HemoSense INRatio2 PT Benutzerhandbuch Seite 15

EN
Display Screen
2
Your test result is above the
high target you and your
health care provider set in
the monitor.
(Example shown is in INR
display mode)
Your test result is below the
low target you and your
health care provider set in
the monitor.
(Example shown is in INR
display mode)
1. Hazards and Symbols
The monitor generates radio frequency (RF) energy. If your monitor is not set up and
used according to this User Guide, the RF energy may interfere with other devices in the
area. Call HemoSense Technical Support if you have any questions on RF interference.
Any devices connected to the data port must be certified according to the respective IEC
standards (i.e. IEC 60950 for data processing equipment and IEC 60601-1 for medical
equipment). Furthermore all configurations shall comply with the system standard IEC
60601-1-1. Anybody who connects additional equipment to the data port that
configures a medical system is responsible that the system complies with the
requirements of IEC 60601-1-1. Please contact HemoSense Technical Support if you
have any questions about connecting devices to the data port.
Use only the HemoSense Power Supply (Part #0100011 or 0100260) or you may
damage the monitor.
IEC 60601-1:1988 + A1:1991 + A2:1995
What it Means Action to Take
Contact your health care
provider.
Contact your health care
provider.
Amendment 2, Sub-clause 6.8.2 a (EMC):
This equipment has been tested and found to comply with the limits for medical devices to
the IEC 60601-1-2:2001. These limits are designed to provide reasonable protection against
harmful interference in a typical medical installation. This equipment generates, uses and can
radiate radio frequency energy and, if not installed and used in accordance with the
instructions, may cause harmful interference to other devices in the vicinity. However, there
is no guarantee that interference will not occur in a particular installation. If this equipment
does cause harmful interference to other devices, which can be determined by turning the
equipment off and on, the user is encouraged to try to correct the interference by one or more
of the following measures:
- Reorient or relocate the receiving device.
- Increase the separation between the equipment.
- Connect the equipment into an outlet on a circuit different from that to which
the other device(s) are connected.
- Consult the manufacturer or field service technician for help.
Class II Equipment: The monitor is double insulated.
Type BF Applied Part: The monitor has conductive contact with the patient.
Biological Risks: Disposable items pose biological risks.
The monitor is classified as ordinary equipment.
UL Classification
Medical Electrical Equipment
With respect to electrical shock, fire and mechanical hazards only in
accordance with UL 60601-1 and CAN/CSA C22.2 No. 601.1
Class II/ Internally Powered Equipment
Type BF Applied Part
Continuous Operation
EN
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