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Norav Mobile ECG
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Doc P/N: 2018-005| Norav Medical
Updated 16/12/1 | Revision 2..0)
Document Conventions
otes and Cautions
Pay particular attention at specific points in a procedure when one of the following messages appears:
WAR I G
WAR I G: Warnings call attention to possible hazards involving potential damage or
injury to
persons.
CAUTIO
CAUTIO : autions refer to practices necessary to protect against potential damage or
loss to equipment. Pay careful attention to instructions.
OTE
OTE: Notes provide pertinent information to help obtain optimum performance from
the software or signify an important step or procedure that requires special attention.
Safety
WAR I G
WAR I G: The NR Recorder device uses batteries as the main power supply. It is
also sensitive to electrical interference. To prevent possible injury, read this page
carefully prior to installing the device.
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Other devices which are part of the system must meet the requirements of the Standard for
Information Technology Equipment (IEC 60 50) and the Standard for Electrical Medical
Devices (IEC 60601-1)
■
The computer system should be approved to the appropriate safety standard for non-medical electrical
equipment (IEC 60 50, or its national variants).
■
Computers and printers used with Medical Devices should be evaluated for EN 60 50-1, EN 60601-1 or
equivalent safety standard to maintain the safety of Medical Devices.
■
Accessory equipment connected to the analogue and digital interfaces must be certified according to the
respective IEC/EN standards (e.g. IEC/EN 60 50 for data processing equipment and IEC/EN 60601-1 for
medical equipment). Furthermore, all configurations shall comply with the valid version of the standard
IEC/EN 60601-1-1. Therefore anybody, who connects additional equipment to the signal input or output
connector to configure a medical system, must make sure that it complies with the standard. Use only the
original data cable/power adaptor assembly.
■
Magnetic and electrical fields can have an influence on the function of instruments. Ensure that all non
Norav Medical equipment which is operated nearby complies with the EMC requirements (regulations
for Electro Magnetic Compatibility). X-Ray, CTs, etc. can cause interference to other equipment, as a
result of their authorized higher emission of electromagnetic interference.
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Pacemaker – It is recommended that a minimum separation of 15 cm (6 inches) be maintained between
the wireless NR Recorder and a pacemaker to avoid potential interference with pacemaker. Some
studies have shown that wireless devices might interfere with implanted cardiac pacemakers if used
within eight inches of the pacemaker. Pacemaker users may want to avoid placing or using a wireless
device this close to their pacemaker. Patients with a pacemaker:
•
Should always keep the wireless NR Recorder unit at least 30 cm from their pacemaker when the
NR Recorder unit is turned on.
•
Should not carry the NR Recorder in their breast pocket.
