Vitrolife CulturePro User manual

CulturePro™incubator
User manual
CulturePro incubator, software version 7.8
User manual, first issue 2021.08.02, revised 2022.06.01/230 V/English

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Table of contents
1Introduction............................................................................................................................5
1.1 Warnings, restrictions and limited warranty.....................................................................6
1.2 Intended use.................................................................................................................10
1.3 Intended users..............................................................................................................10
1.4 Clinical benefit...............................................................................................................10
1.5 Proposed workarounds.................................................................................................11
2Overview of the CulturePro incubator................................................................................11
2.1 Overview of features in the CulturePro incubator ..........................................................12
2.1.1 Barcode labelling system...................................................................................13
2.2 Installation and required conditions...............................................................................15
2.2.1 Transportation and relocation of the CulturePro incubator.................................16
2.3 Starting up the CulturePro incubator.............................................................................16
2.4 Shutting down the CulturePro incubator and removing all culture dishes ......................17
2.5 Restarting the integrated PC.........................................................................................18
3Connections to supporting systems ..................................................................................19
3.1 Gas...............................................................................................................................21
3.2 ES server (standard configuration only) ........................................................................22
3.3 External alarm output....................................................................................................23
3.4 Incubator data...............................................................................................................23
3.5 USB connection for barcode printer (stand-alone configuration only)............................23
4Operating the CulturePro incubator ...................................................................................24
4.1 The incubator screen ....................................................................................................24
4.1.1 Navigating on the incubator screen....................................................................25
4.1.2 Change set point mode......................................................................................27
4.1.3 Validation and calibration mode.........................................................................29
4.1.4 Controlling the incubator temperature................................................................32
4.1.4.1 Changing the temperature set point.....................................................32
4.1.4.2 Calibrating the temperature..................................................................33
4.1.5 Controlling the CO2/O2concentration.................................................................36
4.1.5.1 Changing the CO2/O2set point.............................................................36
4.1.5.2 Validating the CO2/O2concentration ....................................................37
4.1.5.3 Calibrating the CO2/O2concentration...................................................40
4.1.6 Incubator O2regulation......................................................................................43
4.1.6.1 Turning on/off the O2regulation ...........................................................43
4.2 The PC screen..............................................................................................................43
4.2.1 PC home screen................................................................................................43

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4.2.1.1 Colours on the home screen................................................................44
4.2.1.2 Starting a culture dish ..........................................................................45
4.2.1.3 Barcode errors.....................................................................................48
4.2.1.4 Removing a single culture dish ............................................................50
4.2.1.5 Removing all culture dishes .................................................................50
4.2.1.6 Resuming culture in a culture dish (standard configuration only)..........51
4.2.2 Settings screen..................................................................................................52
4.2.2.1 Enabling and disabling the screen saver..............................................53
5Cleaning and disinfecting the CulturePro incubator.........................................................54
5.1 Periodic cleaning of the CulturePro incubator................................................................54
5.2 Disinfection of the CulturePro incubator........................................................................57
6Changing the VOC HEPA filter............................................................................................60
7Replacing the main fuses....................................................................................................66
8Alarms, warnings and notifications....................................................................................68
8.1 Types of alarms, warnings and notifications..................................................................68
8.1.1 Alarms...............................................................................................................68
8.1.2 Warnings...........................................................................................................69
8.1.3 Notifications (standard configuration only).........................................................69
8.2 Temporarily pausing alarms..........................................................................................70
8.3 Overview of the display colours of alarms, warnings and notifications...........................71
8.3.1 Alarms...............................................................................................................71
8.3.2 Warnings...........................................................................................................71
8.3.3 Notifications (standard configuration only).........................................................72
8.4 Multiple simultaneous alarms........................................................................................72
8.5 Resetting alarms...........................................................................................................73
8.6 Graphical overview of alarms and operator response....................................................74
8.7 Graphical overview of warnings and operator response................................................78
8.8 Graphical overview of notifications and operator response (standard configuration
only)..............................................................................................................................80
8.9 Overview of error conditions and control unit responses ...............................................81
8.10 External alarm system...................................................................................................82
8.10.1 Overview of errors sent to the external alarm system ........................................82
8.10.2 Delay of external alarms and warnings..............................................................83
8.10.3 Connecting the external alarm...........................................................................83
9Emergency procedure .........................................................................................................84
9.1 Removing culture dishes after a system failure.............................................................84
10 Technical specifications......................................................................................................86
11 EMC and HF technical review..............................................................................................90

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11.1 Electromagnetic emissions............................................................................................90
11.2 Electromagnetic immunity.............................................................................................91
12 Accessories and materials ..................................................................................................95
12.1 Peripheral devices ........................................................................................................95
13 Planned service and maintenance......................................................................................96
13.1 Planned service ............................................................................................................96
13.1.1 Regular service visits.........................................................................................97
13.1.2 Routine calibration checks.................................................................................97
13.2 Planned maintenance ...................................................................................................97
13.2.1 Maintenance screen ..........................................................................................98
13.2.2 Generating a monthly incubation report.............................................................99
13.2.3 VOC HEPA filter and sensor maintenance.......................................................100
14 Symbols and labels............................................................................................................103
14.1 Product information labels...........................................................................................103
14.2 Warning labels............................................................................................................104
14.3 Connection labels .......................................................................................................105
14.4 Labels on the shipping crate .......................................................................................106
15 Disposal of waste...............................................................................................................107
16 Contact information...........................................................................................................108
CohortView, CulturePro, EmbryoScope, EmbryoSlide, EmbryoViewer, Guided Annotation,
iDAScore and KIDScore are trademarks or registered trademarks belonging to the Vitrolife Group.
©2022 Vitrolife A/S. All rights reserved.

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1 Introduction
This user manual provides information on how to use the CulturePro incubator.
The end user is strongly encouraged to carefully follow the scheme outlined in the section entitled
Planned service and maintenance to ensure error-free operation of the incubator.
The CulturePro incubator is a medical device that must be operated by trained personnel
according to the instructions contained in this user manual. Users must be qualified to operate the
device and qualified to perform procedures associated with device use in accordance with local
qualification standards.
The product fulfils the requirements of the UL 60601-1 edition 1, IEC 60601-1:2012 and 61010-2-
081 standards; class I, type B equivalent. The CulturePro incubator is suitable for continuous
operation.
•The CulturePro incubator and related accessories conform to the requirements of
Regulation (EU) 2017/745 on medical devices, classified as class IIa.
•Conforms to ANSI/AAMI ES 60601-1:2005 + A1 + A2.
•Conforms to IEC 61010-2-081:2001 + A1:2003.
•Certified to CAN/CSA - C22.2 No. 60601-1:R2013 addendum.

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1.1 Warnings, restrictions and limited warranty
Users must agree to read and understand this user manual and observe the safety instructions
before operating the incubator.
RESTRICTIONS ON USE
•The CulturePro incubator may only be used by persons who have been trained in its use
by a person certified by Vitrolife.
•The CulturePro incubator may only be used with sterile disposable culture dishes
produced and sold by Vitrolife.
•The culture dishes may not be reused.
•The culture dishes must be covered with sterile lids before insertion into the CulturePro
incubator.
•The CulturePro incubator may not be used in a wet environment. No fluids other than
culture medium and oil and the cleaning agents specified in this user manual may be
used in or near the incubator.
•Never cover the vent holes on the back of the incubator in part or in whole as this may
cause the incubator to overheat.
•Users should contact Vitrolife immediately to report any incident and/or injury to a patient,
operator or maintenance employee that occurred as a result of operating the CulturePro
incubator. Any serious incident that has occurred in relation to the incubator should be
reported to the competent authority of the Member State in which the user is established.
•Should an accident occur while using the CulturePro incubator, stop using the incubator
until it has been checked by a person certified by Vitrolife.

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WARNING
•The CulturePro incubator includes moving parts with safety stops. Do not try to block
safety sensors. If the safety sensors are blocked, inserting a finger or a hand into the
incubator while it is turned on is dangerous and may cause injury.
•To avoid risk of electric shock, this incubator must only be connected to a mains supply
with a protective earth connection.
•Detachable main power supply cord with inadequate ratings should not be used. See
section 10 for power supply ratings.
•The incubator must be positioned to allow the operator to turn on/off the main power
switch on the back of the incubator.
•Portable and mobile RF communications equipment may affect the CulturePro incubator.
•If the incubator is used in a manner not specified by Vitrolife, the protection against
hazards provided by the incubator may be impaired.
•The CulturePro incubator is not suitable for use in the presence of a flammable
anaesthetic mixture with air or with oxygen or nitrous oxide.
•It is the user’s responsibility to validate the performance of the CulturePro incubator by
performing quality control checks on the temperature, CO2and O2* levels every two
weeks.
* Only if the clinic incubates with reduced O2concentration.
•During initial start-up and after an incubator shutdown, always validate the gas and
temperature levels using calibrated, external validation devices as detailed in this user
manual. Do NOT rely solely on values displayed on the incubator screen.
INSTALLATION AND SERVICE
•Installation and service of the CulturePro incubator may only be carried out by a person
certified by Vitrolife. The CulturePro incubator must remain at the location where it was
installed. If the CulturePro incubator is disconnected and/or moved without supervision
by a person certified by Vitrolife, the incubator is no longer approved for clinical use and
the warranty may be voided.
•If the CulturePro incubator or parts of it are modified, appropriate inspection and testing
must be conducted by a person certified by Vitrolife to ensure continued safe use.
•When cleaning and disinfecting the CulturePro incubator, always use the prescribed
chemical agents as specified in section 5 of this user manual.

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TRANSPORTATION AND RELOCATION OF THE CULTUREPRO INCUBATOR
•While the CulturePro incubator is still in the shipping boxes, it must only be moved by
using a lift truck or a pallet lifter. Do NOT open the shipping boxes without the presence
of a person certified by Vitrolife.
•When the CulturePro incubator has been unpacked, it must only be moved by two
persons supporting the incubator in accordance with the instructions contained in this
user manual and only under the supervision of a person certified by Vitrolife (see section
2.2.1).
CONNECTION TO EXTERNAL EQUIPMENT
(EN 60601-1 MEDICAL ELECTRICAL EQUIPMENT –PART 1)
•External equipment intended for connection to signal input, signal output or other
connectors must comply with the relevant IEC standard (i.e. EN 60601-1:2006 –Part 1
for medical electrical equipment). In addition, all such combinations –systems –must
comply with the standard EN 60601-1:2015 –Part 2, General requirements for basic
safety and essential performance. Equipment not complying with EN 60601-1:2006 –
Part 1 must be kept outside the patient environment, i.e. at least 1.5 m from the patient or
the patient support.
•Any person who connects external equipment to signal input, signal output or other
connectors has formed a system and is therefore responsible for ensuring that the
system complies with the requirements of EN 60601-1:2006 –Part 1. If in doubt, contact
a qualified medical technician or your local representative.

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ELECTROMAGNETIC COMPATIBILITY
•The CulturePro incubator has been tested and found to comply with the limits for medical
devices set out in the IEC 60601-1-2 Edition 4.0 for electromagnetic compatibility. These
limits are designed to provide reasonable protection against harmful interference in a
typical medical installation.
Compliance with IEC 60601-1-2 Edition 4.0 ensures compatibility when the CulturePro
incubator is placed at a minimum distance to nearby instruments. If the incubator is
placed close to other instruments, it is necessary to observe that the performance of all
instruments remains unaffected by the placement.
The CulturePro incubator generates, uses and can radiate radio frequency energy and, if
not installed and used in accordance with the instructions, may cause harmful interference
to other instruments in the vicinity. However, there is no guarantee that interference will
not occur in a particular installation. If this incubator does cause harmful interference to
other instruments, which can be determined by turning the incubator off and on, the user
is encouraged to try to correct the interference by one or more of the following measures:
a) Reorient or relocate the receiving instrument.
b) Increase the separation between the instruments.
c) Connect the incubator to an outlet on a circuit different from that to which the other
instrument(s) are connected.
Consult the manufacturer, its representative or its dealer for help.
WARNING
•The use of accessories, transducers and cables other than those specified, with the
exemption of transducers and cables sold by the manufacturer of the system as
replacement parts for internal components, may result in increased emissions or
decreased immunity of the equipment or system.
•The CulturePro incubator should not be used adjacent to or stacked with other equipment.
If adjacent or stacked use is necessary, the incubator should be observed to verify normal
operation in the configuration in which it will be used.
CONFIDENTIALITY
•All identification numbers, names and treatment data presented in this manual are
fictional.

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LIMITED WARRANTY
•Vitrolife warrants the CulturePro incubator to be free from defects in materials and
workmanship for a period of one (1) year from the first installation date.
The limited warranty will terminate immediately if installation, service, repair or relocation
of the incubator is carried out by other than Vitrolife-certified personnel.
The limited warranty does not apply to damage resulting from:
a) failure to perform routine maintenance in accordance with this user manual;
b) accident, abuse, misuse or misapplication of the incubator;
c) use and operation that does not comply with instructions provided in this user
manual; or
d) normal wear and tear.
GENERAL CYBER SECURITY RECOMMENDATIONS
•Users are advised and expected to take the following measures to reduce cyber security
risk in order to ensure that the device will work as designed in the intended user
environment:
oEnsure that personnel are properly trained in cyber security awareness
oPrevent physical access to the equipment by unauthorised users.
•Users must inform Vitrolife A/S without any undue delay upon becoming aware of a cyber
security vulnerability incident or any suspected security events.
1.2 Intended use
The intended use of the CulturePro incubator is to provide an environment with controlled
temperature and gas concentrations (CO2and optionally O2) for the culture of gametes and/or
embryos.
1.3 Intended users
Embryologists, other laboratory personnel and clinic staff at IVF clinics trained by Vitrolife A/S-
certified instructors.
1.4 Clinical benefit
Supports optimum embryo development.

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1.5 Proposed workarounds
For details about any known anomalies and limitations in the software as well as proposed
workarounds, refer to the separate handout on this subject provided by Vitrolife.
2 Overview of the CulturePro incubator
The CulturePro incubator is a tri-gas incubator that logs the incubation conditions during operation.
The incubator is available in two different configurations:
•A stand-alone configuration, which cannot be connected to any accessory systems.
•A standard configuration, which can be connected to the ES server and communicate with
other Vitrolife systems such as the EmbryoViewer software and share data with any
available EmbryoScope+, EmbryoScope Flex or EmbryoScope 8 incubators in the clinic.
Service lid:
Access to reset button,
VOC HEPA filter,
indicator LEDs and USB
connector to access
e.g. system log data
Back of incubator:
Main power switch, main power inlet, gas inlets, connection
to external alarm, Ethernet connection, USB connection and
connection to external logging system
Incubator screen
Cover to gas
sample port
Load door
Emergency
unlock button
Load door
open button
PC screen

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2.1 Overview of features in the CulturePro incubator
The CulturePro incubator incorporates a gas and temperature system that controls the incubation
conditions.
The blue components in the above illustration represent the gas and temperature system of the
incubator. These components maintain the desired gas concentrations inside the incubation
chamber. The gas is circulated through a VOC HEPA filter before entering the incubation chamber.
The same system also controls the temperature conditions inside the incubation chamber.
The embryos that are incubated reside in the culture dish inside the incubation chamber. The
culture dish holder in the incubation chamber is disc-shaped and has a maximum capacity of 15
culture dishes.
VOC HEPA filter
Gas flow
components
Incubation
chamber
Load door

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The culture dishes are placed on the culture dish holder in the CulturePro incubator. The culture
dish holder is a sandwich construction controlled by a thermostat. The holder provides direct heat
transfer to the culture dishes and automatically moves the culture dishes to load position during
door openings.
The incubation conditions inside the incubation chamber are unaffected by load door openings.
The removable frame surrounding the culture dish in load position combined with the fixed
partitions between the culture dishes shield the dishes contained within the incubator from outside
atmospheric conditions.
2.1.1 Barcode labelling system
In order to use barcode labels, the operator must print them and attach them to the designated
area on the culture dish (see the user manual for the culture dishes).
The information contained in the barcode is displayed in the Identification area of the PC screen
when a new culture dish has been inserted:
Removable
frame
Partitions between
culture dishes

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In the standard configuration of the incubator, the barcodes can be printed from the EmbryoViewer
software.
In the stand-alone configuration, the barcodes can be printed from the Create Patient and Print
Barcode screen. Go to this screen by pressing in the bottom left corner of the screen.
Stand-alone configuration:
Print barcodes
Stand-alone configuration:
Open the Create Patient
and Print Barcode page

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2.2 Installation and required conditions
The incubator must be set up in accordance with the installation checklist. It should not be moved
or disconnected by persons who are not certified by Vitrolife (see section 2.2.1 for information on
how to move the incubator).
Installation requirements:
•Clean room with a stable temperature between 20°C and 28°C.
•Sturdy table. The footprint of the device is approx. 0.6 m x 0.6 m. The lab bench space
required equals the size of the footprint with the addition of at least 22.5 cm on each side of the
device to allow maintenance operations to be performed. A minimum distance of 22.5 cm is
also required between the CulturePro incubator and other devices placed on the same bench.
•Attachment plug provided with grounding pole and fulfilling local requirements.
•CO2gas supply with pressure regulator capable of providing stable output of CO2 between
0.6 bar - 1 bar above ambient.
•N2gas supply with pressure regulator capable of providing stable output of N2between
0.6 bar - 1 bar above ambient (only required if the clinic wants to incubate with reduced O2
concentration).
•Medical electrical equipment requires special precautions regarding EMC and must be
installed and put into service according to the EMC information provided.
NOTE
•No cooling facilities are implemented in the incubation chamber. The incubation
temperature will always be higher than the ambient temperature. If the temperature rises
above the specified limits, the temperature inside the incubation chamber may exceed
the set point.
•It is strongly recommended, although not required, to connect the incubator to an
uninterruptible power supply (UPS) with earth connector to ensure stable operating
conditions in case of power failure. Any UPS connected to the CulturePro incubator must
comply with the following directives and harmonised standards:
oLow Voltage Directive 2014/35/EU
oElectromagnetic Compatibility Directive 2014/30/EU
oEN 62040-1:2009 Uninterruptible power systems (UPS) –Part 1: General and safety
requirements for UPS
oEN 62040-2:2006 Uninterruptible power systems (UPS) –Part 2: Electromagnetic
compatibility (EMC) requirements
For further details about how to install the incubator, please refer to the manual entitled Planned
service and maintenance (English only).

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2.2.1 Transportation and relocation of the CulturePro incubator
The CulturePro incubator must be moved by two persons positioned on each side of the incubator.
Place one hand under the side of the incubator, and place the other hand to support the front of the
incubator as illustrated below:
TRANSPORTATION AND RELOCATION OF THE CULTUREPRO INCUBATOR
•While the CulturePro incubator is still in the shipping boxes, it must only be moved by
using a lift truck or a pallet lifter. Do NOT open the shipping boxes without the presence
of a person certified by Vitrolife.
•When the CulturePro incubator has been unpacked, it must only be moved by two
persons supporting the incubator in accordance with the instructions contained in this
user manual and only under the supervision of a person certified by Vitrolife.
2.3 Starting up the CulturePro incubator
In order to start up the CulturePro incubator (e.g. after service or cleaning), turn on the incubator
by pressing the green main power switch on the back of the incubator. The incubator and
integrated PC will then automatically start.
After a complete shutdown and during the first installation of the incubator, the CulturePro
incubator should be turned on at least three hours before use to ensure temperature equilibration
throughout the incubator. Ensure that the CulturePro incubator is grounded through the power
connector, that the gas connections are not leaking, and that the connected gas cylinders are full.
A gas regulator must be used to reduce the pressure in the connected CO2and N2gas tubes to a
level between 0.6 bar and 1.0 bar above ambient pressure.

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2.4 Shutting down the CulturePro incubator and removing all
culture dishes
NOTE
•In case of an emergency, follow the procedure described in section 9.
In order to shut down the CulturePro incubator and remove all culture dishes (e.g. for service or
cleaning), follow the procedure described below.
1. On the PC home screen, press the settings icon and select Shutdown.
2. Select Remove all culture dishes and shut down and press OK. The first culture dish is
moved to the load door, which is unlocked.
3. Open the load door and remove the available culture dish.
4. Close the load door and confirm that you have removed the culture dish.
5. Continue until you have removed all culture dishes from the incubator.
6. Select Shut down computer.
7. In order to turn off the incubator completely, use the main power switch located at the back.

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2.5 Restarting the integrated PC
In case an irrecoverable error occurs, an error message is displayed on the screen and the
integrated PC will automatically restart when you press OK.
To manually restart the PC:
1. Open the lid at the top of the incubator.
2. Use a pointed object such as a pencil or a ballpoint pen to press the small red button
available under the service lid:
The PC will now shut down.
3. Press the small red button again to restart the PC.
PC reset button

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3 Connections to supporting systems
A number of connectors and sockets are found at the back of the CulturePro incubator. They
should only be used by persons certified by Vitrolife for establishing the relevant connections
during installation. Operators should never use or attach any tubing/wiring to the incubator without
supervision.
Main power switch
Main power
inlet
CO2inlet
Ethernet
connection
N2inlet
External
alarm
connection
Product
information
label
USB connection
Connection for external
system to collect
incubation data

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In addition, a USB port that can be used by the clinic to extract monthly incubation reports (see
section 13.2.2) is available under the service lid at the top of the incubator:
USB port