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Interfaces
Connecting devices to the data interfaces (serial ports and network ports) can lead
to an increased leakage current. If the protective ground conductor of one of these
devices fails, the patient leakage current may rise above the permissible values.
This may result in an electric shock and the user and patient may be at risk.
► Only use USB devices that do not have their own power supply.
► Only connect devices or networks to a serial port, or to the network port, that
have a maximum nominal voltage of 24 V DC and meet one of the following
standards:
– IEC 60950-1 / IEC 62368-1: Ungrounded SELV circuits
– IEC 60601-1 (as of 2nd edition): Touchable secondary circuits
► Have service personnel check the leakage current, especially if additional
devices will be connected.
► If the permissible value is exceeded, disconnect the devices from the serial
ports.
► Do not touch the interface ports and the patient simultaneously.
4.1.5
Explosion protection
Flammable gases
In combination with oxygen or nitrous oxide, ignition sources such as
electrosurgery, laser surgery, and faulty cables or connectors can cause fires. As a
result, user and patient could be put at risk.
► This device is not approved for use in areas where oxygen concentrations
greater than 25 Vol%, combustible, or explosive gas mixtures are likely to occur.
► Maintain a distance of at least 200 mm (7.9 in) between electrical connections
and components which conduct oxygen and nitrous oxide.
► Cables and connections must be sufficiently insulated and must not be
damaged. Check cables for damage daily.
► Disconnect all oxygen feeds if oxygen leakage is suspected in the device or its
vicinity (e.g., because a corresponding flowing noise can be heard). Do not
operate the device, and contact service personnel.
► Keep ignition sources away from the device.
If a fire starts in the immediate vicinity of the patient, the device could also catch
fire. Personal injury and property damage may occur as a consequence.
► Disconnect the oxygen-carrying connections from the device and the patient.
► Extinguish the fire and tend to the patient's medical needs.
Flow sensors
Deposits that were not removed during reprocessing can damage the measuring
wires in the flow sensor or cause a fire. As a result, user and patient could be put at
risk.
► Check the flow sensor before insertion and at regular intervals afterwards for
visible damage, soiling, and particles.
► Replace flow sensors when damaged, soiled, or not particlefree.
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Instructions for use
Atlan A100 (XL), A300 (XL), A350 (XL) SW 2.1n
Assembly and preparation
63
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