safety, efficacy & microbiological...

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Endoscope Cleaning and Disinfection System

(With optional cleaning cycle that eliminates manual cleaning)

Safety, Efficacy &

Microbiological

Consideration

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MEDIVATORS®, INTERCEPT

®, RAPICIDE

® and ADVANTAGE

®, are registered trademark of Medivators Inc.

Olympus is a registered trademark of Olympus Corporation.

Pentax is a registered trademark of Hoya Corporation.

Fujinon is a registered trademark of Fujifilm Corporation.

50097-698 Rev C – ADVANTAGE PLUS 2.0

© 2015 Medivators Inc.

All rights reserved. This publication is protected by copyright. Copying, disclosure to others, or the use of this publication is

prohibited without the express written consent of Medivators Inc.

Medivators reserves the right to make changes in the specifications shown herein without notice or obligation. Contact your Medivators representative or Medivators customer service for more information.

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INTENDED USE

The MEDIVATORS® ADVANTAGE PLUS

® Endoscope Reprocessing System is intended to test, clean, disinfect, and rinse

endoscopes, such as fiber-optic 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 scopes 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 direction for use. The system uses Intercept

Detergent in the cleaning cycle at a concentration of 0.5%.

PRODUCT DESCRIPTION

The ADVANTAGE PLUS automated endoscope reprocessor tests, cleans, and high-level disinfects endoscopes and related

accessories between uses. This advanced system performs automated cleaning of endoscopes, a feature which eliminates the

need for manual cleaning. Built-in continuous leak testing and channel blockage monitoring provide additional levels of safety

to ensure consistent results. Results are then recorded in the sophisticated data management storage system.

The ADVANTAGE PLUS automated endoscope reprocessor has two large, easy loading independent basins, which perform

asynchronous reprocessing and accommodate most endoscope models. Endoscopes are connected to the ADVANTAGE

Hookup Connector Block*, which contains individual connectors for each endoscope channel. These validated hookups test for

channel connectivity blockage and outer sheath leaks and provide perfusion of internal endoscope channels. Upon successful

completion of the connectivity, blockage and leak tests, the system proceeds to rinse the instrument and start the cleaning and

disinfection cycle.

The ADVANTAGE PLUS utilizes INTERCEPT

® Detergent and the high-level disinfectant RAPICIDE PA, a single-use

peracetic acid. Both INTERCEPT and RAPICIDE PA have been validated for use in the ADVANTAGE PLUS automated

endoscope reprocessor. Endoscopes will not require manual cleaning if the wash cycle utilizing Intercept Detergent is

performed. For reprocessing cycles that will not include the wash cycle, manual cleaning of the endoscope is required. The

ADVANTAGE PLUS automated endoscope reprocessor also has the ability to perform a 70% isopropyl alcohol flush with

subsequent air purge to assist in drying of endoscope channels.

*It is important to use the correct connections (hookups) for connecting the scope to the machine. A list of endoscope and

corresponding hookups can be found on the online interactive hookup guide: www.minntech.com/medivators/hookuplookup.

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PRODUCT FEATURES

• Asynchronous operation of two large independent basins

• A dedicated personal computer (PC) for cycle recording, powerful quality assurance reporting, easy backups, networking

availability, and remote diagnostics

• Contains second hard drive for easy data backups.

• Hookup blocks dedicated to a family of endoscopes to ensure correct connectivity and flow rates to meet manufacturers’

specifications

• Individual channel identification and blockage monitoring

• Continuous endoscope leak testing throughout entire reprocessing cycle

• Remote diagnostics for operator assistance and troubleshooting

• Uses single-shot, environmentally friendly RAPICIDE® PA High-level disinfectant

• Optional cleaning claim cycle that eliminates manual cleaning

• Easy-to-fill detergent and alcohol reservoirs

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REPROCESSING CYCLE

The ADVANTAGE PLUS® automated endoscope reprocessor has an average reprocessing cycle time of 35 minutes, which

includes leak testing, washing, disinfecting, rinsing and a final alcohol and air purge.

The ADVANTAGE PLUS automated endoscope reprocessor utilizes an advanced software program that continuously monitors

all system sensors. This highly advanced program was designed specifically for the ADVANTAGE PLUS automated

endoscope reprocessor and monitors each phase of the reprocessing cycle.

Each overall cycle on the ADVANTAGE PLUS automated endoscope reprocessor consists of a combination of fourteen possible

phases:

Phase

Number

Phase Usage Details

1 Leak Test

2 Flush Rinse approximately 5 liters of water

3 Wash 3.5 liters water plus 17.5 ml Intercept detergent

4 Flush Rinse approximately 5 liters of water

5 Post Rinse 10 liters of water

6 Wash 3.5 liters water plus detergent

7 Flush rinse approximately 5 liters of water


9 Disinfect 10 liters of RAPICIDE® PA

10 Flush Rinse 5 liters of water



13 Final Rinse 5 liters of water

14 Alcohol Purge/Vent 10-30 ml per cycle depending on the scope channel configuration

The minimum requirements for a cycle are 1, 2, 3, 4, 9, 10, 13, 14 – which can be configured with any different combination of washes and rinses.

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LEAK TESTING

The ADVANTAGE PLUS® automated endoscope reprocessor performs leak testing during the first phase of the reprocessing

cycle by pressurizing the endoscope. The pressure level is maintained throughout each following cycle until reprocessing is

complete. If a gross leak is detected, the ADVANTAGE PLUS automated endoscope reprocessor will automatically stop the

reprocessing cycle so no fluid enters the endoscope preventing further damage. If a small leak is detected in the endoscope but

its sheath remains pressurized, no fluid invasion can occur so the ADVANTAGE PLUS automated endoscope reprocessor will

finish the disinfection cycle. Therefore, the leak testing capability of the ADVANTAGE PLUS automated endoscope reprocessor

minimizes associated endoscope repair costs while providing the endoscope manufacturer with a high-level disinfected

endoscope.

CHANNEL MONITORING & BLOCKAGE DETECTION

The ADVANTAGE PLUS automated endoscope reprocessor uses specially designed Hookup Connector Blocks, which are

specific for each endoscope make and model. Individual connections are made via the Connector Block tubing to the

endoscope channels: air, water, suction, biopsy, etc. Through these connections, the advanced software system performs

continuous monitoring of each channel connection and will alert the operator if a connection is not secure or if there is

blockage. These quality assurance procedures provide consistency not offered with manual reprocessing.

AUTOMATED CLEANING

Automated cleaning of endoscopes must be performed using INTERCEPT® Detergent in the high performance cleaning cycle.

This automated cleaning cycle has been shown to be equivalent to manual cleaning, achieving results that meet the AAMI TIR-

30 standard for residual soil.

The endoscope cleaning phase for the ADVANTAGE PLUS automated endoscope reprocessor consists of four phases:

1. Phase 2 – Flush phase. This phase flushes the endoscope channels with fresh water. The outside of the endoscope is

also sprayed with fresh water using the spray arm. This is the initial flush of the endoscope. This phase also flushes the

water up to temperature. This phase is part of cycles programmed without the cleaning claim wash phase as well.

2. Phase 3 – Detergent Wash phase. This phase dispenses detergent into the basin to a detergent concentration of 0.5%.

The basin is filled with 3.5 liters of fresh water. The endoscope channels are rigorously flushed with the detergent

solution. The exterior soaks in the 3.5 liter solution and is sprayed with the solution using the spray arm and the

hydrodynamic spray tower.

3. Phase 4 – Second Flush phase. This phase is used to remove the bulk of the detergent solution from the basin and the

endoscope. This phase flushes the endoscope channels with fresh water. The outside of the endoscope is also sprayed

with fresh water using the spray arm and the hydrodynamic spray tower. The drain is open and the water level is not

maintained in the basin.

4. Phase 5 – Post rinse. This rinse fills the basin with 10 liters of water. The endoscope channels are flushed while the

exterior soaks in 10 liters of water and the exterior of the endoscope is sprayed with rinse water using the spray arm and

the hydrodynamic spray tower.

Air is then blown through the channels to remove residual rinse water prior to the introduction of disinfectant. This ensures

surface contact with disinfectant and minimizes dilution.

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Cleaning Validation

Validation of the automated cleaning by the ADVANTAGE PLUS® automated endoscope reprocessor was done both with Artificial

Test Soils (ATS) and with clinically soiled endoscopes. The endoscopes chosen were representative of the most complex scopes

in three different classes: bronchoscopes, gastroscopes, and colonoscopes. The scopes in the simulated use testing were soiled in

the channel lumens and on the surface with ATS, to the worst case limits reported (Alfa, 1999). The soils used were the Alfa test

soil (Alfa, 2002) for the gastroscopes and colonoscopes, and a respiratory test soil (based on published reports of respiratory soil

composition) for the bronchoscopes. The test markers followed were the total protein, total carbohydrate, and total hemoglobin.

The total protein detection was done using the BCA assay (Smith et al., 1985), a standard method widely used in biochemistry and

medicinal chemistry. The total carbohydrate detection was done using the anthrone/acid method (Morris, 1948), which produces a

very stable color change and does not require prior hydrolysis of the polysaccharides. The hemoglobin quantitation was

performed using cation exchange on a PolyCAT HPLC column, after cyano-derivatizing the hemoglobin. All of the methods were

validated with the soils, including matrix validation. The quantitation for each analyte was reported in total (per scope) and also

normalized to the total surface area that was soiled.

The target criteria were taken from AAMI TIR-30. The goal of the cleaning phase was to achieve more than 90% reduction of

protein, more than 90% reduction of carbohydrate, and a residue of <6.4 µg protein/cm2, <1.8 µg carbohydrate/cm

2, and <2.2 µg

hemoglobin/cm2. All criteria were required to be met in all cases. A minimum of 5 repetitions were completed for each scope, in

addition to 5 positive control (soiled but not cleaned, then recovered) and 5 negative control (not soiled, recovered) repetitions.

The simulated studies were performed on scopes from three different manufacturers; in each case, the scopes used were

representative of the most complicated and difficult to clean instruments in their class. The scopes were soiled in all lumens and

on the surface, and dried for 1 hour. The total amount of soiling was determined both by dry weight difference and by the use of

positive controls (where the soil was immediately recovered without being cleaned). Negative controls were performed in each

case by performing soil recoveries on the scopes prior to the soiling/cleaning tests (i.e., on unsoiled scopes). This demonstrated

that the scopes used did not have residual soil from previous use. Soiled/cleaned scopes were processed on the cleaning cycle of

the ADVANTAGE PLUS automated endoscope reprocessor, using 0.3% Intercept cleaner, which is worst-case (the normal cycle

uses 0.5% Intercept); this worst- case condition insures that variation in dilution is accounted for.

After cleaning, the residual soil was recovered by brushing and flushing the channels and scrubbing the surface; all cleaning

brushes and scrubs were recovered as well, using sonication and extraction. The recovery method for all cases (positive controls,

negative controls, and soiled/cleaned scopes) was validated by demonstrating that >90% of the soil was recovered, and that

successive soil recoveries of the same scope did not produce significant residuals of the analytes.

The recovered soil was analyzed for the markers, and the data were totaled for each scope, and also normalized to the total surface

area inoculated. The data, shown in tables 1,2, and 3, show that the target residual criteria were met in all cases.

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Table 1. Residual soil recovered after cleaning, Olympus scopes

Residuals

Endoscope

Channel

protein

average,

µg/cm2

carbohydrate

average,

µg/cm2

hemoglobin

average,

µg/cm2

Olympus Bronchoscope

BF-P30

B/S 0.95 0.63 0.38

Out 0.68 0.87 0.23

Whole 1.95 1.36 0.67

Olympus Gastroscope

GIF-2T160

B/S 0.43 0.13 0.13

B2 0.65 0.13 0.14

Air 0.39 0.11 0.12

water 0.34 0.10 0.11

Elevator 0.41 0.12 0.13

Out 0.45 0.12 0.05

Whole 0.53 0.15 0.13

Olympus Colonoscope

XCF-H160AYL

B/S 0.33 0.12 0.11

Air 0.45 0.15 0.15

water 0.49 0.16 0.16

Elevator 0.48 0.15 0.16

Out 0.34 0.12 0.03

Whole 0.45 0.17 0.12

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Table 2. Residual soil after cleaning, Pentax scopes.

Residuals

Endoscope

Channel

protein

average,

µg/cm2

carbohydrate

average,

µg/cm2

hemoglobin

average,

µg/cm2

Pentax

Bronchoscope

VB 1530

B/S 3.20 0.75 0.74

Valve 1.48 0.46 0.44

Out 1.50 0.52 0.55

Whole 2.14 0.59 0.59

Pentax

Gastroscope

EG 3830K

B/S 0.43 0.13 0.14

Air 0.32 0.10 0.10

water 0.34 0.11 0.12

Elevator 1.26 0.30 0.30

Out 0.17 0.05 0.05

Whole 0.48 0.14 0.15

Pentax

Colonoscope

EC 3830FK

B/S 0.25 0.07 0.08

Air 0.26 0.08 0.09

water 0.28 0.09 0.09

Elevator 0.72 0.23 0.23

Out 0.10 0.02 0.03

Whole 0.32 0.09 0.10

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Table 3. Residual soil after cleaning, Fujinon scopes.

Residuals

Endoscope

Channel

protein

average,

µg/cm2

carbohydrate

average,

µg/cm2

hemoglobin

average,

µg/cm2

Fujinon Bronchoscope

EB-470S

B/S 1.27 0.57 0.42

Valve 1.06 0.44 0.35

Out 0.92 0.59 0.23

Whole 1.54 0.78 0.47

Fujinon Gastroscope

ED-530XT

B/S 0.32 0.14 0.10

Air 0.27 0.14 0.09

water 0.36 0.16 0.12

Out 0.31 0.15 0.04

Whole 0.41 0.18 0.11

Fujinon Colonoscope

EC-450LS5

B/S 0.31 0.14 0.10

Air 0.28 0.13 0.09

water 0.36 0.19 0.12

Elevator 0.79 0.34 0.26

Out 0.41 0.16 0.05

Whole 0.47 0.20 0.12

The cleaning, indicated by the markers followed, achieved >99.9% removal of organic soil, and the average of residual soil was

well below the target levels identified in AAMI TIR-30. This demonstrates that the ADVANTAGE PLUS® automated endoscope

reprocessor was effective in removing the organic load from flexible endoscopes.

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Clinically Soiled Scopes

In addition to the simulated soiling/recovery, clinically soiled endoscopes were also cleaned, in order to evaluate the cleaning

efficacy on actual patient soil, and also to demonstrate that the automated cycle achieves the same level of soil removal/residual

as manual cleaning.

Scopes were obtained from 2 different endoscopy clinics, representing multiple manufacturers, models, and classes

(bronchoscopes, gastroscopes, and colonoscopes). The manual cleaning was performed by the clinical staff, in accordance with

their normal cleaning methods. The scopes for automated cleaning were picked up from the clinics immediately after use and

brought to the laboratory for processing on the ADVANTAGE PLUS® automated endoscope reprocessor cleaning cycle (cleaning

cycle only). Both the manually cleaned scopes and the scopes cleaned on the automated cycle of the ADVANTAGE PLUS

automated endoscope reprocessor were harvested for residual soil by the same method that was validated and used in the

simulated soiling. The same markers for residual soil (protein, carbohydrate, and hemoglobin) were followed.

Three endoscopes of each model and type were performed by each method (automated and manual). The results are shown in

Table 4. Both of the cleaning processes met the criteria set in AAMI TIR-30, for all scopes tested. In all cases the automated cycle

of the ADVANTAGE PLUS automated endoscope reprocessor performed comparably to manual cleaning.

Table 4. Cleaning of clinically soiled scopes, by automated and by manual cleaning.

Protein residual, µg/cm2 Carbohydrate residual, µg/cm2 Hemoglobin residual, µg/cm2

Scope

Channels

Automated

Clean

Manual

Clean

Automated

Clean

Manual

Clean

Automated

Clean

Manual

Clean

Bron.

BF-P40

Biopsy 1.80 2.81 1.01 0.62 1.63 1.42

Out 0.78 0.74 0.68 1.01 0.82 0.65

Whole 1.76 2.02 1.04 1.02 1.72 1.44

Gastro

GIF-H180

B/S 0.73 0.63 0.69 0.32 0.73 0.46

Air 0.39 1.31 0.29 0.35 0.29 0.27

Water 0.70 0.51 0.36 0.30 0.38 0.29

Out 0.62 1.36 0.32 0.31 0.14 0.11

Whole 0.73 1.10 0.45 0.35 0.43 0.31

Colon

PCF-

H180AL

B/S 0.42 0.34 0.17 0.16 0.30 0.34

Air

0.77

3.83

0.36

0.41

0.39

0.50

Water 0.67 0.85 0.33 0.27 0.57 0.48

Elevator 0.56 1.75 0.28 0.32 0.51 0.51

Out 0.24 0.39 0.13 0.15 0.09 0.06

Whole 0.44 0.90 0.21 0.22 0.29 0.28

All of the cleaning processes met the criteria set in AAMI TIR-30. These data show that the automated cleaning cycle on the

ADVANTAGE PLUS automated endoscope reprocessor performs as effectively as manual cleaning in removing the organic load

of even the most complicated endoscopes.

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HIGH-LEVEL DISINFECTION

High-Level disinfection is achieved with RAPICIDE® PA High-level disinfectant, a single-use environmentally friendly

peracetic acid. RAPICIDE PA High-level disinfectant enters the basin and is perfused through internal endoscope channels via

hookups.

RAPICIDE PA Solutions A and B are combined to produce a single use-solution for High-Level Disinfection (HLD) of endoscopes

with peracetic acid (PAA) as the active agent. RAPICIDE PA High-level disinfectant also contains corrosion inhibitors and water

conditioning agents. The ADVANTAGE PLUS® automated endoscope reprocessor is constructed with high-grade components

compatible with peracetic acid.

The characteristics of the single use-solution are:

• Active Ingredient: Peracetic Acid

• PAA Concentration: 1000-1300 ppm

• Minimum Recommended Concentration (MRC): 850 ppm

• Reuse Period: Single use

• High-Level Disinfection Claim: 5 Minutes at 30ºC (Use conditions may vary by country. Please contact your Medivators

distributor for information)

• Dilution Required: 1:1 to 48 water

• Activation Required: No

• Corrosion Inhibitors: Yes

RAPICIDE PA High-level disinfectant has been shown to be effective in killing vegetative bacteria, M. tuberculosis, fungi and

viruses, MRSA, VRE C. difficile and other spores of Bacillus and Clostridium species. Test strips are used to determine

whether an effective concentration of active ingredient is present following reprocessing.

Antimicrobial Activity Results

Sporicidal Clostridium sporogenes spores Total Kill

Sporicidal Bacillus subtilis spores Total Kill

Tuberculocidal Mycobacterium bovis (BCG) Total Kill

Virucidal Polio virus type 2 Complete Inactivation

Virucidal Herpes Simplex virus type 1 Complete Inactivation

Virucidal Human Immunodeficiency Virus

type 1

Complete Inactivation

Fungicidal Trichophyton mentagrophytes Total Kill

Bactericidal Pseudomonas aeruginosa Total Kill

Bactericidal Staphylococcus aureus Total Kill

Bactericidal Salmonella enterica Total Kill

Simulated Use Mycobacterium terrae >6 log Reduction

In-Use GI Tract Normal Flora Total Kill

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AUTOMATED ALCOHOL FLUSH & AIR PURGE

After the high-level disinfection cycle is completed, the endoscope is given a final rinse and purged with alcohol and air to assist

in drying all channels. This automated alcohol flush and air purge is an important step to sustaining a high-level disinfected

endoscope.

Table 5. Total Residues Extracted from Colonoscopes after ADVANTAGE PLUS® automated endoscope

reprocessor Processing

Disinfectant

Safe

residual

level (mg)

Range of total extracted

residuals from 3 endoscopes

(mg)

Required

Endoscope Rinses

RAPICIDE® PA 250 mg 0 2

ELECTRICAL SAFETY TESTING

All electrical safety aspects of the ADVANTAGE PLUS automated endoscope reprocessor have been tested by an outside testing

service (Intertek Testing Services) for compliance with UL-61010-1 Standard for Safety Requirements for Electrical Equipment.

It has also been tested for emissions that may affect other devices, and for immunity to the effects that other devices may have on

the reprocessor. These test data meet the requirements of IEC 60601-1-2. Testing on file with shows the machine meets all required

standards and will be safe under its labeled conditions.

REPROCESSOR SELF-DISINFECTION

The ADVANTAGE PLUS automated endoscope reprocessor needs to be sanitized at regular intervals to ensure that water

pathways and filters do not become contaminated. Testing was performed on ADVANTAGE PLUS automated endoscope

reprocessor using the self-disinfection cycle with RAPICIDE® PA High-level disinfectant. Concentrations of both disinfectants

relative to the MRC in the water filter were determined in three replicate runs during the self- disinfection hold period. Results in

Table 6 demonstrate that RAPICIDE PA High-level disinfectant concentrations are within the normal use concentration and well

above the MRC during the disinfection hold period.

Table 6. Disinfectant Concentrations During ADVANTAGE PLUS automated endoscope reprocessor Self-Disinfection Cycles

Disinfectant MRC Range of baseline

disinfectant

Range during self-

disinfection

Rapicide PA 850 ppm 1060-1090 ppm 1413-1453 ppm

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MATERIAL COMPATIBILITY

Material compatibility testing has been performed on all components of the ADVANTAGE PLUS® automated endoscope

reprocessor that will be contacted by the labeled disinfectants. Metals, ceramics, plastics, composites and elastomers were

exposed to RAPICIDE® PA High-level disinfectant at full strength at recommended use temperatures. Components were exposed

for 325 hours to meet the equivalent of 1.5 years of field use. All materials had parameter changes less than the 5% criterion and

are acceptable for use with disinfectants under labeled use conditions.

SOFTWARE VERIFICATION

Laboratory studies were conducted to verify that the ADVANTAGE PLUS automated endoscope reprocessor will perform its

specified functions. Each system and sensor has been studied, and the complete integrated system has been shown to perform in

an effective manner.

Software system parameter verification testing included:

• Control of machine draining

• Control of the pre-rinse and final rinse requirements

• Execution of the proper self-disinfection cycle

Software detection of error conditions verification testing included:

• Compromised endoscope sheath (leak detection)

• Disconnected or improperly connected channels

• Endoscope channel blockage

• Reservoir temperatures above or below labeled parameters

• Open/ajar basin lids

• Low water or disinfectant level in basin

• Deviation from maximum/minimum cycle step times

• Disinfectant overflow sensor

• Disinfectant low level sensor

• Electrical power supply at incorrect cycle phase

• Disinfection contact times inadequate

• Unsatisfactory completion of self-disinfection phase

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References

AAMI TIR 30 (2003). A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical

devices.

Alfa, MJ, Degagne, P, Olson, N (1999), Worst-case soiling levels for patient-used flexible endoscopes before and after cleaning.

Am J. Infection Control 27:5, 392-401.

Alfa, MJ (2002). Artificial Test Soil. US Patent 6,447,990.

Morris, DL (1948). Quantitative determination of carbohydrates with Dreywood’s anthrone reagent. Science 107:254-5

Smith, P.K. et al. (1985). Measurement of protein using bicinchonic acid. Anal. Biochem. 150: 76-85.

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