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FINAPRES NOVA User Manual

FINAPRES NOVA
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FINAPRES NOVA
BASIC USER MANUAL
Document ID: 0283-02-001-EN (910700)
Version 1.9
Version date: 04 April 2016

Table of Contents

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FINAPRES NOVA Specifications

General IconGeneral
BrandFINAPRES
ModelNOVA
CategoryMedical Equipment
LanguageEnglish

Summary

Customer Support

Warranty

Disclaimer

Preface

Introduction

1.1 Finapres Nova

Describes the Finapres NOVA device for noninvasive blood pressure and hemodynamic monitoring.

1.2 Intended Use and Environment

Details the device's purpose and operating environment, emphasizing desktop use and operator surveillance.

1.3 Intended User

Specifies that the user must be a qualified operator with relevant medical education and system knowledge.

1.4 Intended Patient Population

Outlines age, weight, health conditions, and contraindications for patient use.

1.5 Device Classification

States that the Finapres Nova is class I ME equipment according to IEC 60601-1.

1.6 Accessories

Lists the available accessories for measuring blood pressure, including cuffs and units.

Warnings and Safety Precautions

2.1 Safety and Precautionary Symbols

Explains symbols indicating suggestions, potential problems, and dangers of serious injury if instructions are ignored.

2.2 Warning Pictorials

Illustrates various warning symbols, including consult instructions, mandatory action, dangerous voltage, and equipotentiality.

2.3 Warnings and Cautions

Details critical warnings about qualified personnel, supervision, electrical safety, modifications, and proper cuff application.

Installation

3.1 Unpacking the Finapres Nova

Guides on checking packing for damage and contacting the manufacturer if issues arise.

3.1.1 Package Contents

Instructs to verify package contents against the delivery note and report discrepancies.

3.2 Installation

Details the steps for physically setting up the Finapres Nova device.

3.2.1 Finapres Nova

Covers placing the device on a flat surface and connecting the power cable.

Finapres Nova Description

4.1 Description of the Finapres Nova

Provides a general overview and visual representation of the Finapres Nova device.

4.2 Connections and Controls

Details the placement and types of connections and controls on the device.

4.2.1 Accessories

Lists the accessories provided with the Finapres Nova, such as the Frontend Unit.

4.3 Graphical User Interface

Explains the touch-screen interface for operating the Finapres Nova and its main menu.

Operation

5.1 Switching On

Step-by-step guide on how to power on the Finapres Nova device.

5.2 Switching Off

Instructions for safely powering down the Finapres Nova device.

5.3 Disconnecting from Mains Supply

Details how to disconnect the device from the power source for storage or maintenance.

5.4 Measuring

Covers the entire measurement process, from patient connection to data recording.

5.4.1 Connecting the Patient

Explains how to connect the patient using the finger cuff and Frontend Unit for accurate measurement.

5.4.2 Connecting the Frontend Unit

Guides on connecting the Frontend Unit to the main Finapres Nova device.

5.4.3 Starting a Measurement

Details the procedure for initiating a measurement, including patient data entry and zeroing.

5.4.4 Actions During a Measurement

Describes available actions that can be performed while a measurement is in progress.

5.4.5 Stopping the Measurement

Explains how to stop a measurement and the options for confirmation or restart.

5.4.6 Disconnecting the Patient

Outlines the steps to safely disconnect the patient and accessories after measurement.

5.5 Reviewing a Measurement

Guides on how to access and review previously recorded measurement data.

5.6 Selecting a User Profile

Explains how to choose and manage user profiles for customized settings.

5.7 Measurement Settings

Describes how to adjust measurement parameters and settings, either during use or via user profiles.

5.8 File Management

Covers operations for opening, deleting, moving, and copying measurement data files.

Maintenance and Cleaning

6.1 Maintenance

Details that technical maintenance is restricted to qualified personnel or Finapres Medical Systems B.V.

6.1.1 Maintenance Schedule

Recommends yearly return of the device for service and calibration checks.

6.2 Cleaning

Provides instructions on how to clean the device and finger cuffs safely and effectively.

Transport and Storage

7.1 Transport

Instructions for shipping the Finapres Nova, including packaging and labeling recommendations.

Appendix 1 Graphical User Interface

A1.1 General Screen Description

Explains the layout of the graphical interface, including status bar and contents box.

A1.2 On-screen Keypad

Describes the virtual keyboard that appears for text input on the interface.

A1.3 Main Menu

Details the main menu screen and the function of its elements.

A1.4 Setup and Start Measurement

Covers the initial steps for preparing and starting a measurement procedure.

A1.4.1 Review Measurement

Explains how to view and analyze previously recorded measurement data.

A1.4.2 Manage User Profiles

Guides on creating, copying, renaming, and deleting user profiles for settings.

A1.4.3 Finger Cuff Settings

Details the settings and configuration options for finger cuffs used in measurements.

A1.4.4 Measurement Settings

Covers selection of signals for graphs, numeric values, and signal properties.

A1.4.5 File Management

Explains how to manage measurement data files, including opening, deleting, copying, and moving.

A1.4.6 System Settings

Provides access to regional settings, hardware configuration, and software information.

A1.5 Basic Warnings and Error Messages

Lists and explains common warnings and error messages displayed by the Finapres Nova.

Appendix 2 Technical Specifications

A2.1 Characteristics

Lists the key characteristics of the Finapres Nova, including product type and measurement accuracy.

A2.2 Finger Cuffs

Details safety measures, electrical specifications, cuff pressure limits, and general considerations for finger cuffs.

A2.2.1 Protective Measures for Finger Cuff

Explains safety features and comfort measures for finger cuffs during use.

A2.2.2 Electrical

Describes electrical safety features related to finger cuffs, such as low current and circuit protection.

A2.2.3 Cuff Pressure

Specifies the limits and behavior of cuff pressure during operation.

A2.2.4 General

Covers general considerations regarding cuff pressure oscillations and interaction with contracted arteries.

A2.3 Signals

Provides an overview of the available signals with their abbreviations, names, descriptions, and units.

A2.4 Technical Description

Details the technical specifications related to connectivity, mechanical aspects, electrical properties, and environmental conditions.

A2.4.1 Connectivity

Explains the usage of USB, RS232, and LAN ports for data transfer and peripherals.

A2.4.2 Mechanical

Lists the physical dimensions and console weight of the main unit and frontend unit.

A2.4.3 Electrical

Outlines power cord specifications, AC power, electrical protection, and power consumption.

A2.4.4 Environmental Conditions

Specifies the recommended operating and storage temperature, humidity, and atmospheric pressure.

A2.4.5 EMC Guidance and Manufacturer's Declaration Tables

Provides guidance on electromagnetic compatibility and manufacturer declarations related to emissions and immunity.

Appendix 3 Connecting the Patient

A3.1 Using Finger Cuffs

Emphasizes the importance of proper finger cuff application for measurement success.

A3.1.1 Finger Cuff Selection

Guides on choosing the correct size and color of finger cuffs based on circumference.

A3.1.2 Notes on Cuff Handling

Provides key notes to prevent damage to finger cuffs during use and handling.

A3.1.3 Cuff Application

Details the step-by-step procedure for correctly wrapping and applying the finger cuff.

A3.2 Connecting the Height Correction Unit

Explains how to connect the height correction unit to the patient and the Frontend Unit.

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