User's Manual
Table Of Contents
- system manual.pdf
- system manual.pdf
- system manual.pdf
- Chapter 2
- Chapter 2: Initial Setup and Operation
- Initial Setup
- Powering on the SmartSponge System
- Step 1 Connect the system to a grounded, 120 VAC power outlet, using the power cord supplied.
- Step 2 Check that the other end of the power cord is securely plugged into the power entry module of the system.
- Step 3 Set the power (|/O) switch shown in Figure 2-1 to the | (on) position, and observe that a series of power-up screens briefly appears on the display.
- Figure 2-1 Location of On/Off Switch
- Figure 2-2 SmartTag Placement
- Figure 2-3 Boot-up Screens
- Standby Mode
- Figure 2-4 Standby Screen
- Step 1 Locate and open the surgical kit. Within the kit, locate the following components:
- Step 2 Move the system as close as possible to the sterile field.
- Step 3 Using an Aseptic technique, cover the Count In Scanner and display with the Count Out Bucket liner. Make sure the scanner and display are completely covered. Proceed to scan sponges and towels into the surgical case.
- Step 1 Locate the following components:
- Step 2 Install the liner into the CountOut Bucket. Proceed to scan sponges and towels into the surgical case.
- Figure 2-4 Standby Screen
- Operations
- Scanning Items Into and Out of Surgery
- Step 1 Scan packages of SmartSponge surgical sponges and towels into the surgical case by holding them flat on the Scanner Tray over the area marked Touch Here to Scan. A message Scanning In appears on the screen when items are placed on the Scanner ...
- Step 2 After sponges are scanned in, they may be passed into surgery using standard sterile technique. ClearCount SmartSponges are to be used in the same manner as generic surgical sponges.
- Step 1 When all items used in the surgery have been discarded into the Count Out Bucket, press the FINAL REPORT button on the Count Mode screen.
- Step 2 Enter the case number in the patient’s record.
- Step 3 Press the END CASE button to close the surgical case and the Ending Case screen appears. When the case has been closed, the system returns to the Standby Mode.
- Step 4 Remove the bag liner that contains the discarded sponges from the Count Out Bucket. Dispose of the bagged items according to the standard protocol for your hospital.
- Step 5 Clean the entire SmartSponge System according to the procedure in Chapter 3 before entering it into the next surgical case.
- Figure 2-6 Final Report Screen: Counts Equal
- Figure 2-7 Final Reports Screen: Counts Not Equal
- Step 1 Press the OVERRIDE button at the bottom of the display.
- Step 2 The responsible party for the Admin card will need to be sent for or on hand. Then scan the Admin card by placing it onto the Count In Scanner and holding it there until you hear an audible alert. The Verified by Admin screen shown in Figure 2...
- Step 3 Enter the case number in the patient’s record.
- Step 4 By pressing the OVERRIDE button again, the Ending Case and the Powering Down screens will appear. The system then displays the Standby screen and waits to start a new case.
- Figure 2-8 Counts not Equal Verified By Override Screen
- Powering on the SmartSponge System
- Wand Mode Operation
- Figure 2-9 Wand Mode Screen
- Step 1 Remove the SmartWand from its holder below the Count In Scanner and free its cable.
- Step 2 Cover the SmartWand with a sterile cover using a standard sterile technique while passing the wand into the sterile field.
- Step 3 Press the WAND MODE button on the Count Mode screen to activate the wand. The Wand Mode screen shown in Figure 2-10 will then appear.
- Figure 2-10 Wand Mode Screen
- Step 4 Using the handle, hold the SmartWand over the site where the SmartTag has been placed. A green indicator on the wand flashes and the screen displays the message Scan Range Confirmed. This message confirms that the wand is reading completely th...
- Step 5 Slowly scan the patient from head to toe moving at a rate of 0.2 meters a second (7 inches/sec), holding the SmartWand 1 to 3 inches above the patient. Follow the onscreen instructions shown in figure 2-10. It is important to do all the scans(...
- Figure 2-11 Patient Scan Procedure
- Step 6 When the patient scan is complete, press the COUNT MODE button to return to the Count Mode screen. If a retained item was found, place the item into the SmartBucket.
- Step 7 Remove the SmartWand from the sterile field. Remove the sterile cover and discard it according to the standard protocol.
- Step 8 Return the SmartWand to its holder and the cable to the cord wrap.
- Figure 2-9 Wand Mode Screen
- Chapter 3
- Chapter 3: Cleaning and Maintenance
- Cleaning Instructions
- Step 1 Unplug the power cord from the power entry module.
- Step 2 Pre-clean surfaces by removing any contaminants with a damp cloth and wiping them dry.
- Step 3 Wipe the entire length of the cord with Sporicidin disinfectant.
- Step 4 Wipe down the entire system; including the display, the Count In Scanner, all four sides of the Count Out Bucket (inside and outside), the SmartWand, its cable and holder, and all four casters with Sporicidin disinfectant.
- Step 5 After wiping down the system, rinse it with a water-dampened cloth.
- Maintenance
- Chapter 4
- Appendix
- Appendix: Technical Specifications
- Operating Temperatures:
- Transport and Storage Temperatures:
- Guidance and Manufacturer’s Declaration - Emissions
- Emissions Test
- Compliance
- Electromagnetic Environment – Guidance
- Guidance and Manufacturer’s Declaration – Immunity
- Immunity Test
- IEC 60601 Test Level
- Compliance Level
- Electromagnetic Environment – Guidance
- Guidance and Manufacturer’s Declaration – Emissions
- Immunity Test
- IEC 60601 Test Level
- Compliance Level
- Electromagnetic Environment – Guidance
- Recommended Separations Distances for the SmartSponge System Model A02
- system manual.pdf
- rear cover
i
Preface
Indications for Use
The ClearCount Medical Solutions SmartSponge® System is indicated for use in
counting and recording the number of RFID-tagged surgical sponges, laparatomy
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 System:
• Use only one SmartSponge System during a surgical procedure.
• 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 System outside of the sterile field, unless it is properly
covered.
• Place only ClearCount disposables in the SmartBucket.
• The sterility of disposables is guaranteed only for unopened, undamaged packages.
Disposables are for single use only; do not re-use or re-sterilize disposables.
• Do not cut or tear SmartSponge disposables, as the RFID tags might become
separated.
• When scanning items contained in a surgical kit (bundles of items not in their own
sterile packages) into the SmartSponge System, cover the head of the system with
the sterilized bucket liner from the surgical kit. This prevents non-sterile
contamination of the items being scanned in.
• Using the scanning wand without a sterile wand cover could contaminate the sterile
field.
• Holding items close to the SmartBucket may result in items being added to the Count
Out column prior to disposal. Dispose of any items into the SmartBucket without
using them if the Count Out Bucket has detected them prior to use.
• Disposables should not be left inside the patient’s body for more than 24 hours.
• Do not subject patients to an MRI with SmartSponge disposables still inside the
patient.
• Tags may become damaged by surgical lasers. Do not apply a surgical laser directly