Intended use
Instruction For Use • C-MAC
®
video laryngoscope 8401xxx, Electronic Module 8401/8402 X, C-MAC
®
PM 8401
XD • 96076011EN-US • V3.1
6
2 Intended use
2.1 Intended use
The C-MAC
®
video laryngoscope 8401 AX/BX/HX/AXC/BXC/DXC/GXC/KXC/HXP is used in
conjunction with the Electronic Module 8401 X/8402 X and the monitor 8401 ZX/8402 ZX/8403
ZX or the C-MAC
®
PM for endotracheal intubation and the inspection of the oropharynx. The
Monitor 8403 ZX has separate instructions for use (96076008D).
2.2 Contraindications
No contraindications relating directly to the product are currently known. The use of the C-
MAC
®
video laryngoscope is contraindicated if, in the opinion of a responsible physician, the
health of the patient is endangered by its use, for example, due to the patient's general
condition, or if laryngoscopy as such is contraindicated.
2.3 Target user populations
The C-MAC® Videolaryngoskop may only be used by persons with an appropriate medical
qualification and who are acquainted with the laryngoscopy technique. The information in
these instructions for use is intended only to instruct in the correct handling, cleaning and
sterilization of the C-MAC® Videolaryngoskop, and is not suitable as an introduction to
laryngoscopy technique. The use of the C-MAC
®
video laryngoscopes must be used in
accordance with the airway algorithm in the respective country of application or the official
specifications for airway management.
2.4 User qualifications
Only physicians and medical support staff with a relevant specialist qualification and who have
received training on the product may use the product. Only persons with appropriate specialist
training may provide training. The user profile includes the following features:
– Recognized medical qualification of the user (specialist physician, qualified medical staff)
– Adequate powers of comprehension to rationally assess the current surgical situation
– Adequate language skills in the languages used in the instructions for use
– Be thoroughly trained in the operation and use of the medical device
– Knowledge of the contents of the instructions for use
– No physical impairments that could diminish perception of activation and alarm signals
(visual and acoustic)
2.5 Safety precautions when using the C-MAC
®
video
laryngoscope
The C-MAC
®
video laryngoscope must be used according to the medical rules and procedures
recognized for laryngoscopy.
The C-MAC
®
video laryngoscope has been successfully tested on helicopters BK 117 B2,
EC 135 and EC 145 for electromagnetic compatibility according to DRF EMI Test REPORT
(Rev. C).
The C-MAC
®
video laryngoscope as well as the C-MAC
®
Monitor 8402 ZX have been
successfully tested on the RTCA/DO-160F (Section 21).
The C-MAC
®
video laryngoscope as well as the C-MAC
®
Monitor 8402 ZX have been
successfully subjected to a fall and crash test.
