Multi-zone ART Workstation User Manual Rev. 6.0
12
(IVF)/assisted reproduction technology (ART) procedures. The workstation also pro-
vides humidified gas to maintain gametes and embryos in the working environment.
4 About the product
The Multi-zone ART Workstation is a laminar flow workstation intended to work with
gametes and/or embryos at or near body temperature during
in vitro
fertilization
(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 ideal tempera-
ture conditions compared to conventional layouts.
The system has 12 separate temperature controllers for maximum performance, control-
ling and regulating each zone's temperature.
The workstation has been primarily developed and designed to provide short-term tis-
sue, gametes and embryos with an overlay of either Paraffin or mineral oil, incubation
storage conditions.
If open culture is used, the user can utilize the humidified gas system built into the tab-
letop. 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 condi-
tions are not maintained.
An integral part of the Multi-zone ART Workstation is the All-in-one PC, which runs with
the Workstation 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 software includes data logging, data storage and report functions for ISO quality
management compliance. The All-in-one PC can also be used for microscope camera
imaging. Using a microscope camera will still warn the user by bringing an alarm
notification to the screen while working with the microscope camera imaging.
The device is manufactured under a full EU certified ISO quality management system.
This product fulfills EN60601-1 3rd edition standards as a Class I type B equivalent
device suited for continuous operation. It also conforms to the EU Council directive's
2017/745 requirements concerning medical devices and is classified as a Class I device
under annex VIII rule 13.
Personal Protective Equipment (89/686/EEC) and Machine Directive (2006/42/EC) is
