Envitec PhysioQuant Manuale utente
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 Tel.: +49 - (0) 3841-360-1
Alter Holzhafen 18 Fax: +49 - (0) 3841-360-222
Germany Website: www.envitec.com
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Contents
1GENERAL REMARKS / SYMBOLS 7
2SAFETY INSTRUCTIONS AND USE 8
3INSTALLATION 11
3.1 Software 11
3.2 Settings 14
3.3 Attaching the connecting cable to the recorder 17
3.4 Network installation 18
3.5 GDT interface 18
4PHYSIOQUANT RECORDER 21
4.1 Operation controls 21
4.2 Symbols on the device 22
4.3 LCD display with all symbols and display options 23
4.4 Power supply 23
4.5 Inserting batteries 24
4.6 Function control 25
4.7 Connecting the cuff to the recorder 26
5PHYSIOQUANT CUFFS 26
6COMMENCING LONG-TERM BLOOD PRESSURE MEASUREMENT 27
6.1 Connecting the recorder 27
6.2 Starting the programme 27
6.3 Selecting a patient 28
6.4 Adding a new patient 29
6.5 Editing patient data 29
6.6 Programming the recorder 30
6.7 Attaching the cuff and the recorder 32
6.8 Test measurement 33
6.9 Instructing the patient 34
6.10 Important measurement information 35
6.11 Button functions 36
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7IMPORTING RECORDER DATA AFTER MEASUREMENTS 37
7.1 Connecting the recorder 37
7.2 Starting the programme 37
8ANALYSIS OF MEASUREMENT RESULTS 38
8.1 Starting the programme 38
8.2 Find/delete measurement results 38
8.3 Representation 39
8.4 Overview 40
8.5 Single-value graph 40
8.6 Single-value table 40
8.7 Hourly mean values graph and table 40
8.8 Findings report 40
8.9 Printing 41
8.10 GDT export to general practice IT systems 41
9ERROR CODES 42
10 SCOPE OF DELIVERY 43
11 ACCESSORIES AND SPARE PARTS 43
12 CLEANING AND MAINTENANCE 44
12.1 Cleaning and disinfection of device surface 44
12.2 Cleaning and disinfection of cuffs 44
12.3 Cleaning of tubes 45
12.4 Maintenance and validity check prior to any use 45
12.5 Calibration mode 46
12.6 Disposing of the device 46
13 TECHNICAL INFORMATION 47
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1 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
situation. Failure to observe this warning may
result in injuries and/or damage to the
product.
CAUTION!
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2 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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•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).
CAUTION!
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