Foreword; Scope Of Application; Contraindications; Intended User - Eighteeth E-FLOW User Manual

3 Foreword

3.1 Scope of application

E-FLOW is intended for use only in subcutaneous or intramuscular
injections of local anesthetic agents for dental applications. It should not be
used for intravascular (IV) or other routes of administration.
This device must only be used in hospital environments, clinics or dental
offices by trained and qualified dental personnel and not used in the oxygen-
rich environment.

3.2 Contraindications

Intraligamentary injections are contraindicated in patients with active
periodontal disease.

3.3 Intended user

This device should be used only by practitioners who are familiar with, and
observe applicable labeling regarding the use of local anesthetic agents for
dental applications.
Read the following warnings before use:
 The device should be used in combination with oral local anesthetic and sterile
single use injection needle
 The cartridge of anesthetic shall be 1.7ml or 1.8ml bottle in accordance with
ISO 11499, and the needle shall be sterile single use injection needle in
accordance with ISO 7885.
 The device must not be placed in humid surroundings or anywhere it can come
into contact with any type of liquids.
 Do not expose the device to direct or indirect heat sources. The device must
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