lt gt mg key and press the ENTER key Concentration available if dose mode in mass units Press the PROG key Select the required units using the ml gt mg key and enter concentration value using the numerical keypad Press the ENTER key to confirm MAXIMUM PATIENT WEIGHT available if dose mode based on patient weight Press the PROG key Enter maximum patient weight using the numerical keypad and press the ENTER key Induction Loading dose Initial bolus Press the PROG key Select the required units using the ml gt mg key and enter required value using the numerical keypad NOTE Using the F key during programming it is possible to select the naming of parameter Induction Loading dose or Initial Bolus Duration Press the PROG key Enter the Induction Loading dose Initial bolus duration h min sec usi
38. ion SEP 10S Plus SEP 12S Plus SP 12S Pro Syringe sizes 10 100 ml of main brands 5 ml optional Infusion rates 0 1 to 99 9 ml h in 0 1 ml h steps 100 to 1500 ml h in 1 ml h steps Note Maximal infusion and Bolus rates 200 ml h for syringe 5 ml 450 ml h for syringe 10 ml 750 ml h for syringe 20 ml 950 ml h for syringe 30 ml 1500 ml h for syringes 50 60 ml and 100 ml Volumetric accuracy 2 or 0 1 ml h the greater of these values with approved syringes Mechanical accuracy 1 Volume To Be Infused VTBI 0 1 to 99 9 ml 0 1 ml steps 100 to 999 ml in 1 ml steps unlimited volume Bolus rates 0 10 to 1500 ml h in 1 ml h steps IKOR Keep Open Rate rate 0 1 10 0 ml h in 0 1 ml h steps or set rate if lower than KOR IKOR volume 1 0 of syringe volume Standby time 1 to 999 min in 1min steps Volume infused 0 1 to 99999 ml Occlusion alarm pressure high 120 kPa 25 kPa medium 80 kPa 20 kPa low 40 kPa 15 kPa or only for SP 12S Pro high 90 kPa 20 kPa medium 60 kPa 15 kPa low 30 kPa 15 kPa Medium and low levels for 50 60 ml and 100 ml syringes only Concentration 0 01 to 9 99 ug mg ml in 0 01 ug mg ml steps 10 0 to 99 9 ug mg ml in 0 1 ug mg ml steps 100 to 999 ug mg ml in 1 ug mg ml steps SEP 10S PL
39. itters in these frequency ranges 52 Table 3 Guidance and manufacturer s declaration electromagnetic immunity for LIFE SUPPORTING EQUIPMENT and SYSTEMS continued Syringe pump is intended for use in the electromagnetic environment specified below The customer or the user of syringe pump should assure that it is used in such an environment IEC 60601 test level Compliance level Immunity test Electromagnetic environment guidance Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which syringe pump is used exceeds the applicable RF compliance level above syringe pump should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating syringe pump d Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Table 4 Recommended separation distances between portable and mobile RF communications equipment and syringe pump for LIFE SUPPORTING EQUIPMENT and SYSTEMS Syringe pump is intended for
40. lectrical safety and EMC IEC 60601 1 1 2 2 24 Maximum volume under single fault condition lt 0 5 ml 44 SEP 10S PLUS SEP 12S PLUS SP 12S PRO PUMP MANUAL Operating temperature range 5 C 40 C Transport and storage temperature 20 C 40 C Operating atmospheric pressure 60 kPa 106 kPa Permissible relative humidity 20 90 no condensation IMemory retention For more than 10 years when not powered up Event log up to 2000 events Infusion modes Continuous Profile optional in SEP 12S Plus SP 12S Pro Use in ambulances Optional in SEP 10S Plus and SP 12S Pro Interfaces RS 232 optional in SEP 10S Plus Nursecall optional Dimensions WxHxD 305 x 135 x 195 mm Weight 2 6 kg Transport In the original packaging Volumetric Accuracy of the System Startup Graph Description The pump using the appropriate syringe identified in Chapter 2 maintains a volumetric accuracy with delivery errors not exceeding 2 for any one hour period over 72 hours at 5 ml h Note that flow fluctuations can be caused by unusual conditions or combinations of conditions that may involve but are not limited to the following fluid density positive and negative pressure and the environment Flow fluctuations are most likely to occur when the conditions mentioned above are exacerbated or when the device is operated in condition
41. lines supply lines commercial or hospital environment IEC 61000 4 4 1kV for 1kV for input output lines input output lines Surge IEC 61000 4 5 1kV differential mode 2 kV common mode 1kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment 50 SEP 10S PLUS SEP 12S PLUS SP 12S PRO PUMP MANUAL Table 2 Guidance and manufacturer s declaration electromagnetic immunity continued Syringe pump is intended for use in the electromagnetic environment specified below The customer or the user of syringe pump should assure that it is used in such an environment y IEC 60601 Compliance Immunity test test level level Electromagnetic environment guidance Voltage dips short lt 5 Ur gt 95 lt 5 Ur gt 95 Mains power quality should be that of a typical interruptions and voltage variations on power supply input lines TEC 61000 4 11 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Uy for 25 cycles lt 5 Ur 95 dip in Ur for 5 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Uy for 25 cycles lt 5 Ur 295 dip in Ur for 5 commercial or hospital environment If the user of the syringe pump requires continued operation during power mains interruptions it is recommended that th
42. message will be displayed Protocol review Press the ENTER key Review the protocol profile parameters using the scroll keys 34 SEP 10S PLUS SEP 12S PLUS SP 12S PRO PUMP MANUAL 6 SETUP MENU Pump mode code 100 In order to access optional functions or certain parameters keep the START key in pressed position and switch the pump on by pressing the ON OFF key When short beep is heard release the START key enter appropriate code see codes below using the numerical keys Confirm it by pressing the ENTER key List of optional functions may be reviewed using the scroll keys If displayed name is marked with the asterisk it means that function is active To activate an inactive function press the ENTER key and the asterisk will appear in front of the item name To deactivate a function press the C key The asterisk shall disappear To exit setup menu press the START STOP key This option is used to set the infusion mode the pump will operate in Following infusion modes are available Continuous rate mode Easy pump mode Event history review optional code 111 Syringe set code 137 Drug set code 147 This option is used to review the event history Use the scroll keys to review the events In order to get more detailed information on events use the Event History utility to upload the event history to PC This option is used to configure the type and size of syringe permitted for use o
43. n condensing environment to safeguard against prolonged exposure to dust and moisture In conditions falling outside the Environmental Operating Limits see the Technical Specifications Table in chapter 9 Viltechmeda recommends that the device be repackaged in the original shipping materials The test routines are designed to allow confirmation of many of pump parameters functions and calibration without requiring internal inspection Refer to Service Manual for a complete list of test and calibration procedures The right to repair the pump or carry out periodical part replacements is reserved only to the Manufacturer authorised service representative The pump as well as its replaceable spare parts shall be disposed of taking local legislation into consideration Do not send back to the manufacturer None of the pump s components does not pose hazard to environment and can be safely disposed of in accordance with hospital protocols Table 1 Pump part to be periodically replaced Part Part Name Periodicity of Criterion for Number Replacement Replacement IB6640001 Battery 3 4 years Cordless work time has diminished more than twice check at 25 C IB8123009 Cap 3 4 years Damages cracks etc periodicity of replacement depends mainly on the frequency of use for each part SEP 10S PLUS SEP 12S PLUS SP 12S PRO PUMP MANUAL 9 TECHNICAL SPECTFICATIONS Component Descript
44. n the pump Select all possible syringes which may be used and disable any that should not be used This option allows to compose drug library to be used on the pump Drug library can comprise up to 30 drug names To replace drug name open the drug list and select the drug name to be replaced by the new one Press the PROG key the following message is displayed Replace drug name SEP 10S PLUS SEP 12S PLUS SP 12S PRO 35 PUMP MANUAL Press the YES key to edit selected drug name or the NO key and afterwards the YES key in response to message to add drug name Add drug name Enter the new drug name using keys in accordance with the table below e g to enter letter Z press the 9 key four times Key 1 2 3 4 5 6 7 8 9 0 YES NO Character 1 AB D E G H J K M N P Q T U W X 0 Space Backspace IC 2 F 3 0 4 L 5 0 6 R S 7 V 8 Y Z 9 Confirm the new drug name by pressing the ENTER key NOTES 1 Entered character can be reset by means of the C or NO keys 2 Old drug name can be restored by means of the PROG key until new name is confirmed Default drug set code 157 This option restores default manufacturer s drug set Language set code 337 This option allows the language of the pump to be set Date and Time setting code 637 This option allows to set of date and time Parameter set
45. nal battery Reconnect the pump to AC power supply or press the CANCEL key to silence the alarm and continue operation on internal battery Connect the mains cable to the pump Switch on the pump and launch infusion After few seconds disconnect the mains cable LOW BATTERY and BATTERY LED flashing Battery charge low Connect the pump to AC power supply and charge the internal battery Run the pump on battery until alarm signal is generated VERY LOW BATTERY The internal battery is depleted Connect the pump to AC power supply Run the pump on battery until it is depleted completely OCCLUSION Pressure in the extension set and the syringe has reached the alarm limit Identify and remove the cause of the blockage in the extension set syringe or drive While infusion is in progress block the extension line and wait until alarm is generated OCCLUSION or END The pump ceased its operation due to blockage in the extension set syringe or drive or if the syringe plunger has reached the end of its travel It may happen when syringe was not fully filled If the cause of stopping is an occlusion remove the cause of blockage and resume infusion by pressing the START STOP key When the cause of stopping is the syringe plunger reaching the end of its travel the syringe shall be replaced Use BD Plastipak 50 ml syringe Pull out syringe plunger to the value of 1 ml Launch
46. ng the numerical keypad Use the key to skip between hours minutes and seconds NOTES 1 When duration is disabled set to 0 Induction Loading dose Initial bolus will be infused at the bolus rate 2 In order to set the pause after Induction Loading dose Initial bolus it is necessary to leave profile first step rate 0 and set the step duration conforming to the required pause time see below 8 Rate N Time N Step count Press the PROG key and enter the number of steps using the numerical keypad Confirm the entered value by pressing the ENTER key Rate N Time N Select one by one and program parameters of each step pressing the PROG key and having entered required value confirm it pressing the ENTER key Post profile mode Press the PROG key set the post profile rate and press the ENTER key to confirm set 0 to stop the infusion after profile completion SEP 10S PLUS SEP 12S PLUS SP 12S PRO 33 PUMP MANUAL Modyfing drug protocol NOTES 1 Itis possible to exit drug protocol programming by pressing the START key and afterwards the YES key In such case all previous settings are discarded 2 To review the programmed protocol select the drug name with symbol and press the F key When the message PROTOCOL review is indicated press the ENTER key and review the drug protocol using the scroll keys Press the C key to exit review mode Enter Drug set and select the drug name with ko symbol Press the P
47. nge clamp 6 Mounting clamp handle optional in SEP 10S Plus 16 SEP 10S PLUS SEP 12S PLUS SP 12S PRO PUMP MANUAL Keypad indicators reference guide The green BATTERY LED lights when the pump is operating on battery power Flashing if LOW BATTERY alarm condition occurs The green MAINS LED lights when the pump is connected to the AC and battery is charging ie de During infusion three yellow LEDs are sequentially flashing If the rightmost LED is on permanently the infusion is stopped de Keypad keys reference guide Key to switch the pump on off keep it pressed for several seconds in order to switch off a Key to start stop the infusion Key to move the syringe driver arm rapidly to the left hand side during syringe insertion or to initiate the Bolus mode it is also intended for air removal from the extension set after syringe insertion GE Key to move the syringe driver arm to the right hand side g O Keys to scroll up down the list of parameters and syringe brands or answer positively or negatively the dialog questions Key to select dimensions of parameters when programming only in SEP 12S Plus and SP 12S Pro Key to program modify parameters Pressing it once more restores previous values DOG Key to confirm the selected parameter OLD Numerical keys to enter digits of the parameter being programmed Key to select additi
48. ntal impact of waste electrical and electronic equipment WEEE Complies with the directive 95 54 EEC concerning the suppression of radio interference in road ambulances optional in SEP 10S Plus and SP 12S Pro 10 SEP 10S PLUS SEP 12S PLUS SP 12S PRO PUMP MANUAL Warnings WARNING E Possible explosion hazard if used in the presence of flammable anesthetics Always read and follow the instructions which accompany the syringe and extension sets you are using Carefully follow the instructions for priming the set as well as the recommended set change interval Set use should not exceed the label set change interval Viltechmeda will assume no responsibility for incidents which may occur if the product is not used in accordance with product labeling The pump has no means to detect air presence in the extension set The pump operator shall ensure there is no air in the extension set 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 Do not connect the IV extension set to the patient when purging This device should be used only with Viltechmeda accessories specified for this device There are risks associated with using anything other than the recommended accessories with this device The specified accuracy of the syringe pump can only be maintained when recommended syringe and accessories are used Inter connection of
49. olus VOLUME ACCUVACY ceceseseeseeseesesssesecaseuseeseesecacesecuceccuseesessecatesecseeeesseecessecseesscaesecceaeeceeseeaeesecaeeerenaes 48 10 GUIDANCE AND MANUFACTURER S DECLARATION ON ELECTROMAGNETIC EMISSIONS 49 Electromagnetic Compatibility StateMment cccccccccsscessescesesseesecsseeecseesecessecseesccecseesecseeseceeeecseaeseeceaseseeseeeeeaeeatee 49 11 DRAWING OF CABLES FOR MULTIFUNCTIONAL CONNECTOR MEC cssssssssssssssssssssssessseserseees 55 12 WARRANTY AND SERVICE INFORMATION scscssssssssesssssssescsssnessssssssesssessscssenessssseesesssssossossnessssserseses 56 WATT ONY codec tah A A A ison dia E N de ces scah dd OS 56 Seryicednformation ER A A AS E A A oe ase cs oh 56 13 ACCESSORIES scssssssssrsssssssssrsessessrsersessssersesscssrsnssessrsesssssssnssesessessesensssssensssssesssessesesssesessssecesensessessessesenees 57 SEP 10S PLUS SEP 12S PLUS SP 12S PRO 5 PUMP MANUAL CE osos This symbol represents compliance with the essential requirements according to MDD 93 42 EEC 14 June 1993 of the European Communities concerning medical devices Compliance The pumps comply with IEC 60601 1 IEC 60601 1 2 IEC 60601 2 24 standards SEP 10S Plus and SP 12S Pro intended for use in road ambulances comply with EN 1789 1999 SEP 10S Plus and SP 12S Pro FDA approved The pumps have been manufactured by the company which has implemented and maintains a Quality Assurance System meeting the requir
50. onal functions or to review programmed parameters PO Key to cancel the numerical value or the meaning of the parameter or silence the alarm signal It deletes TOTAL INFUSED and INFUSED DOSE values and clears the numerical value on display when programming SEP 10S PLUS SEP 12S PLUS SP 12S PRO 17 PUMP MANUAL 2 BASIC OPERATION Switching pump on 18 1 Fasten the pump to the stand by turning the pole clamp handle 2 Connect the power cord to the corresponding socket on the pump 3 Secure the power cord to the pump by means of the metal clamp 4 Connect the power cord into the mains receptacle The green indicator will light on 2 5 Switch the pump on by pressing the ON OFF key Si oD of aay Ia on START BOLUS oF O L stant 4 H r gt AYES PROG ENTER There are three possible situations a the following message is displayed Insert SYRINGE into SLOTS Insert the syringe filled and with the extension set connected see Section Loading the syringe or b the following message is displayed Close CLAMP Remove air from the extension set and fasten the syringe by means of the clamp see Section Loading the syringe or c the following message is displayed if syringe inserted prior to switching the pump on Syringe XX ml syringe brand name Confirm syringe size
51. proper operation This manual has been developed with consideration to the requirements in the International Standard IEC 60601 2 24 Medical Electrical Equipment Part 2 24 Particular Requirements for Safety of Infusion Pumps and Controllers Data presented in the Technical Specifications reflect specific test conditions defined in this standard Other external factors such as varying back pressure temperature head height set usage fluid restrictions solution viscosity or combinations of these factors may result in deviations from the performance data enclosed Definitions Warning messages indicate a possible hazard which if not avoided could result in severe personal injury or death Caution messages indicate a problem or unsafe practice which if not avoided could result in minor or moderate personal injury product or property damage Note messages provide supplemental information to the accompanying text SEP 10S PLUS SEP 12S PLUS SP 12S PRO 9 PUMP MANUAL Symbol definition A 0 IPX4 CE ooo RS 232 g Dx XXXXXX Attention consult accompanying documents Protection Class II CF type device leak currents protection Splashing water protected Complies with MDD 93 42 EEC directive Nurse call connector optional RS232 interface Do not dispose of this product as unsorted municipal waste Follow local municipal waste ordinances for proper disposal provisions to reduce the environme
52. ro 3 Enter the required value of Bolus dose using the numeric keypad 4 Press the ENTER key to confirm the selected Bolus dose NOTE When the Bolus rate value is set to zero the Bolus dose can not be programmed as well Programming occlusion pressure level Occlusion pressure level can only be programmed for 50 60 and 100 ml syringes For syringes from 5 to 30 ml only HIGH occlusion pressure level is available Select the message Occlusion level on the display 1 Press the PROG key 2 Select the required occlusion pressure level using the scroll keys 3 Confirm selected occlusion pressure level by pressing the ENTER key NOTE The pump has an anti bolus function which reduces the pressure in the syringe and the extension set in case of occlusion and at the same time diminishes the volume of unwanted Bolus injected to the patient after removal of the occlusion cause SEP 10S PLUS SEP 12S PLUS SP 12S PRO 27 PUMP MANUAL 4 INFUSION Starting and stopping infusion oD Of lt A A YES PROG Y No mie mg ENTER on OFF O BOLUS D 444 gt Bolus dose injection The infusion is started from the STOP mode when the following message is displayed Stop X X ml XX ml h X X amount of drug in ml mg or ug infused during observation time i e period from the last clearin
53. s can be easily reviewed and the chosen configuration can be changed to meet new or different requirements SEP 10S Plus General ward syringe pump SEP 12S Plus Anaesthesia syringe pump SP 12S Pro Universal syringe pump XXXX yy year the pump was manufactured sequential number 0001 9999 8 SEP 10S PLUS SEP 12S PLUS SP 12S PRO PUMP MANUAL Items supplied with pump 1 The pump 2 Operator s manual 3 AC power cord 4 Packaging 5 Spare parts cap B8123009 2 pes Additional items supplied with pump to be used in ambulance 1 The pump with clamp for Draeger bar mounting 2 12VDC cable Operational Warnings and Cautions General Ifa software change occurs and the operation specification for the device changes new or additional operating instructions will be issued if needed Although the pumps have been designed and manufactured to exact specifications it 1s not intended to replace trained personnel in the supervision of IV infusions In accordance with the international standard IEC 60601 1 Medical Electrical Equipment Part 1 General Requirements for Safety the pump is classified as e Class II e Type CF e IPX4 splashproof e Not suitable for use with flammable anesthetic mixtures with air oxygen or nitrous oxide e Continuous operation Prior to operating the pump the user should carefully read this manual to fully understand the functionality and to ensure safe and
54. s outside of its normal limits The accuracy figures as stated are based upon operation at a room temperature of 22 C NOTE The all data shown is for the BD Plastipak 50 ml syringe with BALTON PPI LL 120 cm extension set The Startup Graph was developed in accordance with IEC 60601 2 24 The Startup data shown in the graph illustrates the startup performance of the pump during the first 120 minutes of operation with a sampling period of 30 seconds SEP 10S PLUS SEP 12S PLUS SP 12S PRO 45 PUMP MANUAL A Startup graph of flow versus time illustrates initial stability with selected rate time Even with the proper components and set up the flow of any manufacturer s pump may be erratic during the 120 minute startup period Therefore we have included the startup or stabilisation data It should be noted that as the time interval over which accuracy is measured is lengthened all pumps show considerable improvement in flow accuracy Startup Graph Example How Trumpet Curve Graphs are Interpreted Error of flow The trumpet curve provides a graphical view of the maximum deviation in flow rate from the programmed delivery rate for Percentage error max j i a E Selected cate specific segments of delivery time The horizontal axis does not A represent elapsed delivery time but rather acts as a graphical reference for selecting specific observation time intervals The X widest area of the trumpet curve greatest
55. secure Ensure that the pole is able to support the pump along with any other devices without tipping or falling Only use approved and pressure proved syringes with Luer lock connections and lines in accordance with chapter 2 It is recommended that the extension lines are changed according to hospital protocols It is recommended to minimize number of parameters types of syringes drug names and other functions leaving only that SEP 10S PLUS SEP 12S PLUS SP 12S PRO 13 PUMP MANUAL necessary for work It will help to avoid errors in parameters programming and thereby decrease patient s risk Notes NOTE Before initially powering on the device charge the battery 14 SEP 10S PLUS SEP 12S PLUS SP 12S PRO PUMP MANUAL 1 PUMP DESCRIPTION Front view of SEP 10S Plus l 2 3 1 Display 2 Indicators 3 Keypad Front view of SEP 12S Plus SP 12S Pro 1 2 3 4 Z O D J E alolelo E Em E lola ls les sar 1 Display 2 Indicators 3 Keypad 4 Key to select dimensions of parameters SEP 10S PLUS SEP 12S PLUS SP 12S PRO 15 PUMP MANUAL Rear Panel Assembly 1 Syringe driver arm 7 Cap 2 Slot for inserting the push button of 8 Mounting pole clamp the syringe plunger 9 Fuse holder 3 Rubber bellows 10 Mains inlet 4 Slot for inserting the finger grips of 11 MFC the syringe barrel 12 Audio volume control 5 Syri
56. sesesieeeeeneeeree 31 5 ADVANCED FEATURES c sssccicisscsiccssoccieceissassciccsesessscsserateucescdcnisbobsascdsastensesasostesets cocsSapnesstbasseadies SSE Eos iDO Eoso 32 Drug protocols optional in SEP 12S Plus and SP 12S Pro unavailable in SEP 10S Plus c ccccccccceccesseteeteeeees 32 Parameters used to configure drug protocol ccccccccscceceescessesecnseeseusesseeseseeeecseesceseeseesecseeecneseecetseseeseeseesesieeeeenseeten 32 Creating drug Protocol sieneen A Mi ess ho BE een BAR cle RANE Shore eae Be RA da 32 Modyfing AFUL DEOOCO li A A Tease aad assets esd chins ah da 34 Infusion of drug with Protocol somereni reai EEA eE E TE i aeS E aeea E Eaei Saaai 34 DIUE AE LAN T AEE E E EAE E E E A 34 6 SETUP MENU cssssssssrssssrserscsrenssserenssscerensensessensssssesensesseseseseesenseseesesesseesenesssenenessenessesssssesessesessessesessesseseseens 35 PUMP MIE A ta 35 Event history review Opti0MAD cccccccscscssesesesseesecuseesesseesecsceecseescsesseesecsesecsaeescaaeeseesecsesseceseeeeseseeaeeaeeaeeneseeneeren 35 LINDOS CL i oes LI ii E E A CIES A esse O An id SOS als 35 DUES CA A A A A A A A tt ols 35 Default ALLE A A a A A ae chee aA ida 36 LANTUADO A A AA Deeds AAA A A E E a OE EEES ees 36 Date nd TIMES CUNA a o ias 36 POArameter Selamine a e e e e e e e eae e a a TE 36 7 VISUAL AND AUDIBLE ALARM SIGNALS seseseseseseeeseeeeeeceeeeeeeeeceeeeeceeeceeeeeeeeececeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeereeeeeeeee 38 8 MAINTENANC
57. tattiasssashenses ntistsavanei testes crete teotersteshsssetassuaredts 15 Front view of SEP 12S Plus SP 12S Pro aitor 15 Rear Panel Assembly A AAA ase A A A A EAE E 16 Keypad indicators reference guide cccccccccsceccssssesseesceeesesuseeecseescesessessecseesecseeseseeseesecseesecesecateeseeseeseeaeseeereneereed 17 Keypad Keys reference Buide ti A die duc A A a Ei A ia A 17 2 BASIC OPERATION cccsssssssssesssssssessessesesscsssssssesscssesessessesessessesessesessessessesessessesesessesesessesesscssesessessesessassesessens 18 SWICAIAS PUMP A A a ee aes Deve ee anis 18 SWILCHING DUMP IA E sacar ee 19 LOGGING NESYTINGE aii Ai a aia etaa ainia 19 SVFIN BE TEMOVA TIE PANETE EEES EEES sia isla iris 21 PUEBLA AA E AAA A A AAA A AAA EA 21 Recommended SYNGES deta 23 3 PROGRAMMING OF INFUSION PARAMETERS sscsssssssssssssssssessssssssesesssesesssssnesssessesessoesesssssnsssssnessesones 24 Selecting drug Name sai vd tl id 24 Selecting dose mode only in SEP 12S Plus and SP 12S Pro cccccccssccssssvesssveeevseescusesseeecseeeecuseeecuseeseeseseeneeneeesenseets 24 Programming drug concentration only in SEP 12S Plus and SP 12S Pro ocer 25 Programming patient s weight only in SEP 12S Plus and SP 12S Pro occse 25 Programming infusion rate or volume over time cceccecesceecceseetecsseeecuseusecseesecaseescsceeseesecseeaeceseecateeseeseeseeseeseeseeaeeatee 25 Programming volume to be infused VT BI c ccccccccceseeseesessseeecns
58. the infusion and wait until alarm is generated SYRINGE EMPTY The syringe is empty Replace the syringe or turn the pump off Use BD Plastipak 50 ml syringe Pull out syringe plunger to the value of 20 ml Launch the infusion and wait until syringe is emptied Stop X X ml KOR XX ml h Infusion has been stopped and not resumed within 2 min Resume the infusion or press the CANCEL key to silence the alarm In the setup menu switch on the KOR FUNCTION Launch the infusion and after few seconds stop it Wait until alarm is generated In the setup menu switch on the KOR FUNCTION Set the END OF INFUSION The pump has reached the Replace the syringe or turn ee eae KOR XX ml h E E epa o O El 8 Volume limit Launch the infusion t Le ia and wait until preset volume limit is infused 38 SEP 10S PLUS SEP 12S PLUS SP 12S PRO PUMP MANUAL Table 1 Troubleshooting Pump Alarm Messages continued MESSAGE SYRINGE EMPTY CORRECTION Replace the syringe or turn CHECKING In the setup menu switch on the KOR FUNCTION Launch the KOR XX ml h The syringe is empty the pump off infusion and wait until syringe is emptied The pump is left for 2 min A Ae a without starting the Press the CANCEL key ue AINA UAB SS wei on 2 mn operation In the setup menu switch on the STANDBY TIME The preprogrammed standby S1 ANDRA o ao ELAPSED time intervali d Press the CANCEL key
59. umps hereinafter Syringe pump were subjected to the minimum test level identified in the standard the level that the pump meets and general guidance on the EMC environment The pump is intended for use in the electromagnetic environment specified in the following tables As with most microprocessor based electronic products syringe pump creates RF radio frequency energy as a side effect of its internal functions Precautions should be taken to avoid exposing syringe pump to powerful sources of electromagnetic radiation such as MRI magnetic resonance imaging and ESU electro surgical equipment Note that portable and mobile communications equipment such as cell phones can affect MEDICAL ELECTRICAL EQUIPMENT such as syringe pump WARNING The use of ACCESSORIES and cables other than those specified in the Operator s Manual may result in increased EMISSIONS or decreased IMMUNITY of syringe pump WARNING Syringe pump should not be used adjacent to or stacked with other equipment and if adjacent or stacked use is necessary syringe pump should be observed to verify normal operation in the configuration in which it will be used SEP 10S PLUS SEP 12S PLUS SP 12S PRO 49 PUMP MANUAL Table 1 Guidance and manufacturer s declaration electromagnetic emissions Syringe pump is intended for use in the electromagnetic environment specified below The customer or the user of syringe pump should assure that it is use
60. use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of syringe pump can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and syringe pump as recommended below according to the maximum output power of the communications equipment Rated Separation distance according to frequency of transmitter maximum m output power of transmitter 150 kHz to 80 MHz 150 kHz to 80 MHz 80 MHz to 800 800 MHz to 2 5 Ww outside ISM bands in ISM bands MHz GHz d 1 17 P d 1 2 P d 1 2NP d 2 3 P 0 01 0 12 0 12 0 12 0 23 0 1 0 37 0 38 0 38 0 73 1 1 17 1 20 1 20 2 30 10 3 70 3 80 3 80 7 28 100 11 70 12 00 12 00 23 00 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer SEP 10S PLUS SEP 12S PLUS SP 12S PRO 53 PUMP MANUAL Table 4 Recommended separation distances between portable and mobile RF communications equipment and syringe pump for LIFE SUPPORTING EQUIPMENT and SYSTEMS continued Syringe pump is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of syringe pump c
61. would ensure that the drug s efficacy was being maintained In this example the medical professional would be wise to select a device whose trumpet curve indicated a small or narrow range of deviations in flow rate 46 SEP 10S PLUS SEP 12S PLUS SP 12S PRO PUMP MANUAL Startup and Trumpet Curves Startup graph BD Plastipak 50 ml 1 ml h Startup graph BD Plastipak 50 ml 5 ml h 2 000 Rate Qi mim 10 00 Rate Qi mlh 8 00 1 500 4 6 00 1 000 4 00 0 500 200 0 000 0 00 0 20 40 60 80 100 120 D 20 40 50 80 100 120 Time min Time min Trumpet graph BD Plastipak 50 ml 1 ml h Trumpet graph BD Plastipak 50 ml 5 ml h 10 0 Deviation 10 0 Deviation 8 04 80 6 04 604 404 Epmax 404 Epmax 20 4 _e __ 2 0 4 en a ql Fe 0 88 S aa fe 0 62 204 i Epin 204 Epmin 40 4 4 0 4 60 4 6 04 8 04 8 04 Ss ea Sa E A E O 10 0 34 1 1 31 Influences of Back Pressure at 5 ml h Startup graph BD Plastipak 50 ml 100 mmHg Startup graph BD Plastipak 50 ml 100 mmHg 10 00 Rate Qi mlsh 10 00 Rate Qi ml h 8 00 4 8 00 6 00 4 6 00 4 00 4 4 00 2 00 4 2 00 0 00 Sp pt 3 90 Sy ttt ttt D 20 40 60 80 100 120 0 20 40 60 80 100 120 Time min Time min Trumpet graph BD Plastipak 50 ml 100 mmHg Trumpet graph BD Plastipak 50 ml 100 mmHg 10 0 Deviation 10 0 Deviation a 8 04 604 404 Epmax Epmax 204 P o EA 0 0 9
62. y KEYPAD LOCK protection of the keypad against y y y accidental or unauthorized usage QUIET MODE short beep accompanying any z a s J keystroke INO MAINS ALARM alarm on condition the pump is AT POWER UP powered a y y y up while not connected to the mains IKOR FUNCTION executing of KOR function x NI y y KOR RATE programming of KOR rate y y i 1 3 XX ml h z 4 DATE and TIME displaying of date and time x J al J DISPLAY enabled disabled y available X unavailable NOTES 1 To modify the value of parameter press the PROG key enter the new value using the numerical keypad and confirm it by pressing the ENTER key 2 These parameters are not displayed when both Manual and Automatic boluses disabled 3 Parameter is not indicated when KOR FUNCTION disabled 4 If parameter disabled default KOR rate is 5 0 ml h 5 Does not affect infusion rates set in drug protocols SEP 10S PLUS SEP 12S PLUS SP 12S PRO 37 PUMP MANUAL 7 VISUAL AND AUDIBLE ALARM SIGNALS Alarm signals are issued by means of sound flashing display backlight and corresponding message displayed Alarm signals are cancelled by pressing the C key Sound volume can be adjusted with rotary switch optional on the bottom of the pump Table 1 Troubleshooting Pump Alarm Messages MESSAGE CORRECTION CHECKING NO MAINS Check power cord The pump has been disconnected from the AC power supply and is operating on inter

Aitecs 10S & 12S Syringe Pump Operator`s - Med-E

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Aitecs 10S & 12S Syringe Pump Operator`s - Med-E