Indications for use and contraindications

1. USA
2. UK and EU

USA

USA Indications for use

The VS Newborn Heart Rate Monitor is indicated for the continuous monitoring of heart rate in neonatal patients. The device uses reflectance photoplethysmography to determine heart rate. The sensor is integrated into a cap placed on the head of the patient. The VS Newborn Heart Rate Monitor is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

Contraindications

• The contraindications are listed as follows:
• Its use is contraindicated if any part of the device is broken/damaged or dirty.
• The device is not suitable for domestic use.
• The contraindications for using the device include any skin condition where the integrity of the skin could be breached
• For the cap being used (without the sensor) for more than 30 days
• Outside the operating temperature range of 0 to 40 degrees celcius.

UK and EU

Intended Use

The SurePulse VS Newborn Heart Rate Monitor (VS) is a device which utilises reflectance photoplethysmography (PPG) to determine heart rate (HR) in newborn babies. The sensor is placed on the head of the newborn baby such that the sensor contacts the forehead of the baby. The sensor may be integrated into a soft cap or affixed separately. The HR and PPG signals are transmitted to a Display via a wireless connection. The device is intended for application only by medically qualified personnel.

The Caps are designed for head circumferences from 20 cm to 40 cm in five sizes. The Cap and Sensor are single-use items. The device is non-invasive. The Cap and Sensor can be worn for up to four hours. However, the Sensor can be removed from the Cap, and the Cap on its own can be worn as long as is required up to 30 days. The Cap serves to keep the baby’s head warm and to provide a fixation point for an endotracheal tube holder or CPAP apparatus.

The user should take precaution to read all information in the Operating Manual, where all relevant cautions and warnings are provided.

Contraindications

The SurePulse VS has been designed to measure heart rate of newborn babies. The contraindications are listed as follows:

• Its use is contraindicated if any part of the device is broken, damaged or dirty.
• The device should be used in conjunction with this Operating Manual by trained staff only and is not suitable for domestic use.
• The contraindications for using the device include any skin condition where the integrity of the skin could be breached.
• For the sensor being used continuously for more than 4 hours
• For the cap being used (without the sensor) for more than 30 days
• Outside the operating temperature range of 0 to 40 degrees Celcius.