User`s Manual
Contents
1. s Declaration Electromagnetic Emissions Tablel 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 Electrical fast 2kV for power 2kV for power Mains power quality should be that of a transient burst supply lines supply lines typical commercial or clinical environment IEC 61000 4 4 1kV for input output 1kV for input lines output lines Surge 1KV line to line 1KV line to line Mains power quality should be that of a 2kV line to earth typical commercial or hospital IEC 61000 4 5 2kV line to earth environment 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 4 8 NOTE Uris the a c mains voltage prior to application of the test level Syringe Pump Operation Manual 28 ACCESSORIES Every new pump s package includes 1 x Pole Clamp 1 x 3 core standard power cord 3 x Disposable extension tube for testing 2 x Fus2. 25VA b DC input 12VDC 1 6A c Battery power 12VDC 1200mA In event of losing AC power product will switch to battery power automatically Syringe Pump Operation Manual 5 GENERAL INFORMATION FIGURES AND SIGNS NWARNINGS Must operate this pump with Pump Use syringes Fail to comply will cause inaccurate infusion result and may harm the patient Signs Symbols Definitions lt 01 97 Meet MDD 93 42 EEC Requirement and certified by the notified body 0197 Protection Against Electric Shock Type CF defibrillator proof IPX1 Protection Against vertically falling water drips Attention consult user s manual ad a Manufacturer s information Product Serial Number OE ee EE EE MEE EE PRECAUTIONS amp NOTES SAVE THIS MANUAL FOR YOUR FUTURE REFRENCE Syringe Pump Operation Manual 6 GENERAL INFORMATION IMPORTANT USER SHOULD READ THIS ENTIRE MANUAL BEFORE OPERATING THIS SYRINGE PUMP THIS DEVICE SHALL BE OPERATED BY AUTHORIZED PERSONNEL THE RUNNING OF THE DEVICE SHALL BE CONSTANTLY SUPERVISED BY AUTHORIZED PERSONNEL NWARNINGS CRITICAL EXPLOSION HAZARD DO NOT USE IN THE PRESENCE OF Inflammable and explosive materials 1 ONLY USE THE 3 CORE AC MAINS POWER CORD INCLUDED WITH THIS PUMP USE OF ANY OTHER CORD PRESENTS SHOCK OR DEATH HAZARD TO PATIENTS THE AC MAINS OUTLET MUST BE PROPERLY GROUNDED EARTHED TO PREVENT SHOCK HAZARDS TO PATIENT THE MAINS OUTLET AND THE GROUND EARTH SHOULD BE TESTED ON
3. OF BROKEN EXTERNALLY IN SUCH SITUATION THE PUMP PERFORMANCE MAY BE AFFECTED DO NOT USE THE PUMP AND CONTACT AUTHORIZED DISTRIBUTORS FOR SERVICE THIS PUMP HAS BUILT IN BATTERIES WHEN AC POWER IS DISCONNECTED THE PUMP SWITCHES TO BATTERY POWER AUTOMATICALLY BEFORE INITIALLY POWERING ON THE PUMP CHARGE THE BATTERY FOR AT LEAST 8 UNINTERRUPTED HOURS Syringe Pump Operation Manual 10 SPECIFICATIONS SPECIFICATIONS 1 Environmental Temperatures of Operation 5C 40C 41F 104F Less than 90 4 Power Source 1 AC Input 100 240AC 50 60Hz 25VA 2 DC Input 12VDC 1 6A 8 Flow Rate Range 10 Alarms Audible alarms with visual indicators of NEAR EMPTY COMPLETE OCCLUSION and LOW BATT With 50ml syringe Min 1 mh Mid 5 mh 15 TT 335 L x142 B B x120 H mm 13 x 5 1 2 x 4 3 4 Syringe Pump Operation Manual 11 PREPARING FOR THE INFUSION PREPARING FOR THE INFUSION 1 Keep the pump horizontally before use The pump can be used either on horizontal table or on the IV pole with the designated pole clamp packaged with the pump 2 Prepare the disposable syringe and extension tube according to its accompanying instructions 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 NWARNINGS THIS SYRINGE PUMP HAS BEEN PROGRAMMED TO USE BD PLASTIPAK SYRINGE BY DEFAULT
4. ee 30 MAINTENANCE mesnine oe RO OR OE OR ea 31 MAINTENANCE SERVICE RECOPRD aiaaiaaaaaaaaaaaaaaaaaaadanaaaaaaaaaaaaaaaaaaaaaaaaaaaaaadaaaaadaaaaadaaaaaaaaaaa 32 HNITED WARRANT Es tes een Se GR es ee ee ee ie Oe e e ee oe eed 34 Syringe Pump Operation Manual 3 GENERAL INFORMATION GENERAL INFORMATION This Syringe Pump is a conventional device for specialty practices universities and general practices A wide variety of clinical departments such as internal medicine cardiology and oncology require being equipped with this type of syringe pump This pump is mainly used for intravenous arterial infusion anesthetic injection IV antibiotics cancer therapy etc This Micro Infusion Syringe Pump offers a reliable alternative for fluid control especially suitable for long term micro fluid and precise injections SIGNS AND SYMBOLS HEADINGS USED IN THIS MANUAL THIS GUIDE CONTAINS WARNINGS CAUTIONS AND IMPORTANT INFORMATION TO HELP CALL YOUR ATTENTION TO THE MOST IMPORTANT SAFETY AND OPERATIONAL ASPECTS OF THE PUMP TO HELP IDENTIFY THESE ITEMS 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 ATTENT
5. A REGULAR BASIS TO ENSURE PATIENT SAFETY OPERATE AWAY FROM STRONG MAGNETIC FIELDS LARGE EQUIPMENT OR BIG MOTORS 2 DO NOT OPERATE THIS DEVICE IN THE PRESENCE OF FLAMMABLE ANESTHETISCS A MIXURE OF Air oxygen nitrogen oxides DO NOT USE A PUMP SYRINGE OR ACCESSORY THAT SHOWS ANY SIGN OF DAMAGE 4 This pump is not a portable device To use this pump in a mobile environment attach the pump onto an V pole with a pole clamp which is included in the accessories Qo 5 DO NOT CONNECT THE DEVICE TO THE PATIENT WHILE PURGE THE TUBING 6 BEFORE CONNECTING THE TUBING TO THE PATIENT THE USER MUST PRIME THE TUBING TO PREVENT AIR FROM MOVING INTO THE PATIENT 7 TO CLEAN THE PUMP USE A DAMP NOT WET CLOTH OR SPONGE DO NOT IMMERSE PUMP OR POWER CABLE INTO WATER OR OTHER CLEANING SOLUTIONS 8 BEFORE START AN INJECTION CHECK THE EXTENSION TUBING TO MAKE SURE IT IS NEATLY PLACED MAKE SURE THERE IS NO AIR IN THE gt gt SYRINGE AND EXTENSION TUBING CHECK ALL SETTINGS Al ON THE SYRINGE PUMP sd 2E 9 TO AVOID ELECTRIC SHOCK UNPLUG THE POWER CORD EE e FROM THE PUMP AND THEN CLEAN THE DEVICE MUST NOT SPRAY THE CLEANSER ON THE EXTENSION TUBING OR THE POWER CORD DO NOT IMMERSE THE PUMP INTO ANY SOLUTION 10 IF THE PACKAGE OF SINGLE USE SYRINGE IS DAMAGED MUST NOT USE THIS SYRINGE 11 USE ONLY AUTHORIZED SYRINGES SEE PAGE 29 CONTACT MANUFACTURER FOR THE AUTHORIZED CALIBRATION VALUE BEFORE USING SYRIN
6. ALWAYS CHECK THE ACCURACY CALIBRATION SETTING EVERY TIME BEFORE USING A NEW DIFFERENT SIZE BRAND SYRINGE USING A NEW DIFFERENT SIZE BRAND SYRINGE WITHOUT CORRECT CALIBRATION SETTING WILL CAUSE INACCURATE INFUSION RESULT o For use in USA B D Monoject TERUMO brand syringe can be used without calibration Syringe Pump Operation Manual 12 STARTING AN INFUSION STARTING AN INFUSION NWARNINGS The user must read this manual carefully before first time use 1 Plug the power cord into a wall outlet to charge the internal battery The pump can be used normally during the charging or use the DC 12V built in battery power Under battery operation charge battery at least 8 hours before use A fully charged NEW battery can support continuous running up to 3 hours at a flow rate of 25 ml hr If the power cord is unplugged during the operation the pump will switch to the built in battery automatically Load syringe with medication or desired fluid then purge the syringe to expel the air Lift up the syringe securing bar and rotate 90 degrees counter clockwise to make it hold the position Place the syringe on the top of the pump Be sure to insert the syringe flange firmly into the flange slot on the pump firmly so the syringe won t be able to move during the infusion NWARNINGS A loose installation of the syringe will cause inaccurate infusion result 3 Press the release button on the plunger driver block and slide the o i dri
7. C IMMUNITY OF THIS SYRINGE PUMP 21 USE THIS PUMP FOR INJECTION OF LIFE SUSTAINING MEDICATION MAKE SURE THERE IS AN EXTRA PUMP STANDBY AND THERE ARE ENOUGH SYRINGES STANDBY IMPORTANT 1 TO PREVENT ELECTRIC HAZARDS BEFORE CLEANING TURN OFF THE PUMP AND THEN UNPLUG THE POWER CORD FROM THE PUMP USE 70 ALCOHOL ON A SOFT CLOTH TO WIPE OUT ANY FLUID ON THE PUMP KEEP THE PUMP CLEAN AND DO NOT IMMERSE THE PUMP INTO ANY LIQUID FOR CLEANSING PURPOSE 2 BATTERIES USED IN THIS PUMP ARE HYNB 762 AAx10 1200MAH TO ENSURE THE PERFORMANCE OF THE SYRINGE PUMP MAKE SURE THE BATTERIES ARE FULLY CHARGED BEFORE OPERATE THE PUMP ON BATTERY POWER ALWAYS CHECK THE BATTERY PERFORMANCE BEFORE OPERATE ON BATTERY POWER AFTER A FULL BATTERY CHARGING CYCLE IF THE BATTERIES ARE STILL DEPLETED CHANGE THE BATTERY PACK IMMEDIATELY THE BATTERIES MUST BE CHARGED FOR ONCE AT EVERY 3 MONTHS OF STORAGE WHILE CONNECT THE PUMP TO AC POWER MAKE SURE THE POWER IS PROPERLY GROUNDED IF AC POWER IS NOT RELIABLE USE INTERNAL Syringe Pump Operation Manual 9 GENERAL INFORMATION BATTERIES TO OPERATE THE PUMP TO CHANGE THE FUSE OF THE PUMP DISCONNECT THE AC POWER ONLY AUTHORIZED SERVICE PERSONNEL SHOULD REPAIR THIS PUMP THE MANUFACTURER ASSUMES NO RESPONSIBILITY FOR INCIDENTS THAT OCCUR IF THE PUMP IS NOT REPAIRED ACCORDING TO MANUFACTURER AUTHORIZED PROCEDURES IF THE PUMP FALLS OFF ON THE GROUND OR HAS IMPACT IT MAY BE DAMAGED INTERNALLY WITH NO SIGN
8. E SURE THAT THE IV STAND IS SOLID VERTICALLY AND WON T FALL WITH THE WEIGHT OF THE PUMP 12 TO CHANGE THE FUSE MUST DISCONNECT THE PUMP WITH AC POWER BE 13 DURING THE OPERATION THIS SYRINGE PUMP SHALL 35 0 BE CONSTANTLY MONITORED BY MEDICAL PERSONNEL fmo ge 14 THE PUMP WILL GO THROUGH A SELF DIAGNOSTIC 4 ani PROGRAM WHEN THE POWER SWITCH IS TURNED ON IF AN ERR IS SHOWN IN THE DISPLAY REBOOT THE PUMP Ho IF THE ERROR CONDITION STILL EXISTS DO NOT CONTINUE OPERATION AND CONTACT DISTRIBUTOR OR MANUFACTURER FOR TECHNICAL SERVICE IMMEDIATELY 15 READ MANUAL OF SYRINGES CAREFULLY BEFORE OPERATING THE SYRINGE STRICTLY FOLLOW THE MEDICAL RULES AND REGULATIONS DURING OPERATION 16 ONLY AUTHORIZED PERSONNEL SHALL OPERATE THIS SYRINGE PUMP 17 LUER LOCK SYRINGES SHOULD ALWAYS BE USED TO ENSURE SECURE CONNECTION OF THE EXTENSION TUBING 18 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 ONLY USING APPROVED CLEANSERS OR DISINFECTANTS 19 THESE CHEMICALS MAY DAMAGE THE PUMP S FRONT PANEL ACETALDEHYDE ACETONE AMMONIA BENZENE HYDROXYTOLUENE METHYLENE CHLORIDE OR OZONE DO NOT USE THOSE CHEMICALS OR CLEANSERS CONTAINING N ALKYLDIMETHYLBENZYLAMMONIUM CHLORIDE 20 THE USE OF NON RECOMMENDED ACCESSORIES MAY RESULT IN INCREASED EMC EMISSIONS OR DECREASED EM
9. FORE USE AVOID CONNECT TUBING OF PUMP CONTROLLED SYRINGE WITH TUBING OF MANUAL CONTROLLED SYRINGE IT MAY AFFECT THE INFUSION ACCURACY AND ACTIVATE FALSE ALARMS THE SYRINGE PUMP WILL GENERATE A PRESSURE DRIVING MEDICATION INTO THE PATIENT BUT THE PUMP CAN NOT DETECT THE DAMAGE OF SYRINGE CAUSED BY OVERPRESSURE E G LEAKING IN THE TUBING DISENGAGEMENT OF SYRINGE AND EXTENSION TUBING DURING THE OPERATION CONSTANTLY CHECK FOR THE DAMAGE OF TUBING SYSTEM WHILE PUMP IS USING AC POWER PLEASE ENSURE THE POWER OUTLET IS PROPERLY GROUNDED ALWAYS OPERATE THE PUMP WITH AC POWER CONNECTED UNLESS AC POWER IS NOT AVAILABLE WHENEVER AC POWER IS AVAILABLE CONNECT THE PUMP TO AN AC POWER SOURCE AND CHARGE THE BATTERY IN THIS WAY BATTERY POWER CAN BE WELL PRESERVED FOR EMERGENCY USE DISPOSABLE SYRINGE USED IN THE PUMP SHOULD COMPLY WITH THE GOVERNMENT REGULATIONS AND HAS TO BE DESIGNED FOR PUMP USE USE AND CHANGE SYRINGES AND EXTENSION TUBING ACCORDING TO HOSPITAL REGULATIONS SINGLE USE SYRINGE AND TUBING SHALL BE STORED IN A CENTRALIZED STORAGE AFTER USE AND BE DISPOSED ACCORDING TO REGULATIONS OF DISPOSAL OF MEDICAL WASTE 10 THE CIRCUIT DIAGRAM AND PARTS LIST WILL ONLY BE PROVIDED TO MANUFACTURER ASSIGNED TECHNICIANS Syringe Pump Operation Manual 8 GENERAL INFORMATION 11 THE PUMP CAN BE USED ON A HORIZONTAL PLATFORM OR ON THE IV STAND WITH THE IV POLE CLAMP BEFORE SECURING THE PUMP ON THE IV POLE PLEASE MAK
10. GES NOT LISTED ON PAGE 29 DO NOT CALIBRATE UNAUTHORIZED SYRINGES WITHOUT MANUFACTURERS AUTHORIZATION PRECAUTIONS 1 TO AVOID A MALFUNCTION CAUSED BY ELECTROMAGNETISM DISTURBANCE PUMP SHALL OPERATE AWAY FROM DEVICES SUCH AS ELECTROCOAGULATOR AND DEFIBRILLATOR Syringe Pump Operation Manual 7 GENERAL INFORMATION WHICH MAY CREATE A STRONG ELECTROMAGNETIC FIELD DURING OPERATION PLEASE NOTICE THAT THE PUMP a MUST KEEP ENOUGH DISTANCE FROM ELECTROCOAGULATOR AND OR DEFIBRILLATOR b DO NOT SHARE SAME POWER OUTLET WITH ELECTROCOAGULATOR AND OR DEFIBRILLATOR c MUST OPERATE UNDER CONTINUOUS SUPERVISION d DO NOT USE THE PUMP IN THE MRI ROOM OR HIGH PRESSURE ROOM THAT CREATES A STRONG ELECTROMAGNETIC FIELD e DO NOT USE CELLULAR PHONES RADIOS AND DEVICES WHICH MAY EMIT HIGH FREQUENCY SIGNAL KEEP THE SYRINGE PUMP AWAY FROM THE MENTIONED DEVICES lt gt USE ONLY AUTHORIZED SYRINGES SEE PAGE lt lt a 29 CONTACT MANUFACTURER FOR THE AUTHORIZED S CALIBRATION VALUE BEFORE USING SYRINGES NOT LISTED ON PAGE 29 DO NOT CALIBRATE UNAUTHORIZED SYRINGES WITHOUT MANUFACTURERS AUTHORIZATION TO STORE THE PUMP MAKE SURE THE BATTERIES ARE FULLY CHARGED BEFORE STORAGE BATTERIES MAY BE DAMAGED IF LEAVE UNCHARGED FOR A LONG PERIOD OF TIME USE THE PUMP AFTER MIN 3 MONTHS OF STORAGE THIS PUMP MUST BE TESTED AND CALIBRATED FOR ACCURACY BATTERY POWER AND ALL ALARM FUNCTIONS ENSURE THE BATTERIES ARE FULLY CHARGED BE
11. HE INEFUSION ses ese ee ge ee ee ee ee Ee ee ee Gee ee ee Ge ee ee be 12 STARHNGANINEUSION teo se gnin de De ee ee De EE DE Di ee 13 PURGE FEUNETION ei EE SE EE EG eo GE REG Ge RE ee ee be ee ee eie 17 BOLUS SE FUNG si ES ee Ee Ee EE ere renee ene Ee 18 ALARM a OR OE ra N N OE N 19 SOON ARE AE EE EE ED 19 COMPLETE si ies ee ee n Sj Ge Ge ee Ge a De AG Ge EE N EE Ge ed 19 LOW BATTERY DE DE DI DE DE DE cnr rere DE a Ee Ee 19 NEAFENIE TE sn se ee Reet ee ee Ge caer Sine a tne nt ee ten Oe N ee Ee er 19 WEBER ep eN TO OON ON OOS OOS OE 19 SYRINGE DISENGAGEDALARM ese ee Ge ee ee ee tja ee oe Ro 20 KEYPAD DESERIPTIO N ie EE EE GE EO GE EO GE GE De EE GE 20 KE PAD FUNETIONS ii preter tes eve rece enter tea ten IG l a wea ver Ge DE ee a eee ER ere ee 22 CALIBRATION SETTINGS ii ee ES ee RE a RE Ge GE RE es ERGE DE RE 23 ACCURACY CALIBRATION ee ss se ee N ee ee N ee be Ge ee ee N ee ee N ee 23 ADJUSTOGCLUSION PRESSURE 3 iS ei ee ie ee ee ee ee ee 23 ADJUST ALARM VOLUME ai ie ee seg ee ee Ie eg ee ee Ie Ge ee ee ee Ie eg ee ee eg Ge Ede ee ie 24 RESETTO FACTORY DEFAULI S is beslis bee Doe ees Do ees ees Da ees de es ies 25 TROUELESIOOTING ie ee ee GR ee RR ee Re ee ee 26 INFUSION ACCURACY OF THE SYSTEM Ge ee ee ee eh Ge ek Ge eek 27 HEGLULATORYINEORMATION sk he ee ee Ge eh ee ee eee eee ed 28 AEEES OIE RES EE aa ee EG Ee 29 PACKAGE TRANSPORTATION AND STORAGE esse esse esse sees ees ees ee ee ee ee ee ee ee ee ee
12. ION TO ADDITIONAL SIGNIFICANT INFORMATION ABOUT THE DEVICE OR A PROCEDURE Syringe Pump Operation Manual 4 GENERAL INFORMATION PRODUCT FEATURES Category Type Internal Power Supplied K Type CF Degree of Protection Against Ingress of Drip Proof IP X1 Type of Protection Against Electric Shock Fluids Mode of Operation Continuous operation Power Supply AC100 240V or DC12V or Internal rechargeable battery Application Single use syringe size 10 ml 20 30 ml 50 60 ml 100 ml Power Consumption Rated Power 25VA 25 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 diagnose when turn on the power 3 This pump automatically recognizes amp calibrate for B D MONOJECT Terumo BRAND SYRINGES For complete list of authorized syringes see Page 29 4 Wide range of injection rate with 100 ml syringe maximum flow rate setting is 1500 ml nr 5 Settings of last injection are memorized even after pump is power off 6 When unitary error happens pump stops immediately No siphon happens The volume infused at the responding interval between error happening and pump stopping is less than 15 ml 7 The product is DC AC power supplied with rechargeable internal batteries Product is able to charge the batteries and to operate at the same time Power sources are a AC input 100 240AC 50 60Hz
13. MIDMARI lt Versaflo 300 Micro Infusion Syringe Pump User s Manual For Veterinary Use Only ALARMS VERSAFLO 300 MICRO INFUSION poWER SYRINGE PUMP Midmark Corporation 60 Vista Drive Box 286 Versailles OH 45380 0286 Customer Service and Technical Service TEL 1 800 MIDMARK 1 800 643 6275 www midmark com GENERAL INFORMATION Versaflo 300 Micro Infusion Syringe Pump Features Capability to Load 100ml Syringe With 100ml syringe you can treat larger animal with larger volumes continuously without changing syringes Broad Infusion Applications General medication Analgesics PCA therapy parenteral and eternal nutrition Micro to Macro Infusion Delivers precise infusion at rates from 0 1 to 1500 ml hr Excellent Linearity Performance Continuously linear infusion at both low and high infusion rate for the best even medication treatment Alarms Alert Light 6 alarms using both light and sound Syringe Pump Operation Manual 2 GENERAL INFORMATION TABLE OF CONTENTS GENERALINFORMATION r araba a ee ee Gee ed Ge dee de de ed ee 4 SIENS AND SYMBOLS vember 4 FRODUETEEATURES se Eg ee ala suas ooie Me ee Gee be sues S a g 5 FIGURE AND SIEN Sies hees nasa Res hoop REG nasa REEDE Naan Re kaa REG a Ros oe 6 PRECAUTIONS amp NOTES iese de oe ae ge ee ae ae ge ee ee ee ge ee ee ee ge se ae ee ge ed ee 6 SP EOIRIOATION ss oe tere ne DE De Ee RE EE GE EE ee re 11 PREPARING F R T
14. cclusion occurs the infusion stops Press MUTE button to silence the alarm buzzer User can only resume the after the alarm condition is cleared ALARMS COMPLETE When an infusion is completed the operation stops and audible and visual alarms are activated Press MUTE button to silence the alarm buzzer elem LOW BATTERY Audible and visual alarms are activated if the battery runs low In such situation the pump should be connected to an AC or DC power supply immediately to charge the battery The pump will continue to operate while recharging the battery The LOW BATT alarm will keep 30 minutes if pump wasn t not plugged in the power supply will remain activated during 30 minutes if the pump is not plugged into a power outlet Pump will stop if the battery will be depleted in 3 minutes NEAR EMPT Y When there is approximately 5 ml of medication left an audible and visual alarm is activated Press the MUTE button to silence the alarm buzzer ALARMS MALFUNCTION If the pump s LED screen displays 2222 during the infusion its indicating that the pump has internal mechanism problem Stop using the pump immediately until the it is serviced by authorized personnel Syringe Pump Operation Manual 19 ALARMS FLOW RATE ALARMS dd Ed OPERATION SYRINGE PUMP POWER CAUTION Alarm can be silenced by pressing button However the alarm will resume if the alarm condition is not clear
15. e T1AL 250V 1 x Users manual Authorized syringe brands to use with this pump without additional calibration 10ml 20ml 50ml syringes B D Monoject Terumo NIPRO Europe JMS 100ml syringe JMS KDL Syringe Pump Operation Manual ACCESSORIES 29 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 keep the manuals and all accessories 2 Transportation Avoid shake and impact during transportation keep away from moistures no rain or snow 3 Storage lf the pump is to be stored for an extended period it should be cleaned and the battery fully charged at least 8 hours Store in a clean dry atmosphere Environmental temperatures 10 C 55 C Relative Humidity Less than 93 Atmosphere Pressure 500hPa 1060hPa There should be no erosive air or harmful dust Leaving the battery in an uncharged state for a long period of time may discharge completely and damage the battery permanently Perform operational and safety standard checkout to ensure the pump works properly and infuses accurately before use if the pump is stored over 3 months Perform operational and safety standard checkout and fully charge the battery every three months Syringe Pump Operation Manual 30 MAINTENANCE MAINTENANCE Service of this syringe pump must be done by manufacturer authorized technic
16. ed within 2 minutes SYRINGE DISENGAGED ALARM lf the syringe is disengaged during the normal infusion an alarm will sound and both NEAR EMPTY and COMPLETE LED lights will be ON Only resume the infusion after the syringe is installed properly ALARMS KEYPAD DESCRIPTION A Control panel amp pump structure 1 23 4 5 6 78 9 10 11 1213 14 15 16 17 Syringe Pump Operation Manual 20 ALARMS NR Ed l A N NE V SY 1 oS N a O o O O O WwW V y Fa o O KO YS lt A 21 22 Syringe size indicator AC power indicator Battery power indicator Increase rate Numeric display Decrease rate Flow rate Delivered volume Near empty indicator Check Complete alarm indicator Rapid purge operation Syringe Pump Operation Manual Occlusion alarm indicator Run Low battery alarm indicator Stop Mute Syringe securing bar Syringe plunger head On Off switch DC 12V Socket AC 100 240V Power cord socket Fuse Power supply indicator Green for external power supply Orange for battery 21 ALARMS KEYPAD FUNCTIONS ps INCREASE Button Increases flow rate Press to increase the flow rate hold to accelerate the rate changing DECREASE Button Decreases flow rate NZ Press to decrease the flow rate hold to accelerate the rate changing CHECK VOLUME Button Press or hold during RUN mode to display the volume deliv
17. emedies 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 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 ON Be se Syringe Pump Operation Manual 34
18. ered Release to return the current flow rate BOLUS or PURGE Button If pump is in RUNNING mode this button function as a BOLUS button Hold this button for 2 seconds to enter BOLUS infusion setting to infuse at preset flow rate maximum BOLUS volume is 10ml If pump is in STOP mode this button function as a PURGE button Hold this button to run the pump at preset flow rate to expel air out of the syringe or to purge the syringe Syringe Size ml BOLUS Purge Rate ml h RUN Button Press RUN button to start infusion the LED indicator flashes during the infusion STOP Button Press to stop the pump MUTE Button Press to silence the alarm buzzer when NEAR EMPTY COMPLETION COMPLETE OR OCCLUSION alarms are sounded Audible and visual alarms Syringe Pump Operation Manual 22 CALIBRATION SETTINGS CALIBRATION SETTINGS ACCURACY CALIBRATION NWARNINGS Contact manufacturer for authorized calibration value before using syringes not listed on Page 29 Do not calibrate unauthorized syringes without manufacturer s authorization 1 Turn on the power switch 2 Load the applicable syringe 3 Press the STOP button 4 consecutive times The pump will enter the calibration model with the first digit displaying 1 on the display screen Screen 3 mi h 4 gt I Screen 3 5 Press XJ to enter the Accuracy Calibration setting 6 Press or to change the calibration val
19. ian Replacing the fuse lf the pump can t be turned on when it s plugged in the electrical outlet please make sure there that the electrical outlet is working Then unplug the power cord and check the fuses in the fuse box on under the power socket If the fuse is burned please replace the fuse SUGGESTED CLEANING STERILIZATION GUIDELINES Always keep the pump clean use 70 alcohol soft cloths to wipe out any fluid on the pump Use EOG Ethylene oxide gas to sterilize the pump under 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 Before cleaning turn off the power and disconnect power cord NWARNING The operational and safety standard checkout must be performed at least every 24 month by factory authorized service representative to ensure the pump works properly and infuse accurately not covered by warranty paid service 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 replace all major components by manufacturer authorized technician or stop use Pollution Free Treatment And Recycling 1 Remove the Ni MH before recycling o
20. ing the pump Contact our authorized distributor for the maintenance service 1 Stop the pump to change the pump setting on the keypad 2 Stop using the pump Contact our authorized distributor for service Syringe Pump Operation Manual 26 flow ml n varlation in flowrate INFUSION ACCURACY OF THE SYSTEM INFUSION ACCURACY OF THE SYSTEM Infusion Accuracy Syringe pump at Sml hr 20 40 60 60 100 120 time min Trumpet Curve Syringe pump at 2ml hr overall percentage error A T Epi min 5 11 19 31 observation window min flow ml n varlation in flowrate Syringe pump at 1ml hr 0 20 40 60 60 100 120 time min Syringe pump at 1ml hr Ep max t overall percentage error A i E pimin 2 5 11 19 31 observation window min REGULATORY INFORMATION REGULATORY INFORMATION This volumetric syringe pump complies with the following standards e 93 42 EEC European directive for medical devices including EN 60601 1 2 and collaterals Electrical Safety and Electromagnetic Compatibility standards IEC CEM 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
21. lume Screen 8 There are three levels of alarm volume to select LOW Lowest alarm volume MEDIUM Medium alarm volume HIGH Maximum alarm volume F X r de 8 J mi h J Screen 8 Syringe Pump Operation Manual 24 CALIBRATION SETTINGS 7 Press pza to confirm and exit NWARNINGS The default alarm volume setting is HIGH Set the alarm volume to MEDIUM or LOW may cause the alarm not heard in distance If the volume is set to MEDIUM or LOW the user may not hear the alarm from a distance Always check if the alarm volume that the alarm volume is on HIGH before a new infusion Make sure the alarm sound at the current volume setting can be heard at any time by the responsible personnel in any situation RESET TO FACTORY DEFAULTS 1 Turn on the power switch 2 Load the applicable syringe 3 Press the STOP button 4 times continuously the pump will enter the calibration model with the first digit displaying 1 on the display screen Screen 9 4 Press 3 times to display 4 in the first digit on the display screen Screen 10 NN jml h J Screen 9 Default settings Infusion Rate 0 1ml h Accuracy Calibration 2 Medium 3 High Ee ri i Tai gt VL L TE ml Mj Screen 10 5 Press XJ to confirm the factory reset and exit The pump will be restored to the factory default settings Syringe Pump Operation Manual 25 TROUBLESHOOTING Description Possible Cause Pump cant be turned o
22. n Pump won t charge the battery OCCLUSION alarm but no visible block on the IV line Over under infusing over 5 Keypad locked frozen 1 Circuit overload 2 The power cord is loose or battery is depleted 3 Pump s power supply transformer is not working 1 Circuit overload 2 The rechargeable main battery needs to be replaced 1 Hidden occlusion can t be seen 2 The pump was set at HIGH occlusion sensitivity 1 User uses different brand size syringe without proper calibration setting 2 The pump wasnt sent for calibration within last 24 months according to the service protocol 1 The pump is running and most keypads are locked 2 The control buttons are broken TROUBLESHOOTING Required Actions 1 Unplug the pump from the AC power Check change fuses on the bottom of the pump only use fuse type T 1AL 250V 2 Make sure the power cord is firmly connected and power switch is turned on 2 Contact our authorized distributor to replace the main power supply 1 Unplug the pump from the AC power Check and change fuses 2 Contact our authorized distributor to replace the main battery 1 Check carefully the IV line and connection area and then resume the infusion 2 Change the pump to lower Occlusion sensitivity setting 1 Stop using the pump Check the pump accuracy with the currently used syringe brand size and pump calibration setting according to the manual 2 Stop us
23. nd to start the bolus The pump will give a short buzz reminding user of initialing bolus has started Numeric sign b is flashing Screen 2 The displayed bolus volume will decrease as the bolus injection goes on When the displayed bolus volume reaches 0 the pump will give a short buzz reminding user of the bolus completion Then the pump will go back to original injecting mode STER 17 TER ber ae J C Lid ef ie LY OE aJ an Screen 1 SS r TT iF ges k fr gt mi lt mi al Fi AHN screen 2 When the bolus is completed the pump goes back to the original injecting infusion rate mode CAUTION When the user enters the Bolus Setting screen original infusion rate and volume are not affected Each bolus shall not exceed 10 ml CAUTION Press in case bolus infusion needs to be stopped the pump will stop bolus injection and will return to original infusion mode IMPORTANT Bolus volume will be included into the total volume infused NWARNINGS Before starting a bolus infusion the user shall confirm the bolus volume and make sure the additional volume is safe for the patient Environment Condition Operating Transportation Storage Relative humidity lt 90 lt 93 non condensing Temperature 5C to 40C 10 C to 55C 41 F to 104 F 14 F to 131 F Atmospheric 700 to 1060 hPa 500 to 1060 hPa Syringe Pump Operation Manual 18 ALARMS ALARMS OCCLUSION When an o
24. o set the desired flow rate You can also hold the button or to accelerate the rate changing FLOW RATE ran ALARMS NEAR OPERATION SYRINGE PUMP OVER Flow rate range for different size of syringe Syringe Size ml Infusion Rate Range ml h 0 1 300 0 1 500 0 1 1200 0 1 1500 8 Press button to start infusion The lt lt lt lt led lights will keep rolling from right to left during infusion User can check the infused volume by pressing button The ml h LED light will switch to ml FLOW RATE ALARMS 5 Le ml h OPERATION lt 1 lt 1 lt SYRINGE PUMP POWER Syringe Pump Operation Manual 15 STARTING AN INFUSION 9 To stop an infusion press button Reason for the failure of the Self Diagnostic program If the pump fails the start up initial Self Diagnostic program the LED screen will display 1111 indicating that the pump did not pass the Self Diagnostic program Stop using the pump until the it is serviced by authorized personnel FLOW RATE ALARMS NEAR ZA OPERATION SYRINGE PUMP POWER ALARMS NEAR compere COMPLETE foccusion Low sarr LOW BATT BATT NWARNINGS If the pump s LOW BATT alarm is ON after the pump is turned on the user must connect the pump to into an AC power outlet immediately DO NOT use the pump if the LOW BATT alarm is ON The pump may stop during the infusion if the LOW BATT alarm is ON after the pump was turned on Syringe Pum
25. p Operation Manual 16 PURGE FUNCTION PURGE FUNCTION NWARNINGS The extension line must be disconnected or clamped before removing the syringe to prevent free flow to the patient The user must purge the syringe to expel the air completely from the syringe and the associated tubing every time before connecting to the patient Failure to do so may cause the patient s blood to drain backward at a low rate WARNING Do not remove a syringe from the pump while connected to a patient I To purge the syringe stop the pump first if the pump is running Hold the PURGE button to expel the air or fluid from the syringe IMPORTANT Depending on the syringe size the pump will purge the syringe at different rates for different size of syringe Syringe Size ml BOLUS Purge Rate ml h 10 240 20 30 400 50 60 960 100 1200 Syringe Pump Operation Manual 17 BOLUS SETTING BOLUS SETTING BOLUS BOLUS 1 During an injection use ka to give extra dose to the patient If you press Ca for 2 times pump enters Bolus settings First numeric sign will display b unit indicator ml is on at the same time The screen will display b with unit indicator ml Screen 1 2 Press or to set the desired bolus volume Maximum bolus volume is 10 ml Bolus volume will be displayed The pump will automatically calculate the bolus rate according to the syringe size and the bolus volume 3 Press to confirm the bolus setting a
26. r disposal 2 Manufacturer will accept used pump for proper pollution free treatment and recycling Syringe Pump Operation Manual 31 MAINTENANCE SERVICE RECORD 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 E Accuracy Calibration _ Functional tests Maintenance Detail Serviced by Print Technician Name Signature Service Company Name Print Tel Syringe Pump Operation Manual 32 MAINTENANCE SERVICE RECORD Date of Service Accuracy Calibration _ Functional tests Maintenance Detail Serviced by Print Technician Name Signature Service Company Name Print Tel Syringe Pump Operation Manual 33 LIMITED WARRANTY LIMITED WARRANTY This 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 6 months 6 for rechargeable battery 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 mate
27. rial or workmanship The repair or replacement of any product under this Limited Warranty shall not extend the above mentioned Warranty period All repairs under 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 r
28. ue the calibration range is 30 30 30 represents 30 30 represents 30 Screen 4 r n m i V WE i J J j m h J 1 Screen 4 7 Press god to confirm and exit ADJUST OCCLUSION PRESSURE 1 Turn on the power switch 2 Load the applicable compatible syringe 3 Press the STOP button 4 consecutive times The pump will enter the calibration model with the first digit displaying 1 on the display screen 4 Press once and the pump will display 2 in the first digit Screen 5 Syringe Pump Operation Manual 23 CALIBRATION SETTINGS ra R ri My ml N he ml od m Sh F n r Screen 5 5 Press XJ to enter the Accuracy Calibration setting 6 Press or to change the occlusion pressure Screen 6 There are 3 levels of occlusion pressure settings 1 LOW 0 04 MPa 5 8 PSI 2 MEDIUM 0 08 Mpa 11 6 PSI 3 HIGH 0 12 Mpa 17 4 Pel 7 Press pza to confirm and exit FER I J mi h Screen 6 ADJUST ALARM VOLUME 1 Turn on the power switch 2 Load the applicable syringe 3 Press the STOP button 4 times continuously the pump will enter the calibration settings with the first digit displaying 1 on the display screen 4 Press button two times and the pump will display 3 in the first digit on the display screen Screen 7 3722 V ai N ur J ml h EP Screen 7 5 Press L amp C to enter the alarm volume setting 6 Press or to select the alarm vo
29. ver block into position so that the end of the syringe plunger can be mi placed into the slot in the driver block Make sure the syringe plunger is properly seated in the plunger driver block OPERATION AI J PURGE l J STOP 4 Turn the syringe securing bar 90 clockwise to secure the syringe barrel Make sure the syringe barrel is secured so the syringe won t move during the infusion Syringe Pump Operation Manual 13 STARTING AN INFUSION FJ g lo i aS Wl 5 Turn the power switch ON ON OFF switch is located on the right side of the pump When it is initialized the pump will go through a Self Diagnostic program After the pump passes the Self Diagnostic tests previous infusion rate setting will appear on the display The pump is then ready to be programmed for an infusion OPERATION AAI cHECK sous I ge as STOP 6 Press and hold the PURE button to purge air from the syringe and associated extension tube before connecting to patient TT Doa ll A P a nn AF Pe V FLOW RATE SYRINGE PUMP POWER Syringe Pump Operation Manual 14 STARTING AN INFUSION IMPORTANT If the syringe was not installed or not installed properly the syringe size indicators will keep flashing After the syringe was installed the corresponding LED light will Keep ON indicating the syringe size e g 100ml as below sample 7 Press or t
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