Oldelft Benelux Easy DR User manual

User Manual: Easy DR
ODB-100-5070ENG 1 Rev.:17-04-2020
User Manual
Easy DR
Rev.: 17-04-2020
0344

User Manual: Easy DR
ODB-100-5070ENG 2 Rev.:17-04-2020
Blank Page

User Manual: Easy DR
ODB-100-5070ENG 3 Rev.:17-04-2020
List of revisions
Equipment
Easy DR
Document
User Manual
Document number
ODB-100-5070ENG
revision
Date
Comment
01
09-05-2011
First setup F Vijn
02
14-07-2011
Added label position (1.3) and user warning (4.10)
03
31-10-2011
Changed Symbols (page 5 and 6)
Added EMC warning (page 7)
Added Warning Squeezing hazards chapter 3.1 and 4.10
Changed text chapter 4.2 Powering up.
Added separate chapter 5.1 Cleaning.
Changed chapter 5.2 Safety check.
Changed technical specifications (chapter 6)
04
16-10-2012
Changes regarding 60601- 3e edition and text updates
05
31-05-2016
Changed Sedecal interface to CPI interface
Added detailed power on/off instructions.
Updated collimator info.
06
29-09-2016
List with manuals delivered with the Easy DR
Add Harmony3-ST Docking
07
02-03-2017
Correction telephone- and faxnumber
08
07-09-2018
Add Variant 183cm arm/correction environment conditions
/correction WEEE symbol
09
17-04-2020
Add Lateral positioning arm (option)

User Manual: Easy DR
ODB-100-5070ENG 4 Rev.:17-04-2020
Oldelft Benelux offices
Head Office
The Netherlands
Oldelft Benelux B.V.
Wiltonstraat 41
3905 KW VEENENDAAL
Tel. [phone]
Fax. [phone]
E-mail: in[email protected]
Internet: http://www.oldelftbenelux.nl

User Manual: Easy DR
ODB-100-5070ENG 5 Rev.:17-04-2020
Preface
Identification
Manuals are identified by a part number.
The part number is printed at the bottom of the title page. Numbers printed on
other pages are for internal revision control and may differ.
CE Classification
Manuals made for products that have been CE (Conformité Européenne) marked
have the CE mark on the front page. The number behind the CE Mark defines the
responsible notified body.
Oldelft Benelux B.V. systems are classified according to IEC 60601-1 as Class I,
type B. Oldelft Benelux B.V. systems meet the relevant provisions of the European
Medical Device Directive 93/42/EEC; this is based on conformity of the products
and the quality system according to ISO 13485:2016.
Symbols
Symbol
Meaning
Remarks
Location: Near or on
the type identification
plate.
Symbol for separated collection of
electrical and electronic equipment
per Directive 2002/96 of the
European Parliament and the
Council of the European Union
(Directive on Waste of Electrical
and Electronic Equipment - WEEE).
If applicable to the type of device,
it indicates legally imposed
obligations within EU member
states, Iceland, Norway and
Switzerland when the equipment is
disposed of, at the end of its life-
time.
Owners of marked equipment
should contact the organization that
imported the equipment into their
country, when they want to dispose
of the equipment, at the end of its
lifetime. The Directive prioritizes re-
use of equipment over re-use of
components over re-use of
materials over disposal as waste.
Article 5 part 2d allows producers to
decline the return of any used
equipment that is or may be
biologically or radiologically
contaminated.
Legal manufacturer

User Manual: Easy DR
ODB-100-5070ENG 6 Rev.:17-04-2020
Date of manufacture
Serial number
This mark indicated that this is a
Type B Applied Part according to
EN60601-1. This unit can be
installed in the patient
environment.
Caution: Consult Instructions for
Use
Consulting the accompanying
documents is advised.
Consulting the accompanying
documents is a mandatory action.
General warning sign
Placed together with a
supplementary symbol or text. The
text associated shall be an
affirmative statement (i.e., a safety
notice) describing the principal
risk(s) foreseen (e.g. “Causes
burns”, “Risk of explosion”, etc.).
0344
The CE Mark is a declaration by the
manufacturer that the product
complies with the requirements of
the applicable European Union (EU)
medical device directive and that
the product has been subject to
conformity assessment procedures
as provided in that directive.
The number behind the CE Mark
defines the responsible notified
body.

User Manual: Easy DR
ODB-100-5070ENG 7 Rev.:17-04-2020
Conventions
The Easy DR has been designed to meet all safety requirements applicable to
medical equipment. However, anyone using the Easy DR must be fully aware of
potential safety hazards. The information contained in this chapter is provided to
help users to operate the Ease DR safely.
Throughout this manual certain conventions are used. These are Warnings,
Cautions and Notes. They provide a means of prioritizing information to be brought
to the attention of the user. They are given as follows:
WARNING:
Indication of an important warning that is to be obeyed to
eliminate the risk of personal injury or an incorrect clinical
diagnosis.
CAUTION:
Indication of important information to avoid serious system
equipment damage.
Note:
Additional information for reader understanding or
simplification of a task.
Precautions
The user is expected to use the product (soft and hardware) in accordance with
the instructions given in this manual, which must be read before the system is
used. Any unauthorized deviation from the procedures laid down in this manual
can affect the contractual obligations between purchaser and vendor.
WARNING:
This product was designed and manufactured to ensure
maximum safety of use. It should be installed and serviced
in strict compliance with safety instructions described in
this Document.
WARNING:
Never attempt a shortcut to procedures which may degrade
the safety considerations of the system.
WARNING:
Class 1 MD: To avoid the risk of electric shock, this
equipment must only be connected to a supply mains with
protective earth.
WARNING:
The user shall take care that potentional electromagnetic
or other interferences between the unit and other
equipment is avoided. If necessary certain actions must be
taken.
WARNING:
Only trained and qualified personal are allowed to operate
the Easy DR system.

User Manual: Easy DR
ODB-100-5070ENG 8 Rev.:17-04-2020
WARNING:
Do not modify any part of Oldelft Benelux supplied
hardware, software or software configuration. Any
modification, installation or running an application that has
not explicitly been approved by Oldelft Benelux may
compromise patient safety and will result in termination of
all warranty and service contracts.
a. If this equipment is modified, repaired or
maintained, appropriate inspection and testing must
be conducted to ensure continued safe use of the
equipment.
b. Do not leave problems unattended that may affect
the safety of the product. In case you have doubts
concerning the Easy DR‘s save operation, call the
service number of your vender for further
instructions.
c. The Easy DR should be cleaned regular to prevent
the accumulation of dust. The contact surface should
be cleaned after each patient for hygienic reasons.
WARNING:
The Oldelft Benelux products are designed for use and
maintenance using only parts available from Oldelft
Benelux. No liability for failure can be accepted by Oldelft
Benelux through the use of parts obtained from other
suppliers unless written permission is obtained from
Oldelft Benelux.
Copyright
All rights reserved. No part of this manual may be reproduced or
transmitted in any form whatsoever, including photocopying and
recording without written permission of the copyright holder:
Oldelft Benelux B.V., Wiltonstraat 41, 3961 KW VEENENDAAL, The
Netherlands.
Concerning this Publication
Information contained in this publication is subject to change
without notice. Whenever the equipment is delivered with a
documentation medium such as a CD or DVD, the user shall
always check the medium for latest information. This information
is part of Release Notes and Document Upgrade files.
Neither Oldelft Benelux B.V. and its subsidiaries nor anyone else
who has been involved with the development, production or
delivery of the documentation be liable for any special, incidental
or consequential damages, whether based upon breach of
warranty, breach of contract, negligence, strict liability in tort or
any other legal theory.
This manual was originally drafted in the English language.

User Manual: Easy DR
ODB-100-5070ENG 9 Rev.:17-04-2020
1Introduction..................................................................... 10
1.1 Variants ........................................................................... 10
1.2 About this manual.............................................................. 10
1.3 Classification..................................................................... 10
1.4 Installation ....................................................................... 11
1.5 Technical description .......................................................... 11
1.6 Label and symbols ............................................................. 12
1.7 Reference manuals ............................................................ 12
1.8 General description/indications for use .................................. 13
1.9 Physical description............................................................ 15
1.10 Functional description......................................................... 18
2Safety devices .................................................................. 21
2.1 General safety................................................................... 21
2.2 System safety ................................................................... 22
3Operating controls ........................................................... 23
3.1 Hand control ..................................................................... 23
3.2 X-ray generator control panel .............................................. 24
3.3 Collimator controls............................................................. 25
3.4 The user interface of control computer .................................. 26
4Operating instructions ..................................................... 27
4.1 Releasing the shipping locks ................................................ 27
4.2 Powering up...................................................................... 27
4.3 Switching off, applying the shipping locks .............................. 29
4.4 Entering patient and exposure related data............................ 31
4.5 Patient data entry .............................................................. 32
4.6 Protocol selection............................................................... 34
4.7 Changing exposure settings................................................. 34
4.8 Making an exposure ........................................................... 35
4.9 Making a pa thorax X-ray.................................................... 36
4.10 Reviewing images .............................................................. 38
5Maintenance..................................................................... 40
5.1 Cleaning........................................................................... 40
5.2 Safety switch check............................................................ 40
5.3 Troubleshooting................................................................. 40
5.4 Sending images afterwards ................................................. 42
5.5 Calibrate .......................................................................... 43
5.6 Calibration procedure ......................................................... 43
5.7 Troubleshooting after calibration procedure............................ 47
6Technical specifications ................................................... 48

User Manual: Easy DR
ODB-100-5070ENG 10 Rev.:17-04-2020
1 Introduction
1.1 Variants
The Easy DR is produced in two variants:
Easy DR
FDD
Rotation
Use
1
145cm
0⁰~ -90⁰
Chest screening
Multipurpose
2
183cm
Non-rotation
Chest screening
FDD = Focus Detector Distance (distance between Focal spot of X-ray tube to
the detector)
Note:
This manual is based on the variant 1.
When the Easy DR is Variant 2:
the 145cm have to be substituted by 183cm;
rotation of the arm is not possible and can be skipped.
Al other functions are similar as variant 1.
1.2 About this manual
This user manual is a guide for the operator of the Easy DR multifunctional X-
ray unit. In this manual it is assumed that the operator is a professional and
trained X-ray user, who has gained sufficient knowledge to operate Easy DR
system safely.
In particular this document describes the daily operation and interpretation of
the user interface for the Easy DR. It also contains:
•A brief description of the Easy DR system
•System safety
•Operating procedures
•User maintenance procedures
Please study this manual carefully before attempting to use the Easy DR.
Proper functioning of the apparatus can be guaranteed only if the instructions
in this manual are adhered to.
1.3 Classification
The system is classified according to Class 1 type B.
The system meets the relevant provisions of the European
Medical Device Directive 93/42/EEC.