6
ENGLISH
Medical Device
INTENDED USE
CTi Custom
The device is intended for external support, stabilization and protection
of the knee.
CTi OA
The device is intended for unicompartmental unloading of the knee
The device must be fitted and adjusted by a healthcare professional.
Indications for use
• For knee conditions that may benefit from increased AP and ML
stability around the knee, such as: ACL, MCL, LCL, PCL, rotary, and
combined instabilities.
• The OA model also treats mild to severe unicompartmental
osteoarthritis.
No known contraindications.
Warnings and Cautions:
• The use of the device may increase the risk of deep vein thrombosis
and pulmonary embolism.
GENERAL SAFETY INSTRUCTIONS
The healthcare professional should inform the patient about everything in
this document that is required for safe use of this device.
Any serious incident in relation to the device must be reported to the
manufacturer and relevant authorities.
The patient should stop using the device and contact a healthcare
professional:
• If there is a change or loss in device functionality, or if the device
shows signs of damage or wear hindering its normal functions.
• If any pain, skin irritation, excessive pressure, or unusual reaction
occurs with the use of the device.
The device is for single patient – multiple use.
This device is not guaranteed to prevent injury.
FITTING INSTRUCTIONS
While carrying out the following instructions, please refer to the overview
figure for locating components mentioned in the text
(Fig. 1)
.
Fitting the CTi Custom and The CTi OA is the same procedure, except the
CTi OA frame alignment is adjusted at manufacture to provide unloading
of the affected compartment of the knee.
Device Application
1. Unfasten all straps from the outer side of the device.
2. Ask the patient to bend the knee at a 90° angle, with the foot flat on
the floor
(Fig. 2)
.
3. Ensure that the CTi logo goes on the outside of the leg. Place the
device on the patient’s leg such that the patella is centered between
the Condyle Pads (A)
(Fig. 3)
.
Ensure proper alignment of the device on the leg:
Summary of Contents for CTI CUSTOM
Page 1: ...Instructions for Use CTI CUSTOM CTI OA...
Page 3: ...3 1 E A B C D 2 3 4 5 6 7 8 9...
Page 4: ...4 10 12 14 16 18 11 13 15 17 19...
Page 5: ...5 20...
Page 40: ...40 1 CTi Custom CTi OA CTi OA 1 2 90 2 3 CTi A 3 4 3 5 6 11 12 7 4 8 C D 9 D 10 E...
Page 41: ...41 ACL 1 2 D 3 PCL 1 PCL 2 3 PCL PCL 1 2 15 13 mm 3 3 16 5 mm 16 4 17 5 6 18 19 1 8 3 mm...
Page 43: ...43 4 D 5 Pro Sport 6 1 80 2 ssur ssur ssur...
Page 68: ...68 6 7 D D D D CTi 1 1 5 D 6 2 D D 8 3 D D 9 4 D 5 2 Pro Sport 6 1 80 2 ssur ssur 1 3 5...
