Integra LifeSciences Syringes, Dental Self-Aspirating - Manual

Description
Integra ™ Miltex ® Self-Aspirating Syringes are used in conjunction
with a needle and a 1.8cc pre-filled anesthetic cartridge
(not supplied by Integra™ Miltex®). Aspirating syringes are available
in Type CW (Cook-Waite) and Type A (Astra). The syringes are
reusable and are provided clean and supplied non-sterile.
Indications
Integra ™ Miltex ® Self-Aspirating Syringes are indicated to be used in
conjunction with anesthetic needles and anesthetic cartridges for
injection of anesthetic solutions in the oral cavity.
Contraindications
None known.
Warnings
• To avoid needle sticks, re-cap needle after injection
has been given.
• To avoid leakage during an injection, ensure that needle is
straight as it penetrates the cartridge diaphragm.
Precautions
• Syringes must be sterilized prior to use. See sterilization
instructions.
• Hubs cannot be removed. Do not attempt to remove hub
from syringe for sterilization or for any reason as damage to
the syringe will occur.
• Do not mix metals when sterilizing syringes. Sterilizing syringes
with other non chrome-plated brass instruments may cause
damage to syringes.
• Do not use cold sterilants, as they will react to the chrome
plating of the syringe.
• Keep needle capped while affixing or removing from syringe.
• Aspiration should be performed prior to injection to reduce
the chance of intravascular injection. If blood is aspirated,
reposition the needle until no blood is aspirated. Absence of
blood in the syringe is not a definitive indication that an
intravascular injection will not occur. Proper aspiration is
dependent upon professional knowledge and experience
with use of the device.
Instructions
Loading Instructions
1. Retract piston rod fully.
2. Insert 1.8cc cartridge, plunger end first, into syringe barrel.
3. Hold cartridge firmly in place.
4. Affix needle to aspirating syringe.
5. Expel a few drops of solution to clear needle.
6. Aspiration occurs during injection whenever pressure on thumb
rest is released.
Unloading Instructions
1. Remove needle from syringe.
2. Withdraw piston rod to clear cartridge for removal.
3. Tilt syringe to expel cartridge.
Cleaning Instructions
• For best and long service life, syringes should be processed
according to Integra™ Miltex® Care and Cleaning guidelines.
• Remove all traces of blood, saliva, and anesthesia solution.
• Remove paraffin that has accumulated on the harpoon.
Sterilization Instructions
• Syringes are supplied non-sterile and must be sterilized
prior to each use.
• Syringes should not be sterilized with other instruments to
avoid syringe damage.
• Before each use, sterilize and inspect instrument. Sterilize
syringes according to an approved National/International
Standard. Integra™ Miltex® syringes have been tested with
no adverse effects under the following sterilization parameters
in a standard, gravity steam, sterilizer:
- Temperature: 250ºF (121ºC)
- Exposure Time: 30 minutes
- Dry Time: 20 minutes
• Do not use cold sterilants, as they will react to the chrome
plating of the syringe.
Symbols
Symbols may be used on some package labeling for easy identification.
Integra and the Integra logo are trademarks of, and Miltex is a registered
trademark of, Integra LifeSciences Corporation or its subsidiaries.
©2011 Integra LifeSciences Corporation. All rights reserved.
DENTSLFASPDFU Rev. B 06/13
EC REP
Manufacturer
Authorized Representative
in the European Community
Catalog number
Lot number
Caution: see warnings or precautions
Product complies with requirements of directive
93/42/EEC for medical devices
Federal (USA) law restricts this device to sale by or
on the order of a physician or practitioner
Consult instructions for use and website address
Integra LifeSciences Services (France) SAS Immeuble Sequoia 2
97 allée Alexandre Borodine
Parc Technologique de la Porte des Alpes
69800 Saint Priest–France
Telephone: 33 (0) 4 37 47 59 10
Fax: 33 (0) 4 37 47 59 29
EC REP
Manufacturer
Integra York PA, Inc.
i 589 Davies Drive, York, PA 17402 USA
866-854-8300 USA i 717-840-2763 outside USA i 717-840-9347 fax
integralife.com/integra-miltex
ENGLISH
Integra
™
Miltex
®
Dental Self-Aspirating Syringes
Directions for Use