EmbryoScope time-lapse incubator
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INSTALLATION AND MAINTENANCE
• Installation and repair of the EmbryoScope time-lapse incubator may only be carried out
by a person certified by Vitrolife. The EmbryoScope time-lapse incubator must remain at
the location where it was installed. If an EmbryoScope time-lapse incubator is
disconnected and/or moved without supervision by a person certified by Vitrolife, the
EmbryoScope time-lapse incubator will no longer be approved for clinical use and the
warranty may be voided.
• If the EmbryoScope time-lapse 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 time-lapse incubator, always use the
prescribed chemical agents as specified in section 8 of the EmbryoScope user manual.
TRANSPORTATION AND RELOCATION OF THE EMBRYOSCOPE TIME-LAPSE
INCUBATOR
• While the EmbryoScope time-lapse 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 time-lapse incubator has been unpacked, it must only be moved
by two persons supporting the device underneath the left and right sides and only under
the supervision of a person certified by Vitrolife.
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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