CARESTREAM

SPT1 Radiographic Table

Safety and Regulatory Guide

2013-04-04
PN AA4597
Version 2.0

Table of Contents
Safety and Regulatory
Overview ........................................................................................................................................1
Manual Conventions .................................................................................................................1
Safety and Regulatory ...............................................................................................................2
Publication History.........................................................................................................................8

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Overview
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 for
this information.
Carestream Health, Inc. 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 Healths negligence or
other fault.
IMPORTANT: Personnel operating and maintaining the SPT1
Radiographic Table should receive training and be
familiar with all aspects of operation and
maintenance. To ensure safety, read the Safety and
Regulatory Information carefully before using the
table and observe all Cautions, Importants, and
Notes located throughout the manual.
The Safety and Regulatory Guide language of origin is English.

Manual Conventions

This manual uses three types of messages to emphasize

information or potential risks to personnel or equipment: Notes,
Importants, and Cautions.
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.

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Safety and Regulatory

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.

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 authorized representative for additional
information.

Safety and Regulatory

CAUTION:

Safety Cautions

Follow all safety labels on the equipment.

CAUTION:

Thoroughly check that there is no interference or

possibility of collision between the patient and other
equipment.
CAUTION:

Do not use the patient table on stairs or steep ramps.

CAUTION:

Do not roll the patient table over toes or other extremities.

CAUTION:

Keep fingers and other body parts away from the table
pinch points when the table is in motion.
CAUTION:

The weight limit of the table is 227 kg (500 lb). Exceeding

this limit may result in injury to the patient or
malfunction of the table controls.

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Safety and Regulatory

CAUTION:

Avoid damaging the tabletop. Keep surface clear of

sharp-edged objects.
CAUTION:

Do not use the table to move patients.

Conforming Standards Safety

This medical device meets the provisions of the Medical Directive

93/42 EEC, and the basic requirements according to Annex II. If
you have further questions regarding the applicable national or
international standards, please contact your Carestream Health
representative.

IEC 606011: 1988+A1+A2/EN 606011: 1990+A1+A2

IEC/EN 6060113: 1994
IEC/EN 60601232: 1994
UL 606011: 2003 R6.03
CAN/CSAC22.2 No. 601.1M90
IEC 606011: 2005
IEC/EN 6060113: 2008
IEC/EN 60601254: 2009
EN 606011:2006
This product complies with 21 CFR 1020.30/.31 Performance
Standards for Radiation SafetyRadiographic Equipment.

Carestream Health France

1, rue Galile
93192 NOISY-LE-GRANDE CEDEX
FRANCE

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Environmental Requirements
Transit and Storage

The receiving and storage area(s) must be dry and able to provide
the proper humidity and temperature control required for the
equipment.
Temperature

23 to 66 C
(9 to 150 F)

Relative Humidity

3575 % (non condensing)

Atmospheric Pressure

70 kPa106 kPa

Temperature

1040 C
(50104 F)

Relative Humidity

3575 % (non condensing)

Atmospheric Pressure

70 kPa106 kPa

Operating

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Safety and Regulatory

Labels

Data Plate Label Sample

Official Product Name (English)

Official Product Name (Japanese, if required)
Official Product Name (Chinese, if required)
SC

1
2

SN

Manufactured:

MODEL

7
8
THIS PRODUCT COMPLIES WITH 21 CFR CHAPTER 1, SUBCHAPTER J

11

Made in China by
Carestream Health, Inc.
150 Verona Street, Rochester, NY 14608 USA


1510

10
P/N XXXXXX REV A

Official product name

Service code and serial number

Manufactured date

Model type as required/consistent with product safety test

reports

Voltage range, rated frequency in hertz and amps/consistent with

product safety test reports: V = volts, Hz = hertz, A = amperes

Symbols for product safety, EMC, and CE marking

SFDA Registration number

SFDA Product Standard number

Compliance statement according to FDA requirements for

radiation emitting products

10

Label manufacturer registration number and material

specification.

11

Made in China by (signature)

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Safety and Regulatory

data plate

H225_1076HC

Float Label

Up-Down Label

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Tabletop Weight Limit

Use caution to prevent pinching fingers and other body parts

while moving the table.

Warning Label: Hold The Table Top Firmly While Pressing

the Float Control Pedal.

2G7598 REV. B

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Publication History

Revision

Date

Description of Changes

9J0220

2011-06-14

Initial Release

AA4597

2012-11-01

Third Edition update,

Standards, graphics,
labels.

AA4597 Rev B

2013-04-02

Changed Data Plate Label

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CARESTREAM HEALTH, INC.

150 Verona Street
Rochester, NY 14608
United States
CARESTREAM is a trademark of Carestream Health.
Carestream Health, Inc., 2013
PN AA4597
Revision B
Printed in China