Simbona
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Simbona
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Infant Radiant Warmer
Controlled radiant heat for infants and paediatric patients, with Servo, Manual and Pre-warm modes.
Overview
Provides a controlled source of radiant heat for infants and paediatric patients. The control system uses a microprocessor with three modes — Servo (Auto), Manual and Pre-warm.
Locally manufactured with precise temperature control, a radiant heating system, safety alarms and a user-friendly interface. Mobile with lockable castors, adjustable height, examination lamp and integrated controls. The heating element uses ceramic with high-quality quartz for rapid radiant efficiency.
Specifications
Transcribed from the Simbona product catalogue.
| Heat source | Far-infrared heating tube made of ceramic (Elstein far-infrared ceramic heating tubes) |
|---|
| Observation lamp | LED puncture / examination lamp for clear view of neonate skin colour |
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| Dimensions (L × W × H) | 1400 mm × 700 mm × 1780 mm |
|---|---|
| Weight | 55 kg |
| Floor to mattress (neutral) | 900 mm |
| Floor to header | 1600 mm |
| Mattress to heater | 780 mm |
| Mattress size | 620 mm × 550 mm × 18 mm |
| Heating mechanism | Far Infrared (FIR) radiation |
|---|---|
| Compliance | Complies with IEC 60601-2-21 |
| Far infrared (at any point on the mattress) | < 60 µW/cm² |
| Near infrared (760–1400 nm) | < 10 µW/cm² |
| Illuminance — high | 4500 Lux ± 500 Lux |
|---|---|
| Illuminance — medium | 2500 Lux ± 500 Lux |
| Illuminance — low | 1500 Lux ± 500 Lux |
| Spot size | 250 mm ± 10% |
| Temperature | 18–30 °C |
|---|---|
| Humidity | 15–80%, non-condensing |
| Barometric pressure | 70–106 kPa |
| Air flow velocity | < 0.3 m/s |
| Temperature | −20–60 °C |
|---|---|
| Humidity | 15–80%, non-condensing |
| Barometric pressure | 50–106 kPa |
| Preset skin temperature | Approx. 30–42 °C, increments 0.1 °C |
|---|---|
| Skin temperature monitoring | 30–42 °C (sensitivity 0.2 °C) |
| Preset heater output | 0–100%, in 10% increments |
| Integrated timer | 1–59 min, up/down count, 1 min increments |
| Alarms | Audiovisual on skin temperature (±0.1 °C of preset) and timer elapsed |
| LED display | Mode (servo or manual), preset / actual skin temperature, air temperature, elapsed or remaining time |
| Supply | 220 V / 50 Hz |
|---|---|
| Power consumption (approx.) | 650 W |
| Input current | 5–7 A |
| Included / spare probes | 1 × reusable skin temperature probe (with cable and plug); 1 × spare probe |
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| Heating element | 1 × spare heating element |
| Fuses | 1 × set of spare fuses |
| Particular standard | IEC 60601-2-21 (infant radiant warmer / related particular requirements as printed) |
|---|---|
| Standards applied | IEC 60601-1:2005; IEC 60601-2-21:2009; IEC 60601-1-2:2007; ISO 9001:2007; EFDA registration guideline; ESA; ECAE conformity and safety test |
Regulatory status
Clinical performance testing was conducted at Jimma University Medical Center under EFDA supervision (14 Oct 2023 – 14 Oct 2024). Products received EFDA market authorisation and registration in May 2025.
Bodies & standards
May 2025: Simbona's products received EFDA market authorisation and registration.
EFDA
Ethiopian Food & Drug Authority
ECAE
Ethiopian Conformity Assessment Enterprise
IEC
International Electrotechnical Commission
IES
Institute of Ethiopian Standards
ETA
Ethiopian Technology Authority
Directives
Standards applied
This device
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