Naris
Naris
User’s
Manual V14 14/02/20 Page 5 of 52
correctly. Appendix 1 provides guidance on the Electromagnetic environment in which to
operate the instrument.
The NR6 Rhinomanometer is a medical instrument, which has an electrical classification of
Class I Type B and a Medical Device Directive Classification of Class I with a measuring
function.
A Class I Type B device categorisation is used to describe an instrument which:
a) Does not rely on basic insulation only to provide protection against electrical shock but is
constructed in such a way that accessible metal parts cannot become live in the event of
failure of the basic insulation, and
b) Applied parts offer protection to the subject against electrical shock and in the event of a
single fault condition arising, leakage current will be limited to less than 0.5 mA.
Any incident, which results in actual or potential injury or death to a subject while using an
NR6, should be immediately communicated to GM Instruments at the address on page 7.
NR6 should only be connected to other mains-powered devices such as computers and
printers, which comply with EN 60950-1 and we also advise the use of a separating
transformer. Unless computers and printers built to EN 60950 are used, patient safety might
be compromised.
Non-medical equipment such as computers and printers should be kept out of reach of
subjects being tested as such equipment does not comply with medical safety standards.
Refer to clause 16 of EN 60601-1:2006 to ensure compliance.
If the PC is allowed to go into sleep mode, the USB interface is powered down. When brought
out of sleep mode, the PC does not re-initialise the USB interface, and therefore it is effectively
not present. A solution is to remove the USB connection at the PC or instrument side then re-
connect. That may be sufficient, but if not - save any results, then close down the instrument
software and restart it.
Servicing can only be carried out by GMI approved and
authorised personnel. No modifications are allowed
.
Storage
The A1/NR6 and its accessories should be stored within the following temperature and
humidity ranges:
Temperature
-40
o
C to +60
o
C
Humidity
20% to 80% RH non-condensing
Pressure
50 kPa to 106 kPa
