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B-1

EMC and Radio Regulatory Compliance

B.1 EMC

The device meets the requirements of IEC 60601-1-2:2014.

NOTE



Use of accessories, transducers and cables other than those specified

or provided by the manufacturer of this device could result in increased

electromagnetic emissions or decreased electromagnetic immunity of

this device and result in improper operation.



Use of this device adjacent to or stacked with other device should be

avoided because it could result in improper operation. If such use is

necessary, this device and the other device should be observed to verify

that they are operating normally.



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 interference of nearby equipment. It

may be necessary to take mitigation measures, such as re-orienting or

relocating the non-ME EQUIPMENT or shielding the location.



This device is intended for use in professional healthcare facility

environment only. If it is used in special environment, such as magnetic

resonance imaging environment, the equipment/system may be

disrupted by the operation of nearby equipment.

Содержание BeneFusion SP3 Vet

Страница 1: ...BeneFusion SP3 Vet Syringe Pump Operator s Manual ...

Страница 2: ......

Страница 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 ...

Страница 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 ...

Страница 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 animals Illustrations All illustrations in this manual serve as examples only...

Страница 7: ...ting 3 1 3 1 Installation 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 DS3 Infusion Supervision System Optional 3 4 3 1 5 Connect the AC Power Source 3 4 3 2 Conventional Settings 3 5 3 2 1 Adjust Alarm Sound Volume 3 5 3 2 2 Adjust Screen Brightness 3 5 3 2...

Страница 8: ...y Weight Mode 5 2 5 4 Intermittent 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 Pressure Unit 6 2 6 3 3 Dynamic Pressure Scanning DPS 6 2 6 3 4 Automatic Pressure Release Function Anti Bolus 6 3 6 4 Key Lock Function 6 3 6 5 Reminder Function 6 3 6 6 Time Near End 6 3 6 7 Commonly Used Syringes 6 4 7 Other ...

Страница 9: ...ing 11 3 12 Accessories 12 1 A Product Specifications A 1 A 1 Safety Specifications A 1 A 1 1 Product Classification A 1 A 1 2 Operating Environment A 2 A 2 Physical Specifications A 2 A 3 Hardware Specifications A 3 A 3 1 Display A 3 A 3 2 Battery A 3 A 3 3 Host LED A 3 A 3 4 Auditory Indicator A 4 A 3 5 External Ports A 4 A 3 6 Signal Output Interface A 4 A 4 Specifications A 5 A 5 A Reference T...

Страница 10: ...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 Elements E 1 F Declaration of Conformity F 1 ...

Страница 11: ...in 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 product property NOTE Provides application tips or other useful information to ensure that you get the most out of the product ...

Страница 12: ...ing to the actual needs Operation and performance relying solely on the auditory alarm system alone is not sufficient and setting the alarm at a low volume may endanger the animal If the alarm volume is less than the surroundings volume which can further lead to operators identify alarm mistakenly The interconnection of other infusion systems or ACCESSORIES to the PATIENT LINE may lead to performa...

Страница 13: ...ct your distributor or the manufacturer Electromagnetic fields may affect equipment performance This makes it necessary for other equipment used in the vicinity of the pump to meet EMC standards Mobile phones X ray and MRI equipment are all potential interference sources because of their high intensity electromagnetic radiation Before the equipment is connected to the power supply check that the v...

Страница 14: ... Do not insert devices that are not specified by the manufacturer into the multifunction interfaces During infusion the syringe pump can accurately control the rate infusion volume and infusion time and monitor the operation in real time to effectively prevent over currents under currents and instances of backflow The device is not in touch with the drugs or animals directly Thus there is no need ...

Страница 15: ...h the requirements of Directive 2012 19 EU Waste Electrical Electronic Equipment IP34 Protected against solid foreign objects with a diameter no less than 2 5mm and protected against spraying liquid water Authorized representative in the European Community CE mark comply with the requirements of the Council Directive 93 42 EEC Medical Device Directive Recovery recyclable Input output Environmental...

Страница 16: ...2 Contraindications None 2 1 3 Appearance Parts and Features The syringe pump primarily consists of a housing pole clamp and BeneFusion DS3 Infusion Supervision System By precisely controlling the rotational speed of the stepping motor the screw rod is driven to run at the set speed the dose of liquid infused into the animal s body by syringe can be controlled the syringe pump can be used for prec...

Страница 17: ...value Under non setting status press this key to return to the previous menu 5 OK Used for entering setting status confirming input operation and saving value 6 START After the syringe is loaded correctly and the infusion parameters are set press this key to start the infusion In the Bolus settings screen after bolus parameters are set press this key to auto bolus 7 STOP During infusion press this...

Страница 18: ... pump is connected to an AC DC power supply including shutdown Off The pump is not connected to an AC DC power supply 13 Extension cannula clamp Fixes the extension cannula 14 Syringe fixation clamp 15 Battery indicator light Steady green indicates that the battery is charging including shutdown Flashing green indicates that the battery is providing power Light off indicates that the pump is turne...

Страница 19: ...clamp mounting holes two 3 AC power supply port Connection for the AC power cord 4 Multifunction interface with the following functions DC power supply port RS232 interface Nurse call interface 2 2 3 Side View 1 Handle 2 Extension cannula clamp ...

Страница 20: ...2 5 1 Clip 2 Syringe fixation clamp 3 Slot 4 Spindle clamp 5 Slider 6 Handle 2 2 4 Bottom View 1 Speaker hole ...

Страница 21: ... 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 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 beco...

Страница 22: ...ould 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 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 fo...

Страница 23: ...ating Environment The operating environment should also be appropriately protected from 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 syringe pump to ensure that air ca...

Страница 24: ...amp clockwise to firmly fix the device on the IV stand round vertical bar with diameter size of 15 32mm 3 1 3 2 Advanced Pole Clamp Optional Align the mounting holes on the pole clamp with the mounting holes on the back side of the machine and tighten the screws Press the button of pole clamp horizontally or vertically adjust pole clamp the button will pop up after loosening the pole clamp Turn th...

Страница 25: ...eously touch animal and device to prevent animal leakage current from exceeding the requirements specified by the standard Only devices designated by the manufacturer can be connected to the system Based on animal safety do not insert devices that are not specified by the manufacturer into the system 3 1 5 Connect the AC Power Source To connect the pump to the AC power source follow this procedure...

Страница 26: ... power cable should be correctly inserted and secured into the socket Removing power cord is to disconnect device from power supply Please ensure suitable clearance around the device to facilitate connect and remove power cord 3 2 Conventional Settings This chapter only introduces the general settings for the syringe pump please refer to other relative chapters for parameters and other feature set...

Страница 27: ...l update new format automatically 3 3 Restore Factory Default During operation you may change some settings in some situations However the changes may not be appropriate or correct especially when animal or syringe brands are changed Therefore you should restore to the default factory settings during operation according to actual needs to guarantee that each configuration of the syringe pump is ap...

Страница 28: ... activate and turn on the pump the pump will run start up checks and display the start up screen Please refer to 4 2 2 Load the Syringe Select according to the syringe brand currently being used Select infusion mode Refer to 4 2 7 Purge Air Refer to 4 2 8 Set Infusion Parameters Connect to the animal Press Press Disconnect from the animal and remove the syringe in a correct manner Hold down 2s unt...

Страница 29: ...ting the system 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 successfully Otherwise please contact the company and do not operate the pump until maintenance is performed Please contact the company if the syringe pump is damaged or cannot operate proper...

Страница 30: ... plate Before using this syringe pump the syringe pump syringe and other accessories should be installed correctly Before using this syringe pump the brand and specifications of the syringe used must be confirmed The brand of syringe pump should be calibrated on the equipment If there are no settings for the syringe used the rate and the alarms may not be accurate 4 2 3 Change the Syringe Follow t...

Страница 31: ...ing emergency situations infuse the liquid drug into the animal s body in the shortest time possible and set the detailed parameters later during infusion 1 Select Main Menu User Maintenance Input User Maintenance Password Para Memory 2 Select Para Memory On If Off is selected the following steps cannot be conducted 3 After selecting the syringe brand the previous infusion screen will appear the p...

Страница 32: ...mal before purge Otherwise the animal will be in serious danger NOTE Purge rate can not be changed 4 2 8 Set Infusion Parameters Under each infusion mode users can set infusion parameters by pressing and 4 2 9 Infusion When ready connect the extension cannula to the animal Press to start the infusion and the screen will display the running icon An arrow moves from right to left The speed of the ar...

Страница 33: ...start the bolus Manual Bolus Set Bolus Rate press and hold to manual 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 syringe pump will automatically exit the Bolus Settings screen and the procedure must be repeated Animal s clinical condition and working condition of the ...

Страница 34: ...itch to VTBI Complete alarm After KVO mode runs for 30 minutes the KVO Finish alarm will be triggered Set KVO rate please refer to 6 1 KVO 4 2 14 Standby Under non running status press to enter the standby countdown shutdown interface Press to modify standby time range is 00 01 99 59 h min The pump cannot be put in standby mode if there is a high level alarm When the standby state is ended the tit...

Страница 35: ...e Mode Mode Parameters Parameter Range Rate Mode Rate 5ml syringe 0 1 150ml h 10ml syringe 0 1 300ml h 20ml syringe 0 1 600ml h 30ml syringe 0 1 900ml h 50ml 60ml syringe 0 1 2000ml h VTBI 0 1 9999ml Time 00 00 01 99 59 59 h m s ...

Страница 36: ... h 20ml syringe 0 1 600ml h 30ml syringe 0 1 900ml h 50ml 60ml syringe 0 1 2000ml h 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 Conc Configuration Drug Amount and Volume Configuration ...

Страница 37: ...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 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 9999ml Rate 5ml syringe 0 1 150ml h 10ml syringe 0 1 300ml h 20ml syringe 0 1 600ml h 30ml syringe 0 1 900ml h 50ml 60ml syringe 0 1 2000ml h NOTE 1 Conc will be automatically calculated acco...

Страница 38: ...rs Parameter Range Intermittent Mode Rate 5ml syringe 0 1 150ml h 10ml syringe 0 1 300ml h 20ml syringe 0 1 600ml h 30ml syringe 0 1 900ml h 50ml 60ml syringe 0 1 2000ml h Intmt Vol 0 1 9999ml Intmt Time 00 00 01 99 59 59 h m s VTBI 0 1 9999ml Note After a certain intermittent infusion period is finished system will display the remaining time for the next startup press to continue the infusion ...

Страница 39: ...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 List of Drugs Metoprolol Dobutamine Insulin Flumazenil Amiodarone Dopamine Sodium Nitroprusside Fentanyl Esmolol Epinephrine Diazoxide Remifentanil Lidocaine Isoprenaline Nimodipine Morphine Propafenon...

Страница 40: ...ds 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 if any abnormal condition occurs 6 3 2 Set Pressure Unit 1 Select Main Menu User Maintenance Input User Maintenance Password Pressure Unit 2 Select Pressure Unit The 4 various forms of pressure units mmHg kPa...

Страница 41: ...ual Lock In the running interface under the unlocking condition press and hold 3 seconds to lock the keyboard Note If unlocking is needed press and hold 3 seconds to unlock it is automatically locked during the high level alarm 6 5 Reminder Function 1 Select Main Menu General Options Reminder Time 2 Select Reminder Time Off 1 5min After a specific time is set the syringe is loaded If no operations...

Страница 42: ...ed with this syringe pump For specific syringe brands please refer to actual syringes as the standard 1 Select Main Menu User Maintenance Input User Maintenance Password Syringes 2 Select in Syringes according to actual needs Note Please ensure that at least one Syringes to be selected Brand and model of compatible syringes No Brand and Model 5ml 10ml 20ml 30ml 50ml 1 Dove Sterile Hypodermic Syrin...

Страница 43: ...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 Indicates switching on the nurse call function Off Indi...

Страница 44: ...ected 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 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 select Confirm and press 3 Select Adv...

Страница 45: ... is no more than 50 meters 2 4 GHz Wi Fi frequency 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 company It is recommended that not access the pump to public network If the pump is required to access to public network firewall shall be added to prevent cyber ...

Страница 46: ...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 syringe 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 audible...

Страница 47: ...m 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 syringe 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 pause alarm...

Страница 48: ... 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 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 syri...

Страница 49: ... be used normally under the condition of the animal s migration within the hospital or during the circumstance of a power failure When the syringe pump switches to the AC power the battery can be charged regardless of whether the syringe pump is on or off The battery is chargeable only within the syringe pump During charge the battery icon in the upper right corner of the screen floats up and down...

Страница 50: ...ned Please follow the steps below during optimization 1 Disconnect the pump from the animal and stop the infusion 2 Switch the syringe pump on the AC power and charge the battery incessantly for over 10 hours 3 Disconnect the AC power and use the battery to charge the syringe pump until the syringe pump is closed 4 Switch the syringe pump over to AC power again and charge the battery incessantly f...

Страница 51: ...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 battery every two months for lifespan guarantee Please replace the battery if the length of its lifetime is obviously shortened during optimization The length of the battery s lifetime depends on the device...

Страница 52: ...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 ...

Страница 53: ...ess 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 syringe 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...

Страница 54: ...ompany 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 syringe 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 cr...

Страница 55: ...view the infusion parameters alarm information operation information and other information Select Main Menu System Options Version Information In the Version Information interface you can view the Software Version Brand Library Version and other versions 11 4 Accuracy Calibration The syringe in the syringe pump needs no daily calibration But calibration is required when the syringe pump is used fo...

Страница 56: ... the current interface NOTE The 60ml syringes used in this pump can only support 50ml for infusion at maximum full range infusion is not supported 11 5 Safe Disposal and Recycling Please contact the company for related information about safe disposal and recycling Please align the front end of the plunger rod s sealing plug with the full scale position mark ...

Страница 57: ...9 002758 00 Standard pole clamp 115 031551 00 Advanced pole clamp 115 031552 00 Nurse call cable 115 034140 00 RS232 communication cable 115 034142 00 DC input cable 115 034144 00 Pet bracket 115 033273 00 Cable specifications Item Length m Whether shielded Comments Power cord 2 5 No DC cable 2 8 No With magnetic ring Nurse call cable 2 8 No With magnetic ring Serial port communication cable 2 8 Y...

Страница 58: ...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 nitrous oxide Mode of operation Continuous Mobile level Portable NOTE CF Type CF applied parts can be directly used in the heart IP34 Protected against solid foreign objects with a diameter no less th...

Страница 59: ...e 50 106 kPa Storage conditions Corrosive free and ventilated indoors AC Power Supply Voltage 100 240 V Frequency 50 60 Hz Current 0 40 0 14A Fuse Low interrupting rating T5AL 250V External DC power supply Voltage DC 10V 16V Current 2 00 1 25A A 2 Physical Specifications Components Weight Size Host Less than 1 8kg One battery included without pole clamp Less than 340mm length x125mm width x135mm h...

Страница 60: ...t low battery alarm Battery voltage 7 2V Battery capacity 2600 mAh 1 battery or 5200 mAh 2 batteries Power supply time By factory default continuously operate at a rate of 5 ml h discharge for at least 6h 1 battery or 12h 2 batteries using a fully charged new battery Charging time When the pump is off the charging time is not longer than 5h 1 battery or 10h 2 batteries A 3 3 Host LED Host LED Alar...

Страница 61: ...ternal Ports Ports AC power supply port One AC power supply port Multifunction interface One multifunction interface with the following functions DC power supply port RS232 interface Nurse call interface A 3 6 Signal Output Interface Nurse call signal output Driving mode Relay drive Electric specification 60W 2A 36VDC 25VAC Isolation voltage 1500 VAC Action mode Normally open or normally closed op...

Страница 62: ...nge 0 1 150ml h 10ml syringe 0 1 300ml h 20ml syringe 0 1 600ml h 30ml syringe 0 1 900ml h 50ml 60ml syringe 0 1 2000ml h 1 If the maximum rate of the spec of syringe 800ml h the default bolus rate is the maximum rate of the spec of syringe 2 If the maximum rate of the spec of syringe 800ml h current rate 800ml h and the default bolus rate is 800ml h if current rate 800ml h the default bolus rate ...

Страница 63: ...ilable for B Braun Original Perfusor Syringe at a rate of 100ml h temperature of 20 2 525mmHg KVO Rate 0 1 5 0ml h 0 5ml h Time Near End Off 1 30min when the time is 10min step for 1min and step for 5 min when the time is 10min 3min Max Rate Limit 5ml syringe 0 1 150ml h 10ml syringe 0 1 300ml h 20ml syringe 0 1 600ml h 30ml syringe 0 1 900ml h 50ml 60ml syringe 0 1 2000ml h 5ml syringe 150ml h 10...

Страница 64: ...f On Infusion accuracy Infusion accuracy 2 or 0 005ml h whichever is larger Note 1 The infusion accuracy of the infusion system syringe pump and syringe is affected by inner diameter piston material of the syringe and other factors Therefore syringes of different brand and model may differ in the infusion accuracy Note 2 The above declared infusion accuracy is based on Dove and B Braun Original Pe...

Страница 65: ...tion 20ml Test temperature 20 2 Extension tube length 1 5 meter Occlusion alarm pressure alarm delays and bolus volume may vary depending on test conditions temperature and tube length Using large size syringes to infuse at low rate may cause longer occlusion alarm delay The above data are only typical values under normal test conditions The actual data may vary as test conditions change Please re...

Страница 66: ... two hour measurement period Syringe brand B Braun Original Perfusor Syringe Syringe specification 20ml Sampling quantity of pump 3 Sampling quantity of syringe 3 Sampling rate 1ml h Sampling interval t 0 5 min Test period t 120 mins Infusion rate Q m h Syringe brand B Braun Original Perfusor Syringe Syringe specification 20ml Sampling quantity of pump 3 Sampling quantity of syringe 3 Sampling rat...

Страница 67: ...ourse of a full observation window EPmax Minimum deviation over the course of a full observation window EPmin Average deviation A Syringe brand B Braun Original Perfusor Syringe Syringe specification 20ml Sampling quantity of pump 3 Sampling quantity of syringe 3 Sampling rate 5ml h Sampling interval t 0 5 min Observation windows p t 2 5 11 19 31 mins Maximum deviation over the course of a full ob...

Страница 68: ...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...

Страница 69: ...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...

Страница 70: ...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...

Страница 71: ...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...

Страница 72: ...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...

Страница 73: ... 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...

Страница 74: ...sion pressure reaches the threshold of preset occlusion pressure threshold Infusion is stopped after the alarm is triggered Press to cancel alarm check and eliminate the source of the alarm No Battery High 1 Only powered with built in battery battery is empty 2 Built in battery and external DC power encounter failure Connect to the AC power source to cancel alarm VTBI Complete High Infusion volume...

Страница 75: ...e High Start infusion without loading syringe or loading syringe incorrectly Correctly load the syringe or press to cancel alarm System Abnormal 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 Low The...

Страница 76: ...inge Near Empty Low Required time for the remaining liquid within the syringe reaches the setting value of Time Near End 1 The alarm will not be cancelled automatically until the infusion is completed and then switch to VTBI Complete or Syringe Empty alarm 2 Or press to cancel alarm 3 Or press to acknowledge the alarm condition No AC Power Low Power cord disconnects when the pump has connected to ...

Страница 77: ...r VTBI Complete alarm is triggered and in KVO mode 1 Press to stop infusion and cancel 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 Syringe Disengaged or No Battery alarm is cancelled Press or to cancel alarm Please reset time Low RTC time is reset when the pump is on Reset the time or press...

Страница 78: ...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 ...

Страница 79: ...plus 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 ConformitéEuropéenne CISPR International Special Committee on Radio Interference CPU Central processing unit DC Direct current DPS Dynamic Pressure System ECU EICU Emergency Intensive Care Unit ...

Страница 80: ...tional organization 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 01...

Страница 81: ...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...

Страница 82: ...F 1 F Declaration of Conformity P N 046 013104 00 4 0 ...

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