EmbryoScope time-lapse incubator
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1 Introduction
This user manual provides information on how to use the EmbryoScope time-lapse incubator
Version D (hereafter EmbryoScope time-lapse incubator).
A person certified by Vitrolife will perform scheduled maintenance and recalibration checks
according to a service plan to ensure continued safe and efficient operation. The end user is
strongly encouraged to follow the service plan carefully to ensure error-free operation of the
equipment.
The EmbryoScope
time-lapse 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 and IEC 60601-1:2005 + corr. 1
(2006) + corr. 2 (2007) standards; class I, type B equivalent. The EmbryoScope time-lapse
incubator is suitable for continuous operation.
• The EmbryoScope time-lapse 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.
• Certified to CAN/CSA - C22.2 No. 60601-1:R2013 addendum.
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