The Portex Cuff Inflator Pressure Gauge combines the advantages of controlled cuff inflation with precise pressure monitoring. The Portex Cuff Inflator Pressure Gauge is a reusable cuff inflator/pressure gauge device, designed to allow controlled manual inflation of tracheostomy, tracheal and laryngeal mask product cuffs and also to provide a means of monitoring cuff pressure.

Features:

• With Connecting Tube
• Quantity per Pack: 1 Each

Instructions:

These instructions contain important information for safe use of the product. Read the entire contents of these Instructions For Use, including:

• Warnings and Cautions, before using this product.
• Failure to properly follow warnings, cautions and instructions could result in death or serious injury to
  the patient and/or clinician.

Indications For Use:

• Controlled manual inflation of high volume, low pressure tracheostomy and tracheal
  cuffs, and laryngeal mask cuffs.
• Periodic monitoring of pressure of high volume, low pressure tracheostomy and
  tracheal cuffs, and laryngeal mask cuffs.

Instructions For Use:

1. Before connecting the device to the inflation line, occlude the outlet luer nozzle with one finger and squeeze the flexible bulb until 120 cm H2O is indicated on the gauge. The pressure reading should remain constant for 2 to 3 seconds. If the indicated
   pressure falls then the device should not be used.
2. Connect the device by inserting the male luer nozzle of the device into the female luer mount of the inflation line of the cuffed product, using the connecting tube if preferred (connecting tubes are also available separately, ref. 100/569/000).
3. Inflate the cuff by squeezing the bulb; the pressure can be reduced if required by pressing the button briefly.
4. Unless contrary to local guidelines, clinical judgement or product instructions, it is recommended that the cuff on a tracheal and tracheostomy tube or a laryngeal mask product is inflated with the minimum amount of air to provide an effective seal. An example of good clinical practice for achieving this condition is the use of a stethoscope to listen for air leaks combined with an “inflation g slight deflation (0.5 to 1.0ml) g gradual reinflation” technique.
5. Once this optimum condition has been achieved, the indicated pressure should be monitored periodically to ensure the cuff remains optimally inflated. Use of the connecting tube and/or the integral hook on the device can facilitate this. One potential influence on cuff pressure is the diffusion of nitrous oxide into the cuff. A cuff with insufficient pressure will not provide optimal protection against leakage of colonised subglottic secretions past the cuff. A cuff which is over inflated may cause
   trauma to the surrounding tissues. Unless contrary to local guidelines or clinical judgement, cuff pressure should be monitored 3 times a day1 e.g. at each shift change. More frequent checking is recommended when used in the operating room.
6. The solid green zone indicates the usual cuff pressure range for tracheal and tracheostomy tubes2,3. Note that the red zone on earlier devices is no longer present as this would have coincided with part of the hatched green zone.
7. The hatched green zone indicates the usual cuff pressure range for laryngeal mask products.
8. The specified accuracy of the device is +/- 2cm cm H2O in the green/hatched green zone. Check the device against a reliable pressure gauge once each week, immediately after it has been dropped or if there is any obvious reading error e.g. if
   it does not ‘zero’ correctly.
9. Never immerse the device in any liquid. When the device requires cleaning, use only a soft, lint-free cloth dampened with a mild detergent solution. To disinfect, wipe with a commercially available alcohol based surface disinfectant. Do not attempt
   to clean or disinfect the device with any other process. The transparent face of the gauge and flexible bulb may be damaged by aggressive agents.