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Disposal
The following replaces disposal instructions for electrical and electronic equipment in Chapter 11 of the Trilogy manual.
Separate collection for electrical and electronic equipment per EC Directive 2012/19/EU. Dispose of this device in
accordance with local regulations.
Compliance, Inspiratory and Expiratory Resistance Characteristic
Ratings for Standard Patient Circuits
The following table is in addition to the Technical Specifications in Chapter 11 of the Trilogy manual.
r
Ange
f
s
P
low
et
oint
(
/
)
l
min
10
30
60
90
120
Standards Compliance
The following list of standards for compliance replaces information presented in Chapter 11 of the Trilogy manual
instructions and previous Trilogy addendum.
•
IEC 60601-1: Medical Electrical Equipment – Part 1: General requirements for safety
•
IEC 60601-1-2: General Requirements for Safety – Collateral Standard: Electromagnetic compatibility –
Requirements and tests
•
IEC 60601-1-6: Medical Electrical Equipment – Part 1-6: General requirements for safety and essential
performance – Collateral Standard: Usability
•
IEC 60601-1-8: General Requirements for Safety – Collateral Standard: Alarm systems in medical electrical
equipment and medical electrical systems
•
IEC 60601-1-11: General Requirements for Safety and Essential Performance – Collateral Standard: Medical
equipment and medical electrical systems used in the home healthcare environment
•
IEC 62304: Medical Device Software – Software Lifecycle Processes
•
IEC 62366: Medical Devices – Application of Usability Engineering to Medical Devices
•
ISO 80601-2-12: Medical Electrical Equipment – Part 2-12: Particular requirements for basic safety and essential
performance of critical care ventilators
•
ISO 80601-2-61: Medical Electrical Equipment – Part 2-61: Particular requirements for basic safety and essential
performance of pulse oximeter equipment
•
ISO 80601-2-72: Medical Electrical Equipment – Part 2-72: Particular requirements for basic safety and essential
performance of home healthcare environment ventilators for ventilator-dependent patients
•
RTCA DO-160G Section 21, Category M; Emission of Radio Frequency Energy
Passive
0.56 – 0.70
i
r
(
nsPirAtory
esistAnce
Passive
Active PAP
0
0
0.19
0.23
0.45
0.57
0.76
0.88
1.06
1.27
c
(
/
H
omPliAnce
ml
cm
Active PAP
0.55 – 0.70
H
o/
/
)
e
cm
l
s
2
Active Flow
Passive
0.23
0.91
0.19
1.60
0.45
1.32
0.76
1.82
1.06
o)
2
Active Flow
0.61 – 0.72
r
(
xPirAtory
esistAnce
cm
Active PAP
0
0
0.23
0.57
0.88
1.27
H
o/
/
)
l
s
2
Active Flow
0.23
0.91
1.60
1.32
1.82
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