Embla Sandman, Руководство пользователя

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Safety
SD32+
System
safety of medical devices. Nevertheless, it is not advisable to do an impedance test on pacemaker
patients since it might cause the pacemaker to switch to the interference mode. Prior to using the
system with pacemaker patients, the operator should consult the pacemaker’s accompanying
documents regarding its certifications and requirements of use, or if necessary, contact the
producer.
2.1.2. patient leakage current
The maximum patient leakage current from the SD32+ amplifier, measured according to the test
methods of IEC 60601-1, is less than 100
μ
A.
Warning: When using the SD32+ amplifier in conjunction with other instruments the sum of
leakage currents from all of the devices may exceed 100
μ
A.
2.1.3. patient connection
Connection between the patient and the SD32+ amplifier should only be made through the
electrode sockets on the Headbox or the Pulse Oximetry Sensor port (using a pulse oximeter
cable approved by Embla Systems). Connecting the patient to the amplifier by any other means
may constitute an unsafe condition that could result in injury to the patient.
Warnings: Standard PSG recording guidelines recommend that all patient monitoring devices
connected to an electrical outlet be turned on before connection to the patient.
Once the device is powered up, you may then connect the patient to the device and
begin collection. At the same time, you must disconnect the patient before you
power the device down.
All connections on the Headbox are isolated from the AC power ground. Do not
allow these connections to come into contact with earth ground or AC power
ground as this constitutes an unsafe condition that could result in serious injury to
the patient.
Always use electrodes or sensors cleared for commercial use in your jurisdiction.
It is strongly recommended to check the overall functionality of the system prior
to starting a collection. If anomalies or malfunctions are noticed disconnect the
patient from the system, switch off the system, and contact Embla Technical
Support.
If “flat” traces are observed during a collection and are not rectified by simple
corrections (i.e. poor electrode connection, broken lead, etc.) disconnect the patient
and contact Embla Technical Support.
If skin irritation occurs during collection discontinue the collection and disconnect
the patient. Refer to any directions for use included with the sensor(s) and or paste
involved for further information.
2.2. LCD display
Treat the LCD with great care. If the LCD glass should break and spill liquid, avoid coming in
contact with the liquid. If anyone is exposed to the liquid, carefully wash the affected area with
water for at least 15 minutes. Should the individual experience any irritation, discomfort, or other
symptoms after this period, seek medical assistance immediately.
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