旭化成血透机MDS101_使用手册.pdf

Single Patient Dialysis SystemMDS-101Operation ManualBefore using the product,please read this manual carefully,and thoroughly understand its operation.This manual should be kept in a safe place.MM3-00648-00 2009.9Table of Contents1 Before Using the System.1-21.1 Intended Purpose and Scope of Use.1-21.2 Applicable Standards.1-21.3 Product Specifications.1-31.4 Required Facilities and Environmental Conditions.1-81.5 Assembly,Installation,Setup and Adjustment.1-91.6 Part Names.1-101.6.1 External appearance.1-101.6.2 Operation panel.1-121.7 Operation Modes and Screen Navigation.1-131.8 Operation of the Display.1-141.8.1 Current process.1-151.8.2 Comment window.1-151.8.3 Function keys.1-151.8.4 Title keys.1-171.8.5 Menu key.1-191.8.6 Data screen.1-191.8.7 Setting screen.1-201.8.8 Graph screen.1-211.8.9 History screen.1-221.8.10 Offline mode screen.1-231.8.11 Maintenance screen.1-231.9 Operation of the Major Components.1-241.9.1 Concentrate ports.1-241.9.2 Clamp.1-251.9.3 Blood pump.1-261.9.4 Syringe pump.1-271.9.5 Air detectors.1-281.9.6 Substitution pump(optional).1-301.9.7 Nurse call switch(optional).1-302 Daily Operation.2-22.1 Operation Flow.2-212.2 Operating Procedures.2-32.2.1 Preparing the system for dialysis.2-32.2.2 Installing the dialyzer and the arterial/venous drip chambers.2-32.2.3 Installing the blood line.2-42.2.4 Installing the syringe and priming the syringe pump line.2-42.2.5 Installing the venous line to the air detector and clamp.2-52.2.6 Connecting the pressure lines to the arterial/venous pressure ports.2-62.2.7 Preparing dialysate.2-72.2.8 Setting dialysate.2-82.2.9 Priming the tubing set.2-92.2.10 Gas purge.2-92.2.11 Setting the dialysis parameters.2-102.2.12 Dialysis process.2-102.2.13 Completion of dialysis.2-152.2.14 Blood return.2-152.2.15 Drain.2-152.2.16 Rinsing after the dialysis.2-162.2.17 Completion.2-182.2.18 Pre-rinse.2-192.3 Other Functions.2-212.3.1 Isolated UF.2-212.3.2 Single needle.2-222.3.3 Blood pressure manometer(optional).2-232.3.4 Profile.2-252.3.5 Timer.2-302.3.6 Stopping fluid flow.2-302.4 Setting screen.2-312.4.1 Screen access and setting procedure.2-312.4.2 Dialysate.2-322.4.3 Single needle.2-342.4.4 ArteriaWenous pressure alarm.2-352.4.5 Air detector.2-372.4.6 Setting the functions.2-382.4.7 Blood pressure manometer.2-402.4.8 Compensated values.2-412.5 Data Screen.2-442.5.1 Accessing the Data screen.2-442.5.2 Data 1.2-452.5.3 Data 2.2-462.5.4 Data 3.2-472.5.5 Data 4.2-482.5.6 Operation hours.2-4922.6 Rinse Screen.2-552.6.1 Screen access and setting procedure.2-552.6.2 Rinse time.2-562.6.3 Pre-rinse.2-582.7 Offline Mode Screen.2-592.7.1 Screen access and setting procedure.2-592.7.2 Dialysate.2-602.7.3 Sound/Display.2-642.7.4 Priming.2-652.7.5 Function 1.2-662.7.6 Function 2.2-682.7.7 Rinse.2-702.7.8 Machine Adjustment.2-713 Alarms and Actions.3-23.1 Types of Alarms(Notices).3-23.1.1 System alarms.3-23.1.2 Alarms.3-23.1.3 Notice.3-33.2 How to Reset Alarms.3-43.2.1 The Recover alarm.3-43.2.2 The Interlock alarm.3-43.2.3 The Lock alarm.3-43.2.4 Notice.3-43.3 Alarm Table.3-53.4 Actions to Take in the Event of a Power Failure.3-723.4.1 When a battery is not installed.3-723.4.2 When a battery(optional)is installed.3-733.5 If you require help.3-743.5.1 Emergency shutdown.3-744 Maintenance and Inspection.4-24.1 Daily Maintenance.4-24.1.1 Cautions for maintenance.4-24.1.2 System body.4-24.1.3 Blood leak detector.4-34.1.4 Concentrate port.4-34.2 Storage.4-44.2.1 Storage conditions.4-434.2.2 Storage environment.4-44.2.3 Charging the battery(optional).4-44.3 Daily Inspection.4-54.3.1 Daily inspection items.4-54.4 Periodic Inspection.4-74.4.1 Frequency and items of periodic inspection.4-74.4.2 Periodic replacement parts.4-74.5 About Our After-Sales Services.4-84.5.1 Calling for repair services.4-84.6 Disposal of the System.4-85 Flowchart.5-24IntroductionThank you very much for purchasing our Single Patient Dialysis System.This system is single patient dialysis system intended for hemodialysis treatment of ESRD patients and should not be used for other purposes.This Operation Manual describes requirements for correct and safe use of the system and is not intended as a guide for performing patient treatment or management.Before attempting to use the system,please read this manual carefully to thoroughly understand its correct and safe operation.Keep this Operation Manual in a safe place so as not to lose it.If the manual is lost,please contact your distributor.Information contained in this manual is subject to change.The product can be degraded or worn over time,which may cause an accident under some circumstances.In order to avoid this,be sure to conduct daily inspection and maintenance as well as periodic inspection.Daily inspection should be performed before each use(See Chapter 4).For details on periodic inspection,please contact your distributor.For the periodic inspection procedure,refer to the separate Periodic Inspection Manual.This system may be used only by properly qualified personnel having received proper education and training under the instructions of a physician thoroughly familiar with the patients condition.Adjustment and repair of this system should be performed by personnel having received proper education and training provided by the manufacturer or distributor according to the procedure described in the Service Manual.5For safe use of the systemContraindications Do not use the system near equipment that emits strong electromagnetic waves or noise such as an MRI device,micro wave surgical unit,radiation device(e.g.X-ray device or CT scanner)and an electrocautery device.Do not use tubing sets with a non-specified size.Use of a tubing set with a non-specified size prevents guaranteed performance of the blood pump,substitution pump and air detectors and may result in a medical accident.The system must not be used for purposes other than hemodialysis.Use the arterial air detector(optional)in the arterial segment tubing set and use the substitution fluid air detector(optional)in the substitution fluid segment tubing set.Do not use them in other tubing sets.Failure to follow this instruction may prevent detection of set amounts of air.Ensure that the tube is at least 100 cm in length between the venous air detector and the patient.Otherwise,air may enter into the vessel and cause a patient health hazard.With no explosion prevention provided,this system must not be used in the presence of flammable anesthetics or other substances with possible explosion hazard.Failure to observe this caution may cause an explosion or fire.Use only anticoagulant in the syringe pump.Nothing other than anticoagulant is assumed.Do not use or leave the system in an active gas environment(including disinfection gas)or high humidity environment.With no air-tight construction,the internal electronic parts may be affected and cause failure.Do not use disinfectants or acid cleaning solutions other than those specified Use of non-specified products may damage the system.6Symbols used in this manualThis manual uses the following symbols to indicate items that require the users attention.Warnings and Cautions provide especially important information about safety.Always follow these instructions.Zk WARNINGA warning indicates a situation that involves hazards and requires special attention in the use of this medical device(Non-compliance of the instruction may result in death or severe injury.)cautionA caution indicates a general precaution in the use of this medical device.(Non-compliance to the instruction may result in injury or only damage to property.)CONFIRMCaution is required although it is not likely to cause a hazard described under/LWARNING or zLCAUTION.ManufacturerManufacturing dateSerial number叵Type B applied part大Caution:See Operation Manual before using the system.AThe used system should be disposed of separately form municipal waste.XCautions for Safety小WARNING-Indications for use This system may be used only by personnel having received proper education and training under the instructions of a physician thoroughly familiar with the patienfs condition in accordance with its Operation Manual.Do not cancel the alarm function during treatment.A patient health hazard may be caused.If the alarm function needs to be canceled for some reason,the operator should be responsible for monitoring the system to avoid alarm conditions.The user is responsible for the use and maintenance of the medical equipment.The user must perform daily and periodic inspections.Using the system in an abnormal state may cause a patient health hazard.The exterior of the system is not waterproofed.Do not expose the system to any liquid.Entry of liquid inside the system may cause a patient health hazard due to a malfunction or halt.Monitor the patient,the system and other concurrently used medical equipment at all times.If any abnormal condition is observed,stop the system(machine)in a safe manner for the patient and take any other appropriate actions.In particular,perform a periodic visual check to confirm that all connectors are securely connected to the extracorporeal circuit.For patients with low body weight such as pediatric patients,pay attention to the volumes of extracorporeal circulation,fluid removed and drugs administered.Blood volume must be strictly controlled.Even a small change in blood volume may cause a patient health hazard.For patients with low body weight such as pediatric patients,body temperature must be strictly controlled.Failure to do so may cause a patient health hazard.During treatment,always lock the casters and do not move the system.A patient health hazard may be caused by blood loss due to disconnection of the tubing set or flow rate errors of the pumps.Be sure to select correct dialysate concentrate Incorrect use may result in hemolysis or otherwise cause a patient health hazard.For bicarbonate dialysis,be careful not to confuse A concentrate with B concentrate.A concentrate for acetate dialysis or bicarbonate dialysis:White/Red B concentrate for bicarbonate dialysis:Blue Do not mistake A concentrate(including acetate concentrate)for B concentrate,Disinfectant(sodium hypochlorite solution)or acid cleaning agent(acetic acid).Check the dialyzer-end dialysate line for precipitate formation.Do not use dialysate fluid with precipitate build-up for treatment.8Special attention should be paid to back filtration.Especially,use of a high-performance membrane with large pores may cause an inflammatory reaction or fever due to bacteria or endotoxin contained in dialysate.Also,interdialytic weight gain may result in complications that cause a patient health hazard such as hvoertension,cardiac failure,oericarditis and water intoxication.1Before connecting the tubing set to the patient,confirm the following(hemolysis,air entry or other events may cause a patient health hazard):For each component of dialysate,confirm that its concentration,pH,osmotic pressure and temperature are normal.Confirm that alarm functions for venous pressure and air detectors are normal.After acid cleaning and chemical disinfection using agents,confirm that the equipment is well rinsed with water to remove all residual acid and disinfectant.Confirm that the dialyzer is replaced by dialysate(including Isolated UF mode).When connecting the tubing set and concurrently used medical equipment,pay attention to the following points.Otherwise,a patient health hazard may be caused by hemolysis,coagulation,blood loss due to inability to measure pressure,air entry due to insufficient clamping,or blood loss due to disconnection of the tubing set.Also,this may damage the system and the concurrently used medical equipment.Securely connect the tubing set to the following parts:Air detectors,clamp,blood pump,substitution pump(optional),pressure ports and tube holders Confirm that tubes are firmly interconnected without kinks,bending,pulling or protrusions.Confirm there is no damage or dirt.Always use a hydrophobic air filter at each pressure port of the system.Be sure to use a new filter if hydrophobic air filters are not provided with the tubing set.Also,observe the following cautions.Otherwise,a patient health hazard may be caused by cross infection,or hemolysis,coagulation,blood loss or other anomalies resulting from inability to measure pressure.If the pressure port is contaminated due to damage to the hydrophobic air filter,inspect and disinfect the internal pressure tubes before use.If the hydrophobic air filter gets wet with blood or fluid,replace it immediately.For syringes to be used,follow the precautions below.Otherwise,desired injection speeds will not be obtained and a patient health hazard may be caused.Confirm that the length between the 0-mL and 10-mL marks of the syringe to be used corresponds to that displayed on the screen.Alarms should be set to appropriate values according to the actual operating conditions under a physicians instructions.In particular,the settings for the venous pressure lower limit alarm should satisfy the following requirements.Failure to follow this instruction may cause blood loss or otherwise cause a patient health hazard.Able to detect blood loss due to disconnection of the venous blood line.Able to detect a decrease in the blood flow rate due to coagulation.During treatment,do not touch the system or concurrently used medical equipment carelessly.Failure to follow this caution may cause false operation and cause a patient health hazard.9While the blood pump,syringe pump and substitution pump(optional)are running,be sure to open or close the tubing as required by using tubing forceps or other appropriate tools.Otherwise,intended blood flow rates are not obtained and a patient health hazard may be caused.Also,this system and the concurrently used medical equipment may be damaged.When running the blood pump at an especially low speed,be careful to prevent coagulation.A patient health hazard may be caused.Before using this system,confirm the contents of the initial settings.Do not use the system in a condition in which the tubing set may cause extremely negative or positive pressure.Using the system in such condition will not assure precise flow rate control and a patient health hazard may be caused.When air detection alarm has occurred,observe the following cautions Air may enter into the patients body:Do not turn OFF the power switch.Do not turn the system OFF from the menu window.To avoid entry of air into vessels when the clamp is opened,use a forceps to clip the part of the blood tubing set below the clamp.If air bubbles are produced or have entered,or if any abnormality is found such as blood leakage,coagulation and hemolysis,take appropriate actions in such a way as to ensure patient safety.During blood return,do not turn OFF the air detectors.Air may enter into the patient body.During priming and rinsing of the dialyzer and the blood line,be sure no air is left inside the dialyzer and the tubi