Sensor, reusable, Rad-G, neonate, YI set

GENERAL DESCRIPTION
Starter set for YI multisite reusable sensor for Masimo Rad-G™ handheld pulse oximeter, appropriate for use with neonates (≥ 1kg), as well as infants, children and adults. Comes with 1 sensor and 1 pack of foam wraps. Masimo reference PN 4854.

INTENDED USE
The Rad-G™ YI Reusable Sensor is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, infant, and neonatal (≥ 1kg) patients during both no motion and motion conditions and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.

The Rad-G YI sensor is applied to the sensor site using Masimo attachment wraps. The attachment wraps are for single-patient use only.

The Rad-G YI reusable sensor is for use only with devices containing Masimo SET® oximetry or licensed to use Rad-G YI sensors.

Prior to using this sensor, the user should read and understand the Operator’s Manual for the Rad-G device and the Directions for Use included with the reusable sensor.

TECHNICAL SPECIFICATIONS
This starter set includes:
1 x YI reusable sensor with 2 x YI foam wraps (Masimo ref PN 4653)
1 x pack of YI foam wraps, 12 pcs (Masimo ref PN 1602)

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: 0.2kg
Volume: 2.86dm³

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.