Eligible Patient Group; Patient Selection Criteria / Contraindications; Indications For Use; Users - Mectron Piezosurgery Plus Gebrauchs- Und Wartungsanleitung

WARNING: Qualified and specialised
personnel. This device and its accessories
may only be used by specialised personnel
such as a surgeon with proper medical
culture; no training activities are foreseen

1.2.1 Eligible Patient Group

PIEZOSURGERY plus, equipped with handpieces (PIEZOSURGERY medical and PIEZOSURGERY
medical +) and inserts, is designed to be used with the following patient population:
• Infants;
• Children;
• Adolescents;
PIEZOSURGERY plus, equipped with handpieces (PIEZOSURGERY medical and PIEZOSURGERY
medical +) and inserts, can be used on any patient of any age, weight, height, gender and
nationality.

1.2.2 Patient Selection Criteria / Contraindications

The use of PIEZOSURGERY plus, equipped with handpieces (PIEZOSURGERY medical and
PIEZOSURGERY medical +) and inserts, is not recommended in the following cases:
1. Patients with active implantable medical
devices (for example: pacemakers, hearing
aids and/or other electromagnetic
prostheses) without the prior
authorization of their doctor;
2. Women who are pregnant or
breastfeeding, due to the restrictions
associated with the possible use of
medical solutions such as anaesthetics
3. Patients with allergies;
4. Patients with pathologies or clinical
conditions for which it is not
All models of Mectron bone surgery devices, with their accessories, are intended for
professional use only. Therefore, the user is the only person able to decide if and how to treat
their patients.

1.2.3 Indications for Use

PIEZOSURGERY plus, equipped with handpieces (PIEZOSURGERY medical and PIEZOSURGERY
medical +) and inserts, is suitable for all the appropriate patients (see chapter above) for whom
a bone surgery treatment is prescribed, by the treating physician, within the intended use of
the device (see Chapter 1.1 on page 2

1.2.4 Users

PIEZOSURGERY plus, equipped with handpieces (PIEZOSURGERY medical and PIEZOSURGERY
medical +) and inserts, must be used only by specialised and properly trained personnel, such
as a surgeon physician, able-bodied adults of any weight, age, height, gender and nationality.
for the use of the device and of its
accessories. If correctly used, this device
and its accessories causes no side effects.
Improper use, on the other hand, will
transmit heat to the tissues.
• Adults;
• Elderly.
recommended to perform surgery or for
which it may represent a contraindication
according to the treating physician.
These conditions may include, but are
not limited to: heart disease, diabetes,
cirrhosis, HIV infection, pregnancy
or breastfeeding, radiation therapy,
chemotherapy, immuno-suppressive
therapy, allergies and psychiatric
disorders;
5. Patients with unsuitable treatment sites.
).
INTROdUCTION
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