PhysioQuant

Ambulatory Blood Pressure System

User-Manual

ENVITEC

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User-Manual
PhysioQuant Ambulatory Blood Pressure System

The greatest care has been taken in preparing this manual. However, if you still
come across any incorrect details in this manual when using the system, then
please contact us. This will allow us to correct any errors as soon as possible.
The information and images contained in this manual are subject to any
changes that may result from optical or technological developments
All trademarks stated and used in the text are the property of the present owner
and are protected by law.
All reproduction, translation and duplication in any shape or form including
extracts require the written approval of the manufacturer.
This manual is subject to updates by EnviteC-Wismar GmbH.
Doc.No.:

45-07-0500002-a

2004 Envitec Wismar GmbH

(Printed in Germany)

Envitec Wismar GmbH

Alter Holzhafen 18
23966 Wismar
Germany

Tel.:
Fax:
Email:
Website:

+49 - (0) 3841-360-1

+49 - (0) 3841-360-222
[email protected]
www.envitec.com

3 / 48

4 / 48

Contents

GENERAL REMARKS / SYMBOLS

SAFETY INSTRUCTIONS AND USE

INSTALLATION
3.1
3.2
3.3
3.4
3.5

11

Software
Settings
Attaching the connecting cable to the recorder
Network installation
GDT interface

11
14
17
18
18

PHYSIOQUANT RECORDER
4.1
4.2
4.3
4.4
4.5
4.6
4.7

21

Operation controls
Symbols on the device
LCD display with all symbols and display options
Power supply
Inserting batteries
Function control
Connecting the cuff to the recorder

21
22
23
23
24
25
26

PHYSIOQUANT CUFFS

26

COMMENCING LONG-TERM BLOOD PRESSURE MEASUREMENT

27

6.1
6.2
6.3
6.4
6.5
6.6
6.7
6.8
6.9
6.10
6.11

Connecting the recorder

Starting the programme
Selecting a patient
Adding a new patient
Editing patient data
Programming the recorder
Attaching the cuff and the recorder
Test measurement
Instructing the patient
Important measurement information
Button functions

27
27
28
29
29
30
32
33
34
35
36

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IMPORTING RECORDER DATA AFTER MEASUREMENTS

7.1 Connecting the recorder
7.2 Starting the programme

ANALYSIS OF MEASUREMENT RESULTS

8.1
8.2
8.3
8.4
8.5
8.6
8.7
8.8
8.9
8.10

Starting the programme

Find/delete measurement results
Representation
Overview
Single-value graph
Single-value table
Hourly mean values graph and table
Findings report
Printing
GDT export to general practice IT systems

37
37
37
38
38
38
39
40
40
40
40
40
41
41

ERROR CODES

42

10

SCOPE OF DELIVERY

43

11

ACCESSORIES AND SPARE PARTS

43

12

CLEANING AND MAINTENANCE

44

12.1
12.2
12.3
12.4
12.5
12.6
13

Cleaning and disinfection of device surface

Cleaning and disinfection of cuffs
Cleaning of tubes
Maintenance and validity check prior to any use
Calibration mode
Disposing of the device

TECHNICAL INFORMATION

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44
44
45
45
46
46
47

General Remarks / Symbols

This symbol means: please consult the
manual. It refers to things to which you
should pay careful attention when using the
device.

The safety instructions in this manual are indicated in the following

way:

This refers to a potentially dangerous

CAUTION!

situation. Failure to observe this warning may

result in injuries and/or damage to the
product.

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Safety Instructions and Use

The product PhysioQuant carries the CE mark CE-0123 in accordance

with European Council Directive 93/42/EEC in relation to medical devices
and complies with the fundamental requirements stated in Appendix I of
this Directive. The device has an internal power source and comes within
Class IIa (MDD).

The device has an application part of the type 'BF'.

Standard EN 60601-1 'Medical electrical equipment, Part 1: General

Requirements for Safety' is complied with, as well as the immunity
requirements of standard EN 60601-1-2 'Electromagnetic Compatibility Medical Electrical Equipment'.

The device is interference-free in accordance with EN 55011 - Class B.

The CE mark only includes those components described in the delivery

overview.

This manual forms part of the device. It should always be kept near to the
device. Correctly observing the manual ensures that the device will be
used in an appropriate manner and for the purpose it is intended. It will
also ensure the health and safety of users and patients dependent on it.

Please read through the whole manual carefully, since information that is
relevant to several sections is only provided once.

The printed text of this manual is in accordance with the version of the
device, as well as the relevant safety instructions standards, at the time
that this manual was printed. All industrial property rights are reserved in
relation to any devices, circuits, processes, software programs and names
described in this manual.

The quality assurance system used by EnviteC-Wismar GmbH in all the

company facilities complies with standards EN ISO 9001 and EN ISO
13485.

In order to ensure the highest level of safety for patients and a minimum of
interference, as well as keeping in line with the relevant testing precision
level, the device should only be used in combination with original
accessories provided by EnviteC-Wismar GmbH.

No warranty claims can be made in the event of any damage as a result of

using other inappropriate accessories and consumable materials.

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EnviteC will only assume responsibility for devices in relation to their

safety, reliability and functioning in the following cases:

Assembly, enhancements, resettings, alterations and repairs carried

out by EnviteC, or at locations that have been expressly authorised by
EnviteC to carry out such repairs;

Devices that have been used in accordance with their manuals.

Intended use:
PhysioQuant is a manually-operated blood pressure measuring device,
carried by the patient for long-term measurement of non-invasive blood
pressure. It can be used for adults, children and infants by applying the
corresponding cuffs. PhysioQuant must not be used for newborn babies
and is not suitable for use in Intensive Care Units. PhysioQuant can be
used to take blood pressure measurements at various intervals for up to 30
hours and is able to store measurement results.

Biocompatibility:
The product components described in this manual, including accessories,
which when used for their intended purpose come into contact with
patients, have been explained in such a way that they conform to the
biocompatibility requirements of the relevant standard when used for their
intended purpose. If you have any questions in this regard, then please
contact EnviteC-Wismar GmbH or one of its representatives.

Cleaning:
No fluid should enter the device. If any fluid has entered the device, then it
should only be used again after having been checked and approved by the
Service Department.

Only clean the PhysioQuant Recorder when it is not connected to another

device.

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CAUTION!

The device is not suitable for use in areas where explosions may occur.
Such areas may appear as a result of using inflammable anaesthetics, skin
cleaning and skin disinfection products.

The device should only be used together, or in combination with

components of other equipment, when you have ensured that this
connection does not adversely affect the health and safety of patients and
users, or the environment.

If the information provided with the device is not clear on how to make a
safe connection that will ensure the health and safety of patients, users, as
well as the environment, then please contact the manufacturer or consult a
technical expert. At all times, observe standard IEC 60601-1-1.

The PhysioQuant Recorder can be connected to, and operated from, a PC

on which PhysioQuantWin software has been installed. Please note that
no patient should be connected to the PhysioQuant Recorder as long as it
is connected to the PC.

Before using the device on a patient, the user should check that the device
functions safely and as intended.

Users must be familiar with how to operate the device.

Medico-technical devices should only be used by suitably-qualified or

experienced persons, who can ensure that the device is used correctly.

The device does not contain any components that need to be replaced by
users. Never open the casing of the device (please contact the Service
Department).

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3
3.1

Installation
Software

Put the PhysioQuant CD in your CD-ROM drive.

The installation wizard appears:

Confirm that you are to start the installation by clicking on [Next]

and follow the on-screen instructions.

If the 'Auto start Function' of your CD-ROM drive is activated, then

installation will begin automatically. If not:
- Open Windows Explorer, select your CD-ROM-drive and
double click on setup.exe.

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Enter your name and that of your practice and confirm with [Next].

The programme will normally be installed under your standard program

directory. You can change this location via [Browse].

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All settings are summarised before installation commences. After

confirming with [Next], the copy and installation process begins.

Once the installation has been completed, the PhysioQuant programme

starts automatically and the required settings can be selected.

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3.2

Settings
After the programme has started, the main screen will be displayed.
To configure the software, click on the 'Settings' icon to open the Settings
menu:

Settings menu:

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SYSTEM:

Setting the serial PC interface, to which the PhysioQuant Recorder

will be connected:
This displays all
serial interfaces of
the system.

Setting / changing the folder for the database

(also see 3.4 Network installation, page 18)
Selecting another
folder for the
database.

Setting language, date and time format:

CRITICAL VALUES:

Setting the critical values for day phase and night phase:

These critical values will be displayed as lines in the graphic

representation of the analysis and will be part of the statistical
calculations.

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PRINT:

Activate print
preview.

Selecting standard
print pages.

Headings that
should be included
with every printout.

GDT:
The description of the GDT interface and the required settings can be
found in Section 3.5 GDT interface,18.

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3.3

Attaching the connecting cable to the recorder

In order to start the recorder and read information from it, the recorder
must be connected to the PC via a special connecting cable.
This special connecting cable is connected to a free serial interface of
the PC ('COM x') via the 9-pin DSB port.
If the recorder only has a USB connection, then the connection can also
be made by using one of the commercially available USB-to-serial
converters.
Please contact your specialist dealer for more information.
The cable also needs to be plugged into the 6-pin, black port, which is
located at the back of the casing of the device. Please ensure that the
plug is in the right position when connecting it ('nose' up):

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3.4

Network installation
The PhysioQuantWin software can be used in networks. This allows for
central storage of patient information and measurements (i.e. on the
server). This information can then be accessed from all workstations.
To this end, a corresponding directory is first created on the central
server. This folder must be connected as a 'drive' on all workstations.
A local programme installation is then carried out on all workstations that
will use the PhysioQuant software (as described in Section 3 Installation,
page 11).
The folder for the shared database is then created under [Settings],
whereby selection is facilitated by the integrated Explorer functionality:

3.5

GDT interface
The GDT interface is a standard produced by the German Quality
Assurance Medical Software (QMS 'Qualittsring Medizinische
Software') for system-independent data transfer between medical
devices and general practice IT systems.
The PhysioQuantWin software has an integrated GDT interface ('Device
Data Carrier interface' 'Gerte-Daten-Trger') and therefore allows for
easy data transfer with a general practice IT system.
Please contact your general practice IT dealer to find out what the
correct settings of the GDT interface are in relation to the relevant IT
system.
All standard settings in the GDT standard (Version 2.0) can be adjusted
on an individual basis.

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Operation
This setting activates and deactivates the GDT interface.
When the GDT interface is activated, the software will check during the
start of the programme whether the defined GDT data is available and
processes it. If no data is found, then a 'normal' programme start will take
place.
Note: During GDT operation, the option for manually adding new
patients should not be active, so as to avoid any incorrect
input or non-corresponding patient master data (general
practice IT system and PhysioQuant database).
Identification
The ID is a unique identifier that consists of a minimum of 1 and a
maximum of 8 characters, which uniquely identifies the PhysioQuant
system during GDT data transfer.

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File names
The file names that are used for the communication between general
practice IT systems and PhysioQuant software should be entered in the
'File names' field.
File names consists of a device identification code (1 - 4 characters),
e.g. PHYQ, and a EDP identification code (1 - 4 characters) for the
general practice IT systems, e.g. EDP1.
Both these identification codes are then used to create file names, which
will always have the extension *.GDT.

Directory for communication data files

The data transfer folder can be created where you want. In order to avoid
any networks errors, a separate folder should be created for each
individual work station (e.g. on a local PC).
NB: GDT data files will need to be read and then
deleted by the general practice IT system, before
any further GDT data files can be generated.

Data transfer
Prior selection will determine which data is transferred to general practice
IT system.
Example Short summary (one line)
LZBDM: Day 108/ 67/ 78 -

Night 0/

0/ 78 = -100/-100/-100 %

Example Table
24 h BPM

Day phase

Night phase

06:00-21:59

22:00-05:59

Difference
Day/Night phase

Mean values:

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Ps[mmHg

108

-100%

Pd[mmHg

67

-100%

HR[P/min

78

-100%

4
4.1

PhysioQuant Recorder
Operation controls

5
2

Cuff connection

Start/Stop button to delete additional measurements and to

interrupt a measurement in process.

Info button to display the most recently measured values. The

following values will be displayed respectively:
- Systolic value
'S/mmHg'
- Diastolic value
'D/mmHg'
- Pulse frequency
'HR/min-1'.

Day/Night button to change the measurement interval between

day and night interval.

LCD display to display all information.

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6
7

On/Off switch

Battery compartment lid

Connecting port for PC connecting cable

4.2

Symbols on the device

Warning, please observe the manual

Data export / data import

Application part type BF (defibrillation-proof)

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4.3

LCD display with all symbols and display options

4.4

Flashes for every detected oscillation

Flashes when batteries are running out

Day phase has been selected

Night phase has been selected

Displayed constantly when measurement data has

been stored

Continuous display when batteries are empty and no

measurements can be made

Power supply
The PhysioQuant Recorder requires either two nickel metal hydride
rechargeable batteries, or two alkaline batteries.
When starting the recorder via the PhysioQuantWin software, please
ensure that the relevant power source has been selected (see 6.6
Programming the recorder, page 30)
In addition, the device also has a built-in lithium cell to indicate the time.
The capacity of two fully-charged rechargeable batteries or two new
batteries ensures at least 30 hours of operation or 200 measurements.

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Battery capacity reduces in line with increased use. If the capacity of the
two fully-charged rechargeable batteries clearly falls below 24 operating
hours, then you need to replace them.
Always insert two fully-charged rechargeable batteries or two new
batteries, before taking a new measurement.

4.5

Inserting batteries
The battery compartment is located on the underside of the recorder.
In order to open this compartment, use your thumb to move the battery
compartment lid approx. 6 mm backwards and then remove the lid in an
upward direction:

Please ensure that the batteries are inserted correctly!

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4.6

Function control

The PhysioQuant recorder will automatically carry out a self-test when it

is switched on, which will activate all symbols and segments of the LCD
display.
The device will then check the inserted (rechargeable) batteries and will
display the available capacity.
In this context, e.g. 'C100' refers to a 100% (rechargeable) battery
capacity (fully charged) and 'C50' refers to a 50% (rechargeable) battery
capacity (half empty).
In order to carry out a 24 hour measurement, the capacity needs to be at
least 90%.
If the capacity is below 90%, then you will need to insert new batteries or
fully-charged rechargeable batteries.
When the self-test has been completed successfully, the following
information will appear on the display after the power supply test:

The actual time

The measurement phase (day/night)
Whether any measurement data has been stored

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4.7

Connecting the cuff to the recorder

To connect the blood pressure cuff to the recorder, plug the metal
connection of the cuff as far as possible into the connection point at the
recorder, until it clearly clicks into place.
The cuff can be removed again from the recorder by pulling back the
external metal plug cover.

PhysioQuant Cuffs
Various cuff sizes are available for the PhysioQuant (standard, large and
children size).
Please select the correct cuff size (see printed text on the cuff)
Cuffs that are too small will result in measurements that are too
high. Cuffs that are too large will result in measurements that are
too low.
Replace the cuffs at regular intervals. Damaged Velcro fasteners
may lead to incorrect measurements.

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6
6.1

Commencing Long-Term Blood Pressure Measurement

Connecting the recorder
Connect the PhysioQuant Recorder to the PC (see 3.3 Attaching the
connecting cable to the recorder,17) and switch on the recorder.
The on/off switch is located beneath the lid of the battery compartment.
(see 4 PhysioQuant Recorder
No. 6, page 21)

The recorder display will show

6.2

PC

>
>
>

Starting the programme

After the PhysioQuant software has started, the main screen appears.
To programme the recorder, click on the 'Start' tab to open the relevant
menu:

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6.3

Selecting a patient
The selection window of the patient database appears:

In the 'NAME' field, enter the first letter of the patient's surname. All
patients whose names start with this letter will then be displayed (e.g.
those beginning with P ):

Select the required patient, by double clicking on the relevant line.

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6.4

Adding a new patient

If the required patient is not in the database, then you can directly enter
new patient data.
To do so, open the entry screen with the [NEW] button. Enter all the
required data and save it to the database with [Save]:

6.5

Editing patient data

Patient data that has been entered can be edited and updated at any
time ([Edit] button in the Patient selection window).
EXCEPTION:

Patient ID cannot be changed once it has

been entered and saved!

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6.6

Programming the recorder

After you have selected the patient, a window will appear for configuring
and programming the PhysioQuant Recorder.

Number of measurement intervals

Up to 4 different measurement intervals can be selected. The standard
setting is at 2 intervals (day and night phase).
Power supply
The type (normal battery or rechargeable battery) that is used for longterm measurements is set.
From ... To ...
The beginning and end of selected intervals can be set in minutes.
Measurement interval
Exact:
measurements are taken at the exact intervals in minutes that
have been set.
Approx.: measurements randomly vary at approx. +/- 2 minutes around
the times set.
Minutes
The interval between subsequent measurements can be programmed to
range between 2 and 90 minutes.

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Max. pump pressure

Limits the max. cuff pressure to the value set between 200 mmHg and
280 mmHg.
The number of all programmed measurements will be displayed for each
measurement interval and a summary is provided for each 24 hours.
The [Standard] button will reset the parameters to the following values:
2 measurement intervals
Interval 1 (day phase):
06:00 - 21:59
Exact
Interval 2 (night phase):
22:00 - 05:59
Exact

every 15 min.

250 mmHg

every 30 min.

250 mmHg

After saving the selected configuration, the starting sequence of the

recorder will commence by clicking on the [Start] button.
The recorder will first check whether there are any previous
measurements that have not yet been read. If this is the case, then a
warning will be displayed.
If this is not the case, then the recorder will be switched off and the new
patient data and measurement intervals are stored in the recorder.

NB:
Only when a new long-term measurement is started, will the recorder
delete all old patient data and measurement values.

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6.7

Attaching the cuff and the recorder

CAUTION!

The PhysioQuant Recorder must not

be connected to a PC, while it is being
attached to the patient.

Please remove the connecting cable to the PC.

Attach the cuff to the arm that is less used by the patients. For adults:
approx. 2 finger widths above the elbow. For children: slightly closer to
the elbow. Ensure that the cuff does not rise up when the arm is being
bent.

Please ensure that:

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the connecting tube points upwards to the shoulder

the side of the cuff with 'Patient' written on it makes contact with
the skin
the arrow lies over both the arteria brachialis and arteria femoralis
the cuff is attached tightly and closely surrounds the tissue, but
exerts no pressure on the veins

Switch on the PhysioQuant Recorder and place it in the carrier bag.

Use the belt to attach the bag to the body of the patient. For hygienic
reasons, the bag should not come into direct contact with the skin.
Place the cuff tube around the patient's neck in order to release any
strain and connect it to the PhysioQuant (see
4.7 Connecting the cuff to the recorder, page 26).
Ensure that the tube cannot become disconnected while the
measurement is being taken.

6.8

Test measurement
A test measurement must always be carried out after the cuff has been
attached and the recorder connected.
In order to avoid any incorrect measurements, please ensure that the
patient remains calm while the measurement is being taken. The patient
may stand up or sit down.
Begin the measurement by pressing:

After a brief moment, the device will inflate the cuff. Once the required
inflation pressure has been reached, the device will gradually decrease
the pressure. Cuff pressures are displayed and for every detected
oscillation the letter 'M' will be displayed. Once the measurement has
been taken, the following information is displayed sequentially:

Systolic value (S/mmHg)

Diastolic value (D/mmHg)
Pulse rate (HR/min-1)

If an error message is displayed instead of the measurement value, e.g.

'E 08' (insufficient recognition of oscillation), then attach the cuff more
firmly and press the Start/Stop button again.
If the test measurement has been successful, then the device is ready for
automatic measurement.

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6.9

Instructing the patient

Explain to the patient how the device works (automatic blood pressure
measurement at regular intervals) and make the following points:

Stay calm during the measurement, so that there will be no

incorrect readings as a result of any movement by the patient;

During the night, it is best to place the PhysioQuant Recorder in its

carrier bag on the bedside table;

It is possible to manually switch between the day phase and the

night phase;

Record any unusual events in the patient diary (master copy on

CD) and also carry out an additional measurement with the
Start/Stop button if this happens;

At any time, measurement can be interrupted via the Start/Stop

button. Cuff pressure will then decrease;

Do not open the battery compartment.

Important guidelines for patients:

CAUTION!

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Cancel the measurement with the Start/Stop button, if the cuff

remains inflated for more than approx. 2 minutes;

Take off the cuff if it remains inflated after pressing the Start/Stop
button. It may be that the tube has been disconnected;

Further measurements should only be carried out after the cuff has
been correctly attached again.

6.10 Important measurement information

For the first measurement, the device will inflate the cuff to approx. 160
mmHg (starting pressure). For subsequent measurements, the inflation
pressure will be 25 mmHg above the last measured systolic value
(minimum 120mmHg).
If the measurement value is in excess of the inflation pressure, then
additional inflation of 50 mmHg will take place.
A manual measurement can be taken at any time between automatic
measurements. This will be indicated by '+' in the measurement value
table.
After an incorrect measurement, the measurement will be repeated after
2 minutes. An error message is only displayed in the error table with its
corresponding error code after 3 incorrect measurements.
After the error messages 'E04' (Empty battery/rechargeable battery),
'E07' (Inflation time finished) and 'E10' (200 measurements carried out),
the measurement will not be repeated. After error message 'E07', the
subsequent measurement will again take place according to the selected
measurement cycle.
After error messages 'E04' and 'E10' have been displayed, the device will
switch to a power-saving mode, in order to avoid complete discharge of
the rechargeable batteries. This mode can only be cancelled by
switching the device on and off.

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6.11 Button functions

Recorder buttons have the following functions during long-term blood
pressure measurements:

is used too begin and end a measurement.

is used to display the most recent measured values or

the most recent error message.

is used to manually switch the measurement intervals

from the day to night phase, and vice versa.

Note:
You can only manually switch between day and night phase when 2
measurement intervals only have been programmed via the
PhysioQuantWin software when the starting sequence of the recorder
was commenced.
If more or less measurement intervals have been programmed, then the
Day/Night button has no effect on the measurement intervals.

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7
7.1

Importing Recorder Data after Measurements

Connecting the recorder
Connect the PhysioQuant Recorder to the PC (see 3.3 Attaching the
connecting cable to the recorder,17) and switch on the recorder.

The recorder display will show

7.2

PC

>
>
>

Starting the programme

After the PhysioQuant software has started , the main screen appears.
To import data from the recorder, click on the [Import] tab to open the
relevant menu:

The measurement values are imported from the recorder and assigned
to the relevant patient.
The graphical representation of the measurement results is also
displayed (see 8.5 Single-value graph, page 40).

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Analysis of Measurement Results

8.1

Starting the programme

After the PhysioQuant software has started, the main screen appears.
To request saved measurement results, click on the [Analysis] tab to
open the relevant menu:

8.2

Find/delete measurement results

The selection window of the patient database is displayed. Select the
required patient (see 6.3 Selecting a patient, page 28).
The measurement result selection window appears for those patients
whose data have been stored in the database.

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You can request the relevant saved measurement results by double

clicking on the relevant data in the selection window.
Deleting measurement results
In order to delete a specific measurement result from the database, you
need to click on the relevant date line in the selection window (the line
will appear in blue). Then click on [Delete]. After a confirmation message
appears, the result will be deleted.

8.3

Representation
The saved measurement values can be represented in various ways, by
clicking on the relevant tabs.

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8.4

Overview
The overview displays a numerical summary of the long-term blood
pressure measurements, as well as the statistical measurement results,
for the whole monitoring period, according to day and night phase.

8.5

Single-value graph
This graph displays the results of all individual measurements. The set
critical values for the day and the night phase (see 3.2 Settings, page 14)
are displayed as red lines.

8.6

Single-value table
All measurement results are listed by date/time, systole, diastole, heart
rate and mean pressure.
Additional measurements (that have been carried out manually by using
the Start/Stop button) are displayed behind the time indication and
marked with the '+' symbol.
Deleting individual measurements
In order to delete individual measurements, you need to click on the
relevant line (the line will appear in blue). Then click on [Delete]. After a
confirmation message appears, the measurement will be deleted.

8.7

Hourly mean values graph and table

In order to ensure a clear representation, the calculated hourly mean
values are only displayed as a graph and a table.

8.8

Findings report
You can create a small report in relation to the findings of the long-term
blood pressure measurements. This text will be summarised and can
when activated also be forwarded to the general practice IT system.

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8.9

Printing
You can print every page displaying measurement results by using the
[Printing] button.
The size of the printout can be determined on an individual basis. You
can define a standard format under 'Settings' (see 3.2 Settings, page
14).

The integrated printing preview allows you to view the selected pages
prior to printing.

8.10 GDT export to general practice IT systems

If the PhysioQuant software of the general practice IT system interface
has been activated, you can then create a GDT file in accordance with
the selected settings by using the [GDT export] tab, which will be saved
in the configured directory.

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Error codes

E 03

Internal hardware error (contact the Service Department).

E 04

Batteries are empty. This is displayed as soon as the batteries have

insufficient capacity to carry out measurements.

E 05

Measurement time has elapsed. This is displayed when measurement

time (without inflation time) exceeds 60 seconds.

E 06

This error code will be displayed when:

the actual cuff pressure exceeds the maximum allowable inflation

pressure of 280 mmHg;

the device is not inflating beyond the set maximum pressure and is
waiting for the next measurement time.
E 07

The maximum inflation time of 60 seconds has elapsed. Error refers to

a loose cuff or tube, or another faultysealing.

E 08

Insufficient oscillations have been detected:

At least 8 oscillations need to be detected for a correct measurement.
The cuff should be attached sufficiently tightly (you should be able to
put one finger beneath the cuff, but not two). PhysioQuant will regulate
the deflation rate for follow-up measurements accordingly.

E 10

Memory full. 200 blood pressure measurements have been carried out
and the memory of the device is full.

E 11

Movement during diastole recognition.

E 12

Diastole is outside of the measurement range.

E 20

Systole is outside of the measurement range.

(E12 and E20 are displayed when the calculated systole or diastole
values are outside the range in which the oscillations are recorded.)

E 21

Systole is below the measurement range.

E 22

Systole is above the measurement range.

E 24

Difference between systole and diastole is too small (10 mmHg or less)

E 23

Movement during systole recognition.

Air deflation speed is too high, e.g. as a result of leakage.

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10

Scope of Delivery
PhysioQuant System

45-00-0501

Includes:
PhysioQuant, standard adult blood pressure cuff, PhysioQuantWin
software, interface cable, carrier bag, belt and manual.
PhysioQuant Recorder

45-00-0502

Includes:
PhysioQuant, standard adult blood pressure cuff, carrier bag, belt and
manual.

11

Accessories and Spare Parts

Standard cuff Adult

45-00-0509

Large cuff Adult

45-00-0510

Cuff Child

45-00-0511

Interface cable

45-00-0515

Bag

45-00-0513

Belt

45-00-0512

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12

Cleaning and Maintenance

12.1 Cleaning and disinfection of device surface

CAUTION!

Danger of electric shock

Always disconnect the device from your PC
before cleaning it.

Switch off the PhysioQuant Recorder.

Use only a moist cloth and ensure that no fluid enters the device.
The most commonly used cleaning and disinfection agents in
practices and clinics can be used.

CAUTION!

Damage to the device

Do NOT use any disinfection agents that
contain phenol and peroxide for disinfecting
the surface of the device!
If any fluid has entered the device, then it
should only be used again after having been
checked and approved by the Service
Department.

12.2 Cleaning and disinfection of cuffs

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Light stains can be removed by using a moist cloth.

For heavier stains, rinse the cuff with soapsuds or disinfected

cleaning agent (not in the washing machine!). No fluid should enter
the cuff inflation section or the connecting tube (therefore please
remove the inflation section when cleaning the cuff).

After you have cleaned the cuff, you need to rinse it thoroughly
with water and let it dry at room temperature for approx. 15 hours.

You can also use any of the following to disinfect the device:
isopropyl alcohol 70%, ethanol 70%, Microzid; Burazon liquid,
Sporicidin or Cidex. After you have disinfected the cuff, rinse it
thoroughly with water and leave it to dry at room temperature.

12.3 Cleaning of tubes

Remove the tube from the device.

Rub the tubes with a moist cloth (soapsuds). NEVER dip the tube
into any fluid.

12.4 Maintenance and validity check prior to any use

Prior to using the device, manually check the device for any
mechanical damage.

If you notice any damage or functional errors, which may endanger

the safety of the patient and user of the device, then you should
only use the device again after it has been repaired.

Measurement technical check

The PhysioQuant is a measuring device in accordance with the German
'Medical Device Code - Operation V' ('MP Betrieb V') 11/ Appendix 2.
As a result, the device must undergo a 'measurement technical check'
every 2 years. The first of these checks should take place on the date
indicated on the calibration mark.

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12.5 Calibration mode

, To check for example for any leakages in the pneumatic cycle, the
PhysioQuant Recorder can be switched into a calibration mode:

Connect the pump ball over the T-piece between the supplying
tube and cuff.

Roll up the cuff tightly.

Switch the device off and on quickly.

Wait until the display shows the time.

Press the INFO button 3 times: the display shows an internal

value, which should be between 25 and 100.
If the displayed value is outside this range, then the PhysioQuant
Recorder must be sent away for maintenance.

Press the Start/Stop button:

The display shows '0' (current pressure in mmHg).
Create a test pressure of 200 mmHg and measure the decrease in
pressure after waiting a minimum of 30 seconds.
(Decreases in pressure of 35 mmHg are normal. Decreases in
pressure > 6 mmHg indicate the presence of an unacceptable
leakage. In such an event, the PhysioQuant Recorder will need to
be sent away for repair).

You can exit the calibration mode by pressing the Start/Stop

button.

12.6 Disposing of the device

At the end of its useful life, you need to dispose of the device described
in this manual, including all its accessories, in accordance with the
disposal regulations for devices of this type.
If you have any questions in relation to disposal, then please contact
EnviteC-Wismar GmbH or one of its representatives.

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13

Technical Information

Measurement
Measurement method
Measurement duration
Data preservation
Measurement intervals
Capacity

oscillometric
30 45 sec. (depends on patient)
unlimited
2 90 min., programmable
200 measurements or 30 hours

Measurement range
Systole
Diastole
Heart rate

60 260 mmHg
40 220 mmHg
35 240 beats/min.

Cuff
Connection
Size

Metal locking device

available in various sizes

Cuff pressure
Display/operation controls
Patient display
Operation controls
Interfaces
PC connection
Other
Dimensions (L x W x H)
Weight
Operating temperature
Rel. humidity
Air pressure
Power supply

300 mmHg maximum, adjustable

LCD (measurement values, error codes)
Keypad (Start/Stop, Day/Night, Info)
digital interface (RS-232) / USB via
adapter
10.5 cm x 8.0 cm x 2.7 cm
190 g (incl. batteries)
+10 to +40
30 - 75 % (non-condensing)
700 - 1060 hPa
2 batteries (type Mignon AA, alkaline)
2 NiMH rechargeable batteries (type Mignon
AA, 1500 mAh)

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ENVITEC
Envitec Wismar GmbH
Alter Holzhafen 18
23966 Wismar, Germany
Tel.:
+49-(0)-3841-360-1
Fax:
+49-(0)-3841-360-222
Email: [email protected]
Website: www.envitec.com

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