Introduction
Information relating to intended use
1
Maquet Orchide
IFU 04661 EN 02
13 / 44
Environmental standards and regulations:
Standards Year Title
Directive 2011/65/UE
RoHS2
2011 Limitation of the use of certain hazardous substances in
electrical and electronic equipment
Directive 2015/863
RoHS3
2015 Directive amending AnnexII of Directive 2001/65/EU of the
European Parliament and of the Council as regards the list
of substances subject to limitation
REACH regulation
No.190
2006 Registration, evaluation and authorization of chemical sub-
stances, as well as the restrictions applicable to these sub-
stances
Prop. 65 1986 The Safe Drinking Water and Toxic Enforcement Act of 1986
Chinese RoHS China order No.39, Administration of the Control and Elec-
tronic Information Products
Tab.6: Environmental standards and regulations
1.11 Information relating to intended use
1.11.1 Intended use
The Maquet Orchide product range is designed to capture a view of the surgical site.
1.11.2 Intended users
• The device may be operated only by medical staff who have read this manual.
• The device must be cleaned by qualified personnel.
1.11.3 Inappropriate use
• Use of a damaged product (e.g., lack of maintenance).
• In a setting other than a professional healthcare environment (e.g., home care).
• Use of the camera for assistance during an operation or to establish a diagnosis.
1.11.4 Contraindications
This product does not have any contraindications.
1.12 Primary purpose
The primary purpose of the Maquet Orchide range of cameras is to capture a view of the surgical
site, while being compatible with the illumination intensity of the surgical lights.
1.13 Clinical benefit
Maquet Orchide cameras are medical devices. When used appropriately, they will:
• Broadcast live surgical operations to the medical team in the operating room.
• Document the patient record (video).
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