Dräger Infinity M300 series - Table of Contents

Instructions for use – Infinity
®
M300 and M300+ series – VG3.0 33
Contents
Contents
Trademarks . . . . . . . . . . . . . . . . . . . . . . . . . . .4
Trademarks owned by Dräger . . . . . . . . . . 4
Trademarks owned by third-party
manufacturers. . . . . . . . . . . . . . . . . . . . . . . 4
Open-source software . . . . . . . . . . . . . . . . . . . 5
Safety information definitions . . . . . . . . . . . . . . 5
User group requirements . . . . . . . . . . . . . . . . . 5
Duties of the operating organization . . . . . . 5
User groups . . . . . . . . . . . . . . . . . . . . . . . . 6
Abbreviations and symbols. . . . . . . . . . . . . . . . 6
Product compatibility information . . . . . . . . . . . 6
For your safety and that of your patients. . . 7
Mandatory reporting of adverse events . . . 8
Strictly follow these instructions for use . . . 8
Storing the instructions for use . . . . . . . . . . 8
Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Unauthorized changes to hardware or
software . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . 9
Accessories . . . . . . . . . . . . . . . . . . . . . . . . 9
Installing accessories . . . . . . . . . . . . . . . . . 10
Sterile accessories . . . . . . . . . . . . . . . . . . . 10
Environment of Use . . . . . . . . . . . . . . . . . . 10
Restrictions for use . . . . . . . . . . . . . . . . . 10
Restriction of distribution . . . . . . . . . . . . . . 10
Connected devices . . . . . . . . . . . . . . . . . . . 11
Networking and connection to other
devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Connection to hospital network. . . . . . . . . . 11
Connection to other devices . . . . . . . . . . . . 12
Safe connection with other electrical
equipment . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Electrical safety. . . . . . . . . . . . . . . . . . . . . . 12
Patient safety . . . . . . . . . . . . . . . . . . . . . . . 13
Patient monitoring. . . . . . . . . . . . . . . . . . . . 13
General safety information . . . . . . . . . . . . . . . . 13
Not for use in areas of explosion hazard . . . 15
Information on electromagnetic
compatibility . . . . . . . . . . . . . . . . . . . . . . . . 15
Site of operation . . . . . . . . . . . . . . . . . . . . . 16
Defibrillator precautions . . . . . . . . . . . . . . . 17
Cybersecurity . . . . . . . . . . . . . . . . . . . . . . . . . 19
Definition of cybersecurity terminology . . . . . . 20
Cybersecurity safety information . . . . . . . . . . . 21
Cybersecurity information and
recommendations . . . . . . . . . . . . . . . . . . . . . . 23
Passwords . . . . . . . . . . . . . . . . . . . . . . . . . 25
Cybersecurity incident response . . . . . . . . 26
Product security information . . . . . . . . . . . 26
Infinity network configuration . . . . . . . . . . . 27
Security modes of operation . . . . . . . . . . . 28
Network security troubleshooting and
error conditions . . . . . . . . . . . . . . . . . . . . . 29
M300/M300+ network error message . . . . 31
PSK security credential expiration. . . . . . . 31
Network support matrix . . . . . . . . . . . . . . . 32
Indications for use . . . . . . . . . . . . . . . . . . . . 39
Indications for use . . . . . . . . . . . . . . . . . . . . . . 40
Contraindications. . . . . . . . . . . . . . . . . . . . . . . 40
System overview . . . . . . . . . . . . . . . . . . . . . . 41
Overview of the ICS relative to M300/M300+. . . 42
Overview of the M300/M300+ . . . . . . . . . . . . . 43
Infinity M300 . . . . . . . . . . . . . . . . . . . . . . . 43
Infinity M300+ . . . . . . . . . . . . . . . . . . . . . . 43
Infinity M300/M300+ communications . . . . 44
Infinity M300/M300+ user interfaces and
functions . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Front panel of the M300 . . . . . . . . . . . . . . . . . 45
Battery status LED of the M300. . . . . . . . . 45
Low battery alarm . . . . . . . . . . . . . . . . . . . 46
Critical battery alarm . . . . . . . . . . . . . . . . . 46
Power-save mode . . . . . . . . . . . . . . . . . . . 46
Back panel of the M300. . . . . . . . . . . . . . . . . . 48
Overview of the Bedside Charger . . . . . . . . . . 49
Avoiding charger and adapter damage . . . 49
M300 screen examples . . . . . . . . . . . . . . . . . . 50
Power on/off. . . . . . . . . . . . . . . . . . . . . . . . 50
Overview of the Central Charger. . . . . . . . . . . 51
Infinity M300+ . . . . . . . . . . . . . . . . . . . . . . . . . 52
M300+ swappable battery . . . . . . . . . . . . . . . . 53
Battery safety information . . . . . . . . . . . . . 54
Preventive Maintenance . . . . . . . . . . . . . . 55
Caring for the M300+ lithium-ion
swappable battery . . . . . . . . . . . . . . . . . . . 55