FINAPRES Finometer Model-2 User manual

Finometer® Model-2
User's Guide
Finometer®Midi User’s Guide
This document is for information purposes only
v01.04
10-2012
© Finapres Medical Systems B.V.
0344
Ref. nr: 901700-584-53

2Finometer® Model-2 User’s Guide
Suggested reading order
The suggested reading order for this User's Guide is:
•first turn to the next pages with warnings and cautions.
•next, try out the quick start at section 1.3 [Quickstart] which
describes every step to perform a finger blood pressure
measurement for the first time. Soon thereafter, wrapping a finger
cuff will become routine, and starting a measurement is a one
button operation.
If you find anything missing in this User's Guide please contact
Us at Finapres Medical Systems B.V., see page 9 [Customer support],
as we may be able to provide the missing information.

Finometer® Model-2 User’s Guide 3
Picture of Finometer® Model-2

4Finometer® Model-2 User’s Guide
The Finometer® Model-2 components
Each Finometer® Model-2 device (commercially known as
Finometer® Midi) consists of the units listed below:
•Main unit: A box holding the principal electronic and pneumatic
components, the embedded computer, the front panel control
buttons, and the display. A three-pronged grounded power cord is
included.
•Frontend Unit: A box to be worn on the back of the hand or the
wrist and containing connectors for the finger cuff and the Height
Correction Unit.
•Finger cuff: One M-cuff (beige, medium) and one S-cuff (white,
small) is part of the standard package. Finger cuffs are also
available in one other sizes: blue, L-size, large.
•Height Correction Unit (HCU): A device to automatically correct
for hydrostatic height changes when the measured hand moves
away from heart level. It allows free hand movement during
measurements with the device.
•Serial interface cable (RS232): A cable to connect the main unit
to a PC or laptop with a RS232 (COM) port for on-line recording
and remote control of the device, using the Beatscope® Easy
software.
•USB/RS232 converter: A Converter to connect between the
Serial interface cable and a PC or laptop with a USB port.
•Finometer® Model-2 User's Guide: The document you are
presently reading.
•Finger Pressure Reference Guide: A document containing
background information on finger arterial pressure measurement.
The guides are available on CD-ROM as PDF files in printable format
and in interactive screen display format. Use Acrobat Reader
version 6 or later for viewing. Further copies are available from
Finapres Medical Systems B.V.

Finometer® Model-2 User’s Guide 5
•BeatScope® Easy software: A Microsoft Windows based software
program running on a PC offering a remote monitor screen,
recording functions and remote control of the most important
Finometer® Model-2 device functions. The BeatScope® Easy
software program presents and records waveforms and beat-to-
beat derived data, measured with Finometer® Model-2. The
program CDROM is part of the standard package.
Optional accessories:
•Finger cuff: Sizes: S, M, L.
•Analog I/O unit: Five BNC connectors for four-channels analog
signal output and one-channel analog signal input.
•ECG-module: A three lead ECG module providing an analog ECG
signal which is sampled and stored simultaneously with the blood
pressure waveform.
•BeatScope®: The optional BeatScope® software allows online
monitoring, control, storage and offline review of the complete data
including cardiac parameters.
Packaging:
The Finometer® Model-2 configuration is packed in a specially
developed carton box with spacers to avoid damage during transport.
If the package arrives with external damage please notify Finapres
Medical Systems B.V.
Upon unpacking a quick inspection of proper functioning of the
Finometer® Model-2 device is obtained by following the instructions in
section 1.3 [Quickstart]. Please contact Finapres Medical Systems B.V.
immediately in case of malfunction.

6Finometer® Model-2 User’s Guide
Cautions in using Finometer® Model-2
•Direct finger arterial pressure is not within the ANSI/AAMI SP10
standard. Inverse filtering and level correction improve bias and
precision and are automatically applied in the default configuration,
but systolic precision is still below that required for blood pressure
diagnostics.
•Finometer® Model-2 should not be used without interruption for
periods longer than four (4) hours on a single finger in awake
subjects.
•The only mode of measuring blood pressure levels in compliance
with the recommendations of the ANSI/AAMI SP10 standard is
when the device is used with the return-to-flow method of
calibration, as available in Finometer® Model-1 only.
When to use Finometer® Model-2
The Finometer® Model-2 is a non-invasive instrument to measure
blood pressure in the finger of a human subject. Since it is non-
invasive, application is associated with little risk.
The Finometer® Model-2 is intended to be used when there is a need
for a non-invasive hemodynamic monitor. The Finometer® Model-2
provides a non-invasive characterization of the arterial circulation and
its beat-to-beat variability in pressure and flow as well as in various
hemodynamic parameters derived from these pressure and flow
signals. The device does not report any diagnosis but provides
numerical values. It is the physician's responsibility to make proper
judgments based on these numbers.
The non-invasively blood pressure waveform is measured by using the
Finapres method of Peñáz/Wesseling. Cardiovascular parameters
include cardiac output and total peripheral resistance based on the
Modelflow method of Wesseling.
The Finometer® Model-2 is intended to be installed and operated by a
qualified physician or operator. Pressure measurements are validated
for subjects above 18 years of age.
The device, equivalent to the Finapres device, is not equipped with the
return-to-flow method of calibration and does not allow for the

Finometer® Model-2 User’s Guide 7
measurement of accurate absolute blood pressure data, but provides
optimal trending of blood pressure data.
Modelflow built-in calibration is useful from 18 years on. Cardiac output
measured with this device under the Modelflow model requires a
calibration with thermal dilution.
The physiological parameters provided by the device have clinical
significance only if determined by a physician and should not be used
as the sole means for a subject’s diagnosis.
The data provided by the device can be further processed by the
included PC-based BeatScope® software.
When not to use Finometer® Model-2
When 100% availability of arterial pressure is required in critically ill
subjects since treatment depends on it, and other means are available,
Finometer® Model-2 is not the preferred choice. Still, in two studies
we found that the overall percentage availability of Finapres in the
operating room during coronary artery bypass grafting (Wesseling3)
and of Portapres in 24 hour ambulatory recordings (Imholz2) was
equal to that of the intra-arterial lines. The finger is a distal measuring
site and smooth muscle in the arteries and arterioles of the circulation
of hand and finger can come to full contraction. An extreme example of
this is Raynaud's phenomenon. Measures have been built into
Finometer® Model-2 to alert the user to such conditions developing.
When full contraction does occur finger pressure measurement is no
longer possible, and cannot be restored quickly.
Avoiding injury to subjects and personnel
•(USA) Federal law restricts this device to sale by or on the order of
a physician. This device is intended for use by trained health care
professionals.
•The physiological parameters provided by this device have clinical
significance only if determined by a physician and should not be
used as the sole means for determining a subjects diagnosis.

8Finometer® Model-2 User’s Guide
•Explosion hazard exists when operated in the presence of
flammable gases and liquids.
•Protection against the ingress of liquids is limited. Do not apply
electrical power to the device when liquids did enter, as this may
cause internal short circuits and unpredictable external electrical
currents.
•Always use a grounded 3-wire electrical cable and connector to plug
into the power line.
•Selecting a proper sized cuff and the correct placement of a cuff on
a finger are critical for success.
•Do not wrap finger cuffs around a toe or the wrist of an infant.
•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.
•The zero adjustment of all pressure transducers built-in is
automatic, except for the pressure transducer of the Height
Correction Unit for which nulling has to be performed manually (see
section 5.1). It is the responsibility of the operator to periodically
check the zeros and sensitivities of the transducers. Finometer®
Model-2 devices leave our premises with carefully calibrated
transducers. Immediately after transport, and 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 section 8.4).
•For safe and reliable operation and optimal accuracy only use
Finapres Medical Systems B.V. cuffs and only use software
approved by Finapres Medical Systems B.V.
•Externally generated analog signals coming from other devices,
such as respiratory signal and ECG can be connected to the
Finometer® Model-2 for recording. Furthermore, personal
computing equipment can be interfaced to the digital I/O port of
the Finometer® Model-2 for obtaining signals and data, and for
remote control. Connected equipment has to meet the IEC
specifications (IEC 601 for electro medical devices or IEC 950 for
data processing devices). The configuration has to meet the IEC
system standard (IEC 601-1-1). He who connects such additional
devices is responsible for adherence to the IEC 601-1-1 standard.
•Complete specifications of Finometer® Model-2 are listed in
Chapter 9, Specifications.

Finometer® Model-2 User’s Guide 9
Customer support
The Finometer® Model-2 device is manufactured by Finapres Medical
Systems B.V.
The Finometer® Model-2 device and its accessories are constructed of
high quality materials and great care has been taken in its
manufacture. We stand behind our product and will do whatever is in
our power to have you as a satisfied customer and Finometer® Model-
2 user.
If the product fails to function properly, or when assistance, or service,
or recalibration is needed, please contact our After Sales department:
Finapres Medical Systems B.V.
Paasheuvelweg 34a
NL-1105 BJ AMSTERDAM ZO
The Netherlands
Phone : + 31 20 609 0974
Fax : + 31 20 609 0677
E-mail : [email protected]
If accessories for the Finometer® Model-2 device are needed, such as
extra cuffs, please contact our Sales department.
Phone : + 31 20 697 2228
Fax : + 31 20 609 0677
E-mail : [email protected]
The Finometer® Model-2 device contains no field serviceable
parts.
Servicing of any component of this device, therefore, is to be
performed by Finapres Medical Systems B.V. only. Unauthorized
repairs or modifications may violate the conformity of the Finometer®
Model-2 device with the requirements in the Medical Device Directive
93/42/EEC set forth by Finapres Medical Systems B.V.

10 Finometer® Model-2 User’s Guide
Warranty
The Finometer® Model-2 device and its accessories are constructed of
high quality materials and great care has been taken in its
manufacture.
The Finometer® Model-2 device is guaranteed by Finapres Medical
Systems B.V. for a period of one year after the date of shipment.
During this period of guarantee Finapres Medical Systems B.V. will,
without charge for labor or parts, repair or replace the defective parts.
The guarantee does not include the following:
1. Finger cuffs. Finger cuffs, however, are reusable items which can
often be used for several years, provided that the cuffs are handled
with care.
2. Transport costs and insurance of the shipment of the device to
Finapres Medical Systems B.V.
3. Defects caused by repairs by unauthorized personnel, or the use of
accessories not obtained from, or approved by Finapres Medical
Systems B.V.
4. Periodic check-ups, upon request of the user.
5. Damage through misapplication, misuse, or failure to follow the
instruction in this User’s Guide or in other accompanying
documents.
6. Accidents that affected Finometer® Model-2 or its accessories.
Every Finometer® Model-2 unit has an identification label with a specific identification
string. The string contains the serial number of the Finometer® Model-2 system, e.g.
060605020.

Finometer® Model-2 User’s Guide 11
Disclaimer
DISCLAIMER OF WARRANTIES AND LIMITATIONS
FINAPRES MEDICAL SYSTEMS B.V. MAKES NO WARRANTY OR
REPRESENTATION, EITHER EXPRESS OR IMPLIED, WITH RESPECT TO
THE FINOMETER® MODEL-2 DEVICE, ITS QUALITY,
MERCHANTABILITY, OR FITNESS FOR APARTICULAR PURPOSE. THE
EQUIPMENT IS PROVIDED AS IS,NO ORAL OR WRITTEN INFORMATION
OR ADVICE GIVEN BY EITHER PARTY OR ITS EMPLOYEES SHALL CREATE
AWARRANTY OR MAKE ANY MODIFICATION, EXTENSION OR ADDITION
TO THE WARRANTY
FINAPRES MEDICAL SYSTEMS B.V. SHALL NOT BE LIABLE FOR ANY
DIRECT, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES,
INCLUDING LOST PROFITS AND DAMAGES FOR PERSONAL INJURY OR
PROPERTY DAMAGE, ARISING FROM OR IN CONNECTION WITH THE
LICENSED RIGHTS OR ITS USE WHATSOEVER.
IN NO CASE SHALL FINAPRES MEDICAL SYSTEMS B.V.’S LIABILITY
EXCEED THE PURCHASE PRICE FOR THE DEVICE.
Information in this document is subject to change without notice and
does not represent a commitment on the part of Finapres Medical
Systems B.V.
The BeatScope® Easy software is furnished under a license
agreement. The software may be used only in accordance with that
agreement.
Finapres®, Portapres®, Finometer®, Modelflow® and BeatScope® are
trademarks of Finapres Medical Systems B.V.
No part of this publication may be reproduced, transmitted,
transcribed, stored in a retrieval system, or translated into any
language in any form by any means, for any other purpose than the
purchaser's personal use, without prior written permission of Finapres
Medical Systems B.V.

12 Finometer® Model-2 User’s Guide
Table of Contents
Suggested reading order
Picture of Finometer® Model-2
TThe Finometer® Model-2 components
Packaging
Cautions in using Finometer® Model-2
When to use Finometer® Model-2
When not to use Finometer® Model-2
Avoiding injury to subjects and personnel
Customer support
Warranty
Disclaimer
2
3
4
5
6
6
7
7
9
10
11
1Introduction 17
1.1What is Finometer® Model-2? 17
1.2Related publications 17
1.3Quickstart 19
1.4A first Finometer® Model-2 measurement 21
2Safety information 23
2.1Warnings, subject safety 23
2.2Cautions 23
2.3Precautions 24
2.4Symbols and icons 25
2.5Protective measures 26
3System description 29
3.1Checklist of Finometer® Model-2 configuration units 29
3.2Main Unit 31
3.3Frontend Unit 32
3.4The Height Correction Unit (HCU) 34

Finometer® Model-2 User’s Guide 13
3.5The (optional) 3-lead ECG module 36
3.6Finger cuff 37
3.7Finometer® Model-2 Control 38
3.8Connecting the Frontend Unit 39
3.9Connecting the Height Correction Unit 39
3.10Connecting the ECG (optional) 39
3.11Connecting to a PC 40
4Using the control keypad 41
4.1Control keys 41
4.2Finometer® Model-2 modes 42
4.2.1Startup mode 42
4.2.2Connect Frontend mode 44
4.2.3Ready mode 44
4.2.4Run mode 45
4.2.5Error mode 47
5Configuring the device 48
5.1Height Correction Unit nulling procedure 48
5.1.1Checking Height Correction Unit nulling 49
5.1.2Performing a Height Correction Unit nulling procedure 49
5.2Using the analog I/O cable 52
5.2.1Definition of output signals 53
5.2.2Analog signal input 54
5.3Calibration options 54
5.3.1Analog output calibration 54
5.4Configuration option menu 55
5.4.1Steady pressure calibration check 55
5.4.2Waveform calibration output 56
5.4.3Beeper configuration 57
5.4.4Serial protocol 57
5.4.5Software version 58
5.5PC monitoring and recording with BeatScope® Easy 59
6Performing a measurement 61
6.1Using finger cuffs 61
6.1.1Finger cuff selection 61

14 Finometer® Model-2 User’s Guide
6.1.2Warnings on cuff handling 62
6.1.3Cuff application 62
6.2Checklist 64
6.3Starting a measurement 64
6.3.1Startup messages 64
6.4Measurement options 65
6.4.1Switching Physiocal ON/OFF 65
6.4.2Marking events 66
6.4.3Checking run time information 67
6.5Run time messages 67
6.6Stopping a measurement 68
6.7Data on a PC 68
6.7.1Ohmeda protocol 69
6.7.2Ohmeda protocol and HyperTerminal 69
7Error messages and troubleshooting 71
7.1Audible indicators 71
7.1.1Key beeps 71
7.1.2Error beeps 71
7.2Error messages 72
7.2.1Plethysmogram, finger cuff error messages 72
7.2.2Air pressure, finger cuff error messages 73
7.2.3Miscellaneous errors during a measurement 74
7.2.4Errors due to missing sub device 74
7.2.5Fatal internal errors 74
8Maintenance, storage and calibration 77
8.1Maintenance 77
8.2Cleaning 77
8.3Storage 78
8.4Pressure calibration check 78
9Specifications 79
9.1Instrumental information 80
9.2Instrumental accuracy 81
9.3Analog signal outputs and signal inputs 82

Finometer® Model-2 User’s Guide 15
9.3.1Analog output signals 82
9.3.2Analog input signals 83
9.3.3Analog output connection 84
9.4Mechanical specifications 85
9.5Electrical specifications 86
9.6Environmental specifications 88
9.7EMC / EMI declaration 88
10Literature references 93
11Index 95

16 Finometer® Model-2 User’s Guide

Finometer® Model-2 User’s Guide 17
1Introduction
This introduction represents a general description of Finometer®
Model-2 in terms of methods used, with literature references, features,
available derived parameters from the blood pressure waveform and
bias and precision of the principal blood pressure parameters.
1.1
1.2
What is Finometer® Model-2?
Finometer® Model-2 is an instrument to monitor finger arterial
pressure continuously. Finometer® Model-2 is the successor of the
well-known Finapres (TNO and Ohmeda models) and provides the
measurement of blood pressure in a finger based on the arterial
volume-clamp method of the Czech physiologist Peñáz, and the
Physiocal - physiological calibration - criteria for the proper unloading
of the finger arteries of Wesseling. Hydrostatic pressure changes due
to relatively slow movement of the hand are compensated by a so-
called Height Correction Unit.
Finometer® Model-2 is a novel stationary device for measuring
continuous non-invasive blood pressure and fits in between Portapres
(ambulatory Finapres) and Finometer® Model-1 (refined version of
Finapres with AAMI SP10 accuracy and precision.)
Finometer® Model-2 provides the analog blood pressure waveform in
the same way as Finapres and can be connected to a remote PC to
store the full finger pressure waveform and beat-to-beat derived
parameters on the PC by using the BeatScope® Easy software.
Related publications
This User’s Guide is written for the operator of the Finometer® Model-
2 device. It contains installation and operating instructions, and routine
maintenance procedures. Other documents relevant for a Finometer®
Model-2 user are:

18 Finometer® Model-2 User’s Guide
•Finger Pressure Reference Guide
The reference guide contains background information about the
device, the measurement principles, hints and pitfalls in a finger
blood pressure measurement and a bibliography of finger arterial
pressure measurements.
•BeatScope® Easy User’s Guide
Guide to the PC based BeatScope® Easy recording software
package.
Figure 1.1 The Frontend Unit and ECG cable connectors

Finometer® Model-2 User’s Guide 19
1.3 Quickstart
This chapter describes step by step how to make a first measurement with Finometer®
Model-2 and how to sample an external signal during a finger pressure measurement.
Before you start a first measurement please read the “Warnings, cautions and protective
measures” in chapter 2. Then do the following:
•Connect the power cable at the rear of the Finometer.
•Plug the power cable into a grounded AC power outlet.
•Switch Finometer on, the switch is at the rear. The Starting message will appear on
the LCD display.
•Observe the error message that may show up on the LCD display on Finometer®
Model-2 when the Frontend Unit is not yet connected.
•Take the Finometer Frontend Unit and cable (see Figure 1.2) and
insert the Frontend Unit connector straight into the receptacle at
the Finometer® Model-2 front left, (see Figure 1.1 The Frontend
Unit and ECG cable connectors). The red dot should point upwards.
The connector must go in straight and smoothly and must be
seated firmly and with a click. By pulling smoothly at the cable try
to pull the connector out. This should fail.
•Install BeatScope® Easy onto your laptop or PC.
•Connect the PC to Finometer® Model-2 via the serial I/O port, using the RS232
cable.
•Run the BeatScope® Easy software.
Your system is set up. It is time to turn to your subject.

20 Finometer® Model-2 User’s Guide
Figure 1.2 The Frontend Unit and cable with medium size finger cuff
attached