Vitrolife EmbryoScope Flex Manual de usuario

EmbryoScope™Flex incubator

User manual

EmbryoScope Flex incubator, software version 7.8

User manual, first issue 2021.08.02, revised 2022.06.01/EU/English

EmbryoScope Flex incubator 
 
 
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Table of contents 
 
1Introduction............................................................................................................................5 
1 Warnings, restrictions and limited warranty.....................................................................6 
2 Intended use.................................................................................................................10 
3 Intended users..............................................................................................................10 
4 Clinical benefits.............................................................................................................11 
5 Proposed workarounds.................................................................................................11 
2Overview of the EmbryoScope Flex incubator................................................................... 12 
1 Overview of features in the EmbryoScope Flex incubator .............................................13 
1.1 Barcode labelling system...................................................................................15 
2 Installation and required conditions...............................................................................16 
2.1 Transportation and relocation of the EmbryoScope Flex incubator....................17 
3 Starting up the EmbryoScope Flex incubator................................................................18 
4 Shutting down the EmbryoScope Flex incubator and removing all culture dishes .........18 
5 Restarting the integrated PC.........................................................................................19 
3Connections to supporting systems .................................................................................. 20 
1 Gas...............................................................................................................................22 
2 ES server......................................................................................................................23 
3 External alarm output....................................................................................................24 
4 Incubator data...............................................................................................................24 
5 USB connections ..........................................................................................................24 
4Operating the EmbryoScope Flex incubator...................................................................... 25 
1 The incubator screen ....................................................................................................25 
1.1 Navigating on the incubator screen....................................................................26 
1.2 Change set point mode...................................................................................... 27 
1.3 Validation and calibration mode.........................................................................29 
1.4 Controlling the incubator temperature................................................................32 
1.4.1 Changing the temperature set point.....................................................32 
1.4.2 Calibrating the temperature..................................................................33 
1.5 Controlling the CO2/O2concentration.................................................................36 
1.5.1 Changing the CO2/O2set point............................................................. 36 
1.5.2 Validating the CO2/O2concentration ....................................................38 
1.5.3 Calibrating the CO2/O2concentration...................................................41 
1.6 Incubator O2regulation......................................................................................43 

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1.6.1 Turning on/off the O2regulation ...........................................................43 
2 The PC screen..............................................................................................................44 
2.1 PC home screen................................................................................................ 44 
2.1.1 Colours on the home screen................................................................44 
2.1.2 Starting an EmbryoSlide Flex culture dish............................................46 
2.1.3 Barcode errors.....................................................................................50 
2.1.4 Removing a single EmbryoSlide Flex culture dish................................ 52 
2.1.5 Removing all EmbryoSlide Flex culture dishes.....................................52 
2.1.6 Resuming culture in a culture dish .......................................................53 
2.2 Culture dish overview screen.............................................................................55 
2.2.1 Disabling image acquisition for individual wells....................................57 
2.3 Settings screen..................................................................................................58 
2.3.1 Enabling and disabling the screen saver..............................................59 
5Cleaning and disinfecting the EmbryoScope Flex incubator............................................ 60 
1 Periodic cleaning of the EmbryoScope Flex incubator...................................................60 
2 Disinfection of the EmbryoScope Flex incubator........................................................... 63 
6Changing the VOC HEPA filter............................................................................................ 66 
7Replacing the main fuses.................................................................................................... 72 
8Alarms, warnings and notifications....................................................................................74 
1 Types of alarms, warnings and notifications..................................................................74 
1.1 Alarms............................................................................................................... 74 
1.2 Warnings...........................................................................................................75 
1.3 Notifications.......................................................................................................75 
2 Temporarily pausing alarms..........................................................................................76 
3 Overview of the display colours of alarms, warnings and notifications........................... 77 
3.1 Alarms............................................................................................................... 77 
3.2 Warnings...........................................................................................................77 
3.3 Notifications.......................................................................................................78 
4 Multiple simultaneous alarms........................................................................................78 
5 Resetting alarms...........................................................................................................79 
6 Graphical overview of alarms and operator response....................................................80 
7 Graphical overview of warnings and operator response................................................83 
8 Graphical overview of notifications and operator response ...........................................85 
9 Overview of error conditions and control unit responses...............................................86 

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10 External alarm system................................................................................................... 87 
10.1 Overview of errors sent to the external alarm system ........................................87 
10.2 Delay of external alarms and warnings..............................................................88 
10.3 Connecting the external alarm...........................................................................88 
9Emergency procedure ......................................................................................................... 89 
1 Removing culture dishes after a system failure.............................................................89 
Technical specifications......................................................................................................91 
EMC and HF technical review.............................................................................................. 95 
1 Electromagnetic emissions ...........................................................................................95 
2 Electromagnetic immunity.............................................................................................96 
Accessories and materials ................................................................................................ 100 
Planned service and maintenance.................................................................................... 101 
1 Planned service .......................................................................................................... 101 
2 Planned maintenance ................................................................................................. 102 
2.1 Maintenance screen ........................................................................................ 103 
2.2 Generating a monthly incubation report...........................................................104 
2.3 VOC HEPA filter and sensor maintenance.......................................................105 
Symbols and labels............................................................................................................ 108 
1 Product information labels...........................................................................................108 
2 Warning labels............................................................................................................109 
3 Connection labels .......................................................................................................110 
4 Labels on the shipping crate .......................................................................................111 
Disposal of waste............................................................................................................... 112 
Contact information........................................................................................................... 113 
 
 
 
 
 
 
 
 
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. 

EmbryoScope Flex incubator

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1 Introduction

This user manual provides information on how to use the EmbryoScope Flex 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 EmbryoScope Flex 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 EmbryoScope Flex incubator is suitable for

continuous operation.

•The EmbryoScope Flex 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.

EmbryoScope Flex incubator

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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 EmbryoScope Flex incubator may only be used by persons who have been trained in

its use by a person certified by Vitrolife.

•The EmbryoScope Flex incubator may only be used with sterile disposable EmbryoSlide

Flex culture dishes produced and sold by Vitrolife.

•The EmbryoSlide Flex culture dishes may not be reused.

•The EmbryoSlide Flex culture dishes must be covered with sterile lids before insertion

into the EmbryoScope Flex incubator.

•The EmbryoScope Flex 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

EmbryoScope Flex 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 EmbryoScope Flex incubator, stop using the

incubator until it has been checked by a person certified by Vitrolife.

EmbryoScope Flex incubator

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WARNING

•The EmbryoScope Flex 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 cords 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 EmbryoScope Flex

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 EmbryoScope Flex 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 EmbryoScope Flex

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.

EmbryoScope Flex incubator

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INSTALLATION AND SERVICE

•Installation and service of the EmbryoScope Flex incubator may only be carried out by a

person certified by Vitrolife. The EmbryoScope Flex incubator must remain at the location

where it was installed. If the EmbryoScope Flex 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 EmbryoScope Flex 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 EmbryoScope Flex incubator, always use the

prescribed chemical agents as specified in section 5 of this user manual.

TRANSPORTATION AND RELOCATION OF THE EMBRYOSCOPE FLEX INCUBATOR

•While the EmbryoScope Flex 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 EmbryoScope Flex 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.

EmbryoScope Flex incubator

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ELECTROMAGNETIC COMPATIBILITY

•The EmbryoScope Flex 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 EmbryoScope

Flex incubator is placed at a minimum distance to nearby instruments. If the EmbryoScope

Flex incubator is placed close to other instruments, it is necessary to observe that the

performance of all instruments remains unaffected by the placement.

The EmbryoScope Flex 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 EmbryoScope Flex 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.

EmbryoScope Flex incubator

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LIMITED WARRANTY

•Vitrolife warrants the EmbryoScope Flex 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 EmbryoScope Flex incubator is to provide an environment with controlled

temperature and gas concentrations (CO2and optionally O2) for the culture of gametes and/or

embryos and to acquire images of these during incubation.

1.3 Intended users

Embryologists, other laboratory personnel and clinic staff at IVF clinics trained by Vitrolife A/S-

certified instructors.

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