Carestream Focus HD 43 User manual

User Manual for the Focus HD 43 Detector
Publication No. AL4609
2021-09-21
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.
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.
Copyright
• All rights reserved.
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

Signal Input/Output Parts Port
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
Electrical fast transients/burst IEC 61000-4-4 ±1 kV
100 kHz repetition frequency
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
Reference Cables Provided Against EMC
Cable Recommended
Cable Length
Shielded or
Unshielded Number Cable Classication
LAN Cable
(conguration mode)
3.5 m Shielded 1 pcs Signal
Important Information Regarding Electromagnetic Compatibility (EMC)
Focus HD 43 should be used in the hospital environment except for near active HF
surgical equipment and the RF shielded room of a medical equipment system for
magnetic resonance imaging, where the intensity of electromagnetic disturbances is
high.
Use of Focus HD 43 adjacent or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this equipment
and the other equipment should be observed to verify correct operation.
Focus HD 43 requires special precautions regarding EMC and needs to be installed only
by Carestream or authorized personnel and put into service according to EMC
information provided in the user manual.
Safety and Regulatory Information
AL4609 1-6 2021-09-21

CAUTION:
Portable and RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 in.) to any part of the Focus HD 43,
including cables specied by the manufacturer. Otherwise, degradation of the performance of
this equipment could result.
Focus HD 43 conforms to this IEC60601-1-2:2014/EN60601-1-2:2015 standard for both
immunity and emissions. Nevertheless, special precautions need to be observed.
The use of accessories, transmitters, and cables other than those specied by this user
manual, with the exception of accessories and cables sold by Carestream as Focus HD 43
replacement parts for inner components, may result in increased emission or decreased
immunity.
Battery Safety Standards
Standards Description
IEC 62133:2012 Secondary cells and batteries containing alkaline or other non-
acid electrolytes
UN38.3
United Nations Recommendations on the Transport of
Dangerous Goods Manual of Tests and Criteria ST/SG/
AC.10/11/Rev.5/Amend.1 and Amend.2
Safety and Regulatory Information
AL4609 1-7 2021-09-21

Radio Frequency Compliance
Country Item
U.S.A
FCC CFR47 Part 15C (2019) Radio Frequency Devices
ANSI C63.10 (2013)
FCC Code CFR47 Part15B (2020)
ANSI C63.4 (2014)
FCC CFR47 Part 15E (2019)
IEEE 1528- 2013
IEEE C95.1: 1991
IEEE C95.1: 1992
European Union
ETSI EN300 328 V2.2.2
ETSI EN301 893 V2.1.1
ETSI EN300 440 V2.1.1
ETSI EN 301 489-1 V2.2.3
ETSI EN 301 489-17 V3.2.4
ETSI EN 301 489-3 V2.1.1
EN 55032:2015+A11:2020
EN 55035:2017+A11:2020
EN 50566:2017
EN 62209-2:2010+A1:2019
EN 62479:2010
FCC Regulations
• This device complies with part 15 of the FCC Rules. Operation is subject to the
following two conditions: (1) This device may not cause harmful interference, and
(2) this device must accept any interference received, including interference that
may cause undesired operation.
• This equipment has been tested and found to comply with the limits for a Class B
digital device, pursuant to part 15 of the FCC Rules. These limits are designed to
provide reasonable protection against harmful interference in a residential
installation. This equipment generates, uses and can radiate radio frequency energy
and, if not installed and used in accordance with the instructions, may cause
harmful interference to radio communications. However, there is no guarantee that
Safety and Regulatory Information
AL4609 1-8 2021-09-21

interference will not occur in a particular installation. If this equipment does cause
harmful interference to radio or television reception, which can be determined by
turning the equipment off and on, the user is encouraged to try to correct the
interference by one or more of the following measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different from that to which
the receiver is connected.
• Consult the dealer or an experienced radio/ TV technician for help.
• Changes or modications not expressly approved by the manufacturer could void
the user’s authority to operate the equipment.
• Contains module’s FCC ID：2ACHK-01070189
Radio Frequency (RF) Energy
This device is designed and manufactured not to exceed the emission limits for
exposure to radio frequency (RF) energy set by the Federal Communications
Commission of the United States.
The exposure standard for wireless devices employing a unit of measurement is known
as the Specic Absorption Rate, or SAR. The SAR limit recommended by the general
public is 1.6W/kg averaged over one gram of tissue by IEEE Std 1528.
The FCC has granted an Equipment Authorization for this product with all reported
SAR Levels evaluated as in compliance with the FCC RF exposure guidelines.
While there may be differences between the SAR levels of various product and at
various positions, they all meet the government requirements.
SAR compliance for body-worn operation is based on a separation distance of 0 mm
between the unit and the human body. Carry this device at least 0 mm away from your
body to ensure RF exposure level compliant or lower to the reported level.
IC Notice
This device complies with Industry Canada license-exempt RSS standard(s). Operation is
subject to the following two conditions:
1. This device may not cause interference.
2. This device must accept any interference, including interference that may cause
undesired operation of the device.
This Class B digital apparatus complies with Canadian ICES-003.
Contains IC: 25116-01070189
IC Radiation Exposure Statement
This EUT is in compliance with SAR for general population/uncontrolled exposure limits
in IC RSS-102 and had been tested in accordance with the measurement methods and
procedures specied in IEEE 1528 and IEC 62209. The SAR limit is 1.6 W/kg by Industry
Canada. This equipment should be installed and operated with minimum distance of 0
Safety and Regulatory Information
AL4609 1-9 2021-09-21

cm between the radiator and your body. This device and its antenna(s) must not be co-
located or operating in conjunction with any other antenna or transmitter.
Correction and Calibration Template Generation
Correction and calibration should be performed after installation and every six months.
The new correction and calibration should be performed after any major change on
the system settings and hardware conguration.
Refer to the IMAGEVIEW System Software Online Help for procedures on detector
calibration.
Safety and Regulatory Information
AL4609 1-10 2021-09-21

Intended Use
Intended Use
These devices are indicated for digital imaging solutions designed to provide general
radiographic diagnosis for human anatomy including both adult and pediatric patients.
They are intended to replace lm/screen systems in all general-purpose diagnostic
procedures. This device is not intended for mammography or dental applications.
Application Specication
Patient Population
• Adult and pediatric patients
Pediatric Use: Guidance & Considerations
Special care should be exercised when imaging patients outside the typical adult size
range, especially smaller pediatric patients whose size does not overlap the adult size
range (for example, less than 50 kg (110 lb) in weight and 150 cm (59 in.) in height,
measurements which approximately correspond to that of an average 12 year old.
The following ranges of pediatric subpopulations are to be used as a guide for
manufacturers in developing medical devices:
Pediatric Subgroup Approximate Age Range
Newborn (Neonate) From birth to 1 month of age
Infant Greater than 1 month to 2 years of age
Child Greater than 2 to 12 years of age
Adolescent Greater than 12 through 21 years of age
Exposure to ionizing radiation is of particular concern in pediatric patients because:
1. For certain organs and tumor types, younger patients are more radio sensitive than
adults (the cancer risk per unit dose of ionizing radiation is higher for younger
patients);
2. Use of equipment and exposure settings designed for adults of average size can
result in excessive and unnecessary radiation exposure of smaller patients;
3. Younger patients have a longer expected lifetime putting them at higher risk of
cancer from the effects of radiation exposure.
To help reduce the risk of excessive radiation exposure, you should follow the ALARA
(As Low As Reasonably Achievable) principle and seek to reduce radiation dose to only
the amount necessary to obtain images that are adequate clinically.
Safety and Regulatory Information
AL4609 1-11 2021-09-21

Additional guidance and recommendation are provided by the Alliance for Radiation
Safety in Pediatric Imaging (Image Gently Alliance) https://www.imagegently.org/
Table 1: Techniques for Typical Body Parts
Body Parts Patient Size kVp mAs SID Grid
Abdomen AP/PA
Very Low Birth Weight (Less than
1.5 Kg)
55 1 1m no
Low Birth Weight (Between 1.5
and 2.5 Kg)
55 1.6 1m no
Newborn (Age is less than 1
month and Weight above than
2.5 Kg)
70 1.6 1m no
Infant (Age is between 1 month
and 2 years)
73 2 1m no
Child (Age is between 2 years
and 12 years)
75 7.1 1m yes
Preadolescent (Age is between 12
years and 13 years)
75 14 1m yes
Adolescent (Age is between 12
years and 21 years)
75 20 1m yes
Adult Small 75 18 1m yes
Adult Medium 80 22 1m yes
Adult Large 85 32 1m yes
Safety and Regulatory Information
AL4609 1-12 2021-09-21

Body Parts Patient Size kVp mAs SID Grid
Chest PA/AP
Very Low Birth Weight 50 1 1m no
Low Birth Weight 55 1 1m no
Newborn 65 1 1m no
Infant 70 1.6 1m no
Child 70 1.6 1m no
Preadolescent 90 2 1m yes
Adolescent 90 2 1m yes
Adult Small 110 1.8 1.8m yes
Adult Medium 110 2.8 1.8m yes
Adult Large 120 4 1.8m yes
Extremities AP/PA
Very Low Birth Weight 50 1 1m no
Low Birth Weight 55 1 1m no
Newborn 57 1 1m no
Infant 57 1.2 1m no
Child 58 1.2 1m no
Preadolescent 62 1.6 1m no
Adolescent 62 2 1m no
Adult Regarding adult details techniques
of Extremities, please refer to the
table of “Techniques for Adult
Extremities”
no
Table 2: Techniques for Adult Extremities
Adult Extremities List kVp mAs SID Grid
Ankle - AP 58 4 1 no
Ankle - Lateral 58 4 1 no
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AL4609 1-13 2021-09-21

Adult Extremities List kVp mAs SID Grid
Femur - AP 70 16 1 yes
Femur - Lateral 70 10 1 yes
Hand - PA 53 1.8 1 no
Hand - oblique 53 1.8 1 no
Humerus - AP 75 7.1 1 yes
Humerus - Lateral 70 3.2 1 yes
Knee - AP 65 10 1 yes
Knee - Lateral 65 10 1 yes
Wrist - PA 55 1.8 1 no
Wrist - Lateral 55 1.8 1 no
Intended Operator
All procedures should be carried out by an operator who has completed the
professional training offered by the company’s customer service staff.
Life Time
Lifetime: 7 years without frequency limit
Safety and Regulatory Information
AL4609 1-14 2021-09-21

2Operation
Notes for Using
Do the following to ensure that the detector functions correctly.
Before Exposure
Inspect the detector daily and conrm it is working properly.
Check that there is no condensation on the any of the surfaces of the detector.
Condensation can be caused by the sudden heating of the room in cold areas. If this
occurs, wait until the condensation evaporates before performing an exposure or
problems may occur with the quality of captured images. When changing the
temperature in an air-conditioner environment, be sure to raise or lower the
temperature gradually.
The product should be warmed up for 15 minutes before exposure or updating the
gain map and defect map.
Make sure exposure rate is over 900 nGy/s @70 kV.
Make sure the wave form of the energy going to the X-ray tube is square and not
pulse.
Check if the patient has recently been injected with a radio isotope; this may cause the
detector to transmit an image without performing an X-ray.
During Exposure
Important:
To prevent image noise, artifacts, or incorrect images, do not use the product near equipment
generating a strong magnetic eld.:
After Usage
Remove the battery from the detector if the detector will not be used for more than 5
days. If the battery is stored for an extended time, it should be charged (30 % to 50 %)
every 3 months or charged (50 % to 70 %) every 6 months.
AL4609 2-1 2021-09-21