ScopeTech I.Q Instruction Manual Rev B

TABLE OF CONTENTS Introduction...3

Viewing Error Report...23

Indication for Use... ...3

Downloading and Viewing Reports on PC...24

Safety Precautions...3

PC Summary Report...25

Specifications...4

PC Cycle Report...26

Accessory Kit Parts List...5

PC Setup Report...26

Flushing Tube Kit Parts List.. ...6

Exporting Reports to Excel...27

Inflation Kits...6

Operating ScopeTech I.Q. - Sequence Mode...28

Installation Procedures...7

Operating ScopeTech I.Q. - Express Mode...30

Irrigation Flushing Tube Assemblies...9

Decontamination for ScopeTech I.Q...32

Elevator Wire and Auxiliary Irrigation Tube Assemblies...11

Cycle Errors...33

Connecting Endoscope Adapters...11

Troubleshooting...34

Connecting Flushing Tubes to Endoscope...12

Endoscope Flushing Guides...35

Endoscope Connection Examples...12

Replacement Parts...38

PC Software Installation...13

Parts Diagram...39

Set-up File Programming...13

EC - Declaration of Conformity...43

Programming ScopeTech I.Q...17

Warranty...44

Viewing Summary Report...22

©2014 Knight LLC. All rights reserved. Scope Tech I.Q. is a trademark of Knight LLC. The trademarks and names of other companies and products are the property of their respective owners.

0901136-CM Rev.B

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INTRODUCTION The new Scope Tech I.Q.™ is a comprehensive flexible endoscope pre-cleaning system that dramatically improves the speed of endoscope reprocessing while providing step-by-step cleaning process management, cycle validation, and reports. The ScopeTech I.Q. 4-in-1 system offers an automated, hands-free method for pressurizing your scope during a leak test inspection, a main and auxiliary channel flush with pulsating flow technology to remove contaminants, and precision detergent dosing to achieve optimum cleaning results. An optional barcode scanner reduces the time to input scope serial number and technician I.D.s to ease the documentation and reporting burdens for sterile processing managers. The ScopeTech is an intelligent system with two flow meters that monitor the flow of the flush water into the endoscope channels and meter precise amounts of detergent into the sink. These exclusive “smart” functions insure the internal channels of the endoscope are flushed and rinsed to the optimum clean level each time, eliminating any guesswork by the cleaning technician. Flush and rinse alarms will sound when water or detergent is not flowing at the calibrated flow rate. This will allow the cleaning technician an opportunity to correct the issue and repeat the pre-cleaning step where the error occurred and continue the pre-cleaning process. These alarms will be saved to the internal memory for supervisor inspection and process quality management.

INDICATION FOR USE The ScopeTech I.Q. pre-cleaning assist system is intended for use as an assist device with leak test, detergent dosing, and channel flushing during the pre-cleaning portion of flexible endoscope reprocessing specified by the endoscope manufacturer.

SAFETY SYMBOLS Listed below are explanations of the safety symbols that appear either on the unit, in the instruction manual, or both. Please familiarize yourself with the meaning of each symbol. GENERAL CAUTION: This symbol indicates a general safety caution. SHOCK HAZARD: This symbol indicates that hazardous voltages are inside the enclosure. READ MANUAL: This symbol indicates to read the manual for important instructions and procedures related to safety.

SAFETY PRECAUTIONS CAUTION: Wear protective clothing and eye wear whenever operating this system. CAUTION: Wear protective clothing and eye wear when dispensing chemicals. Observe safe handling instructions (MSDS) provided on chemical container or as supplied by chemical manufacturer. CAUTION: To avoid severe or fatal shock, physical injury, always disconnect main power when servicing the unit. CAUTION: Always follow the endoscope manufacturer’s guidelines and the established professional protocols for the cleaning, maintenance and care of endoscopes and endoscope accessories. CAUTION: When installing any equipment, ensure that all national and local safety, electrical and plumbing codes are met. • System is for indoor use only • Do not submerge or place in direct path of spray/moisture • System operates with safe 24 Volt DC power • Only approved, factory authorized technicians to service unit 3

0901136-CM Rev.B

WARNING ScopeTech I.Q. is NOT a sterilization system, does NOT sterilize, and should NEVER be used for sterilization. It is intended only for pre-sterilization cleaning of flexible endoscopes in lieu of using a counter-top or hand-held pump for air leak testing and using a syringe for detergent dosing, detergent flushing and rinsing. It is NOT a substitute for sterilization. When using the ScopeTech I.Q. system, always follow the testing and cleaning protocols defined by the manufacturer, hospital and/or other facility at which the endoscope is used. Knight is not responsible for the adequacy or efficacy of testing and cleaning protocols. The pump and irrigation flushing tubes for the ScopeTech I.Q. system require regular cleaning (see page 31 of this instruction manual for decontamination of the ScopeTech I.Q. Consult your chemical supplier for appropriate detergents for use in pre-sterilization cleaning of flexible endoscopes and appropriate high level disinfection solutions for use in daily cleaning of pump and irrigation flushing tubes for the ScopeTech I.Q. system.

SPECIFICATIONS Cabinet Materials Dimensions

#304 Stainless Steel, Powder Coated 9-3/4” H x 7-1/8” W x 8-3/4” D 24.76 cm x 18.09 cm x 22.22 cm Case Rating IPX0 Flush Pump Flow Rate 0.36 GPM, 1.4 LPM Flush Pump Suction Maximum suction height = 24”/ 61 cm Dosing Pump Flow Rate 17 oz./min., 500 ml/min. Dosing Pump Suction Maximum suction height = 10’ / 3 m (300 cm) Leak Test Pressure Max PSI: 6.0 Max bar: .4 Power Supply/Voltage Wall Mount Type, In: 100-240 Volts AC,1.4-0.7A, 50-60 Hz Out: 24 Volts DC 2.5A Chemical Compatibility - Flush Pump Industry standard enzymatic and other detergents in diluted form. Do not use Isopropyl Alcohol with the flush pump. Chemical Compatibility – Dose Pump Industry standard enzymatic and other detergents. Flush Tubes/Hook Ups Compatibility Industry standard enzymatic and other detergents in diluted form. Do not use Isopropyl Alcohol with the flush pump. Unit Weight 13.3 lbs., 6.06 Kg Temperature Probe Max temperature = 160° F, 71° C Approvals CAN/CSA-C22.2 No. 61010-1-04 UL Std. No. 61010-1 (2nd Edition) EN 61010-1:2010 Product Testing Barcode Scanner

0901136-CM Rev.B

CSA International, Irvine, California Power Supply: 5 Volts DC +/- 5% Housing material: 30% PC + 70% ABS, UL94U0 Beep Sound Volume: >70dB Safety Approval: CE, FCC Class A, BSMI 4

ACCESSORY KIT PARTS LIST Item No. Part Number 1 7117164 2 7117165

Qty. 1 1

Description Flush Suction Tube with Suction Cup Flush Discharge Tube, Autoclavable

3

7117166

1

Flush Discharge Tube Extension, Autoclavable

4 5 6

7117167 7117155-S 7117155-D

1 1 1

Auxiliary Flush Discharge Tube, Autoclavable Detergent Suction Tube Detergent Discharge Tube

5

4 6

1 2

3

*If items are missing from your accessory kit, please contact Knight customer service immediately: 1-800-854-3764. The serial number on your ScopeTech I.Q. will be required at the time of the call.

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0901136-CM Rev.B

FLUSHING TUBE KIT PARTS LIST Item No. 1 2 3 4 5 6 7 8 9 10 11 12 13

Part Number 0600759 0600726 0600767 0600764 0600765 0600766 0600762 0300121 7117168-1 7117168-2 7117168-3 7117168-4 7117168-5

Qty. 4 12 4 6 4 4 4 12 2 2 2 2 2

Description Tubing, Silicone, 12” (30.48 cm) Cut, 1/16” (.158 cm) ID x 1/8” (.317 cm) OD Tubing, Silicone, 12” (30.48 cm) Cut, 1/8” (.317 cm) ID x 1/4” (.635 cm) OD Tubing, Silicone, 12” (30.48 cm) Cut, 3/16” (.476 cm) ID x 3/8” (.952 cm) OD Fitting, Male Luer w/Lock Ring, 5/32” (.396 cm) Hose Barb Fitting, Reducing, Coupling, 1/4” (.635 cm) x 5/32” (.396 cm) Fitting, Female Luer, 1/8” (.317 cm) Hose Barb Fitting, Female Luer, 5/32” (.396 cm) Hose Barb Cable Ties, 3.5” (8.89 cm) One-Way Adapter, Autoclavable Two-Way Adapter, Autoclavable Three-Way Adapter, Autoclavable Four-Way Adapter, Autoclavable Five-Way Adapter, Autoclavable

4

3

2

6

8

5

7

1

9

10

11

12

13

INFLATION KITS Item No. 1 2 3 4

Part Number 7117161-O 7117161-P 7117161-F 7117161-S

1

0901136-CM Rev.B

Qty. 1 1 1 1

Description Olympus Inflation Test Kit Pentax Inflation Test Kit Fujinon Inflation Test Kit Karl Storz Inflation Test Kit

2

3

6

4

INSTALLATION PROCEDURES 1. Tools you will need: Phillips screw driver, tube cutters (utility knife), needle nose pliers, side cutters, 200 ml graduated cylinder. If the unit is to be mounted on the wall you will also need a drill, drill bit and anchors. 2. To begin the installation of the ScopeTech I.Q., remove all of the accessories from the included accessory kit. 3. ScopeTech I.Q. can be placed on a countertop, shelf, or mounted on the wall using the keyhole openings on the back of the unit. Select a place for the unit within 6ft (1.8m) of a GFI protected power outlet. It is important to keep the power supply cable above the sink level.

Fig. 1

It is not recommended to use an extension cord. It is important to place or mount the unit on a hard, flat dry surface that is level. See Fig. 1. 4. If mounting the unit on the wall, select the proper wall anchors and screws for your wall surface. Self threading drywall anchors work best on drywall. See Fig 2. For stainless steel, tile or stone surfaces use a similar deep set plastic wall anchor and screw combination. 5. Place the paper wall template from the accessory kit on the wall where the unit will be mounted. Mark the screw locations, then pre-drill the holes for the anchors in the wall. Insert the anchors and screws. Make sure to leave enough space between the anchors and the head of the tightened screws for the key holes on the unit to fit. Mount the unit by aligning the key holes with the screws and dropping the dispenser in place. Make sure not to put too much pressure on the unit. See Fig. 3

Fig. 2

Fig. 3

6. Push the detergent suction tube fitting (part #7117155-S) into the detergent suction port marked “Detergent In” on the bottom right of the ScopeTech I.Q. Push the detergent discharge tube with check valve (part #7117155-D) into the “Detergent Out” port on the bottom right of the ScopeTech I.Q. See Fig. 4. To remove fittings from connector push in the collar around the male insert then push in then out. Do not force the fitting out as it will break if the collar is not properly disengaged first. 7. Route the detergent suction tube (part #7117155-S) to the detergent container. 8. Remove the umbrella foot valve and ceramic tube weight from the detergent suction tube. Drill or cut a 3/8” hole into the bottle cap of the detergent container and insert the detergent suction tube through the hole. Slide the ceramic tube weight and umbrella foot valve back onto the detergent suction tube. See Fig. 5. Place the cap on the detergent. Push the suction tube to the bottom of the container. Be sure there are no kinks in the tube or obstructions that would impede the flow of detergent to the pump.

7

Fig. 4

Fig. 5

0901136-CM Rev.B

INSTALLATION PROCEDURES (continued) 9. Use the cable tie mounts and cable ties to secure the detergent suction tube to the wall that leads to the ScopeTech I.Q. unit. Trim the excess plastic from the cable ties once the detergent suction tube has been secured. See Fig. 6. 10. Route the detergent discharge tube (part #7117155-D) and temperature probe to the back of the sink where it will be mounted just above the bottom (1-3”), depending on the total volume of the sink fill. Remove the check valve if needed to trim the excess tubing from the dispenser discharge tube once you have verified the length. Re-attach the check valve to the end of the dispenser discharge tube. Make sure that the arrow points in the direction of the flow. Use the vinyl suction cup and cable ties to secure the discharge tube and temperature probe to the inside of the sink. See Fig. 7. Use additional cable ties to secure the dispenser discharge tube to the temperature probe to keep them together.

Fig. 6

Fig. 7

11. Route the power supply cable to the power outlet and secure with the cable ties. If the detergent suction tube and power supply are located on the same side, secure them together for a cleaner installation. 12. Locate the flush suction tube (part #7117164) and push it over the male fitting labeled “Flush In” on the bottom left of the ScopeTech I.Q. The fitting should snap in place and form a watertight seal. See Fig. 8. Connect the male luer extension tube to lengthen the tube if needed. 13. Locate the flush discharge tube (part #7117165) and push it into the female fitting labeled “Flush Out” on the bottom left of the ScopeTech I.Q. The fitting should snap in place and form a watertight seal. See Fig. 9. Locate the flush discharge tube extension (part #7117166) and plug it into the flush discharge tube. See Fig. 10.

Fig. 8

Fig. 9

14. If using the dual flushing capabilities of the ScopeTech I.Q., locate the auxiliary flush discharge tube (part #7117167) and push it onto the female fitting labeled “Aux Out”. See Fig. 11. 15. Before connecting an endoscope for pre-cleaning, you will need to assemble the irrigation flushing tubes for the type of endoscopes you will be flushing. These irrigation tubes will connect to the flush discharge and auxiliary flush tube extensions.

Fig. 10

16. Locate the inflation test kit (part #7117161-O, 7117161-P, 7117161-F, 7117161-S) and push it into the female fitting labeled “Air Out” on the middle right of the ScopeTech I.Q. The fitting should snap in place to achieve an airtight seal. See Fig. 12. 17. Prior to its first use, ensure to test and document the functionality of the ScopeTech IQ Pre-clean Assist System as per hospital protocol or local guidelines (as necessary).

Fig. 11

Fig. 12

0901136-CM Rev.B

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IRRIGATION FLUSHING TUBE ASSEMBLIES 1. To assemble two-way irrigation flushing, connect the one-way adapter (part # 7117168-1) to one of the barbs on the two-way adapter (Part # 7117168-2). Push the tube over the barb until it reaches the bottom of the barb. See Fig. 2. 2. Next, attach a large silicone tube with male luer and lock ring (part # 0600767) to the one-way adapter by screwing the male luer with lock ring clockwise onto the female luer. See Fig. 3. 3. Connect a medium silicone tube (part # 0600726) to the remaining barb on the two-way irrigation adapter. Again, make sure to push the tube over the barb until the tube reaches the bottom of the barb. See Fig. 4.

Fig. 1

Fig. 2

Fig. 3

Fig. 4

1. To assemble three-way irrigation flushing, connect the one-way adapter (part # 7117168-1) to one of the barbs on the three-way adapter (Part # 7117168-3). Push the tube over the barb until it reaches the bottom of the barb. See Fig. 6. 2. Next, attach a large silicone tube with male luer and lock ring (part # 0600767) to the one-way adapter by screwing the male luer with lock ring clockwise onto the female luer. See Fig. 7. 3. Connect two medium silicone tubes (part # 0600726) to the remaining barbs on the three-way irrigation adapter. Again, make sure to push the tubes over the barbs until the tubes reach the bottom of the barbs. See Fig. 8.

Fig. 5

Fig. 6

Fig. 7

Fig. 8

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0901136-CM Rev.B

IRRIGATION FLUSHING TUBE ASSEMBLIES (continued) 1. To assemble four-way irrigation flushing, connect the one-way adapter (part # 7117168-1) to one of the barbs on the four-way adapter (Part # 7117168-4). Push the tube over the barb until it reaches the bottom of the barb. See Fig. 10. 2. Next, attach a large silicone tube with male luer and lock ring (part # 0600767) to the one-way adapter by screwing the male luer with lock ring clockwise onto the female luer. See Fig. 11. 3. Connect three medium silicone tubes (part # 0600726) to the remaining barbs on the four-way irrigation adapter. Again, make sure to push the tubes over the barbs until the tubes reach the bottom of the barbs. See Fig. 12.

Fig. 9

Fig. 10

Fig. 11

Fig. 12

1. To assemble five-way irrigation flushing, connect the one-way adapter (part # 7117168-1) to one of the barbs on the five-way adapter (Part # 7117168-5). Push the tube over the barb until it reaches the bottom of the barb. See Fig. 14. 2. Next, attach a large silicone tube with male luer and lock ring (part # 0600767) to the one-way adapter by screwing the male luer with lock ring clockwise onto the female luer. See Fig. 15. 3. Connect four medium silicone tubes (part # 0600726) to the remaining barbs on the five-way irrigation adapter. Again, make sure to push the tubes over the barbs until the tubes reach the bottom of the barbs. See Fig. 16.

Fig. 13

Fig. 14

Fig. 15

Fig. 16

0901136-CM Rev.B

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ELEVATOR WIRE AND AUXILIARY FLUSHING TUBE ASSEMBLIES Elevator Wire Flushing Assembly To make the elevator flushing assembly, connect the 1/8” (.317cm) female luer fitting (part # 0600766) to the small tubing, 1/16” (.158cm) ID (part #0600759). Then attach the endoscope adapter to the elevator flushing assembly. See the guidelines below for Connecting the Endoscope Adapters. Auxiliary Flushing Assembly To make the Auxiliary Flushing Assembly, connect the 5/32” (.396cm) female luer fitting (part # 0600762) to the medium tubing, 1/8” (.317cm) ID (part # 0600726). Then attach the auxiliary water channel adapter to the auxiliary flushing assembly. See the guidelines below for Connecting the Endoscope Adapters. Note: Flushing Tube Decontamination - ScopeTech I.Q. flushing tubes and plastic fittings can be decontaminated by autoclaving or using high level disinfectant solutions. Consult the manufacturer’s instructions for use for required soak time and safe handling procedures. Compatible High Level Disinfectants - Ortho-Phthalaldehyde (OPA), Glutaraldehyde, Peracetic Acid (PAA), Quaternary Ammonium.

CONNECTING THE ENDOSCOPE ADAPTERS After you have assembled the flushing tubes for the type of endoscopes that will be flushed, gather the port adapters that were supplied with the endoscope from the manufacturer or provided with your ScopeTech IQ (optional). Connect the endoscope adapters to the flushing tubes to complete the flushing tubes assembly. Follow the manufacturer’s instructions for connecting the endoscope adapters to the channels of the their endoscopes prior to pre-cleaning. Olympus Endoscope Adapters Attaching the Olympus Endoscope adapters to the flushing tubes.

WATER CHANNEL ADAPTER

AIR/WATER CHANNEL ADAPTER

BIOPSY PORT ADAPTER

AUXILIARY WATER CHANNEL ADAPTER

EXAMPLE CONNECTIONS FOR OLYMPUS ENDOSCOPE ADAPTERS

Fujinon Endoscope Adapters Attaching the Fujinon Endoscope adapters to the flushing tubes.

WATER CHANNEL ADAPTER

AIR/WATER CHANNEL ADAPTER

CLEANING ADAPTER

EXAMPLE CONNECTIONS FOR FUJINON ENDOSCOPE ADAPTERS

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0901136-CM Rev.B

CONNECTING THE ENDOSCOPE ADAPTERS (CONT.) Pentex Endoscope Adapters Attaching the Pentex Endoscope adapters to the flushing tubes.

WATER PORT ADAPTER

AIR/WATER CHANNEL ADAPTER

BIOOPSY PORT ADAPTER

SUCTION CHANNEL

EXAMPLE CONNECTIONS FOR PENTEX ENDOSCOPE ADAPTERS

Connecting the Flushing Tubes to an Endoscope After you have assembled the flushing tubes and attached the endoscope adapters, you are ready to connect the endoscope to ScopeTech. Connect the endoscope adapters to the endoscopes. Follow the endoscope manufacturer’s instructions for pre-cleaning and connecting the endoscope adapters to the channels of their endoscopes.

Fig. 1 AIR/ WATER CHANNEL BLOCKER

BIOPSY PORT CAP

FLUSHING TUBE TO SUCTION VALVE

AIR/WATER CHANNEL ADAPTER

Endoscope Connection Examples

0901136-CM Rev.B

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FLUSHING TUBE TO AIR PIPE

AUXILIARY WATER CHANNEL ADAPTER

PC SOFTWARE INSTALLATION 1. Insert the Knight USB drive into the USB port or the Knight CD-ROM into the CD drive on your PC. 2. Locate the “Knight ScopeTech I.Q. Dual Flush Install” file on the USB drive and double-click to run the installation. 3. Follow the installation prompts to install the application.

SET-UP FILE PROGRAMMING 1. Locate the ScopeTech I.Q. Dual Flush desktop icon and double-click it to run the application. 2. The main menu screen will appear after the application has loaded. See Fig. 1. 3. To begin programming a set-up file, click the Create Program File button. The Program File screen will appear. See Fig. 2.

Fig. 1 Fig. 2 4. Enter the serial number for the ScopeTech I.Q. or any other company identifier that you would like to use. 5. Enter a password that allows access to all programming and system data input/output. This number should only be known to the department manager. 6. Select the language (English, German, Spanish, or Chinese). 7. Select unit of measure (standard or metric). 8. Select alarm On or Off for an audible alarm when system errors occur. 9. Select temperature alert On or Off for notification when sink water temperature is not within range.

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0901136-CM Rev.B

SCOPETECH I.Q. SET-UP FILE PROGRAMMING (continued)

10. Enter the name of the hospital or facility. 11. Enter the name of the detergent that will be used. 12. Enter the manufacturer’s minimum required temperature for the detergent. 13. Enter the manufacturer’s maximum required temperature for the detergent.

14. Enter the pressure unit of measurement. 15. Enter the inflation pressure. ScopeTech is set to pressurize your scope to 200 mmHg (3.87psi). The factory default value is generally accepted. 16. Enter the pressure decay rate. The pressure decay rate is the acceptable rate for maintaining positive pressure of the endoscope. The factory default value is set to 5 mmHg/sec and this rate is generally accepted. 17. Enter the amount of detergent to be dispensed in milliliters to achieve chemical supplier recommended concentration taking into consideration the sink volume. 18. Enter the amount of time needed to flush the detergent through the endoscope. 19. Enter the amount of time needed to rinse the detergent from the endoscope.

The decontamination cycle built into the ScopeTech I.Q. has four programmable steps. Consult with your chemical supplier for recommendations on the required soak time to effectively decontaminate the internal fluid contact surfaces of ScopeTech I.Q. See the decontamination procedure on page 31 for step-by-step directions on how to perform the cleaning process. 20. Enter the decontamination flush time. This is the amount of time required to suction the detergent up into the flush pump suction and discharge tubes. The time required varies depending on the length of the suction and discharge tubes, but typically should require less than 30 seconds. 21. Enter the decontamination soak time. Consult with your chemical supplier for how long the soak time should be. The soak time is usually less than 10 minutes, but can be longer depending on the type of high level disinfectant used. 22. Enter the decontamination rinse time. This is the time required to rinse the high level disinfectant from the internal channels of the endoscope. Consult with your chemical supplier as they may have a chemical residual test to validate how much rinse water/time should be used to completely rinse out the chemistry. 23. Enter the amount of time needed to purge the rinse water from the endoscope. Typically this is set for 30 seconds longer than the decontamination flush time. 0901136-CM Rev.B

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SCOPETECH I.Q. SET-UP FILE PROGRAMMING (continued) 24. Enter the names of each of the cleaning technicians as provided by the department manager. See Fig. 3. 25. Enter the endoscope serial number, type and model number for each endoscope that will be pre-cleaned using the ScopeTech I.Q. See Fig. 4.

Fig. 4 Note: To sort the endoscopes by serial number after entering them in any order, press the Sort Scopes by Serial Number button on the bottom of the Program File screen. Fig. 3 Most industry Instruction for Use (IFU) provide that all flexible endoscopes must be inflation tested, manually cleaned inside, and internal channels flushed with a detergent solution and fresh water rinse. The most common sequence for the pre-cleaning process is: (1) Scope Inflation (2) Detergent Dose (3) Detergent Flush (4) Manual Cleaning (5) Rinse (6) Rinse Purge 26. Modify the endoscope pre-cleaning sequence if needed. See Fig. 5.

Fig. 5 Note: a detergent purge can be added to the cleaning sequence if required, but may not be necessary if the rinse cycle removes a sufficient amount of residual detergent.

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0901136-CM Rev.B

SCOPETECH I.Q. SET-UP FILE PROGRAMMING (continued) For systems equipped with a barcode scanner, press the Print Barcodes button on the bottom of the Program File screen which will allow you to print barcodes for the cleaning technicians and endoscopes. Laminate and post these on the wall next to the ScopeTech I.Q. for ease of access. Technician I.D. 1

2

3

4

5 Scope Serial Number

Barcode

*001* *002* *003* *004* *005* *006*

1

2

3

4

5

6

6

7

8

9

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11

Barcode

*U01* *U02* *U03* *U04* *U05* *U06* *U07* *U08* *U09* *U10* *U11*

27. After all fields have been entered click Save and Exit Setup on the bottom of the Program File screen. The setup file will now appear in the System Files view where it can be selected, then uploaded to the ScopeTech I.Q. See Fig. 6 and 7.

Fig. 6 The system uses the serial number to name the setup file followed by “S” suffix to denote a setup file. To save a file for upload to the ScopeTech I.Q., press Copy Setup to a USB drive. See Fig 7. Insert a USB drive, highlight the file to be saved and press Copy. Make sure the USB drive flashes for a second or two while it saves. Remove the USB drive from your PC and place it in the ScopeTech I.Q. USB port for uploading. See page 18 step 11 for instructions in programming mode on the ScopeTech I.Q. 0901136-CM Rev.B

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Fig. 7

PROGRAMMING SCOPETECH I.Q. The ENTER key is the main navigation key that will advance the menu from function to function each time it is pressed. Pressing and holding the ENTER key will save any changes and exit you from the programming menu. The screen is blue when the unit is in run mode and amber when it is in the programming mode.

1.

Instructions To access the programming menu, press and hold the ENTER key until the screen changes to an amber color. The Decontamination Cycle is the first menu when you enter the programming mode.

PRESS START FOR DECONTAMINATION CYCLE

To save changes and exit the programming menu, press and hold the ENTER key until the display changes back to the blue screen. It is recommended that you restart the ScopeTech I.Q. system before using it in run mode. 2.

Upon installation or whenever the chemical container runs low use the prime function to re-prime the dosing pump. Press UP to start and stop priming. Make sure the flow meter pulse counts are 5 or more before completing the prime.

3.

Upon installation use the prime function to re-prime the flush pump. Press UP to start and stop priming. Make sure the flow meter pulse counts are at 5 or more before completing the prime.

4.

Use the SCROLL, then the Up/Down keys to enter the private usercode. The default code is: 0000.

PRESS UP TO START OR STOP DETERGENT PRIMING FLOWMETER 005 PRESS UP TO START OR STOP FLUSH PRIMING FLOWMETER 005 PRESS SCROLL TO ENTER PASS CODE 0000

If you have a configured setup file for ScopeTech I.Q., go to step 7. You may skip steps 5, 6, 12, 14-18, 27-36. The setup file contains ScopeTech programming information to allow you to skip these steps. 5.

A private usercode protects the system settings and allows only authorized personnel to make programming changes and view reports.

PRESS SCROLL TO CHANGE PASS CODE 0000

Use the SCROLL, then the Up/Down keys to set or change a private usercode. 6.

Use the SCROLL, then the UP/DOWN arrows to set the unit serial number. The unit serial number will appear in reports. Press ENTER to proceed.

PRESS SCROLL TO ENTER UNIT S/N: 000000

Note: The setup file name should match the unit serial number or the file will not load correctly.

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0901136-CM Rev.B

PROGRAMMING SCOPETECH I.Q. (continued) 7.

Instructions To view reports press the SCROLL and UP/DOWN arrows to select the date range desired. Press ENTER to proceed. See pages 22-27 for more information.

8.

To download reports to a USB drive for printing/viewing on a PC press ENTER at the first summary report screen.

9.

Insert USB drive in system, then press the UP key and wait until “Done” message appears.

10. To load a setup file that was configured with the ScopeTech I.Q. PC software, insert USB drive, then press UP to load the set-up file from the USB drive into the ScopeTech I.Q.

11. Press SCROLL to select mode of operation. Sequence without ID, Sequence with ID, or Express. Press ENTER to proceed. Sequence without ID - Allows the user to enter directly into the runtime mode without choosing a technician or endoscope. Sequence with ID - Allows the user to choose a technician and endoscope to track pre-cleaning to meet regulatory requirements. Express - Allows the user to choose the operation they would like to perform in any order.

ENTER DATE RANGE TO VIEW REPORTS FROM 08-22-13 TO 08-30-13 Summary Report Colonoscope 002 Incomplete CY 002 Temp. Error 002 Out of Chem 002 COPYING DATA...

PRESS UP TO START LOADING NEW SETUP INTO DISPENSER

PRESS SCROLL TO SELECT MODE OF OPERATION SEQUENCE W/O ID PRESS SCROLL TO SELECT MODE OF OPERATION EXPRESS MODE

12. Use the SCROLL and UP/DOWN arrows to enter the name of the facility. Press ENTER to proceed.

PRESS SCROLL TO ENTER FACILITY SC HOSPITAL

13. Use the SCROLL and UP/DOWN arrows to enter the correct Date/Time. Press ENTER to proceed.

PRESS SCROLL TO CHANGE DATE/TIME TIME 02:31:56 PM DATE 08-20-13

14. Press SCROLL key until the language to be used is displayed. Select the language (English, German, Spanish, or Chinese) for your location.

PRESS SCROLL TO SELECT WHICH LANGUAGE TO USE ENGLISH

0901136-CM Rev.B

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PRESS UP TO START REPORT DOWNLOAD TO USB MEMORY

PRESS SCROLL TO SELECT MODE OF OPERATION SEQUENCE WITH ID

PROGRAMMING SCOPETECH I.Q. (continued) Instructions 15. Press SCROLL to select temperature units. Select Fahrenheit or Celsius.

SCROLL TO SELECT TEMPERATURE UNITS FAHRENHEIT

16. Press SCROLL to select pressure units. Select mmHg, psi or bar. Press ENTER to proceed.

PRESS SCROLL TO SELECT WHICH UNITS TO USE mmHg

17. Press SCROLL to turn on or off the internal audio alarm. Press ENTER to proceed.

PRESS SCROLL TO TURN ALARM SOUND ON OR OFF ALARM SOUND OFF

Note: Alarm sounds will occur anytime temperature is not achieved, detergent supply is empty or flush water is not flowing. The display color will also change to red during any of these events. 18. Using the SCROLL and UP/DOWN arrows enter the name of the detergent. Press ENTER to proceed.

19. Place the detergent discharge tube (part #7117155-D) into a 200 milliliter graduated cylinder and press the UP key. The pump will run and stop on its own. The target calibration volume is 100 ml +/- 3 ml. Enter the volume captured.

PRESS SCROLL TO TURN ALARM SOUND ON OR OFF ALARM SOUND ON

PRESS SCROLL TO ENTER CHEM. NAME: ACME DLS200

PRESS UP TO START DETERGENT PUMP CALIBRATION VOLUME = 100 ml

Repeat step 19 until the volume captured is 100 ml +/- 3ml. 20. Press ENTER. The resulting flow rate should be at least 100 ml/min. Press ENTER to save the volume captured and proceed.

21. Place the flush discharge tube (part #7117150-D) and the auxiliary flush discharge tube (part #7117167) into a 200 ml graduated cylinder and press the UP key. The pump will run and stop on its own. 22. Enter the volume captured and press ENTER. If the volume saved is “out of range” try again until the system accepts the volume entered and displays the flow rate of the pump. Repeat step until you capture 100 ml +/- 5 ml. Press ENTER to proceed.

19

ENTER CAPTURED VOLUME IN ML VOLUME = 98 ml

FLOWRATE FOR THE DETERGENT PUMP IN ML/MIN IS: FLOWRATE = 220

PRESS UP TO START FLUSH PUMP CALIBRATION VOLUME = 100 ml ENTER CAPTURED VOLUME IN ML VOLUME = 094 ml

FLOWRATE FOR THE FLUSH PUMP IN ML/MIN IS: FLOWRATE = 857

0901136-CM Rev.B

PROGRAMMING SCOPETECH I.Q. (continued) Instructions 23. ScopeTech is set to pressurize your scope to 200 mmHg (3.87psi). The factory default value is generally accepted. Should you need to change the pressure, press SCROLL to move the cursor. Press the UP or DOWN arrow to change the pressure value. Always follow the endoscope manufacturer’s recommended pressure parameters.

PRESS SCROLL TO ENTER INFLATION PRESSURE: Press: 200mmhg

CAUTION: If you set the inflation pressure point too low, you may not achieve the required scope pressure to conduct the water immersion bubble test. If you set the pressure point too high, this may damage your endoscope. Follow the endoscope manufacturer’s instruction manual for the recommended inflation pressure and procedures to perform a leak test. 24. The pressure decay rate is the acceptable rate for maintaining positive pressure of the endoscope. The factory default value is set to 5 mmHg/sec and this rate is generally accepted. If you need to change the acceptable pressure decay rate, press the UP or DOWN arrow. 25. The Dry Inflate is a 60-second procedure that allows the technician to inflate the scope in a dry state before the immersion bubble test. Use the Scroll key to disable or enable Dry Inflate. 26. Use the UP/DOWN arrows to set the temperature to match an external temperature gauge. Press ENTER to proceed.

27. Press SCROLL to select temp alert on or off. System will ignore the temp sensor input if turned to off. Note: If water temperatures is not a factor in the cleaning of the endoscopes with your detergent, select off.

28. Use the SCROLL and UP/DOWN arrows to set the minimum and maximum water temperature ranges. Once this range is set, you will have to ensure the sink is filled with water to meet your minimum setting, but not exceed your maximum.

0901136-CM Rev.B

20

PRESS UP/DOWN TO ENTER PRESSURE DECAY: 005 mmHg/sec

PRESS SCROLL TO ENABLE OR DISABLE DRY INFLATE DRY IN. ENABLED

PRESS UP/DOWN TO ENTER CALIBRATION TEMPERATURE Temperature 073 F

PRESS SCROLL TO SELECT OPTION: TEMP. ALERT IS: ON

PRESS SCROLL TO ENTER TEMP. RANGE MIN TEMP. 000 MAX TEMP. 000

PRESS SCROLL TO SELECT OPTION: TEMP. ALERT IS: OFF