ClearCount SmartSponge User manual

Preface

Indications for Use

The ClearCount Medical Solutions SmartSponge® System is indicated for use in

counting and recording the number of RFID-tagged surgical sponges, laparatomy

sponges, and towels used during surgical procedures. It also provides a non-invasive

means of locating retained radio-frequency identification (RFID)-tagged surgical

sponges, towels, and other tagged items within a surgical site.

Warnings

The following list of warnings applies to the SmartSponge System:

•Use only one SmartSponge System during a surgical procedure.

•Do not use the system in the presence of a flammable anesthetic mixture with air, or

with oxygen or nitrous oxide.

•For the system to function, use only ClearCount disposables.

•Keep the SmartSponge System outside of the sterile field, unless it is properly

covered.

•Place only ClearCount disposables in the SmartBucket.

•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.

•Do not cut or tear SmartSponge disposables, as the RFID tags might become

separated.

•When scanning items contained in a surgical kit (bundles of items not in their own

sterile packages) into the SmartSponge System, cover the head of the system with

the sterilized bucket liner from the surgical kit. This prevents non-sterile

contamination of the items being scanned in.

•Using the scanning wand without a sterile wand cover could contaminate the sterile

field.

•Holding items close to the SmartBucket may result in items being added to the Count

Out column prior to disposal. Dispose of any items into the SmartBucket without

using them if the Count Out Bucket has detected them prior to use.

•Disposables should not be left inside the patient’s body for more than 24 hours.

•Do not subject patients to an MRI with SmartSponge disposables still inside the

patient.

•Tags may become damaged by surgical lasers. Do not apply a surgical laser directly

to a tag. The loss of tag function may result.

•Due to possible interference, the system should be separated by at least 1 meter from

an active Electrosurgical Unit (ESU). The system should be checked for normal

operation to ensure there is no interference present.

•Do not dispose of packed sponges from a previous surgical case into the

SmartBucket. Sponge counts may not reconcile properly.

•No part of the ClearCount SmartSponge System is user serviceable. The system

contains no user replaceable fuses. All Service is to be performed by trained

personnel.

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.

Note

A note is an advisory comment or recommendation regarding practices or

procedures.

SECTION

PAGE

Preface ............................................................................................................................ i-ii

Chapter 1:System Description .......................................................................................1-1

Count In Scanner...............................................................................................1-1

Count Out Bucket & Wand Components...........................................................1-2

Display & Function Control Buttons...................................................................1-4

SmartSponge Disposables................................................................................1-6

SmartTags.........................................................................................................1-8

SmartWand........................................................................................................1-9

Wand Cover.....................................................................................................1-10

Override Card..................................................................................................1-10

Chapter 2: Initial Setup & Operation ...............................................................................2-1

Powering on the SmartSponge System.............................................................2-2

Placing the SmartTag........................................................................................2-3

Boot-up Screens................................................................................................2-4

Standby Mode....................................................................................................2-6

Setting Up for Surgery.......................................................................................2-7

Count Mode Operation ......................................................................................2-8

Scanning Items Into and Out of Surgery..........................................................2-10

Requesting Final Item Count Reports..............................................................2-11

Wand Mode Operation ....................................................................................2-14

Restoring Power..............................................................................................2-18

Chapter 3: Cleaning and Maintenance............................................................................3-1

Cleaning Instructions.........................................................................................3-2

Maintenance......................................................................................................3-3

Chapter 4: Troubleshooting.............................................................................................4-1

General Troubleshooting...................................................................................4-2

System Alerts.....................................................................................................4-4

System Warnings ..............................................................................................4-6

System Failure...................................................................................................4-7

Appendix: Technical Specifications................................................................................5-1

SmartSponge System Dimensions....................................................................5-1

Power Requirements.........................................................................................5-2

Environmental Conditions..................................................................................5-2

EMC Considerations..........................................................................................5-3

Device Label......................................................................................................5-8

1-1

•

• • • • • •

Chapter 1: System Description

The SmartSponge® System is used in an operating room to detect and identify tagged surgical items for the

purpose of reconciling surgical counts. The system employs radio-frequency identification (RFID) technology

to detect ClearCount SmartSponge surgical sponges and towels. The system combines the benefits of counting

and detection of surgical items (sponges, gauze, and towels) used during a surgical case. It has a user-friendly

color display that provides detailed item counts. The counts are automatically updated as SmartSponge RFID-

tagged sponges and towels are scanned “in” and “out” of the surgical procedure.

This chapter includes a brief overview of the system and a detailed description of its components.

System Components

Count In Scanner

The Count In Scanner, shown in Figure 1-1, is used to count items into the surgical case prior to using the

items. The Count In Scanner is located below the area marked

Touch Here to Scan.

The proximity sensor

activates the Count In Scanner when sponges are present. As surgical sponges and towels are placed on the

Count In Scanner, it adds the tagged items to the In-Scan Inventory. This inventory or quantity of scanned-in

items appears in the

column of the Count Mode screen on the display. Table 1-1 lists the scanner

components.

Figure 1-1 Count In Scanner Components

Chapter 1: System Description - System Components 1-2

•

Count Out Bucket and Wand Components

The Count Out Bucket detects the RFID-tagged sponges and towels discarded into it during a surgical case.

The Handle and Casters contribute to the mobility of the SmartSponge System. The Handle is strategically

located to protect the Count In Scanner from forcefully hitting a wall, while also providing the user with a

comfortalbe means of manuvering the system. The two rear casters are able to be locked in place to keep the

system stable during use. The Power Entry and On/Off Switch are located at the back of the system near the

floor. The power cord will be inserted into the Power Entry and then switched to On to begin. When not in use,

the SmartWand is mounted to the rear of the system by means of the Wand Holder; and the wand’s cord is

retained on the SmartWand Cord Wrap. See Figure 1-2.

Table 1-1 Count In Scanner Components

Component Description

Scanner Tray The area on which sponges and towels are

to be placed when scanning them into a

surgical case.

Proximity Sensor This sensor detects the presence of items

introduced to the Scan In Location

automatically activating the Scanner Tray.

Display Displays updated information for the user to

track sponge counts throughout the surgical

procedure. Also displays various modes of

operation.

Scan In Location The location on the Scanner Tray to scan

sponges and towels into the surgical case.

The Proximity Sensor is also located here

under the

Touch Here to Scan

label.

1-3

Chapter 1: System Description

System Components

•

Figure 1-2 Count Out Bucket Components

Table 1-2 Count Out Bucket Components

Component Description

Handle Used to move the SmartSponge System.

Also positioned to protect the Count In

Scanner and display from damage.

Count Out Bucket Scans out and contains the discarded

sponges and towels after their use in

surgery.

Wand Holder Used to mount the SmartWand to the

SmartSponge System when not in use.

SmartWand Cord Wrap Keeps the SmartWand’s cord retained while

the wand is mounted to the SmartSponge

System.

SmartWand Used to detect sponges. This is done by

scanning the patient with the SmartWand.

Power Entry and On/Off Switch The Power Entry connects the SmartSponge

System to a 120 VAC power source via the

power cable. The On/Off switch toggles the

power to the system.

Locking Casters Secures the postion of the SmartSponge

System.

Chapter 1: System Description - System Components 1-4

•

Display and Function Control Buttons

The display, function control buttons, and volume buttons are the user’s interface to the SmartSponge System.

This backlit display shows the following types of screens at various points, depending on the mode of

SmartSponge System operation:

•

Starting, Boot, and Power & Diagnostic screens (during system boot-up)

•

Standby, Ready to Count or Continuing case, and Count Mode

•

Final Report: Counts Equal, or Final Report: Counts Not Equal

•

Wand Mode

Each screen defines the operation of the control buttons for the associated mode of operation. There are three

function control buttons along the bottom of the display and two volume control buttons to the right of the

display. Figure 1-3 shows the location of the control buttons in relation to the example screen

Figure 1-3 Display and Control Buttons

1-5

Chapter 1: System Description

System Components

•

Table 1-3 Display/Controls

Display / Controls Description

Display LCD that provides information to the user

regarding operation of the system.

Volume Control Buttons These up and down buttons control the

volume of the audible alert. The Volume of

the alert can be set to four different levels

and off with each button.

Function Control Button [1] Allows the following actions;

- Turns

the system on from Standby Mode.

Off

Returns the system to Standby Mode.

Function Control Button [2] Allows;

Final Count

- Exits Count Mode

and proceeds to a final count screen for

verification before ending a case.

Back

Lets the user exit the final count screen and

return to Count Mode.

Function Control Button [3] Allows;

Wand Mode

- Switches from

Count Mode to Wand Mode.

Count Mode

Switches Back from Wand Mode to Count

Mode.

OverRide

- Allows the user an

option to end a case without reconciling the

sponge counts with an Admin Card.

End

Case

- Ends case and returns to standby.

Chapter 1: System Description - System Components 1-6

•

SmartSponge Disposables

The SmartSponge System utilizes surgical sponges and towels that have been “tagged” with an RFID

identification device. This RFID tag is smaller than a dime and does not contain a battery. Because each sponge

contains a tag with unique identification, the SmartSponge system can quickly and accurately count and

identify each sponge.

Surgical sponges are provided for surgery in two forms: pre-packaged surgical kits (Figure 1-4) and individual

sterile packages (Figure 1-5). There are different procedures involved when using one presentation versus the

other. Refer to Chapter 2 of this manual for further details.

Additionally, the SmartSponge System relies on several accessories for proper use and patient care. These

accessories are described briefly in Table 1-4.

Table 1-4 SmartSponge Disposables and Accessories

Accessory Description

Surgical Kits A pre-packaged kit of materials and

equipment assembled for a specific surgery.

Included are various banded packs of

SmartSponges for use with the

SmartSponge System.

Sterile Packages SmartSponges packaged by type for use

with the SmartSponge System that are not

pre-packaged in Surgical Kits.

Bucket Liner A large drawstring plastic bag used to

protect the Count Out Bucket from

contamination as soiled sponges are

discarded.

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.

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