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..."

Measurement validity of an electronic inspiratory loading device during a loaded breathing task in patients with COPD

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.

The Directive

• Specifies “essential requirements” which must be met before any device can be placed on the market 
• Introduces controls covering the safety, performance, specification, design, manufacture and packaging of devices 
• Specifies requirements for assessment of clinical investigation protocols, and the evaluation of any adverse incidents that occur 
• Introduces a system of assessment of clinical investigation protocols, which is matched to the degree of risk inherent in the device 
• Empowers a Competent Authority to identify and designate “notified bodies” who check and verify that devices meet the relevant essential requirements 

EC Medical Devices Directives Guidance Notes for Manufacturers of Class 1 Medical Devices

ISO Certificates of approval for ‘Design & manufacture of medical devices for improvement of respiratory function'

How to use:

1. The patient puts the nose-clip on so that it pushes their nostrils together (this is optional but prevents the patient from breathing in through their nose).
2. The patient should then breathe in quickly and forcefully through POWERbreathe for 30 breaths twice a day (preferably morning and night to allow the inspiratory muscles time to recover in between sessions). This is the scientifially proven training regimen.
3. As inspiratory muscle strength and stamina improve, the patient may adjust and increase the resistance.
4. Full instructions are provided in the accompanying user manual.

Cleaning:

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.

1. POWERbreathe will be exposed to saliva during use. After each training session, remove the Valve Head from the POWERbreathe KHP2 and soak it in warm water for about ten minutes. Now hold the valve head under warm running water whilst opening and closing the valve to aid cleaning of the valve surfaces. Shake off excess water and leave on a clean towel to dry ( the POWERbreathe Manual has full details).
2. Once a week POWERbreathe should be soaked in a mild cleansing solution instead of water, using  POWERbreathe Cleansing Tablets - only 1 tablet is required each time. After cleaning, hold the valve head under a running tap allowing water to run through it. Shake off excess water and leave on a clean towel to dry.

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.

Precautions:

• The patient must not make changes to any prescribed medication or prescribed treatment programme without consulting their doctor.
• POWERbreathe should not be used if the patient is suffering from a ruptured eardrum.
• To prevent the potential transmission of infections, we recommend that patients do not share the POWERbreathe K-Series mouthpiece or valve head with other users, including family members.
• This product is not intended to diagnose, treat, cure or prevent any disease.
• POWERbreathe is designed for exercising the inspiratory muscles only. No other use is intended or implied.
• Anyone who is under the age of 16 should only use POWERbreathe with supervision from an adult. POWERbreathe contains small parts and is not suitable for children under 7 years.
• Whilst training with POWERbreathe the patient should feel resistance when inhaling but it should not be painful. If the patient feels pain whilst using POWERbreathe they should stop immediately and consult their doctor.
• Some users may experience slight ear discomfort when training with POWERbreathe, especially if they are recovering from a cold. This is caused by inadequate equalisation of pressure between the mouth and ears. If symptoms persist, patients should consult their doctor.
• If a patient is suffering from a cold, sinusitis or respiratory tract infection, we advise that they do not use POWERbreathe until symptoms have disappeared.
• POWERbreathe KH-Series is not intended for use by persons with reduced physical, sensory or mental capabilities, unless they have been given supervision or instruction concerning use of the appliance by a person responsible for their safety.
•  If the patient feels light headed or dizzy whilst training with POWERbreathe, they should slow down their rate of breathing or pause until they have fully recovered.
• Patients with a pacemaker or other medical implant containing magnets or electronics should consult their doctor before using this product.
• POWERbreathe is manufactured in a hygienic environment. However, POWERbreathe is not provided sterile – we recommend that the mouthpiece be cleaned prior to use.

Healthcare Professional should take into consideration the following conditions before patients use POWERbreathe:

1. A history of spontaneous pneumothorax (a collapsed lung that was not due to traumatic injury e.g. broken rib), as it may lead to a recurrence of the condition.
2. Pulmonary hypertension or large bullae on chest x-ray
3. Marked osteoporosis with history of rib fractures
4. Desaturation during or following IMT (<94%)

Contraindications

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:

• Asthma patients who have low symptom perception and suffer from frequent, severe exacerbations or with an abnormally low perception of dyspnoea
• If a patient is suffering from a ruptured eardrum or any other condition of the ear
• Patients with marked elevated left ventricular end-diastolic volume and pressure
• Patients with worsening heart failure signs and symptoms after RMT / IMT
• A collapsed lung due to a traumatic injury that has not healed fully

• Mouthpiece: PVC (Not made with natural rubber latex or and phthalates) 
• Soft-touch grips and seals: TPE 
• Screen cover: PMMA 
• Buttons: PC 
• Stand:PC-ABS 
• Gears: Acetal 
• Valve Rotor: PBT (PTFE filled) 
• Valve Stator: Acetal (PTFE filled)
• O-ring: Nitrile rubber 
• Nose-clip rubber: Silicone 40 
• Nose-clip bridge: Nylon 
• Filter Adapter: Polypropylene 
• All other components: PC-ABS 

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)

• POWERbreathe IMT device with UK plug (AUS, EU and US plugs are sold separately)
• Mouthpiece (PVC - not made with natural rubber latex or and phthalates)
• Nose clip
• Spacer
• Storage pouch
• 4 cleansing tablets (These will be removed if shipping to the USA and the box resealed).
• User manual
• Software on disc