Vitalograph Spirotrac Instructions for Use
IFU Part No.: 07402
Issue 22
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Page 72 of 78 DT_0006-15
maintenance of anti-virus software and firewall(s) on IT systems to prevent
intrusion and protect those systems, in line with customer’s internal IT policies.
14 CE Notice
Marking by the symbol indicates compliance of the Vitalograph Spirotrac to the
Medical Devices Directive of the European Community.
Medical Devices may be affected by cellular telephones and other personal or
household devices not intended for medical facilities. It is recommended that all
equipment used near the Vitalograph product comply with the medical
electromagnetic compatibility standard and to check before use that no interference
is evident or possible. If interference is suspected or possible, switching off the
offending device is the normal solution, as is required in aircraft and medical
facilities.
Medical electrical equipment needs special precautions regarding EMC and needs
to be installed and put into service according to the EMC information provided.
Portable and mobile RF communications equipment can affect medical electrical
equipment
15 FDA Notice
Caution: Federal Law restricts this device to sale by, or on the order of a
physician.
16 Declaration of Conformity
Product: Model 7000, Spirotrac
Vitalograph hereby ensures and declares that the above product associated with these
instructions for use, is designed and manufactured in accordance with the following
QMS regulations and standards:
• European Medical Devices Directive {MDD} 93/42/EEC, as amended.
This device is classified as 2a per Annex IX of the MDD also meets
the provisions of the Essential Requirements, Annex I, via compliance
with Annex II of the Medical Devices Directive as per Article 11,
section 3a, excluding point 4 of Annex II.
• Canadian Medical Device Regulation {CMDR SOR/98-282}
• FDA Quality System Regulation {QSR} 21 CFR 820.
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