TheSmar t WandDTX Syst em TM Oper at i ng Pr oc edur es Manual 100936Rev.
Preface •••••• Indications for Use The ClearCount Medical Solutions SmartWand-DTX™ System is indicated for use in counting and displaying the number of RFID-tagged surgical sponges, laparatomy sponges, and towels detected by the device and providing a non-invasive means of locating retained RFID-tagged surgical sponges, towels and other tagged items within a surgical site.
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.
Preface ...............................................................................................................................................i Chapter 1: System Description ......................................................................................................1-1 System Components ...................................................................................................1-2 SmartWand Box.........................................................................................
Chapter 1: System Description •••••• The SmartWand-DTX™ System is used in an operating room to detect and identify tagged surgical items for the purpose of preventing a retained foreign body. The system employs radio-frequency identification (RFID) technology to detect ClearCount SmartSponge® surgical sponges and towels. The system combines detection with the benefit of identification of surgical items (sponges, gauze, and towels) so detected items can be quickly identified.
System Components SmartWand Box The SmartWand Box, shown in Figure 1-1, is the information and user hub of the SmartWand-DTX System. The Power Entry Switch is located on the back panel of the box, where the power cord is to be connected. The system provides visual cues to the user through the front mounted LCD Display where detected item information and system messages are shown. Two Bi-Color LEDs, also located on the front panel, will show system and detection statuses.
Table 1-1 SmartWand Box Component Left Bi-Color LED Description Changes color with the wand’s detection status. Solid Blue - SmartTag detected Off - SmartTag/SmartSponge not yet detected Solid Amber - SmartSponge detected Right Bi-Color LED Changes color with the system’s status. Off - System not powered Solid Green - System powered Flashing Green - Wand not connected Red - System Error LCD Display Displays user information for system operation and item detection/identification.
SmartWand The SmartWand, shown in Figure 1-2 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 SmartWand Box. Two LEDs mounted on the wand provide visual cues about the system’s operation.
Table 1-2 SmartWand (Continued) Component Description Handle Used to hold the SmartWand while performing the patient scan. Wand Cord Provides power to the SmartWand while also allowing it to communicate with the SmartWand Box. SmartSponge Disposables The SmartWand-DTX System utilizes surgical sponges and towels that have been “tagged” with an RFID transponder. This RFID tag is similar in size to a Tic Tac® and does not contain a battery.
Table 1-3 SmartSponge Disposables and Accessories (Continued) Accessory SmartTag / SmartTag Special Description An adhesive backed RFID tag applied between the sheets of the OR table prior to surgery, which assures that the SmartWand is operational.
SmartWand Cover A sterile wand cover is used when scanning the patient with the SmartWand. The cover is passed into the sterile field and then applied to the SmartWand as it is handed in. Figure 1-5 shows the wand cover package.
SmartTags SmartTags are passive RFID labels that have an adhesive backing (see Figure 1-6). Prior to surgery, a SmartTag is to be positioned under the surgical site between the bottom sheet and the draw sheet on the OR table. Chapter 2 describes the positioning of the SmartTag on the OR table. The purpose of the SmartTag is to provide confidence to the user that the SmartWand is working properly and scanning the entire depth of the surgical site.
Chapter 2: Initial Setup and Operation •••••• Chapter 2 describes the initial setup and operation of the SmartWand-DTX System.
Initial Setup Preparing the SmartWand-DTX System for Use The following procedure describes how to set up the SmartWand-DTX System. If problems with the system occur, call ClearCount Medical Solutions. Step 1 Attach the wand cable to the front of the wand box. Step 2 Find a stable place in the operating room within reach of the wand cable length to set the system. Warning! Inspect the power cord prior to each use, and replace it if damaged.
Placing the SmartTag Before the start of a surgery, place a SmartTag between the surgical sheets under the surgical site of 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.
System Operation Activating the System After the SmartWand-DTX System has been plugged in and the power switch turned on, the system starts out in Ready to Wand Mode after system diagnostic checks have completed. The green LED on both the wand and box will illuminate (Figure 2-3) to signal that the SmartWand is now active. “Ready to Wand” will appear on the display along with an audible tone signifying the wand is now ready to scan the patient.
Using the SmartWand The following section explains the patient scanning procedure for the SmartWand. With the SmartTag in place and the system active, the wand is now able to be passed into the sterile field by means of the sterile cover. Warning! If the wand is not covered properly, it may jeopardize the sterility of the field. Step 1 Using sterile technique, apply the sterile cover to the SmartWand as it is passed into the sterile field.
3 2 • 4 5 1 • • • • • Hold the wand 2-3 inches above the patient while scanning at a rate of 7 inches a second for each pass. 1 Starting at 90 degrees to the patient, scan from 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.
Figure 2-6 Displaying Sponge Types Deactivating the System After the SmartWand has been used to perform a patient scan, it is now ready to be deactivated and set aside for the next surgical case. Deactivating the system will turn off the radio frequency reader and place the system into a standby “Sleep Mode”. Step 1 Remove the SmartWand from the sterile field and discard the wand cover and any recovered items according to standard protocol.
Chapter 3: Cleaning and Maintenance •••••• This chapter includes a post-surgery cleaning procedure for the SmartWand-DTX System. Also included is information regarding routine maintenance of the system.
Cleaning Instructions Collect the following supplies for cleaning the SmartWand-DTX 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.
Maintenance ClearCount recommends that routine maintenance be performed on the SmartWand-DTX 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 system’s 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 SmartWandDTX System. This chapter is divided into the following sections: • • • General troubleshooting System Message System Error 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 SmartWand-DTX System. SmartWand-DTX System Will Not Turn On CAUSE: ACTION: Power cord is not plugged into the SmartWand-DTX 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 Not Functioning Check Connection” CAUSE: ACTION: 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 has been placed on or near a metal surface. Move wand away from metal, and allow 20 seconds for the wand to adjust. Wand cable has become detached. Connect wand cable. Wand cable is damaged or kinked. Call ClearCount Medical Solutions for a replacement.
System Message System Messages are temporary warning messages that ensure proper operation of the SmartWand-DTX System. Once the condition causing the message has been corrected, the system will continue. “WAND NOT FUNCTIONING CHECK CONNECTION” is caused by the loss of communication between the wand and system. The most notable cause would be a problem with the wand cord that links the two. If the wand cord is unplugged this system message will appear; to clear it, simply plug in the wand cord.
System Error A System Error is a serious condition that will cause the SmartWand-DTX System to stop working. If you receive a System Error 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. See Figure 4-2 for an example of a system response to a System Error.
Appendix A: Technical Specifications •••••• SmartWand-DTX System Dimensions Figure A-1 SmartWand-DTX System - Model A03 12” (30.5 cm) 3.5” (8.9 cm) 318.5” (809 cm) Wand Cord 10.5” (26.7 cm) 22.5” (57 cm) 5.25” (13.3 cm) Weight: • Wand Box - 5 lbs (2.2 kg) • SmartWand - 2 lbs (.9 kg) 17.2” (43.
Power Requirements Power supply: 120 - 240 VAC, 50/60 Hz, 60 W Power consumption: 0.
EMC Considerations The ClearCount SmartWand-DTX 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 SmartWand-DTX 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 SmartWand-DTX System Model A03 is intended for use in the electromagnetic environment specified below. The customer or user of the SmartWand-DTX System Model A03 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 SmartWand-DTX System Model A03 is intended for use in the electromagnetic environment specified below. The customer or user of the ClearCount SmartWand-DTX System Model A03 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 SmartWand-DTX System Model A03 Equipment and Systems that are NOT Life-supporting Recommended Separations Distances for the SmartWand-DTX System Model A03 The ClearCount SmartWand-DTX System Model A03 is intended for use in the electromagnetic environment in which radiated disturbances are controlled.
Device Label Figure A-2 Device Label FCC ID: WWQCCMS002 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.
