Blood Pressure Cuff User and Maintenance Guide


Intended Use

Blood pressure cuffs (NIBP) are for manual or automatic non-invasive blood pressure monitoring.

Instructions for Use

1) Select the appropriate cuff size. Measure the patient’s limb and select an appropriately sized cuff according to the size marked on the cuff or the cuff's packaging. When the cuff sizes overlap for a specified circumference, choose the larger size. Accuracy depends on the use of a proper-sized cuff.

2) Before use, check that the cuff, cuff tubing, and hose are clean and free of damage. Replace old and tearing cuffs. Do not inflate the cuff when not on a patient.

3) Select the appropriate blood pressure measurement site. Inspect the patient’s limb prior to application.

4) Apply the cuff by wrapping it around the upper arm and make sure the index line falls between the range marks on the cuff. If it does not, either a larger or a smaller cuff should be used. Make sure to align the arrow marked artery over the patient’s brachial artery. Press the rough and soft sides of the closure together.

5) The cuff should be snug but not too tight, allowing space for two fingers to fit between patient and cuff.

Cleaning and Disinfection

Used products must be thoroughly cleaned and disinfected with the specified method described below before reuse. Apply the cuff wash plugs before cleaning to avoid liquid from entering the cuff tubing, air hose openings, and inflation system valves. A liquid in the airway may affect blood pressure determination accuracy and damage automatic or manual monitors.

Procedure

1) Prepare the enzymatic detergent (ENZOL® enzymatic detergent (US) or Cidezyme® or equivalent and distilled water) according to the manufacturer’s instructions, and 10% bleach solution, in separate spray bottles.

2) Spray detergent liberally on the cuff, tubing, and hose. If soil is dried on, allow the detergent to sit for 1 minute.

3) Wipe smooth surfaces with a soft cloth. Use a soft-bristle brush on visibly soiled areas and irregular surfaces.

NOTE:Take particular care when cleaning the bulb and control valve knob on a complete inflation system. Do not allow fluid to enter the back valve or saturate the control valve knob. Remove visible contaminants from the periphery and the underside of the control valve knob.

4) Rinse with copious amounts of distilled water.

5) To disinfect, spray 10% bleach solution on the cuff until it is saturated and allow sitting for 5 minutes.

6) Wipe away the excess solution and rinse again with distilled water. Allow the cuff to air dry. The user has the responsibility to validate any deviations from the recommended method of cleaning and disinfection.

Sterilization

Sterilize with ethylene oxide gas(EtO) at a max temperature of 50 / 122°F. After ethylene oxide sterilization, follow the recommendations from the sterilizer ℃ manufacturer for the required aeration period.

Operating Warnings

1) Connect the cuffs only to systems designed for non-invasive blood pressure monitoring.

2) Do not connect the cuff to intravascular fluid systems which may allow air to be pumped into a blood vessel, which could lead to serious patient injury.

3) To assure accuracy, minimize limb movement while taking a reading.

4) Avoid contact with the cuff while monitoring, since it may cause inaccurate blood pressure values.

5) Devices that apply pressure on tissue have been associated with purpura, skin avulsion, compartmental syndrome, ischemia, and/or neuropathy.

6) Do not use more frequently than clinically indicated, weighing benefits of frequent measurement against risk.

7) Check the cuff site and limb frequently for signs of impeded blood flow, especially when monitoring at frequent intervals and/or over extended periods of time. Rotate the site if appropriate.

8) Remove the cuff from the patient when monitoring has been suspended.

9) Do not apply the cuff to a limb used for intravenous infusion or areas where circulation is compromised.

10) Use care when placing the cuff on a limb used to monitor other patient parameters.

11) Do not apply the cuff to the upper arm if the width of the cuff is greater than the length from the armpit to the elbow of the patient.

12) Apply the cuff according to the instructions.

13) Use the cuff only under direct supervision by a trained healthcare professional when attached to automated monitors without fail-to-read alarms.

14) Fluids that enter the tubing can damage the monitor. When cleaning reusable cuffs, use care to prevent liquid from entering the tubing. Do not immerse the tubing.