ACUTRONIC fabian Therapy evolution - Maintenance and Liability

12 Warnings cautions and notices
fabian Therapy evolution | SW 5.1.x
Ref: 121003.EN / Date 2020-01-22
33.
Before use, carefully read the Oximetry Sensor Directions for Use and PC-
Series Patient Cable Directions for Use.
34.
EXPLOSION HAZARD: Do not use the pulse oximeter in the presence of
flammable anesthetics or other flammable substances in combination with
air, oxygen-enriched environments, or nitrous oxide.
35.
Check alarm limit settings each time the pulse oximeter is used.
36.
A pulse oximeter should NOT be used as an apnea monitor.
37.
A pulse oximeter should be considered an early warning device. As a trend
towards patient deoxygenation is indicated, blood samples should be
analyzed by a laboratory co-oximeter to completely understand the patient's
condition.
38.
Always remove the sensor from the patient and completely disconnect the
patient from the pulse oximeter before bathing the patient.
39.
Do not use malfunctioning equipment. Have the pulse oximeter unit repaired
by Masimo or a qualified service person.
40.
ELECTRIC SHOCK HAZARD: Do not remove the pulse oximeter cover.
There are no user-serviceable items inside the pulse oximeter. An operator
may only perform maintenance procedures specifically described in this
manual. ONLY connect IEC 60601-1 or IEC 60950-1 compliant devices to
Ethernet, Nurse call, and RS232 ports.
41.
If the accuracy of any measurement by the pulse oximeter does not seem
reasonable, first check the patient's vital signs by alternate means, and then
check the oximeter for proper functioning.
42.
WARNING: Only use air and O
2
hoses which are in accordance to the ISO
5359 standard
43.
WARNING: Do not use the ventilator in association with HF (High
Frequency) electrosurgical equipment.
44.
WARNING: Connect pulse oximetry cables to the machine before the patient
is connected.
2.2 Maintenance
The device is a ventilator classified as Class IIb according to the European Directive, as such:
• Inspection according to manufacturer specifications is required every 12 months.
• Maintenance must be performed by ACUTRONIC Medical Systems trained personnel with
access to appropriate test and measuring equipment.
We strongly recommend ACUTRONIC Medical Systems AG exclusive representatives for service
agreements and repairs.
Only use original ACUTRONIC Medical Systems parts for repairs.
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