FINAPRES NOVA Basic User Manual Ver 1.9 April 2016

Basic user manual

Finapres Nova

In addition to this Basic User Manual the following documents come with the Finapres Nova: 

EC Declaration of Conformity



Additional manuals of optional hardware modules and software applications

Copyright © Finapres Medical Systems B.V. All rights reserved. No part of this publication may be reproduced, stored in database or retrieval system, or published, in any form or in any way, electronically, mechanically, by print, photo print, microfilm or any other means without prior written permission from the manufacturer.

Version date: 04 April 2016

1

Basic user manual

Version date: 04 April 2016

Finapres Nova

2

Basic user manual

Finapres Nova

Customer support If the product fails to function properly or when assistance, service, or recalibration is needed, please contact: Finapres Medical Systems B.V. Hogehilweg 8 1101 CC Amsterdam The Netherlands Phone:

+31 20 609 0974

Fax:

+31 20 609 0677

Internet:

www.finapres.com

Email:

[email protected]

The year of manufacture of the Finapres Nova is mentioned on the identification plate at the back side of the device. An example of a Finapres Nova identification plate is shown below.

Figure C-1: Identification plate of the Finapres Nova

If accessories for Finapres Nova are needed, such as extra cuffs please contact the Finapres Medical Systems B.V Sales Department: Phone: Fax: Email:

+31 20 697 2228 +31 20 609 0677 [email protected]

The Finapres Nova contains no parts that can be serviced by others than Finapres Medical Systems B.V. Unauthorized repairs and modifications will void the warranty and may violate the conformity of the Finapres Nova with the requirements of the Medical Device Directive 93/42/EEC.

Version date: 04 April 2016

3

Basic user manual

Version date: 04 April 2016

Finapres Nova

4

Basic user manual

Finapres Nova

Warranty Finapres Medical Systems B.V. issues a 12 month guarantee on the Finapres Nova. This guarantee is only valid if the Finapres Nova is operated in accordance with the specifications and the instructions for use and maintenance. The guarantee of the Finapres Nova is void in the event of: 

Improper use



Insufficient maintenance



Improper maintenance



Modifications without prior consent of Finapres Medical Systems B.V.

The guarantee does not apply to parts that need to be replaced periodically.

Version date: 04 April 2016

5

Basic user manual

Version date: 04 April 2016

Finapres Nova

6

Basic user manual

Finapres Nova

Disclaimer Finapres Medical Systems B.V. is not liable for unsafe situations, accidents and injury or damage which are caused by: 

Neglecting warnings or prescriptions as shown on the Finapres Nova or stated in this Basic User Manual and/or additional hardware and software manuals.



The use of the Finapres Nova for other applications or under other circumstances than stated in this Basic User Manual.



Modifying the Finapres Nova in any way (including application of other spare parts and changing the control program).



Insufficient and improper maintenance.

Finapres Medical Systems B.V. is not liable for resulting injury following Finapres Nova malfunctions, such as operation breaks etcetera. (US) Federal law restricts this device to sale by or on the order of a physician.

Version date: 04 April 2016

7

Basic user manual

Version date: 04 April 2016

Finapres Nova

8

Basic user manual

Finapres Nova

Preface This Basic User Manual informs the user about the safe operation and everyday maintenance of the Finapres Nova. Read this Basic User Manual carefully before starting to use the Finapres Nova. Only then optimal safety can be obtained. Operation (and everyday maintenance) of the Finapres Nova may only be done by qualified personnel. The user must be acquainted with the entire contents of this Basic User Manual before starting to use the Finapres Nova. Always keep this Basic User Manual near the Finapres Nova.

Version date: 04 April 2016

9

Basic user manual

Version date: 04 April 2016

Finapres Nova

10

Basic user manual

Finapres Nova

Contents Customer support ... 3 Warranty ... 5 Disclaimer ... 7 Preface... 9 Contents ... 11 1

Introduction... 15

1.1 1.2 1.3 1.4 1.5 1.6

Finapres Nova ... 15 Intended use and environment ... 15 Intended user... 16 Intended patient population ... 16 Device classification ... 16 Accessories ... 17

2

Warnings and safety precautions ... 19

2.1 Safety and precautionary symbols ... 19 2.2 Warning pictorials ... 19 2.3 Warnings and cautions ... 20

3

Installation... 23

3.1 Unpacking the Finapres Nova... 23 3.1.1 Package contents ... 23 3.2 Installation... 23 3.2.1 Finapres Nova ... 23

4

Finapres Nova description ... 25

4.1 Description of the Finapres Nova ... 25 4.2 Connections and controls ... 25 4.2.1 Accessories ... 26 4.3 Graphical user interface ... 27

5

Operation ... 29

5.1 Switching on ... 29 5.2 Switching off ... 30 5.3 Disconnecting from the mains supply... 30 5.4 Measuring ... 31 5.4.1 Connecting the patient ... 31 5.4.2 Connecting the Frontend Unit ... 31 5.4.3 Starting a measurement ... 32 Version date: 04 April 2016

11

Basic user manual

Finapres Nova

5.4.4 Actions during a measurement ... 33 5.4.5 Stopping the measurement ... 34 5.4.6 Disconnecting the patient ... 34 5.5 Reviewing a measurement ... 35 5.6 Selecting a user profile... 37 5.7 Measurement settings ... 37 5.8 File management ... 38

6

Maintenance & cleaning ... 39

6.1 Maintenance ... 39 6.1.1 Maintenance schedule ... 39 6.2 Cleaning ... 39

7

Transport and storage ... 41

7.1 Transport ... 41

Appendix 1

Graphical user interface... 43

A1.1 General screen description ... 43 A1.2 On-screen keypad... 44 A1.3 Main menu ... 44 A1.4 Setup and start measurement ... 46 A1.4.1 Review measurement ... 54 A1.4.2 Manage user profiles ... 56 A1.4.3 Finger cuff settings ... 58 A1.4.4 Measurement settings... 59 A1.4.5 File management ... 67 A1.4.6 System settings ... 69 A1.5 Basic warnings and error messages ... 79

Appendix 2

Technical specifications ... 85

A2.1 Characteristics ... 85 A2.2 Finger cuffs ... 85 A2.2.1 Protective measures for finger cuff... 85 A2.2.2 Electrical ... 85 A2.2.3 Cuff pressure ... 86 A2.2.4 General ... 86 A2.3 Signals ... 86 A2.4 Technical description ... 87 A2.4.1 Connectivity ... 87 A2.4.2 Mechanical ... 87 A2.4.3 Electrical ... 88 A2.4.4 Environmental conditions ... 88 A2.4.5 EMC Guidance and manufacturer's declaration tables ... 89

Appendix 3

Connecting the patient ... 93

A3.1 Using finger cuffs ... 93 A3.1.1 Finger cuff selection ... 93 A3.1.2 Notes on cuff handling ... 94 Version date: 04 April 2016

12

Basic user manual

Finapres Nova

A3.1.3 Cuff application ... 94 A3.2 Connecting the height correction unit ... 95

Version date: 04 April 2016

13

Basic user manual

Version date: 04 April 2016

Finapres Nova

14

1 Basic user manual

1

Introduction

1.1

Finapres Nova

Finapres Nova

The Finapres NOVA is intended to be used with patients who have a need for a noninvasive blood pressure and hemodynamic monitor. The noninvasive blood pressure waveform is measured on the subject’s finger. The Finapres NOVA provides a noninvasive characterization of the arterial circulation and its beat-tobeat variability in pressure and flow and in various hemodynamic parameters derived from these pressure and flow signals. Cardiac output derived from the flow signal requires a calibration with thermodilution. The Finapres NOVA has the option to include additional modules to extend its functionality with ECG and SpO2 measurements and blood pressure calibration. When the SpO2 module is present, the Finapres NOVA can additionally monitor the functional oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate. When the ECG module is present, the Finapres NOVA can additionally monitor the ECG parameters of a patient and their pulse rate. Alarms concerning the pulse rate will be available from the monitor. The ECG module provides only a visual clinical alarm. When the blood pressure calibration module is present, the Finapres NOVA can additionally provide an upper arm non-invasive blood pressure measurement to determine the blood pressure value for calibration. The Finapres NOVA is intended to be used for subjects above 18 years of age. The Finapres NOVA is intended for use in a professional medical environment. Except of the ECG module, no visual clinical alarms are given by the Finapres Nova. The Finapres Nova can generate alerts for technical but not for clinical issues.

Data produced by the Finapres Nova and/or the accompanying software is intended as an adjunct in patient assessment. It should not be used as a sole means for determining a patient's diagnosis.

1.2

Intended use and environment The Finapres Nova is a standalone device intended for desktop use. Measurements are to be performed under uninterrupted patient surveillance of the operator.

Version date: 04 April 2016

15

1 Basic user manual

Finapres Nova

The Finapres Nova is used in a professional medical environment (i.e. hospitals, clinics and research institutions etc.). The Finapres Nova is suitable for use in an operating room in the non-sterile zone. The Finapres Nova is not intended for use in an oxygen rich environment. The Finapres Nova should not be used in combination with systems that can cause electromagnetic interference. This includes devices such as defibrillators, MRI’s, or electro-surgical units The Finapres Nova should not be used in combination with HF surgery devices.

1.3

Intended user The user of the Finapres Nova should be a qualified operator. The operator should have knowledge of the system and data interpretation, obtained via medical education, system manuals and/or specific courses. He/she is the person operating the Finapres Nova instrument.

1.4

Intended patient population Age 18 years and up Weight 20 up to 255 kg Health With respect to the measurement principle it is known that the application of the device in patients with Raynaud’s disease is limited. Condition Provided the device can detect a sufficient pulsating artery (according to its own acceptance criteria) and the finger cuff is applied correctly, the measurement can be performed. The Finapres Nova can be used with pregnant, pre-eclamptic patients with caution. Diagnosis The device has an added value for diagnosing a patient. However, an uninterrupted availability of measurement data cannot be guaranteed. Therefore, in situations where this is required additional patient monitoring equipment is needed. Contraindications Not known.

1.5

Device classification 

The Finapres Nova is class I ME equipment according to IEC 60601-1.

Version date: 04 April 2016

16

1 Basic user manual 

1.6

Finapres Nova

The Finapres Nova has a protection degree against harmful ingress of water or particulate matter of IP31. This means that the Finapres Nova is protected against ingress of solid foreign objects having a diameter of ≥2,5 mm and against harmful effects of dripping water per IEC 60529.

Accessories The Finapres Nova has the following accessories for measuring blood pressure: 

Frontend Unit



Height correction unit



Finger cuffs:



S(mall) finger cuff (white),



M(edium) finger cuff (beige),



L(arge) finger cuff (blue). The Finapres Nova may only be used in combination with accessories provided by the manufacturer!

Version date: 04 April 2016

17

1 Basic user manual

Version date: 04 April 2016

Finapres Nova

18

2 Basic user manual

Finapres Nova

2

Warnings and safety precautions

2.1

Safety and precautionary symbols Suggestion to carry out tasks easier.

Draws attention to potential problems.

Draws attention to the danger of serious injuries to the user or patient if the instructions are not carried out carefully.

2.2

Warning pictorials

Consult instructions for use

General mandatory action sign

Dangerous voltage

Equipotentiality

USB connection

Type B applied part

Manufacturer

Version date: 04 April 2016

19