Safety
Instruction For Use • C-MAC
®
video laryngoscope 8401xxx, Electronic Module 8401/8402 X, C-MAC
®
PM 8401
XD • 96076011EN-US • V3.1
8
3 Safety
3.1 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.
3.2 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.
3.3 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.
3.4 Correct reprocessing
Incorrectly reprocessed products expose patients, users, and third parties to a risk of infection.
The instructions for use "Cleaning, Disinfection, Care, and Sterilization of KARL STORZ
Instruments" (item no. 96216003) must be downloaded from http://www.karlstorz.com and
followed.
3.5 Risks due to damaged parts
Check the following points before and after every use of the product:
1.
Completeness
2.
Good working order
3.
Correct assembly of the components
