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SPHYGMOMANOMETERSri-cardioUSER GUIDE0124

IMPRESSION03INTRODUCTION TO AMBULATORY BLOOD PRESSURE MONITORING04INTRODUCTION TO THE ri-cardio ABD-SYSTEMIndication for UseOperationProducts and AccessoriesSpecifications0505050607SAFETY AND EFFECTIVENESS CONSIDERATIONS08WARNINGS AND CONTRAINDICTIONS10ri-cardio AT A GLANCE12SETTING UP THE SYSTEMHardware RequirementsSoftware RequirementsPowering the ri-cardio for useInstalling the Software1313131414CONDUCTING AN AMBULATORY BLOOD PRESSURE STUDYProgramming the ri-cardio for an ABP StudyFitting a patient with the ri-cardio and ABP cuffPreparing and educating the patientStarting the StudyFinishing the Study151618202122TROUBLESHOOTING24MAINTAINING AND CLEANING THE ri-cardio25CHECKING THE CALIBRATION26LIMITED SSION03

INTRODUCTION TO AMBULATORY BLOODPRESSURE MONITORINGINTRODUCTION TO THE ri-cardioABD-SYSTEMAmbulatory blood pressure monitoring is an accepted clinical tool forcollecting multiple blood pressure measurements. It better assists clinicianswith the diagnosis and management of hypertension by providing: bloodpressure variability, an estimation of true blood pressure, overnight changesin blood pressure, and morning surge in blood pressure.1 In-clinic and homeblood pressure measurements cannot provide the same depth of informationthat a 24-hour study provides. Several studies have shown that ambulatoryblood pressure monitoring, when compared to clinic or home blood pressuremeasurements, is superior in predicting target organ damage, morbidevents, or cardiovascular risk.1, 2, 3Indication for UseThe ri-cardio is a non-invasive oscillometric blood pressure monitor capableof measuring systolic and diastolic blood pressures of adult patients (13years or older). It is intended for use as an aid or adjunct to diagnosis andtreatment.The data obtained from ambulatory blood pressure monitors is highlyaccurate and useful for managing a wide variety of hypertensive situationsincluding: White-coat hypertensionResistant hypertensionMasked hypertensionChildhood hypertensionEfficacy of anti-hypertensive drug therapy on a 24-hour basisNocturnal hypertensionEpisodic hypertension and/or anxiety disordersHypotensive symptomsChanges in diet and daily routine designed to reduce hypertensionHypertension in pregnancyOperationThe ri-cardio unit is worn by the patient on a waist belt and is connected toa cuff around the non-dominant upper arm. The cuff is inflated automaticallyat intervals which can be programmed during setup. Blood pressure ismeasured by the oscillometric method which senses pressure waves in theartery when occluded by pressure in the cuff. Measurement of the frequencyof the pressure waves enables heart rate to also be measured.Blood pressure measurements determined with this device are equivalent tothose obtained by a trained observer using the cuff/stethoscope auscultationmethod, within the limits prescribed by the American National Standard,Electronic or Automated Sphygmomanometers.1 The Korotkoff sounds heardover the artery below the compression cuff vary in character as the pressurein the cuff is reduced from above systolic toward zero or atmosphericpressure. They are divided into phases. Phase 1 (K1) or systolic begins withthe sudden appearance of a faint, clear tapping or thumping sound thatgradually increases in intensity. Phase 5 (K5) or diastolic begins when silencedevelops, and was used to determine overall efficacy of the ri-cardio.1. Pickering, T.G., Shimbo, D., & Haas, D. (2006). Ambulatory Blood-Pressure Monitoring. New England Journal of Medicine, 354(22), 2368-2374.2. Marchiando, R.J. & Elston, M.P. (2003). Automated Ambulatory Blood-Pressure Monitoring: Clinical Utility inthe Family Practice Setting. American Femily Physician, 67(11), 2343-2350.3. White, W.B. (1999). Ambulatory blood pressure as a predictor of target organ disease and outcomes in thehypertensive patient. Blood Pressure Monitoring, 4(3), N05

SPECIFICATIONSProducts and AccessoriesYour ri-cardio package should contain the following items. If you aremissing any item please contact Rudolf Riester GmbH (refer to LimitedWarranty, for contact information)ri-cardio 24-Hourbloodpressuremonitorri-cardio SoftwareMethod ofMeasurement:Oscillometry with step deflationBlood Pressure Range:25-260 mmHg (max inflate 280 mmHg)Heart Rate Range:40-200 bpmAccurary:Clinically validated to ESH InternationalProtocol, BHS (A/A), ANSI/AAMI (SP10)InternationalStandards:EN 60601-1, EN 60601-2-30,EN 60601-1-2 (EMC),EN 1060-1, EN 1060-3, “Non-InvasiveSphygmomanometers -General Requirements&Supplementary Requirements For ElectroMechanical BP Measuring Systems”, AAMISP10 ES1 category C’ (battery powered)Operating Conditions:10 C (50 F) to 50 C (122 F)20-95% RH non-condensingPower:Two “AA” alkaline batteries or high capacityrechargeable batteries (NiMH)Data Memory:Flash memory stores up to 250 readingsCalibration:Minimally, once every two yearsSafety Systems:Maximum inflation pressure limited to 300mmHg; Auto safety release valve for powerfailure; Maximum BP measurement time limitedto less than 140 secondsSampling Periods:3 independently programmable periods (5, 10,15, 20, 30, 45, 60, 90 and 120 minutes)Size:120 x 70 x 32 mmWeight:Approx 284 g (including batteries)Storage Conditions:-20 C bis 65 C, 15%-90% RF non-condensingData Connection:USB (RS232-option)2 Cuffs (Adult and Large Adult)Pouch with BeltUSB Interfacecable4 AA Alkaline BatteriesUser Guideri-cardioPRODUCTS AND ACCESSORIES06ri-cardioSPECIFICATIONS07

SAFETY AND EFFECTIVENESSCONSIDERATIONSThe following safety and effectiveness issues are to be considered prior tothe usage of the ri-cardio unit. This device is defibrillator protected.DisposalThis symbol indicates that the monitor contains materials (such as electricalcomponents) which are hazardous. Used electrical and electronic devicesshould not be thrown away with the regular trash but rather should bedisposed of separately in accordance with national and/or EU guidelines.NOTE:No precautions specific to the ri-cardio are required during defibrillation,and defibrillation discharge has no effect on the ri-cardio. The monitor is intended for use following consultation and instruction by aphysician. The reliability of the device is dependent upon conformance with the operation and service instructions, as detailed in this manual.Adverse ReactionsAllergic exanthema (symptomatic eruption) in the area of the cuff mayresult, including the formation of urticaria (allergic reaction including raisededematous patches of skin or mucous membranes and intense itching)caused by the fabric material of the cuff.Petechia (a minute reddish or purplish spot containing blood that appearsin the skin) formation or Rumple-Leede phenomenon (multiple petechia) onthe forearm following the application of the cuff, which may lead to Idiopathicthrombocytopenia (spontaneous persistent decrease in the number ofplatelets associated with hemorrhagic conditions) or phlebitis (inflammationof a vein) may be observed. This device has been designed for use on patients with normal sinusrhythms.Meaning of the symbol on the type plateCaution! Observe accompaying documents! The interpretation of blood pressure measurements should only be madeby a physician. The accuracy of any blood pressure recording may beaffected by the position of the subject, his or her physical condition, anduse outside the operating instructions detailed in this manual.StartStop Safety and effectiveness on pregnant women and neonates have not beentested.Latex-freePVCri-cardioSAFETY AND EFFECTIVENESS CONSIDERATIONS08PVC-freeri-cardioSAFETY AND EFFECTIVENESS CONSIDERATIONS09

WARNINGS AND CONTRAINDICTIONSPrecautions for UseThis monitor is designed to perform in conformity with the description containedin this manual when operated, maintained and repaired in accordance withthe instructions provided. The monitor should not be modified in anyway.Ensure pressure compatibility to all patients. If any abnormality occurs in themonitor, suspend the operation immediately and disconnect it from the patient.If the monitor has been used or stored outside of its acceptable range (seeSpecifications page), it may not meet performance specifications. If the cuff failsto deflate, the patient should be instructed on its proper and safe removal.CAUTION: Substitution of a component different from that supplied may result inmeasurement error. Repairs should be undertaken only by personnel trained orauthorized by Rudolf Riester GmbH.DO NOT use in the presence of flammable anesthetics; this could cause anexplosion.CAUTION: A compressed or kinked connection hose may cause continuous cuffpressure resulting in blood flow interference and potentially harmful injury to thepatient.DO NOT immerse the monitor in any fluid, place fluids on top, or attempt toclean the unit with any liquid detergents or cleaning agents. This may cause anelectrical hazard. If accidental wetting occurs, please return to Rudolf RiesterGmbH (see Limited Warranty). Refer to Maintaining and Cleaning the ri-cardioSystem, for care instructions.DO NOT remove unit covers. The monitor does not contain any user serviceablecomponents.DO NOT use the monitor if it has failed its diagnostic self test, or if it displays agreater than zero pressure with no cuff attached. The values displayed by such aunit may be inaccurate.DO NOT use on neonates or children, and patients known to be readilysusceptible to bruising.CAUTION: If cuff fails to deflate within two and a half minutes, instruct thepatient on manual removal of cuff.CAUTION: Check that operation of the unit does not result in prolongedimpairment of the circulation of the patient.WARNING: Ensure batteries are inserted with the correct polarity. Improperinstallation is a hazard.WARNING: Too frequent measurements can cause injury to the patient due toblood flow interference.WARNING: The cuff should not be applied over a wound as this can causefurther injury.WARNING: The cuff should not be placed on the arm on the side of amastectomy. In the case of a double mastectomy use the side of the leastdominant arm.WARNING: Pressurization of the cuff can temporarily cause loss of function ofsimultaneously used monitoring equipment on the same limb.DO NOT attach the cuff to a limb being used for IV infusions or any otherintravascular access, therapy or an arterio-venous (A-V) shunt. The cuff inflationcan temporarily block blood flow, potentially causing harm to the patient.ri-cardioWARNINGS AND CONTRAINDICTIONS10ri-cardioWARNINGS AND CONTRAINDICTIONS11

ri-cardio AT A :TO POWER ON: When the monitor is off, press the Start/Stopbutton.TO POWER OFF: When the monitor is on but not taking areading, press and hold the Start/Stop button until you hearfive quick beeps, then release.TO ABORT A MEASUREMENT: When the monitor is taking areading and the cuff pressure is displayed, press the Start/Stop button.TO START THE PROGRAMMED ABP STUDY: When the timeis flashing, press the Start/Stop button.TO START A SINGLE BP READING: When the time is displayed, press the Start/Stop button.Time:Indicates current time; when flashing, the monitor will turnoff in the next 20 seconds unless an ABP study is started.Pressure:Indicates the pressure of the cuff in mmHg during a BPreading.BDReading:Immediately after a BP reading, the display shows theresults of the reading if enabled. Blood pressure in mmHgfollowed by heart rate in beats per minute.Battery:Indicates low battery voltage; BATTERIES NEED TO BEREPLACED.ri-cardioAT A GLANCE12SETTING UP THE SYSTEMInstalling the SoftwareNOTE:If a previous version of ri-cardio Software is already installed, werecommend backing up any previously collected patient files beforeupgrading.Place the installation CD in the CD drive located on your computer. If CDautoplay is enabled on your computer, follow the instructions that appear onyour screen.If autoplay is not enabled, follow these steps:1. Open Windows Explorer or Windows NT Explorer (Press the Windows “Start” button and find “My Computer” or “Computer”).2. Click on the CD drive.3. Double-click the AUTORUN.EXE file.4. Follow the instructions on the screen.NOTE:The USB cable should not be connected to the computer before ri-cardioSoftware is installed.ri-cardioSETTING UP THE SYSTEM13

SETTING UP THE SYSTEMCONDUCTING AN AMBULATORY BLOODPRESSURE STUDYPowering the ri-cardio for useInstall 2 AA batteries in the bay located at the back of the monitor. The labelin the bay shows the orientation in which the batteries should be placed.When batteries are properly loaded, the monitor’s display will show thefollowing:Communtication withe the ri-cardioTo successfully complete an ABP study, you need your computer to be able tocommunicate with your ABP monitor in order to program it and retrieve datafrom it.1.2.3.4.5.Incrementing dashes for two secondsSoftware and safety version of the monitorBattery voltage for two secondsThree quick beepsThe number of BP readings in memory with flashing printer for threeseconds6. One long beep7. Time flashing for twenty secondsConnecting the monitor to your computer1. Connect the PC interface USB cable to the connection site at the bottom ofthe ABP monitor (Fig. 1).2. Connect the USB end of the PC interface cable to the USB port on the backof your computer (Fig. 2).Configuring your computer for communicationInstalling ri-cardio Software will load the driver(s) for the USB cable. Oncethe cable is connected to the PC, ri-cardio Software will recognize the cableand auto-select it as the connection to the monitor (Fig. 3).The monitor is now ready to be used.Installing the SoftwareThe ri-cardio Software components include: ri-cardio Software User s Guide ri-cardio Software CD ri-cardio USB cableFig. 1Fig. 2Place the installation CD in the CD drive located on your computer and followthe instructions appearing on the screen if CD autoplay is enabled on yourcomputer.If autoplay is not enabled, follow these steps:1. Open Windows Explorer or Windows NT Explorer (Press the Windows“Start” button and find “My Computer”)2. Click on the CD drive3. Double click the AUTORUN.EXE file4. Follow the instructions on the screenri-cardioSETTING UP THE SYSTEM14Fig. 3: Configure Portri-cardioAMBULATORY BLOOD PRESSURE15

PROGRAMMING THE ri-cardio FOR AN ABPSTUDYTo prepare the monitor for an ABPstudy, simply fill out an on-screen formto set the parameters for your patient tobe programmed into the monitor.1. Select the Program button on thetoolbar or Program study underMonitor in the menu bar.2. Enter the settings in the form (Fig. 4).Fields are described below.3. Programming begins when OK isFig. 4clicked.4. An indicator bar shows the progress as the data is transferred to themonitor and disappears when programming is successfully completed.The test parameters can be adjusted as follows:Max Pressure:60 to 280 mmHg; suggested setting is 30 mmHg above the highest expectedsystolic BP.NOTE:The ABP monitor will not inflate to Max Pressure with each reading; it inflatesto 30 mmHg above the previous systolic reading.Keypad:Enabled will allow the patient to start readings.Display:Enabled will allow the patient to view the results immediately after ameasurement.Note:Keypad and Display are always enabled for the first 30 minutes of a study.Patient name and ID:For reporting and referencing data.Start study in 5 minutes:Check denotes that the study will start automatically after programming;unchecked denotes that the first push of theStart/Stop button with unit powered on will start the study.Time zone difference:Adjust the monitor’s clock to the time zone that the patient is in relative toyour time zone.ri-cardioPROGRAMMING16Intervals:Set intervals between programmed readings to Standard for /- 5 minutesaround selected times or Fixed for exact times. 5 and 10 minute intervals arealways exact.Time Periods:Up to 3 allowed.Time Intervals:None, 5, 10, 15, 20, 30, 45, 60, 90 and 120-minute intervals between readings.ri-cardioPROGRAMMING17

FITTING A PATIENT WITH THE ri-cardioAND BLOOD PRESSURE CUFFAfter you have successfully programmed the ri-cardio using ri-cardioSoftware, you may begin fitting the patient with the monitor and a bloodpressure cuff. Cuffs may be used on either arm.5. Begin BP readingTo verify proper monitor operation, ensure that the monitor is on and starta BP reading by pressing the Start/Stop button. If problems occur, reviewthe setup and fitting of the system or consult Troubleshooting for tips.1. Choose the proper cuff sizeTo determine the correct cuff size for your patient, wrap the cuff aroundthe patient’s upper arm. Use the color-coded RANGE indicator onthe inside of the cuff and the bold INDEX marker to check that the armcircumference falls within the cuff range. If the arm is within range,this cuff size is correct for your patient. If the measurement is outside theRANGE indicator, select a new cuff size as indicated by color.IMPORTANT:Using an incorrect cuff size could result in erroneous and misleading bloodpressure measurements.2. Apply the cuffThe cuff should be midway between the elbow and shoulder. Be sure theARTERY indicator is over the patient’s brachial artery, between the bicepand tricep muscles. Wrap the cuff snugly around the patient’s upper arm.Please make sure that the arm is inserted through the cuff.3. Connect the hosesConnect the hoses from the cuff and monitor by twisting the fittingstogether until you hear a snap. Drape the hose over the patient’s shoulder,around the neck and across the opposite side of the body.4. Attach to patientInsert the Bravo into its pouch with the display visible. Attach the pouch tothe patient using the belt.ri-cardioFITTING18ri-cardioFITTING19

PREPARING AND EDUCATING THE PATIENTWhen conducting blood pressure measurements, including hypertensionblood pressure measurements, with an oscillometric NIBP device, it isimportant to follow suitable procedures to ensure valid, accurate results.Preparing your patient for the ABP study is the most important step toachieving a successful test. Review the following instructions with yourpatient. The patient should not talk during the BP measurements. When the pressure in the cuff increases, the patient should avoid excess movement during measurements. Let the cuffed arm hang loosely, slightly awayfrom the body with the middle of the cuff at heart level. Avoid flexing the muscles or moving the hand and fingers of the cuffed arm.Starting the studyBefore the patient leaves with the monitor and cuff correctly instrumented,verify that the monitor operates correctly. The patient should be seated, standing or lying down. If the patient is seated,they should have their legs uncrossed, feet flat on the floor with their back andarms supported. The patient can stop a measurement in progress by pressing the Start/Stopbutton. If the keypad is enabled when programmed, the patient can start a measurement at any time by pressing the Start/Stop button. Between BP readings the cuff should not be removed. While sleeping, the patient should make sure that the hose is not kinked. The batteries can be replaced during a study without the data being lost orinterrupting the monitor’s program. Alternatively, the monitor can be turnedoff without losing its data. Instruct the patient on how and when to fill out the patient diary. Ensure the patient knows how to care for the monitor. Keep the monitor dryand do not drop it. If the monitor or cuff causes extreme pain or pain not normally associated withblood pressure measurement, the patient should remove the cuff and turn offthe monitor.ri-cardioPREPARING AND EDUCATING20ri-cardioPREPARING AND EDUCATING21

FINISHING THE STUDYIf you wish to finish the study before the patient returns, instruct the patientto turn off the monitor by holding down the Start/Stop button for 5 seconds.The Bravo will beep 5 times and the display will turn off. When the patientreturns, take the cuff, monitor, and belt off.Notes on blood pressure dataAny blood pressure reading can be affected by the measurement site, theposition of the patient, exercise, or the patient’s physiologic condition.Environmental or operational factors which can affect the performance of thedevice and/or its blood pressure reading are common arrhythmias such asatrial or ventricular premature beats or atrial fibrillation, arterial sclerosis,poor perfusion, diabetes, age, pregnancy, pre-eclampsia, renal diseases,patient motion, trembling, and shivering.Before retrieving data from the monitor, ensure that the monitor isdisconnected from the patient before connecting the ABP monitor to anypiece of hardware such as your personal computer.To retrieve the data1. Click on the Retrieve toolbar button, or pull down the Monitor menu andselect Retrieve Data.Fig. 8: Retrieving data, choosingpatientAbb. 9: Retrieving data, patientinformationThe patient’s BP data is now saved as a file on your computer. The ABP Datatab displays the retrieved data. The patient’s name, ID#, test date, file nameand its location are displayed in the status line located at the bottom of thedisplay area.NOTE:If you do not retrieve data from the monitor, this data will be lost when youprogram it for the next study.2. Communication starts automatically. The dialog box on the screen showsthe progress as the data is transferred.3. After completion, a dialog box asks if this is a new patient. If you click No,a list of current patient files will appear (Fig. 8). Select the patient file tosave the retrieved data.4. If you click Yes, the Patient information dialog box (Fig. 9) will appear.Enter patient information in the data fields.5. Click the OK button to save the data.ri-cardioFINISHING THE STUDY22ri-cardioFINISHING THE STUDY23

TROUBLESHOOTINGEvent Description inCode ri-cardio Software:1Weak or no oscillometric signalCheck position of cuff, tighten cuff.2Artifact/Erratic OscillometricSignalRemain still during BP reading.3Exceeded retry count(4 inflate attempts)Remain still during BP reading.4Exceeded measurement timeCheck air hose connections and makecertain cuff is tight.85Reading Aborted(blocked valves or pneumatics)Check air hose connections and makecertain air tubing is not crimped.86Reading Aborted (user abort)Push START/STOP button to restartreadin87Reading Aborted(inflate time-out or air leak)Check air hose and cuff.88Reading Aborted (Safety time-out)Retry reading, push START/STOPbutton. If problems persist, return unitfor servicing.89Reading Aborted (cuff overpressure)Check for blocked or kinked air hose.90Service Required(power supply out-of-range orother hardware problem)Replace batteries. If problem persists,return unit for servicing.91Service Required(safety override fitted or autozeroout-of-range)Retry by pushing START/STOP button.If problems persist, return unit forservicing97Service Required(transducer out-of-range)Return for servicing.98Service Required(A/D out-of-range)Return for servicing.99Service Required(EEPROM calibration data CRCfailure)Unit needs to be recalibrated. Returnfor AINING AND CLEANING THEri-cardioAfter use, it is important to perform preventative maintenance to ensure thesafe and efficient operation of the monitor.Cleaning after useThe ri-cardio unit is not sterilizable. DO NOT immerse the monitor in anyfluid, or attempt to clean with any liquid detergents, cleaning agents, orsolvents. You may use a soft, damp cloth to remove dirt and dust from themonitor. If the unit does become immersed in water, do not use; contact ourservice department.You may use a mild disinfectant solution to clean the cuff, belt, and pouch.Alternatively, you may also wash these items in a washing machine. Removethe bladder from the cuff before machine washing. Wash these items usingwarm water and a mild detergent; if needed, hang to dry.Maintenance after useVisually inspect cables, pneumatic hoses, and the monitor case for cracks,fraying, or kinks. DO NOT use the monitor if there are any signs of damage.Please contact our service department.MaintenanceIt is recommended that you check the accuracy of the ri-cardio once everytwo years. If needed, an authorized Riester service center may need torecalibrate the pressure transducers in the monitor.ri-cardioMAINTAINING AND CLEANING25

CHECKING THE CALIBRATIONThe ri-cardio must first be placed into the proper mode. Follow the stepsbelow:1. Remove and then replace one of the two “AA” batteries.2. While the LCD is displaying the dashes, press and hold down the STARTSTOP key.3. The unit will display the software version.4. The unit will display the battery voltage.5. You will then hear a click as the valves are closed.6. You will now see “0 mmHg” displayed.NOTE:To return the ri-cardio to its normal mode, remove and replace one of thebatteries.The ri-cardio does not contain any user serviceable internal parts andshould only be opened by an authorized service representative. To return forservice, please send to Rudolf Riester GmbH, care of Support and Service.The calibration of the unit can now be checked against a calibrated mercurycolumn.1. Place a t-tube (part #98-0030-00) between the hose from the monitor andthe cuff.2. Wrap the cuff around a suitably sized can or bottle. This simulates theupper arm.3. Attach the third end of the “T” tube into a calibrated mercury column,which gives you access to the bulb and a reference.4. Using the bulb of the calibrated mercury column, inflate the cuff to 250mmHg. Once the pressure has stabilized at this level, the LCD shouldmatch the mercury column by 2.0 mmHg.5. Check the unit against the column every 50 mmHg from 250 to 50 mmHgand the unit should be within 2.0 mmHg. If not, the unit needs to bereturned to the service department for recalibration or repair.ri-cardioCHECKING THE CALIBRATION26ri-cardioCHECKING THE CALIBRATION27

LIMITED WARRANTYri-cardio Ambulatory BP MonitorRudolf Riester GmbH provides to the original purchaser the following limitedwarranty from the date of invoice.Blood pressure serialized monitorAccessories (i.e. patient hoses, interface cables, etc.)Cuffs24 months90 days12 monthsThis limited warranty is void if the instrument has been damaged byaccident, misuse, negligence, or serviced by any person not authorized byRudolf Riester GmbH.This limited warranty contains the entire obligation of Rudolf Riester GmbH,and no other warranties expressed, implied, or statutory are given. Norepresentative or employee of Rudolf Riester GmbH is authorized to assumeany further liability or grant any further warranties except as set herein.Rudolf Riester GmbH warrants each instrument to be free from defects inmaterial and workmanship. Liability under this warranty covers servicing ofthe instruments when returned from the customer’s facility prepaid to theprospective factory depending on location. Rudolf Riester GmbH will repairany component(s) or part(s) that it finds to be defective during the period ofthis limited warranty. Should a defect become apparent, the original purchaser should notify Rudolf Riester GmbH of the suspected defect. The instrument should be carefully packaged and shipped prepaid to:Rudolf Riester GmbHP.O. Box 35Bruckstraße 31DE - 72417 JungingenGermanyThe instrument will be repaired in the shortest possible time and returnedprepaid by the same shipping method as received by the factory.ri-cardioLIMITED WARRANTY28ri-cardioLIMITED WARRANTY29

INDEXACILri-cardio AT A GLANCE12CONDUCTING AN AMBULATORY BLOOD PRESSURE STUDYProgramming the ri-cardio for an ABP StudyFitting a patient with the ri-cardio and ABP cuffPreparing and educating the patientStarting the StudyFinishing the Study151618202122CHECKING THE CALIBRATION2630STIMPRESSION03INTRODUCTION TO AMBULATORY BLOOD PRESSUREMONITORING04INTRODUCTION TO THE ri-cardio ABD-SYSTEMIndication for UseOperationProducts and AccessoriesSpecifications0505050607INDEX30LIMITED WARRANTY28ri-cardioINDEXMWMAINTAINING AND CLENAING THE ri-cardio25SAFETY AND EFFECTIVENESS CONSIDERATIONS08SETTING UP THE SYSTEMHardware RequirementsSoftware RequirementsPowering the ri-cardio for useInstalling the Software1313131414TROUBLESHOOTING24WARNINGS AND CONTRAINDICTIONS10ri-cardioINDEX31

Guidance and manufacturer’s declaration – electromagnetic emissionsThe Rudolf Riester GmbH 222B is intended for use in the electromagneticenvironment specified below. The customer or the user of the The Rudolf RiesterGmbH 222B should assure that it is used in such an environment.The Rudolf Riester GmbH 222B is intended for use in the electromagneticenvironment specified below. The customer or the user of the The Rudolf RiesterGmbH 222B should assure that it is used in such an environment.Emissions testComplianceElectromagnetic environment – guidanceImmunity testRF emissionsCISPR 11Group 1The Rudolf Riester GmbH 222B usesRF energy only for its internal function.Therefore, its RF emissions are verylow and are not likely to cause anyinterference in nearby electronicequipment.IEC 60601 testlevelCompliancelevelElectromagnetic environment – guidanceElectrostatic discharge(ESD) IEC 61000-4-2 6 kV contact 8 kV air 6 kV contact 8 kV airRF emissionsCISPR 11N/AThe Rudolf Riester GmbH 222B usesbatteries only and is not connected tomains.Floors should bewood, concrete orceramic tile. If floorsare covered withsynthetic material,the relative humidityshould be at least30%.Harmonic emissionsIEC 6100-3-2N/AElectrical fasttransient/burst IEC61000-4-4N/AN/AVoltage fluctuations/flicker emissions IEC61000-3-3N/ASurge IEC 61000-4-5N/AN/AVoltage dips, shortinterruptions andvoltage variations onpower supply inputlines IEC 61000-4-11N/AN/APower frequency (50/60Hz) magnetic field IEC61000-4-83 A/m3 A/mri-cardio32Guidance and manufacturer’s declaration – ele

The ri-cardio is a non-invasive oscillometric blood pressure monitor capable of measuring systolic and diastolic blood pressures of adult patients (13 years or older). It is intended for use as an aid or adjunct to diagnosis and treatment. Operation

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