zebris PDM Operating instructions

zebris Medical GmbH
REF 79010135
Text-Release: 03/01/2019
Measuring System for
Pressure Distribution Measurement
PDM/PDM mobile
Specifications
and Operating Instructions

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PDM/PDM mobile Technical Data and Operating Instructions
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Inhalt
1INTRODUCTION.............................................................................................................................4
1.1 MANUFACTURER INFORMATION......................................................................................................4
1.2 STRUCTURE OF THE PDM SYSTEM USER MANUAL...........................................................................5
1.3 SYMBOLS USED ............................................................................................................................6
2SAFETY ..........................................................................................................................................7
2.1 ENVIRONMENTAL CONDITIONS........................................................................................................7
2.2 STORAGE AND TRANSPORT............................................................................................................7
2.3 USER OBLIGATIONS......................................................................................................................8
2.4 GENERAL SAFETY INSTRUCTIONS...................................................................................................9
3PRODUCT DESCRIPTION...........................................................................................................10
3.1 SYSTEM COMPONENTS ................................................................................................................10
3.2 TECHNICAL SPECIFICATIONS.........................................................................................................10
3.2.1 PDM Sensor..............................................................................................................................10
3.2.2 PDM-Platform Types.................................................................................................................11
3.3 CONTROLS AND CONNECTORS.....................................................................................................13
3.4 STATUS INDICATOR LED..............................................................................................................14
3.5 ZEBRIS SYNC.............................................................................................................................15
3.5.1 Specification SYNC Interface....................................................................................................15
3.5.2 Synchronization of Video Recordings.......................................................................................16
3.5.3 Infrared synchronization with zebris DAB-Bluetooth (EMG).....................................................17
3.5.4 Connection of two PDM-L Platforms (Inter-PDM IR-SYNC).....................................................18
4VIDEO-MODUL.............................................................................................................................19
4.1 SYNCCAM .................................................................................................................................19
4.2 SYNCLIGHTCAM ........................................................................................................................20
4.3 LED VIDEO LIGHTS (SYNCLIGHT /SYNCLIGHT PLUS).................................................................23
4.3.1 SYNCLight ................................................................................................................................24
4.3.2 SYNCLight plus.........................................................................................................................25
4.3.3 Power Supply Unit SYNCLights................................................................................................26
4.4 REPLACEMENT PARTS PDM SYSTEM...........................................................................................28
4.5 ACCESSOIRES PDM-SYSTEM ......................................................................................................28
5OPERATION OF THE PDM SYSTEM..........................................................................................30
5.1 SET UP THE MEASURING SYSTEM .................................................................................................30
5.2 CONNECTION OF THE MEASURING SYSTEM TO MAINS SUPPLY.........................................................31
5.3 ANSCHLUSS AN DEN PC...............................................................................................................33
5.4 INSTALLING THE ZEBRIS FDM SOFTWARE .....................................................................................33
5.5 CLOSING THE SAFETY LOCK OF THE PLUG TRAY.............................................................................34
5.6 CONNECTION OF THE PLATFORM VIA BLUETOOTH INTERFACE (MOBILE ONLY)..................................35
5.7 SWITCH THE PDM PLATFORM ON/OFF........................................................................................36
5.8 CHARGING THE BATTERY (PDM MOBILE ONLY)..............................................................................36
5.9 SETTING THE SYSTEM OUT OF OPERATION ....................................................................................36
5.10 RECOMMENDATIONS FOR RECORDING DATA..................................................................................37
5.10.1 Walking range.......................................................................................................................37
5.10.2 Data recording ......................................................................................................................37
5.10.3 Gait velocity ..........................................................................................................................37
5.10.4 Posture..................................................................................................................................37
5.10.5 Acrosclerosis ........................................................................................................................37
6CONTROL MEASURES, PREPARATION, DISPOSAL ..............................................................38
6.1 MANDATORY PERIODIC INSPECTIONS............................................................................................38
6.2 CHECKING THE PDM PLATFORM..................................................................................................39
6.2.1 Control measures......................................................................................................................39
6.2.2 Calibration measures................................................................................................................39
6.3 TROUBLESHOOTING.....................................................................................................................40

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6.4 CLEANING AND DISINFECTION.......................................................................................................41
6.4.1 Cleaning....................................................................................................................................41
6.4.2 Manual Disinfection...................................................................................................................41
6.5 DISPOSAL ...................................................................................................................................42
6.5.1 Packaging .................................................................................................................................42
6.5.2 Disposal of electronics..............................................................................................................42

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1 Introduction
© 2019 zebris Medical GmbH
All rights reserved. Reproduction in whole or in part only with the express permission of
zebris Medical GmbH.
Illustrations of this manual may differ.
1.1 Manufacturer Information
Manufacturer
zebris Medical GmbH Phone [phone] - 0
Am Galgenbühl 14 Fax [phone] - 50
88316 Isny im Allgäu E-Mail [email protected]
Germany Web www.zebris.de
Sales / Support
zebris Medical GmbH Phone [phone] - 300
Am Galgenbühl 14 Fax [phone] - 50
88316 Isny im Allgäu E-Mail [email protected]
Germany Web www.zebris.de
Please always provide the serial number of the product for inquiries!
NOTE
In order to facilitate the readability of the text, further on instead of
PDM/PDM mobile the term PDM-System is used. Nevertheless, if
not noted otherwise, all information is valid for both versions.

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1.2 Structure of the PDM System user manual
The measuring system PDM consists of the force distribution measuring sensor technolo-
gy as well as the corresponding application software including a PC.
Therefore, the user manual of the PDM measuring system consists of several parts:
Part 1 - PDM technical specifications and user manual
Part 2 - User manual for the zebris FDM application software
Part 3 - User manual of the accessories, like e.g. projector or PC
NOTE
Please closely observe the user manuals with initial operation,
use or maintenance as well as transport of the PDM measuring
system.
Part 1 - PDM technical specifications and user manual primarily contains information on
technical data and the operation of the PDM pressure distribution measuring sensor tech-
nology as well as on their safe operation.
WARNING
The precise adherence to the instructions in all sections of the oper-
ating Instructions for the measuring system is a precondition for its
intended use.

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1.3 Symbols Used
The green markings in the margin of the User Manual denote
new information about the product safety.
WARNING symbols indicate a potential hazard to the health and
safety of the users and/or patients. The warnings describe the
risks involved and those can be avoided.
NOTE symbols indicate a potential risk which could lead to
damaging of the device. These NOTE symbols describe the
risks involved and how those can be avoided.
CE mark according to EC Directives 2014/30/EEC and
2014/35/EEC (Low Voltage Directive and EMC Directive).
Manufacturer
Symbol for the connection of the external power supply unit.
USB-Interface
HF-transmitter (Bluetooth-Interface)
This symbol shows that pursuant to the Directive on Waste Elec-
trical and Electronic
Devices (2012/19/EU) and national legislation, a product cannot
be disposed of via the household waste
Refer to instructions for use.
Item Number
Serial Number

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2 Safety
2.1 Environmental conditions
PDM Measuring Systems are suitable for application in dry interiors with level ground such
as those in hospitals, doctors' surgeries and laboratories.
Temperature 10°C to 40°C
Relative humidity 30% to 70%, non condensing
Air pressure 700 to 1100 hPa
WARNING
PDM systems must NOT be operated in wet zones, wet rooms
(swimming pools, saunas) or climatic chambers.
Direct contact with liquids must always be avoided, as the measur-
ing system is not protected against the entering of liquids. Liquids
entering the device can cause fire, electrical shock or other severe
accidents.
The PDM system is NOT specified for the operation in vacuum, hy-
perbaric or altitude chambers.
The measuring systems are not intended for operation in potentially
explosive atmospheres of medically used rooms or oxygen-enriched
atmospheres.
The devices must not be operated in proximity to e.g. engines or
transformers with a high connected load as well as mains current
lines, as electrical or magnetic interference fields can falsify correct
measurements resp. turn them impossible.
2.2 Storage and Transport
Storage and transport of the measuring system are only to be effected in the original
packaging provided by zebris.
Temperature -20°C to +70°C
Relative humidity max. 95%, non condensing
Protect from moisture

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2.3 User Obligations
The relevant, general guidelines and/or national laws, national regulations and technical
rules for the commissioning and the operation of measuring systems must be applied
and fulfilled corresponding to the indicated purpose of the zebris product.
Users are obliged to:
Observe all safety guidelines of the user manual.
Carry out any inspection and maintenance works on a regular basis as stipulated in
the user manual.
Only use work equipment that is free of defects.
Check the functional safety and the proper condition of the device before operating.
Make all user manuals that are included in delivery and part of the measuring sys-
tem accessible to all users at all times and keep the manuals in close proximity of
the measuring system.
Protect him-/herself, the patient or third parties against dangers.
Avoid a contamination through the product.
When using the system, national legal regulations must be observed, in particular:
The valid industrial safety regulations.
The valid accident prevention.
For the safety, reliability and performance of the components delivered by zebris, re-
sponsibility is assumed, if:
Assembly, extensions, re-settings, changes or repairs were carried out through
zebris or third parties authorised by zebris, trained technicians or employees of au-
thorised dealers. Storage and transport are only to be effected in the original pack-
aging delivered by the manufacturer.
The device is operated in accordance with the user manual.
In case of repair, the regulations of the VDE 0751-1 “Recurrent test and test before
commissioning of medical electrical equipment –general regulations” are fully com-
plied with.
The components of information technology provided by the operator correspond to
the technical requirements of hard and software included in this user manual and
also were installed and set up according to the relevant descriptions in this user
manual.
The set-up room corresponds to the given environmental conditions of the measur-
ing system and the valid installation regulations.
The PDM system including accessories is connected to the mains socket with a pro-
tective grounding conductor and is operated with the correct mains voltage.
Exclusively the software provided by zebris as well as the components and acces-
sory parts listed in this user manual are used together with the system.

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2.4 General safety instructions
The application and operation of the system and also the evaluation of the measuring
data and their interpretation may only be carried out by trained qualified personnel. The
manufacturer assumes no liability for any injury to persons, damage to property, or loss
of data due to improper use of the software, the device or its component parts.
Measuring data may only be copied, moved, or deleted using the data-base function
provided by the zebris application programs. In the case of data being changed inten-
tionally without using the database functions, the user alone bears full responsibility for
all risks involved.
Should there be any detectable damage to the device or component parts, they should
be returned to the manufacturer for a safety check. It is not permissible to continue us-
ing the device or its component parts, as severe damage and serious injuries - even le-
thal injuries - may result. The manufacturer or authorized sales partner must always be
contacted in all cases of fault or doubt.
If any fluids should penetrate the device, it is mandatory for the device to undergo a
technical safety test. Damaged plug connectors and leads are to be replaced by an au-
thorized service technician. The device must be put out of operation immediately,
marked as "Not working“ and prevented from being used by removing the mains cable.
The measuring system must be checked at regular intervals to make sure it is function-
ing properly. More details on this can be found in the section, "Maintenance of the De-
vice" in this User Manual
Be sure that all the mains and connection cables are laid safely and that they are pro-
tected against stepping on, so that nobody can trip over them. Check all the cables and
the connection plug regularly for any damage. Damaged power supplies and cables
have to be replaced before further operation
Never try to service the measuring system in any other way as described in the provid-
ed user manual. When removing the covers, you may expose yourself to lethal voltages
or other risks.
We also point out that if any changes are made to this certified device or its accessories
without the prior written consent of zebris, your legal right to operate the device will be
nullified.

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3 Product description
3.1 System components
In its basic configuration the PDM measuring system consists of the following components:
PDM platform
Netzteil
USB Cable (Type A/mini-B, 3 m length)
Application software zebris FDM
Windows compatible computer or notebook
User Manual for PDM Platform, accessories and zebris FDM software
3.2 Technical specifications
3.2.1 PDM Sensor
The sensors of the different PDM system only vary in size of the measuring area, the
number of single sensors included in the sensor module and the supported sampling fre-
quency.
All other technical data is identical:
Interfaces USB
Bluetooth (optional)
Synchronization input/output (optional)
Video synchronization
Infrared synchronization (optional)
Inter-PDM synchronization (PDM-L only)
Connection Interface box in bottom of housing frame
Measuring principle capacitive pressure distribution measure-
ment
Operating voltage 16-18V DC
Power consumption max. 60W (depends on type)
Power supply (external power supply unit) 100-230V AC / 50-60Hz
Measuring Range 1-120N/cm2
Accuracy of the calibrated measuring range (1-120N/cm2) ±5% (FS)
Mechanical crosstalk -25dB
Pressure threshold 1N/cm²