DRX-Evolution Safety and Regulatory Information Ver 1.0 June 2011

Table of Contents

1 CARESTREAM DRX-Evolution Safety Information Overview ...1-1 General ...1-2 Electrical/Mechanical...1-2 Mechanical ...1-2 Usability ...1-2 Training ...1-3 Safety Cautions ...1-4 Manual Conventions...1-4 General Use Cautions and Special Messages ...1-4 Laser Cautions...1-6 Table...1-7 Wall Stands ...1-8 Full-Featured Wall Stand Weight and Travel Limits ...1-8 Carestream Wall Stand Weight and Travel Limits ...1-8 The BABIX Holder...1-10 Overhead Tube Crane...1-10 Compatible Components ...1-14 Collimator Filtration Information ...1-14 X-Ray Tube Components ...1-14 X-ray Source Assembly ...1-14 DRX-Evolution Tabletop ...1-14 DRX-Evolution Wall Stand Bucky Cover ...1-14 Method of Cleaning ...1-14 Flammability ...1-14 Using the Ralco Collimator Table ...1-15 Radiation and Magnetic Field Cautions...1-16 Electrical and Flammable Cautions...1-16 Replacing the UPS ...1-17 Warnings about Moving and Using the Equipment...1-17 Cleaning Cautions...1-18 Safety Symbols...1-18

9G8668

i

Radiation and X-ray System Safety and General Compliance Information... 1-20 Safety ... 1-20 Maximum Permissible Dose (MPD)... 1-21 Manufacturer’s Responsibility... 1-21 Radiation Protection ... 1-22 Positive Beam Limitation (PBL) ... 1-23 CDRH Compliance ... 1-24 Classification in Accordance with IEC 60601-1 ... 1-24 IEC/EN 60601-1-3 Compliance ... 1-24 Labels ... 1-25 Systems Label Locations... 1-25 Component Labels ... 1-27 Product Disclosure Table... 1-31 Caution Regarding Small-Object Image Handling ... 1-32 Restrictions on Use ... 1-33 Conforming Standards - Safety ... 1-34 USA... 1-34 Canada... 1-34 Europe... 1-34 International... 1-34 Conforming Standards - EMC ... 1-36 CARESTREAM DRX-Evolution ... 1-36 For European Market Only... 1-36 Electromagnetic Emissions/Immunity ... 1-36 Appendix A: Technical Specifications PC Requirements ... A-1 Highest Loading Factors... A-1 Rated Input... A-2 X-ray Tube Voltage... A-2 X-ray Tube Current ... A-2 Loading Time... A-2 Current Time Product ... A-2 Range of Motion ... A-2 Image Quality... A-2

ii

9G8668

CARESTREAM DRX-Evolution Safety Information

1

CARESTREAM DRX-Evolution Safety Information The information contained herein is based on the experience and knowledge relating to the subject matter gained by Carestream Inc. prior to publication. No patent license is granted by this information. Carestream Inc. reserves the right to change this information without notice, and makes no warranty, express or implied, with respect to this information. Carestream 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’s negligence or other fault.

Overview The CARESTREAM DRX-Evolution is a digital radiography system. The DRX-Evolution consists of: • X-ray Generator and Power Distribution Unit (PDU) • Ceiling-mounted Overhead Tube Crane (OTC) with diagnostic X-ray tube assembly (X-ray tube and collimator) attached • Wall Stand • Table This system is an alternative to current dedicated film screen or CR imaging systems and provides the capability to directly capture and convert X-ray energy into digital signals. Personnel operating and maintaining the DRX-Evolution should receive training and be familiar with all aspects of operation and maintenance. To ensure safety, read the Safety Information section carefully before using the system and observe all Cautions, Importants, and Notes located throughout this manual and other manuals supplied with the equipment.

1-1

9G8668

CARESTREAM DRX-Evolution Safety Information

General

The following are general safety precautions: • Do not remove the covers for any purpose. • Do not defeat or bypass built-in equipment safety features. • Do not attempt to move equipment, or connect or disconnect any communication cables. Call a person qualified and authorized to alter the equipment installation. • Observe all cautions, stated or implied, in the procedures. • Follow all safety labels on the equipment. CAUTION:

Do not attempt any repairs if the equipment fails to operate correctly. Immediately call a person qualified and authorized to repair the equipment. CAUTION:

Electrical/Mechanical Mechanical

Only a qualified authorized Service Provider should replace electrical and mechanical components. The following are mechanical safety precautions: • Keep fingers, hands, and tools clear of moving parts. • Do not operate the equipment with covers or access panels removed. • Route cables properly to eliminate hazards from tripping.

Usability The design and development of a diagnostic X-ray system incorporated a usability engineering process in accordance with IEC 60601-1-6: Medical Electrical Equipment, Part 1-6: General requirements for safety - Collateral Standard: Usability. However, it is not possible or practical to resolve every potential Usability issue without affecting the intended use of the system. Therefore, some precautions must be observed. These precautions appear throughout the manual.

1-2

9G8668

CARESTREAM DRX-Evolution Safety Information

Training

This equipment is intended for use by appropriately educated and skilled radiological health care professionals who have received specific training on the operation and use of this equipment. CAUTION:

Only qualified personnel may operate the DRX-Evolution. Operation of the equipment by persons who have not been trained or who are unfamiliar with the functions and controls of the DRX-Evolution may cause serious injury to the patient, serious injury to the operator, or equipment damage. CAUTION:

Only allow trained X-ray personnel to operate the Operator Console. For training in the operation of this equipment, contact Carestream Inc.

1-3

9G8668

CARESTREAM DRX-Evolution Safety Information

Safety Cautions Manual Conventions

This manual uses three types of messages to emphasize information or potential risks to personnel or equipment: Notes, Cautions, and Important. 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:

Cautions point out procedures that you must follow precisely to avoid injury to yourself, others, damage to the system or any of its components, loss of data, or corruption of files in software applications. Disregarding the caution statement may lead to abnormal use.

General Use Cautions and Special Messages In the European Union, this symbol indicates that when the last user wishes to discard this product, it must be sent to appropriate facilities for recovery and recycling. Contact your local representative or refer to http://recycle.carestreamhealth.com for additional information on the collection and recovery programs available for this product.

1-4

9G8668

CARESTREAM DRX-Evolution Safety Information

CAUTION:

Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure. CAUTION:

Do not operate this equipment outside of its operating environment limits. Doing this may cause the equipment to malfunction. The operating environment limits are as follows: Temperature: 18 - 30° C (50 - 81° F) Relative humidity: 10 - 75% humidity (non-condensing) Maximum temperature gradient: 5° C (9° F) per hour Altitude: maximum 3,048 m (10,000 ft)

CAUTION:

This product contains lead and mercury. Disposal of components that contain these materials may be regulated due to environmental conditions. For disposal or recycling information, contact your local authorities or visit the Electronics Industry Alliance Web site at http://www.eiae.org. CAUTION:

The flat panel display in this system contains mercury. Disposal is regulated due to environmental considerations. Return the equipment to the manufacturer for proper disposal. CAUTION:

The DRX-Evolution includes no user serviceable parts. For service assistance contact Carestream Inc. CAUTION:

This device must be maintained according to the directions in the CARESTREAM DRX-Evolution Hardware Guide. Failure to maintain this equipment as directed may result in injury, equipment malfunction, or unacceptable images. CAUTION:

United States federal law restricts this device to sale by or on the order of a physician.

1-5

9G8668

CARESTREAM DRX-Evolution Safety Information

CAUTION:

Laser Cautions

LASER WARNING: The Collimator is equipped with a low power red laser to produce an alignment beam used when aligning the X-ray Tube with the detector. This is a Class 2M laser product according to IEC 60825-1 and is labeled by Ralco as a Class 2M laser product. DO NOT STARE DIRECTLY INTO THE BEAM OR VIEW DIRECTLY WITH OPTICAL INSTRUMENTS. Viewing with eye loupes, magnifiers, or microscopes within a distance of 100 mm may pose an eye hazard.

Whenever the Collimator light is on, the laser is on. The laser is activated whenever the Collimator light is switched on. The laser beam is emitted in the shape of a line and projects across the mid-line of the collimated beam. When performing procedures in which the laser beam may be projected close to the patient’s eye (e.g. radiographs of the skull, face, etc.), instruct the patient to close his or her eyes. In cases where the patient may not be able to respond to instructions (e.g. trauma patients), other means of protecting the eyes should be considered. This laser will not harm skin.

1-6

9G8668

CARESTREAM DRX-Evolution Safety Information

Table CAUTION:

The top of the Table is a moving part. Ensure that articles of clothing do not get caught in moving parts. • Keep hands and other body parts clear while moving the table Bucky. • Use caution to prevent pinching fingers between the table top and the Bucky assembly. • The Bucky may move automatically while you are positioning the X-ray tube.

Table

Bucky Drawer Handle

H230_1600HC

CAUTION:

The weight limit of the Table is 272 kg (600 lb). Exceeding this limit may result in injury to the patient or malfunction of the Table controls.

1-7

9G8668

CARESTREAM DRX-Evolution Safety Information

CAUTION:

The weight limit of the table Bucky drawer is 9 kg (20 lb). Do not exceed this weight on the Bucky surface.

Wall Stands CAUTION:

The weight limit on the Wall Stand Bucky is 23 kg (50 lb). Do not exceed this weight on the Bucky.

Full-Featured Wall Stand Weight and Travel Limits

Carestream Wall Stand Weight and Travel Limits

1-8

9G8668

CARESTREAM DRX-Evolution Safety Information

Swing (angulate) Tilt

Rotate H230_1000GC

Use caution when rotating the Wall Stand Bucky. Keep hands and other body parts away from the moving parts.

Use the handles on the Wall Stand extension arms to extend or retract the Bucky. Use caution to prevent pinching fingers in the openings of the arms.

Keep the patient away from the Bucky assembly when rotating the Bucky, or when moving it horizontally or vertically. Do not position people near the X-ray tube when adjusting the Bucky position.

1-9

9G8668

CARESTREAM DRX-Evolution Safety Information

The standard lateral arm support is a bar that helps a patient hold their arms up when they are positioned for an X-ray at the Wall Stand. The lateral arm support is not designed to bear a patient’s full weight. The support is intended to be used only as an overhead hand grip, positioning the arms of the patient while the X-ray is taken.

The BABIX Holder

A BABIX is a cradle that is suspended from a hook attached to an arm at the top of the Wall Stand. See the DRX-Evolution Hardware Guide for details on this component.

Overhead Tube Crane

햿

햲

햾 햽 햻

햺

햸

햳 햴 햵 햶 햷

햹 H230_0700GC

햲

Master Brake Release

햹

Detent Skip

햳

Back and Forth (Transverse)

햺

Horizontal Swing (Beta)

햴

Up and Down (Vertical)

햻

Master Brake Release

햵

Detent Skip

햽

Vertical Swing (Alpha)

햶

Master Brake Release

햾

Detent Skip

1-10

9G8668

CARESTREAM DRX-Evolution Safety Information

햷

Left and Right (Longitudinal)

햸

Master Brake Release

햿

Detent Skip

CAUTION:

Do not allow the Table and the Overhead Tube Crane (OTC) to collide with the patient or operator, with each other, or with other objects during manual or powered movement. A collision can injure the patient or operator and damage the equipment. Position the OTC away from the Table before moving the Table.

NOTE: The buttons and screen features of the OTC display are discussed in the CARESTREAM DRX-Evolution Hardware Guide. Overhead Tube Crane Controls Rotation (Merry-Go-Round)

Transversal

1-11

9G8668

CARESTREAM DRX-Evolution Safety Information

Vertical Movement

Detent Skip

Longitudinal Movement

Angulate (Windmill)

Master Brake Release: Longitudinal, Transversal, Vertical

Horizontal Collimator Control

Vertical Collimator Control

Auto Position

Auto Centering

Auto Tracking

1-12

9G8668

CARESTREAM DRX-Evolution Safety Information

Detector Selection

Collimator Presets

Automatic Mode on Collimator

Manual Mode on Collimator

Collimator In Motion

Press Detent Skip in addition to any Movement button. You can have your Service Representative or Key Operator set up to four detents for X, Y, aand Z axis.

1-13

9G8668

CARESTREAM DRX-Evolution Safety Information

Compatible Components Collimator Filtration Information Type

Description

Inherent Filtration

2.0 mm Al at 75 kV

Additional Spectral Filtration

Press the Spectral Filtration button. The filter wheel displays the following filtration sequence as you press the button: • F: ∅AL (None) • F: 1AL (1 mm Aluminum) • F: 1AL 0.1 CU (1 mm Aluminum + 0.1 mm Copper) • F: 1AL 0.2 CU (1 mm Aluminum + 0.2 mm Copper)

X-Ray Tube Components

Either: • Varian B130 housing with a RAD 60 or RAD 92 insert • Inherent Filtration = 0.7 mm Al Or: • TOSHIBA Housing = XH-157 • Tube Insert = E7254X • Inherent Filtration = 0.8 mm Al/75

X-ray Source Assembly

• Total Inherent Filtration = 2.7 mm Al

DRX-Evolution Tabletop

• DRX-Evolution Tabletop attenuation equivalent = 0.7 mm Al

DRX-Evolution Wall Stand Bucky Cover

• DRX-Evolution Wall Stand Bucky Cover attenuation equivalent = 0.65 mm Al

Method of Cleaning

See the CARESTREAM DRX-Evolution Hardware Guide.

Flammability

Not suitable for use in the presence of a flammable anesthetic mixture with oxygen or nitrous oxide.

1-14

9G8668

CARESTREAM DRX-Evolution Safety Information

Using the Ralco Collimator Table Cassette (x-ray field) size =

SID in use =

Knob setting =

cm

13

18

24

30

35

40

43

90

14

20

27

33

39

44

47

36”

100

13

18

24

30

35

40

43

40”

120

11

15

20

25

29

33

36

48”

150

9

12

15

20

23

26

28

60”

180

8

10

13

16

19

22

24

72”

200

7

9

12

15

17

20

22

78”

5”

7”

9.5”

12”

14”

16”

17”

inch

0_1625HA

The table on the face of the collimator provides the value to use for the X-ray field size setting using the shutter knobs on the collimator. To determine the correct number to set: 1. Select the SID (Source to Image Distance). 2. Locate the X-ray field size in centimeters at the top of the chart. At the bottom is the X-ray field size in inches. 3. Set the collimator knob to the number shown at the intersection of the SID row and field size column. In the example above, the SID is 120 cm, the knob setting is 25, and the X-ray field size is 30 cm.

1-15

9G8668

CARESTREAM DRX-Evolution Safety Information

Radiation and Magnetic Field Cautions CAUTION:

The DRX-Evolution System produces ionizing radiation. Operators must meet all international, national, state, and local requirements and regulations. CAUTION:

This x-ray unit may be dangerous to patient and operator unless safe exposure factors and operating instructions are observed.

Electrical and Flammable Cautions CAUTION:

Only allow trained X-ray personnel to use the Operator Console.

CAUTION:

The DRX-Evolution is not suitable for operation in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide. CAUTION:

The optional Uninterruptible Power Supply (UPS) in the Power and Distribution Unit (PDU) must be replaced by an authorized Service Provider. The UPS contains lead and poses a hazard to the environment and human health if not disposed of properly.

1-16

9G8668

CARESTREAM DRX-Evolution Safety Information

Replacing the UPS The optional Uninterruptible Power Supply (UPS) must be replaced by an authorized Service Provider. The UPS battery contains lead and poses a hazard to the environment and human health if not disposed of properly. Due to the toxicity of lead, the US Environmental Protection Agency (EPA) Resource Conservation and Recovery Act (RCRA) and state solid/hazardous waste authorities consider a spent lead-acid battery a regulated waste. The customer must treat this battery as a hazardous waste if it is not recycled. A recycling infrastructure is widely available in the US to manage this battery type. For recycling/disposal options in the European Union, visit the European Portable Battery Association (EPBA) web site at http://www.epbaeurope.net/. In other areas, contact local or regional solid waste authorities for recycling/disposal guidance. Replace the UPS periodically. Contact your authorized Service Provider for UPS Service and replacement.

Warnings about Moving and Using the Equipment CAUTION:

Excessive use of the keyboard and mouse may result in repetitive strain injury. CAUTION:

The equipment is fragile and must be handled with care.

1-17

9G8668