Medivators ADVANTAGE PLUS User Manual

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User

Manual

Endoscope Cleaning and Disinfection System

(With optional cleaning cycle that eliminates manual cleaning)

CLEVO® is a registered trademark of Clevo Corporation EPSON

is a registered trademark of Seiko Epson Kabushiki Kaisha FUJIFILM™ is a trademark of Fujilm Corporation HEPA JUN-AIR MEDIVATORS ADVANTAGE PLUS INTERCEPT OLYMPUS PENTAX WINDOWS XION

is a registered trademark of HEPA Corporation

is a registered trademark of Gast Manufacturing, Inc.

is a registered trademark of Medivators Inc.

is a registered trademark of Olympus Corporation.

is a registered trademark of Hoya Corporation.

and WINDOWS EXPLORER® are registered trademarks of MICROSOFT Corporation.

is a registered trademark of XION Medical GmbH.

and RAPICIDE® are registered trademarks of Medivators Inc.

50097-429 REV E– ADVANTAGE PLUS 2.0

Medivators reserves the right to make changes in the specications shown herein without notice or

obligation. Contact your Medivators representative or Medivators customer service for more information.

TABLE OF CONTENTS

CHAPTER 1

Using this manual ...................................................................................................................5

Safety ......................................................................................................................................6

Operator Safety .......................................................................................................................7

Installation and Maintenance ..................................................................................................9

Guidelines for Reliable Disinfection ....................................................................................10

Professional Guidelines ........................................................................................................12

Reprocessor Specications ...................................................................................................13

Dimensions and Clearances ..................................................................................................14

Installation Specications .....................................................................................................15

Storage ..................................................................................................................................16

Transport ...............................................................................................................................16

Symbols and Icons ................................................................................................................17

Warning Summary ................................................................................................................18

CHAPTER 2

Main Components .................................................................................................................22

Software System ...................................................................................................................33

Printing ................................................................................................................................ 41

Backup ................................................................................................................................ 43

Fluid System .........................................................................................................................44

CHAPTER 3

System Startup ......................................................................................................................54

Daily Service .........................................................................................................................54

Prepare the Endoscope ..........................................................................................................62

Disinfection Process Summary .............................................................................................68

Run the Disinfection Program ..............................................................................................69

Cycle Interruptions ................................................................................................................74

Taking a Sample of Disinfectant – Check MRC ...................................................................77

Complete the Disinfection Process .......................................................................................79

Reports ..................................................................................................................................81

Shutdown ..............................................................................................................................85

Procedure Summary ..............................................................................................................86

Downtime ..............................................................................................................................86

CHAPTER 4

Daily Maintenance ................................................................................................................88

Weekly Maintenance .............................................................................................................88

Monthly Maintenance ...........................................................................................................89

Air Filter Replacement ..........................................................................................................89

Water Filter Replacement ......................................................................................................92

CHAPTER 5

Introduction .........................................................................................................................100

Error Overview ...................................................................................................................104

System Errors ......................................................................................................................109

Barcode Errors ....................................................................................................................113

Endoscope Errors ................................................................................................................114

Reprocessing Cycle Errors ..................................................................................................119

Control Errors (SCU) ..........................................................................................................126

Warning Errors ....................................................................................................................130

CHAPTER 6

MEDIVATORS

ADVANTAGE PLUS® Automated Endoscope Reprocessor Software ...138

Management Program .........................................................................................................140

Endoscope Registration ......................................................................................................145

User (operator) Registration ...............................................................................................150

Physician/Assistant Registration .........................................................................................153

Reports ................................................................................................................................155

Events ..................................................................................................................................159

Systems ...............................................................................................................................161

LIO Expert Operations ........................................................................................................163

Networking .........................................................................................................................167

APPENDIX A .......................................................................................................................171

Registration Forms

APPENDIX B .......................................................................................................................179

Replacement Part Numbers

APPENDIX C .......................................................................................................................181

Warranty

CHAPTER 1

INTRODUCTION

This chapter describes the MEDIVATORS® ADVANTAGE PLUS® Automated Endoscope Reprocessor.

Using This Manual

This manual describes the features of the MEDIVATORS ADVANTAGE PLUS endoscope reprocessor, including the hardware, software, setup, operation, safety, maintenance, and troubleshooting procedures. It is important to follow the instructions provided to keep the MEDIVATORS ADVANTAGE PLUS System in proper operating order and to ensure that endoscopes receive adequate disinfection.

This is not a service manual and does not provide detailed instructions for service beyond general maintenance. See Service Manual for servicing instructions. Contact your service representative for additional service information.

Medivators ADVANTAGE PLUS Features

The MEDIVATORS ADVANTAGE PLUS System was designed for ease of use and maintenance in the disinfection of endoscopes. Features include:

• Individual channel connectivity and channel blockage monitoring.

• Single use germicide: fresh disinfectant solution for each endoscope.

• Asynchronous operation of dual reprocessing basins with transparent glass lids.

• A dedicated personal computer (PC) for system operation of reprocessing cycle, cycle recording, powerful quality assurance reporting, easy backups, networking availability, and remote diagnostics

• Easy-to-ll detergent and alcohol reservoirs

• Hookup blocks dedicated to a family of endoscopes ensure correct connectivity and ow rates to meet manufacturers’ specications

• Diagnostics for operator assistance and troubleshooting

• Cleaning phase validated to eliminate manual cleaning of endoscopes prior to reprocessing (endoscopes must be pre-cleaned immediately after procedures).

Safety

Intended Use

The MEDIVATORS cleaning and high level disinfection of endoscopes and endoscope accessories.

ADVANTAGE PLUS® Automated Endoscope Reprocessor is intended for the

The MEDIVATORS ADVANTAGE PLUS System has been validated by MEDIVATORS for use only with RAPICIDE

PA High-Level Disinfectant or INTERCEPT® Detergent. Indications for Use of the ADVANTAGE PLUS System: MEDIVATORS ADVANTAGE PLUS Endoscope Reprocessing System tests, cleans, disinfects and rinses

endoscopes, such as beroptic and video endoscopes between patient uses. The ADVANTAGE PLUS

system is indicated to provide high level disinfection of heat sensitive semi-critical endoscopes and related accessories. Manual cleaning of endoscopes is not required prior to placement in the ADVANTAGE PLUS system. The endoscopes must be pre-cleaned immediately after use.

The ADVANTAGE PLUS Endoscope Reprocessing System uses RAPICIDE PA High Level Disinfectant to provide high level disinfection of endoscopes when used according to the directions for use. The system uses INTERCEPT Detergent in its cleaning cycle at a concentration of 0.5%.

RAPICIDE PA Test Strips are used after the disinfection cycle to ensure that the used disinfectant is at or above the minimum recommended concentration (MRC) of 850 ppm peracetic acid; this ensures that the disinfectant was above MRC during the entire disinfection cycle. RAPICIDE PA should be used in the ADVANTAGE PLUS System under the following contact conditions*:

Contact Time: 5 minutes

Temperature: 30°C

MRC: 850 ppm

Use-conditions may vary by country. Please contact your MEDIVATORS representative for information.

Caution: When using the cleaning cycle, endoscopes must be precleaned according to SGNA and facility guidelines. Manual cleaning of the endoscopes is not required. It is recommended that reprocessing using the cleaning cycle be performed within one hour after the procedure. If the cleaning cycle is not chosen, endoscopes must be manually cleaned before placing in the Reprocessor for disinfection.

Regulatory Compliance

The MEDIVATORS

ADVANTAGE PLUS® Automated Endoscope Reprocessor complies with EN

60601-1-2 Electromagnetic Compatibility (EMC) Standards.

The reprocessor is ETL and cETL certied and listed for safety per IEC Standard IEC 61010-1, UL

Standard UL 61010-1 and Canadian Standard CAN/CSA-C22.2 No. 61010-1 for laboratory equipment.

Notes, Cautions, and Warnings

Throughout the manual are notes, service notes, cautions, and warnings. These provide important information and you should pay special attention to them. Examples are shown below.

Note: A note refers to important information to which you should pay special attention.

Service: A service note refers to operations or repairs that only a trained service technician may perform.

Caution A caution describes actions or conditions that may cause damage to or destruction of the equipment.

WARNING A warning describes actions and conditions that may cause severe personal injury or death to the operator or patient.

Operator Safety

• Equipment must be operated solely by qualied personnel, and used for its intended use only. Never use the reprocessor for any purpose other than the manufacturer’s specic intended purpose.

WARNING: To avoid biological contamination and chemical burns, always wear appropriate personal protective equipment (PPE) when handling endoscopes or disinfectant solutions.

• Cleaning and disinfectant solutions must be used according to the regulations governing their use, safety, and shelf life.

• Do not attempt to open the reprocessor lid during operation.

• Do not place heavy objects on the glass covers.

• For peracetic acid (PAA) disinfectant handling guidelines, refer to the American National Standard recommended practice titled, Chemical Sterilants and High Level Disinfectants: A Guide to Selection and Use (AAMI TIR7:1999) and/or Safe Handling and Biological Decontamination of Reusable Medical Devices in Health Care Facilities and in Nonclinical Settings (AAMI/ANSI ST35:2003). The documents are available from the Association for the Advancement of Medical Instrumentation.

• In the event of a disinfectant or other chemical leak, use personal protective equipment (clothing, gloves

& safety glasses) & follow the disinfectant manufacturer’s guidelines for spill clean-up procedures.

• Place guidelines for disinfectant clean-up in an easily visible area near the reprocessor to ensure users

will have access to the information when needed.

• It is recommended that the facility conduct regular training of all personnel concerned with the

operation and maintenance of this equipment, including emergency procedures for toxic, ammable

or pathogenic material released into the environment. Records of attendance at training should be maintained and evidence of understanding demonstrated.

Handling and storage of 70% Isopropyl Alcohol.

Handling

Avoid prolonged or repeated contact with skin. Extinguish any naked ames. Remove ignition sources.

Avoid sparks. Do not smoke. Take precautionary measures against static discharges. Earth all equipment. Do not empty into drains.

Handling Temperatures

Ambient.

Storage

Keep away from direct sunlight and other sources of heat or ignition. Do not smoke in storage areas. Keep container tightly closed and in a well-ventilated place.

Storage Temperatures

Ambient.

Product Transfer

Take precautionary measures against static discharges. Earth all equipment. Avoid splash lling.

Respiratory Protection

No specic measures.

Eye Protection

Monogoggles.

Body Protection

Standard issue work clothes. Safety shoes or boots – chemical resistant.

Installation and Maintenance

Proper maintenance ensures effective disinfection and prolongs the life of the reprocessor.

• The MEDIVATORS in accordance with applicable regulations.

• The system default is factory-set for the specic disinfectant immersion time for RAPICIDE

• All pressure regulators are factory-preset. Do not adjust the settings. Contact your Technical Support representative for assistance.

• Do not allow the washing solution to contact metal components.

• Do not use alcohol or alcohol-based products to clean the reprocessor cabinet.

• MEDIVATOR endoscope hookups are not autoclavable. The hookups are automatically disinfected with each use due to their exposure to the entire disinfection cycle; no further disinfection or rinsing is required prior to their next use.

• Do not remove covers, doors, or panels fastened with screws while the reprocessor is in use.

• Replacement parts must be ordered from the manufacturer to maintain the warranty.

• Do not block ventilation openings.

• Regularly check all cables, tubing, and drains for damage or leaks.

• Do not carry out any maintenance that is not described in this manual.

• Ensure that the power supply connection is accessible in the event that emergency disconnection is necessary.

ADVANTAGE PLUS® Automated Endoscope Reprocessor must be grounded

PA.

• Prior to undertaking any service or maintenance operations or when resetting the GFI, ensure that the MEDIVATORS ADVANTAGE PLUS System is disconnected from the main power supply. If service or maintenance operations are to be conducted on the water system, ensure that the MEDIVATORS ADVANTAGE PLUS System is isolated from the main water supply.

For service or service-related questions, contact MEDIVATORS Technical Support at 1-800-444-4729 in the United States or your local MEDIVATORS Distributor.

Guidelines for Reliable Disinfection

Water Quality

Potable water is the minimum standard, Medivators recommends the use of a high quality water pre

ltration system that lters incoming water to a minimum of 0.1 micron. A typical water pre-ltration system, such as the one offered by Medivators, lters incoming water through a 1 micron, 0.4 micron, and

0.1 micron series of lters.

• The high performance 0.1 micron (absolute rated) water lter included with the reprocessor is highly effective at removing microorganisms and particles larger than 0.1 microns. Appropriate pre-ltration and regular disinfection are required to maintain the performance of this lter.

• The routine maintenance schedule recommends replacing the 0.1 micron water lter every six months or sooner, depending on the pre-ltration system and the quality of the incoming water. If the lter clogs to the point of non effectiveness, the reprocessor will alarm and will not continue until the lter

is replaced.

Detergent Solution

INTERCEPT Detergent is low-foaming and formulated to use with medical instruments. INTERCEPT Detergent has a neutral pH and also bacteriostatic properties to inhibit bacterial growth in the detergent reservoir and detergent lines.

Monitoring Disinfectant Potency

The efcacy of a disinfection procedure is directly related to the disinfectant solution used, and the amount

of time the endoscope is exposed to that solution.

• RAPICIDE in this manual.

Detergent must be used in the cleaning phase of the reprocessing cycle. INTERCEPT

PA must be monitored for potency every reprocessing cycle according to the instructions

• Use the RAPICIDE PA test strips to test the potency of the solution. If the potency of the solution is below MRC minimum recommended concentration (MRC), discard and replace it with fresh solution.

• Never use disinfectant with unacceptable potency levels.

Disinfectant Solution

Use only with RAPICIDE PA High Level Disinfectant (Part A & Part B).

Endoscope Cleaning and Testing

The MEDIVATORS

ADVANTAGE PLUS® Automated Endoscope Reprocessor may be used with all

makes and sizes of exible, immersible endoscopes that can be internally and externally disinfected.

Proper endoscope disinfection is required because endoscopes have multiple internal valves and channels that have the potential to harbor microorganisms that could cross-contaminate patients. Reprocessing

quality depends largely on a thorough ushing of all endoscope channels, valves and ttings where

contamination can occur. This reprocessor includes a cleaning cycle that may be used to eliminate manual cleaning of the endoscopes.

Used endoscopes must be pre-cleaned according to manufacturers, guidelines and your internal facility procedures before reprocessing. Follow the endoscope manufacturer’s, instructions and established professional guidelines while pre-cleaning and disinfecting endoscopes. Leak test all endoscopes prior to disinfection.

If the cleaning cycle is not chosen, endoscopes must be manually cleaned before placing in the reprocessor for disinfection.

Only INTERCEPT

detergent has been validated for use in the cleaning cycle. It is recommended that

cleaning and reprocessing take place within one hour after the procedure is completed.

Professional Guidelines

The following organizations have published recommended guidelines for cleaning and disinfecting endoscopes.

Society of Gastroenterology Assoc. for Professionals in Infection Nurses and Associates, Inc. Control and Epidemiology, Inc.

401 North Michigan Ave. 1275 K Street NW, Suite 1000 Chicago, IL 60611-4267 Washington, DC 20005-4006 USA USA Tel: 800-245-7462 Tel: 202-789-1890 Fax: 312-527-6658 Fax: 202-789-1899 www.sgna.org www.apic.org

American Society for American Society for Gastrointestinal Endoscopy Testing and Materials

1520 Kensington Rd., Suite 202 100 Barr Harbor Dr. Oak Brook, IL 60523-2141 West Conshohocken, PA 19428-2959 USA USA Tel: 630-573-0600 Tel: 610-832-9585 Fax: 630-573-0691 Fax: 610-832-9555 www.asge.org www.astm.org

Association of periOperative Canadian Society of Gastroenterology Registered Nurses, Inc. Nurses & Associates

2170 S. Parker Rd., Suite 300 27 Nicholson Dr. Denver, CO 80231-5711 Lakeside, NS B3T 1B3 USA CANADA Tel: 800-755-2676 Fax: 902-473-4406 Fax: 303-750-3462 www.csgna.com www.aorn.org

British Society of Société Française d’Hygiène Hospitalière S.F.H.H. Gastroenterology Hôpital de la Croix-Rousse

3 St. Andrews Place Unité d’Hygiène Hospitalière-Épidémiologie Regents Park 93 Grande Rue de la Croix-Rousse London NW1 4LB 69317 Lyon Cdx04 ENGLAND FRANCE Tel: (+44) (0)20 7387 3534 Tél: 04 72 07 19 83 www.bsg.org.uk Fax: 04 72 07 19 85

www.sfhh.net

Reprocessor Specications

General Specications

The basic reprocessor specications required for installation and operation of the MEDIVATORS ADVANTAGE PLUS® Automated Endoscope Reprocessor are summarized in Table 1 .

Table 1 Reprocessor Specications

Equipment Type Laboratory Equipment

Electrical rating 100-240 VAC, 50/60 Hz

Power rating 1000 Watts

Air pressure range 87 – 145 psi (6 - 10 bar)

Water pressure range 35 - 87 psi (2 - 6 bar)

Water ow range 2 – 8 Liters/minute

Water temperature operating range 30ºC – 40ºC, set mixing valve to 35ºC

Humidity range for operation 20–80%, non-condensing

Temperature range for operation 50°F – 80.6°F (10°C - 27°C)

Environment Indoor use only

Installation/Over voltage category II

Pollution degree 2

Connection to power supply Cord connection

45”W X 31” D X 62” H (inches)

Dimensions

114 W X 79 D X 157 H (cm)

Weight 400 lbs. (182 kg)

Dimensions and Clearances

Figure 1 Front Dimensions

Figure 2 Side Dimensions & Clearance

Installation Specications

Electrical

The MEDIVATORS single electrical outlet capable of supplying 1000 watts at 100-240 volts AC, 50/60 Hz. The outlet must be properly grounded.

Water

Potable water is the minimum standard. For optimum performance, water must be delivered at a minimum

ow rate of 5 L/min (1.32 gpm) at a dynamic pressure of 30 psi (2 bar) during the basin ll. For optimum

performance water must be delivered at 35ºC by use of a mixing valve (required). The mixing valve must be purchased separately and installed by the facility. A back siphonage prevention device must be purchased separately and installed between the water line & the reprocessor to prevent contamination of the water supply in the event of a sudden drop in water pressure.

Drain

For optimum performance the MEDIVATORS ADVANTAGE PLUS System should be connected to a vented sanitary drain system capable of draining at a minimum rate of 12 L/min (3.17 gpm).

Room Ventilation

The MEDIVATORS ADVANTAGE PLUS System must be installed in a room with a ventilation system capable of delivering a minimum of 10 air exchanges per hour.

An optional vapor management system is available for ductless fume removal.

ADVANTAGE PLUS® Automated Endoscope Reprocessor must be connected to a

Air

The MEDIVATORS ADVANTAGE PLUS System must be connected to an air supply for proper operation. The ADVANTAGE PLUS system includes an air compressor that requires a dedicated 120

VAC, 20 Ampere service or 230 VAC, 10 Ampere service. The air compressor delivers proper air ows

and pressure for correct system operation. If the ADVANTAGE PLUS model purchased did not include the air compressor, the system may utilize

house compressed air (dry, oil free) which must meet these required air pressure specications : 58 to 125 PSI with a minimum ow volume of 1.5 CFM, maximum particle size is 5 microns, maximum dew point

is 7°C (45°F), maximum oil concentration is 5 mg/m

Storage

If the MEDIVATORS® ADVANTAGE PLUS® Automated Endoscope Reprocessor will be out of service for an extended period of time, the following steps must be followed:

• Remove the side covers, purge all liquids from the system, and then replace the covers.

• Place a covering over the unit to protect it from dust and moisture.

• The storage temperature must not go below 0°C (32°F), or exceed 60°C (140°F).

• The maximum relative humidity must not exceed 80% during storage.

Transport

The MEDIVATORS ADVANTAGE PLUS System can be safely moved on a smooth, level oor. However, if you encounter any thresholds or oor level changes, the base cover must be removed to avoid damage.

For all other moves, place the MEDIVATORS ADVANTAGE PLUS System on a pallet with a kraft liner. Before moving MEDIVATORS ADVANTAGE PLUS System, ensure the electrical cord, drain line and

water supply are either disconnected or are appropriate lengths to accommodate the relocation of the machine.

Symbols and Icons

Symbol Symbol Meaning Symbol Symbol Meaning

LIO software shortcut

Management software shortcut

Server software shortcut

Expert Operation

Cancel

Open/Close

OK/Enter

Cancel

Release All

Start

Stop

Active report, lter applied.

Edit

Expand

Scroll Down

Scroll Up

Start

Stop

Import data

The icons in the grayed area are only used by Service Personnel.

Export data

Filter data

Generate report

Minimize report details

New

Warning Summary

WARNING Portable and mobile communication devices can affect electrically-operated medical equipment

WARNING Connecting a chemical container with the incorrect uid may cause the endoscope to

be improperly disinfected. Do not use the endoscope on a patient if this occurs.

WARNING Wear personal protective equipment (PPE) (clothing, mask, gloves & eye wear).

WARNING All endoscope hookups must be periodically inspected for wear. Discard and replace damaged hookups otherwise it could result in an endoscope that is not disinfected and therefore should not be used on a patient.

WARNING Verify all connections to the endoscope are secure and tubing is not linked. Failure to do so could result in an endoscope which is not disinfected and therefore should not be used on a patient.

WARNING Verify the connection tubing does not interfere with the spray head and conrm that

the spray function is working during the cycle. Failure to do this could result in an endoscope that is not disinfected and therefore should not be used on a patient.

WARNING Before removing the endoscope, verify all connections to the endoscope are secure. If an adapter is loose or disconnected, the disinfection was not complete and must be repeated. Failure to do so could result in an endoscope which is not disinfected and therefore should not be used on a patient.

WARNING Report all system errors to your supervisor. WARNING Wear clean gloves to prevent soiling of the disinfected endoscope. If a run error was generated, a channel is blocked, or the endoscope is leaking, the endoscope

must not be released for patient use. If there is any doubt as to whether an endoscope is correctly disinfected, it must be disinfected again before use. Contact your supervisor for further instructions.

Verify all endoscope connections are secure. Failure to do so could result in an endoscope which is not disinfected and therefore should not be used on a patient.

WARNING Avoid possible chemical burns. Wear personal protective equipment (clothing, mask, gloves & eye wear).

WARNING Use only uids approved by Medivators Inc.

Check the expiration date of the disinfectant in the reprocessor each day. Never use disinfectant beyond the manufacturer’s expiration date, even if the MRC level is

acceptable. Never use disinfectant that tests below the acceptable MRC level, even if it has not yet reached

the expiration date.

When replacing disinfectant, wear personal protective equipment (clothing, mask, gloves & eye wear). The disinfectant and detergent manufacturers may recommend additional protection.

If leaking liquid is present and you suspect it is disinfectant, read and follow the disinfectant instructions before attempting a cleanup.

WARNING Ensure that the reprocessor is installed and maintained in a position that allows access to the power cord for emergency disconnection if necessary.

Never use the equipment in a manner inconsistent with the manufacturer’s guidelines. Using the equipment in a manner inconsistent with the manufacturer’s guidelines may impair the protections that are designed into the device and may cause injury to the user.

RAPICIDE

PA containers must be triple rinsed before disposal.

NOTE

CHAPTER 2

OPERATOR CONTROLS

This chapter describes the MEDIVATORS® ADVANTAGE PLUS® Automated Endoscope Reprocessor operator controls, and how to set up and program the reprocessor.

Main Components

Exterior Components

The MEDIVATORS of two independent reprocessing modules. Each has a basin, automatic cover, endoscope hookups, and

the necessary pumps and valves clean to disinfect, rinse, and dry most models of exible, immersible

endoscopes.

ADVANTAGE PLUS® Automated Endoscope Reprocessor reprocessor consists

Figure 1 MEDIVATORS ADVANTAGE PLUS System Front View

1. PC: Runs the programs on the MEDIVATORS ADVANTAGE PLUS System that disinfect the machine and endoscopes.

2. PC Monitor: Displays messages, menu selections, and the operational status.

3. Basin Lid: Cover for the left or right basin of the MEDIVATORS ADVANTAGE PLUS System. Open the lid to add or remove endoscopes.

4. Control Panel: Used to select settings, operate the reprocessor, and view system messages, errors and warnings.

5. Access Door: Opens to allow access to the reservoirs, lters, transfer valves, and pressure gauges.

6. Foot Switch: Pressing the right foot switch opens the right basin lid, and pressing the left foot switch opens the left basin lid.

7. Spray Arm Feeds: Provides the uid to the spray arms.

Figure 2 MEDIVATORS

ADVANTAGE PLUS® AER Back View

1. PC: Runs the programs on the MEDIVATORS ADVANTAGE PLUS System that disinfect the reprocessor and endoscopes.

2. PC Monitor: Displays messages, menu selections, and the operation status.

3. Base Shroud: Covers and protects the bottom of the MEDIVATORS ADVANTAGE PLUS System.

4. Castors: Wheels which make the MEDIVATORS ADVANTAGE PLUS System easier to move. Caster wheels can be locked.

5. Water Supply Inputs: Inlet for ltered water, one for each module (3/8” barb tting with hose clamp, provided).

6. System Power: Electrical power supply connection.

7. Discharge: Fluids output to the drain (1” barb tting).

8. On-Board Air Compressor (Optional accessory not shown): provides pressurized air to the system in the event that a pressurized air line from the facility is not available.

9. Compressed Air Hookup: Connects with facility pressured air line, if on-board air compressor

accessory is not purchased (1/4” NPT).

10. Circuit Breaker/Power Switch: Toggle switch turns MEDIVATORS ADVANTAGE PLUS on and off.

11. Vent: Exhausts internal chemical vapor build-up.

12. Self-Disinfection Port: Connects to water line ltration system for water line disinfection.

Interior Components

Figure 3 MEDIVATORS® ADVANTAGE PLUS® System Top View

1. Basin Lid: Cover for the left or right basin of the MEDIVATORS

ADVANTAGE PLUS® Automated

Endoscope Reprocessor. Open the cover to load or remove endoscopes.

2. Basin: Containers where endoscopes are reprocessed.

3. Fluid Inlet: Port where liquids are dispensed into the basin.

4. Spray Head: Disperses a ne jet of uid into the basin.

5. Connection Manifold: Attaches endoscope hookup block to the system.

6. Drain: Outlet port through which waste uids are discarded.

7. Overow: Outlet used to drain off excess uids.

8. Control Panel: Used to select settings, operate the reprocessor, and view system messages, errors and warnings.

9. Spray Arm: Provides uid spray for disinfection and rinsing of exterior surfaces of endoscopes.

Figure 4 Chemical Reservoirs

1. Main (High) Pressure Gauge: Measures air pressure in the MEDIVATORS

PLUS

Automated Endoscope Reprocessor. Must be set to 3 bar (45psi). Only to be adjusted by

ADVANTAGE

trained MEDIVATORS technicians.

2. Disinfectant Container: Holds disinfectant Part A used in the disinfection process.

3. Disinfectant Container: Holds disinfectant Part B used in the disinfection process.

4. Detergent Reservoir: Holds detergent used in the wash process.

5. Alcohol Reservoir: Holds alcohol that may be used in the alcohol/air purge process.

6. Leak Test (Low) Pressure Gauge: Measures air pressure in the endoscope sheath and MDS system. Must be set to 0.25 bar (3.75 psi). Only to be adjusted by trained MEDIVATORS technicians.

7. Sample Ports: Dispenses RAPICIDE

PA High Level Disinfectant for MRC testing at the end of

each cycle.

PC Monitor and Connections

Figure 5 PC Monitor and Connections

1. On/Off Switch : Turns the computer on or off.

2. USB Ports : Connector between the PC and external peripherals, (i.e. mouse and keyboard)

3. Power Connection : Bottom of monitor in back (not shown)

4. Audio Out : Audio output connector for connection to monitor

5. Video Out DVI : DVI-I connector fro connection to monitor

6. USB : Extra USB connection for accessories (Printer or Barcode scanner)

7. Ethernet : Ethernet connection for Network or internet.

8. Main Power Switch : 10 Amp breaker with integrated main power switch.

9. Water Filter/OX Left : Low voltage output for connection to Water Filter System or left side of Sterilox Control Box.

10. OX Right : Low voltage output for connection to right side of Sterilox Control Box.

11. AC Input : IEC 60320 C20 Inlet connector for Main input power connection.

12. AC Out : IEC 60320 C13 outlet connector for accessory power.

Control Panel

The control panel allows the operator to select settings, operate the reprocessor, and view system messages,

errors and warnings, and cycle information. It consists of ve main groups:

1. Left and right basin control buttons

2. Function buttons

3. Touchpad and mouse buttons

4. Selection buttons

5. Left and right basin LED lights

Figure 6 Control Panel

Basin Control Buttons

Each module is controlled by its own keypad grouping. The group shown in Figure 7 is for the right module.

Figure 7 Basin Control Buttons

• Press the Open/Close button to open or close the lid on the basin. Note that during disinfection,

the lids will not open.

• Press the Start button to start a disinfection program. The button is also used to restart a program

after an error.

• Press the Cancel button whenever you have a reason to stop a disinfection program. If disinfectant

is in contact with the endoscope when the button is pressed, the program will run until conditions are safe.

• Press the Menu

button to log in, select programs, and enter data.

• The green LED will display when system is operating normally, LED ashes green upon cycle

completion. If LED is red, system error has occurred. Verify the error condition. The endoscope may not be disinfected. Do not use.

Touchpad and Mouse Buttons

Figure 8 Touchpad and Buttons

The touchpad works as a mouse to enter information. Moving your nger on the pad causes the cursor to

move on the monitor. Tapping the touchpad or pressing the left button has the same result as clicking the left button on a mouse. The two buttons correspond to the left and right buttons on a mouse.

Function Buttons

Figure 9 Function Buttons

Table 1 Function Buttons

Function

Key

Press Button

(No. of times)

Result

F1 1 I/O Inputs / Outputs,

left basin

F1 2 I/O Inputs / Outputs,

right basin

F1 3 I/O Inputs / Outputs,

both basins

F1 4 Re-opens program window F2 — — F3 1 Opens system parameters. Press again to close. F4 1 History report for the current day. Press again to close.

F5 — — ABC 1 Get keyboard to appear on the monitor ABC 2 Close keyboard screen

Help (?) — —

Selection Buttons

• Pressing the OK

• The Cancel

button is the same as clicking on the button in the software.

button corresponds to the button in the software.

• Pressing the Scroll Up

• Pressing the Scroll Down

button allows you to scroll up through a list on the monitor.

button allows you to scroll down through a list on the monitor.

Figure 10 Selection Keys

Connector Blocks

The endoscope channels are connected to the MEDIVATORS

ADVANTAGE PLUS® Automated Endoscope Reprocessor channel manifold via a connector block. Each endoscope model requires a unique connector block to ensure that proper disinfection can be achieved. Refer to the hookup application guide to identify the correct connector block to use for the endoscope to be reprocessed.

Note: Before a new type of endoscope is reprocessed or if you have any questions about a connection

block, contact your eld service representative.

Accessories

Endoscope accessories, buttons and valves may be disinfected in MEDIVATORS ADVANTAGE PLUS system. Use the provided mesh bag.

Data Entry

Bar Code Reader

A bar code scanner can be used to automatically enter data rather than manually entering it with the control

panel. The system administrator may dene a list for any of the following items:

• Operator login name

• Endoscope code

• Doctor/specialist ID

• Assistant ID

• Patient number

Figure 11 Bar Code Reader for Operator Login and Endoscope ID

Software System

Available Programs

Three separate programs control the MEDIVATORS Reprocessor:

1. LIO (Logic Input/Output) is the main software program that operators use to perform and run an endoscope cycle. This part of the software controls the MEDIVATORS ADVANTAGE PLUS System and is what runs and displays on the PC monitor. This program is used most often by daily operators of the reprocessor.

2. Management is the software program for managing endoscopes, users and cycle information. It allows an administrator access to input data, process reports, and can manage multiple MEDIVATORS ADVANTAGE PLUS System reprocessors..

3. Print Service automatically prints a certicate to the cycle log printer which is dedicated to each reprocessor. The certicate contains system information and reprocessing cycle details pertaining to a specic reprocessing cycle.

ADVANTAGE PLUS® Automated Endoscope

Figure 12 MEDIVATORS ADVANTAGE PLUS System Programs

Re-Starting LIO Before using the LIO software, you should have a working knowledge of PC computers and the Windows

operating system. Make sure you know how to use the control panel, including the touchpad and its buttons. If you are uncertain how to proceed, contact your supervisor or the system administrator for assistance. LIO and the server are initiated during normal PC power up.

1. Verify the PC is on, Windows is running.

2. Find the MEDIVATORS

ADVANTAGE PLUS® Automated Endoscope Reprocessor folder on the

Windows desktop and double click on it. It is titled “ADV”.

Figure 13 MEDIVATORS ADVANTAGE PLUS System Folder on the Desktop

3. Double click on the LIO icon to start the MEDIVATORS

ADVANTAGE PLUS® Automated

Endoscope Reprocessor operational program.

4. Double click the Print Server icon to start the cycle log print service.

Figure 14 LIO in the MEDIVATORS ADVANTAGE PLUS System Window

User Screen

The monitor displays all necessary information for operating and maintaining the MEDIVATORS

ADVANTAGE PLUS® Automated Endoscope Reprocessor. Use the buttons on the control panel, to access different screens, programs and functions.

Figure 15 Typical Program Screen

Menu Bar

Each program has a separate release version shown in the upper left corner of the screen. If a system error occurs, a red message bar appears here until the error is resolved.

The Expert Operation icon appears in the upper right of the menu bar. Double clicking the icon will display a login dialog box. After logging in, a side bar is displayed on the left with the following icons. Expert operation is only available to operators with the correct level of user rights.

Figure 16 Side Bar with icons

Module and Program Status

The status of each module is indicated in the main section of the screen. Program operations for the left module are on the left side of the screen; operations for the right module are on the right side of the screen.

Running program operations for each module are indicated in the section. The information provided includes:

• Operator name • Run time remaining

• Endoscope ID • Volume

• Program name • Temperature

• Parameter set • Program progress bar

• Number of cycles • Phase progress bar

• Program status • Step progress bar

• Expected run time • Cycle messages

Heartbeat

The red heartbeat indicator blinks on and off to show that the current program is active. Each module has a heartbeat indicator.

Program Messages

Program messages and operator instructions are shown in the lower section of the screen. The messages are presented with text and color. If an error occurs, an audible alarm also sounds.

The text shows the program time elapsed at which the message occurred, the message code, and a description of the message or instructions for the operator to follow. For troubleshooting purposes, the message codes and additional message details are listed in Chapter 5 Troubleshooting. The meaning of each screen color is shown in Table 2:

Table 2 Screen Color and Program Status

Screen Color Program Status

1 Gray Program in standby

2 Orange Standby, with lid open or a warning is present

3 Blue Cycle in process

4 Red Error or Cycle Failed, endoscope not disinfected

5 Green

Cycle completed successfully, endoscope disinfected

Reservoir Status

The percentage of alcohol and detergent remaining in the reservoirs is provided at the bottom of the screen.

System Information

The bar at the bottom of the screen provides system communication information, reprocessor identication,

and the software version for your selected language. MEDIVATORS

ADVANTAGE PLUS® Automated Endoscope Reprocessor software has two possible

system connections:

1. MEDIVATORS ADVANTAGE PLUS System PC to the MEDIVATORS ADVANTAGE PLUS System (SCU).

2. MEDIVATORS ADVANTAGE PLUS System PC to a server application (may be networked)

The left eld on the bar indicates if the reprocessor is connected to a server. The next eld to the right indicates if the PC is correctly connected to the reprocessor SCU. If the PC is disconnected the eld

appears red.

Many processes on the MEDIVATORS ADVANTAGE PLUS System require you to supply a login name

and password. This conrms that you have the proper authorization to run each program. Data gathered

from each process, including the operator’s name, is stored in the database and printed on reports. To enter your login name, move the cursor to the window. Press the down arrow on the right side and scroll

down until your login name is highlighted. Click on the name to select it.

Figure 17 Login Name Selection

To enter your password, click on the appropriate numeric buttons in the window. If you enter an incorrect password, click the CLR button and enter the password again. Press the OK button to continue.

Figure 18 Password Entry

Printing

Print Service Utility

1. Check for the printer icon in the system tray. The Print Server utility supports the printing of the Cycle

Logs on the certicate printer.

Figure 19 System Tray

2. If the icon is not present, display the Windows desktop by minimizing all open programs.

3. Open the MEDIVATORS

ADVANTAGE PLUS® Automated Endoscope Reprocessor folder by

double-clicking the ADV icon.

Figure 20 Desktop Detail

4. Double-click on the PrintService icon.

Figure 21 MEDIVATORS

ADVANTAGE PLUS® Automated Endoscope Reprocessor Folder

5. The PrintService icon should now appear in the System Tray.

Set the Default Printer

1. Click on Start > Settings > Printers.

Figure 22 Printer Selection

2. Double-click the icon for your cycle log printer.

3. In the dialog box for the printer, double-click on Set As Default Printer. A checkmark appears above the printer icon and in the submenu the next time it is accessed.

Figure 23 Set As Default Printer

Backups

The computer on the MEDIVATORS® ADVANTAGE PLUS® Automated Endoscope Reprocessor is equipped with mirrored hard drives. Mirrored hard drives consist of a main hard drive and a second hard

drive which contains an exact copy of the rst hard drive. This conguration provides a backup of the

entire computer system. The MEDIVATORS ADVANTAGE PLUS endoscope reprocessor uses MICROSOFT SQL Server 2008

Express to generate the database les.

The databases should be backed up on a regular basis. Although the mirrored hard drives do provide protection against a single hard drive failure, regular backups of the database to a remote location (CD, memory stick or remote server) will protect against database corruption or complete system failure. Follow the procedures established by your facility for scheduling and storing backups.

MEDIVATORS provides a backup utility, SQLBackupAndFTP, preinstalled on the MEDIVATORS

ADVANTAGE PLUS system. This utility must be congured.

Fluid System

Fluid Reservoir Status

The system monitors the use of disinfectant, alcohol, and detergent. The percentage of uid remaining

appears in the footer of all screens.

Figure 24 Reservoir Levels

WARNING Relling the container with the incorrect uid may cause the endoscope to be

improperly disinfected. Do not use the endoscope on a patient if this occurs.

Wear protective clothing, gloves and eye wear. The disinfectant and detergent manufacturers may recommend additional protection.

If the uid reservoir status indicates that the detergent or alcohol volume is low, then you must follow the alcohol or detergent loading process to ll the appropriate uid reservoir.

Note: A program does not stop if a 0% volume level is reached during a cycle. An error message appears

and you must replace the uids.

The uid levels in the detergent and alcohol reservoirs are monitored with oat switches. A cycle cannot be initiated if sufcient uid is not available. The replace uid utilities must be run once out of uid is detected even though the reservoirs have been relled.

Detergent and Alcohol (Optional)

The detergent and alcohol reservoirs serve both the left and right modules. Each reservoir is threaded into a captive header and is removed by unscrewing the body. The alcohol must be 70% isopropyl. The detergent must be INTERCEPT

Detergent manufactured by Medivators Inc.

Figure 25 Alcohol and Detergent Reservoirs

NOTE: Upon relling of the detergent or alcohol reservoirs, the Replace Fluids Utility must be run. If a

container empty condition has been detected, the Replace Fluids utility must be run to correct the error condition.

Because the two reservoirs are identical, you must pay attention to the labeling to ensure that the correct

uid is in each reservoir. To prevent errors, complete relling one reservoir before removing the other.

WARNING To prevent the accidental switching of the Alcohol and Detergent reservoirs always

remove, rell and replace each reservoir bottle separately. Return the reservoir (bottle) to its

original position by matching up the reservoir label to the label above the reservoir header.

WARNING Relling the container with the incorrect uid may cause the endoscope to be

improperly disinfected. Do not use the endoscope on a patient if this occurs.

Wear personal protective equipment (clothing, mask, gloves & eye wear). The disinfectant and detergent manufacturers may recommend additional protection.

Disinfectant

Rapicide PA Part A and Part B

The two disinfectant containers serve both the left and right modules. One container holds Part A while the other container holds Part B of the disinfectant solutions. The MEDIVATORS

ADVANTAGE PLUS® Automated Endoscope Reprocessor automatically mixes the two parts with water at the appropriate time during the disinfection cycle.

Note: Upon replacing RAPICIDE

PA Part A and B containers, the Replace Fluids utility must be run. A reprocessing cycle cannot be initiated if an out of disinfectant has been detected. The Replace Fluids utility must be run to clear the error condition.

Part A uses a blue cap, and is positioned to the left as you look into the front of the MEDIVATORS ADVANTAGE PLUS System. Part B uses a white cap, and is positioned to the right as you look into the front of the MEDIVATORS ADVANTAGE PLUS System. Part A and B must always be positioned in the correct location in the machine, and must always be attached to the appropriately colored cap. To facilitate

the correct connection, the blue cap is larger than the white cap, and only ts the Part A container. The smaller white cap only ts the Part B container.

Contact Time

Prior to replacing Part A or B the Replace Fluids utility must be run. Information from the containers is required. The disinfectant contact time and disinfectant temperature is pre- set during manufacturing. The

contact time and temperature eld is not congurable.

Figure 26 Parts A and B

WARNING Use only cleaning and disinfectant uids approved by Medivators Inc.

Water Line and Water Filter Disinfection

The ISO 15883-4:2008 (Washers-disinfectors Part 4) water quality standard, requires that chemical

disinfection of the water treatment (ltration) and delivery system must be performed on a weekly basis and whenever the 0.1 micron bacterial retentive lter is replaced. This standard requires that all rinse

water delivered to the washer/disinfector contain no more than 10 cfu (colony forming units) per 100 ml. Microbiological quality of even potable water varies considerably. If you are unsure of the microbiological

quality of your washer/disinfector supply water, you should have it tested according to either local or internal guidelines.

The Water Line Disinfection program or utility is used to disinfect both the water line and the water lter. Activating this utility lls the water line and water lter with disinfectant, and circulates it through the

channels and the basin.

1. Ensure that the disinfectant reservoirs are lled and the water supply is turned on.

2. Open the cover by pressing the Open/Close

button.

3. Remove any endoscope(s).

4. Install a Disinfection Block on each basin connection manifold.

Figure 27 Disinfection Block

5. Press the Menu ADVANTAGE PLUS

button for the left module on the control panel. The left side of the MEDIVATORS®

System controls this utility.

6. Log in to the system.

7. When the Program Selection screen opens, click on Program Selection and click the OK button.

Figure 28 Program Selection

8. Select Water Line Disinfect from the Select Program screen and click the OK

button.

Figure 29 Water Line Disinfect

9. When the Program Set Selection screen opens, choose the self-disinfection cycle and then click on the OK button:

S Disinfect 4 hours

Figure 30 Program Set Selection

10. Select either Normal Start or Delayed Start and click on the OK

Figure 31 Normal Start

button.

Figure 32 Delayed Start

11. If a delayed start is selected, a screen opens called Select the Time. It lists start times in 15 minute

increments for the next 7 days. Note that the dates are listed in MM/DD/YYYY, where M = month, D = day, and Y = year. Scroll down to select the desired start time and click the OK

button.

Figure 33 Select Delayed Start Time

12. An informational screen is displayed to verify that the disinfection blocks are installed. Select the OK

button if the blocks are in place or select the Cancel button to install the water line disinfect

blocks.

Figure 34 Summary/Information Screen

13. Press the Start

button to initiate the water line disinfection. Disinfectant is ushed through the water line and water lled. The disinfectant remains in the water lter and water lines while the system is disinfected. The water lines and lter are ushed, the basin is rinsed and the utility terminates.

NOTES

CHAPTER 3

OPERATION

This chapter explains how to prepare and disinfect an endoscope in the MEDIVATORS® ADVANTAGE

PLUS

Automated Endoscope Reprocessor.

System Startup

1. Verify that the MEDIVATORS® ADVANTAGE PLUS® Automated Endoscope Reprocessor PC and main power source are on.

2. Open the shutoff valve to the incoming water line. For optimum performance the water supply must be capable of delivering a minimum of 1.32 gpm (5 L/min) at 35 psi (2 bar).

3. Turn the external air source on (if applicable). External air supply must be capable of delivering house compressed air (dry / oil free) at a minimum rate of 10.58 G/min (40 L/min) at 87 psi (6 bar).

Daily Service

System Air Pressures

The main air pressure and leak test air pressure are maintained by regulators. The air pressure adjustment controls and corresponding gauges are located behind the front access door, just above the disinfectant reservoirs.

Proper operation of the MEDIVATORS ADVANTAGE PLUS System reprocessor requires that the air pressure be set and maintained at the values shown in the table below.

Figure 1 Air Pressure Controls

Table 1 Acceptable Pressure Ranges

Pressure Control Acceptable Pressure Range

Main Air Pressure 42 – 45 psi (2.8–3.0 bar)

Leak Test Air Pressure 3.6 – 3.75 psi (0.24–0.25 bar)

Channel Connectivity 25.5 – 30 psi (1.7 – 2.0 bar)

If the pressure control readings do not fall within the acceptable ranges, contact technical service. Do

not attempt to adjust the settings yourself as damage may occur to the MEDIVATORS

PLUS

Automated Endoscope Reprocessor.

ADVANTAGE

O-Rings

Check the connection manifolds to verify that all the O-rings are present and undamaged. The manifolds are located in each basin and are the studs onto which the connector block slides down and seals.

Drain Filters

Replace the lters in the rinse basin if they are excessively soiled (See Appendix B for replacement part numbers).

Figure 2 Connection Manifold

Figure 3 Drain Filters

Fluids

WARNING: Relling a reservoir with the incorrect uid may cause the endoscope to be improperly

disinfected. Do not use the endoscope on a patient if this occurs.

Always wear appropriate personal protective equipment (PPE) when handling endoscopes or disinfectant solutions. The detergent and disinfectant manufacturers may recommend additional protection.

Loading Alcohol (Optional)

Alcohol is an optional feature and may not be congured in the system. If congured, the alcohol must be

70% isopropyl.

1. Press the Menu

button on the control panel.

2. Log in to the system.

3. When the Program Selection screen opens, select Replace Fluids and click the OK button.

Figure 4 Program Selection Screen

4. When the Select Fluid Type screen opens, select Alcohol and click the OK

Figure 5 Select Fluid Type Screen

5. Enter the code found on the manufacturer’s container and press OK

button.

Endoscope repr

Figure 6 Container Code

6. Remove, rell and replace the reservoir.

Loading Detergent (Optional)

Detergent is an optional feature and may not be congured in the system.

Note: The MEDIVATORS® ADVANTAGE PLUS® Automated Endoscope Reprocessor cleaning phase

requires the use of INTERCEPT

detergent.

Remove, rell and replace the detergent reservoir.

1. Press the Menu

button on the control panel. Log in to the system.

2. When the Program Selection screen opens, select Replace Fluids and click the OK

Figure 7 Program Selection Screen

button.

3. When the Select Fluid Type screen opens, select Detergent and click the OK

Figure 8 Select Fluid Type Screen

4. Enter the code found on the manufacturer’s container and press the OK

button.

Figure 9 Container Code

5. Remove, rell and replace the reservoir.

Loading Disinfectant

WARNING Use only RAPICIDE

Check the expiration date of the disinfectant on the machine each day.

Never use disinfectant beyond the manufacturer’s expiration date, even if the MRC level is acceptable.

Never use disinfectant that tests below the acceptable MRC level, even if it has not yet reached the expiration date.

When replacing disinfectant, always wear protective clothing, gloves and eye wear. The disinfectant manufacturer may recommend additional protection.

If leaking liquid is present and you suspect it is disinfectant, read and follow the manufacturer’s instructions before attempting a cleanup.

Service: If leaking uids are present, contact a qualied service technician.

PA High Level Disinfectant.

1. Press the Menu

button on the control panel.

2. Log in to the system.

3. When the Program Selection screen opens, select Replace Fluids and click the OK button.

Figure 10 Program Selection Screen

4. When the Select Fluid Type screen opens, select Disinfectant and click OK.

5. Enter the code found on the manufacturer’s container and press OK.

6. Remove, and discard the empty containers of Part A and Part B solutions.

7. Place the new containers of Part A and Part B solutions into the machine.

Prepare the Endoscope

Place the Endoscope in the Basin

1. Endoscopes t best in the machine if they are installed in a particular fashion. The nal position of the

endoscope in the rinse basin depends primarily on the type of endoscope. To a lesser extent, the brand

of endoscope may also affect the nal position in the basin. Do not forcibly bend the endoscope to get it to t. When positioned properly, the endoscope will t appropriately in the basin.

2. Hold the control housing in your left hand and the insertion tube and light guide in your right hand.

3. Place the control housing in the basin with the angulation controls facing up.

Figure 11 Place Control Housing in Basin

4. Set the insertion tube in a clockwise circle in the basin.

Figure 12 Set the Insertion Tube in Basin

5. Fit the light guide tube in a counterclockwise circle in the basin.

6. Select the proper connection block and channel separator from the endoscope hookup guide.

Figure 13 Fit the Light Guide Tube in Basin

Install the Channel Separator

Note: Reference the endoscope hookup application guide for the correct channel separator.

Select the correct channel separator for the endoscope to be disinfected. Position the adapter so that the

stem with the O-ring ts properly in the water/air valve.

Because the valve design may vary depending on the brand and type of endoscope, attachment of the adapters may differ.

Figure 14 Fitting the Separator

Install the Connector Block

1. Hold the connector block with the handle positioned to the right in Figure 15.

Figure 15 Fitting the Connector Block

2. Place the block lightly over the manifold as shown in Figure 16 making sure that none of the hoses run or are pinched under the block.

Figure 16 Press Block Over the Manifold

3. Lock the connector block in place by moving the handle to the left as shown in Figure 17.

Figure 17 Close the Handle

WARNING Inspect the seating of the connector block to the manifold. Failure to achieve a proper connection could result in an endoscope that is not disinfected and therefore should not be used on a patient.

Connection of the Endoscope Channels

1. Connect the endoscope channels. The names of the connections of the different channels may be

found in the endoscope user manual. See Figure 18 for details on how to hookup the endoscope to the connectors.

2. Connect each tube from the labeled port on the connector block to the appropriate endoscope channel.

WARNING All endoscope hookups must be periodically inspected for damage, and replaced if

damaged, otherwise it could result in an endoscope that is not disinfected and therefore should not be used on a patient.

Figure 18 Connecting the Channels

3. Make sure the hoses do not have any sharp bends or kinks.

4. Position the connection hoses in such a way that they will not be caught by the spray tower.

Verify the Connections

WARNING Verify all connection to the endoscope are secure. Failure to do so could result in an endoscope which is not disinfected and therefore should not be used on a patient.

• Before closing the basin lid, inspect the hookup to ensure that all connections are made properly and

the tubing does not interfere with the sprayer.

• All channels must be connected correctly.

• The channel separator must be installed.

• The leak test tubing must be secured under the endoscope so that it does not oat or interfere with

the sprayer.

• The connector hoses must not be kinked.

• Move any connector tubes away from the head of the sprayer so that it can turn freely.

WARNING Verify the connection tubing does not interfere with the spray head and conrm that

the spray function is working during the cycle. Failure to do this could result in an endoscope that is not disinfected and therefore should not be used on a patient.

Figure 19 Sprayer Must Turn Freely

Disinfection Process Summary

The complete reprocessing cycle in the MEDIVATORS® ADVANTAGE PLUS® Automated Endoscope

Reprocessor is comprised of a number of specic steps designed to ensure proper endoscope disinfection.

These steps include: startup, washing, disinfectant, rinse, alcohol, and air phases. All steps must be properly

followed and should not be modied beyond manufacturer recommendations.

Cycle Startup Phase

During the start-up phase, the software reads and monitors all system sensors. If an error is detected, a message is displayed and the process is halted. The system operator then needs to resolve the error before the cycle can be continued.

Next the leak test is activated. The endoscope is pressurized and the pressure is monitored for a period of time. If the pressure drops below a set reading, an error message is displayed and the process is halted.

WARNING: If the machine detects a leak in the endoscope, do NOT use the endoscope on patients.

Refer to Chapter 5: Troubleshooting for appropriate instructions to resolve errors.

Cleaning Phase (Optional)

During the cleaning phase, detergent and water enter the basin. This basin uid is then ushed through

the endoscope channels. At the completion of the phase, the basin is drained and the endoscope channels

are ushed with fresh water. A rinse soak period without detergent then follows. The manual cleaning step

may be eliminated if the cleaning phase using Intercept detergent is programmed.

Disinfectant Phase

During the disinfectant phase, the endoscope channels are ushed with disinfectant. The basin is lled

with disinfectant solutions and the endoscope is soaked for the disinfectant contact time as recommended by the disinfectant manufacturer. After the soak, the disinfectant is drained from the basin.

Rinse Phase

During the rinse phase, the basin is partially lled with water and then drained to eliminate foam residue from inside the endoscope and from the basin. The basin is then lled with fresh water while the endoscope channels are being ushed. Once the basin lls up, water ushes through the endoscope channels. The

basin is then drained while the channels are purged with fresh water.

Alcohol Purge Phase (Optional)

During the alcohol phase, alcohol is injected through the endoscope channels. The alcohol is used to help

purge any residual uids from the endoscope.

Air Purge Phase

The air phase is simply a programmed time during which air is purged through the endoscope channels. The air is used to aid in drying of the endoscope.

Run the Disinfection Program

Normal Start

Data entry must be carried out carefully. Each selection or input must be checked and conrmed by the

operator. Entering erroneous information may lead to machine faults or inadequate disinfection of an endoscope channel.

1. Close the basin lid by pressing the Open/Close

2. Press the Menu

button.

button or the foot switch.

3. When the Operator Selection window opens, select your login name by using the Scroll Down button, or use the touchpad, bar code reader. Then click the OK

button.

4. If the Authorization window opens. Enter your password with the touchpad, bar code reader and then click the OK

button (option).

5. When the Program Selection window opens, highlight Endoscope Selection and click the OK

button.

Figure 20 Program Selection

6. From the Endoscope Selection window, choose the instrument code or endoscope that you wish to disinfect by using the scroll buttons or, bar code reader. Click the OK

button.

Note: The endoscope code or ID is required for the disinfection program to run. If pre-programmed

endoscope codes have been entered by your system administrator, the specic disinfection program for

that endoscope is selected automatically.

Figure 21 Endoscope Selection

7. Select the correct parameter set from the Endoscope Type Parameter Set Selection window by scrolling up or down with the Scroll Down

button or Scroll Up button. Then click the OK

button.

Figure 22 Parameter Set

WARNING Ensure the correct parameter set is selected for the type of endoscope to be processed. An endoscope is not disinfected and should not be used on a patient if the incorrect parameter set is used during a cycle.

8. The Patient Code window opens. Enter the patient ID with the touchpad or bar code reader and click the OK

button.

Figure 23 Patient Code

9. When the Physician Selection window opens, select the desired name by scrolling with the Scroll

Down

button, or use the bar code reader. Then click the OK button.

10. When the Physician Assistant Selection window opens, select the desired name by scrolling with the

Scroll Down button, or use the bar code reader. Then click the OK button.

Note: The patient code, physician code, and assistant code on your MEDIVATORS

ADVANTAGE PLUS® Automated Endoscope Reprocessor are congurable. If your system administrator has determined that these items do not have to be tracked, the screens will not be shown.

11. If the system is congured to automatically start the operator needs to do nothing more and the cycle

will start. If not congured the Start Program window opens. Verify that the Start data on the screen

is correct, and then click the OK

button. The process LED indicator light should turn green.

12. A system check is carried out. If a red error report appears at the bottom of the screen, attempt to correct the error by consulting Chapter 5: Troubleshooting.

13. The Program Screen opens and allows you to follow the progress of the disinfection process.

Figure 24 Process Window

Delayed Start

When selecting an delayed start, the endoscope is placed in the basin but the disinfection cycle will not begin until a pre-determined time. This is an administrative function and is available only during the time period as set up and allowed by the system administrator.

1. Prepare and connect the endoscope as described in “Run the Disinfection Program”, steps 1-12 for

the normal start above.

2. The Select the Time window opens. Select Delayed Start and press the OK Select the Time window does not open, the delayed start features is not available.

button. If the

Figure 25 Delayed Start

3. When the Select the Time window opens, scroll down to select the desired start time and date. Click the OK

button.

Figure 26 Select the Time

4. The Delay Start program window opens. Verify that the data on the screen is correct, and then click the Start

button.

Figure 27 Delayed Start Progress

5. When the designated start time is reached, a system check is carried out. If a yellow error report appears at the bottom of the screen, attempt to correct the error by consulting Chapter 5: Troubleshooting.

6. The reprocessing cycles is initiated at the selected start time.

Cycle Interruptions

Introduction

At startup and during the disinfection program cycle, the MEDIVATORS Automated Endoscope Reprocessor monitors process parameters for the endoscope, machine, and software to ensure accurate disinfection of the endoscope. Reports, program errors, and system errors appear on the screen to communicate the cycle progress to you.

Operator messages and program errors appear at the bottom of the screen in the Reports eld. A code

number and short description of the report or error is shown. The elapsed time at which the message or error is generated is also provided.

System errors appear at the top of the screen in white letters on a red background. Detailed error reports and troubleshooting steps are provided in Chapter 5.

WARNING If system power is lost during a reprocessing cycle, the system will not complete the reprocessing cycle once the power is restored. The endoscope is not disinfected and should not be used on a patient. You must start the reprocessing cycle over so that the endoscope is properly disinfected.

ADVANTAGE PLUS®

Program Errors

Restarting a Program

In a certain instances, a program may be restarted after an error is displayed to restart the program if the following conditions are true:

To restart the program:

1. Press the Start

button.

2. If the program restarts and progresses without any further errors, the disinfection cycle is valid.

3. If the program does not restart, or one or more errors appear, press the Cancel button. Follow the instructions below for the steps to take next.

If a program is stopped by an error condition and lasts longer than 60 minutes, the program can not be restarted, the LED turns red, and the program status is ASC (Reject).

Canceling a Program

If the Cancel

button is pressed, the program runs until a safe state is reached.

The alarm sounds and cancel message appears in the Report section of the screen.

Every time the Cancel button is pressed, the current program step is stopped and the next step in the cancel sequence is called. By pressing the Cancel button multiple times, the program can be forced to the end of the cycle. However, caution must be taken because the endoscope channels remain

lled with uid.

One of two status messages appears on the monitor. Follow the instructions below for the status message on your monitor.

Status: Failure Recovery

1. Press the Cancel button.

2. Press the Open/Close

3. Select your login name and press the OK

4. Enter your login name and password.

5. The basin lid opens.

6. Remove the endoscope or correct the cause of the error.

7. Re-start the disinfection program.

button.

Status: Shutdown

The endoscope cannot be removed from the machine. Continue the disinfection program. After the current program is completed, run the disinfection program again. Except for the operator login

name, all entered data are automatically copied from the previous run if these steps are followed:

1. Press the Open/Close

2. Select your login name and press the OK

button.

3. Enter your login name and password.

4. The basin cover opens.

5. Within 30 seconds, press the Menu

6. Select your login name and press the OK

button.

7. Enter your login name and password.

8. Select “Repeat last run” and press the OK button.

System Errors

If a system error occurs during standby mode, a warning message appears as the fault occurs but disappears as the situation is corrected.

If the error occurs during a disinfection cycle, the program ends and uids are drained from the basin.

A recovery program runs until a safe state is reached and the endoscope can be removed. The recovery program cannot be stopped by the operator.

WARNING Report all system errors to your supervisor.

Taking a Sample of Disinfectant – Check MRC At the end of a cycle, the system will prompt to collect disinfectant.

1. Open the center door to access the sample port.

2. Wearing protective gloves, take a sample of the disinfectant from the sample port by pressing a sample cup up against the metal prong.

Figure 28 Taking a Disinfectant Sample

3. Close the access door.

4. Test the sample using RAPICIDE

PA Test Strip to ensure that the disinfectant is above MRC.

5. Follow the prompt on the screen indicating whether the MRC passed or failed.

If Test Strip Fails

1. If the test strips indicates a fail, rerun the cycle and retest:

2. If the test strip indicates a fail again, open a new bottle of test strips and test the concentration again with a new test strip.

3. If it continues to fail, contact Medivators Technical Support or your Medivators Distributor.

Complete the Disinfection Process

When the disinfection process is complete, the process LED indicator light blinks green, the message

“Completed” displays on the LCD screen, and the alarm sounds.

Table 2 Post-Disinfection Program Status

Status Description

ACTIVE The program is progressing correctly. CORRECT The endoscope was disinfected without any faults or program interruptions. CORRECT!!! The endoscope was disinfected with errors reported. STOP (fault) The program is stopped due to an error. STOP (ASC) The safety control program stopped the program. STOP (OPERATOR) The operator stopped the program without a fault report STOP (LIO) The program stopped automatically after an error report or the maximum

error time (50 minutes) was reached. SHUTDOWN (fault) After an error, the endoscope is rinsed so that it can be safely removed. SHUTDOWN (OPERATOR) The operator stopped the program. Run down program. SHUTDOWN (ASC) The safety control program stopped the disinfection. Completion program. ASC (REJECT) The safety control program rejected the disinfection. Open the lid to close

the program. LIO (REJECT) Disinfection was rejected due to an automatic program stop.

Table 3 Post-Disinfection Instrument Status

Status Description

DISINFECTED The endoscope was run through a complete disinfection program. NOT APPLICABLE The program is not an endoscope disinfection program. Warning: The

endoscope can be used only if the connectors are correctly connected after the program.

NOT SUITABLE FOR USE The endoscope is insufciently disinfected.

WARNING Wear clean gloves to prevent soiling of the disinfected endoscope.

If a run error was generated, a channel is blocked, or the endoscope is leaking, the endoscope must not be released for patient use. If there is any doubt as to whether an endoscope is correctly disinfected, it must be disinfected again before use. Contact your supervisor for further instructions. Verify all connections to the endoscope are secure. Failure to do so could result in an endoscope which is not disinfected and therefore should not be used on a patient.

1. Open the basin lid by pressing the Open/Close

button or by using the foot switch. The run status

report disappears and the Operator selection window opens.

2. Enter your login name and password.

3. Check that all adapters are still connected to the channel connections. If an adapter is loose or disconnected, the disinfection was not complete and must be repeated.

4. Disconnect the channel adapters

5. Remove the channel separator(s).

6. Take the connector block out of the basin and hang up the block to dry.

7. Take the endoscope out of the basin.

8. If appropriate, t the valves.

9. The endoscope is now ready for a new examination. If it will not be used right away, the endoscope

must be stored in an airing cupboard or on a suspension rack.

10. If automatic cycle log printing is enabled, the log is printed.

Reports

Run Data Recorded

For each disinfection program run, the following data is recorded and stored on the PC hard drive:

• Machine ID

• Run number

• Date and time

• Endoscope Code

• Operator ID

• Patient ID

• Process step times

• Errors

• Disinfectant MRC Pass/Fail

• Additional information as set up by the system administrator

Printing Reports

Current Report

A cycle log prints automatically whenever the MEDIVATORS® ADVANTAGE PLUS® Automated Endoscope Reprocessor module cover opens at the end of a disinfection cycle. To redisplay the current cycle log, double-click the printer icon in the system tray.

Earlier Reports

All completed cycle logs may be viewed and reprinted at any time from the Management program.

1. Display the Windows desktop by minimizing all running programs.

2. Double click on the MEDIVATORS ADVANTAGE PLUS System ADV icon to open the folder.

Figure 29 MEDIVATORS ADVANTAGE PLUS System Desktop Folder

3. Double-click on the Management icon.

Figure 30 Management Icon

4. Log in to the Management system.

5. On the Management screen sidebar, click on the General tab.

Figure 31 Management Screen

6. On the sidebar, click on the Cycles icon.

7. On the blank Cycle Reports screen, set the From Date and To Date parameters, and then click on the Generate icon in the toolbar.

8. The Cycle Reports screen opens. Double-click on the desired cycle. Click on the display the Cycle Log Screen. Click on to display the detailed Cycle Report.

icon to

Figure 32 Cycle Log Screen

Figure 33 Cycle Reports Screen

9. The Cycle Details screen appears. Click on the plus sign to the left of each line to expand the report. Click on the printer icon to print a copy of the report.

Figure 34 Cycle Details Screen

Shutdown

Use the following process to shutdown the reprocessor at the end of the day.

1. Clean the system by wiping down all surfaces with a non-scouring cleansing agent. Use a lime dissolving, non-scouring agent for the rinse basin and inside the lids. Use soap and water to clean the rubber gaskets.

WARNING Avoid possible chemical burns. Always wear personal protective equipment (gloves, goggles) when handling disinfectant and/or detergent.

2. Check the detergent and alcohol reservoirs for appropriate levels. Rell them if necessary.

3. Clean the detergent cap, bracket and reservoir. Flush the reservoir thoroughly with hot water. Rell the

detergent reservoir, if necessary.

4. Close the incoming water line shutoff valve (unless either a delayed start program, water-line disinfect or endoscope reprocessing cycle is to be run).

Procedure Summary

1. Open the cover.

2. Connect the endoscope.

3. Close the cover.

4. Enter your login name and password, the endoscope ID, the patient number, the physician ID, and the assistant ID.

5. Start the program.

6. After disinfection, open the basin lid.

7. Enter your login name and password.

8. Check the sprayer and the connections.

9. Disconnect the connector block.

10. Remove the endoscope from the basin.

11. Print a report.

Downtime

Brief Downtime

• If the MEDIVATORS a brief period time—less than seven days—it should remain powered on.

ADVANTAGE PLUS® Automated Endoscope Reprocessor will be unused for

• To prevent moisture in the leak test system, t disinfection blocks in the MEDIVATORS ADVANTAGE PLUS System when it is not is use.

Prolonged Downtime

• If the MEDIVATORS ADVANTAGE PLUS System will be unused for more than seven days, it should be powered off.

• The tubing, blocks, and lters in the machine contain a lot of water where bacterial growth may occur. After a long downtime, replace the bacterial lter and disinfect the MEDIVATORS ADVANTAGE

PLUS System before running any endoscope disinfection procedures.

• To shut down the MEDIVATORS ADVANTAGE System, close all running programs rst before pressing the main PC power switch. Failure to do this may result in software errors.

• See storage section for further information.

CHAPTER 4

MAINTENANCE

This chapter contains basic service procedures required for maintaining the MEDIVATORS® ADVANTAGE

PLUS continuous quality in endoscope reprocessing. Failure to perform required maintenance may result in injury or death to the operator or patient.

Automated Endoscope Reprocessor. Strict adherence to these requirements guarantees optimum

Daily Maintenance

Details and instructions for the daily service requirements are included in Chapter 3: Operation.

The following daily maintenance procedures must be completed at the start of each day:

• Conrm that the main air pressure regulator is set between 2.8–3.0 bar (42.0 – 45.0 psi).

• Conrm that the leak test air pressure regulator is set at 0.24–0.25 bar (3.6 – 3.75 psi).

• Verify a sufcient ow of water into the basin or replace the system lters.

• Check that all O-rings on the connection columns are present and undamaged.

• Replace the screens in the rinse basin if they are soiled.

At the end of each day, clean the MEDIVATORS

ADVANTAGE PLUS® system:

• For the top and outside covers, use a non-scouring cleansing agent.

• On the endoscope basin and inside covers, use a non-scouring, lime-dissolving cleansing agent.

• Use soap and water to clean the cover gaskets and prevent them from sticking.

Weekly Maintenance

Inspection

Inspect the following on a weekly basis. Adjustments or changes should be made by a qualied service

technician.

• Hookup Connector Blocks: Check for cracks in the hookup hoses, especially at the connections to the connector block. If cracks have formed, the hose should be replaced.

• Glass Covers: The basin lids should open and close easily.

• Door: The front door should open and close easily.

• MEDIVATORS ADVANTAGE PLUS System Tubing, Connections, Fittings, Hydraulics and Dosing System: Check for wear and leakage and replace as needed.

O-Ring Lubrication

1. Using a cloth, dry the O-rings on the connection columns. Check for wear and replace as needed.

2. Take a small amount of O-ring grease between your thumb and index nger and spread it diagonally

on the connector plate along the rst two columns.

3. Repeat these two steps for the other three pairs of columns.

4. Spread the grease lengthwise along the O-rings with your thumb and index nger.

Monthly Maintenance

Basin Drain Screen

Using a screen hook, remove and clean the screen. Check for wear and replace as needed.

Air Filter Replacement

The MEDIVATORS® ADVANTAGE PLUS® Automated Endoscope Reprocessor has four (4) air lters.

Each lter should be replaced every 6 months.

1. Acquire new inline lter assemblies (See Appendix B for replacement part numbers).

2. Open the right and left blue-doors and locate the lters.

Figure 1 Filter Location

1. Remove one lter at a time. Move the lter away from the machine to allow access to the ttings.

Figure 2 Quick Connect Fitting

4. Press on Quick Connect ttings to release the lter.

Figure 3. Pressing Quick Connect button.

5. Remove and discard the lter assembly.

6. Replace the lter by attaching the Quick Connect ttings. Ensure that the color coded ttings match.

7. Close the doors.

Water Filter Replacement

WARNING: Only replace one water lter at a time. When replacing the water lter, make sure that the lter being removed is the same as the lter replacing it.

The water ltration system removes particulates and biological contaminants as small as 0.1 micron from the supply water. During the water line disinfection procedure, the entire water ltration system and the

incoming water line for the MEDIVATORS is disinfected.

Note: A water line and water ltration disinfection process must be performed whenever a water lter is

replaced. Refer to Chapter 2 Waterline and Water Filter Disinfection.

ADVANTAGE PLUS® Automated Endoscope Reprocessor

Figure 4 Water Filtration System

1. Water inlet (1/2” NPT) 7. 1 micron lter 12. Bleed valve

2. Inlet pressure gauge 8. 0.4 micron lter 13. Bleed valve outlet

3. 1 micron lter outlet pressure gauge 9. Disinfectant inlet 14. 0.1 micron lter

4. 0.4 micron lter outlet pressure gauge 10. Water lter feed line

5. 0.1 micron lter inlet pressure gauge 11. Communication cable connector

6. Water outlet

Water lters should be replaced at a minimum every three months for the 1.0 micron and 0.4 micron lters and every six months for the 0.1 micron lter. If the water pressure drops below 40 PSI or the difference between the gauges is greater than 5 PSI the corresponding lter needs to be replaced.

The following conditions must be met before changing a lter:

• No endoscope reprocessing cycles are running.

• No water line disinfection procedure is running.

• The inlet water supply is turned off. You will need the following materials:

• A container to catch water.

• A lter bowl wrench.

• The necessary lter cartridges (see Table 1) (See Appendix B for replacement part numbers).

Table 1 Filter Cartridges

Key

Filtration

Porosity

Filter Type

Minimum Replacement

1 0.1 micron Hollow ber 6 mos. 2 0.4 micron Pleated 3 mos. 3 1 micron Pleated 3 mos.

Schedule

Figure 5 Filter Cartridges

Figure 6 Filter Cartridges in place

1. Relieve the pressure in the ltration system by opening the bleeder valve on the lter system (rotate

down).

2. Check the inlet pressure gauge to ensure that the pressure is at zero.

3. Place an empty container under the 1 micron lter housing and disconnect the Quick Connect tting

at the bottom of the housing. Allowing all of the water to empty out.

4. Using a lter bowl wrench, remove the 1 micron lter housing and discard the used lter cartridge.

Figure 7 Loosen Filter Housing

Figure 8 Remove Housing and Filter

5. Place a new lter in the housing, ensuring that the O-ring is in place.

Figure 9 Check O-Ring

6. Thread the housing onto the header and tighten by hand only.

7. Repeat the procedure to replace the 0.4 micron and 0.1 micron lter.

Figure 10 Open Bleed Valve

8. To remove the 0.1 micron lter rotate the used lter cartridge counterclockwise, pull downward, and discard.

9. To install a new 0.1 micron lter insert a new lter cartridge into the housing header and rotate

clockwise until the tabs lock into place gure 11.

10. Return the bleed valve to the closed position (rotate up).

11. Slowly open the main water supply valve and check for any leaks.

Figure 11 Filter Mounting Tabs

12. Run the Water Sample Utility

• Push Menu button

• Log in

• Select: Program

• Select: Utility Program

• Choose: Take Water Sample

13. Place a container under the bleed valve outlet tube and slowly open the bleed valve (13 g. 4). Let the water run until it is a steady stream.

14. Close the bleed valve.

15. Push cancel to stop water utility or allow to complete. No actual sample needs to be taken.

16. Perform a water line and water ltration disinfection procedure. Refer to Chapter 2.

NOTE

CHAPTER 5

TROUBLESHOOTING

This chapter lists error messages you may encounter while using the MEDIVATORS® ADVANTAGE

PLUS error recurs, contact your Technical Service representative.

Automated Endoscope Reprocessor. If the suggested action does not solve a problem or if the

Introduction

Error Reports

The MEDIVATORS

display different types of errors which signal and identify specic areas requiring attention. Error types

include:

• System Errors: A communication problem identied by the prex C with errors ranging from C-001 through C-099. This is an error caused by the Windows based PC or MEDIVATORS ADVANTAGE PLUS system.

• Bar Code Errors: A bar code problem identied by the prex M with errors ranging from M-910 through M-940.

• Endoscope Errors: An endoscope problem identied by the prex S with errors ranging from S-102 through S-177.

• Reprocessing Cycle Errors: A problem identied during the endoscope disinfection cycle

identied by the prex S with errors ranging from S-201 through S-297, and S-511 through S-832

• Control Errors (SCU): Lists any deviations in the disinfection program as monitored by the SCU

controller, and identied by the pre-x S with errors ranging from S-300 through S-399.

• Warning Errors: An alert or warning identied so that the operator is aware of a machine condition that requires attention. Warnings are identied by the prex W and range from W-701 through W-821.

ADVANTAGE PLUS® Automated Endoscope Reprocessor system can report and

100

Medivators ADVANTAGE PLUS User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual