SurePulse VS SurePulse VS The NEW wireless heart rate monitor
for newborn babies
[title_box title=”Specifically designed for newborn babies” position=”text-left” pixi_template=”pixi_heading-style4.jpg”]

No other heart rate monitor was specifically designed for newborn babies – they are all adult approaches that have been adapted for newborns. SurePulse VS is therefore, the first.

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[title_box title=”Supports confident decision-making” position=”text-left” pixi_template=”pixi_heading-style4.jpg”]

SurePulse VS facilitates confident decision-making – accurate and reliable heart rate information is displayed in realtime to the whole clinical team.

The heart rate of the baby is critical for guiding the stabilisation process and resuscitation interventions, as is recognised in National and International Guidelines. (Wyllie et al. 2015) However all current heart rate assessment approaches have drawbacks as in the critical first few minutes they do not always provide an early enough or sometimes an accurate enough heart rate.

[title_box title=”Wireless monitoring offers new possibilities” position=”text-left” pixi_template=”pixi_heading-style4.jpg”]

The device is wireless which provides significant opportunities for more flexible, evolving, delivery room practices (whilst monitoring heart rate). These include delayed cord clamping, skin-to-skin care (delivery room cuddles), early breast feeds and less-invasive approaches to stabilization

[title_box title=”Patient Safety” position=”text-left” pixi_template=”pixi_heading-style4.jpg”]

The touchscreen and data download facility supports improves patient safety, audit, clinical governance and training. By facilitating a date/time stamped downloadable record of heart rate information and the sequencing of clinical interventions, SurePulse VS supports the review of Delivery Room experience.

This also addresses a common problem as the recording of heart rate information and clinical interventions is notoriously inconsistent in the delivery room. The SurePulse VS touchscreen interface makes this easy and routine, and may also help if a retrospective review is needed – for example in a Serious Incident Investigation.

[title_box title=”Fits into existing patient clinical pathways” position=”text-left” pixi_template=”pixi_heading-style4.jpg”]

Many babies have a hand-knitted or medical cap put on their heads straight away to prevent heat-loss. As the SurePulse VS heart rate sensor is fitted into a very easy-to-fit cap then little process change needs to be made.

Clinical trials conducted at the Nottingham Universities NHS Trust established the thermoprotective equivalence of the SurePulse Cap, compared to other commonly used caps.

[title_box title=”SurePulse VS comprises a Display Unit (which houses 2 wireless Modules) and a single-use Cap/Sensor” position=”text-left” pixi_template=”pixi_heading-style4.jpg”]
  • Displays heart rate and pulse waveform continuously
  • Touchscreen enables birth timer and event recording
  • Battery life 4 hours (Modules 2 x 2 hours each)
  • Award-winning design (Pickup et al)
  • Carry-handle hooks over resuscitation table
  • Heart rate and time/date stamped event data storage (100 hours)
  • Data downloadable on datastick
  • Reports generated as pdf and csv files
  • Thermoprotective Cap in 5 sizes  (23 weeks GA to 42 weeks)
  • Easy to fit T-design
  • Cap accommodates CPAP & endotracheal tube holders
[title_box title=”SurePulse VS Value Proposition” pixi_template=”pixi_heading-style4.jpg”]

There are significant potential economic and resource savings for healthcare systems if SurePulse VS is deployed clinically. In addition to the significant clinical and emotional consequences, the short and long term cost implications of poor resuscitation management are substantial as a lifetime of disability (as with Cerebral Palsy) carries a huge economic and resource burden. The consequences of overtreatment can also be considerable as unnecessary clinical interventions (for example if a stethoscope-assessed heart rate is underestimated and intubation or chest compressions are indicated) are associated with prolonged hospital stays in expensive Intensive Care facilities.

SurePulse VS provides the right heart rate information at the right time, and therefore will potentially improve adherence to guidelines and outcomes, and therefore has the potential to save healthcare systems many millions of pounds each year.

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[title_box title=”User FAQs” position=”text-left” pixi_template=”pixi_heading-style4.jpg”]

The SurePulse VS is a wireless heart rate monitor specifically designed for newborn babies. It displays this information, the pulse waveform and digital timer on the dedicated Display Unit, and also records this information as a downloadable record.

SurePulse VS uses reflective photoplethysmography (PPG) which is a similar technology to a pulse oximeter, but it utilises green light. The sensor is integrated into a thermoprotective Cap which is placed on the baby’s head at birth. The heart rate information is wirelessly sent to the Display Unit.

SurePulse VS provides wireless, accurate and continuous heart rate information (to within 5 beats per minute of ECG)

The Cap can be kept on the baby’s head (once the sensor has been removed) for 30 days. We recommend that the sensor is only kept in direct contact with the baby’s head for 4 hours – the sensor can be removed from the Cap without removing the Cap from the baby’s head, thereby minimizing heat loss

The Cap/sensor unit is single-use, and should be disposed of following local hospital guidelines and procedures. Due to the possibilities of contamination re-use of the Cap and sensor is not recommended

The Module is not disposable and should be returned to its dock in the Display Unit for re-charging after the monitoring session has ended

Once fully charged the Display Unit battery will last in use for 4 hours (the device can also be used whilst on mains power supply); each Module has, from full charge, a 2 hour battery life in use.

Clinical trials conducted at the Nottingham Universities NHS Trust are complete and have been submitted for publication in peer-reviewed journal; Clinical evaluation is currently taking place in several hospitals in Europe

Publications

M R Grubb et al 2014 Physiol. Meas. 35 881: ‘Forehead reflectance photoplethysmography to monitor heart rate: preliminary results from neonatal patients’ (Link to publications page)

L Pickup et al 2019 JMIR Hum Factors; 6(2): e12055.”The development of a clinical interface for a novel newborn resuscitation device; a Human Factors approach to understand cognitive user requirements.” (Link to publications page)

There are 5 Cap sizes which will accommodate babies from 20cm head circumference up to 40cm. This will normally mean that babies 23 to 42 weeks Gestational Age will be able to use the SurePulse VS device

The device records the heart rate and pulse waveform information and also has a touchscreen that can be used to record clinical events which are time and date stamped. This information can be downloaded as a permanent record and used for audit, training and clinical governance.

Dr. James Carpenter


CEO

James Carpenter has served as CEO of SurePulse Medical since its incorporation in mid-2014, having worked to secure considerable grant funding for early development and trials. He has spent 7 years working in medical device engineering and development, particularly focussed on blood flow analysis in the field of Laser Doppler Blood Flowmetry. More recently his work has been centred on high-reliability heart rate estimation. He holds a PhD in Electronic Engineering from the University of Nottingham.

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Warwick Adams


Non-Executive Director

Warwick Adams has 30 years of experience in the design and manufacture of electronic equipment both in the commercial and medical arena. He started in electronics within the Medical Physics department at the Queens Medical Centre Nottingham and then formed his own business in 1982 designing and manufacturing medical and commercial electronics and systems. Warwick has founded a number of businesses and holds a board position in many of these companies a number of which are certified to ISO 13485. Warwick has also been involved in a number of successful applications and grants for Innovate UK projects with Nottingham University.

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Bill Allan


Chairman

Bill has a strong international track-record of focussed, profitable sales growth and of developing high performance teams through small and large scale organisational development. For the past 10 years, Bill has led and transitioned 2 small Medical Device companies to sale and integration, and is a non-executive Board Member for a number of Medical Technology companies.

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Rohan Byrt


Quality and Operations Manager

Rohan has several years’ experience within the electronics industry at both startups and multinationals. In various positions he has overseen the certification process for numerous international accreditation marks (CE, CB, CCC) and managed the transfer of new designs to manufacture.

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Matthew Butler


Electronics Engineer

Matthew Butler is an experienced electronics and software engineer. He has designed electronics solutions for international companies, and is bewilderingly fluent in a variety of software languages. He holds a PhD degree in electronic engineering.

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Prof. Barrie Hayes-Gill


Research Director

Professor Barrie Hayes-Gill has over 30 years of expertise in medical electronic devices and has considerable experience of taking devices into the clinic including co-founding Monica Healthcare Ltd that has fully commercialised a fetal heart rate monitor. He has taken several devices through regulatory approvals in the EU (CE) and USA (FDA). He has managed and delivered a number of projects that have underpinned SurePulse's development.

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Quentin Hayes


Commercial Manager

Quentin has over 25 years’ experience in pharmaceuticals, medical devices and healthcare services in the private sector and the NHS. His leadership roles include Sales, Marketing, Market Access, Clinical Research, Governance, Operational and Executive Management. He has Project Leadership expertise in Change Management, Business/Process improvement, and Contract Management.

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Yvonne Hooton


Clinical Specialist

Yvonne is our Clinical Specialist who has worked at Nottingham University Hospitals NHS Trust for 30 years, she is a Registered General Nurse/Registered Sick Children's Nurse with a BSC in Health Studies. She has extensive experience in Neonatal care having worked as a Neonatal Sister, Advanced Neonatal Nurse Practitioner and Children's Clinical Research Nurse working on obstetric, paediatric and neonatal studies.

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Russell Hoyle


Non-Executive Director

Russell Hoyle runs an independent business consultancy advising small and medium sized companies on their strategic development opportunities. As well as being a Non-Executive Director of SurePulse Medical Ltd, he is a Special Partner with private equity firm Vitruvian Partners LLP, and Chairman of UK based electronics manufacturer Tioga Ltd. He is a Board member of the Responsible Gambling Strategy Board, which advises Government and Regulators on policy in relation to research, education and treatment for problem gamblers. Until mid-2010, he was Chairman of Inspired Gaming Group plc, an AIM listed technology provider to the land based gaming market.

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Dr Damon McCartney


Principal Engineer

Dr Damon McCartney is an experienced product development manager, and is responsible for all engineering aspects of the company’s products. He has spent several years working in start-ups in a variety of industries. He holds a PhD in electronic engineering.

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Dr Son Nguyen


Electronics Engineer

Son Nguyen has experience in building products to medical device quality standards (e.g. BS EN 60601-1) having spent a number of years designing skin impedance tracking systems. He graduated with a PhD in electronic engineering from the University of Nottingham in 2016.

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Khoa Pham


Administrator

Khoa Pham is our company administrator and literally holds everything together! She has a number of degrees and experience in administration and book-keeping.

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Catherine Procter


Software Engineer

Catherine is a highly experienced software engineer responsible for developing and testing embedded code for our medical devices. She has held positions in multiple reliability-critical industries. She holds a Masters Degree in Reliable Embedded Systems.

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Dr Don Sharkey


Clinical Director

Dr Don Sharkey is a Clinical Associate Professor of Neonatal Medicine and honorary consultant neonatologist at Nottingham University Hospitals. He has overseen previous published newborn baby trials in both the Neonatal Intensive Care Unit and delivery room.

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