Human NIBP Owners Guide

Human NIBP Controller Owner’s Guide

This document was, as far as possible, accurate at the time of release. However, changes may have been made to the software and hardware it describes since then. ADInstruments Pty Ltd reserves the right to alter specifications as required. Late-breaking information may be supplied separately. Trademarks of ADInstruments PowerLab®, LabChart®, LabTutor®, LabAuthor® and MacLab® are registered trademarks of ADInstruments Pty Ltd. The names of specific recording units, such as PowerLab 8/35, are trademarks of ADInstruments Pty Ltd. LabTutor Server, Chart and Scope (application programs) and LabTutor Online are trademarks of ADInstruments Pty Ltd. Other Trademarks Apple, Mac and Macintosh are registered trademarks of Apple Computer, Inc. Windows, Windows 7 and Windows Vista are either registered trademarks or trademarks of Microsoft Corporation. All other trademarks are the property of their respective owners. Product: Human NIBP Controller Part Number for this document: 6113-B Copyright © 2014 ADInstruments Pty Ltd. Unit 13, 22 Lexington Drive, Bella Vista, NSW 2153, Australia All rights reserved. No part of this document may be reproduced by any means without the prior written permission of ADInstruments Pty Ltd. Web: www.adinstruments.com Technical Support: [email protected] Documentation: [email protected]

Human NIBP Controller Owner’s Guide

Contents

Contentsi Safety Notes

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1 Overview7 The Human NIBP Controller������������������������������������������������������������������������8 The Front Panel ����������������������������������������������������������������������������������������8 The Back Panel������������������������������������������������������������������������������������������9 Symbols����������������������������������������������������������������������������������������������������11

2 Using the Controller

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Install ADInstruments Software ���������������������������������������������������������������� 14 Check the installation������������������������������������������������������������������������������������15 The S (HCU)����������������������������������������������������������������������������������������������������17 Using Finger Cuffs ����������������������������������������������������������������������������������������19 Warnings on cuff handling ������������������������������������������������������������������19 Starting up the software��������������������������������������������������������������������������������24 Human NIBP Settings����������������������������������������������������������������������������������26 Auto calibration enabled����������������������������������������������������������������26 Finger cuff switching����������������������������������������������������������������������27 Performing the Height Correction Procedure������������������������������������������29 Starting a measurement��������������������������������������������������������������������������������30 Stopping a measurement������������������������������������������������������������������������������ 31 Use of comments��������������������������������������������������������������������������������������������32 Test mode��������������������������������������������������������������������������������������������������������32 Troubleshooting ��������������������������������������������������������������������������������������������36

A Technical Details

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How it Works��������������������������������������������������������������������������������������������������43 Photoplethysmography ������������������������������������������������������������������������44 Plethysmograph��������������������������������������������������������������������������������������45 The pressure-diameter relationship ��������������������������������������������47 Volume-clamp method������������������������������������������������������������������48 i

Human NIBP Controller Owner’s Guide

PhysioCal algorithm������������������������������������������������������������������������������49 Measurement accuracy����������������������������������������������������������������������������������55 Comparison with intra-arterial blood pressure��������������������������������55 Clinical use����������������������������������������������������������������������������������������������58

B References63 Finger arterial pressure methods ��������������������������������������������������������63 Clinical Experience��������������������������������������������������������������������������������65

C Specifications69 D Warranty77 Product Purchase and License Agreement ����������������������������������������77 Software License Agreement����������������������������������������������������������������82

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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. Furthermore, no product is intended for the prevention, curing or alleviation of disease, injury or handicap. Where a product meets IEC60601-1 it is under the principle that: •• it is a more rigorous standard than other standards that could be chosen. •• it provides a high safety level for subjects and operators. The choice to meet IEC60601-1 is in no way to be interpreted to mean that a product: •• is a medical device. •• may be interpreted as a medical device. •• is safe to be used as a medical device.

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Human NIBP Controller Owner’s Guide

Safety Symbols Devices distributed and manufactured by ADInstruments that are designed for direct connection to humans are tested to standards IEC60601-1:1998 (including amendments 1 and 2) and IEC60601-1-2, and carry one or more of the safety symbols below. These symbols appear next to those inputs and output connectors (or ‘applied parts’) of the medical device that can be directly connected to human subjects.

B symbol

BF symbol

These symbols are: •• B symbol. This classification is a less stringent certification than the BF symbol; it certifies that an instrument is safe for direct human connection. It applies to the Human NIBP Controller. The B symbol appears on the applied parts that, in general, are not conductive and can be immediately released from the subject. Type B applied parts may be connected to earth, while Type BF is ‘floating’ and must be separated from earth. •• BF (body protected) symbol. This symbol appears next to those inputs and output connectors that can be directly connected to human subjects. This means that the input connectors are suitable for connection to humans provided there is no direct electrical connection to the heart. Further information is available on request.

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Human NIBP Controller Owner’s Guide

Avoiding Injury to Subjects and Personnel •• Selecting a properly-sized finger cuff and correct placement of the cuff on a finger are critical for success. Finger cuffs should not be applied to any body part other than the fingers. •• Accuracy of measurement on a toe has not been established. •• An inflated finger cuff applied to the wrist causes congestion of blood in the distal circulation of the hand, which may become painful and restricts distal oxygenation. •• Do not wrap finger cuffs around a toe or the wrist of an infant. •• For safe and reliable operation and optimal accuracy, only use finger cuffs supplied by ADInstruments and Finapres Medical Systems B.V. •• Externally generated analog signals coming from other devices, such as respiratory signals and ECGs, can be connected to the ADInstruments PowerLab system for recording. Connected equipment has to meet the IEC specifications (IEC601 for electro medical devices or IEC950 for data processing devices). The configuration has to meet the IEC system standard (IEC606011-1). He who connects such additional devices is responsible for adherence to the IEC60601-1-1 standard.

General Safety Instructions To achieve the optimal degree of subject and operator safety, consideration should be given to the following guidelines when setting up a Human NIBP system either as stand-alone equipment or in conjunction with other equipment. Failure to do so may compromise the inherent safety measures designed into Human NIBP equipment. The following guidelines are based on principles outlined in the international safety standard IEC60601-1-1: General requirements for safety - Collateral standard: Safety requirements for medical systems. Reference to this standard is required when setting up a system for human connection. The Human NIBP system requires the connection of a personal computer for operation. This personal computer should be certified as complying with IEC60950 and should be located outside a 1.8 m radius from the subject (so that the subject cannot touch it while connected to the system). Within this 1.8 m radius, only equipment complying with IEC60601‑1 should be present.

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Human NIBP Controller Owner’s Guide

Connecting a system in this way obviates the provision of additional safety measures and the measurement of leakage currents. Accompanying documents for each piece of equipment in the system should be thoroughly examined prior to connection of the system. While it is not possible to cover all arrangements of equipment in a system, some general guidelines for safe use of the equipment are presented below: •• Any electrical equipment which is located within the SUBJECT AREA should be approved to IEC60601-1. •• Only connect those parts of equipment that are marked as an APPLIED PART to the subject. APPLIED PARTS may be recognized by the B or BF symbols (see Safety Symbols section). •• 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 system is connected at the same time as making contact with parts of the Human NIBP system (or its peripherals) that are not intended for contact to the subject. •• Cleaning and sterilization of equipment should be performed in accordance with manufacturer’s instructions. The isolation barrier may be compromised if manufacturer’s cleaning instructions are not followed. •• The ambient environment (such as the temperature and relative humidity) of the system should be kept within the manufacturer’s specified range or the isolation barrier may be compromised. An explosion hazard exists when operated in the presence of flammable gases and liquids. •• The entry of liquids into equipment may also compromise the isolation barrier. If spillage occurs, the manufacturer of the affected equipment should be contacted before using the equipment. •• Many electrical systems (particularly those in metal enclosures) depend upon the presence of a protective earth for electrical safety. This is generally provided from the power outlet through a power cord, but may also be supplied as a dedicated safety earth conductor. Power cords should never be modified so as to remove the earth connection. The integrity of the protective earth connection between each piece of equipment and the protective earth should be verified regularly by qualified personnel. •• Avoid using multiple portable socket-outlets (such as power boards) where possible as they provide an inherently less safe environment 4

Human NIBP Controller Owner’s Guide

with respect to electrical hazards. Individual connection of each piece of equipment to fixed mains socket-outlets is the preferred means of connection. If multiple portable socket outlets are used, they are subject to the following constraints: •• They shall not be placed on the floor. •• Additional multiple portable socket outlets or extension cords shall not be connected to the system. •• They shall only be used for supplying power to equipment which is intended to form part of the system.

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.

Preventative Inspection and Maintenance The Human NIBP components are maintenance-free and do not require periodic inspection to ensure safe operation. There is no need to open any of the device’s components for inspection or maintenance, and doing so within the warranty period will void the warranty. The zero adjustment of all built-in pressure transducers is automatic, except for the pressure transducer in the S for which zeroing has to be performed manually (see on page 28). It is the responsibility of the operator to periodically check the zeros and sensitivities of the transducers. Human NIBP components leave our premises with carefully calibrated transducers. Immediately after transport, or at any time that the instrument is dropped or otherwise damaged, the zeros and calibrations should be rechecked. These checks are quick and easy to perform (see Pressure check on page 39). Follow these instructions for testing the device if performing such tests. If the Human NIBP system is found not to comply with such testing you should contact your ADInstruments representative to arrange for the

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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. The Human NIBP Controller has a narrow temperature operating range (see Operating Conditions below) and should be placed apart from other equipment for optimal operation.

Storage Conditions •• Temperature in the range -20–70 °C •• Non-condensing humidity in the range 5–90%.

Operating Conditions •• Temperature in the range 10–40 °C •• Non-condensing humidity in the range 5–90%.

Disposal •• Forward to recycling center or return to manufacturer. •• Unwanted equipment bearing the Waste Electrical and Electronic Equipment (WEEE) Directive symbol requires separate waste collection. For a product labeled with this symbol, either forward to a recycling center or contact your nearest ADInstruments representative for methods of disposal at the end of its working life. WEEE Directive symbol

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Overview

This Owner’s Guide covers the components of the Human NIBP System, which includes ADInstruments LabChart® software. The Human NIBP (Non-Invasive Blood Pressure) System performs continuous, non-invasive arterial blood pressure measurement on human fingers, using switching between two finger cuffs, combined with hydrostatic height correction to correct for pressure changes when the measured hand moves away from heart level. The Human NIBP System comprises: •• The Human NIBP Controller and Wrist Unit, •• A S (HCU), •• LabChart Pro®, and •• Two Finger cuffs, which are available in three sizes: small, medium, and large. If required, these may also be purchased separately. •• Small, for finger circumferences 45-55 mm...[MLE1057] •• Medium, for finger circumferences 55-65 mm...[MLE1058] •• Large, for finger circumferences 65-75 mm...[MLE1059] The Human NIBP Controller is manufactured by Finapres Medical Systems B.V. (FMS) for distribution by ADInstruments, and for use with ADInstruments software.

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Human NIBP Controller Owner’s Guide

Checking Human NIBP Components The Human NIBP components pass quality control inspection before leaving the factory. However, there is a small chance that damage may occur in transit. 1.  Check there are no obvious signs of damage to the outside casing. 2.  Check there are no obvious signs of internal damage (like rattling). If you find a problem, please contact your ADInstruments distributor immediately.

The Human NIBP Controller The Human NIBP Controller contains a computer board and electronics for the servo-controlled finger cuff pressure. It also contains the air circuitry comprising a compressor and pressure control devices. Note: The Human NIBP Controller has a narrow temperature operating range (see Operating Conditions) and should be placed apart from other equipment for optimal operation.

The Front Panel Figure 1–1 Human NIBP Controller Front panel

Wrist Unit Connector

Power Indicator

Air Connector

The Power Indicator The Power indicator will light when the unit is on. If not, check that the unit is properly connected to a power socket and is switched on.

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Human NIBP Controller Owner’s Guide

Wrist Unit Connector This port provides the main connection for the Wrist Unit, which is a box to be worn on the back of the hand or the wrist and contains connectors for the finger cuffs and the Height Correction Unit. Air Connector This port is also for connection of the Wrist Unit to the Human NIBP Controller.

The Back Panel Figure 1–2 Human NIBP Controller Back panel

USB Port

Grounding post (Optional)

Analog Output

Power On/Off Switch

USB Connection

USB icon and port

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The Human NIBP Controller has a USB port, which connects to a computer with USB ports or a PCI USB card installed, allowing high data transfer rates. Your Human NIBP Controller is supplied with a high-speed USB cable. For proper use and reliable results, the Human NIBP Controller needs a high-speed USB connection. In practical terms this means cables between any USB devices must be no more than 5 meters (16 feet) in length. If you replace the USB cable, buy a high-speed cable (fully shielded, twisted-pair and standard USB connections: a narrow rectangular plug at one end and a square plug with a bevelled top at the other).

Human NIBP Controller Owner’s Guide

Analog Output Socket The Human NIBP Controller is designed as a stand-alone unit, to receive power and to output signals via a USB connection to an attached computer. In this way, it can function without an ADInstruments PowerLab. However, an analog output with a BNC connector is provided, allowing the option of connecting the Human NIBP Controller to a PowerLab or similar recording device. The signal at the analog output of the Human NIBP Controller is the raw Finger Pressure signal, which is nearly the same as the signal recorded into the Finger Pressure channel in LabChart as long as the measured hand is kept at heart level (the signal in the Finger Pressure channel has the hydrostatic height correction applied to it). If the analog output is connected to an input of the PowerLab, the signal can be sampled at up to 200 kHz, depending on your model of PowerLab, and recorded into a new channel in LabChart. With the Human NIBP Controller, you are limited to a sampling rate of 200 samples per second. To sample at higher rates using the PowerLab, it is necessary to set the PowerLab as the master device in the Device Discovery dialog. See the LabChart Help for further information. Ground Connection

Equipotential connection point: Grounding post

An earthing (grounding) stud is provided on the rear panel of the Human NIBP Controller. This is an equipotential bonding connection post compatible with the DIN 42801 standard. The earthing stud is directly connected to the earth pin of the power socket and the Human NIBP Controller chassis. It is used as a primary earth connection (equipotential connection point) in situations that require this type of connection, for example where there is no ground connection provided via the power supply. Safety standards in laboratories and similar environments may require additional grounding protection when connecting equipment to human subjects, and their relevant standards or guidelines should be observed. Power Socket It is recommended to always use the grounded 3-wire electrical cable provided with the Human NIBP Controller to connect the power socket to a properly grounded mains power supply. On/Off Switch The Human NIBP Controller should be powered on and off using the On/ Off switch on the back panel of the unit. Note that in the Human NIBP Controller, the USB and main board are powered separately. This means that

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Human NIBP Controller Owner’s Guide

disconnecting the mains power to the device does not disconnect the device from Windows.

Symbols A number of symbols are shown on the back panel. CE Mark. The Human NIBP Controller and ADInstruments PowerLab systems carry the CE mark and meet the appropriate EU directives. Read Documentation symbol. This symbol means that the supplied documentation must be consulted for operating, cautionary or safety information before using the device. Warning symbol. This means that there are no user serviceable components in this device. There is no need to open the instrument for inspection or maintenance, and doing so within the warranty period will void the warranty. Inside use symbol. This symbol indicates that the device is suitable for inside use only.

Manufacturer symbol. The Human NIBP Controller, Wrist Unit and Finger cuffs are manufactured by Finapres Medical Systems B.V. (FMS) for distribution by ADInstruments. Equipotential connection point. Grounding provided for earth connection.

post

Electrical hazard symbol. This symbol indicates that the unit is for connection to a mains electricity supply and sensible precautions should be taken, such as safe connection and disconnection of the power cord. UL Mark. The Human NIBP Controller and ADInstruments PowerLab systems meet standards set by Underwriters Laboratories with respect to electrical shock, fire and mechanical hazards only, in accordance with UL 60601-1 and CAN/CSA-C22.2 NO. 601.1. 11

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Using the Controller

This chapter guides you through installing ADInstruments Human NIBP software and connecting the Human NIBP Controller to your computer. This chapter also covers setting up the components of the Human NIBP hardware, and zeroing the Height Correction Unit. IMPORTANT: Warnings, subject safety •• The data produced by the Human NIBP System, which includes the Human NIBP Controller and accompanying software, is intended as an adjunct in subject assessment and should not be used as a sole means for determining a subject’s diagnosis. •• The Human NIBP Controller is a finger blood pressure monitor. Never use the finger cuffs on other parts of the body. •• The Human NIBP System should only be used in persons aged over 18 years. •• To maintain operator- and subject-safety, only use accessories such as finger cuffs provided by ADInstruments or Finapres Medical Systems B.V. •• The Human NIBP Controller is class B equipment according to IEC 60601-1. It should only be used with a properly grounded AC power supply. •• To maintain operator- and subject-safety, peripheral equipment that is connected to one of the Human NIBP System components should comply with IEC60601-1 and other relevant safety standards. •• For measurements longer than 1 hour, the use of finger switching between two attached finger cuffs is strongly recommended since 13

Human NIBP Controller Owner’s Guide

a prolonged measurement on one finger can be unpleasant for the subject. •• The ADInstruments Human NIBP software is designed to support the connection of a single Human NIBP Controller unit at any one time. It does not support connection of two (or more) Human NIBP Controller devices.

Install ADInstruments Software Please follow the instructions below in the correct order. First, install ADInstruments LabChart software GLP Client

You should first install LabChart 8 on your computer. The Human NIBP Device Enabler is a software add-on for LabChart for Windows, which is compatible with Windows Vista, Windows 7 or later.

LabChart Installers ®

Place the LabChart Pro CD in the CD drive of your computer. The installer should auto‑run. If it doesn’t, see the Read Me on the CD. Follow the onscreen instructions. Next, install the Human NIBP Device Enabler

Human NIBP Device Enabler 6114-A

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. Then, connect the device to a computer 1.  When you have installed the software, connect the Human NIBP Controller to your PC or laptop using the USB cable supplied with the device. Note: Windows may display a message to indicate that the device driver is being installed. The device driver is incorporated in the Human NIBP Device Enabler. It uses a FTDI Virtual COM port (VCP) driver. 2.  Connect the Human NIBP Controller to a grounded AC power supply using the power cord provided, then power the unit ON.

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Human NIBP Controller Owner’s Guide

Check the installation To check the software and driver installation, ensure the Human NIBP Controller is connected to your computer and powered on. Launch LabChart by double-clicking on the LabChart icon on your Desktop.

Figure 2–1 LabChart icon

On start-up, LabChart performs a device discovery process. It should automatically detect the Human NIBP Controller device. If a dialog like the one shown on the left of Figure 2–2 appears, click Device Scan to repeat the device discovery process. Once the Human NIBP Controller is found, click OK to launch LabChart. If this dialog persists, check that the Human NIBP Controller is connected to your computer and powered on. See “Troubleshooting” for further information.

Figure 2–2 Human NIBP Controller not found by LabChart.

Open a new document such as the ‘Human NIBP’ settings file provided for you. This is located in the Getting Started tab of the Welcome Center, which appears when LabChart opens. Figure 2–3 Getting Started tab of the Welcome Center.

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Human NIBP Controller Owner’s Guide

To confirm that LabChart has found the Human NIBP Controller: •• The device name should appear at the top of the new document. •• The Input Amplifier dialog should be disabled for all 11 LabChart channels because data is streamed directly from the Human NIBP Controller. There is no need to change the settings, range or display (see the LabChart Help for more details). •• The Start button should be enabled and ready to start recording. It is necessary to set up the hardware before proceeding to make a finger blood pressure measurement. If you are already familiar with the hardware, please proceed to Starting up the software on page 24.

The Human NIBP Wrist Unit 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 Controller with a cable assembly in which the cable and air tubing run in parallel. The air tubing connects the Wrist Unit to the controlled pressure source in the Human NIBP Controller. The cable assembly and air tubing connect to the front panel of Human NIBP Controller. A screwdriver is provided to secure the cable assembly to the front of the Controller. Figure 2–4 Human NIBP Wrist Unit with two finger cuffs attached.

Cuff cable connector

Air hose

Finger cuff

Note: the HCU (black) is also shown

Cable assembly

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Wrist unit with Velcro strap

HCU transducer attached to a finger cuff

Human NIBP Controller Owner’s Guide