Model note · Infant Incubator
Atom Medical Dual Incu i
The Dual Incu i is a hybrid unit: a closed incubator when its powered canopy is down and an open radiant warmer when the canopy is raised. It controls either skin temperature (servo mode) or hood air temperature or heater output (manual mode), with optional SpO2, servo oxygen, weighing and humidification. It is used for newborn and premature infants, including around neonatal surgery.
The model
Maker, model and type.
- Maker
- Atom Medical Corporation
- Model
- Dual Incu i (Atom Infant Incubator Model 100)
- Device type
- Infant Incubator
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Skin temperature set range (servo mode) | 34 to 38 C including override, in both incubator and warmer use | Source |
| Air temperature set range (manual mode, incubator) | 23 to 39 C including override | Source |
| Radiant heater output (manual mode, warmer) | 0 to 100% in 5% steps | Source |
| Optional components | SpO2 module, oxygen controller, weight monitor, humidifier chamber; can be fitted later | Source |
| Replaceable accessories | Skin temperature sensor, oxygen sensor, oxygen piping hose, electrostatic air filter, access port cover, oxygen calibration tool | Source |
| Mechanical features | Electrically raised canopy, tilting mattress platform, X-ray cassette tray, height adjustable stand on castors | Source |
| Standards tested | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-19 (incubators), IEC 60601-2-21 (radiant warmers); biocompatibility per ISO 10993-1 | Source |
| FDA clearance | K102226, product code FMZ, Class II, 21 CFR 880.5400; predicates Atom V-2200 (K061856) and GE Giraffe OmniBed | Source |
Recalls
Known FDA recalls.
- Z-1945-20122012-05-01
Canopy could move unintentionally in incubator or radiant warmer mode; 377 units reworked in the field.
FDA record - Z-0337-20122011-08-23
Locking castor could loosen or break; 105 units reworked.
FDA record
Safety
Safety warnings from the record.
- A canopy that moves on its own can expose or strike the infant; stop using the unit until the manufacturer's rework is confirmed. Source
- A broken or loose castor can let the unit roll or tip, so check locks before placing an infant. Source
- With the canopy open the infant is warmed by the infrared heater, and in servo mode that heater follows the skin probe, so probe placement directly affects warming. Source
Sources
Where this note comes from.
- FDA 510(k) K102226 summary, Dual Incu i (Atom Infant Incubator Model 100)
- openFDA recall search, Dual Incu i
Not covered: The Dual Incu i operation manual is only listed on a third party site and Atom's own site was not consulted, so there are no alarm codes, numeric accuracy, power or size specs. MAUDE returned no records for the brand name. Most facts rest on the 510(k) summary and two recall records from 2011 and 2012.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
Infant Incubator