SD32+
System
Safety
2.1.1. electrical safety
Use only the power supply distributed with the
SD32+
system.
The
SD32+
system is specifically designed to function with only the provided AC/DC Adapter.
See section
3.7.1. external medical grade ac/dc adapter
on page 20 for more information.
Use caution when operating the amplifier in conjunction with other instruments.
If the patient is connected to several instruments at the same time remember that the sum of
leakage currents from all of the equipment must be considered when assessing patient safety.
Avoid switching the amplifier ON while the patient is connected.
To ensure patient safety, it is necessary to connect the patient after the equipment is powered up
and working correctly.
Avoid switching the amplifier OFF while the patient is connected.
To ensure patient safety, it is necessary to disconnect the patient before powering down the
equipment.
It is not recommended to use the amplifier while using radio-frequency instruments.
In the event the
SD32+
is used in a room at the same time as a Radio-Frequency (RF) instrument,
ensure the RF instrument is kept as far as possible from the electrodes as close proximity may
increase the risk of RF currents flowing through the electrodes and may result in burns. This risk
may be further mitigated by using electrodes with a larger surface area to limit the RF current
density. If these mitigations are not possible, it is recommended to disconnect the patient from
the
SD32+
before using radio-frequency instruments.
The amplifier is not protected against defibrillator discharges.
If a defibrillator must be used disconnect the patient from the amplifier to avoid the risk of
burning the patient along electrode contact areas and damaging the amplifier.
Avoid contacting the patient and the electrodes with conductive metal items.
Do not allow the patient, or any conductive parts connected to the patient such as electrodes or
sensors, to contact any other conductive items, especially an electrical ground. The entire input
circuit the patient is connected to is electrically isolated (known as “floating isolation”) and
contact with conductive items could compromise patient safety.
When connecting the
SD32+
amplifier
to other instruments, observe the IEC 60601-1-1 and IEC
60601-1-2 safety standards.
Only connect the
SD32+
to devices when the safety of the patient, technologist, and the
environment are not compromised. Refer to the device’s manual, manufacturer, or authorized
servicing centre for information on the possible effects of coupling the device with the
SD32+
amplifier.
Replace damaged parts immediately.
Cables, connectors, accessories, or other parts of the amplifier must be replaced immediately
when they show signs of malfunction or damage. In these cases, contact Embla Technical
Support.
Use only accessories or peripherals specified by Embla Systems.
Only use accessories and peripherals specified by Embla Systems in this manual as they have
been tested with the
SD32+
amplifier for safety. Accessories and consumer goods supplied by
other manufacturers do not guarantee the safe or correct operation of the
SD32+
amplifier. Use
peripherals in compliance with the standards of the class to which they belong.
There is no increased safety risk for Pacemaker patients with the SD32+ Amplifier.
The Sandman System when used with the SD32+ Amplifier does not increase the safety risk for
pacemaker patients as long as the pacemakers comply with the EN50061 standard of electrical
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