Warmer system,newborn,radiant,w/access

GENERAL DESCRIPTION
Radiant warmer, newborn, with accessories.

INTENDED USE
Infant radiant warmers are commonly used to provide thermal support for newborns in the delivery suite, for critically ill infants who require constant nursing intervention, and for infants undergoing treatment that prolongs exposure to a cool environment.

TECHNICAL SPECIFICATIONS
Fixed height radiant warmer, mounted on a column.
The unit is supported by a T-shaped sturdy and stable wheeled base.
Bases is provided with a minimum three (3) anti-static swivel castors.
At least two (2) of the castors are equipped with brakes.
The base is equipped with a side handle/rail for easy positioning.
The design of the base is suitable to be fitted over standard cradles, cribs, and bassinets.
Overhead radiant heater at a fixed height of 1.80m.
Radiant heating is achieved by quartz/ceramic elements, placed in a parabolic reflector.
The radiator is equipped with a safety grid.
The unit support three (3) modes: Pre-heating, manual and servo mode.
The unit allows for instant switching been the different operating modes.
The minimum skin temperature setting range is 32°C to 37°C.
The resolution of the temperature is: ± 0.5°C or better.
In manual and pre-heating modes heating settings allow for a range of 0 – 100%.
LED spotlight(s) for examination are integrated in the overhead radiant heater, the angle of the overhead light is adjustable.
Warm-up time < 30 min to 25°C.
Power requirements: 100 - 240 Volts - 50/60 Hz (not necessarily in a single unit).

DISPLAY FEATURES
The display panel is integrated in the column for visualising working parameters and alarms
The display indicates:
- The current active mode: pre-heating, manual or servo.
- The current heating power in percentages.
- The current pre-set temperature.
- The current actual skin temperature.
- The current air temperature.
The unit is equipped with a self-check feature.

ALARM AND SAFETY FEATURES
Alarms are audible as well as visual.
Alarms indicating:
- Sensor disconnection or malfunction.
- Power failure.
- Skin temperature, after stabilizing, varying beyond 0.5° to 1°C from set-point.
- 10 to 15 minutes after manual mode has been engaged an audible alarm will sound. In addition, the unit will either reduce or cut the power to the heater.
In skin mode, when the temperature exceeds 39°C, the unit will cut the power to the heater.

SUPPLIED WITH
Instructions for assembly, use and maintenance in English, French and Spanish:
1 x installed and 2 x spare reusable skin temperature sensors, including connection cable and plug.
1 x spare quartz/ceramic heating element.
2 x spare examination light bulbs.
1 x set of spare fuses, if applicable.

OPTIONAL ACCESSORIES AVAILABLE
At extra costs additional optional features can be requested:
- A cradle/crib.
- Oxygen regulator including a pressure gauge, flow meter, humidifier bottle and all required tubing.
- Integrated weighing scale.
- Electrically operated, slow suction unit including a vacuum regulator, vacuum gauge and autoclavable collection jar.
- Electrical height adjustment.
- T-piece resuscitator.
- Integrated phototherapy unit.

ESTIMATED LIFE SPAN
Eight years.

WARRANTY
Two years from shipping date.

ENVIRONMENTAL CONDITIONS
- Operating conditions: 18°C - 30 °C / 30% – 75% RH.
- Storage conditions: -40°C - 55 °C / < 93% RH.
- Atmospheric pressure: 700 ~ 1060hPa.

WEIGHT AND VOLUME
Weight: 160.00 kg.
Volume: 1,311.00 dm³.

ESTIMATED DELIVERY LEAD TIME
120 days.

INSTALLATION REQUIREMENTS
Assembly and commissioning this product should be carried out by qualified technician.

TRAINING REQUIREMENTS
User training prior to utilization is recommended.

MAINTENANCE/USER REQUIREMENTS
As per user and service manuals.

ALTERNATIVE PRODUCTS
S0002060, Warmer system,newborn, basic.

COMPONENT OF A KIT
No part of a kit.

QUALITY MANAGEMENT SYSTEM
- Manufacturer is certified for ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes.
- Supplier (if not the manufacturer) at a minimum is certified for ISO 9001 Quality management systems – Requirements.

CLASSIFICATION
Classified either under EU MDD 93/42/ECC, or under EU MDR 2017/745 as Class IIb device.

SAFETY & PRODUCT STANDARDS
- IEC 60601-1:2005 + A1:2012(E) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
- IEC 60601-2-21:2009 Medical electrical equipment -- Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers.

NOMENCLATURE
- GMDN code : Infant warmer (17433).
- UMDNS code : Warming Units, Patient, Radiant, Infant (17956), Warming Units, Patient, Radiant, Infant, Mobile (17433), Warming Units, Patient, Radiant (13248).