Safety
Instruction For Use • C-MAC
®
Video Laryngoscope 8403xxx and Connection Cable 8403X • 96076019EN-US •
V4.3
11
4 Safety
4.1 Serious incidents
A "serious incident" includes, according to MDD incidents, those which, directly or indirectly,
had, could have had or could have any of the following consequences (MDD, Art. 2, No. 65 [1]):
– Death of a patient, user, or another person
– Temporary or permanent serious deterioration in the medical condition of a patient, user,
or another person
– A serious threat to public health
The manufacturer and appropriate authority should be notified of all serious incidents.
4.2 Description of warnings
To prevent any injury to persons or damage to property, the warning messages and safety
instructions in the instructions for use must be observed. The warnings describe the following
levels of danger.
WARNING
WARNING
Designates a possible imminent risk. If this is not avoided, it could lead to death or serious
injuries.
CAUTION
CAUTION
Designates a possible imminent risk. If this is not avoided, it could lead to minor injuries.
ATTENTION
ATTENTION
Designates a possibly harmful situation. If this is not avoided, the product could be damaged.
4.3 Notes on use
Every user must be trained in the operation and use of the C-MAC
®
video laryngoscopes in
combination with a C-MAC
®
Monitor 8403 ZX or C-MAC
®
PM 8403 XD, otherwise they may not
be used.
The use of the C-MAC
®
video laryngoscopes together with a C-MAC
®
Monitor 8403 ZX or C-
MAC
®
PM 8403 XD must be used in accordance with the airway algorithm in the respective
country of application or the official specifications for airway management.
4.4 Unsterile instruments
These products are not sterile when delivered. The use of unsterile products poses a risk of
infection for patients, users, and third parties.
Reprocess products before first use.
Inspect products for visible contamination before use. Do not use contaminated products.
4.5 Correct reprocessing
Incorrectly reprocessed products expose patients, users, and third parties to a risk of infection.
