Medela Vario Mode D'emploi page 6

WARNINGS
– For use only by medically trained persons who have been adequately trained in suction
procedures and in the use of aspirators.
– For patients for whom a breakdown of the device can lead to a critical situation (e.g.
patients with acute dyspnoea or severe catarrhal congestion), a replacement device
must always be available.
– Gastric suction: When the device is used for gastric suction, the patient's condition and
correct functioning of the pump (on the basis of acoustic and visual signs) must be
checked at least once every four hours.
– The device must not be used for suctioning explosive, easily flammable or corrosive liquids
– The connecting tubing supplied with the device must never come into direct contact
with the suction area. A sterile suction catheter must always be used (risk of infection).
– Before cleaning the device, pull the plug out of the fixed mains socket.
– No modification of this equipment is allowed.
– Do not connect this device to a passive drainage tube.
– Consult the indications for use and consider risk factors and contraindications before
using the Vario. Failure to read and follow all instructions in this manual prior to use
may result in serious or fatal injury of the patient.
– The Vario pump may shortly shut down with electrostatic discharge (ESD) events at the
DC port of 15kV.
CAUTIONS
– Incorrect use can cause pain and injury to the patient.
– Do not use sterile accessories when the sterile packaging is damaged.
– Wireless communications equipment such as wireless home network devices, mobile
phones, cordless telephones and their base stations, walki-talkie can affect the Vario
and should be kept at least a distance 1ft (30 cm) away from the equipment.
– Portable and mobile RF communications equipment can affect medical devices.
– The patient should be monitored regularly according to the physicians instructions and
facility guidelines. Objective indications or signs of a possible infection or complication
must be met immediately (e.g. fever, pain, redness, increased warmth, swelling or
purulent discharge). Non-observance can lead to con si de rable danger of the patient.
Monitor the Vario frequently for opera ting status.
Safety related tip
– The Vario suction pump is Magnetic Resonance (MR) unsafe. Do not take the pump
into the MR environment.
– For safety tests, it is assumed that the device is serviced and repaired throughout its
service life in accordance with the service manual. Because the Vario is a device of safe-
ty class lI (EN IEC 60601-1, A1, A2:1995), the safety tests are confined to visual inspec-
tion of the housing and power cord. This test must be carried out before each use.
– Testing the patient leakage current: Please see service manual for details.
– The protection of the Vario against the effects of the discharge of a cardiac defibrillator
is dependent upon the use of appropriate cables.
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Warnings and safety instructions