Disposable Sterile Elastic Tourniquet Cuff Exsanguinating Silicone Ring for Limb Surgeries Bloodless Environment Stop Bleeding Emergency Hemostasis
Tianjin Shining Deal Co., Ltd.- Type：Tourniquet
- Material：Silicone Ring, Nylon Straps
- Ethylene Oxide Sterilization：Ethylene Oxide Sterilization
- Quality Guarantee Period：Three Years
- Group：Adult and Children
- Max Wearing Time：90 Minutes
Base Info
- Transport Package：1PC,Box, 100box,Carton
- Specification：200*200(mm)
- Trademark：E. R. A
- Origin：China
- Production Capacity：5000000 Pieces,Year
Description
Lower Limb BLD-QZX-XZL2400 Yellow/2800mm 28-60cm L2500 Red/2800mm 28-60cm L2600 Pink/2800mm 28-60cm L2700 Black/3100mm 50-85cm L2800 White/3100mm 50-85cm 
2)Product compositions
An elastic silicone ring, an elastic stockinet sleeve, two colored pulling straps, two handles, a binder tie, and a plastic card.
5. Main performance index
1)Size
The outer diameter 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 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)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.
3)Tensile Force
The elastic sleeve, binder tie and pulling straps should be able to withstand a force of 150N without damage.
4)Strength
The elastic ring should be stretched to 200mm without breaking.
5)Sterilization
The product is sterilized before leaving the factory and should be delivered in a sterile state too.
6)Residual Ethylene Oxide
The product is sterilized by ethylene oxide, and the residual amount of ethylene oxide should not exceed 10 µg/g.
6. Application Field
1) Limb surgeries;
2) Emergency hemostasis;
3) Trauma surgeries;
4) Plastic surgeries;
5) Vascular surgeries;
6) Skin & bone grafts;
7) Other operations that require a bloodless surgical field.
7. Contraindications
1)Patients with severe skin damage on limbs.
2)Patients with insufficient peripheral blood flow, edema, or deep vein thrombosis (DVT).
3)Patients with limb infections or malignant tumors.
4)Patients who have had heart disease and respiratory disorders that were caused by exsanguination devices.
8. Precautions and suggestive instructions
1)This product is a single-use device. After the expiry 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.
2)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.
3)The hemostasis time of this product should not exceed 90 minutes.
4)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).
5)Before using this product, the operator should read this manual carefully, be familiar with the performance and the use of the device.
6)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.
9. Warnings
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 and tourniquet shock.
Muscle nerve injury.
Vascular damage, thrombosis.
Other complications of combined surgery.
2)The elastic contraction ring of this product must not roll to the distal end of the limb after reaching the working part.
10. Symbols
11. Instructions
12. Storage and transportation conditions
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.
2)Transportation: During transportation, the packaging must neither be bumped nor be exposed to rain.
2)Product compositions
An elastic silicone ring, an elastic stockinet sleeve, two colored pulling straps, two handles, a binder tie, and a plastic card.
5. Main performance index
1)Size
The outer diameter 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 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)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.
3)Tensile Force
The elastic sleeve, binder tie and pulling straps should be able to withstand a force of 150N without damage.
4)Strength
The elastic ring should be stretched to 200mm without breaking.
5)Sterilization
The product is sterilized before leaving the factory and should be delivered in a sterile state too.
6)Residual Ethylene Oxide
The product is sterilized by ethylene oxide, and the residual amount of ethylene oxide should not exceed 10 µg/g.
6. Application Field
1) Limb surgeries;
2) Emergency hemostasis;
3) Trauma surgeries;
4) Plastic surgeries;
5) Vascular surgeries;
6) Skin & bone grafts;
7) Other operations that require a bloodless surgical field.
7. Contraindications
1)Patients with severe skin damage on limbs.
2)Patients with insufficient peripheral blood flow, edema, or deep vein thrombosis (DVT).
3)Patients with limb infections or malignant tumors.
4)Patients who have had heart disease and respiratory disorders that were caused by exsanguination devices.
8. Precautions and suggestive instructions
1)This product is a single-use device. After the expiry 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.
2)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.
3)The hemostasis time of this product should not exceed 90 minutes.
4)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).
5)Before using this product, the operator should read this manual carefully, be familiar with the performance and the use of the device.
6)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.
9. Warnings
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 and tourniquet shock.
Muscle nerve injury.
Vascular damage, thrombosis.
Other complications of combined surgery.
2)The elastic contraction ring of this product must not roll to the distal end of the limb after reaching the working part.
10. Symbols
11. Instructions
12. Storage and transportation conditions
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.
2)Transportation: During transportation, the packaging must neither be bumped nor be exposed to rain.