Professional Documents
Culture Documents
1-Safety and Regulatory
1-Safety and Regulatory
1-Safety and Regulatory
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 Safety Devices
Emergency Buttons
ENABLE Lever
z Patient Safety
Patient Handling
Patient Positioning
z Data Security
z Environmental Protection
z Regulatory Information
General Safety
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.
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 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.
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.
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.
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.
20. Electrical Safety—Power distribution unit used for computer and monitor
power supply, should not be placed on the floor.
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.
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.
CAUTION
The operator should observe the patient, patient table, detectors and patient
at all times in order to avoid unexpected collisions.
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.
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.
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 Indications
Radiation Indication
Indication Description
Location
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
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.
WARNING
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
The X-ray radiation dose received by the operator can be reduced by:
z Increased distance
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.
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.
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.
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.
4. Before starting the scan, ensure that the patient and any support apparatus
are clear of the rotating parts.
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
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.
The system may have labels with one or more of the following symbols. These
symbols indicate the IEC standards to which the system conforms.
Alternating Current
ON / Power
Type B Equipment
Input Power
Output Power
Radiation emission
warning
Safety Devices
The imaging system has four types of safety devices as shown in Figure 1-2:
z Emergency Buttons
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.
Pressure
Sensitive
Devices
Emergency
OFF
Button
Emergency Buttons
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
or
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.
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
5A MAX 5A
5A MAX
MAX 5A MAX 5A MAX
ECGECG COMPUTER TABLE POWER
POWER
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:
Detector
Action
Position
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.
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.
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.
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.
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
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
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.
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.
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.
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.
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 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.
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.
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).
Press
Figure 1-4 Removing the Patient by Pulling the Pallet Away from the Gantry
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, 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.
1. Press the Patient Release Handle to disengage the clutch and pull the
Pallet to the OUT position.
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
z Radial
Radial
Axis Radial #2
#1
Data Security
General
Note If a Patient ID number already exists in the To Do List and the same ID number
is used, a warning message appears:
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.
Collimator Exchange
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
Only R-wave Detectors, ECGs, or other gating devices which comply with
IEC-601-1 may be used with the system.
Daily Tests
Never calibrate, test the system, or warm the tube with patients or personnel in
the scan area.
Environmental Protection
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 CRT Monitor
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.
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
8 13
5
4b
13
13
4a
4b 8 13
10 11 12 18 24
14 or 15 or 23
or 26
16
17
20
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
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
GE Medical Systems Israel
Tirat Hacarmel, Israel
For Distribution By
General Electric Company
Milwaukee, Wisconsin, USA
LBL000949
16 g
17
18
19
26
?
?
JAPAN
2.4DS4
5180511_r1
The warning and rating labels pertaining to the X-ray option are shown below.
# 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
GE Medical Systems Israel
Tirat Hacarmel, Israel
For Distribution By
General Electric Company
Milwaukee, Wisconsin, USA
Regulatory Information
Standard Compliance
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,
CAUTION
CE 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.
The X-ray Option complies with the following regulations and standards:
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.
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
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.
Radiation Considerations
The radiation leakage of the X-ray Tube assembly at one meter from the
tube must be less than 100 mR/h.
X-ray CE Conformity
The name and address of the CE representative appears on the back of the
front page of this manual.
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.