Table,resusc,newborn,w/access

GENERAL DESCRIPTION
Mobile resuscitation table for neonatal patients equipped with a radiant warmer and supplied with accessories.

INTENDED USE
Newborn resuscitation and support of transition of infants at birth. Additionally, used to provide thermal support for newborns in the delivery suite and for critically ill infants who require constant nursing intervention.

TECHNICAL SPECIFICATIONS
The unit is supported by a sturdy and stable wheeled base.
Bases is provided with a minimum four (4) anti-static swivel castors and at least two (2) of the castors are provided with brakes.
The base is equipped with a side handle/rail for easy positioning.
Integrated support for 2 x 10 L oxygen cylinders.
Side rail and IV pole for mounting accessories and equipment.
Provided with a minimum of one (1) lower drawer for storage.
An X-ray cassette compartment is integrated under the infant bed.
Fixed-height hood above the table integrates heating element and overhead light.
The vertical column integrates controls and a display which visualises working parameters and alarms.
Equipped with a Treatment /CPR timer which allows pre-sets between 1 to 59 minutes in increments of 1 min.
Equipped with an APGAR timer which allows for up and down counting, and provides warning signals after 1, 5 and 10 min.
Power requirements: 100 - 240 Volts - 50/60 Hz (not necessarily in a single unit).

TABLE FEATURES:
Surface 58 W x 71 L cm (minimum guaranteed dimensions), minimum surface area 4,118 cm².
The side panels made of transparent acrylic resin are collapsible/foldable for complete accessibility.
Is equipped with a tiltable cradle, up to at least 10°.
Mattress covering the entire table surface, thickness no less than 5 cm.
Mattress cover flame-retardant, waterproof, and able to withstand hospital-grade disinfection products.
Warm-up time < 30 min from 25°C.

OVERHEAD HEATER FEATURES:
Overhead radiant heater at a fixed height of 1.80m.
Radiant heating is achieved by quartz/ceramic elements, placed in a parabolic reflector.
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 temperature control accuracy is: ± 0.5°C and the setting adjustment resolution is 0.1°C.
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.

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 Mattress.
1 x Installed and 2 x spare reusable skin temperature sensors, with connection cable and plug.
1 x Spare quartz/ceramic heating element.
1 x Set of spare fuses, if applicable.

OPTIONAL ACCESSORIES AVAILABLE
At extra costs additional optional features can be requested:
- 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.

ENVIRONMENTAL CONDITIONS
- Operating conditions: 18°C - 30°C / 30% – 75% RH.
- Storage conditions: -40°C - -55°C / ≤ 95% RH.
- Atmospheric pressure: 500 ~ 1060 hPa.

WEIGHT AND VOLUME
Weight: 131 kg.
Volume: 1,299.600 dm³

ESTIIMATED 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.

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 ressuscitation table (36685)
- UMDNS code : Warming Units, Patient, Radiant, Infant, Mobile (17433)