Hot Swap batteries for IT applications on Carts formally require a CE declaration. The Circadian® System also fulfills the "medical CE" or IEC 60601 and related Battery Safety testing IEC 62133 (by Dekra - Certified Body). Under the MDD the Circadian products are class I and are described as a Medical Device accessory. The system is SELV, which means Safe Extra Low Voltage, which means there is no risk to operators and users. System Power Supplies are medically approved to 2xMOPP spec. Quick Boxes use the same certified components. The Circadian® battery has also been tested to verify the IP65 rating confirming Dust and Water proofing. Under IP or Ingress Protection, the 6 stands for "totally dust tight" and the 5 means waterproof, but not protected from immersion.
The ProDurance system also fulfils CE and has passed the IEC 62133 Battery Safety testing (by Kiwa - Certified Body). The system is also SELV, which means there is no risk to operators and users. System Power Supplies are medically approved to 2xMOPP spec. QPD boxes use the same certified components.
Batteries are not medical products, but can serve as accessories to medical products, whose regulatory procedures are required to cover battery failure as a risk as well as other risks. The DCPower4C IEC 62133 declarations are required by any medical product supplier wishing to fulfil IEC 60601.
Lithium Ion batteries require UN 38.3 safety testing, without which they cannot be transported. The Circadian® and ProDurance systems have passed this rigorous test.
T1 – Altitude Simulation
T2 – Thermal Test
T3 – Vibration
T4 – Shock
T5 – External Short Circuit
T6 – Impact
T7 – Overcharge
T8 – Forced Discharge
All products are ROHs compliant. REACH compliance is confirmed by our supplier, we do not import raw materials into Europe and do not work chemically hazardous materials.