Specifications
308 Instructions for Use Apollo SW 4.5n
Part Number: 9053586, 3rd edition
– Without firewall and antivirus software:
– Data are not protected.
– Device settings are changed.
– The device generates false alarms or does not
generate alarms.
– Data are sent incomplete, sent to the wrong
device, or not sent at all.
– Patient data are intercepted, falsified, or
damaged.
– Data have incorrect time stamps.
Requirements on the electrical characteristics of
connected devices and networks
The serial ports are only suitable for connection of
devices or networks that have a rated voltage of at
most 24 V DC on the network side and that meet the
requirements of one of the following standards:
– IEC 60950-1: Ungrounded SELV circuits
– IEC 60601-1 (as of 2nd edition): Touchable
secondary circuits
Relevant standards
In addition to the standards listed here, the medical device also complies with various other standards, e.g.,
standards concerning special national requirements.
IEC 60601-1 2nd ed.
Medical electrical equipment
Part 1:
Requirements for safety
IEC 60601-1-2
Medical electrical equipment
Part 1-2:
General requirements for safety,
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 electrical systems
IEC 60601-2-13
Medical electrical equipment
Part 2-13:
Particular requirements for the safety of anaesthetic systems
ISO 8835-2
Systems for inhalational
anaesthesia
Part 2:
Anaesthetic breathing systems
ISO 8835-3
Systems for inhalational
anaesthesia
Part 3:
Transfer and receiving systems of
active anaesthetic gas scavenging systems
ISO 8835-4 Part 4:
Anaesthetic vapour delivery devices
ISO 8835-5
Systems for inhalational
anaesthesia
Part 5:
Anaesthetic ventilators