The POWERbreathe KH series uses piezo-resistive pressure sensing technology for precise measurement of respiratory pressure 500 times/second. The triple-aperture rotary valve system makes up to 4000 precision movements every second.
The POWERbreathe KHP2 uses an electronically controlled, rapid-response valve to create a resistance to inhalation. Training against this resistance causes the inspiratory muscles to adapt, becoming stronger and more resistant to fatigue. This leads to reduced breathlessness and improved exercise tolerance and quality of life. As the patient breathes through the POWERbreathe KH2 you will notice that they gradually have to work harder to breathe in. This is the effect of resistance training acting on the inspiratory muscles (primarily the diaphragm and intercostal muscles). When breathing out, there is no resistance and the patient should breathe out normally, allowing the chest and breathing muscles to relax, naturally pushing the air from their lungs.
The POWERbreathe KHP2 training resistance is specifically designed to match the dynamic changes in breathing muscle strength throughout the breath and can automatically adapt to increases in inspiratory muscle strength at the beginning of each training session. Results are displayed on screen following a training or assessment session, or can be viewed in real-time using the Breathe-Link Medic PC software supplied. Parameters displayed include Maximal Inspiratory Pressure (cmH2O, highest 1 second average), Peak Inspiratory Flow (L/s), Training load (cmH2O), Average Power (Watts), Average inhaled volume (L) and Energy (Joules).
Training load is gradually introduced over the first five breaths of a training session. The first two breaths are unloaded. During these breaths, inhaled volume and flow are measured and used to set an appropriate training load. Loading is then gradually introduced during breaths three and four until full loading is achieved for breath five and onwards. The POWERbreathe KHP2 training regime of 30 breaths, twice a day typically takes only a few minutes a day and, used properly, patients should start to observe the benefits within just a few weeks.
This study concluded that the K-Series device "provides automatically processed and valid estimates of physical units of energy during loaded breathing tasks..."
Medical Devices Directive
The main purpose of the Directive is to harmonise national controls, so allowing free movement of medical devices throughout the European Union and EFTA whilst at the same time ensuring that all devices within the Union are reasonably safe in use.
The Directive covers most medical devices other than active implantable medical devices and in vitro diagnostics.
EC Medical Devices Directives Guidance Notes for Manufacturers of Class 1 Medical Devices
The POWERbreathe KHP2 should be used in conjunction with disposable bacterial/viral filters for multi-patient use. For single patient use, please follow the guidelines below to ensure that the POWERbreathe KHP2 remains hygienic and in good working order.
Wipe-clean the POWERbreathe handset with a damp cloth. Do not immerse the handset or expose it to running water as this may damage the internal electronics.
NOTE: Never use scouring pads, abrasive cleaning agents or aggressive liquids such as petrol or acetone to clean the appliance. POWERbreathe KHP2 is not suitable for dishwasher or autoclave use.
POWERbreathe is drug free, suitable for almost anyone and should cause no harmful side effects when used properly. Please read the following precautions and contraindications to ensure that POWERbreathe is used safely and appropriately.
Healthcare Professional should take into consideration the following conditions before patients use POWERbreathe:
Inspiratory muscle training, such as training with POWERbreathe, creates a negative pressure inside the chest, throat, ears and sinuses and is not recommended for patients with certain conditions, including the following:
Note: Materials are compliant with regards to composition, additives and properties, where applicable, in accordance with the Medical Device Directive 93/42/EEC Essential Requirements (Annex 1)