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ADInstruments Human NIBP Nano Owner's Manual

Non-invasive hemodynamics
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Human NIBP Nano
Non-invasive hemodynamics
Owner's Guide
Human NIBP Nano Owner's Guide

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  • Page 1 Human NIBP Nano Non-invasive hemodynamics Owner’s Guide Human NIBP Nano Owner’s Guide...
  • Page 2 Human NIBP Nano Owner’s Guide...
  • Page 3 This document was, as far as possible, accurate at the time of release. However, changes may have been made to the soft ware and hardware it describes since then. ADInstruments Pty Ltd reserves the right to alter speci- fications as required. Late-breaking information may be supplied separately.

  • Page 4: Table Of Contents

    Checking Human NIBP Nano components ......8 The Human NIBP Nano Interface ....... . . 8 The Front Panel .
  • Page 5 Soft ware License Agreement ........77 Human NIBP Nano Owner’s Guide...

  • Page 6: Safety Notes

    Safety Notes Statement of Intended Use All products supplied by ADInstruments are intended for use in teaching and research applications and environments only. ADInstruments products are NOT intended to be used as medical devices or in medical environments. That is, no product supplied by ADInstruments is intended to be used to diagnose, treat or monitor a subject.
  • Page 7 Regulatory Symbols Devices manufactured by ADInstruments that are designed for direct connection to humans and animals are tested to IEC60601-1:1998 or IEC60601-1:2005 (including amendments 1 and 2) or EN61326-1:2006, and carry one or more of the safety symbols below. These symbols appear next to those inputs and output connectors that can be directly connected to human subjects.
  • Page 8 No user serviceable parts inside. The Human NIBP Nano system requires the connection of a personal Refer servicing to computer for operation. This personal computer should be certified as authorised complying with IEC60950 and should be located outside a 1.8 m radius...
  • Page 9 • Never connect parts which are marked as an APPLIED PART to those which are not marked as APPLIED PARTS. • Do not touch the subject to which the Human NIBP Nano system WARNING: is connected at the same time as making contact with parts of...
  • Page 10 Cleaning and Sterilization ADInstruments products may be wiped down with a lint free cloth moistened with industrial methylated spirit. Refer to the Data Card supplied with transducers and accessories for specific cleaning and sterilizing instructions.
  • Page 11 If the Human NIBP Nano system is found not to comply with such testing you should contact your ADInstruments representative to arrange for the equipment to be checked and serviced. Do not attempt to service the device yourself. Environment Electronic components are susceptible to corrosive substances and atmospheres, and must be kept away from laboratory chemicals.

  • Page 12: Overview

    C H A P T E R Overview This Owner’s Guide covers the components of the Human NIBP Nano System, which includes ADInstruments LabChart® soft ware. The Human NIBP (Non-Invasive Blood Pressure) Nano System performs continuous, non-invasive arterial blood pressure measurement on...

  • Page 13: Checking Human Nibp Nano Components

    If you find a problem, please contact your ADInstruments distributor immediately. The Human NIBP Nano Interface The Human NIBP Nano interface contains the power supply and necessary circuitry to interface the Human NIBP Nano Wrist Unit to a PC and supply it with power. The Front Panel Figure 1–1...

  • Page 14: The Back Panel

    Made in Australia by ADInstruments Pty Ltd. Power On/Off Switch USB Connection The Human NIBP Nano Interface has a USB port, which connects to a computer with USB ports. Your Human NIBP Nano system is supplied with a Type A to Type B USB cable.
  • Page 15 On/Off Switch diff icult to operate The Human NIBP Nano system should be powered on and off using the On/ the disconnection Off switch on the back panel of the Human NIBP Nano Interface unit.

  • Page 16: Using The System

    • The Human NIBP Nano system should not be used in an Oxygen rich environment or in combination with High Frequency surgery devices •...
  • Page 17 • The ADInstruments Human NIBP soft ware is designed to support the connection of a single Human NIBP Nano unit at any one time. • Diseases or environmental conditions that result in reduced finger arterial compliance (diabetes, Raynaud disease, cold fingers), which causes reduced volumetric pulsations in the fingers, may lead to an inability to measure blood pressure or derived variables.

  • Page 18: Install Adinstruments Software

    (https://www.adinstruments.com/ support/downloads/windows/labchart) Next, install the Human NIBP Device Enabler Place the CD for the ADInstruments Human NIBP Device Enabler in the CD drive of your computer. The installer should auto-run. Follow the on-screen instructions. Alternatively, download the Device Enabler via LabChart Feature Manager.

  • Page 19: Check The Installation

    1. Connect the Human NIBP Nano Interface to a grounded AC power supply using the power cord provided, then power the unit ON. Check the installation To check the soft ware and driver installation, ensure the Human NIBP Nano Interface is connected to your computer and powered on. Launch LabChart by double-clicking on the LabChart icon on your Desktop.
  • Page 20 The Wrist Unit (Figure 2–4) contains an air pressure control valve, a pressure transducer, electronics for the infrared photoplethysmograph in the finger cuff , and electronics for the Height Correction Unit (HCU). The Wrist Unit is connected to the Human NIBP Nano Interface with a single cable. Figure 2–4...

  • Page 21: The Height Correction Unit (Hcu)

    2. Guide the cable assembly along the arm and fasten the arm straps. 3. Ensure the cable is connected to the Human NIBP Nano Interface. 4. The Wrist Unit has attachment points for two finger cuff s, C1 and C2.
  • Page 22 Figure 2–5 Attaching the HCU to the Wrist unit (top) and components of the HCU (bottom). Reference end – to heart level HCU Transducer – to fi nger cuff Connector – to Wrist Unit Human NIBP Nano Owner’s Guide...

  • Page 23: Using Finger Cuffs

    2 – Attach the HCU transducer to the fi nger cuff. Using Finger Cuffs Proper finger cuff application is critical to successful finger arterial pressure measurement with the Human NIBP Nano Interface. Therefore, read the following sections about finger cuff handling, selection and application with special attention!
  • Page 24 Wrist Unit and unwrap the finger cuff . This will prevent accidental damage to the finger cuff . The Human NIBP Nano Interface automatically takes pressure away when the finger cuff is unwrapped. The Finger Cuff The main components of the finger cuff are an inflatable air bladder, and a plethysmograph consisting of a light source and a light detector.
  • Page 25 Only apply a finger cuff to the thumb when it is impossible to measure finger arterial pressure on any other finger and be aware that incorrect blood pressure readings may result. Photocell Figure 2–9 Applying the fi nger cuff. Human NIBP Nano Owner’s Guide...
  • Page 26 To obtain good transmission of pressure from the air bladder to the underlying tissues, both sides of the air bladder should just make contact with one another, as shown in Figure 2–9 on page 20. Human NIBP Nano Owner’s Guide...
  • Page 27 fi nger.. Wrong – Cuff is shifted Wrong – Cuff is rotated. proximally. The photo- The middle phalanx plethysmograph is the preferred is not positioned position. in front of the arteries. Human NIBP Nano Owner’s Guide...

  • Page 28: Starting Up The Software

    Settings... to create your own Human NIBP settings file. See the LabChart Help for further details. The Human NIBP Nano Interface outputs the following signals: • Finger Pressure: This waveform is the continuous finger pressure signal, sampled at 200 samples/second. Systolic, diastolic, mean arterial pressure, heart rate and interbeat interval are beat-to-beat signals derived from this pressure waveform.
  • Page 29 The calculated data (Systolic, Mean Arterial, Diastolic, Heart Rate and Interbeat Interval) is advanced by one interbeat interval value and a second to correctly align with the Finger Pressure signal. Human NIBP Nano Owner’s Guide...

  • Page 30: Human Nibp Settings

    Auto calibration is based on a patented model for blood pressure calibration (see details of the PhysioCal algorithm on page 48). Auto calibration or ‘AutoCal’ is on by default. It improves accuracy in the arterial blood pressure measurement by providing an ongoing calibration, every Human NIBP Nano Owner’s Guide...

  • Page 31: Finger Cuff Switching

    If finger cuff switching is enabled, two finger cuff s must be connected to Channel 1 (C1) and Channel 2 (C2) of the Wrist Unit. The option to start C1 or C2 is now available, as is the option to select a switching interval. Human NIBP Nano Owner’s Guide...
  • Page 32 This is caused by a pressure gradient over the air bladder when the air bladder is inflated too much. The Human NIBP Nano Interface then needs to apply a higher cuff pressure to achieve the same diameter changes in the finger artery.

  • Page 33: Performing The Height Correction Procedure

    This off set is stored in volatile memory and will no longer be available if the Human NIBP Nano Interface is powered off . The same holds true if the HCU is disconnected and later reconnected, or if LabChart is shut down and then restarted.

  • Page 34: Starting A Measurement

    Then an AutoCal is performed and the blood pressure measurement is started. Human NIBP Nano Owner’s Guide...
  • Page 35 In the first one or two minutes aft er the start of a finger blood pressure measurement the Human NIBP Nano device has to deal with the emptying of small microvessels from blood under the cuff . The absorption of the light between light source and light detector usually decreases due to this eff ect.

  • Page 36: Stopping A Measurement

    2. Unwrap and remove the finger cuff s and take the Wrist Unit away from the subject. If the Human NIBP Nano is returning error messages or failing to start a measurement, it is best to disconnect the finger cuff air hoses from the...

  • Page 37: Use Of Cyclic Measurements

    LabChart’s Cyclic Measurements is a useful analysis tool (see the LabChart Help for more information). LabChart’s Cyclic Measurements and the Human NIBP Nano Interface’s outputs return values for derived parameters that are near-identical. For example, derived heart rate values diff er with a standard deviation in the range of +/-0.7 BPM. This is due to the AutoCal periods;...
  • Page 38 Nano to build up to the correct mode and pressure. Figure 2–18 Human NIBP HCU and test dialog (right) showing available options, and the Human NIBP Settings dialog (left) showing AutoCal and fi nger cuff switching options are disabled in Test mode.. Human NIBP Nano Owner’s Guide...
  • Page 39 Available baseline pressure options are 50, 100, 150, 200 and 250 mmHg, and frequency options are 1, 4 and 10 Hz. Note how, in Square wave mode, the Human NIBP Nano Interface uses a fixed off set of ± 50 mmHg that cannot be changed.
  • Page 40 Simulate pressure selected. Using Test Mode In Steady pressure and Square wave modes, the pressure waveforms generated by the Human NIBP Nano are applied at the C1 air hose outlet of the Wrist Unit. Human NIBP Nano Owner’s Guide...

  • Page 41: Troubleshooting

    . To start a recording, click Sample. This dialog will not reappear within the same LabChart session. • In all Test modes it takes 15–30 seconds for the Human NIBP Nano to build up to the correct mode and pressure. Troubleshooting...
  • Page 42 Checking measurement stability If the Human NIBP Nano is returning error messages or failing to start a measurement, it is recommended to disconnect the finger cuff air hoses from the Wrist Unit, which removes any residual air pressure in the finger cuff s.

  • Page 43: Pressure Check

    If LabChart is unable to start sampling and is returning error messages stating “HCU not zeroed” (or if “HCU not connected” appears in the comments log), this is due to a problem with the Human NIBP Nano Wrist Unit. This problem is also evidenced by HCU Pressure channel showing 200 mmHg, even aft er repeatedly zeroing and unplugging and reconnecting the HCU unit.
  • Page 44 To perform a pressure check: 1. Ensure the Wrist Unit is connected to the Human NIBP Nano Interface as described in Connecting the Wrist Unit on page 16. 2. Connect a finger cuff to C1 of the Wrist Unit by its cuff connector but do not attach the air outlet connector.
  • Page 45 Human NIBP Nano Owner’s Guide...

  • Page 46: A Technical Details

    This Appendix describes some important technical aspects of the operation of the Human NIBP Nano. You do not need to know this material to use the Human NIBP Nano, but it is likely to be of interest to the technically-minded. In the Human NIBP soft ware, the periodic...

  • Page 47: Photoplethysmography

    The waveform component that varies with each pulse is oft en referred to as the ‘AC’ component, and this has a frequency of around 1 Hz, depending Human NIBP Nano Owner’s Guide...
  • Page 48 Figure A–1 shows an example signal coming from a finger infrared plethysmograph at five cuff pressure levels. Figure A–1 Finger plethysmogram at fi ve cuff pressure levels (a.u = arbitrary units). In Figure A–1 above the mean blood pressure was about 100 mmHg. Human NIBP Nano Owner’s Guide...

  • Page 49: The Pressure-Diameter Relationship

    Marey in 1876 [Marey 1876]. Figure A–2 shows a stylized pressure-diameter (p-d) plot of a finger artery measured in vitro. Near zero transmural pressure, the p-d curve is steepest. Therefore, for a given pressure change, the diameter change will be largest. Human NIBP Nano Owner’s Guide...

  • Page 50: Volume-Clamp Method

    Volume-clamp method When the volume clamp method of Peñáz is used, the finger cuff pressure is not constant but variable. The Human NIBP Nano, therefore, does not produce calibrated plethysmographs: the cuff pressure changes actually take away (most of) the plethysmogram. If during systole an increase is detected in arterial diameter, the finger cuff pressure is immediately increased by the servo-controller system to prevent the diameter change.

  • Page 51: Physiocal Algorithm

    . A disadvantage of this method is that the measurement of blood pressure is temporarily interrupted during such a period. Therefore, the frequency and duration Human NIBP Nano Owner’s Guide...
  • Page 52 (middle) shows more transmitted light plotted upwards. The Setpoint trace (bottom) corresponds to the total amount of light transmitted through the fi nger. 2 seconds The steps below correspond to the numbers in Figure A–4 above. Human NIBP Nano Owner’s Guide...
  • Page 53 The PhysioCal algorithm also checks that the unloaded diameter is not too close to the fully collapsed state of the finger artery. Human NIBP Nano Owner’s Guide...
  • Page 54 Special AutoCals with variable pressure levels If, during a finger blood pressure measurement, the device is unable to recognize beats, the PhysioCal algorithm uses variable pressure levels instead of constant pressure levels during an AutoCal. Human NIBP Nano Owner’s Guide...
  • Page 55 Occurrence of oscillations The Human NIBP Nano uses a servo system to make cuff pressure follow intra-arterial finger pressure. Servo-systems in general, and the rather complex one needed in Human NIBP Nano Interface in particular, may show oscillations occasionally.
  • Page 56 The reduced washout of metabolites and increased de-oxygenation of the venous blood causes blue finger tips. Note, however, that the PhysioCal algorithm always checks that the artery is suff iciently open during a measurement. Inflow and outflow from the Human NIBP Nano Owner’s Guide...

  • Page 57: Cardiac Output And Stroke Volume

    Although this evidence does not prove that damage to the finger monitored with Human NIBP Nano cannot occur, no problems have been apparent since the introduction of finger blood pressure measurement in the early 1980s.

  • Page 58: Comparison With Intra-Arterial Blood Pressure

    A second basis for the assumption that the Human NIBP Nano correctly measures finger arterial blood pressure is a phenomenon that usually can be observed in a pressure tracing at the start of a Human NIBP measurement.
  • Page 59 Note the small delay between the brachial pressure wave and the finger pressure wave is due to time needed for the pulse wave to travel along the arm artery. Human NIBP Nano Owner’s Guide...
  • Page 60 The mean pressure gradient is clearly present in Figure A–10 and Figure A–11. Bias and precision In a group of 53 subjects, described in previous studies [Bos 1992, Idema 1987, Rongen 1995] the following data were obtained for brachial and finger pressure: Human NIBP Nano Owner’s Guide...
  • Page 61 5.6+ 2.7* 4.7+ to-fl ow calibrated waveform-fi ltered and *P<0.05 using paired Student’s t-test, +P<0.05 using F-test for variance level-corrected pressure ratios. (reBAP), all compared to the measured intra- brachial pressure [Guelen et al., 2003]. Human NIBP Nano Owner’s Guide...

  • Page 62: Recommended Use

    Valsalva straining [Imholz 1998]. Note, however, that the Human NIBP Nano does not meet all requirements for non-invasive blood pressure monitoring, according to the Association of Medical Instrumentation (AAMI).

  • Page 63: Maintenance And Cleaning Of The Nano Core Wrist Unit

    Do not use other disinfecting agents (like alcohol) for cuff cleaning as they may compromise bladder integrity. Doing so may reduce measurement accuracy or lifespan of a finger cuff The wristband and the unit can be cleaned separately Human NIBP Nano Owner’s Guide...
  • Page 64 Finally, apply the velcro strap from one side to the other. It is recommended to change the air filters of the Nano Core wrist unit every year. Remove the filter assembly as shown above and replace it with a new filter assembly as shown below. Human NIBP Nano Owner’s Guide...
  • Page 65 Human NIBP Nano Owner’s Guide...

  • Page 66: B References

    J Biol Chem. 1957 Jul; 227(1): 285–299. Gravenstein JS, Paulus DA, Feldman J, McLaughlin G. Tissue hypoxia distal to a Peňáz finger blood pressure cuff . J Clin Monit 1985; 1: 120-125. Human NIBP Nano Owner’s Guide...
  • Page 67 45 human thoracic and 20 abdominal aortas in vivo and the parameters of a new model. J Biomech 1984; 17: 425-435. Marey EJ. La méthode graphique dans les sciences expérimentales et principalement en physiologie et en médicine. Masson 1878, Paris. Human NIBP Nano Owner’s Guide...
  • Page 68 Appl Physiol 1993; 74: 2566-2573. Wesseling KH, de Wit B, van der Hoeven GMA, van Goudoever J, Settels JJ. Physiocal, calibrating finger vascular physiology for Finapres. Homeostasis 1995; 36: 67-82. Note: See the FMS website (www.finapres.com) for additional references. Human NIBP Nano Owner’s Guide...

  • Page 69: C Specifi Cations

    IEC 320 to local mains plug Protection against electric Type of protection: Class I equipment shock (EN 60601-1): Degree of protection: type BF, applied part Power dissipation: In Wrist Unit: 3.6 W In finger cuff : < 50 mW Human NIBP Nano Owner’s Guide...
  • Page 70 fi nger cuff connected to the Wrist Unit The Human NIBP Nano Interface should not be used adjacent to or stacked with other equipment and that if adjacent of stacked use is necessary, the Human NIBP Nano Interface should be observed to verify normal operation in the configuration in which it will be used.
  • Page 71 Electromagnetic Compatibility The Human NIBP Nano Interface has been tested to comply with the requirements of EN60601-1-2 + A1: medical electrical equipment; EMC requirements and tests. The device also conforms to the following safety standards: CORR.2 (2007) and Canadian/US diff erences according to CAN/CSA-C22.2 No. 60601-1:08, and ANSI/ AAMI ES60601-1:2005.
  • Page 72 CISPR 11 establishments and those directly connected to the public low-voltage power supply Harmonic Class A network that supplies buildings used for emissions domestic purposes. IEC 61000-3-2 Voltage Complies fl uctuations/ fl icker emissions IEC 61000-3-3 Human NIBP Nano Owner’s Guide...
  • Page 73 Electromagnectic Immunity – Guidance and manufacturer’s declaration The Human NIBP Nano Interface is intended for use in the electromagnetic environment specifi ed below. The customer or the user of the Human NIBP Nano Interface should assure that it is used in such an environment.
  • Page 74 fi xed RF transmitters, an electromagnetic site survey should be considered. If the measured fi eld strength in the location in which the Human NIBP Nano Interface is used exceeds the applicable RF compliance level above. The Human NIBP Nano Interface should be observed to verify normal operation.
  • Page 75 Recommended separation distances between portable and mobile RF communications and the Human NIBP Nano Interface The Human NIBP Nano Interface is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Human NIBP Nano Interface can help prevent electromagnetic...
  • Page 76 • Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Human NIBP Nano Owner’s Guide...

  • Page 77: D Warranty

    Product Purchase and License Agreement This Agreement is between ADInstruments Pty Ltd [‘ADI’] and the purchaser [‘the Purchaser’] of any ADI product or solution — software, hardware or both — and covers all obligations and liabilities on the part of ADI, the Purchaser, and other users of the product.
  • Page 78 Products supplied by ADInstruments are intended for use in teaching and research applications and environments. Products supplied by ADInstruments are NOT intended to be used as medical de- vices or in medical environments. That is, no product supplied by ADInstruments is intended to be used to diagnose, treat, or monitor a subject.
  • Page 79 Instruments: Blood FlowMeter, Gas Analyzers, NIBP System (excluding transducers), STH Pump Controller. Third Party Products (Including Transducers) Products not manufactured by ADI are covered by the manufacturer’s warranty. Accessories and Consumables Accessories and Consumables are not covered by any type of warranty. Human NIBP Nano Owner’s Guide...
  • Page 80 ITS SUPPLIERS BE LIABLE FOR ANY DAMAGES IN EXCESS OF THE PRICE PAID FOR THE EQUIPMENT AND SOFTWARE, EVEN IF ADI, OR ITS AUTHORIZED PARTNERS OR SUPPLIERS HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. Human NIBP Nano Owner’s Guide...
  • Page 81 ADI web sites. Inquiries For additional information or service inquiries please contact the nearest ADInstruments office or Authorized Distributor. For contact details see www.ADInstruments.com C006E Human NIBP Nano Owner’s Guide...

  • Page 82: Software License Agreement

    2. Additional License Terms Pertaining to LabChart Products ADInstruments hereby grants Licensee a license to install and use any LabChart product(s) for which Licensee has purchased a license (including LabChart, LabChart Pro, LabChart Modules, LabChart Extensions, GLP Client, and Scope) on up to three (3) Computers for the purpose of data analysis.
  • Page 83 (1) Computer. Licensee may not make LabChart products available to any other person or organization without the express written consent of ADInstruments. Licensee may make copies of LabChart products for backup purposes. Backup copies of any LabChart product are to be used only to replace the original copy in the event that it is destroyed or becomes defective.
  • Page 84 5. Additional License Terms Pertaining to GLP Server License ADInstruments hereby grants Licensee a license to install and use GLP Server on a single Computer that functions as a server to GLP Clients. Licensee may make copies of GLP server for backup purposes. Backup copies of GLP Server are to be used only to replace the original copy in the event that it is destroyed or becomes defective.
  • Page 85 LabTutor Online. Licensee agrees that ADInstruments retains the right to create reasonable limits regarding LabTutor Online usage, such as, without limitation, file size. It shall be the responsibility of Licensee and Authorized Users to maintain the accuracy, completeness, confidentiality and current status of account information at all times.
  • Page 86 To include the Videos solely in LabTutor experiments that Licensee creates using the LabAuthor software package. iii. Other uses for which ADInstruments has provided Licensee with its prior written consent. b. Restrictions. All Permitted Uses shall be for non-profit, non-commercial, educational purposes only.
  • Page 87 Except as expressly permitted by this Agreement, Licensee may not alter the Software in any way or create derivative works based on it. ADInstruments’ company name, logo and product names constitute registered and common law trademarks of ADInstruments, and ADInstruments retains the exclusive ownership of, and rights to, such marks.
  • Page 88 BE LIABLE FOR ANY INCIDENTAL, CONSEQUENTIAL OR SPECIAL DAMAGES RESULTING FROM USE OF THE SOFTWARE. 15. Upgrades ADInstruments may make Upgrades to the Software from time to time. The terms of this Agreement shall apply to Upgrades. 16. Controlling Law...
  • Page 89 19. Agreement Changes ADInstruments may, at its discretion, change, modify, add or remove portions of the terms and conditions constituting this Agreement. ADInstruments will post any such updated terms and conditions at http://www.adinstruments.com/license at least thirty (30) days before any changes become effective.
  • Page 90 Human NIBP Nano Owner’s Guide...

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