Convenient Exsanguinating and Occluding Tourniquet Cuff Non Pneumatic to Stop Blood Loss in Emergency Aid and Limb Surgeries Hemostasis Medical Product

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Basic Info.

Trademark

E. R. A

Transport Package

1PC/Box, 100box/Carton

Specification

200*200(mm)

Origin

China

Trademark

E. R. A

Transport Package

1PC/Box, 100box/Carton

Specification

200*200(mm)

Origin

China

Product Desciption

Exsanguination Tourniquet Ring

What does this do?

Shifting blood from an extremity in limb surgeries. (Exsanguination)
Creating an effective arterial block (Tourniquet)

Why you have to choose Tourniquet Ring?
Convenient Exsanguinating and Occluding Tourniquet Cuff Non Pneumatic to Stop Blood Loss in Emergency Aid and Limb Surgeries Hemostasis Medical Product

1. Product Name, Type, and Specification
1.1 Product Name: Exsanguination Tourniquet (belonging to class II medical device, classification code 14-04-03).
Its core patent-protected technology is a line of single-use devices for quick and effective displacement of blood from the limbs and blocking its re-entry.

Convenient Exsanguinating and Occluding Tourniquet Cuff Non Pneumatic to Stop Blood Loss in Emergency Aid and Limb Surgeries Hemostasis Medical Product

1.2 Product Type: The device can be divided into upper limb type and lower limb type, depending on the position of use. The specifications are distinguished by the different colors of the pulling straps and the total length (L). See the table below for details.
To determine the correct product size, the patient's limb circumference at the desired occlusion location should be measured, as well as their blood pressure to determine the best model.

Type	Specification	Color/Length(L)±40mm	Suited Circumference
Upper Limb BLD-QZX-SZ	L1500	Cyan/1350mm	14-28cm
	L1600	Green/2100mm	24-40cm
	L1700	Blue/2100mm	24-40cm
	L1800	Purple/2100mm	24-40cm
	L1900	Brown/2100mm	24-40cm
	L2000	Beige/2100mm	24-40cm
Lower Limb BLD-QZX-XZ	L2400	Yellow/2800mm	28-60cm
	L2500	Red/2800mm	28-60cm
	L2600	Pink/2800mm	28-60cm
	L2700	Black/3100mm	50-85cm
	L2800	White/3100mm	50-85cm

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
2.1.1 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.
2.1.2 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.
2.1.3 The thickness of the plastic card is between 0.8±0.1mm.

2.2 Appearance
2.2.1 The device should be clean, and free of dirt or damage.
2.2.2 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
2.3.1 The elastic sleeve of the upper limb type should be able to withstand a force of 150N without damage.
2.3.2 The elastic sleeve of the lower limb type should be able to withstand a force of 150N without damage.
2.3.3 A single pulling strap of the upper limb type should be able to withstand a force of 150N without breaking.
2.3.4 The binder ties should be able to withstand a force of 150N after being locked, without breaking or tripping.

2.4 Strength
2.4.1 The elastic ring of the upper limb type should be stretched to 200mm without breaking.
2.4.2 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
5.1.1 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.
5.1.2 This product is sterilized by ethylene oxide. If the inner packaging is damaged, please do not use it.
5.1.3 If the product cannot block the blood flow of the patient's limbs, it should be removed immediately.
5.1.4 The hemostasis time of this product should not exceed 90 minutes.
5.1.5 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
Possible adverse reactions
6.1.1 Numbness, edema, and hematoma at the site of hemostasis.
6.1.2 Skin ecchymosis, blisters and necrosis.
6.1.3 Ineffective hemostasis and worsening bleeding.
6.1.4 Tourniquet pain.
6.1.5 Tourniquet shock.
6.1.6 Muscle nerve injury.
6.1.7 Vascular damage, thrombosis.
6.1.8 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. Symbels
Convenient Exsanguinating and Occluding Tourniquet Cuff Non Pneumatic to Stop Blood Loss in Emergency Aid and Limb Surgeries Hemostasis Medical Product

8. Instructions

8.1 Measure the circumference of the patient's limb at the exsanguination site (mid-upper part of the upper arm; middle thigh). Confirm that the circumference is within the applicable range of Table 1. If it exceeds the above range, please use other methods to conduct hemostasis.
8.2 Take out the product according to the aseptic procedure in the operating room and then place it on the table. Ensure that the plastic card is available at the end of the operation.
8.3 Disinfect the limb up to the mid-upper part of the upper arm or above the middle thigh depending on the surgical site and use a sterile transparent drape to cover the edge of the disinfected area.
8.4 Product application
8.4.1 Upper limb type: If the patient is conscious, ask the patient to gather the fingers together. If the patient is unconscious, the assistant (wearing sterile gloves) should hold the patient's fingers together, squeeze them into the ring (the handles facing away from the patient) and pull the handles to the proximal end, while the other assistant (wearing sterile gloves) grasps the end of the limb to fight against the traction, so that the device could scroll up to the proximal end smoothly.
8.4.2 Lower limb type: the assistant (wearing sterile gloves) should squeeze the patient's toes into the ring (the handles facing away from the patient), and pull the handles to the proximal end, while the other assistant (wearing sterile gloves) grasp the end of the limb to fight against the traction so that the device could scroll up to the proximal end smoothly.
8.4.3 Pull the handles until the elastic ring is on the surgical site: 10cm above the wrist joint or the mid-upper part of the upper arm; 5-15cm above the lateral malleolus that is below the calf muscle, or the middle of the thigh. The device should be kept within the disinfection area.
8.5 Use sterile injection water or 0.9% injection sodium chloride to infiltrate the elastic sleeve at the surgical site and then cut it. Wetting the sleeve before cutting can minimize fabric fragments. The surgical site can be covered with a sterile transparent drape.
8.6 When the operation is over, insert the plastic card from the distal end under the elastic ring, and cut the ring with a scalpel. Use scissors to cut up the sleeve and remove it from the patient's limbs. At this time, blood circulation will be resuming. Hemodynamic changes should be paid attention to and treated in time.

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.
Convenient Exsanguinating and Occluding Tourniquet Cuff Non Pneumatic to Stop Blood Loss in Emergency Aid and Limb Surgeries Hemostasis Medical Product