Steris Medivators Advantage Plus Automated Endoscope Reprocessor Operating instructions

4007235

Revision B

en

MEDIVATORS™

ADVANTAGE PLUS™

Automated Endoscope

Reprocessor

Operator Manual

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4007235_B MEDIVATORS™ ADVANTAGE PLUS™

Automated Endoscope Reprocessor

Operator Manual

TABLE OF CONTENTS

Section Number Description Page

1 Copyright Information....................................................................................................................... 6

2 A Word from STERIS ......................................................................................................................... 7

2.1 Introduction..................................................................................................................... 7

2.2 Intended Use................................................................................................................... 7

2.3 Advisory........................................................................................................................... 7

2.4 Certifications ................................................................................................................... 8

2.5 Service Information ........................................................................................................ 8

2.6 Addresses........................................................................................................................ 8

3 Safety Precautions ..........................................................................................................................10

3.1 Warnings and Cautions ................................................................................................ 10

3.2 Electromagnetic Compatibility..................................................................................... 13

3.3 Waste Products Disposal ............................................................................................. 15

4 Symbols and Labels.........................................................................................................................16

4.1 Components.................................................................................................................. 16

4.2 Nameplate..................................................................................................................... 16

4.3 Transportation and Storage......................................................................................... 17

5 Specifications and Requirements ..................................................................................................19

5.1 Product Specifications.................................................................................................. 19

5.2 Operational Specifications ........................................................................................... 19

5.3 Environmental Requirements...................................................................................... 19

5.4 Installation Requirements............................................................................................ 20

6 Component Identification ...............................................................................................................21

6.1 Exterior .......................................................................................................................... 21

6.2 Interior ........................................................................................................................... 25

6.3 Operator Controls ......................................................................................................... 28

6.4 Accessories ................................................................................................................... 40

6.5 Consumables................................................................................................................. 43

7 Operating Instructions .................................................................................................................... 45

7.1 Getting Started ............................................................................................................. 45

7.2 Replacing Fluids............................................................................................................ 46

7.3 Endoscope Reprocessing ............................................................................................. 50

7.4 Water Line Disinfection ................................................................................................ 59

7.5 Water Sampling ............................................................................................................ 63

8 Administration .................................................................................................................................68

8.1 System Configuration................................................................................................... 68

8.2 Networking.................................................................................................................... 69

8.3 Endoscope Registration ............................................................................................... 70

8.4 Operator Registration................................................................................................... 73

8.5 Physician/Assistant Registration ................................................................................ 76

8.6 Data Management........................................................................................................ 79

9 Routine Maintenance ......................................................................................................................87

9.1 Daily Maintenance ........................................................................................................ 87

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

9.3 Monthly Maintenance .................................................................................................. 90

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9.4 Biannual Maintenance.................................................................................................. 93

10 Troubleshooting...............................................................................................................................97

10.1 C-001; SCU error: %d: %S.............................................................................................. 97

10.2 C-012: No hardware definition received. Hardware not initiated ............................. 97

10.3 C-015; Server disconnected. Selection aborted.........................................................97

10.4 C-016: Run could not be configured, check SQL-server connection ........................ 98

10.5 C-017: User data could not be retrieved, check SQL-server connection ................. 98

10.6 C-019: The clock has been synchronized with the server computer (%S)................98

10.7 C-021: The expert control has been automatically closed, you have to log on

again .............................................................................................................................. 99

10.8 C-030: The previous run has ended incorrectly. Program aborted to a safe

situation ........................................................................................................................ 99

10.9 C-032: A failure occurred during the execution of a run. Program aborted to a

safe situation ................................................................................................................ 99

10.10 C-033: Program aborted to a safe situation, but incorrect parameter set .............. 99

10.11 C-040: Hardware definition contains an invalid signal %d.......................................100

10.12 C-042; Selected hardware definition not correct for “%s”.......................................100

10.13 C-052: Automatic start of program is not possible in the current state................100

10.14 C-053: Automatic start of program is not possible. Another program is

active ...........................................................................................................................100

10.15 C-060: Delayed start of program is not possible in the current state....................101

10.16 C-099: Internal LIO failure:.........................................................................................101

10.17 M-910: Unknown barcode.........................................................................................101

10.18 M-930: Barcode not found ........................................................................................101

10.19 M-940: The code “%S” is not the correct %S code....................................................102

10.20 S-102: Start not allowed: Vent hookup block ..........................................................102

10.21 S-103: Endoscope leak or connected incorrectly.....................................................102

10.22 S-104: Minor endoscope leak, cycle continuing safely............................................103

10.23 S-105: Leak test vented but pressure remains high ...............................................103

10.24 S-106: The block is not pressurized or is not connected ........................................104

10.25 S-112, S-122, S-132, S-142, S-152, S-162, S-172: Start not allowed: vent

hookup block...............................................................................................................104

10.26 S-113, S-123, S-133, S-143, S-153, S-163, S-173: No flow: [channel type]

channel ........................................................................................................................105

10.27 S-114, S-124, S-134, S-144, S-154, S-164, S-174: Blocked [channel type]

channel ........................................................................................................................106

10.28 S-115, S-125, S-135, S-145, S-155, S-165, S-175: No pressure: [channel

type] channel ..............................................................................................................107

10.29 S-116, S-126, S-136, S-146, S-156, S-166, S-176: [Channel type] channel

disconnected...............................................................................................................108

10.30 S-117, S-127, S-137, S-147, S-157, S-167, S-177: [Channel type] channel

disconnected...............................................................................................................109

10.31 S-201: Internal machine fluid leak, check drip tray..................................................109

10.32 S-203: Wrong connection block ................................................................................110

10.33 S-211: Lid open ..........................................................................................................110

10.34 S-222: Start not allowed: check detergent pressure sensor ..................................110

10.35 S-223: No detergent flow..........................................................................................111

10.36 S-224: Start not allowed: detergent level low .........................................................111

10.37 S-241: Alcohol sensor defective................................................................................111

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10.38 S-242: Start not allowed: check alcohol pressure sensor.......................................112

10.39 S-243: No alcohol flow...............................................................................................112

10.40 S-244: Start not allowed: alcohol level low..............................................................112

10.41 S-271: Start not allowed: fluid in basin ....................................................................113

10.42 S-272: Start not allowed: basin not empty ..............................................................113

10.43 S-273: Basin empty....................................................................................................113

10.44 S-274: Basin not emptying........................................................................................114

10.45 S-275: Basin level dropped........................................................................................114

10.46 S-276: Basin minimum level not reached ................................................................114

10.47 S-280: Flowmeter S16 has failed .............................................................................114

10.48 S-281: No incoming water flow ................................................................................115

10.49 S-282: Water inlet flow too high...............................................................................115

10.50 S-283: Water inlet flow too low................................................................................115

10.51 S-285: No water supply .............................................................................................115

10.52 S-286: Volume measurement V1>V2.......................................................................116

10.53 S-287: Volume measurement V1<V2.......................................................................116

10.54 S-288: Unrequested inlet water detected................................................................116

10.55 S-289: External water supply valve failed................................................................116

10.56 S-292: Basin temperature sensor defective ............................................................116

10.57 S-293: Basin Temperature Too High ........................................................................117

10.58 S-294: Basin temperature too low ...........................................................................117

10.59 S-295: Water temperature sensor reading incorrectly............................................117

10.60 S-297: Basin temperature too high ..........................................................................118

10.61 S-300: SCU [error number]: [error description] .......................................................119

10.62 S-301: SCU in “OK” state ...........................................................................................120

10.63 S-302: SCU Wrong configuration ..............................................................................120

10.64 S-304: SCU: No connection........................................................................................121

10.65 S-310: Spray arm speed below minimum ................................................................121

10.66 S-311: Spray arm speed above maximum ...............................................................121

10.67 S-350: Manual control active ....................................................................................122

10.68 S-360: Stopped by operator ......................................................................................122

10.69 S-511: Measured contact time is too short .............................................................122

10.70 S-660: MRC validation failed .....................................................................................123

10.71 S-671: “Machine control” locked by the other side .................................................123

10.72 S-672: Wrong system side ........................................................................................123

10.73 S-810: Check part A container, run replace fluids utility .........................................124

10.74 S-811: Check part B container, run replace fluids utility .........................................124

10.75 S-814: Part A fill sensors do not agree.....................................................................124

10.76 S-818: Dosing reservoir B empty sensor error ........................................................124

10.77 S-819: Dosing reservoir A empty sensor error ........................................................125

10.78 S-820: Part A container empty, run replace fluids utility ........................................125

10.79 S-821: Part B container empty, run replace fluids utility ........................................125

10.80 S-824: Dosing reservoir A not empty .......................................................................125

10.81 S-825: Dosing reservoir B not empty .......................................................................126

10.82 S-828: Part A dosing reservoir empty too soon ......................................................126

10.83 S-829: Part B dosing reservoir empty too soon ......................................................126

10.84 S-831: Air cylinder does not charge..........................................................................126

10.85 S-832: Air cylinder not discharged ............................................................................127

10.86 W-701: SCU: No connection ......................................................................................127

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10.87 W-702: SCU: Wrong configuration ............................................................................127

10.88 W-703: SCU: Incorrect status and lids inactive ........................................................128

10.89 W-704: SCU: Incorrect status ....................................................................................128

10.90 W-705: SCU: In “OK” status.......................................................................................128

10.91 W-711: Lid open .........................................................................................................129

10.92 W-712: Lid will not open............................................................................................129

10.93 W-713; Lid will not close ...........................................................................................129

10.94 W-715: Basin not empty............................................................................................130

10.95 W-716: Fluid leak detected........................................................................................130

10.96 W-721: Water temperature sensor defective ..........................................................130

10.97 W-743: Sensor S03 detergent high ..........................................................................130

10.98 W-744: Sensor S17 minimum level high..................................................................131

10.99 W-749: Sensor S24 alcohol high...............................................................................131

10.100 W-751: Sensor S11 leak test high ............................................................................131

10.101 W-757: Sensor S33 high............................................................................................131

10.102 W-764, W-765, W-766, W-767, W-768, W-769, W-770: [Channel type]

sensor high..................................................................................................................132

10.103 W-800: Manual control active ...................................................................................132

10.104 W-801: Purge in progress..........................................................................................132

10.105 W-802: Venting alcohol line, close lid .......................................................................133

10.106 W-803: Discharging air cylinder, close lid.................................................................133

10.107 W-805: Left side controls the water line disinfect ..................................................133

10.108 W-810: Open lid to complete cycle ...........................................................................133

10.109 W-820: Disinfectant in the basin (lid locked)............................................................134

10.110 W-821: Disinfectant in supply line (lid locked) .........................................................134

11 Appendix.........................................................................................................................................135

11.1 Replacement Parts and Products..............................................................................135

11.2 Change Logs................................................................................................................136

1 — Copyright Information

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4007235_B MEDIVATORS™ ADVANTAGE PLUS™

Automated Endoscope Reprocessor

Operator Manual

Copyright Information

MEDIVATORS™, ADVANTAGE PLUS™, RAPICIDE™ and INTERCEPT™ are trademarks of STERIS. All other company or

product names referenced in this document are trademarks of their respective owners.

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

without the express written consent of STERIS.

STERIS reserves the right to make changes in the specifications shown herein without notice or obligation. For

additional information, contact STERIS.

2 — A Word from STERIS

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A Word from STERIS

2.1 Introduction

This manual contains information about the operation and routine maintenance of the MEDIVATORS™ ADVANTAGE

PLUS™ Automated Endoscope Reprocessor. All personnel who are involved in the operation and/or maintenance of the

automated endoscope reprocessor should carefully review and comply with the warnings, cautions, and instructions

that are contained inside this manual. The manual is intended to protect the health and safety of such personnel and

should therefore be easily accessible for reference.

NOTE:

This manual is not a maintenance manual and does not contain instructions for performing non-routine maintenance.

For additional information, contact STERIS.

2.2 Intended Use

The ADVANTAGE PLUS Endoscope Reprocessing System tests, cleans, disinfects and rinses endoscopes, such as

fiberoptic and video endoscopes between patient uses. The ADVANTAGE PLUS Reprocessor 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 Reprocessor. 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 High-Level Disinfectant should be used in the ADVANTAGE PLUS

Reprocessor under the following contact conditions:

• Contact time: 5 minutes

• Temperature: 30 °C

• MRC: 850 ppm

2.3 Advisory

• The MEDIVATORS™ ADVANTAGE PLUS™ Automated Endoscope Reprocessor should not be used for the thermal

disinfection of heat-stable endoscopes or accessories. If possible, these endoscopes or accessories should always

be thermally disinfected.

• The MEDIVATORS™ ADVANTAGE PLUS™ Automated Endoscope Reprocessor should not be used for the cleaning or

high-level disinfection of endoscopes or related accessories that have been used on patients with known or

suspected prion diseases, such as Creutzfeldt-Jakob Disease (CJD) or variant Creutzfeldt-Jakob Disease (vCJD).

• The MEDIVATORS™ ADVANTAGE PLUS™ Automated Endoscope Reprocessor should not be used for the cleaning or

high-level disinfection of reusable water bottles. The reusable water bottle manufacturer’s instructions should be

followed to ensure that they are properly disinfected.

• The MEDIVATORS™ ADVANTAGE PLUS™ Automated Endoscope Reprocessor should not be used for drying the

channels of an endoscope completely. Endoscopes that are properly disinfected should be dried in a validated

drying cabinet with channel connectivity and instrument air.

2 — A Word from STERIS

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• The MEDIVATORS™ ADVANTAGE PLUS™ Automated Endoscope Reprocessor should not be used to store

information that could be used to identify a patient. Electronic and/or printed reports should be stored in a secure

location.

• The MEDIVATORS™ ADVANTAGE PLUS™ Automated Endoscope Reprocessor has only been validated for use with

RAPICIDE™ PA High-Level Disinfectant and should not be used with other types of disinfectant.

• The MEDIVATORS™ ADVANTAGE PLUS™ Automated Endoscope Reprocessor has only been validated for use with

INTERCEPT™ Detergent. It should not be used with other types of detergent.

• The MEDIVATORS™ ADVANTAGE PLUS™ Automated Endoscope Reprocessor has only been validated for use with

70% isopropyl alcohol and should not be used with other types of alcohol.

• The MEDIVATORS™ ADVANTAGE PLUS™ Automated Endoscope Reprocessor is not manufactured with any

materials that contain latex.

2.4 Certifications

• The MEDIVATORS™ ADVANTAGE PLUS™ Automated Endoscope Reprocessor is ETL and cETL certified.

• The MEDIVATORS™ ADVANTAGE PLUS™ Automated Endoscope Reprocessor complies with the IEC 61010-1:2010,

the UL 61010-1:2012, and the CAN/CSA-C22.2 No. 61010-1-12 (R2022) safety requirements for electrical

equipment for measurement, control, and laboratory use.

• The MEDIVATORS™ ADVANTAGE PLUS™ Automated Endoscope Reprocessor complies with the IEC 61010-2-

40:2020 safety requirements for sterilizers and washer/disinfectors that are used to treat medical materials.

• The MEDIVATORS™ ADVANTAGE PLUS™ Automated Endoscope Reprocessor complies with the IEC 61326-1:2020

electromagnetic compatibility requirements for electrical equipment for measurement, control, and laboratory

use.

• The MEDIVATORS™ ADVANTAGE PLUS™ Automated Endoscope Reprocessor complies with the ISO 15883-1:2006

performance standards for washer/disinfectors that are used to clean and disinfect reusable medical devices.

2.5 Service Information

This manual contains schedules and instructions for a thorough preventative maintenance program. This program is

essential to the safe and proper operation of the automated endoscope reprocessor.

Comprehensive instructions for non-routine maintenance of the automated endoscope reprocessor can be found inside

the maintenance manual. Only STERIS-trained personnel should perform non-routine maintenance.

Customers are encouraged to contact STERIS about our annual maintenance program. Under the terms of the program,

preventive maintenance, adjustments, and the replacement of worn parts are provided on a scheduled basis to help

ensure optimal performance and to help minimize untimely or costly interruptions. STERIS maintains a worldwide staff

of well-equipped, factory-trained technicians to provide these services, as well as on-site installation, training, and

expert repair services.

2.6 Addresses

Manufacturer

Medivators Inc.

14605 28th Avenue North

Plymouth, Minnesota 55447

United States of America

European Community Representative

Cantel Medical (Italy) S.r.l.

Via Laurentia 169

2 — A Word from STERIS

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Operator Manual MEDIVATORS™ ADVANTAGE PLUS™

Automated Endoscope Reprocessor

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00071 Pomezia RM

Italy

Swiss Representative

STERIS GmbH

c/o BDO AG

Längfeldweg 116A

CH-2504 Biel-Bienne

Switzerland

Customer Service

Main: (+1) (440) 354-2600

Healthcare: (+1) (800) 548-4873

Website

www.steris.com

NOTE:

The base language of this document is ENGLISH. Any translations must be made from the base language document.

3 — Safety Precautions

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Safety Precautions

3.1 Warnings and Cautions

WARNING

PERSONAL INJURY

Electrical voltage may be present; ground power cords to protective earth.

Endoscopes may be contaminated with contagious pathogens; wear PPE.

Liquid chemicals and/or chemical vapors may be present; do not obstruct drains and/or

vents.

Liquid chemicals and/or chemical vapors may be present; wear PPE.

Visible laser beam may be present; do not point scan window at eyes.

WARNING

IMPROPER DISINFECTION

Damage to the connector ports and/or connector assemblies on a hookup connection

may prevent an endoscope from being properly disinfected; do not use the endoscope

on a patient if this occurs.

Damage to the O-rings on the automated endoscope reprocessor and/or hookup

connections may prevent an endoscope from being properly disinfected; do not use the

endoscope on a patient if this occurs.

Incorrectly loading a hookup connection may prevent an endoscope from being properly

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

Incorrectly loading chemistry may prevent an endoscope from being properly

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

3 — Safety Precautions

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Incorrectly running the water line disinfection program may prevent an endoscope from

being properly disinfected; do not use the endoscope on a patient if this occurs.

Leaks and/or blockages in the channels of an endoscope may prevent it from being

properly disinfected; do not use the endoscope on a patient if this occurs.

Loading an endoscope that has not been pre-cleaned may prevent it from being

properly disinfected; do not use the endoscope on a patient if this occurs.

Power loss during an ongoing disinfection program may prevent an endoscope from

being properly disinfected; do not use the endoscope on a patient if this occurs.

Retrieving an endoscope with a loose hookup connection or connector assemblies may

prevent it from being properly disinfected; do not use the endoscope on a patient if this

occurs.

Retrieving an endoscope without clean gloves may prevent it from being properly

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

Selecting an incorrect endoscope type, parameter set, and/or hookup connection may

prevent an endoscope from being properly disinfected; do not use the endoscope on a

patient if this occurs.

Using a lint cloth to clean and/or dry the automated endoscope reprocessor may

prevent an endoscope from being properly disinfected; do not use the endoscope on a

patient if this occurs.

Using an incorrect filter and/or running a disinfection program without a filter may

prevent an endoscope from being properly disinfected; do not use the endoscope on a

patient if this occurs.

Using disinfectant that is below the MRC may prevent an endoscope from being

properly disinfected; do not use the endoscope on a patient if this occurs.

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Using expired chemistry may prevent an endoscope from being properly disinfected; do

not use the endoscope on a patient if this occurs.

Using non-silicone lubricant to lubricate the O-rings may prevent an endoscope from

being properly disinfected; do not use the endoscope on a patient if this occurs.

Using unvalidated chemistry may prevent an endoscope from being properly

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

CAUTION

EQUIPMENT DAMAGE

Heavy objects may prevent the basin lids from opening; do not obstruct the basin lids.

Liquid chemicals may damage the automated endoscope reprocessor; do not allow

them to contact metal components.

Screens, touchpads, and buttons may be degraded by static electricity; take

precautionary measures against static discharges.

The automated endoscope reprocessor can move freely when the caster wheels are

unlocked; lock the caster wheels after moving.

USB accessories that contain malware may damage the automated endoscope

reprocessor; scan all USB accessories for malware before use.

Using incorrect power cords may damage the automated endoscope reprocessor; only

use power cords that are provided by STERIS.

Using unvalidated chemistry may damage the automated endoscope reprocessor; only

use chemistry that is validated by STERIS.

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3.2 Electromagnetic Compatibility

Electromagnetic Emissions

Emissions test Compliance Manufacturer’s guidance

CISPR 11:2015/Amd 2:2019 Group 2 The MEDIVATORS™ ADVANTAGE

PLUS™ Automated Endoscope

Reprocessor uses RF energy and

RFID in the UHF band. Nearby

electronic devices can be affected.

Class A The MEDIVATORS™ ADVANTAGE

PLUS™ Automated Endoscope

Reprocessor is not suitable for use in

domestic establishments or

establishments that are directly

connected to the public low-voltage

network unless the following

warning is included:

WARNING! This device is intended for

use by healthcare professionals only.

The device can cause radio

interference and/or disrupt the

operation of nearby electronic

devices. IT MAY BE NECESSARY TO

TAKE MITIGATION MEASURES, SUCH

AS REORIENTING OR RELOCATING

THE DEVICE OR SHIELDING ITS

LOCATION.

IEC 61000-3-2:2018 Class A

IEC 61000-3-3:2018 Complies

Electromagnetic Immunity

Immunity test IEC 61326-1 test level Compliance Manufacturer’s guidance

IEC 61000-4-2:2008

(electrostatic discharge)

4 kV (contact)

8 kV (air)

330 Ω / 150 pF (discharge

impendence)

Complies Floors should be wood,

concrete, or ceramic tile. If

the floors are covered with

synthetic material, then

the relative humidity

should be no less than

30%.

IEC 61000-4-4:2012

(electrical fast

transient/burst)

0.5 – 1 kV (input/output

lines)

0.5 kV (power supply lines)

Complies Mains power quality should

be that of a typical

commercial or hospital

environment.

IEC 61000-4-5:2014/Amd

1: 2017 (surge)

0.5 – 1 kV (common mode

line to earth)

0.5 kV (differential mode

line to earth)

Complies

IEC 61000-4-6:2013

(conducted RF)

0.15 MHz to 80 MHz Complies Radio-frequency fields

should be those of a typical

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hospital or commercial

environment.

IEC 61000-4-11:2020

(voltage dips, short

interruptions, and voltage

variations on power supply

input lines)

< 5% UT(> 95% dip in UT)

(0.5 cycles)

40% UT(60% dip in UT) (5

cycles)

70% UT(30% dip in UT) (25

cycles)

< 5% UT(> 95% dip in UT) (5

seconds)

Complies Mains power quality should

be that of a typical

commercial or hospital

environment. If continued

operation during mains

power interruption is

required, then the

MEDIVATORS™

ADVANTAGE PLUS™ should

be powered by an

uninterruptible power

supply or battery.

IEC 61000-4-3:2006

(perturbations and radiated

RF)

80 MHz to 1000 MHz

1.4 MHz to 6 GHz

3 V/m

Complies Mobile and portable RF

communications

equipment should not be

used closer to the

MEDIVATORS™

ADVANTAGE PLUS™

Automated Endoscope

Reprocessor than the

distances recommended

below. Interference may

occur in the vicinity of

equipment marked with

the following symbol:

IEC 61000-4-6:2013

(conducted RF

disturbances)

0.15 MHz to 80 MHz Complies

Rated maximum output

power of the transmitter

(W)

Separation distance (m) by the frequency of the transmitter

0.15 MHz to 80 MHz

m = [3.5/V1] √W

80 MHz to 800 MHz

m = [3.5/E1] √W

800 MHz to 2.5 GHz

m = [7/E1] √W

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

11.2 1.2 2.3

10 3.7 3.7 7.4

100 12 12 23

NOTE:

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the

compliance level in each frequency range.

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3.3 Waste Products Disposal

The following waste materials are associated with the MEDIVATORS™ ADVANTAGE PLUS™ Automated Endoscope

Reprocessor:

1. Air filters: Air filters should be placed in a sealable bag and disposed of in an outdoor waste container.

2. Drain filters: Drain filters should be placed in a sealable bag and disposed of in an outdoor waste container.

3. Water filters: Water filters should be placed in a sealable bag and disposed of in an outdoor waste container.

4. Chemistries: Chemistries should be disposed of in accordance with local and national regulations and Safety Data

Sheets.

5. Chemistry containers: Chemistry containers should be disposed of in accordance with local and national

regulations and Safety Data Sheets.

Contact STERIS for end-of-life disposal of the automated endoscope reprocessor.

4 — Symbols and Labels

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Symbols and Labels

4.1 Components

The following symbols are found on the components of the automated endoscope reprocessor:

Symbol Name Standard Definition

On (power) IEC 60417:2002, ref. 5007 To indicate connection to

the mains, at least for

mains switches or their

positions, and all those

cases where safety is

involved

Off (power) IEC 60417:2002, ref. 5008 To indicate disconnection

from the mains, at least for

mains switches or their

positions, and all those

cases where safety is

involved

Batch code ISO 15223-1:2021, ref.

5.1.5

Indicates the

manufacturer’s batch code

so that the batch or lot can

be identified

Caution ISO 15223-1:2021, ref.

5.4.4

Indicates that caution is

necessary when operating

the device or control close

to where the symbol is

placed, or that the current

situation needs operator

awareness or operator

action in order to avoid

undesirable consequences

Wear protective gloves ISO 7010:2019, ref. M009 To signify that protective

gloves must be worn

Warning; corrosive

substance

ISO 7010:2019, ref. W023 To warn of a corrosive

substance

4.2 Nameplate

The following symbols are found on the nameplates on the automated endoscope reprocessor:

4 — Symbols and Labels

17

Operator Manual MEDIVATORS™ ADVANTAGE PLUS™

Automated Endoscope Reprocessor

4007235_B

Symbol Name Standard Definition

Manufacturer ISO 15223-1:2021, ref.

5.1.1

Indicates the medical

device manufacturer

Authorized representative

in the European

Community/European

Union

ISO 15223-1:2021, ref.

5.1.2

Indicates the authorized

representative in the

European

Community/European

Union

Date of manufacture ISO 15223-1:2021, ref.

5.1.3

Indicates the date when

the medical device was

manufactured

Catalogue number ISO 15223-1:2021, ref.

5.1.6

Indicates the

manufacturer’s catalogue

number so that the

medical device can be

identified

Serial number ISO 15223-1:2021, ref.

5.1.7

Indicates the

manufacturer’s serial

number so that a specific

medical device can be

identified

Consult instructions for use ISO 15223-1:2021, ref.

5.4.3

Indicates the need for the

user to consult the

instructions for use

Unique device identifier ISO 15223-1:2021, ref.

5.7.10

Indicates a carrier that

contains unique device

identifier information

Authorized representative

in Switzerland

-Indicates the authorized

representative in

Switzerland

Waste electrical and

electronic equipment

-Indicates that the product

should not be discarded as

unsorted waste but must

be sent to separate

collection facilities for

recovery and recycling

4.3 Transportation and Storage

The following symbols are found on the packaging of the automated endoscope reprocessor:

4 — Symbols and Labels

18

4007235_B MEDIVATORS™ ADVANTAGE PLUS™

Automated Endoscope Reprocessor

Operator Manual

Symbol Name Standard Definition

Batch code ISO 15223-1:2021, ref.

5.1.5

Indicates the

manufacturer’s batch code

so that the batch or lot can

be identified

Fragile; handle with care ISO 15223-1:2021, ref.

5.3.1

Indicates a medical device

that can be broken or

damaged if not handled

carefully

This way up ISO 7000:2019, ref. 0623 To indicate correct upright

position of the transport

package

Do not stack ISO 7000:2019, ref. 2402 To indicate that the items

shall not be vertically

stacked, either because of

the nature of the transport

packaging or because of

the nature of the items

themselves

5 — Specifications and Requirements

19

Operator Manual MEDIVATORS™ ADVANTAGE PLUS™

Automated Endoscope Reprocessor

4007235_B

Specifications and Requirements

5.1 Product Specifications

Dimensions 49 in (124 cm) (W) x 32 in (79 cm) (D) x 69 in (175 cm) (H)

Weight 402 lbs (182 kg)

Power supply Cord connection

Overvoltage category II

Pollution degree 2

NOTE:

In addition to the dimensions above, the MEDIVATORS™ ADVANTAGE PLUS™ Automated Endoscope Reprocessor

should be given no less than 12 in (31 cm) of clearance on all sides.

5.2 Operational Specifications

Electrical rating 100 VAC – 240 VAC, 50/60 Hz

Power rating 1000 W

Air pressure 58 psi (4 bar) – 145 psi (10 bar)

Air flow > 1.1 SCFM

Water pressure < 35 psi (2.5 bar)

Water flow 0.6 gal/min (35 mL/s) – 2.9 gal/min (145 mL/s)

Water temperature 30 °C – 40 °C

5.3 Environmental Requirements

Operation

Ambient Temperature 50 °F (10 °C) – 80 °F (27 °C)

Humidity 20% – 80% (non-condensing)

Altitude < 6561 ft (2000 m)

5 — Specifications and Requirements

20

4007235_B MEDIVATORS™ ADVANTAGE PLUS™

Automated Endoscope Reprocessor

Operator Manual

Storage

Ambient Temperature 32 °F (0 °C) – 140 °F (60 °C)

Humidity < 80% (relative)

Altitude < 6561 ft (2000 m)

5.4 Installation Requirements

Electrical rating 100 VAC – 240 VAC, 50/60 Hz

Power rating 1000 W

Air pressure 58 psi (4 bar) – 145 psi (10 bar)

Air flow > 1.1 SCFM

Airborne particle size < 5 microns

Oil vapor concentration < 5 mg/m³

Ventilation 10 air changes/hour

Water pressure 35 psi (2.5 bar) – 87 psi (6 bar)

Water flow 1.4 gal/min (84 mL/s) – 2.9 gal/min (145 mL/s )

Water temperature 95 °F ± 3 °F (35 °C ± 2 °C)

Water hardness < 12 grains/gal (< 200 ppm)

Drain capacity 3.2 gal/min (200 mL/s)

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Steris Medivators Advantage Plus Automated Endoscope Reprocessor Operating instructions

Steris Medivators Advantage Plus Automated Endoscope Reprocessor Operating instructions

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