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VP-1000 Operation Manual - Omron Healthcare Australia

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1. FAP Connector for the FAP sensor CAP Connector for the CAP sensor API Connector for the API unit Power switch Leave it ON To turn power on or off use the main power switch on the stand Refer to page 28 for its location E Fuse Please contact your local distributor when fuses are blown AC Inlet Connect the power cord Please be sure to turn off the main power switch before removing AAC AUTION or connecting each unit and sensors Not doing so may cause elec tric shock or device failure Outline 23 Meaning of the Symbols Meaning of the symbols on the front panel LZ I Measurement START switch NA Q Measurement STOP switch A Alarm mute Meaning of the symbols on the rear and side panel A Refer to manual EN Type BF Classification by leakage current levels with defibrillation protection Type CF Classification by leakage current levels with defibrillation protected Class Equipment BRACHIAL CUFF INPUT OUTPUT ivl or Compact Fllash memory card Qc Qe 24 Outline Jog Dial and Function Switch Jog dial can be turned and pushed to select and edit Tv Turn and Push Start Switch Stop Switch The function switch s operation is as labeled on LCD screen ID 1234 5678 x 2 8 4 5 6 7 Be e How to input ID Select the numerals by rotating the jog dial T
2. 88 Cannot Print Correctly aereo it deeem ev ED acie incase QUE RI REIS DURO Ue IEEE Ree rues veis 88 low MVITIDMIMC C M Sedaaa 88 About Maintenance a ooo aeree D eredi node ra CR ea Uv RR RE d Ree 96 Lt 97 Maintenance Of the DevIce zm treten oa vets redes ee risa ise E Cen ibn nd se ne RT Ia en AETERNA 98 Cleaning of Sensors Attacliments n ndr e nice ED IRAE Redde CLERO REENE Eneias 99 Cuff dEID MEE 100 Technical Specification of BP 203RPEIL 2 6 Itera e teen ERE e catcoeesdvageatans 101 Technical Specific tions of FU 100 1 5 01 ies perti re Eee tp E REED ER TAEAKE NiE Terai 103 Before Use 2 Before Use Omron Healthcare Co would like to thank you for purchasing this unit This device provides indices of PWV pulse wave velocity ABI ankle bra chial index pulse waveforms mecanocardiogram and PCG to support early detection and diagnosis of arteriosclerosis The device you have purchased is comprised of the following components VP 2000 BP 203RPE II Non invasive Vascular Screening Device TU 100 Pulse Wave Unit ST 200A Trolley VP 1000 BP 203RPE II ST 100A Trolley The VP 2000 includes a TU 100 pulse wave unit check that the carotid arterial tonometric sensor and the femoral arterial tonometric sensor are included as components Please be sure to
3. Post Exer Mode Measurement Procedure 73 74 a Blood pressure data when there was no measurement the display will show When the measurement could not be taken the error message will be displayed The error message will also be indicated on the printout page 73 b ABI data the higher brachial systolic BP will be used for the calculation when both arms are measured c Pulse rate the pulse rate is obtained from the brachial cuff Right d This is the result of the analysis hcPWV is displayed at PWV e Select Post Exer mode by the function switch to start ABI measurement after the exer cise test page 57 f Synchronized measurement line this line indicates that all the four blood pressures were taken at the same phase which means that all the systolics were measured at the same time This line will be not shown when all BPs were not measured at the same phase e g upon on cuff measurement retry g The test result will be printed once automatically after the measurement Select PRINT by the function switch when you need additional copies mm ndicates before the measurement or the measurement has failed 3 4 5 Blue back and yellow number indicates that the measurement is outside of the range listed un der Specifications Caution Take actions immediately when following alarms set off during measurement 1 R Wave Not Detected HR o
4. 3 When the measurement is finished the results are displayed on the screen and the results are printed out If No of Print is turned OFF no printing will be performed Results will be displayed on the screen only See User Setting No of Print page 82 For the layout of the results screen see page 53 For the layout of the inspection results sheet see Printing page 54 Measurement Procedure 51 B Printing additional results Use the jog dial to select the print sheet type from the results screen then press Print F3 HR 64 bbm bpm SYS MAP DIA ABI baPWV HR bpm Right Brachial 125 105 94 56 Left Brachial 124 103 92 Right Ankle 125 104 94 129 1271 BP mmHg Left Ankle 144 116 95 115 1287 PWV en g R Bra baPWV cm g R Ank 9 L Ank Alli 2400 L Bra 2200 AU 2000 R Ank 1800 AU 1600 LAnk 1400 i 1208 FM 1000 800 0 5 07 09 11 L3 L5ABI Post Exer Mode Note W When performing the recovery measurement after the continuous exercise measurement press Post Exer Mode F1 For details see Exercise Measurement page 57 4 To end the measurement press Stop Switch Returns to the screen after the measurement In case of ABI measurement R Bra Prs input ID or patient personal information and place the brachial cuff L Bra Pre and the
5. JOG Dial Start SW A S SW KL v gt lt AER mute SW SES c jFunction SW C2 2 S a HF PCG Sensor X p r CAP sensor FAP sensor Main Unit TU 100 is a optional unit for VP 1000 Color LCD i Printer Outline 21 Main unit rear view Connector for the ECG cable Connector for the PCG sensor Connector to the API unit Connector for the printer cable RS 232 Serial communication port Power switch Always leave it On AC Inlet Connector for AC power cord E F Fuse Please contact our customer service center when fuses are blown API unit rear view PPG R Connector for the PPG R sensor as an option PPG L Connector for the PPG L sensor as an option TU Connector to the TU 100 SB Connector for the L R ankle cuff signal cable M Connector to the main unit RA Connector for the right brachial cuff hose LA Connector for the left brachial cuff hose SB Connector for the L R ankle cuff hose Power switch Leave it ON AC Inlet Connector for AC power cord E Fuse Please contact our customer service center when fuses are blown Power switch To turn power on or off use the main power switch on the trolley Refer to page 19 for its location 22 Outline TU 100 rear view
6. Stress Meas Start Measurement Procedure 59 11 Press Screen F2 to display the list screen For details on displaying this screen see Screen Display During Measurement page 61 ECG OK PCG OK d R Bra Press 0 CM LUC ANM R Ank Press b Do ERN L Ank Press DO ao 0 mi Stress Meas Start 12 Check the RR recovery ratio value If it exceeds 1 0 measurement will end Press Meas End F3 ECG OK PCG OK HR 56 bpm Interval 103 sec Auto R Bra Press elap Time RB LB RA LA mh PCG time hh mm Sys svs svs ag RR svs AB RR r ga Press 0000 09 31 159 158 108 0 68 101 0 64 1 09 40 192 t89 47 0 24 0 35 3 7 0 19 0 30 0 iB 2 09 41 165 166 64 0 39 0 57 3 9 0 23 0 36 mi R Ank Press R Ank mmHg L Ank Press Stress Screen Meas End 13 Press End F2 When measurement ends the measurement results recovery ratio will be printed Wi For details about recovery ratio see Example of printout page 63 60 Measurement Procedure Screen Display During Measurement During measurement you can display results on the n
7. During operation check regularly if the unit is working properly This unit and the accessories are precision instruments In case of high impact only use it after confirming problem free operation Do not tilt more than 10 degrees It may topple over and cause injury Heart Rate meters may continue to count the pacemaker rate during accurrenc es of cardiac arrest or some arrhythmias Do not rely entirely upon rate meter alarm Keep pacemaker patient under close surveillance See this manual for disclosure of the pacemaker pulse rejection capability of instrument Do not connect any electric device that does not meet the standard of IEC60601 1 or not fulfilling IEC60601 1 1 Neglecting this caution could cause electric shock to the device For the use of a PC or a printer with this device the connecting device should be approved according to standards mentioned above This unit meets the restricted level of leakage current required for medical devices and it does not include all the connected devices Connecting to other device is not allowed unless the total leakage current of such a combination is within the restricted level o ooeeee AA Before Use 5 WARNINGS and CAUTIONS for Safe Measurement A Patient must meet following conditions M Height 120 210 cm BM Circumference of arm 16 38 cm B Circumference of ankle 17 33 cm Measurements may not be valid for a patient who is using a pace maker
8. Display of the The unit displays an NIBP oscillation graph after each measurement Oscillation Graph Change Patterns E Ru Tem of Pulses bum A E S Pulse Absolute Amplitude DE A of th e Os cill ati on Post Exer Mode Remeas Print Validation with the The reliability of measurement results can be checked based on the display of the graphic Graphic Waveform Change Patterns of Pulses waveforms If there are any doubts about measurement results check the graphic waveforms Good Measurement The display below is a mountain shape and reliability of the measurement is high without noise such as motion artifact Low Reliability of The display below is not mountain shaped Noise motion artifact has interfered with the Measurement measurement S 3 Signal that can be considered as noise From the graphic waveform it can be considered that the blood pressure reading was faulty Outline 15 Outline of TU 100 only for VP 2000 About the product The TU 100 is a device that uses the tonometry method to measure pulse waveforms Connect it to the BP 203RPEII for operation Pulse wave detec The TU 100 and tonometric sensors employ the tonometry method for pulse wave detection tion By the tonometric method the pressure pulse wave sensor pushes on the artery so an area of the artery is flattened When the
9. WARNINGS and CAUTIONS for blood pressure measurement e B When it is impossible to complete a test or there are doubts about the measurement values please confirm the patient s condition The pa tient S condition may have deteriorated to the point where measure ment limits are exceeded Always verify that the cuff and cuff hoses are appropriately used and are not bent or blocked If the display shows 0 the monitor s pressure may be 0 But if the cuff hose is blocked or bent there may be air remaining in the cuff At this time disconnect the hose from the cuff to ensure that blood flow is not restricted re attach and try again B Blood pressure measurement is conducted by putting pressure on arms and ankles and a patient may feel pain or have temporary macula caused by internal bleeding Although this macula will disap pear inform concerned patients about the possibility in advance In some cases the inflation value needs to be adjusted E Stop the measurement if the patient expresses pain In the following cases do not wrap the cuff on the relevant parts E Arm with intravenous drip E Arm with hemodialysis shunt E Lower extremity with deep vein thrombosis gt gt gt Measurements are not possible in the following cases B Patients with insufficient peripheral circulation acute cases of low blood pressure low temperature B6 Patients with a high frequency of arrhythmias In the following cases fol
10. OPERATION MANUAL Optional Accessories BRACHIAL CUFF SET 10cm BRACHIAL CUFF SET 13cm BRACHIAL CUFF SET 15cm ANKLE CUFF SET 10cm ANKLE CUFF SET 13cm ANKLE CUFF SET 15cm SENSOR GEL PACK 1015 20packs box Set of WRIST ECG ELECTRODE AND PCG SENSOR GEL PAD SERVICE MANUAL PRINTER TROLLY ST 100A 200A P No 1730486 REF A057ZZ REF A0482ZZ REF A0557Z REF A056ZZ REF A0497Z REF A053Z7Z REF 047372 REF AN032Z Omron Healthcare Co reserves the rights to modify the design and specifications contained herein without prior notice Specifications 105 Limited Warranty Omron Healthcare Inc warrants the Cardio Vascular Profiling System VP 1000 2000 including the MAIN Unit API Unit and TU 100 to be free from defects in materials and workmanship under normal use and with appropriate maintenance for a period of 3 years from the date of purchase Accessories included in the original system purchase including blood pressure cuffs air tubes connection cables power cords and memory cards are warranted to be free from defects in materi als and workmanship for a period of 1 year from the date of purchase Consumables including printer paper are warranted only that such parts will be free from defects in materials and work manship at the time of purchase Omron will repair or replace at our option within a reasonable period of time any item returned to us within the warranty period The following inf
11. R Ank Press 0 6 e e 04 3 0 02 R Ank 00 mmHg Rest 0 10 20 30 40 50 L Ank Press aa Time min 0 mmHg Stress Screen Meas End Displays the most recently measured values and graphs the pulsatile variation screen ECG OK PCG OK HR 56 bpm Interval 103 sec Auto R Bra Press Last Data mmHg PCG PR 60 bpm L Bra Press Bre SYS MAP DIA ABI mg R Bra 122 87 70 BeAnke ress 1 L Bra 0 0 0 0 R Ank R Ank 172 99 75 1 41 ll m L Ank 148 95 71 1 21 L Ank Press L Ank mmHg 0 mmHg Stress Screen Meas End DEAE Measurement Procedure Example of print This device will automatically printout the results as follows after completing the measure out ment Recovery Ratio Aug 18 2004 16 08 AD 01234 COLIN Age 53 Disease Hypertension Doctor Height 175 cm Weight 83 5 kg Section Sex Male BNI 27 3 Rest 0 5 10 15 20 25 30 35 Time min 88 0 70 97 0 77 0 61 P 16 00 36 120 126 111 Exercise Condition Observation Distance 200 m M Degree 12 4 Say Speed 40 m min D Patient information Prints the patient information Trend chart Graphs the trend in ABI values over the elapsed time 3 List data Dis
12. Reprinting Printing only one item Select the Data by rotating the jog dial After The Selection Press F3 PRINT switch to print Printing all Press FI ALL PRN switch to print all the Displayed Items bY BH Deleting Patient 1 Select the Data by rotating the jog dial Information 2 After The Selection Press F2 DELETE switch to delete Note W If you wish to stop printing while print all is in progress press Stop Switch Settings 83 Time Date Setting This sets the standard time and date used by this device The time and date settings of the device are already set when the machine is delivered Use the procedure below to change them 1 On the menu screen select 3 Time 3 Rotate the jog dial and select the item Setting Screen contents The Time Date Setting Screen will be Yer 2006 Date JN 26 displayed l User setting screen Time TAL How to change TIME l Select the input items by rotating the jog dial located on the upper right corner of the unit 2 Pueh the jog diel The display is reversed and input the value by rotating the dial 3 Press the jog dial once again to deternine the value 4 After inserting the TIME press F3 CONFIRM switch Press STOP switch to stop the input 2 Reprint screen B Time setting screen 4 Usage frequency print 5 System Information Selection method for Menu screen l Select the item by rotating the jog dial on the upper right side
13. 1 Select the item by rotating the jog dial on the upper right side 2 Push the jog dial and indicate or print the next display When you want to intermit the menu selection push F8 Return switch or the STOP switch Menu Contents The table below shows the menu contents Contents Page Reference User Setting Screen Sets numerical values and functions in volving checkup Reprint Screen Prints data for the past 10 measurements Time Setting Screen Sets the default date and time for this de vice Usage Frequency Print Prints a Usage Frequency Report System Information Lets you check version information for the system software used by this device 78 Settings Sets numerical values and functions involving checkup Use the jog dial to make selections and settings User s Settings Distance 00 m Meas Part Both Arms Both Legs Degree 12 Meas Times 1 Speed 40 Wait Time 10 Recorder Speed 25 ABI Base OFF Stiffness 1 OFF STI ET PEP Stiffness Comm ZONE Mo of Print ID Control ON Std Pt Trend Low Inflation 100 l How to input User setting screen 1 Select the input items by rotating the jog dial located on the upper right corner of the unit 2 Push the jog dial The display is reversed and input the value by rotating the dial 3 Press the jog dial once again to determine the value 4 After inserting the Function Data press F3 CONFIRM switch 1 Rot
14. 100 P1 Pulse wave amplitude P2 Mean value of the area the level at which and ES are equal TEX d zx a Soft i e 45 b Hard i e 38 c Constricted i e 50 Blood pressure values The shows the blood pressure values for the left and right arm and left and right ankle If measurement was not possible a message will be displayed For information about the contents of the message and corrective action see Error Messages page 88 B When the blood pressure values for the right and left upper arms are greater than 16 mmHg the highest blood pressure from the AN CAUTION lower side is shaded B if a measured value is in parentheses this indicates that it is a reference value only This is because the accuracy of that value was low for some reason PWV This gives the baPWV value It measures the start of the brachial pulse wave to the start of the ankle pulse wave 9 ABI value Shows the right and left ABI values Measurement Procedure 55 Pulsatile variation graph This graph shows the pulsatile variation obtained from each cuff Synchronization line This line is not printed if synchro nized measurement was not possible Inflation upper limit If the inflation upper limit is set to anything besides AUTO that setting is printed Maximum E E Pressurization 80 here When Estimate or First Measurement is displayed accuracy may be poor Th
15. Settings Maintenance Maintenance 87 Troubleshooting Cannot Print Correctly This section gives possible reasons and corrective actions that apply when the measurement results will not print cor rectly Reprint the document that did not print from the menu screen Cannot Print CAUSE Corrective Actions The power switch on the printer is Turn ON the printer power switch turned OFF No paper is loaded Form Feed Load paper in the printer on the printer is flashing The printer is not connected cor Check the cable connecting the printer rectly Text and graphics print faintly The toner supply is nearly exhausted Replenish the toner Paper jams Paper is jammed inside the printer Remove the paper jam Using damp paper the back of paper that has already been copied or binder paper with holes in it will cause paper jams Do not use such paper Error Messages If an error occurs before measurement or during the measurement process an error message is displayed In addition an error message will be printed in the test results if the measurement could not be accomplished successfully This section explains the cause of error messages and corrective actions that can be taken to resolve them If the symptoms do not improve even after the corrective actions described here are taken turn OFF the power switch and contact the person in charge of servicing the device Bi Error Message Types Error mess
16. 30 to 1 30 When the ABI value in the measurement results is lower than the value set here a second measurement will be automatically performed regardless of the set ting for synchronized measurement Do not use the base ABI value to judge whether to per form a second measurement This selects the formula for actuating the STI ejection index ENCCCHEN NN NN PEP ET Calculate with PEP ET ET PEP Calculate with ET PEP Settings 81 No of Print Sets the number of copies printed for Standard Patient and Trend Pulse Wave Diagnosis Results e e O O O Numerical Value Set the number of copies to print from 1 to 10 Note amp When not using a printer set the number of copies for Standard Patient and Trend to OFF 82 Settings This function lets you print data from past measurements and edit patient information Note WI The past data that can be retrieved from this screen consists of the last 10 items going back from the most recent Reprint screen Date Time 2006 5 10 10 29 2006 5 9 11 49 2006 5 9 11 19 How to input Reprint results 1 Select the Data by roting the jog dial 2 After The Selection Press F3 PRINT switch to print 3 After The Selection Press F2 DELETE switch to delete 4 Press F1 ALL PRN switch to print all the Displayd Items Press the STOP switch to return to Initial Display
17. EC 2 g EM AA zd ECG Gain Auto filter 60Hz med i TmHg i 1 aak Measurement BPimig PWV cm s Comment Ist Measured Data R Bra L Bra R Bra SYS 125 SYS 117 MAP 90 MAP 83 DIA 73 DIA 71 tr PP 52 PP 46 pu em R Ank L Ank SYS 129 SYS 126 b ad baPWV TUE 1426 3 L hk ABT TOF ABIT l Heart Brachial 36 6 E Heart ankle 155 4 Brachial Ankle 118 8 cm 2400 DAPWV cm s 4RA DLA 2m baPWV cm s 4RA DLA 1800 4 1m lt p 1200 Bar 3 a 1000 s ifs 800 800 a aes OA 0 5 0 6 07 08 0 9 10 11 12 1 3 14 ABI 3 n 4 5 6 7 89 AGE D Patient information Shows the patient information entered into the patient information input screen Heart rate Shows the measured heart rate ECG Printout of the ECG waveform PCG Printout of the PCG waveform PVR waveform Shows the pulse wave obtained from the measurement Because the amplitude of these re sults is calibrated from the measured blood pressure value the amplitude may be different than that shown on the screen 54 Measurement Procedure MAP This value is one of the pulse waveform indexes that is calculated from the blood pressure values It expresses as a percentage a value from the area of the wave form P2 divided by the amplitude of the pulse P1 This value is calculated with the following formula MAP P2 P1
18. Measure only at the arm that does not have an internal shunt Request Wi When applying the BRACHIAL CUFF to one arm only select Right Bra or Left Bra Both Ank For details see Entering Measurement Conditions in Patient Information Input page 45 E Position the BRACHIAL CUFF at a height equal to that of the patient s heart Note W If the patient has an irregular pulse it may be impossible to measure accurately unless a regular pulse wave is obtained Bi If there is shivering or cramping an accurate pressure value may be impossible to obtain Caution Wrap the cuff around a bare arm or thin clothing Wrapping the cuff around thick clothing or rolled up sleeves may cause a large margin of error in the blood pressure measurement X Mr a 92 Measurement Procedure Propercuff 1 When required wipe the application site clean with diluted disinfectant alcohol Place the placement patient in a supine position The brachial artery runs down the inside of the arm Attach the cuff so that the artery position mark aligns with the artery Brachial artery e pavo Artery position mark E When applying the cuff above clothing pull the clothing so that it does not bunch up on the side of the artery 3 If the cuff is wrapped around the arm with clothing bunched up at the artery site the blood pressure will measure higher than the actual value Measurement Procedure 33 2 A
19. Push the jog dial and indicate or print the next display CONFIRM When you want to intermit the menu selection push F3 Return switch or the STOP switch 4 Push the jog dial The item contents are set 2 Place the box over the item you wish to none Date JN 26 select and push the jog dial Time Aga Yer 2006 Date JN 26 Time 10 How to chenge TIME l Select the input items by rotating the jog diel located on the upper right corner of the unit 2 Push the jog diel The display is reversed and input the value by rotating the dial 3 Press the jog dial once again to determine the value 4 After inserting the TIME prese F3 CONFIRM switch Press STOP switch to stop the input How to chenge TIME l Select the input items by rotating the jog diel located on the upper right corner of the unit 2 Push the jog diel The display is reversed and input the value by rotating the dial 3 Press the jog dial once again to determine the value 4 After inserting the TIME press F3 CONFIRM switch Press STOP switch to stop the input CONFIRM 5 Repeat steps 2 to 4 until all settings are The changeable part of the item will be made highlighted 6 When finished setting press CON FIRM F3 The display returns to the screen menu To cancel settings before finishing press Stop Switch 84 Settings Usage Frequency Report Prints the Usage Frequency Rep
20. VAN WARNING AA Do not use this system in the presence of a flammable anesthetics or in a hyperbaric chamber or oxygen tent Method of installa The BP 203RPE II and TU 100 are designed to tion mount to the supplied trolley ST 200A The authorized service personnel of Omron Healthcare Co or an authorized distributor will assemble and install this system The device shall be setup by the bed side Air hoses and cable assemblies shall be put in undisturbed place or shall be fixed to a bed with velcro strips Caster wheel Please lock the casters when the device is in use and unlock when moving the system Caution to the place of installation The following locations are not suitable for installing the unit A location where the system may be splashed with any liquid or potential contact with steam Wi A location where direct sunlight is on the unit Cautions for installation E Do not put heavy materials on this unit AN CAUTION It may become out of balance and fall Falling object may become the cause of an injury Caution during transfer Turn off unplug the AC and remove the sensors from the patient before transfer Unlock the stand before transfer Please take a special care for the stand not to fall due to unstable balance when you move the stand without printer loaded Outline 27 Power On Procedure Cautions for Tonometric Sensor CAP FAP sensor for VP 2000 N CAUTION E Be su
21. condition of the patient Make sure that electrodes are correctly applied Make sure the electrodes are not old or dry Make sure the patient s skin is not dirty An unstable R wave interval was detected Noise entered the signal because the patient moved Have the patient rest quietly during measurement Noise entered the signal because of severe arrhythmia or patient convulsions If there is severe arrhythmia measurement accuracy may be poor Judge the results after reading any error messages displayed after measurement The amplitude of the detected signal was small and only inaccurate data was ob tained Check the application positions of the sensors and reposition them correctly Accurate data was not obtained because there was noise in the signal Eliminate the cause of the noise and remeasure Wave data was deleted due to noise in the signal Eliminate the cause of the noise and remeasure Maintenance 95 About Maintenance Principle of main Medical equipment including VP 1000 2000 and TU 100 should be maintained so that the tenance equipment functions are fully utilized while the safety of patients and operators is securely maintained As a principle daily maintenance work such as checks before use should be performed by the operator However in order to conduct a maintenance inspection at regular periods about once every two years and to secure the capabilities and safety of t
22. cuff around the upper arm is fully inflated blood flow stops but pulsation of the artery continues and causes oscillation of the pressure in the cuff As the pressure in the cuff is decreased slowly the magnitude of the pressure oscillation in the cuff gradually increases and eventually reaches a peak Further decrease of the cuff pressure causes the oscillation to decrease The re lationship between the changes of cuff pressure and its oscillation is stored in memory and used to determine blood pressure Namely cuff pressure when the oscillation increases rapidly is taken as the systolic pressure and that when the oscillation decreases rapidly is taken as the diastolic pressure Cuff pressure when the oscillation reaches a peak is taken as the mean arte rial pressure MAP The oscillometric method does not determine blood pressure instantaneously unlike the auscul tatory method and microphone type automatic blood pressure monitor but determines it from the curves of the changes of the pressure and its oscillation as described above This feature gives it antinoise characteristics as it is not affected by external noise or electric surgical units KOROTKOV SOUNDS CUFF PRESSURE 200 OSCILLATIONS IN CUFF PRESSURE RADIAL PULSE 5 SEC Comparison among the auscultatory oscillometric and palpatory methods of measuring blood pressures SOURCE MEASUREMENT OF BLOOD PRESSURE BY L A GEDDES 14 Outline
23. familiarize yourself with usage warnings capacity and limi tations in order to apply this device safely After reading please locate this manual in a convenient place for everyone who uses this device Important In order to use this device correctly and safely please read this manual carefully This manual should be located in a convenient place for future reference Indications for ensuring safety In this manual and the device there are indicating symbols that are designed to prevent haz ards from body and properties and to promote collect and safe use Those indications and meanings are explained as follows Please familiarize yourself with these symbols before reading the manual VAN DANGER DANGER indicates an eminently hazardous situation which if not avoided will result in death or serious injury VAN WARNING WARNING indicates a potentially hazardous situation that if not avoided may result in death or serious injury N CAUTION CAUTION indicates a potentially hazardous situation that if not avoided may result in minor or moderate injury AN Indicates the existence of contents which are included within or nearby the symbol In this case the symbol warns us of the possibility of electrical shock O Indicates a prohibited behavior Specific instructions are included within or nearby the symbol In this case prohibiting disassembly structions are included within or nearby the symbol In this case pullin
24. number is en tered this selection is used to retrieve patient data saved in CompactFlash memory under the same ID This allows measurement to begin for frequently meas urement repeat patients without having to reenter pa tient information each time Only the patient ID number need be entered for measurement to begin Disables ID number control Set this when doing group measurement or when there is no need for ID numbers IDs can be entered they will be recognized as numbers for individual measurements only This sets the inflation value used to when Low Inflation F2 page 45 is pressed while en tering measurement conditions 80 Settings Meas Part Meas Times Wait Time ABI Base STI This sets the default values for blood pressure measurement parts displayed for Meas Part on the patient information input screen When using options such as the Pulse Wave Unit TU 100 review the operation manual for each one a RN Both Arms Both Legs Measure at both Arms and both Legs Both Arms Right Leg Measure at both Arms and right Leg Select 2 for the simultaneous blood pressure measurement of 4 limb When making simultaneous measurements refer to page 46 you can set interval between the measurements This sets the base ABI value that determines whether a second measurement will be per formed 9e Emm Number Value Set an ABI default value in the range of 0
25. of Range The signal is too strong and the circuit may be saturated Check the application positions of the sensors and reposition them correctly 94 Maintenance Message Contents Weak Signal Re Position Sensor Analysis Not Available displayed after measure ment Verify Analysis for Accu racy displayed after meas urement ECG R wave Not De tected displayed after measurement Unstable R R interval 8 displayed after measure ment Weak Signal displayed after measurement Noise Interference dis played after measurement REJECT displayed af ter measurement Cause and Corrective Actions The detected signal is too weak Measurement is impossible Check the application positions of the sensors and reposition them correctly The sensor could be broken f there is no change in the signal display even if the sensor is touched with a fin ger contact the person in charge of servicing the device Strong noise has entered the signal such as from vibrations in the area Remeasure in a quieter location Required data not obtained in analysis could not analyze Refer to the displayed message and remeasure Due to noise effects the minimum number of heartbeats required for analysis was not reached Only low accuracy data was obtained Refer to the displayed message and remeasure R wave was not detected Check the following points and remeasure First check the
26. pressure value This will not be printed if measurement was not possible This level meter shows the size of the pulse wave The baPWV value is plotted on the y axis and the ABI value on the x axis of this graph The baPWV value is plotted on the y axis and the age is plotted on the x axis of this graph The error message if any will be printed here 76 Measurement Procedure If you press Menu F1 in the initial screen displayed after power is turned ON the menu screen is displayed In this screen you can make basic device settings and process past test data Settings 77 This section describes the menu screen and the operations that can be performed there Procedure This section gives the procedure for making menu selections There are two menu types one that displays another screen when a selection is made from the menu and one that prints a document titled after the menu selection Rotate the jog dial on the menu screen 2 Use the box to highlight the menu item As you rotate the dial the selection box you wish to select and push the jog dial moves down the menu Another screen will be displayed or a Deu o HR CCES ton document will be printed eer semp sum WB To cancel without making a selection Me MANN press Return F3 or Stop Switch 4 Usage frequency print 5 System Information Selection method for Menu screen
27. the device An internal communication error has occurred Check the following items then turn OFF the power switch and turn it ON again Is power to the API unit turned ON Are connectors for the cables between the units properly connected The power supply voltage for the cuff control unit has dropped Check the follow ing items then turn OFF the power switch and turn it ON again Make sure the outlet the power cord is plugged in has sufficient capacity Do not use multi line distribution blocks or low rated thin extension cords Do not share the outlet with devices such as laser printers or copiers that tempo rarily draw large amounts of current The pulse wave detected at the ankle sensor cuff was too small to be recognized If the cuff is too loose reapply it If the cuff has been applied over a thick sock or other garment reapply it after removing the garment Make sure the cuff signal cable to the API unit is not disconnected If the cable is reconnected the power supply switch must be cycled OFF then ON again The highest blood pressure measurement was 70 mmHg or below If the patient has low blood pressure take appropriate action f the patient has an obstruction in the brachial area use the other arm to deter mine the central blood pressure Measure with the cuff positioned at the same height as the heart Cannot detect R wave First check the condition of the patient Check that
28. the electrodes are correctly applied Make sure the electrodes are not old or dry Make sure the patient s skin is not dirty An ECG error has been detected First check the condition of the patient The electrodes are not correctly applied or the circuit is saturated by offset volt age Check that the electrodes are correctly applied Make sure the electrodes are not old or dry Make sure that the protective sheet has been removed Make sure the patient s skin is not dirty Maintenance 89 E Error messages that sound an alarm medium priority Message Contents Cause and Corrective Actions During measurement the following is displayed The measurement area setting and the applied cuff may be different Check before starting measure ment Unconnected Cuff Hose 1 is displayed during measurement Check Memory Card In sertion is displayed in the initial screen Read Error Write Er ror or Memory Card Data Failure is displayed on the initial screen Memory Card Cover is Open Open Memory Card Full Full 90 Maintenance The cuff inflation speed was not appropriate Make sure the application site setting matches the actual cuff type For details see Patient Information Input page 44 and Entering Measurement Condi tions page 45 The required pressure cannot be achieved even though the pump is activated Make sure the pump hose
29. used is too small the blood pres sure measurement may be higher than the actual value Check that there is no looseness in the connection area If there is an air leakage correct measurements can not be taken Apply the ankle cuff to the ankle of the patient The ANKLE CUFF are different for the right and left ankles Be careful to attach the correct cuff with the correct location Do not use the ANKLE CUFF for patients that suffer from deep phleboth ZN CAUTION rombosis in the lower leg Note W If the patient has an irregular pulse it may be impossible to measure accurately unless a regular pulse wave is obtained W If there is shivering or cramping an accurate pressure value may be impossible to obtain Caution The dual chamber cuff has a special distal sensor cuff for the purpose of detecting the pulse Wrap the cuff so that the sensor cuff is in contact with the posterior tibial artery of the ankle RR Posterior tibial artery Sensor cuff Measurement Procedure 35 Propercuff 1 Remove socks or stockings There are left ankle cuff and right ANKLE CUFF Put cuffs placement on the correct ankle respectively Put the hose area on the inside ankle When required wipe the application site clean with diluted disinfecting alcohol 2 Apply the cuff to the ankle Position the ankle cuff so that the sensor cuff 2 on the inside is 3 Align the mark at the bottom of the cuff 3 with the top of
30. 0601 2 27 1994 Medical electrical equipmemt Part2 Particular requirements for the safety of Electro cardio graphic monitoring equipment ANSI AAMI EC13 Cardiac monitors heart rate meters and alarms Specifications 103 Phonocardiograph PCG Measurement method Electret Capacitance Microphone Display sensitivity Variable Automatic Gain Control Display sweep speed 25 mm s Frequency characteristics HPF 43 1 Hz LPF 300 Hz Wave size selection Variable Automatic selectivity control Printer Output The parallel interface connector IEEE 1284 B signal compliant 14 pin 10214 55F3JL 3M Serial Port The serial interface connector MINI DIN 8pin MD S8100 10 HIROSE oil C G US Medical Equipment 58JN with respect to electric shock fire and mechanical hazards only in accordance with UL60601 1 1st Edition and CAN CSA C22 2 No 601 1 M90 104 Specifications Standard Accessories RIGHT BRACHIAL CUFF No 20 13 cm LEFT BRACHIAL CUFF No 21 13 cm RIGHT ANKLE CUFF No 22 13 cm LEFT ANKLE CUFF No 23 13 cm RIGHT BRACHIAL CUFF HOSE No 4 pink LEFT BRACHIAL CUFF HOSE No 5 blue ANKLE CUFF HOSE UNIT PCG SENSOR PCG WEIGHT ECG ELECTRODE CLIP Not Available for oder Not Available for oder Not Available for oder Not Available for oder REF A037ZZ REF A038ZZ REF A039Z7Z REF AS031Z REF 049712 REF AGO0031 WRIST ECG ELECTRODE PCG SENSOR GEL PAD Bulk package 25 pieces each Not Available
31. ARNING and CAUTIONS indicated in Check Before Use carefully before the operation Measurement Procedure 31 Application of the BRACHIAL CUFF Cuff Selection The STANDARD BRACHIAL CUFF included with the VP 1000 2000 can be used to take the measurement of a patient whose arm circumference is 23 cm to 38 cm Choosing an appropriate cuff for the patient is necessary to obtain an accurate measurement Choose a cuff appropriate for the patient by referring to the table below To attach to the cuff hose insert the hose and turn it clockwise to lock Arm circumference Bladder width Name cm cm CUFF No 20 21 Standard accessory 23 to 33 CUFF No 7 8 Standard accessory 17 to 26 CUFF No 5 6 Optional accessory 32 to 38 Choose the appropriate cuff to avoid any error caused by gap between cuff and arm in the measurements If the cuff used is too large the blood pressure measurement may be N CAUTION lower than the actual value If the cuff used is too small the blood pres sure measurement may be higher than the actual value Check that there is no looseness in the connection area If there is an air leakage correct measurements can not be taken Apply the BRACHIAL CUFF to the upper arm of the patient The BRACHIAL CUFF are dif ferent for the right and left arms Do not apply the wrong one Bi f the patient has an internal shunt for dialysis do not apply the cuff to VAN WARNING the arm with the shunt
32. Class Degree of Protection NIBP ECG PCG PPG Mode of Operation Other Standard Collateral Standard Environmental Conditions Power supply Main Unit Rating Frequency Power consumption API Unit Type 120 Rating Frequency Power consumption Fuse 297 W x 52 H x 250 D mm 297 W x 105 H x 205 D mm 380 W x 877 H x 565 D mm 380 W x 743 H x 565 D mm approx 3 0 Kg approx 3 6 Kg approx 20 0 Kg TFT color LCD 256 color with back light 640 x 480 dots 170 9 mm H x 129 6 mm V EN60601 1 1990 A1 1993 A2 1995 Medical electrical equipment Part1 General requirements for safety Class II Type BF with defibrillator protection Type CF with defibrillator protection Type BF with defibrillator protection Type BF with defibrillator protection Continuous IEC60601 1 4 1996 IEC 60601 1 4 1996 Al 1999 Medical electrical equipment Part1 General requirement for Safety 4th Programmable electrical medical Systems BSEN1441 1998 Medical devices Risk analysis ISO14971 AC 120 V 50 60 Hz 23 VA 250 V T1AH time lag HBC Cat No 215001 Little fuse Inc AC 120 V 50 60 Hz 45 VA 250 V T2AH time lag HBC Cat No 215002 Little fuse Inc Specifications 101 Operational temperature and humidity Temperature range 10 40 C Humidity range 30 85 not condensed Atmospheric pressure 700 1060 hPa Storage and Transportation Temperature r
33. F CVRR A B Pressure The pressure as gained by each sensor element Tonogram Should ideally form a mountain shape Yellow lines show the selected sensor elements Attach the sensor so that the yellow lines are in the middle insofar as possible If OK is not indicated at each signal s status check the points below and make adjustments until the OK message is displayed CAP Initializing B Please wait for a while CAP Weak Signal B Change the attached position to the position with the strong pulse CAP Ungetable Signal B Change the attached position of the sensor CAP Time out B Check ECG CAP Adjust Sliding Sensor Head B Reposition the sensor as instructed CAP Move sensor toward A side CAP Move sensor toward B side CAP Weak Spring Pressure B Change the pressure adjustment lever of the sensor CAP Strong Spring Pressure NOTE B The contents of the messages for the FAP SENSOR are the same as those for the CAP SENSOR B The tonogram cannot be displayed when ECG electrodes are not attached to a patient Measurement Procedure 71 8 Start Measure Select Start on the screen by the function switch once OK is displayed Alternatively ment you can start the measurement by the start switch on the main unit EC
34. G OK PCG 0K HR 56 bpm CAP OK FAP 0K Auto ECG R Bra Press mmHg PCG L Bra Press A CAP B 0 mmHg d R Ank Press A FAP B mmHg L Ank Press poua Ii Dee ia ms Pacemaker OFF CVRR B CAP SENSOR puts pressure on the neck and detects the pulse wave form Do not use it for any purpose other than brief examination Wi After the sensor is attached a patient may feel sick pain deteriora tion of pulse or become unconscious Keep checking the conscious VAN WARNING level and the condition of a patient and proceed with the examination following the doctor s instruction Be careful of carotid sinus syncope and carotid sinus reflex aller gens Measurement can be started even when OK is not indicated however ZA CAUTION in that case the measurement analysis result may not be accurate 72 Measurement Procedure 9 Completion of 1 After the completion of the blood pressure measurement the results will be displayed See Measurement the display example as follows 2 Disconnect the sensors and cuffs from the patient 3 The results will automatically be printed See the example of the printout as found on the following page 4 Press Stop switch to return the initial screen and examine the next patient Right Brachial Left Brachial Right Ankle Left Ankle hcPWV 564cm s hfPWV 751cm s Right Left faPWV 1023cm s 952cm s baPWV 1385cm s 1302cm s
35. GHT on the patient Doing so will cause injury Cautions about gel pads If they are dry or worn measurements may not taken accurately The PCG SENSOR gel pads are disposable Reuse is possible only if they are being used on the same patient Replace with new sensor gel pads after application to the patient with damp trauma infection disease etc Even when reusing the PCG SENSOR part for the same patient replace it with a new one every time if the skin is moist injured or infected The expiration date for the PCG SENSOR part is printed on its packaging If the sensor is used after the expiration date has passed it may have dried causing inaccurate measurement Al ways use sensors before their expiration date Sometimes the screen does not display PCG OK even when the PCG sensor position is changed The following are likely causes of this There is thick fat or muscle at the application site that attenuates heart sounds The PCG SENSOR cannot adhere easily to the skin due to excessive body hair The PCG SENSOR cannot adhere to the skin due to unevenness of the body surface The PCG SENSOR adheres to the skin at a slant because the body surface is not level These problems can be resolved by using the PCG SENSOR WEIGHT 1 Place the PCG SENSOR WEIGHT 1 over the PCG SENSOR 2 from above so that it covers the sensor Q The PCG SENSOR WEIGHT can be placed over clothing E Do not use a weight that has a hol
36. Normally Both Bra Both Ank is selected For patients who have an internal shunt for dialysis the cuff will be applied only to the arm that has no shunt Select either Both Bra Left Ank or Right Bra Both Ank for such patients When using an option such as a pulse wave unit TU 100 unit read the appropriate operation manual beforehand Normally AUTO is selected here This system is set to inflate the cuff and measure the pa tient s blood pressure automatically If the patient complains of pain caused by inflation you can change to an already set lower value for the ankle by pressing Low Inflation F2 After that the pressure can be changed within the range of 100 to 280 by rotating the jog dial W If Low Inflation F2 is pressed when the pressure upper limit item is selected the set inflation value will be displayed To return to the original value press AUTO Inflation F1 For more information about the inflation value setting see User Setting page 79 Wi Set an appropriate upper limit for inflation using Maximum Pressure 60 mmHg as a guideline E If the valued entered as the upper limit for inflation pressure is not appropriate the blood pressure measurement value will be low as shown in the diagrams below a Accurate measurement b Inaccurate measurement obtained when inflation is not sufficient Measurement Procedure 45 Measurement Times Wait Time Tonometry Mea
37. UR BR EDU SECUN US EORR OE EEEE EE ESERE SIS t SEHR EE EE EET ER eH S 50 RESUMES cr 53 PPD 8 M E 54 Exercise Measurement 42 cccvsteezs es eser rn e e EPA X cvs codes Seven ee vo epe AEN E E E 57 Exercise Measurement ProGedUre ceret eee Gan n e EXER EOD ARE TEET SERE UN FORE EET EE OE EI Ee 27 Screen Display During Measurement 2 2 treo Hee DERE te peat S EXER EH EFE SE le S Ebr eee sbressynawesdaanensotnaes 61 Measurement Procedures VP 2000 with tonometric sensor sssssssssseeeseeeeeeneeee eene 64 epu c M I Men Screen P M 78 PROCS d C M E 78 Men Contents Nc 78 User Seting oae Bi E PO dni tutti er tiie 79 Functions That Can Be Set eterna b Sa den EE nd e ER EAE eR oi cvastesvavssserecussaves eere Re ERE RUR E FEE 80 his 83 Time D te UD 84 Usage Frequency Report E ds 85 System intentio Um 86 I AUS nane eee r E ERR T 87 Troubleshooting
38. ages can be divided into three categories based on their importance An alarm highest priority sounds and the error message is displayed An alarm that goes beep beep beep beep beep sounds repeatedly A serious problem has occurred in the device or some type of abnormality may have occurred in the patient No measurement can be made in this state The content of the error must be investigated An alarm medium level sounds and an error message is displayed An alarm that goes beep beep beep sounds repeatedly A problem has occurred that makes measurement difficult The content of the error must be investigated An error message is displayed An error has occurred that will make it difficult to obtain correct measurement results Investigate the content of the error 88 Maintenance E Error messages that sound an alarm highest priority Message Contents RAM Check S ERROR RAM Check D ERROR ROM Check ERROR MSR Board ERROR Internal Error API Internal Error API Communication Error API DC Voltage Error No Signal from Sensor Cuff Measurement Results are highlighted in red R wave Not Detected Check Patient Electrodes Cause and Corrective Actions An internal problem has been detected in this device Turn OFF overall power to the system and turn it ON again If this action does not change the content of the message repairs are required Contact the person in charge of servicing
39. al alcohol j detergent unner E Do not use solvents such as thinner and benzene for cleaning Also avoid using cleaner with abrasives This could damage unit A CAUTION surface B The main unit should not be sterilized with autoclave or gas EOG formaldehyde gas high density ozone and the like E Ultraviolet radiation is harmful to liquid crystal display 98 Maintenance Cleaning of Sensors Attachments N CAUTION Cleaning and sterilization Cuff and Cuff hose ECG sensor PCG sensor Tonometry sensor Do not put solutions on the accessories Do not wet the connectors When using sterilizing solution follow the manufacturer s instructions Do not use solvents such as thinner and benzene for cleaning Also avoid using cleaners with abrasives This could damage the unit surface Accessories should not be sterilized with autoclave or gases EOG formaldehyde gas high density ozone and the like Based on the rules set by medical institutions cleaning and sterilization should be conducted as below Wipe with 30 5096 isopropyl alcohol or 7096 ethyl alcohol Never put any solutions inside the cuff or the cuff hose lest certain adhesion should develop Care should be exercised to ensure that no fluid enters the cuff or the cuff hose at any time The inside of cuff may adhere Wipe with 30 5096 isopropyl alcohol or 7096 ethyl alcohol The wrist ECG clip electrodes and PCG sensor gel pad are dis
40. al purchaser only and is not transferable 2 This warranty does not cover misuse of the equipment Misuse includes but is not limited to Misuse as described in the Instruction Manual Use of faulty or abnormal electrical power Affixing the equipment to any nonstandard accessory attachment Having the equipment modified improperly disassembled serviced or reassembled by anyone other than Omron unless authorized in writing by Omron Healthcare Inc Installation in a manner that does not conform to local building electrical and fire codes or in their absence the recommendation in the Instruction Manual 3 This warranty does not cover equipment that has failed due to neglect accident Acts of God such as fire earthquake flood lightning other acts of nature environmental disruption or a cause other than the equipment 4 This warranty does not cover any equipment on which the serial number platehas been removed modified or made illegible 5 Omron will not be responsible for the effect on safety reliability or performance of the war ranted equipment if Assembly operations extensions adjustments modifications or repairs are performed by persons other than Omron or persons authorized by Omron to perform such serv ices on Omron s behalf Electrical installation does not comply with applicable national and international stand ards including the requirements of the international electrotechnical commission or The warrant
41. ange Humidity range Atmospheric pressure Dust and Water Resistance 20 60 C 10 95 96 including condensed 500 1060 hPa Class IPXO Reference IEC 529 1989 Degrees of protection provided by enclosures IP Code EMC Reference Standard EN60601 1 2 1993 Particular requirement Medical electrical equipment Part1 General requirements for Safety 2 Electromagnetic compatibility Requirements and tests EN5501 1 11 1998 Class B Collateral Standard Noninvasive blood pressure NIBP Measurement method oscillometric method Measurement technology Linear deflation Pressure display range 0 10 300 mmHg NIBP Measurement range Arm SYS 60 250 mmHg MAP 40 235 mmHg DIA 40 220 mmHg Pulse rate 40 180 bpm Ankle SYS 40 250 mmHg NIBP accuracy Mean error and standard deviation per ANSI AAMI SP 10 Pulse rate accuracy Usable cuff size Numbers of Cuff Alarm Reference Standard 102 Specifications 2 96 or 2 beats 10 15 cm width of bladder 4 Right and Left Brachials Right and Left of Ankles Right Brachial SYS lt 70mmHg IEC60601 2 30 1999 Medical electrical equipment part 2 30 Particular requirements for the safety including essential per formance of automatic cycling non invasive blood pressure monitoring equipment EN1060 1 1995 Non invasive sphygmomanometers General requirements EN1060 3 1997 Non invasive sohygmomanometers Part3 Supplementary
42. ankle cuff R Ank Prs L Ank Prs Confirm the following items at the installation Verify that ECG PCG electrodes are not dry Wrap the brachial cuff so that the air hose tube is located on the outside of arm and faced towards the patient s head Wrap the ankle cuff on a bare ankle so that the cuff hose tube locates at the posterior tibiales artery Relax the patient and start the measurement 5 Remove the sensors from the patient Request W The ECG ELECTRODES CLIP and PCG SENSOR can be reused for the same patient Do not use for another patient 52 Measurement Procedure Hesults This section describes the layout of the measurement results screen that is displayed when a measurement finishes For in formation about printing out the measurement results see Printing page 54 MAP DIA Right Brachial 105 94 Left Brachial l 92 Right Ankle Left Ankle baPWV cm g R Ank 2400 2200 2000 1800 1600 1400 1200 1000 800 05 0 7 0 9 1 1 13 1 5 ABI Post Exer Mode D Pressure measurement values Displays the blood pressure values for each measurement part The fields will be blank for any parts that were not meas ured If the area could not be measured during the second measurement the first measurement val
43. ankle so have the patient remove their socks or thick tights WARNINGS and CAUTIONS during Pulse wave detection AN Follow directions below when placing CAP sensor on a patient E Do not use for a patient whom carotid sinus hypersensitivity is suspected E Do not leave CAP sensor on a patient for more than 10 minutes B Stay with a patient during measurement Always check a patient s condition E Remove CAP sensor immediately when a patient feels pain or discomfort Before Use 7 CAUTIONS of Use N The unit should be installed in the following locations and provide BI Power supply should be within 120V 10 B A level and stable surface for the unit to sit on B A location with the appropriate space required for airflow E Ambient temperature between 10 40 C and humidity less than 85 This device is suitable for use in domestic establishments and in establishments directly connected to a low voltage power supply network which supplies buildings use for domestic purposes The following locations are not suitable for installing the unit B A location where direct sunlight is on the unit for an extended period of time Deterioration of the liquid crystal display will occur B A location where the unit may be splashed with liquids B A location where extreme shock and vibrations may damage the unit BI A location where gas and fire may be present oe The following locations are not suitable for
44. ate the jog dial on the user setting screen As you rotate the dial the selection box moves down the menu 2 Use the box to highlight the menu item you wish to select and push the jog dial The item will be highlighted 3 Rotate the jog dial to select the item content 4 Push the jog dial Confirms the item you have set 5 Repeat steps 1 to 4 to set other items 6 When setting is finished press CONFIRM F3 The display returns to the screen menu To cancel settings before finishing press Stop Switch Settings 79 Functions That Can Be Set Exercise Volume Recorder Speed Stiffness Stiffness Comm ID Control Low Inflation Input values for walking distance walking degree and walking speed to determine the patient s exercise load Selects the sweep rate for the pulse wave diagram Seaton Eme Sets the sweep speed at 25 mm per second Sets the sweep speed at 36 mm per second When Pulse Wave Diagnosis Results 1 is selected this setting determines whether Stiff Include stiffness levels Do not include stiffness levels This setting determines whether arteriosclerosis baPWV comments will be printed in the ness diagrams will be included Pulse Wave Diagnosis Results 1 Display three levels Average High and Low Use numerals to display a percentage Selects whether to manage patients using ID control mem rmm Enables ID number control When an ID
45. ator Connector Cupper PVC Brass PCG Sensor Enclosure Cushion Diaphragm Weight shielding ABS Urethane PVC Brass Silicon PPG Sensor RS 10 as an option Bandage Top Insulator Connector PVC Brass PPG Sensor Extention SCP 10 TU 100 Package Conductor Insulator Connector Box Cushion Envelope Cupper PVC Brass Material s Corrugated Paper Paper Vinyl Main Unit Enclosure Internal Parts ABS General Electronic Parts CAP Sensor CAP 350 Enclosure Shielding ABS POM polyester Silicon FAP Sensor FAP 350 Enclosure shielding ABS POM polyester Silicon Maintenance 97 Maintenance of the Device The power plug should be pulled out from the electric outlet when conducting maintenance work as there is danger of electric shock VAN WARNING Keep the device and the accessories away from water not to mention liquids getting inside the unit When using sterilizing solutions please follow the instructions of the AN manufacture After cleaning the device dry it completely before turning power on again Cleaning and Based on the rules set by medical institutions cleaning and sterilization should be conducted sterilization as below Surface cleaning Use a damp cloth with a neutral detergent or sterilizing alcohol for cleaning the surface How ever do not wipe or wet connectors Sterilizing Benzene Neutr
46. bnormal noise Is the clock correct Is the proper sized cuff for the patient s arm and ankle prepared Are the connections of the cuff hose and cuff secure Are the ECG electrodes and PCG sensor gels new Use the main power switch located on the stand to turn ON OFF the device When turning ON the device E Do not attach the ECG clips to the patient E Do not touch or move the ECG clips In contacting our customer service and referring to manuals please note the system version The system version can be checked in the procedure below In accordance with Menu Screen B Select Menu Wi select 5 System Information WB press jog dial W System version number is indicated on the display Outline 29 Memo 30 Outline Measurement Procedure Measurement procedure is different when tonometric sensor is used Please follow the flow chart below Flow of this chapter Contents Attaching the brachial cuff ankle cuff ECG clip and PCG sensor Sheen sed page 32 2 c 9 Operation procedures when not using tonometric page 42 oo sensors or when the system is VP 1000 O ES oa c gt 5 Operation procedures for post exercise mode ow NC p uA Rum Wee atthe siue tds ET page 57 Only when operation continuing exercise load measurement Z2 fod com Operation procedures for using tonometric sensors J seese page 64 VAN WARNING To avoid any accident read W
47. ces When blood pressure cannot be accurately measured 1 Check whether the screen display shows ECG OK and PCG OK ECG OK ERE PCG OK HR 56 bpm Auo T RES Bra Press ECG Ja ad ns P MN ce Mi M M Mea ms ROG Jj J Jj I L Bra Press Boda R Bra E R Ank Press R Ank mill L Ank Press L Ank 0 nf Pacemaker ie Condition 2 Press Start Switch Measurement begins ECG 0K PCG OK Auto ECG R Bra Press 0 PCG mig 0000 d AA A Ihe L Bra Press bed emm E NE o R Ank Press R Ank g mh p nn L Ank Press L Ank do oe 0 mig Condition Pacemaker 50 Measurement Procedure E Performing second measurement When first measurement is finished a standby time counter is automatically displayed When the count is finished the second measurement begins HR bpm bpm SYS MAP DIA ABI baPWV PWV HR bpm Right Brachial Left Brachial Right Ankle BP mmHg Left Ankle PWV en g wait 2 s ECG OK PCG OK HR 56 bpm R Bra Press PCG S CMS E 9 R Ank Press 0 RAnk o dores si n SSS L Ank Press L Ank Mo c ae 0 m RETE zi ON Pacemaker Condition
48. culating PWV Enter the correct height in centimeters The entered height can range from 120 to 210 WEIGHT This is used when calculating the BMI index Enter in increments of 0 1 kg The entered weight can range from 25 0 to 200 9 Weight input can be omitted BIRTHDAY Enter the month day and year When entry is complete the patient s age are displayed 44 Measurement Procedure Entering Measurement Conditions Required information such as the measurement site can be entered here The information to be entered is shown in area 2 on the screen below ID 1234 5678 SEX Meas Part Both Arme Both Legs HEIGHT 165 cm 5 05 Pressurized Right Ankle AUTO WEIGHT kg Ib Pressurized Left Ankle AUTO BIRTHDAY JUN 15 1955 Measurement Times 1 Age 51 Wait Time 10 s Tonometry Carotid Femoral How to input HEIGHT and BIRTHDAY 1 Select the input items by rotating the jog dial located on the upper right corner of the unit 2 Push the jog dial The display is reversed and input the value by rotating the dial 3 Press the jog dial once again to determine the value 4 After inserting the HEIGHT and the BIRTHDAY prese F3 CONFIRM swi tch Press STOP switch to stop the input AUTO Inflation Low Inflation CONFIRM The following items can be entered or selected Meas Part Pressurized Right Ank Left Ank Note Note Select the default location for measurement
49. d correctly and conduct measurements with the least amount of pressure possible CAP Sensor Communication Error FAP Sensor Communication Error ERROR TYPE System Error CAUSE COUNTER MEASURE ALARM TYPE Communication with a sensor has Check whether a sensor is properly connected High Priorit been interrupted There is a possi then turn on Power again At that time if Ca a y bility that a sensor plug may be rotid Femoral cannot be selected in Menu Mute Unable pulled out of TU 100 connector or User Setting Screen ATP MODE a sensor is a sensor may be out of order possibly out of order Turn off Power then change a sensor for a new one Measurement that does not use a sensor can be continued Maintenance 91 Week Signal ERROR TYPE CAUSE COUNTER MEASURE Technical i i hange an attached position of a sensor in or ALARM TYPE Detected signal is not strong Chang i p c enough for accurate analysis der to obtain a stronger signal If necessary No sound irh change an angle of a sensor head a length of Low Priority h of i d for CAP Non Latch arm a strength of spring and so on for sensor in accordance with a patient Unstable ECG Signal ERROR TYPE Technical CAUSE COUNTER MEASURE ALARM TYPE R wave of ECG signal is unstable Refer to ECG status display No sound Low Priority Non Latch Unstable Signal ERROR TYPE CAUSE COUNTER MEASURE Technical ALARM TYPE Pulse waveform is fluctuating Te
50. d with accessories and op tions There is no warning about accessories and options Do not disassemble or reconstruct medical electron instrument in order to avoid fire and electrification Operate the equipment at the voltage described on the rating label to avoid fire and electrocution In case of using this device for patients with infection device itself cuffs and sen sors are necessary to be cleaned and sterilized before using for other patients To operate this unit safely and properly please inspect this unit before use 4 Before Use ee A onc BEBE Do not put anything on top of this unit in order to avoid fire and electro cution Do not place heavy materials on the AC power cord in order to avoid fire and electrocution 2 During maintenance turn OFF and unplug the AC cord in order to avoid electrocution If the following failures occur turn OFF and unplug the AC cord Ignoring the following conditions may cause fire and electrocution Smoke or the detection of smoke by smell Dropping device Liquid leaks into the unit Equipment malfunction If the failure occurs as mentioned above please promptly follow directions below 1 Confirm the AC plug is unplugged 2 Place a sign Do not use out of order on the front of monitor Do not expose this device to direct strong sunlight or leave it in a sun heated car as this may lead to problems
51. e agents may cause damage to the monitor s exterior E n case the unit is brought in from hot weather or a sun heated car leave it to cool for at least one hour at room temperature 10 to 40 C before using it The unit may break down or correct measurements cannot be taken E When the unit is brought in from the cold to a warm room water droplets may collect inside the machine In this case allow them to evaporate fully and then power it on Otherwise it may cause electric shock or unit failure E Store the sensor gel below room temperature 10 to 35 C avoiding high temperature and humidity and direct light If the sensor gel gets dry correct measurements cannot be performed gt S E n an environment with micro vibrations these micro vibrations may affect the PCG sensor and cuff and measurement may not be possible In this case take measurement after stopping the vibrations Follow directions below in order to prevent CF card data from being damaged 1 Do not turn off the switch while recording data into CF card 2 Turn off the switch while inserting CF card in and removing from a device 3 Do not disassemble CF card nor remodel it 4 Do not expose CF card to static electricity when handling it out of the device 5 Do not bend CF card nor put heavy materials on it 6 Do not get CF card wet keep it dry 7 Be sure not to turn off the power during printing CF memory may be dam aged 8 Use Colin s o
52. e or tear in its surface E If the filling of a weight leaks out clean it up quickly E Be careful not to damage the surface of the weight with a ballpoint pen or other sharp tipped object E If the weight is dampened by sweat or water wipe it dry right away E Do not wash with water Measurement Procedure 41 Measurement Information Input After turning on the power and applying sensors enter information about the patient The following patient information can be entered ID Number Enter up to 13 numeric characters that will be used for managing patient information Patient Information Enter patient information such as sex and height Measurement Enter necessary information related to measurement such as the basic disease and measure Conditions ment location Take care to avoid mistakes in entering information and numerical values because this information will be used when the analysis results are printed out 42 Measurement Procedure ID Number Input Enter up to 13 numeric characters that will be used for managing patient information This section explains the procedure for entering new information Note m ID Number Input Conditions Once a registered ID is entered the associated name and other data can be retrieved from the CompactFlash memory You can also make settings that allow you to manage information using the ID number For details see User Setting on page 79 Pr
53. e part marked with a black dot is the highest blood pressure value This will not be printed if measurement was not possible This level meter shows the size of the pulse wave Border when constriction of the upper arm or ankle is suspected this border will be printed with a thicker line for emphasis Observation Gives observations based on the test results 56 Measurement Procedure Exercise Measurement This function is used when the heart is given a set amount of exercise on a treadmill or similar device and then blood pres sure is measured After exercise is finished the ECG and blood pressure gradually return to their status at rest By measur ing this process recovery abnormalities can be discovered that would be hidden at rest B The amount of exercise given to the patient must be determined in consultation with a physician Furthermore during the exercise al ways pay close attention to the patient s condition PAN WARNING E When giving an exercise test to a patient with heart disease a physi cian must attend and sufficient emergency measures must be pre pared Note W Measurement can be performed for a maximum of 60 minutes after exercise Exercise Measurement Procedure 1 Take a normal measurement with the patient at rest page 42 2 Remove the ANKLE CUFF ECG ELECTRODES CLIP and PCG SENSOR from the patient E The BRACHIAL CUFF can be left on the patient and disconnected from t
54. ed product is not used in accordance with the Instruction Manual 6 Omron will have no obligation to enhance or upgrade any unit once manufactured 7 Omron will not guarantee availability of repair and maintenance parts longer than eight 8 years after discontinuation of the equipment 8 Omron reserves the right to withhold approval of a warranty claim pending visual inspection of the alleged defect Omron s sole responsibility shall be to repair or replace the product within the terms stated alone OMRON SHALL NOT BE LIABLE FOR ANY LOSS OR DAMAGE OF ANY KIND INCLUDING INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING DIRECTLY OR INDIRECTLY FROM ANY BREACH OF ANY WARRANTY EXPRESS OR IMPLIED OR ANY OTHER FAILURE OF THIS PRODUCT ALL IMPLIED WARRANTIES INCLUDING THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS ARE LIMITED TO THE DURATION OF THIS WRITTEN WARRANTY THIS WARRANTY SUPERCEDES ALL OTHER ORAL OR WRITTEN WARRAN TIES OMRON Cardio Vascular Profiling System Call this number for warranty service and repair Omron Heaithcare Customer Service and Technical Support Business Hours 1 800 829 6427 c We reserve the right to close or W W 5850 Fusion Drive change business hours without Local 210 690 6200 Sun Antonio Tx 78249 notice Visit our website at www omronhealthcare com Warranty 107 Memo 108 Warranty Distributor Manufacturer OMRON HEALTHCARE INC 1200 Lakeside Drive Bannoc
55. elect NEW ID F2 on the screen by pressing the function switch Wi To return to the default values press Stop Switch When entry is finished press CONFIRM F3 Up to 13 characters can be entered for the ID number Letters numbers and hyphens can be used ID Number Recognition If you make a mistake in the number of characters when entering an ID number it will be recognized as a different number For example 300 and 0300 are recognized as differ ent IDs Measurement Procedure 43 Patient Information Input Enter patient information The information to be entered is shown in area 1 on the screen below ID 1234 5678 SEX Meas Part Both Arms Both Legs HEIGHT 165 cm 5 05 Pressurized Right Ankle AUTO WEIGHT kg Ib Pressurized Left Ankle AUTO BIRTHDAY JUN 15 1955 Measurement Times 1 age 51 Wait Time 10 s Tonometry Carotid Femoral How to input HEIGHT and BIRTHDAY Select the input items by rotating the jog dial located on the upper right corner of the unit 2 Push the jog dial The display is reversed and input the value by rotating the dial Press the jog dial once again to determine the value 4 After inserting the HEIGHT and the BIRTHDAY press F3 CONFIRM switch Press STOP switch to stop the input AUTO Inflation Low Inflation CONFIRM The following items can be entered SEX Enter the sex HEIGHT This is used when cal
56. ent name Shows the patient information entered into the patient information input screen Tonogram Information from the tonometry sensor elements Measurement Procedure 75 3 MAP This value is one of the pulse waveform indexes that is calculated from the blood pressure values It expresses as a percentage a value from the area of the wave form P2 divided by the amplitude of the pulse P1 This value is calculated with the following formula 9 MAP 22 X 100 P1 Pulse wave amplitude P2 Mean value of the area the level at which and EZJare equal A zx Soft i e 45 Hard i e 38 Constricted i e 50 4 This area shows each blood pressure measurement result If a measurement could not be taken an error message will be recorded Refer to page 88 When the difference of systolic blood pressure between right brachial and left brachial is 15 mmHg or greater the lower of the data is printed with a shaded background This area shows each PWV data Right and left ABI C Oscillometric envelope obtained by each cuff Synchronization line This line is not printed if synchronized ud measurement was not possible Inflation upper limit If the inflation upper limit is set to any e IE iln thing besides AUTO that setting is printed here l When Estimate or First Measurement is displayed accu racy may be poor The part marked with a black dot is the highest blood
57. equip with a protective cap after using FAP SENSOR and store itin a secure location 18 Outline Configuration This device includes the following components Verify before using 1 BP 203RPE II Main unit BP 203RPE II API unit TU 100 only for VP 2000 Laser printer Trolley ST 100A VP 1000 ST 200A VP 2000 PCG sensor ECG clip Cuffs in the rear tray 1 set regular size 1 set large size Ankle Brachial 6 PCG sensor 7 ECG clip Oo o Ny QV tA A W N Operation manual 3 TU 100 In the trolley 1 BP 203RPE II VP 2000 Main unit os d hy Main power supply switch 2 BP 203RPE Il API unit enclosed in the trolley 8 Cuffs 4 Laser printer in the rear tray 5 Trolley ST 200A VP 2000 ST 100A VP 1000 The appearance of the system is subject to change without the prior notice Outline 19 N CAUTION Use only authorized accessories and options in order to avoid problems Standard Accessories ECG ELECTRODES CLIP PCG SENSOR 13cm STANDARD BRACHIAL CUFFS 15cm LARGE BRACHIAL CUFFS 7 S O A SSA Ww 13cm STANDARD ANKLE CUFFS SENSOR CABLE UNIT 15cm LARGE ANKLE CUFFS ANKLE CUFF HOSE SENSOR GEL PACK 101S GROUNDING WIRE VELCRO SET 20 packs 20 Outline Identification Name of each part and concise functions are described Brachial Cuff API Unit Ankle Cuffs Internal communication cable
58. erting the HEIGHT and the BIRTHDAY press H Press STOP switch to stop the input value FIRM switch AUTO Inflation Low Inflation CONFIRM Tonometry When the examination is conducted with using Tonometric sensor select the type of Tonometric sensors Blank vereers No use of Tonometric sensor Carotid Only CAP sensor is used Carotid Femoral Both of CAP sensor and FAP sensor are used 64 Measurement Procedure 3 Confirmation of Verify the stability of ECG and PCG signal on the following screen ECG and PCG signals Signal s Status Refer to pages 48 and 49 when ECG signal or PCG signal is not displayed OK PCG Level meter Make sure that three or more blocks of light are on Pacemaker Pacemaker Pacemaker is on when the patient uses the pacemaker page 47 CAUTION It is possible to start a measurement without the OK display but the accuracy A may be decreased Measurement Procedure 65 4 Attaching the FAP SENSOR is a optional and only when the sensor is selected in User setting screen FAP SENSOR Feel for the pulse Touch the femoral artery and find a place where the pulse is easily felt Attach the sensor Place the sensor on the area of the femoral artery found by touch above Apply a constant pres sure by hand wh
59. ess Meas F3 D In case of ABI measurement R Bra Pre input ID or patient personal information and place the brachial cuff L Bra Prs and the ankle cuff R Ank Prs L Ank Prs Confirm the following items at the installation Verify that ECG PCG electrodes are not dry Wrap the brachial cuff so that the air hose tube is located on the outside of arm and faced towards the patient s head Wrap the ankle cuff on a bare ankle so that the cuff hose tube locates at the posterior tibiales artery Relax the patient and start the measurement Eas o The ID Input Screen will be displayed Enter an ID number for the patient Rotate the jog dial until the box highlights the number or letter you wish to enter 2 then push the job dial to select How to input ID Select the numerals by rotating the jog dial The numerals are confirmed by pressing the jog dial The ID numerals are inserted from left to right Press F2 NEW ID switch when clearing the display ID When all the ID numerals are inserted prese F3 CONFIRM switch When the ID numerals are to be modified press F1 CORRECTION switch The numerals are eliminated from right to left In order to stop the input press STOP switch CORRECTION Ew ID CONFIRM E If you make a mistake press CORRECTION F1 One character will be deleted from the right each time this is pressed E To erase the patient ID s
60. ext screen by pressing Screen F2 Each time you press Screen F2 the display cycles through the following sequence List Screen Trend Screen and Previous Data Screen List Screen Display a list of measurement results along with the elapsed time ECG OK PCG OK HR 56 bpm Interval 103 sec Auto elap Time RB LB RA A d PCG time hh mm SYS sYS sYs ABL RR sYS ABI RR Bra Press 09 31 159 158 108 0 68 101 0 64 1 09 40 192 189 47 0 24 0 35 3 7 0 19 0 30 0 R Bra 2 09 41 165 166 64 0 39 0 57 3 9 0 23 0 36 mmHg R Ank Press R Ank mm L Ank Press L Ank 0 mmH Stress Screen Meas End CD Interval Counts the standby time until the next measurement Q SYS Shows the maximum blood pressure value 3 ABI Shows the ABI value RR Recovery ratio is the ratio of measured ABI to ABI at rest ABI of resting measurement is l Measurement Procedure 61 Trend screen Graphs the trend of ABI values over the elapsed time Previous data ECG OK PCG OK HR 56 bpm Interval 103 sec Auto R Bra Press mmHg PCG ve L Bra Press 12 10 0 RBa e ase mh
61. f ECG signal cannot be counted Check a patient s condition If the patient is in normal condition check whether ECG clip and ECG electrode are placed correctly on the patient 2 SYS lt 70mmHg The numerical indication of systolic blood pressure on the screen is reversed Yellow char acter on black Check a patient s condition If the patient is in normal condition check whether cuffs are placed on correctly and measure again Measurement Procedure Example of a printout HR Pulse Wave Diagnosis Results An example of the printout below gives explanations of the diagnosis results PCG Pulse Wave JUN 28 2006 13 34 48 years fut 176cm 5 09 n 6 Male PP mv opis Temp i Doftor kgt m pybminer ECG Gain Auto filter 60Hz Measurement 1st Measured Data S 126 MAP DIA PP SYS R Ank 89 74 139 3P m g PAV on s Comment SYS 119 MAP 90 DIA 71 L Bra L Apl e L Ank L Bra PP 48 SYS 141 R Ank J fap wa I 952 baPWV 1 302 Carotid Fe moral 59 Heart Carotid 23 9 Ank nili Heart Brachial 36 6 Heart Femoral 80 9 Heart Ankle 155 4 cm aPWV cm s aPWV cm s 0 5 06 0 7 0 8 0 9 1 0 11 12 13 14 ABI D Pati
62. g ndicates necessary action or instructional information Specific in the power cord by its connector Other symbols CAUTION It indicates information that should be known when operating this device Before Use 3 ES D nocn NN Do not use this device in the presence of a flammable anesthetic mixture with ignitable gas or oxygen or nitrous oxide It will cause an explosion BEEN nc RENE Only doctors or authorized personnel should attempt to operate this unit Please do not allow patients to operate this unit in order to avoid accident This unit is designed to conduct examinations This unit is not intended for monitoring patients in the ICU OR and ER This unit cannot be used in the following places Rooms that cause electrical noise such as MRI room CT X ray room opera tional room with the electrosurgical unit rooms with microwaves etc Also avoid using other medical equipment while using this unit During the examinations operator should sit with the unit and by the pa tient and pay attention to the status constantly This unit can be damaged by the electric energy from a defibrillator Dur ing defibrillation remove the sensors from a patient Do not operate a cellular and or radio trans receiver in the presence of this unit in order to avoid malfunction Use only authorized accessories and options in order to avoid accident Oeo oif Please be familiar with manuals accompanie
63. has not become disconnected Make sure the BRACHIAL CUFF or ANKLE CUFF is applied at the correct location Check for looseness in the cuff The cuff or cuff hose is worn out or damaged Replace with a new cuff or cuff hose Power was turned ON with no CompactFlash memory installed Turn OFF the power insert the CompactFlash memory then switch power ON again To continue measurement with no CompactFlash memory installed press the Stop Switch No patient information or measurement data will be recorded An attempt to read data from the CompactFlash memory failed Turn OFF the power switch then switch it ON again If the same error is dis played internal data may be corrupted It may be possible to recover the inter nal data Contact the person in charge of servicing the device The cover for the CompactFlash insertion port is open Close the cover If measurement is performed with the cover open entered pa tient information and measurement results cannot be recorded The CompactFlash memory is full Turn OFF the power and replace with a new CompactFlash memory Turn OFF the power switch remove the memory and copy the patient informa tion to another media Erase the patient information in the card and replace in the device CAP FAP Sensor Failure ERROR TYPE System Error CAUSE COUNTER MEASURE ALARM TYPE A sensor cannot be initialized A Turn off the power and change a sensor for a Medium Pri
64. he CUFF HOSE as shown in the diagram below Tug Wag 3 When the measurement results screen is displayed press Post Exer Mode F1 HR 64 bpm SYS MAP DIA ABI baPWV HR bpm Right Brachial 125 105 94 56 Left Brachial 124 108 92 Right Ankle 125 104 94 1 29 1271 BP mmHg Left Ankle 144 16 95 1 15 1287 PWV cm g baPWV cm g R Ank L Ank d 2400 L Bra 2200 i 2000 R Ank 1800 i 4 1600 L Ank 1400 1200 l 1000 800 0 5 07 09 11 13 1 5 ABI qj 7 1 1 Post Exer Mode 1 I Measurement Procedure 57 4 Set up the exercise Press Stress F1 to display the setup screen The wave display screen will appear R Bra Press 0 mmHg L Bra Press 0 mmHg R Ank Press 0 mmHg L Ank Press 0 mmHg Screen Meas Start 5 Select an exercise item using the jog dial and input it The exercise setup screen will be displayed ECG OK PCG OK HR 56 bpm Auto E J R Bra Press m ee ENERO 0 Distance m m ofl Degree l L Bra Press Speed m min 0 R Bra l H Interval min l R Ank Pres
65. he ECG status For information about this display see ECG Messages page 48 2 PCG Message Displays the PCG status For information about this display see PCG Messages page 49 3 Heart Rate Displays the patient s heart rate ECG Wave Displays the ECG wave If this is not displayed make sure nothing is disconnected See Application of ECG ELECTRODES CLIP page 38 PCG Level Displays the detected PCG level using four level meters It is recommended that at least the third meter be flashing when measurement starts Measurement can be performed even if only the second or lower meter is flashing but accuracy may be reduced When this hap pens adjust the position of the PCG SENSOR or use the PCG SENSOR WEIGHT See Application of PCG SENSOR page 40 6 PCG Wave Displays the PCG wave Pacemaker F1 Press this turning it ON when the patient uses a pacemaker E When measurement is finished the pacemaker setting is reset returning it to OFF Turn it ON each time measurement is performed WB The ECG display gain is normally set by an auto gain function However when the pace maker setting is turned ON the gain becomes fixed at 10 mm mV Condition F3 Changes the measurement conditions This is displayed when Simple Input ON is set Measurement Procedure 47 ECG Messages This section details the contents of the ECG messages When OK is not displayed measure ment accuracy ma
66. he electrodes are used after the expiration date has passed they may be dry causing inaccurate measurement Al ways use electrodes before their expiration date Cautions about ECG ELECTRODES If they are dry or worn measurement cannot be operated accurately The wrist ECG ELECTRODE CLIPS electrodes are disposable Re use is possible only if they are being used on the same patient Re place with new electrodes after application to the patient with damp trauma infection disease etc Measurement Procedure 39 Application of PCG SENSOR Preparation for Put exchange gel pad to PCG SENSOR PCG 1 Take off the protective sheet 1 light 2 Strip clear cover sheet which is on gel blue and put it to the sensor 2 pad side Q Application of Pay attention to the following sensor E Placement of PCG SENSOR is normally at the left edge of 4th rib case 4 as indicated be low Also it is possible to place the sensor at the middle of the 3rd rib case Or the right edge of 2nd rib area Verify proper location by looking at the PCG indicator so that you can obtain the II sound cm 40 Measurement Procedure N CAUTION PCG Sensor Weight Request B When patients have heart murmur or have abnormal sounds accurate heart sound cannot be inspected E When patients generate noise during respiration the sound can not be inspected accurately Do not drop the PCG SENSOR or PCG SENSOR WEI
67. he equipment it is necessary to designate a person in charge of maintenance work Management of Along with disposable consumables that are used daily items applied to patients such as ECG consumables leads are also considered consumables It is recommended that spares be prepared beforehand in view of possible cuts in the wire Daily consumables W SENSOR GEL PACK 101S P No 047372 20 packs Box 3 electrodes and 1 PCG pad pack W Printing Paper W Print Cartridges E Use only authorized accessories and options in order to avoid problems Z CAUTION E Store the sensor gel below room temperature 10 to 35 C avoid ing high temperature and humidity and direct light X Pulse Wave Unit TU 100 is a optional unit for VP 1000 96 Maintenance Disposal BP 203RPE II Package Follow local governing ordinances and recycling plans regarding disposal or recycling of bat teries Lead and Lithium and other device components The composed main material for each part is as follows Box Cushion Envelope Material s Corrugated Paper Paper Vinyl Main Unit Enclosure Internal Parts Chassis Battery on PCBoard ABS General Electronic Parts Aluminium Lithium Battery Api unit Enclosure InternalParts Chassis ABS General Electronic Parts Aluminum CUFF No 20 23 Air bag and Hose PVC Nylon PP polypropylene PE pulyethelene ECG Electrode clip Conductor Insul
68. he numerals are confirmed by pressing the jog dial The ID numerals are inserted from left to right Press F2 NEW ID switch when clearing the display ID When all the ID numerals are inserted press F3 CONF IRM switch When the ID numerals are to be modified press F1 CORRECTION swi tch The numerals are eliminated from right to left In order to stop the input press STOP switch CORRECTION NEW ID F1 F2 F3 Function switch Display of its function Outline 25 Initial Screen The initial screen is displayed soon after power is switched on In case of ABI measurement R Bra Pre input ID or patient personal information and place the brachial cuff L Bra Prs and the ankle cuff R Ank Pre L Ank Prs Confirm the following items at the installation Verify that ECG PCG electrodes are not dry Wrap the brachial cuff so that the air hose tube is located on the outside of arm and faced towards the patient s head Wrap the ankle cuff on bare ankle so that the cuff hose tube locates at the posterior tibiales artery Relax the patient and start the measurement Menu F1 Meas F3 To perform a test press Meas F3 For test procedures and results see Measurement Procedure page 31 To make basic device settings or to process past test data press Menu F1 For details see Settings page 77 26 Outline Installation Potential hazard
69. hould ideally form a mountain shape Yellow lines show the selected sensor elements Attach the sensor so that the yellow lines are in the middle insofar as possible If OK is not indicated at each signal s status check the points below and make adjustments until the OK message is displayed FAP Initializing B Please wait for a while FAP Weak Signal B Change the attached position to the position with the strong pulse FAP Ungetable Signal B Change the attached position of the sensor FAP Time out B Check ECG FAP Adjust Sliding Sensor Head FAP Move sensor toward A side FAP Move sensor toward B side B Reposition the sensor as instructed NOTE The tonogram cannot be displayed when ECG electrodes are not attached to a patient 68 Measurement Procedure 6 Using the When using the a Hand held CAP SENSOR on the patient s neck pay attention to the Hand held following CAP SENSOR Do not use a pillow The pulse will not be properly detected Palpate the neck to find the pulse then place the sensor on the area where the pulse was found The sensor should be applied to the left side of the neck Apply the sensor with gentle pressure and a steadied supported hand to eliminate motion ar tifact Apply the sensor according to the following instructions 1 Palpate the neck to locate the area where the pulse can be found 2 Place he sensor with the transducer over the car
70. ide of the main unit and press the card eject button Bi Installing the CompactFlash Memory 1 Make sure power is turned OFF 3 With the arrow on its side facing upward insert the CompactFlash memory card in the slot until the eject 2 Open the cover on the side of the main unit button comes out with a click 4 Close the cover on the side of the main unit Maintenance 93 E Other Error Messages Message Contents Cause and Corrective Actions Motion Artifact 2 Could not measure because the patient moved frequently during measurement Have the patient rest quietly during measurement When simultaneous measurement has been set two successive measurements will be performed To stop measurement press the Stop Switch Check Cuff Patient 3 Blood pressure cannot be measured because the pulse signal is weak If the cuff is applied over a thick sock or other clothing remove the garment and reapply the cuff When simultaneous measurement has been set two successive measurements will be performed To stop measurement press the Stop Switch Noise Interference 4 Could not measure blood pressure because the patient moved or pressure was ap plied to the outside of the cuff Have the patient rest quietly during measurement Make sure no outside pressure is applied to the cuff When simultaneous measurement has been set two successive measurements will be performed To stop measurement press the Stop S
71. ile taking the measurement The sensor should be applied directly to the skin g u Apply a constant pressure while taking the measurement This will have an influence on the precision of the measurement If a patient is having convulsions or with a venous pulse it may not be able to take a correct carotid pulse waveform N CAUTION If a patient has an arrhythmia the PWV may not be able to be cor rectly measured due to insufficient number of pulsation The sensor head is made to be very precise and delicate Applying undue strength or treating it roughly may cause damage 66 Measurement Procedure Using the belt The belt can be used to hold the sensor in position To use the belt the belt loop has to be attached to the rear of sensor Stable firm pressure can be obtained for the measurement by using the belt The hold down pressure can be measured by the tonogram Measurement Procedure 67 5 Confirmation of Check the stability of each signal FAP signals ECG 0K PCG 0K HR 56 bpm CAP FAP 0K Auto ECG R Bra Press mmH EUG Aj L Bra Press a CAP B 0 mmHg R Ank Press a FAP 8 mmHg L Ank Press _ Ml xs FOREN mm Pacemaker oe CVRR Pressure The pressure as gained by each sensor element Tonogram S
72. is expelled during contraction It is mainly used to evaluate hardness of the artery wall L distance PWV S PTT Pulse Transit Time With this device the PTT of each segment is calculated from the waveform taken from each sensor as shown in the illustration below Lhe ECG hcPWV 2 Tc Ascending Aorta Right Brachial Lhb PCG hbPWV Tb Ascending Aorta Femoral Artery Lhf tee eon artery Femoral Artery Ankle PWV Lfa faPWV 2 Us Tfa Right Bra Right Brachial Ankle PVR Lba baPWV Tba Ascending Aorta Ankle PWV Femoral Lha haPWV artery Tb Tba XX 1 Distance to be measured is Left Ankle HR Heart Rate PVR automatically calculated by patient s height based on statistical studies 7X2 Pulse Wave Unit TU 100 is a optional unit for VP 1000 HR stands for heart rate in a patient during measurement It is calculated by a moving average for 4 or 8 beats of R wave interval of ECG signal and is indicated by a numerical value converted to heartbeats for 1 minute Numerical unit is bpm beat per minutes Outline 11 STI Systolic Time Interval ET Ejection Time PEP Pre Ejection Period ET PEP Ejection Index Q ll Overall control period ABI Ankle Brachial Index PCG Phonocardiogram PVR Pulse Volume Record UT Upstroke Time ET PEP etc are generally called STI used for quanti
73. kburn Illinois 60015 www omronhealthcare com OMRON HEALTHCARE CO LTD 24 Yamanouchi Yamanoshita cho Ukyo ku Kyoto 615 0084 Japan 165891 0B
74. ll a patient to stay still Ifa waveform fluctu Nocsoutid ates even when a patient stays still change a oss Priority position of Sensor in order to obtain a stable Non Latch waveform If necessary change an angle of a sensor head a length of arm a strength of spring and so on for CAP sensor ECG R wave Not Detected ERROR TYPE Technical COUNTER MEASURE ALARM TYPE Necessary R wave of ECG signal Check whether ECG signal is obtained cor No sound as a trigger for analyzing pulse rectly Low Priority waveforms cannot be detected Non Latch Adjust Sliding Sensor Head ERROR TYPE Technical CAUSE COUNTER MEASURE ALARM TYPE Pressure on a sensor head is not ap Change an angle of a sensor or the posion No sound propriate Low Priority Non Latch Move Sensor toward A B side ERROR TYPE CAUSE COUNTER MEASURE Technical ALARM TYPE A position of a sensor head is not Move a sensor head toward A B side No ound adjusted in the center of artery Low Priority Non Latch 92 Maintenance E Removing the CompactFlash Memory If the CompactFlash memory is removed the contents of the user setting screen will return to their default values When the CompactFlash memory has been reinstalled check the contents of the user setting screen and change the settings as needed 1 Turn OFF the power 3 Remove the CompactFlash memory i Q Do not touch the metal parts 2 Open the cover on the s
75. lockage condition by atheroma lipid Phonocardiogram detects heart sound Volume pulse wave record Ankle PVR is taken by the sensor in the dual chamber ankle cuff Time for the pulse wave to rise 12 Outline Al Argumentation Index 9eMAP Augmentation index is a numerical value that displays the percentage of the reflected pressure wave with respect to the effected pressure wave in the brachial pressure pulse wave AP ex presses the post systolic component after subtraction of the maximum wave height of the pre systolic component AP Al x 100 Example of the decrease in the AI value as the wave height of the pre systolic component rises This value is one of the pulse waveform indexes that is calculated from the blood pressure val ues It expresses as a percentage a value from the area of the wave form P2 divided by the amplitude of the pulse P1 This value is calculated with the following formula P2 MAP X 100 P1 Pulse wave amplitude P2 Mean value of the area the level at which 777 and EE are equal Pulse pressure Y Soft i e 45 Hard i e 38 Constricted i 50 i e 50 Outline 13 Measurement Principle of NIBP Oscillometric Method This method measures the blood pressure by detecting the pulsation of the artery which is caused by the contraction of the heart as the pressure oscillation in the cuff When the
76. low the physician s instructions Wi f there is acute inflammation purulent disease external wound etc on the part of the body where the cuff is applied In case a patient is confined to bed for a long time take measurement after checking for thrombus 6 Before Use WARNINGS and CAUTIONS for Safe Measurement AN In the following cases proper measurements may not be possible Wi f the motion artifact occurs by convulsion with a patient due to rheumatism etc If the patient has diabetic arteriosclerosis If the patient has quasi hypertension When the cuff position is above or below the heart level When the patient moves or talks during a measurement When the cuff is placed over thick clothing When a tucked up sleeve is adding pressure on the arm If the patient has cardiac murmur If the patient has abnormal 274 sound If the patient has noise during respiration If the patient has convulsions or shivering WARNINGS and CAUTIONS during ECG monitoring AN AN In the following cases proper measurements cannot be taken E Patients with a high frequency of arrhythmias B Patients who use a pace maker Following clothes are suitable for examination B Thin sleeves Cuffs are wrapped on the brachial so a patient can wear thin sleeves or leave the arm uncovered Do not roll up the sleeves even thin ones as it may cause the measurement to fail B Take off socks and thick tights Cuffs are wrapped on the
77. omnon Cardio Vascular Profiling System VP 1000 2000 Non invasive Vascular Screening Device BP 203RPE Il Pulse Wave Unit TU 100 Operation Important To operate this device properly and safely please read this operation manual carefully before using it Also this manual should be located in a convenient place for future reference C oLi n P No 1730486B 08 2006 Caution Principles No part of this manual should be reprinted or reproduce without permission from Omron Healthcare Co Omron Healthcare Co maintains right to modify the contents without prior notice Ample care has been taken in writing this manual please contact Omron Healthcare Co if you have any questions about the content of this manual If there are missing or disarranged pages the manual will be exchanged Inquire at the place of purchase Trade Mark Product names mentioned in this manual may be a trademark or a registered trade mark of other companies Table of Contents B tore USE e 2 Symbols and Safety TES sciis mme te cete ANNE SEa EEEE E e EMO CI OEC ELE YS ee tp eor RETRO d 3 Pon T 10 Explanation of Technical Werms 2 2n creen ERG EEUU RH E A IRE HRER TV EROR 11 Measurement Principle of NIBB no niece ret Dae RIAL RTT ROTE ERE n DETENER SHEER TE EEVEEEERUR 14 Outline of TU 100 only for VP32000 4 roro nr ente
78. ority sensor may be out of order new one When it is difficult to change a sen Latched sor call our customer service If a sensor is not Mute Enable necessary for measurement press Alarm Mute so that measurement can be continued Sensor Temperature Error ERROR TYPE System Error CAUSE COUNTER MEASURE ALARM TYPE Proper measurement cannot be Power on again after keeping the room air tem High Priority taken due to low room air tempera perature at 15 C Latched ture Mute Unable Check Cable Connection ERROR TYPE System Error CAUSE COUNTER MEASURE ALARM TYPE A different type of a sensor is con Turn off the power and connect a correct sen Medium Priority nected sor If a sensor is not necessary for measure Latched ment press Alarm Mute so that measurement Mute Enable can be continued Excessive FAP pressure ERROR TYPE Technical CAUSE COUNTER MEASURE ALARM TYPE The FAP sensor is pressing against Reduce pressure the measuring device with more Medium Priority pressure than is necessary Latched Mute Enable Excessive CAP pressure ERROR TYPE Technical COUNTER MEASURE ALARM TYPE The CAP sensor is pressing against Reduce pressure Medium Priority the neck with more pressure than is Actions such as swallowing may cause tempo Latched necessary rary activation of this error Mute Enable CAUTION Impact on the patient increases when the pressure rises Ensure that the device is positione
79. ormation is required Customer Service case number call Omron Healthcare Professional Services to obtain Letter stating the problem Serial number Copy of invoice or other proof of Purchaser s name date of purchase phone number and address To return the product to Omron call Omron Healthcare Professional Services There will be no charge for parts and labor performed by Omron to correct warranted defects and Omron will pay the cost of shipping the repaired unit back to you Equipment that has been dam aged or is excluded from this warranty will be repaired for a fee Equipment or any part thereof that is repaired during the limited warranty period will be warranted under the terms of the limited warranty for a period not to exceed the remaining term of the original limited warranty or six 6 months whichever is longer Transportation damage Omron will not be responsible for damage in transit to Omron Contact your freight company to submit claims for shipping damage In the case of damage in transit from Omron Omron will submit a claim to the shipping company Keep all packaging materials for review by the shipping company and as proof of mishandling Do not operate the equipment after discovering transit damage as this may negate the ability to process the claim with the carrier Omron Healthcare Professional Services 1 800 829 6427 106 Warranty Exclusions and Limitations 1 This warranty applies to the origin
80. ort Usage Frequency This function lets you check past usage frequency Report sage Frequency Colin Medical Technology Corporation Hos Aug 19 2004 20 16 TOTA 5421 Times Patient Monthly Frequency Total 16 Times Patient 50 F Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Daily Frequency Total 1 Times Patient 10 F 1 20 21 22 23 24 26 26 27 28 20 3031 1 2 3 4 5 6 7 8 91011 12 13 14 16 16 17 18 19 D TOTAL Times Prints the total number of measurements performed Monthly Frequency Graphs the frequency of usage over the last month 3 Daily Frequency Graphs the frequency of usage over the last day Settings 85 System Information You can use this item to check the version information for the system software used by this device 1 Select 5 System Information on the menu screen System information is displayed Menu screen HR bpm 1 User setting screen 2 Reprint screen 3 Time setting screen 4 Usage frequency print D System Informationl Selection method for Menu screen l Select the item bv rotating the jog dial on the upper right side 2 Push the jog dial and indicate or print the next display When you want to intermit the menu selection push F3 Return switch or the STOP switch Note I You will be asked to provide this information if you contact Colin for customer service 86
81. otid pulse applying steady gentle pressure 3 The sensor should not touch the tendons or Adam s Apple B The CAP SENSOR detects the pulse wave through user applied VAN WARNING pressure to the neck Do not use it for purposes for other than a short examination A CAUTION E f a patient is having convulsions and or with a venous pulse it may not be able to take a correct carotid pulse waveform Measurement Procedure 69 Checking the Fix the position of sensor by checking the tonogram on the screen Adjust the position of the attachment sensor to make the tonogram a mountain shape Adjustment of the When the message Move to A side or Move to B side is shown move the sensor in the position indicated direction and re attach it Move to B side Mountain Move to A side uad is dis TM Tonogram Pressure CAUTION The sensor head is made to be very precise and delicate Applying undue strength or treating it roughly may cause damage 70 Measurement Procedure 7 Confirmation of Check the stability of each signal CAP and FAP signals ECG 0K PCG OK HR 56 bpm CAP 0K FAP 0K Auto ECG Ni R Bra Press 0 mni PCa d L Bra Press A CAP B 0 F l PA d R Ank mun UL Masc 0 mmi A FP B mmHg L Ank Press EM M d 0 TA Duk qm Pacemaker OF
82. plays a list of measurement results along with the elapsed time R in the Measurement time column indicates a measurement made at rest P indicates a post exercise measurement shows unsuccessful measurement Exercise Condition Prints information about the exercise conditions 6 Comment Prints remarks about the measurements ZN CAUTION Do not turn off the power during printing CF memory may be bro ken Measurement Procedure 63 Measurement Procedures VP 2000 with tonometric sensor 1 Sensor Attach Have the patient lay in the supine position then attach the ECG ELECTRODES CLIPS PCG ment SENSOR and the CUFF to the patient page 32 except tonom etry sensors 2 Entering Informa Input the patient information and the measurement condition page 42 tion Setting procedure for Tonometry is as follows ID 1234 678 SEX Male Meas Part Both Arms Both Legs HEIGHT 165 cm 5 05 Pressurized Right Ankle AUTO WEIGHT kg Ib Pressurized Left Ankle AUTO BIRTHDAY JUN 15 1955 Measurement Times 1 Age 51 Wait Time 10 s Tonometry Carotid Femoral How to input HEIGHT and BIRTHDAY 1 Select the input items by rotating the jog dial located on the upper right corner of the unit 2 Push the jog dial The display is reversed and input by rotating the dial 8 Press the jog dial once again to determine the value 4 After ins
83. posable They can be used however approx 10 times of consecutive use Please replace them as soon as following con ditions are observed E Beginning of the day WB Dry and not sticky Bi Dirty and not sticky E When used on the unhealthy skin e g damp trauma infectious disease Maintenance 99 Cuff Replacement Replace soiled or worn cuffs with new ones Note Make sure that all cuff connections are firmly secured Air leaks will cause measurement errors E Arm Cuff Replacement 1 Rotate the connector in the direction of the arrow then 2 Insert the connector for the new cuff into the air hose separate the air hose and connector Rotate in the direction of the arrow ty UEM DH z Connector E Replacing Ankle Cuffs 1 Pull out the connector 2 while pressing the lever 1 2 Insert each connector for the new ankle cuff into the inward on the ankle cuff sensor box ankle cuff sensor box until it clicks Since the lever is small and slippery place your finger on its base while pressing i a Be careful not to mistake the right and left connectors when inserting them 100 Maintenance Technical Specification of BP 203RPEII General Dimension Main Unit API Unit ST 200A 100A operation ST 200A 100A transportation Weight Main Unit API Unit ST 200A 100A Display part Method Display color Resolution Screen dimension Safety Standards Protection
84. re tert are HEU Pea ea e Pru EE TENDER ERN ERREUR NR RS Gus 16 Identification ze ca nen A OE eter OR ER UR estesa Ran RU RYDER EIU Rire RENTRER REESE re WEITER 21 Meaning of the Syribols ci te rete i e ERE OS ERE NE IRE SERIE ORG RED EE EAR EXEC EF Ecke HERO ee VER RSS 24 Jog Dial and Function Switch siia triente Ri e e HR FEE ERRORI Ue ESTY e XR ERE ME Ene E FEN ETE REL ose 25 Initial Screen 26 Installation 27 Power Om Procedure sene REVO EU eet UEM NE E e EE 28 Check om RU 29 Measurement Proced ra up ER M RtepMCAMdu EIDEM CN RUIN D p MD IUE 31 Application of th BRACHIAL CUPP esenee trasee rro ete AEE tm eben iva ire iS P EX RE ees 32 Applicationsof the ANKLE CUEP iriaren e dcn ret p ES b coe PO nece estar EERO 35 Application of ECG ELECTRODES CLID 51 2 1 rect rete pt tbe keen a ene eer egeo es I Ee ER Hebe cue ee cedens 38 Applicationvof PEG SENSOR ion e rhe pe RR VOR des esten rbi een iU ric T vede ies 40 Measurement Information Iput r rosanne be idee e ute eate ui aeo Veo ee ERE Ua ene raa ee ea e equ tee an 42 ID p2diinyii 43 Patient Information InDUL 2er oor EO Errat tenes EE EEEE ios SEGA RENE EOR ERE ERE OE EER EAER 44 Entering Measurement Conditions sises oi rires qe HE REESE EU Se SELLER UO ERH ERE ek a Spon oavanisauesosaionsdtavessoatess 45 Start OF Measurement esre ore er eR EOD E A ERRE
85. re to turn off the Power when Tonometric Sensor is plugged in pulled out of TU 100 or the internal circuit of Sensor may break down Accidentally plugged in pulled out with power on turn Power off and on again for a correct measurement With the trolley To turn on the power use the Main power supply switch on the left side of the trolley MAIN POWER SUPPLY SWITCH In case of No Power please verify that unit power switches are ON for the TU 100 API Unit and MAIN Unit in order When Power of API Unit or TU 100 is turned off during operation Communication Error as System error will be displayed on the screen In this case power cycle each Unit again in accordance with the procedure above 28 Outline Check before Use x6 For safe and proper use the machine has to be checked before use Prior to daily use the following points should be checked Before turning the power ON Appearance Power Cord Printer After turning the power ON Appearance Time Indication NIBP ECG and PCG Turn ON OFF the device System information No deformation due to falling Is the unit clean Is the unit wet Is the power cord secure at the main unit connector No heavy object placed on the power cord No damage to the power cord No core showing Cut Is the power cord connected to an outlet with a grounding wire Is the printer paper enough No smoke or abnormal smell No a
86. requirements for electro mechanical blood pressure measuring systems Technical Specifications of TU 100 PRODUCT NAME Pulse Wave Unit MODEL TU 100 Pulse Wave Sensor Unit Measurement method Frequency Characteristic Signal output range Sensitivity Multi semiconductor strain gauge 2ch DC 300 Hz 0 5 0V Variable Automatic Gain Control Pulse Wave Velocity PWV Pulse Wave Velocities are measured by the heart sound and dicrotic notch of each cuff pulse R wave of ECG counts the heart rate and makes the noise elimination window for the heart sound ECG Lead selection Display sensitivity Display sweep speed Input impedance CMRR Frequency characteristics HPF LPF Ham filter Wave size selection R wave detection sensitivity Tall T wave rejection HR display range HR measurements accuracy Electrode disconnect alarm HR responce time HR averaging HR updating rate Pacemaker pulse rejection Alarm Reference Standard Variable Automatic Gain Control 2 30 mm mV 10mm mV at Pacemaker ON 25 mm s 5 M ohm or more 100 dB or more 0 52 Hz 40 Hz 25Hz at Noise filter ON 50 or 60 Hz Automatic selecting filter Automatic selectivity control 200 uV or less 1 0 mV 0 30 250bpm t1 or 1 beat Displayed 9 sec or less 4 beats moving average at HR 120 8 beats moving average at 120 lt HR every beats amplitude 2 700mV pulse width 0 1 2 0 ms HR 0 EN6
87. riginal CF card generic CF cards cannot be used in the unit Before Use 9 This unit is designed to measure ABI Ankle Brachial Index and PWV Pulse Wave Velocity which are to be used for evaluation of Arteriosclerosis STI Systolic Time Interval which is useful for evaluation of cardiac functions can be measured with Pulse Wave Unit TU 100 VP 2000 The measurement results are displayed on a colored LCD and are recorded by the external printer Special features E Easy operation By using attachable Brachial and ankle cuffs the Doppler blood flow sensor that requires skilled application is not needed Bl High accuracy and high reliability Specially developed tonometer carotid artery sensor phonocardiography and sig nal transaction are accurate and reproducible Bl ABI measurement by measuring 4 limbs simultaneously In ABI systolic blood pressure of 4 limbs is simultaneously measured E Non invasive measurement of ABI and PWV Arteriosclerosis is totally evaluated by ABI and PWV It is effective to evaluate arterioaclerosis of the patient with Pseudo hypertension caused by diabetic arteriosclerosis BB Color LCD The color LCD display makes viewing the measured data easy 10 Outline Explanation of Technical Terms PWV Pulse Wave Velocity Ascending Aorta Carotid Artery Pusle wave velocity is the speed at which the pulse is transmitted from the heart to the end artery when blood
88. s R Ank Meas Part oth Arms Both Legs 0 A o A m oM Pd mmHg L Ank Press L Ank 0 mmHg Stress Screen Meas Start Note Bi The following items can be set Distance Enter the distance to be walked Degree Enter the treadmill s incline angle Speed Enter the treadmill s speed nterval Enter the measurement interval for after the exercise Meas Part Enter the body part where blood pressure will be measured 58 Measurement Procedure 6 When entry is finished press Screen F2 to switch to the ECG PCG wave screen 7 Start the patient s exercise 8 When exercise is finished immediately apply the ANKLE CUFF ECG ELECTRODES CLIP and PCG SENSOR Connect the BRACHIAL CUFF to the CUFF HOSE E Connect the BRACHIAL CUFF to the CUFF HOSE as shown in the diagram below CHR Up 9 Check that ECG OK and PCG OK are displayed on the screen ECG OK PCG OK bpm R Bra Press 0 mmHg L Bra Press 0 Tr R Ank Press 0 mmHg L Ank Press 0 mmHg Stress Meas Start 10 Press Meas Start F3 or Start Switch Measurement begins R Bra Press 0 Th L Bra Press 0 mih R Ank Press 0 mif L Ank Press 0 I m amp
89. s a standard for deciding the up down position align the elbow hinge mark of the arm cuff with the elbow hinge line Elbow hinge line Elbow hinge mark 3 Wrap the cuff around the arm At this time be sure that the index line is inside the range shown by the arrow mark If the mark does not go inside the range use a cuff of another size Index line Range shown by the arrow mark 4 Wrap the cuff snugly so that 2 fingers can be placed between the cuff and the arm s E Ensure there is no kink or closing of cuff and or hose CAUTION When there is kink or closing in the cuff and or hose air is not let out A from the cuff This may result in bad blood circulation in the arm causing peripheral functional disorder 34 Measurement Procedure Application of the ANKLE CUFF Cuff Selection Choosing an appropriate cuff for the patient is necessary to get an accurate measurement Choose a cuff appropriate for the patient according by referring to the table below To attach to the CUFF HOSE insert the hose and turn it clockwise to lock Ankle circumference Bladder width Name cm cm CUFF No 22 23 Standard accessory 23 to 33 13 CUFF No 25 26 Standard accessory 16 to 25 10 Choose the appropriate cuff to avoid any error caused by gap between cuff and ankle in the measurements If the cuff used is too large the blood pressure measurement may be N CAUTION lower than the actual value If the cuff
90. sage Content Status and Corrective Action PCG is stable Measurement can begin Initializing Checking the heart sound Remain at rest Signal Out of Range The sensor has been touched causing noise Remain at rest The PCG SENSOR is not adhering or the shirt or other clothing has come under it Make sure the PCG SENSOR is correctly adhering to the skin If correct adherence cannot be obtained use the PCG SENSOR WEIGHT page 41 The PCG SENSOR pad is dry or dirty 2 Replace with a new PCG SENSOR pad page 40 The PCG SENSOR has been applied upside down gt Apply the PCG SENSOR correctly Weak Signal A position where three or more level meters are flash ing is ideal Measurement is possible even if two or less are flashing However accuracy of measurement may be reduced Re position Sensor Application site is not suitable gt Position the PCG SENSOR in a better location page 40 For patients with cardiac murmur or respiratory noise it may be difficult to clearly distinguish the first and second heart sounds While this may cause reduction in accuracy measurement is still possible PCG Disconnected The PCG cable is disconnected Make sure that PCG cable is securely connected Measurement Procedure 49 Start of Measurement Measurement begins Note WB Measurement ends after either one or two measurements The second measurement is performed automatically under the following circumstan
91. storing the unit E Ambient temperatures decrease below 20 C or higher than 60 C or the humidity exceeds 9596 E A location where chemical products are stored B Environment with extremes of temperature If this unit is left exposed to direct strong sunlight or in a sun heated car the LCD becomes an isotopic liquid This process cannot be reversed and the display is rendered unusable Alternatively the case may become de formed leading to other problems If condensation is present on the unit disconnect the monitor from AC power and dry the unit with a dry cloth Condensation could lead to electric shock and other mechanical problems with the monitor While the monitor is in use constant monitoring of the unit will ensure user as well as patient safety In case of condensation inside the device remove AC cord from the device and dry inside enough before use Always grasp the plug or connector when disconnecting any of the cords Pulling on the cord could cause damage 2 8 Before Use CAUTIONS of Use AN Cautions are required for AC power plug in order to avoid electric shock and fire W Do not touch AC power plug with wet hands W Do not pull AC power cord while unplugging AC power plug B Unplug AC power plug from outlet when this device is not operated for long periods of time o S O When cleaning the unit avoid using any solvents like thinner or ben zene Cleaning with thes
92. surement Condition Input Procedure The device automatically starts the next measurement cycle after waiting for the Wait Time to elapse This sets the period between the end of the first measurement and the start of the second meas urement The default is 10 seconds but this can be adjusted in the range of 10 to 120 seconds if necessary in consideration of the patient s circulation This item is valid when the pulse wave unit TU 100 set only VP 2000 is installed For information about this setting and the measurement procedure see page 64 Use the jog dial to select the item to be set Push the jog dial The item will be highlighted Rotate the jog dial and select the desired numeral or selection Push the jog dial to confirm the selection Repeat steps 1 to 4 to make other settings Nun FW Ne When finished setting press CONFIRM F3 The pulse wave display screen will appear To cancel settings before finishing press Stop Switch 46 Measurement Procedure Screen Display Note d cu s M PCG OK HR 56 bpm Auto Sa ECG R Bra Press dip I cG J Jd dr Wr el P L Bra Press T ofl 0 R Bra mg R Ank Press R Ank mmHg L Ank Press L Ank 0 mmh Pacemaker SY condition D ECG Message Displays t
93. t these steps with the left ECG ELECTRODES CLIP Then remove the protection sheets from all 3 electrodes Use only Ag AgCl type monitaring electrode Application of electrodes E Do prep to the equipment surface as necessity E The sensor that has two electrodes is placed on the left side Wi Put electrodes on the inside of arms WB Make sure to adhere electrodes closely AD Right ECG ELECTRODES CLIP Left ECG ELECTRODES CLIP with one electrode with two electrodes 38 Measurement Procedure N CAUTION It would be impossible to inspect STI because of mismonitoring of R wave if the patient uses pace maker It would be impossible to correctly inspect PWV and STI because of improper reading of waves if the patient has medical history of ar rhythmia The conductive parts of ELECTRODES and associated connec tors for APPLIED PARTS including the NEUTRAL ELECTRODE should not contact other conductive parts including earth Even when reusing an ECG ELECTRODE CLIPS for the same pa tient replace the electrodes with new ones every time if the skin is moist injured or infected As a rule the ECG ELECTRODE CLIPS are applied to both arms but occasionally the ECG signal will be weak and measurement difficult When this happens place the electrodes for the left arm on top of those for the right arm secondary induction and measure The expiration date for wrist electrodes is printed on their pack aging If t
94. tative evaluation of cardiac functions The time from the opening of the aortic valve to the closing The regular value is 285 25 msec but may decrease with an increase in heart action Also it will increase with an increase in the heart contraction volume and decrease with a decrease in the heart contraction volume The time between electrical agitation in the heart chamber and the opening of the aortic valve The regular value is 96 10 msec It will increase with a decrease in the heart action or de crease with an acceleration of heart action The average value for a regular example is 2 94 0 54 Regular reaction 2 5 lt EET PEP lt 3 6 PEP lt 106 msec Volume reaction ET PEP _ 3 6 PEP lt 106 msec Heart action acceleration illness condition Pressure reaction ET PEP _ 2 5 PEP _106 msec Heart action reduction illness condition ET PEP shows the relation between Left Ventricular End Diastolic Volume LVEDP LVEDP Ejection Fraction EF Stroke Volume SV and Ventricular Contraction Fraction VCF The time from the start of the ECG Q wave to the closing of the aortic valve 11 beats ABI is found as shown below Ankle systolic pressure ABI Brachial systolic pressure By using the ABI Arteriosclerosis Obliterans can be diagnosed and the overall health condition of all heart blood vessels can be evaluated ABI is mainly used to evaluate Atherosclerosis find ing the inner radius of the blood vessel and b
95. the ankle protrusion on the in against the posterior tibial artery 1 side of the leg Do not allow the cuff to lie over the ankle W If the cuff position shifts the cuff will not detect the posterior tibial artery and accurate measurement will be impossible Be especially careful for patients with thin legs 4 Wrap the belt on the ankle side 2 then wrap the calf side belt 5 Allow enough slack to insert one finger between the leg and the cuff a m 96 Measurement Procedure The ANKLE CUFF can be used to take the measurements of patients with an ankle circumfer ence of 23 cm to 33 cm If a section of the index line 8 can be seen through the cuff s win dow 2 that measurements can be taken 5 Make sure the cuff does not shift downward The cuff should stop at the top of the protrud ing ankle bone Le Measurement Procedure 37 Application of ECG ELECTRODES CLIP Apply the ECG ELECTRODES CLIP to the patient s wrists There are different clips for the right and left arms Do not apply the wrong one When necessary wipe the application site with diluted antiseptic alcohol or a similar product Attaching electrodes to ECG ELECTRODES CLIPS Application of ECG ELECTRODES CLIP Press and hold the button placed on the side of the ECG ELECTRODES CLIP and insert one electrode to the right ECG ELECTRODES CLIP Release the button to fix the electrode to the clip Repea
96. ue will be displayed as is If measurement was not successful both the first and second times an error message will be displayed ABI Displays right and left ABI When blood pressure is measured at both arms the ABI is calculated from the highest brachial pressure value baPWV This displays the PWV value calculated from the time period from the start of the brachial pulse wave to the start of the ankle pulse wave HR Displays the heart rate from the R R interval obtained from ECG Graph This graph shows the relationship between baPWV and ABI Simultaneous phase display line This line expresses simultaneous phase measurement If the time phases do not match due to remeasurement or other reasons this line is not displayed Post Exer mode F1 Press this when successive exercise measurements will be performed Print F3 Press this to print additional copies of the analysis result sheet The number of copies can be set with the jog dial N CAUTION Do not turn off the power during printing CF memory may be bro ken Measurement Procedure 53 Printing Standard Pulse Wave Diagnosis Results Prints the analysis results saved on the medical device that performed JUN 28 2006 13 23 Di 0023 EM es Age 48 years Doctor 3 0 eos Height 176Em sw Weiglt 63 Qkgi39 m Examiner Name esos eceesee 2 Sex NMal BMI DOR pene ce PRATO hai dio EE
97. wall of the blood vessel is flat the inner pressure of the artery is communicated directly to the pressure sensor The pressure sensor contains a row of 15 ele ments The main unit of the BP 203RPEII analyzes the signal from the pressure sensor and from the 15 elements selects those in the most suitable position The pulse pressure measure ments from those elements are used in analysis Sensor frame Pressure La z LannnnnannannArhm Pressure sensor elements Skin Arterial wall Sensor area with 15 elements in a row 16 Outline CAP FAP SENSOR The SENSOR is primarily used on the tonometric sensor head for measurement of large arte Carotid Arterial Pulse rial pulse waves but it can be applied to other areas Femoral Anenal Pulse Tonometric sensor head Please equip with a protective cap j when not in use SPACER Thick SPACER Thin The SENSOR can be pressed down using the appropriate pressure if an attached spacer is inserted Use of a spacer stabilizes inclination Outline 17 The thicker SPACER is used for subjects with average weight im The thinner SPACER is used for subjects with avobe average weight C C If the BELT LOOP is attached to the FAP SENSOR it can be fixed to a strap The SENSOR head is made to be very precise and delicate AC AUTION Applying undue strength or treating it roughly may cause damage Please
98. witch Measurement was interrupted because it continued more than 160 seconds If the cuff inflation is not sufficient because the patient has pseudo high blood pressure caused by calcification measurement might not be possible Insufficient Cuff Pressure 5 Could not sufficiently inflate the cuff Pressure could not be well detected because the patient moved or pressure was applied to the outside of the cuff Have the patient rest quietly during measurement If the cuff is applied over a thick sock or other clothing remove the garment and reapply the cuff Make sure no outside pressure is applied to the cuff When simultaneous measurement has been set two successive measurements will be performed To stop measurement press the Stop Switch Measurement values are A measurement value was detected that exceeded measurable range displayed in blue on a Use the heartbeat graph to see if the measurement was performed correctly white background If the graph is not normal check cuff application and the patient s status then remeasure Unstable R R inteval An unstable R wave interval was detected Noise entered the signal because the patient moved Have the patient rest quietly during measurement Noise entered the signal because of severe arrhythmia or patient convulsions If there is severe arrhythmia measurement accuracy may be poor Judge the results after reading any error messages displayed after measurement Signal Out
99. y be reduced Take corrective action according to the content of the mes sage Message Content Status and Corrective Action ECG is stable Measurement can begin Initializing Checking the heart s electrical potential Remain at rest Unstable R R Interval The electrodes are dry or dirty gt Replace with new electrodes page 38 The patient is tensing the arm causing electromuscular effects gt Have the patient relax the arm and rest quietly Noise from radio interference is affecting the ECG waveform gt If a cell phone or other device is operating nearby move it farther away Only a weak signal can be obtained from the wrist gt Try placing the ECG ELECTRODES CLIP from the left wrist on top of the one on the right wrist secondary induction Check Electrodes No ECG ELECTRODE is placed in the ECG ELECTRODES CLIP Check Patient Electrodes Make sure that three wrist electrodes are securely placed page 38 R wave not Detected The ECG ELECTRODE still has its protective cover Remove the protective cover from the ECG ELEC TRODE page 38 An ECG CABLE is disconnected Make sure that all ECG CABLE are securely con nected 48 Measurement Procedure PCG Messages This section details the contents of the PCG messages When OK is not displayed measure ment will be impossible or accuracy may be reduced Take corrective action according to the content of the message Mes

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