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B-7

B.2 Radio Regulatory Compliance

RF Parameter

Radio devices

IEEE 802.11b/g/n (2.4GHz Wi-Fi)

Operating frequency

2412MHz to 2472MHz

Modulation mode

DSSS, OFDM

Output power

≤20dBm

The radio device used in this product is in compliance with the essential requirements

and other relevant provisions of Directive 2014/53/EU.

Содержание BeneFusion VP3 Vet

Страница 1: ...BeneFusion VP3 Vet Infusion Pump Operator s Manual...

Страница 2: ......

Страница 4: ...den 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 Responsib...

Страница 5: ...function 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 earthq...

Страница 6: ...t 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...

Страница 7: ...stallation 3 1 3 1 1 Out of Box Audit OOBA 3 2 3 1 2 Operating Conditions 3 2 3 1 3 Mount the Clamp 3 3 3 1 3 1 Standard Pole Clamp 3 3 3 1 3 2 Advanced Pole Clamp Optional 3 3 3 1 4 Fix BeneFusion DS...

Страница 8: ...e 5 1 5 2 Time Mode 5 2 5 3 Body Weight Mode 5 2 5 4 Sequential Mode 5 4 6 Setting Parameters 6 1 6 1 KVO 6 1 6 2 Drug Library 6 1 6 3 Occlusion Pressure 6 2 6 3 1 Set Occlusion Pressure 6 2 6 3 2 Set...

Страница 9: ...ntenance Plan 11 2 11 3 View Information 11 2 11 4 Safe Disposal and Recycling 11 2 12 Accessories 12 1 A Product Specifications A 1 A 1 Safety Specifications A 1 A 1 1 Product Classification A 1 A 1...

Страница 10: ...liance B 7 C Alarm Information C 1 D Symbols and Terms D 1 D 1 List of Units D 1 D 2 List of Symbols D 2 D 3 List of Terms D 2 D 4 List of Unit Conversion D 3 E Toxic and Hazardous Substances or Eleme...

Страница 11: ...n death serious injury or damage to product property CAUTION Indicates a potential hazard or unsafe practice that if not avoided could result in minor personal injury product malfunction or damage to...

Страница 12: ...monitored carefully the alarm volume and alarm levels need to be set according to the actual needs Operation and performance relying solely on the auditory alarm system alone is not sufficient and se...

Страница 13: ...mp and under non running status please carefully check whether there is leakage from the tube export of the infusion set and drop needle of the drip chamber If any leakage is found please contact the...

Страница 14: ...d reload the new tube without extrusion Electromagnetic fields may affect equipment performance This makes it necessary for other equipment used in the vicinity of the pump to meet EMC standards Mobil...

Страница 15: ...devices that are not specified by the manufacturer into the multifunction interfaces During infusion the infusion pump can accurately control the rate infusion volume and infusion time and monitor th...

Страница 16: ...entative in the European Community Serial number Comply with the requirements of Directive 2012 19 EU Waste Electrical Electronic Equipment CE mark comply with the requirements of the Council Directiv...

Страница 17: ...yone 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 and b...

Страница 18: ...status press this key to set the value to 0 Edited value is 0 press this key to return the value to the previous value Under non setting status press this key to return to the previous menu 4 DIRECTIO...

Страница 19: ...state and turning off operations 10 BOLUS During infusion press this key to enter the Bolus settings screen Under non running status press this key to to enter the Purge prompt screen 11 AUDIO PAUSED...

Страница 20: ...2 4 2 2 2 Front View with the Door Opened 1 Liquid check clip button 2 Liquid check clip 3 Infusion set slot...

Страница 21: ...on interface with the following functions DC power supply port RS232 interface Nurse call interface 2 AC power supply port Connection for the AC power cord 3 Drop sensor interface Drop sensor is optio...

Страница 22: ...running operation The icon indicates normal running Arrows move from right to left and the running speed increases as the rate is increased Motor stops caused by alarms during infusion no icon 2 4 Cur...

Страница 23: ...uld be connected based on the requirements of the valid version of the IEC60601 1 system The qualified individual responsible for connecting auxiliary equipment to the input and output signal ports is...

Страница 24: ...e that the package is undamaged before using do not use if there is any damage NOTE Keep the packing case and packaging materials for future transportation or storage 3 1 2 Operating Conditions The op...

Страница 25: ...1 Standard Pole Clamp 1 Turn counterclockwise to loosen the pole clamp until an IV stand can be inserted in 2 Tighten the pole clamp clockwise to firmly fix the device on the IV stand round vertical...

Страница 26: ...manufacturer and evaluated according to the specified IEC60601 1 Please contact the company if you have any queries Please ensure not simultaneously touch animal and device to prevent animal leakage...

Страница 27: ...r moist hands If there is a liquid drug or residue on or around the both ends of the power cord power socket or plug device s AC power supply port the user should completely clean and dry the area bef...

Страница 28: ...infusion the medical staffs need to confirm and eliminate the drops Otherwise the accuracy of drop rate check will be affected and the Empty alarm will be triggered NOTE The surface of the liquid in t...

Страница 29: ...for the darkest setting When operating on battery power you can set a low Brightness to save the power of the battery 3 2 3 Set Language 1 Select Main Menu User Maintenance Input User Maintenance Pas...

Страница 30: ...lt factory settings during operation according to actual needs to guarantee that each configuration of the infusion pump is applicable for clinical use For some default factory settings of this equipm...

Страница 31: ...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 Refe...

Страница 32: ...m self test and now you can operate the system through the key board WARNING Please monitor the self test process to make sure that the speaker the alarm light and the buzzer are all self tested succe...

Страница 33: ...oor 2 Pull the free flow clamp button upward left and open the free flow clamp 3 Load the set confirm it is firmly loaded into the tube slot 4 Close the door the interface will enter Set Selection int...

Страница 34: ...he free flow clamp button upward left and take out the loaded infusion set 3 Please refer to 4 2 2 Load the Infusion Set to reload the infusion set 4 2 4 Change the Infusion Bottle Bag Follow the step...

Страница 35: ...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...

Страница 36: ...The speed of the arrow increases as the rate is increased WARNING Users should inspect and confirm whether the parameter settings are correct before infusion If there is a liquid drug or residue on t...

Страница 37: ...bolus and release to return to the original rate Auto Bolus Set Bolus Rate Bolus VTBI and Bolus Time press to auto bolus NOTE If no operation is performed within 2 minutes the infusion pump will autom...

Страница 38: ...de and KVO mode will run for 30 mins at most Infusion will stop automatically after the KVO is finished and the KVO Finish alarm will be triggered Set KVO rate please refer to 6 1 KVO 4 2 15 Standby U...

Страница 39: ...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 9999ml Time 00 00 01 99 59 59 h m s Please refer to 6...

Страница 40: ...e Mode Time 00 00 01 99 59 59 h m s VTBI 0 1 9999ml 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 Mo...

Страница 41: ...ml EU ml mmol ml mol ml kcal ml mEq ml Dose Rate 0 1 9999 Dose Rate Unit ng kg min ng 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...

Страница 42: ...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 s...

Страница 43: ...ary 2 Select Drug library On Off indicates switching off the function 3 Select Drug on the parameters setting interface of Rate Mode After the drug is selected its name will appear on the Run screen L...

Страница 44: ...ctual needs CAUTION If the animal experiences discomfort at a higher occlusion pressure monitor the animal s physical conditions under the higher occlusion pressure closely and take measures instantly...

Страница 45: ...ilt in ultrasonic sensor bubble size can be calculated by the internal CPU which is compared with the preset threshold Air in line alarm will be triggered if bubble size exceeds the threshold 1 Select...

Страница 46: ...a specific time is set the infusion set is loaded If no operations are performed to the pump within the set time including operations on the keyboard and the door and the Reminder alarm will then ale...

Страница 47: ...tube is high elastic tube please contact us for tube test 6 11 Set the Sensitivity of Empty Bottle Alarm 1 Select Main Menu General Options Empty Sensitivity 2 Select Empty Sensitivity High and Low Hi...

Страница 48: ...s 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...

Страница 49: ...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 Set the encryption mode...

Страница 50: ...quency range and 802 11b g n wireless standard are supported The settings of the wireless network must be conducted by technicians approved by the company or maintenance staff designated by the compan...

Страница 51: ...nd 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...

Страница 52: ...on 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 infu...

Страница 53: ...these steps and take appropriate action 1 Check the animal 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...

Страница 54: ...be used normally under the condition of the animal 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 char...

Страница 55: ...Please follow the steps below during optimization 1 Disconnect the pump from the animal and stop the infusion 2 Switch the infusion pump on the AC power and charge the battery incessantly for over 10...

Страница 56: ...e status Do not charge the failure battery and replace the failure battery If battery will not be used for a long time we recommend keeping the battery in a fully charged state and charging the batter...

Страница 57: ...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 acce...

Страница 58: ...s 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 disi...

Страница 59: ...pany 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 animal 11 1 Inspection The inf...

Страница 60: ...he 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 infu...

Страница 61: ...ls PN Power cord Select PN according to sales area 0020 20 12522 009 002755 00 009 002756 00 009 002757 00 009 002758 00 009 003358 00 009 003651 00 009 002758 00 Standard pole clamp 115 031551 00 Adv...

Страница 62: ...2 8 No With magnetic ring Nurse call cable 2 8 No With magnetic ring Serial port communication cable 2 8 Yes NOTE This Operator s Manual describes the most complete functional configuration of the sys...

Страница 63: ...he 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...

Страница 64: ...Storage conditions Corrosive free and ventilated indoors AC Power Supply Voltage 100 240V Frequency 50 60Hz Current 0 40 0 14A Fuse Low interrupting rating T5AL 250V External DC power supply Voltage D...

Страница 65: ...wer supply time By factory default continuously operate at a rate of 25ml h discharge for at least 4h 1 battery or 8h 2 batteries using a fully charged new battery Note Power supply time is relevant t...

Страница 66: ...upply port One AC power supply port Multifunction interface One multifunction interface with the following functions DC power supply port RS232 interface Nurse call interface Drop sensor interface opt...

Страница 67: ...outer diameter material elasticity of the infusion set and other factors Therefore infusion sets of different brand and model may differ in maximum rates Note 2 The above declared rates are based on...

Страница 68: ...raun Intrafix Safeset infusion sets temperature of 20 2 525mmHg Air detection 6 Levels are adjustable respectively are 20 50 100 250 500 800 l Sensitivity of single air bubble is 20 l Note 1 The detec...

Страница 69: ...W Mode Configuration Conc Drug Amount and Volume Conc Drug Library On Off Off Para Memory On Off Off Date and Time Time _ _ _ _ 00 00 Date _ _ _ _ _ _ _ _ 01 01 2018 Time format 12h 24h 24h Date forma...

Страница 70: ...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 Dose of single fault...

Страница 71: ...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 temperatur...

Страница 72: ...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 240min...

Страница 73: ...A 11 Unit of Rate ml h...

Страница 74: ...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 interv...

Страница 75: ...ly 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...

Страница 76: ...shments 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...

Страница 77: ...r 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...

Страница 78: ...s 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...

Страница 79: ...Hz 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 strengt...

Страница 80: ...Watts W Separation Distance According to Frequency of Transmitter m 150 kHz to 80 MHz P V d 5 3 80 MHz to 800 MHz P E d 5 3 800 MHz to 2 7 GHz P E d 7 0 01 0 04 0 04 0 07 0 1 0 11 0 11 0 22 1 0 4 0 4...

Страница 81: ...ces IEEE 802 11b g n 2 4GHz Wi Fi Operating frequency 2412MHz to 2472MHz Modulation mode DSSS OFDM Output power 20dBm The radio device used in this product is in compliance with the essential requirem...

Страница 82: ...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 in line Accumulate air High...

Страница 83: ...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...

Страница 84: ...alarm 2 Or press to acknowledge the alarm condition Time Near End Low Infusion remaining time reaches the setting value of Time Near End 1 The alarm will not be cancelled automatically until the infu...

Страница 85: ...ncel alarm 2 Or the KVO Finish alarm is triggered when reach the KVO infusion time Infusion interrupted Low The alarm is triggered after any of the Occlusion Air in line Accumulate air Door opened No...

Страница 86: ...mpere 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 millime...

Страница 87: ...lus or minus multiply copyright D 3 List of Terms Abbreviation Meaning AC Alternating current Anti Bolus Anti Bolus BOLUS Bolus CCU CICU Cardiac Intensive Care Unit CE Conformit Europ enne CISPR Inter...

Страница 88: ...ion 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...

Страница 89: ...per 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 homoge...

Страница 90: ...F 1 F Declaration of Conformity P N 046 013101 00 4 0...

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