Safety Considerations; Safety Hazard Symbol Notice; Equipment Misuse Notice; Notice To Users And/Or Patients - Arthrex Lift-Assist AR-1627 Instrucciones De Uso

INSTRUCTIONS FOR USE

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 user of the device shall first contact your supplier for guidance on safe
disposal protocols.

Operating the system:

1.5.1

Applicable Symbols:

Symbol used
Document Number: 80028274
Version: A4
All manuals and user guides at all-guides.com
DO NOT USE IF PRODUCT SHOWS VISIBLE DAMAGE AND MATERIAL
DEGRADATION.
Description
Indicates the device is a medical device
Indicates the medical device manufacturer
Indicates the manufacturer's serial number.
The device serial number is encoded as
1YYWWSSSSSSS.
Page 7
Reference
MDR 2017/745
EN ISO 15223-1
EN ISO 15223-1
Issue Date: 15 APR 2020
Ref Blank Template: 80025118 Ver. D