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1. 1 2 Cross references Cross references refer to chapters where the operator can find additional information about specific topics A cross reference includes the number and title of the chapter referred to e g see chapter 2 General information 1 3 Settings Settings available for menu entries are listed as minimum increment maximum IC A ats CNAP Monitor 500 page 1 1 Version 1 2 BIOPAC PN NIBP100D Introduction 2 General Information Ward Suelta epica dra odiarte era 2 1 Precaution Sra in E Na 2 1 General Precautions taa ti date 2 1 BIOO OS SUT estare riera pet ea ern 2 2 DISPO Alita auices 2 3 Declaration OF INTENGCOMUSS nee ehe A A to dees 2 3 2 1 Warnings e For USA Federal law restricts this device to sale by or on the order of a physician or proper licensed practitioner The CNAP Monitor 500 is not designed for intracardial use Do not connect the device s pneumatic connectors to an intravascular system Do not use the oscillometric cuff on subjects with vascular prostheses Keep the CNAP Monitor 500 out of reach of children The CNAP Monitor 500 is not fit for operation in potentially explosive surroundings as may arise from usage or storage of flammable anaesthetics skin detergents or skin disinfectants Also do not use the CNAP Monitor 500 in possibly combustible atmosphere i e if the ambient air contains more than 25 of oxygen or nitrous oxide gas e The operator has to p
2. In case of persistent error contact service CNAP Monitor 500 page 12 3 Version 1 2 BIOPAC PN NIBP100D Technical alarms and status messages 12 3 Printer 12 3 1 Technical Alarms PRINTER Out Of Paper Printer is out of paper Replenish paper Hardware problem Problem will be solved Excess temperature automatically PRINTER Fault Internal voltage supply In case of repeated messages error contact service Hardware problem l PRINTER Problem will be solved automatically In case of repeated messages Error contact service Communication Interface problem 12 4 CNAP 12 4 1 Status messages CNAP tirantes Check connection of Check Connections CO O AET te et TONNES CNAP controller CNAP Check Cuff CNAP double finger cuff is not Check connection of CNAP Connections connected CNAP double finger cuff CNAP Check Cuff No finger in inactive cuff before E CNAP Change Finger Put finger in cuff CNAP Initializing System Self test na Replace CNAP controller CNAP Controller CNAP controller is not calibrated Contact service for Not Calibrated calibration of CNAP controller CNAP Put Finger In _ CNAP has passed self test and is Cuff ready for measurement ran as up CNAP Calibration E a phase in Wait for measurement NBP measurement to calibrate _ Wait for end of NBP CNAP Calibrating CNAP blood pressure is in
3. In case of persistent fault contact service Check position and fit of NBP cuff Make sure cuff is placed directly on the skin Check position and fit of NBP cuff Avoid artifacts e g movement Check for proper NBP cuff size Avoid artifacts e g movement Check position and fit of NBP cuff Make sure cuff is placed directly on the skin Check for proper NBP cuff size Avoid artifacts e g movement Check position and fit of NBP cuff Make sure cuff is placed directly on the skin Check for right NBP cuff size Version 1 2 PN BIOPAC PN NIBP100D NBP Blocked Line NBP Leakage NBP Safety Timeout NBP Overpressure NBP Hardware Fault NBP Autozero Failure NBP Out Of Range Failure NBP ADC Failure NBP Calibration Failure NBP Terminated By User CNAP Monitor 500 Technical alarms and status messages Blocked line air hose NBP cuff or air hose leaky or loose Safety time limit exceeded Overpressure in NBP cuff Voltage supply exceeds limits or other hardware problem Autozeroing has failed Measuring transducer out of measuring range ADC out of measuring range faulty EEPROM calibration data User has stopped current NBP measurement page 12 10 Make sure that NBP air hose is not bent or twisted too tight Make sure patient is not Iying on NBP cuff or air hose Check position and fit of NBP cuff Check NBP air connections e g for damages loose fit
4. e Do not use bleaching agents e Wipe off detergents and disinfectants with a moist cloth water then dry surfaces with clean cloth A sTOP e No liquid must be spilt on any part of the CNAP Monitor 500 In case this should happen carefully dry device accessory If in doubt whether liquid has ingressed the device do not start up the instrument Contact technical staff or a service partner of CNSystems Medizintechnik AG CNAP Monitor 500 page 11 1 Version 1 2 BIOPAC PN NIBP100D Cleaning and disinfection 11 2 Cleaning In order to clean any part of the device use a lint free cloth moisted with warm water max 40 C and soap diluted non caustic detergents or ammoniac alcohol containing tensides or detergents Do not use strong solvents like dimethylketone or trichloroethylene Do not dip the device any part of the device or any accessories especially not any hoses into liquid As the screen of the CNAP Monitor 500 is easily scratched be particularly careful when cleaning it No liquid must enter the CNAP Monitor 500 so be sure to not spill any liquid directly on the monitor No liquid must enter the connectors of the CNAP Monitor 500 or the CNAP controller so take care not to wipe over but rather around the connectors when cleaning them CAUTION e Be particularly careful when cleaning or disinfecting the insides of the CNAP double finger cuffs Wipe them carefully in order to avoid any
5. BIOPAC PN NIBP100D Management of subject data 5 Management of subject data POU OT GUDICC Wal een ande nee nr pen ma se dede pct 5 1 EUO SUDIECE Cale MAA o O ea era ei Ue IA 5 2 DIE CHOR a a re ee ed ee ee ee ee te er ee er ee E 5 3 Immediately after a subject has been connected to the CNAP Monitor 500 and the setup process has been performed correctly see chapter 3 5 Quick setup the subject set up window is opened automatically Select the correct subject category and start the measurement process by pressing Start Stop NOTE e With regard to the safe operation of the CNAP Monitor 500 as well as the gt unambiguous identification and classification of measurements and prints the input of subject data is a vital prerequisite of essential importance Entering the respective subject category for instance results in the subsequent adjustment of alarm limits as well as of the NBP cuff inflation pressure 5 1 Input of subject data Subject data is entered into the subject set up window appearing on the main screen immediately after subject setup Name 11 Dec 17 04 Setup Patient CNAP Sys mmHo Use Current Patient Data New Patient Pediatric Defaults RR Dia New Patient Adult Defaults NBP Sys mmHg 16 45 17 00 Illustration 19 Subject setup window subject frame CNAP Monitor 500 page 5 1 Version 1 2 BIOPAC PN NIBP100D Management of subject data There are 2 ways of entering su
6. Check NBP cuff for leakage Check position and fit of NBP cuff Check for right NBP cuff size Check position and fit of NBP cuff Avoid artifacts e g movement Check for right NBP cuff size Start new NBP measurement Check for right NBP cuff size Make sure NBP air hose is not bent or twisted too tight Check position and fit of NBP cuff Make sure patient is not lying on NBP cuff or air hose Reboot CNAP monitor In case of persistent error contact service Reboot CNAP monitor In case of persistent error contact service Reboot CNAP monitor In case of persistent error contact service Reboot CNAP monitor In case of persistent error contact service Reboot CNAP monitor In case of persistent error contact service Version 1 2 BIOPAC PN NIBP100D Appendix A 13 Appendix A Glossary A AC Ah B BP Wave Out bpm BSA C CNAP D Dia or diastolic Main Screen Mean min mm sec mmHg msec N NBP Parameter Pulse S Sys or systolic Sec V V CNAP Monitor 500 Alternating current Ampere hour Interface to subject monitors CNAP Beats per minute Body surface area m blood pressure waveform Continuous noninvasive arterial pressure Diastolic blood pressure Hour Hertz Invasive blood pressure Light emmitting diode Liquid crystal display Monitor main screen can be accessed to from any menu via pressing Main Screen fixed key Mean
7. progress end of calibration phase measurement CNAP Artifact Pressure is not within physiological Check and eliminate CNAP Monitor 500 page 12 4 Version 1 2 BIOPAC PN NIBP100D Technical alarms and status messages Cuff Expiring Cuff Ambient measuring range Low signal amplitude in CNAP double finger cuff Interference because of third party measuring devices CNAP hardware is ringing due to artifacts CNAP cuff is reaching end of life cycle thus providing low quality of measurement Ambient light interferes with CNAP double finger cuff 12 4 2 Technical Alarms CNAP Check Connection CNAP Fault Reservoir Pressure CNAP Fault Zero Offset Controller CNAP Fault Initial Pressure CNAP Fault Pump Tubing Valve Leaky CNAP Monitor 500 Leakage in CNAP hardware Air reservoir blocked or faulty pressure offset Zero offset of CNAP controller faulty Pressure could not reach threshold upon initialization Leakage detected upon initialization page 12 5 influence from third party measuring devices Avoid artifacts e g movements Check CNAP cables and connectors Check CNAP double finger cuff Replace CNAP double finger cuff and cable Replace CNAP double finger cuff Reduce ambient light i e brightness switch off Check setup of CNAP double finger cuff Check connections of CNAP hardware Disconnect an
8. 1 2 VG ee re a a a En Ba en ee ee ee al ss nd 12 2 CNAP Monitor 500 page li Version 1 2 BIOPAC PN NIBP100D Table of Content LZ lL EechNical aldimszs see Ven cauaramimnamdeietanenensae 12 2 12 2 gt Wave OUE OP cccerudst locks A EA ARAE tenes AEA 12 3 122 Status Mess ads esla wicca letras 12 3 12 2 2 T CCHMICAl Ada ide 12 3 A3 PANEO aaiae nI a aE a A E EENE A A E E E a 12 4 12255 L FECMMIGAll AIANINS sr aa een E OA E EE A A O 12 4 12 4 CNAP Tere NA ae ee N O A TANTEA A 12 4 124 Status messages alerts ee ee a a a ee aa er 12 4 A ereignet 12 5 A 12 9 12 5 Lo La LS MES AOS Sd 12 9 1202 TECHNICA ala MS aaa dd 12 9 LS ABBERIRFA2IGIOSSATV ae a ds 13 1 13 1 TUS Sia da iii 13 2 La Appendix B ACCESS OMS dd inicio ica 14 1 WA CENAR LEEEN 14 1 WAZ NE a er ee re een ee reihe 14 1 Ao A RAR 14 1 14 3 1 Paperirecommendation ai A Eh 14 2 14 4 EONMMSCUONA S iens olaaa 14 2 14 5 Other acceso es e 14 3 15 Appendix C Technical SpecifiCatiONS ococcccccccccccccccnnnnncnccora canaria rar 15 1 al HENARES MONITO otto odo een nern 15 1 15 1 EXxtermal malns adapter near er eier 15 2 15 1 2 CNAP continuous non invasive arterial PreSSUIC cece cece cece cece eee eeeeeeeeeenans 15 2 15 1 3NBP non invasive DIOOd Pressure u a a ei ds 15 3 LOS A REIT se teaietenr seu Sutunes ee ee a cacetece acu 15 3 Silo PFOGUCE COMMOUPALION Heeres eeaeelgpn 15 4 19 2 COHNectlons serie ee ee 15 4 15 3 Electromagnetic Eomp
9. 3 10 Sed POWE OR O Mercantil een 3 10 3 4 2 ACCeSS return to Maln Sr eeN ee an ee la es 3 11 3 4 3 Fast access Keys ae Aa 3 12 3 4 4 Menu navigation click wheel control usssessessnnnnnnnnnnnn nn nenn anna anna nennen nenn 3 13 3 4 3 MENU SSIECLON rer ee u re doo ads 3 13 3 5 a AS nahe ee RR S 3 14 MONITOR cON TOUR 4 1 4 1 MONILOR SCEL Sucia sti irritan 4 1 4 2 Measurement Settnds rs ad ia 4 1 4 3 SERVICE SENOS ineptam beine e a ee 4 2 4 4 BP Wave Out subject MONITOLS 0 6cicaecave vedere cacenaeauiv E A E A Ra 4 3 4 5 Nt rraces opone di la 4 5 Aol AUX analog OUEPUE DOI ira tt ee 4 5 AL y A ee Pen einer T te wy iw er ouniaese anaes 4 5 eS US o nee 4 5 Management Of SuUbect data ninia 5 1 5 1 INDUEOLSUDJEEL Aal are se el nee ae ee era 5 1 5 2 Editing Or SUD ect data lia rr td e ds ek a DS ld 5 2 5 3 DISE A Suv AR a aia 5 3 SS ee ee ee eine Clad tana ee ee ee 6 1 6 1 ViSU all alar Sind Sid ende 6 2 6 2 ACOUSEIC alarm ION a Saa aia 6 3 CNAP Monitor 500 page Version 1 2 BIOPAC PN NIBP100D Table of Content 6 3 Alarni Sy Steni controlaron ci ains 6 4 6 3 1 Acknowledgement of alarms Audio Off Audio Pause c oocccccccccccncnnnnnnnnnnnnnn 6 4 6 3 2 Pausing switching off alarms Alarms Paused Alarms Off oooccccccccccccncnnnnnnnno 6 4 6 3 3 Reactivation of paused alarms Alarms Off ccc cece cece eee ee eeeeeeeeeeeeeeeeeeees 6 5 6 4 AMO TOQUES ee A SAA nee ee 6
10. 5 8 41 Display OF IRalvidual alar TIMES ias 6 5 A ON 6 6 64 3 AUTO INES ssp ae ra ee ensure 6 7 6 4 4 Alarm MIES Factory Setlings ana a u a ER ae 6 8 6 5 NS Po a ee N ae 6 9 6 6 Bla SYSTEM TUNG LION Testo 6 9 6 7 PRAYSIO OO Cala aMSN nee 6 9 7 TECA ee ee 7 1 7 1 Trende the Meal a da a ee ee 7 2 7 2 SO ode 7 3 eZ TON VIEWS estanca ota es eee ads 7 3 Ki zz GEA PNC tren in rege 7 3 Tal INUIMCIIC LIENS S ere eaa ee en erde 7 6 7 2 Alar MN STON A AOS 7 8 1 5229 OTONO Orren VIEWS tn ee een need 7 9 8 PRICING urraca llana adsl 8 1 8 1 LEAUAENINGFREINEFEDOrEs ee is 8 1 8 2 Canceling prnattTepDorts sd r anti ein 8 2 8 3 PENE FEDORA aa 8 2 8 4 PFINEOPLIORS asar tano etarra 8 3 9 CNAP aer er a Ra ee ee ee erg 9 1 9 1 Generator ao ea ae RE 9 1 9 2 Salety Precautions arista A Ad 9 2 9 3 A 9 3 9 4 WICW TS tU Spira en tacita lecitina ET teaser 9 4 9 4 1 Blood pressure WaVeO Misas ieh 9 5 9 452 A RN 9 5 9 4 3 Numerle Valles ni A AA DA A A awake 9 6 9 5 CNAPE ODUONS cora AA A a 9 6 1O IN oo cies 10 1 LOL Generalinformation nase ih 10 1 10 2 Savery precautions Hase EEEE Eee ee 10 2 10 9 SCUD ea een ea Eee 10 3 LOA A O 10 5 10 5 INBP ODEIONS el ee doi 10 5 Lh Cleaning an GrGiSiNfCCtuon iia ee ee een 11 1 1121 General precautlenssnse ae ee en 11 1 12 2 CIMA oda 11 2 LES DISINIECUN ON ee rd O ee eh 11 2 12 Technical alarms and status Messages 222sunnnnanennnnnnneenennnnnnnnnnnnnennnnnnnnnn nennen nnnnnnnn 12
11. 5 Other accessories E gt 200 CNAP Monitor 500 page 14 3 Version 1 2 BIOPAC PN NIBP100D Appendix C 15 Appendix C Technical specifications CNAP MONITO SU ee nee ee ee n he ner 15 1 External Mallas adapte scanner o OR ae 15 2 CNAP continuous non invasive arterial presSuUre ooocccccccccccncncncncnnnnncn cnn rn rr rr 15 2 NBP non invasive Dood Pressure 2a aa ae 15 3 A AOS 15 3 PFOQUEL CONNIQUFARION ee ad iS ren 15 4 CONNEEHONS re leere 15 4 Electromagnetic compatibili Venen 15 5 SA do ante een ee es Bu EST ware E 15 8 DeclarationvoMmCOnrOnimMiky ee atadas lie 15 9 15 1 CNAP Monitor 500 CNAP Monitor 500 Physical properties Dimensions 280 x 270 x 250 mm 11x 10 6 x 9 8 in Weight 7 5 Kg 16 6 lbs including components and accessories neccessary for operability of device Sealed lead gel operating time gt 2h fully charged battery normal Battery conditions NBP cuff Latex free Electrical properties Nominal voltage 18 VDC 10 Nominal current No time limit if powered by external mains adapter at least 2h if on Ao battery operation fully charged battery UJ Environmental conditions for operation Temperature Operation 10 C 40 C 50 F 104 F Storage 0 C 40 C 32 F 104 F midi Operation 30 bis 85 non condensing y Storage 20 bis 95 non condensing wrapped Operation 647 bis 1059 hPa ETS Storage 500 bis 1059 hPa User interface C
12. CNAP controller the CNAP cable and the CNAP Monitor 500 All the plugs and connectors are designed so as to making it impossible to switch them accidentally e Equip the patient with the CNAP hardware The CNAP double finger cuff is placed on the proximal joints of the index and middle fingers Make sure that the cuff cables run along the upper side of the patient s arm e Fasten the CNAP controller to the patient s forearm by means of the fixing cuff with Velcro fastener e Place the NBP blood pressure cuff on the patient s upper arm calibration for CNAP contralaterally or if necessary on the same arm as the double finger cuff e Start the CNAP measurement by pressing Start Stop on the front side of the device CNAP Monitor 500 page 9 3 Version 1 2 BIOPAC PN NIBP100D CNAP 2 u Illustration 35 Subject setup NOTE pan e The key Start Stop starts or stops both a CNAP measurement as well as the Ey calibration process by means of the NBP measurement j e A current NBP measurement can be stopped without interfering with a concurrently performed CNAP measurement by pressing Start Stop Pressing the same key a second time also stops the CNAP measurement 7 9 4 View features CNAP determines the following blood pressure values which are displayed directly in the Main screen of the CNAP Monitor 500 e Blood pressure waveform morphology e Blood pressure trends o Sys o Mea
13. Numeric 1 beat 1min 5min 15min 30min 1h CNAP Monitor 500 page 7 2 Version 1 2 BIOPAC PN NIBP100D Trends 7 2 Setup 7 2 1 Trend views Recorded data are automatically displayed in the Trend frame including three options e Graphic trend graphical trend of measured parameters displayed on a time axis e Numeric trend numerical trend of measured parameters adjustment of time intervals Alarm history display of all alarms issued during a measurement NOTE 3 e You can select your trend display option by using the click wheel control to open the menu Trend frame in the main screen then to select Trend and access the menu item Trend display 7 2 2 Graphic trend The trend view Graphic trend allows a graphical view of the following parameters on a time axis e CNAP blood pressure values Sys Dia Mean e CNAP Pulse Illustration 25 Graphic trend CNAP Monitor 500 page 7 3 Version 1 2 BIOPAC PN NIBP100D Trends NOTE e The trend view Graphic can be adjusted by changing the following scales BP gt scale Pulse scale and Time scale e The displayed data window can be adjusted by means of the click wheel control in the Navigation frame see chapter 7 2 5 Scrolling of trend views which also determines the amount of data to be printed BP SCALE The scale factor of the CNAP blood pressure trend can be configured in the menu entry BP scale which is located in the menu Trend Scales ar
14. Off Switching on off the monitor 2 Setup Access to configuration menu 3 MainScreen Return to main screen from any submenu Alarm functions control Alarm Pause Off Press key Alarm Pause Off once set alarm reminder Press key Alarm Pause Off twice set alarm pause Press key Alarm Pause Off three times re activate alarm function CAUTION e The key Start Stop controls all CNAP measurements In case of an active NBP A measurement the operator first stops the NBP measurement by pressing the key Start Stop once Only pressing the key Start Stop for a second time will stop the active CNAP measurement CNAP Monitor 500 page 3 12 Version 1 2 BIOPAC PN NIBP100D Introduction 3 4 4 Menu navigation click wheel control Illustration 15 Click wheel control The monitor s click wheel control enables the operator to navigate through menus and setups and to access certain functions Wheeling the control enables the operator to navigate through menus while pressing on the control clicking confirms the menu choice Selection and confirmation of functions menu items 1 Select the desired function menu item by wheeling the control green bar 2 Pressing the click wheel control then confirms the selection Subsequently either a drop down list appears or the function is activated automatically e g from on to off 3 Wheeling the click wheel control drop down menu 3 4 5 Menu selection Menus can be accessed
15. arterial blood pressure Minute Millimeters per second Millimeter of mercury Millisecond Non invasive blood pressure oscillometric blood pressure measurement Monitored biosignal e g pulse rate blood pressure Pulse rate Systolic blood pressure Second Volts page 13 1 Version 1 2 BIOPAC PN NIBP100D 13 1 Ill Illustration 1 Illustration 2 Illustration 3 Illustration 4 Illustration 5 Illustration 6 Illustration 7 Illustration 8 Illustration 9 Illustration 10 Illustration 11 Illustration 12 Illustration 13 Illustration 14 Illustration 15 Illustration 16 Illustration 17 Illustration 18 Illustration 19 Illustration 20 Illustration 21 Illustration 22 Illustration 23 Illustration 24 Illustration 25 Illustration 26 Illustration 27 Illustration 28 Illustration 29 Illustration 30 Illustration 31 Illustration 32 Illustration 33 Abbildung 34 Illustration 35 Illustration 36 Illustration 37 Illustration 38 Illustration 39 Illustration 40 Illustration 41 CNAP Monitor Appendix A ustrations FONE VIEW ee ne ee seen 3 2 Paent CONNOCLORS alla cedo E ReL Eee 3 2 Printer interface Power supply ccc eee eee eee en nnnnnnnnnnnnnnnnnnnnnnn 3 3 BACK VIEW oi ea eee eee ates 3 3 CNAP MonItoOr DOO ee a in 3 5 CNAP INO Ol CU td dd An occa erg 3 5 CNAP CODTONG a BR RE ie esse 3 6 CNAP CA Dl ee ger ee een en a euren 3 6 NPC U re ee A een bcIn 3 7
16. connects the monitor and the CNAP controller Illustration 8 CNAP cable CNAP Monitor 500 page 3 6 Version 1 2 BIOPAC PN NIBP100D Introduction 3 2 4 NBP cuff The NBP cuff is intended for oscillometric blood pressure measurement and is available in four sizes Arm circumference cm 12 19 Small Adult 17 25 Large Adult 31 40 Ya Illustration 9 NBP cuff 3 3 Power supply The CNAP Monitor 500 is supplied with power by means of either mains operation via an external power adapter or by an integrated sealed lead gel battery In case of power supply interruptions or even power outage the monitor will automatically switch to battery operation CAUTION e Carefully read and keep in mind the precautions regarding power supply 3 3 1 Mains operation During mains operation the CNAP Monitor 500 is connected to a power adapter suited for a supply voltage of 100 240 VAC 10 and a mains frequency of 50 60 Hz see Appendix C Technical specifications When the CNAP Monitor 500 is connected to the mains power supply the integrated sealed lead gel battery is recharged as well There is no time limit on the monitor being on mains operation The CNAP Monitor 500 can be connected to a supply network system according to CISPR 11 NOTE ur gt e The battery recharge symbol gt on the battery status of the TFT display shows when the integrated battery is being recharged e The battery
17. damage 11 3 Disinfecting CAUTION e Disinfecting agents Never mix different kinds of disinfectant agents e g bleaching A agents and ammoniac as this might result in the production of dangerous gases e Internal hospital regulations Disinfect the product in accordance with your own hospital regulations in order to avoid long term damage of any kind The device is to be cleaned before disinfection Find recommended detergents and disinfectants listed below Disinfectant Glutar n Alkyl Succindial Alcohol Orthophthal aldehyde Alcohol dehyde Spray Wipe aldehyd Alcohol 0 28 8 11 0 55 Cidex Plus Gigasept FF Microzid AF Cidex OPA Liquid CNAP Monitor 500 page 11 2 Version 1 2 BIOPAC PN NIBP100D Technical alarms and status Messages 12 Technical alarms and status messages Main unit Technical Alarms ccc ccc cece eee e cece cence eee eee nennen een nenn nern nennen ernennen 12 2 BP Wave Out IBP Status Messages 2 0 cece cece creer eee e eee e eee n ene nee EEE Reese ee Ee EEE EE SSDS EEE DEES 12 3 BP Wave Out I BP Technical alarmS ui aa re ren 12 3 Printer Technical alas area ee 12 4 CNAP Status Mess ade Sig eect cys ean a een cece eet ncaa ee 12 4 CNAP ole al alec esi tcl di cae eee ee ee ee er 12 5 NBP Status Messages nn ner a at era sh ccieeadantdenesnuteanssalanceneatuacencseanaesanstans 12 9 NBP Technical ala a en a HP ehe ab En Eee ee ee 12 9 Despite physiological a
18. e DISCHARGE When a patient is discharged all recorded data including the parameters Sys Mean Dia and Pulse as well as the Alarm history are irretrievably deleted e PRINT REPORTS The set up and configuration of the Trend frame also determine the selection and the display of the Print reports Graphic trend report Numeric trend report and Alarm history report Thus before starting a Print report make sure that the data in the Trend frame display is equivalent to the data you wish to include in your Print report concerning for instance amplitude time scale and displayed time span see chapter 8 3 CNAP Monitor 500 page 7 1 Version 1 2 BIOPAC PN NIBP100D Trends Name 11 Dec 16 55 mmmg 30 90 Dia y 4x NBP Sys 131 l Dia 90 16 30 16 45 Illustration 24 Trend frame 7 1 Trend the menu The menu Trend which can be accessed directly from the Main Screen by means of the click wheel control allows the operator to configure trend views in the Trend frame enw Bescon ge Trend Dieola Selection of trend view Graphic or graphic numeric play Numeric display or Alarm history alarm history Adjustment of amplitude scales of CNAP blood BP Mean BP Scale i pressure waveform and trend BP amplitude Pulse Mean Pulse Scale Adjustment of amplitude scales of pulse rate i trends Pulse amplitude Graphic 30min default 1h 2h 4h 8h 12h Time Scale Setting of time scale 24h
19. error contact service Reboot CNAP monitor In case of persistent error contact service Reboot CNAP monitor In case of persistent error contact service Reboot CNAP monitor In case of persistent error contact service Switching to mains operation via power adapter recommended Immediately switch to mains operation via power adapter Immediately switch to mains operation via power adapter Current measurement discontinued monitor switched off automatically Version 1 2 BIOPAC PN NIBP100D Technical alarms and status messages 12 2 BP Wave Out I BP 12 2 1 Status messages Perform zeroing refer to chapter IBP Connected BP Wave out is connected 4 4 to patient monitor Make sure to disable zeroing when calibration is complete BP Wave out is IBP Disconnected disconnected from patient monitor 12 2 2 Technical alarms Reboot CNAP monitor IBP Fault Internal controller problem In case of persistent error contact service IBP In case of persistent error Transmission Fault Interface problem contact service IBP Reboot CNAP monitor EEPROM RW Error I O memory chip defective In case of persistent error contact service IBP Iso Board Fault Isolation board failure Ie Obie tote EERON contact service Disconnect IBP transducer cable Check bridge voltage range refer to chapter 4 4 BP Iso Board Bridge voltage BP wave out Bridge Voltage exceeds 10V
20. from the device 6 3 Alarm system control 6 3 1Acknowledgement of alarms Audio Off Audio Pause In order to acknowledge all activated alarms physiological and technical malfunction reports press Alarm Pause Off once Depending on the respective settings of the Alarm Reminder feature the status message Audio Off or Audio Pause is displayed ALARM REMINDER If the alarm reminder is activated in the monitor setup a repeated acoustic signal reminds the operator of alarm conditions that continue to exist after acknowledgement of the alarm signal by the operator This acoustic reminder may be repeated for a limited or unlimited amount of time A CI Alarm Reminder Setting of alarm reminder NOTE e During measurements an alarm reminder setting may be entered by using the click 3 wheel control to open the Parameter frame and then to select the menu entry Alarms Pediatric or Adult Alarm Limits e The factory setting of the alarm reminder may be restored by using the click wheel contro located in the Service Menu 6 3 2 Pausing switching off alarms Alarms Paused Alarms Off In order to temporarily deactivate pause physiological alarms press Alarm Pause Off twice Temporarily no physiological alarms will be activated e g when a subject is being relocated Depending on the Audio Pause settings either the status Alarms Off or Alarms Paused is displayed ALARM PAUSE Depe
21. reconnect CNAP controller In case of persistent error contact service In case of persistent error contact service for faulty CNAP controller Check connections of CNAP cable In case of persistent error message contact service Check connections of CNAP cable In case of persistent error contact service Version 1 2 BIOPAC PN NIBP100D Technical alarms and status Messages CNAP Failure Valve Blocked Leaky CNAP Failure Reservoir Overpressure CNAP Failure Cuff Overpressure Left CNAP Failure Cuff Overpressure Right CNAP Cuff Cannot Deflate Blocked Line CNAP Check Cuff Low Light Signal CNAP Check Cuff Ambient Light CNAP Monitor 500 Cuff pressure exceeded 450mmHg for more than 10sec in CNAP air reservoir Pressure exceeded 450mmHg for more than 10sec in air reservoir Pressure exceeded 330mmHg for more than 10sec in left CNAP finger cuff Pressure exceeded 330mmHg for more than 10sec in right CNAP finger cuff CNAP finger cuff cannot be deflated CNAP detected low signal in measuring finger Ambient light interferes with CNAP double finger cuff page 12 6 Disconnect CNAP hardware In case of persistent error contact service for faulty CNAP controller Disconnect CNAP hardware Reboot CNAP monitor In case of persistent error contact service Disconnect CNAP hardware Reboot CNAP monitor In c
22. status indicates the present battery charge status when the monitor is running on battery without mains power supply Te CAUTION e Do not use any power supply accessories but those intended and authorized by CNSystems Medizintechnik AG for utilization with the monitor CNAP Monitor 500 page 3 7 Version 1 2 BIOPAC PN NIBP100D Introduction O Power cord D Power adapter 1 GQ Cable connecting power adapter and monitor Illustration 10 Power cord 3 3 2 Battery operation The integrated sealed lead gel battery enables the CNAP Monitor 500 to operate on battery for up to 120 minutes depending on the CNAP calibration intervals printer use and brightness of display If the monitor runs on battery the battery charge status will be indicated on the TFT display in 25 steps The battery charge status is also indicated via the battery LED on the front side of the monitor LED colour Battery charge status Green Device runs on battery battery charge status 100 25 Device runs on battery battery charge status lt 25 rd Device runs on battery automatic shut down within 15 minutes In addition a low battery charge status 5 minutes of remaining operation time on battery is indicated by a status report on the TFT display alarm window For security reasons the measurement is stopped and the monitor shut down automatically While the CNAP Monitor 500 runs on mains power the integrated sealed lead ge
23. to in 2 ways e Frequently used functions can be selected by the monitor s fast access keys see chapter 3 4 3 Fast access keys e Or menus and their functions can be selected by means of the click wheel control see chapter 3 4 4 Click wheel control Dune a Alarm frame WMA es a Click 2 Parameter frame Navigation frame Illustration 16 Menu selection CNAP Monitor 500 page 3 13 Version 1 2 BIOPAC PN NIBP100D Introduction 3 5 Quick setup 1 Starting up the CNAP Monitor 500 Press Power On Off and confirm the alarm self test test alarm signal by pressing Alarm Pause Off 2 Subject setup a Choose the correct CNAP double finger cuff size by means of the graphic on the CNAP controller If a subject s finger size is between two cuff sizes choose the larger cuff b Assemble the CNAP hardware by connecting the CNAP double finger cuff the CNAP controller the CNAP cable with the CNAP Monitor 500 All plugs and connectors are designed so as to making it impossible to switch them accidentally C Equip the subject with the CNAP hardware The CNAP double finger cuff is placed on the proximal joints of the index and middle fingers Ensure that Illustration 17 Subject setup the cuff cables run along the upper side of the subject s arm d Fasten the CNAP controller to the subject s forearm by means of the fixing cuff with Velcro fastener and make sure tha
24. to take a measure e g replace a defective CNAP double finger cuff NOTE e The CNAP Monitor 500 has no other than the mentioned 2 alarm levels physiological alarms yellow and technical malfunction alarms white STOP If several alarms are activated at the same time e the alarm signals will be displayed alternately in intervals of 5 seconds in the alarm frame e physiological alarms and technical malfunction alarms will be displayed one after the other in their order of appearance e the physiological alarm with the highest priority is accompanied by an acoustic signal e new alarms and technical malfunction alarms are displayed immediately CNAP Monitor 500 page 6 1 Version 1 2 BIOPAC PN NIBP100D Alarm system 6 1 Visual alarm signals Alarm signals are displayed visually in the Alarm frame and the Parameter frame directly on the Main screen CNAP Dia High 14 45 15 00 Illustration 20 Visual alarm signals Alarm frame e Background color YELLOW Physiological alarms medium priority WHITE Technical malfunction alarms low priority BLUE Status messages e Alarm priority medium priority low priority e Alarm system status Alarm Alarms Paused be Be gt Alarms Off e ks gt Audio Pause X Audio Off CNAP Monitor 500 page 6 2 Version 1 2 BIOPAC PN NIBP100D Alarm system e Alarm report a text with an alarm message describing the cause for the
25. www cnsystems at a Ci iSystems Ihe Brain amp Heart Company Konformit tserkl rung Declaration of Conformity CE CNS 20080424 Produktspezifikation product details Produktbezeichung product name Continuous non invasive blood pressure measurement equipment Type type CNAP Monitor 500at CNAP Monitor 500i Software Version 2 9 Klassifizierung nach RL 93 42 EWG Anhang IX IIb Classification according 93 42 EEC annex IX Angewandte Normen used standards EN 60601 1 A1 A2 A12 A13 1996 EN 1060 1 A1 1996 EN 60601 1 2 A1 2003 EN 1060 3 2006 EN 60601 1 4 A1 1999 EN ISO 14971 2007 EN 60601 1 6 2005 EN 60601 1 8 2007 EN 60601 2 30 2001 Wir erkl ren in alleiniger Verantwortung dass die oben beschriebenen Produkte den Anforderungen der Richtlinie 93 42 EWG entsprechen Die Produkte werden mit dem CE Kennzeichen und der Kennnummer 0408 versehen We declare under sole responsibility that the products described above are in compliance with directive 93 42 EEC The products are CE marked with the number 0408 G ltig bis valid until 10 2010 Graz 24 04 2008 CNAP Monitor 500 page 15 9 Version 1 2 BIOPAC PN NIBP100D
26. 2345 Gender M Birth Date 1970 Jan 01 Printed 2007 May 10 15 49 50 Last NBP 125 83 15 48 a Ea 20 188 Illustration 33 Snapshot report 8 4 Print options III seine Setting of delay time of print reports for Snapshot Delay Snapshot and Print on alarm Print On Alarm Activation of Print on alarm feature jon off CNAP Monitor 500 page 8 3 Version 1 2 BIOPAC PN NIBP100D CNAP 9 CNAP General INFOFMATION cc ccc cc cece cette eee eee eee a aaa a e eee H ssa eee t esa eeeteeeaeetenegeeetenegeertseagegs 9 1 Salty BFECAUNONS sense ner ee ET ENT Eee 9 2 00 e a ee ae een 9 3 VIEW E E e OE nd 9 4 BIG OG Pressure Wave oN erreneren an aA Ea a a EEA EE a 9 5 TEN ea EE E er en ee ee 9 5 NUOC VAUC E o o E nee 9 6 CNAP OOO NS ee ee ae 9 6 9 1 General information CNAP Continuous Non Invasive Arterial Blood Pressure is a non invasive method for measuring the continuous blood pressure waveform in adult and pediatric patients from the age of 4 years A patient s blood pressure waveform is recorded by the CNAP Monitor 500 by means of a double finger cuff with an integrated IR light sensor and air chambers in connection with NBP measurement oscillometric blood pressure measurement The NBP cuffs can be placed on the patient s upper arm either on the same or on the other arm as the double finger cuff NBP measurement is essential to ensure absolute accuracy of the recorded blood pressure val
27. AP 3S mmHg 103 Dia NBP Sys mmHg 14 45 15 00 Illustration 23 Parameter frame alarm limits In order to view and edit all set alarm limits use the click wheel control to select the Parameter frame and then to open the Alarm menu see chapter 6 4 2 Alarm setup CNAP Monitor 500 page 6 5 Version 1 2 BIOPAC PN NIBP100D Alarm system 6 4 2 Alarm setup The Alarms Menu enables the operator to adjust the alarm functions of all parameters en ser Automatic setting of alarm limits for activated narrow wide alarms Cancel off Auto Limits on off lower Alarm limits for systolic blood pressure upper Alarm limits for mean blood pressure Alarm limits for diastolic blood pressure Alarm limits for pulse rate Alarm Volume Volume settings for alarms 20 100 20 20 100 Function to set alarm reminders see chapter 6 3 Alarm Reminder acknowledgement of alarms Audio Off Audio Pause Pausing of alarms see chapter 6 3 2 Pausing 1 min 2 min 3 Alarm Pause switching off alarms Alarms Paused Alarms min no Off timeout NOTE e The defined safe limits configurated in the factory settings never leave the physiological area SYS MEAN DIA PULSE Setting of alarm function for every single parameter e on off e Lower lower limit e Upper upper limit e Current Display of current numeric value of a given vital parameter STOP e The CNAP Monito
28. CNSystems The Brain amp Heart Company MI Operator s Manual paid Monitor 500 Crap Heartware by CNSysterns The CNAP Monitor 500 meets the requirements of cE mark C 0408 according to the European standard for medical devices 93 42 EWG Distributed by BIOPAC Systems Inc 42 Aero Camino Goleta CA 93117 Tel 805 685 0066 info biopac com www biopac com Manufacturer CNSystems Medizintechnik AG Reininghausstrasse 13 8020 Graz Austria Edition Apr 23 2008 Version 1 2 BIOPAC Part number NIBP100D Table of Content Table of contents 1 2 3 ADOBE TAS Mantas ee ee ae E E Deren 1 1 Led STOP CAUTION NOTES een ae eu siehe 1 1 1 2 Cross Teer ones aaa A A e ASES 1 1 1 3 SCINS ae Eee sanieren 1 1 General MTORIMALION Hensel eii atadas 2 1 2 1 Wa NN Se ee a ae ioc E ea Dee 2 1 2 2 PRECAUTIONS say ee Bee ler arena 2 1 2 221 GENEL Al PrOCAIUTION Suc citas aro a seins ae na re ee eher 2 1 22 2 BIOO pressure nen RER 2 2 2 3 DISDOSAl a man a Ni s 2 3 2 4 Declaration Of INtended USE sis east 2 3 IDELOQUELION Eee ee t dorado rada 3 1 3 1 General Ito Macs dad dada 3 1 3 2 SY Stent COMPONEN S u area ein Heli 3 1 3 2 1 CNAP MONITON S00 ad e aa aia 3 2 3 2 2 CNAP Hardware sist da lila das 3 5 3 23 CNAP E CONTO le radiata 3 6 A O RRA 3 7 3 3 POW CI SUD DIY stata edo o ae ee ern 3 7 3 3 Mans Opera ara a en Seien ocres 3 7 31392 Battery Operation emailen 3 8 3 4 PINS ESOO sitial a ee ea
29. Disconnect CNAP hardware Reboot CNAP monitor CNAP Cuff Failure _ Inflation of CNAP finger cuff Inflation Timeout exceeded time limit In case of persistent error contact service Disconnect and reconnect i CNAP controller CNAP Controller Memory chip in CNAP controller Fault Memory defective In case of persistent error contact service for faulty CNAP controller Check for permutation with equipment from 3 party devices CNAP Controller CNAP controller is not licensed for Fault Unlicensed CNAP Monitor 500 CNAP Monitor 500 page 12 8 Version 1 2 BIOPAC PN NIBP100D Technical alarms and status messages 12 5 NBP 12 5 1 Status messages NBP measurement was stopped from the user NBP Terminated NBP Fault Checksum error occurred NBP Single User has triggered a single Measurement NBP measurement NBP Automatic Measurement Timed NBP measurement NBP Interval NBP is triggered to confirm BP trend CNAP differs more than 25mmHg for more than 1min from last NBP NBP Checking CNAP 12 5 2 Technical alarms NBP Weak or no oscillometric Weak Or No Signal signal Artifact irregular oscillometric signal NBP Artifact NBP Exceeded Retry Count In spite of numerous retries no measurement possible NBP Measurement Timeout Time limit for measurement has been exceeded CNAP Monitor 500 page 12 9 Take new NBP
30. Leakage in left CNAP finger cuff page 12 7 Check NBP for proper setup and measurement Check size of CNAP double finger cuff Check setup positioning of CNAP double finger cuff Warm patients hand before measurement Check CNAP double finger cuff for patient movement i e repositioning Disconnect and reconnect CNAP hardware In case of repeated error contact service Check influence from ambient light In case of persitent error replace CNAP double finger cuff Check influence from ambient light In case of persitent error replace CNAP double finger cuff Replace CNAP double finger cuff Check for permutation with equipment from 3 party devices Replace CNAP double finger cuff immediately Order new CNAP double finger cuff in corresponding size Check connections of CNAP hardware Replace CNAP double finger cuff check with other cuff size In case of persistent error contact service Version 1 2 BIOPAC PN NIBP100D Technical alarms and status Messages o Incase of non persistent error replace defective CNAP double finger cuff Check connections of CNAP hardware Replace CNAP double finger cuff check with CNAP Cuff Fault other cuff size Leakage in right CNAP finger cuff Leakage Right In case of persistent error contact service In case of non persistent error replace defective CNAP double finger cuff
31. POWER COFO ee ne une ee se ee 3 8 FRONCIE N ee er u eis Diener 3 10 Splash SC inet ee een ee 3 10 Malin A A ARO 3 11 Fast ACCESS KOV O Na andenaeet 3 12 ElIcKk WheelContr lze see nee 3 13 Men seleciona rer re sa ene sass 3 13 Patents eta dl ooo cada 3 14 Parameters Menus IBP Zero dns 4 4 Patient setup window patient frame cocccccccccccncnccnnanannn cnc nor 5 1 Misal alar SIN Surtido iaa 6 2 Alarm Tamne alarm condo Start 6 3 Parameter frame alarm CONdITIONS oooccccccccccccccnnnnncncnnnanncncnc orar rr rr 6 3 Parameter frame alarm liMitS ooooocccccccccccccnnnncnccnnanannn cnc nro rr 6 5 Trend TAM a nenn ee ee 7 2 GOI A ee een A nee een hie 7 3 Example or BR Scale re ea ee ee eine r TE 7 4 Numeric trend and Navigation frame susssssseeenenensennnnnnnnnnnn nenn nn nn 7 6 ALARM aaa ee er us ae Eee 7 8 Navigation frame including time specification uusseseseeeeeeeneenennnnnnnnennn nenn nenn 7 9 Grannie Trend EDOM arta rss era 8 2 Namene rend Tepic ee ee ehesten re he 8 2 Alar NISO FEDO ea naar cid 8 3 SHaPSNOE reposan een 8 3 CNAP Far dW a ea na 9 3 Patient SCE Did dia E ae A 9 4 CNAP blood pressure waveform zussseseneesennnnnnnnnnnnnnnnnnnnnnnnnnn nennen nnnnnnnnnen 9 5 Graphic trend and numeric values parameter frame 22sssssneneneeeeeeeeen nennen 9 5 Parametros dol 9 6 CNAP Monitor 500 with NBP air Connector ssssessrrsrssrrrrsrrererrrrrsrrerrrrsrrsrre 10 3 Parameter TM R
32. Pulse as well as the Alarm history see chapter 5 3 Discharge CNAP Monitor 500 page 7 8 Version 1 2 BIOPAC PN NIBP100D Trends 7 2 5 Scrolling of trend views The time slot of the data displayed in the Trend frame can be adjusted in the Navigation frame by using the click wheel control 1 Access the Navigation frame using the click wheel control 2 Select the desired time slot by wheeling the click wheel control 3 Confirm selection by pressing the click wheel control NOTE gt e Scrolling trends by means of the click wheel control is restricted to the start of a measurement and or the current time i e the time slot of a trend can neither be scrolled to before the start of a measurement nor to a prospective time Name 11 Dec 17 01 CNAP SIS ACA dl Sys 1 1 Ox mm q 91 2 Die 76 _ gt 131 90 Illustration 29 Navigation frame including time specification CNAP Monitor 500 page 7 9 Version 1 2 BIOPAC PN NIBP100D Printing 8 Printing Launching prat repor S uers srianan nee aan ae et een 8 1 Soles oia AA o e e o OO II 8 2 PRG LE DOTES ee a ee ee do iaa 8 2 A o a a A es 8 3 The CNAP Monitor 500 is provided with an integrated thermal printer enabling the operator to print a range of predefined print reports 8 1 Launching print reports The operator can launch print reports by means of pressing the key Print for variable lengths of time and select print reports as follows a Dep
33. Start DER Interval O NBP Sys 431 Audio Trend mmHg Adult Alarm Limits 7 90 IBP Zeroing Ok Illustration 18 Parameters menu IBP Zeroing 3 Select the pressure sensor on your subject monitor and start the zeroing process Usually a subject monitor will report successful zeroing must be within 32 mmHg e g by signalling zero completed offset is xx mmHg 4 On the CNAP Monitor 500 deactivate IBP Zeroing by returning to OFF and return to the main menu Now the CNAP blood pressure waveform will also be displayed on the subject monitor NOTE e If you don t deactivate IBP Zeroing and leave it on ON the pressure signal on the subject monitor will display O mmHg CAUTION In order to ensure full accuracy of the CNAP blood pressure waveform and its derived blood pressure values to another subject monitor do not forget to perform an IBP A zeroing when connecting the two devices In addition the CNAP waveform is to be zeroed according to your institute s regulation but at least once a day Plus IBP zeroing should be performed if there is any doubt as to the accuracy of obtained recordings NOTE e Blood pressure values obtained by means of CNAP and invasively obtained reference gt values may differ for the following reasons 1 Difference in beat detection 2 Different settings for Parameter Averaging see chapter 4 2 measurement settings CNAP Monitor 500 page 4 4 Versi
34. TION e In order to connect the CNAP Monitor 500 to other subject monitors the following 2 cables are needed 1 CNAP transducer cable interfaces the CNAP blood pressure waveform from the CNAP Monitor 500 BP Wave Out connector RJ11 6P4C connector is used A e g Abbott IBP catheter The CNAP transducer cable is available from CNSystems Medizintechnik AG refer to chapter 13 4 Connections 2 IBP interface cable connects from the CNAP transducer cable to the IBP port of the subject monitor As there is no cable generally authorized for all brands of subject monitors we strongly recommend you contact BIOPAC Unlike the analog output port see chapter 4 5 the CNAP blood pressure waveform signal via the BP Wave Out is standardized Its sensitivity depends on bridge voltage and amounts to 5 uV V mmHo If for example the supply voltage was 4 V the sensitivity would be calculated as followed 5 uV V mmHg x 4 V 20 uV mmHog In order to connect the CNAP Monitor 500 to a subject monitor you proceed as follows 1 Connect the CNAP Monitor 500 and your subject monitor using a the CNAP transducer cable and b the IBP interface cable 2 Activate IBP Zeroing from the parameters menu CNAP Monitor 500 page 4 3 Version 1 2 BIOPAC PN NIBP100D Monitor configuration Name 11 Dec 16 44 i ee MT ne Parameters un y 1 27 CNAP Change Finger Change Finge CNAP Cal Interval 3 96 Dia ER NBP
35. The displayed values are averaged on the basis of the selected time scale time interval e n Case of an adjustment of the time scale the current point of time is displayed in the far right column of the Trend frame STOP e Time labels displayed in the Navigation frame correspond to the time displayed on the system clock of the CNAP Monitor 500 So it is essential to make sure that the monitor s system clock is showing the correct time CNAP Monitor 500 page 7 7 Version 1 2 BIOPAC PN NIBP100D Trends 7 2 4 Alarm history The Alarm history is a list of up to 100 last released alarms and malfunction reports Each report of the alarm history includes the following information e Date e Time e Priority e Alarm message Name 11 Dec 17 00 alarm history CONAP SIS A AA lt A y Ba mmg 11 Dez 16 49 25 CNAP Dia High 94 Dia 11 Dez 16 49 07 CNAP Sys High IR 11 Dez 16 48 57 CNAP Dia High 11 Dez 16 47 49 CNAP Sys High ae R 131 11 Dez 16 47 03 CNAP Sys High i 90 11 Dez 16 47 02 NBP Sys High Illustration 28 Alarm history NOTE gt e The Alarm history includes the entire list of the last reported alarms up to 100 entries The scroll up and scroll down keys in the Navigation frame can be used to view and complete list of alarms STOP Discharge of a patient fon e The deletion of patient data irretrievably deletes all connected recordings including the parameters Sys Mean Dia and
36. aise 10 5 Status MESSE T ne ee u ee 12 1 500 page 13 2 Version 1 2 BIOPAC PN NIBP100D Appendix B 14 Appendix B Accessories PPP ace cinta A UU III E OE TREE 14 1 A ee E E A SEIS 14 1 A E A O II II A A 14 1 Paper TEC ON INENGALION aa a dos pl ee een eis 14 2 COMMCCH OMS ern ee ee EEE Gene end ee 14 2 Other acessories een ne ae een ee ee 14 3 STOP In order to ensure operational reliability functional safety as well as patients safety gt only original CNSystems Medizintechnik AG accessories and replacement parts are to be used 14 1 CNAP CNAP double finger cuff small CNAP double finger cuff medium CNAP double finger cuff large 14 2 NBP ems Number NBP cuff Child 12 19 cm NBP cuff Small Adult 17 25 cm NBP cuff Adult 23 33 cm NBP cuff Large Adult 31 40 cm 14 3 Printer Thermal paper 20 HVZU 00258 CNAP Monitor 500 page 14 1 Version 1 2 BIOPAC PN NIBP100D Appendix B 14 3 1 Paper recommendation CNSystems Medizintechnik AG recommends to use the following paper with your CNAP Monitor 500 Kanzan KPR 540 In comparison with standard thermal paper for POS or fax this high quality paper is characterized by a considerably higher degree of resistance against substances i e alcohol grease PVC or plasticizers oil hand lotion or cream etc This results in your prints being readable and storable for a longer time If stored
37. al alarm signals STOP The automatic device self test causes the system to release a technical alarm signal of LOW priority white alarm the alarm message reading Alarm Self Test Control the functional reliablity of the alarm system during start up and confirm it by pressing Alarm Pause Off e Visual alarm signal IN Alarm message Alarm Self Test e Acoustic alarm signal LOW PRIORITY 6 7 Physiological alarms message Blinking NBP NBP Sys High NBP Dia High NBP Sys Low NBP Dia Low CNAP Sys High CNAP Dia High CNAP Mean High CNAP Sys Low CNAP Monitor 500 Medium Medium Medium Measured NBP pressure value exceeds upper alarm limit In addition Sys Dia indicates which parameter has exceeded the alarm limit Measured NBP pressure value falls below lower alarm limit In addition Sys Dia indicates which parameter has dropped below the alarm limit Measured CNAP pressure value exceeds upper alarm limit In addition Sys Mean Dia indicates which parameter has exceeded the alarm limit values alarm message and acoustic alarm signal Blinking NBP values alarm message and acoustic alarm signal Blinking CNAP values alarm message and acoustic alarm Signal CNAP Measured CNAP pressure value falls Blinking CNAP page 6 9 Version 1 2 BIOPAC PN NIBP100D Alarm system message CNAP Dia Low below lower alarm limit In addition
38. alarm signal appears in the Alarm frame e Blinking Alarm frame for physiological alarms NE NBP HIGH Illustration 21 Alarm frame alarm conditions Parameter frame e Background color YELLOW Physiological alarms medium priority WHITE Technical malfunction alarms low priority BLUE status messages e Blinking Parameter frame e Numeric values unchanged during physiological alarms blanked during technical malfunction alarms Illustration 22 Parameter frame alarm conditions 6 2 Acoustic alarm signals In accordance with the regulations of EN 60601 1 8 the CNAP Monitor 500 produces acoustic alarm Signals The differently coded alarm signals are repeated until acknowledged by pressing the key Alarm Pause Off NOTE Repetition rate for acoustic alarm signals is e 5 seconds for physiological alarms e 18 seconds for technical malfunction alarms STOP e Do not rely solely on the acoustic alarm signals Especially if the alarm volume is set low alarms might be missed which could constitute a possible danger for subjects CNAP Monitor 500 page 6 3 Version 1 2 BIOPAC PN NIBP100D Alarm system The alarm signal volume is individually adjustable Factory setting is 80 of maximum volume and can be adjusted from 20 to 100 Maximum sound pressure amounts to 93 dB at a distance of 1 meter from the CNAP Monitor 500 whereas minimum sound pressure amounts to 60 dB at a distance of 1 meter
39. amaged sealed lead gel battery e Caution see accompanying documents m m me e Separate disposal of electric and electronic appliances CNAP Monitor 500 page 3 4 Version 1 2 BIOPAC PN NIBP100D Introduction 3 2 2 CNAP hardware O CNAP monitor O CNAP hardware NBP hardware I Illustration 5 CNAP Monitor 500 3 2 2 1 CNAP double finger cuff The CNAP double finger cuff comes in three sizes each size being marked by a differently colored hood aes QU 24 28 O M 18 24 Dark blue 10 18 Light blue IIA Illustration 6 CNAP finger cuff CNAP Monitor 500 page 3 5 Version 1 2 BIOPAC PN NIBP100D Introduction 3 2 3CNAP controller The CNAP controller connects the CNAP double finger cuff and the monitor via the CNAP cable The jacks for the CNAP double finger cuff and the CNAP cable are adequately designed so as to avoid any confusion when putting the cables into the corresponding jacks e The graphics on the upside of the CNAP controller help choosing the right size of CNAP double finger cuff e The CNAP controller is fastened to the subject s lower arm by means of the CNAP forearm fixing cuff with Velcro fastener e The fixture for CNAP controller connects the CNAP forearm fixing cuff mechanically to the CNAP controller Illustration 7 CNAP controller 3 2 3 1 CNAP cable The CNAP cable
40. ase of persistent error contact service Check connections of CNAP controller Reconnect CNAP controller In case of persistent error contact service Replace CNAP double finger cuff check with other cuff size In case of persistent error contact service Check for low perfusion Check size of CNAP double finger cuff Check setup positioning of CNAP double finger cuff Check proper optical path in CNAP double finger cuff Reduce ambient light i e brightness switch off Check setup of CNAP double finger cuff Version 1 2 BIOPAC PN NIBP100D Technical alarms and status Messages CNAP Check Cuff Timeout On Calibration CNAP Cuff Fault Overpressure CNAP Cuff Fault Light Sensor Left CNAP Cuff Fault Light Sensor Right CNAP Cuff Fault Memory CNAP Cuff Fault Unlicensed CNAP Cuff Fault Safety Shutdown CNAP Cuff Fault Leakage Left CNAP Monitor 500 Missing NBP calibration Signal quality insufficient during the calibration cycle max 5min Pressure exceeded 330mmHg for more than 2sec in CNAP finger cuff Light sensor in left CNAP finger cuff defective Light sensor in right CNAP finger cuff defective Memory chip in CNAP double finger cuff defective CNAP double finger cuff is not licensed for CNAP Monitor 500 CNAP double finger cuff cannot provide suffient quality for further measurement
41. asurement Illustration 40 Parameter frame NOTE e The Parameter frame always displays the most recent NBP values as well as the time of measurement 10 5 NBP options Parameter menu en eser ns Change of signal source in CNAP double finger NBP Start Start of a single NBP measurement off Setting of time interval for automatic NBP measurement for the current CNAP recording only 45 60min l natti NN AN r mc far LL NM ata da Td a a Vaig al aa Cie VAAAN Nia Setting of alarms for the parameters Sys Mean Dia CNAP Monitor 500 page 10 5 Version 1 2 BIOPAC PN NIBP100D NBP Measurement Setup Menu item Description Settings Pre set time interval for automatic NBP measurement for each new CNAP recording NOTE e Adjustments in the menu Parameter alter only the current measurement and are F transcribed by Defaults when a new measurement is started e Settings performed in the menu Measurement however alter both the current as well as future measurements CNAP Monitor 500 page 10 6 Version 1 2 BIOPAC PN NIBP100D Cleaning and disinfection 11 Cleaning and disinfection Ei A arten ale peu oe o o EA 11 1 E e IA yg ne ee ee O A 11 2 ISIN as y e EEE E ee o o dee ea dee wre enge 11 2 Only use disinfectants and detergents recommended by CNSystems Medizintechnic AG to clean or disinfect the device and its accessories CNSystems warranty does not cover any damag
42. ate OPONA nee een een ea 4 5 4 1 Monitor settings menen aten sa 20 20 100 Auto Brightness Regulates the brightness of the TFT display Date setti yyyy mm dd Time timesetting mms NOTE e Monitor settings are saved automatically Loss of settings only occurs in case of interruption of power supply no mains operation followed by battery depletion 4 2 Measurement settings Menuitem Description se CNAP Cal Setting of intervals for automatic change of signal Interval source in the CNAP double finger cuff NBP Setting of time interval for automatic NBP rh 5 5 30 45 Interval measurements Audio Trend Setting of source and volume of audio trend Display Setting of trend view Display and scaling Options Submenu Setting of print options Delay time for snapshot Print Options prints activation of Print on Alarm see Submenu chapter 6 3 Parameter Averaging of displayed numeric parameters off 5 10 15 sec Averaging ging play p 9 CNAP Monitor 500 page 4 1 Version 1 2 BIOPAC PN NIBP100D Monitor configuration NOTE gt e Measurement settings are saved automatically for any current or future measurement e Loss of power supply interruption of mains operation followed by depletion of battery entails the loss of measurement settings 4 3 Service settings NOTE e The service menu is divided into 2 layers which can be accessed by entering a password e You find the pas
43. ati lliiy asics ee a ee hard 15 5 15 4 Standardsuche een ni een 15 8 15 5 Declaration CONTON errioa a A AE A 15 9 CNAP Monitor 500 page iii Version 1 2 BIOPAC PN NIBP100D About this manual 1 About this manual STOP CAUTION NOTES cccenenenenanannnnn nn nnnnnnnnn nun nenn nenn nennen EEE 1 1 CESS FO SNCS Saat ns ann en ee tido 1 1 CUEING a e Po EE O o o ee undaeer 1 1 1 1 STOP CAUTION NOTES In this manual the icons STOP CAUTION and NOTE are used to indicate matters of particular interest to keep in mind when operating the CNAP Monitor 500 or dealing with subjects STOP The icon STOP indicates important security relevant information STOP sror e Control the correct positioning of the CNAP double finger cuff Make sure that the cuff is not positioned on the finger joints CAUTION The icon CAUTION indicates important information referring to the correct utilization of the CNAP Monitor 500 CAUTI ON e The life time cycle of a CNAP double finger cuff is 6 months if in constant use on subjects or 12 months at the most NOTE The icon NOTE indicates helpful information referring to the utilization of the CNAP Monitor 500 and its components NOTE e Use the graphics on the CNAP cuff controller to determine the correct finger cuff size 3 sizes e If the size of a subject s finger is between two finger cuff sizes use the larger CNAP finger cuff for the measurement
44. bject data before starting a measurement a Quick default entry of adult or pediatric subjects The functions New Patient Adult Defaults or New Patient Pediatric Defaults automatically sets the respective subject category the measuring process can start immediately by pressing the Start Stop key Detailed subject data input can be performed at a later time via Alarm frame and the Patient menu b Detailed subject data entry and input By selecting the option New Patient the Patient menu see chapter 5 2 Editing of subject data appears immediately NOTE e Default entry should only be resorted if there is not enough time or not all the necessary information available for a complete subject data input Lacking subject data must however be entered at a later time or the prints will show no subject data 5 2 Editing of Subject data At any given time during a measurement you can enter subject data by using the click wheel control to select the Patient frame on the main screen and to open the Patient menu menuitem Deseos seine surname and first name kevboard max 20 characters y file number e g 12345678 m a Birth Date birth date e g 1970 MAR 10 YYYY MMM DD Categor category ADULT gt 14 years Pediatric gory PEDIATRIC 4 14 years Adult STOP e Subject category Entering the correct subject category is an indispensal prerequisite before starting a measurement process Be sure to select the correct
45. c value for phase 5 Korotkoff Sys ADULT 40 260 mmHg PEDIATRIC 40 160 mmHg Dia ADULT 20 200 mmHg PEDIATRIC 20 120 mmHg Heart rate indication range 40 200 bpm Inflation pressure at start ALL eo AS PEDIATRIC 120 mmHg Clinical accuracy Meets ANSI AAMI SP10 1992 und 2002 Accuracy of pressure 3mmHg between 0 300 mmHg at operating temperatures of O recording 50 C Calibration interval for 12 months pressure recording Atmospheric pressure no influence on accuracy of measurement Max cuff pressure 300 mmHg Protection against electric 15 1 4 Printer Integrated thermal paper printer Measuring range CNAP Monitor 500 page 15 3 Version 1 2 BIOPAC PN NIBP100D Appendix C 15 1 5 Product configuration Thermal printer Thermal printer IN TT 15 2 Connections BP Wave Out Sensor bridge voltage 2 10V external monitor Sensitivity 5 uV V mmHg BP Wave Out CNAP 0 3m connector RJ11 6P4C e g Abbott IBP catheter transducer cable AUX analog output port Voltage range 12 V Reference 5 5 V 0 500 mmHg Sensitivity 50 mmHg V Samling frequency 100 Hz Output Offset 50 mV Output Accuracy 5 Output Internal Resistor 100 Ohm Output Current max 2 mA CNAP Monitor 500 page 15 4 Version 1 2 BIOPAC PN NIBP100D Appendix C 15 3 Electromagnetic compatibility Medical electric devices have to comply with special safety regulations regarding EMC electromagnetic co
46. caceuGuuteesasmawuascnteerccthonegsedebuayaneeasmercuaegures rer 6 3 El SY ci ae oigo rei o o A eo OR ORTA 6 4 Acknowledgement of alarms Audio Off Audio Pause c oocccccccccccncnnancncnnc rc rn rr rr rr 6 4 Pausing switching off alarms Alarms Paused Alarms Off ccccc cece cece scene eeeeeeeeeeeeeeeneeeees 6 4 Reactivation of paused alarms Alarms Off ccccccccccce cece cece cece cece ee eee eee eee e eens seen eases eee ee bene nn ES 6 5 AP e ono y EEE 6 5 Display Of INGIVIAUal ala IAS aaa 6 5 A A o e O one 6 6 Udo a I ee o ee ee en ee nee esse 6 7 Alarm limits Tactory SCI Scotia aa aia adas 6 8 Ai EE ara o eo eo 6 9 Alaro System UNCON TEST een een 6 9 PI SIO LOGIC al ala INNS tarot rio apos ta 6 9 The alarm system of the CNAP Monitor 500 distinguishes between two alarm levels physiological alarms yellow and technical malfunction alarms white e MEDIUM PRIORITY Yellow alarms are physiological alarms of medium priority e g exceeding the upper or falling below the lower limit for systolic blood pressure e LOW PRIORITY Technical malfunction alarms indicate that the CNAP Monitor 500 is unable to take a measurement or to reliably detect possible alarm conditions Instead of numeric values the parameter frame displays accompanied by an acoustic signal which has to be confirmed by the operator see chapter 6 3 1 Acknowledgement of alarms Depending on the indicated malfunction the operator may have
47. ding to the regulations of IEC 601 2 30 EN 60601 2 30 non invasive blood pressure measurement is fit for use during electrosurgical surgery as well as during discharge of a cardiac defibrillator e The CNAP Monitor 500 meets the requirements of EN 60601 1 1 and can be used next to subjects without restrictions e While using the CNAP Monitor 500 avoid compressing the air hoses or reducing their diameter in any way e g by bending the cables as this could impair the quality of the measuring signals e No liquid must ingress the CNAP Monitor 500 In case this should happen the instrument must not be started up again until after inspection by a qualified technician e Any chemicals needed for the use and maintenance of the device are only to be prepared and stored in correspondingly designated containers in order to prevent confusions entailing possible serious consequences e Medical devices like the CNAP Monitor 500 are to be operated only by accordingly trained persons who can guarantee proper handling of the device on the basis of their special training or their skills and practical experience e The operator has to be familiar with the operation of the CNAP Monitor 500 Before each measurement process the operator is to check and control the due condition operational reliability and functional safety of the device CNAP Monitor 500 page 2 1 Version 1 2 BIOPAC PN 21 FHZU 10002 Introduction e Before connecting any cab
48. directly above the brachial artery NOTE Do not fix the cuff too tightly around the limb as this might cause problems during inflation and deflation of the cuff and lead to ischemia of the extremities Be sure to inspect the patient s skin colour temperature sensitivity of limb around the cuffs on a regular basis Should any signs of alterations of the skin or decreased blood supply be noticeable immediately change arms or stop the blood pressure measurement altogether 3 Connect the NBP cuff with the NBP air connector on the left side of the CNAP Monitor 500 4 There are 2 ways to start an NBP measurement a The start of a CNAP measurement also automatically starts an NBP measurement NBP measurements are performed after the calibration phase of the CNAP measurement or automatically in defined time intervals To set the desired time intervals acces either the menu Parameter or the menu Measurement b In order to start a single measurement use the click wheel control to access the menu Parameter NOTE e The NBP measurement serves to calibrate the CNAP blood pressure measurement at the height of the heart CNAP Monitor 500 page 10 4 Version 1 2 BIOPAC PN NIBP100D NBP 10 4 View features By means of NBP the blood pressure values Sys and Dia are determined and displayed in the Parameter frame of the CNAP Monitor 500 D Systolic blood pressure D Diastolic blood pressure Time of last NBP me
49. e caused by the use of unsuitable cleaning agents or methods The warranty of CNSystems does not apply to the effectiveness of the mentioned cleaning agents and methods for the purpose of infection prevention and control When in doubt the operator is to contact the hospital hygiene department This particularly applies for the effectivity of disinfectants and detergents against hepatitis B and HI viruses The operator is to follow the regulations of the respective hospital and country 11 1 General precautions The CNAP Monitor 500 including all its components and accesssories are to be kept clean and free of dust After cleaning and disinfecting the devices they must be thoroughly inspected before use If any components show signs of wear or damage these components must not be used for patient measurements Before sending devices and components back to CNSystems they are to be decontaminated CAUTI ON e Always dilute detergents according to manufacturers instruction or use in the smallest possible concentration No liquid must ingress the CNAP Monitor 500 Do not dip instruments device parts or components in liquid Do not pour any liquid directly on the device Do not let residues of detergents or disinfectants air dry on any parts of the device Wipe them off with a cloth moist with water then dry the instruments with a clean cloth e Never use scouring agents or abrasive detergents e g steel wool or silver polish
50. e configured as follows mam amen sa 20 10 240 mmHg 50 25 200 BP Mean Setting of expected mean blood pressure g p p mmHg 100 50 150 Setting of expected mean blood pressure 40 100 BP Amplitude Amplitude 200 mmHg Example Patient s blood pressure 130 80 105 o BP Mean 100 mmHg o BP Amplitude 100 mmHg Name 11 Dec 16 55 Illustration 26 Example of BP scale 3 NOTE e The scale of CNAP blood pressure applies the waveform and trends CNAP Monitor 500 page 7 4 Version 1 2 BIOPAC PN NIBP100D Trends PULSE SCALE The scale factor of the CNAP pulse rate trend can be configured in the menu entry Pulse scale which is located in the menu Trend Scales are configured as follows ICI Bescon see 20 10 240 bpm 50 25 200 Pulse Mean Setting of expected mean pulse rate g p p bpm 100 50 150 bpm Setting of expected mean pulse amplitude max 40 100 Pulse Amplitude min 200 bpm TI ME SCALE The time scale of blood pressure and pulse rate trends can be set in the menu item Time scale which is located in the menu Trend memey oen sem 30min default 1h Time Scale Setting of time scale for Graphic trend 2h Ah 8h 12h 24h NOTE e Time scales of Graphic trend always correspond to the entire time slot which is displayed in the Trend frame e n case of an adjustment of the time scale the current point of time is displayed on the righ
51. ending on how long the operator presses Print he or she can select either Trend reports or Snapshot reports o Press Print once Snapshot reports printing is selected o Press Print for longer than 0 5 seconds printing of Trend reports which correspond to the data displayed in the Trend frame is selected NOTE The duration of Snapshot reports is limited to 20 seconds Snapshot delay settings are edited in the menu Measurement b The way how recordings are displayed in the Trend frame automatically determines the selected Print report o Graphic trend see chapter 8 3 Illustration 30 o Numeric trend see chapter 8 3 Illustration 31 o Alarm history see chapter 8 3 Illustration 32 NOTE e Scaling of trend frame The time slot displayed in the Trend frame including also the time scale settings is correspondingly printed e If necessary adjust scales i e BP Scale Pulse Scale Time Scale and the displayed time slot Navigation Bar NOTE e Depending on the Print options which can be accessed by means of pressing gt Setup in the Measurement menu the CNAP Monitor 500 can automatically launch a Print on alarm report if a physiological alarm is issued In this case printing does not depend on the Trend frame data display i e BP scale is fixed to 0 250mmHo STOP e If the CNAP Monitor 500 is on battery operation and battery charge status is lt 25 printing will be deactivated Current print jobs wil
52. ently measured vital parameters The alarm limits will then be set within a predefined safety range based on the measured individual parameters e Narrow currently measured value Sys Mean Dia Pulse 20mmHg e Wide currently measured value Sys Mean Dia Pulse 30mmHg e Cancel return to Alarm limits menu without changes e Off Alarm limits are restored to user settings Alarm defaults Alarm limits set by means of Auto limits are based on the patient s parameters measured at the time of function activation CNAP Monitor 500 page 6 7 Version 1 2 BIOPAC PN NIBP100D Alarm system 6 4 4 Alarm limits Factory settings The CNAP Monitor 500 has been preset to the following factory settings and default settings for alarm limits which apply to both CNAP and NBP e Alarm limits ADULT Lower limits Upper limits Lower limits Defaults Upper limits e Alarm limits PEDIATRIC Lower limit Upper limit Lower limits Defaults Upper limits sBP mmHg mBP mmHg dBP mmHg Pulse bpm NOTE e The operator can adjust alarm limits within the Alarm defaults menu Alarm limit settings for the patient categories Adult and Pediatric are to be performed separately The respective menu is located in a password protected area of the CNAP Monitor 500 which can be accessed via the Service menu The necessary password as well as further information about configurating individual user settings or restoring factory setti
53. erial oscillations 00000 NOTE e In order to ensure the accuracy of NBP measurings be sure to choose the right size of the upper arm cuff Selecting the wrong size or incorrect donning of the cuff may cause significant inaccuracies of recordings e In case of longer monitorings be sure to inspect the correct blood supply of the patient s limbs on a regular basis e The NBP cuff is made of latex free and skin friendly synthetic material CNAP Monitor 500 page 10 2 Version 1 2 BIOPAC PN NIBP100D NBP 10 3 Setup The NBP hardware consists of the following components e NBP cuff Child Small adult Adult Large adult e NBP module integrated into the CNAP Monitor 500 e NBP air connector NBP air connector Illustration 39 CNAP Monitor 500 with NBP air connector CNAP Monitor 500 page 10 3 Version 1 2 BIOPAC PN NIBP100D NBP Start Stop a measurement 1 Make sure you are using an NBP cuff authorized by CNSystems and make sure to use the correct size NOTE e The width of the cuff should be between 37 and 47 of the circumference of the patient s limb The inflatable part of the cuff should be at least 80 of the respective extremity e The following cuff sizes are available Arm circumference cm Child 12 19 Small Adult 17 25 Adult 23 33 Large Adult 31 40 2 Apply the NBP cuff on the upper arm of the patient at heart level The marker on the NBP cuff Should be
54. hnical alarm Battery Low Immediately switch to mains operation via e Battery depleted operation possible power adapter for 5 minutes at most monitor is Technical Alarm Battery Depleted switched off Current measurement discontinued monitor switched off automatically Immediately switch to mains operation via e Battery depleted operation possible power adapter for at least 15 minutes Current measurement discontinued monitor switched off automatically e Battery malfunction acoustic A technician technical alarm signal a e Battery is being recharged ma al CNAP Monitor 500 page 3 9 Version 1 2 BIOPAC PN NIBP100D Introduction 3 4 First steps 3 4 1 Power On Off The key Power On Off is located in the left lower corner on the front side of the device Illustration 11 Front view Switching on the monitor The CNAP Monitor 500 is switched on by pressing the key Power On Off located on the front side of the device for two seconds While the CNAP Monitor 500 is booting up device and software information is displayed on the screen The green power LED indicates the operation status of the device The operating system of the monitor initializes and performs a system self test then the main screen is displayed In addition the monitor also performs an automatic function test of its alarm system during starting up time see chapter 6 Alarm system CNSystems The Brain amp Heart Company crap moni
55. ing with the minimum distance between portable or mobile RF communication equipment transmitter and CNAP Monitor 500 depending on the power output of the communication equipment as specified below Rated power output of Separation distance depending on the transmit frequency m the transmitter W 150 kHz to 80 MHz 80 MHz to 800 MHZ 800 MHz to 2 5 o 11 67 11 67 23 33 The maximum rated power output values of transmitters that are not listed in the above list can be calculated by means of the respective formula whereas the maximum rated power output is P in watts W according to the specification of the manufacturer At 80 MHz and 800 MHz the higher frequency range applies These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Table 206 from EN 60601 1 2 2003 15 4 Standards The CNAP Monitor 500 meets the following standards OVE EN60601 1 A1 A2 A12 A13 1996 OVE EN 60601 1 2 2003 OVE EN 60601 1 4 1996 A1 1999 OVE EN 60601 1 6 2004 OVE EN 60601 1 8 2004 A1 2006 OVE EN 60601 2 30 2000 ONORM EN 1060 1 1995 ONORM EN 1060 3 1997 A1 2005 ANSI AAMI SP10 2002 CNAP Monitor 500 page 15 8 Version 1 2 BIOPAC PN NIBP100D Appendix C 15 5 Declaration of conformity CNSystems Medizintechnik AG 4 Reininghausstrasse 13 8020 Graz sterreich T 43 316 723456 0 F 2 Email office cnsystems at A Web http
56. ir 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec 6 kV contact 8 kV air 2 kV for power supply lines 1 kV differential mode 2 kV common mode lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec Electromagnetic environment guidelines Floors should be wooden concrete or ceramic tile If floors are covered with synthetic material relative humidity should be at least 30 Mains power supply quality should be that of a typical commercial or hospital environment Mains power supply quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the operator of the CNAP Monitor 500 requires continued operation during power mains interruptions it is recommended that the CNAP Monitor 500 be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Note Uris the a c mains voltage p
57. l battery is automatically recharged STOP e Damaged or time worn batteries might considerably reduce maximal operating time on battery The accuracy of the device s battery charge status is only guaranteed when using undamaged batteries and under normal operation conditions CAUTION e High temperature might impair your battery performance For optimal operability charge and use the battery at temperatures lt 35 C 95 F e When disposing of used batteries adhere to your local waste disposal regulations e Do not use any batteries but those authorized by CNSystems Use of non authorized batteries might damage the monitor e Before turning on the appliance for the first time be sure to charge the integrated sealed lead gel battery for 4 5 hours e In order to guarantee safe operability of the CNAP Monitor 500 the battery has to be replaced after 24 months in the course of maintenance service CNAP Monitor 500 page 3 8 Version 1 2 BIOPAC PN NIBP100D Introduction NOTE gt e When switching from mains operation to battery operation it can take up to a minute until the battery charge status is displayed e The thermal printer cannot be operated when the battery charge status is lt 25 Battery status pa lc a DO e Printing deactivated e Very low battery charge status Current print job cancelled lt 25 battery operation still Switching to mains operation via power possible adapter recommended Tec
58. l be cancelled immediately for safety reasons CNAP Monitor 500 page 8 1 Version 1 2 BIOPAC PN NIBP100D Printing 8 2 Cancelling print reports In order to cancel any print jobs press Print once 8 3 Print reports The CNAP Monitor 500 offers a range of predefined print reports All print reports have the same header containing the following information Print report type Name Patient ID Gender Birth date Printed date and time Last NBP values and time of the last NBP measurement Graphic Trend Report Name TESTER MAX Patient ID 123456789012345 Gander M Birth Date 1970 Jan 01 2007 May 10 15 59 115 75 15 55 L J J I 0 15 43 52 15 48 52 15 53 52 15 58 52 16 03 52 Illustration 30 Graphic trend report Numeric Trend Report ES 2007 May 10 2007 May 10 2007 Mey 10 2007 Mey 10 2007 Mey 10 15 50 51 _ 19 50 54 15 50 54 15 50 55 15 50 55 Name TESTER MAX Patient ID 123456789012345 125 125 134 124 126 a x 79 72 104 103 103 Birth Date 1970 Jan 01 Printed 2007 May 10 15 50 66 66 97 97 Last NBP 125 83 15 48 9 9 27 82 78 Illustration 31 Numeric trend report CNAP Monitor 500 page 8 2 Version 1 2 BIOPAC PN NIBP100D Printing Alarm history a zooren 1002 zoo 10020 nor Mepto 1002 rezo u a w GE 3441 F 2007 May 10 2007 May 10 18 02 125 85 16 02 ia eae orten _ non paa TESTER MAX i Patent ID 12345678901
59. larms the CNAP Monitor 500 displays technical malfunction alarms white and device status messages blue in the Alarm Frame Illustration 41 Status Message The following documentation lists all technical alarms and device status messages that may occur during the use of the CNAP Monitor 500 NOTE e In case you require service support for your CNAP Monitor 500 please report the exact technical alarm to the service partner e A complete list of technical alarms including error code time and date of appearance is available from the Log menu located in the Service Menu You find the password for the service menu in the CNAP Monitor 500 Instructions for service CNAP Monitor 500 page 12 1 Version 1 2 BIOPAC PN NIBP100D 12 1 Main unit 12 1 1 Technical alarms MU Fatal Error Contact Service MU CNAP Failure MU NBP Failure MU IBP Failure MU Battery MU Battery Depleted MU Battery Shutdown CNAP Monitor 500 CNAP monitor must not be used for further measurements Failure in CNAP hardware Failure in NBP hardware Failure in IBP component Very low battery charge status lt 25 battery operation still possible Battery depleted operation possible for at least 15 minutes Battery depleted operation possible for 5 minutes at most monitor is switched off page 12 2 Technical alarms and status messages Reboot CNAP monitor In case of persistent
60. les to a subject all connecting cables need to be visually inspected for signs of damage Any faulty parts e g cables or plugs are to be replaced immediately Only original CNSystems Medizintechnik AG accessories and replacement parts are to be used e Please pay close attention to the proper storage of the device Do not bend the cables excessively or coil them up too tightly as this might result in damaging cables and hoses Any damaged cables or hoses are to be replaced immediately e Take care to ensure regular and sufficient air circulation around the device Also take into consideration the necessary environmental conditions specified in this manual see Appendix C Technical specifications e A thorough examination of the device for its operational reliability is due on a regular basis app once every month e This manual is an integral part of the CNAP Monitor 500 By adhering to its safety measures and recommendations the operator ensures the correct use and operation of the device as well as the operators and the subjects safety Notes and precautions of particular importance are highlighted by the following symbols A gt see chapter 1 1 e In order to ensure the device s faultless functioning accuracy of measurement and immunity of interference as well as the subjects safety use only original CNSystems accessories and replacement parts CNSystems will not warrant for faultless functioning and operation if third party
61. manufacturer replacement parts and accessories are used e CNSystems Medizintechnik AG is not liable for any warranty claim for possible damages if parts of third party manufacturers are used e CNSystems warrants for faultless functioning reliability and safety of this device on the condition that the procedures of installation extensions and enhancements new settings alterations maintenance and repair are exclusively carried out by CNSystems or an authorized company In addition the appliance and operation of the CNAP Monitor 500 must be in accordance with the Instructions in this operator s manual e All copyrights concerning the devices procedures electronic circuits software programmes and labels mentioned in this manual are reserved to CNSystems Medizintechnik AG Never touch the AUX ethernet and USB interface together with the subject All devices that get connected to the AUX ethernet and USB interfaces must meet EN 606950 1 standards 2 2 2 Blood pressure CNAP e In rare cases it might happen that the device is unable to detect a continuous blood pressure signal Usually the middle and index fingers are best suited for applying the finger cuffs as their phalanges are longest If it is not possible to obtain a continuous blood pressure signal it is in most cases caused by a vasospasm Warming the hand for example in warm water may solve the problem e If no continuous blood pressure waveform is displayed within a fe
62. mpatibility Please keep in mind the respective precautions in this operator s manual before installing and operating the CNAP Monitor 500 Also pay attention to the fact that portable and mobile HF communication devices e g mobile phones may interfere with medical electric devices The CNAP Monitor 500 must not be placed immediately beside or stockpiled with other devices If there is no other way but to operate the CNAP Monitor 500 immediately beside or stockpiled with other devices the CNAP Monitor 500 must be closely observed to ensure its normal operability within this arrangment of devices Only original CNSystems Medizintechnik Austria accessories and power cords are to be used with this device Authorized accessories and replacement parts are listed in Appendix B Accessories in this operator s manual Using third party manufacturer accessories may result in increased emission or in decreased functional immunity of the CNAP Monitor 500 As electric and magnetic fields may interfere with the functional reliability of the device avoid using the CNAP Monitor 500 close to devices emitting powerful electromagnetic fields e g x ray equipment diathermy applications or magnetic resonance tomographs Guidelines and manufacturer s declaration electromagnetic emissions The CNAP Monitor 500 is intended for use in an electromagnetic environment as specified below The customer or operator of the CNAP Monitor 500 is to assu
63. n o Dia o Pulse e Numeric blood pressure values o Sys o Mean o Dia o Pulse CNAP Monitor 500 page 9 4 Version 1 2 BIOPAC PN NIBP100D CNAP 9 4 1 Blood pressure waveform The CNAP blood pressure waveform is displayed directly in the Main screen Illustration 36 CNAP blood pressure waveform NOTE e The scale of the CNAP blood pressure waveform is configured in the same way as 3 the scale of the CNAP trend It is set in the Menu trend see chapter 7 Trends e The signal speed of the CNAP blood pressure waveform is set to 12 5 mm s and cannot be adjusted in any way 9 4 2 Trend view The CNAP blood pressure trend is displayed in the Trend frame directly in the Main screen of the CNAP Monitor 500 It enables both graphic as well as a numeric view of blood pressure trends OTE TV ee mmHg 1 2 1 ye 00 Dia 9 NBP Sys 431 90 Illustration 37 Graphic trend and numeric values parameter frame NOTE 3 e Scales for CNAP trends and the CNAP blood pressure waveform are set by means of the click wheel control in the menu Trend Amplitude scales are set likewise for the CNAP blood pressure waveform and the CNAP trend see chapter 7 Trends CNAP Monitor 500 page 9 5 Version 1 2 BIOPAC PN NIBP100D CNAP 9 4 3 Numeric values The CNAP parameter box displays the current blood pressure parameters Sys Mean Dia and Pulse Mean blood pressure Systolic blood p
64. nding on the monitor configuration the alarms may be paused for a limited or unlimited time Hence selecting an alarm pause of an unlimited amount of time equals switching off the alarm signal altogether MI CN O Alarm Pause e Setting of alarm pause 1 min 2 min 3 min no time out NOTE e Pausing alarms is only possible if no physiological alarms are activated e Technical malfunction alarms or malfunction reports are displayed even when the function Alarm Pause has been activated CNAP Monitor 500 page 6 4 Version 1 2 BIOPAC PN NIBP100D Alarm system NOTE e During temporary alarm pauses the remaining pause time is displayed in the Alarm frame e In case of a temporally unlimited alarm pause the Alarm frame displays the message Alarm Off 6 3 3 Reactivation of paused alarms Alarms Off In order to reactivate alarms having been paused for an unlimited amount of time press Alarm Pause Off three times 6 4 Alarm limits Alarm limits set the alarm conditions for physiologigal alarm signals 6 4 1 Display of individual alarm limits The preset alarm limits upper lower of every measuring parameter are displayed beside the respective measured value in the Parameter frame of the main screen If a parameter s alarm function is deactivated the symbol for Alarm off will appear beside the measured value in the Parameter frame refer to chapter 6 1 Visual alarm signals Name 18 Apr 15 02 CN
65. nge applies Note 1 At 80 MHz and 800 MHz the higher EN range Se These guidelines may not apply in all situations Electromagnetic propagation Note 2 is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the CNAP Monitor 500 is used exceeds the applicable RF compliance level above the CNAP Monitor 500 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the CNAP Monitor 500 Above the frequency range 150 kHz to 80 MHz field strengths should be less than 1 V m Table 204 from EN 60601 1 2 2003 CNAP Monitor 500 page 15 7 Version 1 2 BIOPAC PN NIBP100D Appendix C Recommended separation distance between portable and mobile RF communication devices and the CNAP Monitor 500 The CNAP Monitor 500 is intended for use in an electromagnetic environment with controlled RF disturbances The customer or operator of the CNAP Monitor 500 can avoid electromagnetic disturbances by comply
66. ngers before measuring STOP e The operating environment for CNAP hardware has to comply with the directions regarding ambient temperature relative humidity and atmospheric pressure see chapter 14 Appendix C Technical specifications e Take care to ensure regular and sufficient air circulation around the CNAP Monitor 500 by placing the device accordingly e g do not cover it with sheets or blankets CNAP Monitor 500 page 9 2 Version 1 2 BIOPAC PN NIBP100D CNAP 9 3 Setup The CNAP hardware consists of the following components CNAP double finger cuff CNAP controller CNAP cable Graphics to select correct finger cuff size Abbildung 34 CNAP hardware NOTE e CNSystems recommends placing the CNAP double finger cuff on the index and the middle finger of a patient In rare cases if necessary the CNAP double finger cuff may also be placed on the middle and the ring finger Thumb and little fingers are not suited for CNAP blood pressure measurement e The use of a too big too small CNAP double finger cuff may result in faulty blood pressure recordings Start stop a measurement refer to chapter 3 4 Quick setup e Choose the correct size of a CNAP double finger cuff by means of the graphics on the upside of the CNAP controller refer to chapter 3 2 3 CNAP controller e Assemble the CNAP hardware by connecting the CNAP double finger cuff the
67. ngs can be found in the Service manual for users of the CNAP Monitor 500 e The user can restore all adjusted Alarm limits back to factory settings To do this the user has to select the function Restore factory settings which can be accessed via the password protected Service menu see Service manual for users gt Ul UJ UJ UI UI UI 120 180 90 175 UJ Ul 70 170 UJ Ul 130 200 STOP amp e Setting the Alarm limits to extreme and thus unsuitable values results in the b alarm system becoming useless and obsolete CNAP Monitor 500 page 6 8 Version 1 2 BIOPAC PN NIBP100D Alarm system 6 5 Alarm history The Alarm history is displayed directly in the main frame and is a list of up to 100 last released alarms and malfunction reports In order to view the Alarm history use the click wheel control to first select Trend frame and then to open Alarm history Each report of the alarm history includes the following information e Date e Time Priority MEDIUM e Alarm message All entries in the Alarm history will be deleted either if the CNAP Monitor 500 is switched off or if there is a total loss of power supply e g empty battery no mains power supply 6 6 Alarm system function tests When the CNAP Monitor 500 is switched on the alarm system automatically performs a self test in the course of which the operator has to control the functional reliabilty of all acoustic and visu
68. ollowing components e CNAP monitor e CNAP hardware CNAP double finger cuffs CNAP controller CNAP cable e NBP cuff CNAP Monitor 500 page 3 1 Version 1 2 BIOPAC PN NIBP100D Introduction 3 2 1 CNAP Monitor 500 BIOPAC Part Number NIBP100D Carrying handle Display Battery LED Click wheel control Power LED Q Control panel Illustration 1 Front view O CNAP cable port D BP Wave Out analog output port NBP cuff connector Illustration 2 Subject connectors CNAP Monitor 500 page 3 2 Version 1 2 BIOPAC PN NIBP100D Introduction Thermal printer Mains power port USB connector software updates Ethernet connector AUX analog output port Oo Illustration 3 Printer interface power supply O Holding device channel optional D Type plate Illustration 4 Back view CNAP Monitor 500 page 3 3 Version 1 2 BIOPAC PN NIBP100D Introduction CNAP Monitor 500 symbols The following table describes all symbols in use on the CNAP Monitor 500 and its components Symbol e Start Stop of a measurement e Alarm Pause Off e Input port of type BF is protected from defibrillation pulses Ethernet connector TT 18V e 18 V DC supply required e Analog output port e Production date m m m e Device meets the European standard for medical devices 93 42 EWG UJ m D e Recycle d
69. on 1 2 BIOPAC PN NIBP100D Monitor configuration CAUTION During the initialization of CNAP or when changing the signal source in CNAP double finger cuff a calibration waveform rectangle 50 150 mmHg is displayed on the main screen The same waveform is transmitted to subject monitors via the BP Wave Out gt port This may cause misinterpretation of blood pressure if no blood pressure waveform is displayed on a subject monitor and if numerical values of blood pressure are falsely detected from the rectangle calibration signal Thus always check the blood pressure waveform on the CNAP monitor for the calibration signal when receiving unphysiological readings of blood pressure on an external device i e subject monitor 4 5 Interfaces optional On the right side of the CNAP Monitor 500 the following connectors can be found see chapter 3 2 1 illustration 2 4 5 1 AUX analog output port The corrected CNAP blood pressure waveform is available from the device s analog output port AUX Channel 1 Channel 2 Reference 0 5 V 0 500 mmHg 5 5 V 0 500 mmHg Sensitivity 100 mmHg V 50 mmHg V Samling 100 Hz 100 Hz frequency 4 5 2 Ethernet The CNAP Monitor 500 may be connected to a PC via Ethernet standard in future at present the Ethernet port is deactivated 4 5 3 USB The USB port is reserved for service functions e g software updates CNAP Monitor 500 page 4 5 Version 1 2
70. ontrols Fast access keys click wheel control Physiological alarms medium priority Alarmin N I Technical alarm messages low priority Screen Type TFT LCD Size 200 x 150 mm 7 8 x 5 9 in Display 170 x 128 mm 6 6 x 4 9 in 8 4 inch diagonally CNAP Monitor 500 page 15 1 Version 1 2 BIOPAC PN NIBP100D Appendix C CNAP Monitor 500 Resolution 800 x 600 pixel Color resolution 16 Bit Data memory 24 h based on a mean heart rate of 90 Data resolution Beat to beat 15 1 1 External mains adapter 15 1 2 CNAP continuous non invasive arterial pressure CNAP continuous non invasive arterial pressure Parameter classification Sys Dia Mean mmHg Pulse bpm Sys 40 250 mmHg 5 3 33 3 kPa Measuring range Dia 30 210 mmHg 4 28 kPa Mean 35 230 mmHg 4 30 6 kPa Display resolution 1 mmHg 0 1 kPa Typ 120 mmHg 16 kPa Inflation pressure Min 30 mmHg 4 kPa Max 300 10 mmHg 41 3 kPa 1 3 kPa 300 10 mmHg 40 kPa 1 3 kPa Excess pressure limit Response time lt 3 sec Deflation time lt 15 sec Protection against electric Type BF CNAP Monitor 500 page 15 2 Version 1 2 BIOPAC PN NIBP100D Appendix C CNAP continuous non invasive arterial pressure CO 15 1 3 NBP non invasive blood pressure NBP non invasive blood pressure Parameter classification Sys Dia mmHg Measuring method Oscillometric diastolic value oscillometric diastoli
71. patient movement or tremor or respiratory artifacts this may also affect and reduce the accuracy of values measured by the CNAP Monitor 500 e The use of technical surgical devices might cause interference and reduce the quality of CNAP recordings e Do not ever connect the device s pneumatic connectors to an intravascular system e Regularly inspect concerned patient limbs during measurement to avoid possible lasting damages caused by prolonged impairment of the patient s blood circulation In case of any signs of total arterial compression immediately discontinue the measurement process by pressing Start Stop on the front panel of the device e Pain or strong feelings of discomfort are in no way normal and are not a part of CNAP measurements Should a patient report any of these feelings stop the measurement process immediately e Before connecting any cables to a patient visually inspect all components for damages or wearout Any faulty parts e g cables or plugs are to be replaced immediately e Control the correct positioning of the CNAP double finger cuff regularly during measurement Make sure that the cuff is not positioned on the finger joints NOTE e Avoid compressing the air hoses or reducing their diameter in any way e g by bending the cables as this could impair the quality of the CNAP measuring signals To avoid mechanical damage to the finger cuffs remove all objects e g rings from patient fi
72. properly Kenzan guarantees archivability of at least 7 to 10 years when using this kind of paper High quality non topcoated thermal papers like this are suitable for all uses where the influence of external substances like oil grease or water can be excluded as much as possible In addition the characteristics of this high quality paper positively influences the product lifetime of your thermal printer The characteristics of the above KANZAN paper regarding chemical composition thickness surface texture have material influence on the printhead as well as the printer mechanism The use of papers with lower dynamic sensitivity requires a higher level of energy transfer of the printer while papers with a rougher surface lead among others to increased abrasion or mechanical strain All these parameters automatically entail a considerable reduction of your printhead product lifetime For these reasons only use the recommended paper brands or a thermal paper marked as top quality by the manufacturer However when using other paper brands CNSystems Medizintechnik AG cannot guarantee for the printers economic lifetime as this can cause damage or staining of the printhead 14 4 Connections BP Wave Out CNAP transducer cable 20 FEKA 01201 contact BIOPAC BP Wave Out IBP interface cable to subject monitor AUX Analog Out connector 20 FEKA 01100 CNAP Monitor 500 page 14 2 Version 1 2 BIOPAC PN NIBP100D Appendix B 14
73. r be used for pediatric patients e Intravenous infusion lines Never don a NBP cuff to a limb already connected to an intravenous infusion line or an intraarterial catheter The inflation of the cuff might result in the infusion solution being caught up or even cause tissue damage to the punctured area e Cutaneous lesions Never perform NBP measurements in patients suffering from drypanocytemia or from cutaneous lesions or in patients where cutaneous lesions are to be expected e Unsupervised measurements Patients with severe blood coagulation dysfunction may develop hematoma where the NBP cuff has been inflated In these cases carefully consider the pros cons and the necessity of frequent unsupervised blood pressure measurements e Interference by external devices Results of NBP recordings are not to be used if the measured oscillometric pulses have been influenced by other devices or techniques e g counterpulsation or contrapulsation e Interpretation NBP recordings are to be interpreted only by a physician or medical professional staff e Limitations of NBP measurements NBP recordings may be inaccurate or even impossible under the following conditions lack of detectable regular arterial blood pressure arrhythmia strong and persistent patient movement e g tremor or convulsions rapid blood pressure fluctuations severe shock or hypothermia with reduced peripheral blood flow obesity as adipose tissue in the limbs muffles art
74. r 500 determines the alarm limits on the basis of the entered category Thus be sure to enter the correct subject category before starting a measurement e The operator can adjust alarm limits within the Alarm defaults menu Alarm limit settings for the subject categories Adult and Pediatric are to be performed separately The respective menu is located in a password protected area of the CNAP Monitor 500 which can be accessed via the Service menu The necessary password as well as further information about configurating individual user settings or restoring factory settings can be found in the Service manual for users of the CNAP Monitor 500 CNAP Monitor 500 page 6 6 Version 1 2 BIOPAC PN NIBP100D Alarm system STOP e The parallel use of different alarm settings for the same device or similar instruments used in different areas e g in the intensive care unit or in cardiac surgery might constitute a possible danger for subjects 6 4 3 Auto limits By means of the function Auto limits the operator is able to adjust alarm limits to a specific subject Therefore it is necessary to wait for the monitor to display physiological signals of a measurement in order to be able to activate Auto limits Later if subject data is deleted or new subject data is entered the function Auto limits will be deactivated automatically Using this function leads to the alarm limits of activated alarms being adjusted to the curr
75. re it is used in such an environment Emission test Compliance Electromagnetic environment guidelines R F emmissions Group 1 The CNAP Monitor 500 uses RF energy CISPR 11 only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B The CNAP Monitor 500 is suitable for CISPR 11 use in all establishments including domestic establishments and those Harmonic emissions NA directly connected to the public low IEC 61000 3 2 voltage power supply network that supplies buildings used for domestic Voltage fluctuations flicker NA purposes emissions IEC 61000 3 3 Table 201 from EN 60601 1 2 2003 CNAP Monitor 500 page 15 5 Version 1 2 BIOPAC PN NIBP100D Appendix C Guidelines and manufacturer s declaration electromagnetic immunity The CNAP Monitor 500 is intended for use in an electromagnetic environment as specified below The customer or operator of the CNAP Monitor 500 is to assure that it is used in such an environment Immunity test IEC 60601 test level Level of compliance Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 Hz 60 Hz magnetic field IEC 61000 4 8 6 kV contact 8 kV a
76. ressure Diastolic blood pressure Alarm limit settings Illustration 38 Parameter frame 9 5 CNAP options Parameter menu nn Besen seine Change Change of signal source in CNAP double finger cuff Setting of automatic change of signal source in CNAP Cal Interval CNAP double finger cuff min 5 5 60min Alarms Setting of alarms for the parameters Sys Mean Dia u Pulse CNAP Monitor 500 page 9 6 Version 1 2 BIOPAC PN NIBP100D NBP 10 NBP General INFOPMATION 00 ccc eee cece cece ence nenne anna nm n nn nn an En nn nenn naar 10 1 Saler PrECAULON Sarroca rar A E ee TER EEE TEE 10 2 SED e e O ee ee eek 10 3 VIEW TEIUIES ee ee u een 10 5 DNB ONS ee er ER ee ea 10 5 10 1 General information NBP Non Invasive Blood Pressure uses the oscillimetric method to determine a patient s blood pressure on a non continuous basis To achieve this the NBP module is integrated into the CNAP Monitor 500 Blood pressure measurement is conducted by means of a NBP cuff available in 4 sizes which is placed around the patient s upper arm and connected to the CNAP Monitor 500 on the left side of the monitor see chapter 3 Introduction For measurement purposes the pressure in the NBP cuff is controlled by the NBP module The cuff pressure is first increased above systolic blood pressure and decreased step by step The pulsations in the NBP cuff provide the basis for deriving the blood pres
77. revent prolonged impairment of the subject s blood circulation during the measuring process by inspecting the concerned limbs regularly This is particularly important in the case of continuous blood pressure measurement During normal use the pressure in the finger cuff will be the same as in the artery and therefore greater than normal venous pressure As a result depending on variables like skin temperature thickness subject age perfusion or presenting state venous congestion of the finger distal to the cuff may be observed which will quickly subside with the discontinuation of monitoring Check the monitoring area frequently and discontinue the continuous blood pressure measurement immediately in case of any signs of total arterial compression or if the subject reports severe pain or discomfort e Do not use the compressed air supply valves with any devices of a third party manufacturer e Each device is designed for the concurrent measurement of only one subject test subject at a time Never measure two or more subjects at the same time applying only one device e Please pay attention to the precautions regarding electromagnetic compatibility see chapter 14 3 e In perioperative settings the CNAP Monitor 500 is not to be used without additional ECG monitoring 2 2 Precautions 2 2 1 General precautions e The CNAP Monitor 500 is a device of protection class Il The input ports of type BF are protected from defibrillation e Accor
78. rior to application of the test level Table 202 from EN 60601 1 2 2003 CNAP Monitor 500 page 15 6 Version 1 2 BIOPAC PN NIBP100D Appendix C Guidelines and manufacturer s declaration electromagnetic immunity The CNAP Monitor 500 is intended for use in an electromagnetic environment as specified below The customer or operator of the CNAP Monitor 500 is to assure that it is used in such an environment Immunity test IEC Compliance level Electromagnetic environment 60601 test guidelines level NN communication equipment should be Conducted RF 3 Vrms used no closer to any part of the CNAP Monitor 500 including cables IEC 61000 4 150 kHz to 80 MHZ than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance 3 gt VI inv Radiated RF 3 V m IEC 61000 4 3 80 MHz bis 3 gt El inv m for 800 MHz to 2 5 GHz 2 5 GHZ Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Y ai Nte At 80 MHz and 800 MHz the higher frequency ra
79. subject category as this determines the adjustment of alarm limits and the inflation pressure of the NBP cuff NOTE gt e During a measurement the Patient menu can be selected via Alarm frame and the menu item Patient data CNAP Monitor 500 page 5 2 Version 1 2 BIOPAC PN NIBP100D Management of subject data 5 3 Discharge Subject data needs to be deleted even when only a default entry has been performed before The function Discharge e deletes all information in the Patient menu e deletes all trends of data from the monitor e deletes all entries of the Alarm history Subject data can be deleted in 2 ways a Patient menu Open the Patient menu by using the click wheel contol to select the Alarm frame on the main screen Select Discharge and confirm your menu entry in the input window b Setup of a new subject Immediately after a new subject has been set up with the CNAP double finger cuff the subject set up window appears on the Main screen Select New Patient Pediatric Defaults or New Patient Adult Defaults and confirm your choice in the input window This will result in the deletion of any previous data NOTE e In order to avoid loss of data all data and entries must be printed before discharging a subject Deleted data cannot be retrieved CNAP Monitor 500 page 5 3 Version 1 2 BIOPAC PN NIBP100D Alarm system 6 Alarm system pit AM o A EE e OA 6 2 ACOUStUC alar SONA cca cecccewarsedertue
80. sure values Sys Mean and Dia NOTE e When a measurement process is started on the CNAP monitor a NBP measurement is also triggered automatically e However it is also possible to trigger an NBP measurement manually at any time during measurement see chapter 10 5 NBP options gt e NBP measuring interval is pre set in the menu Setup Measurement for every new measurement and can be changed via the menu Parameters for the current measurement only e Inflation pressure of the NBP cuff is determined by the selected patient category see chapter 5 1 Input of patient data NOTE e The CNAP blood pressure waveform is calibrated by means of an oscillometric NBP measurement If the accuracy of the NBP measurement is affected by artifacts e g weak pulse irregular pulse artifacts from patient movement or tremor or respiratory artifacts this may also affect and reduce the accuracy of blood pressure values measured by the CNAP Monitor 500 e An NBP cuff can be donned on the same arm as the CNAP double finger cuff ipsilaterally or on the other arm contralaterally CNAP Monitor 500 page 10 1 Version 1 2 BIOPAC PN NIBP100D NBP 10 2 Safety precautions STOP e Patient category Make sure to select the correct patient category before starting a measurement see chapter 5 1 Input of patient data The higher adult levels of inflation pressure excess pressure limits or measuring time for instance must neve
81. sure waveform and generates trends beat to beat numerics and alarms for the parameters blood pressure and pulse rate The NIBP100D CNAP Monitor 500 is to be used for adults and pediatric subjects from the age of 4 year and is to be operated by trained staff CNAP Monitor 500 page 2 3 Version 1 2 BIOPAC PN NIBP100D Introduction 3 Introduction General NOrmal ON rer nern laa 3 1 SS SM COMPONER 3 1 CNAP MONO di 3 2 CNAP e Par dWAr niert EN 3 5 CNAP double TINGS CUM ae ee ea EA AT a A E a A E E TA 3 5 CNAP CONTO lena A E N S 3 6 CNAP Cala errar AAA AAA eh 3 6 IIE PC Ui ee ee ia 3 7 Man SO Chal OM Serra nants dea asica ceden 3 7 Battery Operar ee areas 3 8 ERES DSE ee a ee A ee 3 10 POWE ON OT Aa 3 10 ACCESSI etU O Mall SCHEN ee arena 3 11 FAS AC A ee re ee EN ee ee 3 12 Menu navigation click wheel control 22s2s2ssenenenenennennnnnnnnnnnn nenn nn A ATAA nenne nnnnnnnnnnn 3 13 MENU Sele cHe ee er ee ee AA O 3 13 OUK SETUD sat a NN 3 14 3 1 General information The CNAP Monitor 500 is suitable for monitoring in grown up and pediatric subjects from the age of 4 years The CNAP Monitor 500 is in principle designed for being operated as a stand alone device If required however it can be integrated into other subject monitoring systems BP Wave Out port for CNAP blood pressure waveform and other devices USB Ethernet 3 2 System components The basic configuration of the monitor consists of the f
82. sword for the user menu in the CNAP Monitor 500 Service manual for users e You find the password for the service menu in the CNAP Monitor 500 Instructions for service NOTE In this manual we distinguish between two groups of users operators and users e Operator a person actually working with this device doctors nurses medical staff e User either the supervisor of the operator or technical employees responsible for general settings nominated by the owner or chosen according to local regulations Menuitem Description settings Restore Factory Restore factory settings yes no Settings Enables to adjust alarm limits reminder pause and volume Alarm for the subject categories Adult Pediatric within the defaults limits of factory settings The operator user can also restore factory settings Lists technical alarms by means of language independend error codes Submenu Function Function tests of the modules IBP analog output printer and Tests CNAP NBP Submenu CNAP Monitor 500 page 4 2 Version 1 2 BIOPAC PN NIBP100D Monitor configuration 4 4 BP Wave Out subject monitors Similar to the BP waveform obtained from an invasive catheter e g radial artery the CNAP registered blood pressure waveform can be interfaced to subject monitors by means of the BP Wave Out output port located on the left side of the CNAP Monitor 500 see chapter 3 2 1 illustration 2 CAU
83. t end of the Trend frame STOP gt e Time labels displayed in the Navigation frame correspond to the time displayed on the system clock of the CNAP Monitor 500 So it is essential to make sure that the monitor s system clock is showing the correct time CNAP Monitor 500 page 7 5 Version 1 2 BIOPAC PN NIBP100D Trends 7 2 3 Numeric trends The trend view Numeric allows a numeric view of the following parameters on a time axis e CNAP blood pressure values Sys Dia Mean e CNAP Pulse Name 11 Dec 16 59 CM A y 2 numeric trend display mmHg DAN 85 Mean 95 94 NBP Sys 131 mmHg 73 18 25 90 Pulse 16 55 16 56 16 57 16 58 16 59 Illustration 27 Numeric trend and Navigation frame NOTE e The trend view Numeric can be configured by adjusting Time scale from the Trend menu e The displayed data window can be adjusted by means of the click wheel control in the Navigation frame which also determines the scope of print reports CNAP Monitor 500 page 7 6 Version 1 2 BIOPAC PN NIBP100D Trends TIME SCALE The time scale for the trend views of blood pressure and pulse rate can be set via accessing the menu Trend and then selecting Time scale BED Bescon u Lbeat Imin 5min 15min 30min 1h Time Scale Setting of time scale for Numeric trend NOTE e The time scale of the Numeric trend corresponds to the time interval between 2 displayed measured values e
84. t the hand with the CNAP double finger cuff is placed at heart level see illustration above 3 Donning of the NBP cuff a b C 4 Subject entry a Make sure that only NBP cuffs authorized by CNSystems are used and that you apply the correct size to the subject Child Small Adult Adult Large Adult Place the blood pressure cuff on the subject s upper arm at the heart level The marker on the NBP cuff should be directly above the brachial artery Connect the NBP cuff with the NBP air connector on the left side of the CNAP Monitor 500 Quick default entry of adult or pediatric subjects The functions New Patient Adult Defaults or New Patient Pediatric Defaults can be selected in the setup window immediately the measuring process can start immediately by pressing the Start Stop key Detailed subject data input can be performed at a later time Use Current Subject Data When selecting the option Use Current Patient Data all subject data remains unchanged the measuring process can start immediately by pressing the Start Stop key Start the CNAP measurement by pressing the key Start Stop on the front side of the device CNAP Monitor 500 page 3 14 Version 1 2 PN BIOPAC PN NIBP100D Monitor configuration 4 Monitor configuration legis ES p Lo AM MP een G ne E E O o 4 1 Meastrement SENOS anreisen ernennen 4 1 SEIVIL EL EIN ee a ee src rbd osas 4 2 BP Wave Out subject ION EA ee ee ee 4 3 EINtert
85. tor CNAP Monitor 500at TM and 2007 by CNSystems Medizintechnik AG All rights reserved Covered by one or more of the following U S European and Japanese patents US 6669648 EP 1675507B1 EP 1522258B1 EP 1608261B1 EP 1179991B1 JP 03890196B2 Additional patents pending in Europe the U S Japan and China Illustration 12 Splash screen CNAP Monitor 500 page 3 10 Version 1 2 BIOPAC PN NIBP100D Introduction Switching off the monitor The CNAP Monitor 500 is switched off by pressing the key Power On Off for 2 seconds CAUTION e The key Power On Off does not interrupt the monitor s power supply In order to interrupt power supply the operator needs to disconnect the power cord 3 4 2 Access return to Main Screen After having started the monitor the main screen appears which displays all measuring parameters and signals and enables to access all menus Arrangement of the screen Alarm frame CNAP signal view Trend frame Parameter frame Navigation frame Q Battery charge and printer status NOTE e In order to return to the main screen from any submenu just press the key Main Screen on the front of the monitor CNAP Monitor 500 page 3 11 Version 1 2 BIOPAC PN NIBP100D Introduction 3 4 3 Fast access keys Illustration 14 Fast access keys Membrane keys on the front side of the CNAP Monitor 500 enable fast access to important functions a Power On
86. ues CAUTION e The accuracy of the CNAP measurement depends on the accuracy of the accompanying NBP measurement which is particularly important during calibrations or before interventions e Make sure that no movement artifacts occur during measurement especially during and until 2 min after measurement initialization e Powerful light sources e g cameras with flashlight may affect the CNAP measurement and cause artifacts CAUTION e Movements of the patient which result in changes of position of the CNAP double finger cuff regarding heartlevel will have influence on the accuracy of blood pressure readings To compensate these physical effects hydrostatic height recalibrate the CNAP measurement by triggering a single NBP measurement manually See chapter 10 5 NBP options CNAP Monitor 500 page 9 1 Version 1 2 BIOPAC PN NIBP100D CNAP 9 2 Safety precautions CAUTION e Do not use CNAP and NBP in patients with vascular prostheses e CNAP is designed for the concurrent measurement of only one patient at a time e Be sure to follow local regulations regarding storage of the CNAP Monitor 500 its accessories and packing material e Keep the CNAP Monitor 500 out of reach of children e The CNAP blood pressure waveform is calibrated by means of an additional NBP measurement If the accuracy of the NBP measurement is affected by artifacts weak pulse irregular pulse artifacts from
87. values alarm CNAP Mean Sys Mean Dia indicates which message and Low parameter has fallen below the alarm acoustic alarm limit signal Blinking CNAP m values alarm CNAP Pulse Medium CNAP Pulse rate CNAP exceeds upper message and High alarm limit acoustic alarm signal Blinking CNAP values alarm CNAP Pulse Medium CNAP Pulse rate CNAP falls below lower message and Low alarm limit acoustic alarm signal NOTE All technical malfunction alarm messages of the CNAP Monitor 500 or its components are found directly in the chapters describing the respective system components CNAP Monitor 500 page 6 10 Version 1 2 BIOPAC PN NIBP100D Trends 7 Trends ISIS anne ee ee ee ee ee are 7 1 Irene Tie Men sense coa ee ge 7 2 SE a ee ee an a E een 7 3 TREN VIEWS cortaron aora ne ovaciones ideo 7 3 Grabaical MeN G nc ari a dai daa idas 7 3 NURDELIE TEE ee er ios 7 6 A o o o o e EIERN ER EEREN 7 8 SCFOIING of rend VIEWS rada ir Are 7 9 The CNAP Monitor 500 automatically displays the parameters Sys Mean Dia and Pulse in the Trend frame on the Main screen Trends can be displayed as graphical as well as numeric trends The display of a list of physiological alarms is optional NOTE 3 e Recorded parameters are saved on a beat to beat basis for a maximum of 24 hours e Saved recordings can be displayed in the Trend frame at any time see chapter 7 2 1 Trend views STOP
88. w minutes it is probably due to an insufficient blood flow in the fingers In this case try using another pair of fingers or the other hand If this is not successful please check if the labelling on the CNAP double finger cuff symbol is on the back of the hand e In case of a definite insufficiency of blood flow you have to abandon the continuous blood pressure measurement completely e To avoid mechanical damage to the finger cuffs never start measuring without a finger in the blood pressure cuff Also remove all objects e g rings from the fingers before measuring NBP e Under the following conditions there might be a decrease in accuracy of the oscillometric blood pressure signal o weak pulses o Irregular pulses o subject movement artifacts o tremor artifacts o respiratory artifacts CNAP Monitor 500 page 2 2 Version 1 2 BIOPAC PN NIBP100D Introduction 2 3 Disposal Packing material e The packing material of the CNAP Monitor 500 is to be disposed of according to the respective national regulations Device and accessories e Dispose of the CNAP Monitor 500 and any accessories at the end of the products lifecycles in accordance with respective national regulations or send the parts back to CNSystems Medizintechnik AG 2 4 Declaration of intended use The NIBP100D CNAP Monitor 500 is intended for the monitoring of noninvasive continuous blood pressure and pulse rate The device displays the blood pres

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