Introduction
Information relating to intended use
1
VOLISTA
IFU 01781 EN 19
27 / 106
1.9 Information relating to intended use
1.9.1 Intended use
The VOLISTA range is designed to illuminate the body of a patient during surgical procedures,
diagnostics or treatment.
1.9.2 Indications
The VOLISTA range is intended to be used for any type of surgery, treatment or examination re-
quiring a specific type of lighting.
1.9.3 Intended users
• The device may be operated only by medical staff who have read this manual.
• The device must be cleaned by qualified personnel.
1.9.4 Inappropriate use
• Use as a secondary lighting system (a lighthead) if an interruption of the operation threatens
the life of the patient.
• Use of a damaged product (e.g. lack of maintenance).
• In a setting other than a professional healthcare environment (e.g. home care).
• Use of the camera for assistance during an operation or to establish a diagnosis.
1.9.5 Contraindications
This product does not have any contraindications.
1.10 Primary purpose
The primary purpose of the Volista surgical light is to illuminate the surgical site whilst minimising
the associated heat energy.
1.11 Clinical benefit
Surgical and examination lights are considered as complementary to invasive and non-invasive
treatment or diagnosis, and are essential to surgeons and healthcare staff for optimal vision.
The assistance they provide during surgical and examination procedures demonstrates their in-
direct clinical benefit. LED surgical lights offer several advantages over other technologies (e.g.
incandescent lighting).
When used appropriately, LED surgical lights will:
• Improve workspace comfort and visual performance by focusing the light where surgeons
and healthcare staff need it, while decreasing the heat released.
• Provide shadow management, which allows the medical staff to concentrate on surgery or
diagnosis.
• Offer improved lifespan, thereby reducing the risk of partial malfunction during surgery.
• Provide steady illumination throughout their use.
• Ensure accurate colour rendering of the various tissues illuminated.
1.12 Warranty
For details of warranty conditions, please contact your local Getinge representative.
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