Warmer system,newborn,basic,set

GENERAL DESCRIPTION
A liquid bases warmer system to assist premature babies maintaining the appropriate body temperature.

INTENDED USE
A warming unit using a heated mattress and a nest type frame to raise or maintain a newborns’ or premature babies body temperature through conductive heating.

TECHNICAL SPECIFICATIONS
System consists of a control unit, a heating pad, a mattress, and an inflatable frame.
Equipped with servo-controlled temperature utilizing the skin temperature as a reference.
Temperature connector fits with standard YSI skin temperature sensor.
Performs self-test of all functions and internal safety circuit with each start-up.
Minimum warming capacity: 4-6°C per hour with a water matrass.
Including pole clamp and/or rail clamp.
Designed for frequent and easy dismount and disinfection with hospital-grade products.
Power requirements: 100 - 240 Volts - 50/60 Hz.

HEATING PAD
Flexible and waterproof heating pad which slides under mattress.
The supply voltage for heating pad should is 24 Volt.
Material: Non-conductive PVC.

CONTROL UNIT
Integrated display shows operational status, with set and measured values and alarms.
Adjustable alarms for high and low temperatures.
Audible and visual alarm if the temperature exceeds safety limits for the patient. This should function independently from any user set alarms. The limit is set at 39.5°C.
The temperature is adjustable between 35 to 38°C in increments of 0,1°C.
Accuracy temperature control of heating pad is: ± 1°C or better.
Alarms are supported during power interruptions for a minimum of 10 minutes.
Ability to connect an external 12- or 24-volt battery, for continuous operation during power outages.

WATER MATRESS
Strong plastic mattress which fills with some kind of liquid/gel.
Material: Medical Grade PVC.
Allows for insertion of the heating pad.

NEST-LIKE FRAME
Strong nest-like frame with a cover from high quality cotton to keep the baby in place.
The nest-like frame including cover should be machine washable.

SUPPLIED WITH
Instructions for assembly, use and maintenance in English, French and Spanish.
1 x Plastic protective dustcover.
2 x reusable skin temperature probes.
1 x set of spare fuses, if applicable.

ESTIMATED LIFE SPAN
Control unit 10 years, heating pad 2-5 years.

WARRANTY
Two years from shipping date.

ENVIRONMENTAL CONDITIONS
- Operating conditions: 10°C - 34°C / 10% – 90% RH.
- Storage conditions: -25°C - 50°C / 10% – 100% RH.
- Ingress protection rating: IP20

WEIGHT AND VOLUME (Packaged)
Weight: 7 kg.
Volume: 60.00 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
S0002065 Warmer system, new-born, radiant, w/access.
S0002064 Incubator, automatic, basic, w/access

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 80601-2-35:2009+AMD1:2016 CSV Consolidated version Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use.