Elastic Single Use Disposable Tourniquet Ring-Shaped Exsanguination and Occlusion Surgical Device Medical Equipment for Limb Procedures Emergency Aid
Tianjin Shining Deal Co., Ltd.- Certification：FDA
- Feature：Disposable
- Color：Cyan, Green, Blue, Pink
- Type：Cloth Tourniquet
- Max Wearing Time：90 Minutes
- Expiry Date：2 Years
Base Info
- Transport Package：1PC,Box, 100box,Carton
- Specification：19.0*7.0*15.0 (cm)
- Trademark：E. R. A
- Origin：China
- Production Capacity：5000000 Pieces,Year
Description
Lower LimbL2500 Red/2800mm 28-60cm, adult leg L2800 White/3100mm 50-85cm, extra large
1.3 Product composition: An elastic silicone ring, an elastic stockinet sleeve, two colored pulling straps, two handles, a binder tie, and a plastic card.
2. Main performance index
2.1 Size
The outer diameter D of the elastic ring of the upper limb type (except model L1500) is between 77±4mm; that of L1500 is between 57±4mm.
The outer diameter D of the elastic ring of the lower limb type (except model L2400, L2500, L2600) is between 99±5mm; that of L2700 and L2800 is between 104±5mm.
The thickness of the plastic card is between 0.8±0.1mm.
2.2 Appearance
The device should be clean, and free of dirt or damage.
Before use, the elastic sleeve is wrapped around the elastic ring, and the shape of the elastic sleeve after unfolding is like a sock tube.
2.3 Tensile Force
The elastic sleeve of the upper limb type should be able to withstand a force of 150N without damage.
The elastic sleeve of the lower limb type should be able to withstand a force of 150N without damage.
A single pulling strap of the upper limb type should be able to withstand a force of 150N without breaking.
The binder ties should be able to withstand a force of 150N after being locked, without breaking or tripping.
2.4 Strength
The elastic ring of the upper limb type should be stretched to 200mm without breaking.
The elastic ring of the lower limb type should be stretched to 200mm without breaking.
2.5 Sterilization
The product is delivered in a sterile state and should be sterile.
2.6 Residual Ethylene Oxide
The product is sterilized by ethylene oxide, and the residual amount of ethylene oxide should not exceed 10 µg/g.
3. Application Field
Limb surgeries that require exsanguination and occlusion.
4. Contraindications
4.1 Patients with severe skin damage on limbs.
4.2 Patients with insufficient peripheral blood flow, edema, or deep vein thrombosis (DVT).
4.3 Patients with limb infections or malignant tumors.
4.4 Patients who have had heart disease and respiratory disorders that were caused by exsanguination devices.
5. Precautions and suggestive instructions
5.1 Potential hazards and restrictions on use
This product is a single-use device. After the expiration date, it cannot be used normally, and after use, it should be disposed of in accordance with the country's existing medical waste safety management regulations.
This product is sterilized by ethylene oxide. If the inner packaging is damaged, please do not use it.
If the product cannot block the blood flow of the patient's limbs, it should be removed immediately.
The hemostasis time of this product should not exceed 90 minutes.
Do not place the elastic ring of this product on the elbow (where it is likely to cause damage to the ulnar nerve) or the knee (where it is likely to cause damage to the common peroneal nerve). Confirm that the circumference of the mid-upper part of the patient's upper arm is between 14-40cm and the middle thigh between 28-85cm. If the measured circumference exceeds the above range, please use other methods to conduct hemostasis. If the systolic blood pressure is higher than 180mmHg, please take other methods to conduct hemostasis.
5.2 Before using this product, the operator should read this manual carefully, be familiar with the performance and the use of the device.
5.3 It is recommended to use the device when the patient is under anesthesia. If not, the patient will feel uncomfortable. Explain to the patient before use.
6. Warnings
6.1 Possible adverse reactions
Numbness, edema, and hematoma at the site of hemostasis.
Skin ecchymosis, blisters, and necrosis.
Ineffective hemostasis and worsening bleeding.
Tourniquet pain.
Tourniquet shock.
Muscle nerve injury.
Vascular damage, thrombosis.
Other complications of combined surgery.
6.2 The elastic contraction ring of this product must not roll to the distal end of the limb after reaching the working part.
7. Symbols
8. Instructions
9. Storage and transportation conditions
9.1 Storage: The product should be placed in a clean room with a relative humidity of no more than 80% RH, no corrosive gas, and good ventilation.
9.2 Transportation: During transportation, the packaging must neither be bumped nor be exposed to rain.
10. Technical Principles
The diameter of the elastic ring is smaller than the minimum size of the limb (even the extremity). When the limb is inserted into the ring, the ring will be expanded, therefore exerts a counter-effect on the limb, squeezing the blood out of vessels. In order to generate enough force to resist the blood pressure, in the meantime not to generate excessive force to damage the tissues, the material of the ring must be selected reasonably.
1.3 Product composition: An elastic silicone ring, an elastic stockinet sleeve, two colored pulling straps, two handles, a binder tie, and a plastic card.
2. Main performance index
2.1 Size
The outer diameter D of the elastic ring of the upper limb type (except model L1500) is between 77±4mm; that of L1500 is between 57±4mm.
The outer diameter D of the elastic ring of the lower limb type (except model L2400, L2500, L2600) is between 99±5mm; that of L2700 and L2800 is between 104±5mm.
The thickness of the plastic card is between 0.8±0.1mm.
2.2 Appearance
The device should be clean, and free of dirt or damage.
Before use, the elastic sleeve is wrapped around the elastic ring, and the shape of the elastic sleeve after unfolding is like a sock tube.
2.3 Tensile Force
The elastic sleeve of the upper limb type should be able to withstand a force of 150N without damage.
The elastic sleeve of the lower limb type should be able to withstand a force of 150N without damage.
A single pulling strap of the upper limb type should be able to withstand a force of 150N without breaking.
The binder ties should be able to withstand a force of 150N after being locked, without breaking or tripping.
2.4 Strength
The elastic ring of the upper limb type should be stretched to 200mm without breaking.
The elastic ring of the lower limb type should be stretched to 200mm without breaking.
2.5 Sterilization
The product is delivered in a sterile state and should be sterile.
2.6 Residual Ethylene Oxide
The product is sterilized by ethylene oxide, and the residual amount of ethylene oxide should not exceed 10 µg/g.
3. Application Field
Limb surgeries that require exsanguination and occlusion.
4. Contraindications
4.1 Patients with severe skin damage on limbs.
4.2 Patients with insufficient peripheral blood flow, edema, or deep vein thrombosis (DVT).
4.3 Patients with limb infections or malignant tumors.
4.4 Patients who have had heart disease and respiratory disorders that were caused by exsanguination devices.
5. Precautions and suggestive instructions
5.1 Potential hazards and restrictions on use
This product is a single-use device. After the expiration date, it cannot be used normally, and after use, it should be disposed of in accordance with the country's existing medical waste safety management regulations.
This product is sterilized by ethylene oxide. If the inner packaging is damaged, please do not use it.
If the product cannot block the blood flow of the patient's limbs, it should be removed immediately.
The hemostasis time of this product should not exceed 90 minutes.
Do not place the elastic ring of this product on the elbow (where it is likely to cause damage to the ulnar nerve) or the knee (where it is likely to cause damage to the common peroneal nerve). Confirm that the circumference of the mid-upper part of the patient's upper arm is between 14-40cm and the middle thigh between 28-85cm. If the measured circumference exceeds the above range, please use other methods to conduct hemostasis. If the systolic blood pressure is higher than 180mmHg, please take other methods to conduct hemostasis.
5.2 Before using this product, the operator should read this manual carefully, be familiar with the performance and the use of the device.
5.3 It is recommended to use the device when the patient is under anesthesia. If not, the patient will feel uncomfortable. Explain to the patient before use.
6. Warnings
6.1 Possible adverse reactions
Numbness, edema, and hematoma at the site of hemostasis.
Skin ecchymosis, blisters, and necrosis.
Ineffective hemostasis and worsening bleeding.
Tourniquet pain.
Tourniquet shock.
Muscle nerve injury.
Vascular damage, thrombosis.
Other complications of combined surgery.
6.2 The elastic contraction ring of this product must not roll to the distal end of the limb after reaching the working part.
7. Symbols
8. Instructions
9. Storage and transportation conditions
9.1 Storage: The product should be placed in a clean room with a relative humidity of no more than 80% RH, no corrosive gas, and good ventilation.
9.2 Transportation: During transportation, the packaging must neither be bumped nor be exposed to rain.
10. Technical Principles
The diameter of the elastic ring is smaller than the minimum size of the limb (even the extremity). When the limb is inserted into the ring, the ring will be expanded, therefore exerts a counter-effect on the limb, squeezing the blood out of vessels. In order to generate enough force to resist the blood pressure, in the meantime not to generate excessive force to damage the tissues, the material of the ring must be selected reasonably.