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500E User Manual - Veterinary Technics
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1. Inthe mode of selecting Bolus rate press this key to select Bolus rate 600mL h In the mode of selecting the level of occlusion sensivity press this key to select 1st level 0 04Mpa 30 In the mode of parameters settings press this key to input 2 In the mode of selecting infusion set tubing types press this key to select NO 2 infusion set 17 In the mode of selecting Bolus rate press this key to select Bolus rate 700mL h Inthe mode of selecting the level of occlusion sensivity press this key to select 2nd level 0 06Mpa 30 Inthe mode of parameters settings press this key to input 3 Inthe mode of selecting infusion set tubing types press this key to select NO 3 infusion set Inthe mode of selecting Bolus rate press this key to select Bolus rate 800mL h In the mode of selecting the level of occlusion sensivity press this key to select 3rd level 0O 09Mpa 30 In the mode of parameters settings press this key to input 4 In the mode of selecting infusion set tubing types press this key to select NO 4 infusion set In the mode of selecting Bolus rate press this key to select Bolus rate 900mL h In the mode of selecting the level of occlusion sensivity press this key to select 4th level 0 12Mpa 30 In the mode of parameters settings press this key to input 5 In the mode of selecting infusion set tubing types press this key to select NO 5 infusion set In the mode of se
2. Trouble shooting connect the IP300 to the AC power to support the IP300 running and the battery is being charged CAUTION The IP300 will give an audible and visible warning 30 min before delivery ceases due to battery exhaustion During this period the IP300 will give a continuous visible and an intermittent audible warning At least 3 min before the end of the battery life the equipment will give and audible and visible alarm and cease delivery And the alarm will be maintained for the duration of the remaining battery lifetime le The infusion volume reaches the preset volume value Empty alarm Alarm status Relevant icon blinking accompanying alarm lights hinting and audio alarm Consequence of the alarm the IP300 gets into KVO mode However If the infusion rate 5mL h when finish infusion the IP300 system do not get into the KVO mode Trouble shooting press START STOP key to stop infusion and KVO If the infusion rate 5mL h when finish infusion the IP300 system do not get into the KVO mode So users can press 8 key to make the IP300 go back to the standby mode AC power is cut off suddenly AC cut off alarm el Alarm status In the LCD screen this icon is blinking accompanying alarm lights hinting and audio alarm 39 gt Consequence of the alarm the IP300 keep working gt Trouble shooting the IP300 is powered by battery In addition the IP300 can connect to AC power again 9 7
3. If users use other infusion sets that are not specified by the manufacturer should il t But tt infusi Don t use the IP300 in the environment of strong RFI or electromagnetic radiation For example the IP300 should be far more than 0 5m from high frequency surgical instrument when being used far from NMRI CT X RAY microwave equipments etc Figure 4 1 Nameplate 22 4 3 The correct installing infusion sets direction See figure 4 2 Fig install tube F Air detection Figure 4 2 4 4 Other relevant accessories information in the IP300 Thermostat information Rechargeable battery information Thermostat 30 5 C 2W 15V with Over temperature protection apparatus Rechargeable battery Ni MH battery 9 6V 1500mAh with 65 C over temperature protection and 2A overcurrent protection 23 5 Installation of the IP300 infusion pump 5 1 Openpackage inspection gt Be careful to take out the IP300 infusion pump and accessories from the package and preserve the package to prepare for the transportation and storage in some day Also the user should check things according to the configures of equipment list Check no damage to the IP300 infusion pump and its accessories Check things and make sure these is nothing missing and everything is qualified VV gt If users find there are some problems with the products please contact the manufacturer immediately 5 2 Fixation of the IP300 infu
4. about the agent Never use any organic halogenate or oil base solvent anesthetic glass agent acestone or other irritant agents Never use any abrasive agent to clean any of the components i e Steel wool silver polish or agent Keep liquids far from the electrical components Prevent liquid from entering the equipment Do not immerse the synthetic rubber components more than 15 minutes any longer will cause inflation or accelerating aging The PH value of the cleaning solution must be from 7 0 to 10 5 Talc zinc stearate calcium carbonate or corn starch that has been used to prevent tackiness could contaminate a patient s lung or esophagus causing injury Check if there is damage in the components Replace if necessary Wipe clean with a damp cloth and mild soap solution or with one of these chemicals or their equivalents Use water to rinse off chemical residue as necessary Forbidden acetic hyctro peroxide or formaldehyde steaming WARNING CAUTION vv gt VV Vv gt Shut down and cut off AC power before cleaning infusion pump or sensors Keep dust free Using shell without these such as soap or fresh water Prevent infusion pump is damaged Do not use strong solvent such as acetone 48 gt It s very important that most detergent must be diluted according to instructions of manufacturer gt Never use any abrasive agent to clean any of the components i e steel wool or silver polish gt Kee
5. data gathered during the second hour of the test period set rates 1mL h Calculate percentage error Ep max and Ep min in observation windows and the average percentage error B of the last hour of the test period Trumpet curve is plotted as follows Figure annex 1 4 54 a Em ax S E m ax amp Overall percentage error B Percentage error of flowy oO 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 Obervation window min Figure annex 1 4 Trumpet curve plotted from data gathered during the last hour of the test period set rates 1mL h 3 Inter mediate rates 25mL h Calculate the actual flow Qi mL h for each sample interval for the first 2 hours analysis period from equation 1 of chapter 50 and plot flow Qi against time TO for the first 2h of the test period see Figure annex 1 5 2T 2G eow J HAAN LUI i Wi Wit Mi 24 o ZO 40 60 30 100 120 Timetmin Figure annex 1 5 Graph plotted from data gathered during the first 2h of the test period set rates 25mL h Calculate percentage error Ep max and Ep min in observation windows and the average percentage error A of the second hour of the test period Trumpet curve is plotted as follows Figure annex I 6 55 a 4 E ma x 4 E min s Overall percentage error A a 0 a Percentage error of flow oO 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 Observation window min Fi
6. in the grooves straighten the tubing and make sure there are no any mistakes Then push the clamp which is for stopping the flow install and clamp the tubing Users make sure that the clamp functions well and no flow moves freely As being shown in the fig 6 3 26 Figs 6 3 install tubing c Close the door As being shown in the fig 6 4 Fig 6 4 close the door Connect to the paitent a Before installing the tubing make sure no air in line b After installing the tubing adjust the infusion set flow regulator and loosen it to make sure no liquid drips out of injection needle or into drip chamber If some liquid drips out of injection needle or into drip chamber it indicates that wrong installing the infusion set tubing and the user need to install tubing right again However if the user makes sure it is right installing tubing it would be the malfunction of the equipment and solve these problems according to the trouble shooting in the instruction If everything is OK the user fasten and close the flow regulator pa A c Make sure that no air in the line or in the tubing and then remove the protective cap of needle and pierce needle into the patient s vein carefully Finally make sure that the IV needle pierces safely CAUTION If wrong installing or not closing the door of the IP300 alarms cannot work properly or flowing abnormally In addition maybe the infusion relevant monitoring fails U
7. needs to be returned to Eternity 1 Obtain the rights of return Contact with the customer service of Eternity by informing them the number and type of the product The number is marked on the surface of the product Return is unacceptable if the number cannot be identified Enclose a statement of the number type and the reason of return as well 2 Transportation charges Transportation and insurance charges must be prepaid by the user for transporting the product to Eternity for repairing Customers charges is added with regard to the products sold to non Chinese mainland users Foreword e Thank you for purchasing and utilizing Eternity equipment O For using the equipment rightly and effectively please read throughtly and carefully the User Manual before use O Any use of the equipment requires full understanding and strict observation of these instructions O The equipment is only to be used for purpose specified here O One who is not authorized by Eternity shall not be allowed to open and dismantle the equipment for maintaining checking and repairing O For further assistance contact Eternity good service would be supplied Welcome to contact Eternity by the following address Manufacture Beijing Eternity Co Ltd Address No 4 Xijing Road Shijingshan District Beijing China PR Tel 86 010 8879 5817 86 010 88795560 Fax 86 010 68827023 Web site www yshmed com E mail yshmed 126 com PreCAUTIONs for
8. present meanwhile audio alarm is eliminated This icon is absent when alarm silence is canceled If the temperature of environment is very cold the users can start up the heat function In addition if the users select the HEAT ON mode the heat function will be continuously on and this icon is also lit If the users select the HEAT OFF mode the heat function will stop and this icon is absent If the users select the HEAT AUTO mode the heat function will start up according to the environment temperature lt 16 3 C to decide to start up the heat function and this icon will keep the same action with the heat function gt Area3 parameters area This part displays 1 Volume preset value 2 Residual volume 3 Preset time and residual time 4 drip chamber indicates whether the infusion is proceeding VOL LIMIT LEFT This part displays Infusion 1 infusion flow rate and the unit can be converted between Rate l E drip min and ml h gt Area4 information options area and accumulated infusion volume display value area TUBE ADJ BOLUS OCCL VOL INFU ml h mi 15 There are IV sets options tubing types options adjustment options BOLUS rate options occlusion detector sensitivity level options from left to right in turns When the parameters are selected the black frame of these parameters will be blinking In addition on the right of this area there is accumulated infusion volume displa
9. return to normal If the user find the information displays incompletely please contact the manufacturer gt Check the air sensors If put no infusion set tubing in the groove of the air sensors or wrong way to install the tubing or the infusion set tubing has some bubbles in it the IP300 will trigger the air in line visual alarm and show it to the users If put the tubing in which no air in it and liquid fills up the visual alarm will be absent and it indicates the air sensors function well gt Check the Occlusion detector When right way to put the infusion set tubing which is filled up with liquid into the grooves and close the door press the START STOP key to get in the running mode At this time users occlude the tubing then the occlusion alarm is triggered it indicates the occlusion detector functions well gt Check the door open detector 29 In the standby mode when open the door the visual alarm of door open is triggered If open the door in the mode of running mode the visual and audio alarm will be triggered at the same time Check the clamp which is for stopping the flow After finish installing the infusion set make the clamp infibulates the tubing and no flow moves freely And push the clamp the flow in the tubing can move freely it indicates that the clamp function well Check the free flow After finish the installation close the door of the IP300 and make the IP300 stable At thi
10. 0 lt flow rate 1300 mL h KVO rate is 5mL h 11 Accuracy of the set delivery rate 5 over 4 hours with specified infusion sets users buy it themselves with manufacturer authorized type 12 Bolus rate 600 mL h 700 mL h 800 mL h 900 mL h 1000 mL h be selectable if the situation requires 13 Air sensor sensitivity 20 015mL 14 Occlusion detector sensitivity Adjustable in 5 levels from 0 04Mpa 0 015Mpa 30 a 5th Level 0 04Mpa 30 b 4th Level 0 06 Mpa 30 c 3rd Level 0 09 Mpa 30 d 2nd Level 0 12 Mpa 30 e 1st Level 0 15 Mpa 30 15 The number of the air sensors 2 sets 16 The number of the occlusion detector 1set 17 The number of the heat function equipment 1set 18 Heat function modes 3 options Auto On Off 19 Heat temperature on the spring board 305 C 20 Display screen colorful LCD screen 21 Specified infusion sets Anaco Disposable infusion sets H O5APD 22 Input power lt 0 5A 23 Alarms Internal Fault Low Battery voltage AC Failure Door Open Occlusion Air in line empty Heat malfunction Interruption of the AC power supply 24 Alarm Volume Alarm volume should be over 65dB A during alarms 25 Pump Running Noise Without Alarms IP300 s running noise should be under 50dB A 26 Battery Capability Infusion Pump can run under intermittent rate 25mL h longer than 4 hours at 20 C 27 Charging AC Power charges automatically Electric quantity could achieve over 85
11. 3 Silence Pressing the B key to cancel audio alarm and no sound for 2 minutes But the alarm lights and relevant alarm icon is still blinking When the IP300 system in the silence status any new triggered alarm can eliminate the silence status AN CAUTION oY When icon appears it indicates that the audio alarm is cancelled and the IP300 system will not give audio alarm in 2 minutes except the AC power interruption alarm which keep no sound if users press the B key until next alarm triggered So users should pay more attention to this function When 2 minutes passed or new triggered alarm system can go back to the normal alarm status 9 7 4 Heat malfunction alarm If the thermostat malfunctions the IP300 system will give a Heat malfunction alarm that the heat indicators are all blinking accompanying audio alarm And the IP300 cannot start to run If users find this problem please press key to re power on the IP300 and do not use the heat function again In addition users should contact the maintenance operators or the manufacturer immediately 40 10 Safety and Sign 10 1 Environment safety Following these 1 Follow the environment condition specified in this manual 2 Keep enough space to operate and connect lines for backboard 3 Ensure enough air circulating A WARNING Under no circumstances should this medical device be operated in the presence of flammable anesthetics or other volatile mat
12. 95 TPoweron TAE TESORO N 29 TAIC ec ete IP SOW modes iros a placa pits 29 S Opera orin tucio AAA E T E E E a a a dts 30 SIS TARTOR SOPAS TESORO AS 30 Bz POW EOM e lletra died ocn Genk a ene eats 30 oC heck the modes OL ie IP300 kia E a tatveda untae crseduapnelabceiendumitataseamaedecatnaldc 31 Skre MOVE Me ar mete turn todo ets atada acre wea de 31 9 Set o AAA II el taba bine dubai edad eden stabbed duds 32 Ol Sette volume preset yale iras AA N R AAA AN 32 92 SEL the mison CALC nia E A E E EEA 32 DNS TYNES OF UNG MUSON S Etaoin a A ae 33 DIESEL TIC bolus LAS AS E AA AAA A A ia ihe la ites El aa awa Sau te 34 95 Deb Ine OCCIUSION detector sensitivity LEVE id A AAA seis dinar DAA dae iad 34 DO TATU ti A a 34 DOLAR A AS ASAS A TIA AAA AE EI E 34 9 6 2 ItUston Tate units CON VECINO rad A AA AAA AAA AAA AAA EA 34 003 Ouer the residual IA TUSIOA VOS A AAA AAA EA IO 35 HOA Over the ACCU MIU ACG VOTA satoi cir duct A AAA AAA AAA AAA DADA 35 9 0 5 Query the tesidual time Of IMIMUSION Procesal aa 35 DO 0 BO US AM SUM ee nes oe est te oe oe 6 a ele e oi ae gd ye See de Se ee ees 35 TO FEAE aie AAA O A SNORE DIU ENTE HU REEET NN DONTE ENO ET ne eT TeyT 35 ESPASE 1061010 J epee ner eats A net brney nme eareg wees Mme nee bres Rent eaten weer nye tees g ean reny 35 O o Alaris ithe Processor IMTUSO puna a a ecn la at ea edit eeate A ccabneeaeaaiae 35 OG TOC OMIPICLS abro IPN A o A 36 A NO 37 E EDON e AE tects TAEA necator ate teh ORARE ERROA ORAR
13. At this time the area of infusion rate display 10 which indicates that the torture equipment rate is 10ml h Users press 1 9 key to select relevant torture rate 10 ml h 50 ml h 100 ml h 300 ml h 500 ml h 700 ml h 1100 ml h 1300 ml h Finally press START STOP to start up torture equipment process If users want to stop torture equipment process press START STOP process A Do not start infusion in the process of torture equipment program Users can press BOLUS key to exit the interface of the IP300 system parameters Ahe Important Things To Know Do not modify the NO 1 type of infusion set parameter Reason Before leaving the factory the NO 1 type of infusion set parameter has been calibrated Users can modify the NO 2 NO 3 NO 4 and NO 5 types of infusion set parameters Reason Before leaving the factory NO 2 NO 3 NO 4 and NO 5 types of infusion set parameters are same as NO 1 Users can modify them carefully After finishing calibration users should make marks to notify other users Reason should notify other users to select right infusion set options otherwise the calibration process may cause unpredicted errors and medical negligence 60 The IP300 infusion pump user s manual Version 1 2010 01 01 Beijing Eternity Electronic Technology Co Ltd 61
14. E RAEE aetna tae 37 97 2 A1dtms and trouble shootne Tor TACA A A E E A A 38 SS A EAN 40 9 TA el AAA A sal ENE A ENE ESEA 40 PO Sale by ANS a A O 41 TOI Eav onneni Saeta AA AAA Ad 41 EOD Precautions Tor CONAM A od 41 10 21 Checktor quid Caras Eu a ASA AEREA AAA AA AS 41 TODD Taree WAY IM USO st A A AAA AAA A A A A a 42 102 3 Bie Citerence comthe dp Tdi II SU O OI a 42 10 24 PhatinaColo gic TE ACOSTA 44 ELMontonno pero ran Ct adria cceda 45 1 1 DOOR MONTON oeno E E E A A E A E TE A E E E 45 A TO 45 PAGE Ee OnO a E a a a E E 47 A ERP IMO MIL OEMS tt E E E aa alles Sane eens Cen enag orate 47 EEO Or ubUpemreename meen own remtn a center eum rr weears i ite Manne ob aae Tce taney trons vacancy ry cteTe tr cettnte ne Teete ine wer reverse 47 Elo battery IO WAMION I LOM INS tilda aeade anaeungee 47 FLI POWEr Cul Onl MOMOM E A ERE E A A ad 47 Picanto and STEAM rr A AAA AA A AAA ES 48 P E o a leani na OT 48 LIA A NO 49 AP O O RR O 49 AUS is AAA O OPE EP A II 51 SIRENA POMO a A A A A ins ASA A AE AA E 51 P OEF NOOO praia a AAA AAA AAA AAA AE Sas 32 AM caidos 53 1 Accuracy test of the IP300 volumetric infusion pump in accordance with standard ENGOGO1 2 24 ccccooooooooooocccccccnnnnnnncnnnnnos 53 Zl ratos Mimo rates di AAA AA a td 54 e A taa 55 Ame ln te E E od e E nat eeenrerT heey e 57 1 Introduction 1 1 What s the IP300 The IP300 Infusion Pump 300 is a volumetric infusion pump which uses the microcontroller for accurate control
15. Eternity IP300 Infusion Pump User s Manual Infusion Pump IP300 Accuracy Reliability Safety lt gt Eternity Beijing Eternity Electronic Technology Co Ltd Statement Beijing Eternity Co Ltd Eternity for short holds the copyrights to this manual which is non publicly published and reserves the rights to keep it as a secure document Refer to this manual when operating maintaining and repairing Eternity products only Anyone other than Eternity may not make it known to others Proprietary materials protected by the copyright law are included in this manual Any section of it cannot be reproduced copied or translated into other languages without any prior written approval from Eternity who reserves the copyright Everything written in this manual is considered to be correct Eternity is not legally responsible for any mistakes printed within and any damages caused by incorrect installation and operation Eternity does not supply privileges endowed by the patent law to any other parties Eternity is not legally responsible for the results caused by patent law breaking and any rights of the third party violating Refer to this manual before any Eternity product is used The manual includes operating procedures which must be performed with cautiously operations that may result in non normal working conditions and the dangers which may damage equipment or cause bodily harm Eternity is not responsible for the secu
16. U ml h ml Fig 0 3 1P300 Frontview gt Area 1 Alarm message area When alarm occurs the corresponding icon will be blinking to remind operator to deal with alarm More details refer to chapter 4 Fault alarm icon When fault alarm triggered this icon is blinking and alarm occurs accompanying audible and visible Must shutdown the pump and restart when fault alarm occurs However if the infusion rate lt 5mL h there is not KVO mode after infusion process completed Occlusion alarm icon When patient tube pressure more than presetting the occluded alarm is triggered and its icon is blinking the alarm is visible and audible the pump stop infusing at the same time If the occlude is removed the occluded alarm icon disabled Door open alarm icon When the pump door is open the door open alarm is triggered and the icon blinking If the pump door closed the icon disabled The door open alarm occurs with audible and visible in the process of infusing and without audible in non infusion state Air in line alarm icon When bubble in the IV line exists and is detected by ultrasonic sensor the bubble alarm occurs and its icon blinking audible and visible accompanied The pump stops infusing at the same time If the bubble is removed the bubble alarm icon disabled Low battery voltage alarm icon When the pump is powered by battery supply only and residual capacity can not ensure the pump continuous operating the low bat
17. after charging for 6 hours 28 The time for which the electronic memory is retained follow switch off or power off 10 years 29 The maximum volume that may be infused under single fault conditions 1mL 21 4 Name Plate 4 1 Warning gt P300 infusion pump should be used with the manufacturer specified infusion sets If users use other infusion sets that are not specified by the manufacturer should calibrate the equipment But the manufacturer is not responsible for the inaccuracy of infusion gt Don t use the IP300 in the environment of strong RFI or electromagnetic radiation For example the IP300 should be far more than 0 5m from high frequency surgical instrument when being used far from NMRI CT X Ray microwave equipments etc See the figure 4 1 4 2 Product information Product Name Product Model Product Registration Number Product Standard Number Product Series Number date of Manufacture Manufacturer Name Address of Manufacturer and Power supply Demands gunin4 JNO YYeeH INOA lt E gt Eternity ara Name Infusion Pump Model IP300 Voltage AC 100 240V Power 15 VA Frequency 50 60Hz sn IP300E1005001 wl 2010 5 Beijing Eternity Electronic Technology Co Ltd ADD NO 17 Xi jing Road Shijingshan District Beijing China EC REP Raymond Lam Sai Kit Address Poolse Winglaan 14 9051 Sint Denijs Westrem Belgium IPX1 ALOR the manufacturer specified infusion sets
18. ck Sse Tes as O own the patien suse tos os oio 25 ss S28 cauton airin line uses 1 1510s 108 may be generated in 25 lt 2s 2s _ this process suseg PL 510s Ss a f pes 1 Special 46 11 3 Air in line monitoring When single bubble volume more than 15x10 ml the system prompts alarm message and sound 11 4 Empty monitoring When infusion volume reaches preset value the system prompts alarm message and sound 11 5 Fault monitoring When drive mechanism for example the error of the IP300 equipment cause overinfusion due to the infusion rate uncontrolled and occlusion detector fault the system prompts alarm message and sound 11 6 Battery low monitoring When inner battery power exhaust the system prompts alarm message and sound 11 7 Power cut off monitoring When exterior AC power supply fault the system prompts and sounds for 3 minutes at least 47 12 Cleaning and Sterilizing A WARNING A CAUTION A WARNING A WARNING 12 1 General cleaning Use a cleaning and sterilizing schedule that conforms to your institution s sterilization and risk management policies gt gt gt Refer to the material safety data policy of each agent Refer to the operating and maintaining manual of all the sterilizing equipments Wear safety gloves and safety goggles To prevent damage gt gt gt Refer to the data supplied by the manufacturer if there are any questions
19. completely closed Door open alarm gt Alarm status a Inthe standby mode relevant icon blinking b If in the running mode this alarm is triggered even more accompanying alarm lights hinting and audio alarm gt Consequence of the alarm the IP300 stop running gt Trouble shooting press the silence key 8 to stop audio alarm and the IP300 will restore previous status and data automatically Then close the door completely and see whether the door open alarm disappears Finally press START STOP to restart infusion 38 4 VV V 5 7 Motor and pump drive mechanism or occlusion detector fail insides the direction of t motor reverse to make reverse flow delivering Fault alarm Alarm status Relevant icon blinking accompanying alarm lights hinting and audio alarm Consequence of the alarm the IP300 stop running Trouble shooting Restart the IP300 if the IP300 does not run again users please contact the manufacturer immediately and solve this problem through the maintenance operators of the manufacturer The residual power of the inner rechargeable battery cannot support the IP300 to run continuously Low battery voltage Alarm status Relevant icon blinking accompanying alarm lights hinting and audio alarm Consequence of the alarm IP300 powered from the inner rechargeable battery will give the alarm in the event of low battery voltage but the power just support running for 30min
20. creen TUBE BOLUS and OCCL icons is blinking And then press the relevant 1 key the IP300 system can get into the setting types of TUBE mode In this mode 1TUBE is the manufacturer specified infusion set But 2 3 4 5 TUBES are other infusion sets that can be specified by the users themselves Users can select these set by pressing relevant digital key and press ENTER to confirm the selected information If users just input data without any operation or ENTER subsequently beyond 10 seconds the current input is saved automatically In addition users can press SETTING key to exit the mode of setting the types of the infusion set 33 9 4 Set the bolus rate In the standby mode press and hold SETTING key for 2 seconds at this moment in the LCD screen TUBE BOLUS and OCCL icons is blinking And then press the relevant 2 key the IP300 system can get into the setting the bolus rate In the IP300 system there are 5 rates options can be selected 600ml h 700mI h 800mI h 900ml h 1000mI h and users can press relevant digital key 1 2 3 4 5 to select required bolus rate After finish selecting rate users can press ENTER to confirm the selected information If users just input data without any operation or ENTER subsequently beyond 10 seconds the current input is saved automaticall
21. d of one year from the date of original delivery the components and assemblies of this product is warranted to be free from defects manufacturing techniques and materials provided that the same is properly operated under the conditions of normal use and regular maintenance The warranty period for other parts is three months Expendable parts are not included Eternity s obligation under the above warranties is limited to repairing free of charge Free Obligations O Eternity s obligation under the above warranties does not include the freight and other fees O Eternity is not responsible for any direct indirect or final product broken and delay which result from improper use alteration by using the assemblies unratified and maintenance by anyone other than Eternity O This warranty does not apply to the followings 1 Improper use 2 Machines without maintenance or machines broken 3 The label of Eternity original serial number or mark is removed or replaced 4 Other manufacturers product Security reliability and operating condition Eternity is not responsible for the security reliability and operating condition of this product in case that O The assemblies are disassembled extended and readjusted O This product is not operated correctly in accordance with the manual instruction The power supply used or operating environment does not follow the requirements in this manual Return Follow the steps in case that the product
22. dle into the infusion bottle close the flow regulator and then hang the infusion bottle on the infusion support and have the infusion set natural downward extension b Open the flow regulator to make the liquid flow fill up the infusion set tubing by gravity to remove the air in the tubing and also use the hand to pinch the drip chamber to make liquid fill from 1 2 to 2 3 volume of the drip chamber c After completely remove air in the tubing close the flow regulator d Right installation of infusion set according to Chapter 6 1 e Make sure that the tubing has no air in it and insert disposal vein infusion needle into the patient s vein in the right way f Open the flow regulator and start up the IP300 to run AN CAUTION The flow regulator should between the infusion pump s site where the liquid flows out and the injection site in order to control the process of bolus or infusion by manual operation When pinch the drip chamber to fill liquid do not get the air in the infusion set tubing After installing the infusion set and opening the flow regulator see whether some drips drip down in the chamber or vein infusion needle If some abnormal phenomena exist check the ways of installing However if users cannot solve these abnormal phenomena don t start up the IP300 and contact the maintenance operators or the manufacturer 2 Remove the air in line by bolus function Steps for operation a Insert the piercing ne
23. edle into the infusion bottle close the flow regulator and then hang the infusion bottle on the infusion support and have the infusion set natural downward extension b Open the flow regulator to make the liquid flow fill up the infusion set tubing by gravity and also use the hand to pinch the drip chamber to make liquid fill from 1 2 to 2 3 volume of the drip chamber c Close the flow regulator d Right installation of infusion set according to Chapter 6 1 e Open the flow regulator and start up the IP300 to run f If there is still some air in the tubing users should press and hold the Bolus key for more than 3 seconds to remove all the air in line 31 g Make sure that the tubing has no air in it and insert disposal vein infusion needle into the patient s vein in the right way An CAUTION The flow regulator should between the infusion pump s site where the liquid flows out and the injection site in order to control the process of bolus or infusion by manual operation When pinch the drip chamber to fill liquid do not get the air in the infusion set tubing After installing the infusion set and opening the flow regulator see whether some drips drip down in the chamber or vein infusion needle If some abnormal phenomena exist check the ways of installing However if users cannot solve these abnormal phenomena don t start up the IP300 and contact the maintenance operators or the manufacturer 9 Set param
24. erials due to a possible explosion hazard A CAUTION Do not put IP300 into the shock environment 10 2 Precautions for connecting 10 2 1 Check for liquid leakage Before use fully fill the liquid into the infusion set line After the infusion set has been clamped to the pump and before the needle is inserted into the vein and the infusion is started put the needle naturally downward Check whether medical liquid drips from the needle as shown in Figure 0 1 If the medical liquid drips it means that the pump head and the spring pressed board are not tight If infusion of medical liquid cannot be blocked when infusion is stopped stop the infusion and repair it in time Infusion bottle Infusion pump Infusion set line fmbing Heddle Figure 0 1 After the installation of infusion set onto the infusion pump and when the tubing is full of liquid manually open the pump door as shown in Figure 0 2 and check whether medical liquid drips from the needle If medical liquid drips it means that the liquid stopping clamp has not clamped tightly and cannot block the infusion of medical liquid when the door is open In this case process it in time 41 Infusion set line Heddle Figure 0 2 10 2 2 Three way infusion When an infusion set is connected with the three way connector and carried out the combined infusion with another way as shown in Figure 0 3 attentions must be paid to taboo at matching of two medicines
25. ery rate selected by the user Flow the measured output in volume per unit of time Bolus a discrete quantity of liquid which is delivered in a short time as an infusion but not part of a priming routine Sample interval S the time between successive mass readings Test period T the total duration of the test from start to finish Ep max maximum measured error in observation window of specified duration Ep min minimum measured error in observation window of specified duration The following graphs and curves were derived from specified infusion sets used 53 2 Set rates minimum rates 1mL h Calculate the actual flow Qi mL h for each sample interval for the first 2 hours analysis period from equation 1 of chapter 50 and plot flow Qi against time TO for the first 2h of the test period see figure annex 1 2 Flow fral hi 1 0 0 38 0 6 0 4 o 20 40 60 so 100 120 Time rin Figure annex 1 2 Graph plotted from data gathered during the first 2h of the test period set rates 1mL h Calculate percentage error Ep max and Ep min in observation windows and the average percentage error A of the second hour of the test period Trumpet curve is plotted as follows Figure annex 1 3 MAE E im ax Overall percentage error 4 E imin Perce ntage error of flow 2 4 6 5 10 42 14 16 18 20 22 24 26 28 30 32 34 Observation window mini Figure annex 1 3 Trumpet curve plotted from
26. eters 9 1 Set the volume preset value In the standby mode Press the VOL LIMIT key the area of volume preset value displays 0000 which is also blinking And the IP300 get the standby mode into the mode of setting the volume preset value screen displays VOL LIMIT and ml press relevant O 9 digital keys to set the volume preset value For example if users want to input 4321ml they can press 4 3 2 and 1 keys Then press ENTER key to save the current input If users just input data without any operation or ENTER subsequently beyond 10 seconds the current input is saved automatically In addition users can press VOL LIMIT key to exit the mode of setting the volume preset value After starting up the IP300 and running it if users want to reset the parameters users need to stop running the IP300 and then press VOL LIMIT to get in the mode of setting The preset volume range is 1mI 9999ml the minimum step is 1ml 9 2 Set the infusion rate In the standby mode press the RATE key the area of the infusion rate value displays 0000 which is also blinking And the IP300 get the standby mode into the mode of setting the rate screen display Infusion Rate and the relevant rate unit press relevant 079 digital keys to set the infusion rate value For example if users want to input 123 they can press 1 2 and 3
27. gure annex 1 6 Trumpet curve plotted from data gathered during the second hour of the test period set rates 25mL h Calculate percentage error Ep max and Ep min in observation windows and the average percentage error B of the last hour of the test period Trumpet curve is plotted as follows Figure annex 1 7 e E max 4 j in hk Over percentage error B 2 De 8 E min dl ee ee P Y 2 s m Percentage error of flow 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 Obserbation window min Figure annex 1 7 Trumpet curve plotted from data gathered during the last hour of the test period set rates 25mL h 56 Annex II The IP300 infusion pump core system parameters set instruction AN WARNING The IP300 has its own system parameters And these parameters are very important thus users modify them as appropriate and the operation condition and cannot set them frequently If the users set wrong parameters or wrong operation to these system parameters the manufacturer is not responsible So users cannot set them unless the well trained technician s help and introduction First the system parameters are classified into 5 different options When users get into the interface of the IP300 infusion pump system parameters press 1 2 3 4 or 5 key the interface displays information as follows dd 1 1 1 1 7 Calibrate the infusion rate acc
28. ing users set the type of tube to NO 5 and exit the setting Other operation users can follow 1 1 Users can press BOLUS key to exit the interface of the IP300 system parameters B Check air sensors sensitivity After finishing the IP300 power on self testing users set the type of tube to NO 1 and exit the setting Then press and hold B for 3 seconds to get into calibration Adjustment interface meanwhile the display screen ADJ icon is blinking Input the password 2010 and press ENTER key and the IP300 display screen displays 1111 and then press 2 At this time the IP300 display screen displays 2222 then press ENTER key to get into Check air sensors sensitivity program In the screen the area of volume limited in the screen displays the top air sensor s sensitivity and down air sensor s sensitivity When users install the infusion set tubing full with liquid and close the pump door to see the air sensors sensitivity If sensitivity value gt 1600 it indicates that the air sensor is OK Otherwise users please refer to Chapter 9 If the error still exist users please contact to the manufacturer Users can press BOLUS key to exit the interface of the IP300 system parameters 58 C Check the temperature around the spring board After finishing the IP300 power on self testing Then press and hold B for 3 seconds to get into calibration Adjustment
29. interface meanwhile the display screen ADJ icon is blinking Input the password 2010 and press ENTER key and the IP300 display screen displays 1111 and then press 3 At this time the IP300 display screen displays 3333 then press ENTER key to get into Check the temperature around the spring board program The area of volume limited in the screen displays the temperature value around the spring board Users can press BOLUS key to exit the interface of the IP300 system parameters D Calibrate the occlusion detector sensitivity Connect all apparatus for calibrating the occlusion detector sensitivity as figure annex II 2 Infision Pressure au E Three 9ray STOPCOCK corrector figure annex 11 2 After finishing the IP300 power on self testing Then press and hold B for 3 seconds to get into calibration Adjustment interface meanwhile the display screen ADJ icon is blinking Input the password 2010 and press ENTER key and the IP300 display screen displays 1111 and then press 4 At this time the IP300 display screen displays 4444 then press ENTER key to get into Calibrate the occlusion detector sensitivity program At this time the area of volume limited in the screen displays the occlusion detector initial reference value different infusion pump has its own different reference value The area of infusion rate in the scree
30. ipment TICO UCA OD Got Pica ASA EAN E AAA E AAA TRAD AAA RA AA AA A 9 LAWS tne IP SOON E AA A AA A A E A AE A E 9 MSV MOONS ata A A A Do is 10 eO E O A PO O O O O a Sea dada ancanascemeniar es 11 Dik S VSLCM COM PONES A A A A AA AA A tomes tiga E 11 Die LOMO VS ASA AAA SADA AAA AA AnS 11 2I RO A EEEE EE R NETERA veeuabe decane EERTE EATA EREA ETRA 12 ZA DOOP n VINE A A A AS A iaa 13 BO A A E E POC EE A a eked aaa 13 PL Ih Chee 6 on PPND ROPERO RR RS ELA 16 Ae ip LEILA Bo EA 0 PE PP A A A 16 A A E AOE AAN RO 16 Be PEEROLM IAIN e Tide Kens Sots ES O A AS AA AA AA ARA A is 20 E A 20 A E AM tal pa teats ne taf tated Ace pte ated at tied el bated det wits cd Stet Ae ade ase EE eis dcaaiedede 20 4 Name Plat coi o a NL ts diac su ES IN VA A IO 22 A A A A A A AS 22 A Product MONATON ecen AAA AAA AAA TET T Siler wis 22 4 3 The correct installing infusion sets direction See figure 4 Z ococcccconnnooononoonnccnncnnnnnnnnnnnononononnnnnnncnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnns 23 4A Other relevant accessories information m the IP300 A AA A AA AA A AA AAA 23 Jsalanomor the IP00 maS oN pn eee taa 24 O oo aa o AAA a PO ES PE a a O S 24 3 2 Eaton Or the IP gt 00 IMTUSTOR PU Pr A AE AA EA A AS EI E 24 9 3 Use the vertical IMMTUSTON UPPOTS srl AAA AA SAA AAA eee es rae AAA AAA AAA 24 Oa Onneet the AC Power cord 10 ENGR SOO a AA AAA AA IO 24 OTastal STONES A AS E A A AA AAA AA A aude 25 6 11 Stepstoranstallie mituston sets to he IPO ai a AS 2
31. is moment in the LCD screen TUBE BOLUS and OCCL icons is blinking And then press the relevant 2 key the IP300 system can get into the setting the bolus rate In the IP300 system there are 5 rates options can be selected 600mI h 700mI h 800mI h 900ml h 1000mI h and users can press relevant digital key 1 2 3 4 5 to select required bolus rate After finish selecting rate users can press ENTER to confirm the selected information If users just input data without any operation or ENTER subsequently beyond 10 seconds the current input is saved automatically In addition users can press SETTING key to exit the mode of setting the bolus rate In the standby mode press and hold BOLUS key for more than 3 seconds the bolus mode start and release the key the bolus mode stop and go back to the standby mode However bolus volume is not calculated and added to the accumulated volume AN WARNING Before use bolus function users should check the infusion liquid s medical property in order to avoid some harmful medical influence to patients bodies When bolus mode starts up the air line alarm occlusion alarm and door open alarm do not work oF 9 7 2 Alarms and trouble shooting for them a Inthe standby mode relevant icon blinking 1 Air in the infusion set tubing AIR in line alarm gt Alarm status b If in the running m
32. keys Then press ENTER key to save the current input If users just input data without any operation or ENTER subsequently beyond 10 seconds the current input is saved automatically In addition users can press RATE key to exit the mode of setting the infusion rate value After starting up the IP300 and running it if users want to reset the parameters users need to stop running the IP300 and then press RATE to get in the mode of setting 32 The rate range is 1ml 9999ml the minimum step is 1ml h AN CAUTION The 1P300 is just an auxiliary equipment So the medical personnel has to be responsible for the medical content of the infusion liquid Set the right infusion volume and rate value according to the physician or doctor in charge If an infusion set is connected with the three way connector and carried out the combined infusion with another way as shown in figure 9 1 attentions must be paid to taboo at matching of two medicines or more Besides since the liquid from another infusion line or IV line may have a minor resistance on the infusion set on the infusion pump the accuracy may exceed the stipulated tolerance Infusion bottle Drip Drip chamber chamber Infusion pump IV line Three way connector Infusion bottle Figure 9 1 9 3 Set types of the infusion set In the standby mode press and hold SETTING key for 2 seconds at this moment in the LCD s
33. lecting Bolus rate press this key to select Bolus rate 1000mL h In the mode of selecting the level of occlusion sensivity press this key to select 5th level 0 15Mpa 30 In the mode of parameters settings press this key to input 6 In the mode of standby and running press this key to convert the unit between ml h and drip min In the mode of parameters settings press this key to input 7 In the mode of standby press this key to see the preset time and in the running mode press this can see the left time or residual time of the process of infusion 18 Inthe mode of parameters settings press this key to input 8 in the running mode press this can see the left amount of the current infusion volume or residual amount of the current process of infusion volume Inthe mode of parameters settings press this key to input 9 Inthe mode of parameters settings press this key to input 0 In the mode of parameters settings press this key to input a decimal point 19 3 Performance Index 3 1 Classification According to EN 60601 1 2006 IEC 60601 1 2005 Medical electrical equipment Part 1 General requirements for basic safety and essential performance IP300 belongs to the following classifications Class equipment Type BF equipment General equipment With internal battery Operate continuously According to EN 60601 2 24 1998 IEC 60601 2 24 1998 Medical electrical equip
34. low rate accuracy However the manufacturer cannot make sure that the infusion flow rate accuracy meets the demands of 5 or 10 and the manufacturer is not responsible for relevant medical malpractice as a result of the use non specified infusion sets If continuous using a infusion set the user should change the infusion set ae compressed site by the peristaltic pump every four hours Infusion sets should be disposable and only used once independently ae The manufacturer specified infusion sets are shown as follows Types of yP manufacturer Performance Index infusion sets Tianjin Hanaco medical CO Ltd 20 drips ml 0 1ml Tianjin Hanaco medical CO Ltd 20 drips ml 0 1ml Other spec demands inside diameter 3 0mm outside diameter 4 0mm Disposable infusion sets H O5APD 6 1 Steps for installing infusion sets to the IP300 First connect the infusion set to infusion bottle and make the drip chamber half full of liquid Then adjust the flow regulator until the liquid flow out of injection site Next adjust the flow regulator to stop the liquid flowing 1 Install the infusion set tubing a Open the door of the infusion pump gt Pull the door switch as being shown in the fig 6 1 25 Fig 6 1 pull the door switch gt Open the door as being shown in the fig 6 2 Fig 6 2 open the door b Install the tubing gt Select the right site of the infusion set tubing install it from top down
35. mal sickroom for infusion and nutrition supply The operator of IP300 infusion pump should be medical staff who have relative professional knowledge and skill and also have been trained for using IP300 infusion pump The installation and maintenance of IP300 infusion pump should be done by qualified service technician E 4 a Fig 1 1 IP300 infusion pump apparence A WARNING The user of IP300 must be professional and trained AN IP300 is unsuitable for use in a magnetic resonance imaging MRI environment 1 2 Symbols A WARNINGs and A CAUTIONS indicate all the possible dangers in case of violation of the stipulations in this manual Refer to and follow them A WARNING Indicates potential hazards to operators or patients A WARNING Indicates potential damage to equipment Instead of illustrations other symbols may also be utilized Not all of them may necessarily appear in the equipment and manual The symbols include OFF Power from batteries ON Power from batteries Alternating Current Type BF equipment Direct Current Attention consult accompanying documents SN Series Number Date of manufacture Silence Hp Bl Os Address of manufacturer ad oul PET Each Eternity product has a serial number such as IP300 XX XX XXX IP300 machine model E machine model for exporting the first xx the year of manufacturing the second xx the month the third xxx equipment number 2 S
36. ment Part 2 24 Particular requirements for the safety of infusion pumps and controllers IP300 belongs to the volumetric infusion pump and it cannot be used as portable equipment 3 2 Main Parameters 1 2 3 4 5 6 7 8 9 Overall size 245 X 180 X 170 mm H X DXW Weight 2 4Kg Operating environment a Temperature 5 C 40 C b Relative humidity 20 90 c Atmospheric pressure 70kPa 106kPa d Power supply I AC100V 240V 50 60HZ II rechargeable battery Ni MH Model Number Kan AA 49 battery 9 6V Zhejiang Suichang Kan Battery Co Ltd Storage amp Transportation If there is no definite demands and declaration IP300 infusion pump should Storage amp Transportation according to these demands a Environment temperature range 20 C 55 C b Relative humidity lt 93 c atmospheric pressure 50 kPa 106 kPa d Other demands No contacting with corrosive gases and well ventilated room Patient type Adult Pediatric and neonatal Driving mode electrical motor drive Flow rate setting range 1mL h 1300mL h minimum step 1ml h Maximum preset volume range 1mL 9999 mL Maximum accumulated infusion volume display value range 1mL 9999 mL 10 KVO rate 20 a 1mL h flow rate 5mL h when finish infusion process the IP300 stop running and comes back to the standby mode b 5mL h lt flow rate lt 50mL h KVO rate is 1mL h c 50 lt flow rate lt 300 mL h KVO rate is 3mL h d 30
37. n displays calibrating step 1 and then open the stopcock and press START STOP key to start up the process of Calibrate the occlusion detector sensitivity Firstly users let the infusion set tubing drain some liquid then close stopcock When the 39 pressure gauge whose max measuring range is 0 1MPa and minimum scale is 0 005Mpa indicates 0 06MPa press START STOP key to stop running of peristaltic pump and then press ENTER key to finish Calibrate the occlusion detector sensitivity A Users can select 5 level of occlusion detector sensitivity a 5st Level 0 04Mpa 30 b 4nd Level 0 06 Mpa 30 c 3rd Level 0 09 Mpa 30 d 2th Level 0 12 Mpa 30 e 1th Level 0 15 Mpa 30 After finishing calibrating occlusion detector sensitivity users have to check every level of sensitivity After checking no error users can use infusion pump Users can press BOLUS key to exit the interface of the IP300 system parameters E Torture equipment program After finishing the IP300 power on self testing Then press and hold B for 3 seconds to get into calibration Adjustment interface meanwhile the display screen ADJ icon is blinking Input the password 2010 and press ENTER key and the IP300 display screen displays 1111 and then press 9 At this time the IP300 display screen displays 9999 then press ENTER key to get into Torture equipment program
38. n tubing exceeds the occlusion sensitivity levels Occlusion alarm 5 Electrical step motor s fault or pump mechanical malfunction or occlusion detector s failure inner Fault alarm 6 The residual power of rechargeable battery cannot support the IP300 low battery voltage alarm 7 Finish the infusion Empty of infusion volume and KVO mode starts up 8 AC power is cut off AC cut off alarm These information and the resolution of alarms can refer to 9 7 2 When finish infusion and the preset volume is empty the alarm MW in the LCD screen is blinking with audio alarm triggered and indicates that infusion process is completed and the IP300 gets into the mode of KVO keep vein open 9 6 10 Complete infusion 9 6 10 1 Avoid thrombus When finish infusion and the preset volume is empty KVO starts up to infuse patients to prevent the thrombus from appearing and also the audio alarm is reporting continuously KVO KVO alarm icon is blinking However if the infusion rate 5mL h there is not KVO mode after infusion process completed KVO rate a 1mL h flow rate lt 5mL h KVO rate is OFF b 5mL h lt flow rate lt 50mL h KVO rate is 1mL h c 50 lt flow rate lt 300 mL h KVO rate is 3mL h d 300 lt flow rate 1300 mL h KVO rate is 5mL h 9 6 10 2 Restart infusion If users need to restart infusion again they have to operate according to the following steps gt Accumulated volume value is zero clearing 1 In
39. necessary Inthe standby mode users can press this key to set the volume preset value In the standby mode users can press this key to set the flow rate In the standby mode if users need bolus infusion or remove the liquid in the infusion set tubing users can press and hold Bolus key for more than 3 seconds to do it But if the users relieve the key the equipment gets into the standby mode This key is Silence key When alarm is given and it is necessary to stop the audio alarm it can stop the audio alarm if this key is pressed This key is a START STOP key When the operating parameters have been set and this key is pressed down the transfusion pump shall start the infusion in accordance with the internally set parameters When it is necessary to stop the infusion after completion of infusion or occurrence of other cases press down this key to stop the transfusion Press this key to eliminate current input in the mode of parameters settings In the standby mode press this key for 2 seconds to eliminate accumulated value of infusion volume Inthe mode of parameters settings press this key can conform the current input value Or pause the infusion process with pressing this key in the running status for 3 seconds In the mode of parameters settings press this key to input 1 Inthe mode of selecting infusion set tubing types press this key to select NO 1 infusion set the manufacturer specified infusion set
40. ode this alarm is triggered even more accompanying alarm lights hinting and audio alarm gt Consequence of the alarm the IP300 stop running gt Trouble shooting press the silence key 8 to stop audio alarm and the IP300 will restore previous status and data automatically Then open the door of the IP300 draw out the infusion set tubing and remove the air bubble by manual operation Then right installing the tubing close the door to see whether the air in line alarm disappears Or bolus function to remove the air Finally press START STOP to restart infusion 2 The block pressure exceeds the occlusion detector sensitivity levels Occlusion alarm gt Alarm status Relevant icon blinking if in the running mode this alarm is triggered accompanying alarm lights hint and audio alarm gt Consequence of the alarm the IP300 stop running gt Trouble shooting press the silence key 8 to stop audio alarm and the IP300 will restore previous status and data automatically Open the door Check whether the infusion set needle rightly injected into the patient s body If wrongly injected the infusion set needle should be wrong injected by the users If the tubing is blocked or bended the user should straighten the tubing to keep the liquid flowing smoothly Close the door to see whether the occlusion alarm disappears Finally press START STOP to restart infusion 3 Door of the IP300 is open or the door is not
41. of infusion rate and volume Its infusion rate can be setup by the operator and be indicated by the liquid volume infused by the device in unit time The infusion pump takes the linear peristaltic pump as its power source for liquid compression and is able to realize the active infusion under positive pressure without reliance on the gravity It can monitor the air bubble and pressure in the pipe of infusion equipment When the test value is higher than the set alarm value of infusion pump the infusion pump shall give out the audio and visual alarm and stop the transfusion so as to guarantee the safety of infusion If there is no power in the MAINS the infusion pump shall automatically switch into the internal battery power supply and gives out the audio and visual alarms Besides when the infusion pump is defective or the door is being opened the visual and audio alarms can be also given and the infusion shall be stopped After infusion the infusion pump shall give out the audio and visual alarms to prompt the operator that the infusion has been completed and meanwhile enter into KVO infusion In addition the IP300 infusion pump has the heat function to be used to heat the infusion sets tubing to warm the cold liquid in order to comfort the patients prevent the cold liquid flow into patients body and alleviate the irritation to patient body IP300 infusion Pump is used in operating room emergency unit ICU CCU anabiosis room ambulance and nor
42. oing on 9 6 2 Infusion rate units conversion In the standby or running mode pressing 6 key can convert the units At this time the LCD screen can convert unit ml h into min drip min After 3 seconds the infusion rate unit goes back to ml h AN CAUTION A statement that the infusion set is like this that 20 drips of distilled water delivered by the drip tube are equivalent to a volume of 1 0 1 ml or a mass of 110 1 g ok Because of the different qualities of different infusion sets and different 34 9 6 3 Query the residual infusion volume In the standby or running mode pressing 8 key can query the residual infusion volume At this time the LCD screen can display LEFT residual infusion volume value and ml After 3 seconds displaying information goes back to VOL LIMIT infusion volume preset value and mi 9 6 4 Query the accumulated volume In any mode users can query the accumulated volume from the Bottom right of the display screen 9 6 5 Query the residual time of infusion process In the standby or running mode pressing 7 key can query the residual time of infusion process At this time the LCD screen displays LEFT residual time and min After 3 seconds display information goes back to Infusion Rate infusion rate value and ml h 9 6 6 Bolus infusion Bolus infusion is used for rapid infusion discrete quantity of liq
43. or more Besides since the liquid from another VEIN INFUSION line may have a minor resistance on the infusion set on the infusion pump the accuracy may exceed the stipulated tolerance Theeaway connector Figure 0 3 10 2 3 Big difference from the drip rate The drip rate is often converted into ml h in clinical application If a big difference from the actual setup flow rate appears there are the following possible reasons 42 1 The drip rate measurement device is not accurate 2 The specifications of infusion set do not satisfy the requirements on IP300 The specifications of the infusion set required by IP300 is 20 drops 1mL 0 1mL The processing method is to replace it with a single use infusion set that satisfies the requirements 3 If the infusion set with the same specifications is not recommend by Eternity errors may occur due to the differences of materials and inside outside diameters of infusion set tubing If the infusion error is caused by the abnormal operation of the apparatus itself the reasons are complicated It can be processed in the following methods obtain physiological saline whose volume is not less than 150ml connect a measuring cup to the output terminal of liquid connect the test system in accordance with Figure 0 4 and set the infusion rate to 150mL h simplified as Va and time 30 minutes When the infusion rate is stable count the number of drops for each minute Then multiply the numbe
44. p liquid from entering the equipment and never immerse any part of IP300 infusion system in the liquid 12 2 Detergent dilute ammonia dilute sodium hypochlorite bleaching powder for washing 35737 formaldehyde dilute 3 hydrogen peroxide alcohol isopropyl alcohol VVVVV V 12 3 Disinfecting Ultraviolet radiation gt Time not less than 2 hours gt Strength not less than 70uw cm gt Temperature 15 40C gt Relative humidity 50 AN CAUTION Do not use gas EtO electron beam steam formaldehyde etc to disinfect 49 13 User Maintenance A WARNING Movable components and detachable parts can cause injury Use caution when system components and parts are being moved or replaced A WARNING Disposal of waste or invalidated apparatus must be in accordance with the relevant policies in local government 13 1 Repair Policy 1 The following checks should be made when the transfusion pump is used for the first time or it is used after a long time storage gt Check whether there are any mechanical damage looseness wobble or poor contact gt Check the accessories are complete and in good conditions gt Check the operation functions of the apparatus and ensure that the apparatus is in good Operating state If troubles have been found refer to Chapter 9 7 2 Alarms and trouble shooting for them The apparatus can be only repaired by the qualified bio medical engineers or contact the manufact
45. r of drops for each minute by 3 The final result shall be the actual estimated flow rate simplified as Vb After 30 minutes have been counted check the volume V of liquid in the measuring cup Divided it by 0 5h the actually measured average rate Vc shall be obtained Compare Va Vb and Vc and process them in light of different results If Va and Vc are close and Vb has a big difference processing is unnecessary since it belongs to the count error If Vb and Vc are close and Va has a big difference it belongs to the operation problem of IP300 Contact the manufacturer in time for processing 0 9 NaCl liquid Drip chamber Infusion measuring cup Figure 0 4 43 10 2 4 Pharmacologic reactions 1 Inthe process of infusion when the BOLUS function is used it should be confirmed that the rapid infusion of medical liquid into the human body shall not bring about pharmacologic reactions 2 The use of pressure raising medicine or blood vessel expansion medicine may bring about minor error of flow rate due to the minor change of vein pressure IP300 has taken sufficient consideration of it in design and can guarantee that the infusion error in this case shall not exceed the specified range 3 Dueto the individual differences of patients the setup of infusion parameters in clinic shall take the feedback information of physiological reactions of patients as the criterion IP300 is only used as the auxiliary infusion apparat
46. rity reliability and function of the equipments in case that the dangers damages and non normal phenomenon mentioned in this manual happen Free repairs for these malfunctions will not be provided by Eternity Eternity have the rights to replace any content in this manual without notice Manufacturer Responsibility Eternity is responsible for the security reliability and function of the equipments when to following conditions are adhered to O Installation adjustments mending and repairs must be performed by individuals authorized by Eternity O Necessary electrical equipment and the working environment must be in accordance with the national standards professional standards and the requirements listed in this manual O Equipment must be used as instructed in the operating instructions The paid theoretical framework diagram will be supplied according to customer requirements by Eternity plus calibrating method and other information to help the customer under the assistance of qualified technicians repair the equipment parts where can be done by customer himself based on the stipulation by Eternity A CAUTION This equipment is not for family use A CAUTION Malfunctioning equipment may become invalid and cause bodily injury if a set of effective and approving repairing proposals cannot be submitted by the institution which is responsible for using this equipment Warranty Manufacturing techniques and materials For a perio
47. s time users can watch the drip chamber and infusion set needle to see whether some drips move freely due to the effect of gravity If no any free flow it indicates that the infusion flow is controlled well 8 Operation instruction 6 1 START OR STOP the IP300 The IP300 power can be supported by AC and inner battery When the IP300 connect to the AC power the inner rechargeable battery will be being charged automatically If the IP300 doesn t connect to the AC power source or be cut off the user can start the IP300 by the inner rechargeable battery completely 6 2 Power on self test 1 2 When the IP300 is power on it starts the self test and peristaltic pump cannot run In the process of self test the display screen shows all the information about the IP300 to assure the display system functions well In the meantime the IP300 gives twice audio and visual alarms to assure the alarms system functions well If the process of the power on self test finishes the IP300 get into the standby mode 30 4 Ifthe alarms system doesn t function well users can solve the IP300 according to the information of the user s manual If users cannot solve problems please contact the maintenance operator in hospital or the manufacturer 6 3 Check the modes of the IP300 Check the modes according to Chapter 7 1 8 4 remove the air in line 1 Remove the air in line by gravity Steps for operation a Insert the piercing nee
48. sers should use the manufacturer specified infusion set and install it according to the user s manual If users cannot operate to base on these demands maybe the effect and accuracy of infusion expectation cannot achieve 28 7 Power on the IP300 Press the power key and switch the IP300 the IP300 ring audio alarm accompanying the alarm lights and indicator blinking twice In the meantime LCD screen is displaying all the information After twice audio alarms LCD is displaying normal information When AC supplies on rechargeable battery can get in the auto charging and managing mode Then the user can operate the IP300 AN WARNING If the user finds the Fault alarm or damage of the IP300 please do not use it for infusion to patients and contact the equipment maintenance operators or the manufacturer la gt normally Every time after finish the infusion users should connect the IP300 to the AC power supply source to make the equipment battery being charged and the battery supply has enough power to support the IP300 running 7 1 Check the IP300 modes gt Check the alarm lights When switch on the IP300 the alarm light blink twice and then return to normal gt Check the audio alarm When switch on the IP300 the audio alarm rings twice and then return to normal gt Check the display screen When switch on the IP300 display screen shows all information such as parameters alarms and statuses And then
49. sion pump gt 2 fixation modes of the IP300 infusion pump a Fix the infusion pump to the vertical infusion support b Put the infusion pump on the table gt If the users require the vertical infusion supports for infusion pumps the manufacturer can equipped the IP300 infusion pumps with these infusion supports 5 3 Use the vertical infusion supports Fix the fixation case to the right height of the infusion supports where is 0 5m higher above hospital beds or 1 2m higher above the floor AN CAUTION When fix the IP300 to the infusion supports the user should fasten the screw in the fixation case and check it to keep the infusion pump firm and stable 5 4 Connect the AC power cord to the IP300 Steps for connecting the AC power cord Make sure the power supply accord to 100 240VAC 50 Hz 60Hz Use accompanying and right power cord to connect AC power supply Connect equipotential line necessarily gt V V Vv CAUTION The equipments after long time transportation and storage should charged for the inner battery Thus connect the equipments to AC power source switch on and the equipments can get in the auto charging and managing battery mode 24 6 Install infusion sets AN WARNING The manufacturer does not recommend other bands of infusion sets that are not specified by the manufacturer If the users cannot use or buy the specified infusion sets the users should calibrate the infusion pump f
50. tery alarm is triggered at the same time the relevant icon blinking and alarm works with audible and 14 visible information Empty alarm icon When medicine liquid infused reaches presetting the pump will turn to KVO state automatically empty alarm icon blinking meanwhile the empty alarm is visible and audible KVO keep vein open alarm icon When infusion finished the pump turns to KVO state automatically The KVO alarm icon and empty alarm icon will be blinking synchronously gt Area2 status information area Audio alarm icon When the audio alarm is triggered this icon is lit if the audio alarm is eliminated or the equipment was silenced this icon is absent Outer AC supply icon When the pump is powered by outer AC supply this icon is lit If the AC supply is cut off this icon is blinking and the IP300 system also triggers audio alarm Battery capacity and charging icon When the battery is charging the four lines in this icon will be lit from the bottom up in turns until battery charging finish And after battery charging finished the four lines in this icon would be lit at the same time In addition this icon can indicate the current capacity of the battery and the number of the lines indicate amount of the capacity of the battery If the capacity of the battery is nearly exhausted or at low voltage this icon is blinking Alarm silence icon If audio alarm occurs press Silence key and then this icon will be
51. the standby mode press CLEAR key for 2 seconds to clear accumulated volume value 2 If need to reset new parameters press VOL LIMIT key and RATE key to reset the infusion volume preset value and infusion rate 3 Press START STOP key to restart infusion gt Accumulated volume value plus the new volume preset value 1 If need to reset new parameters press VOL LIMIT key and RATE key to reset the infusion volume preset value and infusion rate 2 Press START STOP key to restart infusion 36 9 6 10 3 Stop infusion In the KVO mode when finish and want to stop infusion press START STOP to go back to the U standby mode However Alarms icons that MM and 16448 are absent Now the user can draw the vein infusion needle out of the patient s body Then open the door of infusion pump push the clamp to draw out the infusion set pull the tubing out of grooves and do well the nursing work power off the IP300 AN CAUTION Even though the AC power is cut off the IP300 can still work by the inner rechargeable battery If the infusion rate 5mL h when finish infusion the IP300 system do not get into the KVO mode So users can press silence key to make the IP300 go back to the standby mode 9 7 Others 9 7 1 Bolus Discrete quantity of liquid which is temporarily delivered in a short time In the standby mode press and hold SETTING key for 2 seconds at th
52. tructure 2 1 System components 1 Main unit Peristaltic pump display screen surface film control board power board sensor rechargeable battery pile module enclosure 2 Accessorles fuse power supply cord and user s manual 3 Consumables Single used infusion sets users buy it themselves with manufacturer authorized type 2 2 Front view 4 2 1 7 5 3 Fig 0 1 IP300 Front view 1 Display screen 2 Indicators 3 Speaker 4 Alarm lights 5 Door switch 6 Key pad 7 Fixation case 11 2 3 Rear view Fig 0 2 IP300 Rear view 1 nameplate 2 Power Socket 3 Power Socket 4 Fuse installed site Power supply 100 240VAC 50Hz 60Hz fuse F500mAL250V Equipotential terminal connected to equipotential terminal in other equipments with special cable or connected to protective ground by operator if the mains supply used without equipotential terminal If the power cord cannot connect to the ground the infusion pump equipotential terminal has to connect to the ground correctly 12 2 4 Door open view Thermostat inside this component 2 4 Display screen gt Display screen contains 4 areas which are shown in the Fig 2 3 DAlarm message area 2 status information area 3 parameters area information options area and accumulated volume display value area 1 e o e lea G poo Areal CE ATCT Area 2 VOL LIMIT LEFT Area 3 Infusion Rate ml h TUBE ADJ BOLUS OCCL VOL INF
53. uid which is delivered in a short time and removing air in line Operation process can refer to Chapter 8 4 9 6 7 Heat function The cold temperature can affect the infusion accuracy and increase the irritation to the patients body So the heat function can solve all these problems Users can press the HEAT key to select the modes of heating such as ON mode OFF mode and AUTO mode If the users select the HEAT ON mode the heat function will be continuously on If the users select the HEAT OFF mode the heat function will stop If the users select the HEAT AUTO mode the heat function will start up according to the environment temperature lt 16 3 C to decide to start up the heat function and this icon will keep the same action with the heat function Heat temperature on the spring board 30 5 C 9 6 8 PAUSE function ENTER Ml If the user wants to pause the infusion press for 3 seconds in the running status and the IP300 will save the data before this key is pressed And If the user wants to restart the infusion process press START STOP again according to the data that have been saved before pause 9 6 9 Alarms in the process of infusion 1 In the process of infusion these alarms might be triggered 2 There is air in the infusion set tubing Air in line alarm 3 The door of the IP300 is open or the door is not well closed completely Door open alarm 35 4 The pressure in the infusio
54. up battery should be charged to its full capacity when the apparatus is used for the first time and then use the battery for transfusion until no power is available inside the battery Repeat this process for 2 3 times gt The battery is a nickel hydrogen rechargeable one and should be replaced after it has been charged and discharged for 500 times 13 2 Other Notice The IP300 infusion pump and its accessories can be never discarded and can inform manufacturer to recycle it When the rechargeable battery s life is over users have to solve them according to the local laws and regulations but cannot be discarded freely 32 Annex I 1 Accuracy test of the IP300 volumetric infusion pump in accordance with standard EN60601 2 24 The test apparatus shown in figure Annex is used Carry out the tests using a test solution of ISO Class Ill water for medical use and installing an unused administration set Set the required rate Set the sample interval S to 0 5min Begin the test period simultaneously with starting the IP300 And the test period T 120min at the back pressure 13 33KPa 100mmHg Liquid level Liquid container vented or collapsibie bag Drip chamber if included ADMINISTRATION SETIT Needla j 186 1 2 mm see 150 7864 m30 Y fF Output A 0 0000 y Electronica balance Computer Figure annex 1 1 Test apparatus for the IP300 infusion pump Definition of terms Rate r the deliv
55. uracy ES 2222 Check air sensors sensitivity 7 3333 Check the temperature around the spring board 7 4444 Calibrate the occlusion detector sensitivity 66 22 9999 Torture equipment program A Calibrate the infusion rate accuracy introduction for setting 1 1 Modify the NO 1 type infusion set infusion rate accuracy Prepare measure cup of which the measuring range is 50ml and minimum scale is 0 1ml and electronic weighing balance are connected together as figure annex II 1 Also the users have to confirm that no air in the infusion set tubing which is full with ISO Class III water density of water 0 998g ml 1g m at 20 C Uz Liguid leve Liquid container vented or collapsibie bag l Drip chamber if included ADMINISTRATION SET Needle sx 186 1 2 mm see SO 7864 Dutput l C 0 0000 g Electronig Computer rle o balance figure annex II 1 37 After finishing the IP300 power on self testing users set the type of tube to NO 1 and exit the setting Then press and hold B for 3 seconds to get into calibration Adjustment interface meanwhile the display screen ADJ icon is blinking Input the password 2010 and press ENTER key and the IP300 display screen displays 1111 then press ENTER key to get into Calibrate the infusion rate accuracy program At this time the screen of volume limited setting area displays 20ml which indicates the inf
56. urer 2 An all round check including the functional safety check must be made for the apparatus by the qualified personnel every 6 12 months or after each repair The transfusion rate of transfusion pump should be calibrated in accordance with the repair plan of the hospital and at least one check should be made each year by the qualified repair personnel All checks that require opening of the apparatus must be done by the qualified repair personnel and the safety and maintenance checks can be made also by the personnel of our company Before its long storage it is necessary to clean the surface of apparatus exposed to the air with alcohol Dry it naturally The professional personnel remove the backup battery inside open the door put it under the UV ray for sterilization for no less than 2 hours The intensity of UV ray should be no less than 70uw cm2 the sterilization temperature should be 15 40 C and the relative humidity is 50 Then seal pack and store the apparatus and put the dryer into the bag 51 AN Warning gt Ifthe hospital or authority that uses this apparatus cannot implement a set of satisfactory maintenance plan the apparatus shall become ineffective which may endanger the personnel health gt The battery can only be changed in accordance with the guidance of the repair engineer of our company A Cautions gt In order to extend the service life of rechargeable battery it is suggested that the back
57. us for the medical personnel and cannot replace the judgment of clinicians 44 11 Monitoring performance 11 1 Door monitoring When pump door opened the system prompts alarm message and sound 11 2 Occlusion monitoring gt Max infusion pressure Types of infusion set 1 Specified 2 Standard 4 User2 oo o 5 User3 ooo o O Occlusion detector sensitivity Adjustable in 5 levels from 0 04Mpa 0 015Mpa 30 a 1st Level 0 04Mpa 30 b 2nd Level 0 06 Mpa 30 c 3rd Level 0 09 Mpa 30 d 4th Level 0 12 Mpa 30 e 5th Level 0 15 Mpa 30 Users can select them according to own demand however when select these functions users should be careful or have to abide by physiological requirement of the different patients 2 WARNING If the wrong operation or selecting the occlusion detector sensitivity levels cause the untoward effect to patients the manufacturer is not responsible for that 45 gt Trigger time bolus and bolus control caused by occlusion alarm Test method as shown in the figure 11 1 press ute so Figure 11 1 trigger time infusion set ane Level 5 Level 1 lt a BOLUS control 0 04Mpa 30 O enn a a a a iie a S sty press STOP 2 Standard 55 feas Bs ey to stop infsin 1 Tios tos lok te ae 3 User1 patient circuit then 25 lt 2s s ews lo pen pump door suse i St0s Ss pressliquid stopping 25 lt 2s ss lamp and make Memos 10s medicine liquid ba
58. use This equipment can only be used by professional Do not open up enclosure to avoid electric shock Any servicing or updating must only be performed by authorized by our company the maintenance must be performed according to this manual Perform the checking procedure before use Error may be generated by using unspecified IV sets The equipment interconnected with IP300 should be equipotential protect earth line connection It must conform to doctor s advice to use BOLUS function in the process of infusion If there is more than one infusion way to the patient error may be generated for variable block pressure in the pipes Do not use cell phone near IP300 Or else interfere generated from cell phone will affect infusion accuracy of IP300 Avoid sharing the same electrical outlet or over close distance with high power surgery equipment Avoid using this equipment in the strong electric magnetic field surroundings Operator must guarantee the patient safety when IP300 operated with other electrosurgery unit The waste package must be performed according to current waste control rules and place it where the child can t reach Make sure alarm system normal to prevent infusion danger occurs Make sure main supply protective earth line in good condition if not use battery supply As auxiliary equipment for infusion the management of medicament is answered by medical personnel IP300 doesn t belong to portable equ
59. usion volume preset comparative value In addition the screen of infusion rate area displays 100 which indicates the calibration process of countdown Then users press START STOP key and the IP300 starts up the Calibrate the infusion rate accuracy procedure When the countdown number is 0 users input the real value that measured by measuring cup or electronic weighing balance Then users press ENTER to finish calibration of infusion rate accuracy Aeh users use electronic weighing balance first measuring weight of the empty measuring cup M1 then start up the calibration process When finish infusion measuring the weight M2 of current measuring cup with liquid in it The value for input is M2 M1 1 2 Modify the NO 2 type infusion set infusion rate accuracy After finishing the IP300 power on self testing users set the type of tube to NO 2 and exit the setting Other operation users can follow 1 1 1 3 Modify the NO 3 type infusion set infusion rate accuracy After finishing the IP300 power on self testing users set the type of tube to NO 3 and exit the setting Other operation users can follow 1 1 1 4 Modify the NO 4 type infusion set infusion rate accuracy After finishing the IP300 power on self testing users set the type of tube to NO 4 and exit the setting Other operation users can follow 1 1 1 5 Modify the NO 3 type infusion set infusion rate accuracy After finishing the IP300 power on self test
60. y In addition users can press SETTING key to exit the mode of setting the bolus rate 9 5 Set the occlusion detector sensitivity levels In the standby mode press and hold SETTING key for 2 seconds at this moment in the LCD screen TUBE BOLUS and OCCL icons is blinking And then press the relevant 3 key the IP300 system can get into the setting the occlusion detector sensitivity levels 5 4 3 2 1 keys individually indicate relevant occlusion detector sensitivity levels After finishing selecting press ENTER to save the current input If users just input data without any operation or ENTER subsequently beyond 10 seconds the current input is saved automatically In addition users can press SETTING key to exit the mode of setting the occlusion detector sensitivity levels CAUTION In the mode of setting volume and rate press CLEAR can clear the current input In the mode of setting volume and rate press ENTER but without any digital input the system confirm the original parameters automatically 9 6 Infusion 9 6 1 Start up infusion After finishing all process of installing infusion set and check of the IP300 press START STOP key and the IP300 start working At this moment the icons drip chamber and drips begin to display and drips are blinking from top down in turn It indicates that the process of infusion is g
61. y value area 2 5 Indicator AC alternating current gt When the pump is powered by outer AC supply this Indicator indicator is lit green If the AC supply is cut off this icon is dark DC direct current When the pump is powered by inner rechargeable Indicator battery supply this indicator is lit green If the AC supply is on and battery is being charged this indicator is lit yellow If the battery power is completely exhausted and AC power supply is cut off this indicator is dark HEAT HEAT According to the Heat function modes the indicator 7 Indicator will be lit green or dark related to the modes the ON OFF AUTO users select 2 7 Alarm Lights When the alarm occurs the alarm lights are blinking to remind operator to deal with it in time 2 8 Keypad Gl po gt Power key As a soft switch key for power supply it can realize the power on off functions When this key is pressed down the transfusion pump can be powered on and get in the standby mode After the work has been completed the transfusion pump can be powered off if this key has 16 o been pressed down for more than 3 seconds gt Pressing this key for 3 seconds users can get in the IV sets options mode and types of tubing Bolus rate and Occlusion detector sensitivity level can be set by the users if necessary Users can press this to select 3 different heat function mode on off auto if
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