InterX 5002 Operations Manual
This manual provides information regarding the controls and functions of
the InterX 5002. The InterX 5002 must be used strictly in accordance with
these instructions. Further training is required to fully use the device and
obtain optimal patient treatment outcomes.
Indications for use
The InterX 5002 is indicated for:
• symptomatic relief and management of chronic intractable pain
• adjunctive treatment in the management of post-surgical and
post-traumatic pain
The InterX 5002 carries the European CE mark for pain relief.
InterX Technologies is an ISO 13485 Registered company.
Contact InterX Technologies for country specific information or additional
regulatory approvals.
Definition – Warning: A WARNING message contains special
safety emphasis and must be observed at all times. Failure to observe a
WARNING message could result in serious personal injury.
Definition –
Caution: : Failure to observe a CAUTION associated with
use could result in minor injury or product damage. Such problems
include device malfunction, device failure, damage to the device or damage
to other property.
3
Any serious incident that occurs in relation to the device should be reported
immediately to the manufacturer and the competent authority of the Member
State in which the user and/or patient is established.