ClearCount Medical Solutions CCMS002 Detects & counts surgical items with RFID tags. User Manual SmartWand DTX manual

ClearCount Medical Solutions Inc. Detects & counts surgical items with RFID tags. SmartWand DTX manual

Contents

Users Manual

The SmartWand-DTX System
Operating
Procedures
Manual
TM
100936 Rev. A
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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.
Warnings
The following list of warnings applies to the SmartWand-DTX System:
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Do not use the system in the presence of a flammable anesthetic mixture with air, or with
oxygen or nitrous oxide.
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For the system to function, use only ClearCount disposables.
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Keep the SmartWand-DTX System outside of the sterile field, unless it is properly covered.
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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.
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Do not cut or tear SmartSponge disposables, as the RFID tags might become separated.
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Using the scanning wand without a sterile wand cover could contaminate the sterile field.
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Disposables should not be left inside the patient's body for more than 24 hours.
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Do not subject patients to an MRI with SmartSponge disposables still inside their body.
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Tags may become damaged by surgical lasers. Do not apply a surgical laser directly to a
tag. The loss of tag function may result.
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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.
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No part of the ClearCount SmartWand-DTX System is user serviceable. The system
contains no user replaceable fuses. All Service is to be performed by trained personnel.
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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.
Table of Contents
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Preface ...............................................................................................................................................i
Chapter 1: System Description ......................................................................................................1-1
System Components...................................................................................................1-2
SmartWand Box............................................................................................1-2
SmartWand....................................................................................................1-4
SmartSponge Disposables.............................................................................1-5
SmartWand Cover.........................................................................................1-7
SmartTags .....................................................................................................1-8
Chapter 2: Initial Setup and Operation ..........................................................................................2-1
Initial Setup ................................................................................................................2-2
Preparing the SmartWand-DTX System for Use..........................................2-2
Placing the SmartTag....................................................................................2-3
System Operation .......................................................................................................2-4
Activating the System ...................................................................................2-4
Using the SmartWand ...................................................................................2-5
Deactivating the System ...............................................................................2-7
Chapter 3: Cleaning and Maintenance...........................................................................................3-1
Cleaning Instructions..................................................................................................3-2
Maintenance ...............................................................................................................3-3
Chapter 4: Troubleshooting ...........................................................................................................4-1
General Troubleshooting............................................................................................4-2
System Message .........................................................................................................4-4
System Error...............................................................................................................4-5
Appendix A: Technical Specifications .........................................................................................A-6
SmartWand-DTX System Dimensions .....................................................................A-6
Power Requirements .................................................................................................A-7
EMC Considerations .................................................................................................A-8
Device Label ...........................................................................................................A-13
1-1
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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. The system consists of a patient scanning wand and a wand box with a user-friendly display
that provides detailed information about detected items. When an item is detected, the type and quantity will
appear on-screen along with an audible notification. The SmartWand-DTX allows for a quick and easy scan
of the patient to identify retained surgical items.
This chapter includes a brief overview of the system and a detailed description of its components.
Chapter 1: System Description - System Components 1-2
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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 LED
s, also located on the front panel, will show
system and detection statuses. Located inside: the
Embedded Buzzer
gives audible feedback to the user
during detection and system alerts. Directly below the LEDs is the multifunction
Panel Button
; used to
“Wake Up”, “Clear”, and “Sleep” the system. Right below the Panel Button is the
Wand Connection
where
the cord to the SmartWand is connected.
Figure 1-1 SmartWand Box
Right Bi-Color LEDLeft Bi-Color LED
LCD Display Panel Button
Wand Connection
Embedded Buzzer
Power Entry Switch
ON
BACK
1-3
Chapter 1: System Description
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System Components
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Table 1-1 SmartWand Box
Component Description
Left Bi-Color LED 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.
Top 3 lines are for sponge type and count,
bottom line is for status and notification.
Panel Button Multifunction button used to operate the
System.
Press - “Wake Up” (when LCD is OFF)
Press - “Clear” (when LCD is ON)
Press and Hold (3sec) - “Sleep” (system
hibernate)
Embedded Buzzer Alerts the user with an audible tone to
system functions. Signals SmartTag and
SmartSponge detection.
Wand Connection Plug-in location for the SmartWand’s cord.
Power Entry Switch Plug-in location for the power cord. Also
the location of the switch to provide power
to the system.
Chapter 1: System Description - System Components 1-4
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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. The
Bi-Color
LED
displays detection status while the
Single
Color LED
displays the wand’s power status. To
scan the patient; hold the wand by its handle, pass it
over the body maintaining a distance of 2 to 3 inches
above, while completing five head to toe sweeps at
a rate of 7 inches a second. Refer to Chapter 2 for the
complete patient scanning procedure.
Figure 1-2 SmartWand
Table 1-2 SmartWand
Component Description
Bi-Color LED Changes color with the wand’s detection
status.
Solid Blue - SmartTag detected
Off - SmartTag/SmartSponge not yet
detected
Solid Amber - SmartSponge detected
Single-Color LED Changes with the wand’s status.
Solid Green - Wand attached
Off - Wand not attached or system error
Single Color LED
Bi-Color LED
Handle
Wand Cord
1-5
Chapter 1: System Description
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System Components
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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. Because each sponge
contains a tag with unique identification, the SmartWand-DTX can quickly and accurately detect and identify
each sponge.
The SmartWand-DTX System relies on accessories for proper use. These accessories are described briefly in
Table 1-3
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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.
Table 1-3 SmartSponge Disposables and Accessories
Accessory Description
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 SmartWand-
DTX System.
Sterile Packages SmartSponges packaged by type for use
with the SmartWand-DTX System that are
not pre-packaged in Surgical Kits.
Wand Cover A large, sterile, clear plastic sheath used to
protect the sterile field when using the
SmartWand. The sheath covers the wand
and a portion of the wand cord.
Table 1-2 SmartWand (Continued)
Component Description
Chapter 1: System Description - System Components 1-6
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Figure 1-3 Example of Sterile Surgical Kit
Figure 1-4 Example of Sterile Sponge Packages
SmartTag / SmartTag Special An adhesive backed RFID tag applied
between the sheets of the OR table prior to
surgery, which assures that the SmartWand
is operational. (SmartTag Special is only for
use with carbon fiber top OR tables)
Table 1-3 SmartSponge Disposables and Accessories (Continued)
Accessory Description
1-7
Chapter 1: System Description
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System Components
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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.
Figure 1-5 Sterile Cover for SmartWand (outside of surgical kit)
Chapter 1: System Description - System Components 1-8
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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. Using a SmartTag is a direct indication of effective scan depth
and thereby better than proxy methods such as BMI. Detection of the SmartTag assures the user that the wand
is functioning and being used properly such that any SmartSponges remaining inside the patient can be
identified quickly.
There are two types of SmartTags.
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The standard SmartTag is for use with OR tables with phenolic tops. These are the most common OR
tables.
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SmartTag Special is for use on OR tables with carbon-fiber tops. These are less common.
It is important to use the correct SmartTag so that indication of scan depth by the wand is dependable. If you
are uncertain, ClearCount can provide assistance at the time of installation to help determine which SmartTag
type should be used with your OR tables.
Figure 1-6 SmartTag / SmartTag Special
Standard SmartTag SmartTag Special
2-1
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Chapter 2: Initial Setup and Operation
Chapter 2 describes the initial setup and operation of the SmartWand-DTX System. Setup and operation of the
system includes the following topics:
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Initial Setup
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Preparing the SmartWand-DTX System for Use
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Placing the SmartTag
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System Operation
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Activating the System
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Using the SmartWand
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Deactivating the System
Chapter 2: Initial Setup and Operation - Initial Setup 2-2
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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.
Step 3 Check that the power cord supplied with the system is securely plugged into the power entry
module of the system.
Step 4 Connect the power cord to a grounded, 120 VAC power outlet.
Step 5 Set the power ( | / O) switch shown in Figure 2-1 to the | (on) position. The system will then
power on, run a diagnostic check, and enter Ready to Wand Mode. During the diagnostic check
the LEDs on both the wand and box will flash to assure proper operation. The system will beep
once when switched on and again when Ready to Wand Mode is entered.
Figure 2-1 Location of On/Off Switch
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.
Note
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The SmartWand-DTX does not contain any backup power source.
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During the power-on diagnostic check be sure to observe proper LED operation.
Power Switch
Plug In
2-3
Chapter 2: Initial Setup and Operation
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Initial Setup
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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. This tag provides feedback to the
SmartWand-DTX System that the SmartWand is functioning and reading through the depth of the patient when
a scan is performed.
During pre-surgery setup, proceed as follows:
Step 1 Select the correct SmartTag type for the OR table being used.
Step 2 Peel the backing from the SmartTag.
Step 3 Position the SmartTag below the surgical site and apply between the bottom sheet and the draw
sheet.
Step 4 Place the tag adhesive-side down.
Figure 2-2 SmartTag Placement
Warning!
The SmartTag is not approved for application to the patient’s skin.
Note
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If the wrong SmartTag is used on the wrong type of table, it will perform
improperly.
SmartTag
Chapter 2: Initial Setup and Operation - System Operation 2-4
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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.
Step 1 Verify “Ready to Wand” appears on the display, and the Green LEDs on both the wand and the
box are illuminated.
Step 2 If the system is in sleep mode (the display is off), press the Panel Button to restore to Ready to
Wand Mode.
Step 3 If the Green LED on the wand box is blinking and the message “Wand Not Functioning Check
Connection” is displayed, attach the wand cable or see the trouble shooting section for possible
causes.
Figure 2-3 Ready to Wand
Notes
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After 30 minutes the system will hibernate by powering down the wand and
display. To return to “Ready to Wand” from “Sleep” mode, press the Panel Button.
Green LEDs
System Message
2-5
Chapter 2: Initial Setup and Operation
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System Operation
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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.
Step 1 Using sterile technique, apply the sterile cover to the SmartWand as it is passed into the sterile
field.
Step 2 Ensure the Wand is active; look for the green LED on both the wand and box to be illuminated
along with the system message “Ready to Wand”.
Step 3 Using the handle, position the wand 2-3 inches above the patient over the surgical site and
location of the SmartTag. When the wand detects the SmartTag, the blue LED on both the wand
and box will illuminate and the message “SmartTag Detected” will appear on the display.
Proceed to scan the patient.
Step 4 Slowly scan the patient from head to toe moving at a rate of 7 inches a second, while maintaining
a distance of 2-3 inches above the body. It is important to do all 5 scan paths shown in Figure
2-4 to most accurately identify potential retained sponges.
If a sponge is detected the system will produce an audible tone, Amber LEDs on the wand and box
will illuminate, the system message “Sponge Detected” will be displayed, and the type and quantity
of the sponge(s) detected will be displayed on the screen. See
Figure 2-5
Step 5 Press the panel button to reset the display and the Bi-Color LED if a rescan is desired.
Warning!
If the wand is not covered properly, it may jeopardize the sterility of the field.
Notes
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A SmartTag is recommend but not required for system operation. Without the tag,
functionality and scan depth cannot be assured.
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The system will only produce the audible tone and illuminate the Amber LEDs
when the detected sponge is in range of the wand. This aids in locating the
sponge(s) by their vicinity to the wand.
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If more than 3 sponge types are detected, the display will change to “Multi Types”
detected and add the detected sponges into one total quantity. See
Figure 2-6
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The system will remain in Ready to Wand Mode 30 minutes after pressing the
panel button.
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Holding the wand by anything other than the handle will affect its performance.
Chapter 2: Initial Setup and Operation - System Operation 2-6
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Figure 2-4 Patient Scanning Procedure
Figure 2-5 System Response to Sponge Detection
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2
3
4
5
2
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Hold the wand
2-3
inches above the patient while
scanning at a rate of
7
inches a second for each pass.
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1
Starting at
90 degrees
to the patient, scan from head
to toe past the surgical sight.
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2
Scan at a
45 degree
angle to the patient.
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3
Scan
Parallel
to the patient.
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4
Scan opposite of
2
at a
45 degree
angle.
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5
Scan opposite of
1
at
90 degrees
.
5
System Message
Sponge Type and Quantity
Green LEDs = Solid
Amber LEDs = Solid
Audible Alert
2-7
Chapter 2: Initial Setup and Operation
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System Operation
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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.
Step 2 Press and hold the Panel Button for 3 seconds to deactivate the SmartWand-DTX System.
The Display will power off along with the Green LED on the wand.
Step 3 Flip the Power Entry Switch to OFF to completely power off the system, if desired.
Step 4 Clean the entire SmartWand-DTX System according to the procedure in Chapter 3 if necessary.
Notes
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The Green LED on the Box will stay illuminated until the Power Entry Switch is
flipped to the OFF position. As long as the Box LED is Green, the system is in
sleep mode. Press the Panel Button to enter “Ready to Wand” mode.
3-1
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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.
Before cleaning the system or performing maintenance on it, check that:
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The system is unplugged from its 120 VAC power source
3-2
Chapter 3: Cleaning and Maintenance
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Cleaning Instructions
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Cleaning Instructions
Collect the following supplies for cleaning the SmartWand-DTX System:
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Disposable cloths
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Rubber gloves
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Hospital grade disinfectant solution. (Follow the disinfectant manufacturer’s instructions regarding
the duration of contact time for specific biological contaminants.)
Cleaning the System
Step 1 Unplug the power cord from both the wall and power entry module.
Step 2 Wipe the entire length of the power cord with disinfectant.
Step 3 Pre-clean surfaces by removing any contaminants with a damp cloth and wiping them dry.
Step 4 Wipe down the entire system; including the display, the SmartWand, and its cable with
disinfectant.
Step 5 After disinfectants dry on the surface or according to manufacturer’s instructions, rinse it with
a water-dampened cloth.
Warning!
The System needs to be unplugged from it’s power source before cleaning of the wand,
box, and cords can take place.
Caution!
Do not immerse the wand or apply cleaning fluids directly to the wand, but apply the
solution with a dampened cloth; otherwise damage to the electronics could occur.
Chapter 3: Cleaning and Maintenance - Maintenance 3-3
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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.
User or maintenance personnel
Monthly Check for any damage to the Wand
housing, Wand Antenna, Display, Panel
Button, system and wand LEDs, Audible
Buzzer, and the Power Entry Switch.
Maintenance personnel
Annually Annual check per the service manual. ClearCount Medical Solutions
101 Bellevue Road
Pittsburgh, PA 15229
(888) 931-0787
4-1
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Chapter 4: Troubleshooting
This chapter describes the alerts, warnings, and system failures that can occur while operating the SmartWand-
DTX System.
This chapter is divided into the following sections:
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General troubleshooting
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System Message
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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.
Chapter 4: Troubleshooting - General Troubleshooting 4-2
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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
Sponge Detected with SmartWand, but Subsequent Scans No Longer Indicate Sponge Present
CAUSE:
Power cord is not plugged into the
SmartWand-DTX System or wall outlet.
ACTION:
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.
SmartWand-DTX System failure. Call ClearCount Medical Solutions.
CAUSE:
Operator is moving the wand over the patient
too quickly.
ACTION:
Scan at a rate no faster than 0.2m/sec (7 inches/sec).
Operator has not completed all scan paths
recommended.
Complete all recommended scan paths, per Chapter 2
instructions.
System has not been placed into “Ready to
Wand” mode.
Make sure the system is not in “Sleep” mode. “Ready to
Wand” should appear on the display and then scan the
patient.
Wand has been effected by surrounding
electro-surgical equipment.
Remove active electro-surgical equipment from the
vicinity of the wand, or wait until ES equipment is no
longer in use.
Wand has been placed closer than 2 inch to the
body of the patient.
Hold the wand at least 2 inch away from the patient and
re-scan.
Wand has been held too far from the patient. Hold the wand within 3 inches of patient while
performing a re-scan.
4-3
Chapter 4: Troubleshooting
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General Troubleshooting
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System Indicates “Wand Not Functioning Check Connection”
Wand Housing is Cracked, Bent or Broken
Scanning with the Wand Fails to Indicate that a SmartTag is Present
CAUSE:
Wand is experiencing interference from other
surgical equipment.
ACTION:
Move the wand away from the interfering equipment, or
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.
Wand electronics have failed. Call ClearCount Medical Solutions for a replacement
wand.
CAUSE:
Wand has been physically damaged or
misused.
ACTION:
Call ClearCount Medical Solutions for a replacement
wand.
CAUSE:
Wand has not be placed over the SmartTag.
ACTION:
Ensure a SmartTag is present and re-scan the patient.
SmartTag has been moved or was not placed
prior to surgery.
Continue without the SmartTag. (unable to verify scan
depth)
Wand cable is damaged. Call ClearCount Medical Solutions for a replacement.
Wand cable is disconnected. Connect cable.
Patient is too large to detect the SmartTag
through the patient.
Scan the patient despite not being able to detect the
SmartTag.
The wrong type of SmartTag has been placed
on the OR table.
Ensure the correct SmartTag is used on the OR table.
Refer to Chapter 2.
Wand electronics have failed. Call ClearCount Medical Solutions for a replacement
wand.
Chapter 4: Troubleshooting - System Message 4-4
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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.
See
Figure 4-1
for the system response to the wand becoming disconnected.
Figure 4-1 “WAND NOT FUNCTIONING” Screen
4-5
Chapter 4: Troubleshooting
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System Error
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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,
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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.
Figure 4-2 Example of a System Error
Notes
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Be sure to provide ClearCount Medical Solutions service personal with the
numeric Error code when calling to report an issue.
Flashing Red LED
Both LEDs OFF
System Message
Audible Alert
For additional information please call customer service at
(888) 931-0787
A-1
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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)
10.5” (26.7 cm)
17.2” (43.6 cm)
5.25” (13.3 cm)
318.5” (809 cm) Wand Cord
22.5” (57 cm)
Weight:
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Wand Box - 5 lbs (2.2 kg)
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SmartWand - 2 lbs (.9 kg)
A-2
Appendix A: Technical Specifications
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Power Requirements
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Power Requirements
Environmental Conditions
SmartWand-DTX System Sponges and Towels
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All SmartSponge Sponges and Towels are constructed of 100% cotton.
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ClearCount RFID tags are encapsulated in bio-compatible epoxy.
Power supply: 120 - 240 VAC, 50/60 Hz, 60 W
Power consumption: 0.65 Amps at 120 VAC
Outlet requirement: standard, single-phase, grounded three-prong outlet
Power cord length: 10 feet
Internal fuse rating: 3 Amp, Medium Acting, Neutral and Line
Operating Temperatures:
Ambient temperature: 50°F to 104°F (+10°C to +40°C)
Transport and Storage Temperatures:
Ambient temperature: -40°F to 158°F (-40°C to +70°C)
Appendix A: Technical Specifications - EMC Considerations A-3
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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 – Emissions
All Equipment and Systems
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.
Emissions Test Compliance Electromagnetic Environment – Guidance
RF Emissions
CISPR 11
Group 2 The ClearCount SmartWand-DTX System Model A03 must
emit electromagnetic energy in order to perform its intended
function. Nearby electronic equipment may be affected.
RF Emissions
CISPR 11
Class B The ClearCount SmartWand-DTX System Model A03 is
suitable for use in all establishments, including domestic,
and those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic
purposes.
Harmonics
IEC 61000-3-2
Class A
Flicker
IEC 61000-3-3
Complies
A-4
Appendix A: Technical Specifications
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EMC Considerations
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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
ESD
IEC 61000-4-2
±6kV Contact
±8kV Air
±6kV Contact
±8kV Air
Floors should be wood, concrete or
ceramic tile. If floors are synthetic, the r/h
should be at least 30%.
EFT
IEC 61000-4-4
±2kV Mains
±1kV I/Os
±2kV Mains
No I/Os
Main power quality should be that of a
typical commercial or hospital
environment.
Surge
IEC 61000-4-5
±1kV Differential
±2kV Common
±1kV Differential
±2kV Common
Main power quality should be that of a
typical commercial or hospital
environment.
Voltage Dips/Dropout
IEC 61000-4-11
>95% Dip for 0.5
Cycle
>95% Dip for
0.5 Cycle
Main power quality should be that of a
typical commercial or hospital
environment. If the user of the ClearCount
SmartWand-DTX System Model A03
requires continued operation during
power mains interruptions, it is
recommended that the ClearCount
SmartWand-DTX System Model A03 be
powered from a power source that has
automatic emergency backup.
60% Dip for
5 Cycles
60% Dip for
5 Cycles
30% Dip for
25 Cycles
30% Dip for
25 Cycles
>95% Dip for
5 Seconds
>95% Dip for
5 Seconds
Power Frequency
50/60Hz
Magnetic Field
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic fields should
be that of a typical commercial or hospital
environment.
Appendix A: Technical Specifications - EMC Considerations A-5
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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.
Immunity Test IEC 60601 Test
Level
Compliance
Level
Electromagnetic Environment – Guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
3Vrms
3V/m
Portable and mobile communications equipment
should be separated from the ClearCount
SmartWand-DTX System Model A03 by no less
than the distances calculated/listed below:
D=(3.5/3)(Sqrt P)
D=(3.5/3)(Sqrt P)
80 to 800 MHz
D=(7/3)(Sqrt P)
800 MHz to 2.5 GHz
where P is the max power in watts and D is the
recommended separation distance in meters.
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey
a
,
should be less than the compliance level in each
frequency range
b
.
Interference may occur in the
vicinity of equipment marked
with the following symbol:
.
A-6
Appendix A: Technical Specifications
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EMC Considerations
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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. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which the
ClearCount SmartWand-DTX System Model A03 is used exceeds the applicable RF compliance level above,
the ClearCount SmartWand-DTX System Model A03 should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating
the ClearCount SmartWand-DTX System Model A03.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
NOTE: This equipment has been tested and found to comply with the limits for a Class A digital device,
pursuant to part 15 of the FCC rules. These limits are designed to provide reasonable protection against
harmful interference when the equipment is operated in a commercial environment. This equipment
generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the
instruction manual, may cause harmful interference to radio communications. Operation of this equipment in
a residential area is likely to cause harmful interference in which case the user will be required to correct the
interference at his own expense.
Appendix A: Technical Specifications - EMC Considerations A-7
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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
The SmartWand-DTX System contains a receiver operating at a frequency of 13.56 MHz +/- 7 kHz.
The SmartWand-DTX System may be interfered with by other equipment, even if that other equipment
complies with CISPR EMISSION requirements. If abnormal behavior is observed, please refer to the
separation distance chart provided in this appendix.
The SmartWand-DTX System contains a transmitter operating at a frequency of 13.56 MHz, using 10%
amplitude shift keying at a modulation frequency of 423.75 kHz, and maximum effective radiated power of
200 mW.
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. The customer or user of the ClearCount SmartWand-DTX
System Model A03 can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF Communications Equipment and the ClearCount SmartWand-DTX System
Model A03 as recommended below, according to the maximum output power of the communications
equipment.
Max Output Power
(Watts)
Separation (m)
150 kHz to 80MHz
D=(3.5/3)(Sqrt P)
Separation (m)
80 to 800MHz
D=(3.5/3)(Sqrt P)
Separation (m)
800MHz to 2.5GHz
D=(7/3)(Sqrt P)
0.01 .1166 .1166 .2333
0.1 .3689 .3689 .7378
1 1.1666 1.1666 2.3333
10 3.6893 3.6893 7.3786
100 11.6666 11.6666 23.3333
For transmitters rated at a maximum output power not listed above, the recommended separation distance
d
in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where
P
is
the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for 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.
A-8
Appendix A: Technical Specifications
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Device Label
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Device Label
Figure A-2 Device Label
This product and its use are covered by
one or more of the following U.S. Patents:
5,650,596, 5,923,001, 6,998,541, other
patents pending.
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.
The System contains no user replaceable
fuses. Any attempt to service this device
by the user will result in voiding of any and
all warranties.

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