Model note · Infant Incubator
Draeger Isolette 8000 plus
The Isolette 8000 plus is a closed neonatal incubator for premature and term infants up to 10 kg. A single controller regulates air or skin temperature and, as options, servo oxygen and automatic humidity. It is sold on a variable height trolley (model I8KP-1) or a fixed cabinet stand (I8KP-1C), and is meant for NICU, step down and newborn nurseries, not home use.
The model
Maker, model and type.
- Maker
- Draeger Medical Systems, Inc.
- Model
- Isolette 8000 plus
- Device type
- Infant Incubator
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Air temperature mode | Set point 20 to 39 C (override 37 to 39 C); warm up under 35 min at 22 C ambient; variability and overshoot under 0.5 C; uniformity under 0.8 C | Source |
| Skin temperature mode | Set point 34.0 to 37.0 C, override to 38.0 C; deviation alarm limit 0.3 to 1.0 C (default 1.0 C) | Source |
| Servo oxygen (optional) | 21 to 65% O2; inlet 40 to 150 psi, 30 L/min; deviation limit 3 to 5% (default 3%) | Source |
| Humidity (optional) | 30 to 95% RH set range, plus or minus 6% RH accuracy; 1500 mL reservoir lasting over 24 h at 85% RH and 37 C | Source |
| Hood environment | Noise 47 dB(A) with 37 dB(A) ambient; air speed over mattress under 10 cm/s; CO2 under 0.8% | Source |
| Electrical | 100/120 V 50/60 Hz, 1900 W max, 9.9 A; Class I, type BF; earth leakage under 500 uA | Source |
| Physical | Height 133.3 to 153.7 cm (VHA trolley); width under 104 cm; depth under 76.2 cm; weight under 98.5 kg (VHA) or 95.3 kg (cabinet); tilt to 12 degrees | Source |
| Data interface | Isolated 9 pin Sub-D RS-232; serial data output (2400 baud) or MEDIBUS.X (9600 baud, even parity) | Source |
| FDA clearance | K182977 (cabinet stand variant), predicate K172154; product code FMZ, Class II, 21 CFR 880.5400; standards IEC 60601-1, -1-2, -2-19 | Source |
Recalls
Recalls.
This note lists no recalls. Check the FDA recall database for the latest record.
Safety
Safety warnings from the record.
- Not intended for home use and limited to infants up to 10 kg. Source
- The ingress rating in the summary is IPX0, so keep liquids away from the electronics and follow the reprocessing instructions. Source
- Only connect the COM port to equipment meeting IEC 60950-1 SELV or IEC 60601-1 secondary circuit limits (60 V DC nominal). Source
- Alarms can reach 75 dB(A), so place the unit so that alarms are heard but noise inside the hood stays low. Source
Sources
Where this note comes from.
- FDA 510(k) K182977 summary, Isolette 8000 plus with cabinet stand
- openFDA recall search, Draeger incubators (product code FMZ)
- openFDA MAUDE problem counts, Isolette 8000 brand
Not covered: Draeger's website and product PDFs refused automated access (HTTP 403), and the instructions for use (SW 5.n, Edition 4) are only listed on a third party site that could not be opened, so the alarm, cause and remedy table is not included and errorCodes is empty. No FDA recall names the Isolette 8000 or 8000 plus; Draeger's FMZ recalls cover the older TI500 and GlobeTrotter only. MAUDE counts are single figures and cover the 8000 brand generally. How the override range is entered on the device is described in the IFU, not the summary.
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