Getinge Maquet SERVO-s - Information Required by ISO Standards

11.18 Information required by ISO
80601-2-12
11.18.1 Volume-controlled breath type
Characteristics valid for patient categories and
circuit configurations intended to provide the
indicated tidal volume, at conditions specified
in ISO 80601-2-12, table 201.103.
Maximum inaccuracy of inspired tidal
volume (V
T
)
• ±(4 ml + 7 % of set volume) for V
T
≥300 ml
• ±(4 ml + 7 % of set volume) for
100 ml ≤ V
T
≤300 ml
Maximum inaccuracy of PEEP
• ±(1 cmH
2
O + 5 % of set value) for
V
T
≥300 ml
• ±(1 cmH
2
O + 5 % of set value) for
100 ml ≤ V
T
≤300 ml
Maximum inaccuracy of inspired oxygen
concentration (FiO
2
) at the patient
connection port
• ±(3 % + 0 % of set value) for V
T
≥300 ml
• ±(3 % + 0 % of set value) for
100 ml ≤ V
T
≤300 ml
11.18.2 Pressure-controlled breath type
Characteristics valid for patient categories and
circuit configurations intended to provide the
indicated tidal volume, at conditions specified
in ISO 80601-2-12, table 201.104.
Maximum inaccuracy of airway pressure
(P
AW
) at the end of the inspiratory phase
• ±(1 cmH
2
O + 5 % of set value) for
V
T
≥300 ml
• ±(1 cmH
2
O + 5 % of set value) for
100 ml ≤ V
T
≤300 ml
Maximum inaccuracy of PEEP
• ±(1 cmH
2
O + 5 % of set value) for
V
T
≥300 ml
• ±(1 cmH
2
O + 5 % of set value) for
100 ml ≤ V
T
≤300 ml
Maximum inaccuracy of inspired oxygen
concentration (FiO
2
) at the patient
connection port
• ±(3 % + 0 % of set value) for V
T
≥300 ml
• ±(3 % + 0 % of set value) for
100 ml ≤ V
T
≤300 ml
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SERVO-s VENTILATOR SYSTEM V8.0, User's Manual
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