Carestream Focus HD 43 Manuale utente

User Manual for the Focus HD 43 Detector

Publication No. AL4609

2021-09-21

Supersedes:

2021-07-08

means—graphic, electronic, or mechanical, including photocopying, typing, or information

retrieval systems—without written permission.

Notices and Conventions

The information 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, even if loss or damage is caused by

Carestream Health’s negligence or fault.

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 a potentially hazardous situation which, if not avoided, might cause minor

or moderate injury.

Authorized European Representative

Carestream Health France SAS

207, Rue de Bercy

75012 Paris

France

CAUTION:

Federal law restricts this device to sale by or on the order of a physician.

CAUTION:

If you witness or become aware of a potential safety issue with this equipment, take the

appropriate safety measures and report this to your Carestream Service representative

immediately.

AL4609 -iii 2021-09-21

Disclaimer

• Carestream shall not be liable to the purchaser of this product or third parties for

any damage, loss, or injury incurred by the purchaser or third parties as a result of

re, earthquake, any accident, misuse, or abuse of the product.

• Carestream shall not be liable for any damage, loss, or injury arising from

unauthorized modications, repairs, or alterations to the product or failure to

strictly comply with Carestream’s operating and maintenance instructions.

• Carestream shall not be liable for any damage or loss arising from the use of any

options or consumable products other than those dedicated as original products by

Carestream.

• It is the responsibilities of the user or physician to maintain the privacy of image

data and provide medical care services. Carestream shall not be responsible for the

legality of image processing, reading, and storage nor shall it be responsible for loss

of image data for any reason.

• Information regarding the specications, compositions, and appearance of this

product is subject to change without prior notice.

Notices and Conventions

AL4609 -iv 2021-09-21

Contents

Notices and Conventions

Disclaimer......................................................................................................................................... -iv

1 Safety and Regulatory Information

Medical Equipment Classication..................................................................................................1-1

Standards.........................................................................................................................................1-2

Emissions and Immunity Compliance to the IEC60601-1-2 Standard.....................................1-3

Battery Safety Standards.......................................................................................................... 1-7

Radio Frequency Compliance.........................................................................................................1-8

Correction and Calibration Template Generation................................................................ 1-10

Intended Use................................................................................................................................. 1-11

2 Operation

Notes for Using............................................................................................................................... 2-1

Symbols............................................................................................................................................2-2

Cautions...........................................................................................................................................2-5

Detector Position............................................................................................................................ 2-9

Panel Installation.......................................................................................................................... 2-10

Install the Detector Battery.................................................................................................... 2-10

Power on the Detector........................................................................................................... 2-11

Install the Detector Battery Charger........................................................................................... 2-15

Detector Battery Activation......................................................................................................... 2-16

3 Overview

Components and Specications.....................................................................................................3-2

Product Components................................................................................................................ 3-2

Product Specications...............................................................................................................3-5

Disposal......................................................................................................................................... 3-11

Publication History

AL4609 i2021-09-21

1Safety and Regulatory Information

Medical Equipment Classication

Type of protection against electrical shock Internal electrical power source equipment (battery)

Degree of protection against electrical shock Type-B applied part

Degree of protection against ingress of water IP56

Mode of operation Continuous operation

Flammable anesthetics Not suitable for use in the presence of a ammable

anesthetic mixture with air or with oxygen or nitrous

oxide

Not suitable for use in an oxygen-rich environment

AL4609 1-1 2021-09-21

Standards

IEC 60601-1:2005/AMD1:2012 Medical electrical equipment — Part 1: General

requirements for basic safety and essential

performance

IEC 60601-1-2:2014/EN60601-1-2:2015 Medical electrical equipment — Part 1-2: General

requirements for basic safety and essential

performance — Collateral standard:

Electromagnetic disturbances v Requirements and

tests

IEC 62133-2:2017 Secondary cells and batteries containing alkaline or

other non-acid electrolytes — Safety requirements

for portable sealed secondary lithium cells, and for

batteries made from them, for use in portable

applications — Part 2: Lithium systems

IEC 62220-1-1:2015/EN 62220-1-1:2015 Medical electrical equipment — Characteristics of

digital X-ray imaging devices — Part 1-1:

Determination of the detective quantum efciency

- Detectors used in radiographic imaging

IEC 62304:2006/AMD1:2015 Medical device software — Software life-cycle

processes

IEC 62366-1:2015/IEC 62366:2007/EN62366:2008 Medical devices — Part 1: Application of usability

engineering to medical devices

IEC 60601-1-6:2010+A1:2013 Medical electrical equipment — Part 1-6: General

requirements for basic safety and essential

performance — Collateral standard: Usability

EN ISO14971:2012 Medical device — Application of risk management

to medical devices

ANSI/AAMI ES60601-1:2005/

(R)2012+A1:2012+C1:2009/(R)2012+A2:2010/

(R)2012

Medical electrical equipment — Part 1: General

requirements for basic safety and essential

performance (IEC 60601-1:2005, MOD)

CAN/CSA-C22.2

No.60601-1:14

Medical electrical equipment — Part 1: General

requirements for basic safety and essential

performance

ISO 15223-1:2016/ EN ISO 15223-1:2016 Medical devices — Symbols to be used with

medical device labels, labeling and information to

be supplied-Part 1: General requirements

Safety and Regulatory Information

AL4609 1-2 2021-09-21

Emissions and Immunity Compliance to the IEC60601-1-2

Standard

Electromagnetic Emissions

Emissions Test Compliance Electromagnetic Environment

RF emissions CISPR 11

Group 1, Class B

The Focus HD 43 Detector uses RF energy

only for its internal function. Therefore, its

RF emissions are very low and are not likely

to cause any interference in nearby

electronic equipment.

Harmonic distortion IEC 61000-3-2

Class A

The Focus HD 43Detector is suitable for use

in all establishments, including domestic

establishments and those directly

connected to the public low voltage power

supply network that supplies buildings

used for domestic purposes.

Voltage uctuations and icker IEC 61000-3-3

Compliance

Electromagnetic Immunity

Emissions Test EMC Standard

Test Levels

Professional healthcare facility

environment

Electrostatic discharge IEC 61000-4-2 ±8 kV contact

±2 kV, ±4 kV, ±8 kV, ±15 kV air

Radiated RF EM eld IEC 61000-4-3 3 V/m

80 MHz–2.7 GHz

80 % AM at 1 kHz

Proximity elds from RF wireless

communications equipment

IEC 61000-4-3 Refer to Proximity Fields From RF Wireless

Communications Equipment

Rated power frequency

magnetic elds

IEC 61000-4-8 30 A/m

50 Hz or 60 Hz

Safety and Regulatory Information

AL4609 1-3 2021-09-21

Proximity Fields From RF Wireless Communications Equipment

Test Frequency

(MHz) Band (MHz)

Test Levels

Professional healthcare facility environment

385 380–390 Pulse modulation 18 Hz, 27 V/m

450 430–470 FM, ±5 kHz deviation, 1 kHz sine, 28 V/m

710

704–787 Pulse modulation 217 Hz, 9 V/m745

780

810

800-–960 Pulse modulation 18 Hz, 28 V/m870

930

1720

1700–1990 Pulse modulation 217 Hz, 28 V/m1845

1970

2450 2400–2570 Pulse modulation 217 Hz, 28 V/m

5240

5100–5800 Pulse modulation 217 Hz, 9 V/m

5500

5785

Safety and Regulatory Information

AL4609 1-4 2021-09-21

Input AC Power Port

Emissions Test EMC Standard

Test Levels

Professional healthcare facility environment

Electrical fast transients/burst IEC 61000-4-4 ±2 kV

100 kHz repetition frequency

Surges

Line-to-line

IEC 61000-4-5 ±0.5 kV, ±1 kV

Surges

Line-to-ground

IEC 61000-4-5 ±0.5 kV, ±1kV, ±2 kV

Conducted disturbances

induced by RF elds

IEC 61000-4-6 3 V, 0.15 MHz–80 MHz

6 V in ISM bands between 0.15 MHz and

80 MHz

80 % AM at 1 kHz

Voltage dips

IEC 61000-4-11

0 % UT; 0.5 cycle

At 0 º, 45 º, 90 º, 135 º, 180 º, 225 º, 270 º and

315 º

Voltage dips IEC 61000-4-11 0 % UT; 1 cycle

and

70 % UT; 25/30 cycles

Single phase: at 0 º

Voltage interruptions IEC 61000-4-11 0 % UT; 250/300 cycles

Safety and Regulatory Information

AL4609 1-5 2021-09-21

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