GSM CUFF-A-(08) Disposable Sterile Tourniquet Cuff Owner’s Manual

GSM CUFF-A-(08) Disposable Sterile Tourniquet Cuff

SPECIFICATION

1. Product name: Disposable sterile tourniquet Cuff
2. Scope of application: Used in limb surgery to drive blood in the limbs.
3. Models and specifications: There are 13 models and specifications, as shown in the following table:

This product corresponds to different tourniquet instruments, there will be other specific specifications and sizes of tourniquets. It has different hose specifications, shapes and interfaces.

Serial numb er| Type& Specification| specific size L1×W (mm）| Hose Length L2| The circumference range of the applicable limb(mm )| Serial number| Type& Specification| specific size L1×W(mm）| Hose Length L2| The circumference range of the applicable limb(mm )
---|---|---|---|---|---|---|---|---|---
1| CUFF-A-(08)| 205×65| 780| 55-155| 8| CUFF-A-(38)| 965×100| 780| 815-915
2| CUFF-A-(12)| 305×90| 155-255| 9| CUFF-A-(44)| 1115×100| 965-1065
3| CUFF-A-(15)| 380×100| 230-330| 10| CUFF-B-(24)| 610×100| 460-560
4| CUFF-A-(18)| 455×100| 305-405| 11| CUFF-B-(30)| 762×100| 612-712
5| CUFF-A-(24)| 610×100| 460-560| 12| CUFF-B-(34)| 865×100| 715-815
6| CUFF-A-(30)| 762×100| 612-712| 13| CUFF-B-(43)| 1092× 130|

942-1042

7| CUFF-A-(34)| 865×100| 715-815

Description and diagram of main structure and composition:

The product is composed of cuff, hose, adhesive tape and horizontal binding band.
The aseptic package of the product contains gauze covers.
All tourniquets come in a different rim color, as well as a different adhesive buckle color for identification. The product is connected to the hemostat through a hose. Refer to your hemostat instrument operator’s manual for the correct number of tourniquet connections and channels. Check figure for composition.

1- adhesive tape (barbed buckle); 2 – the hose; 3 – cuff; 4- adhesive tape (wool buckle); 5- transverse banding; 6 – gauze
Note: THE ILLUSTRATED PRODUCT IS THE STRAIGHT CUFF FOR EXAMPLE. For OTHER STRUCTURAL ILLUSTRATIONS, SEE THE LAST PAGE OF THE MANUAL.

Notes

This product is a disposable sterile medical device. Before use, please check whether the sterile packaging bag is damaged and cracking. If the packaging is damaged or cracking, please replace it to avoid the risk of bacterial infection.
Products beyond the validity period will be required to be prohibited.
The product has indicated hose sizes and specifications and standard plug nozzle ports. But there are also different hose sizes, specifications, shapes, and interfaces. To use different brands of electric pneumatic hemostatic equipment, please understand and confirm before procurement and use.
The maximum inflatable pressure condition of this tourniquet product is 100kPa (750mmHg) / 2 hours. To avoid the risk of surgical ischemic necrosis, a tourniquet is usually used for limb surgery lasting less than 90 minutes.
Attention should be paid to the selection of appropriate specifications of tourniquet. The tourniquet should be fastened on the patient’s limb before inflation, otherwise the internal TPU soft film will be excessively compressed and deformed, leading to use failure. Too long, too short tourniquet is not suitable, not only cannot meet the clinical requirements, but also will bring about the poor stability of the cuff (cuff torsion) and uneven pressure distribution, and even will produce abnormal surgical bleeding.
A matching gauze cover should be used, which can enable the pressure to be distributed more evenly on the surface of the patient’s limb and improve the feeling of surface compression of the patient. No use of gauze cover will cause the cuff gas pressure cannot be evenly spread on the surface of the patient’s limb, there may be excessive local compression and blood infiltration and other conditions.
The standard hose connector of the product is a quick plug and pull connector. Please note, be sure to match with the inflatable output interface of the inflatable equipment before use. Surgery must be confirmed before its use.
Strict attention must be paid to the surgical compression hemostasis time of the patients, and the selection and control of the surgical compression hemostasis time must be decided by the qualified clinicians. And pay attention to more than 90 minutes of compression and hemostasis, and even will bring serious hypoxic limb damage to the patient.
Strict attention must be paid to the selection of tourniquet use pressure. General patients’ body weight, blood pressure, age, etc., will need different pressure choices. Clinical surgery is recommended to just have a trace amount of infiltration of blood, for the appropriate pressure to choose the data. Excessive pressure selection will bring about the possibility of hypoxic necrosis of the limb.

It is strictly prohibited to use it for multiple times, otherwise the effect of disinfection and sterilization cannot be guaranteed, and the harm of cross- infection will also be used twice. And because of multiple filling and discharging, will bring the airbag seal failure and damage. The product test can withstand up to 15 times, exceeding the maximum charge and discharge times not only can easily lead to unstable product performance, but also will bring serious failure possibility.
The too long inflation time of the tourniquet will bring ischemic harm to the patient, and will also increase the patient’s blood coagulation, and further produce blood coagulation changes.
Too fast and too slow charging and gas discharge will bring about the possibility of thrombosis, or the possibility of shock caused by pressure loss, due to the individual physical differences of the patients. These are the clinical surgeons need to pay attention to the matters.
Attention must be paid to the influence and relationship of anesthetics when using a tourniquet. Attention must be paid to some relevant clinical literature recommendations.
When using the double airbag tourniquet, you must be familiar with the order of inflation and discharge. Accidentally wrong air pressure release, which may lead to serious consequences of patient casualties.
There are many causes of bleeding during surgery. Includes:
a) A pressure setting was used.
b) No effective tourniquet was tied on the limb.
c) A leaky tourniquet was used.
d) Incorrect or invalid connection pipe is used
e) Blood remains in the limb because of insufficient blood drive.
f) Blood leaking through the cavity passage inside the human shaft.

Use methods

1. Choose the right specifications of products, selected and decided by a professional clinical surgeon.
2. Before use, the biofilm is coated in the upper end of the surgical site (the meditation end is the upper end of the limb), and the biofilm is purchased and used by the clinical user unit itself.
3. Open the sterile single packing bag, remove the gauze cover and coat the biofilm.
4. Then take out the cuff and wrap it on the gauze sleeve, fix the adhesive tape and fasten it with the horizontal straps on both sides of the cuff, and double fix it to prevent the product from being inflated and twisted. The elasticity of the cuff should be appropriate. Generally speaking, the length of the overlapping part of the cuff after binding should be 50mm to 150mm. Too long or too short is not suitable, which will lead to poor cuff stability (cuff twisting). and uneven pressure distribution, and even abnormal surgical bleeding. When fixing the cuff, attention should be paid to adjusting the direction of the trachea to facilitate the connection between the trachea and the inflation device.
5. Connect the trachea to the inflatable output interface of the inflatable device such as the Tourniquet system instrument. The interface of the inflatable device should have a locking function to ensure that it will not be automatically disengaged during work.
6. After the above work is completed, set the appropriate parameters on the inflatable device and start the device to inflate the product. When the product needs to be removed at the end of the work, the connection between the trachea and the inflatable device should be disconnected first, then the straps and adhesive tapes should be loosened, the cuff and gauze cover should be removed, and they should be disposed of as medical waste.
7. For the selection of pressure and the selection of working hours, see clauses 5.6) and 5.7) above.

Requirements for supporting inflatable equipment

This disposable sterile pneumatic tourniquet is suitable for common clinical tourniquet system instruments, and its maximum output pressure is required to be below 650mm Hg. It should be noted that the tourniquet system instrument used should have the actual pressure indication, and have the function of automatic air pressure balance and compensation.
The electro-pneumatic hemostatic instrument used should be equipped with a time timer to connect with the working air pressure to avoid the inability to judge the excessively long operation time.

The contraindications of related inflatable equipment should be basically the same as the contraindications of this disposable sterile tourniquet.
When you are not sure whether it is applicable, please contact our company, or contact our company’s special distribution service provider.
If this tourniquet is used in a manual inflatable pneumatic hemostat, it must have a pressure indicating device and a safety pressure limiting device. In order to avoid the surgical risk caused by too high and too fast air pressure.

Transport packaging and storage

This product is packaged in aseptic paper-plastic packaging, medium carton packaging, and transport outer carton packaging. The sterile single packaging is paper-plastic dialysis bags, the medium carton packaging is single- corrugated glossy carton, and the transport outer box is generally double- corrugated paper. box. The sterilized product should be stored in a room with a temperature of 30℃, a relative humidity of not more than 80%, no corrosive gas, no strong sunlight and good ventilation, and the product should be fully protected.
During transportation and storage of this product, it is strictly forbidden to stack with excessive external pressure to prevent damage to the protective packaging.

Contraindications

This tourniquet is used as a tool for routine surgery, and clinical surgeons must clearly know the specific contraindications of the product and the risks that these contraindications will bring to patients. These risks and contraindications should also be explained and reminded in the product manual of the tourniquet system device used. Therefore, clinical surgeons should carefully study these contraindications and clinical surgical risks before using this product.
The medical literature lists many possible contraindications. However, the final decision in each case rests with the clinical surgeon.
The following are some examples of common contraindications. It should be noted that the clinical contraindications will also increase and vary according to the actual situation of the patient:
Arterial thrombosis, thromboangiitis obliterans, pulmonary embolism, obvious peripheral vascular disease and impaired circulation, hypertension, diabetes complicated by severe vascular disease, open fractures, skin damage at the binding site, severe allergies, associated with Excessive swelling and other conditions that doctors think are not applicable should be used with caution and disabled.

The presence of sickle cell disease is a relative contraindication.
Special reminders and warnings: If this product is used twice, it will wear, excessively expand and deteriorate with use, resulting in tourniquet failure. and further risk of surgery.

Explanation of graphics, symbols, abbreviations, etc. used in medical

device labels:

Sterilized by radiation

Not to be used twice

Consult the instructions for use

After-sales service commitment

The service and after-sales work involved in the product are all the responsibility of the company or authorized dealers.
If this product has quality problems and non-artificial damage, it can be exchanged.

Environmental protection

After the product is used, it should be disposed of by a professional company according to the disposal method for disposable hazardous waste of medical equipment. And need to pay attention to local environmental protection laws and regulations.

13.Date of preparation of the manual：26th, Feb 2020
14.Production date: see label
15.Use period: 2 years
16.Illustration of cuff structure

Customer Support

Gold Station Medical
1505 George Dieter Drive St 109502 El Paso, Texas 79936
1(888)392-2566 | info@goldstationmedical.com

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