NIBP100A MANUAL - NONINVASIVE BP MONITOR
Contents
1. Figure 6 Test Sensor Display Screen 1 Place the sensor end of the patient cable in the hanger on the left side panel of the unit as shown Loop the bale over the top of the hanger tab making sure the bottom of the sensor end of the patient cable engages the two locating pins of the hanger Ensure the sensor end of the patient cable wrist strap and cable hang freely from the hanger 2 Press TEST soft key and observe status message on top line of screen e If PASSED is displayed proceed to step 3 e If FAILED is displayed follow on screen instructions Figure 7 Sensor End of the Patient Cable amp Hanger 3 Remove from the hanger and place the sensor on the patient See Section 4 3 Note If the clock time in the upper right corner of the LCD is incorrect press the Set Up key four times followed by Select to set the correct time When set press Accept This is further described in Section 4 5 4 4 3 Sensor Application Process Once Test process has been completed the monitor will display the Waveform Trend screen Page 12 Select the correct placement guide and strap for your patient The NIBP100A comes with the Adult Normal Wrist Size Range installed and a handy Placement Guide Accessory Kit ay selection Measure your Patient s Adult Normal Large Adult Pediatric Black Guide Gray Guide Blue Guide Black Wrist Strap Black Wrist Strap Blue Wrist Strap Wrist Sizes Wrist Sizes Wrist Sizes2. c cece eee eee 31 4 8 3 HP Printer Installation ereere eerren 32 4 8 4 HP Printer Operation sc ccsscesvas lt seeesneviena ccd evenness soaceyes genes 32 4 8 5 Trend Printing Operation cece cece eee e eee eee enee ea enee 34 4 9 Data POUR S292 or ernearen nne oa Ate tetera ia els EEEN orbs Eat 34 4 10 Aen alos OUt eaaa E ai AEA E EEA RAAR ENOR EAEE RERA EEA 34 Section 5 System Features and Specifications sesesssssssssssrsssserrrrerrrees 35 5 1 System Feats Sr ee raa E E AEE E O EAE EIEE SERA 35 Page 1 5 2 Technical Specifications vscecceeexteuswivs sawangesedecencs sys eoaetetsaylasagsedd 36 5 3 Performance Specifications 03 vievveiosavnddevenseeicddeavetueaseeudeveybavicdns vac 37 Section 6 Troubleshooting 38 6 1 Troublesh tng ee an i E TE E aa E E E E EE ee ee tas 38 6 2 Error and Warning Messages ccecceeceeece eee eeeeeeeaeeeeeenaeeees 39 6 2 1 Non Recoverable Errors 00 cece eee e eee eeneeeeeeeeeeennaes 39 6 2 2 Recoverable Errors c cece cece eee e ee eea eee eeeeenaaeeeeeeeeens 41 Section 7 Maintenance and Care 0 cece cece cence cee n nee eee e eee n eae e eee eees 41 Jai SELVICE PONCY cigs thie be iesea EE AEA E E ER EOR 41 Joo Cleaning PrOCCdUIES 5 apace eneen e a EA AEE DEE EEREN TE E 42 Secti n 3 Warranty sao orrein an ra E N E See tans EE ERE RES ee ee D 43 8 1 One Year Limited Warranty 02 scescdsssaze ay yenardasi aeespeukade
3. 15 18 cm 18 22 cm 11 15 cm Wrist Circumference F Sensor Placement 1 To locate proper sensor position with one finger a palpate while you find the distal edge of the radius bone la 2 Place the sensor directly over this point b Secure the strap snugly c The Placement Guides are color coded and labeled for easy Figure 8 Correct Sensor Placement Figure 8 1 Securing the Velcro Strap 3 The green indicator lines on the placement guide and the sensor will align to the distal edge of the radius bone Figure 8 2 Place a finger through the access hole of the placement guide and feel the distal edge of the radius bone Verify your nylon Velcro strap is secure Note When set in the CONTINUAL cycle mode the NIBP100A is designed to obtain and update accurate blood pressure readings once every 12 15 heart beats Once the NIBP100A begins displaying blood pressure readings you should see updated readings every 12 15 seconds If the time lapse display is greater than the 12 15 seconds are check your placement Figure 8 2 Placement Verification Page 13 Sensor Application Process continued 4 Press start to begin monitoring Your first reading will take approximately fifteen heartbeats Start stop Figure 9 Start Monitoring 5 Always conclude the monitoring session by pressing the start stop key prior to removing sensor from patient Once the NIBP100A displays the initial pressu
4. to the data port of the NIBP100A Turn on the printer and then turn on the NIBP100A 4 8 4 HP Printer Operation For each print job the printer will print one page containing a header bar graph and table data Refer to a sample printout Figure 19 1 The header contains the date printed in the YY month DD format A Patient ID field and a Doctor field are provided for user completion The bar graph may have up to 24 bars that represent the data collected over the period of time the user previously selected The y axis scale represents pressure in mmHg and is set to 40 220 mmHg The x axis scale is set to the first and last times of the actual data available for printing The time of the data is represented as hours minutes A 1 is used when the data collection occurred over the midnight hour The bars have three hash marks The top hash mark denotes the systolic pressure the middle hash mark denotes the mean pressure and the lower hash mark denotes the diastolic pressure If any of these pressure values go beyond the graph scale of 40 220 mmHg the bars are clipped and a message Data exceeds graph scale is printed below the graph The table of pressure values contains up to 40 data values covering the time selected by the user The table data is organized in time sequence two columns each containing up to 20 readings printing from the left column to the right column A 1 is printed before a time value when the
5. 5 10 seconds No data has printed 345 350C 350Cbi 630C 640C or 648C Printer screen displays the CANCEL Verify the printer cable is P N 000 9017 key resets to Printer HP screen in 60 Verify NIBP100A is connected to HP DeskJet models 120 seconds No data has printed 345 648C or 952C Check printer cable connection Power printer off on Check printer is powered on Power printer off on Check paper in printer Power printer off on Check paper path clear Power printer off on 38 Page 6 2 Error and Warning Messages Error messages will appear on the LCD display to alert the user of system errors There are several system alarms to alert the operator to abnormal conditions with the internal system or with a particular reading System alarms fall in one of two categories 1 Recoverable and 2 Non Recoverable errors 6 2 1 Non Recoverable Errors All non recoverable errors will halt system operation and will require intervention by either the user or a service technician to repair or adjust the unit to eliminate the malfunction A screen error message will be displayed giving specific details of the error An alternating ON OFF alarm will sound in case of severe system hardware problems until the unit s power is switched off Certain non recoverable errors will cause the system to discontinue monitoring and switch itself to an auto shutdown screen In these cases the user may be able to remedy the cause of the error and
6. 7 Alarms The NIBP100A has both audible and visual alarms When an audible alarm can be silenced by pressing the MUTE key at any time except in the case of non recoverable system errors When the MUTE key is pressed the bell symbol in the upper right corner of the display will appear with an X through it In the case of patient alarms the pressure value that has set off an alarm will continue to flash until the condition is resolved even when the MUTE key has been pressed 4 7 1 Patient Alarms Defined as those alarms tripped when the patient s blood pressure or pulse rate goes above or below the predetermined limits See Section 4 5 3 for adjusting these limits Flashing Alarms Display Audible Alarms Blood pressure mean or pulse Indicated by for the Three 3 beeps pause two 2 rate reading is above or below corresponding pressure reading beeps pause three 3 beeps the set limits pause two 2 beeps repeated every 15 seconds until muted or until the condition causing the alarm is corrected 4 7 2 System Alarms The NIBP1OOA has an alarm that activates when multiple readings have been missed and takes certain actions to inform the user of its findings Sweep Cycle Time Flashing Monitoring Stops Continual 10 seconds Cycle time 3 minute Cycle time 10 minutes Cycle time 3 minute Cycle time 10 minutes Cycle time 3 minutes Cycle time 10 minutes Cycle time 3 minute Cycle
7. Procedures The monitor sensor placement guide and patient cable may be cleaned on an as needed basis To clean the monitor sensor placement guide and or patient cable dampen a cloth with a commercial nonabrasive cleaner and wipe the surfaces lightly Always apply the solution to the cloth not directly to the monitor placement guide sensor and or patient cable Do not immerse any part of the NIBP100A system Page 42 Section 8 WARRANTY 8 1 ONE YEAR LIMITED WARRANTY FOR THE NIBP100A UNIT EQUIPMENT The NIBP100A Blood Pressure Monitor consists of 1 monitor 2 patient cable and 3 power cord Here after referred to as the System WARNING Medwave Inc makes no representation or warranty as to the effectiveness of the System as a treatment LIMITATIONS The System is sold in an as is condition The entire risk as to the quality and performance of the System is with the buyer except to the extent set forth in the LIMITED WARRANTY This Limited Warranty is expressed or implied including any implied warranty of merchantability or fitness for a particular purpose whether arising from statute common law custom or otherwise The remedies set forth in this Limited Warranty shall be the exclusive remedy available to any person No person has any authority to bind Medwave Inc to any representation condition or warranty except this Limited Warranty Some states do not allow limitations on how long an implied warranty lasts so t
8. Test PROCESS eis nas aig ualayy aneu ne lavaseads ave ub vagh lt ueanakavaysoauass ANE ANETE Aa 12 4 3 Sensor Application Process cecce eee e ence eee eeneeeeeeeeaeeenee enna eens 12 4 4 Display Screens wyiajscc sss ccvachareaveideeg veavasataressaabarecavaghasonvesneuieg eens 16 4 4 1 Waveform Trend Display Screen c ce eeee ence eee eee ee ees 17 4 4 2 Table Display Screens ics cccgccsieks cesaasrasvexran sansa cmmanaeasenneeys 18 4 4 3 Graphical Reading Display 00 ccc eee ence eee e eect ee eeneenaeeeaeees 19 4 4 4 Real Time Display sc cevesy cs ecg cnn dese ees ep tic ee cone wees Cavey s daa Vea eenan geese 20 45 Set Up Screensav cs ceviaccavesdoadacs ceseys cas spe cvvavecaeaskecereesseteesmntesyecs 21 AD NAV CIE Screen See putea a a E E E E ee 21 AD Sensor HEINE Scree eonna a ea a a eae een Re 22 4 5 5 Alarm Set Up Screens reser ess E ter ai EEEE 23 4NA Set Clock Sereen aitsrnooens r E E E aE 24 AO Special SerecnS ris e e a ANE E E 25 4 6 1 GSD or TP245 Print Sheen 255605 chee exeepcke ey eeeenyed es 26 402 HP PRM Sereen ni a sce E teen E E aia 27 4 KAVAS ae i g eae ug REE EE E ETS A TEELE EE cate 29 ATA Patient Alarms enin a EE AA E EEOAE 29 4 T72 SVEN Alaris ener eera e eos EE N tales 29 4 8 Printet eserse e a a a E e EE Gide a a npe Ee e int 30 4 8 1 TP201 Printer Installation cece eee eee cence een e eee ees 30 4 8 2 TP201 or TP245 Printer Operation
9. become defective within the warranty period or at Medwave Inc s discretion it may elect to supply a substantially similar new or equivalent replacement sensor or refund the price as of the date of system sale in lieu of repairing or replacing any defective part or parts in such sensor To qualify for such repair replacement or refund the defective sensor must be returned within thirty 30 days after discovery of the defect Such repair replacement or refund obligation does not apply to any sensor which has been repaired or altered outside of Medwave Inc s facility in anyway so as in the judgment of Medwave Inc to affect its stability and reliability or which has been subjected to misuse negligence or accident including but not limited to membrane damage from sharp objects or submersion of sensor into any kind of fluid MISCELLANEOUS A Medwave Inc shall not be liable for any medical expenses or any damages resulting from or caused by any defect failure or malfunction of the System whether a claim for such damages is based upon warranty contract tort or otherwise However some states do not allow the exclusion of incidental or consequential damages so the above limitations may not apply to you B This Warranty gives you specific legal rights and you may have other rights which vary from state to state 8 2 Contact Information Ditributor BIOPAC Systems Inc Address 42 Aero Camino Goleta CA 93117 Telepho
10. data collection occurred over the midnight hour The time field is followed by pressure values in mmHg and the heart rate in beats per minute NOTE The date and time of the first table entry may not coincide with the PRINT FROM date and time of the PRINT screen Remember if data is not available in the memory of the NIBP100A for the TOT DATA selection then the first table entry will correspond to the time of the oldest data record available Page 32 Vasotrac APM205A Date 00 SEP 25 Patient Id Doctor 220 mmHg 100 40 23 40 time 1 00 40 Data exceeds graph scale only printed if systole mean or diastole values exceed the graph scale of 40 220mmHg time syst dias mean HR time syst dias mean HR 23 39 123 85 105 78 00 23 150 102 125 71 23 42 121 85 103 77 00 26 142 96 123 75 23 45 120 88 108 76 00 29 139 100 120 74 23 47 117 82 100 73 00 32 139 91 112 76 23 50 121 86 105 76 00 35 133 95 115 78 23 53 126 81 101 77 00 37 130 87 111 73 23 56 129 88 108 78 00 40 130 82 107 75 23 58 133 92 115 74 1 00 01 133 93 115 76 00 03 127 91 110 79 00 06 133 90 112 72 00 09 137 86 115 77 Figure 19 1 HP Printout 00 11 134 93 115 74 00 14 137 100 117 72 00 17 145 98 120 75 00 20 143 99 119 74 Page 33 4 8 5 Trend Printing Operation The operator may choose to print data when monitoring is complete using the data stored in the tabular trend table Section 4 8 describes the screen and keys necessary to print
11. for general purpose computer such as a personal computer interface Details on GSD is described in Appendix A HP is an option to print data on a Hewlett Packard DeskJet s printer To activate this option please call Medwave s Technical Support Department at 800 894 7601 You will find additional information on HP Printer Selections in Section 4 6 2 and Section 4 8 4 If NONE is selected the print screen will be bypassed when using the setup key Make sure power is off to the NIBP100A before attaching the printer The TP245 printer will have a mounting bracket The TP245 printer has dual lock fasteners Either printer mounts to the top of the top of the NIBP100A to the right side as shown by inserting the clip in the slots on the rear of the device and then slipping the bracket hooks over the front edge of the monitor The cable should be attached and the screws secured finger tight only Use only the Medwave supplied cable 131 0014 It has been specifically designed to supply power to the printer Figure 18 Printer Installation rear view Page 30 4 8 2 TP245 Printer Operation To activate the TP201 or the TP245 printer move the printer power switch to the middle position The printer is powered from the NIBP100A so it may be turned on before or after power is applied to the NIBP100A One blank line is printed when the printer is turned on When printing begins the printer will print a standard header w
12. time 10 minutes Cycle time 3 minutes ycle time 10 minutes The NIBP100A may be equipped with an optional printer The printer is attached to the top of the NIBP100A with a bracket and is connected by cable to the Data Port on the rear of the device Refer to Figure 18 Page 29 4 8 Printer You may need to initially configure your NIBPIOOA This is done by holding down the start stop key while turning on the NIBP100A power switch A brief message will appear on the Self Test screen which should show one of the following PRINTER TP245 or PRINTER GSD or PRINTER HP or PRINTER NONE release the key at this point The message indicates either thermal printer TP245 or general serial device GSD described in appendix A Hewlett Packard DeskJet printer HP To activate the HP option please call Medwave s Technical Support Department at 800 894 7601 or no printer NONE was selected You will need to power off power on while holding down the start stop key to toggle between PRINTER TP245 or PRINTER GSD or PRINTER HP or PRINTER NONE selections Your selection will be stored in memory 4 8 1 TP245 Printer Installation You need the PRINTER TP245 to connect to the Medwave printer 400 0011 If the NIBPIOOA is set for GSD or HP data will appear garbled on the printer or the print setup screen If the NIBPIOOA is set for NONE the Print screen will not appear GSD is an option
13. weaeesnesee OSes 44 8 2 Contact Information ccc cece cece eee e ence cece ee en este eee eeenea antes 44 Section 9 Accessories and Supply Information c sce eee sees cence eee een ens 44 Appendix A Computer Interface cece seen nena ee 46 Appendix B Real Time Screen Output 0 eee 48 Appendix C Replacing the Sensor eseeee eee eee es 50 Appendix F Wrist Strap Replacement e eee 51 Index of Figures FIGURE 1 FRONT PANEL 00000000 eee 6 FIGURE 2 REAR PANEL 00 ceeeeeeeeees 7 FIGURE 3 LEFT SIDEPANEL 065 7 FIGURE 4 RIGHT SIDE PANEL 06 8 FIGURE 5 SENSOR END OF PATIENT CABLE 000cceeeeeeeeeeees 8 FIGURE 6 TEST SENSOR DISPLAY SENSOR 00cceeeseeeeeeeeees 12 FIGURE 7 SENSOR END OF PATIENT CABLE amp HANGER 12 FIGURE 8 CORRECT SENSOR PLACEMENT 00cceeeeeeeeeeenees 13 FIGURE 8 1 SECURING THE VELCRO STRAP ccceceecccceeeeeeeees 13 FIGURE 8 2 PLACEMENT VERIFICATION 0 ceeeceeeeeeeeeeeeeees 13 FIGURE 9 START MONITORING 00cccccccceeeseeecececeeeueneeseus 14 FIGURE 10 WAVEFORM TREND DISPLAY SCREEN 00000000000 17 FIGURE 11 TABLE TREND DISPLAY SCREEN 00cceeeeeeeeeeees 18 FIGURE 12 CYCLE SCREEN ccccsececccccceeeenecececeeeeunnecsees 21 FIGURE 13 SENSOR HEIGHT SCREEN cccceeeeccccceee
14. 1 Operator s Manual 797 0025 Your Patient Cable comes installed with a 1 Adult Normal Placement Guide for Wrist Sizes 15 18 cm 1 Sensor 000 9032 and 1 Adult Wrist Strap The sensor must be replaced every 6 months Sensor replacement programs are available through Medwave or an authorized Medwave Distribution Partner 1 Unpack the NIBP100A System Verify that all your components are included Place the unit on a firm flat surface The vents at the back and bottom must be free of obstructions Attach the power cord to the receptacle on the back panel directly below the power switch Plug the power cord into an appropriate outlet Verify the Patient Cable is plugged into the connector located just below the power cord connection Turn the unit on The power switch is located in the back of the unit just above the power cord The NIBP100A automatically performs a Self Test before displaying the Test Sensor Screen Proceed to TEST Process Section 4 2 Page 11 4 2 TEST Process A TEST process is required each morning after 5 00 AM prior to use or when a new sensor or patient cable is attached or when damage to the sensor or patient cable is suspected This TEST will check the integrity of the sensor This screen will also display the number of days until the sensor expires Once TEST process is completed it is not affected by loss of power TEST SENSOR Status WAITING 16 66 1 Install an its_h lt
15. 1 Warnings Carefully read all of the instructions and precautions described in this manual prior to clinical use of the NIBP100A Noninvasive Blood Pressure Monitoring System 1 Place the NIBP100A system on a firm flat surface assuring that the vents on the back and bottom panels are free of obstructions 2 NIBP100A sensors are not sterile devices and should not be sterilized ETO or autoclaving will damage sensors 3 Using the NIBP1OOA in the presence of flammable anesthetics represent an explosion hazard 4 A power interruption will cause the NIBP100A system to stop monitoring 5 Proper functioning of NIBP100A requires pulsatile arterial flow The NIBP100A cannot be used during cardiopulmonary bypass or cardiopulmonary resuscitation 6 The NIBPIOOA system is to be used only by trained medical personnel 1 2 Precautions and Limitations 1 The NIBP100A may not operate effectively on patients experiencing tremors arrhythmias or excessive movement 2 The NIBPIOOA is not intended for use on patients during cardiopulmonary bypass 3 To measure central pressure the sensor must be at heart level to compensate for the difference in the NIBP100A reading due to the hydrostatic pressure differences Approximate rule for every 1 above or below heart level the sensor 1 90mmHg should be added or subtracted to the displayed reading 4 Ifa NIBPIOOA reading does not appear to correspond with other physiological parameters e Ve
16. 100mmHg approximately Both S and S are driven by an op amp with 33 ohm resistors in series with each output This is to provide balanced impedance to the external recording device as well as to provide short circuit protection and stability with capacitive loads Note the signals are not isolated so the user should be aware that this jack is a potential path for leakage currents from the external device T O Port Pin Connections ene unction Description E BEANE e Page 49 Appendix C NIBP100A Replacing the Sensor on the Sensor Holder To remove the sensor from the sensor holder grasp the sensor holder in the palm of your hand label facing up With one hand place your thumb over the flex cable Figure 20 With the other hand slowly lift and pull up the edge of the Medwave label The flex cable will disconnect from the flex cable connector slot and come up with the label Turn the sensor over bubble side up Remove sensor from holder by pulling up from post ector slot Figure 21 Figure Z3 Page 50 Figure 20 To replace the sensor position the new sensor on post Figure 21 bubble side away from post Press firmly You should feel the sensor click into position Conductor end of flex cable Figure 22 Thread the flex cable through the arm relief of the sensor holder Figure 22 Line up the flex cable with cable cut out of the sensor holder Plug conductor end into the flex cable connector sl
17. 4 6 1 Cycle Setup Pressure accuracy specifications are based on clinical data The pressure range of this clinical data was less thahe range min max specification Page 37 SECTION 6 TROUBLESHOOTING 6 1 Troubleshooting Guide If the NIBP100A is unable to take pressure readings the pressure and heart rate numeric displays will all flash in unison In the case of certain errors the NIBP1O0A will automatically discontinue monitoring In either of these two cases the user should then make an assessment of the system to look for one or more of the following possible causes Possible Solution Artifact caused by patient movement Immobilize the patient s arm Improper strap tension Tighten or loosen strap as directed by screen instructions Verify patient s wrist size is in range of Placement Guide and Wrist Strap in Use Check the placement of the sensor on the patient refer to Section 4 4 other than the strap Check the sensor for leaks Replace the sensor and run the failure TEST process No Display Check Contrast Dial Check Power Cords Plug and Power Connection Check On Off Switch Check Sensor Placement No Signal Display Check Sensor Connections Check Sensor Wires For Breaks Check Sensor Placement Runs Self Test Check Patient Cable for Breaks Printer screen error displayed HP Verify the printer cable is P N 000 9017 offline Resets to Printer HP screen Verify NIBP100A is connected to HP DeskJet models in
18. NIBP100A MANUAL NONINVASIVE BP MONITOR Section Safety COMSIGeralions sercc ie scevdaaayovee eee see dee ws sewosn wads evenceba cide we 4 Lak Warnes cconetaachyssaktesauevgaxeveagene we r imacarvedeosngawewee 4 1 2 Precautions and Limitations vy acauesdenadsackodavdeg nabva duavehetd dee oaandeates 4 Section 2 IMerOd UCU ON esd euschopesecutusb sire teat uray eseeh vondunteeeeeeesueamublyasiedyiuet 5 Ari Intended USS risser re pae enere tase REESS tat aunts 5 2 2 General Desp O vs a TAE tea EE AREE AALIS ESE EE SPIRER ths 5 Section 3 Displays Keys and Connectors cccceeeee eee eeeeeeeeeaeeeaeeenaes 6 Dail Front Panela wawaaag dick ae ea aioe denne aaea dente ad pnesawade weer aan EEr OE 6 3 2 Rear Panele oy oss bos EE shee EI eR I Reem ANT ODAS 7 De De La wis sich E A E E ETT T 3 4 Sensor End of Patient Cables ccviG ses is naceedaesie seas ae sedaneneneeese ciate ee 8 3 5 Description of Dedicated Keys nereveas deer secu esasde sts aun scdgtennaszaedes 9 3 6 Description of Soft KEYS iis cceccc oud cn vis da tedden deenaase dees bes convenes escenatens 9 3 7 Description of Display Contrast Dial cee eee ee sees cence eee ne eens 10 3 8 Description of Audible Indicators cc cee cee eee ene ee eeeeeneeeeeeenes 10 section 4 Set Up and Usase ys seis desea vs dedkeunsecaviaes vrais ceaade ciandasses tegeaudevnte 11 4 1 Initial SetU Pien aicrxsenssnrmacasaa traverse eeavsiaananveaied shane savenad av EONA 11 4 2
19. NIBP1O0A for a printer option TP245 245 GSD or HP see Section 4 8 for details The PRINT screen allows for selecting printing mode and for tabular trend table Table Display Section 4 4 2 data to be printed if the NIBP100A System is equipped with a printer The screen will display initial time values for the printing from when the unit was turned on to the current time Press PRINT NOW to print the tabular data since the unit was last turned on in 5 minute increments The NIBPIOOAA may continue to be used while the printer is in operation The top line of the screen will indicate the printer type The printer type is stored permanently in memory however there is a provision for connecting to other equipment If you wish to connect the NIBP100A to a general purpose computer with an RS232 serial port see Appendix A Figure 17 Print Screen Trend Print Mode Selected PRINT MODE Choices are Trend print or Print as BP s occur Trend print is the default value after power up In this mode pressure readings from the tabular trend table will be sent to the printer only when the PRINT NOW key is pressed When Print as BP s occur mode is selected each successful blood pressure BP determination will be sent to the printer immediately Trend printing is not available in this mode so the system soft keys are blanked accordingly and the trend time selections are labeled inactive PRINT FR
20. OM Indicates the time of the oldest data to be printed Default value is when the unit was most recently turned on May be changed in 1 hour increments with the INCREMENT or DECREMENT keys but may not be decreased past the oldest data in the trend table nor increased past the PRINT TO time Page 26 GSD or TP245 Print Screen continued TO Indicates the time of the most recent data to be printed Default value is the current time May be changed with the INCREASE or DECREASE keys like the PRINT FROM time field but may not be increased past the current time nor decreased closer than 30 minutes to the PRINT FROM time INTERVAL Indicates the tabular trend table from which data is printed Default is 5 minutes Choices are the same as the tabular trend tables 1 3 5 15 or All readings May be changed with the INCREASE or DECREASE keys GSD or TP245 Print Screen Soft Key Descriptions SELECT Moves cursor to the desired parameter MODE PRINT FROM TO or INTERVAL MODE Toggles the printer mode Choices are Trend print or Print as BP s occur Trend print is the default value after power up In this mode pressure readings from the tabular trend table will be sent to the printer only when the PRINT NOW key is pressed When Print as BP s occur mode is selected each successful blood pressure BP determination will be sent to the printer immediately Trend printing is not available in this m
21. Verify strap tension discontinues pressure monitoring Verify position of patient Press Start Stop key to proceed If error persists pull NIBP100A from service and contact service representative WRIST UNIT Failed During power on self test or during use the Remove sensor from patient Power NIBP100A was unable to detect the full Off On If error persists pull the extension of the sensor end of the patient cable NIBP1OOA from service and call authorized service rep LOOSEN REMOVE After a WRIST UNIT Failed error the pressure on Loosen and or remove the strap from STRAP the patient s wrist as measured by the sensor is not the patient s wrist low enough 40Page 6 2 2 Recoverable Errors These errors will not halt system operation but will prevent any new pressure values from being displayed until the cause of the error is remedied If consecutive recoverable errors last longer than 70 seconds at the minimum cycle time setting a message on the LCD will indicate the time when the last valid reading occurred and the LED s will flash until the error has recovered The LCD display is the error message area The message displayed will be the highest priority message which occurred since power on in the case of non recoverable errors or since the previous sweep in case of recoverable errors SECTION 7 MAINTENANCE AND CARE 7 1 Service Policy The monitor portion of the NIBP100A does not require any rou
22. ally discontinues pressure sensor cable for damage For repair or monitoring replacement contact an authorized service technician Page 39 NownncovemanmemmRoRs SSCS ERROR MESSAGE CAUSE BAD VOLTAGE An internal power supply is at an incorrect Inspect sensor and patient cable voltage The system automatically cord for cuts and or fraying discontinues pressure monitoring Replace any damaged parts Press Start Stop key to proceed If error persists pull the NIBP100A from service and call an authorized BIOPAC service representative NO READINGS Consecutive invalid readings have occurred Verify proper sensor placement for 10 minutes Verify strap tension Verify position of patient Verify wrist is not in motion Press Start Stop key to proceed If error persists pull NIBP100A from service and contact service representative SENSOR FAILURE ERROR A105 has repeated for 4 consecutive Run a Zero Test Procedure sweeps This is caused by an incorrect Inspect the sensor for leaks If relationship on the main and auxiliary pressure leaks are detected or the sensor sensors Indicates a sensor leak fails the plate test replace the sensor SIGNAL HIGH Sensor pressure on the patient has gone above Verify sensor plugs into the its allowed limits for 10 beats or 19 seconds patient cable housing Verify Generally indicates damaged or missing patient cable is connected to the components The system automatically monitor
23. e trend data including waveform and graphical trend data When this option is selected a confirmation notice is displayed with YES and NO options If YES is chosen the data is erased if NO is chosen you are taken back to the trend screen TABLES Allows the user to change the frequency of data displayed All readings 1 minute 3 minutes 5 minutes and 15 minutes Page 18 4 4 3 Graphical Reading Display The Graphical Reading Display Screen displays the patient s blood pressure mean and pulse rate in graphical forms over a selected period of time tandby 15 MIN 4 GRAPH 10 14 08 35 to 68 50 i 4 E s i J MEAN PULSE Figure 11 10 15 Min S D Graph Display MEAN User is able to view graphical display of Mean Pressure readings SYS DIA User is able to view graphical display of Systolic and Diastolic readings PULSE User is able to view graphical display of Pulse readings TIME Changes the increments that are displayed on the graph Toggles through display increments of 15 30 minutes 1 2 4 8 hour Page 19 4 4 4 Real Time Display The Real Time Display Screen displays the pressure signal as produced by the sweeping motor activity This signal is NOT the patient s blood pressure waveform in mmHg The pressure graphically displayed is the amount of pressure being sweeped against the patient s wrist Figure 11 20 Real Time Display Screen SCALE Reduces the graphical scale to provide maximum viewin
24. ended for use by competent trained healthcare providers that will determine a diagnosis based on many factors of which the NIBP100A is one component Incorrect readings due to such things as motion artifact are expected to be disregarded by the practitioner The sensor placement and associated extremity should be periodically checked when the NIBP100A is used over a prolonged period of time 2 2 General Description The NIBP1OOA system is a non invasive blood pressure monitor that uses a pressure sensor placed directly on top of the radial artery This sensor is noninvasive and eliminates the need for an occlusive inflatable cuff This device is intended to be used on patients by medical personnel to continually monitor systolic diastolic and mean blood pressure and pulse rate The NIBPIOOA uses a patented sweep technique which applies a varying force on the radial artery The counterpressure in the artery produces a signal which is digitized and used to calculate blood pressure parameters The sensor measures the pulse at the point of maximum energy transfer the wave shapes are analyzed by Medwave s proprietary algorithms Parameters are extracted from the waveforms and a set of coefficients are applied to them yielding systolic mean and diastolic pressures approximately every 15 heart beats These algorithms have been tested and validated in clinical studies by synchronized comparisons to arterial line pressure waveforms Patien
25. eneeesees 22 FIGURE 14 WAVEFORM TREND SCREEN WITH SENSOR HEIGHT 22 NCONE odee a es ti ors el ade tan eels te de diate Sete de takes FIGURE 15 ALARM SET UIP SCREEN ss0ccceeccscecccseeeceeesass 23 FIGURE 16 SET CLOCK SCREEN cccccccceseeeecccccceeeueesveeeseees 24 FIGURE 17 PRINT SCREEN TREND PRINT 000cceeeeeeeeeees 26 FIGURE 17 1 HP PRINT SCREEN cccccccceeeeeeecceceeeeueuees 28 FIGURE 18 PRINTER INSTALLATION 000cceeeeeeeeeeeeeeneeees 30 FIGURE 19 TP 201 OR TP245 PRINTOUT 0008 31 Page 2 Index of Figures continued FIGURE 19 1 HP PRINTOUT 0000 cece cece eee e cece cece eee eeeeeee ees 33 FIGURE 21 WRIST PIECE SENSOR SLOT 000eeeeeeeeeeeeeeeeeeeees 49 FIGURE 22 WRIST PIECE CONDUCTOR END OF CABLE 000008 49 FIGURE 23 INSTALLED SENSOR cc ccc cece cece sees eee e essen eee eee 49 FIGURE 23 1 PLACEMENT GUIDE INSTALLATION 0000005 50 FIGURE 24 POLE BRACKET INSTALLATION 000cceceeeeeeeeeeees 51 FIGURE 25 POLE ADAPTER INSTALLATION ccccscccceeeeeeeeee sees 51 FIGURE 26 WRIST STRAP INSTALLATION ccc cece cece eee e eee ens 52 FIGURE 27 SECURING THE INSTALLED WRIST STRAP 00cc0ee0000s 52 FIGURE 28 MEASURE YOUR PATIENT WRIST CIRCUMFERENCE 52 Revision History B 99085 COLI D oooss Cf SOI Page 3 SECTION 1 SAFETY CONSIDERATIONS 1
26. ent for 5 readings to establish a baseline prior to selecting HMT ON Always secure 4 6 of the patient cable to the patient s forearm to prevent excessive cable movement For those caregivers who have a specific and predictable patient activity monitoring session HMT AUTO may be your choice Press the soft key below the screen prompt The HMT OFF and scroll to the HMT AUTO prompt Insure that your patient is resting or is in little or no motion Complete five consecutive readings After the fifth reading is displayed you will not be required to press a soft key the high motion tolerant filter is activated automatically Remember your patient must begin the higher constant motion OO 08 Lapsed time since displayed reading Inactive Key Note While monitoring if no keys are pressed for a period longer than one minute the NIBP100A automatically reverts back to the Waveform Trend Screen Note When the sensor height option is selected and in use the sensor height icon will appear on the left hand side of screen Refer to Figure 13 Page 17 4 4 2 Table Display Screen The Tabular Trend Display Screen displays the patient s blood pressure mean and pulse rate in tabular form This screen is selected by toggling the Display Key Figure 11 Table Trend Display Screen SCAN FWD Allows the user to scroll forward in time SCAN BACK Allows the user to scroll back in time to view previous readings CLEAR Eases all of th
27. esigned for continuous usage as programmed by the user Equipment is not suitable for use in the presence of a flammable anaesthetic mixture See warnings section The monitor has line voltage present inside the case Refer servicing to a qualified technician C 0123 Marking by this symbol indicates compliance with the medical Device directive 93 42 EE Electrical Input 100 240 VAC 50 60 Hz 0 25 0 5 Amp Fusing Two 5x20mm 2 Amp fast acting 250 volt Recommended replacements Littlefuse series 217 or 235 Wickmann series 191 or 19193 or Bussmann series GMA or GDB Electromagnetic Compatibility Complies with the requirements of IEC 601 1 2 1993 for electromagnetic emissions and immunity Environmental Operating Temperature 10 C to 40 C 50 F to 104 F Humidity 10 to 90 RH non condensing Environmental Storage amp Transport Temperature 20 C to 70 C 4 F to 158 F Humidity 10 to 90 RH non condensing Equipment Interface Data Port RS232 25 Pin RS 232 see appendix A for details Analog I O Standard Phone Jack see Appendix B for details Page 36 5 3 Performance Specification Performance Range Accuracy Min Max Systolic 40 mmHg 240 mmHg 5 mmHg SD 8 mmHg Mean 30 mmHg 200 mmHg 5 mmHg SD 8 mmHg Diastolic 20 mmHg 180 mmHg 5 mmHg SD 8 mmHg Pulse 40 bpm 200 bpm 5 bpm or 10 Trend Updated tabular following each reading approximately 900 readings Blood pressure measureme
28. g of signal SCALE fl Increases the graphical scale to provide Minimum viewing of signal ERRORS Accesses a numeric coded error log for troubleshooting technical phone support Page 20 4 5 Set Up Screens SET UP MODES Repeatedly pressing the SET UP key scrolls through five different screens Cycle See Section 4 5 1 Sensor Height See Section 4 5 2 Alarms See Section 4 5 3 Set Clock See Section 4 5 4 Printer if option is enabled see Section 4 6 1 4 5 1 CYCLE Screen The CYCLE Screen allows the user to select the length of time between pressure measurements You may make an immediate STAT measurement except in the continual mode CYCLE Adjusts the time between pressure measurements Cycle Time is CONTINUAL 1 minute 3 minutes 5 minutes or 15 minutes This value is stored and selected whenever power is cycled STAT Takes continual readings for one minute then reverts to previously set cycle time These three dashes will appear when STAT key is inactive Page 21 4 5 2 SENSOR HEIGHT Screen To measure central pressure the sensor must be at heart level to compensate for the difference in the NIBP100A reading due to the hydrostatic pressure differences Approximate rule for every 1 above or below heart level the sensor 1 90mmHg should be added or subtracted to the displayed reading The SENSOR HEIGHT Screen allows the user to enter the height difference between the wrist sensor and the heart level The range i
29. gram to view and or store the data on a personal computer For example with Windows 95 run HyperTerminal and configure for a direct connection to a port such as COM1 or COM2 Configure the port settings for 9600 baud 8 data bits no parity and 1 stop bit You may use the capture text option to record data to a file Data transfer is initiated on the NIBP100A by using the printer control screens use PRINT NOW key or change mode to Print as BPs Occur even though the NIBP100A is really connected to a computer Page 48 Appendix B NIBP100A Real Time Screen Output Introduction The 4 phone jack connector labeled Analog I O on the rear of the NIBP100A may be used for viewing or recording the signal displayed on the Real Time screen This appendix describes the signal at the jack The jack uses a standard 4 stereo phone plug See chart below for pin definitions A shielded cable is recommended Medwave does not provide this cable nor does Medwave provide any recording equipment The sleeve is tied to the chassis of the NIBP100A which is grounded through the power cord It may be used to connect to a cable shield It is recommended the cable shield be tied to the chassis of the NIBP100A or the external equipment but not both Tying to both may result in undesirable ground loops and possibly leakage currents in excess of medical standards The I O port S signal ranges from approximately 0 to 3 volts with a scale of 1 volt per
30. he above limitation may not apply to you DISCLAIMER LIMITED WARRANTY ON MONITOR Medwave Inc warrants the monitor to be free from defects in material and workmanship for one 1 year following the delivery of the monitor to the original purchaser Medwave Inc shall repair or replace any part or parts of the monitor upon which Medwave Inc s examination shall disclose to have become defective within the warranty period or at Medwave Inc s discretion it may elect to supply a substantially similar new or equivalent replacement monitor or refund the price as of the date of the System sale in lieu of repairing or replacing any defective part or parts in such monitor To qualify for such repair replacement or refund the defective monitor must be returned within thirty 30 days after discovery of the defect Such repair replacement or refund obligation does not apply to any monitor which has been repaired or altered outside of Medwave Inc facility in any way so as in the judgment of Medwave Inc to affect its stability and reliability or which has been subjected to misuse negligence or accident Page 43 LIMITED WARRANTY ON SENSORS Medwave Inc warrants the sensor to be free from defects in material and workmanship for three 3 months following the delivery of the sensor to the original purchaser Medwave Inc shall repair or replace any part or parts of the sensor upon which Medwave Inc s examination shall disclose to have
31. he user to enter the height difference between the wrist sensor and the heart level Alarm Setup Allows for selection of alarm values for Systolic Diastolic and Mean blood pressures and Pulse rate other than default values Set Clock Allows the user to set the internal clock to the correct time Printer Allows the user to select the printing mode for the optional printer Located on the LOWER RIGHT corner of the front panel Pa MUTE Silences the audible alarm for all recoverable mute errors The bell symbol in the upper right corner of the d display will appear with an X through it when the MUTE is activated 3 6 Description of Soft Keys Soft Keys function with different menus The screen label above the key indicates its function These keys are not touch screen keys Page 9 3 7 Description of Display Contrast Dial CONTRAST The Display Contrast Dial is used to adjust the on screen clarity i It is located on the lower right side of the unit 3 8 Description of Audible Indicators The list below represents tones for which there is no accompanying symbol or button One 1 second beep when the unit turned on Refer to Section 4 7 for further description of alarms Page 10 SECTION 4 SET UP amp USAGE 4 1 Initial Set Up The NIBP100A System consists of 1 Monitor 400 0051 1 Patient Cable 000 9002 1 Power Cord 131 0011 1 Placement Guide and 1 Placement Guide Kit and
32. ith information as follows Medwave Vasotrac APM205A Patient Physician Procedure mmHg 20 60 100 140 180 time sys dia bpm map Figure 19 TP201 or TP245 Printout Whenever pressures are printed the value will be printed as follows Date 97 OCT 14 14 22 110 68 v 66 91 14 22 Ipa 122 82 v 72 101 The graphic values will be lined vertically with the scale such that if the paper strip is turned sideways a graphical trend can be discerned The is diastolic pressure is mean arterial pressure map is systolic pressure and is the pulse in beats per minute bpm The numeric values are shown to the right of the graphic portion per the legend in the header Page 31 4 8 3 HP Printer Installation You need PRINTER HP to connect to the HP DeskJet printer If the NIBP100A is set for GSD or TP245 data will appear garbled on the printer If NONE is selected the HP Print screen will be bypassed when using the setup key Disconnect the NIBP100A from the patient Move the HP Desk Jet printer away from the patient Make sure the power is off to the NIBPIOOA and the HP DeskJet printer before connecting Use only the P N 000 9017 HP printer cable provided by Medwave Inc to connect to HP DeskJet models 345 350C 350Cbi 630C 640C or 648C Connect the end marked PRINTER to the parallel port of the printer Connect the end marked VASOTRAC
33. its no parity and 1 stop bit The data is transmitted at 9600 baud but with one character sent every 128 of a second This is slow enough that handshaking is generally not required by the external computer but the NIBP100A does respond to CTS handshaking CTS must be active or the NIBP100A will wait indefinitely If your computer does not provide CTS simply tie RTS to CTS in the connector housing at the NIBP100A Page 46 Warning As shipped from the factory the data port is not electrically isolated since power is brought out for the optional thermal printer Any leakage current sourced by the external computer will be accessible on the NIBP100A enclosure Contact Medwave if you require an isolated serial data port Software Requirements You will need to configure the NIBP100AA once to talk to a general purpose computer instead of the Medwave printer This is done by holding down the start stop key while turning on the NIBP100AA power A brief message will appear on the screen which should show either PRINTER TP201 or PRINTER GSD or PRINTER HP or PRINTER NONE Release the key at this point The message indicates thermal printer TP201 general serial device GSD Hewlett Packard Deskjet HP or no printer NONE will be selected Each time the start stop key is used this way the unit will toggle between TP201 GSD HP AND NONE You want GSD to connect to a computer The device will al
34. ne 805 685 0066 Facsimile 805 685 0067 e mail support biopac com Page 44 SECTION 9 ACCESSORY AND SUPPLY INFORMATION Please use the BIOPAC web site www biopac com or call 805 685 0066 oo Page 45 Appendix A NIBP100A Computer Interface Introduction The 25 pin connector labeled Data Port on the rear of the NIBPIOOA may be used for either the Medwave supplied thermal printer or may be connected to a user supplied general purpose computer such as a personal computer with an RS232 port This bulletin describes the steps to connecting the NIBP100A to a computer Blood pressure readings may be directed to the data port either from the trend history table or as readings occur The data port is controlled by using the printer control screens even though there is actually a computer attached to the data port See the operator s manual for sending data to the printer Hardware Requirements The data port is an EIA 232 serial port commonly referred to as RS232 A standard RS232 cable is normally used 25 pins at one end for the NIBP100A and whatever your computer needs at the other end Also a 25 pin null modem connector is usually required when connecting to a personal computer such as an IBM PC Connect the null modem to theNIBP100A then the cable to the null modem NIBP100A Data Port Pin Connections ground 5 volts for Medwave printer onl Connection not required Port settings 9600 baud 8 data b
35. nts determined with this device are equivalent to those obtained by an intra arterial blood pressure measurement device within the limits prescribed by the American National Standard Electronic or automated sphygmomanometers The proposed ANSI AAMI SP10 1992 Standards are For systolic and diastolic pressures treated separately the mean difference of the paired measurements of the test system and the comparison system shall be or 5mmHg or less with a standard deviation of 8mmHg or less At minimum cycle time setting ae Determination Time Range Min Max soon ee mean difference every 15 seconds 40mmHg 240mmHg 5mmHg SD 8mmHg every 15 seconds 30mmHg 200mmHg 5mmHg SD 8mmHg every 15 seconds 20mmHg 180mmHg 5mmHg SD 8mmHg every 15 seconds 40bpm 200 bpm Sbpm or 10 Updates following each BP Approximately 900 readings reading in tabular mode bs Determination time will vary depending on the pulse rate The minimum cycle occurs at high pulse rates is 10 seconds The minimum or continual cycle is 14 beats plus the time to retract the sensor plus the time to step from fully retracted to 50 of the previous valid mean pressure In recovery sweep mode after power on or a recoverable error there is no step up and a slow default motor speed Recovery sweeps therefore take somewhat longer 20 to 25 seconds generally The cycle time may be set by the user to be greater than the minimum Refer to section
36. ode so the system soft keys are blanked accordingly and the trend time selections are labeled inactive PRINT NOW Starts printing the selected data Key will change to CANCEL once started You may continue to use the NIBP100A while printing is in progress CANCEL Stops printing of data There may be a delay of a few secon as the printer finishes printing a reading Key will change to PRINT NOW when pressed 4 6 2 HP PRINT Screen The top line of the screen should read PRINTER HP The HP PRINT screen allows you to select the total amount of data to be printed on the HP DeskJet printer The screen will display the initial values for printing The PRINT FROM default is set to 2 hours prior to the last data record in memory The TO default is set to the date and time of the last data record in memory The TOT DATA default is two hours The user can select the TOT DATA only Your selection can be 20 minutes hour 2 hours or 5 hours Press PRINT NOW to print the selected amount of data to the printer The Vaostrac Model APM205A may continue to be used in normal mode while the printer is in operation Page 27 HP PRINT Screen continued TOT DATA PRINT FROM TO PRINTER HF PRINT MODE PRINT FROM TO TOT DATA Figure 17 1 HP PRINT Screen Indicates the amount of data to be printed Default is 2 hours Using the INCREASE and DECREASE keys the user can choose to print 20 minutes 1 h
37. ot of sensor holder Figure 21 Remove backing from label exposing the adhesive Align label to the rectangular cut out area Press the label into position Figure 23 Appendix F NIBP100A Wrist Strap Replacement The NIBP100A Wrist Strap is manufactured from durable nylon webbing One side of the strap has Velcro hook and loop pieces attached the other side has a single one inch Velcro hook piece attached To install a new wrist strap position the hook and loop piece side upwards Thread the single one inch Velcro loop end piece through the strap loop guide Pull just to the end of the strap loop guide align the Velcro loop end to the hook piece press into position Figure 26 Installing the Wrist Strap Figure 27 Wrist Strap Secured Recommended Placement Guide and Wrist Strap Guide According to Wrist Circumference ut Figure 28 Measure your subject s wrist size Wrist Circumference Placement Guide Name Doria o a a D a Page 51
38. our 2 hours or 5 hours of data starting from the most recent recording The setting can not be decreased more than 5 hours from the TO date and time nor increased past the TO date and time Indicates the start time of the data to be printed This value is determined by your selection It is based on the TOT DATA selection of a prior time period to the date and time of the last record in memory This field cannot be modified by the user Indicates the date and time of the last record in memory This field cannot be modified by the user The printer type is stored in memory however there is a provision for connecting to other printers and equipment If you wish to connect the NIBP100A to the TP245 thermal printer Refer to Section 4 8 1 on TP245 Printer Installation and 4 6 1 GSD or TP245 PRINT Screen To connect to a GSD general purpose computer with an RS232 serial port see Appendix A and 4 6 1 GSD or TP245 PRINT Screen Print Screen Soft Key Descriptions PRINT NOW CANCEL Page 28 Starts printing selected data Key will change to CANCEL once printing has started You may continue to use the NIBP100A while printing is in progress Stops printing of data There is a delay of up to 20 seconds as the printer finishes canceling the current print job The message canceling is put up while canceling is in progress You may continue to use the NIBP100A while canceling is in progress 4
39. play Graphical Readings Display Real Time Page 16 4 4 1 Waveform Trend Display Screen The Waveform Trend Screen displays the patient s arterial waveform and pressure readings This screen is designed to be used for routine monitoring y 18 3i WAVEFORM TREND E J TMK Libsteteteletatetate Figure 10 Waveform Trend Display Screen SCALE When UP or DOWN is selected moves the graduations of the graph 40 100 30 150 20 200 10 250 0 300 UP Increases the mmHg scale to provide maximum viewing of the signals DOWN Decreases the mmHg scale to provide greater viewing of signals AUTO Automatically scales the graduations of the graph as the waveforms are displayed HMT Turn High Motion Tolerant Algorithm HMT off and on OFF HMT ON Default is HMT OFF HMT OFF should be used when patient is engaged in little or no motion HMT ON should be selected when the patient is in motion and the caregiver desires a higher level of motion tolerance When HMT OFF is displayed the high motion tolerant algorithm is not activated When HMT ON is displayed the high motion tolerant algorithm is activated Press the soft key to toggle between choices Note HMT ON should be selected only when the patient is in motion and the caregiver desires a higher level of motion tolerance When the patient is resting or engaged in little or no motion select HMT OFF Always begin your monitoring session with HMT OFF Monitor your pati
40. re reading it does not require additional adjustment If the NIBP100A is not providing reading the strap tension may need to be adjusted or the sensor repositioned Refer to Section 4 3 of this manual Patient movement or motion artifact may also cause missed readings this will be noticeable on the arterial waveform on the Waveform Trend screen The system requires the initial strap tension to be within acceptable limits before it allows monitoring to begin Note The first reading may take up to 30 seconds During this time it is especially important the wrist remain still Page 14 Sensor Application Process continued NOTE Accurate and repeatable operation of the NIBP100A System is dependent upon the proper preparation and placement of the sensor It will tolerate some flexibility in placement However for best signal placement needs to be over a hard surface not where tissue is soft Optimum sensor position occurs when the sensor signal is the clearest and the signal strength bar is at its maximum height In addition consistent arterial waveform readings are obtainable with proper placement If sensor placement is in question these two parameters Arterial waveform consistency and sensor signal clarity may be used as indications of improper sensor placement Page 15 4 4 Display Screens DISPLAY MODES Repeatedly pressing the DISPLAY key scrolls through four different screens Waveform Trend Display Table Trend Dis
41. rify the patient s physiological state Check the patients body position to account for hydrostatic pressure differences Check the sensor placement Observe for motion or noise artifact Refer the system to a qualified service representative Page 4 SECTION 2 INTRODUCTION 2 1 Intended Use The NIBP1OOA system is a noninvasive blood pressure monitor which uses a pressure sensor placed on the wrist over the radial artery This device is intended to be used on patients by trained medical personnel to continually monitor systolic diastolic and mean blood pressure and pulse rate The information from this device is intended to guide clinicians in the therapeutic management of their patients by providing accurate and frequently updated blood pressure information in a safe non invasive easily obtained and comfortable manner The device will not function in certain situations including when patients are on cardiopulmonary bypass or any other conditions in which rendering a pulsatile pressure signal from the radial artery is unavailable Also since the NIBP100A intermittently compresses the radial artery it should be used with caution in patients with absent ulnar artery collateral circulation If the Allen s test suggests that this is the case the NIBP100A should not be used in continual mode If the opposite arm has better ulnar collateral circulation then this arm should be used instead It should be recognized that this device is int
42. s or preset default values Additional alarms will alert the caregiver of any abnormal condition or failure with the system LCD display provides the caregiver viewing of the pressure waveforms trending and alarms settings LED displays provide clear continuous readout of patient blood pressure value Provides an analog output signal for external recording Provides data for the optional printer or external computer 5 2 Technical Specifications Product Description BIOPAC NIBP100A Noninvasive Continual Arterial Blood Pressure Monitor Physical Description Case Aluminum Size S h x 4 5 w x 8 F 1 13 cm x 12 cm x 21 5 cm Weight 5 lbs 2 5 kg with power cord and patient cable approximate Displays Liquid crystal LCD with Cold Cathode Fluorescent CCF back light Size 2 5 h x 4 5 w 6 4 cmx 11 4 cm Three 3 high intensity light emitting diodes LED s Size 75 h x 1 5 w 1 9 cm x 3 8 cm Safety Classification oie The NIBP100A is classified to U S and Canadian safety standards by Underwriters Laboratories Inc with respect to electric shock fire and mechanical hazards only in accordance with C US UL2601 1 and IEC 60601 2 30 and with CAN CSA C22 2 No 601 1 Control number 39RM Classification Class I equipment lt Type BF defibrillation proof Fluid protection Ordinary Equipment monitor and printer Drip proof IPx1 for patient cable housing only Equipment is d
43. s 12 inches 30 cm above the heart to 24 inches 62 cm below the heart MSENsoR HEIGHT THE SENSOR HEIGHT OPTION IS TURNED ON Enter height difference between wrist sensor andi heart level Cinches cm Displayed Pressures are radial Pressures minus 7 6 mmHg Decreases the height difference between the sensor housing and the heart SENSOR level in one inch increments Range is through 24 inches Increases the height difference between the sensor housing and the heart SENSOR level in one inch increments Range is through 12 inches INCH CM Selects inches or centimeters as the height units OFF ON Turns feature off or on Default is OFF height difference is set to zero Note When the sensor height option is selected and in use the sensor height icon will appear on the left hand side of screen Refer to Figure 14 o VASOTRAC APM 205A Continual WRUEFORN 7 15 Figure 14 Waveform Trend Screen with Sensor Height Icon Page 22 4 5 3 Alarm Set Up Screen ALARM SET UP Screen allows for customizing alarm values for systolic diastolic and mean blood pressures and pulse rate igure p Screen Default Settings SELECT Selects the desired parameter The selected parameter will be indicated by a solid vertical bar HI LMT Moves the high limit up for the selected parameter in increments of SmmHg until the maximum value allowed for that parameter is reached The limit then rolls over to the minim
44. t pressures can be monitored visually by viewing the screen and audibly entering limits into the NIBP100A alarm menu Patient measurements above or below the limits will be automatically brought to the attention of the caregiver through these visual and audible alarms A Start Stop key provides the operator with an option to cancel operation at anytime Page 5 SECTION 3 DISPLAYS KEYS AND CONNECTORS 3 1 Front Panel Figures 1 4 show the front rear and side views of the NIBP100A and identifies displays controls indicators and connectors Figure 1 NIBP100A Front Panel 1 Start Stop Key 2 Display Key 3 Set Up Key 4 Mute Key 5 System Soft Keys 6 Systolic Display 7 Diastolic Display 8 Mean Display The keys on the front panel of the NIBP100A are used to access various program functions Each key allows the operator to perform its function with a simple touch of the key There are three dedicated keys to the left of the display and four soft keys at the bottom of the display A dedicated key alarm mute is located in the lower right corner Key functions are listed below For additional information on how to use each key please refer to Section 3 5 Page 6 3 2 Rear Panel Figure 2 NIBP100A Rear Panel 9 Analog Input Output Jack 10 On Off Power Switch 11 Power Cord Connection 12 Sensor Holder Cable Connection 13 Data Port Connection 14 Mounting Nuts for Pole Mounting Bracket Accessor
45. then restart the monitoring process by pressing the START STOP key twice The first selection of the START STOP key switches the system to the SENSOR PLACEMENT screen the second selection initiates monitoring Note that the system will automatically retract the sensor when monitoring is discontinued and as always during retraction the keys are disabled An audio alarm is emitted for these types of errors Co ERRORS SYSTEM ERROR Error in memory CALL FOR SERVICE Memory corrupted Possible AC line transients EMI or faulty component Turn system off and restart If error persists Error in object allocation contact authorized service technician generally occurs only on power up No audible alarm is sounded WRONG SENSOR TYPE FOR During power on self test the NIBP100A Turn system off Replace with sensor THIS MODEL has determined that the attached labeled SENSOR FOR APM205A Restart sensor is the incorrect type Sensor signal at high During power on self test the main sensor Check all electrical connections to the limit signal was at its highest pressure patient cable and sensor Also verify that high pressure is not being applied to the sensor face Memory alloc error in Insufficient memory is available Indicates Refer to an authorized service technician new_Xxx damaged component s NO SIGNAL The expected sensor signal is absent The Check if the sensor is on the patient Check system automatic
46. this data 4 9 Data Port RS232 The NIBP100A may be connected to an external computer in place of the printer using the RS232 Data Port on the rear of the device See Appendix A for further details on computer interface Note that only equipment meeting UL2601 1 or EN60601 1 standards should be connected to preserve electrical safety 4 10 Analog Output The NIBP100A may be connected to an strip chart recorder or other recording device using the Analog I O port on the rear of the device This will record a single wave shape for each pressure determination See appendix B for further details wave form output Note that only equipment meeting UL2601 1 or EN60601 1 standards should be connected to preserve electrical safety Page 34 SECTION 5 SYSTEM FEATURES AND SPECIFICATIONS 5 1 System Features NONINVASIVE MICROPROCESSOR BASED DESIGN ARTIFACT REJECTION Automatic Pressure Zeroing AUDIBLE amp VISUAL ALARMS LCD and LED DISPLAYS ANALOG I O JACK DATA PORT Page 35 Eliminates those risks associated with invasive monitoring to the patient and caregiver Provides reliable high speed digital signal processing Advanced programming allows the system to identify and eliminate some noise and motion artifact The microcomputer remembers the zero pressure offset even when power is off Audible and visual alarms for systolic diastolic and mean pressures and pulse rate can be set to individual parameter
47. tine maintenance Should service be required it should be performed by a qualified technician All maintenance and repair procedures should be directed to BIOPAC To obtain information on or order repair parts call BIOPAC Sytems Inc at 805 685 0066 or e mail support biopac com For authorization and instructions for repair service contact your local Field Service Representative Provide the following information Your Name Monitor S N Hospital Name Patient cable S N Address Sensor S N Telephone Number Describe the problem Facsimile Number E mail Address You will be advised of the corrective action to take Page 41 7 2 Cleaning Procedures Sensor Cleaning Procedures The sensor face should be cleaned after each use Clean the surface of the sensor by wiping with a damp cloth Preferred cleaning solutions are 70 isopropyl alcohol 64 1 dilution bleach solution or diluted phenolics such as Lysol disinfectant Always apply the solution to the cloth not directly to the sensor Do not use solutions based on iodine or terpene Should the sensor be punctured and or leak fluid the sensor will need to be replaced The fluid is non toxic silicone and should be washed from skin or other surfaces with soap and water Warning Do not sterilize the sensor by autoclaving steaming irradiation or ethylene oxide ETO Do not soak sensor or any part of the NIBP100A system in any solution or water Monitor amp Sensor Housing Cleaning
48. um value allowed for that parameter LO LMT Moves the low limit down for the selected parameter in increments of SmmHg until the minimum value allowed for that parameter is reached The limit then rolls over to the maximum value allowed for that parameter DEFAULT Returns to Default settings as shown in Figure 15 Alarm Parameter Ranges High Limits High Limit ee eee Low Limit Default Systolic 75 250 40 150 Diastolic 40 180 20 120 20 Page 23 4 5 4 Set Clock Screen The SET CLOCK Screen controls setting of time and will bring up this screen Figure 16 Set Clock Screen SELECT Moves cursor to the hours or minutes INCREASE Increases the numerical values of the selected parameter DECREASE Decreases the numerical values of the selected parameter ACCEPT Sets the clock to the time and date on the screen NOTE The time is displayed in 24 hour format To exit this screen without changing time press one of the keys on the left of the screen START STOP DISPLAY or SETUP The date is factory set and may be changed only by increasing or decreasing the hours through a 24 hour period Page 24 4 6 Special Screens Self Test Screen Appears only during power up Test Screen Test for sensor performance and integrity before allowing the system to proceed See Section 4 2 for details Page 25 4 6 1 GSD or TP45 Print Screen You will need to initially configure
49. ways remember this setting even when power is turned off If the unit is not set for GSD data will appear garbled at the computer Data sent via the data port are standard ASCII characters in a simple format as follows sys map dia hrt total_secs yy mmm ddd hr mn ss xx Each line is terminated by a line feed OxOA and carriage return 0x13 The fields have exactly the number of digits as shown above with leading zeros used if necessary total_secs is an integer number of seconds since January 1 1993 to when the pressure determination was made This is the same as the human readable date and time that follows but provided for easier plotting by computer programs The total_secs field is year 2000 compliant The xx field is an ASCII checksum field that may be optionally used by the receiving computer to verify the integrity of the string It is calculated by adding the ASCII value of each character up to xx and including spaces taking the 256 modulo i e least significant 8 bits and converting the resulting 8 bits into two hexadecimal ASCII values 0 9 a f Example data output 9 087 065 081 0151601382 97 OCT 2 5 29 42 O7 7 088 066 078 0151601397 97 OCT 2 SE2Z9I97 19 9 091 074 084 0151601412 97 OCT 2 3 3 03 12 F4 134 099 082 076 0151601429 97 OCT 2 5 30 29 09 Page 47 Medwave does not presently provide any software for the computer You can run a terminal emulation pro
50. y 000 9015 3 3 Side Panels Figure 3 NIBP100A Left Side Panel 15 Hanger for Sensor End of Patient Cable Page 7 Side Panels continued 16 Display Contrast Dial o poe 4 Figure 4 NIBP100A Right Side Panel 3 4 Senor End of Patient Cable 23 17 Bale 18 Bale Cord 19 Wrist Strap 413 0000 20 Placement Guide Posts 21 Sensor 400 0049 22 Adult Normal Wrist Size 15 18 cm Placement Guide 374 008 1 23 Placement Guide Indicator Line 24 Wrist Strap Loop Guide 17 Figure 5 Sensor End of Patient Cable Page 8 3 5 Description of Dedicated Keys Start The START STOP key starts or stops monitoring ae The DISPLAY key scrolls through two screens displa Note These screens can only be accessed after the daily y self test and TEST have been performed g Oo Waveform Trend Display Display of scaled pressure beats from the previous several sweeps Table Trend Display Scan through and display in tabular form 5 of approximately 900 readings saved in non volatile memory Graphical Reading Display Display of pressures and pulse readings in graphical form from fifteen minutes to eight hours Real Time Graphical display of the pressure signal as produced by the sweeping motor activity The SETUP key scrolls through five screens the Cycle Time Allows the user to select the length of time setup between pressure measurements bd Sensor Height Allows t
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