Carestream Focus HD 35 User manual

User Manual for the Focus HD 35 Detector
Publication No. AL4608
2021-09-07
Supersedes:
2021-07-08

All rights reserved. No part of this manual may be reproduced or copied in any form by any
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.
AL4608 -iii 2021-09-07

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.
Copyright
• All rights reserved.
Notices and Conventions
AL4608 -iv 2021-09-07

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
AL4608 i2021-09-07

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
AL4608 1-1 2021-09-07

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
AL4608 1-2 2021-09-07

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 35 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 35 Detector 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
AL4608 1-3 2021-09-07

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
AL4608 1-4 2021-09-07

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
AL4608 1-5 2021-09-07