Intended Use; Explanation Of Symbols - WALLACH PAPETTE 908000-1 Manual De Instrucciones

Read all safety information and instructions listed below before using this product!
CAUTION: U.S. Federal law restricts this device to sale by or on the order of a physician.

INTENDED USE

•
For Cervical Cytology utilizing the ThinPrep® Pap Test™
•
The PAPETTE is the most gentle, yet effective means of simultaneously taking both ectocervical and
endocervical cell samples.
INSTRUCTIONS
1. Contact the cervix with the PAPETTE and insert the central bristles into the cervical canal deep enough to allow
the shorter bristles to fully contact the ectocervix.
2. While maintaining gentle pressure in the direction of the cervix, rotate the brush 5 times in a clockwise
direction.
3. Rinse the brush into the PreservCyt
the bottom of the vial 10 times, forcing the bristles apart. Swirl the brush vigorously to further release material.
Discard the collection device.
4. Tighten the PreservCyt
®
5. Dispose of PAPETTE in accordance with local Medical Hazardous Waste practices.
.
PAPETTE® U.S. Patent #4,700,713
Trademarks: ThinPrep® and PreservCyt® are registered trademarks of Cytyc Corp.

EXPLANATION OF SYMBOLS

Attention, see instructions for use
Do not use if pouch has been opened or damaged
Batch Code
LOT
Expiration Date
Single-Use Only
REF
Reorder Number
Symbol for Method of Sterilization Using Ethylene Oxide
For Professional Use Only
Storage Temperature (max 30ºC / 86ºF: min 10ºC / 50ºF)
CE Mark (for medical devices only) made in accordance
with 93/42/EEC medical devices directive
Authorized European Representative: Leisegang Feinmechanik GmbH
®
PAPETTE Cervical Cell Collector (STERILE)
utilizing the ThinPrep® Pap Test™
REF 908000-1
0086
solution for use with the ThinPrep
®
vial cap so that the torque line on the cap passes the torque line on the vial.
Leibnizstrasse 32
D-10625, Berlin, GERMANY
Pap Test™ by pushing the brush into
®
Surgical Devices
95 Corporate Drive, Trumbull, CT 06611 USA
Tel: (203) 799-2000 • Fax: (203) 799-2002
IMMS028-1 • Rev. A • 1/09 Side 2