百特AQUARIUS床旁血滤机英文操作手册（英文版）.pdf

191 Edwards Lifesciences一Operating ManualAutomated Fluid Balance MonitorAQUARIUSFor Platinum software version 4Table of Contents1.GETTING STARTED WITH AQUARIUS.11.1.Setting Up.11.2.Installation.11.3.Equipment:Disposables and Consumables.11.4.Waste Management.21.5.Materials Used.21.6.Transport and Storage.21.7.Packing.31.8.Service.31.9.Set time and date.32.INTRODUCING AQUARIUS.42.1.General Machine Description.42.2.Proper Usage/Fields of Application.82.2.1.SCUF(Slow Continuous Ultra-filtration):.82.2.2.CVVH(Continuous Veno-Venous Hemofiltration):.92.2.3.CVVHD(Continuous Veno-Venous Hemodialysis):.102.2.4.CVVHDF(Continuous Veno-Venous hemodiafiltration):.112.2.5.TPE(Therapeutic Plasma Exchange):.122.2.6.Hemoperfusion(Blood Detoxification):.132.3.Labelling.142.4.Side Effects,Contraindications.152.5.Safety Instructions and Warnings.152.6.Operational Sequence(Modes).162.6.1.System test.162.6.2.System test failed.162.6.3.Preparation.162.6.4.Priming.172.6.5.Clamp&Pressure Test.172.6.6.Recirculation.172.6.7.Connecting the Patient.172.6.8.Treatment.182.6.9.Disconnecting the Patient.182.6.10.Terminating the Treatment.182.7.Operating Concept.182.8.Safety Concept.213.Performing a Treatment with AQUARIUS.223.1.Preparing AQUARIUS.223.2.Priming mode-Priming the AQUARIUS.243.3.Recirculation mode-Recirculating saline solution.253.4.Programming-Entering Patient Parameters.263.5.Start Connection-Connecting the Patient.263.5.1.Single connectiorj.263.5.2.Double connection.273.6.Treatment mode-Description of functions throughout Treatment.273.7.Access Disconnection and Return Disconnection-Disconnecting the Patient.293.8.Treatment end-End of Treatment.303.9.AQUARIUS Therapies Choices.303.9.1.SCUF(Slow continuous ultrafiltration).313.9.2.CVVH(Continuous veno-venous hemofiltration).323.9.3.CVVHD(Continuous veno-venous hemodialysis).343.9.4.CVVHDF(Continuous veno-venous hemodiafiltration).353.9.5.TPE(Therapeutic plasma exchange).373.9.6.Hemoperfusion.384.AQUARIUS Alarms and Messages.394.1.Description of Alarm Operation.394.2.Alarms,Messages,System Errors,and Removal Options.394.2.1.Alarms.394.2.2.Messages.424.2.3.System Errors.445.AQUARIUS Technical Data.475.1.Dimensions and Weight.475.2.Electrical Power Supply.475.3.Electrical Safety.475.4.Power Outage Operation.485.5.Technical Data of Individual Components.486.AQUARIUS Cleaning and Disinfection.516.1.Cleaning.516.2.Disinfection.517.AQUARIUS Warranty and Liability.528.Appendix.538.1.References.531.GETTING STARTED WITH AQUARIUS1.1.Setting UpPersonnel authorised by the manufacturer must perform set up and installation of the AQUARIUS system,according to the requirements.When setting up the AQUARIUS system,the room and the necessary power installations must comply with the currently valid standards.Line voltage must conform to the data specified on the data plate of the AQUARIUS system.Before putting the AQUARIUS system into operation carefully read the complete operating manual.1.2.InstallationBefore operating the AQUARIUS system for the first time,ensure that the system is complete and that all parts have been delivered with it.If the AQUARIUS system is damaged,do not put it into operation.In this case,notify the service technician responsible for this system.The AQUARIUS system may only be set up and installed by qualified staff authorized by the manufacturer.Authorized staff together with the prescribing physician may do basic modifications of particular settings that do not change the safety concept of the AQUARIUS system.1.3.Equipment:Disposables and ConsumablesThe AQUARIUS system is designed to operate exclusively with the standard disposables and consumables intended for the indicated treatments.Follow the instructions for use provided by the manufacturer.Warning:Use only the tubing sets stated below to ensure the proper operation of the AQUARIUS system.ItemDescriptionManufacturerTubing setCode:AQUALINEAdult Standard line setExtracorporeal volume(Blood circuit)=100 mlHaemotronicTubing setCode AqualineSPediatric line setExtracorporeal volume(Blood circuit)=64 mlHaemotronicHemofilters,plasma filters,hemoperfusion cartridges and solutions to be used with the AQUARIUS system must conform to applicable standards.Use only products with blood port connections compatible with ISO 594(Part 1+2)female Luer lock connectors,and connections of dialysate,filtrate and plasma ports compatible with male Luer lock connectors.Use catheters according to the instructions provided by the manufacturer;the catheter connector has to be compatible with male Luer locks.Use only hemofilters that are CE marked,according to the Medical Device Directive(93/42/EWG)and are registered for the indications CVVH,CVVHD and CVVHDF.For hemofilters do not exceed a maximum pressure of 400 mmHg to avoid pre-filter pressure alarms.Maximum TMP is 400 mmHg.Caution:Risk of plasma filter damage.For plasma filters do not exceed a pressure of 100 mmHg.This alarm limit is preset in TPE therapy mode.Page 1 of 53Replacement solutions and dialysate have to be sterile and must meet PH.Eur.requirements.Use only 4.5 litres or 5 litres bags with female Luer lock connectors or a sterile adapter to male Luer lock.The prescribing physician must define concentration and composition requirements.Caution:Never use solutions of different compositions simultaneously with the AQUARIUS system!For information on disposables and consumables supplied and recommended by Edwards Lifesciences please contact your Edwards Representative or call Edwards Customer Service.1.4.Waste ManagementThe AQUARIUS system and used disposables should be disposed of according to the local provisions.The system must be cleaned before disposal to prevent biohazardous risks.Electronic components of the AQUARIUS system must be disposed of,according to currently valid regulations for the disposal of electronic components.For more information on disposal please contact the system manufacturer:Edwards Lifesciences Services GmbHEdisonstr.685716 UnterschleiBheimGermany1.5.Materials UsedThe patients blood does not have contact with the components of the AQUARIUS system,thus there is no danger of infection for patients,operators or other persons dealing with the system and there are no special requirements regarding the biocompatibility of the materials used for manufacturing this system.All tubing sets through which blood circulates,must be discarded after every treatment(refer section 1.3).This is also true for the integrated transducers that separate and protect the pressure sensors of the AQUARIUS system by means of an impermeable membrane.1.6.Transport and StorageTo move or transport the AQUARIUS system it is necessary to release the locking tabs on the wheels.The AQUARIUS can then be rotated and freely moved about.To move the AQUARIUS system over steps or stairs the locking tabs must be released.The system should be tilted,lifted,and carried by at least three peoples.Never carry the AQUARIUS system holding on to the display,the I.V.pole,or the scale.The AQUARIUS system must not be pushed over uneven floors.The following environmental conditions are required when storing and transporting the AQUARIUS system:Relative humidity:30 to 80%,non-condensingAmbient temperature:-5 to+45(23 to 113F)Ambient air pressure:50 to 105 kPaThe AQUARIUS system must be stored in a room with good ventilation facilities and little temperature variations.Page 2 of 531.7.PackingWithin the land where AQUARIUS is manufactured the system will be mounted and fixed and carried on special pallets.For special shipments,a box bearing all safety-relevant labels will be used.1.8.ServiceThe AQUARIUS system is subject to technical safety checks and maintenance between 6 month and 12 month intervals.Only qualified service staff,authorized by the manufacturer,must carry out this maintenance and any other repair work.Any work done by non-qualified and non-authorized personnel immediately voids all warranties.More detailed information on the safety check and maintenance can be obtained from Edwards Lifesciences Technical Service:Tel:[phone]-option 4.1.9.Set time and dateWhen help screen is opened,it is possible to set time and date by selecting Set time and date key.Turn selector button to see set time and date key highlighted.Press selector button to validate.Select value to be change by turning the selector button until the value key is highlighted.Press selector button to validate.Press the selector button when the value reaches its target.Turn the selector button to select another value to be change if necessary or select Exit clock mode key to go back to the help screen.Accessible values for change are:For time:Hour Minute SecondFor date:Day Month YearPage 3 of 532.INTRODUCING AQUARIUS2.1.General Machine DescriptionThe AQUARIUS system is an Automated Fluid Balance Monitor,designed to be use with various extracorporeal treatments in the field of renal replacement therapies or plasma therapies.All therapies must be prescribed by a physician.The AQUARIUS system is divided into two circuits:the extracorporeal(blood)circuit and the substitution or filtrate circuit.Toxic substances are removed by filters and clean blood is returned to the patient.The AQUARIUS system uses two scales to accurately measure and precisely balance filtration and substitution volumes.Anticoagulant may be supplied to the extracorporeal circuit via an anticoagulant pump.The prescribing physician may select continuous or intermittent options.The AQUARIUS protective system is designed as a 2-channel system to protect the patient from foreseeable danger.At the back of the scale system there is mounted a removable hand-crank.This can be used to manually turn the blood pump in case a pump stops.For future applications the machine has two ports on its back side where a datalog box can be connected to realise a data transfer of patient or machine data.Page 4 of 53AQUARIUSFront viewPressure sensor:Prefilter pressureBlood pumpFiltrate pumpPressure sensor:Filtrate pressureFilterAnticoagulant pumpPressure sensor:Return pressurePressure sensor:Access pressureFiltration fluid scaleWheeled base-句）通 颔I.V.poleDisplayPostdilution pumpPredilution pumpReturn line chamberDegassing chamber(Temp.Sensor)Air detectorReturn line clampSubstitution fluid scaleLocking wheelsBrakesFigure 1Page 5 of 53AQUARIUSSide View(Left)Figure 2Page 6 of 53AQUARIUSSide View(Right)Page 7 of 532.2.Proper Usage/Fields of ApplicationThe AQUARIUS system is an Automated Fluid Balance Monitor.It is only designed for use with the treatments described in the following.It may only be operated within the given specifications and limits detailed in the manual.2.2.1.SCUF(Slow Continuous Ultra-filtration):During Slow Continuous Ultra-filtration blood is driven through a highly permeable hemofilter via an extracorporeal circuit.SCUF is used primarily to manage fluid overload.The principle of clearance is Convection.Fluid removal is controlled and balanced by the filtrate pump and the scales.The filtrate is not replaced by substitution solution.Post-dilutionPre-dilutionFigure 4Page 8 of 532.2.2.CWH(Continuous Veno-Venous Hemofiltration):During Continuous Veno-Venous Hemofiltration blood is driven through a highly permeable hemofilter via an extracorporeal circuit.Sterile,physiological substitution solution is infused into the blood circuit before or after the filter(pre-dilution or post-dilution respectively)and filtrate is removed simultaneously,at an equal or greater rate.CWH is used to achieve solute removal(small and medium-sized molecules)and fluid balance.The principle of clearance is Convection.The substitution solutions and the filtrate are controlled and balanced by the substitution pumps,filtrate pump,and the scales.Page 9 of 532.2.3.CWHD(Continuous Veno-Venous Hemodialysis):During Continuous Veno-Venous Hemodialysis blood is driven through a highly permeable filter via an extracorporeal circuit.Dialysate solution flows through the dialysate compartment of the filter,counter-current to the blood flow.CWHD is used to achieve solute removal(small molecules)and fluid balance.Filtrate should correspond to the desired net weight loss.No substitution solution is used.The principle of clearance is Diffusion.The dialysate solution and the filtrate are controlled by the substitution pumps(Pre-dilution pump is dialysate pump),filtrate pump and the scales.Dialysate substitution pumpPost-dilutionrBlood leak DetectorAir bubble r 3 detectorFigure 6Page 10 of 532.2.4.CWHDF(Continuous Veno-Venous hemodiafiltration):During Continuous Veno-Venous Hemodiafiltration blood is driven through a highly permeable hemofilter via an extracorporeal blood circuit.Sterile,physiological substitution solution is infused into the blood circuit after the filter.Filtrate is removed,simultaneously,at an equal or greater rate.Dialysate solution flows through the dialysate compartment of the filter,counter-current to the blood flow.CWHDF is used to achieve solute removal(small and medium-sized molecules)and fluid balance.The principles of clearance are Convection and Diffusion.The substitution solutions,dialysate solutions and the filtrate are controlled and balanced by the substitution pumps(Pre-dilution pump is dialysate pump),filtrate pump,and the scales.Page 11 of 532.2.5.TPE(Therapeutic Plasma Exchange):During TPE blood is driven through a plasma filter via an extracorporeal blood circuit.Plasma is separated from the rest of the blood components and replaced by albumins or FFP(Fresh Frozen Plasma).TPE is used to achieve the removal of toxic substances(large molecules).Fluid balance usually remains unchanged.The plasma exchange is controlled and balanced by the substitution pump,filtrate pump,and the scales.Page 12 of 532.2.6.Hemoperfusion(Blood Detoxification):During hemoperfusion blood is driven through a hemoperfusion cartridge via an extracorporeal circuit.Hemoperfusion is intended to remove toxic substances from the blood using a hemoperfusion cartridge.The principle of clearance is Adsorption.Fluid removal or substitution solutions are not used.When using the special tubing sets and filters,cartridges,and solutions be sure to follow the instructions of the respective manufacturers.Page 13 of 532.3.LabellingThe following labels are on the AQUARIUS system:I.Data plateII.Filtrate scale III.Substitution fluid scaleThe Filtrate scale is marked yellow.The substitution fluid scale is marked green.IV.Fuses230V:2xT3,15A 115V:2xmT4AV.Potential bonding conductor VI.Protective conductorPage 14 of 532.4.2.5.Side Effects,ContraindicationsAll generally applicable side effects and contraindications for extracorporeal therapies must be observed.There are no special side effects or contraindications known for the described therapies at present.Safety Instructions and Warnings A During the system test the operator must wait for the generation of the visual and audible alarm signals.If there are errors during the initial functional s