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III

Exemptions

Mindray Scientific's obligation or liability under this warranty does not include any
transportation or other charges or liability for direct, indirect or consequential damages
or delay resulting from the improper use or application of the product or the use of parts
or accessories not approved by Mindray Scientific or repairs by people other than
Mindray Scientific authorized personnel.

This warranty shall not extend to

■

Malfunction 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 not caused by instrument or part itself.

Company Contact

Manufacturer:

Shenzhen Mindray Scientific Co., Ltd.

Address:

6/F, Bldg 2, 1203 Nanhuan Avenue, Yutang Block,

Guangming District, 518106 Shenzhen, P.R.China

Website:

www.mindray.com

E-mail Address:

[email protected]

Tel:

+86 755 81888998

Fax:

+86 755 26582680

EC-Representative:

Shanghai International Holding Corp. GmbH (Europe)

Address:

Eiffestraβe 80, 20537 Hamburg, Germany

Tel:

0049-40-2513175

Fax:

0049-40-255726

Summary of Safety
and Clinical
Performance
(SSIP):

https://www.mindray.com/content/dam/xpace/en/
site/mdr-sscp/ivp-and-uvp/kf-h-046-024481-00-uvp-
instruction-for-use.pdf

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Содержание BeneFusion uVP

Страница 1: ...BeneFusion uVP BeneFusion uVP ex Infusion Pump Instruction for Use ...

Страница 2: ......

Страница 3: ...I Copyright 2021 2023 Shenzhen Mindray Scientific Co Ltd All rights reserved Release date 2023 01 Revision 4 0 ...

Страница 4: ...r 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 liable for errors contained herein nor for incidental or consequential damages in conne...

Страница 5: ...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 not caused by instrument or part itself Company Contact Manufacturer Shenzhen Mindray Scientific Co Ltd Address 6 F Bldg 2 1203 Nanhuan Avenue Yutang Block Guangming District 518106 Shen...

Страница 6: ...this manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety This manual is based on the maximum configuration and therefore some contents may not apply to your product If you have any question please contact us This manual is an integral part of the product It should always be kept close to the equipment so that it can be obtained conv...

Страница 7: ...fusion Set 4 1 4 3 Purge 4 2 4 4 Starting Infusion 4 2 4 5 Bolus Infusion 4 3 4 6 Setting Keep Vein Open KVO Rate 4 3 4 7 Replacing the IV Container 4 3 4 8 Unloading the Infusion Set 4 4 4 9 Turning Off the Pump 4 4 5 Alarms 5 1 5 1 Alarm Safety Information 5 1 5 2 Understanding the Alarms 5 1 5 3 Alarm Solutions 5 2 5 4 Occlusion Alarm 5 2 6 Menu Options 6 1 7 Infusion Modes 7 1 7 1 Rate Mode Ti...

Страница 8: ...0 4 Disposing of the Equipment 10 3 11 Care and Cleaning 11 1 12 Accessories 12 1 A Product Specifications A 1 A 1 Specifications A 1 A 2 Wireless Network A 3 A 3 Infusion Specifications A 3 A 4 Recommended Infusion Sets A 5 A 5 Occlusion Alarm Delay and Bolus Volume A 6 A 6 Infusion Accuracy Graphs A 6 A 7 Operating Environment A 10 B EMC and Radio Regulatory Compliance B 1 B 1 EMC B 1 B 2 Radio ...

Страница 9: ...of the product 1 1 1 Warnings WARNING To avoid risk of electric shock the equipment must only be connected to mains power with protective earth If a protective earth conductor is not provided operate it on battery power if possible To avoid explosion hazard do not use the equipment in the presence of oxygen rich atmospheres flammable anesthetics or other flammable agents The equipment is not inten...

Страница 10: ...1 1 2 Cautions CAUTION When several infusion lines are connected to the same vascular access there may be back flow or prolonged response time of occlusion alarm Therefore use check valve at the line end or follow local hospitals instructions while in connection with other infusion system When using this equipment for enteral nutrition do not use enteral fluids for intravenous infusion to avoid pa...

Страница 11: ...as developed in compliance with IEC62304 The equipment provides power down storage Alarms limit setting and history record are saved and will be maintained if the equipment is powered down suddenly The storage time is equals to the equipment s service life The alarm limit settings before power down are reloaded when the equipment is restarted This manual describes all features and options Your equ...

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Страница 13: ...ects that can occur during or after the use of the medical device And there is no need for the operator to make extra preparations Thus no residual risk associated with using the medical device should be disclosed 2 1 1 Indication for Use Infusion pumps are for patients who need receive various types of medications solutions nutrition lipids blood and blood components in controlled amounts through...

Страница 14: ...ion pump is not directly used to treat diseases it will not produce the direct clinical benefits and its clinical benefits are mainly indirect clinical benefits a positive impact on patient management precise infusion 2 3 Applied Part The applied part of the equipment is the infusion set ...

Страница 15: ...tems standard Any personnel who connect devices to the equipment s signal input output port are responsible for providing evidence that the safety certification of the devices has been performed in accordance to the IEC 60601 1 If you have any questions please contact Mindray Scientific If it is not evident from the equipment specifications whether a particular combination with other devices is ha...

Страница 16: ...ect the drop detection accuracy and cause the Empty alarm NOTE The liquid surface in the drip chamber should be lower than the lower edge of the drop sensor and lies between the one third and a half of the drip chamber The positioning block of the drip chamber must be vertically inserted through the positioning groove of the drop sensor Do not excessively tilt the drop sensor or expose it to direc...

Страница 17: ...oundings of the AC power input connector and power cord connectors Use the battery if the integrity of the protective earth conductor or the protective earthing system in the installation is in doubt CAUTION When connected with the adapter it is specified as a part of the equipment Use only the specified adapter ...

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Страница 19: ...isolation means to the mains power Do not locate the equipment in a place difficult to operate the mains plug 4 2 Loading the Infusion Set WARNING To ensure the accuracy of air bubble detection check and remove the remained fluid in the infusion set slot before loading the infusion set While loading the infusion set do not touch the free flow clamp to avoid being hurt This pump uses standard singl...

Страница 20: ...infusion set 4 3 Purge NOTE If required set the purge rate after the purge is started The initial purge rate is 1200 ml h The Air in Line or Accumulated Air alarm will not given during purging The volume used for purging is not added to the infused volume 4 4 Starting Infusion WARNING Do not connect patient until disposables have been purged and loaded into the pump Connecting to patient before di...

Страница 21: ...d bolus volume will be added to the total infusion volume and subtracted from the volume to be infused VTBI The pump gives a beep every time a 0 5 ml bolus volume is infused 4 6 Setting Keep Vein Open KVO Rate NOTE If the KVO rate is greater than the infusion rate the pump will continue to infuse at the set infusion rate The pump runs for 30 minutes at a KVO rate At the completion of the KVO infus...

Страница 22: ...t the fixing site every four hours It is recommended that the disposable enteral nutrition sets be changed every 24 hours If the infusion sets are not changed within the recommended time the accuracy of the infusion may be affected 4 9 Turning Off the Pump CAUTION Press and hold the power switch for no less than 10 seconds to forcibly shut down the pump if it could not be shut down normally This m...

Страница 23: ... the patient frequently Do not rely exclusively on the audible alarm system during an infusion Adjustment of alarm volume to a low level may result in a hazard to the patient Always make sure that the audio alarm volume level is adequate in your care environment Always keep the patient under close surveillance Fully evaluate the risk before changing the alarm mode setting New alarms may be failed ...

Страница 24: ...es infusion when a low priority alarm is triggered The pump stops infusion after the first Battery Depleted alarm occurs and the shutdown delay is at least three minutes 5 4 Occlusion Alarm NOTE If this pump is running at 0 1ml h and respectively configure the occlusion pressure alarm limit to the lowest level and highest level the occlusion alarm delay time may reach up to one hour and 20 5 hours...

Страница 25: ... 1 6 Menu Options CAUTION The maintenance settings can only be changed by authorized personnel Contact your department manager or biomedical engineering department for the passwords used at your facility ...

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Страница 27: ...gs are optional 7 2 Dose Mode NOTE Time can only be obtained by calculation It is not available for manual input Some departments for example the Neonatology may use fixed drug amounts diluent volumes or concentrations Using the drug info library to predefine these infusion parameters can simplify the setting process 7 3 Loading Dose Mode NOTE If you do not configure the loading dose parameters th...

Страница 28: ...anual input Up Time and Down Time are optional parameters The pump runs an infusion at the steady rate if they are not set 7 6 Dose Time Mode NOTE In the dose time mode the supported dose rate units are X min X h and X 24h in which X represents ng ug mg g mU U kU EU mmol mol mcal cal kcal and mEq Time can only be obtained by calculation It is not available for manual input 7 7 Rhythm Dose NOTE In ...

Страница 29: ...als Checked that the drug and parameter settings are suitable for the care area before use The facility is responsible for performing initial checks to ensure that the proper drug library drug info library is loaded NOTE The predefined parameters can be changed during a therapy This does not affect the embedded library ...

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Страница 31: ...p network authentication information for example password safe protecting the network from being accessed by unauthorized users Do not connect non medical devices to the network If wireless network signal is poor there may be a risk of CMS data loss RF interference may result in wireless network disconnection Disconnecting from the network may result in CMS data loss and function failure Check the...

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Страница 33: ... checks or maintenance involving any disassembly of the equipment should be performed by professional service personnel Otherwise undue equipment failure and possible health hazards could result The service personnel must be properly qualified and thoroughly familiar with the operation of the equipment CAUTION The equipment and accessories shall not be served or maintained while in use with a pati...

Страница 34: ...battery has a service life Replace your battery when it reaches the end of its service life Failure to replace the battery may cause serious damage to your equipment from battery overheating Do not open the battery heat the battery above 60 C incinerate battery or short battery terminals They may ignite explode leak or heat up causing personal injury NOTE Remove the battery if it will not be used ...

Страница 35: ...d down The time of equipment power down is also recorded as an event The pump stores up to 5000 events When the capacity is reached earlier events will be overwritten by later ones 10 4 Disposing of the Equipment WARNING For disposal of parts batteries packaging materials and accessories where not otherwise specified follow local regulations regarding disposal of hospital waste ...

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Страница 37: ... remove the power cord from the equipment before cleaning and disinfecting Never immerse any part of the equipment or accessories in liquids or allow liquid to enter the interior of the equipment or accessories Any contact of cleaners or disinfectants with connectors or metal parts may cause corrosion Do not pour or spray any liquid directly on the equipment or accessories or permit fluid to seep ...

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Страница 39: ...meet the performance specifications if stored or used outside the specified temperature and humidity ranges If accessory performance is degraded due to aging or environmental conditions contact your service personnel Check the accessories and their packages for any sign of damage Do not use them if any damage is detected Use the accessories before the expiry date if their expiry date is indicated ...

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Страница 41: ...dity noncondensing 15 to 95 Barometric 57 0 kPa to 107 4 kPa Storage conditions Temperature 20ºC to 60ºC Relative humidity noncondensing 10 to 95 Barometric 16 0 kPa to 107 4 kPa Corrosive free and ventilated Shock Complies with requirements for medical devices of 6 3 4 EN1789 10 1 3 a IEC60601 1 12 Peak acceleration 300m s2 30g Duration 11ms Pulse shape half sine Number of shocks 3 shocks per dir...

Страница 42: ...dual smart batteries operating at a rate of 5ml h or 25ml h under standard operating conditions At least 1 hour for normal battery and at least 2 5 hours for smart battery and dual smart batteries operating at a rate of 2000ml h under standard operating conditions Operating with a fully charged new battery at 20 C 2 C default screen brightness and volume Wi Fi disabled without accessories Battery ...

Страница 43: ...on TKIP and AES System capacity Number of the pumps supported by a single AP 16 Data transmission delay between the pump and the CMS Total data transmission delay time between the pump and the CMS is 8s Interruption number and time between the pump and the CMS Total interruption duration 0 01 total communication time Test within 24 hours with 16 pumps in which three pumps are roaming for 30 times ...

Страница 44: ...lume under single fault conditions 0 5ml KVO rate 0 1 to 5 0ml h Minimum resolution 0 01ml h Time set range 00 00 01 to 99 59 59 h min sec VTBI set range 0 1 to 9999 99 ml Minimum resolution 0 01ml Micro infusion mode 0 1 to 1000ml Weight set range 0 1 to 499 0 kg 0 2 to1100 1 lb Drug Amt set range 0 001 to 99999 Drug Amt unit set range ng μg mg g mU U kU EU mmol mol mcal cal kcal mEq Volume set r...

Страница 45: ...fect the quality of disposables from other suppliers Changes in quality may affect the technical data of the pump Mindray Scientific is not responsible for such changes Prescription Accepting and performing the prescription Product Name Type Manufacturer Transfusion Sets for Single Use Transfusion SHANDONG WEIGAO GROUP MEDICAL POLYMER CO LTD Single Use Infusion Set for Pump Regular SHINVA ANDE HEA...

Страница 46: ...nd bolus volume may vary depending on test conditions temperature and tube length A 6 Infusion Accuracy Graphs A 6 1 Infusion Accuracy at 1 ml h Rate ml h Occlusion alarm delay time hh mm ss High occlusion alarm pressure level Low occlusion alarm pressure level 1 02 01 00 00 04 37 25 00 03 25 00 00 30 Rate Bolus volume after occlusion ml High occlusion alarm pressure level Low occlusion alarm pres...

Страница 47: ...ml h 2nd hour Observation window min Percentage error of flow Ep Max Ep Min Overall percentage error A Trumpet Curve at 1ml h last hour Percentage error of flow Observation window min Ep Max Ep Min Overall percentage error B ...

Страница 48: ... 2 Infusion Accuracy at 25ml h Start up graph first 2 hours at 1ml h Rate ml h Time min Trumpet Curve at 25ml h 2nd hour Observation window min Percentage error of flow Ep Max Ep Min Overall percentage error A ...

Страница 49: ...on accuracy may be influenced by the pump s environment such as pressure temperature humidity and any infusion consumables used Trumpet Curve at 25ml h last hour Percentage error of flow Observation window min Ep Max Ep Min Overall percentage error B Start up graph first 2 hours at 25ml h Time min Rate ml h ...

Страница 50: ...A 10 A 7 Operating Environment Operating system FreeRTOS Classification OS Core Version Information 9 0 0 ...

Страница 51: ...ng 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 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 electromagn...

Страница 52: ...oup 1 The device uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic device Conducted and radiated RF EMISSIONS CISPR 11 Class B The device is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that sup...

Страница 53: ...e is lost or degraded it may be necessary to take mitigation measures such as re orienting or relocating the ME EQUIPMENT or ME SYSTEM or shielding the location or stopping using the pump system and contact the service personnel If the device is operated within the electromagnetic environment listed in Table Guidance and Declaration Electromagnetic Immunity the system will remain safe and provide ...

Страница 54: ...mercial or hospital environment Surge IEC 61000 4 5 0 5 kV 1 kV line s to line s 0 5 kV 1 kV 2 kV line s to earth 0 5 kV 1 kV line s to line s 0 5 kV 1 kV 2 kV line s to earth Voltage dips and Voltage interruptions IEC 61000 4 11 0 UT 0 5 cycle At 0 45 90 135 180 225 270 and 315 0 UT for 1 cycle and 70 UT for 25 30 cycles 0 UT for 250 300 cycle 0 UT 0 5 cycle At 0 45 90 135 180 225 270 and 315 0 U...

Страница 55: ...ation distance 150kHz to 80 MHz 150kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 7 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site surveyb should be less than the compliance level in each f...

Страница 56: ...agnetic site survey should be considered If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above the device should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the device c Over the frequency ranges 150 kHz to 80 MHz field strengt...

Страница 57: ...ording to the maximum output power of the communications equipment Portable and mobile radio communications equipment e g two way radio cellular cordless telephones and similar equipment should be used no closer to any part of this system including cables than determined according to the following method Test frequency MHz Band MHz Service Modulati on Maximu m power W Distance m Immunit y test lev...

Страница 58: ...hich radiated RF disturbance are controlled The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the device as recommended below according to the maximum output power of the communication equipment RatedMaximum Outputpowerof Transmitter Watts W Separation Dista...

Страница 59: ...ded 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 and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by a...

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