Esco Multi-zone ART Workstation User manual

Multi-zone ART Workstation
Rev. 3.0
Date of revised 9.22.2020
Rx only

MAW® User Manual Rev. 3.0
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For Technical Service, contact
North America
Esco Technologies, Inc.
903 Sheehy Drive, Suite F, Horsham, PA 19044, USA
Tel [phone] • Fax [phone]
www.escolifesciences.us • [email protected]
Rest of the World
Esco Micro Pte. Ltd.
21 Changi South Street 1 • Singapore 486 777
Tel [phone] • Fax [phone]
www.escoglobal.com • [email protected]
Copyright Information
© Copyright 2014 Esco Micro Pte Ltd. All rights reserved.
The information contained in this manual and the accompanying product is copyrighted and
all rights are reserved by Esco.
Esco reserves the right to make periodic minor design changes without obligation to notify
any person or entity of such change.
Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare
practitioner.
Only to be used by a trained and qualified professional. The device is sold under exemption
21 CFR 801 Subpart D.
“Material in this manual is provided for informational purposes only. The contents and the
product described in this manual (including any appendix, addendum, attachment or
inclusion), are subject to change without notice. Esco makes no representations or warranties
as to the accuracy of the information contained in this manual. In no event shall Esco be held
liable for any damages, direct or consequential, arising out of or related to the use of this
manual.”

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Unpacking and Inspection
Follow standard receiving practices upon receipt of the instrument. Check the shipping
carton for damage. If damage is found, stop unpacking the instrument. Notify the freight
carrier and ask for an agent to be present while the instrument is unpacked. There are no
special unpacking instructions, but be careful not to damage the instrument when un-
packing it. Inspect the instrument for physical damage such as bent or broken parts,
dents, or scratches.
Claims
Our routine method of shipment is via common carrier. Upon delivery, if physical damage
is found, retain all packing materials in their original condition and contact the carrier
immediately to file a claim.
If the instrument is delivered in good physical condition but does not operate within spec-
ifications, or if there are any other problems not caused by shipping damage, please con-
tact your local sales representative or Esco Medical immediately.
Standard Terms and Conditions
Refunds & Credits
Please note only serialized products (products labelled with a distinct serial number) and
accessories are eligible for partial refund and/or credit. Non-serialized parts and acces-
sory items (cables, carrying cases, auxiliary modules, etc.) are not eligible for return or
refund. In order to receive a partial refund/credit, the product must not have been dam-
aged, and must be returned complete (meaning all manuals, cables, accessories, etc.)
within 30 days of original purchase, in “as new” and resalable condition. The Return Pro-
cedure must be followed.
Return Procedure
Every product returned for refund/credit must be accompanied by a Return Material Au-
thorization (RMA) number, obtained from Esco Medical Customer Service. All items being
returned must be sent prepaid (freight, duty, brokerage and taxes) to our factory location.
Restocking Charges
Products returned within 30 days of original purchase are subject to a minimum restock-
ing fee of 20% of the list price. Additional charges for damage and/or missing parts and
accessories will be applied to all returns. Products which are not in “as new” and resalable
condition are not eligible for credit return and will be returned to the customer at their
own expense.
Certification
This instrument has been thoroughly tested/inspected and found to meet Esco Medical´s
manufacturing specifications when shipped from the factory. Calibration measurements
and testing are traceable and done according to Esco Medicals ISO certification.

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Warranty and Product Support
Esco Medical warrants this instrument to be free from defects in materials and workman-
ship under normal use, and service for two (2) years from the date of original purchase,
provided the instrument is calibrated and maintained in accordance with this manual.
During the warranty period Esco Medical will, at our option, either repair or replace a
product that proves to be defective at no charge, provided you return the product (ship-
ping, duty, brokerage and taxes prepaid) to Esco Medical. Any and all transportation
charges incurred are the responsibility of the purchaser and are not included within this
warranty. This warranty extends only to the original purchaser and does not cover dam-
age from abuse, neglect, accident or misuse, or as the result of service or modification by
parties other than Esco Medical.
IN NO EVENT SHALL ESCO MEDICAL LTD. BE LIABLE FOR CONSEQUENTIAL DAMAGES.
No warranty shall apply when damage is caused by any of the following:
Power failure, surges, or spikes
•Damage in transit or when moving the instrument
•Improper power supply such as low voltage, incorrect voltage, defective wiring or in-
adequate fuses
•Accident, alteration, abuse or misuse of the instrument
•Fire, water damage, theft, war, riot, hostility, acts of God such as hurricanes, floods, etc.
Only serialized products (those items bearing a distinct serial number tag) and their ac-
cessory items are covered under this warranty.
PHYSICAL DAMAGE CAUSED BY MISUSE OR PHYSICAL ABUSE IS NOT COVERED UNDER
THE WARRANTY. Items such as cables and non-serialized modules are not covered under
this warranty.
This warranty gives you specific legal rights and you may have other rights, which vary
from province to province, state to state, or country to country. This warranty is limited
to repairing the instrument per Esco Medical's specifications.
When you return an instrument to Esco Medical for service, repair or calibration, we rec-
ommend shipment using the original shipping foam and container. If the original packing
materials are not available, we recommend the following guide for repackaging:
•Use a double-walled carton of sufficient strength for the weight being shipped
•Use heavy paper or cardboard to protect all instrument surfaces. Use non-abrasive ma-
terial around all projecting parts
Use at least four inches of tightly packed, industrial-approved, shock-absorbent
material all around the instrument

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Esco Medical will not be responsible for lost shipments or instruments received in dam-
aged condition due to improper packaging or handling. All warranty claim shipments
must be made on a prepaid basis (freight, duty, brokerage, and taxes). No returns will be
accepted without a Return Materials Authorization ("RMA”) number. Please contact Esco
Medical to obtain an RMA number and receive help with shipping/customs documenta-
tion.
Re-calibration of instruments, which have a recommended annual calibration frequency,
is not covered under the warranty.
Warranty Disclaimer
Should you choose to have your instrument serviced and/or calibrated by someone other
than Esco Medical Ltd. and their representatives, please be advised that the original war-
ranty covering your product becomes void when the tamper-resistant Quality Seal is re-
moved or broken without proper factory authorization.
In all cases, breaking the tamper-resistant Quality Seal should be avoided at all cost, as
this seal is key to your original instrument warranty. In an event where the seal must be
broken to gain internal access to the instrument, you must first contact Esco Medical Ltd.
You will be required to provide us with the serial number for your instrument, as well as
a valid reason for breaking the Quality Seal. You should break this seal only after you have
received factory authorization. Do not break the Quality Seal before you have contacted
us! Following these steps will help ensure that you will retain the original warranty on
your instrument without interruption.
WARNING
Unauthorized user modifications or application beyond the published specifications may
result in electrical shock hazard or improper operation. Esco Medical will not be respon-
sible for any injury sustained due to unauthorized equipment modifications.
ESCO MEDICAL LTD. DISCLAIMS ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED,
INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE OR APPLICATION.
THIS PRODUCT CONTAINS NO USER-SERVICEABLE COMPONENTS.
UNAUTHORIZED REMOVAL OF THE INSTRUMENT COVER SHALL VOID THIS AND ALL
OTHER EXPRESSED OR IMPLIED WARRANTIES.

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Table of contents
1 How to use this manual...........................................................................................................8
2 Safety warning........................................................................................................................8
3 Indication for use ....................................................................................................................8
4 About the product ...................................................................................................................9
5 transport, Storage and Disposal ............................................................................................10
5.1 Transport........................................................................................................................10
5.2 Storage ...........................................................................................................................10
5.3 Disposal..........................................................................................................................10
6 Accessories supplied.............................................................................................................11
7 Manuals supplied..................................................................................................................11
7.1 The user manual.............................................................................................................11
7.2 The validation manual....................................................................................................11
7.3 The maintenance manual ...............................................................................................11
8 Safety symbols and labels.....................................................................................................12
9 Important safety instructions and warnings..........................................................................13
9.1 Before installation..........................................................................................................13
9.2 During installation .........................................................................................................13
9.3 Post installation..............................................................................................................14
10 Getting started.....................................................................................................................14
11 Mains connection................................................................................................................15
12 Gas connection and the humidification system ..................................................................15
12.1 MAW without compartments ......................................................................................17
12.2 MAW with compartments............................................................................................19
12.3 MAW with compartments and built-in gas mixer .......................................................20
13 User interface......................................................................................................................21
13.1 Activating the heat and gas flow controls....................................................................22
13.1.1 Temperature sub-menu .........................................................................................22
13.1.2 Gas flow set point .................................................................................................22
13.1.3 Heated Mode.........................................................................................................23
13.2 Surface temperatures....................................................................................................25
13.3 Menu Options...............................................................................................................27
13.3.1 Main Menu............................................................................................................27
13.3.2 Sub-menu..............................................................................................................28
13.3.3 Temperature sub-menu .........................................................................................28
13.3.4 CO2sub-menu (only for models with built-in gas mixer) ....................................30
13.3.5 O2sub-menu (only for models with built-in gas mixer).......................................32

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13.3.5 Service sub-menu..................................................................................................33
14 Alarms.................................................................................................................................34
14.1 Temperature alarms .....................................................................................................34
14.2 Gas pressure alarms .....................................................................................................35
14.3 Multiple alarms............................................................................................................36
14.4 Loss of power alarm.....................................................................................................36
15 Changing the set points.......................................................................................................36
16 Firmware.............................................................................................................................36
17 The Laminar Flow...............................................................................................................37
18 Cleaning instructions ..........................................................................................................38
18.1 Considerations about a sterile device...........................................................................38
18.2 Manufacturer recommended cleaning procedure.........................................................38
18.3 Manufacturer recommended disinfection procedure...................................................39
19 Heat optimization plates. ....................................................................................................39
20 Humidification....................................................................................................................40
21 Temperature validation.......................................................................................................40
22 All in one PC.......................................................................................................................41
23 Maintenance........................................................................................................................47
24 Emergency Procedures........................................................................................................47
25 User Troubleshooting..........................................................................................................48
26 Specifications......................................................................................................................50
27 Electromagnetic compatibility............................................................................................51

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1 How to use this manual
The manual is designed to be read by sections, and not ideally cover to cover. This means
that if the manual is read, from start to finish, there will be some repetition and overlap. We
recommend the following method to go through the manual: first, familiarize yourself with
the safety instructions; then proceed to the basic user functions that are needed for operat-
ing the equipment on a day to day basis; then review the alarm functions. The menu function
of the user interface details information that is needed for the advanced level of users only.
All parts must be read before the device is taken into use.
2 Safety warning
• Anyone working with, on or around this equipment should read this manual. Failure to
read, understand and follow the instructions given in this documentation may result in dam-
age to the unit, injury to operating personnel, and/or poor equipment performance.
• Any internal adjustment, modification or maintenance to this equipment must be under-
taken by qualified service personnel.
• If the equipment must be relocated, make sure it is fixed properly on a support stand or
base, and move on a flat surface. When necessary move the equipment and the support
stand/base separately.
• The use of any hazardous materials in this equipment must be monitored by an industrial
hygienist, safety officer or other suitably qualified individual.
• Before you proceed, you should thoroughly understand the installation procedures and
take note of the environmental/electrical requirements.
• In this manual, important safety related points will be marked with the following symbols:
NOTE
Used to direct attention to a specific item.
WARNING
Use caution
• If the equipment is used in a manner not specified by this manual, the protection provided
by this equipment may be impaired.
3 Indication for use
The MAW, Multi-zone ART Workstation is a laminar flow workstation that is intended for
working with gametes and/or embryos at or near body temperature during in vitro fertili-
zation (IVF)/assisted reproduction technology (ART) procedures. The workstation also pro-
vides humidified gas to maintain gametes and embryos in the working environment.

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4 About the product
The MAW, Multi-zone ART Workstation is a laminar flow workstation that is intended for
working with gametes and/or embryos at or near body temperature during in vitro fertili-
zation (IVF)/assisted reproduction technology (ART) procedures. The workstation also pro-
vides humidified gas to maintain gametes and embryos in the working environment.
The 12-zone heating system (8 x table plate and 4 x compartments) gives superior temper-
ature conditions in comparison to conventional layouts.
For maximum performance, the system has 12 separate temperature controllers, control-
ling and regulating the temperature in each zone.
The workstation has been primarily developed and optimized for tissue culturing with an
overlay of either Paraffin or Mineral oil.
If open culture is used the user can utilize the humidified gas system that built into the table
top. The dish is placed under the gas hood where the pH conditions in a buffered media
without oil overlay can be maintained.
Open culture may lead to evaporation and a change in pH if the correct conditions
are not maintained.
An integral part of the ART Workstation is the All-in-one PC that is running with the Work-
station logger software. The software functions as a constant surveillance system that will
give the user early warnings if any parameter drifts beyond safe limits. The monitor can be
used for a microscope camera image, as any warning will still be brought to the attention of
the user and an easy possibility to toggle the modes presented. The software includes data
logging, data storage and report functions for ISO quality management compliance.
The device is manufactured under a full EU certified ISO quality management system.
This product fulfils the requirements of EN60601-1 3rd edition standards as a Class I type
B equivalent device suited for continuous operation. It also conforms to the requirements
of the EU Council directive 93/42/EEC concerning medical devices and is classified as a
Class I device under rule XII.
Personal Protective Equipment (89/686/EEC) and Machine Directive (2006/42/EC) is not
applicable for MAW, Multi-zone ART Workstation.

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5 transport, Storage and Disposal
5.1 Transport
The devices is packed in a carton box, it is wrapped to a polyethylene. The Box is affixed to
pallet with the special straps.
Visual inspection should be done if there is any damage and then the Multi-Zone ART Work-
station is prepared to be transported.
These labels should be glued on the box:
•Label with marked packing date
•Label with the product name and serial number
•Label with the country of origin
•Warning labels “Fragile” and “Handle with care”
5.2 Storage
The device may only be used under the following conditions:
•The unit can be in store for one year
•If stored longer than one year, the unit must be returned to the manufacturer for a
new release test
•Store between -20 and + 50 degrees C temperature limits
•Keep away from direct sunlight
•Caution consult the accompanying documents for important safety-related infor-
mation such as warnings and precautions that cannot, for a variety of reasons, be
presented on the device itself
•Do not use if the packing material is damaged
•Keep dry
5.3 Disposal
The unit contains reusable materials. All components (with the exception of the HEPA filter)
can be discarded after having been cleaned and disinfected.
Please note, that the HEPA filters must be discarded in accordance with the applicable na-
tional regulations for special solid waste.
The device may have been used for treating and processing infectious sub-
stances. Therefore, the device and device components may have been contaminated.
Prior to disposal, all device components must be decontaminated.