Category: Article

At The Heart Of Healthcare Technology For 48 Years!

As we celebrate our 48th year in business I’ve recently taken a nostalgic look back over the various innovative products PMS have introduced to the UK healthcare market since 1975.

Some of them really were ahead of their time and have led to the development of subsequent products still in use today. Here I take a look back at a few of the more notable ones.

1994 – A&D Medical TM-2421 24 Hour Blood Pressure Monitoring System

The UK’s first dual method, Korotkoff Sound/Oscillometric 24 hour BP monitor, it proved to be very popular from 1994 to 2007 when it was replaced by the improved A&D TM-2430 24 Hour BP monitor.

1995 – E – Z Therm The 3 Second Thermometer

This was one of the UK’s first Tympanic thermometers. It was very popular and sold in large numbers. The fast measurement time meant it was popular for use in children and as a replacement for Mercury thermometers.

1997- A&D Medical UA 767 Digital Blood Pressure Monitor

The classic low cost and easy to use three in one digital BP monitor that gave systolic, diastolic and heart rate simultaneously on a large LCD display. Clinically validated it was popular with GPs and Hospitals as well as being used for clinical research. The latest generation is the A&D Medical UA-767 + AFib still one of our most popular digital BP monitors used extensively by the NHS.

2003 – Meditech Merlin ECG watch

Ahead of its time and before Smartwatches were available the Merlin watch was a low-cost ECG event recorder designed to capture transient arrhythmias. It was easy to wear and activate and could store up to 15 minutes of ECG recordings. PMS sold the watch until 2013 when it was discontinued by Meditech. It led to the development of the Meditech CardiUP3! Holter ECG. The latest AliveCor KardiaMobile 1L and 6L are great examples of how mobile ECG technology has moved on.

2009 – Tidi Disposable Cuff Barriers

Originally introduced by PMS as a cost-effective alternative to expensive single use blood pressure cuffs and as a hygienic solution to using fabric cuffs. They are still by the NHS today and were especially popular during the COVID-19 pandemic.

Introducing these products helped establish the PMS Instruments ethos of being At The Heart Of Healthcare Technology and to the development our innovative product range which still includes 24 hour blood pressure monitors, waiting room and digital blood pressure monitors, and mobile, resting and Holter ECG monitors.

SysToe, an accurate option for the diagnosis and evaluation of Peripheral Arterial Disease (PAD)

Peripheral arterial disease (PAD) occurs when plaque builds up in the arteries that carry blood to head, organs, and limbs.

Limitations of Ankle Brachial Index (ABI)

The Ankle Brachial Index (ABI) test has been in use for diagnosis and evaluation of peripheral arterial disease (PAD) for over half a century. Nevertheless, it is not without its issues.

  • Training is required before the operator is able to carry out reliable measurements
  • Some patients feel pain in the leg during cuff inflation
  • It takes time to perform the measurement
  • False values can result from medial calcification of the tibial/peroneal arteries which may prevent the measurement of ABI.

Why measure Toe Systolic Pressure?

The toe arteries are affected by medial calcification later than the leg arteries. The toe systolic pressure can be measured to circumvent the problem of medial calcification of the tibial/peroneal arteries.

Toe pressure measurements show a good agreement with ABI and remain measurable and reliable in patients with arterial wall calcification.

Does the measurement of toe systolic pressure using SysToe improve the diagnosis and reliability of diagnosis?

The SysToe is easy to use, quick and fully automatic and not operator dependent. It improves clinical evaluation and follow-up of PAD in every day practice.

SysToe drastically improves the reliability of distal toe pressure measurement, especially in diabetic and chronic renal failure patients, since the measurement of ankle pressure and ankle brachial index may be difficult or impossible in these patients because of medial calcification.

As a fully automated, totally non-invasive and painless (unlike ankle pressure measurement)  technique, systolic toe pressure measurement with SysToe is easily performed outside the Vascular Lab by Diabetologists, Podiatrists and General Practitioners for the follow-up of patients with peripheral arterial disease.

Therefore, the use of more expensive examinations (such as complete duplex Doppler ultrasound of lower limb arteries) can now be reduced. The use of a SysToe can have major clinical care pathway advantages and cost savings as well as saving patient assessment time.

PMS customers use the SysToe for

  • Assessment and diagnosis of peripheral arterial disease
  • Diagnosis of critical limb ischemia
  • Follow up of diabetic patients, patients with chronic renal failure, elderly patients
  • Assessment of healing potential of ulcers

Pulse Oximeters and COVID-19

NHS England recently updated their guidance to support the remote monitoring, using pulse oximetry, of patients with confirmed or possible COVID-19.

It builds on the COVID Oximetry @home standard operating procedure, as well as the general practice and community health services standard operating procedures which were published last year.

Patients most at risk of poor outcomes are best identified by oxygen levels.

NHS England and NHS Improvement coronavirus have developed a standard operating procedure for using pulse oximeters to monitor oxygen saturation levels and an assessment pathway. Pulse oximeters can help detect asymptomatic presentations of “silent hypoxia” with low oxygen saturation but often with normal heart rate and other obs.

The assessment pathway classifies Oxygen saturation levels in to one of three classifications. Mild where O2 is 95% or higher, moderate where O2 is 93-94% or severe where O2 is 92% or lower. At a severe stage urgent admission to Hospital should be considered.

According to NHS England guidance an ideal blood oxygen level is between 95% and 99% and an ideal heart rate is between 50 and 90 beats per minute (bpm).

The NHS England Annex 2: Remote monitoring COVID-19 diary gives some practical tips on how to use a pulse oximeter correctly. These include

  • Remove any nail polish or false nails and warm your hand if cold.
  • Make sure you have been resting for at least five minutes before taking your measurement.
  • Rest your hand on your chest at heart level and hold still.
  • Pulse oximeters works best on your middle or index finger. It should not be used on your ear.
  • Keep still and keep the pulse oximeter in place for at least a minute, or longer if the reading keeps changing.
  • Record the highest result once the reading has not changed for five seconds.
  • Be careful to identify which reading is your heart rate and which is your oxygen level.

They have also produced a diary card which can be used to record results and any symptoms.

The link for the guidance and diary is below.

https://www.england.nhs.uk/coronavirus/wp-content/uploads/sites/52/2020/06/C0445-remote-monitoring-in-primary-care-annex-2-diary-jan-21-v1.2.pdf

ECG electrodes. Cost Vs Convenience and time.

For many customers price is the only focus when purchasing electrodes for resting 12 lead ECG’s. It’s undoubtedly an important factor but should it be the only criteria considered when purchasing? 

In 2019 The Royal Papworth Hospital under took a trial to compare the cost effectiveness of two different brands of ECG electrodes. Ambu and a Brand Competitor.

Comparison was made between quality of ECG trace, time taken to carry out the ECG procedure, electrode attachment and patient comfort.

During the trial electrodes were placed on patients according to clinical guidelines for a 12 lead ECG recording.

Before the electrodes were applied, if needed, skin preparation was performed to obtain a better electrode-skin contact. The patient’s skin was shaved and cleaned with alcohol wipes and wiped by a gauze swab before the electrodes were placed to obtain an artefact-free ECG.

All filters on the ECG monitor were ‘off’ when recording an ECG. To minimize any noise, all forms of electronic devices that may cause interference were also switched off and patients were advised and encouraged to relax as much as possible to reduce muscle artifact.

Participants were assigned to two groups either using AMBU BlueSensor SU ECG electrodes or Skintact Easitab Resting ECG electrodes (competitor).

The average time it took to take an ECG using the Ambu electrodes was 3.39 minutes. The average time using the competitor Brand was 6.53 minutes. The time includes the preparation of the patient’s skin, shaving where necessary.

When using the Brand Competitor 7 razors were used, none were used with the Ambu electrodes.

The use of wipes and gauze was eight times higher for patients being monitored with the competitor electrodes and 28 additional competitor electrodes were used in comparison with five of the Ambu electrodes.

The average price (including wipes, razors, skin preparations and extra electrodes) of taking an ECG using the competitor electrodes was 57 pence compared to 54 pence using the Ambu electrodes.

The trial concluded that: The Ambu SU is the lower cost electrode when the additional patient preparation, extra electrodes and staff time are considered and that the reduced need for skin preparation improves the patient journey.

Celebrating Meditech’ s 30 Year Anniversary

2020 is a memorable year and not just because of the COVID-19 pandemic. It also marks the 30th year in business of one of our key partners, Meditech.

Established in Hungary in 1990 Meditech have established a reputation for quality, accuracy and reliability in the design and manufacture of professional cardiovascular medical devices. From small beginnings their Distributor reseller network now covers 5 continents and I am proud to say PMS have been their exclusive UK and Ireland Distributor and Service Partner for over 20 years.

We sold our first Meditech product the Elite PC based ECG back in 1997. The E-Lite was one of the world’s first “plug and play” cost effective 12-lead resting ECG systems. It was popular with GP surgeries and pioneered the use of computers in the recording of ECG’s helping to start the trend for paperless ECG’s.

Next up was the ABPM-04 24 hour ambulatory blood pressure monitor introduced in 2003. This product really put Meditech on the map. Clinically validated to the demanding British Hypertension Society accuracy protocol it launched with the first generation CardioVisions analysis software fully compatible with Windows XP.

With thousands of ABPM-04’s sold worldwide it has become a classic ABPM renowned for its reliability that is still available to this day.

Several of the original monitors we sold over 17 years ago are still in regular use!

Other product milestones include

2000 Merlin ECG Event watch
2000 CardioTens combined ABPM and ECG Event monitor
2003 CardioClip 7 day looping ECG recorder
2004 CardXplore combined ABPM and Holter ECG recorder
2007 ABPM-05
2007 CardioMera 24 Hour Holter ECG
2017 CardiUP3!/12! Second generation Holter ECG
2019 ABPM-06

The latest ABPM-06 is the result of 30 years of product design, engineering precision and of course customer feedback that sets Meditech apart from competitors.

On behalf of everyone at PMS I would like to offer congratulations to the team at Meditech for the achievements and innovations over the last 30 years. We are looking forward to many more.

Life Goes On

It’s very easy to forget that life, although not as we knew it, is still going on. Covid 19 has dominated our lives for the last 6 months and it looks set to continue that way for at least the next 6.

Many GP surgeries have put a temporary hold on offering 24 hour ABPM services

Some are using waiting room BP monitors in place of face to face measurements. Others are not using them at all to reduce the number of patients in the waiting room.

Some are not using the waiting room at all requesting that their patients wait outside the surgery until called directly into the consulting room.

There are so many different ways and we are all trying to provide the best service we can during these strange unprecedented times.

Now could be the perfect time to get your Surgeries BP monitors serviced, if they are not currently being used, so they are ready for when things return to a more normal service.

Some surgeries have decided to wait until they feel comfortable in offering monitoring again.

Either way however you are dealing with the current pandemic we will continue to offer service and calibration of A&D Medical waiting room BP monitors, Meditech ABPM monitors and ECG monitors.

I am pleased to report that for the 27th year running we recently passed the ISO9001 quality standard audit. We are registered to provide repairs and support services for a range of specialised medical instruments.

With us you can be assured that when your monitors are serviced they go through a  comprehensive assessment of up to 70 tests carried out by our own manufacturer trained engineers.

As all monitors are collected and returned by our courier the engineer does not have to enter your premises, therefore maintaining all of your existing covid-19 safety measures.

Despite the Pandemic we are maintaining our fast turnaround time which remains at 3-5 working days. All it to takes to arrange is a quick call or email to us and we will do the rest.

Nothing is normal right now but life does go on and you can be assured we are still here offering you our support and service.

Cleaning Blood Pressure Equipment and Cuffs During COVID-19

As customers start to get ready for the new normal we’ve been receiving a number of calls and emails regarding the safe cleaning of blood pressure cuffs, including 24 hour ABPM cuffs.

Our advice is to use a disinfectant from a reputable brand which complies to the BS EN 14476 standard as this will ensure the spray is effective against a range of viruses including Coronavirus.

Different disinfectants have different contact times, the time the surface must remain wet for the product to be effective. If the solution is not left wet on the surface for the directed time it may not work as effectively.

Before disinfecting cuffs ensure they are dirt and grease free otherwise this may make the disinfectant less effective.

If you are using old style Meditech woven cloth material cuffs we recommend you upgrade to the new hygienic wipe style. ERKA and A&D Medical also have wipe able cuffs in their range.

Purchasing additional cuffs could also provide further protection by leaving time between patient uses.

Even before the outbreak of Covid-19 our TiDi blood pressure cuff barriers were popular. Since the outbreak they have become indispensable for many customers.

Intended for single patient use they are manufactured in latex free FABRICEL tissue fused with a leak proof polyethylene film. They wrap around the patients arm and the cuff is applied over the top ensuring the blood pressure cuff never comes in to direct contact with the skin.

They can be used with all ABPM, digital and manual blood pressure cuffs and are thin enough not to affect measurements. 

They are available in 3 sizes

Adult (TID916114)- 300 barriers are supplied in 6 boxes of 50.

Large Adult (TID916115)- 150 barriers are supplied in 3 boxes of 50.

Paediatric (TID916113)- 300 barriers are supplied in 6 boxes of 50.

For waiting room BP monitors the same disinfectant complying with BS EN 14476 can be used. Single use protective overarm sleeves (AND093) protect the TM-2655P and TM-2657P inner from dirt and liquid and from coming into direct patient contact. Manufactured from latex free polythene they are 40cm long and fit an arm circumference of 38cm.

Improving the AF clinical pathway with the Kardia Mobile

Clinical Background

1.4 million people in the UK have atrial fibrillation; that’s 2.4% of the population. It’s known that in the 45 – 65 age group over 80% of people will suffer from the condition.

Public Health England (PHE) believes almost half a million people with AF remain undiagnosed. AF is known to be a direct cause of a third of all strokes and consequently 2,000 premature deaths per year. Early diagnosis could help avoid this.

AF and AF-related illness costs the National Health Service over £2.2 billion annually – a cost that is expected to rise as the incidence of AF increases due to the ageing population.

Current Clinical Pathway

The current clinical pathway varies according to each GP surgery and CCG but generally it can be a lengthy and costly process to achieve a definitive diagnosis.

The process typically begins with a manual pulse check and then auscultation, a 5 or 12 lead ECG in the surgery is followed by a 24 hour ECG tape or seven day Holter recording which then has to be analysed. With a positive (or indecisive) test, the patient is then referred to a cardiologist. If a diagnosis of AF is confirmed, the patient is then referred back to the GP for anticoagulant therapy.

PHE estimates that 2,000,000 people in the UK have Atrial Fibrillation and that the cost per patient using the current pathway is £1,305 without interventional procedures. This includes three GP visits, 12 lead ECG and Holter recordings, and outpatient costs.

The cost reduction achieved by using Kardia Mobile is significant. Assuming the patient requires two GP visits and a Kardia Mobile is provided for each patient, the cost is £189 rising to £352 if a patient is also sent for a 12 lead ECG. The minimum saving is therefore in the region of £950 per patient.

The cost to the NHS of screening the population with the current pathway is prohibitive. Kardia Mobile makes it possible.

Cost £ Of Current Pathway

First GP visit (incl. ECG test) £81
Outpatients £230
24 hr ECG £163
7 day Holter test £163
Outpatients and decision £230
Implantable loop recorder (ILP) £4021-£4556
Second GP visit £45
Total £1305 with ILR £5861

Cost £ When Using Kardia Mobile

First GP visit (incl. ECG test) £81
GP Supplies Kardia Mobile £99
Second GP visit £81
Total £189

Therefore using the AliveCor Kardia Mobile is a faster, simpler and more effective pathway.

Added Benefits. Early diagnosis of AF in 30 seconds

 In surgery, the GP or the nurse can use the Kardia Mobile for a quick check when a patient presents with palpitations, fast heart rate or irregular rhythm.

The presence of AF can be immediately identified. Due to its simplicity, speed of use and low cost, Kardia Mobile can routinely be used to screen patients for AF and become part of the protocol for health checks in key age groups.

It can also be used to screen newly registered patients, in the well woman/well man NHS health checks and to form part of the routine in flu clinics.

As AF may be transient in nature, a test in the GP’s surgery may still not reveal the presence of the condition. A doctor can then issue a Kardia device to the patient for home use to make a recording when he or she experiences symptoms.

Kardia Mobile will also provide a simple ECG rhythm strip recording with heart rate when used during home visits.

The Cost/Benefit Analysis Of Using The Kardia Includes

  •  Reduction in the number of ECG tests, 24 hour tapes and 7 day Holter recordings.
  • Reduction in the number of GP appointments and outpatient appointments.
  • Savings to the NHS through early diagnosis of AF and prevention of stroke.

Why Is There A Need For The Systoe Toe Pressure Measurement System?

Clinical situation

Peripheral arterial disease (PAD) is when the arteries, in this case, to the legs, become fully or partially blocked. This blockage most commonly occurs due to atherosclerotic (cholesterol) plaques.

Arterial blood brings oxygen and nutrients to the muscles of the legs, and when blocked may result in pain in the legs, also called intermittent claudication. Intermittent claudication is typically described as pain in the patient’s calf after walking a distance that goes away when the patient rests.

In advanced peripheral arterial disease, the patient may have pain in the legs at rest, and may develop leg ulcers and gangrene.

When a patient is first seen and suspected of having PAD, the underlying diagnosis is usually not difficult if a proper history and physical examination is performed.

For this purpose the Ankle brachial index (ankle systolic pressure/brachial systolic pressure) is usually measured.

Why is there a need for the Systoe?

Limitations of Ankle Brachial Index (ABI)

In the case of diabetic patients, old patients and renal failure patients, medial calcification (deposit of calcium on the middle part of the artery wall) of the tibial/peroneal arteries may prevent the measurement of the ABI pressure.

ABI measurement is impossible in

  • 15 %  of diabetic patients at the time of the diagnosis.
  • 20 % of the diabetic patient present a PAD
  • 30 % after 15 years

Weitz et al. Circulation. 1996; 94: 3026-3049

As the toe arteries are affected by medial calcification later than the leg arteries, the toe systolic pressure can be measured to circumvent the problem of medial calcification of the tibial/peroneal arteries. Toe pressures are a clinical indicator. For clinical purposes a normal Toe brachial Index (TBI = toe systolic pressure/brachial systolic pressure) is considered to be higher than 0.7

For any value less than that, the patient will be found to have some occlusive disease proximal to the recording site.

A major advantage of TBI is its use following the progress of disease and after any form of intervention.

The Atys SysToe can also be used in the following circumstances

  • Triage patients before referral to vascular specialist
  • Opportunistic Screening and follow up after intervention
  • Wound and Ulcer healing

The Atys SysToe is a fully automatic clinically validated device that gives consistent readings which are not operator dependent. Using the SysToe clinicians can quickly determine whether a patient does or doesn’t have PAD without necessarily referring to a specialist Ultrasound Dept saving time and money

What’s the future for manual blood pressure measurement devices?

Since 10 April 2014 and the implementation of EU Commission regulation no 847/2012 the sale of new Mercury sphygmomanometers to the healthcare sector has been banned.

The alternative? Electronic manual sphygmomanometers like the A&D UM-102A mimic the Mercury sphygmomanometer but have none of the inherent disadvantages. These devices blend the best of modern, reliable vertical LCD technology, with the traditional advantage and reassurance of a manual measurement whilst listening to Korotkoff sounds with a stethoscope.

Unlike Mercury sphygmomanometers, devices like the A&D UM-102A sphygmomanometer don’t require routine cleaning or maintenance and can be used at any angle with a wide range of cuffs sizes and on patients with arrhythmias.

There is no oxidisation of the LCD which could alter the dynamic response and readings can be read to a single digit mm/Hg. Most importantly, if a product like the A&D UM-102A gets dropped you won’t end up with a contaminated treatment room and an expensive and time consuming mercury spill to clean up!

Alternative clinically validated Mercury free sphygmomanometers are available, so clinicians do still have a choice as to whether they use a manual method to record blood pressure with a stethoscope or an automatic device.

Manual devices, like the A&D UM-102A, are more tactile to use and can provide the clinician with additional useful information, like regularity or strength of pulse, provided they are used correctly and users have proper training.

Could AliveCor SmartRhythm Monitoring Revolutionise AF Detection?

The latest App version 5.0.2 from AliveCor introduces a new premium feature “SmartRhythm” monitoring.

What is SmartRhythm monitoring?

SmartRhythm monitoring from AliveCor is a system that takes heart rate and activity data gathered from an Apple Watch, and evaluates it using a deep neural network to predict heart rate patterns. If  heart rate differs from the neural network prediction, SmartRhythm will notify you to record an ECG either on your phone with Kardia Mobile or for convenience and if you have one with the KardiaBand.

Taking frequent ECGs can help you better manage your heart health, and capturing an ECG specifically during times when heart rate does not match activity levels may be useful.

SmartRhythm monitoring uses the Apple Watch Photoplethysmogram (PPG) sensor to evaluate heart rate approximately every 5 seconds. Your heart rate itself depends on many factors such as activity, stress, time of day and more. So at times your heart rate pattern should be high (during exercise), sometimes, it should be low (at rest) and sometimes it may signify a heart problem.

Patented AliveCor SmartRhythm monitoring technology uses an autoregressive, deep neural network that can learn the normal relationship between heart rate and activity, and notify you when it sees an unexpected pattern. It notifies you when the actual data from the Apple Watch doesn’t match what the SmartRhythm model expects to see.

Receiving a SmartRhythm notification does not necessarily mean that something is wrong. There are many perfectly normal situations that can cause a SmartRhythm notification, including exercise the Apple Watch can’t detect, stress or anxiety, consumption of caffeine or alcohol, and even motion artifact from wearing the watch band too loosely.

Conversely, not getting a SmartRhythm notification does not necessarily mean that everything is normal, since the Apple Watch sensor is only measuring your heart rate and does not capture the full complexity of your heart. SmartRhythm monitoring should be used as an additional means to capture frequent ECGs.

Does SmartRhythm monitoring affect Apple Watch battery life?

Yes. SmartRhythm causes a higher battery usage and you will need to charge your Apple Watch more frequently. This is because SmartRhythm requires the Apple Watch to be in Workout mode as it is evaluating heart rate data continually which increases battery usage.

AliveCor internal testing has shown that with a series 2 or newer watch you can expect around 16 hours of battery life. It can still be worn over night just top up the charge for an hour or so.

The first generation Apple Watch is not supported because it has a smaller battery and will only last 5 hours.

What’s Next?

Kardia for Apple Watch is just the first step in bridging the gap between consumer wearable devices and the science of clinically validated ECG healthcare devices.

The availability of a wearable, mobile ECG device like the Kardia has the potential to dramatically improve early detection of arrhythmias. Many arrhythmias start as occasional, intermittent problems that usually don’t show up in a doctor’s office and are notoriously difficult to diagnose.

AliveCor products including the Kardia Mobile and Kardia Band are available directly from UK Distributor PMS Instruments.

AliveCor®, KardiaBand™ and SmartRhythm™ are trademarks of AliveCor, Inc. Apple Watch® is a trademark of Apple Inc.

Published Clinical Research Demonstrates The Effectiveness Of Key Products

At PMS Instruments we are always looking to share published clinical research that demonstrates the effectiveness of key products we distribute.

At the European Society of Cardiology Congress in Barcelona recently there were a number of clinical studies, papers, posters and presentations focusing on the Kardia Mobile ECG and its effectiveness in AFib detection.

This is important as the research helps validate the accuracy of AliveCors medical grade algorithm giving users’ confidence in Kardia Mobile ECG technology and potentially saving lives.

In one recent Study Professor Julian Halcox of Swansea University Hospital in Wales presented The REHEARSE-AF Study with simultaneous publication in Circulation and the The Journal of the American Heart Association. This randomized study provided AliveCor Kardia units to 500 patients, who used them to record two ECGs per week for a year and compared the results to 500 patients who received conventional care from their General Practitioner. At the end of the year, the Kardia group had a 4-fold increase in AFib diagnosis compared to the control group, thereby enabling the initiation of potentially life-saving anticoagulant therapy.

A Cleveland clinic study showed Kardia Mobile AFib detection accuracy similar to that of Doctors. Dr Khaldoun Tarakji from the Cleveland Clinic presented the iREAD Study which evaluated the accuracy of the AliveCor automatic AFib algorithm versus expert cardiology over-read of both the Kardia recordings and 12-lead ECGs. Dr Tarakji found that in 52 patients the Kardia algorithm had a 96.6% sensitivity and a 94% specificity compared to a cardiology over-read of the simultaneous 12-lead ECGs for the diagnosis of AFib. Additionally, over 93% of the patients found the Kardia to be easy to use and that it “lessened AFib-diagnosis anxiety.”

Another Study found that the Kardia Mobile was able to detect more patients with AFib that were previously undiagnosed. Dr Bryan Yan of The Chinese University of Hong Kong presented research of over 12,000 patients aged 65 and older. He found that for each 30-second ECG recorded using the Kardia Mobile, his team were able to identify more patients with previously undiagnosed AFib. This demonstrates the empirical value of convenient, inexpensive self-screening using the Kardia Mobile ECG.

Finally at the ECS Dr Ngai Yin Chan of Princess Margaret Hospital in Hong Kong presented the AFinder Study which used community volunteers to perform opportunistic screening for AFib using AliveCor’ s Kardia Mobile in over 10,000 Hong Kong citizens age 50 and older. 244 participants were found to have AFib, with 74 of those previously undiagnosed. This study verifies that by using Kardia Mobile senior citizens who were not medical professionals could perform medical screening of their peers with successful identification of a serious medical condition.

These are examples of just some of the many published research articles from around the world which demonstrate that if the AliveCor Kardia Mobile ECG is trusted by Clinicians you can trust it to!

European Society of Cardiology. Diagnosis and timeley detection of AF.

 

I have recently been re-reading the 2016 European Society of Cardiology (ESC) Guidelines for the management of atrial fibrillation (European Heart Journal (2016) 37, 2893–2962 doi:10.1093/eurheartj/ehw210.

Of particular interest was the section on “Diagnosis and timely detection of atrial fibrillation” especially in the light of the popularity of the low cost clinically validated Kardia Mobile ECG from AliveCor.

In their latest review, when putting forward proposals to enhance current guidelines the ESC specify 4 different recommendation classes. A Class I recommendation is defined as

“Evidence and/or general agreement that a given treatment or procedure is beneficial, useful, effective”.

Within the section for screening for atrial fibrillation they have issued a class I recommendation that  

“Opportunistic screening for AF is recommended by pulse taking or ECG rhythm strip in patients >65 years of age”

Clearly that is advice worth taking but in a busy GP Practice, where appointment time is limited to 10 or 15 minutes and resources under pressure, is it always practical to carry out a 12 lead ECG to get a rhythm strip?

Fortunately technology has the answer and there is the Kardia Mobile ECG App for that!

For under £99 the Kardia Mobile and App produces a 30 second rhythm strip that has the same diagnostic accuracy as a 12 lead single channel ECG Lau JK, Lowres N, Neubeck L, Brieger DB, Sy RW, Galloway CD, et al. Int J Cardiol. 2013;165(1):193-4.

It is therefore ideal for use in Primary Care to implement the recommendations of the ESC. The ESC go on to say

“There is good evidence that prolonged ECG monitoring enhances the detection of undiagnosed AF, e.g. monitoring for 72 h after a stroke…and daily short-term ECG recordings increase AF detection in populations over 75 years of age”

Again the Kardia Mobile is ideally suited for regular home monitoring, for instance once in the morning and once in the afternoon.

As it records a 30 second rhythm strip in real time, it is ideal for capturing paroxysmal AF for later analysis by a GP or Cardiologist.

It can be used to replace manual pulse checks providing qualitative ECG evidence in 30 seconds.

There is also an association with high blood pressure and AF. The Kardia Mobile ECG can help here as well.

To save time during a consultation, as well as to opportunistically screen for AF, why not use a Kardia Mobile before taking a blood pressure reading?

In the UK NICE have provided guidance on this with NICE Guideline CG127 Hypertension in adults: diagnosis and management on whether to use an automatic or manual blood pressure device.

Clause 1.1.2 states

“Because automated devices may not measure blood pressure accurately if there is pulse irregularity (for example, due to atrial fibrillation), palpate the radial or brachial pulse before measuring blood pressure. If pulse irregularity is present, measure blood pressure manually using direct auscultation over the brachial artery.”

Using a clinically validated Kardia Mobile by AliveCor before taking a blood pressure reading can save time as well as ensuring the most appropriate (automatic or manual) BP device is used. For up to date independent reviews on the Kardia Mobile ECG or to purchase visit our website.

 

 

 

 

AliveCor Kardia ECG Technology. Bringing Wearable Medtech and innovation to the NHS.

It’s not hard to get excited about the difference that innovations like the AliveCor Kardia mobile and Kardia Band ECG Watch could make to the NHS and its patients.

Both devices bring low cost wearable medtech to the NHS and capture medical grade ECG recordings using algorithms to monitor and manage heart arrhythmias. They can automatically detect atrial fibrillation (AF) which if undiagnosed can lead to strokes.

In the UK strokes kill 100,000 a year. Each one is estimated to cost the NHS between £9,500 and £14,000.

The financial impact of Atrial Fibrillation (AF), the most common type of arrhythmia, becomes more apparent when considering the cost to the UK economy as a whole which has been estimated to be £2.4 million.

That’s apart from the human impact strokes have on patients quality of life and their carers. Early detection then is crucial.

So how does the NHS currently identify these at risk patients?

As a busy GP at the moment when patients visit you, depending on their age and medical profile they may receive a simple manual pulse check. If you have time you count their pulse over 60 seconds. If you don’t you count to 30 and multiple the figure by 2!

The problem with a manual pulse check is that it remains a ‘one off’ check. An assessment of an irregular heart rhythm with this method is a snap shot in time and in part relies on chance to identify at risk patients, especially those with asymptomatic paroxysmal atrial fibrillation.

Depending on the result you may or may not then refer to secondary care for a 24 hour or 7 day Holter ECG to confirm the findings. The CCG will remind you there is a cost for this oh and probably a waiting list!

The existing pathway takes the time and resources of both you, your patients and the NHS.

What can AliveCor technology and innovation do to help?

The AliveCor Kardia Mobile and Kardia Band ECG devices offers huge benefits in early diagnosis of AF as they allow simple validated, quantitative and qualitative assessment of a patient’s ECG and heart health using a smart phone App.

 

With AliveCor ECG technology patients can record a 30 second medical grade ECG unobtrusively at any time helping reduce appointment times and detect AF.

At a time when Primary Care resources are under real pressure it means less time and money is wasted on nurse appointments, resources and follow ups for the NHS and patients.

It also means the anxiety some patients feel about their condition can be removed and they can take a proactive role in their heart health.

The wider adoption of AliveCor technology by the NHS and Primary Care will be a big step forward. It’s one to watch for sure.

The AliveCor Kardia Mobile costs £94.99 and the Kardia Band for the Apple Watch costs £226. Buy both from our web site.

 

PMS Instruments. Expertise, Experience and Trust for service, calibration and support.

These are the key words our customers associate with PMS Instruments as well as being the fundamental foundations of our calibration and service department.

I recently posted on Facebook a picture of an A&D Medical TM-2655P waiting room blood pressure monitor that had recorded a staggering 103366 readings since we originally supplied it in 2004!

Having visited the R&D centre in Japan I know the engineering quality, research and development that A&D Medical put into the design and manufacturer of their products but was intrigued and asked one of our service engineers to give me the service history of the monitor over the last 12 years.

We keep detailed service and calibration records for every item of equipment we service and repair. The monitor had a new cuff mechanism fitted in 2007 which we replaced under warranty but other than that had had no other parts fitted just regular, routine and preventative maintenance.

What’s the secret of this reliability and low cost of ownership?

I am convinced it is regular, preventative and routine servicing by PMS Instruments which extends the in service life of the monitors and prolongs the investment our customers make in their equipment.

Why do I think this? There are any number of medical companies that visit GP surgeries in the UK offering to service and calibrate a wide range of blood pressure monitoring equipment. That may be the case but the TM-2655P and TM-2657P waiting room blood pressure monitors are specialist instruments, requiring specialist knowledge and test equipment.

So what are you actually getting from us and how does our service differ?

With our service and calibration service each monitor is subjected to an approved individual ISO-9001 quality assured Work Instruction. This comprises a series of up to 70 detailed steps our service engineers must follow and which the product must pass in accordance with the manufacturer’s service manuals. You get so much more from PMS Instruments than the basic 10 minute on site functional test some companies offer.

You get what you pay for?

Depending on the model it can take up to 90 minutes for our Service Engineers to adjust, calibrate and service an A&D Medical waiting room blood pressure monitor and we are the experts at it! Rapid turnaround time means minimum downtime and a full service and calibration certificate is issued.

Not convinced and want to use another company?

To ensure you are getting a proper and professional service for your A&D Medical waiting room blood pressure monitor and compare like for like ask your current service provider these questions.

  • Are you authorised by A&D Medical to work on this equipment?
  • Have the service engineers working on your equipment been on an A&D training course?
  • Do you follow a preventative service and maintenance schedule?
  • Do you perform an internal inspection of the equipment?
  • Do you check and replace routine original service parts?
  • Do you use an A&D Medical BP Checker?

Was it yes to all of these?

I was happy for the customer that their A&D Medical waiting room blood pressure monitor had provided so many years of reliable and trouble free service.

Has your TM-2655P monitor reached 100000 + readings during its lifetime yet? If your current service company can’t tell you call us on 01628 773233 and we will.

The secret by the way is Test Mode 41 or is it 42!

Know Your Numbers Week 12 – 18th September

The 12th to the 18th of September this year sees the return of ‘Know your Numbers’, a Blood Pressure UK run awareness campaign to promote blood pressure testing. KYN was first launched in 2001 and has since gone on to encourage around 1.5 million people to have their blood pressure checked. The idea is that we should all know our blood pressures like we know our height and weight.

For me, that’s a great analogy. If you weigh yourself and realise you’ve put on a few pounds, then you might start eating a bit differently or moving a bit more. The difference, however, is that with weight gain you have a visual clue before anything else. Blood Pressure is only known once tested, but knowing those figures and tracking the changes could one day save your life.

As part of KYN week, ‘Pressure Stations’ will be setup all around the country at the more obvious venues such as GP surgeries, hospitals and health clubs, but also shopping centres and supermarkets, so it should be easy for everyone to get checked out.

At P.M.S (Instruments), we think this is a great initiative, and hope it does it a lot of good, but we can’t forget that we’re here to supply both surgeries with the equipment they need and also those at home or in the private healthcare sector. With that in mind, we’d like to share some news on two great new products.

The A&D TM-2657P is the follow up to the TM-2655P, popular with GPs as it saves consultation time. This is particularly useful at this time of year when it comes to screening elderly patients who are having the flu jab in large volumes. My favourite new feature of this machine is the added value of the Irregular Heartbeat Indicator (IHB) function – a highly useful new feature. Check out the write up below for some more specs!

The other great new Blood Pressure Monitor is the A&D UA-767-S, which is the latest in a generation of models of the same name. This is a really portable BPM, which makes it perfect for either home use, those who are regularly out and about on home visits or just in the surgery. Another brilliant bit of kit from A&D, again, check below for full specs!

Here at PMS, we’re proud to have a 40 year plus history of supplying technology you can trust. We’ve been the main A&D UK distributer since 1990 (A&D have been making Blood Pressure Monitors since 1979) so we can guarantee the best equipment and a genuine pedigree. For is, this is the perfect marriage to support the upcoming Know Your Numbers week.

 

A&D TM-2657PA&D TM-2657P – For Waiting Room Use

Key features

  • User-friendly with small footprint
  • BHS AA grade clinical validation 
  • Simple one-touch fully automatic measurement
  • Accurate and reliable Torque Controlled Belt drive Method
  • Antibacterial inner arm cuff cover
  • Easy load paper tray
  • Reliable high speed printer with easy paper replacement
  • Irregular Heart Beat (IHB) indicated on printout

 

The TM-2657P is the latest waiting room blood pressure monitor from A&D Medical. It builds on the speed, reliability and accuracy of the previous TM-2655P, which it replaces, but now features a new ergonomic, modern, compact design. The new integrated armrest helps ensure the patient’s arm is comfortable and in the correct position during a measurement.

A new antibacterial arm cuff cover is also now fitted as standard with the TM-2657P. Designed and engineered in Japan, the new TM-2657P has a faster printout speed and offers added optional connectivity features including Bluetooth.

The “Torque Controlled Belt drive Method” (TCBM) cuff mechanism in the TM-2657P provides sophisticated automatic cuff size adjustment, ensuring the arm is positioned correctly for accurate high speed measurement, first time, every time.

With a centrally located simple one-button operation, it can be used on children (13 years or above) and adults with either the left or right arm. After the reading, the results are output to the inbuilt thermal printer with the date, time systolic, diastolic and pulse rate clearly displayed. New printing options also permit the inclusion of a barcode or QR code on the print out.

The printout will also display (if present) an irregular heartbeat symbol. An irregular heartbeat is defined as a heartbeat that varies by 25% from the average of all heartbeats during the blood pressure measurement.

Like the previous model, the TM-2657P looks set to be popular with GP Practices looking for a clinically validated, easy to use professional waiting room blood pressure monitor.

 

 

Key features

  • Compact size and weight (140(w) x 60(h) x 105(d) mm weighs (245g) ex batteries
  • Advanced Oscillometric method for hospital accuracy
  • 60 reading memory with average
  • Correct cuff fit and movement detector
  • Irregular heartbeat indicator with frequency detected
  • WHO blood pressure classification index
  • European Society of Hypertension International Protocol clinical validation
  • Five- year warranty
  • Battery or mains (optional extra) operation

The frequency of IHB (Irregular Heart Beat) detection is divided into different grades and shown by icons.

  • 0-24% : No Indication
  • 25-49% : Grade 1
  • 50-74% : Grade 2
  • 75-100% : Grade 3

The latest A&D Medical UA-767S builds on the popularity, accuracy and reliability of the original UA-767 series but it adds additional new advanced features. It is a popular upper arm blood pressure monitor with a 60 reading memory with averaging function, cuff fit and movement error functions and a simple one-button operation. This model features a new Irregular Heartbeat Indicator (IHB) function, which identifies the frequency of IHB by dividing the number of IHBs by the total number of readings taken to grade the occurrence of IHB accordingly. The more frequent the IHB appears the greater the risk. This feature is for monitoring purposes only. The UA-767S is supplied with a standard 22-32cm cuff. For customers with a larger arm we recommend the UA-767S-W, which has a 22-42cm cuff. It has a proven reliability record and is used extensively in the UK.

 

24/7 ABPM Guidelines Revisited

NICE clinical guideline 127 states that ABPM monitoring is the most accurate method for confirming a diagnosis of hypertension, and its use should reduce unnecessary treatment in people who do not have true hypertension. Originally published in 2013 it was updated in September 2015.

In a recent review with our technical support team I asked them what were the practical questions they were most frequently asked about the guideline and ABPM in general.

I thought I would share the results on our Blog as they may be of interest to other ABPM customers. In no particular order this is what they told me.

Continue reading “24/7 ABPM Guidelines Revisited”

Waiting Room Blood Pressure Monitors Rebooted

The TM-2657P is the latest waiting room blood pressure monitor from A&D Medical. It builds on the speed, reliability and accuracy of the previous TM-2655P, which it replaces, but now features a new ergonomic, modern, compact design.

The new integrated arm rest helps ensure the patient’s arm is comfortable and in the correct position during a measurement. A new antibacterial arm cuff cover is also now fitted as standard with the TM-2657P.

Designed and engineered in Japan, the new TM-2657P has a faster printout speed and offers added optional connectivity features including Bluetooth.

The “Torque Controlled Belt drive Method” (TCBM) cuff mechanism in the TM-2657P provides sophisticated automatic cuff size adjustment, ensuring the arm is positioned correctly for accurate high speed measurement, first time, every time.

With a centrally located simple one button operation, it can be used on children (13 years or above) and adults with either the left or right arm.

After the reading, the results are output to the inbuilt thermal printer with the date, time systolic, diastolic and pulse rate clearly displayed. New printing options also permit the inclusion of a barcode or QR code on the print out.

The printout will also display (if present) an irregular heartbeat symbol. An irregular heartbeat is defined as a heartbeat that varies by 25% from the average of all heartbeats during the blood pressure measurement.

Like the previous model, the TM-2657P looks set to be popular with GP Practices looking for a clinically validated, easy to use professional waiting room blood pressure monitor.

AliveCor ECG APP Update

The latest version of the AliveCor AliveECG app now comes with two new FDA-cleared and CE-marked automated detectors. The latest version of the mobile app instantly detects when an ECG is either Normal or unreadable. The Normal Detector provides added peace of mind allowing patients to go about their regular daily activities knowing that no abnormalities were detected in their ECG.

The Interference Detector goes a step beyond the existing enhanced filter to make sure the ECG is readable and physicians receive only the highest quality recordings.

Now whenever an ECG is taken with the AliveCor Heart Monitor, the AliveECG app will tell users if atrial fibrillation (AF), a leading cause of stroke is present, if the ECG is normal or if there is too much interference and another ECG should be taken. These features allow for the delivery of more efficient clinical decision-making and follow-up, as Doctors are able to focus on reviewing the ECGs that are most important.

At The Heart Of Healthcare Technology

P.M.S (Instruments) Ltd will now be distributing the AliveCor® Heart Monitor, a single-channel ECG (electrocardiogram) recorder. The AliveCor Heart Monitor provides people with suspected or diagnosed heart conditions, and those at risk of heart conditions, the ability to track their heart health anytime, anywhere, at an affordable cost.

As we celebrate our 40th anniversary in business we are well placed to say that  truly unique medical products come along infrequently. The AliveCor® ECG heart monitor is a game changer that looks set to change the way ECG is recorded and the whole management and diagnosis of Atrial Fibrillation.

It is one of a growing number of products that are using the power of smart phones and tablets and turning them into “medical devices”. The AliveCor® and associated App is a fully CE certified and approved validated medical device which looks set to be a true game changer when it comes to medical products.

Using the AliveECG app from iTunes or Google Play with automatic AF detection, patients and physicians can manage existing conditions with intelligent, personalized features. Tracking of medications, lifestyle choices and ongoing symptoms allows patients to have a better understanding of their health status. Advanced search features and enhanced graphical trends provide a more comprehensive and reliable view of a patient’s overall health.

The AliveCor Heart Monitor, when used with the AliveECG app, becomes an, easy-to-use, cost effective medical device that records high resolution, accurate ECGs and heart rate anywhere, and at any time. A user simply attaches the monitor to their mobile device, downloads the AliveECG app, and records an ECG by resting the monitor on the fingers for 30 seconds.

Users will immediately see their ECG recording on the device screen. ECGs are then stored in the app and on secure, encrypted servers located in the EU. ECGs can also be printed or e-mailed directly from a mobile device.

Medical professionals can also utilize the free web-based Patient Management Provider dashboard provided by AliveCor that allows them to choose to receive and review ECG recordings from their patients once given viewing permission.

Once connected, the patient’s future recordings automatically start showing up. This is a great way of monitoring a patient’s condition remotely from pre-diagnosis to long-term care.

Clinical studies have demonstrated the AliveCor Heart Monitor’s accuracy to be comparable to readings from Lead 1 of a standard ECG machines, but at a fraction of the cost.

The AliveCor system is a cost effective atrial fibrillation screening device and heart monitor which can be used by U.K. and Ireland medical professionals, patients and health conscious individuals, to record, display, store, and transfer single-channel electrocardiogram (ECG) rhythms.

Measurements Made Easy

The demise of the mercury sphygmomanometer in clinical practice has been discussed and debated for over 10 years.

Until recently they could still be sold for professional use in the healthcare sector. However, since 10 April 2014 and the implementation of EU Commission regulation no 847/2012 the sale of mercury-containing sphygmomanometers to the healthcare sector, is now prohibited.

The exception is where new sphygmomanometers will be used in ongoing epidemiological studies or as reference standards in clinical validation studies of mercury-free sphygmomanometers.

Despite this and as recently as December 2013, the MHRA were still recommending that calibrated, non-mercury devices, which are not automatic, should be made available in all clinical areas.

They should be used to check automatic device results and should also be used in clinical conditions where automatic monitors may be inappropriate e.g. arrhythmia, pre-eclampsia or specific vascular disease.

This presents the Practice Manager and Clinician with a potential dilemma. How do they comply with the MHRA guidelines?

Fortunately for Clinicians with the right training and skillset, there are a number of manual devices available which include shock resistant aneroid sphygmomanometers (ERKA Switch) and manual electronic devices like the A&D Medical UM-101A which have the same look and feel as Mercury.

Assuming Clinicians are comfortable using the Auscultation (manual) technique of recording blood pressure with a stethoscope, then a new generation of hybrid devices like the  Omron HBP-1300 are now also available.

These new devices are designed specifically with the professional user in mind. During an automatic measurement if the Irregular Pulse Wave symbol feature is indicated, the user can switch to manual mode and use a stethoscope to verify a reading is accurate without having to change device or cuff.

This is in line with MHRA recommendations.

Conclusion

Mercury sphygmomanometers have not been banned but new ones cannot now be purchased for general clinical use. That doesn’t mean the end of manual readings which in certain clinical situations may be required.

Suitable alternative clinically validated mercury free sphygmomanometers are available, so clinicians do still have a choice.

New hybrid automatic and manual blood pressure monitors specifically designed for the professional market are now available. They offer the advantage of a clinically validated automatic measurement or back up of a manual measurement where circumstances dictate.

Why You Should Use ECG Event Recorders in Primary Care.

The updated NICE clinical guideline CG180 (2014) was published in June 2014. It gives guidance on the management of atrial fibrillation and recommends an ECG should be performed on all patients where atrial fibrillation is suspected where an irregular pulse has been detected, whether symptomatic or not.

It recommends using ambulatory ECG recording in patients with suspected paroxysmal AF as follows:

  • A 24-hour Holter ECG monitor should be used in those with suspected asymptomatic episodes or symptomatic episodes less than 24 hours apart.
  • An event recorder ECG should be used in those with symptomatic episodes more than 24 hours apart.

The National Service Framework for Coronary Heart Disease chapter on cardiac arrhythmias lists three quality requirements relating to patient support, diagnosis and treatment and sudden cardiac death.

So why aren’t more GPs using Event Recorders in Primary Care?

There are two main types of ECG recorders worn by patients in an ambulatory setting away from the

Surgery. They are Holter ECG recorders like the Meditech CardioMera or Event Capture ECG recorders like the Meditech CardioBlue and DCBiomed InstantCheck.

They are generally used to investigate suspected symptoms of arrhythmia including palpitations, light-headedness or syncope (partial or complete loss of consciousness), which have not been detected during a shorter 12 lead, surgery based ECG.

Holter or event recorder

Continuous full disclosure Holter ECG monitors were first used in the 1970s and typically operate for 24-48 hours recording every single heartbeat during this period.

This can mean that upwards of 100,000 beats are recorded over a 24 hour period. They are especially useful if the wearer does not feel or is not aware of the ECG abnormality, and are typically more expensive than event recorders.

In most cases data is now stored digitally either on internal flash memory or on removable SD data cards.

Data is uploaded to a computer where software automatically analyses the recording classifying it by beat type, identifying and labelling specific arrhythmias and in some cases, providing a textual summary for the clinician.

Reports should be customisable and have the ability to be attached to the patient’s clinical notes electronically.

Most Holter analysis software can run on a desktop PC and a separate dedicated PC is not required. This makes the analysis of the recording much quicker.

Event ECG recorders are different and are designed for patients who experience symptoms very infrequently and require monitoring over several days or even weeks.

This type of recorder is usually patient activated by pushing a button, but some can be programmed to record automatically at pre-set intervals or will trigger automatically at the onset of certain arrhythmias.

Some event recorders record post event data only. Others operate in a ‘loop’ memory mode so the device records 30 seconds of pre event and 30 seconds post event data. This is useful should the patient lose consciousness and allows the clinician to view the ECG immediately leading up to the event.

Traditionally, post event recorders would have had an external lead with electrodes fitted to the patient’s chest or be held against the chest to record. Recent advances in technology have seen the development of new recorders, which have built in finger or wrist watch type electrodes, which permit long term monitoring without the discomfort or irritation of a patient lead.