Image Diagnostics Compass Product Line User manual

Compass Product Line
Radiation Protection System
Versions may vary from the picture shown.
Setup & Operator Manual
The text of this manual was originally written, approved, and published by the manufacturer in English. The
information and images in this document are proprietary to IDI and is only for use for and by IDI
representatives or their Agents.

Setup & Operator Manual Compass Product Line
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OVERVIEW
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.
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.
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 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, radiation testing results, component part lists, 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 Compass Product top pipe near vertical spring arm connection point at time of contact.
This Personnel Protective Shield component manufactured by Image Diagnostics, Inc. complies with
applicable FDA performance standards contained in 21CFR Sec. 892.6500 at date of manufacture.
Image Diagnostics, Inc.
310 Authority Drive
Fitchburg, MA 01420 USA

Setup & Operator Manual Compass Product Line
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Table of Contents
1. Symbol Identification............................................................................................................ 4
2. Intended Use........................................................................................................................... 5
3. Safety Hazards....................................................................................................................... 6
4. EMC (Electromagnetic Compatibility) Statement............................................................. 7
5. Compass Product Main Assemblies (versions may vary).................................................. 7
6. Compass Product Components ............................................................................................ 7
7. Compass Accessories & Disposables.................................................................................... 8
8. Instructions for Operation & Usage .................................................................................... 8
9. General Cleaning................................................................................................................... 9
10. Service & Repair.............................................................................................................. 10
11. Maintenance ..................................................................................................................... 10
12. Disposal of Components.................................................................................................. 11
13. Specifications.................................................................................................................... 12
14. Label Identification.......................................................................................................... 13
15. Warranty .......................................................................................................................... 14

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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 relevant drawings,
BOMs, and documentation are included with the service manual for reference.
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.
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.
Model of Compass Product Line.
Serial Number of Compass Product Line.
Date of manufacture of the device.
Location where device was manufactured.
Read the Manual.
REF
SN
or

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2. Intended Use
The Compass Product Line is a discreet radiation shield barrier protection system which can be
attach onto a ceiling suspension or mobile cart suspension platforms. The product line will have
initial use for fluoroscopic procedures. The products would be positioned between patient and
medical professionals within treatment table work area. These products would provide a discreet
sized partial radiation protective barrier shielding physicians or tableside assistants from
exposure to primary radiation that emanates directly from the x-ray source, as well as secondary
radiation reflected or scatter by an object such as the x-ray detector, the x-ray table and the
patient. The products would provide a minimum of 0.5mm lead equivalency. This is a minimum
recommendation and subject to individual hospital radiation safety regulations and guidance by
staff physicists.
✓All persons using this equipment must fully understand its operation instructions,
emergency procedures, capabilities 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.
It is imperative that all personnel operating Compass Productsbe familiar with the equipment
operation, transport and all documentation supplied by IDI.
•The Compass Product Line is intended to be used in typical clinical or research
environments in accordance with national standards.
•Product contains a leaded acrylic window; it may become damaged from wear and must
be inspected from time to time per the institutions radiation safety policy to instill
essential performance functions that pose a risk due to failure or degradation of the unit
or any of its components.
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].

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3. Safety Hazards
Safety Hazard Level
Potential Consequences with Use
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!
Do not modify this equipment.
CAUTION!
It is the user’s responsibility to make sure the equipment
is safe and operates properly prior to use.
WARNING!
There is the potential of exposure to harmful x-rays.
Improper shield panel positions can allow radiation
exposure to operator.
be grounded to a protective earth location.
WARNING!
Use only vendor OEM vertical articulation spring arms
which support a spring rating between 10-11 Kg and will
accept a Compass connection shaft of 28.5-29mm.

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4. EMC (Electromagnetic Compatibility) Statement
Portable and Mobile RF Communications Equipment will not affect the Compass Products,
which are non-electrical system. No special precautions needed regarding EMC when Compass
Products are installed, operated, and maintained.
5. Compass Product Main Assemblies (versions may vary)
6. Compass Product Components
7.1. Item 1: Yoke Shaft –inserts into vertical spring arm, attached by means of a shaft arm key and
collar to lock key in place. Arrows show full rotation in both directions.
7.2. Item 2: Window Side Supports
7.3. Item 3: Compression Hubs with Hardware. Arrows show full rotation in both directions.
7.4. Item 4: Window Clamping Brackets
7.5. Item 5: Sterile Bag Retention Tabs –When installing a Sterile Bag, slip bag up from the bottom of
the window and place bag elastic over Retention Tabs on both sides. Dashed line in view above
represents bag position during procedures.
7.6. Item 6: Leaded Acrylic Window –Pb 0.5 mm rating.
2
1
6
1
5
1
1
1
4
1
3
1
7
1

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7. Compass Accessories & Disposables
7.1. Item 7: X610-0208 –Bag, Sterile, Compass Contour, 17”x 27” with contoured notch
7.2. Item 7: C610-0209 –Bag, Sterile, Compass Frame, 28”x 20”
8. Instructions for Operation & Usage
8.1. Vendor OEM vertical articulation spring arms weight and connection data.
8.1.1.Compass Contour and Frame weight varies from 10 –11 kg/22 –24 lbs.
8.1.2.Use only vendor OEM supplied vertical articulation spring arms having a spring force rating
that supports a 10-11 kg load and will accept a Compass connection shaft diameter of
between 28.5-29mm.
8.2. Emergency Patient Access
8.2.1.For emergency access to patient, manually rotate and move the shielding barrier away from
patient area to a safe distance and location for emergency access.
8.3. Compass Product attachment to vertical spring arms will vary per OEM vendor. See
spring arm manufacturer’s installation & user manual for instructions.
8.3.1.On the vertical spring arm connection end, remove small metric screw from the collar or
plug. Slide collar up (Ondal) or remove insert plug (OASYS) and remove key (Do not lose).
Having key ready, move Compass shaft hub into vertical arm shaft hole, insert key, slide
collar over (Ondal) or insert plug (OASYS), insert metric screw and tighten (See photos
below).
8.4. Vertical arm adjustments for vertical limits
8.4.1.Adjust vertical heights and spring force per OEM vendor adjustment manual instructions.
Height and Force adjustments are up to the user’s discretion.
WARNING!
In the event of an emergency where direct accessed to
patient is needed, do these steps quickly to move
Compass Radiation Shield Barrier away from patient.
Key

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9. General Cleaning
After each medical procedure, Compass Product components and visible contaminated areas
should be properly cleaned. Do not use harsh abrasives, solvents, sprays, or corrosive agents.
If room is to be disinfected by means of an atomizer, the equipment must be covered with
plastic bag or similar sheeting.
APPROVED/TESTED DISINFECTANT CLEANERS FOR COMPASS PRODUCTS
METALS/PLASTICS: Do not apply on acrylic window surfaces!
•Alcohol (generic).
•Precise Hospital Foam Cleaner Disinfect
•Envirocide ® Disinfectant and Cleaner.
•Disinfecting Wipes (Lysol or equivalent), Ammonium Chloride –0.20-0.50 %
APPROVED AND TESTED CLEANER FOR ACRYLIC WINDOWS:
•Standard Dish washing liquid, one drop to a quart. Use only a very soft damp cloth
when cleaning acrylic surfaces. It is possible to scratch acrylic, so NEVER use any
scouring compounds or chemical cleaners such as Windex or other glass cleaners (even if
they are environmentally friendly, organic or non-scented). Should anything ever stick to
an acrylic surface (such as an adhesive label or gummy substance) do not use any type of
solvent.
•Never use the same cloth for multiple cleanings –it can retain dirt, grit, and chemical
residues that may harm your acrylic items. We recommend using a new or separate cloth
for your acrylic care.
•However, scratches do happen –but don’t worry! Unlike other materials, scratches on
acrylic can be easily removed with Novus products.
•Keep your acrylic surfaces free from dust and dirt, with “Novus 1“. It’s a clear, anti-static
formula specially created to remove the negative charge that can attract dust and dirt to
the surface of acrylic. It is easy to use simply wipe on and wipe off! The “Novus 2” anti-
static formula to remove surface scratches while it cleans. The “Novus 3” is for removal
of heavier scratches and requires Novus 2 for final finishing.
•Avoid !!!!!!!!!!! Ammonia or Vinegar-based cleaners (Windex) and regular use of
Isopropyl Alcohol which can cause tiny cracks in window.
APPROVED AND TESTED GENERAL PURPOSE CLEANERS:
•Simple Green ™ cleaner.

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CLEANING STEPS FOR COMPASS PRODUCTS:
a) Wipe off any excess fluids with a water dampened cloth or sponge.
b) Clean the Compass Product metals using an approved cleaner listed above.
c) Clean the articulating arms and components from either the ceiling mount or mobile
platform systems with Simple Green ™ cleaner as needed.
CLEANING STEPS ACRYLIC WINDOWS:
a) To Clean, stay away from abrasive tools and cleaners. Us a mild, non-abrasive cleaning
solution, soft cloth, and careful minimal pressure motion.
b) Clean using a microfiber or non-abrasive damp cloth. Either wet the cloth directly in the
soapy mild water solution, or moisten it completely before using.
c) Always use a new, clean cloth to wash. Never use a cloth used for another cleaning job
for this could scratch the acrylic. Approved cleaner listed above.
d) Do not use paper towels, scrub pads, or other abrasive cleaning tools.
For repairs or replacement of components, please contact Image Diagnostics for Service and
Repair at [phone].
All maintenance procedures should be done by an experienced and qualified technician with
demonstrated knowledge and skills (mechanical) in the service of medical equipment.
✓This individual must have access to this manual and the proper tools.
✓Lubrication of this device is not required.
RECOMMENDED PERIODIC PERFORMANCE CHECKS
Daily (Prior to use)
Inspect all surfaces for procedure use
contamination. Refer to general cleaning
instruction, Section 9
Quarterly
Visually inspect all components, loose
hardware and the shielding for wear and
damage. Maintain as needed.
10. Service & Repair
11. Maintenance

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12. Disposal of Components
The Compass Products are constructed with components made of steel, aluminum,
and shielding materials. Steel and aluminum are easily recycled. Shielding
materials will be consider waste disposal products. Components must be
disassembled before recycling.
Disposal Considerations for shielding materials –Waste Disposal: Classified in
Europe as non-hazardous under EWC code 12 01 99. Should be disposed of in
registered landfill sites in accordance with Local Authority regulations.
COMPONENT
ITEM
RECYCLING GROUP
Frame & Brackets
Support and clamping
components
Metal (Steel and Aluminum)
Spacers/Washers
Clamping
Plastics
Lead Acrylic Windows
Windows
Lead Composites
WARNING!
Radiation shields require careful handling and periodic
testing for safe use.
Test upon receipt and at regular intervals to ensure
shielding integrity.
Test procedure and schedule to be the responsibility of the
appropriate department of the facility where used.
WARNING!
Any system repairs and maintenance must be done by
trained service personal, only hardware adjustments may
be made.

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13. Specifications
Mode of Operation
▪All products are manually moved.
Electrical:
▪N/A
Environmental:
▪Operating Temperature Range: 32F to 104F (0C to +40C)
▪Operating Humidity Range: 30% to 80% relative humidity, noncondensing.
▪Operating Pressure Range: 700 hPa to 1010 hPa.
▪Transport & Storage Temperature Range: -4F to 131F (-20C to +55C).
▪Transport & Storage Humidity Range: 10% to 80% relative humidity, noncondensing.
▪Transport & Storage Pressure Range: 500 hPa to 1010 hPa.
Product features included with Compass Products:
▪All Compass products have leaded acrylic shielded windows rated for Pb 0.50mm.
▪All Compass products have horizontal rotation of 360 degrees.
▪All Compass products have vertical rotation of 350 degrees.
▪Only vendor OEM vertical spring arms with spring ratings between 9-15 Kg may be used for
connecting Compass Products.
Product accessories for use with Compass Products:
▪X610-0208 –Bag, Sterile, Compass Contour, 17”x 27” (box of 20). Elastic top edged sterile bag
slide onto lower portion of the lead acrylic window where elastic bag bang is placed above
window clamp bracket tabs, see Section 5 & 6 for placement information.
▪C610-0209 –Bag, Sterile, Compass Frame, 28”x 20”(box of 20). Elastic top edged sterile bag
slide onto lower portion of the lead acrylic window where elastic bag bang is placed above
window clamp bracket tabs, see Section 5 picture & 7 for item placement information.
Physical Characteristics:
▪Compass Product size varies per model.

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14. Label Identification
Item
No.
Part No.
Description
Qty.
Label
1
L610-0218
LABEL,
SERIAL
NUMBER,
COMPASS
1
2
L000-0004
LABEL, UDI
BARCODE
1
3
L610-0224
LABEL,
COMPASS,
MANUAL,QR,
RATING
1
Date Code of Manufactured
Compass Products in the
format of Year-Month
Device Serial Number
Unique per Manufactured
Compass Products
GTIN 14
Digit
Company
Prefix
Date Code
YYMMDD
Device
Serial
Number

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15. Warranty
Warranty details for IDI Products can be obtained directly from Image Diagnostics, Inc.
Image Diagnostics, Inc.
310 Authority Drive
Fitchburg, MA 01420 USA
Or call IDI at [phone].