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Beschikbare talen
This device can be operated in combination with other Dräger
devices or with devices from other manufacturers. Follow the
accompanying documents of the individual devices.
If a device combination is not approved by Dräger, the safety and
the functional integrity of the individual devices can be compro-
mised. The operating organization must ensure that the device
combination complies with the applicable editions of the relevant
standards for medical devices.
Device combinations approved by Dräger meet the requirements
of the following standards:
–
IEC 60601-1 (Edition 3.2)
Medical electrical equipment
Part 1: General requirements for basic safety and essential
performance
–
IEC 60601-1-2
Medical electrical equipment
Part 1-2: General requirements for safety and essential
performance
Collateral standard: Electromagnetic compatibility –
Requirements and tests
–
IEC 60601-1 (Edition 2)
Medical electrical equipment
Part 1: General requirements for safety
–
IEC 60601-1-1
Medical electrical equipment
Part 1-1: General requirements for safety
Collateral standard: Safety requirements for medical elec-
trical systems
–
IEC 60601-1-2
Medical electrical equipment
Part 1-2: General requirements for safety and essential
performance Collateral standard: Electromagnetic com-
patibility - Requirements and tests
–
IEC 60601-1-4
Medical electrical equipment
Part 1-4: General requirements for safety
Collateral standard: Programmable electrical medical sys-
tems
If Dräger devices are connected to other Dräger devices or third-
party devices and the resulting combination is not approved by
Dräger, the correct functioning of the devices may be compro-
mised. The operating organization is responsible for ensuring that
the resulting system meets the requirements of the applicable
standards.
Electromagnetic compatibility (EMC)
Medical electrical equipment is subject to special precautionary
measures concerning electromagnetic compatibility (EMC) and
must be installed and put into operation in accordance with the
EMC information provided in the instructions for use of the patient
monitor.
WARNING
Risk of device failure
Electromagnetic fields e.g., those generated by radio fre-
quency communication equipment such as mobile phones,
high-frequency electrical surgery equipment, defibrillators
or shortwave therapy devices can disrupt the function of
the medical device.
Only operate radio frequency devices at a sufficient safety
clearance.
Supplement Scio Four modules
WARNING
Risk due to electromagnetic disturbance
Wireless communication devices (e.g., cellular phones) and
medical electrical equipment (e.g., defibrillators, electro-
surgical devices) and their peripherals (e.g. antenna cables
and external antennas) emit electromagnetic radiation.
When such devices are operated too close to this device or
its cables, the functional integrity of this device may be
compromised by electromagnetic disturbances. As a
result, the patient could be put at risk.
–
Maintain a distance of at least 0.3 m (1.0 ft) between this
device and wireless communication devices, to ensure
that the essential performance of this device is fulfilled.
–
Maintain an adequate distance between this device and
other medical electrical equipment.
Connections to IT networks
During operation, this device can exchange information with other
devices by means of IT networks. An IT network can be any data
interface (e.g., printer interface, USB interface, RS 232 interface)
that is described in standards and conventions.
The exchange of data using wired technologies enables the fol-
lowing functions in the network:
–
Display of waveforms and parameter data
–
Recording, storing, and printing
–
Service mode, access to logbooks
Connecting this device to a network that incorporates other
devices or making subsequent changes to that network can lead
to new risks for patients, users, and third parties. Before the device
is connected to the network or the network is changed, these risks
must be identified, analyzed, and evaluated, and appropriate mea-
sures taken.
Examples of subsequent changes to the network:
–
Changing the network configuration
–
Removing devices from the network
–
Adding new devices to the network
–
Performing upgrades or updates on devices that are con-
nected to the network
Information on connecting to the network
Prerequisites
This device must only be connected to the network by service per-
sonnel. The IT representative of the hospital must be consulted in
advance.
The following documents must be followed:
–
Accompanying documents of this device
–
Description of the network interface
–
Description of the network-based alarm systems
Dräger recommends complying with IEC 80001-1 (risk manage-
ment for IT networks with medical devices).
Serial interfaces
The following interfaces are supported:
–
RS232 interfaces conforming to EIA RS-232 (CCITT
V.24/V.28) for the following applications:
–
MEDIBUS
–
Connections to medical devices from other manufacturers
–
Service Interface
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