ClearCount SmartSponge Guida di riferimento

About the AORN Seal of Recognition Program

The AORN Seal of Recognition provides a visual representation and

confirmation that the content of training and in-service programs has

satisfied a review by AORN according to the AORN’s Perioperative

Standards and Recommended Practices. The seal is intended to convey

to end-users, customers and others that the content has met AORN

standards.

The AORN Seal of Recognition provides acknowledgment that this

program is a premier and recognized resource for perioperative nurses.

AORN is considered an authority throughout the perioperative community

on safe operating room practices, evidence-based practices,

perioperative research, and guiding principles that support day-to-day

perioperative nursing practice. The AORN Seal of Recognition

communicates to over 43,000 AORN members and the rest of the

perioperative nursing community that this program is dedicated to that

same excellence in safe patient care.

The AORN Seal of Recognition has been awarded to the SmartSponge System Operating

Procedures Manual and does not imply that AORN approves or endorses any product or

service mentioned in any presentation, format or content. The AORN Recognition program

is separate from the AORN, ANCC Accredited Provider Unit and therefore does not

include any CE credit for programs.

Disclaimer

•

• • • • • •

Preface

Indications for Use

The ClearCount Medical Solutions SmartSponge

System is indicated

for use in counting and

recording the number of RFID-tagged surgical sponges, laparotomy sponges, and towels

used during surgical procedures. It also provides a non-invasive means of locating retained

radio-frequency identification (RFID)-tagged surgical sponges, towels, and other tagged

items within a surgical site.

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 Count Out Bucket.

•

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 sterile 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 contamination of the

items being scanned.

•

Using the scanning wand without a sterile wand cover could contaminate the sterile field.

•Holding items that have been scanned in too close to the Count Out Bucket may result

in these items being added to the Out column of the inventory (detected) prior to use

and disposal. Dispose of any items into the Count Out Bucket without using them if

they have been scanned out 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 their body.

•

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

The loss of tag function may result.

•

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

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

ensure there is no interference present.

•Do not dispose of sponges from a previous surgical case into the Count Out Bucket.

Sponge counts may not reconcile properly.

•

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.

Notes

A note is an advisory comment or recommendation regarding practices or procedures.

Table of Contents

•

Preface .............................................................................................................................................................i

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

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

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

Display and 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 and 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 .................................................................................... 2-13

Wand Mode Operation ........................................................................................................... 2-16

Restoring Power ..................................................................................................................... 2-19

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 A: Technical Specifications .......................................................................................................A-1

SmartSponge® System Dimensions ........................................................................................A-1

Power Requirements ...............................................................................................................A-2

Environmental Conditions ......................................................................................................A-2

SmartSponge System Sponges and Towels .............................................................................A-2

EMC Considerations ................................................................................................................A-3

Device Label ............................................................................................................................A-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. It is intended to be used as an adjunct to count policy and procedure

based on AORN Recommended Practices. The system employs radio-frequency identification (RFID)

technology to detect ClearCount SmartSponge surgical sponges and towels. 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 along with audible notification. 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 In-Scan Tray is located below the area marked “Touch Here to Scan”

The SCAN IN button is used

to activate the In-Scan Tray. As surgical sponges and towels are placed on the In-Scan Tray, it adds the tagged

items to the In-Scan Inventory. This inventory or quantity of scanned-in items appears in the IN

column of the

Count Mode screen on the display.

Table 1-1

lists the Count In Scanner components.

Figure 1-1 Count In Scanner Components

Display

In-Scan Tray

Scan In location

SCAN IN button

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

comfortable means of maneuvering 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. Insert the power cord into the Power Entry and then switch to On to power up the system. 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

In-Scan Tray The area on which sponge and towel packs

are to be placed when scanning them into a

surgical case.

SCAN IN button This button activates the In-Scan Tray to

detect items introduced to the Scan In

Location.

Display Displays information for the user to track

sponge counts throughout the surgical

procedure. Also displays various modes of

operation.

Scan In Location The surface of the In-Scan Tray where

spongeandtowelpacksarescannedintothe

surgical case.

Notes

•

The Count Out Bucket will not count items when the system is in SCANNING IN

mode.

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 KeepstheSmartWand’scord retainedwhile

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 ThePowerEntryconnectstheSmartSponge

System to a 120 VAC power source via the

power cable. The On/Off switchtoggles the

power to the system.

Locking Casters Secures the position of the SmartSponge

System.

Wand Holder

SmartWand

Handle

Power Entry and

ON-OFF Switch

Count Out

Bucket

SmartWand

Cord Wrap

Locking

Casters

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 (Scanning In/Counting Out)

•

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

•

Wanding Mode

The Volume Control buttons allow for the adjustment of the SmartSponge System’s internal buzzers. These

may be set to four preset levels; off, low, medium, and high. The system will beep when booting up, when it

is ready to count, when sponges are scanned in, detected with the SmartWand, or scanned out, and any system

alert.

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

Display

Function

Control

Button [1]

Function

Control

Button [3]

Function Control Button [2]

Volume

Control

Buttons

Mode of

Operation

1-5

Chapter 1: System Description

System Components

•

Table 1-3 Display/Controls

Display / Controls Description

Display An LCD that displays information for the

user to track sponge counts throughout the

surgical procedure. Also displays various

modes of operation.

Mode of Operation Located in the upper right-hand corner of

the Display, this indicates the current status

of the system.

Volume Control Buttons These up and down buttons control the

volume of the audible tones. The Volume of

the tones can be set to four different levels;

off, low, medium, and high.

Function Control Button [1] Allows the following actions;

- Turns

the system on from Standby Mode.

SCAN

- Activates the In-Scan Tray.

BACK

Returns to the previous screen and mode.

STANDBY

- Returns the system to

Standby Mode.

Function Control Button [2] Allows;

END

- Exits Count Mode and

proceeds to the Final Report screen for

verification before ending a case.

RESET

- Clears the detection status for a rescan in

Wanding Mode. Also

BACK

in Final

Report Mode.

Function Control Button [3] Allows;

WAND

- Switches from Counting

Out Mode to Wanding Mode.

OVERRIDE

- Allows the user to end a

case without reconciling the sponge counts

by using an Override Card.

END CASE

Saves case data and returns system to

Standby Mode.

BACK

- Returns to the

previous screen and mode.

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