Safety
Instruction For Use • C-MAC
®
video laryngoscope 8401xxx, Electronic Module 8401/8402 X, C-MAC
®
PM 8401
XD • 96076011EN-US • V3.1
9
4.
Functionality
Inspect products for visible contamination before use. Do not use contaminated products.
Reprocess the products before use.
Do not leave missing or broken-off components inside the patient.
3.6 Combination with other devices and accessories
Combinations of medical devices are only assured to be safe if
– they are identified as such in the respective instructions for use or
– the intended use and interface specifications of the devices used in combination permit
this.
The use of unauthorized devices and accessories or unauthorized changes to the product can
result in injuries.
Additional devices connected to electrical medical equipment must comply with the relevant
IEC or ISO standards (e.g. IEC 60950 for data processing equipment). Furthermore, all
configurations must comply with the requirements for medical electrical systems (see IEC
60601-1-1 or clause 16 of the 3rd edition of IEC 60601-1).
Anybody connecting additional equipment to medical electrical equipment is a system
configurator and is therefore responsible for the system's compliance with the standard
requirements for systems. Please note that local laws take priority over the above-mentioned
standard requirements. Should you have any queries, please contact your local specialist
dealer or the Technical Service (Standard/directive references: IEC 60601-1+A1+A2:1995:
6.8.2.c, 19.2.b, 19.2.c, IEC 60601-1:2005: 7.9.2.5, 8.1, 16.2.d, MDD 93/42/EEC: Annex I clause
13.6.c).
3.7 Damage to the instrument
– The C-MAC
®
video laryngoscopes may not be cleaned in an ultrasound bath.
– The C-MAC
®
video laryngoscopes may not be sterilized with steam.
3.8 Damaged products
WARNING
Risk of injury from damaged products
Before each use the outer surfaces of the parts of the laryngoscope and all the laryngoscopic
accessories which are to be inserted into the patient must be checked in order to ensure that
there are no unintentional rough surfaces, sharp corners or projecting parts which could
present a hazard to the patient.
3.9 Allergic reactions
C-MAC
®
laryngoscope blades contain a nickel compound and may cause nickel allergy in
predisposed individuals.
