Codonics SLS550i User manual

Table of Contents
EN - English .............................................................................................................................................. 10
Components........................................................................................................................................... 26
Unpacked Components ..................................................................................................................... 26
Front Components................................................................................................................................ 27
Components Inside Front Cover....................................................................................................... 28
Rear Components................................................................................................................................. 29
Touch Screen Components ............................................................................................................... 30
Wi-Fi Adapter USB Port ......................................................................................................................... 31
Hardware Setup..................................................................................................................................... 32
Ethernet Cable (Optional).................................................................................................................. 32
Wi-Fi Adapter (Optional)..................................................................................................................... 33
Power, SmartDrive................................................................................................................................. 33
Startup ...................................................................................................................................................... 35
Loading Media ...................................................................................................................................... 36
Installing the Ink Cartridge.................................................................................................................. 37
Loading Label Media........................................................................................................................... 38
Login.......................................................................................................................................................... 39
Making a User Badge........................................................................................................................... 40
Logging In................................................................................................................................................ 40
Touch Screen User Interface.............................................................................................................. 42
Printing a Syringe Label —Basic Use ............................................................................................... 43
Printing a Syringe Label —Advanced Operations...................................................................... 46
Matching Container IDs ...................................................................................................................... 46
Mapped Master IDs (USA Only)......................................................................................................... 47

Drug Verification.................................................................................................................................... 47
Monitoring Status................................................................................................................................... 48
Dashboard Status Information........................................................................................................... 48
System Information ............................................................................................................................... 48
Maintenance.......................................................................................................................................... 49
Displaying the Utilities Screen............................................................................................................. 49
Clearing a Label Jam .......................................................................................................................... 51
Clearing a Label Jam in the Front Media Guide................................................................................. 51
Clearing a Label Jam in the Rear Media Guide.................................................................................. 52
Installing Update Packages ............................................................................................................... 53
Shutdown and Power Off ................................................................................................................... 55
Troubleshooting ..................................................................................................................................... 56
LT - lietuvių kalba................................................................................................................................... 57
Komponentai.......................................................................................................................................... 74
Išpakuota Komponentai ..................................................................................................................... 74
Priekis Komponentai ............................................................................................................................. 75
Komponentai Viduje Priekis Viršelis................................................................................................... 76
Galinis Komponentai............................................................................................................................ 77
Palieskite Ekranas Komponentai....................................................................................................... 78
Bevielis internetas Adapteris USB Port.............................................................................................. 79
Aparatinė įranga Sąranka.................................................................................................................. 80
„Ethernet“ Kabelis (Neprivaloma).................................................................................................... 80
Bevielis internetas Adapteris (Neprivaloma) ................................................................................. 81
Galia, „SmartDrive“ .............................................................................................................................. 81
Pradėti ...................................................................................................................................................... 84

Įkeliama Žiniasklaida............................................................................................................................. 84
Diegimas Rašalas Kasetė................................................................................................................... 85
Įkeliama Etiketė Žiniasklaida............................................................................................................... 87
Prisijungti................................................................................................................................................... 88
Gamyba a Vartotojas Ženklelis ......................................................................................................... 88
Prisijungimas Į .......................................................................................................................................... 89
Palieskite Ekranas Vartotojas Sąsajae ............................................................................................. 91
Spauda a Švirkštas Etiketė - Pagrindinis Naudokite ..................................................................... 91
Spauda a Švirkštas Etiketė - Išplėstinė Operacijos ....................................................................... 94
Derinimas Konteineris Asmens tapatybės dokumentai.............................................................. 94
Žemėlapis Meistras Asmens tapatybės dokumentai (JAV Tik) ................................................. 95
Vaistas Patikrinimas............................................................................................................................... 95
Stebėjimas Statusas .............................................................................................................................. 96
Prietaisų skydelis Statusas Informacija ............................................................................................. 96
Sistema Informacija .............................................................................................................................. 97
Priežiūra .................................................................................................................................................... 97
Rodoma Komunalinės paslaugos Ekranas.................................................................................... 97
Kliringas a Etiketė Uogienė ................................................................................................................. 99
Kliringas a Etiketė Uogienė į Priekis Žiniasklaida Vadovas............................................................. 99
Kliringas a Etiketė Uogienė į Galinis Žiniasklaida Vadovas........................................................... 100
Diegimas Atnaujinti Paketai ............................................................................................................. 101
Išjungti ir Galia Išjungta ...................................................................................................................... 103
Problemų sprendimas ........................................................................................................................ 104
LV - latviešu valoda ............................................................................................................................ 106
Komponenti .......................................................................................................................................... 123

Izpakots Komponenti.......................................................................................................................... 123
Priekšpuse Komponenti ..................................................................................................................... 124
Komponenti Iekšā Priekšpuse Piesegt ........................................................................................... 125
Aizmugurē Komponenti..................................................................................................................... 126
Pieskarieties Ekrāns Komponenti..................................................................................................... 127
Bezvadu internets Adapteris USB Port............................................................................................ 127
Aparatūra Uzstādīt.............................................................................................................................. 128
Ethernet Kabelis (Neobligāti)........................................................................................................... 128
Bezvadu internets Adapteris (Neobligāti).................................................................................... 129
Jauda, SmartDrive .............................................................................................................................. 130
Uzsākt...................................................................................................................................................... 132
Notiek ielāde Mediji............................................................................................................................ 133
Instalēšana Tinte Kārtridžs ................................................................................................................ 134
Notiek ielāde Etiķete Mediji.............................................................................................................. 135
Pieslēgties .............................................................................................................................................. 137
Izgatavošana a Lietotājs Žetons...................................................................................................... 137
Mežizstrāde In....................................................................................................................................... 137
Pieskarieties Ekrāns Lietotājs Saskarnee ........................................................................................ 140
Drukāšana a Šļirce Etiķete - Pamata Izmantot ........................................................................... 140
Drukāšana a Šļirce Etiķete - Papildu Operācijas........................................................................ 143
Saskaņošana Konteiners ID............................................................................................................... 143
Kartēts Meistars ID (ASV Tikai) .......................................................................................................... 144
Narkotika Pārbaude........................................................................................................................... 144
Uzraudzība Statuss............................................................................................................................... 145
Mērinstrumentu panelis Statuss Informācija................................................................................. 145

Sistēma Informācija ............................................................................................................................ 146
Apkope .................................................................................................................................................. 146
Attēlošana Komunālie pakalpojumi Ekrāns................................................................................ 146
Notīrīšana a Etiķete Ievārījums......................................................................................................... 148
Notīrīšana a Etiķete Ievārījums iekšā Priekšpuse Mediji Vadīt..................................................... 148
Notīrīšana a Etiķete Ievārījums iekšā Aizmugurē Mediji Vadīt...................................................... 149
Instalēšana Atjaunināt Iepakojumi................................................................................................. 150
Izslēgt un Jauda Izslēgts..................................................................................................................... 152
Problēmu novēršana.......................................................................................................................... 153
MT - Malti................................................................................................................................................ 155
Komponenti .......................................................................................................................................... 172
Mhux ippakkjat Komponenti............................................................................................................ 172
Quddiem Komponenti....................................................................................................................... 173
Komponenti Ġewwa Quddiem Għatti......................................................................................... 174
Wara Komponenti............................................................................................................................... 175
Tmiss Skrin Komponenti ...................................................................................................................... 176
Wifi Adapter USB Port ......................................................................................................................... 176
Ħardwer Setup ..................................................................................................................................... 177
Ethernet Cable (Mhux obbligatorju).............................................................................................. 177
Wifi Adapter (Mhux obbligatorju)................................................................................................... 178
Qawwa, SmartDrive ........................................................................................................................... 178
Ibda......................................................................................................................................................... 181
Tagħbija Midja...................................................................................................................................... 182
Installazzjoni il Linka Skartoċċ........................................................................................................... 182
Tagħbija Tikketta Midja...................................................................................................................... 184

Safe Label System®
Drug Labeling Solution
EN - English
Documentation Notice
This document is part of the EU MDR requirements. The Codonics Safe Label System® Product is a
Class I medical devices intended for use by Healthcare Professionals. Product packaging and labeling,
including Graphic User Interface (GUI) for operation are offered in English and meet MDR, Annex I,
Chapter III, 23.4, taking account the training and the knowledge of the potential user.
Web information, Key Specifications, Intended Use, User Manual Appendices, Quick Start Guide and
Setup IFU (Instructions for use) are available in basic translation for Member State Languages. Primary
IFU are available in English.
Codonics Products are Class I products intended for use by Healthcare Professionals.
Products packaging and labeling, including Graphic User Interface (GUI) for operation are
Offered in English and meet MDR, Annex I, Chapter III, 23.4, taking account the training and the
knowledge of the potential user.
*Web information, Key Specifications, Intended Use, User manual Appendix, Quick Start Guide & Setup
IFU are available in simple translation Member State Languages; primary IFU are available in English
Overview:
Codonics Safe Label System SLS 550i Point of Care Station (PCS) is the standard of care in the world’s leading hospitals.
An award-winning FDA Class II medical device, the system improves the safety and accuracy of medication
management and labeling compliance anywhere medications are prepared. In the OR, SLS integrates with anesthesia
medication carts to electronically identify the drug in hand. Visual and audible confirmation based on the NDC of the
vial/ampoule provides clinicians with a real-time safety check that acts as a second set of eyes, helping to eliminate the
most prevalent medication errors. On demand, SLS produces a ready-to-apply TJC-compliant label that includes a
barcode that captures the NDC from the parenteral vial for integration at administration with Epic and Cerner. When
used in conjunction with Codonics SLS-WAVE, this process electronically documents the patient record ‘hands-free’ to
improve charge capture, billing accuracy and 340B compliance, creating standardization and
enabling BCMA in the OR.
Safe Label System:
Integrates with existing workflows, adding TJC compliance and pharmacy oversight at every location where on-demand
medications are prepared, such as the OR, ICU, PACU, patient floors and pharmacy
Provides clinicians with electronic medication safety checks while increasing productivity

Allows hospital-approved drugs, diluents, concentrations, and total dose/total volume preparations to be integrated
with worldwide recognized best practices and international standards in a formulary managed by pharmacy and
available at the fingertips of anyone
preparing medications
Captures the exact NDC of the parenteral vial and carries it to the prepared label to provide 100% accurate
documentation for charge capture and 340B accountability
Can be managed remotely including software updates and provides status feedback to specified users via the
Administration Tool and Email Notifier (optional)
When used in conjunction with SLS-WAVE, the complete solution enables ‘hands-free’ integration with Epic and Cerner
to maximize revenue, improve patient outcomes and clinician workflow by reducing manual clicks
Improve Patient Safety
Errors in preparation and selection as well as documentation inaccuracies occur for a number of reasons. Multiple
distractions, poor handwriting and look-alike /sound-alike drugs greatly contribute to the potential for medication errors.
SLS embraces the call to improve patient and medication safety by:
Reduces the most common drug errors made during the selection, preparation and administration of injectable and
intravenous medications in the OR, including vial/ampoule swaps, mislabeling/illegible labeling, syringe swaps and
expired syringes
Meets the ISMP and APSF recommendations that every anesthetizing location should have a mechanism to identify
medications before drawing them up or administering them (barcode reader)
Automatically presents clinicians with visual and audible confirmations of each drug and concentration, incorporating
electronic safety checks to remove the element of human error
Specifications
System: Integrated touch screen computer, 2D barcode scanner, color ink jet printer, audio feedback and network
capable
(Ethernet standard, Wi-Fi optional)
Power: Universal Input: 100-240 VAC, 50/60 Hz
Dimensions: 10.43 “ (26.5 cm) W, 15.67“ (39.8 cm) D, 16.50 “ (41.9 cm) H
Weight: 14.5 lbs. (6.6kg)
Regulatory: Full medical device compliance including Class 2 FDA and Class I MDR 2017/745/EU (CE), GMP/QSR, ISO
13485:
2016/NS-EN ISO 13485:2016, Electrical Safety IEC 60601-1 Ed. 3.1 and EMC/EMI: FCC Class A and IEC 60601-1-2: Ed. 4 for
Professional Healthcare Facilities
Readable Barcodes: Code 128, GS1-128, Data Matrix, UPC-A, UPC-E, EAN-13, EAN-8,
GS1 DataBar Family, Interleaved 2 of 5, ITF-14, Code 39, Code 32,
ISBT 128, QR Code
Writable Barcodes: Data Matrix, EAN-13/UPC-A

SLS User Manual
Preface
Conventions Used in This Manual
Bulleted Lists
Bullets are used to display a list of nonprocedural items. For example:
The following events trigger a synchronization of SLS data to that stored on the
SmartDrive:
Automatically every 15 minutes
Formulary updates
Numbered Steps
The icon indicates the beginning of a procedure. The steps in a procedure are
numbered. For example:
Open the front cover.
Press the Ink button.
Notes
Notes contain additional information related to a topic or procedure. For example:
NOTE: The system will ensure that a test print is performed at least once a day.
Cautions and Warnings
Cautions alert you to actions or situations that could cause harm to equipment or data.
For example:
Warnings alert you to actions or situations that could result in personal injury. For
example:
Important Information and Filenames
Bold type is used for emphasis, user interface object names, and paths or filenames.
For example:
The Barcode Scanner scans drug container barcodes for identity and verification.
Use the controls to correct the date and time, then press the OK button.

Purpose and Scope
Refer to this User’s Manual for procedures on how to perform Safe Label System (SLS)
user operations, including:
Setting up the hardware and software
Performing basic functions such as logging in and out, and configuring some
System settings (for example, sound volume, brightness)
Printing and confirming syringe labels
Checking drug syringes by scanning their barcodes
Maintaining the system
Monitoring system status and troubleshooting common problems
Product Information
For technical assistance with SLS Point of Care Station, call Codonics Technical
Support at the following number:
Phone: [phone]
Toll Free: 800.444.1198 (USA only)
Technical Support is available 24/7/365. Technical Support is also available online via
email and the Codonics web site:
Email: [e-mail]
Web Sites: www.codonics.com
General product information can also be requested by sending email to:
Email: [e-mail]
Please include your postal mailing address and telephone number in the email message.
Basic product information is returned via email unless otherwise requested.
Warnings and Limitations of Use
Location of Safety and Compliance Labels
Codonics is in compliance with various regulations.
The SLS PCS safety and compliance label, shown below, is located on the bottom of the device
(shown on the following page).

Voltage Warning
The exclamation point within a triangle is intended to alert the user to the presence of
important operating and maintenance (servicing) instructions in the literature
accompanying this device.
REFER SERVICING TO QUALIFIED SERVICE PERSONNEL. REMOVAL OF LABELS,
COVERS, OR ENCASEMENT FASTENERS MAY VOID THE WARRANTY.
THIS APPARATUS MUST BE ELECTRICALLY GROUNDED.
TO PREVENT FIRE OR SHOCK HAZARD, DO NOT EXPOSE THIS DEVICE TO RAIN OR
MOISTURE.
EQUIPMENT IS NOT TO BE USED AS A COMPONENT OF A LIFE SUPPORT SYSTEM.

Life support devices or systems are devices or systems that support or sustain life, and
whose failure to perform can be reasonably expected to result in a significant injury or
death to a person. A critical component is any component of a life support device or
system whose failure to perform can be reasonably expected to cause the failure of the
life support device or system, or to affect its safety or effectiveness.
Laser Warning
WARNING This device emits CDRH/IEC Class 2 laser and IEC Class 1M light. Do not stare
into beam.
Serial Number, Configuration, Date Code, and Modification
Codes
The serial number label is placed onto the safety and compliance label.
The serial number label includes the following information:
The serial number (SN), which uniquely identifies the unit.
The configuration number (CN), which details the build configuration.
The modifications codes, which are to the right of the CN number and are a
series of 20 numbers. When any of these numbers are blocked out, that identifies a
modification that was made to the unit.
Potential for Radio Frequency Interference on Device Operation
Both portable and mobile RF communications equipment can affect medical electrical
equipment, including SLS PCS. SLS PCS is intended for use in the electromagnetic
environment specified in the guidance and manufacturer’s declaration section.

Potential for Radio and Television Interference
SLS PCS generates and uses radio frequency energy, and if not installed and used
properly, that is, in strict accordance with the manufacturer’s instructions, may cause
interference to radio and television reception. It has been type tested and found to
comply with Class A emission limits for a computing device in accordance with the
specifications in Subpart J of Part 15 of FCC Rules, which are designed to provide
reasonable protection against such interference when operating in a commercial
environment. SLS PCS is not intended for use in a residential Class A environment.
SLS PCS requires a medical power/ground. If your SLS does cause interference to radio or
television reception, you are encouraged to try to correct the interference by one or more of
the following measures:
Reorient the receiving antenna
Relocate SLS PCS with respect to the receiver
If necessary, you should consult Codonics Technical Support or an experienced
radio/television technician for additional suggestions. You may find the following booklet
prepared by the Federal Communications Commission helpful: How to Identify and Resolve
Radio-TV Interference Problems. This booklet is available from the U.S. Government Printing
Office, Washington, D.C. 20402, Stock No. 004-000-00345-4.
This product is in conformity with the protection requirements of EC Council directive
MDR 2017/745/EU(CE) on the approximation of the laws of the Member States relating to
medical devices. This product satisfies the Class A limits of IEC 60601-1-2 for Professional
Healthcare Facilities and CISPR 11. A declaration of conformity with the requirements of the
Directive has been signed by a Codonics vice president.
Guidance Regarding Electromagnetic Emissions and Immunity
Suitable environments are as follows:
SLS550i is intended for use in hospital and clinical environments including operating
rooms and the perioperative environment.
SLS550i has not been evaluated for use near HF surgical equipment. If use near HF
surgical equipment is desired, the user is responsible for verifying proper operation
of the SLS550i. If SLS550i does not perform correctly in this environment, move the
SLS550i farther from the source of the electromagnetic disturbance.
SLS550i has not been evaluated for use in emergency medical vehicles or in residential
applications.

NOTE: The radio frequency emissions characteristics of this equipment make it suitable for use
in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for
which CISPR 11 class B is normally required) this equipment might not offer adequate
protection to radio-frequency communication services. The user might need to take mitigation
measures, such as relocating or re-orienting the equipment.
As a support device, SLS550i does not provide essential performance.
WARNING Use of this equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary, this equipment
and the other equipment should be observed to verify that they are operating normally.
WARNING Use of accessories, transducers and cables other than those specified or provided by
the manufacturer of this equipment could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and result in improper operation.
WARNING Portable RF communications equipment (including peripherals such as antenna cables
and external antennas) should be used no closer than 30 cm (12 inches) to any part of the
SLS550i, its cables, or accessories. Otherwise, degradation of the performance of this equipment
could result.
Electromagnetic Emissions Standards and Test Level

Electromagnetic Immunity Standards and Test Levels
Safety Precautions
•Never connect the device’s external power supply to any outlet or power supply that has a
voltage or frequency different than that specified (100 –240 VAC, 50/60 Hz). Use only the
external power supply provided with the device (Codonics part Number SLS-PS).
•When replacing the device, always power it down (refer to “Powering Off the System”) and
disconnect the AC power cord prior to servicing it.
•Damage to a power cord is a fire and shock hazard. When unplugging a power cord, hold it
by the plug only and remove the plug carefully.
•If a power cord or external power supply needs to be replaced, replace it only with another
Codonics power cord or Codonics external power supply. Alternatively, replace it with a
power cord or external power supply manufactured specifically for your power
configuration.

•If the device is smoking or making unusual sounds, power off and unplug the device
immediately.
•Do not insert foreign objects of any kind into the device; doing so can constitute a safety
hazard and cause extensive damage.
•Do not place any liquid containers on the device. If, for some reason, liquid seeps into the
device, power off the device and unplug the power cord from the source outlet. If used
without taking corrective measures, the device may be damaged.
•Do not expose the device to flammable gases in concentrations high enough to cause fire
or explosion.
Location Precautions
•The operating ambient temperature range of SLS PCS is 15–30ºC (59–86ºF), with a relative
humidity of 20%–80%.
•If SLS PCS is moved quickly from an extremely cold location to a warmer one,
condensation is likely to form. Do not use SLS PCS if condensation has formed.
•Wait until the condensation has evaporated. You can speed up the evaporation time by
moving SLS PCS to a dryer location.
•Do not place SLS PCS in a location with high humidity or high dust. Airborne dirt particles
can cause print quality problems. Avoid placing SLS PCS in locations where ventilation
ducts, open doors, or frequent passers-by might expose SLS PCS and labels to high levels
of debris.
•Do not locate SLS PCS in hot-springs areas where hydrogen sulfide and acidic ions are
likely to be generated.
•Do not locate SLS PCS where there are oily fumes and vapors.
•Do not locate SLS PCS in direct sunlight.
•Do not locate SLS PCS near sources of high RF energy.
•Do not locate SLS PCS where it might be subject to jarring or vibrations, such as a table or
desk in a high-traffic area. Jarring and vibrations can affect the print quality of labels.
•If using a VESA mount to mount the device on a wall, stand, or anesthesia supply cart,
refer to the VESA Mounting Interface Standard (MIS), available at www.vesa.org, for proper
location and installation information.
Cleaning Precautions
To avoid damage to the device, observe the following general precautions for cleaning
the device:
•Apply the cleaner to a clean, lint-free cloth first and then clean the device.
•Liquid applied directly to the device could possibly leak inside the device and cause
damage. Use extra caution when cleaning around the vents on the back of the
touchscreen and speaker.
•Allow the device to completely dry before operating it again.
•Many plastic components are used in SLS PCS construction. Coat flecking and
deformation is likely to occur if the device is wiped with chemical dusters, benzene,
thinners, insecticides, or other solvents. Rubber and PVC materials left in contact with

SLS PCS for extended periods of time will cause damage. Never use petroleum-based
solutions or abrasive cleansers.
•Never use abrasive material.
•Always dilute cleaning agents according to the manufacturer’s instructions, or use the
lowest possible concentration.
•Do not allow the cleaning agent to remain on the device surfaces. Wipe it off immediately
with a lint-free cloth moistened with water.
For cleaning instructions, refer to “Cleaning the Enclosure”.
It is recommended that you disinfect the product only when necessary as determined by your
hospital’s policy, to avoid long-term damage to the product.
The device must be cleaned first, as described in “Cleaning the Enclosure”, before using a
general disinfecting agent.
Cleaning the Enclosure
WARNING Always power off the system before cleaning. An electrical shock could occur if the
system is powered on and liquid is spilled into it.
To clean the system’s enclosure, use a clean, lint-free cloth moistened with either
warm water and mild soap, a diluted non-caustic detergent, or one of the following
approved cleaning agents:
Ammonia: Dilution of Ammonia <3%
Alcohol: Ethanol 70%, Isopropanol 70%.
•Over time, ink overspray might gather at the base of the device. The device uses a vacuum
system to gather most of this ink on a series of saturation pads.
•Eventually, these pads might need to be replaced. Contact Codonics Technical Support to
determine if pad replacement is necessary.
•If ink has gotten onto the system’s enclosure, it can be cleaned with an ammonia based
window cleaner and a lint-free cloth.
•If scanning barcodes is inconsistent or the device is having difficulty scanning, clean the
scanner’s glass window.
Disinfecting the Enclosure
Recommended disinfecting agents include:
1 part household bleach and 5 parts water solution
A-456-N

Virex II 256
PDI Sani-Cloth®
WARNING Codonics makes no claims regarding the efficacy of the listed chemicals or methods as
a means of controlling infection. Consult your hospital’s infection control officer or
epidemiologist.
Disinfecting Precautions
To avoid damage to the device, observe the following general precautions for disinfecting the
device:
•Do not use Povodine, Sagrotan, or Mucocit disinfecting agents or strong solvents (for
example, acetone).
•Do not use any disinfecting agents that corrode or damage polycarbonate.
Media Precautions
•Unwanted labels should be destroyed or disposed of to ensure that improper labels are
not used.
•Only use Codonics ink cartridges and labels to ensure proper operation of the device and
proper labeling of syringes. Using unapproved ink cartridges and labels could lead to
unacceptable results, including poor print quality and poor label adhesion to syringes.
•Damage from unapproved ink or labels will void the warranty.
•Never refill ink cartridges, as this can result in incorrect color usage.
Disposal Requirements
Disposal of this product and consumables shall be in accordance with all applicable laws and
regulations in effect at the locality at the time of disposal. For additional information, refer
Hazardous Material Information.
European Disposal Requirements
Codonics imagers and electronic accessory devices are not to be discarded or recycled;
rather they are to be returned to the manufacturer. Contact Codonics directly or by the
link provided for the latest information concerning:
Identification of the country-specific Importer/Distributor/Producer
Product return and treatment of our electronic products
Manufacturer: Codonics Inc.
17991 Englewood Drive
Middleburg Heights, OH 44130 USA
Phone: [phone]
Fax: [phone]
E-mail: [email protected]

www.codonics.com
Codonics electronic products and accessories bearing the following symbol are subject to
European Directive on Waste Electrical and Electronic Equipment (WEEE) 2002/96/EC,
amended by Directive 2003/108/EC. The EN 50419 symbol indicates separate collection and
return required.
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.
Typical users of this system are trained professionals, including but not limited to
physicians, nurses, and technicians.
The major characteristics and functions of the family of devices include:
•Scanning the drug container barcode directly from a vial or other type of container
•Decoding the manufacturer-issued barcode into the required FDA National Drug Code
(NDC) or Unique Drug Identifier (UDI) number
•Referring the NDC/UDI number to a site-managed formulary lookup database
•Providing audio and ISO-compliant visual “readback” of the drug name
•Providing an alert if the drug container is listed as “recalled/obsolete” in the site’s
formulary
•Printing an easy-to-read, water resistant ISO 26825 compliant color label meeting The
Joint Commission medication management standards and the American Society of
Anesthesiologists guidelines for labeling
•Providing the basic information by which the printed label barcode can be read to
document medication administration in an AIMS
•Printing labels with insertion and expiration date and time for IV lines
Device Indications for Use Statement: Prescription Use Device
The Codonics SLS PCS device and SLS software provides a simple computer-based barcode
scanning and printing system to automatically verify drug identity from NDC and other drug
container UDI barcodes, and to print labels for prepared drugs and other items in use on
patients during surgical procedures.
The Codonics SLS PCS is generally placed in, however not limited to, the perioperative
environment to identify syringes prepared for anesthesiology use during surgery. Additional
uses include producing labels for IVs and other artifacts used during a surgical procedure. SLS
PCS can also be used to print “non-surgical environment” color and text labels as required.
Typical users of this system are trained professionals, including but not limited to physicians,
nurses, and technicians.
CAUTION Federal law restricts this device to be sold for use by or on the order of a physician.
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