Sterile Silicone Ring Exsanguination Tourniquet L2500

Exsanguination Tourniquet Ring

8. Operation Principle
The contraction diameter of the elastic silicone ring is smaller than the minimum size of the limb (including the end of the limb). Therefore, due to the expansion effect of
the limb on the elastic silicone ring, the elastic silicone ring is expanded and squeezed by the limb, which produces tensile force. In turn, the elastic silicone ring reacts
on the limb, squeezing the limb, and the squeezing force is transmitted to the blood vessels and extruding the blood in the blood vessels. In order to produce enough
force to resist the blood pressure in the blood vessel and not to produce excessive force to damage the limb tissue, the material of elastic silicone ring must be selected
reasonably.
9. Product Performance
9.1Size
9.1.1The diameter (D) of the silicon ring of the upper limb (except L1500) is 77±4mm, the diameter of L1500 is 57±4mm.
9.1.2 The diameter of the silicon ring of the lower limb (including L2400, L2500 and L2600) is 99±5mm, the diameter of another two specification (L2700 and L2800) is
104±5mm.
9.1.3 The thickness of the protective card is 0.8±0.1mm.
9.2 Appearance
9.2.1 The surface of all components should be clean, no dirt or damage.
9.2.2 Wrap the elastic sleeve around the elastic silicon ring, the elastic sleeve should be in the shape of socks after the sleeve expanded.
9.3 Tensile Strength
9.3.1 The elastic sleeve of the upper limb should withstand a strength not less than 150N, no breakage.
9.3.2 The elastic sleeve of the lower limb should withstand a strength not less than 150N, no breakage.
9.3.3 The single colored strap could withstand a strength not less than 150N, no breakage.
9.3.4 After the cable tie locked, the cable tie should withstand a strength not less than 150N, no breakage or uncoupled.
9.4 Elastic Force
9.4.1 Pull the silicon ring of the upper limb to the length of 150mm, the elastic force should be within 84±10N.
9.4.2 Pull the silicon ring of the lower limb to the length of 250mm, the elastic force should be within 215±25N.
9.5 Strength
9.5.1 Pull the silicon ring of the upper limb to length of 200mm, there should be no rupture.
9.5.2 Pull the silicon ring of the lower limb to length of 300mm, there should be no rupture.
9.6 Sterility The product should be sterile when supplied. SAL≤10-6
.
9.7 EO Residual The sterilization method is by EO gas, the EO residual should be ≦4mg/device.
10. Contraindication
10.1 Not using the device if the limb has signifificant skin lesions (skin disease, burns).
10.2 Not using the device on patients with poor peripheral blood flow, edema, or deep vein thrombosis.
10.3 Not using the device if the limb is infected or has a malignancy.
10.4 Not using the device if the patient is at a risk of heart disease and respiratory problems due to the use of antiseptic devices.
10.5 Not leaving the device on the patient’s limb for more than 90 min.
10.6 Not placing silicon ring directly over the ulnar nerve (at the elbow) or peroneal nerve (at proximal tibia).
10.7 Immediate removal of the device if it does not stop the blood flow to the limb.