About the AORN Seal of Recognition Program The AORN Seal of Recognition provides a visual representation and confirmation that the content of training and in-service programs has satisfied a review by AORN according to the AORN’s Perioperative Standards and Recommended Practices. The seal is intended to convey to end-users, customers and others that the content has met AORN standards.
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, 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.
• • • • Tags may become damaged by surgical lasers. Do not apply a surgical laser directly 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 sponges from a previous surgical case into the Count Out Bucket. Sponge counts may not reconcile properly.
Preface .............................................................................................................................................................i Chapter 1: System Description .................................................................................................................. 1-1 Count In Scanner ...................................................................................................................... 1-1 Count Out Bucket and 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. It is intended to be used as an adjunct to count policy and procedure based on AORN Recommended Practices. The system employs radio-frequency identification (RFID) technology to detect ClearCount SmartSponge surgical sponges and towels.
Table 1-1 Count In Scanner Components Component Description In-Scan Tray The area on which sponge and towel packs are to be placed when scanning them into a surgical case. SCAN IN button This button activates the In-Scan Tray to detect items introduced to the Scan In Location. Display Displays information for the user to track sponge counts throughout the surgical procedure. Also displays various modes of operation.
Handle Count Out Bucket Wand Holder SmartWand Power Entry and ON-OFF Switch Figure 1-2 • • • • • Locking Casters Count Out Bucket Components Handle 1-3 • SmartWand Cord Wrap 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.
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 An LCD that displays information for the user to track sponge counts throughout the surgical procedure. Also displays various modes of operation. Mode of Operation Located in the upper right-hand corner of the Display, this indicates the current status of the system. Volume Control Buttons These up and down buttons control the volume of the audible tones.
SmartSponge Disposables The SmartSponge System utilizes surgical sponges and towels that have been “tagged” with an RFID identification device. This RFID tag is about the size of a typical medicine capsule 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.
Table 1-4 SmartSponge Disposables and Accessories (Continued) Accessory Override Card A Smart Card used by the authorized staff member to enable an un-reconciled case to be closed. SmartTag / SmartTag Special A sticker applied between the sheets of the OR table prior to surgery, which allows the user to ensure that the SmartWand is operational.
SmartTags 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 bottom sheet and the draw sheet on the OR table. Figure 1-7 shows a typical position of the SmartTag on the OR table. The purpose of the SmartTag is to provide confidence to the user that the SmartWand is scanning the entire depth of the surgical site.
SmartWand The SmartWand, shown in Figure 1-8 is a patient scanning wand that houses an antenna for detecting ClearCount SmartSponges. The Handle of the wand is designed to ease the process of sterile sheathing while handing it into the sterile field by giving each person a place to grip. The Wand Cord exits the back end of the handle and connects to the Wand Connection on the back of the SmartSponge System. Two LEDs mounted on the wand provide visual cues about the system’s operation.
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 SmartWand (outside of surgical kit) Override Card The SmartSponge System requires the user to acknowledge the closure of an un-reconciled 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, place a SmartTag between the surgical sheets under the patient. The standard SmartTag is to be used on phenolic top OR tables while the SmartTag Special is for use with carbon fiber top OR tables. Figure 2-2 shows a SmartTag and its placement. The SmartTag is an adhesive sticker that contains a radio-frequency identification (RFID) tag.
Boot-up Screens After the on/off switch is set to on (|), the system will produce an audible tone, and the Starting screens shown in Figure 2-3 will 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.
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 should be left in this state when not in use. The Standby Mode of operation 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.
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 must be used with ClearCount sponges. These may either be packages of sterile sponges, or sponges in sterile surgical kits. The procedure for using one type versus the other is slightly different, as noted below. Using Sterile 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 Count Mode for the majority of the surgery (unless switched by the user), until it is complete and the sponge count has been reconciled. This mode consists of two available functions; Scanning In and Counting Out (appears on the mode of operation line of the display in the top right).
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. 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 In appears on the screen when the SCAN IN button is pressed to activate the In-Scan Tray.
Scanning Items Into and Out of Surgery Warning! • Holding items that have not been scanned in too close to the Count Out • • • • • Bucket may result in the items unintentionally being detected prior to use. Follow the on screen prompts to remove the sponges from the scanned out inventory or accept them into the case. Holding items that have been scanned in too close to the Count Out Bucket may result in the items unintentionally being detected prior to use.
that was not scanned in was intentionally discarded into the bucket. Declining infers that a sponge(s) was held too close to the Count Out Bucket prior to being scanned in (in this case move the sponges away from the bucket and select Decline). If declined, the system will go back to the previous counts and continue. Before pressing Decline, be sure to remove the detected sponge(s) from the vicinity of the Count Out Bucket or the system will continue to prompt for Accept/Decline of the detected sponge(s).
Figure 2-6 Example of Decline or Accept Screen Protocol Broken note shows up after the user accepts sponges into the Count Out Bucket inventory without first scanning them into the case via the In-Scan Tray.
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 END button, the Counts Not Equal screen appears. Figure 2-9 shows the screen progression to scan the Override card. The OVERRIDE button allows the case to be closed if the counts are not reconciled. Sponges may be intentionally withheld from the Count Out Bucket for procedural or clinical reasons. Alert the OR manager, and note this on the patient’s record along with the Case Number.
When you press the OVERRIDE button, the SCAN IN OVERRIDE CARD screen appears.
Wand Mode Operation The SmartWand may be used to scan patients for retained ClearCount 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, an audible alert is produced while the amber indicator on the wand flashes and the screen displays the type and quantity found, as shown in Figure 2-11.
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 sterile technique while passing the wand into the sterile field. Step 3 Press the WAND button on the Count Mode screen to activate the wand. The green LED on the handle will start to flash when the wand is activated.
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 2 to 3 inches above the patient. Follow the onscreen instructions shown in Figure 2-12. It is important to do all the scans(1-5) in order to most accurately identify potential retained sponges.
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 Hospital grade disinfectant solution. (Follow the disinfectant manufacturer’s instructions regarding the duration of contact time for specific biological contaminants.) Warning! The System needs to be unplugged from it’s power source before cleaning of the wand, box, and cords can take place. Cleaning the System Step 1 Unplug the power cord from the power entry module.
Maintenance ClearCount recommends that routine maintenance be performed on the SmartSponge System according to the following schedule: Frequency Required Action Responsible Party Per hospital protocol Follow the cleaning procedure. User Prior to each use Visually inspect the SmartWand’s cord and power cord for fraying and signs of wear. Check for cracks or other damage to system components. Make sure the wand antenna is not bent and the wand housing is not damaged.
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 Pack Not Verified - Retry Pack CAUSE: ACTION: The system is unable to scan the sponge pack. Flip or rotate sponges and rescan the pack. If rescanning does not correct the condition, discard the pack and resume scanning a new pack.
Multiple Packs Detected - Remove and Scan One Pack at a Time CAUSE: ACTION: The system is unable to scan in multiple packs Ensure that only one pack of sponges is being placed on at the same time. the In-Scan Tray at a time. Pack Already Scanned CAUSE: ACTION: The sponge pack has already been counted. The sponge pack is ready for use - continue with system setup or operation.
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 80 or more sponges in the Count Out Remove sponges and separate into groups of no more 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 A: Technical Specifications •••••• SmartSponge® System Dimensions Figure A-1 SmartSponge System - Model A02 48” (122 cm) 26” (66 cm) 20” (51 cm) 25” (64 cm) 34” (86 cm) Weight - 96 lbs (44 kg) • • • A-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.
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.
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.
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 c • • • • • A-8 • Appendix A: Technical Specifications - Device Label