Lower limb type usage

2 year ago

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Tianjin Shining Deal Co., Ltd

 2 year year

Product details

Exsanguination Tourniquet (Class II medical device, classification code 14-04-03) is designed for shifting blood from an extremity during limb surgeries, creating an effective arterial block to prevent blood re-entry into the limb. Its core patent-protected technology features a line of single-use devices for quick and effective displacement of blood from the limbs and blocking its re-entry.

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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.

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).

Exsanguination Tourniquet Composition

An elastic silicone ring

An elastic stockinet sleeve

Two colored pulling straps

Two handles

A binder tie

A plastic card

Performance Parameters

Performance Parameters	Upper Limb Type	Lower Limb Type
Outer Diameter (D)	77±4mm (except model L1500) 57±4mm (L1500)	99±5mm (except models L2400, L2500, L2600) 104±5mm (L2700, L2800)
Plastic Card Thickness	0.8±0.1mm	0.8±0.1mm
Tensile Force	Elastic sleeve: 150N without damage Single pulling strap: 150N without breaking Binder ties: 150N after being locked, without breaking or tripping	Elastic sleeve: 150N without damage Single pulling strap: 150N without breaking Binder ties: 150N after being locked, without breaking or tripping
Appearance	Clean, free of dirt or damage Elastic sleeve wrapped around the elastic ring, shape like a sock tube when unfolded	Clean, free of dirt or damage Elastic sleeve wrapped around the elastic ring, shape like a sock tube when unfolded
Strength	Elastic ring should be stretched to 200mm without breaking	Elastic ring should be stretched to 200mm without breaking
Sterilization	Delivered in a sterile state and should be sterile	Delivered in a sterile state and should be sterile
Residual Ethylene Oxide	Not exceed 10 µg/g	Not exceed 10 µg/g

Application Field
Limb surgeries that require exsanguination and occlusion.

Contraindications

Patients with severe skin damage on limbs.
Patients with insufficient peripheral blood flow, edema, or deep vein thrombosis (DVT).
Patients with limb infections or malignant tumors.
Patients who have had heart disease and respiratory disorders that were caused by exsanguination devices.

Precautions and suggestive instructions
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.

2. Before using this product, the operator should read this manual carefully, be familiar with the performance and the use of the device.

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.

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.
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. 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. 11. Precautions 11.1 Do not use the device if the inner package is damaged, otherwise cross-infection may be caused. 11.2 The circumference of the hemostatic site of the patient's limbs should be between 14-85cm. If the measured circumference is outside this range, use other methods to stop bleeding. 11.3 If the systolic blood pressure is higher than 180mmHg, use other methods to stop the bleeding. 11.4 Read this instruction carefully to get familiar with the device properties and use method before use. 11.5 It is recommended to be used under anesthesia. Patients may feel uncomfortable if it is not used under anesthesia, so it should be explained to patients before use. 12. Warning 12.1 Possible adverse reaction: 12.1.1 Numbness, edema and hematoma may appear at the hemostatic site. 12.1.2 Ecchymosis, blisters and necrosis of the skin. 12.1.3 Hemostasis is ineffective and bleeding is aggravated. 12.1.4 Tourniquet Pain. 12.1.5 Tourniquet Shock. 12.1.6 Muscle and nerve injury. 12.1.7 Vascular injury and thrombosis. 12.1.8 Other complications arising from combined surgery. 12.2 The elastic silicon ring of the device shall not roll to the distal end of the limb after reaching the working position. "

Storage and transportation conditions

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.
Transportation: During transportation, the packaging must neither be bumped nor be exposed to rain.

Other solutions include Methylene Chloride, Isopropyl Alcohol, Glacial Acetic Acid