User's Manual

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Preface
Indications for Use
The ClearCount Medical Solutions SmartSponge
®
Basin is indicated for use in counting and
recording the number of RFID-tagged surgical gauze, laparotomy sponges, and towels used
during surgical procedures. It also provides a non-invasive means of locating retained
radio-frequency identification (RFID)-tagged surgical sponges, towels, and other tagged
items within a surgical site.
Warnings
The following list of warnings applies to the SmartSponge Flex:
• Use only one SmartSponge Flex during a surgical procedure.
• Do not dispose of sponges from a previous surgical case into the Count Out Basin.
Sponge counts may not reconcile properly. Use only sponges from the current surgery.
• Do not use the system in the presence of a flammable anesthetic mixture with air, or with
oxygen or nitrous oxide.
• For the system to function, use only ClearCount disposables.
• Keep the SmartSponge Flex outside of the sterile field, unless it is properly covered.
• Place only ClearCount disposables in the Count Out Basin.
• The sterility of disposables is guaranteed only for unopened, undamaged packs.
Disposables are for single use only; do not re-use or re-sterilize disposables.
• Do not cut or tear ClearCount disposables, as the RFID tags might become separated.
• When scanning items contained in a sterile surgical kit (bundles of items not in their
own sterile packs) into the SmartSponge Flex, cover the system with the sterilized liner
from the surgical kit. This prevents contamination of the items being scanned.
• Using the wand without a sterile wand cover could contaminate the sterile field.
• Holding items that have been scanned in too close to the Count Out Basin may result
in these items being added to the Out column of the inventory (detected) prior to use
and disposal. Dispose of any items into the Count Out Basin without using them if they
have been counted out prior to use.
• Disposables should not be left inside the patient's body for more than 24 hours.