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Instruction for use
Q Path
NOVABRUSH
®
______________________________________________________________
According to Regulation (EU) 2017/745, Annex I, EN ISO 15223-1:2021 and EN ISO 20417:2021.
PRODUCT NAME
Catalogue Number
720-2067
720-2068
720-2070
720-2071
INTENDED PURPOSE
The Q Path NovaBrush family of devices are single-use cervical brushes intended for the collection of cells from the endocervix (Q Path® NovaBrush® 1) or from
the ecto- and endocervix (Q Path® NovaBrush® 2, 3 and 4).
These cells are subsequently fixed and assessed for morphological changes associated with cervical cancer using conventional or liquid-based cytology or subjected
to testing for human papillomavirus.
For professional use.
INDICATIONS AND CONTRAINDICATIONS
Indications
The Q Path® NovaBrush® 1, 2, 3 and 4 are indicated for the collection of endo- and ectocervical cells for subsequent conventional cytology, liquid-based cytology,
and human papillomavirus testing.
Contraindications
Q Path® NovaBrush® family is contraindicated for use on pregnant women after 10 weeks of pregnancy.
Potential side effects
No potential side effects.
Warnings and precautions
Brushes are intended for single use only. The re-use can be source of viral, bacterial, and fungal contaminations. Furthermore, the re-use of a
contaminated brush carries the risk of a false diagnosis.
Factors that may decrease the quality of the smear:
o
Menstruations, important losses of blood.
o
Infection and\or vaginal inflammation.
o
Severe genital atrophy (menopause).
o
Preliminary physical action or chemical irritation as:
Check that brushes are clean and without debris before use.
Collect the specimen according to the protocol.
Patient Population
The Q Path® NovaBrush® Family is intended to be used for adult female patients, including pregnant women before 10 weeks of pregnancy.
User Profile
The Q Path® NovaBrush® Family is intended for professional use by clinicians or other adequately qualified healthcare professionals.
Ref. RACE-U001-IFU02
DETACHABLE BRUSHES
®
Name, Description
Q Path® NovaBrush® 2, detachable
Q Path® NovaBrush® 2, detachable
Q Path® NovaBrush® 3, detachable
Q Path® NovaBrush® 3, detachable
Vaginal touch before the smear or the sexual intercourse within hours which precedent
Disinfecting liquid, lubricant.
Vaginal ovules (within the limits of 48 h).
Colposcopy with acetic acid (within the limits of 24 h).
Smear or cervical surgery in the 3 months.
Radiotherapy
1 / 3
For professional use only
English
Pack Size
Bag of 24 x 50
Unit bag x 500
Bag of 24 x 50
Unit bag x 500
Rev. 09, Date 2021-07
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