SAMSUNG

SMART DIGITAL
RADIOGRAPHY SOLUTION

Safety Instructions
GF50
v2.0.0

GF50_SI_v2.0.0
Revision History
Version Date History

Rev.0 2013.09.26 • Initial release of document

• Updated the procedure related to 40kW

generator.
Rev.1 2014.06.21
• Corrected unclear procedures.
• Removed the “5.Firmware upgrade” chapter.

Rev.2 2014.11.24 • Updated PBT6/PBT4 Connection Diagram

Patient Privacy Policy
Treatment of Patients' Personal Information
One of Samsung's social responsibilities is to recognize the importance of patient privacy, and handle
and protect the personal information provided by patients in an appropriate manner.
Patient information stored in repaired and demo products should be handled as follows.
• Patient Information: IDs, names, DOBs, and images are information used to identify patients.
• Patient Information Management: Personal information provided by patients must be protected
during repairs and demonstrations. Do not use, distribute, or lose patient information.

Management of Patient Information on Demo and Trade Products

• Patient information stored on a product during the course of its use must be handled as the patient
desires. (delete or backup)
• When a demo or trade product is collected, patient information must be deleted if so requested by
the patient, to prevent its unintended distribution.

Management of Patient Information on Repaired Hospital Products

• Before removing the product from hospital premises for repairs, all patient information should be
backed up to an external HDD or memory device.
• Before removing the product from hospital premises, each patient should sign the patient privacy
agreement.
 Request for Repairs and Patient Privacy Agreement
Date: MM/DD/YY
[Customer Information]

Hospital

Handler

[Product Information]

Product Name
Software Version
S/N
Symptom
 None  Main unit  HDD  DVD/CD
Stored Item
 USB  Photo  Other ( )

 None
Outsourced Product
 Provide details if applicable ( )

[Administration]

Handling date MM/DD/YY

Customer Service Representative

* Please sign inside the box below if you agree to the following.
Data saved on memory devices, for example, hard disks, can be lost during tests and repairs.
Data saved on a product being repaired must be backed up by the customer.
Samsung will not be held responsible for any loss of data not backed up.
Samsung does not use or modify patient information, or provide it to third parties.

I entrust my product to ( ) to be repaired and agree to the above policies.

Date: MM/DD/YY Name: (Signature)

[Customer Signature]
GF50 | Safety Instructions General Safety

Table of Contents

1. General Safety ......................................................................................................... 6

2. Safety Instructions ................................................................................................. 7
2.1.Medical Device Safety ............................................................................................................... 7
2.1.1. General Safety .......................................................................................................... 7
2.1.2. Electrical Safety ......................................................................................................... 8
2.1.3. Safety from Explosion ............................................................................................... 8
2.1.4. Electromagnetic Compatibility (EMC) ....................................................................... 8
2.1.5. Mechanical Safety ..................................................................................................... 9
2.1.6. Radioactive Safety .................................................................................................... 9
2.1.7. User Information and User Messages ..................................................................... 10
2.2.Labels ..................................................................................................................................... 11
2.3.Maintenance and Cleaning ...................................................................................................... 15
2.3.1. Maintenance ............................................................................................................ 15
2.3.2. Cleaning .................................................................................................................. 15
2.3.3. Disinfection .............................................................................................................. 15
2.3.4. Disposal ................................................................................................................... 15

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General Safety GF50 | Safety Instructions

1. General Safety

Before installing or servicing this system, you must read and comply with all the safety instructions in
the "General Safety" manual.

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GF50 | Safety Instructions Safety Instructions

2. Safety Instructions
This chapter provides safety information and instructions that users and physicians must be fully
familiar with before using the system.
It is provided to protect users of the system from unintended safety hazards and prevent property
damage, please read thoroughly and follow the instructions. If you need any additional training,
please contact the designated service personnel authorized by the manufacturer.

Before using the GR40 system, please read the safety instructions thoroughly. The
manufacturer assumes no liability for any accidents that may occur as a result of
operations performed without following the relevant safety instructions.

2.1. Medical Device Safety

2.1.1. General Safety

• This system must be serviced by engineers who have received professional

installation training.
• Since this system generates X-rays, it must be installed and used in compliance with
the relevant international laws and regulations.
• Only authorized users are permitted to use this system. If it is used by someone who
is not fully familiar with the safety precautions, operating instructions and
maintenance schedule, it may be hazardous to both the patient and the user.
• Please consult the manufacturer before connecting a component from another
system to this system. Any auxiliary device connected to the system must be IEC
certified (data processing equipment: IEC60950, medical device: IEC60601-1). Also,
if the auxiliary device is connected to a signal I/O port, it should comply with
IEC60601-1.
• If an error message appears while the system is in use, it may stop operating. When
an error message appears, contact the service center.
• The manufacturer will not accept liability for:
– Fault, damage or personal injury incurred by any user as a result of performing
system maintenance incorrectly.
– Personal injury incurred due to the user's carelessness
– Fault, damage or personal injury incurred due to the use of an auxiliary device
which was not provided by the manufacturer.

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Safety Instructions GF50 | Safety Instructions

2.1.2. Electrical Safety

• In compliance with IEC 60601-1, this medical equipment complies with the
requirements for Safety class 1, type B.
• This system must be used in an environment complying with the requirements of the
IEC.
• Do not remove the safety cover of this system unless absolutely necessary. When it
is removed, the high voltage current inside the system may cause electric shocks.
• Be careful to ensure that no liquids enter the system.
• If the system malfunctions and there is an imminent danger to the patient or yourself,
please press one of the Emergency Stop buttons to stop the system.
• An unstable power supply may cause the system to malfunction or to suddenly stop
operating, and may cause personal injury to the patient or the user. Make sure that
the system is installed with a stable power supply.
• Emergency Stop buttons
– If the system poses a danger of causing personal injury to the patient or yourself,
you can switch it off forcibly by pressing one of the Emergency Stop buttons.
– The Emergency Stop buttons are located on the THU, the patient table, wall
stand, and the CIB. Pressing any one of them will switch off the system.

2.1.3. Safety from Explosion

Do not operate the system in a location where there is a danger of explosion. This
system is not designed to be used in a location where there is a danger of explosion.

2.1.4. Electromagnetic Compatibility (EMC)

• Do not use any wireless devices, including cellular phones, near the system. All
wireless devices, whether they comply with the EMC standard or not, may emit
electromagnetic interference and cause the system to malfunction when they are
used nearby.
• When using this system on a patient with an implantable pacemaker or an
implantable cardioverter defibrillator, the patient must be informed that continuous X-
ray exposure in pulse form may cause the pacemaker or cardioverter defibrillator to
malfunction. When using this system, ensure that X-rays are not exposed directly
onto the patient's implantable pacemaker or cardioverter defibrillator, and that the
patient's exposure time is kept as short as possible.

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GF50 | Safety Instructions Safety Instructions

2.1.5. Mechanical Safety

• Do not remove the system cover and cables except when directed to do so by an
engineer who has received professional training.
• Check the connection status of the assembled cables when operating the device.
Not inserting the connector, or inserting it partially, incorrectly, or backwards may
cause a serious system failure. When an examination is in progress, auditory and
visual communication between the patient and the user must be possible at all
times.
• Be careful not to pinch any part of your or the patient's body or clothing in the
equipment while using the system. The following warnings, as shown in the figure
below, are attached to parts of the system where pinching or crushing of the patient
or user are more likely to occur during use.

Pinching Warning Crushing Warning

Figure 2-1. Warning Symbols for Pinching and Crushing

2.1.6. Radioactive Safety

• This system complies with IEC60601-1-3 (X-ray Radiation Protection).

• When examining a patient, the effective X-ray emission area must be made as small
as possible. If it is impossible to emit X-rays only onto the area to be examined, use
lead shields to protect the surrounding parts of the patient's body.
• Capture images precisely to prevent the patient from being exposed to excessive
radiation.
• Please comply with the following to minimize the amount of X-ray exposure to the
patient during examination.
– High tube voltage
– Short emission time
– Enough distance between the patient and the X-ray tube
• When you emit X-rays in the examination room, you must wear lead protection. Also,
monitor the amount of radiation exposure by using a film badge or radiation
dosimeter.
• Do not leave the shielding door between the test room and interior space open while
operating the equipment.
– This equipment must be used in an authorized shielded room. The manufacturer
assumes no liability for any failure or damage which may occur as a result of
operations performed in an unauthorized shielded room.
• Do not leave any windows open in the test room while operating the equipment.
High temperatures or rapid changes in temperature may damage the PCB inside the
equipment and cause a malfunction or fire.

GF50_SI_v2.0.0 9
Safety Instructions GF50 | Safety Instructions

2.1.7. User Information and User Messages

• This chapter provides the safety information and instructions that users and
physicians must be fully familiar with before using the system. It is provided to protect
users of the system from unintended safety hazards and prevent property damage,
please read thoroughly and keep instructions.
• Before using the system, make sure to read through and fully understand the safety
instructions presented in this manual. The manufacturer assumes no liability for any
accidents which may occur as a result of operations performed without following the
relevant safety instructions.

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GF50 | Safety Instructions Safety Instructions

2.2. Labels
The following symbols and labels are used in the XGEO GF50.
Symbol - Maximum

Symbol - Caution

Symbol - Warning

Symbol-Manual

Label - Warning

GF50_SI_v2.0.0 11
Safety Instructions GF50 | Safety Instructions

Label - Caution

12 GF50_SI_v2.0.0
GF50 | Safety Instructions Safety Instructions

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Safety Instructions GF50 | Safety Instructions

14 GF50_SI_v2.0.0
GF50 | Safety Instructions Safety Instructions

2.3. Maintenance and Cleaning

2.3.1. Maintenance
• Inspect the equipment periodically for patient and user safety.
• For more information on system inspection, refer to System Information and Inspection.

2.3.2. Cleaning
• There is a risk of system malfunction, electric shock, or danger of fire, so the system and X-ray
room should be cleaned periodically.
• Turn off the equipment power as well as the power supply on the wall before cleaning.
• Do not open the cover and insert liquids into the system.
• When cleaning the exterior of the system, use a soft cleaning cloth slightly dampened with warm
water and soap. Do not use detergents or chemical solutions.
• Use a soft cleaning cloth when cleaning the THU user interface and the LCD screen. When using
a spray cleaner for the LCD screen, do not spray it directly onto the screen.
• Cables connected to the equipment may be lifted or pulled while the cleaner cleans the room.
When cables are lifted or pulled they may get caught and cause malfunction, electric shock, or
danger of fire. Be careful not to move the equipment and cables when cleaning. Also, water may
be absorbed into the equipment if mopped with a damp cloth, which may cause electric shock or
fire.

2.3.3. Disinfection
• Any part of the system coming into direct or indirect contact with a patient should be disinfected
periodically.
• Please comply with the hygiene regulations of the hospital.
• When disinfecting the system, use a soft cloth dampened with warm water and soap. Do not use
detergents or chemical solutions.

2.3.4. Disposal
• Since it contains industrial waste materials, improper disposal of this system may pollute the
environment. Never dispose of it with general industrial waste or household waste.
• When disposing of a part of or the whole system, be sure to comply with the local laws and
regulations. For more information on disposal, contact an authorized agent in your region. Any part
of the system coming into direct or indirect contact with a patient should be disinfected periodically.

GF50_SI_v2.0.0 15
 This document is the technical property of
Samsung Electronics Co Ltd. Using this
document without prior permission or for
purposes other than repairs of the products of
Samsung Electronics without approval may be
subject to legal actions.

Samsung Electronics Co, Ltd. All rights reserved