Intended User And Environment Of Use; Patient Target Group; Type Of Contact; Contraindications - K-Systems G210 InviCell User Manual

• Medical treatment to restore fertility (e.g. drugs for ovulation induction)
• Surgical treatment to restore fertility (e.g. laparoscopy for ablation of endometriosis)
• ART treatment, including all kinds of conception other than normal coitus, involving
a large variety of techniques for in vitro handling of gametes and embryos (incl.
intrauterine insemination (IUI)/artificial insemination, in vitro fertilisation (IVF), and
intracytoplasmic sperm injection (ICSI).

Intended user and environment of use

The product should only be used by professionals trained in ART procedures, such
as embryologists, gynaecologists, and laboratory technicians in a controlled clinical
environment.

Patient Target Group

G210 InviCell Long Term Incubators can be used for all persons/couples assessed suitable
for ART treatment by a gynaecologist.

Type of contact

G210 InviCell Long Term Incubators do not come into direct contact with human
reproductive tissues.

Contraindications

There are no contraindications associated with this device.

Applicable Part Numbers

K59500 G210 InviCell Standard Incubator
K60000 G210 InviCell Plus with SignipHy
SignipHy is an optional system that is not included as standard with G210 Invicell Plus
and requires additional installation by CooperSurgical service personnel.
pH Monitoring System
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Section 2
Introduction
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