1-Safety and Regulatory

Chapter 1 – Safety & Regulatory Information
WARNING
The X-ray unit (if installed) may be dangerous to patient and operator unless
safe exposure factors and operating instructions are observed.
The safety precautions and regulatory information included in this chapter are
provided in the following sub-sections:
z General Safety
z X-ray Safety Guidelines (Hawkeye Option)
z Safety Definitions and Symbols Used
z Safety Devices
Emergency Buttons
Pressure Sensitive Device (PSD)
Patient Release Handle
ENABLE Lever
z Patient Safety
Patient Handling
Patient Positioning
Emergency Removal of Patient
z Data Security
z Safe Operation Guidelines
z Environmental Protection
z Safety Labels and Rating Plates
z Testing Safety Devices
z Regulatory Information
Direction 5195795-100, Rev. 2, Copyright© 2006 by GE Healthcare 1–1

Infinia + Hawkeye 4 User’s Guide
General Safety Safety & Regulatory Information
General Safety
1. This product was designed and manufactured to ensure maximum safety

of operation. It should be operated and maintained in strict compliance with
the safety precautions, warnings and operating instructions contained
herein.
2. The system has been designed to meet all the safety requirements
applicable to medical equipment. However, anyone attempting to operate
the system must be fully aware of potential safety hazards.
3. There are no user serviceable parts in this system. The product should be
installed, maintained and serviced by qualified service personnel according
to procedures detailed in the product service manuals.
4. The system in whole or in part should not be modified in any way without
prior written approval by GE Healthcare.
5. The owner should make certain that only properly trained, fully qualified
personnel are authorized to operate the equipment. An authorized
operators list should be maintained by the owner.
6. It is important that this manual is kept nearby, studied carefully and

reviewed periodically by the authorized operators.
7. GEMS makes no representation, however, that the act of reading this

manual renders the reader qualified to operate, test or calibrate the
system.
8. Unauthorized personnel should not be allowed access to the system.
9. If the system does not operate properly or fails to respond to the controls
as described in this manual, the operator should:
z Ensure the safety of the patient and then the safety of the equipment.
z Follow the safety precautions as specified in this manual.
z Leave the system as is and not make any changes to the equipment.
z Immediately contact the service office, report the incident and await
further instructions.
10. The images and calculations provided by this system are intended as tools
for the competent user. They are not to be regarded as a sole or
indisputable basis for clinical diagnosis. Users are encouraged to study the
literature and reach their own professional conclusions regarding the
clinical utility of the system.
1–2 Direction 5195795-100, Rev. 2, Copyright© 2006 by GE Healthcare

Safety & Regulatory Information General Safety
11. The user should be aware of the product specifications and of system
accuracy and stability limitations. These limitations must be considered
before making any decision based on quantitative values. In case of doubt,
please consult your sales representative.
12. Do not load non-system software onto the system computer. Running
non-system applications may interfere with operations.
13. For user maintenance of the system and performance tests, refer to
Maintenance and QC sections, respectively.
14. Do not place any liquid or food on any part of the system.
15. Electrical Shock Hazard — Do not remove or open system covers or

disconnect plugs when the system is turned ON. Internal circuits use high
voltage capable of causing serious injury.
An electrical hazard may exist if any light, monitor or visual indicator stays
on after the system is turned off. To prevent possible injury, turn off the
mains power line to the system and contact your service office immediately.
Fuses that blow within 36 hours of being replaced may indicate

malfunctioning electrical circuits within the system. Have the system
checked by qualified service personnel, and do not attempt to replace any
fuse.
16. Explosion Hazard —Do not operate the equipment in the presence of
flammable explosive liquids, vapors or gases. Do not plug in or turn on the
system if hazardous substances are detected in the environment. If these
substances are detected after the system has been turned on, do not
attempt to turn off the unit or unplug it. Evacuate and ventilate the area
before turning off the system.
17. Implosion Hazard —Do not subject the computer monitor to serious
mechanical shock, as the Cathode Ray Tube (CRT) can fracture if struck or
jarred. This may result in flying pieces of glass and Phosphor coating, that
can cause serious injury.
18. Overheating—Do not block the ventilation ports of the electronic

equipment. Always maintain at least 6 inches (15.24 cm) clearance around
the ventilation ports to prevent overheating and damage to the electronic
hardware.
19. Collimator Carts—The cart is intended to be used in the vicinity of the

system. It is not intended to be transported over floor gaps or barriers such
as elevator thresholds.
20. Electrical Safety—Power distribution unit used for computer and monitor
power supply, should not be placed on the floor.

General Safety Safety & Regulatory Information
21. The Safety Area marked around the Gantry and Patient Table (as
described in the Infinia Site Preparation Manual) is a restricted area. The
area must be vacant for Gantry rotation and table movement. No people or
objects (including Collimator Carts) should be in this restricted area.
22. Owner’s responsibility—It is the owner’s responsibility to ensure that

anyone using the system reads and understands the User’s Guide and
other relevant literature.
The owner should ensure the provision of continuous power supply to the
system, with voltage and current according to the specifications of GEMS.
If power outages are frequent, a UPS (Uninterruptible Power Supply) is
recommended to avoid data loss.
For UPS specifications, refer to the Power Requirements section of the

Site Preparation manual.
CAUTION
The operator should observe the patient, patient table, detectors and patient
at all times in order to avoid unexpected collisions.

Safety & Regulatory Information X-ray Safety Guidelines (Hawkeye Option)
X-ray Safety Guidelines (Hawkeye Option)
The X-ray unit (if the Hawkeye option is installed) may be dangerous to patient
and operator unless safe exposure factors and operating instructions are
observed.
1. This option was designed and manufactured to ensure maximum safety of

operation. It should be operated and maintained in strict compliance with
the safety precautions, warnings and operating instructions contained
herein.
2. The option has been designed to meet all the safety requirements
applicable to medical equipment. However, anyone attempting to operate
the system must be fully aware of potential safety hazards.
3. There are no user serviceable parts in this option. The option should be
installed, maintained and serviced by qualified service personnel according
to procedures and planned maintenance schedules laid down in the option
service manuals.
4. The operation of the X-ray tube must be reviewed and approved by the
local Radiation Protection Advisor.
5. The images and calculations provided by this option are intended as tools
for the competent user. They are explicitly not to be regarded as a sole
incontrovertible basis for clinical diagnosis. Users are encouraged to study
the literature and reach their own professional conclusions regarding the
clinical utility of the system.

X-ray Safety Guidelines (Hawkeye Option) Safety & Regulatory Information
Potential Radiation Hazard
Potential Radiation Hazard
WARNING
The X-ray option produces X-rays which may be dangerous to the operator
unless suitable precautions are taken, as specified in Operator’s Safety on
page 1-9 and in Safe Operation Guidelines on page 1-29
Radiation Safety Control Mechanism
A precise control mechanism is implemented to reduce patient and operator

exposure to X-rays:
z X-rays are only produced when an acquisition protocol specifying X-ray

transmission has been started.
z During X-ray acquisition, X-rays are generated only by a time-out

controlled, dual-step mechanism. To start an X-ray acquisition it is
necessary to press <GO>+<ENABLE> on the RCU, followed by clicking
[OK] in the confirmation window displayed on the Acquisition Console.
If the allowed time between these two steps (default = 30 seconds)
expires, X-rays will not be generated.
z Whenever a problem occurs in the Gantry, the Detectors and/or the

Acquisition Console, the generation of the X-rays is stopped
immediately.
z An optional door interlock mechanism ensures that X-rays are produced

only when the door of the imaging room is closed.

Radiation Indications
Radiation Indications
The X-ray option includes the following radiation indications:
Table 1-1 Radiation Indications
Radiation Indication
Indication Description
Location
The light turns ON automatically

whenever X-rays are produced. The
Light outside of imaging light should be installed above the
Light turned ON
room entrance(s) to the imaging room or at
any other conspicuous location
specified by the customer
The message appears whenever

Gantry Display Unit X-ray ON! appears
X-rays are produced
Flashing Radiation When X-rays are ON, the Radiation

Acquisition Console Key symbol symbol appears in the X-ray Scan
Parameters Screen and Values Area (see Figure 7-9 on
Graphic Gantry Display page 7-37). The Acquisition User
Unit. Interface shows the X-ray Tube kV, mA
and the on-line updated exposure time.
Note After system reset, the Radiation Warning light turns ON for a few seconds, due
to the automatic testing sequence, and then turns OFF.

Patient Handling
Patient Handling
The X-ray imaging area is further into the gantry than the Nuclear Detectors.
When patients are loaded onto the table for X-ray Transmission scanning, the
operator should check that the table will reach the X-ray imaging area, as shown
in Figure 1-1.
NM Imaging Area X-Ray Imaging Area
Figure 1-1 NM and X-Ray Imaging Areas
WARNING
During X-ray transmission scans, the gantry rotates continuously at a

maximum speed of 2.6 revolutions per minute, during which time the patient
table moves inwards or outwards of the gantry tunnel. Before starting the
scan, the operator should verify that the patient and any support apparatus
and accessory devices are clear (and will remain clear) of rotating parts
during the scan.

Operator’s Safety
Operator’s Safety
WARNING
1. The operator must never look into the Slice Collimator when X-rays are
ON.
2. No part of the operator should be in the X-ray beam when the X-rays
are ON
Reducing the Operator’s Exposure
The X-ray radiation dose received by the operator can be reduced by:
z Using additional shielding
z Increased distance
z Reduced exposure time
For detailed operator dose information, please refer to X-ray Dose to the
Operator on page B-26.
Additional Shielding
The nuclear Detectors act as shields, so that in certain positions the Nuclear
Detectors are between the source of radiation and the operator.
Additional dose reduction can be achieved using a screen between the Gantry
and the operator. Clear glass or plastic screens are available with 1 mm lead
equivalent attenuation, which would reduce the dose from scatter by a factor of
10, at least.
Such a shield must be placed between the X-ray Tube and the Operator Console
to obtain a protected area, where the operator can observe the patient during
X-ray exposure.

Reducing the Operator’s Exposure
CAUTION
Although the X-ray shielding screen may also be used against low energy
gamma radiation up to 140 keV, it may be ineffective for emission radiation
with higher energies.
Distance
Since the scatter and leakage arise from a small area, the dose reduction is
proportional to the inverse square of the distance from the source of radiation.
Doubling the distance between the operator and the scan range should reduce
the dose to the operator by four times.
During system installation, the Operator Console must be placed as far as

possible from the X-ray Tube.
Time
To reduce the operator’s exposure time, after patient set-up, the operator can
retreat to a larger distance, and observe the patient through a clear radiation
shield.

Safety & Regulatory Information Safe Operation Guidelines
Safe Operation Guidelines
1. Operation of the X-ray option involves exposing the patient to X-rays which
can only be performed by qualified personnel. The local regulations will
determine what qualifications are required in order to initiate X-rays.
2. The area around the X-ray Gantry becomes a radiation area when X-rays
are ON, and all non-radiation workers should be prevented from entering
this area. It is likely that the local rules already define the gamma camera
rooms as radiation areas whenever source or injected patients are present.
3. Perform X-ray Daily QC on a daily basis according to the instructions given

in X-ray Daily QC (Hawkeye Option) on page 10-37.
4. Before starting the scan, ensure that the patient and any support apparatus
are clear of the rotating parts.

Safety Definitions and Symbols Used Safety & Regulatory Information
Safety Definitions
Safety Definitions and Symbols Used
Safety Definitions
The safety instructions in this manual are used for the protection of the patient,
operator and service personnel. They identify hazards that will or may occur if
instructions are ignored. The identified hazards are defined and classified as
follows:
DANGER
DANGER Danger is used to identify conditions or actions for which a specific hazard
is known to exist which will cause severe personal injury, or substantial
property damage if the instructions are ignored.
WARNING
Warnings are used to identify conditions or actions for which a specific

hazard is known to exist, which may cause severe personal injury, death or
substantial property damage if the instructions are ignored.
CAUTION
Cautions are used to identify conditions or actions for which a potential hazard
may exist, which will or can cause minor personal injury, or property damage
if the instructions are ignored.

Safety & Regulatory Information Safety Definitions and Symbols Used
IEC Standard Symbols Used
The system may have labels with one or more of the following symbols. These
symbols indicate the IEC standards to which the system conforms.
Symbol IEC Standard
Alternating Current
Protective Earthing Point
ON / Power
OFF / Power OFF
OFF (only for part of equipment)
ON (only for part of equipment)
Type B Equipment
Input Power
Output Power
Functional Earth Ground
Warning, Caution - consult accompanying documents
Electrical Shock Hazard

Safety Definitions and Symbols Used Safety & Regulatory Information
X-Ray Symbols (Hawkeye Option)
Radiation emission
warning

Safety & Regulatory Information Safety Devices
Safety Devices
The imaging system has four types of safety devices as shown in Figure 1-2:
z Emergency Buttons
z Pressure Sensitive Devices (PSD)
z Patient Release Handle
z ENABLE Lever on the Remote Control Unit (RCU)
The operator must be familiar with the location and operation of each type of
safety device.
WARNING
If there is any sign of danger to the patient, press one of the emergency
buttons to shutdown the system.
The Safety Devices must be maintained and tested on a regular basis as

described in Chapter 11 – System Maintenance.

Safety Devices Safety & Regulatory Information
Remote Control Unit

Emergency
OFF
Button
Enable
Gantry Display Unit Lever
Pressure
Sensitive
Devices

Operator Station
Emergency
OFF
Button
Figure 1-2 Imaging System Safety Devices

Emergency Buttons
Emergency Buttons
The system includes two spring-loaded emergency OFF buttons.
z A wall mounted emergency OFF button, located near the operator

station according to the site layout.
z A red emergency OFF button located above the Gantry Display Unit
(GDU).
When either button is pressed, it stops any motion of the detectors and powers
down the system. When the OFF button is pressed, data may be lost.
Note The operator must be familiar with the location of the emergency buttons prior
to operating the system.
Emergency Shutdown
Press either the wall mounted emergency OFF button
or
the red, Emergency OFF button located above the GDU.
Resetting the Emergency OFF Button
To resume system motion:
1. Remove the patient (see Emergency Removal of Patient on page 1-25).
2. Release the depressed emergency OFF button by turning it a quarter turn

clockwise.
3. Switch ON the Mains circuit breaker which is located on the rear side of the
Gantry—next to the standby button (see Figure 1-3).
4. Push the ON button (SW2) on the on the rear side of the Gantry (next to
Mains circuit breaker).
For safe patient release refer to the section Emergency Removal of Patient on
page 1-25.

Safety Devices Safety & Regulatory Information
Emergency Buttons
Standby On
Button Button
(Yellow) (Green)
Circuit Breaker
CB1 J16J16
J18
J18 J14
J14
F1 F2 F3 F4
MAINS
J7 J2
ON 1 STANDBY
STANDBY ON
ON RS232
J19J19 J15 RS232
J17
POWER J17
120V/T20A
F5
220V/T15A
F6
120V/T20A
F7
120V/T3A
F8 E-STOP OUTLETS SLIP RING BYPASS TABLE SIGNALS PSDPSD BYPASS
BYPASS
SLIP RING BYPASS TABLE SIGNALS
J1 OFF 0 J3 J4 J5 J6 HAWKEYE J13
GND J13
33V/T10A 120V/T2A 120V/T10A 120V/T5A
F9 F10 F11 F12 TABLE MOTORS
TABLE MOTORS
220V/T15A 120V/T15A 24V/T2A 33V/T6.25A

PSD MAINS IN 120v/AC 120v/AC
120v/AC 120v/AC 120v/AC
GND
GND
5A MAX 5A
5A MAX
MAX 5A MAX 5A MAX
ECGECG COMPUTER TABLE POWER
POWER
Figure 1-3 On/Off Controls with Circuit Breaker Switch

A Pressure Sensitive Device is provided on the inner surface of each collimator.

Pressing on the PSD activates the PSD. Activation of the PSD stops and
disables all Gantry and Patient Table motion. It does not turn off power to the
system.
Note When one of the PSDs is activated, only the Remote Control Unit (RCU) keys
that are used to move the detectors away from the patient are enabled. All
other keys are disabled.
To enable system motion after the PSD has been activated, either:
z Press <UNLOAD> together with the ENABLE Lever
z Perform one of the following depending on detector position:
Table 1-2 Enabling System Motion
Detector
Action
Position
Press the <OUT> key on the Remote Control Unit

H-Mode together with the ENABLE Lever to move the
detectors radial out.
Press the <UP> key on the Remote Control Unit

L-Mode together with the ENABLE Lever to move the
detectors lateral out.
The Patient Release Handle is located at the head of the Patient Table. This is
the end that is farthest from the Gantry (see Figure 1-4).
When pressed, the Patient Release Handle disengages the Pallet’s clutch to
enable moving the Pallet forwards and backwards manually.
When the Handle is pressed, it stops the motion of the detectors.

Testing Safety Devices Safety & Regulatory Information
ENABLE Lever
ENABLE Lever
An ENABLE Lever is provided on the right hand side of the Remote Control
Unit (RCU). To prevent movement of the Gantry when one of the RCU keys is
accidently pressed, the system responds to an RCU key only when the ENABLE
Lever is depressed.
Note During Whole Body Scan, Tomo or Gated Tomo acquisitions, pressing the
<ENABLE> lever or any RCU key stops Gantry motion.
Testing Safety Devices
Each of the safety devices must be tested on a daily/weekly basis as detailed

in Maintenance of Safety Devices on page 11-10.

Safety & Regulatory Information Patient Safety
Patient Handling
Patient Safety
Patient Handling
1. Observe the patient and verify his well-being at all times while in the
restricted area.
2. Before placing the patient on the Patient Table, verify that the Pallet
mattress is clean. If it is not clean, wipe it with a cloth moistened with 95%
ethyl alcohol. For additional information on cleaning the system, refer to
Cleaning the Imaging System on page 11-3.
3. Under no condition shall the patient be left unobserved within the system
area.
4. If there is any sign of risk to the patient, do not activate any system motion.
If the patient is in jeopardy, press one of the emergency buttons.
5. The operator should be familiar with the Patient Release procedure. The
operator should practice this procedure several times in order to be
prepared to react immediately in a real emergency.
6. To stop all motion, press on any one of the two emergency stop buttons
located on the wall or above the GDU.
7. If the patient’s body comes in contact with the gantry or detectors and if
there is danger to the patient’s safety, press the emergency OFF button
and release the patient manually as described in Emergency Removal of
Patient on page 1-25. Release the patient after stopping all Gantry and
table motion.
8. If there is a system problem or safety incident, contact the Field Service

Office.
9. During studies, the table or gantry movements are automatic. Monitor the
patient during the entire scan to ensure that there is enough clearance
between the patient and the rotating detectors.
WARNING
Injury may occur to a patient due to unintended motion. Do not leave the
patient unattended at any time. Always monitor the position of the patient
and equipment during scan procedures.
Do not allow anybody to stand between the detectors at any time.

Patient Safety Safety & Regulatory Information
Patient Handling
10. Potential Pacemaker Hazard - Although the possibility of interference with

pacemakers is small, the operator should be alert to such a potential
hazard from any equipment using high frequency electrical signals.
11. Never exceed the maximum allowable load of the patient table (200
kilograms or 440 pounds).
12. The user should be aware of system limitations regarding particularly large
or overweight patients. Please be aware of any particular system limits or
safety precautions and labels regarding large or overweight patients. In
case of doubt, please contact the nearest Vendor’s office.
13. In order to minimize artifacts, the patient must remove clothing and
accessories containing metal, including belts, jewelry, under-wire bras,
lighters, etc. prior to the scan.
CAUTION
Large or overweight patients may encounter difficulties with the physical

clearance of the system and removal from the system.
WARNING
Exceeding the load limit specifications of patient table may result in part
breakage and possible injury.
WARNING
Do not initialize the Gantry while a patient is on the Table or between the
Detector Heads.

Patient Positioning
Patient Positioning
The system has safety operation limits. These limits must be adhered to.
WARNING
1. Do not use L-Mode with body contour for studies of children or small
patients. Contact between the Detectors and the Table may occur in
such cases.
2. Infants placed directly on the detector surface or on the pallet must be

held and supervised at all times. Exercise caution to protect the detector
from contamination from body fluids. Whenever possible, it is
recommended to image babies using the PediaScan (optional
accessory).
3. Body contour in L-Mode is designed for non-brain applications only.
4. For brain scans, use only H-Mode, recommended without body contour.
5. Verify that all ECG cables, intravenous (IV) lines, tubes, etc. that are
connected to the patient are fixed alongside the patient so that they will
not become pinched or pulled by any of the moving parts of the system
(rotating detectors during Tomo or X-ray, motorized stretcher support,
etc.). ECG cables, intravenous (IV) lines, tubes, etc. must be long
enough to allow full extension of the table during the scan.
6. Never leave the patient unobserved within the system area.
7. Ensure that the patient’s fingers and clothing do not get caught in
equipment during patient positioning.
8. When positioning patients on the patient table, the patient’s head should
not protrude beyond the end of the Pallet. Failure to follow this
precaution may result in the patient’s hair getting caught between the
Pallet and the Pallet support. If under special circumstances, it is
required for the patient’s head to protrude from the edge of the Pallet,
then it is recommended to use a Head Holder (optional accessory).
Additional precautionary measures, such as a hair cap, should be used.
9. It is important to select the correct patient position in order to ensure

correct processing of the data.
10. A Feet First Whole Body scan should not be started when the feet of the
patient are in the area delimited axially by the rear side of the detectors
and the front plane of the gantry (see Figure 7-23 on page 7-71).
11. Employ special care when moving the detectors with the patient seated
with knees below the detectors.

Patient Positioning
The operator should:
z Always assist the patient during loading/unloading.
z Ensure that the patient is placed securely on the Pallet and is not in
danger of falling.
z Ensure that the table’s straps are properly secured and that the patient’s
hands and legs do not protrude beyond the limits of the patient table.
If the straps are insufficient for large patients, longer straps (Strips with
velcro hook) are available and can be ordered from a GE Sales
representative (see Optional Patient Table Accessories on page 2-30).
z Verify that the stretcher is not manually pushed below the table support
(rollers).
z Ensure that all patient supports are not damaged or cracked. If there
are cracks or any other damage, they must be replaced. Check that the
headholders and leg supports are secured to the Pallet.
z Ensure that patients do not raise their heads or hands or move their
bodies during scans. Advise patients not to raise their heads or move
their bodies during scans.
z Advise the patient not to move during the positioning and study
procedures.
z Advise patients not to touch any equipment.
z Ensure that obstacles do not interfere with the movement of the

detectors.
z Whenever possible, the patient should be placed in the “legs in” position
for all acquisitions except Brain Scan. If the patient’s hands need to be
placed under/behind the neck, the Arm Support Strap set (comprising
DTP000244 and DTP000245) should be used to keep the patient's arms
from moving outward. For additional information refer to Patient
Positioning with Hands Above the Head on page 7-68.
z Before starting any scan in that position, the operator must perform a
full clearance test (rotate the gantry 360° using the RCU) to ensure that
there are no obstacles in the path of gantry motion.

System operation may be stopped automatically due to a power failure or a

safety event (such as a PSD was pressed), or may be initiated by the operator
in response to emergency conditions.
If one of the safety devices is activated and system operation is stopped, the
operator must first remove the patient safely, using the removal procedure
described below.
Removing the Patient When a Safety Event Occurs
1. Press the <UNLOAD> key for each detector on the Remote Control Unit
(RCU) to move the Detectors outwards away from the patient.
2. Pull the Pallet away from the Gantry (see Figure 1-4).
3. Assist the patient to get down from the Patient Table.

Press
Figure 1-4 Removing the Patient by Pulling the Pallet Away from the Gantry
Removing the Patient When System Power is Down
The system power can be down either due to a power failure or due to activation
of one of the Emergency buttons.
When system power is down, pull the Pallet out and assist the patient to get
down from the Table.
During a Brain scan:
During a Brain scan, the Pallet is already in the OUT position. In this case no
special procedure is required to move the patient. Assist the patient to get down
from the Patient Table.

During any other acquisition:
1. Press the Patient Release Handle to disengage the clutch and pull the
Pallet to the OUT position.
2. Assist the patient to get down from the Patient Table.
System Stopping Distance
When the RCU Enable Lever is released, system motion is stopped. The
maximum Software Stopping Distance is the maximum motion that occurs once
the RCU Enable lever is released.
When the PSD is touched, system motion is stopped. The maximum Hardware
Stopping Distance is the maximum motion that occurs once the PSD is activated.
The maximum travel stopping distance for the Table and Gantry are shown
below:
z Table
Up/ Backward/
Axis
Down Forward
Hardware Stopping Distance ≤6mm ≤6 mm
Software Stopping Distance ≤10 mm ≤10 mm
z Radial
Radial
Axis Radial #2
#1
Hardware Stopping Distance ≤5 mm ≤5 mm
Software Stopping Distance ≤5 mm ≤5 mm
z Rotation and Lateral
Axis Rotation Lateral
Hardware Stopping Distance ≤2.0 ° ≤6 mm
Software Stopping Distance ≤5.0 ° ≤6 mm

Data Security Safety & Regulatory Information
General
Data Security
General
Before starting a scan:
z Verify and record the patient’s identification.
z Observe and record the patient’s orientation, position and anatomical

landmarks. Verify and correct this information within the scan
parameters.
Note If a Patient ID number already exists in the To Do List and the same ID number
is used, a warning message appears:
Warning: Patients with the same patient ID exist in the

system. Select an existing patient?
Do not load non-system software onto the system computer. Running

non-system applications may interfere with operations.
Never place user files (e.g. backups, archives of QC reports) within the
Important
D:\Infinia and D:\var directories or their sub-directories.
Connectivity
Always ensure that the data transferred to another system has been correctly
received.
Infinia data must not be transferred to or archived on an eNTEGRA system. This will
Important
cause loss of data attributes.

Safety & Regulatory Information Safe Operation Guidelines
Collimator Exchange
Safe Operation Guidelines
Collimator Exchange
Collimators should be properly installed and firmly secured.
Moving the System
Always check for obstacles before moving the Patient Table and the Collimator
Carts. Special care should be taken not to move these units over cables
connecting the Gantry to the wall outlet, to the Patient Table and to the Operator
Console.
Collimator Carts are intended to be used in the vicinity of the system. They are
not intended to be transported over floor gaps or barriers such as elevator
thresholds.
Using Accessories
Use only patient support devices or accessories specifically recommended for

this system.
Only R-wave Detectors, ECGs, or other gating devices which comply with
IEC-601-1 may be used with the system.
Daily Tests
Perform QC tests and Maintenance on a daily basis, according to the instructions

given in Chapter 10 – Quality Control (QC) and Chapter 11 – System
Maintenance.
Never calibrate, test the system, or warm the tube with patients or personnel in
the scan area.

Environmental Protection Safety & Regulatory Information
Environmental Protection
GE is committed to the protection of the environment and natural resources.

Our devices are manufactured under strict guidelines to prevent contamination
of the surrounding water, ground and air.
The packing materials you received your product in, are recyclable. Please
ensure that all packing materials are either reused, recycled, or disposed of
properly.
The majority of the material in this product (for example, metals, covers, etc.)
are recyclable. GE encourages its customers to dispose of the product at the
end of its useful life, for recycling, according to the local regulations.
The following parts are hazardous to the environment. They must be segregated
and disposed of properly, according to local regulations:
z Batteries
z Lead from Detector Containers
z Scintillation Crystals from Detectors
z CRT Monitor
z Lead from X-ray Assembly and Slice Defining Collimator.
This WEEE symbol indicates that waste electrical and electronic equipment
must not be disposed as unsorted municipal waste and must be collected
separately. Please contact an authorized representative of the manufacturer for
information concerning the decommissioning of your equipment.

Safety & Regulatory Information Safety Labels and Rating Plates
Safety Labels and Rating Plates
Figure 1-5, Figure 1-6 and Figure 1-7 depict the location of the safety and rating
labels of the imaging system. The numbers used in the figures correspond to
the numbers shown alongside the labels themselves.
2
3
19
4b
4b 4a
22
21
4b
1
4a
21
7A 7B 24
4b Front of Table
6 Both sides of the table
8 13
5
4b
Figure 1-5 Labels Location - Front View

Safety Labels and Rating Plates Safety & Regulatory Information
13
13
4a
4b 8 13
10 11 12 18 24
14 or 15 or 23
or 26
16
Figure 1-6 Labels Location - Rear View

17
20
Figure 1-7 Label Location–Monitor and Acquisition Computer

WARNING!
DON’T MOVE CART
3 WITH ONE
COLLIMATOR ONLY!
MOVE COLLIMATOR
BY HANDLE ONLY!
LBL000879

This label comes in two sizes. In Figure 1-5 on page 1-31, the
smaller label is shown as 4a and the larger label is shown as 4b.
CAUTION
5
X-ray Scan Area Labels under ruler on Patient Table
LBL000519 LBL000529

Front of Table
g ASM001171
INFINIA TABLE
7A
LBL000775-AA
MANUFACTURED FOR
GE MEDICAL SYSTEMS
BY: xxxxxxxx
7B MADE IN: xxxxxx
MODEL
SERIAL:
LBL000510

10
11

g
INFINIA
12 4.2
13

g GE Medical Systems
MODEL: HS3000WY
INFINIA VC
Ser. No.
14
Manufactured:
Manufactured By
GE Medical Systems Israel
Tirat Hacarmel, Israel
For Distribution By
General Electric Company
Milwaukee, Wisconsin, USA
LBL000951
g GE Medical Systems
MODEL: H3000WT
INFINIA GP 3
Ser. No.
15
Manufactured:
Manufactured By
For Distribution By
LBL000949
16 g

17
18

19
26
THIS PRODUCT CONTAINS

AN APPROVED WiFi – AP
TYPE: WL-455 / WL-463
FCC ID: HEDWL463EXT
CANADA: 3857A-WL463EXT
JAPAN: 003NY040820000
?
?
JAPAN
2.4DS4
5180511_r1

X-ray Safety Labels and Rating Plates (Hawkeye Option)
The warning and rating labels pertaining to the X-ray option are shown below.
z The radiation warning label is located on the Monitor of the Acquisition

Station.
z The Radiation label is located on the Table
# Location Label
20 Keyboard
21 Table
LBL000503
X-ray
22 Assembly
Cover

# Location Label
23

# Location Label
24
LBL000892
H3000WD
INFINIA_VC
HAWKEYE 4
Ser. No.:
25 Manufactured:
Complies with FDA radiation
performance standards,
21 CFR subchapter J.
Manufactured By
For Distribution By

Safety & Regulatory Information Regulatory Information
Standard Compliance
Regulatory Information
Standard Compliance
The equipment complies with the following standards:
z IEC 601-1 Medical Electrical Equipment General Requirements for

Safety. It is classified as Class 1 Type B equipment, Mode of Operation:
Continuous.
z IEC 601–1–2 “Electro–Magnetic Compatibility Requirements and

Tests”
z UL and CSA relevant standards to IEC 601-1
Wireless LAN
The system contains a Radio device Wireless LAN Access Point. The Access
point complies to the following radio standards:
z RF: FCC Part 15.247, Part 15.205, Part 15.209, & Part 15.407, RSS-
210,
z EN 300 328-2, EN 301 893, TELEC RCR STD 33 & T66
CAUTION
Wireless Communication Interference – Wireless LAN equipment contains

an intentional RF radiator that has the potential of interfering with other
medical devices.
Note Device Proximity - Operation of a wireless LAN device in close proximity to

microwave ovens, or strong electromagnetic fields (for example, radio station
transmitters, citizen's band radios, cellular phones, etc.) may cause radio-
frequency (RF) interference. This may cause connection loss to the CT device
and might stop the CT scan. Normal operation will resume when the source of
interference is removed.

Regulatory Information Safety & Regulatory Information
CE Conformity
CE Conformity
This product conforms with the requirements of council directive 93/42/EEC

concerning Class IIb medical devices, and therefore bears the CE mark of
conformity.
The name and address of the CE Representative appears on the back of the
front page of this manual.
USA Regulations
z The system was cleared for sale in the USA by the FDA.
z Caution: Federal US law restricts this device for sale by or on the order
of a physician.
z In the USA, this system should only be used with FDA approved radio
pharmaceuticals.
X-Ray Regulatory Information
The X-ray Option complies with the following regulations and standards:
z IEC 601–1 Medical Electrical Equipment General Requirements for

Safety
z IEC 601-1-3 “General requirements for radiation protection in

Diagnostic X-ray equipment”.
z IEC 601-2-32 “Particular Requirements for the Safety of Associated

Equipment of X-ray Equipment”.
z IEC 601-2-44 “Particular Requirements for the Safety of X-ray

Equipment for Computer Tomography”.
z USA Government Code of Federal Regulations 21 CFR 1020.30; 33,

[April 1, 1997]
Unauthorized change or modifications of the equipment could void the user’s

authority to operate the equipment.

Electro-magnetic Considerations
Electro-magnetic Considerations
This equipment complies with the IEC60601-1-2 (2nd Edition) EMC standards
for medical electrical equipment.
This equipment generates, uses, and can radiate radio frequency energy. The
equipment may cause radio frequency interference to other medical and non-
medical devices and radio communications.
To provide reasonable protection against such interference, this product

complies the radiated emission as per CISPR11 Group1 Class A standard limits.
Detailed requirements and recommendations about the power supply

distribution and installation are listed in the Pre-installation or Site Preparation
Manual.
However, there is no guarantee that interference will not occur in a particular

installation.
If this equipment is found to cause interference (which may be determined by

turning the equipment on and off), the user (or qualified service personnel)
should attempt to correct the problem by one or more of the following measures:
z reorient or relocate the affected device
z increase the separation between the equipment and the affected device
z power the equipment from a source different from that of the affected
device
z consult the point of purchase or service representative for further

suggestions
The manufacturer is not responsible for any interference caused by using other
than recommended interconnect cables or by unauthorized changes or
modifications to this equipment. Unauthorized changes or modifications could
void the users' authority to operate the equipment.
All interconnect cables to peripheral devices must be shielded and properly

grounded, except when technologically prohibited. Use of cables not properly
shielded and grounded may result in the equipment causing radio frequency
interference.
Do not use devices which intentionally transmit RF Signals (Cellular Phones,

Transceivers, or Radio Controlled Products) in the vicinity of this equipment as
it may cause performance outside the published specifications. The medical
staff in charge of this equipment are required to instruct technicians, patients
and other people who may be around this equipment to comply fully with the
above stipulations.

Radiation Considerations
In order to achieve the maximum Electromagnetic Compatibility, it is important

to comply with the recommended requirements and separation distances
described in the appropriate Pre-installation or Site Preparation Manual.
Radiation Considerations
The radiation leakage of the X-ray Tube assembly at one meter from the
tube must be less than 100 mR/h.
For detailed dose information, please refer to Dose Information, X-ray

Dose Information on page B-17.

X-ray CE Conformity
X-ray CE Conformity
This product conforms with the requirements of council directive 93/42/EEC

concerning Class IIB medical devices, and therefore bears the CE mark of
conformity.
The name and address of the CE representative appears on the back of the
front page of this manual.
X-ray Conformity With USA Regulations
z The system was cleared for sale in the USA by the FDA.
z Caution: Federal US law restricts this device for sale by or on the order
of a physician.
z In the USA, this system should only be used with FDA approved
radio pharmaceuticals.

X-ray Conformity With USA Regulations


1-Safety and Regulatory

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Chapter 1 – Safety & Regulatory Information

z X-ray Safety Guidelines (Hawkeye Option)

z Safety Definitions and Symbols Used

 Pressure Sensitive Device (PSD)

 Patient Release Handle

 Emergency Removal of Patient

z Safe Operation Guidelines

z Safety Labels and Rating Plates

z Testing Safety Devices

Direction 5195795-100, Rev. 2, Copyright© 2006 by GE Healthcare 1–1

1. This product was designed and manufactured to ensure maximum safety

6. It is important that this manual is kept nearby, studied carefully and

7. GEMS makes no representation, however, that the act of reading this

8. Unauthorized personnel should not be allowed access to the system.

z Follow the safety precautions as specified in this manual.

1–2 Direction 5195795-100, Rev. 2, Copyright© 2006 by GE Healthcare

15. Electrical Shock Hazard — Do not remove or open system covers or

Fuses that blow within 36 hours of being replaced may indicate

18. Overheating—Do not block the ventilation ports of the electronic

19. Collimator Carts—The cart is intended to be used in the vicinity of the

Direction 5195795-100, Rev. 2, Copyright© 2006 by GE Healthcare 1–3

22. Owner’s responsibility—It is the owner’s responsibility to ensure that

For UPS specifications, refer to the Power Requirements section of the

1–4 Direction 5195795-100, Rev. 2, Copyright© 2006 by GE Healthcare

X-ray Safety Guidelines (Hawkeye Option)

1. This option was designed and manufactured to ensure maximum safety of

Direction 5195795-100, Rev. 2, Copyright© 2006 by GE Healthcare 1–5

Potential Radiation Hazard

Radiation Safety Control Mechanism

A precise control mechanism is implemented to reduce patient and operator

z X-rays are only produced when an acquisition protocol specifying X-ray

z During X-ray acquisition, X-rays are generated only by a time-out

z Whenever a problem occurs in the Gantry, the Detectors and/or the

z An optional door interlock mechanism ensures that X-rays are produced

1–6 Direction 5195795-100, Rev. 2, Copyright© 2006 by GE Healthcare

The X-ray option includes the following radiation indications:

Table 1-1 Radiation Indications

The light turns ON automatically

The message appears whenever

Flashing Radiation When X-rays are ON, the Radiation

Direction 5195795-100, Rev. 2, Copyright© 2006 by GE Healthcare 1–7

NM Imaging Area X-Ray Imaging Area

Figure 1-1 NM and X-Ray Imaging Areas

During X-ray transmission scans, the gantry rotates continuously at a

1–8 Direction 5195795-100, Rev. 2, Copyright© 2006 by GE Healthcare

Reducing the Operator’s Exposure

z Using additional shielding

z Reduced exposure time

Direction 5195795-100, Rev. 2, Copyright© 2006 by GE Healthcare 1–9

During system installation, the Operator Console must be placed as far as

1–10 Direction 5195795-100, Rev. 2, Copyright© 2006 by GE Healthcare

Safe Operation Guidelines

3. Perform X-ray Daily QC on a daily basis according to the instructions given

Direction 5195795-100, Rev. 2, Copyright© 2006 by GE Healthcare 1–11

Safety Definitions and Symbols Used

Warnings are used to identify conditions or actions for which a specific

1–12 Direction 5195795-100, Rev. 2, Copyright© 2006 by GE Healthcare

IEC Standard Symbols Used

Symbol IEC Standard

Protective Earthing Point

OFF / Power OFF

OFF (only for part of equipment)

ON (only for part of equipment)

Functional Earth Ground

Pressure Sensitive Device (PSD)

Patient Release Handle

Emergency Removal of Patient