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PHYSIO-PORT

User Manual Version 2017-11-12

- 5 -

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

Содержание PHYSIO-PORT

Страница 1: ...ory 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 info par berlin com Web http www par...

Страница 2: ...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 Connectio...

Страница 3: ...OAD 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...

Страница 4: ...tenance 47 10 3 1 Safety and Measurement technical check 47 10 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 Stand...

Страница 5: ...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 contr...

Страница 6: ...ices 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...

Страница 7: ...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 o...

Страница 8: ...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 m...

Страница 9: ...ed 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 requireme...

Страница 10: ...erned 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 stand...

Страница 11: ...hange the measurement interval between day and night interval 4 Info button to display the most recently values The following values will be dislayed respectively sytolic value S mmHg diastolic value...

Страница 12: ...measured blood pressure reading to mark this measurement The device confirms the successful marking with 1111 on the LCD display The marking is shown in the value table of the analysis software For ma...

Страница 13: ...t phase has been selceted Time display 4 3 2 The built in clock of the recorder is automatically set at the current PC time A manual change of recorder time is not possible Figure 3 LC Display of the...

Страница 14: ...pacity 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 di...

Страница 15: ...y 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 ful...

Страница 16: ...ro fasteners may lead to incorrect measurements 4 6 Connections Connection of the cuff to the recorder 4 6 1 To connect the blood pressure cuff to the recorder plug the metal connection of the cuff as...

Страница 17: ...art setup exe on the Physioport CD via Windows Explorer CAUTION The program must be installed with Administrator rights The selection menu for the installation language appears on the PC display Later...

Страница 18: ...on folder Click Change to install to a different folder or click Next to install to this default folder Figure 10 Destination Folder Displaying of the installation settings Click Install to begin of t...

Страница 19: ...nish to complete the software installation Figure 12 End of the software installation 5 2 Settings Click Settings to get the configuration of the program Figure 13 Settings The different settings are...

Страница 20: ...lly too Figure 16 Recorder connection This setting allows to start the recorder with or without patient data Figure 17 Enter of patient data The database folder for PHYSIO PORT can be set to another f...

Страница 21: ...ring Medizinische Software for system independent data transfer between medical devices and general practice IT systems The Physioportwin software has an integrated GDT interface Device Data Carrier i...

Страница 22: ...aster data general practice IT system and PHYSIO PORT 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...

Страница 23: ...DT 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 Figure 24 Folder for communication data files Character set Act...

Страница 24: ...made on this tabsheet Figure 27 Setting page for print and export of analysis Print out Set of the default printout pages preview and colored print out Figure 28 Configuration of print out Entered he...

Страница 25: ...e REPORT for print workstation name of workstation slot 1 slot number on the workstation id Patient number last Last name first First name StartTime Start time of the measurement format YYYYMMDDHHMMSS...

Страница 26: ...33 Configuration of parameter Day and night phase Default values can be set Figure 34 Default values for day and night phase Limit values Limit values for day and night phase can be set These limit v...

Страница 27: ...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 loca...

Страница 28: ...der to the PC and switch on the recorder The on off switch is located beneath the lid of the battery compartment The recorder display will show after self test 6 2 Starting the program After the PHYSI...

Страница 29: ...licking on the relevant line Figure 39 Selecting a patient Adding a new patient 6 3 2 If the required patient is not in the database then you can directly enter new patient data To do so open the entr...

Страница 30: ...d 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 m...

Страница 31: ...22 00 05 59 exact every 30 min 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...

Страница 32: ...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 PHYSIO PORT R...

Страница 33: ...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 D...

Страница 34: ...n 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 Af...

Страница 35: ...ant menu The measured values are read from the recorder and stored in the database for the corresponding patient The graphical evaluation of the results is then displayed Figure 43 Main menu Download...

Страница 36: ...e data have been stored in the database You can request the relevant saved measurement results by double clicking on the relevant data in the selection window In order to delete a specific measurement...

Страница 37: ...s 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 indicat...

Страница 38: ...values Default setting JNC 7 AHA ESH and custom Figure 48 Limit values Magnifying glass 8 3 2 The integrated magnifying function is used to display the measured values more precisely A mouse click in...

Страница 39: ...as well as the statistical measurement results for the whole monitoring period according to day and night phase Figure 51 Overview statistics The software calculates dipper non dipper extreme dipper o...

Страница 40: ...an values In order to ensure a clear representation the calculated hourly mean values are only displayed as a graph and a table Comparison 8 3 5 A comparison or a contrasting of two measurement series...

Страница 41: ...Histogram 8 3 6 The histogram presentation of measured values is possible Figure 55 Histogram of the measurered values Pie graphic 8 3 7 The measured values can also be displayed as a pie graphic Figu...

Страница 42: ...Each dot corresponds to one measurement Figure 57 Correlation of blood pressure values 8 4 Additional buttons Findings report 8 4 1 You can create a small report in relation to the findings of the lon...

Страница 43: ...button The size of the printout can be determined on an individual basis You can define a standard format under Settings PDF Export 8 4 3 The PDF Export button creates PDF files from the print pages t...

Страница 44: ...erface 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 CSV Export 8 4 5 The CSV E...

Страница 45: ...tions 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 bu...

Страница 46: ...gent not in the washing machine No fluid should enter the cuff inflation section or the connecting tube Spray disinfection has proved successful after the usage of the cuff Incidin Foam or equivalent...

Страница 47: ...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 valu...

Страница 48: ...device Size available in various sizes Cuff pressure Display operation controls 300 mmHg maximum adjustable Patient display LCD measurement values error codes Operation controls Interfaces Keypad Star...

Страница 49: ...The charging unit now trickle charges the battery to compensate for self discharging The battery temperature is monitored in the charger When the temperature is too high the bar in the battery symbol...

Страница 50: ...32cm Part no A2524 User manual A8135 CD Physioportwin analysis PC Software Part no A8139 13 2 Optional accessories The optional accessories can be ordered from the manufacturer User manual A8135 Conn...

Страница 51: ...n proof P N Product number S N Serial number CE marking according to the Medical Device Directive 93 42 EEC of the European Union The notified body is MEDCERT GmbH Date of manufacture The number found...

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