EDAN iM50, Руководство пользователя

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Patient Monitor User Manual Monitoring CO
2
- 152 -
For Masimo Sidestream Module:
WARNING
1 To avoid water condensation inside the module and the connecting tubings, ensure
that the surrounding temperature of the module and the connecting tubings does not
fall below the ambient temperature of the Sampling line.
2 The fulfillment of the EMC requirement is the responsibility of the integrator.
3 The Masimo sidestream CO
2
module’s exhaust gas is not intended to be returned to
the patient circuit.
4 The host power supply shall employ current limiting, whereby current is reduced or
cut-off under overload conditions.
5 The host power supply shall provide 2 MOPP of isolation to Mains according to IEC
60601-1.
6 Alarm messages corresponding to each bit in the status summary field of the software
interface protocol must be implemented in the host equipment.
7 The host equipment shall be equipped with appropriate alarm systems to alert the
user of situations which could lead to death or severe deterioration of the patient's
state of health.
8 Make sure that Masimo sidestream CO
2
module is used in the electromagnetic
environment specified in this manual.
9 Portable and mobile RF communications equipment (including peripherals such as
antenna cables and external antennas) should be used no closer than 30 cm (12
inches) to any part of Masimo sidestream CO
2
module, including the cable. Otherwise,
degradation of the performance of the Masimo sidestream CO
2
module could result.
10 Use of this equipment adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this equipment
and the other equipment should be observed to verify that they are operating properly.
11 Use of accessories and cables other than those specified or provided could result in
increased electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.
12 Do not use the module if it appears or is suspected to be damaged. Damage to the
device can result in exposed electrical circuits that may cause patient harm.
13 Do not adjust, repair, open, disassemble, or modify the module. Damage to the device
may result in degraded performance and/or patient injury.
14 Do not start or operate the module unless the setup was verified to be correct.
Improper set-up of this device may result in degraded performance and/or patient
injury.