When selecting a BFR system to utilize in Blood Flow Restriction Therapy, it is crucial to select a device that has the equivalent technical and safety features as a surgical tourniquet device to ensure safe and effective use while restricting blood flow during low load and low intensity exercises. Surgical grade technology ensures that applied pressures are precise and accurate, pressures are monitored and auto-regulated to prevent over/under pressurization, time limits and alarm conditions are monitored and activated to mitigate risks,

Personalized Pressure Control

Select a BFR system with automatic pneumatic pressure control which has:

1. automatic LOP measurement technology, above, that is supported by scientific, peer-reviewed, and published evidence,
2. surgical grade auto-regulation, above, to prevent over/under pressurization and ensures that the selected personalized restriction pressure is maintained throughout the entire BFR protocol
3. self-calibrated and self test capability to ensure accurate pressure control and confirm there are no leaks present in the system prior to use
4. real time display of the applied pressure, so the user can confirm the pressure is applied as intended

Alarms and Safety Checks

Select a BFR system that automatically monitors its function and performance and alerts the user with audio and visual cues if proper function is not being maintained:

1. automatically performs calibration checks to ensure that the device is functioning as intended with each use and alerts the user if the device requires maintenance
2. contains an accurate timer which automatically tracks the total inflation time of the cuff through the BFR session
3. time limit which auto-deflates the cuff if the inflated time passes a pre-set limit
4. automatically monitors the pressure control system and alerts the user if there are any leaks within the system, or any instance of over/under pressurization
5. self-monitoring of the system to ensure that all components are functioning correctly,

BFR Cuffs and Limb Protection

Personalized tourniquet cuffs with matching limb protection sleeves should be used when implementing a personalized BFR exercise protocol. The cuffs utilized with BFR should follow similar design guidelines developed from surgical tourniquet cuffs to best fit the patient’s limb shape and size, providing efficient application of cuff pressure to the limb, thereby allowing lower and safer personalized pressures to be used.

Cuff Shape & Size:

BFR cuffs should have a contoured shape to allow for an optimal fit on tapered (conically shaped) limbs. The cuff should be wide to allow for lower measured limb occlusion pressures and personalized pressures, ensuring the BFR protocol is more comfortable and tolerable [1]. Select a BFR cuff size that is appropriate for the patient’s measured limb circumference, based upon fit selection guides by the cuff manufacturer.

Figure 3: A comparison of applied pressures and pressure gradients typically produced by (a) a modern pneumatic surgical tourniquet cuff, (b) a non-pneumatic, non-surgical strap-type tourniquet and (c) a non-pneumatic elastic ring designed to combine exsanguination and tourniquet functions. Each tourniquet was selected and applied as recommended by the respective manufacturer to stop arterial bloodflow in an upper limb. Higher levels of pressure and higher pressure gradients are associated with higher probabilities of patient injuries. Reproduced from McEwen J., Casey V., (2009). CMBEC32. Calgary, Canada; 2009 May 20-22.

Matching Limb Protection Sleeve

Prior to applying the tourniquet cuff on the patient’s limb, select a matching limb protection sleeve designed to be used in conjunction with the BFR cuff. A sleeve is used to protect the skin underlying the cuff from pinching, wrinkling or shearing during exercise movement [2, 3]. The correct sleeve matched to the chosen cuff size is important as the sleeves applies a small level of compression to the limb prior to cuff application. Selecting an unmatched sleeve can add risk for the patient; too small may cause venous congestion, too large may allow for opportunities for cuff movement during exercise.

Cuff and Sleeve Application

The matching limb protection sleeve should be first applied to the most proximal location on the exercising limb, ensuring smooth, wrinkle free application. The BFR cuff can then be applied over top of the sleeve. Position the cuff high on the limb, with the ports oriented on the lateral side of the limb and the connectors facing upwards towards the patient’s head. Ensure the cuff is secured snugly on the limb, without applying excessive force to overtighten the cuff. There should not be any gap on either the proximal or distal edges of the cuff.

Quality from the Manufacturer

Select a BFR system from a manufacturer who maintains a transparent and effective quality system. The manufacturer should make available their:

1. Quality Management System (QMS) Certificates
   • Having a registered quality management system means that the manufacturer is regularly audited by an external body to ensure that the manufacturer is complying with international standards and regulations. Compliance to such standards decreases the risk of product not meeting its specifications and claims, improves the safety and effectives of the device’s function, and decreases the risk of financial and legal liabilities for purchasers and users.
2. Technical certifications for electrical devices
   • International standards are developed to ensure standardized safety and compliance for electrical devices. A BFR system should be tested by an authorized external company and certified to comply with such standards (such as IEC 60601-1 for medical electrical equipment). Lack of certification increases the risk of harm to the operator and/or patient and may increase the risk of financial and legal liabilities for purchasers and users.
3. Device classification and registrations
   • It is important to understand how the manufacturer has classified the device in the country the product is available in. Different types of classifications (e.g., medical device vs consumer goods) are registered and reviewed differently.

Sources

[1] Younger AS, McEwen JA, Inkpen K. Wide contoured thigh cuffs and automated limb occlusion measurement allow lower tourniquet pressures. Clinical orthopaedics and related research. 2004 Nov 1;428:286-93.

[2] Tredwell SJ, Wilmink M, Inkpen K, McEwen JA. Pediatric tourniquets: analysis of cuff and limb interface, current practice, and guidelines for use. Journal of Pediatric Orthopaedics. 2001 Sep 1;21(5):671-6.

[3] McEwen JA, Inkpen K. Tourniquet safety: preventing skin injuries. Surgical Technologist. 2002;34(8):6-15.