AA4597 SPT1 Safety and Regulatory 2013-04-04_en.pdf

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CARESTREAMSPT1 Radiographic Table

Safety and Regulatory Guide

2013-04-04

PN AA4597

Version 2.0


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AA4597 i

Table of Contents

Safety and Regulatory

Overview ........................................................................................................................................1

Manual Conventions .................................................................................................................1

Safety and Regulatory ...............................................................................................................2

Publication History.........................................................................................................................8


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OverviewThe 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 SPT1Radiographic Table should receive training and befamiliar with all aspects of operation andmaintenance. To ensure safety, read the Safety andRegulatory Information carefully before using thetable and observe all Cautions, Importants, andNotes located throughout the manual.

The Safety and Regulatory Guide language of origin is English.

Manual Conventions This manual uses three types of messages to emphasizeinformation or potential risks to personnel or equipment: Notes,

Importants, and Cautions.

NOTE: Notes provide additional information, such as expandedexplanations, hints, or reminders.

IMPORTANT:Important highlights critical policy information thataffects how you use this manual and this product.


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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 thelast user wishes to discard this product, it must be sent to

appropriate facilities for recovery and recycling.

Contact your local authorized representative for additionalinformation.


Safety CautionsCAUTION:

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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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.

Operating

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


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Labels Data Plate Label Sample

1 Official product name

2 Service code and serial number

3 Manufactured date

4 Model type as required/consistent with product safety testreports

5 Voltage range, rated frequency in hertz and amps/consistent withproduct safety test reports: V = volts, Hz = hertz, A = amperes

6 Symbols for product safety, EMC, and CE marking

7 SFDA Registration number

8 SFDA Product Standard number

9 Compliance statement according to FDA requirements forradiation emitting products

10 Label manufacturer registration number and materialspecification.

11 Made in China by (signature)

Made in China byCarestream Health, Inc.150 Verona Street, Rochester, NY 14608 USA1510

SNSC

MODEL

Manufactured:

P/N XXXXXX REV A

Official Product Name (Engl ish)

Official Product Name (Japanese, i f required)

Official Product Name (Chinese, i f required)

THIS PRODUCT COMPLIES WITH 21 CFR CHAPTER 1, SUBCHAPTER J

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9

8

7

6

5

4

3

2

1

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Float Label

Up-Down Label

H225_1076HC

data plate


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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

AA4597 SPT1 Safety and Regulatory 2013-04-04_en.pdf

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