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USER’S DESCRIPTION

The device can be used autonomously by the patient (for adults and children aged 5 and older and weighing over 14kg), requiring only 2 or 3 simple instructions. Furthermore, the device requires no installation or planned maintenance. There are no special environmental characteristics for the premises where it is to be used beyond the minimum requirements for domestic premises. In case of failure, RespInnovation or RespInnovation’s appointed dealer must be immediately advised. The faulty equipment must then be returned to your supplier or directly to RespInnovation for repair by their technicians or other technicians specifically trained and authorized by RespInnovation.

INDICATIONS FOR USE

The RespIn 11 is intended to provide bronchial clearance therapy when external manipulation of the thorax is the physician's choice of treatment. Indications for this form of therapy are described by the American Association for Respiratory Care (AARC) in the Clinical Practices Guidelines for Postural Drainage Therapy' (1991). According to AARC guidelines, specific indications for external manipulation of the thorax include evidence or a suggestion of retained secretions, evidence that the patient is having difficulty with secretion clearance, or presence of atelectasis caused by mucus plugging. In addition, the RespIn 11 is also indicated for external manipulation of the thorax to promote bronchial clearance or improve bronchial drainage for purposes of collecting mucus for diagnostic evaluation.

The use of RespIn 11 is indicated for treatment of bronchial obstruction (airway lumen reduction with secretions stasis and possible bacterial over-infection). This alteration is characterized by edema, peri-bronchial muscle spasm and hyper-secretion in response to inflammatory, infectious and irritating stimuli. The primary purpose of such therapy is to reduce or eliminate bronchial obstruction, preventing complications from stasis of secretions, improve mucociliary clearance and the effectiveness of cough.

'FOCUSED PULSE' FREQUENCY

The RespIn 11 Bronchial Clearance System delivers 'focused pulses' to the thorax at frequencies ranging from 2 to 20 Hz. To know the frequency simply multiply the frequency level displayed screen by 2. Example : level 5 is 10 Hz, level 8 is 16 Hz.

INTENDED ENVIRONMENT OF USE

RespIn 11 is intended to be used in hospital, sub-acute, clinician offices and home environment.

KNOWN / FORESEEABLE CONTRAINDICATIONS

According to the American Association for Respiratory Care (AARC) Guidelines for Postural Drainage Therapy, the decision to use the Bronchial Clearance Device requires careful consideration and assessment of the individual patient’s case if the following conditions exist:

  • Intracranial pressure (ICP) greater than 20 mm Hg
  • Recent spinal surgery or acute spinal injury
  • Bronchopleural fistula
  • Pulmonary edema associated with congestive heart failure
  • Large pleural effusions or empyema
  • Pulmonary embolism
  • Head and/or neck injury that has not yet been stabilized
  • Active hemorrhage with hemodynamic instability
  • Distended abdomen
  • Active or recent gross hemoptysis
  • Uncontrolled airway at risk for aspiration such as tube feeding or a recent meal
  • Subcutaneous emphysema
  • Recent epidural spinal infusion or spinal anesthesia
  • Suspected pulmonary tuberculosis - Lung contusion
  • Bronchospasm
  • Coagulopathy
  • Complaint of chest wall pain
  • Rib fractures, with or without flail chest (within 30 days – after this may help splint/stabilize)
  • Surgical wound or healing tissue or recent skin grafts or flaps on the thorax
  • Recent esophageal surgery
  • Burns, open wounds, and skin infections on the thorax
  • Recent placement of transvenous or subcutaneous pacemaker (within 30 days)

 

Currently in the European market there are no norms or standards for HFCWO therapy, so RespInnovation refers to the AARC Guidelines for the definition of Contraindications.