Safety
Instruction For Use • C-MAC
®
Video Laryngoscope 8403xxx and Connection Cable 8403X • 96076019EN-US •
V4.3
12
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.
ð
This is not applicable to U.S. market.
4.6 Risks from electric current
If several products supplied with energy are used simultaneously, the patient leakage currents
accumulate. These leakage currents can exceed the limit values and injure patients.
Only use products of the same type, for example, endotherapy device and application part
of type CF.
4.7 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
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.
4.8 Damaged products
Damaged products can result in injury to patients, users, and third parties.
Before every use, check all components of the product for damage.
Do not use damaged products.
4.9 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).
4.10 Damage to the instrument
– The C-MAC
®
video laryngoscopes may not be cleaned in an ultrasound bath.
