Device Description; Indications For Use - smith&nephew T-MAX Modo De Empleo

Device Description

The T-MAX Beach Chair provides ideal access, adjustability, and
stability for Beach Chair shoulder procedures. It is designed to fit
over the rails of most O.R. tables. On most tables the head section is
removed and the T-MAX is placed over the rails. Some tables require
the leg section to be lowered and the table to be turned around.

Indications for Use

T-MAX Beach Chair is indicated for use during beach chair shoulder
procedures.
A. Fixed Leg
B. Sliding Leg
C. Hex Shaft
D. Lower Frame
E. Lower Back Pad
F. Gas Spring Cylinders
G. Lift System Release
Handle
H. Lateral Support
Adjustment Knob
I. Upper Frame
J. Slide Pad
K. Headset Vertical
Adjustment Knob
L. Headset Slide Hex Bar
T-MAX Beach Chair Instructions for Use
M. Double Ball and Socket
N. Ball and Socket Knob
O. Headset Pad
P. Intubation Tree
Q. Strap Support
R. Headset Straps
S. Headset Forward Slide
Collar and Knob
T. Lateral Supports
U. Knee Bolster
V. SPIDER Attachment Bar
W. Intubation Pad
X. Body Strap (Not Shown)
Warnings
Failure to comply may result in injury to patient and/or health care
worker.
Table specific T-MAX Square Rail Clamps must be securely tightened
over tips of table specific legs before loading patient. Please see
29-99-09 O.R. Table Fit Guide for details on approved Tables. Tables
that do not appear on the O.R.
the T-MAX Beach Chair. For O.R. Tables that do not appear on the O.R.
Table Fit Guide please contact Smith & Nephew.
U.S. Federal law restricts this device to sale by or on the
order of a physician.
• It is the responsibility of the surgeon to be familiar with the
appropriate surgical techniques prior to the use of this product.
• Maximum weight limit for O.R. table must not be exceeded.
Most older tables have a 300 lb (136 kg) limit. The T-MAX will
accommodate patients up to 350 lbs (159 kg).
• Review O.R. table instruction manual to ensure operational
parameters of table are not exceeded.
• Ensure O.R. table is locked and not mobile. In most cases this
requires the castors to be completely off the floor.
• Never place T-MAX on extended head/foot section of table.
• Secure patient's legs with Body Strap to prevent traveling during
positioning.
• Do not use T-MAX without T-MAX Square Rail Clamps in place
(Fig. 1).
• Do not use other manufacturer's rail clamps. T-MAX Square Rail
Clamps have the letter markings of either AM, EU, JE or DE.
• Ensure Face Mask is not applying pressure on the patient's eyes
and pressure on the face is evenly distributed.
• Do not over tighten straps holding chin in place and ensure there
is no pressure on structures under the chin.When the patient is
lowered, the head will slide down the headset pad. The Face Mask
must be released when the patient is raised or lowered.
• To lower patient during an emergency, loosen the Headset Vertical
Adjustment Knob (for up and down movement) and release the
Face Mask. The patient can then be quickly and safely lowered to a
flat position.
• It is the responsibility of the anesthetist to ensure patient's airway,
eyes and neck are clear from any pressure and that the positioning
will not create any surgical complications.
• Ensure the Face Mask's chin portion is not below the patient's chin
and does not contact the neck area.
• DO NOT reuse single use stabilization kits. Failure to comply may
result in patient injury and/or infection.
• To ensure the understanding and the safe use of the T-MAX Beach
Chair, please read the T-MAX Beach Chair Instructions for Use.
• It is recommended that two people attach T-MAX to O.R. table.
• Ensure O.R. table rail has at least 1" of overlap under back leg tabs.
English
Table Fit Guide MUST NOT be used with
29-99-01 Rev. C
3