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.
• • • • • • • • • • • • ii • • • • • • When using the wand, the system may experience a slight degradation of read range of RFID tagged items when metal objects are within the scanning field. Small metal objects like implants and pacemakers will have no impact in most cases. To the extent possible, remove metal from the scanning site or keep the RFID tags at least ½ an inch from direct contact with metal objects.
Conventions Used Warning! A warning is a statement that identifies conditions or actions that could result in personal injury or loss of life. Caution! A caution is a statement that identifies conditions or actions that could result in damage to the system. Notes A note is an advisory comment or recommendation regarding practices or procedures.
iv • • • • • •
Preface .............................................................................................................................................................i Chapter 1: System Description .................................................................................................................. 1-1 Counting System ...................................................................................................................... 1-3 SmartWand ...............................................
Chapter 8: Troubleshooting ....................................................................................................................... 8-1 System Alerts ........................................................................................................................... 8-2 System Warnings ...................................................................................................................... 8-4 System Failure .................................................................
Chapter 1: System Description •••••• The SmartSponge® Flex 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 gauze, sponges, and towels.
SmartSponge Flex System Counting System SmartWand Mobile Cart Accessories • • • • • 1-2 • Chapter 1: System Description -
Counting System The SmartSponge Flex utilizes surgical gauze, sponges, and towels that have been “tagged” with an RFID tag. 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 system can quickly and accurately count and identify each sponge. See Figure 1-1 for the location of the components and Table 1-1 for the description.
Display • • • • • 1-4 • Table 1-1 Counting System Components Component Description A touch screen that displays information for the user and provides an interface for operating the system. In Scanner The area on which sponge and towel packs are to be swiped when scanning them into a surgical case. Count Out Basin Receptacle to contain the discarded sponges and towels after their use in surgery that also counts the items out of the case.
SmartWand The SmartWand is used for detecting RFID-tagged ClearCount items. The wand can quickly identify tagged items in and around the patient during a surgical procedure. See Figure 1-2 for the location of the components and Table 1-2 for the description.
Table 1-2 SmartWand Components Component Description Wand Handle Used to hold the SmartWand while the wand is in use. Bi-Color LED Changes with the wand’s detection status. Off - Nothing detected Solid Blue - SmartTag detected Solid Amber - SmartSponge being detected Single-Color LED Changes with the wand’s status. Solid Green - Wand attached and powered Off - Wand not attached or not powered • • • • • 1-6 • Wand Cord Provides power and communications to the SmartWand from the SmartSponge Flex.
Mobile Cart The Mobile Cart mounts the Counting System and SmartWand. It also manages the system’s power and wand cables. See Figure 1-3 for the location of the components and Table 1-3 for the description.
Table 1-3 Mobile Cart Components Component Description System Mount The plate at the top of the cart used to secure the SmartSponge Flex to the cart. • • • • • 1-8 • Cable Management A series of cable hooks used to route and secure the power and wand cords. Wand Cord Hanger Used to retain the wand’s cord while the wand is being stored on the cart. Wand Hanger Holds the SmartWand when not in use. Power Cord Wrap Used to retain any excess power cord while the system is in use or being transported.
Accessories Additionally, the SmartSponge Flex relies on several accessories for proper use and patient care. These accessories are described as follows. See Figure 1-4 for an example of the accessories and Table 1-4 for the description.
Sterile Packs Surgical Kit SmartTag SmartTag Special Override Card System Cover Figure 1-4 • • • • • 1-10 • Accessories Chapter 1: System Description - Accessories Wand Cover
Table 1-4 ClearCount Disposables and Accessories Accessory Description Sterile Packs Individual sterile packs of surgical sponges tagged with ClearCount RFID tags. Surgical Kits A pre-packaged sterile kit of materials and equipment assembled for a specific surgery. Included are various banded packs of SmartSponges for use with the SmartSponge Flex.
• • • • • 1-12 • Chapter 1: System Description - Accessories
Chapter 2: System Interface •••••• This chapter presents an overview of the various screens, and navigation features for the SmartSponge Flex.
Boot Up Screens These screens appear for brief periods when the system is powered on. Splash Screen The Splash screen is the first thing displayed when the system is powered on. It will appear for a few seconds. Figure 2-1 Splash Screen Self Diagnostics Screen The Self Diagnostics screen follows the Splash screen when the system boots up. The system displays this screen while key components are checked. Their status is displayed on the screen.
Case Selection Screen The Case Selection screen will be displayed after the self diagnostics have finished. From this screen, you have the option to start a new surgical case, review past case data, edit the system settings, or adjust the system volume. These features are described below: SETTINGS ICON VOLUME ICON Figure 2-3 Case Selection Screen PAST CASES Pressing the PAST CASES button from the Case Selection screen will display the Case Review screen.
SETTINGS Screen The Settings screen appears after pressing the settings icon from the Case Selection screen. From this screen, you have the option to select from a list of adjustable settings. When finished, press the BACK button to return to the Case Selection screen. Refer to Chapter 5 for a description of editing the system’s settings. Figure 2-4 Settings Screen VOLUME Screen The Volume screen appears after pressing the volume icon from the Case Selection screen.
Active-Case Screens Active-Case screens are present during a surgical case. They are initiated after pressing the NEW CASE button from the Case Selection screen. When in an active surgical case, the current case number is displayed in the upper left corner of the screen and the current mode is displayed in the upper right corner of the screen.
Standby Screen The system defaults to Standby mode when a new surgical case is started and the Standby screen is displayed. All antennas are off while in Standby. The system will not count sponges into or out of the surgical case while in Standby. The purpose of Standby is to allow the system to stay inactive while not in use. You can switch to any other mode from the Standby screen with the navigation buttons along the bottom of the screen. Refer to page 4-3 for a description of Standby mode.
Count Out Screen The Count Out screen is displayed while in Count Out mode. Count Out mode is used for scanning sponges out of the surgical case that are discarded into the Count Out Basin. The Count Out Basin’s antennas are only active while in Count Out mode. Sponges that are scanned out will increase the Out column of the onscreen sponge counts and the Find column will subsequently decrease. Refer to page 4-7 for a description of Count Out mode.
Case Summary Screen The Case Summary screen is displayed while in Case Summary mode. Case Summary displays information about the current case and sponge counts at the time Case Summary is entered. Press the CASE SUMMARY button at the bottom right corner of the screen to enter the Case Summary. From this screen, you can close out a reconciled case by pressing END CASE or override an unreconciled case with an Override Card by pressing OVERRIDE.
Chapter 3: Preparing for a New Case •••••• Chapter 3 describes the initializing the SmartSponge Flex for a new case.
Powering the SmartSponge Flex The following procedure describes how to set up the SmartSponge Flex before each surgical case. Place the SmartSponge Flex in the desired position in the Operating Room (OR) and lock the two locking casters at the base of the cart. Warning! Inspect the power cord prior to each use, and replace it if damaged. A frayed or worn cord presents an electrical shock hazard that may result in personal injury or death.
Boot-Up Sequence The Splash screen, shown at the top left of Figure 3-2, appears on the display first for a few seconds after the On/Off switch is set to On. The Self Diagnostic screen, shown at the bottom right of Figure 3-2, is displayed for about a minute directly after the Splash screen and shows a Progress Bar that fills in from left to right. The screen shows the versions of system firmware, device ID, and system time.
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 3-3 shows a SmartTag and its typical placement. The SmartTag is an adhesive sticker that contains a radio-frequency identification (RFID) tag.
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. ClearCount sponges must be used with the SmartSponge Flex. These may either be packs of ClearCount sterile sponges, or ClearCount sponges supplied in sterile surgical kits. The procedure for using one type versus the other is slightly different, as noted below.
• • • • • 3-6 • Chapter 3: Preparing for a New Case
Chapter 4: System Operation •••••• Chapter 4 explains operating the SmartSponge Flex by describing the following functions: • Beginning a Case • • • • • Standby Mode Scanning Items Into Surgery Scanning Items Out of Surgery Pausing a Case Scanning a Patient for Retained Items • • • Detecting the SmartTag Ending a Surgical Case • • • Using the SmartWand Counts Equal Counts Not Equal Restoring Power Warning! • For the system to function, use only ClearCount disposables.
The SmartSponge Flex is designed to assign a unique number, referred to as a Case ID, to a single session of counting RFID-tagged disposables that are used in a particular surgical case. This Chapter describes how to begin a case, proceed through a case, and end a case. Beginning a Case The system will perform a series of self checks and display a progress bar when power is applied. The system will enter the Case Selection mode after the self checks finish.
Standby Mode The SmartSponge Flex is designed to not perform any scanning function until you specifically select to do so. Therefore, the system will enter Standby mode when you select to begin a new case. While in Standby mode, all antennas are off. The system can remain in Standby mode for as long as necessary while you prepare for surgery. When you are ready, you can navigate to any of the following modes: • • • • Count In - Activates the In Scanner for scanning SmartSponges into the case.
Scanning Items Into Surgery Sponges are “scanned in” to a surgical case so that the “In” count can be later reconciled with the “Out” count at the end of the case. This is possible because the system preserves in memory the unique identity of each sponge scanned into the case. Before a pack is scanned in, the system instantly verifies functionality of each individual tag and that the quantity matches the expected quantity for the pack.
As packs of sponges are scanned in, they will appear on the Count In screen by type in the order in which they were presented. The Count In screen contains fields that are populated with data as packs are scanned in. These fields are illustrated in Figure 4-4. IN: The number of OUT: The number of sponges scanned in. sponges counted out. MODE: COUNT IN must be displayed to scan sponges in. TYPE: The FIND: The number of sponge type scanned in. sponges not reconciled.
Warning! • Holding items that have not been scanned in too close to the Count Out Basin while in Count Out mode may result in the items unintentionally being detected prior to use. Follow the on screen prompts and decline acceptance if the sponges were inadvertently held too close to the Count Out Basin. Holding items that have already been scanned in too close to the Count Out Basin while in Count Out mode may result in the items unintentionally being counted out prior to use.
Scanning Items Out of Surgery Sponges removed from the surgical field are to be placed into the SmartSponge Flex so they can be scanned out. The system compares the identity of each sponge scanned out against the sponges that were scanned in and stored in memory. The system continuously monitors the comparison of the identities of sponges scanned in to those scanned out to determine if the counts are reconciled. Sponges may be discarded into the Count Out Basin at any time during the surgical case.
When switching to Count Out mode, an interim System Info screen will appear for 12 seconds requesting that all sponges be removed from the vicinity of the Count Out Basin to avoid accidentally being counted out before they are used. All of the antennas are off during this screen. To bypass the 12 second countdown, press the CONTINUE button to immediately advance to the Count Out screen.
Instructions for Counting Out: Step 1 Press the COUNT OUT button to activate the Count Out Basin. “COUNT OUT” will appear in the top right corner of the screen once the system enters Count Out mode. Remove unused sponges from the vicinity of the Count Out Basin while waiting 12 seconds for the System Info screen to pass after pressing COUNT OUT, or press the CONTINUE button to advance to the Count Out screen. Step 2 Place soiled sponges into the Count Out Basin.
Warning! • Do not fill the Count Out Basin beyond its fill line. Items above the fill line may not be counted. Packs of sponges, either partial or complete, may not be counted when discarded into the Count Out Basin. If a pack is discarded and the contents cannot be read, separate the sponges from each other to ensure a correct count. • Notes • The Count Out Basin will not count items while the system is in COUNT IN mode.
The SmartSponge Flex is designed on the premise that you will follow a standard practice of counting sponges prior to use and again after use to then reconcile those counts. It is recognized that there could be instances where, either intentionally or mistakenly, that sponges that have not been scanned into the case are presented to the Count Out Basin while in Count Out mode. This is referred to as Broken Protocol.
Press ACCEPT and the system will prompt you to confirm your action to add the detected sponge (and the rest of the pack’s contents) into the surgical case’s counts and break protocol. Press ACCEPT again to confirm the action and all absent sponges from the same pack as the accepted sponge automatically become accepted into the case. The pack contents will be added to the IN column, with the detected sponge entered into the OUT column.
Sponges from a pack of 4x4s not scanned in, is detected by the Count Out Basin. Press ACCEPT. Confirm the action by pressing ACCEPT again or BACK to return to the previous screen. The Row of the sponges that were accepted will turn red. Broken Protocol is now displayed at the bottom of the screen.
The TimeStamp for any Broken Protocols along with the Type of sponge triggering it, is displayed within the top section of the Case Summary. Listed under the Notifications within the bottom of the Case Summary is the user’s selected action to any Broken Protocol Warnings they received. Broken Protocol is displayed at the bottom of the CASE SUMMARY screen.
Count Out Basin Capacity Limits The capacity of the Count Out Basin is limited to ensure optimal performance when counting out sponges that are discarded into it. There should never be more than 20 RFID-tagged sponges or towels in the Count Out Basin at the same time. • BASIN LIMIT REACHED If more than 20 sponges accumulate in the Count Out Basin simultaneously, the System Alert “BASIN LIMIT REACHED” will appear on the display.
Pausing a Case There may be reasons you might want to pause the counting and detection functions of the system. The Standby mode is provided to allow you to pause a case. Placing the system into standby suspends all counting and detection functions by turning off all power to the system’s antennas. All count information is retained. You may resume the case by exiting Standby mode and entering the desired mode of operation.
Scanning a Patient for Retained Items The SmartWand allows you to scan patients for retained ClearCount sponges and towels at any point during surgery. Remove wand from holder then press the WAND button to enter Wand mode. It is important to note that an item found by the wand is not counted out. An item can only be counted out when it is presented to the Count Out Basin and the system is in Count Out mode. The SmartWand performs best when passed over the patient in a slow, steady fashion, no faster than 0.
Wand LED Function The wand uses two LEDs and three colors to communicate status to the user. The combinations of colors result in four basic states, which are described below: 2) WAND ON 1) WAND OFF Both LEDs OFF When both LEDs are OFF, the wand is not active. (Wand is not active in any mode except Wand Mode.) 3) SMARTTAG DETECTED Blue & Green LEDs ON The Green LED indicates the wand is active. The Blue LED will illuminate and stay on when a SmartTag is detected.
Patient Scanning Procedure Step 1 Remove the SmartWand from the wand hanger on the mobile cart and free its cable from the cord wrap. 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 to activate the wand. The green LED on the handle will illuminate when the wand is activated and the Wand screen shown in Figure 4-13 will also appear.
3 2 Hold the wand 1-2 inches above the patient while scanning at a rate of 7 inches a second for each pass. 4 1. Starting at 90 degrees to the patient, scan from 5 head to toe past the surgical sight. 2. Scan at a 45 degree angle to the patient. 3. Scan Parallel to the patient. 4. Scan opposite of 2 at a 45 degree angle. 5. Scan opposite of 1 at 90 degrees.
Step 8 When the patient scan is complete, deactivate the wand by pressing the appropriate navigation button to leave Wand mode and go to the desired mode. The green LED on the wand will shut off when deactivated. Step 9 Remove the SmartWand from the sterile field. Remove the sterile cover and discard it according to the standard protocol. Step 10 Return the SmartWand to the wand hanger and the cable to the cord wrap.
Caution! Do not shorten the length of the SmartWand’s cable in order to replace the connector at either end. Adjusting the cable length will affect the wand’s performance. Replace the entire cable with a new one if any complications arise. Notes • Remove instruments from the surgical site prior to scanning with the SmartWand.
Wand Help Screen To enter the Wand Help screen, press the icon on the right hand side of the Wand mode screen. An illustration of the patient scanning procedure will be displayed onscreen as a reference. Sponges will continue to be detected by the wand during this screen. To return to the Wand mode screen, press the BACK button. Press ? icon to bring up the Wand Help screen.
Ending a Surgical Case When surgery has concluded, pressing the CASE SUMMARY button allows you to review information about the current case. A complete summary of the critical items related to the case are displayed; including sponge counts, use of the SmartWand, errors and alerts, etc. The Case Summary mode may also be entered to review the status of the current case at anytime. To return to the mode in which Case Summary was entered from, simply press the BACK button.
Start Time: This is the time that the current case was started. Case ID: This is the same case number that appears in the upper left of the screen. Record this in the patient’s record. Sponge Counts: Lists the sponges used in the case. End Time: Will show “In Process” until the case is ended. Then will show the time the case was closed when reviewing case data. Broken Protocol Events: Lists the time a Broken Protocol was accepted and with what type of sponge.
There are two possible outcomes when ending a case; sponge counts are equal or sponge counts are NOT equal. Each outcome is described below. COUNTS EQUAL When all of the surgical items have been returned and the system has reconciled the sponge count, the Case Summary screen will indicate a count status of “COUNTS EQUAL” when the CASE SUMMARY button is pressed. In this situation, the END CASE button will be available at the bottom of the screen. Pressing the END CASE button will end the case.
COUNTS NOT EQUAL If any of the surgical items are not accounted for when the CASE SUMMARY button is pressed, the Case Summary screen will indicate a count status of “COUNTS NOT EQUAL”. You may select the BACK button to return to the case and search for the missing items. If you desire to close the case without reconciliation by the system, the OVERRIDE button will need to be selected. The SmartSponge Flex requires that the user acknowledge the closure of an un-reconciled case.
Press the OVERRIDE button to trigger the SCAN ADMIN CARD screen. Swipe the Override Card across the In Scanner. After the Override Card is scanned, “VERIFIED BY ADMIN” will appear on the Case Summary. The END CASE button will also be available to close out the surgical case.
Ending a case with “COUNTS NOT EQUAL”: Step 1 Press the CASE SUMMARY button located at the bottom of the screen. Case Summary mode can be entered from any other mode. If the counts are not reconciled, the Case Summary screen displays “COUNTS NOT EQUAL”. See Figure 4-20. Step 2 With “COUNTS NOT EQUAL” displayed at the top of the Case Summary screen, press the OVER RIDE button located at the bottom of the screen. The “SCAN ADMIN CARD TO PROCEED” message will now be displayed on the OVERRIDE screen.
Restoring Power In the event of a power failure, move the power cord from a standard wall outlet to a red emergency powered outlet if available. Ensure the On/Off switch remains in the On ( | ) position. When the system restarts it will continue with the current case and advance to Standby mode. The screen will notify you that the case is in progress. Press the appropriate button to enter the desired mode. The system will resume counting exactly where it left off.
Chapter 5: System Settings •••••• Chapter 5 describes how to adjust the system’s settings.
Edit Settings Mode The SmartSponge Flex allows you to adjust some system settings and parameters to aid your use of the system. Press the Edit Settings icon from the Case Selection screen to enter the Edit Settings mode. This will trigger the Override screen. An Override Card will need to be placed on the In Scanner of the system to proceed to the Edit Settings mode. The system will enter the Edit Settings mode after the Override Card is scanned. Press the Edit Settings Icon to trigger the OVERRIDE screen.
There are five adjustable items within the Edit Settings mode. They are described as follows: Edit: Date/Time Press “EDIT: DATE/TIME” from the Edit Settings mode screen, to adjust the system’s date and time. The Edit Date/Time screen will appear where the system’s date and time can be adjusted with up and down arrows for both the date and the time. Adjust a number within the screen, by pressing that number and then adjust its value with the up and down arrows.
Adjust Screen Brightness Press the “SCREEN BRIGHTNESS” button from the Edit Settings mode screen to adjust the brightness of the display. This will bring up the Adjust Screen Brightness screen where the brightness can be adjusted from 2 (dimmest) to 10 (brightest). Press the up arrow to increase the brightness of the screen and the down arrow to decrease it. When finished press the ACCEPT button to retain the new brightness or press the CANCEL button to abandon the change.
Adjust Screen Timeout The system is set to dim the brightness of the display after a set number of hours of inactivity to prevent screen burn in. If the system is set for 2 hours, an inactivity screen will appear and the display will be dimmed after 2 hours of no activity. Simply touch anywhere on the screen to restore the brightness back to the set level and remove the inactivity message. Press the “SCREEN TIMEOUT” button from the Edit Settings mode screen to set the inactivity timeout of the display.
Calibrate Screen The SmartSponge Flex uses a resistive touchscreen for interfacing with the system. This allows the screen to be calibrated for precision. The screen should only be calibrated if buttons become difficult to activate. Calibrating the screen will realign the point of contact with the system’s reference point. To calibrate the screen, press the “CALIBRATE SCREEN” button from the Edit Settings screen; a CONFIRM ACTION screen will follow.
Adjust Volume Press the VOLUME icon from the Edit Settings screen (or anywhere it appears) to adjust the system volume. This will bring up the Volume screen where the system’s volume can be adjusted from 0 (off) to 10 (loudest). Press the up arrow to increase the level and the down arrow to decrease it. When finished, press the ACCEPT button to retain the new level or press the CANCEL button to abandon the change.
• • • • • 5-8 • Chapter 5: System Settings - Edit Settings Mode
Chapter 6: Review Case Data •••••• This chapter explains how to view data for the surgical cases completed by the SmartSponge Flex. The operation available for reviewing case data is explained on the following pages.
Review Case Data on the System The SmartSponge Flex provides the operator with the ability to view the results of previous surgical cases directly on the device. To view data for each case stored on the device, press the PAST CASES button from the Case Selection screen. This brings up the Case Review screen where all cases stored on the device are presented in a list with the most recent on top.
Once you’ve selected a Case ID to view, the Case Review screen with the selected case’s information will appear. The information for the case is formatted exactly like it was in the Final Report screen. Use the side scroll bar to view all the information for the case. You can also cycle through cases by pressing the NEWER CASE button to view the next newer case or press the OLDER CASE button to view the next older case.
• • • • • 6-4 • Chapter 6: Review Case Data -
Chapter 7: Cleaning and Maintenance •••••• This chapter includes a post-surgery cleaning procedure for the SmartSponge Flex. Also included is information regarding routine maintenance of the system. Before cleaning the system or performing maintenance on it, check that: • • The System is Off The System is unplugged from its power source. Notes • No disassembly is required prior to cleaning.
Cleaning Instructions Collect the following supplies for cleaning the SmartSponge Flex: • • • 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 device, wand, 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 Flex 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.
• • • • • 7-4 • Chapter 7: Cleaning and Maintenance - Maintenance
Chapter 8: Troubleshooting •••••• This chapter describes the alerts, warnings, and system failures that can occur while operating the SmartSponge Flex. This chapter is divided into the following sections: • • • • System Alerts System Warnings System Failures General troubleshooting Each section contains a list of the error conditions, possible causes for each condition, and suggested actions to help resolve the situation.
System Alerts System Alerts are temporary warning messages of which you should be aware to ensure proper operation of the SmartSponge Flex. Correct the condition causing the alert, press CONTINUE, and the system will resume. Figure 8-1 Example System Alert Message Screen Discard Pack CAUSE: ACTION: The system has detected a problem with the sponge pack. Discard the sponge pack and resume scanning with a new pack.
Basin Limit Reached CAUSE: ACTION: There are over 20 sponges in the Count Out Basin. Remove sponges or discard the full bag and replace with a new liner - sponge counts will not change. Each additional sponge or group of sponges discarded into the Out Scan after its capacity is already at 20 will trigger this System Alert.
System Warnings System Warnings are serious conditions that have been caused by misuse of the SmartSponge Flex. To correct a system warning condition, follow the onscreen instructions and press the CONTINUE button to resume system operation. Figure 8-2 Example Warning Message Screen Basin Limit Exceeded CAUSE: ACTION: There are 30 or more sponges in the Count Out Remove sponges and separate into groups of no more Basin.
System Failure A system failure is a serious condition that will cause the SmartSponge Flex to stop working. If you receive a system failure message: • Power cycle the system to clear the error and restart. Do this by flipping the power switch off and then back on to restart the system. Resume normal operation if the error no longer appears.
General Troubleshooting This section contains general troubleshooting information to help you resolve issues that may arise while operating the SmartSponge Flex. SmartSponge Flex Will Not Turn On CAUSE: ACTION: Power cord is not plugged into the SmartSponge Flex 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. Check that the power source is working properly.
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 is disconnected. Connect wand cable. Wand cable is damaged. Call ClearCount Medical Solutions for a replacement.
• • • • • 8-8 • Chapter 8: Troubleshooting - General Troubleshooting
Appendix A: Technical Specifications •••••• SmartSponge® Flex System Dimensions 16” (40.6 cm) 26” (66 cm) 12” (30 cm) device FRONT SIDE 34” (86 cm) cart 23” (58.5 cm) 23” (58.5 cm) System Weight - 38 lbs (17.2 kg) Figure A-1 Cart Weight - 35 lbs (15.
Power Requirements Power supply: Power consumption: Outlet requirement: Power cord length: Internal fuse rating: 120 - 240 VAC, 50/60 Hz, 60 W 0.
EMC Considerations The ClearCount SmartSponge Flex 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 Flex. 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 Flex Model A04 is intended for use in the electromagnetic environment specified below. The customer or user of the SmartSponge Flex Model A04 should ensure that it is used in such an environment.
Guidance and Manufacturer’s Declaration – Emissions Equipment and Systems that are NOT Life-supporting Guidance and Manufacturer’s Declaration – Emissions The ClearCount SmartSponge Flex Model A04 is intended for use in the electromagnetic environment specified below. The customer or user of the ClearCount SmartSponge Flex Model A04 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 Flex Model A04 Equipment and Systems that are NOT Life-supporting Recommended Separations Distances for the SmartSponge Flex Model A04 The ClearCount SmartSponge Flex Model A04 is intended for use in the electromagnetic environment in which radiated disturbances are controlled.
Device Label SmartSponge® Flex Model A04 FCC ID: WWQCCMS004 This device complies with Part 15 of FCC rules. Operation is subject to the following two conditions: 1) this device may not cause harmful interference and, 2) this device must accept any interference received, including interference that may cause undesired operation. Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.