ClearCount SmartSponge Operating Procedures Manual Download | Manualshive

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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 SmartSponge System Model A02 is intended for use in the electromagnetic environment
specified below. The customer or user of the SmartSponge System Model A02 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
SmartSponge System Model A02 requires
continued operation during power mains
interruptions, it is recommended that the
ClearCount SmartSponge System Model
A02 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.

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Summary of Contents for SmartSponge

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Page 2: ...t 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...

Page 3: ...he 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 sys...

Page 4: ... 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 caut...

Page 5: ...de 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 Tec...

Page 6: ... 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...

Page 7: ...nto 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 ...

Page 8: ...e 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 PowerEntryconnectstheSmartSponge System to a 120 VAC power source via the power cable The On Off switch toggles the...

Page 9: ...ns 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...

Page 10: ...nd high Function Control Button 1 Allows the following actions ON Turns the system on from Standby Mode SCAN IN 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 r...

Page 11: ... 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 sterile kit of materials and equipment assembled for a specific surgery Included are various banded packs of SmartSponges for u...

Page 12: ...e authorized staff member to enable an un reconciled case to be closed SmartTag SmartTag Special A sticker applied between the sheets of the OR table prior to surgery which allows the user to ensure that the SmartWand is operational SmartTag Special is only for use with carbon fiber top OR tables Table 1 4 SmartSponge Disposables and Accessories Continued Accessory Description ...

Page 13: ...h 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 The standard SmartTag is for use with OR tables with phenolic tops These are the most common OR tables SmartTag Special is for use on OR tables with carbon fiber tops These are les...

Page 14: ... Press the WAND button after the wand has entered the sterile field 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 shown on the display at a rate of 7 inches a second Refer to Chapter 2 for the complete patient scanning procedure Figure 1 8 SmartWand Table 1 5 SmartWand Component Description Bi Color LED Chan...

Page 15: ...e term un reconciled indicates that the number of sponges scanned in and counted out is not the same The user acknowledges this condition by placing the system into Override Mode This is done by pressing the OVERRIDE button on the Final Reports Counts Not Equal screen to enter the Override Mode and end the case with unequal counts The user then places the RFID tagged Override Card on the In Scan t...

Page 16: ...gery Using pre packaged sterile surgical kits Using individual sterile packages The chapter also covers operating the SmartSponge System to perform the following surgery related functions Using the System in Count Mode Scanning items into and out of surgery Requesting final item count reports Obtaining the final report counts equal Obtaining the final report counts not equal Scanning a Patient for...

Page 17: ... in the desired position in the Operating Room OR and lock the rear casters Step 1 Connect the system to a grounded 120 VAC power outlet using the power cord supplied Step 2 Check that the other end of the power cord is securely plugged into the power entry module of the system Step 3 Set the power O switch shown in Figure 2 1 to the on position There will be an audible tone and a series of power ...

Page 18: ...io frequency identification RFID tag This tag provides feedback to the SmartSponge System that the SmartWand is reading through the depth of the patient when a scan is performed Figure 2 2 SmartTag Placement During pre surgery setup proceed as follows Step 1 Peel the backing from the SmartTag Step 2 Position the SmartTag below the surgical site and apply between the bottom sheet and the draw sheet...

Page 19: ...device SmartSponge System identification ID Diagnostic Screen The Diagnostic Screen shown at the bottom of Figure 2 3 appears for 9 seconds This screen has a Progress Bar that fills in from left to right in segments When the bar completely fills in the system produces an audible tone and displays the Standby Screen See Figure 2 4 The Standby Screen remains on the display until the user presses the...

Page 20: ...2 5 Chapter 2 Initial Setup and Operation Initial Setup Figure 2 3 Boot up Screens Boot Screen Starting Screen Diagnostic Screen ...

Page 21: ...gery The SmartSponge System enters the standby mode under the following conditions When the system powers up When you press the STANDBY button on the Final Report screen during a surgical case After the END CASE button is pressed to save the case data and power down the device Upon restoration of power following a power failure When you are ready to begin a new surgical case press the ON button on...

Page 22: ...d in one bundle at a time Do not remove the band until the bundle has been scanned in Step 2 Move the system as close as possible to the sterile field Step 3 Using aseptic technique cover the Count In Scanner and display with the Bucket Liner Make sure the In Scan Tray and display are completely covered Proceed to scan sponges and towels into the surgical case Step 4 After the sponges and towels h...

Page 23: ...ay in the top right These functions of Count Mode are cycled by the first Function Control button which changes from SCAN IN to BACK While in the Count Mode the display is continually updating the number of sponges scanned into and out of the case by either the In Scan Tray or Count Out Bucket depending on the mode selected To enter Count Mode press the ON button while in the Standby Mode From the...

Page 24: ...rded into the Count Out Bucket The FIND column lists the number of items not reconciled by the system A green check mark appears if the number of items scanned into surgery is equal to the number of items discarded into the Count Out Bucket If the number of items in the IN and OUT columns are not equal a red X will appear Scanning In appears on the screen when the SCAN IN button is pressed to acti...

Page 25: ... are to be used in the same manner as generic surgical sponges Step 3 Sponges may be discarded into the Count Out Bucket at any time during the surgical case If a sponge s that has not been scanned in is detected by the Count Out Bucket the system will prompt the user on what action to take with the detected sponge s There is an option to Accept the detected sponge s into the case or Decline them ...

Page 26: ... will accommodate accidental or intentional scenarios If more than 50 SmartSponges are in the Count Out Bucket the alert Change Bag Bucket Limit Has Been Exceeded appears When this alert occurs remove the sponges from the Count Out bucket and replace the bucket liner if necessary Sponge counts are not affected by removing sponges from the Count Out Bucket If the Change Bag message is ignored and t...

Page 27: ...12 Figure 2 6 Example of Decline or Accept Screen Figure 2 7 Example of Protocol Broken Note Protocol Broken note shows up after the user accepts sponges into the Count Out Bucket inventory without first scanning them into the case via the In Scan Tray ...

Page 28: ...est of the case data Obtaining the Final Report Counts Equal Step 1 When all items used in the surgery have been discarded into the Count Out Bucket press the END button on the Count Mode screen If the counts are reconciled the final report indicates that all counts are correct See Figure 2 8 Step 2 Enter the case number in the patient s record Step 3 Press the END CASE button to close the surgica...

Page 29: ...e Override Card is used by placing it on the In Scan Tray until an audible alert is heard while the system is in the OVERRIDE Mode Step 1 Press the END button at the bottom of the display Step 2 With the COUNTS NOT EQUAL press the OVERRIDE button Step 3 The person responsible for the Override card will need to present the card Scan the Override card by placing it onto the In Scan Tray and holding ...

Page 30: ...itial Setup and Operation Operations Figure 2 9 Final Reports Screen Counts Not Equal Figure 2 10 Counts not Equal Verified By Override Screen When you press the OVERRIDE button the SCAN IN OVERRIDE CARD screen appears ...

Page 31: ...mber indicator on the wand flashes and the screen displays the type and quantity found as shown in Figure 2 11 The SmartWand performs best when passed over the patient in a slow steady fashion no faster than 0 2 m second approximately 7 inches second Maintain a distance of 2 to 3 inches above the patient On a typical patient each scan pass should take approximately 5 seconds to complete Figure 2 1...

Page 32: ... 2 12 will then appear Figure 2 12 Wand Mode Screen Step 4 Using the handle hold the SmartWand over the site where the SmartTag has been placed When detected the green LED on the wand will stay illuminated and the screen displays the message Scan Range Confirmed This message confirms that the wand is reading completely through the patient Without a SmartTag under the patient the user is unable to ...

Page 33: ...atient for the retained item s Figure 2 13 Patient Scan Procedure Step 6 When the patient scan is complete press the BACK button to return to the Count Mode screen If a retained item was found place the item into the Count Out Bucket Step 7 Remove the SmartWand from the sterile field Remove the sterile cover and discard it according to the standard protocol Step 8 Return the SmartWand to its holde...

Page 34: ...rn of power Notes Remove instruments from the surgical site prior to scanning with the SmartWand Before removing the SmartWand from the sterile field the user should return the system to Count Mode to reduce the chance of inadvertently detecting items in the path of the wand While in Wand Mode do not set the wand on large metal surfaces If this occurs remove the wand from the surface and give the ...

Page 35: ...the SmartSponge System Also included is information regarding routine maintenance of the system Before cleaning the system or performing maintenance on it check that The SmartSponge System is off The system is unplugged from its 120 VAC power source Notes No disassembly is required prior to cleaning ...

Page 36: ...iping them dry Step 3 Wipe the entire length of the cord with disinfectant Step 4 Wipe down the entire system including the display the Count In Scanner all four sides of the Count Out Bucket inside and outside the SmartWand its cable and holder and all four casters with disinfectant Step 5 After disinfectants dry on the surface or according to manufacturer s instructions rinse it with a water dam...

Page 37: ...d 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 user controls the Count In Scanner the Count Out Bucket and the power switch Also check for correct operation of the LEDs on the wand housing by scanning a...

Page 38: ...ur while operating the SmartSponge System This chapter is divided into the following sections General troubleshooting System Alerts System Warnings System Failures Each section contains a list of the error conditions possible causes for each condition and suggested actions to help you resolve the situation ...

Page 39: ...operly SmartSponge 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 the onscreen instructions System has not been placed into wand mode Place the system into wand mode and scan the pat...

Page 40: ...Count In Scanner of the device or over the Count Out Bucket Move wand away from the system 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 Sm...

Page 41: ...cted the case will continue Figure 4 1 Example System Alert Message Screen Pack Not Verified Retry Pack Discard Pack CAUSE The system is unable to scan the sponge pack ACTION Flip or rotate sponges and rescan the pack If rescanning does not correct the condition discard the pack and resume scanning a new pack CAUSE The system has detected a problem with the sponge pack ACTION Discard the sponge pa...

Page 42: ... a time CAUSE The sponge pack has already been counted ACTION The sponge pack is ready for use continue with system setup or operation CAUSE There are over 50 sponges in the Count Out Bucket ACTION Remove sponges or discard the full bag and replace with a new liner sponge counts will not change CAUSE There are over 70 sponges in the Count Out Bucket ACTION Remove sponges or discard the full bag an...

Page 43: ...m Case Overload More Than 500 Sponges Detected Remove Sponges and Power Cycle the System CAUSE There are 80or more sponges in the Count Out Bucket ACTION Remove sponges and separate into groups of no more than 50 Power cycle the system and then reinsert the groups into the Count Out Bucket one group at a time to assure all sponges have been accounted for The system suspends counting while in this ...

Page 44: ...op working If you receive a system failure 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 Figure 4 3 Example System Failure Screen For additional information please call customer service at 888 931 0787 ...

Page 45: ...A 1 Appendix A Technical Specifications SmartSponge System Dimensions Figure A 1 SmartSponge System Model A02 Weight 96 lbs 44 kg 48 122 cm 26 66 cm 34 86 cm 20 51 cm 25 64 cm ...

Page 46: ... Hz 60 W Power consumption 0 65 Amps at 120 VAC Outlet requirement standard single phase grounded three prong outlet Power cord length 20 feet Internal fuse rating 3 Amp fast acting on Neutral N and Line L Operating Temperatures Ambient temperature 50 F to 104 F 10 C to 40 C Relative humidity 30 to 75 Atmospheric pressure 700 to 1060 hPa Transport and Storage Temperatures Ambient temperature 40 F ...

Page 47: ...ystem Model A02 is intended for use in the electromagnetic environment specified below The customer or user of the ClearCount SmartSponge System Model A02 should ensure that it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF Emissions CISPR 11 Group 2 The ClearCount SmartSponge System Model A02 must emit electromagnetic energy in order to perform it...

Page 48: ...uality 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 ...

Page 49: ...ic 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 SmartSponge System Model A02 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 ...

Page 50: ...bove the ClearCount SmartSponge System Model A02 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 SmartSponge System Model A02 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 lim...

Page 51: ...ontrolled The customer or user of the ClearCount SmartSponge System Model A02 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications Equipment and the ClearCount SmartSponge System Model A02 as recommended below according to the maximum output power of the communications equipment Max Output Power Watts Separation m 150 kHz to ...

Page 52: ...A 8 Appendix A Technical Specifications Device Label Device Label Figure A 2 Device Label Read instructions prior to use Type B equipment Non ionizing radiation ...

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