Carestream Focus 35C User manual

Publication No. AJ4309
2019-08-13
User Manual for the
CARESTREAM Focus 35C Detector

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.

AJ4309 | 2019-08-13 1–i
1 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 Representative (European Union)
Carestream Health France
1, rue Galilée
93192 NOISY-LE-GRAND CEDEX
FRANCE
Importer for European Union
Carestream Health Netherlands B.V.
Bramenberg 12
3755 BZ Eemnes
The Netherlands

Notices and Conventions
1–ii AJ4309 | 2019-08-13
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.

Notices and Conventions
AJ4309 | 2019-08-13 1–iii
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 fire,
earthquake, any accident, misuse, or abuse of the product.
• Carestream shall not be liable for any damage, loss, or injury arising from
unauthorized modifications, 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 specifications, compositions, and appearance of this
product is subject to change without prior notice.
Copyright
• All rights reserved.
• No part of this publication may be reproduced in any form or by any means without
the written permission of Carestream. The information contained herein is designed
only for use with the CARESTREAM Focus 35C Detector.

Notices and Conventions
1–iv AJ4309 | 2019-08-13

AJ4309 | 2019-08-13 v
Contents
1 Notices and Conventions
Disclaimer...................................................................................................................................... 1-iii
1 Safety and Regulatory Information
Symbols .......................................................................................................................................... 1-1
Cautions ......................................................................................................................................... 1-5
Medical Equipment Classification............................................................................................... 1-16
Standards ..................................................................................................................................... 1-17
Emissions and Immunity Compliance to the IEC60601-1-2 Standard ....................................... 1-19
Radio Frequency Compliance...................................................................................................... 1-23
Correction and Calibration Template Generation............................................................... 1-23
Battery Safety Standards............................................................................................................. 1-24
Intended Use and Essential Performance................................................................................... 1-25
2Overview
Components and Specifications.................................................................................................... 2-2
Product Components............................................................................................................... 2-2
Product Specifications ............................................................................................................. 2-6
IT Network ............................................................................................................................. 2-11
Service Information ..................................................................................................................... 2-14
Disposal ........................................................................................................................................ 2-15
3 Installation
Panel Installation........................................................................................................................... 3-1
Install the Detector Battery..................................................................................................... 3-1
Power on the Detector............................................................................................................ 3-2
Install the Detector Battery Charger ............................................................................................ 3-7
Detector Battery Lock and Activation .......................................................................................... 3-8
4 Operation
Notes for Using.............................................................................................................................. 4-1
Detector Position ........................................................................................................................... 4-3
AAppendix
Software and Settings .................................................................................................................. A-1
Operating Modes.......................................................................................................................... A-8
Software Mode ....................................................................................................................... A-8
Inner2 Mode ........................................................................................................................... A-9
Freesync Mode ...................................................................................................................... A-10
Software Installation.................................................................................................................. A-12

Contents
vi AJ4309 | 2019-08-13
Set the Connection Mode .......................................................................................................... A-13
Wireless Client Mode............................................................................................................ A-13
Wireless AP Mode................................................................................................................. A-19
Shortcuts ..................................................................................................................................... A-24
Establish a Connection with the Detector ................................................................................ A-25
Configure the Detector.............................................................................................................. A-26
Correction and Calibration Template Generation.................................................................... A-29
Pre-offset Template Generation.......................................................................................... A-29
Gain Calibration Template Generation............................................................................... A-30
Defect Correction Template Generation............................................................................. A-32
Image Check and Upload........................................................................................................... A-35
Local Image Check ................................................................................................................ A-35
Panel Image Upload ............................................................................................................. A-35
Defect Template Check and Modification ................................................................................ A-37
Defect Template Check ........................................................................................................ A-37
Defect Template Modification............................................................................................. A-38
Correction and Calibration Management................................................................................. A-40
Correction and Calibration Template Synchronization...................................................... A-40
Correction and Calibration Management........................................................................... A-42
Update the Firmware ................................................................................................................. A-44
Publication History

AJ4309 | 2019-08-13 1–1
1 Safety and Regulatory Information
Symbols
Symbols and Conventions
Labels and Markings on the Equipment
WARNING:
This is used to identify conditions under which improper use of the
product may cause death or serious personal injury.
This is used to indicate a prohibited operation.
This is used to indicate an action that must be performed.

Safety and Regulatory Information
1–2 AJ4309 | 2019-08-13
This indicates that the product has passed CE certification and is fol-
lowed by the CE number.
This is used to identify the manufacturer’s series number, which is after,
below, or adjacent to the symbol. The series number usually consists of
19 digits as shown in the following example:
1A2A3A4 B1B2 C1C2 L M1M2 D1D2 Y1Y2 X1X2X3X4
• 1A2A3A4 - Product code
• B1B2 - Derived classes
• C1C2 - Version
• L - Production site
• M1M2 - Month
• D1D2 - Day
• Y1Y2 - Year
• X1X2X3X4 - Numerical order
This indicates the name and address of the manufacturer.
This indicates the name and address of a Carestream authorized repre-
sentative in the European region.
This indicates consulting the user guide for general information.
Safety sign: Dangerous Voltage
Handle with care.

Safety and Regulatory Information
AJ4309 | 2019-08-13 1–3
This indicates operational temperature limits.
This indicates storage temperature limits.
This indicates the product radiates a wireless signal.
Package symbol: Fragile
Package symbol: Keep away from sunlight.
Package symbol: Keep dry.
This indicates the humidity limits.

Safety and Regulatory Information
1–4 AJ4309 | 2019-08-13
Keep the product upright.
Do not roll the transportation packaging.
This indicates the stacking limit number.
This indicates a Type-B applied part.

Safety and Regulatory Information
AJ4309 | 2019-08-13 1–5
Cautions
Environment for Installation and Use
Environment for Installa-
tion and Use
WARNING:
Do not use or store the product near flammable chemicals such as alcohol,
thinner, benzene, etc.
Chemicals that are spilled or evaporated may result in fire or electric shock
through contact with electric parts inside the product. Also, some disinfec-
tants are flammable. Be sure to take care when using them.
WARNING:
Do not connect the equipment with anything other than the specified
connectors to avoid fire or electric shock.
WARNING:
Keep all patients with active implantable medical devices away from the
product.

Safety and Regulatory Information
1–6 AJ4309 | 2019-08-13
Installation and Environ-
ment of Use
CAUTION:
Do not install the product in any of the locations listed below to avoid failure,
malfunction, falling, fire, or injury.
• Close to facilities where water is used
• Where there is exposure to direct sunlight
• Close to the air outlet of an air conditioner or ventilation equipment
• Close to a heat source such as a heater
• Where the power supply is unstable
• In a dusty environment
• In a saline or sulfurous environment
• Where temperature or humidity is high
• Where there is freezing or condensation
• In areas prone to vibration
• On an incline or in an unstable area
Installation and Environ-
ment of Use
CAUTION:
Do not allow cables to become tangled to avoid a malfunction of the
product.
Do not get your feet caught by a cable to avoid tripping and injury.
CAUTION:
Non-medical equipment such as battery chargers and access point and
infrared register tools cannot be used in the vicinity of a patient.

Safety and Regulatory Information
AJ4309 | 2019-08-13 1–7
Power Supply
Power Supply
WARNING:
Do not operate the product with a power supply other than the one indicated
on the rating label to avoid fire or electric shock.
WARNING:
Do not handle the product with wet hands to avoid electric shock that could
result in death or serious injury.
WARNING:
Do not place heavy object on cables and cords. Co not pull, bend, bundle, or
step on them to prevent damage to the sheath. Do not alter them.
Avoid damage to the cords, which could result in fire or electric shock.
WARNING:
Do not supply power from the same AC outlet to more than one product to
avoid fire or electric shock.
WARNING:
Do not turn on system power when condensation has formed on the equip-
ment to avoid fire or electric shock.

Safety and Regulatory Information
1–8 AJ4309 | 2019-08-13
Power Supply
WARNING:
Do not connect multiple portable socket outlets or extension cords to the
system to avoid fire or electric shock.
WARNING:
Connect this product only to a power supply with protective earth to avoid fire
or electric shock.
WARNING:
Do not use the adapter cord when connecting the panel to a patient.

Safety and Regulatory Information
AJ4309 | 2019-08-13 1–9
Power Supply
WARNING:
Securely insert the power cord into the AC outlet to avoid a contact failure.
If a contact failure occurs or if metal objects come in contact with the exposed
metal prongs of the plug, fire or electric shock may result.
WARNING:
Be sure to turn off the power before connecting or disconnecting the cords to
avoid an electric shock that could result in death or serious injury.
WARNING:
Be sure to hold the plug or connector to disconnect the cord.
If you pull the cord, the core wire may be damaged, resulting in fire or electric
shock.
Power Supply
CAUTION:
• Always connect a three-core power cord plug to a grounded AC power
outlet.
• Keep the outlet free of obstacles for easy access to disconnect the plug at
any time and in an emergency.
• Be sure to ground the product to an indoor grounded connector. Be sure
to connect all the grounds of the system to common ground.
CAUTION:
Do not use any power source other than the one provided with the product
to prevent leakage that could result in fire or electric shock.

Safety and Regulatory Information
1–10 AJ4309 | 2019-08-13
Handling
Handling
WARNING:
No modification is allowed. Never disassemble or modify the product to avoid
fire or electric shock.
The product incorporates parts that may be hazardous or cause electric shock
Touching them may cause death or serious injury.
WARNING:
Do not place an object on top of the product. The object may fall and cause
an injury.
Metal objects such as needles or clips that fall into the product or spilled liquid
may result in fire or electric shock.
WARNING:
Do not strike, drop, or cause a strong jolt to the product to prevent damage
and avoid fire or electric shock.
Handling
WARNING:
Do not place the product and pointed objects together to prevent damage.
If so, it should be used in Bucky.
WARNING:
Have the patient take a fixed posture and do not let the patient touch parts
unnecessarily.
If the patient touches connectors or switches, it may result in electric shock or
malfunction.

Safety and Regulatory Information
AJ4309 | 2019-08-13 1–11
Handling
CAUTION:
Do not spill liquid or chemicals onto the equipment. Do not allow an injured
patient’s blood or body fluids contact with the equipment.
Doing so may result in fire or electric shock.
In such a situation, protect the equipment with a disposable cover as neces-
sary.
CAUTION:
For safety Turn OFF the power and remove the plug for all equipment when
not used.
CAUTION:
Handle the product carefully.
Do not submerge the product in water.
Handling
CAUTION:
The internal image sensor may be damaged if struck or dropped. If the product
is dropped, the drop sensor inside would record and the product would not
be under warranty.

Safety and Regulatory Information
1–12 AJ4309 | 2019-08-13
Handling
CAUTION:
Do not place excessive weight on the panel to avoid damage to the internal
image sensor and an incorrect image.
Patients stand on the product temporarily, and the intended weight can be
135 kg.
Based on the internal TFT character, cannot load the dynamic forces due to
loading from persons
Load Limit
Uniform load:150 kg over the whole area of the surface
Local load:100 kg on an area 4 cm diameter