Q: Is there a tool to analyze usage on the Safe Label System?

A: Yes, the Data Analytics tool is available on SLS. Contact Codonics for more information.

Q: Where is Safe Label System available?

A: Safe Label System is available worldwide.

Q: Is Safe Label System FDA compliant?

A: The system is an FDA Class II device, K101439

Q: Is Safe Label System designed for medical usage?

A: Yes, the system was designed for use anywhere medications are prepared. It includes a medical grade (safety compliant) power supply and has been designed such that it can be cleaned with disinfectants without any risk of damage to the system.

Q: Are the labels created by Safe Label System compliant with current National Patient Safety Goals (NPSG) of The Joint Commission?

A: Yes, the labels contain all elements required by the National Patient Safety Goals of The Joint Commission (TJC) and the American Society of Anesthesiologists (ASA) color guidelines. Labels are also compliant with ISO standard 26825.

Q: Does Safe Label System support Tallman lettering?

A: Yes, the labels are configurable by each site and can be customized including Tallman lettering. Additional information on Tallman lettering can be found at ismp.org.

Q: Can labels printed on Safe Label System be written on with a standard ball point pen?

A: Yes, the labels can be written on with ball point pens and felt tip pens. No special pen is required.

Q: What elements can be included on the labels created by Safe Label System?

A: The labels are properly color coded according to the ASA guidelines (and ISO standard 26825). The labels may include:

• Medication name (with configurable tallman lettering) and concentration
• Dilutions and diluents
• Preparation time/date
• Expiration time/date
• Identification of the preparer
• Site-specific warnings and messages.
• Site’s address, billing code or hospital ID

Q: What other types of labels can be printed with Safe Label System?

A: Safe Label System can print labels for IV lines, invasive monitors, patient sample labels and other custom operating room needs on-demand. The labels are configurable by the site.

Q: What is the barcode printed on SLS labels used for?

A: The barcode on prepared medications can be used to integrate into an Anesthesiology Information Management System (AIMS), a Bar Coded Medication Administration system (BCMA) or a broader hospital information system such as an EHR.

Prior to administration to the patient, the barcode on the prepared medication can be scanned at SLS enabling a safety “triple-check” to avoid syringe swaps. When a clinician scans the prepared syringe on SLS, the system speaks and displays the drug name and concentration as well the time remaining until the syringe expires.

SLS-WAVE, when combined with Safe Label System as a total solution for the OR, is a robust and highly accurate “hands-free” scanner that integrates with Epic Anesthesia and Plexus Anesthesia Touch. Situated conveniently within the anesthesia workflow, SLS-WAVE can be affixed to the Epic monitor or an IV pole, keeping the patient within reach. On the way to the port, the clinician simply waves the barcode of an SLS prepared syringe (or most prefilled syringes) past SLS-WAVE and the NDC data is electronically passed to the AIMS/EHR workspace, significantly improving workflow. Simultaneously, the drug name and concentration are visually displayed to ensure safety and prevent syringe swaps.  This process greatly increases the accuracy of NDC data to improve charge capture and decrease inventory discrepancies, and – for the first time – extends BCMA to the operating room to close the loop.

Q: What are the benefits of using the Safe Label System with an AIMS?

A: Additional safety features available when integrated with an AIMS include:

• Automatic identification of each syringe to be administered
• Warnings for expired syringes
• Warnings for syringes previously used on other patients
• Warnings for patient allergies or adverse drug interactions
• Added safety, inventory accuracy, charge capture, billing and 340B initiatives

Q: Will Codonics provide the barcode information to different AIMS companies or is it exclusive to Codonics partners?

A: Codonics will provide the barcode information and sample labels to AIMS, BCMA and EHR companies upon request to enable system integration.

Q: Can the Safe Label System’s formulary database be customized for specific hospital formularies?

A: Yes, Safe Label System includes a customizable formulary database. This database can be customized to specify all of the details of the label (name to be displayed, concentration, Tallman lettering, drug-class color, etc.).

Q: Who manages Safe Label System’s formulary database?

A: The architecture of the Safe Label System is similar to that of a SmartPump. We expect that all sites will assign a pharmacist or drug librarian to manage the database just like they do for their SmartPumps.

Q: Does Safe Label System’s formulary support pre-defined combinations of drugs?

A: Yes, Safe Label System can support combinations of drugs. These must be defined in the system’s formulary and a custom barcode must be defined for the combination.  If a cocktail (combination drug) is prepared “on the fly”, then a blank label must be prepared and completed by the clinician.

Q: How is Safe Label System’s formulary database updated?

A: The formulary database in Safe Label System may be updated remotely via the network, or manually by inserting a USB drive containing the update into each unit.

Q: What is the barcode reader on Safe Label System^® used for?

A: The barcode reader on the system is used to scan the barcode on drug vials and ampoules. The barcode tells Safe Label System all of the pertinent information on the drug including manufacturer, manufacturing location, date, etc.  This information is used by Safe Label System to prepare a label and is used to identify recalled and/or expired drugs prior to preparation.

Prepared syringe labels can also be scanned prior to administration to identify drug name, expiration and the time remaining until the syringe expires.

Q: What happens if a drug vial is scanned on Safe Label System that is not in the formulary?

A: Safe Label System will alert a user visually and audibly that the drug is classified as a DRUG NOT FOUND. SLS will allow the user to print a blank label that can be completed by hand and used for labeling the syringe. If Email Notifier is enabled, an email will be sent to the system administrator(s). See Email Notifier FAQ.

Q: What is the speaker on Safe Label System used for?

A: The system audibly presents messages for drug name, concentration and warnings.

Q: Is the speaker volume on Safe Label System adjustable?

A: Yes, the speaker volume can be adjusted or muted.

Q: Is the backlight on Safe Label System adjustable?

A: Yes, the backlight’s brightness can be adjusted.

Q: What are the dimensions of Safe Label System?

A: The system is approximately 16 inches deep, 10 inches wide and 14 inches high to the top of the touch-screen.

Q: How much does Safe Label System weigh?

A: The system weighs approximately 14 pounds.

Q: Can Safe Label System^® be mounted on a cart or anesthesia boom?

A: The system has been designed for mounting on carts and booms. Codonics sells a variety of shelves and arms for the system.  In addition, the base of the system has a VESA-compliant  mounting pattern so that standard mounts can be used.  Additional information on VESA can be found at www.vesa.org.

Q: What kind of printing technology does Safe Label System use?

A: The system uses thermal drop-on-demand ink jet technology with dye-based inks.

Q: What types of consumables are required for Safe Label System?

A: The system uses two consumables, a multi-color ink cartridge and a label roll. The ink cartridge should last approximately one month depending upon the colors used (typical usage is 10 labels per procedure, 6 procedures per day, 5 days per week).  The label roll contains 1,000 labels.

The labels used in the system are specially designed to comply with stringent medical guidelines and requirements.  The labels have a plastic base so that they do not tear and can be dipped in alcohol and other liquids without degradation in image quality.  In addition, they have a special adhesive that ensures that they do not peel or curl for at least 24 hours.

Q: How will the user know that the consumables on Safe Label System are low?

A: The system will tell the user that the ink is low on the user interface with a Warning message and then will provide another message, as well as not print labels, when empty. The label rolls have a color mark on the label’s leader indicating that the media is low when only a few days’ supply is left.  This is similar to the indications used on a cash register.

Q: Is there a cutter in Safe Label System to support cutting and dropping of the labels?

A: Yes. This is a standard feature of the product.

Q: What is the standard warranty for Safe Label System?

A: The system includes a 1-year return-to-factory warranty. Extended warranties and upgrades to a SWAP warranty are available.

Q: Can Safe Label System be managed over a network?

A: Yes, the SLS can be managed over a network. The site must have Administration Tool 1.3 .0 or later installed and all SLS systems to be managed must have the same version of software installed on each of them.  An optional Wi-Fi interface is also available from Codonics.

Q: What network interfaces does the Safe Label System support?

A: An Ethernet interface is standard on each SLS. An optional Wi-Fi interface is also available. Contact Codonics for further details.

Q: Can both the Ethernet and Wi-Fi network interfaces be active simultaneously on Safe Label System?

A: Yes. Both interfaces can be configured and used at the same time.  However, only one interface should be used at a time because the Device Manager in the Administration Tool is usually set up with only one IP address per system.

Q: Can I buy an off-the-shelf USB Wi-Fi interface for Safe Label System?

A: No. SLS is a medical device with hardware and software designed and validated by Codonics.  Only use Codonics-supplied hardware and software.  Use of unauthorized hardware or software will invalidate Codonics warranty and support.  A Feature Key is required to enable the Wi-Fi interface on SLS.

Q: Can Safe Label System report a problem over the network?

A: Yes. The Email Notifier program and the Device Manager on the Administration Tool can be used to monitor the status of SLS systems on the network.

Q: Can I run Safe Label System’s Administration Tool from my home network?

A: Yes. The Administration Tool can usually be used from home to access SLS systems in a hospital if you have a VPN connection to the hospital network.  Performance will probably be slower, but network operations between the Administration Tool and SLS will work.

Q: How does the Email Notifier work?

A: Email Notifier is provided by Codonics via a Feature Key that can be installed on any Windows-based computer or server in the facility. Email Notifier can be configured to monitor any or all the SLS units in the facility. A Feature Key is required on each SLS to allow the Email Notifier to access events on that SLS.  Emails of important SLS events are sent to any user or set of users.

Q: Can I control what is in email messages and how often they are sent out?

A: Yes. The list of events, email addresses and frequency of sending events are configurable.  When multiple events occur, a user receives all the events in a single email.

Q: Can I receive notifications on my SmartPhone or tablet?

A: Yes. Event notifications can be sent to any email account including accounts that are received on portable devices like an iPhone, Android phones and tablets like the iPad.

Q: Are network transfers to Safe Label System fast?

A: Yes. A typical formulary package is significantly less than 50MB and can be transferred from the Device Manager on the Administration Tool to the SLS in a couple of minutes.  A network with many SLS systems can deploy a formulary to 50+ systems in less than 1 hour.  If the hospital network is very busy, it may require more time.

Q: Can I manage multiple Safe Label System^®s from one Administration Tool?

A: Yes. The Device Manager on the Administration Tool can handle hundreds of SLS systems.

Q: Can multiple Administration Tools talk to the same Safe Label Systems at the same time?

A: Yes. While there are practical considerations when multiple users are deploying formularies to the same SLS units, the SLS and Administration Tool were specifically designed to allow multiple copies of the Administration Tool to monitor and control SLS systems concurrently.

Q: Will installing a new formulary interrupt a doctor using the Safe Label System?

A: No. Formularies will only be installed when no users are logged into the system.  If a user is logged in, the formulary will be received and stored by SLS until the user logs out.  After the user logs out, the front panel will provide a notice that a formulary is going to be installed and give the user a chance to defer the installation.

Q: Will I know if a formulary successfully installed on an Safe Label System?

A: Yes. The Email Notification program can be configured to alert you of successful or failed formulary installations.  Also, the Device Manager on the Administration Tool can be used to check the version of the formulary on all SLS devices.

Q: Will Safe Label System continue to function if the network connection is lost?

A: Yes. SLS is designed to run without a network connection. The network is primarily used to simplify installation of formularies and provide centralized monitoring of SLS units. A network connection is not required to use SLS.

Q: Will the AT Device Manager tell me if the network connection is lost?

A: Yes. The Device Manager on the Administration Tool will indicate any SLS unit that is not responding on the network.  The software, formulary and configuration version information will not be displayed while the unit is not accessible on the network.

Q: Is an external scanner available for Safe Label System so that I can scan items that are too large to put under the scanner?

A: Yes, an optional tethered hand scanner is available from Codonics^® for SLS (requires software release 1.4.0 or newer) that will allow the user to scan with either the integrated or external scanner.

Q: Is it possible to scan the syringes labeled with Safe Label System before the medication is administered in order to confirm the correct syringe was selected?

A: Yes, with Administer Mode, an optional feature (requires software release 1.4.0 or newer and an Administer Mode feature key) the user can scan a label prepared on SLS and the system will present the user with the drug name and concentration as well as check the expiration status of the syringe. In addition, SLS-WAVE, when integrated with Epic Anesthesia or Plexus Anesthesia Touch and other AIMS systems that support barcode scanning can read the SLS syringe label barcode prior to administration to confirm the correct syringe was selected.

Q: Can I use the labels prepared on Safe Label System with a BCMA system?

A: Yes, labels prepared with SLS can be used with BCMA systems. The 2D bar code label contains the NDC number of the medication and systems like Epic’s 2010 release (and newer) can be configured to read the bar code.  Other systems will require that the labels include a 1D NDC-like bar code on the label.  This can be read by most legacy BCMA systems.