idi Aspect Q-CARD 100-4T User manual

Made in the USA
Aspect 100-4T and ISR
Mobile Image Tables
Operator Manual

Operator Manual Aspect 100-4T and ISR
L100-2843 Rev. E www.imagediagnostics.com 2
OVERVIEW
An Aspect 100-4T or Aspect ISR along with any accessories shall be referred to in this manual as “this
equipment.” This manual is not intended as a substitute for certified training for the use of this equipment.
The operation of this equipment should be limited to qualified medical personnel who have been trained in
the use of medical equipment.
The text of this manual was originally written, approved and published by the manufacturer in English.
This equipment complies with applicable FDA performance standards contained in 21CFR at date of
manufacture.
OWNER RESPONSIBILITIES
The owner of this equipment is responsible to ensure system compatibility, the qualifications of operators and
maintenance personnel. Operators must be properly trained and have obtained credentials from the
appropriate authorities.
This equipment must be installed in an area provided with the proper electrical power.
The owner of this equipment is responsible for verifying continued compliance with all applicable regulations
and standards. Consult local, state, federal and/or international agencies regarding specific requirements and
regulations applicable to the use of this equipment.
Image Diagnostics, Inc. certifies only this equipment. Operating practices and safety for this equipment are
the sole responsibility of the owner and operators. Image Diagnostics, Inc. assumes no liability or
responsibility for personal injury or damage resulting from misuse of this equipment.
Never make modifications or adjustments to this equipment unless directed by a qualified Image Diagnostics
representative. This equipment, when properly manufactured, meets US federal regulations and international
standards. Unauthorized modifications to this equipment may impact adherence to these standards and make
this equipment unsafe to operate.
CUSTOMER SUPPORT
Image Diagnostics, Inc. may provide on request circuit diagrams, component part lists, calibration
instructions, or other information toassist the user’s appropriately qualified technical personnel to repair those
parts of equipment which are designated by the manufacturer as repairable.
For technical assistance, call IDI at [phone]. Be prepared to give the complete model
and serial number found on the data plate on the table base at the time of contact.

Operator Manual Aspect 100-4T and ISR
L100-2843 Rev. E www.imagediagnostics.com 3
Table of Contents
1. SYMBOL IDENTIFICATION............................................................................................. 5
2. INTENDED USE & ESSENTIAL PERFORMANCE....................................................... 8
3. SAFETY INSTRUCTIONS.................................................................................................. 8
4. SAFETY HAZARDS............................................................................................................. 9
5. EMC (Electromagnetic Compatibility) STATEMENT ................................................... 11
6. EMERGENCY STOP PUSHBUTTON............................................................................. 12
7. SETUP INSTRUCTIONS................................................................................................... 12
7.1. Setup.............................................................................................................................. 12
8. INSTRUCTIONS FOR TABLE OPERATION................................................................ 14
8.1. CASTER LOCKING AND UNLOCKING SETTINGS........................................... 14
8.2. POWER INDICATOR LIGHT .................................................................................. 15
8.3. TABLE MOTION CONTROLS................................................................................. 15
8.4. TABLETOP MOTION HANDSET CONTROLS.................................................... 18
8.5. FOOT ACTUATED MOTION CONTROLS ........................................................... 19
9. PATIENT PREPARATION............................................................................................... 20
9.1. Preparation for Patient Use......................................................................................... 20
9.2. Patient Loading ............................................................................................................ 20
9.3. Preparation for Performing CPR............................................................................... 21
10. STANDARD ACCESSORIES............................................................................................ 21
10.1. Patient Mattress Pad for Tabletop.......................................................................... 21
10.2. Patient Restraint Straps........................................................................................... 22
11. ADD-ON ACCESSORIES.................................................................................................. 23
11.1. Clamp-on Accessory Rail......................................................................................... 23
11.2. Vascular Access Arm Board (VAB)........................................................................ 23
11.3. Quick Release Rail Mount Arm Board (requires Clamp-on Accessory Rail) .... 24
11.4. Arm Board, Shoulder Mount .................................................................................. 24
11.5. Tabletop Catheter Tray Extensions........................................................................ 24
11.6. Articulating Headrest Extension............................................................................. 25
11.7. Peripheral Headrest Extension................................................................................ 25
11.8. Radiation Shield........................................................................................................ 26
11.9. Anesthesia Screen Holder. (May require a pair of side rail clamps).................. 26
11.10. Side Rail Clamps, Rotating...................................................................................... 26

Operator Manual Aspect 100-4T and ISR
L100-2843 Rev. E www.imagediagnostics.com 4
12. GENERAL CLEANING..................................................................................................... 27
13. MAINTENANCE, SERVICE & REPAIR........................................................................ 28
13.1. RECOMMENDED PERIODIC PERFORMANCE CHECKS............................ 28
13.2. SERVICE & REPAIR STATEMENT.................................................................... 28
14. TROUBLESHOOTING...................................................................................................... 29
15. DISPOSAL OF COMPONENTS....................................................................................... 32
16. PRODUCT DATA............................................................................................................... 33
17. SPECIFICATIONS............................................................................................................. 34
18. WARRANTY AND CONTACT INFORMATION.......................................................... 38

Operator Manual Aspect 100-4T and ISR
L100-2843 Rev. E www.imagediagnostics.com 5
1. SYMBOL IDENTIFICATION
Attention! Consult accompanying documents.
Failure to follow these instructions could cause serious
personal injury or damage to equipment.
Warning! Information or instructions shown near this symbol must be adhered
to in order to prevent a potentially hazardous situation which if not avoided,
could result in death, personal injury or damage to the equipment.
Emergency Stop Pushbutton.
Electric Shock hazard present. Information or instructions shown near this
symbol must be adhered to in order to prevent a potentially hazardous
situation which if not avoided, could result in death, personal injury or
damage to the equipment.
Equipotential Terminal of the table which provides for a connection between
the table and the equipotential bus bar of the facility.
Recyclable material.
There is the potential of exposure to harmful x-rays. Be sure to read and
comply with all warnings.
Not made with natural rubber latex.
Not for Patient Transport. The Table should never be moved with a patient on
it.
or

Operator Manual Aspect 100-4T and ISR
L100-2843 Rev. E www.imagediagnostics.com 6
Protective Ground. This is the common tie point between the AC Electrical
Power Cord Ground, Frame Ground, and Controller Ground.
Patients must be loaded from the side of table. There is possible tilting or
instability if patient is loaded onto the pedestal end of table or the imaging end
of the table.
European Authorized
Representative:
Model of Table.
Serial Number of Table.
Indication of European Conformity for sale in the European Economic Area
(EEA).
Item complying to Type B applied part per IEC 60601-1.
Date of manufacture of the device.
Location where device was manufactured.
Alternating Current (AC).
CPR (Cardiopulmonary resuscitation)
This symbol denotes that the product contains electronic devices and cannot
be disposed of with household waste. This product cannot be included in
municipal waste and must be disposed or recycled according to local waste
regulations.
EC
REP
REF
SN
Advena Ltd. Tower Business Centre, 2nd Flr.,
Tower Street, Swatar, BKR 4013 Malta

Operator Manual Aspect 100-4T and ISR
L100-2843 Rev. E www.imagediagnostics.com 7
Elevate tabletop.
Lower tabletop.
Tilt tabletop’s imaging end up
(Trendelenburg).
Tilt tabletop’s imaging end down
(Trendelenburg).
Roll tabletop clockwise.
Roll tabletop counterclockwise.
Tabletop is centered from side to side.

Operator Manual Aspect 100-4T and ISR
L100-2843 Rev. E www.imagediagnostics.com 8
2. INTENDED USE & ESSENTIAL PERFORMANCE
The Aspect ISR & Aspect 100-4T are mobile imaging tables used by the medical
industry for vascular surgery, endovascular procedures and interventional radiology.
They are designed to be used in a professional healthcare environment in conjunction
with “C-arm” style radiological imaging equipment. The tables have backup battery
power which should only be used temporarily for necessary function of the table if the
external power supply is disrupted.
Functional capabilities and operation of the equipment described herein can be
employed in a variety of diagnostic, therapeutic, and surgical applications. The device
is designed for use as either a fluoroscopic or radiographic table.
3. SAFETY INSTRUCTIONS
✓All persons using this equipment must fully understand its operation instructions,
emergency procedures, capabilities including total range of motion and be aware of
all potential safety hazards.
✓This manual should be accessible to all personnel installing, operating, or servicing
this equipment.
✓Only a qualified technician may install or service this equipment.
Failure to follow safety precautions may result in serious injury to patient or
user or damage to equipment.
Comments and questions regarding safety should be addressed to:
Customer Support
Image Diagnostics, Inc.
310 Authority Drive
Fitchburg, MA 01420 USA
Or call IDI at [phone].
Review the SAFETY HAZARDS and OPERATING
INSTRUCTIONS sections before operating table

Operator Manual Aspect 100-4T and ISR
L100-2843 Rev. E www.imagediagnostics.com 9
4. SAFETY HAZARDS
Safety Hazard Level
Potential Consequences with Use
DANGER
Indicates an imminently hazardous situation which, if not
avoided, will result in death or serious injury.
WARNING
Indicates a potentially hazardous situation which, if not
avoided, could result in death or serious injury.
CAUTION
Indicates a potentially hazardous situation which, if not
avoided, may result in minor or moderate injury or
equipment damage.
WARNING!
This equipment has not been tested for use with high
frequency surgical equipment, cardiac defibrillators, or
cardiac defibrillator monitors. Use with such equipment
may cause patient burns, explosion hazards or
electrical shock to the patient or operator.
CAUTION
Do not leave patient unattended on table.
WARNING!
To avoid electric shock, plug the electrical power cord
into a properly grounded hospital grade outlet!
WARNING!
This equipment may be used in conjunction with x-ray
equipment. This constitutes potential exposure to
harmful x-rays for both the patient and operator. Be
sure to use proper radiation shielding.
WARNING!
If an antistatic path is required, use this equipment on
an antistatic floor.
Use only the Patient Mattress Pad supplied with the
table.

Operator Manual Aspect 100-4T and ISR
L100-2843 Rev. E www.imagediagnostics.com 10
WARNING!
Safely position and secure patient onto table.
Do not exceed table weight capacity of 600 pounds
(272kg).
CAUTION
The carbon fiber top is subject to damage or possible
damage from impact from other objects.
Take caution when moving the table or using power
driven diagnostic equipment around table. Collisions
with nearby equipment can cause equipment damage or
patient harm. Regular inspection of the tabletop is
necessary for the safety of patient and operator.
CAUTION
During operation of the table, if any unusual sounds
and/or erratic movement is observed, immediately
discontinue use of the table.
CAUTION
Do not use table for patient transport.
CAUTION
Do not place or store any containers or large items
underneath the tabletop. As the tabletop is descending,
contact with an obstruction may cause permanent
damage to the table.
CAUTION
When lying on the table, patient must be restrained at
all times. The restraining straps are not intended to
restrain an uncontrollable patient.
WARNING!
Use of table extensions is only allowed with decreased
table load. Table weight capacity reduced to 500 pounds
(227kg) when using table extension.

Operator Manual Aspect 100-4T and ISR
L100-2843 Rev. E www.imagediagnostics.com 11
5. EMC (Electromagnetic Compatibility) STATEMENT
Portable and Mobile RF Communications Equipment can affect Medical Electrical
Equipment including this equipment. Use special precautions regarding EMC when these tables
are installed, operated, and maintained. EMC operating parameters for these tables are in the
SPECIFICATIONS section of this manual (Section 17).
The use of accessories, transducers and/or cables other than those specified, with the
exception of those sold by the manufacturer as replacement parts for internal components, may
result in increased emissions or decreased immunity of the equipment or system.
WARNING: This equipment should not be used adjacent to or stacked with other
medical electrical equipment and that if adjacent or stacked use is necessary, the
equipment or system should be observed to verify normal operation in the
configuration in which it will be used.
WARNING: Portable RF communications equipment (including peripherals
such as antenna cables and external antennas) should be used no closer than 30
cm (12 inches) to any part of this equipment, including cables connected to the
table. Otherwise, degradation of the performance of this equipment could result.
NOTE: The emissions characteristics of this equipment make it suitable
for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential
environment (for which CISPR 11 class B is normally required) this equipment might not offer
adequate protection to radio-frequency communication services. The user might need to take
mitigation measures, such as relocating or re-orienting the equipment.
If this equipment receives excessive electromagnetic interference, motion controls for
the table may be slow or unresponsive to user inputs. In this event:
1. Verify the cause by turning nearby equipment off and retest motions. (Note: All
motions will be slowed when operating on battery backup as compared to full
AC power)
2. If this problem is not resolved, immediately remove power to the equipment by
engaging the Emergency Stop Pushbutton as shown in section 6 of this manual.
3. Notify IDI customer service using the contact information in section 18 of this
manual.
CAUTION
Applying more than 50 pounds of force to the side of
the tabletop can overcome the braking system causing
the tabletop to move.

Operator Manual Aspect 100-4T and ISR
L100-2843 Rev. E www.imagediagnostics.com 12
6. EMERGENCY STOP PUSHBUTTON
➢The red Emergency Stop Pushbutton is located in the center of the base
cover on the back of the table.
➢Pressing this button until it is fully engaged will stop all motorized
movement by cutting off power from all system components.
➢RESET: Restore the electrical functions by rotating the button a quarter turn.
7. SETUP INSTRUCTIONS
7.1. Setup
•Hand operated controls for the movement of the tabletop are included with the table.
The operator should become familiar with the controls before using them.
•External electrical power connection and disconnection is through the AC power cord
and outlet. The table will operate on 110 V~, 230 V~ or on internal battery backup
power (see section 8.2). When external electrical power is applied to the actuators
which control the movement of the tabletop, the green LEDs on the Handset Control
will illuminate.
•The electrical power outlet used should be visible and accessible to the user. The
electrical power cord should be routed where it will not be subject to damage or be a
tripping hazard.
•Check that the ground pin on the electrical cord plug is in good condition before each
time it is plugged in.
WARNING!
To avoid electric shock, plug the electrical power cord
into a properly grounded hospital grade outlet!
EMERGENCY
STOP
PUSHBUTTON
IMAGING END OF TABLETOP
PEDESTAL END OF TABLETOP

Operator Manual Aspect 100-4T and ISR
L100-2843 Rev. E www.imagediagnostics.com 13
•When the table is not connected to AC power, the table will automatically switch to
backup battery mode. The table should only be used under backup battery power
temporarily for necessary function if the external power supply is lost.
•It is recommended that AC power be applied for a minimum of 8 hours every day to
keep a proper charge on the batteries and achieve maximum battery life. Batteries
are constantly being charged during normal use when connected to AC power.
When the table is not in use and not connected to AC power, the
Emergency Stop Pushbutton must be fully engaged to prevent the
batteries from being discharged and to safely power off the equipment.
•This equipment’s tabletop braking systems utilize a passive magnetic brake; it remains
engaged/energized in the event of a complete loss of electrical power. Power is
necessary to release the brakes.
•As the braking system utilizes permanent magnetic brakes, braking force is limited by
the magnet strength. Use caution when applying pressure to the side of the table as the
brakes can be overcome if more than 50 pounds (22.8 kg) of force is applied.

Operator Manual Aspect 100-4T and ISR
L100-2843 Rev. E www.imagediagnostics.com 14
8. INSTRUCTIONS FOR TABLE OPERATION
8.1. CASTER LOCKING AND UNLOCKING SETTINGS
The rear casters can be configured in a locking setting which totally locks all motion of
the rear casters and an unlocked setting which allows the rear casters to swivel freely.
The front wheels can be set to roll unidirectionally forwards and backwards or swivel
freely.
•The Table is in the “LOCK” setting when the Rear Caster Lock Pedal is pushed
forward on the TOP half until it is fully engaged and when the Front Steer Lock Pedal
is pushed DOWN. The Rear Casters will be totally locked and will not roll in any
direction. Always lock all casters in this way before loading the patient onto the
table.
•The table is in the “UNLOCK” setting when the Rear Caster Lock Pedal is pushed
down on the BOTTOM half until it is fully engaged and when the Front Steer Lock
Pedal is pulled UP to disengage the unidirectional wheels and engage the free swiveling
casters. The Rear and Front Casters will be allowed to roll and swivel in any direction.
WARNING!
Before loading a patient onto the table, always set the
base caster pedals in BOTH the front AND the rear to
their “LOCK” positions. Failure to do so could result in
death or serious injury.
REAR
CASTER
LOCK PEDAL
REAR CASTERS
FRONT
STEER LOCK
PEDAL
FRONT WHEELS
& CASTERS

Operator Manual Aspect 100-4T and ISR
L100-2843 Rev. E www.imagediagnostics.com 15
8.2. POWER INDICATOR LIGHT
The Power Indicator Light, located just below the Emergency Stop
Pushbutton on the back side of the table will be illuminated green
when there is sufficient electrical power to the Table and unlit when
there is no electrical power to the Table or when the Emergency
Stop Pushbutton is engaged.
8.3. TABLE MOTION CONTROLS
All Aspect ISR & Aspect 100-4T tables are equipped with tabletop motion control boxes that
allow users to move the tabletop in many different directions.
PANHANDLE KNOB (PLACE PALM ON TOP OF KNOB,
LIFT LIP UNDERNEATH THE KNOB WITH FINGERTIPS
TO FLOAT TABLETOP IN HORIZONTAL DIRECTION)
LATERALLY
CENTERED
TABLETOP
INDICATOR
TABLETOP
ELEVATE
MOTION SWITCH
TABLETOP
TRENDELENBURG
(TILT) MOTION
SWITCH
TRENDELENBURG
(TILT) LEVEL
TABLETOP
INDICATOR
TABLETOP
ISO-ROLL
MOTION SWITCH
(ISR ONLY)
ISO-ROLL LEVEL
TABLETOP
INDICATOR
(ISR ONLY)

Operator Manual Aspect 100-4T and ISR
L100-2843 Rev. E www.imagediagnostics.com 16
Continually pressing down on the Rocker Switch to
the right of this symbol will raise the Tabletop
vertically.
Continually pressing down on the Rocker Switch to
the right of this symbol will lower the Tabletop
vertically.
Continually pressing down on the Rocker Switch to
the right of this symbol will tilt up the imaging end
of the Tabletop in a Trendelenburg direction.
When the Tabletop reaches a level position, motion
will stop for 1 second. When the Rocker Switch is
pressed down if the Tabletop is already in a level
position, it will take 1 second for motion to begin.
Continually pressing down on the Rocker Switch to
the right of this symbol will tilt down the imaging
end of the Tabletop in a Trendelenburg direction.
When the Tabletop reaches a level position, motion
will stop for 1 second. When the Rocker Switch is
pressed down if the Tabletop is already in a level
position, it will take 1 second for motion to begin.
Continually pressing down on the Rocker Switch to
the right of this symbol will roll the Tabletop in a
clockwise direction if looking down the length of
the Table from the pedestal end. When the Tabletop
reaches a level position, motion will stop. The
Rocker Switch will need to be released and pressed
down again for the motion to begin again.
Continually pressing down on the Rocker Switch to
the right of this symbol will roll the Tabletop in a
counter-clockwise direction if looking down the
length of the Table from the pedestal end. When the
Tabletop reaches a level position, motion will stop.
The Rocker Switch will need to be released and
pressed down again for the motion to begin again.
When using the Panhandle knob to pan the tabletop
laterally, the light in this symbol will illuminate
green when the tabletop is centered from side to side
(crossways).

Operator Manual Aspect 100-4T and ISR
L100-2843 Rev. E www.imagediagnostics.com 17
Lifting the lip under the mushroom shaped Panhandle releases
the brakes that stop all lateral and longitudinal motion of the
Tabletop. Holding the ring up with fingertips allows the
Tabletop to be manually repositioned. The Switch Lockout
Pushbutton only disables Elevate, Trendelenburg, and ISO-
Centric Roll (ISR only) motions to prevent accidental
activation.
The Tabletop Motion Control Unit clamps onto either the left
or right Accessory Rail on the Tabletop and can be moved
along the length of the rails by rotating the lever down on the
bottom of the Motion Control Unit until the clamp releases
tension on the Accessory Rail. Then the Unit can be slid along the rail or removed.

Operator Manual Aspect 100-4T and ISR
L100-2843 Rev. E www.imagediagnostics.com 18
8.4. TABLETOP MOTION HANDSET CONTROLS
•When using the Handset Control shown above, each button must be held down to
get continuous motion of the tabletop. Motions will stop as soon as the button is
released.
•When the Trendelenburg (tilt) function buttons are used, the Tabletop motion will
stop at level position for 1 second before motion begins again. When the Table’s
Trendelenburg (tilt) position is already level and the Trendelenburg buttons are
pressed, it will take 1 second before the motion of the Tabletop begins.
•When the ISO-Roll function buttons are used (ISR only), the Tabletop motion will
stop at level position. When this happens, release and repress the button again to
continue the motion.
WARNING!
The Handset Control is always active when
connected to a powered-up table.
WARNING!
The Switch Lockout Pushbutton on the Motion
Control Panhandle does not disable the Handset
Control.

Operator Manual Aspect 100-4T and ISR
L100-2843 Rev. E www.imagediagnostics.com 19
8.5. FOOT ACTUATED MOTION CONTROLS
100-4T FOOT SWITCH CONTROL
Foot Switch activated control motions
for the Aspect 100-4T Tabletop are:
elevate/lower and Trendelenburg
down/up. (Safety hood helps avoid
accidental motorized table movement
from Foot Switch).
•When the Trendelenburg Foot Pedal
is used, the tabletop motion will stop
at level position for 1 second before
motion begins again. When the
Table’s Trendelenburg position is
already level and the Trendelenburg
Foot Pedal is pressed, it will take 1
second before the motion of the
Tabletop begins.
ISR FOOT SWITCH CONTROL
Foot Switch activated control motions
for the Aspect ISR table are: ISO-Roll,
Trendelenburg down/up and
elevate/lower. (Safety hood helps avoid
accidental motorized Table movement
from Foot Switch Control).
•When the Trendelenburg Foot
Switch Pedal is used, the Tabletop
motion will stop at level position for
1 second before motion begins again.
When the Table’s Trendelenburg
position is already level and the
Trendelenburg Foot Switch Pedal is
pressed, it will take 1 second before
the motion of the tabletop begins.
•When the ISO-Roll Foot Switch Pedal
is used, the Tabletop motion will stop
at level position. When this happens,
release and repress the ISO-Roll Foot
Switch Pedal again to continue the
motion.

Operator Manual Aspect 100-4T and ISR
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9. PATIENT PREPARATION
9.1. Preparation for Patient Use
•New Installation: This equipment will need to be properly cleaned before patient use as it will
inevitably come into contact with contaminants during shipping, unpacking, storage, and
installation.
•After initial use, this equipment will need to be properly cleaned between uses
with patients as it will inevitably come into contact with contaminants during
procedures. Refer to section 13 of this manual for cleaning instructions and
approved cleaning substances.
9.2. Patient Loading
•Patients must be loaded from the side of table. There is a possibility of tilting,
instability and/or tipping if patient is loaded onto the pedestal end or the imaging end
of the table.
•To reduce potential motion during patient transfers with larger patients, move the tabletop
lateral (side to side) in the direction the patient will be moving until the limit of the tabletop
travel is reached, release the Panhandle Tabletop Float Break to re-engage the break and then
transfer the patient onto the Table.
CAUTION
If the tabletop is struck hard enough, it may slide
to reduce damage to the carbon fiber top.
WARNING!
Before loading a patient onto the table, always set
the base caster pedals in BOTH the front AND the
rear to their “LOCK” positions. Failure to do so
could result in death or serious injury.