idi Aspect ISO-Drive User manual

Made in the USA
Aspect ISO-Drive
Mobile Imaging Table
Operator Manual

Operator Manual Aspect ISO-Drive
L100-3265 Rev. A www.imagediagnostics.com 2
The text of this manual was originally written, approved and published by the manufacturer in English.
OVERVIEW
This manual pertains to the specified devices only and does not intend to replace or substitute for certified
training in the application of this equipment. The device is intended for qualified medical personnel who
have been trained in the use of medical equipment.
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.
OWNER RESPONSIBILITIES
The owner of this device is responsible to ensure system compatibility, the qualifications of the operator and
maintenance personnel. The operator 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 device 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 the equipment. After-sale operating practices and safety are the
responsibility of the owner and operator. Image Diagnostics, Inc. assumes no liability or responsibility for
after-sale operating or safety practices; nor can it be responsible for personal injury or damage resulting from
misuse.
Never make modifications or adjustments to the equipment unless directed by a qualified Image Diagnostics
representative. This equipment, when properly assembled, meets US federal regulations and international
standards. Unauthorized modifications to the equipment may impact adherence to these standards and make
the equipment unsafe to operate.
CUSTOMER SUPPORT
Image Diagnostics will make available, on request, circuit diagrams, component part lists, calibration
instructions, or other information which will assist 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.
This X-ray component manufactured by Image Diagnostics, Inc. complies with applicable FDA performance
standards contained in 21CFR at date of manufacture.

Operator Manual Aspect ISO-Drive
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Table of Contents
1. SYMBOL IDENTIFICATION............................................................................................. 5
2. INTENDED USE & ESSENTIAL PERFORMANCE....................................................... 7
3. SAFETY INSTRUCTIONS.................................................................................................. 7
4. SAFETY HAZARDS............................................................................................................. 8
5. EMC (Electromagnetic Compatibility) STATEMENT ................................................... 10
6. EMERGENCY STOP PUSHBUTTON............................................................................. 11
7. SETUP INSTRUCTIONS & PATIENT PREPARATION ............................................. 11
7.1. Installation.................................................................................................................... 11
7.2. Preparation for Patient Use......................................................................................... 12
7.3. Patient Loading ............................................................................................................ 12
7.4. Preparation for Performing CPR............................................................................... 13
8. INSTRUCTIONS FOR TABLE OPERATION................................................................ 14
8.1. CASTER MOTION AND STEERING SETTINGS................................................. 14
8.2. TABLE MOTION CONTROLS................................................................................. 15
9. STANDARD ACCESSORIES............................................................................................ 16
9.1. Patient Mattress Pad for Tabletop. ............................................................................ 16
9.2. Head Positioning Pads. ................................................................................................ 16
9.3. Patient Restraint Straps............................................................................................... 17
9.4. Arm Comfort Strap...................................................................................................... 17
10. ADD-ON ACCESSORIES.................................................................................................. 18
10.1. Clamp-on Accessory Rail......................................................................................... 18
10.2. Vascular Access Arm Board (VAB)........................................................................ 18
10.3. Quick Release Rail Mount Arm Board (requires Clamp-on Accessory Rail) .... 19
10.4. Arm Board, Shoulder Mount .................................................................................. 19
10.5. Radiation Shield........................................................................................................ 19
10.6. Clamp-on Radiation Shield...................................................................................... 19
11. GENERAL CLEANING..................................................................................................... 20
12. MAINTENANCE, SERVICE & REPAIR........................................................................ 21
12.1. RECOMMENDED PERIODIC PERFORMANCE CHECKS............................ 21
12.2. SERVICE & REPAIR STATEMENT.................................................................... 21
12.3. REINITIALIZE ACTUATOR CONTROLLER................................................... 21
13. TROUBLESHOOTING...................................................................................................... 23

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L100-3265 Rev. A www.imagediagnostics.com 4
14. DISPOSAL OF COMPONENTS....................................................................................... 25
15. PRODUCT DATA............................................................................................................... 26
16. SPECIFICATIONS............................................................................................................. 27
17. WARRANTY....................................................................................................................... 31

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L100-3265 Rev. A 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. CD ROMs
containing digital files of Instructions for Use included
with manual.
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. 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 not be relocated with a patient on
it nor should it be used to move a patient.
or

Operator Manual Aspect ISO-Drive
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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.
Presence of non-ionizing electromagnetic radiation.
Model of Table.
Serial Number of Table.
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)
REF
SN

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2. INTENDED USE & ESSENTIAL PERFORMANCE
The Aspect IS0-Drive is a mobile multipurpose imaging table used by the professional
healthcare industry for pain management, endoscopy, G.I. and general procedures. The
table is used to support and position the patient as required by the medical procedures.
It is a “C-arm” style table to allow radiological imaging equipment to be used in
conjunction with the table. The table has backup battery power which should only be
used temporarily for necessary function of the table if the external power supply is
disrupted.
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 before operating table

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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 potentiallyhazardous 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.
WARNING!
To avoid electric shock, plug the electrical power cord
into a properly grounded hospital grade outlet!
WARNING!
This product 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.

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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 uncontrolled patient.

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5. EMC (Electromagnetic Compatibility) STATEMENT
Portable and Mobile RF Communications Equipment can affect Medical Electrical
Equipment including the Aspect ISO-Drive table. Use special precautions regarding EMC when
these tables are installed, operated and maintained. EMC operating specifications for these
tables are in the SPECIFICATIONS section of this manual (Section 16).
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: The Aspect ISO-Drive 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 the Aspect ISO-Drive, 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 the section 3 of
this manual.

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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 removing power from all system components.
• ACTIVATE: Engage the emergency stop mode by pressing the button.
• RESET: Restore the electrical functions by rotating the button a quarter turn.
7. SETUP INSTRUCTIONS & PATIENT PREPARATION
7.1. Installation
•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. 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.
WARNING!
To avoid electric shock, plug the electrical power cord
into a properly grounded hospital grade outlet!
EMERGENCY
STOP
PUSHBUTTON
PEDESTAL END OF
TABLETOP
IMAGING END OF TABLETOP

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•Check that the ground pin on the electrical cord plug is in good condition before
each time that it is plugged in.
•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 battery from being
discharged and to safely power off the equipment. Storage of the table for
longer than 3 months requires the table to be connected to AC power with the
Emergency Stop Button released to charge the battery.
7.2. 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 Installation: 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 11 of this manual for cleaning instructions and approved cleaning
substances.
7.3. 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 of
Table or the imaging end of the Table.

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7.4. Preparation for Performing CPR
•Return table to level position and lower table position to a
comfortable height before performing CPR on a patient.

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8. INSTRUCTIONS FOR TABLE OPERATION
8.1. CASTER MOTION AND STEERING SETTINGS
The motion of the table can be configured two ways:
1. “STEER” where the rear casters are free rolling in all directions.
2. “LOCK”where the rear casters will not be able to roll at all.
Note: The front wheels only roll forwards and backwards.
The Table is in “STEER” mode with the Caster Lock Pedal as
shown in this picture. The Rear Casters can swivel freely and roll
in any direction while the front wheels remain in line with the
table.
The Table is in “LOCK” mode with the Caster Lock Pedal as
shown in this picture. The Rear Casters will be locked and will
not roll or swivel.
Always lock casters in this way before loading the patient.
WARNING!
Before loading a patient onto the table, always set the
caster motion pedals in the “LOCK” position. Failure to
do so could result in death or serious injury.

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8.2. TABLE MOTION 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.
•To store the current position of the table to a memory location press “Store
Memory Position” then the desired recall button; 1, 2, or 3.
•To recall a memory position, hold the desired recall button continuously until the
table motion stops.
WARNING!
The Handset Control is always active when
connected to a powered-up table.

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9. STANDARD ACCESSORIES
9.1. Patient Mattress Pad for Tabletop.
The Patient Mattress Pad is held in place by hook and loop fasteners. To remove the pad,
simply pull pad up gently to remove. Replacement pads are supplied with new self-
adhesive fasteners installed and new adhesive backed mating pieces for the tabletop. Peel
off old fasteners from Table Top. Peel off the protective paper and carefully put new pad
into position. Apply pressure to complete installation.
Note: Pad complies with California Technical Bulletin 117.
9.2. Head Positioning Pads.
Four Head Positioning Pads are provided with the ISO-Drive’s unique tapered top, these
are held in place by hook and loop fasteners. To remove the pad, simply pull pad up
gently to remove. Replacement pads are supplied with new self-adhesive fasteners
installed and new adhesive backed mating pieces for the tabletop, when replacing Head
Positioners peel off old fasteners from Table Top. Peel off the protective paper and
carefully put new pad into position. Apply pressure to complete installation. When
changing Head Positioners, it isn’t necessary to replace the mating fastener on the tabletop
•1” Thick positioner with facial opening
•Full height positioner with facial opening
•Wedge positioner with facial opening
•Full height positioner without facial opening
Note: Positioning pads comply with California Technical Bulletin 117.

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9.3. Patient Restraint Straps.
The Patient Restraint Straps can be used in
two different ways depending on where the
strap is to be located along the length of the
Table Top. If the strap is to be used on the
end of the table that has the two long
accessory rails, then the whole strap drapes
over the Table Top, hangs down between
the rails and the tabletop and wrapped over
the outside of the rails to meet over the top
of the table. If the strap is to be used along
the rest of the tabletop, slide the strap over
the end of the table with the thin part of the
strap over the Table Top and the thicker
part under the tabletop. The ends of the
strap meet over the top of the table and
connect with hook and loop fasteners.
9.4. Arm Comfort Strap.
A strap is provided to rest the arms of the patient for their comfort. This strap is passed
through the slot at the head end of the tabletop, exposed beyond the Head Positioner, using the
hook and loop to size the strap appropriately the patient can rest their arms either above or
below the facial recess of the tabletop.
WARNING!
Strap configuration is recommended; however, patient
restraint is a case-by-case condition. Please refer to
the facility’s policy on restraining a patient.

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10. ADD-ON ACCESSORIES
10.1. Clamp-on Accessory Rail
Fits on left or right side of table. 6” length. (European version with 10mm x 25mm metric
rail is available).
10.2. Vascular Access Arm Board (VAB)
One-piece, extra wide carbon fiber arm board for vascular access procedures. Mounts to
table by laying across the width of the tabletop underneath the Patient Mattress Pad and
uses a hook pin to hold in place. Includes arm board, pad and restraint strap.

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10.3. Quick Release Rail Mount
Arm Board (requires
Clamp-on Accessory Rail)
Radiolucent materials. Includes arm board, pad
and restraint straps. (European version for
10mm x 25mm metric rail size is available)
10.4. Arm Board, Shoulder Mount
Carbon fiber base. Mounts to table by sliding under Patient Mattress Pad. Includes
padded arm board and restraint strap.
10.5. Radiation Shield
Articulating with removable upper panel.
Panels are lead-free. Can be used on either
side of table. Mounts to both the accessory
rail and the tabletop by clamp.
Shown mounted on Aspect ISR G2, similar
mounting on Iso-Drive.
10.6. Clamp-on Radiation Shield
Fixed shield with integrated clamp system. Panels are
lead-free. Can be used on either side of table. Clamps to
the tabletop sides. Snap-on upper section above level of
tabletop is removable.
Shown mounted on Aspect 100-RT, similar mounting on
Iso-Drive.

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11. GENERAL CLEANING
After each medical procedure, the table should be properly cleaned. Do not use harsh
abrasives, solvents, sprays, or corrosive agents. Some accessories may come with
individual cleaning instructions.
APPROVED AND TESTED DISINFECTANT CLEANERS FOR TABLE:
•Sodium hypochlorite (generic household bleach) in solution of 5.25% sodium
hypochlorite diluted between 1:10 and 1:100 with water.
•Alcohol (generic).
•Envirocide ® Disinfectant and Cleaner.
APPROVED AND TESTED DISINFECTANT CLEANER FOR RADIATION SHIELD:
•Scrubbles(Infab Corporation)
https://www.infabcorp.com/apron-cleaning/
APPROVED AND TESTED GENERAL PURPOSE CLEANERS:
•Simple Green ™ cleaner.
CLEANING STEPS FOR TABLE:
a) Move the tabletop to a level horizontal position.
b) Lower the tabletop to its lowest position.
c) Disconnect the table from the AC power outlet and press the Emergency Stop
Pushbutton.
d) Power cord, Handset Control and Foot Control cords must be plugged in at the table
base to protect the inside of the connectors from debris.
e) Remove all pads and accessories.
f) Wipe off any excess fluids with a water dampened cloth or sponge.
g) Clean the Table Top and accessories using an approved cleaner listed above.
h) Clean all pads according to the instructions attached to the pad.
i) Clean the table frame, castors, and base with Simple Green ™ cleaner.
j) Thoroughly rinse Patient Mattress Pad, Table Top and Accessory Rails with water.
k) Gently rub with a soft clean cloth until dry.
CLEANING STEPS FOR RADIATION SHIELD:
a) Lift off the upper section and lay it flat before using the recommended cleaner in an
adequately ventilated area.
b) Apply approved cleaner to one side at a time and allow to stand a few minutes.
c) Scrub with a soft bristle scrub brush. Do not let the solution dry before rinsing.
d) Rinse with water and a damp cloth.
e) Scrub and rinse again, if necessary.
f) Remove the main section of the Radiation Shield and clean in the same manner.
g) Attach Radiation Shield back onto Table Top.
h) Install upper panel of Radiation Shield.