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Instructions for Use | Carilex® VT • One
Iortant notes for safe use
ualication reuireents on te iene staff
When using the device, the disinfection and cleaning must be carried out on the
product or parts only by appropriately qualied personnel, who are familiar with
the relevant hygiene regulations.
ailailit of te instructions for use
The Instructions for use are an integral part of the device and must be stored
in a place so that the safety instructions and other important information are
accessible at any time and can reviewed by the users.
Do not pass the device to a third party without these Instructions for use. Using
the ID number and the edition date as a guide always ensure that a current and
valid Instructions for use document is supplied with the device.
urose of te eice
The device meets all the requirements of a medical device class IIa comply with
93/42/EEC and class II comply with 21 CFR 878.4780. To ensure the security of
patients and users, the device can only be used for its intended use.
Intene use
Carilex® VT • One is indicated for patients who benet from wound management
therapy via the application of negative pressure wound therapy for removal of
fluids and excess exudates, infectious material, and tissue debris, which may
promote wound healing.
The
VT • One suction therapy unit is indicated on use with patients with the
following wounds:
• Traumatic
• Dehisced wounds
• Partial-thickness burns
• Chronic wounds including pressure ulcers, diabetic foot ulcers and venous leg
ulcers
• Acute wounds
•
Flaps and grafts
OT
This product is for use only by individuals who have been adequately trained in
use of NPWT devices and who have had medical training in wound care. Operating
this device or changing the setting should only be done under order of a physician
or other qualied clinical caregiver.
iene easures
Oliation to roie inforation
Intended use
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