Foam wraps, for YI sensor, Rad-G/PAC-12

GENERAL DESCRIPTION
Foam YI attachment wraps, for use with Rad-G™ YI reusable sensor, pack of 12. Masimo reference PN 1602.

INTENDED USE
Masimo YI attachment wraps are used to attach the YI sensor to the application site. The attachment wraps are for single-patient use only.

Non-sterile.

Prior to using Masimo Attachment Wraps, the user should read and understand the Operator’s Manual for the Rad-G device, the Directions for Use for the YI Sensor, and the Directions for Use included with the attachment wraps.

ENVIRONMENTAL CONDITIONS
Storage Temperature: -40°C to +70°C.
Storage Humidity: 10% to 95% relative humidity (non-condensing).

SUPPLIED WITH
1 x Instructions for use in English/French/Spanish at minimum. Other languages can be requested. If digital manuals will be provided, then a quick reference guide in English/French/Spanish languages which clearly indicates the URL to access complete manuals will be supplied with each device.

WARRANTY
12-month warranty, dated from the completion of the terms of delivery.

COMPONENT OF A KIT
Yes

WEIGHT & VOLUME (Packaged)
Weight: 0.05kg
Volume: 1.32dm³

ESTIMATED LEAD TIME
3 weeks

MARKET CLEARANCE AND DEVICE CLASSIFICATION
CE certified under the EU MDD 93/42/EEC or MDR 2017/745/EEC as Class IIb device.

QUALITY MANAGEMENT SYSTEM
Manufacturer is certified to ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes.

SAFETY AND PRODUCT STANDARDS
Complies with the following standards:
ISO 14971 Medical Devices -- Application of risk management to medical devices.
ISO 80601-2-61 Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.
IEC 60601-1 Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance.
IEC 60601-1-2 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral standard: Electromagnetic compatibility -- Requirements and tests.