Infant Radiant Warmers are used primarily in neonatal intensive care units (NICUs), delivery rooms, and pediatric wards. Their primary function is to maintain the body temperature of newborns, especially premature or critically ill infants who cannot regulate their own heat effectively. Unlike an incubator, which encloses the infant in a controlled environment, a radiant warmer is an open-bed system that uses an overhead heating element to deliver warmth.

Intended Use of Infant Radiant Warmer

The Infant Radiant Warmer is a device consisting of an infrared heating element intended to be placed over an infant to maintain the infant’s body temperature by means of radiant heat. The device may also contain a temperature monitoring sensor, a heat output control mechanism, and an alarm system (infant temperature, manual mode if present, and failure alarms) to alert operators of a temperature condition over or under the set temperature, manual mode time limits, and device component failure, respectively. The device may be placed over a pediatric hospital bed, or it may be built into the bed as a complete unit.

Intended Use:

The Infant Radiant Warmer is intended to provide non-invasive thermal support using radiant heat to maintain the normal body temperature of newborn infants during care in hospital and clinical environments.

Device Description:

The Infant Radiant Warmer is a stationary, AC-powered medical device intended to provide controlled radiant heat to newborn infants to assist in maintaining normal body temperature during clinical care. The device includes an overhead infrared heating assembly positioned above an open infant bed platform to allow unobstructed clinical access. It operates in manual mode or servo-controlled mode, where heater output is automatically adjusted based on feedback from a skin temperature probe attached to the infant. The system incorporates a microprocessor-based control unit, temperature monitoring, visual and audible alarms, and over-temperature protection mechanisms. The device is intended for use in hospital environments, including delivery rooms, nurseries, and neonatal intensive care units (NICUs).

Radiant Infant Warmer Cabinet

Intended Use:

The device is intended to provide an enclosure for the storage of a radiant infant warmer. It may also provide a bassinet for use with the radiant infant warmer and provide power to the Infant Radiant Warmer.

Device Description:

The Radiant Infant Warmer Cabinet is a stationary support and storage unit designed for integration with a radiant infant warmer system. The device:

• Provides a structural enclosure for the storage of the radiant warmer.
• Opens to form a bassinet platform beneath the radiant heater.
• Includes an electrical power outlet to supply power to the radiant warmer.
• Incorporates a power disconnect mechanism to prevent unintended operation when the cabinet is closed.
• It is intended for use in hospital and clinical neonatal settings.

The cabinet does not provide direct thermal therapy; rather, it supports and powers the radiant infant warmer, which delivers infrared heat to maintain neonatal body temperature.

1. Electrical Safety & EMC

• EMC and Electrical Safety – IEC 60601
• Thermal Performance Testing (Critical)
• Alarm System Testing
• Software Validation (If Microprocessor Controlled)
• Cybersecurity documentation (if applicable)
• Biocompatibility (ISO 10993)
• Stability testing (tip-over resistance)
• Load testing (infant bed platform)
• Caster durability (if mobile)
• Mechanical strength
• Hinge durability (if cabinet opens)
• Door open/close cycle testing
• Bassinet platform load testing
• Usability / Human Factors
• Cleaning & Disinfection Validation

Clinical Testing:

No Guidance available for 510k submission