ChARM

In the box, the user will receive: one device (Community HW/Professional HW depending on the model purchased), one instruction for use (IFU), one Quick reference guide (QRG), one belt, and a power adapter with plug heads and cable in case of PHW.

The ChARM comprises an accelerometer based device, with a belt to attach the device to the child. If the child’s breathing rate is under the limit based on the World Health Organization’s IMCI (Integrated Management of Childhood Illness) guidelines, the device will light up green, meaning the child does not have fast breathing. If the breathing rate is above the limit, the device will light up red and blink, indicating that the child has fast breathing. There are two variants, Community health worker model called CHW and a Professional Health worker model called PHW.

Specifications:

– Principle: Uses a 3D accelerometer with advanced signal processing to measure the specific abdominal motions related to breathing.

– Accuracy: ±2 Breaths per minute when measured under the recommended conditions.

– Measurement Range: 10 to 150 Breaths per minute.

– Mode of Operation: Non-Continuous.

– Power Specifications for Charging Adapter PHW: Input Voltage: 100-240V@50/60 Hz; Output Voltage: 5VDC Output; Current: > 0.5A.

– Battery Type: Alkaline for Community Healthcare Worker (CHW) and Rechargeable NiMH for PHW.

– Automatic Shut-off: After approximately two minutes of inactivity.

– Memory: 300 measurement records PHW.

– Operating Conditions: 0 °C to 40 °C; 10% to 90% RH.

– Dimensions (approx.): 65 x 65 x 28 mm (without belt).

– Weight (approx.): 95 g including belt

Breathing Rate Guidelines:

– <2 months: ≥60 breaths/min

– 2-11 months: ≥50 breaths/min

– 12-59 months: ≥40 breaths/min

Distributor can be contacted for technical support. Users may also refer to the instructions for use.

2,000 measurements over two-year usage for the CHW model, 4,380 measurements over three years of usage, and 200 measurements per full charge cycle for PHW model. The PHW model uses a rechargeable battery that can run for several days with normal use (~10 measurements/day).

Results:

– Root Mean Squared Error( RMSE) values (overall: 1.9 and balanced: 2.1) were close to 2

– Balanced percentage below 2 RPM as 83% which is higher than values revealed by clinician (73%)

These study results indicate that ChARM device is at least as good as a trained physician for measuring breath count. Given these findings, ChARM device can be recommended an acceptably accurate and alternate method of breath count for under 5 children population.

Safety:

– This Device has to be used by trained and authorized personnel only.

– This system should only be used on FULL TERM babies (i.e. babies completed 37 weeks of gestation).

– The system shall not be used on Children wearing any supportive device at the area of the chest/belly.

– The system does not need direct skin contact for measurement, the user is recommended to attach directly on cloth. If used without a cloth use on intact skin only.

– Use only the belt supplied with the system, use of any other belt is not allowed.

– Be cautious while attaching the Belt to ensure that no injuries are caused to the child.

– Ensure that the belt is not too tightly attached to the child.

– Do not connect the Charging Cable to the device when it is attached to the child.

– Charge the Professional HW device to full before first use. Always charge the device to full battery state for correct battery indication and functioning.

– Do not leave the system unattended while not in use.

– Ensure the system is not exposed to unhygienic conditions.

– The device or the belt should not be sterilized in any sterilizer equipment.

– The concerned device user is responsible for proper disposal of the device past their expected life span or when no longer be used for its intended purpose, dispose in accordance with applicable waste disposal laws and local regulations.

The ChARM should be disinfected after each use and routinely cleaned.

Steps to clean:

1 Turn off the device before cleaning.

2 Wipe the external surfaces of the device and the belt with a cloth dampened in mild soap solution or water.

It is mandatory to disinfect the system after every use to prevent cross-contamination. Wipe the patient contact surface of the device and the belt before every use with a clean cloth moistened with 70% Isopropyl alcohol.