VF-100 Portable Syringe Pump Operation Manual
Contents
1. To turn on or turn off the pump BOLUS ENTER Button When the pump is paused this button is functioned as ENTER key Press this button to confirm the syringe size and the flow rate settings When the pump is in the running mode this button is functioned as BOLUS key Press and hold it for 2 seconds to activate the bolus The maximum bolus volume is the syringe volume size In near empty status bolus function is disabled RUN STOP Button When the pump is paused press this button to start the infusion the green LED indicator is flashing While the pump is in the bolus mode press this button to stop the bolus and to go back to the regular infusion When the pump is in a normal running status press this button to stop the infusion the green LED indicator is off Press this button to start the bolus after the bolus rate setting is completed The maximum bolus volume is no more than 1 4 of the syringe volume size PROGRAMMING THE SETTINGS IMPORTANT Read this operation manual carefully before operating this product 1 Select the syringe size 1 Press the power switch ON 2 the pump goes into the menu of selecting the syringe size Press or to select preferred syringe size Press ENTER to confirm the setting Compatible syringe sizes 1ml 3ml 5ml 10ml 20ml syringes Portable Syringe Pump Operation Manual 15 PROGRAMMING THE SETTINGS SYRINGE TYPE SEL 0m 2 Set the flow rate 1 After the syri2. 4 8 Portable Syringe Pump Operation Manual 21 ACCESSORIES ACCESSORIES Every new pump s package includes 1 x User s manual 4 x AA battery 1 x QA pass 1 x Syringe protecting cover 1 x Syringe securing strap ooo Oo pw RECOMMENDED SYRINGE BRANDS 1ml 3ml 5ml 10ml 20ml syringes B D TERUMO Portable Syringe Pump Operation Manual 22 PACKAGE TRANSPORTATION AND STORAGE PACKAGE TRANSPORTATION AND STORAGE 1 Package Please save the original package and Styrofoam put the syringe pump in this original package for storage and keep the manuals and all accessories 2 Transportation Avoid shaking and impact during transportation keep away from moisture rain and snow 3 Storage a If the pump is to be stored for an extended period it should be cleaned and the batteries taken out Store in a clean dry environment Environmental temperatures 10C 55C Relative Humidity Less than 93 Atmosphere Pressure 500hPa 1060hPa Keep away from erosive air or harmful dust Leaving the batteries inside the pump for a long period of time may discharge the batteries completely and may cause battery leakage this will damage the pump permanently b Perform operational and safety standard checkout to ensure the pump works properly and infuses accurately before use if the pump is stored more than 3 months c Perform operational and safety standard checkout every 3 months Portable Syringe Pump Operation M
3. Application Single use syringe size 1 ml 3 ml 5 ml 10 ml 20 ml NWARNING Must operate this pump with Pump Use syringes Fail to comply will cause inaccurate infusion result and may harm the patient 1 This product controls the flow rate of an injection The rate is not affected by intravenous artery pressure or by thickness of the fluid 2 This product performs a self diagnosis when power is turned on 3 Support wide range of syringe brands Refer to chapter of Recommended Syringe Brands 4 Infusion setting is from 1 to 99 mm hr 5 This product memorizes the last previous infusion settings even after the pump is power off 6 When an error occurs pump stops immediately No siphon happens The volume infused is less than 0 15ml during the interval between an error occurrence and the pump stopping Portable Syringe Pump Operation Manual 4 GENERAL INFORMATION FIGURES AND SIGNS IPX1 Protection against vertically falling water drips a are ME X Environmental Protection LOW BATT Low Battery LED Indicator ALARM Alarm LED indicator z Power Switch O or PRECAUTIONS amp NOTES SAVE THIS MANUAL FOR YOUR FUTURE REFRENCE IMPORTANT USER SHOULD READ THIS ENTIRE MANUAL BEFORE OPERATING THIS SYRINGE PUMP THIS DEVICE SHALL BE OPERATED BY AUTHORIZED PERSONNEL OPERATIONS OF THE DEVICE SHALL BE CONSTANTLY SUPERVISED BY AUTHORIZED PERSONNEL N WARNINGS CRITICAL EXPLOSION HAZARD DO NOT USE IN THE PRESENCE
4. OF INFLAMMABLE AND EXPLOSIVE MATERIALS 1 DO NOT OPERATE THIS DEVICE IN THE PRESENCE OF FLAMMABLE ANESTHETISCS A Portable Syringe Pump Operation Manual 5 GENERAL INFORMATION MIXTURE OF AIR OXYGEN AND NITROGEN OXIDES DO NOT USE A PUMP SYRINGE OR ACCESSORY THAT SHOWS ANY SIGN OF DAMAGE DO NOT CONNECT THE DEVICE TO THE PATIENT WHILE PURGING THE TUBING DO NOT IMMERSE THE PUMP INTO WATER OR ANY ANTOHER LIQUID BEFORE CONNECTING THE EXTESION TUBING TO THE PATIENT CHECK THE EXTENSION TUBING TO MAKE SURE IT IS NEATLY PLACED MAKE SURE THERE IS NO AIR IN THE SYRINGE AND EXTENSION TUBING THIS PUMP CAN NOT DETECT AIR IN LINE BEFORE STARTING INFUSION CHECK ALL SETTINGS ON THE SYRINGE PUMP IF THE PACKAGE OF THE SINGLE USE SYRINGE IS DAMAGED DO NOT USE THIS SYRINGE DO NOT USE THE SYRINGES THAT HAVE NOT BEEN TESTED FOR OR AUTHORIZED ON THIS SYRINGE PUMP USE OF UNTESTED OR UNAUTHORIZED SYRINGES MAY INJURE THE PATIENT CONTACT LOCAL DISTRIBUTOR FOR INFORMATION ON SYRINGE ACCURACY AND AUTHORIZED SYRINGE BRANDS PRECAUTIONS 1 TO AVOID A MALFUNCTION CAUSED BY ELECTROMAGNETIC DISTURBANCE THE PUMP SHOULD BE OPERATED AWAY FROM DEVICES SUCH AS ELECTROCOAGULATORS AND DEFIBRILLATORS WHICH MAY CREATE A STRONG ELECTROMAGNETIC FIELD DURING OPERATION PLEASE NOTICE THAT THE PUMP a MUST BE KEPT AT ENOUGH DISTANCE FROM ELECTROCOAGULATORS AND OR DEFIBRILLATORS b DO NOT SHARE THE SAME POWER OUTLET WITH ELECTROCOAGULATORS AND OR DE
5. still in progress IMPORTANT during the setting of a bolus to stop the setting Press to set the bolus volume to 0 0 ml and then press EEA the pump will switch to regular infusion mode and the regular infusion will continue To stop a bolus press EEA the pump will stop bolus and switch to regular infusion mode and the regular infusion will continue Ax WARNING before starting a bolus the user must confirm the bolus volume again to ensure a safe infusion Portable Syringe Pump Operation Manual 17 TROUBLE SHOOTING Description Possible Required Actions Cause The Pump can not be turned on OCCLUSION alarm but no visible in blockage IV line Over under infusing over 5 Keypad locked frozen 1 Circuit overload 2 Battery is depleted 3 Battery polarity is wrong 1 Hidden occlusion can not be seen 1 new syringe is used without proper calibration settings 2 The pump has not been sent for calibration for the last 24 months as recommended in this manual 1 The pump is running and most keypads are locked 2 The control buttons are broken TROUBLE SHOOTING 1 Change for new batteries 2 Make sure the battery polarity is correct 3 Contact authorized personnel for service 1 Check carefully the syringe and extension tubing system to clear the occlusion and then resume the infusion 1 Stop using the pump Check the pump accuracy with the currently used syrin
6. this Limited Warranty should be undertaken only by qualified trained service personnel In the event that a pump is found to be defective during the warranty period the purchaser shall notify manufacturer or its designated representative within thirty 30 days after such defect is discovered The defective pump should be sent immediately to manufacturer or its designated representative for inspection repair or replacement Material returned should be properly packaged to avoid shipping damage This Limited Warranty shall not apply to defects or damage caused wholly or in part by negligence spilt fluids dropping of the pump misuse abuse improper installation or alteration by anyone other than qualified trained personnel or to damage resulting from inadequate packaging in returning the pump This Limited Warranty is the sole and entire warranty pertaining to manufacturer s products and is in lieu of and excludes all other warranties of any nature whatsoever whether stated or implied or arising by operation of law trade usage or course of dealing including but not limited to warranties of merchantability and warranties of fitness for a particular purpose Purchaser expressly agrees that the remedies granted to it under this limited warranty are purchaser s sole and exclusive remedies with respect to any claim of purchaser arising under this Limited Warranty EXCLUSIONS WHAT IS NOT COVERED 1 Accessories used with this pump such as
7. ACCURATE INFUSION A WIDE VARIETY OF CLINICAL DEPARTMENTS SUCH AS INTERNAL MEDICINE CARDIOLOGY AND ONCOLOGY REQUIRE BEING EQUIPPED WITH THIS TYPE OF SYRINGE PUMP BEFORE USING THE PUMP BE SURE TO READ THIS OPERATION MANUAL CAREFULLY AND UNDERSTAND ALL SECTIONS OF THIS MANUAL FAILURE TO READ AND UNDERSTAND THE INSTRUCTION MANUAL MAY LEAD TO MISUSE OF THE PUMP WHICH COULD RESULT IN HARM TO THE PATIENT HEADINGS USED IN THIS MANUAL THIS GUIDE CONTAINS WARNINGS CAUTIONS AND IMPORTANT INFORMATION TO BRING TO YOUR ATTENTION AS WELL AS IMPORTANT SAFETY AND OPERATIONAL ASPECTS OF THE PUMP TO HELP IDENTIFY THESE ISSUES WHEN THEY OCCUR IN THE TEXT THEY ARE SHOWN USING THE FOLLOWING HEADINGS NWARNING STATEMENTS THAT DESCRIBE SERIOUS ADVERSE REACTIONS AND POTENTIAL SAFETY HAZARDS CAUTION STATEMENTS THAT CALL ATTENTION TO INFORMATION REGARDING ANY SPECIAL CARE TO BE EXERCISED BY THE PRACTITIONER FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE IMPORTANT STATEMENTS THAT CALL ATTENTION TO ADDITIONAL SIGNIFICANT INFORMATION ABOUT THE DEVICE OR A PROCEDURE Portable Syringe Pump Operation Manual 3 GENERAL INFORMATION PRODUCT FEATURES This syringe pump is a continuous micro infusion device Category Type I Internal Power Supplied Type of Protection Against Electric Shock dl Degree of Protection Against Ingress of Drip Proof IPX1 Fluids Mode of Operation Continuous operation Power Supply DC 3 6V 4 5V By AA Battery X 3
8. E AND TUBING SHALL BE STORED IN A CENTRALIZED LOCATION AFTER USE AND BE DISPOSED OF ACCORDING TO REGULATIONS OF DISPOSAL OF MEDICAL WASTE 8 THE CIRCUIT DIAGRAM AND PARTS LIST WILL ONLY BE PROVIDED TO THE TECHNICIANS ASSIGNED BY THE MANUFACTURER 9 THE PUMP WILL GO THROUGH A SELF DIAGNOSIS PROGRAM WHEN THE POWER SWITCH IS TURNED ON IF AN ERR IS SHOWN IN THE DISPLAY REBOOT THE PUMP IF THE ERROR CONDITION STILL EXISTS DO NOT CONTINUE THE OPERATION AND IMMEDIATELY CONTACT A DISTRIBUTOR OR THE MANUFACTURER FOR TECHNICAL SERVICE 10 READ THE INSTRUCTIONS ON THE PACKAGE CAREFULLY BEFORE LOADING THE SYRINGE ONTO A PUMP STRICTLY FOLLOW THE MEDICAL PROTOCOLS AND REGULATIONS DURING THE OPERATION 11 LUER LOCK SYRINGES SHOULD ALWAYS BE USED TO ENSURE SECURE CONNECTION OF THE EXTENSION TUBING 12 DO NOT CLEAN DISINFECT OR STERILIZE ANY PART OF THE PUMP WITH ETHYLENE OXIDE GAS OR BY AUTOCLAVING THIS MAY DAMAGE THE PUMP AND WILL VOID THE WARRANTY DISINFECT THE PUMP S EXTERNAL PARTS USING APPROVED CLEANSERS OR DISINFECTANTS ONLY 13 THESE CHEMICALS MAY DAMAGE THE PUMP S FRONT PANEL INCLUDING DISPLAY ACETALDEHYDE ACETONE AMMONIA BENZENE HYDROXYTOLUENE METHYLENE CHLORIDE OR OZONE DO NOT USE CHEMICALS OR CLEANSERS CONTAINING N ALKYLDIMETHYLBENZYLAMMONIUM CHLORIDE 14 USE OF NON RECOMMENDED ACCESSORIES MAY RESULT IN INCREASED EMC EMISSIONS OR DECREASED EMC IMMUNITY OF THIS PUMP 15 WHILE USING THIS PUMP FOR INFUSION OF L
9. FIBRILLATORS c OPERATE UNDER CONTINUOUS SUPERVISION d DO NOT USE THE PUMP IN A MRI ROOM OR HIGH PRESSURE ROOM THAT CREATES A STRONG ELECTROMAGNETIC FIELD e DO NOT USE DEVICES WHICH MAY EMIT HIGH FREQUENCY SIGNALS IN PLACE WHERE THE PUMP OPERATES KEEP THE SYRINGE PUMP AWAY FROM THE MENTIONED DEVICES ONLY USE SYRINGES RECOMMENDED BY THE MANUFACTURER REFER TO CHAPTER OF RECOMMENDED SYRINGE BRANDS ACCURACY OF AN INFUSION AND ALARMS WILL BE AFFECTED BY THE ACCURACY OF DIFFERENT SYRINGES MAKE SURE THE BATTERIES ARE TAKEN OUT OF THE PUMP IF THE PUMP WILL NOT BE USED FOR ALONG PERIOD OF TIME AFTER MIN 3 MONTHS OF STORAGE CHECK THE ACCURACY OF INFUSION AND MAKE SURE THAT ALL ALARMS FUNCTION PROPERLY BEFORE USING THE PUMP AVOID CONNECTING TUBING OF A PUMP CONTROLLED SYRINGE WITH TUBING OF A MANUAL CONTROLLED SYRINGE IT MAY AFFECT THE INFUSION ACCURACY AND ACTIVATE FALSE ALARMS THE SYRINGE PUMP GENERATES A PRESSURE DRIVING MEDICATION INTO THE PATIENT BUT THE PUMP CANNOT DETECT DAMAGE CAUSED BY OVERPRESSURE E G LEAKING DISENGAGEMENT OF SYRINGE AND EXTENSION TUBING DURING THE OPERATION CONSTANTLY CHECK THE STATUS OF THE TUBING SYSTEM DISPOSABLE SYRINGES USED IN THE PUMP SHOULD COMPLY WITH THE GOVERNMENT REGULATIONS AND HAVE TO BE DESIGNED FOR PUMP USE Portable Syringe Pump Operation Manual 6 GENERAL INFORMATION 7 USE AND CHANGE SYRINGES AND EXTENSION TUBING ACCORDING TO HOSPITAL REGULATIONS SINGLE USE SYRING
10. IFE SUSTAINING MEDICATION MAKE SURE THERE IS AN EXTRA PUMP ON STANDBY AND THERE ARE ENOUGH SYRINGES ON STANDBY IMPORTANT 1 TO PREVENT ELECTRIC HAZARDS TURN OFF THE PUMP AND TAKE BATTERIES OUT OF THE PUMP BEFORE CLEANING USE 70 ALCOHOL ON A SOFT CLOTH TO WIPE OFF ANY FLUID ON THE PUMP KEEP THE PUMP CLEAN AND DO NOT IMMERSE THE PUMP INTO ANY LIQUID FOR CLEANSING PURPOSES 2 BATTERIES USED IN THIS PUMP ARE AA X 3 4 5V TO ENSURE THE PERFORMANCE OF THE SYRINGE PUMP MAKE SURE THE BATTERIES HAVE ENOUGH POWER BEFORE STARTING AN INFUSION 3 ONLY AUTHORIZED SERVICE PERSONNEL SHOULD REPAIR THIS PUMP THE MANUFACTURER ASSUMES NO RESPONSIBILITY FOR INCIDENTS IF THE PUMP IS NOT REPAIRED ACCORDING TO THE AUTHORIZED PROCEDURES 4 IF THE PUMP FALLS ON THE GROUND IT MAY BE DAMAGED INTERNALLY WITH NO EXTERNAL SIGN OF DAMAGE IN SUCH SITUATION THE PUMP PERFORMANCE MAY BE AFFECTED DO NOT USE THE PUMP AND CONTACT AUTHORIZED DISTRIBUTORS FOR SERVICE Portable Syringe Pump Operation Manual 1 PREPARING FOR THE INFUSION PREPARING FOR THE INFUSION Keep the pump horizontal Prepare the disposable syringe and extension tube according to the instructions on the packages ONLY use syringes and extension tube with a luer lock connection This connection guarantees that the drain will not slip off due to a rise in pressure during the infusion To ensure an accurate performance use syringes recommended by the manufacturer or dealers Use on
11. VF 100 Portable Syringe Pump Operation Manual MIDVMARK Midmark Corporation 60 Vista Drive P O Box 286 Versailles Ohio 45380 0286 1 800 MIDMARK www midmark com 003 2498 00 Rev B 12 1 12 GENERAL INFORMATION TABLE OF CONTENTS GENERAL INFORMATION caca So 3 PRODUCT PEATURES ups RS 4 PERES AND SIGN rd 5 PRECAUTIONS Sc NOTES tt 5 PREPARING FOR THE NFS ON 8 STARTING AN INFUSION Vurder 8 ALARMS AND INDICATION s ren 11 OOCPLUSION ed ee we eee 11 COMPLETED vr 11 VENN 12 NEAR EMPTY RER 12 MECHANISM ERROR va 12 SYBINGE DISENGAGE D tati 13 1 RINGENOTINSTALEED Gas 13 KEYPAD DESCRIPTION Var 13 KEYPAD FUNGTIONS morire nnan a a A a S 15 PROGRAMMING THE SETTINGS sv 15 TROVBPESHOOTING sa 18 PERL TIN lle Tee 19 INFUSION ACCURACY OF THE SYSTEM eee eecceccesececeeneceseceeeesceeaeeenesseceseceeecaeeeaeceaeeeeeeeeaeeeaeees 20 REGUEATORY INFORMATION rana rada 21 NESSE cates ieee eg ei ee eh eee 22 PACKAGE TRANSPORTATION AND STORAGE rrnnrrenrnnvenenenenernsnrnensnnnesnnrensernesnrneneneresnrnsnsnsnssnnesnne 23 MAIN TENANG E coceira e A 24 MAINTENANCE SERVICE RECORD snarest radar sende 25 EIMI TED WABRAN Prats E E E E E E S O EE A lee RER 27 Portable Syringe Pump Operation Manual 2 GENERAL INFORMATION GENERAL INFORMATION THIS PORTABLE SYRINGE PUMP IS AN EASY TO OPERATE DEVICE FOR INFUSION WITH 1 20ML SYRINGES IT IS LIGHT WEIGHT AND OFTEN USED IN A MOBILE ENVIRONMENT PROVIDING A MICRO CONSISTENT AND
12. Y When the syringe is almost finished a low level alarm sound is activated with an interval of 15 seconds tip 3 times The ALARM indicator is on with a flashing yellow light at 0 5 Hz 25 duty cycle The screen displays NEAR EMPTY This is to remind the user of infusion near end and the user shall prepare to change a new syringe NEAR EMPTY 45mm h MECHANISM ERROR During a normal infusion if the mechanical system is malfunctioning and the pump cannot continue the operation the pump will stop immediately A high level alarm sound is activated with an interval of 5 seconds The ALARM indicator is on with a flashing red light at 2 Hz 40 duty cycle The screen displays MECHANISM ERROR Pump should only be used after the alarm status is cleared Do not use the pump until it is serviced by authorized personnel Portable Syringe Pump Operation Manual 12 ALARMS AND INDICATION MECHANISM ERROR 45mm h SYRINGE DISENGAGED If the syringe is disengaged during the infusion the pump wil stop the infusion immediately high level alarm sound is activated with an interval of 5 seconds The ALARM indicator is on with a flashing red light at 2 Hz 25 duty cycle The screen displays SYRINGE DISENAG Only resume the infusion after the syringe is installed properly SYRINGE DISENAG 45mm h SYRINGE NOT INSTALLED If the user presses the START button with no syringe installed a m
13. anual 23 MAINTENANCE MAINTENANCE Service of this syringe pump must be performed by manufacturer s authorized technicians 3 SUGGESTED GUIDELINES FOR CLEANING AND STERILIZATION 1 Before cleaning the pump make sure the power is off 2 Always keep the pump clean use 70 alcohol on soft cloths to wipe out any fluid on the pump 3 Use EOG Ethylene oxide gas to sterilize the pump under the following conditions Environmental temperatures under 58 C Relative Humidity Less than 60 After the sterilization please keep the room ventilated for 24 hours or longer or leave the pump in the ventilation device for 8 hours or longer IMPORTANT Avoid using solvents and thinners to clean the pump ANWARNING The operational and safety standard checkout must be performed at least every 24 months by the factory s authorized service representative to ensure the pump works properly and infuses accurately not covered by warranty fees apply NWARNING Perform functional tests and ensure that battery is fully charged at least once every month The designed life time of this pump is 6 8 years After designed life time please have all major components replaced by manufacturer authorized technician or stop use 4 Pollution Free Treatment And Recycling 1 Remove the batteries before recycling or disposal of the pump 2 The distributors will accept used pumps for proper pollution free treatment and recycling Portable Syringe Pu
14. edium level alarm sound is activated with an interval of 15 seconds The ALARM indicator is on with a flashing yellow light at 0 5 Hz 25 duty cycle The screen displays SYRINGE DISENAG When the syringe is installed properly the yellow indicator is off and the alarm sound will be silenced SYRINGE DISENAG 45mm h IMPORTANT This is a portable device so the sound pressure level is greater than 50dB Portable Syringe Pump Operation Manual 13 ALARMS AND INDICATION KEYPAD DESCRIPTION A Control panel amp pump structure TAN ENTER Pr Cl marga Ange Eltronic asset Oo Ltd AF biie 5 Mo 1130 Baal Rd fanghe P M Chien Alarm LED indicator Gauge indicator Low Batt LED indicator Syringe plunger slot OLED displaying screen Syringe flange slot BOLUS ENTER indicator Syringe securing strap Power switch Product label Increase set number key Product logo Decrease set number key Battery compartment RUN STOP key Lead screw Running LED indicator Pushing mechanism releasing button Rate gauge 1 2 3 4 5 6 7 8 9 1 Portable Syringe Pump Operation Manual 14 PROGRAMMING THE SETTINGS KEYPAD FUNCTIONS INCREASE Button Press to increase the flow rate hold longer than 0 5 second to accelerate the speed of scrolling DECREASE Button Press to decrease the flow rate hold longer than 0 5 second to accelerate the speed of scrolling Power ON OFF switch
15. ge brand size and pump calibration setting according to the manual 2 Stop using the pump Contact our authorized distributor for maintenance 1 Stop the pump and then change the settings with the buttons 2 Stop using the pump Contact our authorized distributor for service Portable Syringe Pump Operation Manual 18 SPECIFICATIONS SPECIFICATIONS 2 Relative Humidity Less than 90 3 Atmospheric Pressure 700hPa 1060hPa 1 Environmental Temperatures of Operation 5C 40C 1 10 Occlusion Alarm Triggering Time and Dose Infused With 10ml syringe Infusion Rate Occlusion Alarm Pressure Low rate 10 mm hr 0 08 0 04 Mpa Medium rate 50 mm hr 0 08 0 04 Mpa 11 Dimension x b x h mm 166 x 30 x 60 12 Net Weight No More Than 180 g without batteries Portable Syringe Pump Operation Manual 19 flowiml h flow ml h 0 INFUSION ACCURACY OF THE SYSTEM INFUSION ACCURACY OF THE SYSTEM Accuracy Testing Rate 10 mm hr 1 Starting Curve 2 Trumpet Curve AJ5805 SYRINGE PUMP at 10mmihr AJ5805 SYRINGE PUMP at 10mmihr varlation in flowrate overall percentage error A 20 40 60 80 100 120 gt ll 5 11 19 31 time min observation window min Accuracy Testing Rate 50 mm hr 1 Starting Curve 2 Trumpet Curve AJ5805 SYRINGE PUMP at S0mmihr AJ5805 SYRINGE PUMP at 50mmihr overall percentage error A varlation in flowrate 20 40 60 80 100 120 val 5 11 MAR 31 time min observation w
16. indow min Portable Syringe Pump Operation Manual 20 REGULATORY INFORMATION REGULATORY INFORMATION This syringe pump complies with the following standards e 93 42 EEC European directive for medical devices including EN 60601 1 2 and collaterals e Electrical Safety IEC and Electromagnetic Compatibility standards EMC e Guidance and Manufacturer s Declaration Electromagnetic Emissions Electromagnetic Compatibility Precautions Medical electrical equipment requires special precautions regarding electromagnetic compatibility EMC Medical equipment must be installed and put into service according to the EMC information provided in the following documentation Guidance and Manufacturer s Declaration Electromagnetic Emissions Tablet 1 Electromagnetic Immunity for Equipment and Systems Fully Compliant with EN 60601 1 2 2007 This syringe pump is intended for use in the electromagnetic environment specified below Immunity Test IEC 60601 Compliance Electromagnetic Environment Guidance Test Level Level Electrostatic 6kV contact 6kV contact Floors should be wood concrete or Discharge ESD ceramic tile If floors are covered with 8kV air 8kV air synthetic material The relative humidity IEC 61000 4 2 should be at least 30 Power frequency Power frequency magnetic fields should 50 60Hz magnetic be at levels characteristic of a typical field location in a typical commercial or hospital environment IEC 61000
17. ly pump use syringes VERSAFLO 100 SYRINGE PUMP INDICATORS STARTING AN INFUSION NWARNING Read this manual carefully before using the pump for the first time 1 Open the battery cover located at the back of the pump Insert 3 AA batteries into the battery compartment with the correct polarity as shown in the picture Three NEW batteries may support continuous running for up to 24 hours at a flow rate of 5 mm hr with a syringe size 10 ml When the power is turned on the pump will go through a self diagnostic program to self diagnose the major components Purge the syringe to expel the air Load the syringe and place the extension tubing properly Be sure to insert the syringe flange firmly into the flange slot on the pump Use securing strap to secure the syringe to the pump These are to prevent the syringe from moving during the infusion Portable Syringe Pump Operation Manual 8 STARTING AN INFUSION ANWARNINGS A loose installation of the syringe will cause an inaccurate infusion 5 Press the release button on the plunger holder and slide the mechanism to the right until the end of the syringe plunger placed into the slot in the plunger holder Make sure the syringe plunger is properly seated in the plunger holder 6 Press the power switch ON When it is initialized the pump will go through a Self Diagnostic program After the pump passes the Self Diagnosis previous infusio
18. mp Operation Manual 24 MAINTENANCE MAINTENANCE SERVICE RECORD Serial Number Date of Purchase Date of Service Accuracy Calibration Functional tests Maintenance Detail Serviced by Print Technician Name Signature Service Company Name Print Tel Date of Service Accuracy Calibration _ Functional tests Maintenance Detail Serviced by Print Technician Name Signature Service Company Name Print Tel Portable Syringe Pump Operation Manual 25 MAINTENANCE Date of Service Accuracy Calibration _ Functional tests Maintenance Detail Serviced by Print Technician Name Signature Service Company Name Print Tel Portable Syringe Pump Operation Manual 26 LIMITED WARRANTY LIMITED WARRANTY The syringe pump has been carefully manufactured from the highest quality components The pump is guaranteed against defects in material and workmanship for two 2 years from date of purchase by the original purchaser User should keep the service record according to manufacturer s instruction to keep the warranty valid Manufacturer s obligation or that of its designated representative under this Limited Warranty shall be limited at our option to repairing or replacing the pump which upon examination is found to be defective in material or workmanship The repair or replacement of any product under this Limited Warranty shall not extend the above mentioned Warranty period All repairs under
19. n rate settings will be displayed The pump is then ready to be programmed for an infusion 7 When the pump is not loaded with a syringe the ALARM indicator which is a yellow LED will light accompanied by a beeping sound with 15 seconds interval Not until the syringe is installed properly will the yellow LED indicator turn off and the beeping sound turn off 8 Press to start infusion then the RUN indicator which is a flashing green LED light Portable Syringe Pump Operation Manual 9 STARTING AN INFUSION 9 In situations where the user wants to stop an infusion press the button 10 This syringe pump is compatible with the following syringe sizes Imi 3ml 5ml 10ml 20ml syringe with rate range 1 99mm hr Reason for the failure of the Self Diagnostic program 1 If the pump fails to initialize the Self Diagnostic program the screen will display INITIAL ERROR SYSTEM STOP indicating that the pump did not pass the Self Diagnostic program Check the following position for cause of alarm 1 In a situation that the plunger holder is placed at the very left end Move the plunger holder to the right end where it is possible to load the syringe and reboot the pump 2 In a situation that the plunger holder is at a proper position Stop using the pump until it is serviced by authorized personnel INITIAL ERROR SYSTEM STOP 2 Ifthe pump fails to initialize the Self Diagnostic program the screen will displa
20. nge size is selected the pump goes into the next menu of setting flow rate n l 10 8 6ml h 2 Press A or Ka to select the flow rate The syringe size flow rate in mm h and equivalent flow rate in ml hr are shown on the screen 3 Press to confirm the rate setting and to start the infusion The green LED indicator 1s flashing to remind of starting the infusion 4 To stop the infusion press Kin The green LED indicator is off which means the infusion has stopped 3 Set a bolus 1 During a regular infusion the user may have an additional dose by using ENTER button Press and hold for at least 2 seconds the pump will enter into BOLUS mode zl 10 8 6ml h Bo 2 Sm 2 Press A or to select the bolus volume Bolus volume in ml and corresponding flow rate are shown on the screen The maximum bolus volume is the syringe volume size De 3 After the bolus setting is completed press VENTER to start blousing While the bolus is in Portable Syringe Pump Operation Manual 16 PROGRAMMING THE SETTINGS progress the green LED indicator is flashing the number of bolus volume shown on the screen is decreasing 10 BOLUS e 2 5ml 4 When the bolus is completed a buzzer sets off reminding the user of bolus completion The pump automatically switches to the regular infusion mode CAUTION during the time of infusing additional dose bolus the regular infusion dose will not stop and is
21. pole clamp power cord etc are not covered under this limited warranty policy This warranty becomes void if opened or serviced by un authorized personnel This warranty does NOT cover freight cost insurance and any other incidental charges Failure to service the pump periodically as scheduled will void this warranty policy This warranty becomes void if the pump shows evidence of having been dropped impact sand and or water damage mishandling tampering battery or chemical corrosion use contrary to this instruction manual NE OD Portable Syringe Pump Operation Manual 27
22. syringe tubing system or at the needle the pump stops immediately A high level alarm sound is activated with an interval of 5 seconds The ALARM indicator is on with a red flashing light at 2 Hz 40 cycle The screen displays OCCLUSION The infusion can only be resumed when the alarm condition is cleared OCCLUSION 45mm h COMPLETED When the syringe is finished the pump stops A high level alarm sound is activated with an interval of 5 seconds The ALARM indicator is on with a red flashing light at 2 Hz 40 duty cycle The screen displays COMPLETED Portable Syringe Pump Operation Manual 11 ALARMS AND INDICATION COMPLETED 45mm h LOW BATTERY REMIND and ALARM If the battery runs low a medium level alarm sound is activated with an interval of 15 seconds The LOW BATT indicator is on with a yellow flashing light at 0 5 Hz 25 duty cycle In this situation the user shall change new batteries immediately After the Low Batt reminder the batteries may support the pump for another 30 minutes and then Low Batt Alarm is activated 3 minutes after Low Batt Alarm goes off the pump will stop the infusion When the pump is operating under low battery status a high level alarm sound is activated with an interval of 5 seconds At the same time the screen displays LOW BATT with a red flashing light at 2 Hz 40 duty cycle STOPS IN 3 MINS LOW BATT STOPS 45mm h 45mm h NEAR EMPT
23. y BATTERY LOW SYSTEM STOP a change of new batteries is required immediately NWARNINGS DO NOT use the pump if the BATTERY LOW alarm is ON The pump may stop during the infusion because of low battery power BATTERY LOW BATTERY LOW SYSTEM STOP 45mm h Portable Syringe Pump Operation Manual 10 ALARMS AND INDICATION ALARMS AND INDICATION The pump has a complete alarm and indicating system While the pump is running and the alarm is set off the system will notify the user of the unusual parameters during the operation The occlusion alarm may have a delayed effect The rest of the alarms will reflect the unusual parameters immediately less than 10 seconds All alarms are technical alarms There is no biological alarm ALARM CATEGORY AND PRIORITY LIST Alarm Category Alarm Indicating Method Syringe Not Installed With medium sound accompanied by a flashing yellow light With high level sound accompanied by a flashing red light Completed With high level sound accompanied by a flashing red light Near Empty loo With low sound accompanied by a flashing yellow light Low Batt Remind With medium sound accompanied by a flashing yellow light Low Batt Alarm With high level sound accompanied by a flashing red light Syringe Disengaged With high level sound accompanied by a flashing red light With high level sound accompanied by a flashing red light OCCLUSION During a normal infusion when an occlusion occurs in the
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