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BIOPAC Systems CNAP 500 Operator's Manual

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CNAP
MONITOR
OPERATOR'S MANUAL
Monitor 500/500 HD
Distributed by BIOPAC
as NIBP100D & NIBP100D-HD
®

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Summary of Contents for BIOPAC Systems CNAP 500

  • Page 1 ® CNAP MONITOR OPERATOR’S MANUAL Monitor 500/500 HD Distributed by BIOPAC as NIBP100D & NIBP100D-HD ®...
  • Page 2 This manual refers to the following products: Monitor 500 & 500 HD, Software Version 5.2.x • CNAP ® BIOPAC NIBP100D & NIBP100D-HD • BIOPAC Systems, Inc. CNSystems Medizintechnik GmbH 42 Aero Camino Reininghausstrasse 13 Goleta, CA 93117 8020 Graz Austria...
  • Page 3 NIBP100D-HD - Operators Manual Table of contents About this manual......................7 STOP, CAUTION, NOTES ................. 7 Cross references .................... 7 Settings ......................7 General information ...................... 8 Warnings ...................... 8 Precautions ....................8 2.2.1 General precautions ..................8 2.2.2 Blood pressure ................... 9 Disposal ......................
  • Page 4 NIBP100D-HD - Operators Manual Feature activation ..................36 BP Wave Out (patient monitors) ..............37 4.5.1 BP Wave Out configuration ................ 37 4.5.2 Compatibility list ..................38 4.5.3 Zeroing ....................39 Interfaces (optional) ..................41 4.6.1 AUX Analog Out (analog output port) ............41 4.6.2 Ethernet ....................
  • Page 5 NIBP100D-HD - Operators Manual General information ..................67 Safety precautions ..................68 Setup ......................69 View features ....................71 9.4.1 Blood pressure waveform ................71 9.4.2 Trend view ....................71 9.4.3 Numeric values ..................72 CNAP ® options ..................... 72 CNAP values during calibration ...............
  • Page 6 NIBP100D-HD - Operators Manual 14.6.1 Status messages ..................100 14.6.2 Technical alarms ..................101 14.7 EEPROM ....................101 Appendix A – Glossary....................102 15.1 Illustrations ....................103 Appendix B – Components ..................105 16.1 CNAP ® ...................... 105 16.2 NBP ......................105 16.3 Printer ......................
  • Page 7 NIBP100D-HD - Operators Manual 1 About this manual 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 or dealing with patients. STOP The STOP icon indicates important security-relevant information: STOP:...
  • Page 8 NIBP100D-HD - Operators Manual 2 General information 2.1 Warnings • Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner. • The CNAP ® Monitor is not designed for intracardial use. • The CNAP ®...
  • Page 9 NIBP100D-HD - Operators Manual • While using the CNAP ® Monitor, 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 and be a risk for the patient. •...
  • Page 10 NIBP100D-HD - Operators Manual hand. If this is not successful either, please check if the labeling on the CNAP ® double finger cuff (symbol) is on the side of the back of the hand. • To avoid mechanical damage to the finger cuffs, never start measuring without a finger in the blood pressure cuff.
  • Page 11 NIBP100D-HD - Operators Manual 2.6 Requirements for using The CNAP ® Monitor has a life expectancy of 7 years. Following are the requirements for the application of CNAP ® Monitor: • Application in medical facilities (hospitals, clinics, nursing homes, etc.) •...
  • Page 12 NIBP100D-HD - Operators Manual 3 Introduction 3.1 General information Adult The CNAP ® Monitor is suitable for monitoring in patients. The CNAP ® Monitor is in principle designed for being operated as a stand-alone device. If required, however, it can be connected with BP Wave Out other patient monitoring systems ( analog output port for CNAP...
  • Page 13 NIBP100D-HD - Operators Manual  CNAP ® cable port  BP Wave Out: analog output port  NBP cuff connector Illustration 2: Patient connectors  Thermal printer  Mains power port  USB connector: software up- dates, data storage  Ethernet connector ...
  • Page 14 NIBP100D-HD - Operators Manual  Holding device channel (op- tional) Type plate  Illustration 4: Back view Edition: July 4 , 2024 Page 14 of 116 Version: 5.2.20,  1050001...
  • Page 15 NIBP100D-HD - Operators Manual CNAP ® Monitor symbols The following table describes all symbols in use on the CNAP ® Monitor and its components: Symbol Description Power On/Off • (monitor on/off) Setup • (monitor, measurement, service settings) Main Screen • (return to main screen) Print •...
  • Page 16 NIBP100D-HD - Operators Manual 40°C • Temperature limit  0°C 1060 hPa • Atmospheric pressure limitation (Note: the shown values are  valid for transport only. For operation please see section 17). 500 hPa 95 % • Humidity limitation: Maximum range of relative humidity ...
  • Page 17 NIBP100D-HD - Operators Manual • Consult instructions for use  • Catalogue number  • Quantity of parts in packing unit • US: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner. NOTE: Do not use the device if conditions were not met during transport or storage.
  • Page 18 NIBP100D-HD - Operators Manual Size Diameter (mm) Color 24 - 28 Dark red 18 - 24 Dark blue 10 - 18 Light blue Illustration 6: CNAP ® finger cuffs 3.2.2.2 CNAP ® controller The CNAP ® controller connects the CNAP ®...
  • Page 19 NIBP100D-HD - Operators Manual 3.2.3 NBP cuff The NBP cuff is intended for oscillometric blood pressure measurement and is available in three sizes: Arm circumference Size (cm) Small Adult 17 - 25 Adult 23 - 33 Large Adult 31 - 40 Illustration 9: NBP cuff 3.3 Power supply The CNAP...
  • Page 20 NIBP100D-HD - Operators Manual  Power cord  Power adapter  Cable connecting power adapter and monitor Illustration 10: Power cord LED color Status Green Device is powered on and ready for use Green System startup Orange Device error - alarm signal is audible 3.3.2 Battery operation The integrated sealed lead gel battery enables the CNAP ®...
  • Page 21 NIBP100D-HD - Operators Manual CAUTION: • Total discharge may damage the battery. Therefore, charge the battery at every op- portunity. • Immediately charge the battery with a battery charge status ≤ 25%, or as soon as possible and for at least 5 hours at ≤ 50%. •...
  • Page 22 NIBP100D-HD - Operators Manual 3.4 First steps 3.4.1 Power On/Off Power On/Off key is located in the left lower corner on the front side of the device. Illustration 11: Front view Switching on the monitor Power On/Off The CNAP ® Monitor is switched on by pressing the key located on the front side of the device for two seconds.
  • Page 23 NIBP100D-HD - Operators Manual Illustration 12: Splash screen Switching off the monitor Power On/Off The CNAP ® Monitor is switched off by pressing the key located on the front side of the device for 2 seconds. CAUTION: Power On/Off • key does not interrupt the monitor's power supply.
  • Page 24 NIBP100D-HD - Operators Manual NOTE: Main • In order to return to the main screen from any submenu, just press the Screen key on the front of the monitor. 3.4.3 Fast access keys Illustration 14: Fast access keys Membrane keys on the front side of the CNAP ®...
  • Page 25 NIBP100D-HD - Operators Manual 3.4.4 Menu navigation – click-wheel control The CNAP ® Monitor's click-wheel control enables the operator to select menus and settings 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.
  • Page 26 NIBP100D-HD - Operators Manual 3.5 Performing a measurement 3.5.1 Patient setup 1. Starting up the CNAP ® Monitor: Power On/Off Press and confirm the alarm self-test (test alarm signal) when the system Alarm Pause/Off. has started by pressing 2. Patient setup: a) Choose the correct CNAP ®...
  • Page 27 NIBP100D-HD - Operators Manual 3.5.2 Improving the measurement quality Poor quality of the CNAP ® measurement usually has one of the following two causes: Suboptimal positioning or sliding finger cuff Poor perfusion of the fingers In order to improve the CNAP ®...
  • Page 28 NIBP100D-HD - Operators Manual Illustration 19: CNAP ® Monitor Armsling 3.5.3 Shutting-down the device The measurement is terminated by pressing the Start/Stop-button at the front bottom of the CNAP ® Monitor. To remove the CNAP ® double finger cuff from the patient's hand, it is necessary to stop an ongoing measurement in order to deflate the finger cuff.
  • Page 29 NIBP100D-HD - Operators Manual 3.6 Timer The timer displays the CNAP ® change of finger and/or NBP measurements following within the next 30 minutes (calibration measurements), thus making the following measurement-related interruptions of continuous blood pressure perceptible and allowing adequate time manage- ment (see below).
  • Page 30 NIBP100D-HD - Operators Manual TIME MANAGEMENT: Example: As next calibration a CNAP ® change of finger (+ NBP measurement) will be due in 5:00 minutes; however, continuous blood pressure will probably be essential at this time. • Option 1: Delay interruption CNAP: Cal Interval The user delays the next calibration by increasing the in the...
  • Page 31 NIBP100D-HD - Operators Manual 3.8 Dismantling device from mount To dismantle the CNAP ® Monitor from the mount, follow the instructions on the label which is placed on the backside of the CNAP ® Monitor. Illustration 20: Unmounting of the CNAP Monitor from Trolley mount Edition: July 4 , 2024 Page 31 of 116...
  • Page 32 NIBP100D-HD - Operators Manual 4 Monitor configuration 4.1 Monitor settings Menu item Description Settings Brightness 20(20)100, Auto Regulates the brightness of the TFT-display EN, DE, FR, ES, IT, Language Language setting for the user interface NL, PT Metric, US Custom- Units Select measuring units for Patient Data dialog YYYY/MMM/DD...
  • Page 33 NIBP100D-HD - Operators Manual NOTE: • Measurement settings are saved automatically for any current or future measure- ment. • Loss of power supply (interruption of mains operation, followed by depletion of battery) entails the loss of measurement settings. Service • All settings can be changed to factory settings in the menu (see chapter 4.3 –...
  • Page 34 NIBP100D-HD - Operators Manual Illustration 21: Trending calibration of blood pressure signal 4.2.2 External calibration In external calibration mode the CNAP ® Monitor expects a manually entered blood pressure value (or height offset – see below) for the calibration of the CNAP ®...
  • Page 35 NIBP100D-HD - Operators Manual 4.2.3 NBP calibration The NBP calibration automatically performs an NBP measurement in predefined intervals between 5 and 60 minutes. For some special applications it is possible to trigger an NBP measurement directly after the start of the measurement without any repeating NBP measurement afterwards. NOTE: •...
  • Page 36 NIBP100D-HD - Operators Manual Menu item Description Settings Restore Factory Set- Yes, No Restore factory settings tings Enables to adjust alarm limits, reminder, pause and vol- ume within the limits of factory settings. The alterations Alarm Defaults… Submenu will be used for each new measurement. The opera- tor/user can also restore factory settings.
  • Page 37 NIBP100D-HD - Operators Manual Illustration 23: Overview of device features and sequence numbers for limited number of measurements 4.5 BP Wave Out (patient monitors) 4.5.1 BP Wave Out configuration Similar to the BP waveform obtained from an invasive catheter (e.g. radial artery), the CNAP ®...
  • Page 38 NIBP100D-HD - Operators Manual If, for example, the supply voltage is 4 V, the sensitivity will be calculated as follows: 5 µV/V/mmHg x 4 V = 20 µV/mmHg 4.5.2 Compatibility list Make Type Transducer Cable Interface Cable SC 9000XL, SC 9000, 20-FFKA-01200 Siemens 20-HHKA-01201...
  • Page 39 NIBP100D-HD - Operators Manual 4.5.3 Zeroing After having connected the CNAP ® Monitor and the patient monitor using a) the CNAP ® Transducer Cable and b) the IBP Interface Cable (see 4.5.1 - BP Wave Out configuration), zeroing must be performed: a) Zeroing without active measurement: Before and after an active measurement (without displayed CNAP...
  • Page 40 NIBP100D-HD - Operators Manual NOTE: • Blood pressure values obtained by means of CNAP ® and invasively obtained reference values (e.g. radial measurement) may differ for the following reasons: a) Difference in beat detection Parameter Averaging b) Different settings for (see chapter 4.2 –...
  • Page 41 NIBP100D-HD - Operators Manual 4.6 Interfaces (optional) On the right side of the CNAP ® Monitor, the following connectors can be found (see chapter 3.2.1 - illustration 3): 4.6.1 AUX Analog Out (analog output port) The following parameters are available as analog signals from the device's analog output port (see chapter 17.3): Calibrated blood pressure wave Mean arterial blood pressure (MAP)
  • Page 42 NIBP100D-HD - Operators Manual CAUTION: • Do not connect any input devices or devices with high power consumption to the USB port. Only USB flash drives are supported. STOP: • Because of a possible influence on the patient safety it is not allowed to connect USB hard drives or any other devices using external power supplies to the CNAP ®...
  • Page 43 NIBP100D-HD - Operators Manual 4.7 Output options Menu settings for AUX Analog Out and print output: Menu item Description Settings The value for the reference voltage range of the AUX 0V to 5V, Analog Out Reference Analog Out interface can be set here. -5V to 5V Default: 0V to 5V Analog Out 1...
  • Page 44 NIBP100D-HD - Operators Manual 5 Management of patient data Immediately after a patient has been connected to the CNAP ® Monitor and the setup process has Start Measurement been performed correctly (see chapter 3.5.1 - Patient setup), the dialog for starting the measurement opens automatically.
  • Page 45 NIBP100D-HD - Operators Manual a) New Patient: It is possible to select the NBP Measurement Type before starting a measurement. In the menu Start Measurement a new measurement can be started with different prop- erties: • New BP + HD Measurement: Measures blood pressure and all hemodynamic pa- rameters •...
  • Page 46 NIBP100D-HD - Operators Manual NOTE: Patient Data • Before applying the CNAP ® finger cuff and during a measurement, the Alarm frame menu can be selected via the • If, before starting a measuring process, you want to enter additional patient data, you Use Current have to do this before applying the CNAP ®...
  • Page 47 NIBP100D-HD - Operators Manual NOTE: • If the values for the patient data exceeds the following limits, an out of range advisory message for CO is shown: • Age > 90 years • Weight > 120 kg • Height > 190 cm & height < 150 cm 5.4 Pay-per-use measurement The CNAP Monitor supports the activation of a limited number of measurements –...
  • Page 48 NIBP100D-HD - Operators Manual - Alarm system 6 Alarm system The alarm system of the CNAP ® Monitor distinguishes between two alarm levels: physiological alarms (yellow) and technical malfunction alarms (cyan). • 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).
  • Page 49 NIBP100D-HD - Operators Manual - Alarm system 6.1 Visual alarm signals Alarm frame Parameter frame Alarm signals are displayed visually in the and the directly in Parameter frame the main screen. In the , only those parameters are visually marked which exceed the defined alarm limits.
  • Page 50 NIBP100D-HD - Operators Manual - Alarm system ** CNAP: Sys High ** CNAP: Sys High Illustration 29: Alarm frame – alarm conditions Parameter frame • Background color: YELLOW – Physiological alarms (medium priority) CYAN - Technical malfunction alarms (low priority) BLUE - Status messages •...
  • Page 51 NIBP100D-HD - Operators Manual - Alarm system Technical 54 dB 79 dB D#5/Eb5 – B4 Information Signal 34 dB 67 dB Reminder Signal 54 dB 78 dB A-weighted sound pressure level averaged over the measurement surface (dB) Scientific notation 6.3 Alarm system control The fast access key Alarm Pause/Off has various functions.
  • Page 52 NIBP100D-HD - Operators Manual - Alarm system 6.3.2 Pausing/switching off alarms – alarms paused, alarms off Alarm Pause/Off In order to temporarily deactivate (= pause) physiological alarms, press twice. Temporarily no physiological alarms will be activated, e.g. when a patient is being relocated. De- Alarm Pause Alarms Off Alarms Paused...
  • Page 53 NIBP100D-HD - Operators Manual - Alarm system Illustration 31: Parameter frame – alarm limits Parameter In order to view and edit all set alarm limits, use the click-wheel control to select the frame Alarm Limits and then to open the menu (see chapter 6.4.2 –...
  • Page 54 NIBP100D-HD - Operators Manual - Alarm system Menu item Description Settings Off, 1 min, 2 Function to set alarm reminders (see chapter 6.3.1 Alarm Reminder – Acknowledgement of alarms) min, 3 min Pausing of alarms (see chapter 6.3.2 – Pausing 1 min, 2 min, 3 Alarms Paused Alarm Pause...
  • Page 55 NIBP100D-HD - Operators Manual - Alarm system 6.4.4 Alarm limits – factory settings The CNAP ® Monitor has been preset to the following factory settings and default settings for alarm limits, which apply to both CNAP ® and NBP. • Alarm limits (ADULT): Lower limits Upper limits...
  • Page 56 NIBP100D-HD - Operators Manual - Alarm system 6.6 Alarm system function tests When the CNAP ® Monitor is switched on, the alarm system automatically performs a self-test in the course of which the operator has to check the functional reliability of all acoustic and visual alarm signals.
  • Page 57 NIBP100D-HD - Operators Manual - Alarm system 6.8 Deactivation of alarm limits In some situations, it is reasonable to have no active alarm limits because the parameters do not represent the physiological state of the patient. The following table gives an overview what alarm limits are deactivated in which situation: Situation Duration Parameters...
  • Page 58 NIBP100D-HD - Operators Manual 7 Trends On the CNAP ® Monitor the user can select to display the blood pressure waveform or the trend view alternatively. The view can be switched by clicking the frame right beside the signal/trend view once (see illustration 31).
  • Page 59 NIBP100D-HD - Operators Manual 7.1 Trend – the menu for display options Trend (Display Options) menu, which can be accessed directly from the main screen by Trend frame. means of the click-wheel control, allows the operator to configure trend views in the Menu item Description Settings...
  • Page 60 NIBP100D-HD - Operators Manual Illustration 33: Graphic Trend Display In the trend display the blood pressure will always be shown. Depending on the measurement mode (BP, BP+PPV, BR+HD) it is possible to display up to two additional Parameters at the same time. The configuration of the parameter display is done in the submenu Display Options | Trend Parame- ters | Parameter 1 and Parameter 2.
  • Page 61 NIBP100D-HD - Operators Manual STOP: Navigation frame • Time labels displayed in the correspond to the time displayed on the system clock of the CNAP ® Monitor. Therefore, it is essential to make sure before starting the measuring process that the monitor's system clock is showing the correct time.
  • Page 62 NIBP100D-HD - Operators Manual TIME SCALE: Time scale The time scale of blood pressure and pulse rate trends can be set in the menu item Display Options which is located in the menu. Menu item Description Settings 1min, 5min, Time Scale Numeric Trend Display Setting of time scale for 15min, 30min, 1h...
  • Page 63 NIBP100D-HD - Operators Manual NOTE: Alarm History • includes the entire list of the last reported alarms (up to 500 Time Scale entries). Therefore, cannot be selected. STOP: • The deletion of patient data irretrievably deletes all affiliated recordings, including the Sys, MAP, Dia Pulse Time Scale...
  • Page 64 NIBP100D-HD - Operators Manual Illustration 37: Automatic and manual interventions during a CNAP ® measure- ment 7.2.6.1 Automatic interventions In the menu Setup | Measurement | Display Options | Auto Interventions the setting of auto- matic interventions in the trend view can be activated or deactivated. The marker of an automatic intervention is displayed in cyan color (see illustration 32).
  • Page 65 NIBP100D-HD - Operators Manual 8 Printing The CNAP ® Monitor is provided with an integrated thermal printer, enabling the operator to print a print reports range of predefined 8.1 Launching print reports Print Snap- Depending on how long the operator presses the key he/she can select either shot Report Trend Report...
  • Page 66 NIBP100D-HD - Operators Manual 8.3 Print reports The CNAP ® Monitor 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; Age; Printed (date and time); Last NBP (values and time of the last NBP measurement) Illustration 38: Graphic Trend Report Illustration 39: Numeric Trend Report Illustration 40: Alarm History Report...
  • Page 67 NIBP100D-HD - Operators Manual 9 CNAP ® 9.1 General information CNAP ® - Continuous Non-Invasive Arterial Blood Pressure – is a non-invasive method for measuring the continuous blood pressure waveform in adults. A patient's blood pressure waveform is recorded by the CNAP ®...
  • Page 68 NIBP100D-HD - Operators Manual CAUTION: • Movements of the patient, which result in changes of position of the CNAP ® double finger cuff regarding heart level, will have immediate influence on the absolute values of blood pressure readings. To compensate these physical effects (hydrostatic height), recalibrate the CNAP ®...
  • Page 69 NIBP100D-HD - Operators Manual 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 Illustration 43: CNAP ®...
  • Page 70 NIBP100D-HD - Operators Manual Start/Stop a measurement (refer to chapter 3.5.1 – Patient setup): • 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 9.3 - CNAP ®...
  • Page 71 NIBP100D-HD - Operators Manual 9.4 View features CNAP ® determines the following blood pressure values which are displayed directly in the Main Screen of the CNAP ® Monitor: • Blood pressure waveform (morphology) o Blood pressure trends and numeric blood pressure values: Sys, Dia, MAP, Pulse 9.4.1 Blood pressure waveform The CNAP ®...
  • Page 72 NIBP100D-HD - Operators Manual 9.4.3 Numeric values Parameter frame Sys, MAP, Dia The CNAP ® displays the current blood pressure parameters Pulse  Systolic blood pressure  Diastolic blood pressure  Mean blood pressure  Alarm limit settings Illustration 48: Parameter frame 9.5 CNAP ®...
  • Page 73 NIBP100D-HD - Operators Manual Measurement menu: Menu item Description Settings External, NBP Measurement Selection of the type of blood pressure calibration or 5(5)30, 45, Type the time interval of the automatic NBP measurement Setting of automatic change of signal source in CNAP ®...
  • Page 74 NIBP100D-HD - Operators Manual 9.7 CNAP ® Component Organizer Set Illustration 49: CNAP ® Component Organizer Set NOTE: • To avoid damages always store the CNAP ® Controller in the provided CNAP ® Controller bracket. NOTE: • Avoid a vertical storage of the CNAP ®...
  • Page 75 NIBP100D-HD - Operators Manual 10 NBP 10.1 General information NBP (Non-Invasive Blood Pressure) uses the oscillometric 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. Blood pressure measurement is conducted by means of a NBP cuff (available in 4 sizes) which is placed around the patient's upper arm (brachial artery) and connected to the CNAP ®...
  • Page 76 NIBP100D-HD - Operators Manual 10.2 Venous stasis Venous stasis to support punctures of intravenous lines can be performed by means of the NBP cuff. NBP: Start Venous After putting on the NBP cuff, venous stasis can be started by selecting Stasis Parameter NBP: Start Venous...
  • Page 77 NIBP100D-HD - Operators Manual 10.3 Safety precautions STOP: • Repeating measurements: Measuring too frequently may cause harm to the patient because blood flow is reduced. • Intravenous infusion lines: Never put on an NBP cuff to a limb already connected to an intravenous infusion line or an intra-arterial catheter.
  • Page 78 NIBP100D-HD - Operators Manual Start/Stop a measurement: 1. Make sure you are using an NBP cuff authorized by CNSystems and always use the correct size. NOTE: • The width of the cuff should be between 37% and 47% of the circumference of the patient's limb.
  • Page 79 NIBP100D-HD - Operators Manual 10.6 NBP options Parameter menu: Menu item Description Settings CNAP: Change Finger Change of signal source in CNAP ® double finger cuff NBP: Start/Stop Start/Stop of a single NBP measurement NBP: Start/Stop Venous Start/Stop venous stasis Stasis Setting of automatic change of signal source in CNAP: Cal Interval...
  • Page 80 NIBP100D-HD - Operators Manual 11 Pulse Pressure Variation (PPV) CNAP ® -PPV is a dynamic, non-invasive indicator for hemodynamic optimization of patients. The PPV values are calculated directly from the non-invasive CNAP ® blood pressure curve. Illustration 54: Pulse Pressure Variation (PPV) 11.1 Warnings Additionally, to the following instructions special attention must also be paid to the general warnings and limitations in chapter 0.
  • Page 81 NIBP100D-HD - Operators Manual 11.2 Performing CNAP ® -PPV measurements The measurement of CNAP ® -PPV (Pulse Pressure Variation) ) is an optional feature and therefore not available on all devices. The activation of the CNAP ® -PPV parameters with a license key is described in chapter 4.4.
  • Page 82 NIBP100D-HD - Operators Manual 12 Hemodynamics The measurement of hemodynamic parameters is an optional feature and therefore not available on all devices. Based on the method of the pulse contour analysis the following hemodynamic parame- ters can be calculated directly from the CNAP ®...
  • Page 83 NIBP100D-HD - Operators Manual The permanent activation of the hemodynamic measurement can be set in the setup menu Setup | Measurement | Hemodynamic. With the activated hemodynamic option, the hemodynamic frame on the display gets activated and the parameters are displayed in the trend display – depending on the settings. When starting a new CNAP ®...
  • Page 84 NIBP100D-HD - Operators Manual Illustration 59: CO calibration Menu Access Note: • Only if all necessary patient data have been entered in the patient dialog (gender, age, weight and height) the hemodynamic parameters are displayed. 12.3 CO calibration It is required to set a reference calibration value for the cardiac output. This can be done either at the start of the measurement or in the menu Hemodynamic | CO Calibration (CI Calibration) in the menu option Calibration, by entering a CO respectively CI calibration value.
  • Page 85 NIBP100D-HD - Operators Manual Illustration 60: CO calibration Detail The entered calibration value needs to be confirmed with Ok to calibrate the HD parameter values. An advisory message will be shown when the calibration value has been accepted and the time of calibration and the reference value are shown in the hemodynamic field.
  • Page 86 NIBP100D-HD - Operators Manual Illustration 61: Indexed HD parameter display The selection of parameters to be displayed in the trend view can be changed in the menu Display Options | Trend Parameters. There can be selected between • CO or SV •...
  • Page 87 NIBP100D-HD - Operators Manual 13 Cleaning and disinfection Only use disinfectants and detergents recommended by CNSystems Medizintechnik GmbH to clean or disinfect the device and its components. CNSystems’ warranty does not cover any damage 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.
  • Page 88 NIBP100D-HD - Operators Manual careful to also wipe the cable-crease and the space between the CNAP ® double finger cuff shell and cable. Velcro of the Fixture for CNAP ® controller: To wash the Velcro rinse it with lukewarm water and soap, diluted non-caustic detergents, surfactants or detergents containing ammonia or alcohol.
  • Page 89 NIBP100D-HD - Operators Manual 4. Pull the sensor foil slightly away from the shell to reach the area between the shell and the foil. Disinfect this part carefully to not destroy the adhesion of the foil to the shell. 5. After a few minutes remove any disinfectant residues with a moist cloth (water) from the surface. 6.
  • Page 90 NIBP100D-HD - Operators Manual - Technical alarms and status messages 14 Technical alarms and status messages Besides physiological alarms, the CNAP ® Monitor displays technical malfunction alarms (white) and Alarm frame device status messages (blue) in the Illustration 62: Status messages The following documentation lists all technical alarms and device status messages that may occur during the use of the CNAP ®...
  • Page 91 NIBP100D-HD - Operators Manual - Technical alarms and status messages 14.1 Main unit 14.1.1 Status messages Message Possible cause Measures MU: No USB Stick At- - Connect USB stick and reboot No USB stick connected tached CNAP ® Monitor - Connect USB with free storage MU: USB Stick Full USB memory full capacity and reboot CNAP...
  • Page 92 NIBP100D-HD - Operators Manual - Technical alarms and status messages Message Priority Possible cause Measures - Immediately switch to mains operation via power adapter - Immediately switch to mains MU: Battery: operation via power adapter Battery depleted, monitor is Low * Shutdown switched off - Monitor switched off automati-...
  • Page 93 NIBP100D-HD - Operators Manual - Technical alarms and status messages Message Priority Possible cause Measures - Check bridge voltage range of patient monitor (refer to chapter 4.5) - In case of persistent error, contact service 14.3 Printer 14.3.1 Technical alarms Message Priority Possible cause...
  • Page 94 NIBP100D-HD - Operators Manual - Technical alarms and status messages Message Possible cause Measures CNAP: Put Fingers in CNAP ® self-test successful; CNAP ® is ready for patient - Patient setup Cuff setup and measurement CNAP ® calibration phase in pro- CNAP: Calibration…...
  • Page 95 NIBP100D-HD - Operators Manual - Technical alarms and status messages Message Possible cause Measures - Use a smaller finger cuff on CNAP: CNAP cuff is too the patient A too big finger cuff was used on the patient - Check the correct placement of the finger cuff - Use a bigger finger cuff on CNAP: CNAP cuff is too...
  • Page 96 NIBP100D-HD - Operators Manual - Technical alarms and status messages Message Priority Possible cause Measures - Disconnect and reconnect CNAP: Fault – Air reservoir blocked or CNAP ® controller Low * Reservoir Pressure faulty pressure offset - In case of persistent error, contact service CNAP: Fault –...
  • Page 97 NIBP100D-HD - Operators Manual - Technical alarms and status messages Message Priority Possible cause Measures - Check size of CNAP ® double finger cuff - Check setup of CNAP ® double finger cuff - Check proper optical path in CNAP ®...
  • Page 98 NIBP100D-HD - Operators Manual - Technical alarms and status messages Message Priority Possible cause Measures CNAP® double finger cuff CNAP: Cuff Fault – - Check for permutation with is not licensed for CNAP® Low * equipment from third party de- Unlicensed Monitor vices...
  • Page 99 NIBP100D-HD - Operators Manual - Technical alarms and status messages Message Possible cause Measures - Start new NBP measurement NBP: Fault Checksum error occurred - In case of persistent error, contact service NBP: Single Meas- User has triggered a single NBP - none urement measurement...
  • Page 100 NIBP100D-HD - Operators Manual - Technical alarms and status messages Message Priority Possible cause Measures - Check NBP air connections (e.g. for damages, loose fit) - Check NBP cuff for leakage NBP cuff or air hose NBP: Leakage Low * leaking or loose - Check position and fit of NBP cuff...
  • Page 101 NIBP100D-HD - Operators Manual - Technical alarms and status messages Message Possible cause Measures Initializing... Initializing - none Patient data out of vali- CO calibration out of range - Check patient data dated range Missing patient data - no Missing patient data - Enter patient data CO displayed 14.6.2...
  • Page 102 NIBP100D-HD - Operators Manual - Appendix A 15 Appendix A – Glossary Alternating current Ampere-hour BP Wave Out Interface to patient monitors (CNAP ® blood pressure waveform) Beats per minute Body surface area (m²) CNAP ® Continuous non-invasive arterial pressure Dia or diastolic Diastolic blood pressure Hour...
  • Page 103 NIBP100D-HD - Operators Manual - Appendix A 15.1 Illustrations Illustration 1: Front view ..................... 12 Illustration 2: Patient connectors ..................13 Illustration 3: Printer, interface, power supply ............... 13 Illustration 4: Back view ..................... 14 Illustration 5: CNAP ® Monitor ....................17 Illustration 6: CNAP ®...
  • Page 104 NIBP100D-HD - Operators Manual - Appendix A Illustration 58: CO Calibration ..................... 83 Illustration 59: CO calibration Menu Access ................84 Illustration 60: CO calibration Detail ..................85 Illustration 61: Indexed HD parameter display ............... 86 Illustration 62: Status messages ..................90 Edition: July 4 , 2024 Page 104 of 116...
  • Page 105 NIBP100D-HD - Operators Manual - Appendix B 16 Appendix B – Components STOP: In order to ensure operational reliability, functional safety as well as patients' safety, only original CNSystems Medizintechnik GmbH components and replacement parts are to be used. 16.1 CNAP ®...
  • Page 106 NIBP100D-HD - Operators Manual - Appendix B 16.3 Printer Item Number Thermal paper 20-HVZU-00258 16.3.1 Paper recommendation CNSystems Medizintechnik GmbH recommends using the following paper with your CNAP ® Monitor: 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.
  • Page 107 NIBP100D-HD - Operators Manual - Appendix B Option PPV “200” 21-HHCS-02220 Option PPV “100” 21-HHCS-02210 Option PPV “50” 21-HHCS-02201 Option HD “unlimited” 21-HHCS-02300 16.6 Other components Items Number External mains adapter 21-FHET-01010 Manufacturer: Cincon Electronics Co Power cord Standard 20-HEKA-01014 Power cord (4 m) 20-HEKA-01015 Power cord British Standard...
  • Page 108 NIBP100D-HD - Operators Manual - Appendix C 17 Appendix C – Technical specifications 17.1 Essential performance Applicable essential performance characteristics based on the standard IEC 80601-2-30:2018 (Edition 2.0): Electrosurgery interference recovery Device returns to the previous operating mode within 10s after exposure to the field produced by the HF SURGICAL EQUIPMENT, without loss of any stored data.
  • Page 109 NIBP100D-HD - Operators Manual - Appendix C Operation: 700 - 1060 hPa Atmospheric pressure Storage/Transport: 500 - 1060 hPa User interface Controls Fast access keys, click-wheel control Physiological alarms: medium priority Alarming Technical alarm messages: low priority Screen Type TFT-LCD Size 200 x 150 mm (7.8 x 5.9 in.) Display...
  • Page 110 NIBP100D-HD - Operators Manual - Appendix C 17.2.2 CNAP ® - continuous non-invasive arterial pressure CNAP ® - continuous non-invasive arterial pressure Sys, Dia, MAP [mmHg] Parameter classification Pulse [bpm] Sys: 40 - 250 mmHg (5.3 – 33.3 kPa) Measuring range Dia: 30 - 210 mmHg (4 - 28 kPa) MAP:...
  • Page 111 NIBP100D-HD - Operators Manual - Appendix C Measuring time max. 130 s (ADULT) Max. inflation time 75 s Max. cuff pressure 300 mmHg Automatic deflation after 180 s Protection against electric Defibrillation protected applied part – Type BF shock Defibrillation protection According to IEC 60601-1 HF surgery No restrictions...
  • Page 112 NIBP100D-HD - Operators Manual - Appendix C AUX (analog output port) Channel 1 Channel 2 Channel 3 Channel 4 Parameter BP waveform systolic BP diastolic BP Pulse Pulse Range 0 – 500 0 – 300 mmHg 0 – 300 mmHg 0 –...
  • Page 113 NIBP100D-HD - Operators Manual - Appendix C 17.4 Electromagnetic compatibility Medical electric devices have to comply with special safety regulations regarding EMC (electromag- netic compatibility). Please keep in mind the respective precautions in this operator's manual before installing and operating the CNAP ®...
  • Page 114 NIBP100D-HD - Operators Manual - Appendix C Table 2: Manufacturer's declaration – electromagnetic immunity (Device successfully tested according EN 60601-1-2:2015+A1:2021) Immunity test Test Level (IEC 60601-1-2) Compliance level Contact discharge: Contact discharge: Electrostatic ±8 kV ±8 kV discharge (ESD) Air discharge: Air discharge: (IEC 61000-4-2) ±2 kV, ±4 kV, ±8 kV, ±15 kV...
  • Page 115 NIBP100D-HD - Operators Manual - Appendix C Table 3: Proximity fields from RF Wireless communications equipment (IEC 61000-4-3) Test frequency Band Service Modulation Immunity test (MHz) (MHz) level Pulse modulation 380 to 390 TETRA 400 18 Hz GMRS 460, 430 to 470 ±...
  • Page 116 NIBP100D-HD - Operators Manual - Appendix C • Documentation including: safety protocol, inspection sticker, shipping documents Detailed instructions how to perform the SC can be found in the CNAP Service Manual – Users. 17.5.2 Metrological control (MC) The MC is performed according to EN 62353 and includes the following activities: •...

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