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ORBITEC Star-Tek Alliance S3 User manual

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1
USER MANUAL
Star-Tek Alliance Electric Treatment Table
Model S3 - with Side Bar Lift Controller
USA version – July 2019 revision
IT IS YOUR RESPONSIBILITY TO READ THIS USER MANUAL.
It only takes a few minutes and it will make you a better caregiver!
IMPORTANT SAFETY ISSUES!
WARNINGS, CAUTIONS and SAFE USE PROCEDURES are contained within this Manual.
This Treatment Table is a Class 1 Medical Device registered with the FDA and
MUST be used under the supervision of a licensed practitioner.
DO NOT allow anyone to operate this table until they have read and fully
understand this manual entirely.
Each Star-Tek Alliance Treatment Table sold in the USA is serialized to be uniquely identifiable
and traced to the clinic to which it was delivered. This User Manual is also serialized and linked
to its matching table. All service performed to this table should be documented in the Service
History section.
2
Table of Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Our Commitment to Excellence . . . . . . . . . . . . . . . . . . . . . 3
Important General Warnings . . . . . . . . . . . . . . . . . . . . . . 4
General Safety & Use Information . . . . . . . . . . . . . . . . . . . . 5
Cleaning Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Load Distribution & Weight Lift Capacity . . . . . . . . . . . . . . . . . 6
General Product Overview . . . . . . . . . . . . . . . . . . . . . . . 7
Head & Foot Section Tilt Operation . . . . . . . . . . . . . . . . . . . . 8
Side Bar Lift Control Operation . . . . . . . . . . . . . . . . . . . . . . 9
Interchangeable Head Inserts . . . . . . . . . . . . . . . . . . . . . . . 9
Castor Lift / Drop . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Leveling Foot Adjustment . . . . . . . . . . . . . . . . . . . . . . . . 11
Table Relocation Within Your Facility . . . . . . . . . . . . . . . . . . . 11
Table Relocation To A New Facility . . . . . . . . . . . . . . . . . . . . 12
Table Identification Label . . . . . . . . . . . . . . . . . . . . . . . . 12
Motor Control Box Identification Label . . . . . . . . . . . . . . . . . . . 12
Label Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . 13
General Service Information . . . . . . . . . . . . . . . . . . . . . . . 14
Control Box (Motor) Connections. . . . . . . . . . . . . . . . . . . . . . 14
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Product Regulatory Compliance . . . . . . . . . . . . . . . . . . . . . . 16
Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . 17
Manufacturer’s Standard Warranty . . . . . . . . . . . . . . . . . . . . . 18
Customer Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Table Model, Serial No., & Warranty Start Date . . . . . . . . . . . . . . . . 18
Service History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
3
Introduction
Congratulations on your decision to purchase this Star-Tek Alliance (STA) Model S3
Medical Treatment Table! We appreciate your business!
Our Product Development Team strives to provide the very best value and performance with every
product. This electric Model S3 with Side Bar lift controllers was developed to maximize stability,
patient & therapist comfort, safety, and reliability.
Before 1
st
Use:
First: Read the entire User Manual to learn the features, proper use, and care of this product.
Then: Test the function and features of this table.
If you have any questions, or concerns, contact us.
Star-Tek Alliance highly values your opinion and input. We understand that you, the
practitioner, have the best insight. We welcome and encourage your feedback, suggestions, and
any new feature or product ideas. Please refer to the Customer Service section to communicate.
Our Commitment to Excellence: We need you!
We are committed to excellence in product design, engineering, testing, manufacture, delivery,
and service. Our goal is to make you well satisfied and exceed expectations whenever possible. It
is our goal to track the location and service record of every Treatment Table sold in the USA.
To do that, we need your cooperation.
Automatic Registration
Our delivery team automatically associates your table’s serial number with your clinic. So, you do
not have to do anything to register this product and activate the warranty.
Service History Recording
Please contact us with any, and all, service issues pertaining to this product. That is the best way
we can provide the best service and record the service history of this product. Please retain this
User Manual and record any issue or service in the Service History section at the back of this
manual. STA will also document service issues and actions in our Consumer Service database
based on your communication. Tracking the service issues helps us improve our products!
Warranty Transfer
If the ownership of this table is transferred, Star-Tek Alliance (STA) will honor and allow transfer
of the warranty, provided the transfer is communicated to STA before the transfer, and the table
service history is in good standing. The warranty period is established from the original clinic
delivery date.
How to keep your Warranty Intact
Any service provided without the direction or consultation of STA may void your warranty, so
please contact us to keep your warranty intact.
Moving Service Availability
The local STA product delivery professionals in your area are available to assist you with any
clinic or treatment table relocation. To arrange a move, please contact Customer Service.
4
Important General Warnings
1. ONLY use this table indoors, on a dry, flat, level floor.
2. ALWAYS plug table directly into grounded (3 prong) power wall outlet.
DO NOT use extension cords or power junction boxes.
3. ALWAYS check for obstructions above and below the table top before
raising or lowering.
4. DO NOT exceed the maximum load ratings of the table. See page 6.
5. NEVER allow more than one person on the table at a time.
6. People must get onto the table at the center of either side of the table.
7. NEVER allow a person to sit on the head section or foot section.
8. DO NOT allow any person to jump up onto, or bounce on, the table.
9. ALWAYS make sure a person on the table has all hands, feet, arms, legs,
and clothing above the table top before raising or lowering.
10. ALWAYS assure the cables are safely away from moving parts.
11. ALWAYS instruct the person on the table when you intend to change the
table position and instruct them to remain still (not move) until the table
motion stops.
12. DO NOT use the table to transport people or objects.
13. DO NOT allow children to use, or be near, the table during operation.
14. NEVER operate this table if some defect or malfunction is observed.
15. DO NOT disassemble any parts of the table as some components are under
high stress. Unfastening can cause sudden force release that could cause
injury.
5
General Safety & Use Information
1. The table top can be lifted without power by two people if an object or person
is caught in the lifting mechanism. Lift from the center of each side if possible,
for best results.
2. The Head and Foot sections are supported by powerful twin Gas Spring
mechanisms. Use your hands to hold the table top section when you want to
re-position before pressing the Release Control Bar. (See page 8).
NEVER attempt to remove or adjust the Gas Springs.
3. Overloading the Gas Springs will cause them to become damaged.
a. ALWAYS assure that the Foot Section is fully down against the table
top support frame before a person gets onto the table.
b. STOP usage and call STA for service if any Gas Spring shows damage.
4. It is your responsibility to use this table in a safe environment with adequate
clearance from any other people or objects.
5. Keep the table clean using only safe, gentle cleaning products.
6. If any problem related to this table occurs, it is best to communicate with our
Customer Service professionals. Our team will determine if there is something
that can be done immediately, assist you with ordering parts, and/or set up an
appointment for service at your facility.
Cleaning Care
Use only gentle cleaning solution such as:
• mild soap & water
• diluted 1/3 isopropyl alcohol in 2/3 water
• common treatment table cleaning product
6
Load Distribution & Weight Lift Capacity
All therapists who will operate the table must know this information.
Load Distribution per Individual Section
Maximum lifting capacity, distributed evenly, is 495 lbs.
WARNING!
DO NOT allow anyone to sit on the Head Section or Foot Section
as they could FALL if the Tilt Control Level is pressed!
Caution:
Gas Springs supporting the Head Section & Foot Section
will be damaged if overloaded!
Caution:
Patients must only get on and off at the “table center”, not from either end.
Head Section
Max Load
80-lbs
Mid Section
Max Load
495-lbs
Foot Section
Max Load
80-lbs
TABLE
CENTER
HEAD SECTION
TILT
CONTROL LEVER
(SEE WARNING)
FOOT SECTION
TILT
CONTROL LEVER
(SEE WARNING)
7
General Product Overview
Side Bar Lift Controllers not shown above
Head Section
Tilt Control Lever
Foot Section
Tilt
Control Lever
8
Head & Foot Section Tilt Operation
Caution:
Both Head Section & Foot Section are supported by twin Gas Spring mechanisms.
Pressing a Control Lever unlocks the Gas Springs. They are VERY POWERFUL pushing
upward. Position your hands as shown in the diagrams below to HOLD the table top
BEFORE you press a Tilt Control Lever.
Head Section
Incline/Recline
Tilt
Control
Lever
Head Section
Gas Springs
Foot Section
Gas Springs
Control Lever
9
Side Bar Lift Control Operation
The Side Bar Lift Control is designed to be foot operated:
A – Ascending the table up requires the bar to be pressed down.
B – Descending the table down requires the bar to be lifted by your toe.
EMERGENCY SAFETY FEATURE
The table top can be lifted without power by two people if an object or person is
caught in the lifting mechanism. Lift from the center of each side for best results.
Caution:
The Side Bar Lift Controllers are intended to be foot touched, not stepped on. The therapist
should ask the patient not to use the Side Bar as a “step” to get on or off the table.
Interchangeable Head Insert
All STA tables come with interchangeable Head Inserts for maximum comfort and easy
replacement. The “face hole” insert is stitched such that the patient does not touch the stitching.
• Each insert is installed from the top. Push in fully to engage snug fit to hold it in place.
• To remove: Push the insert out from under the table top in an upward motion,
10
Castor Lift / Drop
STA tables use a design that enables all four castors to be raised or lowered with one mechanism.
Use the Castor Foot Bar
located at the
head end of the table
Castor Drop = Table Lift
Step down on the Castor Foot Bar to lift the table on to the castors.
Castor Lift = Table stabilizes on the Leveling Feet
Lift the Castor Foot Bar up with your toe to lift the Castors.
WARNING!
DO NOT use this table to transport people or heavy objects!
11
Leveling Foot Adjustment
Proper adjustment = maximum table rigidity, stability, and patient comfort.
Initial Table Set-up:
Each corner post is supported by an adjustable Leveling Foot. These
are installed at the factory in the full-up position. The diagram to the
right shows the castors dropped (table lifted) and a 2cm (3/4inch)
height. STA recommends that all feet be adjusted at initial set-up
to lower (unscrew) each Leveling Foot such that the 3/4-inch
becomes 1/8 – 1/4 inch above the floor surface. Thus, a patient on the
table will not feel uncomfortable as a therapist drops the table position.
1. Place table where it will be used
2. Step on Castor Foot Bar to lift table
3. Loosen each Foot and locking nut with proper wrench
4. Unscrew each Level Foot (4) so gap to floor is 1/8 to 1/4 inch (leave locking nut loose)
5. Lift the Castor Foot Bar to drop all Level Feet
6. Check table rigidity by rocking table. If there is no rocking and the table is stable, you are
done. However, if there is some rocking motion, follow Step 7 carefully.
7. Only one level foot needs to be adjusted. Note: Two opposite diagonal feet will remain
stable (always touching the floor), and the other two will move up and down as the table is
rocked. Determine which two feet remain touching the floor when rocking. You adjust
either one of these. IMPORTANT! Screw either stable foot back in (upward) a little and
recheck the rocking. It is much easier to screw the foot upward, and you will not reduce
the gap you adjusted in Step 4. This may take a few iterations, as it is better to make small
adjustments to zero in on the stability. You will notice the table gets more stable each time.
Continue until the table stabilizes.
8. Step on Castor Foot Bar to lift table. Make sure all feet are off the ground 1/8 – 1/4 inch.
9. Drop the table again and re-check stability.
10. Repeat 4-9, if required, until the table is rigid, and the feet clear the ground when lifted.
11. With table on rigid level feet…tighten lock nuts upward with wrench. Do not over tighten.
Normal Adjustment:
STA tables are designed to be extremely rigid and stable…but this requires proper adjustment of
the leveling feet. You should check the table before each use and adjust as needed. Only one foot
requires adjustment to stabilize the table. You should always check, and perform adjustment as
required. With practice you can do this quickly. Always do this when the table is relocated.
Table Relocation within your Facility:
For relocation of this table within your building, where the move involves bumps or unlevel
flooring, please adhere the following procedure:
1. Loosen each Leveling Foot and locking nut with proper wrench
2. Raise each Leveling Foot by screwing all the way upward…including locking nut
3. Secure power cable such that it cannot get tangled or run over by the castors.
4. DO NOT use the table to transport other objects or people.
5. Once relocated…follow the procedure detailed above in “Initial Table Set-Up”
Caution: Large bumps in the path of this rolling table can cause the table to drop suddenly.
Failure to raise the Leveling Feet can cause unexpected ramming into raised floor surfaces.
12
Table Relocation to a new Facility:
If there is a need to move your STA table to a new facility. STA strongly recommends that you
request a professional move from our trained moving experts. They will eliminate all your worry,
prevent damage, and set-up the table in your new location ready to use. Failure to do this may void
your warranty. Please consult the Customer Service section to learn how to do this.
Table Identification Label
Motor Control Box Identification Label
Motor
Control
Box
located
at base
of table
13
Label Symbol Definitions
14
General Service Information
Star-Tek Alliance Treatment Tables are delivered by our trained professional movers. They place
the table in your desired location. They adjust the leveling feet and test the operation of the gas
springs and motorized up and down functions.
• It is important to follow the recommended use procedures in this manual. This will provide
the best safety and the longest trouble-free life of the product.
• The bearing system is intentionally over-designed and should never wear out.
• The Motor lift system operates trouble-free for a long time so long as it is not over loaded.
• The Gas Springs (head & foot section struts) operate by gas pressure and contain seals that
will fail if over loaded and will wear out with excessive use over time.
• The Side Bar Lift Controllers (one on each side of the table) activate the Motor Control Box.
These are balanced at the factory. They can be damaged if stepped on and over loaded.
• This table allows easy replacement of all critical components by our trained service experts.
Control Box (Motor) Connections
Side Bar Lift
Controller Cable
Plug
Motor Cable
(Linear Actuator)
Plug
15
Troubleshooting
The Motor Control Box has a green LED light to indicate if it is receiving power. When a Side
Bar (lift control) is lifted or lowered, green and yellow LED lights indicate proper operation.
If you encounter a problem with the table, some suggestions are provided below to remedy the
situation. If those to not provide a resolution, please refer to the Consumer Service section at the
end of this manual. Please be prepared to provide the model and serial numbers of the table.
(See Page 12)
16
Technical Specifications
17
Product Regulatory Compliance
Manufacturing & Quality Management
ANSI/AAMI/ISO 13485 Medical Devices, Quality Management Systems, Requirements for
Regulatory Purposes
Safety
IEC 60601-1:2005+AMD1:2012 CSV: Medical electrical equipment – Part1: General
requirements for Basic Safety and Essential Performance of Medical Tables, Beds or Couches
EMC
IEC 60601-1-2:2007, Section 6.1 and 6.2: Medical electrical equipment – General Requirement
for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Disturbances
Static and Dynamic Loading Force
IEC60601-1 9.8.3.3 Dynamic Load Test IEC 60601-2-52:2009 Part 2-52: Medical electrical
equipment – Particular Requirements for the Basic Safety and Essential Performance of Medical
Tables, Beds or Couches
Gas Spring (Strut)
Drop Test – Dynamic Functional Load Impact Test - Cyclic
Ignitability & Flammability
BS 7176:2007 – Specification for resistance to ignition of upholstered furniture for non-domestic
seating by testing composites. Tested in accordance with BS EN 1021-1:2006 (Smoldering
Cigarette)
Motor Control Box Enclosure
IEC 60529: Degrees of Protection against dust and/or water by mechanical casing and electrical
enclosure
Electric Motor Components
The electrical components (LINAK) are approved by IEC 60601-1(ed.3); am1, IEC 60601-1-
6(ed.3), IEC 60601-1-6(ed.3); am1, IEC 60601-1:2005, IEC 60601-1-2:2007
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Manufacturer’s Standard Warranty
Star-Tek Alliance warrants that the following parts shall be free from manufacturing defects in
materials and workmanship within the periods listed below:
1-Year Warranty
• Upholstery
• Castors & Lift System
• Head Section & Foot Section Adjust Mechanisms including Gas Springs
• Side Bar Lift Controllers
2-Year Warranty
• Linear Actuator (Motor & Gearing)
• Control Box
• Power Cable
3-Year Warranty
• Metal Frame Structure (Feet, Base, Pillars, Pillar Linkage, Bearings, Table Top Structure)
This Warranty does not cover or apply to any parts or components that are not listed above and does not cover or apply to
ordinary wear and tear. In addition, notwithstanding the foregoing, this Warranty does not apply to, and Manufacturer shall
have no obligation or liability to any purchaser under this Warranty, to the extent that the nonconformity arises from: (i) use
of the Product not in accordance with Manufacturer’s written instructions, documentation or specifications; (ii) alteration,
modification, or revision of the Product not expressly authorized by Star-Tek Alliance in writing; or (iii) the combination of the
Product with materials or products not provided, specified or approved by Star-Tek Alliance in writing; or (iv) service performed
on this product by someone other than a Star-Tek Alliance approved service provider . The purchaser must notify Star-Tek
Alliance of any warranty claim under this Warranty within thirty (30) days after such claim arises; otherwise the purchaser
waives all rights to such claim. This Warranty is personal to, and intended solely for the benefit of, the original purchaser.
However, if the ownership of this table is transferred, Star-Tek Alliance (STA) will honor and allow transfer of the warranty,
provided the transfer is communicated to Star-Tek Alliance before the transfer; the table service history is in good standing;
and any relocation of the product is performed by a Star-Tek Alliance approved delivery team. The warranty period is established
from the original purchaser delivery date.
Customer Service 352-433-5200 or email: service@startka.net
Please feel free to call our Customer Service Hotline at any time. This phone will be answered
during normal business hours. You will be able to speak directly to our USA Service Engineer
who will assist you with any issues and/or resolve any problems. If you are asked to leave a
message, we will respond as quickly as possible. Calls may be recorded. All calls will be logged.
Contact us for:
• Service Issues and Action
• Technical Assistance
• Relocation or Transfer of Ownership
• Customer Feedback
• General Business Inquiries
Model: _
Serial No.:
Purchaser:
Date of Delivery:
19
Service History
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