Mindray BeneFusion VP5 Operator'S Manual Download Page 23

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2-7

2.2.4.3 Infusion Pump with PVC Specified Infusion Sets

1. Connection rail

2. Liquid check clip operating lever

3. Ultrasonic sensor

4. Downstream pressure checkout slot

5. Infusion set slot

6. Waterproof membrane

7. Upstream pressure checkout slot

8. Liquid check rod

9. Door

10. Door latch

2.2.5 Bottom View

1. Product label

2. Placement area for pole clamp

Summary of Contents for BeneFusion VP5

Page 1: ...BeneFusion VP5 BeneFusion VP5 Ex BeneFusion VP5 Neo Infusion Pump Operator s Manual ...

Page 2: ......

Page 4: ...dden and are the registered trademarks or trademarks owned by Mindray in China and other countries Mindray Scientific is authorized by Mindray to use above registered trademarks or trademarks Responsibility on the Manufacturer Party Contents of this manual are subject to changes without prior notice All information contained in this manual is believed to be correct Mindray Scientific shall not be ...

Page 5: ...lfunction or damage caused by improper use or man made failure Malfunction or damage caused by unstable or out of range power input Malfunction or damage caused by force majeure such as fire and earthquake Malfunction or damage caused by improper operation or repair by unqualified or unauthorized service people Malfunction of the instrument or part whose serial number is not legible enough Others ...

Page 6: ...rt of the product It should always be kept close to the equipment so that it can be obtained conveniently when needed Intended Audience This manual is geared for clinical professionals who are expected to have a working knowledge of medical procedures practices and terminology as required for monitoring of critically ill patients Illustrations All illustrations in this manual serve as examples onl...

Page 7: ...Infusion Sets 2 6 2 2 4 3 Infusion Pump with PVC Specified Infusion Sets 2 7 2 2 5 Bottom View 2 7 2 3 Screen Display 2 8 2 4 Cursor 2 8 3 Installation and Setting 3 1 3 1 Installation 3 1 3 1 1 Out of Box Audit OOBA 3 1 3 1 2 Operating Conditions 3 2 3 1 3 Mount the Clamp 3 3 3 1 4 Multi channel Pumps Combination 3 3 3 1 5 Mount the Handle Set 3 4 3 1 6 Connect the AC Power Source 3 5 3 1 7 Insta...

Page 8: ...Select Infusion Mode 4 8 4 2 8 Purge Air 4 8 4 2 9 Set Infusion Parameters 4 9 4 2 10 Infusion 4 9 4 2 11 Infusion Pause 4 9 4 2 12 BOLUS 4 10 4 2 13 Change the Rate during Operation 4 10 4 2 14 Complete 4 10 4 2 15 Standby 4 11 4 2 16 Turn off the Pump 4 11 5 Infusion Mode 5 1 5 1 Rate Mode 5 1 5 2 Time Mode 5 2 5 3 Body Weight Mode 5 2 5 4 Sequential Mode 5 4 5 5 Loading Dose Mode 5 5 5 6 Micro ...

Page 9: ...nt Information 7 4 7 8 Day s Prescription 7 4 8 Alarms 8 1 8 1 Alarm Level 8 1 8 2 Alarm Types 8 1 8 2 1 Multi level Alarm Rules 8 2 8 3 Alarm Handling Rules 8 2 8 4 Alarm Countermeasures 8 3 9 Battery 9 1 9 1 Battery Performance Optimization 9 2 9 2 Check the Battery 9 2 9 3 Insert Batteries 9 3 9 4 Battery Recycling 9 3 10 Preservation and Sanitation 10 1 10 1 Description 10 1 10 2 Cleaning 10 1...

Page 10: ...ecified Infusion Sets A 9 A 5 3 Infusion Pump with PVC Specified Infusion Sets A 10 A 6 Infusion Accuracy Curve and Trumpet Curve A 11 A 6 1 Infusion Pump with Conventional Infusion Sets A 11 A 6 2 Infusion Pump with Silicone Specified Infusion Sets A 14 A 6 3 Infusion Pump with PVC Specified Infusion Sets A 15 B EMC and Radio Regulatory Compliance B 1 B 1 EMC B 1 B 2 Radio Regulatory Compliance B...

Page 11: ...ected before use to guarantee their normal and safe operation This equipment can only be connected to the socket with ground protection Please adopt a rechargeable battery instead of the socket as the power supply if the socket is not provided with a ground lead To prevent fire or explosion do not operate the equipment in the presence of anesthetic flammable or explosive materials Do not open the ...

Page 12: ...e hospital policy on waste management They must be kept out of the reach of children Infusion tube knots filter coagulation and occlusions arising from needle insertion can cause the pressure inside the infusion set to rise during infusion When this occurs removing the occlusion can cause excessive liquid to be infused into the patient so appropriate measures should be taken The pump should not be...

Page 13: ...guarantee the patient s safety When this infusion pump and its accessories exceed their service life they must be disposed of in accordance with local statutes or hospital regulations If you have any queries please contact your distributor or the manufacturer After loading the infusion set and before infusion check for leakages If any are found they should be rectified as soon as possible Infusion...

Page 14: ...fusion set with the luer taper is recommended for use which can effectively prevent patients from under current caused by the occurrence of the cannula to slip out when under tension 1 1 3 Notes NOTE Install the equipment in a position where it can be easily accessed for inspection operation and maintenance Keep this Operator s Manual near to the equipment for future ease of reference The software...

Page 15: ...ve right Night mode Equipotentiality Input Input output Wireless networking normal communication with BeneFusion CS5 Infusion Supervision System Wireless networking no communication with BeneFusion CS5 Infusion Supervision System Wireless network is establishing a network connection Non ionizing electromagnetic radiation Current pump communicated successfully with BeneFusion DS5 Infusion Supervisi...

Page 16: ...MIT BY NUMBER Environmentally friendly use periods of electronic products 20 years CE mark comply with the requirements of the Council Directive 93 42 EEC Medical Device Directive IP23 Protected against solid foreign objects with a diameter no less than 12 5mm and protected against spraying liquid water Comply with the requirements of Directive 2012 19 EU Waste Electrical Electronic Equipment Atmo...

Page 17: ...propriate conditions by professional clinicians medical device technicians or by suitably trained nurses Personnel using this product must receive sufficient training This product must not be operated by anyone who has not been authorized to do so or has not received suitable training 2 1 2 Contraindications None 2 1 3 Appearance Parts and Features The infusion pump primarily consists of a housing...

Page 18: ...ese additional parts and their relevant functions 2 2 Host 2 2 1 Front View 1 Alarm light Indicates different alarm levels using colors and frequencies please refer to Chapter 8 Alarms for details 2 Display Shows the infusion parameters and details 3 Direction of flow label Informs the user on the proper direction of flow for infusion setup 4 AC indicator light On The pump is connected to an AC po...

Page 19: ...y to auto bolus 10 STOP During infusion press this key to stop infusion Infusion stops caused by alarms such as Occlusion press this key to cancel the alarm 11 BOLUS During infusion press this key to enter the Bolus settings screen Under non running status press this key to to enter the Purge Air prompt screen 12 AUDIO PAUSED Pauses alarm sound 13 POWER Used for turning power on entering in standb...

Page 20: ...e pump to eliminate ground potential difference between different devices and ensure safety 4 AC power supply port Connection for the AC power cord 5 Multifunction interface with the following functions DC power supply port RS232 interface Nurse call interface 2 2 3 Side View 1 Tubing channel Loading track for the IV administration set 2 Speaker Provides sound for audible alarms 3 Multi channel pu...

Page 21: ...on Pump with Conventional Infusion Sets 1 Connection rail 2 Liquid check clip button 3 Ultrasonic sensor 4 Downstream pressure checkout slot 5 Infusion set slot 6 Waterproof membrane 7 Upstream pressure checkout slot 8 Liquid check rod 9 Door 10 Door latch ...

Page 22: ...ecified Infusion Sets 1 Connection rail 2 Liquid check clip operating lever 3 Ultrasonic sensor 4 Downstream pressure checkout slot 5 Locating slot 6 Waterproof membrane 7 Upstream pressure checkout slot 8 Liquid check rod 9 Door 10 Door latch ...

Page 23: ...il 2 Liquid check clip operating lever 3 Ultrasonic sensor 4 Downstream pressure checkout slot 5 Infusion set slot 6 Waterproof membrane 7 Upstream pressure checkout slot 8 Liquid check rod 9 Door 10 Door latch 2 2 5 Bottom View 1 Product label 2 Placement area for pole clamp ...

Page 24: ...splays the running operation Green icon indicates normal running Arrows move from right to left and the running speed increases as the rate is increased Blue icon lighting indicates bolus 2 4 Cursor In the main screen and parameter settings screen when the cursor is located at an option or at a data value the grounding of the option or the data value will turn to white and the font will become bla...

Page 25: ...he valid version of the IEC60601 1 system The qualified individual responsible for connecting auxiliary equipment to the input and output signal ports is also accountable for making the system in accordance with the IEC60601 1 standard Please contact the company if you have any queries When this equipment combining with other electrical equipments forms a combination with a special function and th...

Page 26: ...m noise vibration dust and corrosive inflammable or explosive substances If installed inside the equipment case a sufficient space before and after the equipment case should be ensured to facilitate operation maintenance and repairing work There should be a 2 5 cm gap around the infusion pump to ensure that air can circulate freely for a better cooling effect When the pump is transferred from one ...

Page 27: ...the IV stand round vertical bar with diameter size of 15 32mm 3 1 4 Multi channel Pumps Combination A maximum of 2 pumps can be combined infusion pump and syringe pump can be cross combined When multi channel pumps are combined align the rail on the bottom of the upper pump to the rail slot on the top of the lower pump slide from backward to frontward until the alignment is matched then strain the...

Page 28: ...t the Handle Set Align the rail on both sides of the handle set to the rail slot on the top of the lower pump slide from backward to frontward until the alignment is matched When disconnecting toggle the button of the handle set outward and pull out the handle set or pump Press the button of pole clamp horizontally or vertically adjust pole clamp turn the handle pump can be fixed to cross bar or v...

Page 29: ...er supply port and check that internal and surrounding AC power supply port without liquid drug and other residues 3 Insert the other end of the power cord into the three plug connector Check that the AC indicator light is on WARNING The earthing wire in the three plug connector should be grounded if there is a doubt whether the AC power system is grounded or not please adopt the built in battery ...

Page 30: ...the Drop Sensor Optional NOTE This section should be used with the optional drop sensor The user may skip the instructions in this section if a drop sensor is not included with the infusion pump 1 Firmly insert the signal line of drop sensor into the drop sensor interface of the pump 2 Clip the drop sensor to the drip chamber making sure that the drop sensor is above the surface of the liquid 3 Pr...

Page 31: ...the positioning groove on the drop sensor Do not excessively tilt the drop sensor or expose it to direct sunlight during infusion Otherwise accuracy of the drop sensor may be influenced Make sure that the drip chamber is not clamped too tightly by the drop sensor It is suggested that the singal line of drop sensor should be changed every six months 3 2 Conventional Settings This chapter only intro...

Page 32: ...yyyy or dd mm yyyy CAUTION Please check the system date and time to keep accurate records in the History function After changing the time format or date format the record will update new format automatically For infusion pump inserted to BeneFusion DS5 Infusion Supervision System time and date can t be changed 3 3 Restore Factory Default Select Main Menu Manufacturer Maintenance Input Manufacturer...

Page 33: ... the pump will run start up checks and display the start up screen Please refer to 4 2 2 Load the Infusion Set Select according to the infusion set brand currently being used Select infusion mode Refer to 4 2 8 Purge Air Refer to 4 2 9 Set Infusion Parameters Connect to patient Press Press Shut down the Robert clip or flow rate regulator disconnect from the patient and remove the infusion set in a...

Page 34: ...RNING Please monitor the self test process to make sure that the speaker the alarm light and the buzzer are all self tested successfully Otherwise please contact the company and do not operate the pump until maintenance is performed Please contact the company if the infusion pump is damaged or cannot operate properly and it cannot be used for patient infusion 4 2 2 Load the Infusion Set 4 2 2 1 In...

Page 35: ... confirm the set is loaded correctly 4 Push the door latch and close the door gently the system will enter the Set Selection interface indicating that the infusion set is loaded correctly otherwise it needs to be reloaded WARNING The infusion set should be firmly loaded into the slot and not jutting on the outside of the slot Before using this infusion pump the infusion pump infusion set and other...

Page 36: ...r or Loading Guide interface If silicone specified infusion set is correctly loaded and door is closed and User Maintenance Brand Selection On enter the Set Selection interface if the switch of Brand Selection is Off then skip the Set Selection interface Load infusion set according to the following method 1 Pull the door latch up to open the door 2 Load the set clips to the locating slot in the di...

Page 37: ...th PVC Specified Infusion Sets System will inspect whether the set is loaded after completing the self test If infusion set is not loaded enter the infusion set Loading Guide interface If the infusion set is not required to load press to skip the step If conventional infusion set is loaded correctly or PVC specified infusion set is loaded incorrectly and door is closed enter the Loading Error or L...

Page 38: ...the outside of the slot Before using this infusion pump the infusion pump infusion set and other accessories should be loaded correctly Infusion pump with PVC specified infusion sets has to be used with PVC specified infusion sets 4 2 3 Change the Infusion Set 4 2 3 1 Infusion Pump with Conventional Infusion Sets Follow the steps below to change the infusion set 1 To prevent patient injury due to ...

Page 39: ...he steps below to change the PVC specified infusion set 1 To prevent patient injury due to free flow before changing the infusion set please shut down the Robert clip or flow rate regulator During infusion press to stop the pump 2 Pull the door latch up to open the door and push the door downward till the liquid check clip of the infusion set completely falls off from door hook 3 Press the liquid ...

Page 40: ...he previous therapy parameters will be loaded the users can use the previous treatment parameters 4 2 7 Select Infusion Mode Press to enter Main Menu Select Mode On this interface users can press and to select infusion mode Please refer to Chapter 5 Infusion Mode for detailed introduction of each infusion mode 4 2 8 Purge Air During infusion the user should prevent air bubbles from entering the bl...

Page 41: ...t before infusion If there is a liquid drug or residue on the ultrasonic sensor or the nearby tube surface the user should completely clean the area before infusion Users should regularly monitor the connection between the infusion set pump and patient and infuse according to the method mentioned in the manual NOTE When in running status if there is no operation in other interface over 2 minutes i...

Page 42: ... expected rate press or again for confirmation then start to infuse under the new set rate 4 2 14 Complete When VTBI is not set during the infusion and infusion is completed if drop sensor is installed and the switch of Drop sensor is on the Empty alarm will be triggered When VTBI is set during the infusion and the remaining infusion time is close to the Time Near End set by the users the Time Nea...

Page 43: ...is a high level alarm When the standby state is ended the title bar will display Standby Time Expired press or to cancel alarm 4 2 16 Turn off the Pump Follow the steps below to turn off the infusion pump 1 Disconnect from the patient 2 Hold down until the Turn Off progress bar complete and the power will turn off NOTE When powering off normally the current operating data and saved data will be au...

Page 44: ... of Rate gtt min Mode Parameters Parameter Range Rate Mode Rate Unit of Rate ml h 0 1 2000ml h Unit of Rate gtt min 1 400 Drip 60 gtt min VTBI 0 1 9999 99ml Time 00 00 01 99 59 59 h m s Please refer to 6 6 Drip Setting for the settings of the unit of gtt min ...

Page 45: ... Mode Time 00 00 01 99 59 59 h m s VTBI 0 1 9999 99ml Rate Same as Rate Mode 5 3 Body Weight Mode 1 Select Main Menu User Maintenance Input User Maintenance Password BW Mode Configuration 2 Select BW Mode Configuration Conc Drug Amount and Volume 3 Select Main Menu Select Mode Body Weight Mode ...

Page 46: ...U ml EU ml mmol ml mol ml kcal ml mEq ml Dose Rate 0 01 999 99 Dose Rate Unit ng kg min μg kg h ug kg min ug kg h ug kg 24h mg kg min mg kg h mg kg 24h g kg min g kg h mU kg min mU kg h U kg min U kg h U kg 24h kU kg h EU kg h mmol kg h mol kg h kcal kg h kcal kg 24h mEq kg min mEq kg h VTBI 0 1 9999 99ml Rate 0 1 2000ml h NOTE 1 Conc will be automatically calculated according to the formula Drug ...

Page 47: ...e of the current sequence can be changed during the operation process In Sequential Mode the VTBI Rate and Time are settable and the ranges of the set values are taken to be the same with Rate Mode A sign denotes the total VTBI and the total time of all sequences NOTE If only set Rate or VTBI for a sequence the sequence is invalid If there is invalid sequence between sequences the infusion can not...

Page 48: ...he same with Rate Mode NOTE 1 Total VTBI should be greater than loading VTBI and if set over the specified limit the parameters that exceed the system limit can not be set 2 When any two parameters of the loading dose are null the pump will run at the Rate of primary parameters until the infusion set is empty or infuison is completed 5 6 Micro infusion Mode Clinically the Micro infusion Mode is ma...

Page 49: ...e during the Ramp down time Mode Parameters Parameter Range Ramp Up Down Mode VTBI 0 1 9999 99ml Total time 00 00 01 99 59 59 h m s Ramp up time 00 00 01 99 59 59 h m s Ramp down time 00 00 01 99 59 59 h m s NOTE 1 Steady rate Up rate and Down rate are calculated automatically and the range is the same as the rate of Rate Mode 2 When both ramp up time and ramp down time are null the pump will run ...

Page 50: ...ff the function 3 Select Drug on the parameters setting interface After the drug is selected its name will appear on the Run screen List of Bulit in Drugs Epinephrine Noradrenaline Isoprenaline Phenylephrine Dopamine Dobutamine Aramine Ephedrine Phentolamine Metoprolol Tartrate Uradil hydrochloride Atropine Anisodamine Scopolamine Belladonna Probanthine ProPafenone Amiodarone Esmolol Lidocaine Nic...

Page 51: ...actual needs CAUTION If the patient experiences discomfort at a higher occlusion pressure monitor the patient s physical conditions under the higher occlusion pressure closely and take measures instantly if any abnormal condition occurs When the infusion set with ultrafilter at a lower occlusion pressure the Occlusion alarm might be triggered at high rate due to resistence generated from liquid fl...

Page 52: ... the infusion set between the device and the patient or occlusion pressure reaches the threshold value The occlusion alarm will sound and the screen will display Downstream occlusion 6 3 4 Automatic Pressure Release Function Anti Bolus When occlusion occurs infusion will stop and the Downstream occlusion alarm will be triggered After the alarm is triggered the motor is reversed and the cannula pre...

Page 53: ...k Function When locked an icon in the upper right corner of the screen emerges The following are two ways for automatic lock and manual lock Automatic Lock 1 Select Main Menu General Options Auto lock Time 2 Select Auto lock Time Off 1 5min After a specific time is set during the running state and if there is no operation or high level alarm within the set Auto lock time the key board will be auto...

Page 54: ...n Set to be selected Brand and model of compatible infusion sets No Type Brand and Model specification 1 Regular BOON A2 20drops 2 Regular B Braun Intrafix Safeset 20drops WARNING It is recommended that infusion pump is used with high elastic tube If you are not sure whether the tube is high elastic tube please contact us for tube test 6 10 2 Infusion Pump with Silicone Specified Infusion Sets 1 S...

Page 55: ...r SK SK ZPQ 2 Regular SK SK 150mL 3 Light sensitive SK SK JMB 6 11 Set the Sensitivity of Empty Bottle Alarm 1 Select Main Menu General Options Empty Sensitivity 2 Select Empty Sensitivity High and Low High indicates high sensitivity of Empty alarm detection Empty alarm will be triggered in shorter time Low indicates low sensitivity of Empty alarm detection Empty alarm will be triggered in longer ...

Page 56: ...f the infusion pump powers down suddenly after it is restarted the last infusion parameters will display the alarm information and will remain in consistency with those before the power down and will be reloaded You can refer to History Record to view such information as infusion parameters and alarm 7 3 Nurse Call Select Main Menu System Options Nurse call and set in the open menu Switch On Indic...

Page 57: ...t the name of the to be connected network Select Password If password is not required for to be connected network you can connect the network directly If password is required for to be connected network please enter the password Select Encryption mode Set the encryption mode of the to be connected network which shall be the same encryption mode as the Ap After the above settings are completed sele...

Page 58: ...o public network If the pump is required to access to public network firewall shall be added to prevent cyber attacks 7 5 Data Export To export the data in the infusion pump please refer to the following steps 1 Log on PC tools and connect the PC to the infusion pump 2 When the infusion pump is in working communication with the PC the PC automatically reads all the data in the pump 3 Select Histor...

Page 59: ...escription Infusion pump has been inserted to BeneFusion DS5 Infusion Supervision System and the system contains prescription information the system will automatically assign all non executed prescription to all idle infusion pumps when pumps are on You will enter the Prescription detail interface press to execute prescription To execute prescription 1 Select Main Menu Day s Prescription press to ...

Page 60: ...und for the user may get used to the previous alarm sound operators may not perceive the alarm in a timely manner due to new alarm sound 8 1 Alarm Level According to the severity scale of the alarm the alarms of the infusion pump can be classified to high level alarms medium level alarms and low level alarms 8 2 Alarm Types When an alarm occurs the pump indicates it to you through visual or audibl...

Page 61: ...ion System are delayed for 3 minutes while other alarms are delayed for less than 5 seconds 8 3 Alarm Handling Rules Under normal working conditions when an alarm occurs all the alarm types of the infusion pump will alert according to their respective alarm levels In addition the user can pause the alarm sound according to demands For high level except No Battery and medium level alarms press to p...

Page 62: ... these steps and take appropriate action 1 Check the patient 2 Check the alarm type and the parameter which triggered the alarm 3 Determine the reason for the alarm 4 Eliminate the reason for the alarm 5 Check whether the alarm has cleared NOTE Please refer to C Alarm Information for specific handling procedures for each alarm The operator position shall be the normal operating position of the inf...

Page 63: ... the red alarm light will continuously flash The infusion pump is configured with rechargeable Lithium batteries to ensure that the infusion pump can be used normally under the condition of the patient s migration within the hospital or during the circumstance of a power failure When the infusion pump switches to the AC power the battery can be charged regardless of whether the infusion pump is on...

Page 64: ... shortened Please follow the steps below during optimization 1 Disconnect the pump from the patient and stop the infusion 2 Insert the battery needing optimization into the battery jar of the infusion pump 3 Switch the infusion pump on the AC power and charge the battery incessantly for over 10 hours 4 Disconnect the AC power and use the battery to charge the infusion pump until the infusion pump ...

Page 65: ...attery s lifetime 9 3 Insert Batteries Batteries need to be replaced 1 It is suggested to turn off the infusion pump power source and disconnect the power source line 2 Tilt or lay the infusion pump down 3 Open the battery door and unlock the battery lock 4 Remove the old battery install the new one into the battery box and insert the battery lock 5 Close the battery door and return the infusion p...

Page 66: ...s and disinfectants in accordance with the manufacturer s instructions or use as low a concentration as possible Do not immerse or submerge the device in liquid Do not pour liquid on the device or accessories Avoid liquid from entering the pump body Do not use abrasive materials such as steel wool or silver polishes or any strong solvent such as acetone or any detergent containing acetone WARNING ...

Page 67: ...ss cleaning agents 5 Place the pump in a cool and ventilated environment to dry 10 3 Disinfection The operation of disinfection may cause certain damage to the infusion pump You are recommended to disinfect only when it is necessary in your desired maintenance plan Clean the equipment before disinfection The recommended disinfectants include Ethanol 70 Isopropanol 70 glutaraldehyde type 2 liquid d...

Page 68: ...mpany immediately if you encounter problems with the device such as the warning label off The device and accessories shall not be served or maintained while in use with a patient 11 1 Inspection The infusion pump must be given a thorough inspection before use after 6 12 months of continuous use and after maintenance or upgrades to ensure that it is operated and functioned normally The inspection c...

Page 69: ...the Maintenance Manual for pressure calibration sensor calibration and pump inspection Once every two years or when you suspect the occlusion alarm is abnormal the flow volume is inaccurate or the infusion set is incorrectly identified 11 3 View Information Select Main Menu History Record In the History Record interface you can view the infusion parameters alarm information operation information a...

Page 70: ...ower cord Select PN according to sales area 009 004829 00 009 004830 00 009 004831 00 009 004825 00 009 004822 00 009 004823 00 Pole clamp 115 022050 00 Nurse call cable 009 004287 00 DC input cable 009 004285 00 Serial communication cable 009 004286 00 Handle set 115 028601 00 Drop sensor 115 032580 01 Cable specifications Item Length m Whether shielded Comments Power cord 2 5 No DC cable 2 8 No ...

Page 71: ...12 2 NOTE This Operator s Manual describes the most complete functional configuration of the system The device you are using may not have some of the settings or functions described herein ...

Page 72: ...23 Degree of safety of application in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide The equipment is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide Mode of operation Continuous Mobile level Portable NOTE CF Type CF applied parts can be directly used in the heart IP23 Protected against solid for...

Page 73: ...condensing Atmospheric pressure 50 106kPa Storage conditions Corrosive free and ventilated indoors AC Power Supply Voltage 100 240V Frequency 50 60Hz Current 0 53 0 28A Fuse Low interrupting rating T 1A 250V External DC power supply Voltage DC 10V 16V Current 2 25 1 5A A 2 Physical Specifications Components Weight Size Host Less than 2 5kg Less than 245 x 174 x 87 mm length width height ...

Page 74: ...scharge for at least 9h using a fully charged new battery Note Power supply time is relevant to rate By factory default continuously operate at the maximum selectable rate typically discharge for about 5h using a fully charged new battery Charging time When the pump is off the charging time is not longer than 6h A 3 3 Host LED Host LED Alarm light 1 red yellow bi color AC indicator light 1 green B...

Page 75: ...4 Specifications Parameters Specifications Factory Default Infusion set standard Infusion set used in conjunction with infusion pump should meet the requirements of ISO 8536 4 2004 Infusion equipment for medical use Part 4 Infusion sets for single use gravity feed MOD Compatible conventional set sizes ml Infusion set diameter 3 0 4 5mm Infusion set thickness 0 8 1 2mm Rate Unit of Rate ml h 0 1 20...

Page 76: ... other pressures the error is 20 or 113mmHg 15 1kPa whichever is larger Maximum occlusion pressure is about 1170mmHg Note 1 The detected pressure of the infusion system infusion pump and infusion set is affected by inner and outer diameter material elasticity of the infusion set and other factors Therefore infusion sets of different brand and model may differ in the detected pressure range Note 2 ...

Page 77: ...3min Max Rate Limit 0 1 2000ml h 2000ml h Drip Setting Drip 10 60drop ml 20drop ml gtt min On Off Off Drip Abnormal On Off Off Empty Sensitivity High Low Low Auto lock Time Off 1 5min step for 1min Off Reminder Time Off 1 5min step for 1min 2min Weight Unit kg lb kg Sound Volume 1 8 4 Brightness 1 8 4 Night Mode On Off Off Nurse call On Off Off History Record Can store up to 2000 records Brand Sel...

Page 78: ...ion set and other factors Therefore infusion sets of different brand and model may differ in the infusion accuracy Note 2 The above declared infusion accuracy is based on BOON A2 and B Braun Intrafix Safeset infusion sets temperature of 20 2 Infusion pump with silicone specified infusion sets Infusion accuracy of the whole rate 5 temperature of 20 2 Infusion pump with PVC specified infusion sets I...

Page 79: ...IDA4 PLUS tester Infusion set brand and model B Braun Intrafix Safeset Test temperature 20 2 Extension tube length 1 meter Occlusion alarm pressure alarm delays and bolus volume may vary depending on test conditions temperature and tube length The above data are only typical values under normal test conditions The actual data may vary as test conditions change Please refer to the test data for the...

Page 80: ...ion set brand and model M IS 000 Test temperature 20 2 Extension tube length 1 meter Occlusion alarm pressure alarm delays and bolus volume may vary depending on test conditions temperature and tube length The above data are only typical values under normal test conditions The actual data may vary as test conditions change Please refer to the test data for the product you have purchased Under the ...

Page 81: ... set brand and model SK ZPQ Test temperature 20 2 Extension tube length 1 meter Occlusion alarm pressure alarm delays and bolus volume may vary depending on test conditions temperature and tube length The above data are only typical values under normal test conditions The actual data may vary as test conditions change Please refer to the test data for the product you have purchased Under the same ...

Page 82: ...nt such as pressure temperature humidity and any infusion consumables used A 6 1 Infusion Pump with Conventional Infusion Sets Plotted on the basis of data collected over a two hour measurement period Infusion set brand and model B Braun Intrafix Safeset Sampling quantity of pump 3 Sampling quantity of infusion set 3 Sampling interval t 0 5min Test period t 240mins Infusion rate Q m h Flow rate de...

Page 83: ...A 12 Unit of Rate ml h ...

Page 84: ...ns Maximum deviation over the course of a full observation window Ep Max Minimum deviation over the course of a full observation window Ep Min Average deviation A Sampling rate 20gtt min Sampling interval t 0 5min Observation windows p t 2 5 11 19 31mins Maximum deviation over the course of a full observation window Ep Max Minimum deviation over the course of a full observation window Ep Min Avera...

Page 85: ...of pump 3 Sampling quantity of infusion set 3 Sampling interval t 0 5min Test period t 8h 1ml h 72h 25ml h Infusion rate Q m h Flow rate deviation over time p t Sampling interval t 0 5min Observation windows p t 2 5 11 19 31 mins Maximum deviation over the course of a full observation window Ep Max Minimum deviation over the course of a full observation window Ep Min Average deviation A and B ...

Page 86: ...ump 3 Sampling quantity of infusion set 3 Sampling interval t 0 5min Test period t 8h 1ml h 24h 25ml h Infusion rate Q m h Flow rate deviation over time p t Sampling interval t 0 5min Observation windows p t 2 5 11 19 31 mins Maximum deviation over the course of a full observation window Ep Max Minimum deviation over the course of a full observation window Ep Min Average deviation A and B ...

Page 87: ...lly Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to any part of the this device including cables specified by the manufacturer Otherwise degradation of the performance of this device could result The non ME EQUIPMENT e g ITE that is a part of an ME SYSTEM may be disrupted by the electromagnetic...

Page 88: ...ishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Voltage fluctuations and flicker IEC 61000 3 3 Complies NOTE The device needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided below Other devices may affect this device even though they mee...

Page 89: ...or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines length greater than 3 m 2 kV for power supply lines 1 kV for input output lines length greater than 3 m Mains power quality should be that of a typical commercial or hospital environment Surge...

Page 90: ...ms 150 kHz to 80 MHz 10 Vrms Portable and mobile RF communications equipment should be used no closer to any part of the device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance P V d 5 3 150k to 80 MHz P E d 5 3 80 MHz to 800 MHz P E d 7 800 MHz to 2 7 GHz where P is the maximum out...

Page 91: ...MHz to 5 4 MHz 7 MHz to 7 3 MHz 10 1 MHz to 10 15 MHz 14 MHz to 14 2 MHz 18 07 MHz to 18 17 MHz 21 0 MHz to 21 4 MHz 24 89 MHz to 24 99 MHz 28 0 MHz to 29 7 MHz and 50 0 MHz to 54 0 MHz b Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretical...

Page 92: ... 0 04 0 04 0 07 0 1 0 11 0 11 0 22 1 0 4 0 4 0 7 10 1 1 1 1 2 2 100 4 4 7 For transmitters at a maximum output power not listed above the recommended separation distanced in meters m can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz a...

Page 93: ...s infusing the alarm is triggered due to an occlusion in the infusion tube between the equipment and the patient Infusion is stopped after the alarm is triggered Press to cancel alarm check and eliminate the source of the alarm Air in line High Size of single air detection reaches to the preset value Infusion is stopped after the alarm is triggered Press to cancel alarm check and eliminate the air...

Page 94: ...on Infusion is stopped after the alarm is triggered Press to cancel alarm and close the door correctly System Error High Power supply voltage abnormal overhigh AD value of sensor abnormal communication abnormal and other errors Alarm cannot be cancelled Please stop operation and contact the company Empty High If drop sensor is installed correctly and the switch of Drop sensor is on no liquid drop ...

Page 95: ...ameters for starting infusion in parameter setting interface Press or insert infusion pump to BeneFusion DS5 Infusion Supervision System System Abnomal Medium Power supply voltage abnormal low and other abnormal Alarm cannot be cancelled Please stop operation and contact the company Standby Time Expired Medium Pump is in standby mode and standby time is completed Press or to cancel alarm Reminder ...

Page 96: ...ncel the alarm 2 Or press to cancel alarm Communication interrupted Low Communication is abnormally interrupted for 3 minutes due to pump been pulled out or internal abnormality after pump inserted to BeneFusion DS5 Infusion Supervision System and communicated successfully with the system no pump serial number conflict or version number compatible or the pump and CIMS are communicated successfully...

Page 97: ...s to cancel alarm Para Unconfirm ed Low The alarm is triggered if no operation is performed within 10s under the parameters setting status Press any key to cancel alarm No Battery Inserted Low No battery inserted or battery disengaged Correctly insert the battery Pump serial number conflict Low After inserted to BeneFusion DS5 Infusion Supervision System the pump has the same serial number with ot...

Page 98: ...ampere centigrade cm centimeter dB decibel g gram h hour Hz hertz inch inch k kilo kg kilogram kPa kilopascal l litre lb pound m meter mg milligrams min minute ml milliliter mm millimeters mmHg millimeters of mercury s second μg Microgram V volt VA volt ampere W watt ...

Page 99: ...y copyright D 3 List of Terms Abbreviation Meaning AC Alternating current Anti Bolus Anti Bolus BOLUS Bolus CCU CICU Cardiac Intensive Care Unit CE Conformité Européenne CISPR International Special Committee on Radio Interference CPU Central processing unit DC Direct current DHCP Dynamic Host Configuration Protocol DPS Dynamic Pressure System ECU EICU Emergency Intensive Care Unit ...

Page 100: ...tion for Standardization KVO Keep vein open LED Light emitting diode Max Maximum MDD Medical Device Directive Min Minimum MRI Magnetic resonance imaging N A Not applied NICU Newborn Intensive Care Unit OR Operating room SN Series Number TIVA Total Intra Venous Anesthesia VTBI Volume To Be Infused D 4 List of Unit Conversion Unit Symbols Unit Conversion kPa 1kPa 7 5mmHg 0 145psi 0 01bar psi 1psi 51...

Page 101: ...aper Foam packages EPE Plastic bag PE General Connecting pieces Power cord Battery Battery Accessories Accessories Remark Indicates that this toxic or hazardous substance contained in all of the homogeneous materials for this part is below the limit requirement in Directive 2011 65 EU Indicates that this toxic or hazardous substance contained in at least one of the homogeneous materials used for t...

Page 102: ...F 1 F Declaration of Conformity P N 046 013877 00 1 0 ...

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