WWQCCMS003Detects and counts surgical items with RFID tags.

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 i • • • • • • • • • • • • 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. Wa r n in g s 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. ii • • • • • • •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 ......................................................…

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100417 Rev. D For use with SmartSponge® Surgical Sponges In Scan Tray Count Out Bucket SmartWand Serial Number Power Entry Lift ® Apply between sheets, directly below surgical site. Pre-Surgery (May be left in ON position when not in use) Press to enter COUNT MODE. Place into Count Out Bucket. Press “ to scan packs in by holding them on the . Open and use sponges. Plug in power cord, flip switch to . ON SCAN IN END WAND Ensure System is in “COUNTING OUT”Mode; verified by display. If the ” Change Bag”System Alert appears, remove the sponges or discard the full bag and replace with a new liner. Sponge counts will not change. Do not fill the Count Out Bucket with more than 50sponges at a time. During Surgery If a sponge that has not been scanned in is detected by the Count Out Bucket, the system will prompt the user on what action to take. Accept infers the sponge was intentionally discarded into the bucket. Decline infers the sponge was accidentally held too close to the Count Out Bucket prior to being scanned in. ● ● Discard all sponges directly into the Count Out Bucket. Ensure that all sponges have been accounted for by placing them into the Count Out Bucket before ending the case. Press the button to view the final sponge counts. Make sure all columns have a green check mark. Press the button to save the case data and power down the device. If the is requested and the sponge counts are not reconciled, an will be needed to end the case. Ending Surgery Press the “STANDBY” button to retain case data and temporarily power down the device. Hold the wand over the surgical site above the location of the . When the SmartTag is detected, the on-screen figure will change to green as shown. SmartWand Slowly scan the patient holding the wand inches above, at a rate no faster than inches a second while following the onscreen directions. When a sponge is detected, the Amber LED on the wand will illuminate followed by an audible tone and the type and quantity will be displayed on the screen. Press to clear the “FOUND”column to rescan. Cover the with a sterile cover while passing it into the sterile field. Press the button to activate the wand. The green LED on the wand will illuminate when activated. Press to return to count mode. 1 2 3 4 5 WAND SYSTEM MESSAGECAUSEACTION Pack Not Verified – Retry Pack System unable to scan pack. Flip or Rotate pack and Rescan. If rescanning does not work, discard pack. Discard Pack System has detected a problem with pack. Discard pack and resume scanning with a new pack. Multiple Packs Detected – Remove and Scan One Pack at a Time System unable to scan more than one pack at a time. Ensure onepack is placed on the In-Scan Tray at a time. Pack Already ScannedPack already counted. Pack ready for use – open and use / continue. Change Bag – Bucket Limit Has Been Exceeded – Remove Sponges to Continue Over 50 sponges in Count Out Bucket. Remove sponges or discard bag and replace. (Counts will not change) Bag Overflow Warning – Bucket Limit Has Been Exceeded – Remove Sponges to Continue Over 70 sponges in Count Out Bucket. Remove sponges or discard bag and replace. (Counts will not change) System Reset – Bucket Limit Has Been Exceeded – Remove Sponges and Power Cycle the System Over 80 sponges in Count Out Bucket. Remove sponges and power cycle system. Rescan sponges in groups of no more than 50 to assure each has been counted. System Failure A system failure will prevent the system from functioning properly. In this event. Contact ClearCount for Service, Provide Numeric Error Code from screen, Power down the system. ClearCount Medical Solutions 101 Bellevue Road. Suite 300 Pittsburgh, PA 15229 (888) 931-0787 [email protected] Service Contact Messages System Messages are displayed on-screen as System Alerts, Warnings, or Failures.

Non-Conformities FCC ID: WWQCCMS 003 (CKC CS Ref # E10-000011-FCC-01) The items listed below represent requests for information following review of this application for certification under United S tates (FCC) regulations. Further question may arise pending review of responses to these items. OK ID # Non-Conformity or Comment Subm itted Response Respondent / Date of Response x 1 With regard to the Fieg transmitter portions of the equipment, please provide schematic diagrams for thes e portions, and as necessary to supplement required showing operational descriptions and block diagrams. Special note: This item also attach es to application E10-000007-FCC, FCC ID: WWQCCMS002. This item has a 20-day time window in which to provide the information. Failure to provide the requested information within this time fr ame will result in an application dismissal. Items received from Fe ig Feig Electronics. x 2 The spec limits used in the test report F2LQ3784B-02E for fundamental emissions are inconsis tent with the requirements of 15.225 (see pages 11 and 16 for ex amples). Please update test report to show demonstration of complian ce to the appropriate limits in 15.225. Updated test report provided. F2labs 2/4/09 x 3 The file size of the users manual provided is too large. Please provide the manual in file sizes less than 6MB (per FCC upload requirements). Compressed manual provided F2Labs 2/4/09 4 5 6 The items indicated above must be submitted before processing can continue on the referenced application. Failure to provide t he requested information within 60 days may result in application dismissal pursuant to Section 2.917(c) and forfeiture of the filing fee pursuant to Se ction 1.1106. How to read the table: OK column indicates closure by CKC CS. ID column is for use with Agents to assist in identifying the probable source for closure. A – Application issue TL – Test lab issue C – Client issue R – Retesting may be necessary # column indicates unique or separate non-conformity items (note some items may be related). Non-Conformity or Comment column indicates the evaluators specific question or comment. Submitted response column indicates the response or a summary of the response provided. Respondent / Date of Response column indicates the responding party or agent and the date of the response was either received or logged.

Client: ClearCount Medical Solutions, Inc. F-Squared Laboratories EUT: SmartSponge Plus System Order No.: F2LQ3784B External Photographs Page 1 of 6 Jan. 20, 2010 SmartBucket Front SmartBucket Rear Client: ClearCount Medical Solutions, Inc. F-Squared Laboratories EUT: SmartSponge Plus System Order No.: F2LQ3784B External Photographs Page 2 of 6 Jan. 20, 2010 SmartBucket Right SmartBucket Left Client: ClearCount Medical Solutions, Inc. F-Squared Laboratories EUT: SmartSponge Plus System Order No.: F2LQ3784B External Photographs Page 3 of 6 Jan. 20, 2010 Wand Assembly Front Wand Assembly Side Client: ClearCount Medical Solutions, Inc. F-Squared Laboratories EUT: SmartSponge Plus System Order No.: F2LQ3784B External Photographs Page 4 of 6 Jan. 20, 2010 Wand Assembly LED Panel Client: ClearCount Medical Solutions, Inc. F-Squared Laboratories EUT: SmartSponge Plus System Order No.: F2LQ3784B External Photographs Page 5 of 6 Jan. 20, 2010 SmartBucket with New Wand Client: ClearCount Medical Solutions, Inc. F-Squared Laboratories EUT: SmartSponge Plus System Order No.: F2LQ3784B External Photographs Page 6 of 6 Jan. 20, 2010 SmartBucket with New Wand 2

COMPONENT SPECIFICATION SHEET CCM PART NO. REVISION Label, SmartSponge System Model & Serial Number 100278 C Page 1 of 2 For use by affiliates of ClearCount Medical Solutions. This document contains proprietary information and may not be reproduced or disclosed without prior written approval. A printed version of this document is considered an uncontrolled copy. The user of this document is responsible for verifying the current issue date and revision level. PHYSICAL CHARACTERISTICS / SPECIFICATIONS:  DIMENSIONS: 5.00" WIDE X 3.75" HIGH; CORNER RADII = .25 MAX  MATERIAL: .007" PRE-TEXTURED POLYESTER, UL / CSA RECOGNIZED  REAR ADHESIVE: 3M 9472 HIGH STRENGTH 5 MIL, UL / CSA RECOGNIZED  COLOR: BACKGROUND – WHITE o TEXT AND GRAPHIC – BLACK o CLEARCOUNT LOGO – BLUE (Need color spec) o 1.00" WIDE X 0.25" HIGH - CLEAR WINDOW TO BE ADHESIVE FREE FOR REFERENCE ONLY 5.00 3.50 .25 COMPONENT SPECIFICATION SHEET CCM PART NO. REVISION Label, SmartSponge System Model & Serial Number 100278 C Page 2 of 2 For use by affiliates of ClearCount Medical Solutions. This document contains proprietary information and may not be reproduced or disclosed without prior written approval. A printed version of this document is considered an uncontrolled copy. The user of this document is responsible for verifying the current issue date and revision level. SUPPLIER INFORMATION: Approved Mfr(s) Mfr Description Mfr Part No. Possible Distributors Distributor Descr/Part# Butler Technologies N/A N/A SPECIAL HANDLING: N/A SHELF LIFE: N/A REVISION HISTORY: Revision Effective Date Change Notice # Contributor(s) B 04/17/2009 PCN 5016 SCS C 1-21-10 PCN 5045 JRZ

5 PLCS 12 5 2X 11 7 8 6 28 2 9 28 1 SEE SH 4FOR LOC. 2X SEE SH 4FOR LOC. 31 14 13 15 3X SEE SH 4FOR LOC. 13 17 5 18 19 3 34 11 34 1134 1134 ASME Y14.5M - 1994 03 THIRD ANGLE PROJECTION 2 D C B AB C D 1 2 3 4 5 6 7 8 8 765 4 3 2 1 E F E F A SYSTEM INTERPRET GEOMETRICTOLERANCING PER: CLEARCOUNT MEDICAL SOLUTIONS 100800 SHEET 1 OF 5 ASSEMBLY; SMARTSPONGE SCALE: 1:24 APP DATE: REV DWG. NO. C SIZE TITLE: - SEE BOM FINISH MATERIAL 3 4 .005 PROHIBITED. PROPRIETARY AND CONFIDENTIAL .010 TWO PLACE DECIMAL: THREE PLACE DECIMAL: UNITS FOR ALL DIMENSIONS UNLESSOTHERWISW NOTED: INCHESFRACTIONAL: ANGULAR: MACH: 1 BEND 1 THE INFORMATION CONTAINED IN THISDRAWING IS THE SOLE PROPERTY OFCLEARCOUNT MEDICAL SOLUTIONS. ANY REPRODUCTION IN PART OR AS A WHOLEWITHOUT THE WRITTEN PERMISSION OFCLEARCOUNT MEDICAL SOLUTIONS IS 1 SEE "DETAIL N", SHEET 3 THE HEAD UNIT BOTTOM PAN EL ASSEMBLY, ON THE H EAD UNIT ASSEMBLY (PN 100693) USING A BOX END WRENCH. TORQUE AS REQUIRED. GENERAL NOTES : APPLY A PEA SIZE DROP OF SILICONE (PN 100238) ON THE CABLE ASSEMBLIES 1. CONNECTOR AT THE INTERFACE POINTS IN THE ELECTRICAL BOX ASSEMBLY(PN 100694) AND THE TUNER BO ARD (PN 200068) LOCATED ON HEAD UNIT ASSEMBLY (PN 100693). 2. DELETE3. INSTALL THE SNAP RING TH AT CONNECTS HEAD UNIT ASSEMBLY (PN 100693) TO THE FRAM E ASSEMBLY (PN 100695) DURI NG THE ASSEMBLY OF HEAD UNIT ASSEMBLY. SEE SHEET 4 FOR DETAILS. 4. TIGHTEN WAND ASSEMBLY (PN 100674) CONNECTOR NUT TO 2.5in-lbs. 5. SECURE THE IN SCAN CABL E ASSEMBLY (PN 200110) AND CONNECTOR TO THE TUNER BOARD (P N 200068), LOCATED IN REVISIONS REV. DESCRIPTION OF CHANGE DWN BY APP BY APP DATE 02 ECN 1096 JRZ - 11-20-09 03 ECN 1113 JRZ JZ 1-7-10 16 17 17 3 33 SECURING BUCKET ASSEMBLY TO FRAME ASSEMBLY 03 ASME Y14.5M - 1994 THIRD ANGLE PROJECTION D C B AB C D 1 2 3 4 5 6 7 8 8 765 4 3 2 1 E F E F A SYSTEM INTERPRET GEOMETRICTOLERANCING PER: CLEARCOUNT MEDICAL SOLUTIONS 100800 SHEET 2 OF 5 ASSEMBLY; SMARTSPONGE SCALE: 1:24 APP DATE: REV DWG. NO. C SIZE TITLE: - SEE BOM FINISH MATERIAL UNITS FOR ALL DIMENSIONS UNLESSOTHERWISW NOTED: INCHESFRACTIONAL: ANGULAR: MACH: 1 BEND 1 TWO PLACE DECIMAL: .010 THREE PLACE DECIMAL: .005 PROPRIETARY AND CONFIDENTIAL THE INFORMATION CONTAINED IN THISDRAWING IS THE SOLE PROPERTY OFCLEARCOUNT MEDICAL SOLUTIONS. ANY REPRODUCTION IN PART OR AS A WHOLEWITHOUT THE WRITTEN PERMISSION OFCLEARCOUNT MEDICAL SOLUTIONS IS PROHIBITED. 4 3 2 1 19 30 20 21 21 21 SPONGE COUNTER ASSEMBLY w/ BUCKET PANELS REMOVED 6 5 10 BOTTOM VIEW (SOME ITEMS REMOVED FOR CLARITY) PANELS, BUCKET PLATE, Z-STRIP DETAIL C SCALE 2 : 1 1 25 22 26 GROUND LUG CONNECTION (FRAME TO EBOX) 232425 22 GROUND LUG CONNECTION (FRAME TO EBOX) 15 5 SEE NOTE 4 03 ASME Y14.5M - 1994 THIRD ANGLE PROJECTION D C B AB C D 1 2 3 4 5 6 7 8 8 765 4 3 2 1 E F E F A SYSTEM INTERPRET GEOMETRICTOLERANCING PER: CLEARCOUNT MEDICAL SOLUTIONS 100800 SHEET 3 OF 5 ASSEMBLY; SMARTSPONGE SCALE: 1:24 APP DATE: REV DWG. NO. C SIZE TITLE: - SEE BOM FINISH MATERIAL UNITS FOR ALL DIMENSIONS UNLESSOTHERWISW NOTED: INCHESFRACTIONAL: ANGULAR: MACH: 1 BEND 1 TWO PLACE DECIMAL: .010 THREE PLACE DECIMAL: .005 PROPRIETARY AND CONFIDENTIAL THE INFORMATION CONTAINED IN THISDRAWING IS THE SOLE PROPERTY OFCLEARCOUNT MEDICAL SOLUTIONS. ANY REPRODUCTION IN PART OR AS A WHOLEWITHOUT THE WRITTEN PERMISSION OFCLEARCOUNT MEDICAL SOLUTIONS IS PROHIBITED. 4 3 2 1 N DETAIL N SCALE 1 : 4 14 ITEM 3 IN BOM OF 100693#8-32 x 3/4" SHCS BUNDLE OUTSCAN CABLES AND WANDBULKHEAD CABLE WITH CABLE MOUNTPART NUMBER 100258 AND CABLE TIEPART NUMBER 200127TO BASE. NOTE: LOCATION OF CABLE MOUNT SHOULD BE SELECTEDAS CABLE LENGTHS ALLOW. ALL UNITS SHOULD HAVECABLE MOUNT LOCATED IN THE SAME LOCATION. 21 20 SEE NOTES 1, 5 20 14 CONNECT POWER/COM CABLE ASSEMBLY TO MCU2 PCB ASM LOCATED IN THE HEAD UNIT TOP ASSEMBLY AS SHOWN CONNECT TO MAIN POWER PORT CONNECT TO RS232 PORT 2 CONSOLETERMINAL ASM 19 HEAD UNIT ASSEMBLY INSTALLATION 03 ASME Y14.5M - 1994 THIRD ANGLE PROJECTION D C B AB C D 1 2 3 4 5 6 7 8 8 765 4 3 2 1 E F E F A SYSTEM INTERPRET GEOMETRICTOLERANCING PER: CLEARCOUNT MEDICAL SOLUTIONS 100800 SHEET 4 OF 5 ASSEMBLY; SMARTSPONGE SCALE: 1:24 APP DATE: REV DWG. NO. C SIZE TITLE: - SEE BOM FINISH MATERIAL UNITS FOR ALL DIMENSIONS UNLESSOTHERWISW NOTED: INCHESFRACTIONAL: ANGULAR: MACH: 1 BEND 1 TWO PLACE DECIMAL: .010 THREE PLACE DECIMAL: .005 PROPRIETARY AND CONFIDENTIAL THE INFORMATION CONTAINED IN THISDRAWING IS THE SOLE PROPERTY OFCLEARCOUNT MEDICAL SOLUTIONS. ANY REPRODUCTION IN PART OR AS A WHOLEWITHOUT THE WRITTEN PERMISSION OFCLEARCOUNT MEDICAL SOLUTIONS IS PROHIBITED. 4 3 2 1 31 .183 2.125 TYP. BOTH SIDES 28 .25 .25 32 9 14 14 20 TO ATTACH THE HEAD UNIT ASSEMBLY TO THE FRAME UNIT, REMOVE THE (4) FOURMOUNTING SCREWS THAT SECURE THE TOP HEAD UNIT TO THE BOTTOM HEAD UNITAND REMOVE THE INNER TRAY ASSEMBLIES/PARTS AND EXPOSE THE RETAINING HUB.PLACE THE SNAP RING INTO THE GROOVE ON THE HUB UNIT UNTIL SECURE. 03 ASME Y14.5M - 1994 THIRD ANGLE PROJECTION D C B AB C D 1 2 3 4 5 6 7 8 8 765 4 3 2 1 E F E F A SYSTEM INTERPRET GEOMETRICTOLERANCING PER: CLEARCOUNT MEDICAL SOLUTIONS 100800 SHEET 5 OF 5 ASSEMBLY; SMARTSPONGE SCALE: 1:24 APP DATE: REV DWG. NO. C SIZE TITLE: - SEE BOM FINISH MATERIAL UNITS FOR ALL DIMENSIONS UNLESSOTHERWISW NOTED: INCHESFRACTIONAL: ANGULAR: MACH: 1 BEND 1 TWO PLACE DECIMAL: .010 THREE PLACE DECIMAL: .005 PROPRIETARY AND CONFIDENTIAL THE INFORMATION CONTAINED IN THISDRAWING IS THE SOLE PROPERTY OFCLEARCOUNT MEDICAL SOLUTIONS. ANY REPRODUCTION IN PART OR AS A WHOLEWITHOUT THE WRITTEN PERMISSION OFCLEARCOUNT MEDICAL SOLUTIONS IS PROHIBITED. 4 3 2 1 ITEM NO. QTY UOM CLEARCOUNT PART NUMBER DESCRIPTION 34 11 EA 101023 Washer 1/4" Screw Size, 5/8" OD, .04"-.06" Thick 33 2 EA 100097 FLAT HD PHILLIPS SHEET METAL SCREW; #12 x 1-3/4" LONG 32 1 EA 100529 Retaining Ring-External; 1-1/4" Shaft Diameter, SS 31 1 EA 100278 LABEL; SMART BUCKET MODEL & SERIAL NUMBER 30 1 EA 200113 WAND BULKHEAD CABLE ASSEMBLY 29 2 EA 100247 GROMMET WITH 1/8" GROOVE 28 2 EA 100166 SIDE LO…

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Client: ClearCount Medical Solutions, Inc. F-Squared Laboratories EUT: SmartSponge Plus System Order No.: F2LQ3784B Internal Photographs Page 1 of 21 Jan. 20, 2010 Bucket Antenna Front Client: ClearCount Medical Solutions, Inc. F-Squared Laboratories EUT: SmartSponge Plus System Order No.: F2LQ3784B Internal Photographs Page 2 of 21 Jan. 20, 2010 Bucket Antenna Rear Client: ClearCount Medical Solutions, Inc. F-Squared Laboratories EUT: SmartSponge Plus System Order No.: F2LQ3784B Internal Photographs Page 3 of 21 Jan. 20, 2010 Bucket Antenna Right Side Client: ClearCount Medical Solutions, Inc. F-Squared Laboratories EUT: SmartSponge Plus System Order No.: F2LQ3784B Internal Photographs Page 4 of 21 Jan. 20, 2010 Bucket Antenna Left Side Client: ClearCount Medical Solutions, Inc. F-Squared Laboratories EUT: SmartSponge Plus System Order No.: F2LQ3784B Internal Photographs Page 5 of 21 Jan. 20, 2010 Bucket Antenna Bottom Client: ClearCount Medical Solutions, Inc. F-Squared Laboratories EUT: SmartSponge Plus System Order No.: F2LQ3784B Internal Photographs Page 6 of 21 Jan. 20, 2010 EBox Inside EBox Inside EBox 2 Client: ClearCount Medical Solutions, Inc. F-Squared Laboratories EUT: SmartSponge Plus System Order No.: F2LQ3784B Internal Photographs Page 7 of 21 Jan. 20, 2010 Inside Head Unit Client: ClearCount Medical Solutions, Inc. F-Squared Laboratories EUT: SmartSponge Plus System Order No.: F2LQ3784B Internal Photographs Page 8 of 21 Jan. 20, 2010 Inside Head Unit 2 Client: ClearCount Medical Solutions, Inc. F-Squared Laboratories EUT: SmartSponge Plus System Order No.: F2LQ3784B Internal Photographs Page 9 of 21 Jan. 20, 2010 MCU 1 MCU 1 Rear Client: ClearCount Medical Solutions, Inc. F-Squared Laboratories EUT: SmartSponge Plus System Order No.: F2LQ3784B Internal Photographs Page 10 of 21 Jan. 20, 2010 MCU 2 MCU 2 Rear Client: ClearCount Medical Solutions, Inc. F-Squared Laboratories EUT: SmartSponge Plus System Order No.: F2LQ3784B Internal Photographs Page 11 of 21 Jan. 20, 2010 MCU 2-2 Rear Client: ClearCount Medical Solutions, Inc. F-Squared Laboratories EUT: SmartSponge Plus System Order No.: F2LQ3784B Internal Photographs Page 12 of 21 Jan. 20, 2010 SmartBucket Rear Panel Removed Client: ClearCount Medical Solutions, Inc. F-Squared Laboratories EUT: SmartSponge Plus System Order No.: F2LQ3784B Internal Photographs Page 13 of 21 Jan. 20, 2010 SmartBucket Rear Panel Removed 2 Client: ClearCount Medical Solutions, Inc. F-Squared Laboratories EUT: SmartSponge Plus System Order No.: F2LQ3784B Internal Photographs Page 14 of 21 Jan. 20, 2010 Power Supply Top Power Supply Bottom Client: ClearCount Medical Solutions, Inc. F-Squared Laboratories EUT: SmartSponge Plus System Order No.: F2LQ3784B Internal Photographs Page 15 of 21 Jan. 20, 2010 SmartSponge LCD Client: ClearCount Medical Solutions, Inc. F-Squared Laboratories EUT: SmartSponge Plus System Order No.: F2LQ3784B Internal Photographs Page 16 of 21 Jan. 20, 2010 Wand LED PCB Front Wand LED PCB Rear Client: ClearCount Medical Solutions, Inc. F-Squared Laboratories EUT: SmartSponge Plus System Order No.: F2LQ3784B Internal Photographs Page 17 of 21 Jan. 20, 2010 FEIG Module Front FEIG Module Rear Client: ClearCount Medical Solutions, Inc. F-Squared Laboratories EUT: SmartSponge Plus System Order No.: F2LQ3784B Internal Photographs Page 18 of 21 Jan. 20, 2010 FEIG Module Right Side FEIG Module Left Side Client: ClearCount Medical Solutions, Inc. F-Squared Laboratories EUT: SmartSponge Plus System Order No.: F2LQ3784B Internal Photographs Page 19 of 21 Jan. 20, 2010 FEIG Module Top FEIG Module Bottom Client: ClearCount Medical Solutions, Inc. F-Squared Laboratories EUT: SmartSponge Plus System Order No.: F2LQ3784B Internal Photographs Page 20 of 21 Jan. 20, 2010 FEIG MUX Top FEIG MUX Bottom Client: ClearCount Medical Solutions, Inc. F-Squared Laboratories EUT: SmartSponge Plus System Order No.: F2LQ3784B Internal Photographs Page 21 of 21 Jan. 20, 2010 FEIG DAT Board in Wand Top FEIG DAT Board in Wand Bottom

This report shall not be duplicated except in full without the written approval of F-Squared Laboratories. Form EMC009-102209 Report Number: F2LQ3784B-02E Page 1 of 73 Issue Date: Feb. 3, 2010 F-Squared Laboratories 16740 Peters Road Middlefield, Ohio 44062 (440) 632-5541 Fax: (440) 632-5542 For a SmartSponge Plus System – Phase I Cost Reduction Manufacturer: Testing Laboratory: Clearcount Medical Solutions, Inc. F-Squared Laboratories 101 Bellevue Road, Suite 300 16740 Peters Road Pittsburgh, Pennsylvania 15229 Middlefield, Ohio 44062 United States of America United States of America The SmartSponge Plus System - Phase I Cost Reduction, model A02, was tested and was found to comply with the requirements of the Federal Communications Commission outlined in the Federal Register CFR 47, Part 15.225. The product was received on Dec. 23, 2009 and the testing was completed on Jan. 27, 2010. Evaluation Conducted By: Report Reviewed By: Ken Littell Russell Beattie Wendy Fuster EMC Project Eng. EMC Technical Mgr. President Certification Test Report Client: Clearcount Medical Solutions, Inc. Order Number: F2LQ3784B Model: A02 Form EMC009-102209 Report Number: F2LQ3784B-02E Page 2 of 73 Issue Date: Feb. 3, 2010 Table of Contents Section Title Page Cover Page 1 Table of Contents 2 1 Engineering Statement 3 2 List of Measurement Instrumentation 5 3 EUT Information and Data 6 4 EUT Configuration and Cables 7 5 Product Description 8 6 FCC Part 15.225(a)-(d) – Radiated Emissions 9 7 Figures – Spectral Data Plots 17 8 Pictorials – Test Setup 48 9 Pictorials – EUT 52 Client: Clearcount Medical Solutions, Inc. Order Number: F2LQ3784B Model: A02 Form EMC009-102209 Report Number: F2LQ3784B-02E Page 3 of 73 Issue Date: Feb. 3, 2010 1. ENGINEERING STATEMENT This report has been prepared on behalf of Clearcount Medical Solutions, Inc. to provide documentation for the testing described herein. This equipment has been tested and found to comply with Part 15.225 of the FCC Rules using ANSI C63.4 2003 standards. The test results found in this test report relate only to the items tested. 1.1. Equipment Under Test: SmartSponge Plus System FCC ID: WWQCCMS003 1.2. Trade Name: Clearcount Medical Solutions, Inc. 1.3. Model: A02 1.4. Power Supply: Input: 100-240V~, 50-60 Hz, 1.3A. 1.5. Applicable Rules: CFR 47, Part 15.225, (a)-(e) Reference FCC ID PJMLRM2000. Test results for Part 15.225(e) may be found on page 33 of 58 of CETECOM ICT Services GmbH Test Report 2-4112-01-02/05, under separate cover. 1.6. Equipment Category: Low Power Communication Device Transmitter Frequency: 13.56 MHz 1.7. Antenna: Handheld Wand 1.8. Measurement Location: F-Squared Laboratories in Middlefield, Ohio. Site description and attenuation data are on file with the FCC's Sampling and Measurement Branch at the FCC Laboratory in Columbia, MD. Client: Clearcount Medical Solutions, Inc. Order Number: F2LQ3784B Model: A02 Form EMC009-102209 Report Number: F2LQ3784B-02E Page 4 of 73 Issue Date: Feb. 3, 2010 1.9. Measurement Procedure: All measurements were performed according to the 2003 version of ANSI C63.4 and recommended FCC parts 15.31, 15.33 and 15.35. A list of the measurement equipment can be found in Section 2. 1.10. Uncertainty Budget: Conducted Emissions – Combined uncertainly + 1.13 dB, expanded +2.26 dB Radiated Emissions – Combined Uncertainty + 2.24 dB; Expanded Uncertainty +4.48 dB Client: Clearcount Medical Solutions, Inc. Order Number: F2LQ3784B Model: A02 Form EMC009-102209 Report Number: F2LQ3784B-02E Page 5 of 73 Issue Date: Feb. 3, 2010 2. LIST OF MEASUREMENT INFORMATION Equipment Type Asset Number Manufacturer Model Serial Number Calibration Due Date Shield Room CL014 Shielding Resources 3 Meter 001 Aug. 14, 2010 Temp/Hum. Recorder CL118 Extech RH520 H005870 Dec. 11, 2010 Spectrum Analyzer 0141 Hewlett Packard 8591E 3520A04145 Oct, 8, 2010 Receiver 0145 Rohde & Schwarz Display, EASI-0- 804-8932-52; RF Unit, ESMI-RF 1032-5640-53 84982/015; 849152/005 Apr. 23, 2010 Antenna 1-Chamber 0142 ETS/EMCO 3142B 9811-1330 Aug. 31, 2010 Antenna 2-OATS 0105 Sunol Sciences JB1 A101101 July 22, 2011 Pre-Amplifier 0197 Hewlett-Packard 8447D 1726A01006 Oct. 20, 2010 OATS CL017 Compliance Labs N/A 001 Jan. 13, 2010 Transient Limiter CL102 Hewlett Packard 11947A 3107A03325 Dec. 31, 2010 LISN 1 0149 Solar 8028-50-TS-24- BNC 1130 Oct. 20, 2010 LISN 3 0148 Solar 8028-50-TS-24- BNC 1129 Oct. 20, 2010 Active 18” Loop Antenna CL082 A.H. Systems, Inc. SAS-562B 241 Sept. 14, 2011 Client: Clearcount Medical Solutions, Inc. Order Number: F2LQ3784B Model: A02 Form EMC009-102209 Report Number: F2LQ3784B-02E Page 6 of 73 Issue Date: Feb. 3, 2010 3. EQUIPMENT UNDER TEST (EUT) INFORMATION AND DATA 3.1 Test Item Condition: The equipment to be tested was received in good condition. 3.2 Testing Algorithm: The EUT was on and operating, waiting to count out sponges as they were scanned. Three modes were tested: out, in and wand. 3.3 Radiated Emission Testi…

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