Steris Medivators Advantage Plus Automated Endoscope Reprocessor Operating instructions

Brand
Steris
Model
Medivators Advantage Plus Automated Endoscope Reprocessor
Type
Operating instructions
4007235
Revision B
en
MEDIVATORS™
ADVANTAGE PLUS™
Automated Endoscope
Reprocessor
Operator Manual
2
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
3
Operator Manual MEDIVATORS™ ADVANTAGE PLUS™
Automated Endoscope Reprocessor
4007235_B
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
4
4007235_B MEDIVATORS™ ADVANTAGE PLUS™
Automated Endoscope Reprocessor
Operator Manual
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
5
Operator Manual MEDIVATORS™ ADVANTAGE PLUS™
Automated Endoscope Reprocessor
4007235_B
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
6
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.
© 2023 STERIS Corporation 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 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
7
Operator Manual MEDIVATORS™ ADVANTAGE PLUS™
Automated Endoscope Reprocessor
4007235_B
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
8
4007235_B MEDIVATORS™ ADVANTAGE PLUS™
Automated Endoscope Reprocessor
Operator Manual
• 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
9
Operator Manual MEDIVATORS™ ADVANTAGE PLUS™
Automated Endoscope Reprocessor
4007235_B
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
10
4007235_B MEDIVATORS™ ADVANTAGE PLUS™
Automated Endoscope Reprocessor
Operator Manual
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
11
Operator Manual MEDIVATORS™ ADVANTAGE PLUS™
Automated Endoscope Reprocessor
4007235_B
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.
3 — Safety Precautions
12
4007235_B MEDIVATORS™ ADVANTAGE PLUS™
Automated Endoscope Reprocessor
Operator Manual
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.
3 — Safety Precautions
13
Operator Manual MEDIVATORS™ ADVANTAGE PLUS™
Automated Endoscope Reprocessor
4007235_B
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
3 — Safety Precautions
14
4007235_B MEDIVATORS™ ADVANTAGE PLUS™
Automated Endoscope Reprocessor
Operator Manual
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.
3 — Safety Precautions
15
Operator Manual MEDIVATORS™ ADVANTAGE PLUS™
Automated Endoscope Reprocessor
4007235_B
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
16
4007235_B MEDIVATORS™ ADVANTAGE PLUS™
Automated Endoscope Reprocessor
Operator Manual
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)
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
Page is loading ...
  • Page 1 1
  • Page 2 2
  • Page 3 3
  • Page 4 4
  • Page 5 5
  • Page 6 6
  • Page 7 7
  • Page 8 8
  • Page 9 9
  • Page 10 10
  • Page 11 11
  • Page 12 12
  • Page 13 13
  • Page 14 14
  • Page 15 15
  • Page 16 16
  • Page 17 17
  • Page 18 18
  • Page 19 19
  • Page 20 20
  • Page 21 21
  • Page 22 22
  • Page 23 23
  • Page 24 24
  • Page 25 25
  • Page 26 26
  • Page 27 27
  • Page 28 28
  • Page 29 29
  • Page 30 30
  • Page 31 31
  • Page 32 32
  • Page 33 33
  • Page 34 34
  • Page 35 35
  • Page 36 36
  • Page 37 37
  • Page 38 38
  • Page 39 39
  • Page 40 40
  • Page 41 41
  • Page 42 42
  • Page 43 43
  • Page 44 44
  • Page 45 45
  • Page 46 46
  • Page 47 47
  • Page 48 48
  • Page 49 49
  • Page 50 50
  • Page 51 51
  • Page 52 52
  • Page 53 53
  • Page 54 54
  • Page 55 55
  • Page 56 56
  • Page 57 57
  • Page 58 58
  • Page 59 59
  • Page 60 60
  • Page 61 61
  • Page 62 62
  • Page 63 63
  • Page 64 64
  • Page 65 65
  • Page 66 66
  • Page 67 67
  • Page 68 68
  • Page 69 69
  • Page 70 70
  • Page 71 71
  • Page 72 72
  • Page 73 73
  • Page 74 74
  • Page 75 75
  • Page 76 76
  • Page 77 77
  • Page 78 78
  • Page 79 79
  • Page 80 80
  • Page 81 81
  • Page 82 82
  • Page 83 83
  • Page 84 84
  • Page 85 85
  • Page 86 86
  • Page 87 87
  • Page 88 88
  • Page 89 89
  • Page 90 90
  • Page 91 91
  • Page 92 92
  • Page 93 93
  • Page 94 94
  • Page 95 95
  • Page 96 96
  • Page 97 97
  • Page 98 98
  • Page 99 99
  • Page 100 100
  • Page 101 101
  • Page 102 102
  • Page 103 103
  • Page 104 104
  • Page 105 105
  • Page 106 106
  • Page 107 107
  • Page 108 108
  • Page 109 109
  • Page 110 110
  • Page 111 111
  • Page 112 112
  • Page 113 113
  • Page 114 114
  • Page 115 115
  • Page 116 116
  • Page 117 117
  • Page 118 118
  • Page 119 119
  • Page 120 120
  • Page 121 121
  • Page 122 122
  • Page 123 123
  • Page 124 124
  • Page 125 125
  • Page 126 126
  • Page 127 127
  • Page 128 128
  • Page 129 129
  • Page 130 130
  • Page 131 131
  • Page 132 132
  • Page 133 133
  • Page 134 134
  • Page 135 135
  • Page 136 136
  • Page 137 137
  • Page 138 138
  • Page 139 139
  • Page 140 140

Steris Medivators Advantage Plus Automated Endoscope Reprocessor Operating instructions

Brand
Steris
Model
Medivators Advantage Plus Automated Endoscope Reprocessor
Type
Operating instructions
Download PDF
report

Ask a question and I''ll find the answer in the document

Finding information in a document is now easier with AI

Related papers

Other documents