Medela Invia Motion, Инструкции для медицинских работников по применению

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– Patients with spinal cord injuries (stimulation of sympathetic nervous system) who experience
Autonomic Hyperreflexia during therapy should have NPWT discontinued.
– In the event that defibrillation is required, disconnect the pump from the wound dressing before the
patient is defibrillated.
– Special care is advised for dressing placement and removal in order to avoid situations such as
unintentional gauze or foam retention.
– This device has not been studied in pediatric patients.
– Do not bring the device into the following areas: Positron Emission Tomography (PET) or Hyperbaric
Oxygen Chamber (HBO).
– The Invia Motion NPWT system is Magnetic Resonance (MR) Unsafe. Do not take the Invia Motion
NPWT system into the MR environment.
– HF (high-frequency) surgical equipment, radio networks or the like can influence the operation of the
device and may not be operated in combination with the Invia Motion pump.
– Explosion hazard – the Invia Motion NPWT pump is not for use in potentially explosive environments
including oxygen enriched environments and in areas of flammable anesthetics.
– Portable Radio Frequency (RF) communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 0.3 m to any part of the Invia Motion
NPWT system, including cables specified by the manufacturer. Otherwise, degradation of the
performance of this equipment could result.
– The Invia Motion NPWT system is intended to be used in conjunction with the Invia foam and gauze
dressings.
– Invia Foam Dressing Kit with FitPad, X-Large should not be used in conjunction with the Invia
Motion NPWT pump.
Cautions
CAUTIONS
– Incorrect use may cause pain and injury to the patient. Excessive negative pressure or an infection
of the wound may cause pain to the patient. In either case, the dressing must be changed and the
wound inspected in detail.
– The patient should be monitored regularly according to physician instructions and facility guidelines
to monitor patient comfort, therapy compliance and signs of wound infection.
– Do not use an Invia Motion canister/tubing set if the sterile packaging is damaged.
– Wireless communication equipment such as wireless home network devices, mobile phones,
cordless telephones and their base stations, and walkie-talkies can interfere with the Invia Motion
pump and should be kept at a minimum distance of 30 cm away from the Invia Motion pump.
– The Invia Motion NPWT pump must remain in an upright (carrying case) or lying (display side up)
position during use.
– The total wound volume connected to the Invia Motion NPWT pump shall be 1l or less.
The following statements describe medical conditions that may require special care for the safe and effective
use of the Invia Motion NPWT system.
– Patients at high risk for bleeding and hemorrhage, including patients experiencing active bleeding or
difficult wound hemostasis.
– Patients taking anticoagulants or platelet aggregation inhibitors.
– Patients with a history of vascular anastomosis or friable, irradiated, sutured or infected blood
vessels.
– Patients with spinal cord injury (sympathetic nervous system stimulation): in the event a patient
experiences autonomic dysreflexia (sudden changes in blood pressure or heart rate in response to
stimulation of the sympathetic nervous system), discontinue negative pressure wound therapy to
help minimize sensory stimulation and seek immediate medical assistance.