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.
• • • to a tag. The loss of tag function may result. Due to possible interference, the system should be separated by at least 1 meter from an active Electrosurgical Unit (ESU). The system should be checked for normal operation to ensure there is no interference present. Do not dispose of packed sponges from a previous surgical case into the SmartBucket. Sponge counts may not reconcile properly. No part of the ClearCount SmartSponge System is user serviceable. The system contains no user replaceable fuses.
SECTION PAGE Preface ............................................................................................................................ i-ii Chapter 1: System Description ....................................................................................... 1-1 Count In Scanner ............................................................................................... 1-1 Count Out Bucket & Wand Components ...........................................................
Chapter 1: System Description •••••• The SmartSponge® System is used in an operating room to detect and identify tagged surgical items for the purpose of reconciling surgical counts. The system employs radio-frequency identification (RFID) technology to detect ClearCount SmartSponge surgical sponges and towels. The system combines the benefits of counting and detection of surgical items (sponges, gauze, and towels) used during a surgical case.
Table 1-1 Count In Scanner Components Component Description Scanner Tray The area on which sponges and towels are to be placed when scanning them into a surgical case. Proximity Sensor This sensor detects the presence of items introduced to the Scan In Location automatically activating the Scanner Tray. Display Displays updated information for the user to track sponge counts throughout the surgical procedure. Also displays various modes of operation.
Figure 1-2 Count Out Bucket Components Handle • • • • • 1-3 • Table 1-2 Count Out Bucket Components Component Description Used to move the SmartSponge System. Also positioned to protect the Count In Scanner and display from damage. Count Out Bucket Scans out and contains the discarded sponges and towels after their use in surgery. Wand Holder Used to mount the SmartWand to the SmartSponge System when not in use.
Display and Function Control Buttons The display, function control buttons, and volume buttons are the user’s interface to the SmartSponge System.
Table 1-3 Display/Controls Display / Controls • • • • • 1-5 • Description Display LCD that provides information to the user regarding operation of the system. Volume Control Buttons These up and down buttons control the volume of the audible alert. The Volume of the alert can be set to four different levels and off with each button. Function Control Button [1] Allows the following actions; On - Turns the system on from Standby Mode. Off Returns the system to Standby Mode.
SmartSponge Disposables The SmartSponge System utilizes surgical sponges and towels that have been “tagged” with an RFID identification device. This RFID tag is smaller than a dime and does not contain a battery. Because each sponge contains a tag with unique identification, the SmartSponge system can quickly and accurately count and identify each sponge. Surgical sponges are provided for surgery in two forms: pre-packaged surgical kits (Figure 1-4) and individual sterile packages (Figure 1-5).
Table 1-4 SmartSponge Disposables and Accessories Accessory Override Card A Smart Card used by the appropriate staff member to enable an unreconciled case to be closed. SmartTag A sticker applied between the sheets of the OR table prior to surgery, which allows the user to ensure that the SmartWand is operational.
Smart Tags SmartTags are passive RFID labels that have an adhesive backing. See Figure 1-6. Prior to surgery, a SmartTag is positioned under the surgical site between the sheets on the OR table. Figure 1-7 shows a typical position of the SmartTag on the OR table. This tag, working together with the SmartWand, provides feedback to the system that the SmartWand has scanned through the depth of the patient’s body.
SmartWand The SmartWand provides a fast and accurate patient scan for retained sponges. The handle of the circular shaped wand, shown in Figure 1-8, has two LEDs to give the operator feedback from the scan. The Green LED will begin to blink when WAND Mode is entered. When the SmartWand detects the presence of a SmartTag the Green LED will stay illuminated; this also triggers a notification on the display.
Wand Cover A sterile wand cover is used when the patient needs to be scanned with the SmartWand. The cover is passed into the sterile field and then applied to the SmartWand as it is handed in. Figure 1-9 shows the wand cover package. Figure 1-9 Sterile Cover for Smart Wand (outside of surgical kit) Override Card The SmartSponge System requires the user to acknowledge the closure of an unreconciled surgical case.
Chapter 2: Initial Setup and Operation •••••• Chapter 2 describes the initial setup of the SmartSponge® System.
Initial Setup Powering on the SmartSponge System The following procedure describes how to set up the SmartSponge System before each surgical case. Before its initial use, a technician will unpack, set up, and check the system to ensure it is functioning properly. If problems with the system occur later during its use, call ClearCount Medical Solutions. After the SmartSponge System has been set up, place it in the desired position in the Operating Room (OR) and lock the rear casters.
Placing the SmartTag Before the start of a surgery, a SmartTag must be placed under the patient. Figure 2-2 shows a SmartTag and its placement. The SmartTag is an adhesive sticker that contains a radio-frequency identification (RFID) tag. This tag provides feedback to the SmartSponge System that the SmartWand is reading through the depth of the patient when a scan is performed. Figure 2-2 SmartTag Placement During pre-surgery setup, proceed as follows: Step 1 Peel the backing from the SmartTag.
Boot-up Screens After the on/off switch is set to on (|), the Starting screens shown in Figure 2-3 appear. Starting Screen The Starting Screen, shown at the top of Figure 2-3, appears on the display first for 10 seconds after the on/off switch is set to on. Boot Screen The Boot Screen, which follows the Starting Screen appears for 3 seconds. Shown in the center of Figure 2-3, this screen shows the version of system firmware and the device (SmartSponge System) identification (ID).
Starting Screen Boot Screen Diagnostic Screen Figure 2-3 • • • • • 2-5 • Boot-up Screens Chapter 2: Initial Setup and Operation - Initial Setup
Standby Mode Following the startup screens, the Standby screen appears, and the system enters Standby Mode. The system may be left in this state when not in use. The Standby Mode of operations is the starting point for operating the SmartSponge System. The system can remain in this mode for as long as necessary while you prepare for surgery. The SmartSponge System enters the standby mode under the following conditions: • • • When the system powers up, it automatically enters the Standby Mode.
Setting Up for Surgery With the system in position, and the SmartTag placed between the sheets on the OR table, you are ready to prepare the sponges and other supplies necessary for surgery. The SmartSponge System uses both individually packaged sterile sponges, as well as sponges in pre-packaged surgical kits. The procedure for using one type versus the other is slightly different, as noted below. Using Pre-Packaged Surgical Kits Step 1 • • • Step 2 Locate and open the surgical kit.
Operations Count Mode Operation Count Mode is the primary mode of operation for the SmartSponge System. It is used for scanning sponges into and out of the case during surgery. The SmartSponge System remains in the Count Mode until the surgery is complete and the sponge counts have been reconciled. While in the Count Mode, the display is continually updated on the number of sponges scanned into and out of the case. To enter the Count Mode, press the ON button while in the Standby Mode.
The IN column lists the number of items that have been scanned into surgery. The OUT column lists the number of items that have been discarded into the Count Out Bucket. The FIND column lists the number of items not reconciled by the system. A green check mark appears if the number of items scanned into surgery is equal to the number of items discarded into the Count Out Bucket. If the number of items in the IN and OUT columns are not equal, a red X will appear.
Scanning Items Into and Out of Surgery Warning! • Holding items too close to the Count Out Bucket 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. For the system to function, use only ClearCount disposables. Do not place packed sponges from a previous surgical case into the Count Out Bucket. This will cause the sponge counts to not reconcile properly.
Requesting Final Item Count Reports When placed in the Final Report Mode, the system provides final sponge counts for the surgery. Before ending the case, verify that the quantities displayed in the IN and OUT columns on the Count Mode screen are equal, and a green check mark appears next to them. See Figure 2-5. The green check mark indicates that the count is reconciled.
Obtaining the Final Report: Counts Not Equal If counts are not reconciled when you press the FINAL REPORT button, the Counts Not Equal screen appears. If items are intentionally withheld from the Count Out Bucket for procedural or clinical reasons, alert a nursing manager or an OR manager, and note this discrepancy on the patient’s record. The SmartSponge System requires that the user acknowledge the closure of an unreconciled case. This is accomplished by using the override card.
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 2-8 will then appear. 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.
Wand Mode Operation The SmartWand may be used to scan patients for retained SmartSponge System sponges and towels at any point during the surgery. Onscreen instructions guide the user on performing a patient scan. If the SmartWand detects a retained item(s) in a patient, the red indicator on the wand flashes and the screen displays the type and quantity as shown in Figure 2-10. The SmartWand performs best when passed over the patient in a slow, steady fashion, no faster than 0.
Warning! • Using the SmartWand without a sterile wand cover may contaminate the sterile field. Scanning Procedure 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.
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(1-5) in order to most accurately identify potential retained sponges.(Figure 2-11) If the wand detects an item retained in a patient, the red light on the wand flashes, and the Wand Mode screen displays the type and quantity of the item(s).
Notes • Remove instruments from the surgical site prior to scanning with the SmartWand. • Before removing the SmartWand from the sterile field, the user should return the • • • • • system to Count Mode to reduce the chance of inadvertently detecting items in the path of the wand. While in Wand Mode do not set the wand on large metal surfaces. If this occurs, remove the wand from the surface and give the system 20 seconds to readjust.
Chapter 3: Cleaning and Maintenance •••••• This chapter includes a post-surgery cleaning procedure for the SmartSponge System. Also included is information regarding routine maintenance of the system. Before cleaning the system or performing maintenance on it, check that: • • The SmartSponge System is off The system is unplugged from its 120 VAC power source Notes • No disassembly is required prior to cleaning.
Cleaning Instructions Collect the following supplies for cleaning the SmartSponge System: • • • Disposable cloths Rubber gloves Sporicidin brand disinfectant or equivalent hospital-grade disinfectant. (Follow the manufacturer’s instructions regarding the duration of contact time for specific biological contaminants.) Cleaning the System 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.
Maintenance ClearCount recommends that routine maintenance be performed on the SmartSponge System according to the following schedule: Frequency Required Action Responsible Party After each surgical case Follow the cleaning procedure. User Prior to each use Visually inspect the SmartWand’s cord and power cord for fraying and signs of wear. Also check for cracks or other damage to system components.
Chapter 4: Troubleshooting •••••• This chapter describes the alerts, warnings, and system failures that can occur while operating the SmartSponge System. This chapter is divided into the following sections: • • • • General troubleshooting System Alerts System Warnings System Failures Each section contains a list of the error conditions, possible causes for each condition, and suggested actions to help you resolve the situation.
General Troubleshooting This section contains general troubleshooting information to help you resolve issues that may arise while operating the SmartSponge System. SmartSponge System Will Not Turn On CAUSE: ACTION: Power cord is not plugged into the SmartSponge System or wall outlet. Ensure that both ends of the power cord are plugged in. Power cord is damaged. Call ClearCount Medical Solutions for replacement cord. Power is not available at power outlet.
System Indicates Wand Failure CAUSE: ACTION: Wand has been placed on or near a metal surface. Move wand away from metal, and allow 20 seconds for the wand to adjust. Wand is experiencing interference from other Move the wand away from the interfering equipment, or surgical equipment. wait until the equipment is no longer in use. Wand cable has become detached. Connect wand cable. Wand cable is damaged or kinked. Call ClearCount Medical Solutions for a replacement.
System Alerts System Alerts are temporary warning messages of which you should be aware to ensure proper operation of the SmartSponge System. Once the condition causing the alert has been corrected, the case will continue. Figure 4-1 Example System Alert Message Screen Bad Pack CAUSE: ACTION: The system is unable to scan the sponge pack. Flip or rotate sponges before rescanning the pack. If rescanning does not correct the condition, discard bad pack and resume use with a new one.
Bag Overflow Warning - Bucket Limit Has Been Exceeded - Remove Sponges to Continue CAUSE: ACTION: There are over 75 sponges in the Count Out Bucket. Remove sponges or discard the full bag and replace with a new liner - sponge counts will not change. Multiple Packs CAUSE: ACTION: The system is unable to scan in multiple packs Ensure that only one pack of sponges is being scanned at the same time. in at a time. Pack Already Scanned CAUSE: ACTION: The sponge pack has already been counted.
System Warnings System Warnings are serious conditions that have been caused by misuse of the SmartSponge System. To correct a system warning condition, remove the full bag of sponges, place a new liner on the Count Out Bucket, and power cycle the system. Figure 4-2 Example Warning Message Screen System Reset - Bucket Limit Has Been Exceeded - Remove Sponges and Power Cycle the System CAUSE: ACTION: There are 100 or more sponges in the Count Out Bucket.
System Failure A system failure is a serious condition that will cause the SmartSponge System to stop working. If you receive a system failure message: • • • Contact ClearCount Medical Solutions for service, Provide service with the numeric error code, and Power down the system. The system should not be used again until it has been serviced.
Appendix: Technical Specifications •••••• SmartSponge® System Dimensions Figure A-1 SmartSponge System - Model A02 Weight - 96 lbs (44 kg) • • • 5-1 • • •
Power Requirements Power supply: 120 - 240 VAC, 50/60 Hz, 60 W Power consumption: 0.
EMC Considerations The ClearCount SmartSponge System needs special precautions regarding Electromagnetic Compatibility (EMC), and must be installed and put into service according to the EMC information provided in this manual. Portable and mobile RF equipment can affect the ClearCount SmartSponge System. Compatibility of cables, transducers, and other accessories: Not applicable.
Table 202 – Guidance and Manufacturer’s Declaration – Immunity All Equipment and Systems Guidance and Manufacturer’s Declaration – Immunity The ClearCount SmartSponge System Model A02 is intended for use in the electromagnetic environment specified below. The customer or user of the SmartSponge System Model A02 should ensure that it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment – Guidance Floors should be wood, concrete or ceramic tile.
Table 204 – Guidance and Manufacturer’s Declaration – Emissions Equipment and Systems that are NOT Life-supporting Guidance and Manufacturer’s Declaration – Emissions The ClearCount SmartSponge System Model A02 is intended for use in the electromagnetic environment specified below. The customer or user of the ClearCount SmartSponge System Model A02 should ensure that it is used in such an environment.
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
Table 206 – Recommended Separation Distances between portable and mobile RF Communications equipment and the ClearCount SmartSponge System Model A02 Equipment and Systems that are NOT Life-supporting Recommended Separations Distances for the SmartSponge System Model A02 The ClearCount SmartSponge System Model A02 is intended for use in the electromagnetic environment in which radiated disturbances are controlled.
Device Label Figure A-2 Device Label Read instructions prior to use Type B equipment Non-ionizing radiation • • • • • 5-8 • Appendix: Technical Specifications - Device Label