Safety Considerations; Safety Hazard Symbol Notice; Equipment Misuse Notice; Notice To Users And/Or Patients - Skytron F-SLSKY Instrucciones De Uso

INSTRUCTIONS FOR USE

1.4 Safety Considerations:

1.4.1

Safety hazard symbol notice:

1.4.2

Equipment misuse notice:

Do not use product if package is damaged or unintentionally opened before use.
All modifications, upgrades, or repairs must be performed by an authorized specialist.
1.4.3

Notice to users and/or patients:

Any serious incident that has occurred in relation to the device should be reported
using the contact details provided in section 1.3 of this Instruction for Use and to the
competent authority of the Member State in which the user and/or patient is
established.
Note: Refer to the surgical table manufacturer's user guide for instructions on use.
Always refer to the surgical table manufacturer's weight limits.
NEVER EXCEED THE WEIGHT CAPACITY OF THE OPERATING ROOM TABLE
1.4.4

Safe disposal:

Customers should adhere to all federal, state, regional, and/or local laws and
regulations as it pertains to the safe disposal of medical devices and accessories.
If in doubt, the users of the device shall first contact their supplier for guidance on
safe disposal protocols.

1.5 Operating the system:

1.5.1

Applicable Symbols:

Symbol used
Document Number: 80024539
Version: B
DO NOT USE IF PRODUCT SHOWS VISIBLE DAMAGE AND MATERIAL
DEGRADATION.
Description
Indicates the device is a medical device
Indicates the medical device manufacturer
Page 7
Reference
MDR 2017/745
EN ISO 15223-1
Issue Date: 18 MAR 2020
Ref Blank Template: 80025118 Ver. E