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Pulsehaler™ Safety Information
Indications for Use

Pulsehaler™ is indicated for use as a Positive Expiratory Pressure (PEP) Device.

  • The use of Pulsehaler™ improves clearance of secretions

  • The use of Pulsehaler™ may reduce the need for postural drainage

  • Pulsehaler™ facilitates opening of airways in patients

  • Pulsehaler™ may be used to prevent or reverse atelectasis

  • Pulsehaler™ may also be useful in the removal of mucus from the lungs

 

Pulsehaler™ is intended for single patient, adult users in a home or hospital environment.

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Warnings

  • PATIENT INJURY OR INEFFECTIVE THERAPY CAN RESULT FROM IMPROPER ASSEMBLY OR OPERATION. READ THE FOLLOWING WARNINGS BEFORE ASSEMBLING OR OPERATING DEVICE.

  • DO NOT USE BEFORE READING THIS USER MANUAL.

  • Basic safety precautions should always be taken, including all those listed below.

  • DO NOT use this device for any purpose other than specified in this manual.

  • US Federal Law restricts the sale of this instrument only by, or on the order of, a physician.

  • The system should only be used by patients who can properly self-administer, after training and under the care of a physician.

  • DO NOT USE THE PULSEHALER™ WITH A FACE MASK OF ANY KIND.

  • If breathing on Pulsehaler™ becomes uncomfortable at any time, the patient should remove the Pulsehaler™ immediately from the mouth.

  • Always unplug the device before cleaning.

  • Use only as intended and described in this manual and supporting documentation.

  • Use only with the supplied parts and accessories.

  • Use only with the supplied power supply.

  • Health care practitioners using Pulsehaler™ on patients should be prepared to help patient with removal of secretions (coaching, suction) as needed.

  • Strictly follow the warning instructions in this manual.

  • The Pulsehaler™ is for single patient, multiple treatment session use. Do not share Pulsehaler™ among multiple patients.

  • The mouthpiece, disc, middle layer, saliva trap, and Hand Unit air filter should be replaced periodically as directed.

  • Do not expose the Pulsehaler™ to any solid foreign objects less than 12 mm diameter, which might infiltrate inside the interior space causing damage to the device.

  • Do not expose the Pulsehaler™ to any direct falling water which might seep into the interior space causing damage to the device.

  • Do not make any modifications to the Pulsehaler™.

  • Except as directed in the cleaning section below, do not try to disassemble the Pulsehaler™ or to replace any of the original external and internal parts.

  • Do not connect or interface the Pulsehaler™ to any airway clearance device or aerosol delivery system.

  • Check all connections before starting treatment.

  • Inspect the device and tubing for damage before starting the treatment.

  • Do not position the Pulsehaler™ so that it is difficult to disconnect the power plug if required.

  • Do not breathe on the device when the system is turned off or when the screen specifically indicates not to place into mouth.

  • In the unlikely occurrence of an electrical fault, contact service and replace the device.

  • The Pulsehaler™ is MR Unsafe (ie. must not be used near an MRI system).

  • Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.

  • Use of accessories, transducers and cables other than those specified or provided by Respinova Ltd. could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.

  • Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of Pulsehaler™, including cables specified by the Respinova. Otherwise, degradation of the performance of this equipment could result.

  • Long cables and cords may present a strangulation hazard. Never wrap cords or cables around your neck.

Cautions

  • PATIENT INJURY OR INEFFECTIVE THERAPY CAN RESULT FROM IMPROPER ASSEMBLY OR OPERATION. READ THE FOLLOWING CAUTIONS BEFORE ASSEMBLING OR OPERATING DEVICE.

  • Do not open or attempt to disassemble the Pulsehaler™ (other than the parts necessary for cleaning). There are no user-serviceable parts inside. The Pulsehaler™ must be returned to Respinova Ltd. for service.

  • Do not attempt to clean or disassemble the Pulsehaler™ while it operates.

  • Do not use the Pulsehaler™ in extremely moist and humid environments such as near the shower or outside when it is raining.

  • Do not immerse any part of the Pulsehaler™ in liquid or allow liquid to seep into the housings.

  • Do not attempt to disinfect parts with boiling water, steam, or using baby bottle sterilizers, dishwashers, or microwave ovens.

  • In case of visible damage to any part of the system, do not use Pulsehaler™. Return the system to Respinova Ltd.

  • If the device packaging is not intact, do not use the device.

  • If the device does not turn on, or is not working correctly, discontinue use. Re­fer servicing or replacement to qualified service personnel.

  • Do not use the equipment if it is has suffered any damage, for example, by dropping the equipment or splashing water on it.

  • If, during treatment, there are no air pulses detected at the mouth piece, discontinue use and contact Respinova customer service.

  • If the LCD screen is cracked or damaged, do not use the device.

  • Repairs should be undertaken only by personnel trained or auth­orized by Respinova Ltd. Do not modify this equip­ment without authorization from Respinova Ltd.

  • The device may not operate correctly if used or stored outside the relevant temperature or humidity ranges, as described in the per­formance specifications.

  • Handle the device with care, including while packing and unpacking.

  • Do not change, add, remove or disassemble any system parts.  Warranty shall not apply to any defects, failure or damage caused by improper use and/or improper or inadequate maintenance and care.

  • The unit is classified as Class IIb, continuously operated, ordinary equipment with applied part and with signal input/output parts.

  • Use only with parts purchased from Respinova Ltd. or an authorized distributor. Use of other parts may damage the unit, function incorrectly, harm the patient, and void the warranty.

  • If the device has been exposed to either very hot or very cold temperatures, allow it to adjust to operating temperature before using. Do not operate the device outside of the operating temperature range shown in the Specifications chapter later in this manual.

  • Do not use in direct sunlight.

  • Some RF emitters (e.g. RFID) in the intended environment of use might be concealed. The device could potentially be exposed to fields from these RF emitters without user awareness. Take the following precautions to prevent electromagnetic interference:

  • Maintain a minimum distance between portable and mobile RF communications equipment (transmitters) and the Pulsehaler as recommended below

  • Move to a different environment if experiencing device malfunction

  • Visually inspect all consumables that are subjected to the cleaning or disinfection process set out below. In the event of any degradation or deformation of any consumable, discard and replace as necessary.

Previous Versions

  • There are no previous versions of this Safety Information

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