Terumo CDI OneView - System Specifications; Manufacturer-Defined Default Alarm Limits

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System Specifications
Manufacturer-Defined Default Alarm Limits
The CDI OneView System provides alarm functionality for the parameters the system
is capable of measuring in accordance with the IEC 60601-1-8:2006+A1:2012, Medical
electrical equipment – Part 1-8: General requirements for basic safety and essential
performance – Collateral standard: General requirements, tests and guidance for alarm
systems in medical electrical equipment and medical electrical systems.
Based on these requirements and the known clinical use of the CDI OneView System,
manufacturer-dened default limits provide alarm functionality at the medium-priority
level. Physiological alarm priorities were established for both out of range – High and
out of range – Low parameter values based on the potential harm to the patient and
the time to occurrence of harm if the alarm is ignored.
Medium Priority conditions are dened in the standard as conditions that can result in:
• reversible injury within a time period sufcient for manual corrective action.
• death or irreversible injury within an unspecied time greater than prompt.
• minor injury or discomfort within a time period not usually sufcient for manual
corrective action.
Parameter Default Alarm-Min Default Alarm-Max
pH A: 7.10 V: 7.00 A: 7.65 V: 7.65
pCO
2
A: 30 mmHg V: 35 mmHg A: 55 mmHg V: 60 mmHg
pO
2
A: 85 mmHg V: 30 mmHg A: 500 mmHg V: 65 mmHg
K
+
3.0 mmol/L 7.0 mmol/L
SO
2
A: 85% V: 60% A: 100% V: 95%
HCT 21% 45%
Hgb 7.0 g/dL 15 g/dL
Q

0.05 L/min 8.00 L/min
CI 0.1 L/min/m
2
10.0 L/min/m
2
BE -25 mEq/L 25 mEq/L
HCO
3
−
0 mEq/L 50 mEq/L
VO
2
1 mL/min 400 mL/min
VO
2
i 1 mL/min/m
2
1000 mL/min/m
2
DO
2
50 mL/min 3000 mL/min
DO
2
i 262 mL/min/m
2
1000 mL/min/m
2
O
2
ER 0% 40%
SaSO
2
calc 85% 100%
SvSO
2
calc 60% 95%