For your safety and that of your patients
10 Instructions for use Oxylog 3000 plus SW 1.n
Functional safety
The essential performance of
Oxylog 3000 plus is defined as:
Appropriate delivery of ventilation to the patient-
connection port or generation of an alarm
condition.
Appropriate monitoring
The monitoring functionality of Oxylog 3000 plus
ensures appropriate monitoring of the ventilation
therapy. To ensure appropriate monitoring during
ventilation, always set alarm limits for the following
parameters:
– Airway pressure Paw
– Expiratory minute volume, MVe
– Respiratory rate (if applicable), RR
–etCO
2 (if applicable)
If appropriate alarm limits are not set, alarms may
not be triggered in the following cases:
– Acute changes in the patient’s condition
– Incorrect settings and faulty handling
– Hose system leakage
Connection to other devices
Device combinations (Dräger devices + Dräger
devices or Dräger devices + third-party devices)
approved by Dräger (see instructions for use of
individual devices) meet the requirements of the
following standards:
– IEC 60601-1 (3rd edition)
Medical electrical equipment
Part 1-1: General requirements for safety and
essential performance
– IEC 60601-1-2
Medical electrical equipment
Part 1-2: General requirements for safety
and essential performance
Collateral standard: Electromagnetic
compatibility – Requirements and tests
– IEC 60601-1-8
Medical electrical equipment
Part 1-8: General requirements for safety
Collateral standard: General requirements,
tests, and guidance for alarm systems in
medical equipment and medical electrical
systems
– IEC 60601-1 (2nd edition)
Medical electrical equipment
Part 1: General requirements for safety
– IEC 60601-1-1
Medical electrical equipment
Part 1-1: General requirements for safety
Collateral standard: Safety requirements for
medical electrical systems
– IEC 60601-1-2
Medical electrical equipment
Part 1-2: General requirements for safety
Collateral standard: Electromagnetic
compatibility; Requirements and tests
– IEC 60601-1-4
Medical electrical equipment
Part 1-4: General requirements for safety
Collateral standard: Programmable
electrical medical systems
CAUTION
Always use a separate SpO2 monitor for
patients who are dependent on an exact O
2
concentration.