ri-cardio - QuickMedical
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1. Rated maximum Separation distance according to frequency of transmitter m output power of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800MHz to 2 5GHz W d 3 5 V1 VP d 3 5 E1 VP d 7 E1 VP 0 01 N A 012 028 BE N A 0 38 Owe 1 N A 12 2 9 10 N A 378 7 3 100 N A 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters can be estimated 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 separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people ri cardio rve de modifications Sujeto a modificaciones Con riserva di apportare modifiche Rudolf Riester GmbH P O Box 35 BruckstraBe 31 DE 72417 Jungingen Germany Tel 49 7477 9270 0 Fax 49 7477 9270 70 E Mail info riester de www riester de2. SPHYGMOMANOMETERS ri cardio US mine C 0124 Riester IMPRESSION 03 INTRODUCTION TO AMBULATORY BLOOD PRESSURE MONITORING 04 INTRODUCTION TO THE ri cardio ABD SYSTEM 05 Indication for Use 05 Operation 05 Products and Accessories 06 Specifications 07 SAFETY AND EFFECTIVENESS CONSIDERATIONS 08 WARNINGS AND CONTRAINDICTIONS 10 ri cardio AT A GLANCE SETTING UP THE SYSTEM 13 Hardware Requirements 13 Software Requirements 13 Powering the ri cardio for use 14 Installing the Software 14 CONDUCTING AN AMBULATORY BLOOD PRESSURE STUDY lo Programming the ri cardio for an ABP Study 16 Fitting a patient with the ri cardio and ABP cuff 18 Preparing and educating the patient 20 Starting the Study 21 Finishing the Study 22 TROUBLESHOOTING 24 MAINTAINING AND CLEANING THE ri cardio 25 CHECKING THE CALIBRATION 26 LIMITED WARRANTY 28 INDEX 30 ri cardio ri cardio OVERVIEW IMPRESSION INTRODUCTION TO AMBULATORY BLOOD PRESSURE MONITORING Ambulatory blood pressure monitoring is an accepted clinical tool for collecting multiple blood pressure measurements lt better assists clinicians with the diagnosis and management of hypertension by providing blood pressure variability an estimation of true blood pressure overnight changes in blood pressure and morning surge in blood pressure In clinic and home blood pressure measurements cannot provide the same depth of information that a 24 hour study provides Se
3. a 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 theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the SunTech 222B device is used exceeds the applicable RF compliance level above the Rudolf Riester GmbH 222B 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 Rudolf Riester GmbH 222B device b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m ri cardio Recommended separation distances between portable and mobile RF communications equipment and the SunTech 222B device The Rudolf Riester GmbH 222B device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Rudolf Riester GmbH 222B device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Rudolf Riester GmbH 222B device as recommended below according to the maximum output power of the communications equipment
4. A SINGLE BP READING When the time is dis played press the Start Stop button Time Indicates current time when flashing the monitor will turn off in the next 20 seconds unless an ABP study is started Pressure Indicates the pressure of the cuff in mmHg during a BP reading BD Immediately after a BP reading the display shows the Reading results of the reading if enabled Blood pressure in mmHg followed by heart rate in beats per minute Battery Indicates low battery voltage BATTERIES NEED TO BE REPLACED ri cardio AT A GLANCE SETTING UP THE SYSTEM Installing the Software NOTE If a previous version of ri cardio Software is already installed we recommend backing up any previously collected patient files before upgrading Place the installation CD in the CD drive located on your computer If CD autoplay is enabled on your computer follow the instructions that appear on your 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 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 cardio Software is installed ri cardio SETTING UP THE SYSTEM SETTING UP THE SYSTEM Powering the ri cardio for use Install 2 AA batteries in the bay locat
5. Attach to patient Insert the Bravo into its pouch with the display visible Attach the pouch to the patient using the belt ri cardio ri cardio FITTING FITTING PREPARING AND EDUCATING THE PATIENT When conducting blood pressure measurements including hypertension blood pressure measurements with an oscillometric NIBP device it is important to follow suitable procedures to ensure valid accurate results Preparing your patient for the ABP study is the most important step to achieving a successful test Review the following instructions with your patient e When the pressure in the cuff increases the patient should avoid excess move ment during measurements Let the cuffed arm hang loosely slightly away from the body with the middle of the cuff at heart level Avoid flexing the mus cles or moving the hand and fingers of the cuffed arm e The patient can stop a measurement in progress by pressing the Start Stop button f the keypad is enabled when programmed the patient can start a measure ment at any time by pressing the Start Stop button e Between BP readings the cuff should not be removed e While sleeping the patient should make sure that the hose is not kinked e The batteries can be replaced during a study without the data being lost or interrupting the monitor s program Alternatively the monitor can be turned off without losing its data e Instruct the patient on how and when to fill out the patient diary e
6. Ensure the patient knows how to care for the monitor Keep the monitor dry and do not drop it e f the monitor or cuff causes extreme pain or pain not normally associated with blood pressure measurement the patient should remove the cuff and turn off the monitor ri cardio PREPARING AND EDUCATING e The patient should not talk during the BP measurements e 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 and arms supported Starting the study Before the patient leaves with the monitor and cuff correctly instrumented verify that the monitor operates correctly ri cardio PREPARING AND EDUCATING FINISHING THE STUDY If you wish to finish the study before the patient returns instruct the patient to 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 patient returns take the cuff monitor and belt off Notes on blood pressure data Any blood pressure reading can be affected by the measurement site the position of the patient exercise or the patient s physiologic condition Environmental or operational factors which can affect the performance of the device and or its blood pressure reading are common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation arterial sclerosis poor perfusion diabetes ag
7. G Event Code 85 86 87 88 89 90 91 97 98 99 Description in ri cardio Software Weak or no oscillometric signal Artifact Erratic Oscillometric Signal Exceeded retry count 4 inflate attempts Exceeded measurement time Reading Aborted blocked valves or pneumatics Reading Aborted user abort Reading Aborted inflate time out or air leak Reading Aborted Safety time out Reading Aborted cuff over pressure Service Required power supply out of range or other hardware problem Service Required safety override fitted or autozero out of range Service Required transducer out of range Service Required A D out of range Service Required EEPROM calibration data CRC failure ri cardio TROUBLESHOOTING Solution Check position of cuff tighten cuff Remain still during BP reading Remain still during BP reading Check air hose connections and make certain cuff is tight Check air hose connections anc make certain air tubing is not crimped Push START STOP button to restart readin Check alf hose and NETUS Retry reading push START STOP button If problems persist return unit for servicing Check for blocked or kinked air hose Replace batteries If problem persists return unit for servicing Retry by pushing START STOP button If problems persist return unit for servicing Return for servicing Return for servicin
8. HE CALIBRATION LIMITED WARRANTY ri cardio Ambulatory BP Monitor This limited warranty is void if the instrument has been damaged by accident misuse negligence or serviced by any person not authorized by Rudolf Riester GmbH provides to the original purchaser the following limited Rudolf Riester GmbH warranty from the date of invoice This limited warranty contains the entire obligation of Rudolf Riester GmbH Blood pressure serialized monitor 24 months and no other warranties expressed implied or statutory are given No 90 days representative or employee of Rudolf Riester GmbH is authorized to assume Accessories i e patient hoses interface cables etc any further liability or grant any further warranties except as set herein Cuffs 12 months Rudolf Riester GmbH warrants each instrument to be free from defects in material and workmanship Liability under this warranty covers servicing of the instruments when returned from the customer s facility prepaid to the prospective factory depending on location Rudolf Riester GmbH will repair any component s or part s that it finds to be defective during the period of this limited warranty Should a defect become apparent the original purchas er should notify Rudolf Riester GmbH of the suspected defect The instru ment should be carefully packaged and shipped prepaid to Rudolf Riester GmbH POBox 25 BruckstraBe 31 DE 72417 Jungingen Germany The instrument will be r
9. U guidelines Adverse Reactions Allergic exanthema symptomatic eruption in the area of the cuff may result including the formation of urticaria allergic reaction including raised edematous 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 appears in the skin formation or Rumple Leede phenomenon multiple petechia on the forearm following the application of the cuff which may lead to Idiopathic thrombocytopenia spontaneous persistent decrease in the number of platelets associated with hemorrhagic conditions or phlebitis inflammation of a vein may be observed Meaning of the symbol on the type plate e Caution Observe accompaying documents Start Stop H Latex free PVC free ri cardio SAFETY AND EFFECTIVENESS CONSIDERATIONS WARNINGS AND CONTRAINDICTIONS Precautions for Use This monitor is designed to perform in conformity with the description contained in this manual when operated maintained and repaired in accordance with the instructions provided The monitor should not be modified in anyway Ensure pressure compatibility to all patients If any abnormality occurs in the monitor suspend the operation immediately and disconnect it from the patient If the monitor has been used or stored outside of its acceptable range see Specifications page it may not meet performance specifications I
10. ading Monitor in the menu bar HEN CTR 2 Enter the settings in the form Fig 4 Ende fke Fields are described below E 27 Keypad 3 Programming begins when OK is Fig 4 Enabled will allow the patient to start readings clicked 4 An indicator bar shows the progress as the data is transferred to the Display monitor and disappears when programming is successfully completed Enabled will allow the patient to view the results immediately after a Measurement The test parameters can be adjusted as follows Note Keypad and Display are always enabled for the first 30 minutes of a study Patient name and ID For reporting and referencing data Intervals Start study in 5 minutes Set intervals between programmed readings to Standard for 5 minutes Check denotes that the study will start automatically after programming around selected times or Fixed for exact times 5 and 10 minute intervals are unchecked denotes that the first push of the always exact Start Stop button with unit powered on will start the study Time Periods Time zone difference Up to 3 allowed Adjust the monitor s clock to the time zone that the patient is in relative to your time zone Time Intervals None 5 10 15 20 30 45 60 90 and 120 minute intervals between read ings ri cardio ri cardio PROGRAMMING PROGRAMMING FITTING A PATIENT WITH THE ri cardio AND BLOOD PRESSURE CUFF After you have successfully programmed the ri cardio us
11. e pregnancy pre eclampsia renal diseases patient motion trembling and shivering Before retrieving data from the monitor ensure that the monitor is disconnected from the patient before connecting the ABP monitor to any piece of hardware such as your personal computer To retrieve the data 1 Click on the Retrieve toolbar button or pull down the Monitor menu and select Retrieve Data 2 Communication starts automatically The dialog box on the screen shows the 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 to Saye nre Cea 4 f 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 cardio FINISHING THE STUDY Fig 8 Retrieving data choosing patient Abb 9 Retrieving data patient information The patient s BP data is now saved as a file on your computer The ABP Data tab displays the retrieved data The patient s name ID test date file name and its location are displayed in the status line located at the bottom of the display area NOTE If you do not retrieve data from the monitor this data will be lost when you program it for the next study ri cardio FINISHING THE STUDY TROUBLESHOOTIN
12. ect the PC interface USB cable to the connection site at the bottom of the monitor Fig 1 2 Connect the USB end of the PC interface cable to the USB port on the back of your computer Fig 2 Configuring your computer for communication Installing ri cardio Software will load the driver s for the USB cable Once the cable is connected to the PC ri cardio Software will recognize the cable and auto select it as the connection to the monitor Fig 3 Konfisurationsname Default Hardwareeinstellungen Daten Farben Tagebuchkommentar E Mail Bericht Exportieren Serieller Anschluss COM 1 v ABD Gerat Oscar 2 v Anschluss testen Standard Fig Configure Port ri cardio AMBULATORY BLOOD PRESSURE PROGRAMMING THE ri cardio FOR AN STUDY To prepare the monitor for an ABP berwachungsgerit programmieren ABD Untersuchungsparameter Max Pressure study simply fill out an on screen form 60 to 280 mmHg suggested setting is 30 mmHg above the highest expected to set the parameters for your patient to systolic BP be programmed into the monitor Mon 15Dec2008 0952 i Mon 15 Dec 2008 Pd Zeitunterschied N OT E 1 Select the Program button on the Em o pede Dmm al The ABP monitor will not inflate to Max Pressure with each reading it inflates toolbar or Program study under vor EL II to 30 mmHg above the previous systolic re
13. ed at the back of the monitor The label in the bay shows the orientation in which the batteries should be placed When batteries are properly loaded the monitor s display will show the following Incrementing dashes for two seconds Software and safety version of the monitor Battery voltage for two seconds Three quick beeps The number of BP readings in memory with flashing printer for three seconds ne long beep 7 lime flashing for twenty seconds art QO N The monitor is now ready be used Installing the Software The ri cardio Software components include e ri cardio Software User s Guide e ri cardio Software CD e ri cardio USB cable Place the installation CD in the CD drive located on your computer and follow the instructions appearing on the screen if CD autoplay is enabled on your compter 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 drive Double click the AUTORUN EXE file 4 Follow the instructions on the screen ri cardio SETTING UP THE SYSTEM CONDUCTING AN AMBULATORY BLOOD PRESSURE STUDY Communtication withe the ri cardio To successfully complete an ABP study you need your computer to be able to communicate with your ABP monitor in order to program it and retrieve data from it Connecting the monitor to your computer 1 Conn
14. epaired in the shortest possible time and returned prepaid by the same shipping method as received by the factory ri cardio ri cardio LIMITED WARRANTY LIMITED WARRANTY INDEX ri cardio AT A GLANCE CONDUCTING AN AMBULATORY BLOOD PRESSURE STUDY Programming the ri cardio for an ABP Study Fitting a patient with the ri cardio and cuff Preparing and educating the patient Starting the Study Finishing the Study CHECKING THE CALIBRATION IMPRESSION INTRODUCTION TO AMBULATORY BLOOD PRESSURE MONITORING INTRODUCTION TO THE ri cardio ABD SYSTEM Indication for Use Operation Products and Accessories Specifications INDEX LIMITED WARRANTY ri cardio 0 20 21 22 26 03 04 05 05 05 06 07 30 28 ri INDEX M MAINTAINING AND CLENAING THE ri cardio SAFETY AND EFFECTIVENESS CONSIDERATIONS SETTING UP THE SYSTEM Hardware Requirements Software Requirements Powering the ri cardio for use Installing the Software TROUBLESHOOTING W WARNINGS AND CONTRAINDICTIONS cardio 25 08 1s ds 05 24 Guidance and manufacturer s declaration electromagnetic emissions Guidance and manufacturer s declaration electromagnetic immunity The Rudolf Riester GmbH 222B is intended for use in the electromagnetic The Rudolf Riester GmbH 222B is intended for use in the electromagnetic environment specified below The customer or the user of the The Rudolf Riester e
15. f the cuff fails to deflate the patient should be instructed on its proper and safe removal DO NOT use in the presence of flammable anesthetics this could cause an explosion DO NOT immerse the monitor in any fluid place fluids on top or attempt to clean the unit with any liquid detergents or cleaning agents This may cause an electrical hazard If accidental wetting occurs please return to Rudolf Riester GmbH see Limited Warranty Refer to Maintaining and Cleaning the ri cardio System for care instructions DO NOT remove unit covers The monitor does not contain any user serviceable components DO NOT use the monitor if it has failed its diagnostic self test or if it displays a greater than zero pressure with no cuff attached The values displayed by such a unit may be inaccurate DO NOT use on neonates or children and patients known to be readily susceptible to bruising DO NOT attach the cuff to a limb being used for IV infusions or any other intravascular access therapy or an arterio venous A V shunt The cuff inflation can temporarily block blood flow potentially causing harm to the patient ri cardio WARNINGS AND CONTRAINDICTIONS CAUTION Substitution of a component different from that supplied may result in measurement error Repairs should be undertaken only by personnel trained or authorized by Rudolf Riester GmbH CAUTION f cuff fails to deflate within two and a half minutes instruct the patient on ma
16. g Unit needs to be recalibrated Return for servicing MAINTAINING AND CLEANING THE ri cardio After use it is important to perform preventative maintenance to ensure the safe and efficient operation of the monitor Cleaning after use The ri cardio unit is not sterilizable DO NOT immerse the monitor in any fluid or attempt to clean with any liquid detergents cleaning agents or solvents You may use a soft damp cloth to remove dirt and dust from the monitor If the unit does become immersed in water do not use contact our service 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 Remove the bladder from the cuff before machine washing Wash these items using warm water and a mild detergent if needed hang to dry Maintenance after use Visually 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 Maintenance It is recommended that you check the accuracy of the ri cardio once every two years If needed an authorized Riester service center may need to recalibrate the pressure transducers in the monitor ri cardio MAINTAINING AND CLEANING CHECKING THE CALIBRATION The ri cardio must first be placed into the proper mode Follow the steps below 1 Remove and then replace one of the t
17. ing ri cardio 5 Begin BP reading Software you may begin fitting the patient with the monitor and a blood To verify proper monitor operation ensure that the monitor is on and start pressure cuff Cuffs may be used on either arm a BP reading by pressing the Start Stop button If problems occur review the setup and fitting of the system or consult Troubleshooting for tips 1 Choose the proper cuff size To determine the correct cuff size for your patient wrap the cuff around the patient s upper arm Use the color coded RANGE indicator on the inside of the cuff and the bold INDEX marker to check that the arm circumference falls within the cuff range If the arm is within range this cuff size is correct for your patient If the measurement is outside the RANGE indicator select a new cuff size as indicated by color IMPORTANT Using an incorrect cuff size could result in erroneous and misleading blood pressure measurements 2 Apply the cuff The cuff should be midway between the elbow and shoulder Be sure the ARTERY indicator is over the patient s brachial artery between the bicep and 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 hoses Connect the hoses from the cuff and monitor by twisting the fittings together 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
18. ity The Rudolf Riester GmbH 222B device is intended for use in the electromagnetic environment specified below The customer or the user of the Rudolf Riester GmbH 222B device should assure that it is used in such an environment Immunity test IEC Compliance Electromagnetic 60601 level environment guidance test level Portable and mobile RF communications equipment should be used no closer to any part of the SunTech 222B including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance dis s Conducted RF IEC 61000 4 6 N A N A 3 5 11 80MHz to 800MHz oL 800MHz to 2 56Hz Radiated RF 3V m 3 V m where P is the maximum output ECTS 10002229 771 SONIS power rating of the transmitter 1952 5 in watts W according to the GHz transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol a 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 absorption and reflection from structures objects and people
19. mbH refer to Limited Warranty for contact information ri cardio 24 Hourbloodpressuremonitor ri cardio Software 2 Cuffs Adult and Large Adult Pouch with Belt USB Interfacecable 4 AA Alkaline Batteries User Guide ri cardio PRODUCTS AND ACCESSORIES Method of Measurement Blood Pressure Range Heart Rate Range Accurary International Standards Operating Conditions Power Data Memory Calibration Safety Systems Sampling Periods Size Weight Storage Conditions Data Connection SPECIFICATIONS Oscillometry with step deflation 25 260 mmHg max inflate 280 mmHg 40 200 bpm Clinically validated to ESH International Protocol BHS A A ANSI AAMI SP10 EN 60601 1 EN 60601 2 30 EN 60601 1 2 ENTOG MEN T T0602297P2Non2lnvasiv Sphygmomanometers General Requirements amp Supplementary Requirements For Electro Mechanical BP Measuring Systems AAMI SP10 ES1 category C battery powered Pe Orie Oye 20 95 RH non condensing Two AA alkaline batteries or high capacity rechargeable batteries Flash memory stores up to 250 readings Minimally once every two years Maximum inflation pressure limited to 300 mmHg Auto safety release valve for power failure Maximum BP measurement time limited to less than 140 seconds 3 independently programmable periods 5 10 sina 1205270523240111 Approx 284 g i
20. ncluding batteries G USB RS232 option ri cardio SPECIFICATIONS SAFETY AND EFFECTIVENESS CONSIDERATIONS The following safety and effectiveness issues are to be considered prior to the usage of the ri cardio unit This device is defibrillator protected NOTE No precautions specific to the ri cardio are required during defibrillation and defibrillation discharge has no effect on the ri cardio IVAN e The monitor is intended for use following consultation and instruction by a physician The reliability of the device is dependent upon conformance with the opera tion and service instructions as detailed in this manual This device has been designed for use on patients with normal sinus rhythms The interpretation of blood pressure measurements should only be made by a physician The accuracy of any blood pressure recording may be affected by the position of the subject his or her physical condition and use outside the operating instructions detailed in this manual Safety and effectiveness on pregnant women and neonates have not been tested ri cardio SAFETY AND EFFECTIVENESS CONSIDERATIONS Disposal This symbol indicates that the monitor contains materials such as electrical components which are hazardous Used electrical and electronic devices should not be thrown away with the regular trash but rather should be disposed of separately in accordance with national and or E
21. nual removal of cuff CAUTION Check that operation of the unit does not result in prolonged impairment of the circulation of the patient CAUTION compressed or kinked connection hose may cause continuous cuff pressure resulting in blood flow interference and potentially harmful injury to the patient WARNING Ensure batteries are inserted with the correct polarity Improper installation is a hazard WARNING Too frequent measurements can cause injury to the patient due to blood flow interference WARNING The cuff should not be applied over a wound as this can cause further injury WARNING he cuff should not be placed on the arm on the side of a mastectomy In the case of a double mastectomy use the side of the least dominant arm WARNING Pressurization of the cuff can temporarily cause loss of function of simultaneously used monitoring equipment on the same limb ri cardio WARNINGS AND CONTRAINDICTIONS ri cardio AT A GLANCE START STOP Systolic Diastolic Start Stop POWER ON When the monitor is off press the Start Stop Button button TO POWER OFF When the monitor is on but not taking a reading press and hold the Start Stop button until you hear five quick beeps then release TO ABORT A MEASUREMENT When the monitor is taking a reading and the cuff pressure is displayed press the Start Stop button TO START THE PROGRAMMED ABP STUDY When the time Is flashing press the Start Stop button TO START
22. nvironment specified below The customer or the user of the The Rudolf Riester GmbH 222B should assure that it is used in such an environment GmbH 222B should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance Immunity test IEC 60601 test Compliance Electromagnetic en RF emissions Group 1 The Rudolf Riester GmbH 222B uses NES i D ncs RF energy only for its internal function Electrostatic discharge 6 kV contact 6 kV contact Floors should be Therefore its RF emissions are very E DIEC NS 8 kV air 8 kV air WOOd concrete or low and are not likely to cause any ceramic tile If floors interference in nearby electronic are covered with equipment synthetic material the relative humidity RF emissions N A The Rudolf Riester GmbH 222B uses 1 batteries only and is not connected to nice dicus mans m Electrical fast N A N A Harmonic emissions N A transient burst IEC IEC 6100 3 2 61000 4 4 Voltage fluctuations N A Surge IEC 61000 4 5 N A N A flicker emissions IEC 61000 3 3 Voltage dips short N A N A interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 3 A m 3 A m Power frequency Hz magnetic field IEC magnetic fields 61000 4 8 should be at levels characteristic of a typical commercial or hospital environment ri cardio ri cardio Guidance and manufacturer s declaration electromagnetic immun
23. ures of adult patients 13 years or older It is intended for use as an aid or adjunct to diagnosis and Operation The ri cardio unit is worn by the patient on a waist belt and is connected to a cuff around the non dominant upper arm The cuff is inflated automatically at intervals which can be programmed during setup Blood pressure is measured by the oscillometric method which senses pressure waves in the artery when occluded by pressure in the cuff Measurement of the frequency of the pressure waves enables heart rate to also be measured Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff stethoscope auscultation method within the limits prescribed by the American National Standard Electronic or Automated Sphygmomanometers The Korotkoff sounds heard over the artery below the compression cuff vary in character as the pressure in the cuff is reduced from above systolic toward zero or atmospheric pressure They are divided into phases Phase 1 K1 or systolic begins with the sudden appearance of a faint clear tapping or thumping sound that gradually increases in intensity Phase 5 5 or diastolic begins when silence develops and was used to determine overall efficacy of the ri cardio ri cardio INTRODUCTION Products and Accessories Your ri cardio package should contain the following items If you are missing any item please contact Rudolf Riester G
24. veral studies have shown that ambulatory blood pressure monitoring when compared to clinic or home blood pressure measurements is superior in predicting target organ damage morbid events or cardiovascular risk The data obtained from ambulatory blood pressure monitors is highly accurate and useful for managing a wide variety of hypertensive situations including e White coat hypertension e Resistant hypertension e Masked hypertension e Childhood hypertension e Efficacy of anti hypertensive drug therapy on a 24 hour basis e Nocturnal hypertension e Episodic hypertension and or anxiety disorders e Hypotensive symptoms e Changes in diet and daily routine designed to reduce hypertension e Hypertension in pregnancy 1 Pickering T G Shimbo D amp Haas D 2006 Ambulatory Blood Pressure Monitoring New England Jour nal of Medicine 354 22 2368 2374 2 Marchiando R J amp Elston M P 2003 Automated Ambulatory Blood Pressure Monitoring Clinical Utility in the 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 the hypertensive patient Blood Pressure Monitoring 4 3 181 184 ri cardio INTRODUCTION INTRODUCTION TO THE ri cardio ABD SYSTEM Indication for Use The ri cardio is a non invasive oscillometric blood pressure monitor capable of measuring systolic and diastolic blood press
25. wo AA batteries 2 While the LCD is displaying the dashes press and hold down the START STOP 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 The calibration of the unit can now be checked against a calibrated mercury column 1 Place a t tube part 498 0030 00 between the hose from the monitor and the cuff 2 Wrap the cuff around a suitably sized can or bottle This simulates the upper arm 3 Attach the third end of the T tube intoa 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 250 mmHg Once the pressure has stabilized at this level the LCD should match the mercury column by 2 0 mmHg 5 Check the unit against the column every 50 mmHg from 250 to 50 mmHg and the unit should be within x2 0 mmHg If not the unit needs to be returned to the service department for recalibration or repair ri cardio CHECKING THE CALIBRATION NOTE To return the ri cardio to its normal mode remove and replace one of the batteries The ri cardio does not contain any user serviceable internal parts and should only be opened by an authorized service representative To return for service please send to Rudolf Riester GmbH care of Support and Service ri cardio CHECKING T
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