PAR PHYSIO-PORT User manual

User manual
PHYSIO-PORT
Ambulatory Blood Pressure Monitor (ABPM)
Version 2017-11-12
PAR Medizintechnik GmbH & Co. KG
Sachsendamm 6
10829 Berlin
Germany
- 0482
Tel.:
+49 30/ 2350700
Fax:
+49 30/2138542
E-Mail:
[e-mail]
Web:
http: www.par-berlin.com
Printed in Germany

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Contents
1. GENERAL INFORMATION............................................................................................................................- 6 -
1.1 To this manual................................................................................................................................................................- 6 -
1.2 Confirmity.......................................................................................................................................................................- 6 -
1.3 Identifier..........................................................................................................................................................................- 6 -
2. INTENDED USE:............................................................................................................................................- 8 -
2.1 Oscillometric Measurement Method.............................................................................................................................- 8 -
2.2 Biocompatibility..............................................................................................................................................................- 9 -
2.3 Standards ........................................................................................................................................................................- 9 -
3. SAFETY INSTRUCTION AN USE................................................................................................................- 10 -
4. PHYSIO-PORT RECORDER ...................................................................................................................................- 11 -
4.1 Operations controls .......................................................................................................................................................- 11 -
4.2 Button functions ...........................................................................................................................................................- 12 -
4.3 LCD display..................................................................................................................................................................- 13 -
Displayed symbols..................................................................................................................................................- 13 -4.3.1
Time display...........................................................................................................................................................- 13 -4.3.2
Functional control...................................................................................................................................................- 13 -4.3.3
4.4 Power supply.................................................................................................................................................................- 15 -
General...................................................................................................................................................................- 15 -4.4.1
Inserting batteries ...................................................................................................................................................- 15 -4.4.2
4.5 PHYSIO-PORT Cuffs..................................................................................................................................................- 16 -
4.6 Connections...................................................................................................................................................................- 16 -
Connection of the cuff to the recorder....................................................................................................................- 16 -4.6.1
The connection cable to the recorder......................................................................................................................- 16 -4.6.2
5. SOFTWARE INSTALLATION......................................................................................................................- 17 -
5.1 PC software Physioportwin .........................................................................................................................................- 17 -
5.2 Settings..........................................................................................................................................................................- 19 -
System....................................................................................................................................................................- 20 -5.2.1
GDT interface.........................................................................................................................................................- 21 -5.2.2
Print/Export............................................................................................................................................................- 24 -5.2.3
Parameter................................................................................................................................................................- 26 -5.2.4
5.3 Network Installation.....................................................................................................................................................- 27 -
6. COMMENCING LONG TERM BLOOD PRESSURE MEASUREMENT.......................................................- 28 -

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6.1 Connecting the recorder ..............................................................................................................................................- 28 -
6.2 Starting the program....................................................................................................................................................- 28 -
6.3 Selecting a patient.........................................................................................................................................................- 29 -
Known patient ........................................................................................................................................................- 29 -6.3.1
Adding a new patient..............................................................................................................................................- 29 -6.3.2
Editing patient data.................................................................................................................................................- 29 -6.3.3
6.4 Programming recorder................................................................................................................................................- 30 -
6.5 Attaching the cuff.........................................................................................................................................................- 32 -
6.6 Attaching the belt .........................................................................................................................................................- 32 -
6.7Test measurement.........................................................................................................................................................- 32 -
6.8 Instructing the patient..................................................................................................................................................- 33 -
6.9 Important measurement information.........................................................................................................................- 34 -
7. DOWNLOAD ................................................................................................................................................- 34 -
7.1 Connecting the recorder ..............................................................................................................................................- 34 -
7.2 Start program...............................................................................................................................................................- 35 -
8. ANALYSE.....................................................................................................................................................- 35 -
8.1 Start program...............................................................................................................................................................- 35 -
8.2 Find/delete measurement results.................................................................................................................................- 36 -
8.3 Representations ............................................................................................................................................................- 37 -
Single values...........................................................................................................................................................- 37 -8.3.1
Magnifying glass....................................................................................................................................................- 38 -8.3.2
Overview / statistics ...............................................................................................................................................- 39 -8.3.3
Hourly mean values................................................................................................................................................- 40 -8.3.4
Comparison ............................................................................................................................................................- 40 -8.3.5
Histogram...............................................................................................................................................................- 41 -8.3.6
Pie graphic..............................................................................................................................................................- 41 -8.3.7
Correlation..............................................................................................................................................................- 42 -8.3.8
8.4 Additional buttons........................................................................................................................................................- 42 -
Findings report .......................................................................................................................................................- 42 -8.4.1
Print........................................................................................................................................................................- 43 -8.4.2
PDF-Export ............................................................................................................................................................- 43 -8.4.3
GDT -Export to general practice IT system............................................................................................................- 44 -8.4.4
CSV-Export............................................................................................................................................................- 44 -8.4.5
9. ERROR CODES...............................................................................................................................................45
10. CLEANING AND MAINTENANCE...................................................................................................................46
10.1 Cleaning and disinfection of device surface.....................................................................................................................46

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10.2 Cleaning and disinfection of cuffs ....................................................................................................................................46
10.3 Functional check, Maintenance, STC and MTC.............................................................................................................47
Functional check, Maintenance...................................................................................................................................4710.3.1
Safety- and Measurement- technical check .................................................................................................................4710.3.2
10.4 Calibration mode...............................................................................................................................................................47
10.5 Disposing of the device......................................................................................................................................................47
11. TECHNICAL INFORMATION...........................................................................................................................48
12. CHARGER........................................................................................................................................................49
13. DELIVERY OVERVIEW....................................................................................................................................50
13.1 Standard delivery..............................................................................................................................................................50
13.2 Optional accessories ..........................................................................................................................................................50
14.EXPLANATION OF SIGNS AND SYMBOLS...................................................................................................51
14.1 Symbols used on the equipment .......................................................................................................................................51
14.2 Symbols used on the display .............................................................................................................................................51

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EU Declaration of Conformity
PAR Medizintechnik GmbH & Co. KG, Sachsendamm 6, 10829 Berlin
We declare that the medical device
PHYSIO-PORT, Hardware-Version HW E, Firmware-Version FW 3.0
(Including system-components and accessories)
is in conformity with the Medical Device Directive 93/42/EEC
Including amendment 2007/47/EC.
The medical device is defined as class IIa devices in accordance to annex IX of the Medical
Device Directive. It is marked with
CE-0482
The medical device is designed, produced and verified under control of a quality system in
accordance to EN ISO 13485:2012 + AC:2012 and annex II of the Medical Device Directive.
The conformity of the quality system is certificated by:
MEDCERT Zertifizierungs- und Prüfungsgesellschaft für die Medizin GmbH
Pilatuspool 2
20355 Hamburg
Germany
Berlin, August 17, 2017
PAR Medizintechnik GmbH & Co. KG
Dipl.-Ing. L. Engel
Technical Manager

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1. General Information
1.1 To this manual
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 PAR Medizintechnik
GmbH & Co. KG.
1.2 Confirmity
The product PHYSIO-PORT bears the CE marking CE-0482 (notified body MEDCERT GmbH) indicating
its compliance with the provisions of the Council Directive 93/42/EEC about medical devices (including
amendment 2007/47/EC) and fulfills the essential requirements of Annex I of this directive. It has an
internal power source and is an MDD class IIa device.
1.3 Identifier
The device has an application part of the type 'BF'.
The product fulfills the requirements of the standard EN/IEC 60601-1 "Medical Electrical Equipment,
Part 1: General Requirements for Basic Safety and Essential Performance" as well as the electromagnetic
immunity requirements of the standard EN/IEC 60601-1-2 " Medical electrical equipment –Collateral
standard: Electromagnetic compatibility –Requirements and tests" and applicable amendments.
This symbol means:
Please consult the manual. It refers to things to which you should pay careful attention when using the
device. This manual is an integral part of the equipment. It should be available to the equipment
operator at all times. Close observance of the information given in the manual is a prerequisite for
proper equipment performance and correct operation and ensures patient and operator safety. Please
note that information pertinent to several chapters is given only once. Therefore, carefully read the
manual once in its entirety.

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This manual reflects the equipment specifications and applicable safety standards valid at the time of
printing.
All rights are reserved for devices, circuits, techniques, software programs, and names appearing in this
manual.
The quality assurance system used by PAR Medizintechnik GmbH & Co. KG in all the company facilities
complies with standard EN ISO 13485.
The safety instructions in this manual are indicated in the following way:
CAUTION
This refers to a potentially dangerous
situation failure to observe this warning may
result in injuries and/or damage to the
product.
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 PAR Medizintechnik GmbH & Co. KG.
No warranty claims can be made in the event of any damage as a result of using other inappropriate
accessories and consumable materials.
PAR Medizintechnik GmbH & Co. KG 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 PAR
Medizintechnik GmbH & Co. KG, or at locations that have been expressly authorized by PAR
Medizintechnik GmbH & Co. KG to carry out such repairs;
- Devices that have been used in accordance with their manuals.

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2. Intended use:
PHYSIO-PORT are handy, patient-carried (long-term) blood pressure monitors for the measurement of
non-invasive blood pressure. The devices work with the innovative technology of the upward blood
pressure measurement (‘IMT’), which considerably reduces the duration of the individual measurement
compared to conventional blood pressure measuring devices. This greatly improves patient comfort.
The switchover to the conventional mode, which operates by means of blood pressure measurement
during the gradual release of the cuff pressure (down-measuring), is possible without problems during
programming. PHYSIO-PORT can be used with adults, children and small children with their respective
cuffs. The devices can carry out blood pressure measurements at different intervals for up to 48 hours
(max. 400 individual measurements) and store the measurement results.
.
Notes on foreseeable misuse
PHYSIO-PORT must not be used for newborn babies and is not suitable for use in Intensive Care Units.
During a long-term blood pressure measurement, the instructions for the safety and functional reliability
of the device must be observed.
The sensors should remain attached to the body over the entire period, according to the instructions of
the medical personnel performing them.
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.
2.1 Oscillometric Measurement Method
The blood pressure is measured by the oscillometric method. The criteria for this method are the
pressure pulsations superimposed with every systole on the air pressure in the cuff. In order to measure
the blood pressure, a blood pressure cuff wrapped around the upper arm needs to be inflated and
subsequently deflated. The blood pressure is determined either during deflation of the cuff (deflation
measurement method) or, by using a novel and faster technology, already during inflation of the cuff
(inflation measurement method). The deflation measurement method is the most common method
used. With this technique, the cuff is inflated to a pressure which must be clearly above the expected
systolic value. Including cuff inflation, the measurement typically takes approx. 40 seconds (Figure A).
The inflation measurement method is a novel method based on the "Inflation Measurement
Technology (IMT)" developed by PAR Medizintechnik. With this innovative technique, the cuff is inflated
to a pressure just above the expected systolic value. Once the systolic value is determined, the cuff can
immediately and quickly be deflated (Figure B).
The measurement typically takes only approx. 20 seconds. If disturbances occur during measurements
with the inflation measurement method, which may be due to motion artifacts, for example, PHYSIO-
PORT will automatically switch to the deflation measurement method and complete the blood pressure
measurement.

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With both methods, a pressure transducer measures the cuff pressure as well as the superimposed
pressure pulsations. During blood pressure measurements, the cuff must be at heart level. If this is not
ensured, the hydrostatic pressure of the liquid column in the blood vessels will lead to incorrect results.
When the patient is sitting or standing during measurements, the cuff is automatically at the correct
level.
2.2 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 PAR Medizintechnik GmbH & Co.
KG or one of its representatives.
2.3 Standards
93/42/EC
89/336/EEC
EN 1060-1
EN 1060-3
DIN EN 60601-1
DIN EN 80601-2-30
Figure A: Waveform representing the pressure in the
cuff during a measurement using the deflation
measurement method.
Figure B: Waveform representing the pressure in the
cuff during a measurement using the inflation
measurement method.

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3. Safety Instruction an Use
Danger
• Risk of explosion •
The equipment is not designed for use in areas
where an explosion hazard may occur. Explosion
hazards may result from the use of flammable
anesthetic
mixtures with air or with oxygen, nitrous
oxide (N2O), skin cleansing agents, or
disinfectants.
CAUTION
• Rist to persons, Equipment damage •
Equipment may be connected to other equipment
or to parts of systems only when it has been made
certain that there is no danger to the patient, the
operators, or the environment as a result. In those
instances where there is any element of doubt
concerning the safety of connected equipment, the
user must contact the manufacturers concerned or
other informed experts as to whether there is any
possible danger to the patient, the operator, or
the environment as a result of the proposed
combination of equipment. Compliance with the
standard IEC 60601-1 must always be ensured.
PHYSIO-PORT may be connected to a PC with the
Physioportwin program. While
connected to any of these devices, PHYSIO-PORT
must be disconnected from the patient.
Before using the equipment, the operator must
ascertain that it is in correct working order and
operating condition.
CAUTION
• Rist to persons, Equipment damage •
The operator must be trained in the use of the
equipment.
Only persons who are trained in the use of medical
technical equipment and are capable of applying
it properly are authorized to apply such
equipment.
There are no user-replaceable components inside
the equipment. Do not open the housing.
For service or repair, please contact your local,
authorized dealer.