SHT - 37 - 102 - 001 - 01 - E Chapter 01 Safety Regulation Compact Series Service Manual

Service Manual ddRCompact™ Series
Chapter 1: Safety Regulations
Safety Regulations
Caution: US Federal Law restricts this device to use by or on the

order of a physician.
Mise en garde: Les lois fédérales des États-Unis limitent l'utilisation

de cet appareil à un médecin ou à un tiers agissant
sur son ordre.
Revision Date By Reason for Change
01 2009-02-10 SRCH / WOL First Official Release
This document is the English original version, edited and supplied by Swissray Medical AG.
All rights reserved by Swissray Medical AG.
2009-02-10 / WOL SHT_37_102_001_01_E 1/25

TABLE OF CONTENTS
Section Page
1 Safety Regulations ................................................................................... 3

1.1 Safety ......................................................................................................... 3
1.2 Electrical Safety.......................................................................................... 5
1.3 Mechanical Safety ...................................................................................... 5
1.4 Radiation Protection ................................................................................... 6
1.5 Laser Protection ......................................................................................... 7
1.6 Software & Data Protection ........................................................................ 8
1.7 Magnetic Risk............................................................................................. 9
1.8 Disposal...................................................................................................... 9
1.9 Labeling ddRCompact™ .......................................................................... 10
1.9.1 ddR System ......................................................................................................... 10
1.9.1.1 Machine Nameplate ...........................................................................................................10
1.9.1.2 Detector HD-3000™...........................................................................................................10
1.9.1.3 Monitor eXpert™3000 ........................................................................................................11
1.9.1.4 Workstation (IPS) ...............................................................................................................11
1.9.1.5 Measuring Chamber...........................................................................................................11
1.9.1.6 Anti Scatter Grid .................................................................................................................12
1.9.1.7 Mobile Patient Table IGS 500M / IGS 1500 .......................................................................12
1.9.2 X-Ray HV Generator............................................................................................ 13
1.9.2.1 Main Label & Firmware ......................................................................................................13
1.9.2.2 Input Voltage ......................................................................................................................14
1.9.2.3 Tank & Cabinet...................................................................................................................14
1.9.3 Collimator............................................................................................................. 15
1.9.4 X-Ray Tube.......................................................................................................... 16
1.9.5 Warning Labels .................................................................................................... 17
1.9.5.1 Electrical Warning Labels...................................................................................................17
1.9.5.2 Mechanical Warning Labels ...............................................................................................17
1.9.5.3 Radiation Warning Labels ..................................................................................................19
1.9.5.4 Laser Warning Labels ........................................................................................................21
1.9.5.5 Magnetic Warning Labels...................................................................................................21
1.10 Conformity ................................................................................................ 22
1.11 Software Copyright................................................................................... 22
1.12 Normal Use .............................................................................................. 23
1.13 Electromagnetic Compatibility (EMC) ....................................................... 24
1.14 Use of the User Manual............................................................................ 25
1.14.1 Symbols and their Meaning ................................................................................. 25
1.14.2 For your Information............................................................................................. 25
2009-02-10 / WOL SHT_37_102_001_01_E 2/25

1 Safety Regulations
This service manual describes the use of the ddRCompact™, the

SwissVision® XG for ddRCompact™, the eXpert™3000 and the X-ray HV generator.
1.1 Safety
This service manual is meant to allow you to work safely with the X-ray equipment
described there in. You may only use the X-ray equipment in compliance with the
safety instructions in this service manual and not for purposes other than those for
which it is intended. Only authorized and properly trained service and operating
personal are allowed to work with this X-ray equipment.
Do not use the X-ray equipment, if it has any electrical,

mechanical or radiation defects!
CAUTION
This applies particularly to faults in indicators, displays,
warnings and alarms!
N'utilisez pas l'équipement radiologique si ce dernier
présente des défaillances électriques, mécaniques ou
MISE EN radiologiques!
GARDE Cela s'applique particulièrement aux défaillances des
indicateurs, des affichages, des avertissements et des
alarmes!
If you operate the X-ray equipment incorrectly or fail to have maintenance carried out
properly, Swissray cannot be held liable for any malfunctions, damages or injuries.
This X-ray equipment shall only be used in compliance with the regulations of the
ministry of health institutions of the local government.
In the United States, Federal law restricts this device to be used by or on the order of
a physician.
As any technical equipment, this X-ray equipment requires not only correct operation
but also regular, competent maintenance and care, which are described in chapter
„Maintenance”.
Swissray will only assume responsibility for the safety features of its products, if
Swissray or authorized Swissray agents acting on explicit authorization by Swissray,
perform maintenance, repairs and modifications.
2009-02-10 / WOL SHT_37_102_001_01_E 3/25

Safety circuits must neither be removed nor modified.
You may only remove or open parts of the housing, if you are instructed to do so by
the service manual.
If you wish to connect the X-ray equipment to other equipment, components or

assemblies, and if it is not apparent from the technical data, whether it can be safely
combined with such equipment, components or assemblies, you must consult the
respective manufacturers or an expert to ensure that the safety of the patient,
operating staff and the environment is not affected by the intended combination.
• Do not place the remote control, where it can be

accidentally engaged!
• Do only use one remote control per room. Any spare
CAUTION
remote control(s) should be stored in a safe and locked
place!
• Do not put foreign materials on the remote control!
• Ne placez pas la télécommande à un endroit où elle
pourrait être actionnée par inadvertance!
MISE EN • Utilisez une seule télécommande par pièce. Les
GARDE télécommandes non utilisées doivent être conservées
dans un endroit sûr et verrouillé!
• Ne posez aucun objet étrangers sur la télécommande!
2009-02-10 / WOL SHT_37_102_001_01_E 4/25

1.2 Electrical Safety
The ddRCompact™ meets the safety class I (type of protection against electric
shock) and type B (level of protection against electric shock) according to
IEC / EN 60601-1 (Clause 5), UL 60601-1, CSA C22.2 No.601.1-M90.
This X-ray equipment may only be operated in medical rooms, which fulfill IEC / EN
standards and local requirements.
Only trained maintenance staff is allowed to remove the covers from the X-ray tube
and the high-voltage generator.
This X-ray equipment may not be operated in areas where

CAUTION
there is an explosion hazard!
MISE EN Cet équipement radiologique ne doit pas être utilisé dans

GARDE les zones où il existe un risque d'explosion!
Detergents and disinfectants, including those used on patients, can create explosive
mixtures of gases. Please observe all relevant regulations.
The X-ray equipment is not suitable for use in the presence of a FLAMMABLE
ANAESTHETIC MIXTURE WITH OXYGEN or NITROUS OXIDE.
1.3 Mechanical Safety
The X-ray equipment is prepared for installation in accordance with environmental

specifications. During installation, the X-ray equipment will be programmed by the
service engineers to prevent possible collisions with the ceiling, walls or floor.
Collisions are only possible with objects, which are free-moving in the X-ray room like
mobile patient tables.
There is a risk of injury from the movement of mechanical parts when the patient,
operator, or clothing is in too close proximity to moving parts.
Please ensure that the patient and operator maintain a safe

distance from the radius of movement of the X-ray
CAUTION equipment!
Remove all objects from the radius of movement of the
X-ray equipment!
Veuillez vous assurer que le patient et l'opérateur
conservent une distance de sécurité par rapport au rayon
MISE EN
de déplacement de l'équipement radiologique!
GARDE
Retirez tous les objets du rayon de déplacement de
l'équipement radiologique!
2009-02-10 / WOL SHT_37_102_001_01_E 5/25

1.4 Radiation Protection
The use of conventional X-ray application with X-ray tube

positions out of detector, Swissray Medical AG is not
CAUTION
responsible for X-ray protection (incl. room condition) and
parameter application (parameter, doserates)!
Swissray Medical AG décline toute responsabilité
concernant les mesures de protection contre les
MISE EN rayonnements (environnement de la pièce inclus) ainsi que
GARDE les paramètres et doses choisis pour l’application du
système de radiologie conventionnel avec le tube orienté
hors du champ du détecteur!
Ensure before each X-ray exposure that all the necessary

CAUTION
radiation precautions have been taken!
Assurez-vous que toutes les précautions nécessaires ont

MISE EN
été prises contre les rayonnements avant chaque
GARDE
exposition radiologique!
The ddRCompact™ is delivered with preset exposure dose

rate and imaging algorithm parameters!
CAUTION These parameters shall not be modified without clearance
from the manufacturer Swissray Medical AG CH-6280
Hochdorf Switzerland!
Le ddRCompact™ est fourni avec des paramètres
prédéfinis pour le dosage de l'exposition et les algorithmes
MISE EN
d'imagerie!
GARDE
Ces paramètres ne doivent pas être modifiés sans l'accord
de Swissray Medical AG CH-6280 Hochdorf Suisse!
When using X-ray radiation, the staff in the examination room must observe the
applicable radiation protection regulations. Please observe the following rules:
- To protect the patient against radiation, always use radiation protection

accessories in addition to devices that are mounted on the X-ray equipment (e.g.
diaphragm, spacer, filter).
- Always use the smallest X-ray field collimation that is possible.
- Wear protective clothing. A radiation protection apron with a lead equivalent to
0.35 mm reduces X-ray radiation at 50 kV by 99.05 %, and at 100 kV by 94.5 %
(DIN 6813).
- Distance is the most effective radiation protection. Keep as large a distance as
possible away from the object exposed and the X-ray tube assembly.
- Avoid working in the direct beam of the X-ray source.
2009-02-10 / WOL SHT_37_102_001_01_E 6/25

1.5 Laser Protection
The ddRCompact™ is equipped with a weak laser pointer.

Peak Power < 1mW
Wave Length 540-700 nm
Class II Laser Product
Puissance de pointe < 1mW

Longueur d’onde 540-700 nm
Produit laser de la classe II
Do not stare into the laser beam!

If the laser line is switched on, take care that no person
CAUTION
looks directly into the laser to avoid eye injury or impaired
vision!
Ne regardez pas directement le faisceau laser!
MISE EN Si la ligne de laser est mise en circuit, faire attention
GARDE qu'aucune personne ne regarde directement dans le laser,
pour éviter une blessure d'oeil ou un trouble visuel!
2009-02-10 / WOL SHT_37_102_001_01_E 7/25

1.6 Software & Data Protection
It is the responsibility of the users to take preventive

measures to protect against software viruses and similar
CAUTION damages!
This concerns the workstation, the network and the storage
system (archive)!
Il est de la responsabilité des utilisateurs de prendre des
mesures de prévention pour se protéger contre les virus
MISE EN
logiciels et les dommages similaires!
GARDE
Cela concerne le poste de travail, le réseau et le système
de stockage (archives)!
Users are responsible for the safety and privacy of data on

CAUTION
the Swissray workstation and their local network area!
Les utilisateurs sont responsables de la sécurité et de la

MISE EN
confidentialité des données sur le poste de travail Swissray
GARDE
et sur leur espace réseau local!
The local data storage on the image processing station of

the ddRCompact™ is not intended for permanent storage!
CAUTION The operating institution is responsible to establish means
and procedures for permanent archiving of the X-ray
exposures in accordance with state regulations!
Le stockage local de données sur la station de traitement
des images du ddRCompact™ n'est pas prévu pour être
permanent!
MISE EN
L'établissement d'exploitation doit mettre en oeuvre les
GARDE
moyens et les procédures nécessaires pour un archivage
permanent des expositions radiologiques en conformité
avec les réglementations nationales!
Swissray disclaims any responsibility for loss or damage of

CAUTION data on hardware systems connected to the network by the
user!
Swissray décline toute responsabilité en cas de perte ou
MISE EN
d'endommagement des données sur les systèmes
GARDE
matériels connectés au réseau par l'utilisateur!
2009-02-10 / WOL SHT_37_102_001_01_E 8/25

1.7 Magnetic Risk
The detector top cover is equiped with four magnets to hold the anti scatter grid. Do
not place credit cards or other magnetic sensitive objects on the top cover to prevent
any damages.
Do not place magnetic sensitive objects on the detector top

cover!
CAUTION The magnets at the detector top cover may damage data at
credit cards, hard disks or other magnetic sensitive
objects!
Ne mettez pas d'objets magnétique sensibles sur la
couvercle de détecteur!
MISE EN
Les aimants dans la couvercle de détecteur peuvent
GARDE
endommager des données sur des cartes de crédit, des
disques durs ou d'autres objets magnétique sensibles!
1.8 Disposal
Swissray manufactures state-of-the-art X-ray equipment in terms of safety and

environmental protection. Assuming no parts of the system housing are open and
assuming the system is used properly, there are no hazards for persons or for the
environment.
To comply with regulations it is necessary to use materials, which can be harmful to

the environment and therefore these have to be disposed in a proper manner.
For this reason, you must not dispose of the X-ray equipment or parts of it together
with industrial or domestic waste.
Swissray:
- supports you in disposing of the X-ray equipment in a proper manner;

- returns reusable parts to the production cycle via certified disposal companies;
- thus helps to reduce environmental pollution.
Feel free to contact your closest Swissray Service Organisation for question or help
regarding disposal.
2009-02-10 / WOL SHT_37_102_001_01_E 9/25

1.9 Labeling ddRCompact™
1.9.1 ddR System
1.9.1.1 Machine Nameplate
Swissray Medical AG
Turbistrasse 25 - 27
6280 Hochdorf
Switzerland
Type: ddRCompact Plus

Part No: 8.3200.0080.x Manufacturer: Swissray Medical AG
Ver (x): 0 MF Date: March 2008
S/N: S402835 Complies with DHHS Radiation
V~: 208/230VAC 50/60 Hz Performance Standard Regulations
A: 8A Title 21 CFR subchapter J
Fuse: 250V~, D8
Class I Type B
IEC/EN 60601-1
UL 60601-1
0124
CAN/CSA C22.2 No. 601.1
8.3200.0010.0 ddRCompact™ EU Version

8.3200.0020.0 ddRCompact™ US Version
8.3200.0070.0 ddRCompact™ Plus US Version

8.3200.0080.0 ddRCompact™ Plus EU Version
1.9.1.2 Detector HD-3000™
Swissray Medical AG
6280 Hochdorf
Switzerland
Type: HD-3000 Manufacturer: Swissray Medical AG

MF Date March 2008
Part No.: 6.1030.0031.x
Ver (x) 0 Complies with DHHS Radiation
S/N: S402835 Performance Standard Regulations
V~: 24 VDC Title 21 CFR subchapter J
A: 3A
Class I Type B
IEC/EN 60601-1
UL 60601-1
CAN/CSA C22.2 No. 601.1 0124
2009-02-10 / WOL SHT_37_102_001_01_E 10/25

1.9.1.3 Monitor eXpert™3000
Swissray Medical AG
6280 Hochdorf
Switzerland
Type: eXpert3000 Part Gen-X-4000 (INDICO 100)

Part No.: 6.4010.2000.x Manufacturer: Swissray Medical AG
Ver (x) 0 MF Date March 2008
S/N: S402835 Complies with DHHS Radiation
V~: 115/230 VAC 50/60Hz Performance Standard Regulations
A: 1/0.5 A Title 21 CFR subchapter J
Class I Type B
IEC/EN 60601-1
UL 60601-1
0366 0124
CAN/CSA C22.2 No. 601.1
1.9.1.4 Workstation (IPS)
Swissray Medical AG
6280 Hochdorf
Switzerland
Type: Workstation (IPS) Manufacturer: Rave
Part No: 6.4010.1000.x MF Date March 2008
Ver (x): 0
UL 60950-1:2003
S/N: S402835 CAN/CSA-C22.2 No.60950-1-03
V~: 115/230VAC 50/60 Hz
CU 72073013 01
A: 6/3 A
IC Class B 0124 US
1.9.1.5 Measuring Chamber
2009-02-10 / WOL SHT_37_102_001_01_E 11/25

1.9.1.6 Anti Scatter Grid
1.9.1.7 Mobile Patient Table IGS 500M / IGS 1500
2009-02-10 / WOL SHT_37_102_001_01_E 12/25

1.9.2 X-Ray HV Generator
1.9.2.1 Main Label & Firmware
EU (400 VAC) US (480 VAC)
2009-02-10 / WOL SHT_37_102_001_01_E 13/25

1.9.2.2 Input Voltage
EU (400 VAC) US (480 VAC)
1.9.2.3 Tank & Cabinet
2009-02-10 / WOL SHT_37_102_001_01_E 14/25

1.9.3 Collimator
2009-02-10 / WOL SHT_37_102_001_01_E 15/25

1.9.4 X-Ray Tube
2009-02-10 / WOL SHT_37_102_001_01_E 16/25

1.9.5 Warning Labels
1.9.5.1 Electrical Warning Labels
1.9.5.2 Mechanical Warning Labels
Enlevez tous les objets du rayon de

mouvement d'équipement de
radiologique.
Les objets placés sous cette zone

risquent d'être endommagés.
2009-02-10 / WOL SHT_37_102_001_01_E 17/25

Ne dévissez jamais sans avoir pris des

mesures de sécurité.
Le système risque de chuter.
Composants mobiles.
2009-02-10 / WOL SHT_37_102_001_01_E 18/25

Câblage de montre et raccordement de

tube.
Après activation du déplacement manuel,

la protection contre les collisions est
inactive.
1.9.5.3 Radiation Warning Labels
Cette unité radiologique peut présenter un

danger pour les patients et l'opérateur si
les facteurs d'exposition sécuritaire et les
instructions d'utilisation ne sont pas
respectés.
Ne placez pas la télécommande à un
endroit où elle pourrait être actionnée par
inadvertance!
2009-02-10 / WOL SHT_37_102_001_01_E 19/25

movement
system stop
2009-02-10 / WOL SHT_37_102_001_01_E 20/25

1.9.5.4 Laser Warning Labels
Rayonnement laser.
Ne regardez pas directement le faisceau.
1.9.5.5 Magnetic Warning Labels
2009-02-10 / WOL SHT_37_102_001_01_E 21/25

1.10 Conformity
This medical device meets the provisions of the Medical

Directive 93/42 EEC and the basic requirements according
0124
to Annex II.
If you have further questions regarding the applicable national or international

standards, please address them to your Swissray representative.
1.11 Software Copyright
National laws and international treaties protect the software included in the
ddRCompact™.
Copyright 1996 - 2008 © Swissray Medical AG, Turbistrasse 25-27,

CH-6280 Hochdorf Switzerland.
The software shall only be used in conjunction with the hardware components
delivered by Swissray. Swissray grants the user a non-exclusive, non-transferable
license to use the software in connection with one ddRCompact™ system delivered
by Swissray. Under this license you may not:
(i) use the software on multiple systems, unless you have been explicitly granted a
multiple use license in writing from Swissray;
(ii) permit other individuals to use the software except under the terms listed above;
(iii) modify, translate, reverse engineer, decompile, disassemble (except to the extent
that this restriction is expressly prohibited by law) or create derivative works based
upon the software or documentation;
(iv) copy the software or documentation (except for back-up or archival purposes);
(v) rent, lease, transfer, or otherwise transfer rights to the software or documentation;
(vi) remove any proprietary notices or labels on the software or documentation.
You agree that you shall only use the software and documentation in a manner that
complies with all applicable laws in the jurisdiction in which you use the software and
documentation, including, but not limited to, applicable restrictions concerning
copyright and other intellectual property rights.
2009-02-10 / WOL SHT_37_102_001_01_E 22/25

1.12 Normal Use
The ddRCompact™ features a C-arm design with the X-ray tube always centered to
the detector HD-3000™ for fastest, most precise and convenient patient positioning.
The system efficiently performs all general radiographic procedures with a single
detector. It comes with off-center imaging capability for orthopedic and pediatric
applications.
The APS™ (Automated Positioning System) enables full programmable user

functions including automatic positioning from the eXpert™3000 for every body part.
The ddRCompact™ Plus performs off-detector examinations on cassette based

media with the rotating X-ray tube. This functionality makes it an ideal system for
Emergency Room applications combining highest patient throughput with utmost
flexibility. It delivers high quality radiographic images in just seconds. The single
detector technology dramatically improves overall productivity.
The ddRCompact™ is a fully digital, multifunctionals X-ray system that allows the
direct digitization of X-ray information without use of cassettes or other media.
The normal use of the ddRCompact™ is radiographic examinations of patients in

standing, recumbent or seated positions.
Swissray considers other types of examinations as unsafe applications outside its

definitions of normal and intended use.
2009-02-10 / WOL SHT_37_102_001_01_E 23/25

1.13 Electromagnetic Compatibility (EMC)
In accordance with its intended use, this electronic apparatus complies with the law
governing EMC, which defines the permissible emission levels from electronic
equipment and its required immunity against electromagnetic fields.
Nevertheless, it is not possible to exclude with absolute certainty the possibility that
radio signals from high-frequency transmitters, e.g. mobile phones or similar mobile
radio equipment, which themselves comply to the EMC regulations, may influence the
proper functioning, if operated in close proximity and with relatively high transmitting
power. In unusual circumstances unintended functions of the apparatuses could be
initiated, possibly giving rise to undesirable risks for the patient or user.
Mobile phones or other mobile radio equipment must be

switched off in the vicinity of the ddRCompact™ system to
CAUTION eliminate any risk of unintended functions due to
interference!
This also applies when the system is in “standby“ mode!
Les téléphones portables ou tout autre équipement de

radio mobile doivent être gardés éteints à proximité du
système ddRCompact™ afin d'écarter tout risque
MISE EN
d'activation accidentelle de fonctions suite à des
GARDE
interférences!
Cela s'applique également lorsque le système est en mode
« veille » !
2009-02-10 / WOL SHT_37_102_001_01_E 24/25

1.14 Use of the User Manual
1.14.1 Symbols and their Meaning
This symbol is used in the user manual to point out the

correct procedure for operating the X-ray equipment! In
CAUTION order to protect the users against bodily injuries and the
X-ray equipment against damage, the operator must strictly
observe the instructions of this user manual!
Ce symbole est utilisé dans le manuel d'utilisation afin de
signaler la procédure d'utilisation correcte du système
MISE EN radiologique! Afin de protéger les utilisateurs de toute
GARDE blessure corporelle et de protéger le système radiologique
de tout dommage, l'opérateur doit strictement respecter les
instructions figurant dans ce manuel!
1.14.2 For your Information
Basic knowledge of Microsoft Windows based computers is a prerequisite to operate

the SwissVision® XG for ddRCompact™ image processing station and understand
this user manual.
2009-02-10 / WOL SHT_37_102_001_01_E 25/25

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SHT - 37 - 102 - 001 - 01 - E Chapter 01 Safety Regulation Compact Series Service Manual

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Service Manual ddRCompact™ Series

Chapter 1: Safety Regulations

Caution: US Federal Law restricts this device to use by or on the

Mise en garde: Les lois fédérales des États-Unis limitent l'utilisation

Revision Date By Reason for Change

01 2009-02-10 SRCH / WOL First Official Release

2009-02-10 / WOL SHT_37_102_001_01_E 1/25

1 Safety Regulations ................................................................................... 3

2009-02-10 / WOL SHT_37_102_001_01_E 2/25

This service manual describes the use of the ddRCompact™, the

Do not use the X-ray equipment, if it has any electrical,

2009-02-10 / WOL SHT_37_102_001_01_E 3/25

Safety circuits must neither be removed nor modified.

If you wish to connect the X-ray equipment to other equipment, components or

• Do not place the remote control, where it can be

2009-02-10 / WOL SHT_37_102_001_01_E 4/25

1.2 Electrical Safety

This X-ray equipment may not be operated in areas where

MISE EN Cet équipement radiologique ne doit pas être utilisé dans

1.3 Mechanical Safety

The X-ray equipment is prepared for installation in accordance with environmental

Please ensure that the patient and operator maintain a safe

2009-02-10 / WOL SHT_37_102_001_01_E 5/25

1.4 Radiation Protection

The use of conventional X-ray application with X-ray tube

Ensure before each X-ray exposure that all the necessary

Assurez-vous que toutes les précautions nécessaires ont

The ddRCompact™ is delivered with preset exposure dose

- To protect the patient against radiation, always use radiation protection

2009-02-10 / WOL SHT_37_102_001_01_E 6/25

1.5 Laser Protection

The ddRCompact™ is equipped with a weak laser pointer.

Puissance de pointe < 1mW

Do not stare into the laser beam!

2009-02-10 / WOL SHT_37_102_001_01_E 7/25

1.6 Software & Data Protection

It is the responsibility of the users to take preventive

Users are responsible for the safety and privacy of data on

Les utilisateurs sont responsables de la sécurité et de la

The local data storage on the image processing station of

Swissray disclaims any responsibility for loss or damage of

2009-02-10 / WOL SHT_37_102_001_01_E 8/25

1.7 Magnetic Risk

Do not place magnetic sensitive objects on the detector top

Swissray manufactures state-of-the-art X-ray equipment in terms of safety and

To comply with regulations it is necessary to use materials, which can be harmful to

- supports you in disposing of the X-ray equipment in a proper manner;

2009-02-10 / WOL SHT_37_102_001_01_E 9/25

1.9 Labeling ddRCompact™

1.9.1 ddR System

1.9.1.1 Machine Nameplate

Type: ddRCompact Plus

8.3200.0010.0 ddRCompact™ EU Version

8.3200.0070.0 ddRCompact™ Plus US Version

1.9.1.2 Detector HD-3000™

Type: HD-3000 Manufacturer: Swissray Medical AG

2009-02-10 / WOL SHT_37_102_001_01_E 10/25

1.9.1.3 Monitor eXpert™3000