Indications For Use; Device Description; Device Characteristics - Codonics Safe Label System 550I Handbuch

Indications for Use

Device Description

Drug preparation and administration in the perioperative environment are integral
aspects of anesthesiologist's patient care responsibilities. The Codonics Safe Label System (SLS)
is a simple, integrated system utilizing a barcode scanner to read and confirm drug identity
from FDA NDC (National Drug Code) and other drug ID Barcodes from drug containers and
automatically print labels for prepared drugs and other items in use on patients during surgical
procedures. The labels are compliant with national regulations focused on improving
medication safety in the perioperative environment.
The software components provide functions for scanning container barcodes; creating,
reviewing, and approving the hospital-managed promotion of a formulary database;
displaying on-screen and audibly confirming drug type; and printing ISO, ASTM, and TJC (The
Joint Commission) content- and color-compliant labels with 1D and/or 2D barcodes. The system
reads drug container barcodes and produces water resistant, color labels. The system can be
integrated to function with an Anesthesia Information Management System (AIMS) workflow to
provide real-time documentation of drug administration when the syringe 1D or 2D barcode is
read. The system can be accessed and managed via a network (Ethernet or Wi-Fi).

Device Characteristics

The use of drug class specific pattern and color per ASTM D4774 and ISO 28625
Specifications for User Applied Drug Labels in Anesthesiology is configurable by site and
dataset. Formularies (datasets) are uniquely named configurations that may differ in drugs,
colors, dilutions, and comments to accommodate different practices within a
single site or hospital (for example, pediatric versus cardiac).
Additional uses include producing labels for IVs and other artifacts used during a surgical
procedure.
The Codonics SLS is generally placed in, however not limited to, the perioperative
environment to identify syringes prepared for anesthesiology use during surgery.