Carestream HEALTH DRX-1 System Installation manual

CARESTREAM DRX-1 System
Safety and Regulatory Information
with
Hardware
User’s Guide
Version 3.0
PN 7H8166
6 April 2009
CarestreamCarestreamDRX1 System
H224_0028HC

7H8166 1
Table of Contents
1 Safety and Regulatory Information
Document Conventions ....................................................................................................................................1-1
Intended Use and Indications for Use...............................................................................................................1-1
Safety and Related Information.........................................................................................................................1-2
Medical Equipment Classification...............................................................................................................1-2
Compatibility with Other Manufacturer’s Equipment ..................................................................................1-3
Product Safety Standards............................................................................................................................1-4
EMC Standards for Detector and System.....................................................................................................1-7
Safety .........................................................................................................................................................1-7
Additional Guidance and Manufacturer’s Declaration - Electromagnetic Emissions/Immunity....................1-7
Electromagnetic Compatibility Precautions...........................................................................................1-7
Communications Equipment ................................................................................................................1-8
Replacement of Cables, Accessories, or Transducers ...........................................................................1-8
Other Equipment..................................................................................................................................1-9
Shielded Locations ...............................................................................................................................1-9
DRX-1 System Product Information................................................................................................................1-14
DRX-1 System Detector ............................................................................................................................1-14
DRX-1 System Battery Charger..................................................................................................................1-15
DRX-1 System Battery...............................................................................................................................1-16
DRX-1 System Console .............................................................................................................................1-16
DRX-1 System Wireless Access Point ........................................................................................................1-17
DRX-1 System Tether Interface.................................................................................................................1-17
Patient Vicinity .........................................................................................................................................1-18
Mode of Operation...................................................................................................................................1-18
Labels ......................................................................................................................................................1-19
Disposal Information .....................................................................................................................................1-24
Operating Environment ..................................................................................................................................1-24
For European Market Only.......................................................................................................................1-24
General Contact Information ....................................................................................................................1-25
2 Hardware and Operation
Overview ..........................................................................................................................................................2-1
CARESTREAM DRX-1 System ............................................................................................................................2-2

2 7H8166
Table of Contents
Cautions...........................................................................................................................................................2-3
Installing the Hardware....................................................................................................................................2-3
Attaching Accessories.................................................................................................................................2-4
Turning the System On and Off...................................................................................................................2-4
CARESTREAM DRX-1 System Battery.................................................................................................................2-5
Installing the Battery ..................................................................................................................................2-5
Removing the Battery .................................................................................................................................2-6
Labeling the Detector .......................................................................................................................................2-7
DRX-1 Detector LED.........................................................................................................................................2-7
Positioning the Detector in the Bucky...............................................................................................................2-9
Positioning the Detector on a Tabletop.....................................................................................................2-10
Range of Operation ........................................................................................................................................2-10
Using a Single Detector ............................................................................................................................2-10
Using Two or More Detectors...................................................................................................................2-11
Using Detectors in Two or More Rooms...................................................................................................2-12
Wireless Operation.........................................................................................................................................2-12
Tether Operation............................................................................................................................................2-13
Tether Interface Box ................................................................................................................................2-14
Cleaning the Hardware...................................................................................................................................2-14
With Each Occurrence of Patient Contact .......................................................................................................2-15
System Maintenance.......................................................................................................................................2-16
Checking the Equipment Integrity.............................................................................................................2-16
Grid Recommendation .............................................................................................................................2-17
Protective Enclosures...............................................................................................................................2-17

7H8166 1-1
1 Safety and Regulatory
Information
The information contained herein is based on the experience and knowledge
relating to the subject matter gained by Carestream Health, Inc. prior to
publication.
No patent license is granted by this information.
Carestream Health reserves the right to change this information without
notice, and makes no warranty, express or implied, with respect to this
information. Carestream Health shall not be liable for any loss or damage,
including consequential or special damages, resulting from any use of this
information, even if loss or damage is caused by Carestream Health’s
negligence or other fault.
Document Conventions
NOTE: Notes provide additional information, such as expanded
explanations, hints, or reminders.
IMPORTANT: Important highlights critical policy information that
affects how you use this manual and this product
CAUTION:
Caution points out procedures that you must follow precisely
to avoid damage to the system or any of its components,
yourself or others, loss of data, or corruption of files in
software applications.
Intended Use and Indications for Use
The CARESTREAM DRX-1 System is intended to capture for display
radiographic images of human anatomy. It is intended for use in general
projection radiographic applications wherever conventional screen-film or
Computed Radiography (CR) systems may be used. Excluded from the
indications for use are mammography, fluoroscopy., tomography, and
angiography applications.

1-2 7H8166
Safety and Regulatory Information
Safety and Related Information
Medical Equipment
Classification
CARESTREAM DRX-1 System Detector Medical Electrical
Equipment Classification
Type of protection against electrical shock: Internally powered equipment. Class I
Equipment.
Degree of protection against electrical
shock:
Type B Applied Part.
Degree of protection against ingress of wa-
ter:
Ordinary protection.
Mode of operation: Continuous operation.
Flammable anesthetics: Not suitable for use in the presence of flam-
mable anesthetics or a mixture of flamma-
ble anesthetics with air or oxygen or
nitrous oxide.
CARESTREAM DRX-1 System Tether Interface Medical Electrical
Equipment Classification
Type of protection against electrical shock: Class I Equipment.
Degree of protection against electrical
shock:
Type B.
Degree of protection against ingress of wa-
ter:
Ordinary protection.
Mode of operation: Continuous operation.
Flammable anesthetics: Not suitable for use in the presence of flam-
mable anesthetics or a mixture of flamma-
ble anesthetics with air or oxygen or
nitrous oxide.

Safety and Regulatory Information
7H8166 1-3
The CARESTREAM DRX-1 System includes the following components:
CARESTREAM DRX-1 System Detector (one or more)
CARESTREAM DRX-1 System Battery (any quantity)
CARESTREAM DRX-1 System Battery Charger
CARESTREAM DRX-1 System Tether Interface
CARESTREAM DRX-1 System Console
CARESTREAM DRX-1 System Access Point
Compatibility with
Other Manufacturer’s
Equipment
The CARESTREAM DRX-1 System (DRX-1 System) is a digital X-ray image
capture system. The DRX-1 System connects with existing analog x-ray
equipment using a safety certified electrical isolation device (DRX-1 System
Interface Box). The isolation device is designed to prevent any failures, loss of
power or power surge in the DRX-1 System from affecting the X-ray
equipment.
CARESTREAM DRX-1 System Medical Electrical Equipment
Classification
Type of protection against electrical shock: Internally powered equipment. Class I
Equipment.
Degree of protection against electrical
shock:
Type B Applied Part.
Degree of protection against ingress of
water:
Ordinary protection.
Mode of operation: Continuous operation.
Flammable anesthetics: Not suitable for use in the presence of flam-
mable anesthetics or a mixture of flamma-
ble anesthetics with air or oxygen or
nitrous oxide.
H224_9001BA
Prep Start
Expose Request
X-ray Console
Input
Exposure
Switch
Expose Start
Box
Interface
DRX-1 System
Prep Request
Output

1-4 7H8166
Safety and Regulatory Information
The DRX-1 System uses an existing exposure switch connector on the X-ray
equipment. No modification to the X-ray equipment is required. The intended
use of the X-ray equipment is not affected and the X-ray equipment remains
certified by the X-ray equipment manufacturer.
Model-specific documentation and cables are provided to allow service
personnel to connect and run functional testing on the DRX-1 System. The
DRX-1 System is compatible with the X-ray equipment listed on the Certificate
of Compatibility available from your local authorized service provider. Contact
your local authorized service provider for further information.
Product Safety
Standards
The following Product Safety Standards apply to CARESTREAM
DRX-1 System, which includes:
• CARESTREAM DRX-1 System Detector
• CARESTREAM DRX-1 System Tether Interface
USA UL 60601-1:2003 - Medical Electrical Equipment
Canada CAN/CSA-C22.2 No. 601.1-M90 (R2001) Medical Electrical Equipment
CAN/CSA-C22.2 No. 601.1S1-94 (R1999) - Supplement No. 1-94 to
CAN/CSA-C22.2 No. 601.1-M90
CAN/CSA-C22.2 No. 601.1B-90 (R2002) - Amendment 2 to CAN/CSA-C22.2
No. 601.1-M90
Europe EN 60601-1:1990 + Amendment 1:1993 + Amendment 2:1995 - Medical
Electrical Equipment
International IEC 60601-1:1988 + Amendment 1:1991 + Amendment 2:1995 - Medical
Electrical Equipment

Safety and Regulatory Information
7H8166 1-5
The following Product Safety Standards apply to the CARESTREAM
DRX-1 System. The DRX-1 System includes the following:
CARESTREAM DRX-1 System Detector (one or more)
CARESTREAM DRX-1 System Battery (any quantity)
CARESTREAM DRX-1 System Battery Charger
CARESTREAM DRX-1 System Tether Interface
CARESTREAM DRX-1 System Console
CARESTREAM DRX-1 System Wireless Access Point
USA UL 60601-1:2003 - Medical Electrical Equipment, 1st Edition
Canada CAN/CSA-C22.2 No. 601.1-M90 (R2001) Medical Electrical Equipment
CAN/CSA-C22.2 No. 601.1S1-94 (R1999) - Supplement No. 1-94 to
CAN/CSA-C22.2 No. 601.1-M90
CAN/CSA-C22.2 No. 601.1B-90 (R2002) - Amendment 2 to CAN/CSA-C22.2
No. 601.1-M90
Europe EN 60601-1:1990 + Amendment 1:1993 + Amendment 2:1995 - Medical
Electrical Equipment
EN 60601-1-1:2001 - Medical Electrical Systems
EN 60601-1-4:1996 + Amendment 1:1999 - Programmable Electrical
Medical Systems
International IEC 60601-1:1998 + Amendment 1:1991 + Amendment 2:1995 - Medical
Electrical Equipment
IEC 60601-1-1:2000 - Medical Electrical Systems
IEC 60601-1-4:1996 + Amendment 1:1999 - Programmable Electrical
Medical Systems

1-6 7H8166
Safety and Regulatory Information
The following Product Safety Standards are applicable to the
CARESTREAM DRX-1 System Battery.
The following Product Safety Standards are applicable to:
• CARESTREAM DRX-1 System Battery Charger
• CARESTREAM DRX-1 System Console
• CARESTREAM DRX-1 System Wireless Access Point
USA UL 60601-1:2003 - Medical Electrical Equipment, 1st Edition
Canada CAN/CSA-C22.2 No. 601.1-M90 (R2001) Medical Electrical Equipment
CAN/CSA-C22.2 No. 601.1S1-94 (R1999) - Supplement No. 1-94 to
CAN/CSA-C22.2 No. 601.1-M90
CAN/CSA-C22.2 No. 601.1B-90 (R2002) - Amendment 2 to CAN/CSA-C22.2
No. 601.1-M90
Europe EN 60601-1:1990 + Amendment 1:1993 + Amendment 2:1995 - Medical
Electrical Equipment
International IEC 60601-1:1988 + Amendment 1:1991 + Amendment 2:1995 - Medical
Electrical Equipment
USA UL 60950-1, Information Technology Equipment - Safety - Part 1: General
Requirements
Canada CAN/CSA C22.2 No. 60950-1-03, Information Technology Equipment - Safety
- Part 1: General Requirements
Europe EN 60950-1:2001 + A11, Information Technology Equipment - Safety - Part
1: General Requirements
International IEC 60950-1:2001, Information Technology Equipment - Safety - Part 1:
General Requirements