Download Sensor - Imperial College London

18
GENERAL INFORMATION
18.1
Description of the intended purpose of device.
The Cardionetics C.Net5000 device The C.Net5000 is intended for in-context monitoring of
adult patients, where symptoms occur infrequently, or where resting ECG monitoring is
unlikely to capture symptomatic or asymptomatic arrhythmia.
Symptoms commonly indicative of arrhythmia include syncope, presyncope, dizziness, and
palpitation. Shortness of breath, chest discomfort, weakness, diaphoresis, or neurological
symptoms, such as transient ischaemic attack, may also be caused by arrhythmia.
Where clinically appropriate, the C.Net5000 can assist in ongoing monitoring of the
frequency of arrhythmia in patients receiving antiarrhythmic medication or rehabilitation
therapy. Approximately 95% of patients are suitable for single-channel automated
arrhythmia and ST segment analysis. In these cases, the C.Net5000 is able to analyse the
ECG for:
- Heart rate, including tachycardia and bradycardia.
- Paroxysmal wide complex tachycardia.
- ST segment depression.
- Atrial fibrillation and flutter.
- RR variability.
- Pauses and arrests.
- Atrial and ventricular ectopic beats.
In the remaining 5% of patients, automated analysis may not be possible due to an
abnormal heart beat morphology. The C.Net5000 follows the ACC/AHA Guidelines for
Ambulatory Electrocardiography (1999) and excludes:
- Patients with wide morphologies, such as those due to an intraventricular
conduction delay. These include, but are not limited to, left bundle branch block,
right bundle branch block, and preexcitation syndromes (including Wolff-ParkinsonWhite syndrome). A wide morphology may also be evident in patients who have
previously had a myocardial infarction.
- Patients with significant cardiac axis shift.
- Patients whose size or other physiology results in ECG signals of low amplitude. In
these cases, the C.Net5000 can be used as an event recorder
The patient can press the symptom button on the C.Net5000 at any time during the test.
The C.Net5000 records a 24-second ECG trace each time the symptom button is pressed,
which may show the presence or absence of arrhythmia leading up to the symptom. This
can be a powerful diagnostic aid.
The standard Cardionetics C.Net5000 conforms to all the Essential Requirements listed in
Annex I of the Medical Devices Directive 93/42/EEC, as embodied in Statutory Instrument SI
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2002/618 as amended, for Class IIa Medical Devices. However, for the purposes of the
SAPHE trial, the C.Net5000 has been modified by the addition of a Philips low power radio
(low power wireless transmitter) module. This is designed to allow wireless communication
of the information from the C.Net5000 to the SAPHE system
The C.Net5000 devices will be used in this case as part of the SAPHE project. The SAPHE
project is a three year project funded by Technology Strategy Board and Department of
Health. The project partners include Liverpool PCT, University of Dundee, BT, Philips,
Cardionetics, Docobo and Smart Solutions Research Consultants. One of the objectives of
the project is to develop next generation of body worn miniature physiological sensors and
to test them with people under real life conditions. A second objective is to combine these
physiological sensors with other environmental and activity monitoring sensors to create
the SAPHE system and to trial it with people with long term conditions and their carers. The
SAPHE system consists of a package of sensors installed in the home linked via wireless to a
hub device. The hub then transmits the data from the sensors to a server where it is collated
and transmitted to a PC in the office of the professional carer. The trial of the SAPHE system
in Liverpool is the subject of this submission for ethical approval
The objective of the trial is to assess the effect of the technology on the user and their
informal carers and how their professional carers can use the information provided to help
them manage the person’s care.
The devices will be used in the SAPHE trial which can be summarised as follows:
A package of SAPHE sensors will be installed in the homes of 20 patients selected by
the Community Matrons (CMs) who are currently administering and delivering their
care (The intervention group). The data collected by the sensors will be made
available to the CMs through terminals in their offices. No personal information will
be stored with the SAPHE data and only the CM will be able to link the individual to
the SAPHE data record. No attempt will be made to fuse SAPHE data with the
electronic care record held by the CM. A group of 20 similar patients will be
identified (the comparison group) and compared with the intervention group. The
comparison will make use of the record of their activity that the CMs routinely
complete. The objective of the trial is to investigate how SAPHE technology could
support patients and their informal carers, provide CMs with a toolkit of information
that helps them to manage their patients and to change the way service is prioritised
and delivered
The start of the trial will be staggered with the number of patients on the trial rising
over a period of eight weeks to the full 20 patients (This allows for 33% of patients to
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decline to be involved in the trial. If no patients decline then the trial will be fully
operational in six weeks). For several practical reasons this is preferable to trying to
arrange that all 20 patients (and 20 comparison group patients) are ready at the
same time. There will be a staggered finish as well so that all patients receive
approximately the same exposure to the technology.
At all times the CM is in control. She will select the patients, work with members of
the SAPHE team to devise a package of SAPHE sensors, explain the trial to the
patient (and any relevant informal carers), obtain informed consent and in extremis
stop the trial for a particular patient if she feels continuing is not in the patient’s best
interest.
In addition to that, the device will be used in Lab Tests at Imperial College for testing the
system with healthy subjects and actors before installation in patients’ houses, and
alongside the patient trials, to validate the system and respond to new research questions
as they arise. Two sets of consent forms have been developed: for patients (study 1) and for
lab tests (study 2).
It is important to note that all sensing devices used in the Imperial College C.Net5000
sensor are standard commercially available products and in current use.
A list of all sensors involved in the SAPHE system is included below:
Sensor
Role
Environmental
PIR Sensors
(Passive Infra Red)







3
Bedroom
Hall
Bathroom
Living Room
Toilet
Landing
Kitchen


Detects movement of a person (without any
identification possible) within the field of view,
used for the purposes of:
 Room occupancy
 Activity profiles
 Multiple occupancy/visiting
 In/out detection
Room temperature
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Sensor
Role
Doors – magnetic contacts









Detects the opening and closing of a door,
used for the purposes of:
In/out detection
Visitors
Activity profile
In/out detection
External activity
Activity profile
Eating related activity
Cooking related activity
Temperature



Bed occupancy
Sleep profile (actigraphy)
Internal vs. external temperature differentials
Scales

Weight
e-AR – Activity and SPO2



ECG



Blood oxygen saturation
Heart rate
Motion characteristics/profile (in house and
external)
ECG events (cardiac disturbances)
Heart Rate
Heart Rate Variability

Blood pressure long term trend

Front Door

Back Door


Fridge
Freezer
Bed Sensor
Body Worn
Home Unit
Blood Pressure
Table 1: Sensor list showing sensors that could be included in the SAPHE patient trial
systems and the Lab Tests.
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18.2
A letter from the Local Research Ethics Committee which has approved this trial
The trial is being submitted to Liverpool Children’s Research Ethics Committee and we will
keep the MHRA team informed about its progress.
Full title of study: “A Demonstration of the Role and Effectiveness of the SAPHE system to
enhance care delivery in Liverpool PCT”
REC Ref. number: 08/H1002/69
18.3
*Copy of informed consent.
Patient/Volunteer Information Sheet and Consent Form: All patients and volunteers will be
given an information sheet explaining the questionnaires, the role of the ambient and
wearable wireless sensor devices that will be used in this study as well as the aims of the
study. This will also contain a section where the subjects will be asked to consent to wearing
the wireless body sensor network, the use of ambient sensors in their surrounding (home
installation in the case of the Liverpool patients), and the wireless transfer of their data to a
secured central server as part of the trial. It is important to note that participation in this
study will in no way change the way the patient is otherwise managed. The
patient/volunteer information sheets and consent forms for all the studies are shown over
the following pages:
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A Demonstration of the Role and Effectiveness of the SAPHE System- Home
patient study
PATIENT INFORMATION SHEET & CONSENT FORM
‘You are being invited to take part in a research study. Before you decide it is important for
you to understand why the research is being done and what it will involve. Please take time
to read the following information carefully and discuss it with others if you wish. Ask us if
there is anything that is not clear or if you would like more information. Take time to decide
whether or not you wish to take part.
Thank you for reading this.’
1.
What is the purpose of the study?
The purpose of the study is to try and identify ways in which we can make use of modern
technology to try and help the Community Matrons give you the best care they can. To give
you the best care the Community Matron needs up to date information on how you are.
Currently she does this by visiting and calling you. We have developed the SAPHE system
which automatically collects information about you all the time and sends it the Community
Matron so she is getting information about how well you are coping when she can’t visit
you. The SAPHE system consists of a number of devices carefully chosen by the Community
Matron and installed in your home that collect information about your health and
wellbeing. These devices automatically collect information such as your body temperature
or whether you’ve had a disturbed night and send it through a box attached to your
television set to the Community Matron. She can look at the information on her computer
and decide if for instance there is a need to contact you more regularly.
Because we are still developing the system we don’t know exactly which pieces of
information will be most helpful to the Community Matrons or the best way to show it to
them. So we will be collecting a lot of data and researchers from both Imperial College and
the University of Dundee will be analysing the data collected from the devices installed in
your house. They will not be able to identify you from the data so your privacy is assured.
This data will include information such as the times at which you enter and leave rooms in
the house, or the duration of your periods of sleep. Our goal is to provide information on
how you are coping on a regular basis to the Community Matron that she can be more
aware of your needs. Ultimately, this approach should allow elderly people with health
problems to live independently for longer in their own homes.
This study is expected to last up to 6 months.
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2.
Why have I been chosen?
We want to test out the ideas behind the SAPHE system with as wide a range of people as
possible. Those with different long term illnesses, in different domestic arrangements, with
different ages and at different stages in their illness.
3.
Do I have to take part?
It is up to you to decide whether or not to take part. If you do decide to take part you will
be given this information sheet to keep and be asked to sign a consent form. If you decide to
take part you are still free to withdraw at any time and without giving a reason. A decision
to withdraw at any time, or a decision not to take part, will not affect the standard of care
you receive.
4.
What will happen to me if I take part?
If you decide to take part in this study then a packages of devices will be installed in your
house. This installation will not take more than one day and will not require any
refurbishment. The installers may fix some of the devices with screws, for example to walls
or doors, but most of the devices will not need to be fixed this way.
You will also be asked to wear an ear worn monitoring device (e-AR sensor) which looks like
a hearing aid.
Specifically, the devices that will be installed in your home will be selected from the list
shown at the end of this leaflet. Obviously not all these sensors will be installed in your
home – only the ones that your Community Matron thinks will give her extra information.
We will keep the number of sensors to a minimum.
5.
What do I have to do?
You will be asked to wear one ear-worn (e-AR sensor) device along with a small belt
mounted unit (Mobile Hub) during the day. These are very light-weight devices which
should not affect you. Apart from this, you will merely be asked to follow your normal
routines and to behave as you usually do.
6.
What are the possible disadvantages and risks of taking part?
There are no risks involved. All the devices that will be installed are either approved for use
in trials such as this or commercially available devices, manufactured to meet the
appropriate safety standards.
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7.
What are the possible benefits of taking part?
The benefits to you may not be immediate. However, the data we collect from you will
greatly help our research and development work. Our goal is to be able by putting discrete
devices in people’s homes to provide care professionals with information that allows them
to improve the delivery of that person’s care. In the future, this approach may also help to
predict the approach of critical events and alert carers to take appropriate action before
they occur. This would allow elderly people with health problems to live independently for
longer.
8.
What happens when the research study stops?
At the end of this study we will remove the SAPHE system from your home and make good.
We will write a report describing what we have discovered in the trial which we will discuss
with Liverpool PCT.
9.
What if something goes wrong?
Imperial College London holds insurance policies which apply to this study. If you experience
harm or injury as a result of taking part in this study, you may be eligible to claim
compensation without having to prove that Imperial College is at fault. This does not affect
your legal rights to seek compensation.
If you are harmed due to someone’s negligence, then you may have grounds for a legal
action but you may have to pay for it. Regardless of this, if you wish to complain, or have
any concerns about any aspect of the way you have been approached or treated during the
course of this study, the normal National Health Service complaints mechanisms are
available to you.
10.
Will my taking part in this study be kept confidential?
All the data that is collected in your home during the course of the research will be kept
strictly confidential. That not only includes the data from the sensors but any interviews that
you may have about the project with research workers.
No video cameras or microphones will be installed in your house.
We will want to tell your GP that you are on the trial
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11.
What will happen to the results of the research study?
The results from this study will be reported in scientific papers, to be submitted to
appropriate conferences or journals. In all publications the results will be written in such a
way that no one can infer that the data corresponds to you. This is a standard way of
informing fellow researchers and service providers while respecting your confidentiality.
Depending on the nature of the results, they may give rise to further research and the
creation of new projects on the same field, which could involve the same or different
researchers.
12.
Who is organising and funding the research?
In addition to the Community Matrons from Liverpool PCT the organisations involved in this
research and their roles are shown in the table. You may meet people from some of these
organisations during the course of the trial.
15.
Organisation
Role
Imperial College London
Design and development of SAPHE technology,
system integration, trial design and
implementation
University of Dundee
Research into ways of showing data to Community
Matrons
BT
Design and development of SAPHE technology,
system integration, data collection, system
installation
Philips
Design and development of SAPHE technology,
system integration
Smart Solutions
Local liaison, interviewing participants
Who has reviewed the study?
Chairperson of the Liverpool Children’s Research Ethics Committee.
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16.
Contact for Further Information
Names and details of local contacts
Liverpool PCT Community Matron
Ms. Claire Henegan, Liverpool PCT Headquarters, 1 Arthouse Square, 61-69 Seel Street,
Liverpool, L1 4AZ. Tel: 0151 296 7000. Email: [email protected]
SAPHE field team
Dr Richard Curry, Tanaka Business School, Imperial College, South Kensington Campus,
London, SW7 2AZ. Tel: 0207 594 3084. Email: [email protected]
Thank you for taking part in this study.
You will be given a copy of this information sheet and a signed consent form to keep.
Sensors available in the SAPHE trial.
Sensor
Role
Environmental
PIR Sensors
(Passive Infra Red)







10
Bedroom
Hall
Bathroom
Living Room
Toilet
Landing
Kitchen

Detects movement of a person (without any
identification possible) within the field of view,
used for the purposes of:
 Room occupancy
 Activity profiles
 Multiple occupancy/visiting
 In/out detection
 Room temperature
Doors – magnetic contacts

Detects the opening and closing of a door,
used for the purposes of:
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
Front Door

Back Door


Fridge
Freezer
Bed Sensor
Scales









In/out detection
Visitors
Activity profile
In/out detection
External activity
Activity profile
Eating related activity
Cooking related activity



Bed occupancy
Sleep profile (actigraphy)
Weight
You will be given a copy of the information sheet and a signed consent form to keep.
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CONSENT FORM
Study 1
Title of Project:
A Demonstration of the Role and Effectiveness of the SAPHE system
- Home patient study.
Name of Researcher:
Please tick all boxes that apply:
1.
I confirm that I have read and understand the information sheet for the
above study and have had the opportunity to ask questions.
2.
I understand that my participation is voluntary and that I am free to withdraw
at any time, without giving any reason.
3.
I agree to take part in the above project.
4.
I agree that my GP should be informed that I am taking part in this trial
5.
I agree that SAPHE technology can be installed in my house, with the purpose
of collecting data regarding my daily activities and health.
6.
I agree that data collected by the devices installed in my house can be
analysed, if kept anonymous and for research purposes only.
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7.
I agree that parts of the data collected by the devices installed in my house
can be used in reports and publications, if kept anonymous.
Name of Participant
Date
Signature
Name of Researcher
Date
Signature
(Copies: 1 for participant; 1 to be kept by research team 1 in CM notes.)
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18.4 *Reference to important relevant scientific literature (if any) with an analysis and
bibliography.
It is thought that within the next decade, many of the sensor technologies already used in
the industrial sector are likely to have a dramatic impact on healthcare, with the
development of combined sensing and processing abilities (the “smart sensor”) adding to
this effect1. The use of this wireless sensor technology in medical practice not only allows
an unparalleled level of sophistication in patient monitoring with regards to existing
parameters (such as vital signs), but also offers the prospect of identifying new ways of
diagnosing and preventing disease.
Over the past years, starting with the “UbiMon” (Ubiquitous Monitoring) project
(www.ubimon.org), the pervasive sensing group at Imperial College, headed by Professor
Guang-Zhong Yang, has been developing the concept of a wireless networking of wearable
body sensors that allow the continuous monitoring of patients in both home and hospital
environments2,3. At present these sensors all measure vital signs such as oxygen saturation,
heart rate and motion data. Each of these sensors has a battery power source, and is
connected to a “body sensor network node” (BSN node), which collects the data from the
sensor, processes it, and wirelessly transmits it to a personal digital assistant (PDA) device.
Ubiquitous wireless monitoring systems such as those being evaluated in this study offer the
ability for the patient to move freely around their home environment whilst being
continuously and unobtrusively monitored. The BSN node, which processes the output from
the sensors and wirelessly transmits this to the desired destination, also removes the need
for physical patient attachments to bulky equipment.
The ability to monitor patients in their home offers a unique opportunity to study patients,
their diseases and recovery in an environment where up until now little subjective
measurement has been possible. A number of projects have been pursuing this approach to
patient monitoring across the world. The SAPHE consortium includes partners from a
number of such projects, and in particular, from two of the Next Wave Technologies and
Markets Centres: the Care in the Community Centre, and the UbiCare Centre.
[1]
1
[2]
22
[3]
3
14
Wilson CB. Sensors 2010. Bmj 1999; 319(7220):1288.
Ng JWP, Lo BPL, Wells O, et al. Ubiquitous Monitoring Environment for Wearable and Implantable
Sensors (UbiMon). International Conference on Ubiquitous Computing (Ubicomp) 2004; September.
Lo B, Yang GZ. Key Technical Challenges and Current Implementations of Body Sensor Networks. 2005
Apr; Department of Computing, Imperial College London. London 2005 p. 1-5.
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19
INVESTIGATION PARAMETERS AND DESIGN
19.1 Aims and objectives of clinical investigation (bearing in mind which essential
requirements are being addressed by the clinical investigation in question).
The purpose of SAPHE is to develop a novel architecture for unobtrusive pervasive sensing
to link physiological/metabolic parameters and lifestyle patterns for improved well-being
monitoring and early detection of changes in disease state. The project addresses both the
design of telecare service strategies and the development of innovative technologies to
deliver them. In the final stages, a complete system will be integrated and trialled with
Community Matrons from the Liverpool Primary Care Trust. Using the results of these trials,
the value of this technology for sensing under normal physiological conditions combined
with intelligent trend analysis will be demonstrated. This should open up new opportunities
for the UK ICT and healthcare sectors in meeting the challenges of the demographic changes
associated with the aging population.
In this study, the C.Net5000 will be used in conjunction with other sensing devices (referred
in table 1) to provide a multi-dimensional view of the patient’s health. Parameters
measured by the C.Net5000 will be used by the Community Matrons during their visits and
monthly case reviews, in support of their knowledge of each patient. The interpretation of
the C.Net5000 data is supported by a number of laboratory studies and clinical trials which
have taken place in several sites over the last ten years.
19.2 Type of investigation i.e. whether the use of a controlled group of patients is
planned.
A Demonstration of the Role and Effectiveness of the SAPHE system - Home
patient study.
Study Design
A package of SAPHE sensors will be installed in the homes of 20 patients selected by the
Community Matrons (CMs) who are currently administering and delivering their care (The
intervention group). The data collected by the sensors will be made available to the CMs
through terminals in their offices. No personal information will be stored with the SAPHE
data and only the CM will be able to link the individual to the SAPHE data record. No
attempt will be made to fuse SAPHE data with the electronic care record held by the CM. A
group of 20 similar patients will be identified (the comparison group) and compared with
the intervention group. The comparison will make use of the record of their activity that the
CMs routinely complete. The objective of the trial is to investigate how SAPHE technology
could support patients and their informal carers, provide CMs with a toolkit of information
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that helps them to manage their patients and to change the way service is prioritised and
delivered
20 patients in the intervention group will be recruited by the Community Matrons and
SAPHE assessment team over a maximum period of 8 weeks. For several practical reasons
(e.g. installation of equipment, patient withdrawal, etc.) this is preferable to trying to
arrange that all 20 patients (and 20 comparison group patients) are ready at the same time.
The end of the trial will be staggered as well so that all patients receive approximately the
same exposure to the technology.
At all times the CM is in control. She will select the patients, work with members of the
SAPHE team to devise a package of SAPHE sensors, explain the trial to the patient (and any
relevant informal carers), obtain informed consent and in extremis stop the trial for a
particular patient if she feels continuing is not in the patient’s best interest.
The use of the C.Net5000 will depend on the judgement of the CM and her assessment of its
value to the individual patient.
Study Coordinators

Dr Richard Curry, Tanaka Business School, Imperial College, South Kensington
Campus, London, SW7 2AZ. Tel: 0207 594 3084. Email: [email protected]

Mr Nigel Barnes, British Telecommunications Plc, Adastral Park, Martlesham Heath,
Ipswich, IP5 3RE. Tel: 01473 664118. Email: [email protected]

Ms. Claire Henegan, Liverpool PCT Headquarters, 1 Arthouse Square, 61-69 Seel
Street, Liverpool, L1 4AZ. Tel: 0151 296 7000. Email:
[email protected]
Study Supervisors
Professor Guang Zhong Yang is Director of Royal Society/Wolfson Foundation Medical Image
Computing Laboratory at Imperial College London and has been responsible for the
development of the Pervasive Body Sensor Network developed in this study. He will be the
custodian for any data collected during this study.
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19.3
Number of patients, (with rationale).
The maximum number of patients (in the Liverpool Trial) expected to have the SAPHE
system installed is 20. The initial recruitment phase will recruit 30 patients for the
installation (the intervention group), however, assuming an expected 33% drop out rate, the
final aim is for 20 patients in the intervention group; and 20 in the non-intervention (or
comparison group). The number of 20 patients has been selected so that the Community
Matrons are not overwhelmed by the sudden introduction of lots of new data from many
patients in their care, but this number is great enough to test the accuracy, feasibility,
scalability and impact of the SAPHE technology on the Community Matrons working
practice.
19.4 Duration of study with start and finish dates and proposed follow-up period, (with
rationale).
Duration of study for the Liverpool Trial is 6 months, starting from 1st September 2008 to
28th February 2009. It is expected that the 20 patients who will have the SAPHE systems
installed will be reached after a 6–8 week recruitment period in July/August, therefore, the
maximum length of time that any patient is expected to have the SAPHE system installed in
their home (and thus the duration of their participation in the trial) is 6 months.
19.5 Criteria for patient selection. Inclusion and exclusion criteria. Criteria for
withdrawal.
Patient Recruitment
Patients will be recruited by their Community Matron based on their personal knowledge of
each patient, their health requirements and their suitability for the trial. The recruitment
process will be supported by the SAPHE assessment team.
Inclusion criteria
Patients in the care of Liverpool PCT Community Matrons are from a range of ages (mostly
elderly) with a range of conditions. Selection of patients for the SAPHE trial will be based on
the knowledge of the Community Matrons, assisted by the SAPHE assessment team.
Patients will be identified following assessment with the help of a selection and recording
tool. The selection tool considers the health and social conditions of the patients including:
Major health needs, other health needs, domestic arrangements, social needs, severity of
needs and special concerns. Having identified the intervention group, the CM and the
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assessment team will devise a technology package that could be installed in the home of
that patient according to their requirements. Exclusion criteria for patients from the SAPHE
trial may include: patients who are extremely frail, or patients who suffer serious mental
impairment.
Exclusion Criteria
The following patients will be excluded from this trial:
• Poor understanding of the English language
• Drug dependence
• Dementia or current psychiatric disturbance
• Receiving palliative treatment for incurable cancer
• Undergoing emergency surgery
• Prolonged admission (> 2 weeks)
• Patients who have a neurological disability, symptomatic neurovascular disease or history
of symptomatic neurovascular disease
Criteria for withdrawal
A patient will be able to withdraw from the study at any point should they wish to no longer
take part. The other criteria for withdrawal will be if following discharge home from
hospital, the patient is re-admitted to hospital for the management of an early postoperative complication.
19.6 *Description of the generally recognised methods of diagnosis or treatment of the
medical condition for which the investigational testing is being proposed.
Over the next half a century, the proportion of people aged 60-plus is expected to double
from the current 10% to 22%1. By 2050, for the first time in human history the number of
old people will outnumber children. Such a change represents a triumph of modern
healthcare and medicine but it also introduces a significant burden to public healthcare
systems as in most developed countries, there is a steady decline of workers to retirees.
Although tackling the main causes of death, namely stroke, cancer and cardiovascular
diseases, would lead to a drop in mortality rates, it is prudent to address ageing itself as a
process that starts earlier in life. Ageing is a complex, multi-factorial process leading to a
progressive deterioration in function with advancing age. People age differently and an
understanding of ageing requires studying not only its intrinsic physical and biological
processes, but also demographic, social and psychological factors. Understanding the daily
living habits and tracking changes across time would give an insight into the effects of diet,
exercise, and social interaction on ageing.
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Despite significant advances in medical devices, current monitoring tools are only able to
provide a snap-shot of a person’s physical parameters rather than offering a continuous
view of his/her wellbeing. In most cases, detailed diagnostic assessment only takes place
during an elderly person’s stay in a hospital or during a doctor’s visit. When living in the
community, the status of people is monitored by Community Matrons and other staff who
may be providing long term care. Times between such visits and assessments will depend
significantly on case load, and integration between records of the several support teams is,
at best, patchy.
Recent advances in sensors and embedded computing technologies have led to miniaturised
sensor networks that can be worn or integrated within the home environment without
affecting the person’s lifestyle or daily activities. Integrated micro-sensors no more than a
few millimetres in size, with onboard processing and wireless data transfer capabilities are
the basic components of such networks already in existence 2. Extensive research has been
directed to biosensor design, interfacing and bio-compatibility, wireless communication,
ultra-low power processing, power scavenging, autonomic sensing, and integrated wireless
sensor micro-systems. Although there are currently a range of parallel projects investigating
wireless sensor networks, most of them are highly application specific. In the healthcare
area, examples include Intel’s Digital home technologies for aging in place 3, MIT’s Placelab4
and Harvard University’s Code blue project5. These projects offer a large range of
technologies that are highly application specific and in general, not interchangeable.
A person’s well-being can also be assessed through a set of questionnaires that give an idea
on how well that person is coping with a certain condition. However, these questionnaires
can also be quite specific to certain conditions and do not offer a general image of the
person’s wellbeing6. Using a set of sensors can be quite useful to monitor a patient over
large periods of time. Thus, the aims of this project are:

To provide a pervasive health and social care model that is optimised for the aging
population and patients with long-term conditions.

To develop new sensing and inferencing technology that permits early detection of
frailty or changes in disease, and responsive changes to care plans.

To analyse detailed service needs and developments, including initial field trials in
collaboration with primary health and social care providers.

To assess pervasive technology deployment strategies and services, and their
potential commercial and economic impacts. Due to time constraints, the scope of
the project aims to provide an evolutionary prototype rather than a model for
commercial development.
References
1.
2.
19
“Aging, can we stop the clock?” Wellcome Trust Report (http://www.wellcome.ac.uk/)
Yang, G.-Z., “Body Sensor Networks”, ed. G.-Z. Yang. 2006, London: Springer-Verlag
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3.
4.
5.
6.
http://www.intel.com/research/prohealth/dh_aging_in_place.htm
http://architecture.mit.edu/house_n/placelab.html
http://www.eecs.harvard.edu/~mdw/proj/codeblue/
Aziz O, Lo B, King R, et al. Pervasive Body Sensor Network: An Approach to Monitoring the Postoperative Surgical Patient. BSN 2006. Boston: IEEE, 2006.
20
DATA COLLECTION/ANALYSIS/STATISTICS
20.1 Description of end points and the data recorded to achieve the end points, method
of patient follow-up, assessment and monitoring during investigation.
The objective of the trial is to assess the effect of the technology on the user and their
informal carers and how their professional carers can use the information provided to help
them manage the person’s care.
The study will have the following main outcome measures (or end-points):
1. Patient Demographics: age, ethnic origin, sex, smoking status, co-morbidity
(diabetes, COPD, IHD, etc), number of people living at home, ability to self care, preoperative risk score, left ventricular function (cardiac patients), and renal function
will be recorded from the pre-operative assessment.
2. Community Matron response to data provided by SAPHE system: this will be based
on structured interviews with each of the Community Matrons at the outset and
close of the trial; and on analyses of the case conferences during the progress of the
trial.
3. Service User - responses to use of the SAPHE system, and the control group who
have not been using the system: this will be based on structured interviews at the
outset trial and close of the trial.
4. SAPHE Project sensing system: this will provide information on the frequency and
quality of use made if the SAPHE system by the service users. This will comprise
both the body worn sensing systems (where the user can determine the extent to
which it is actually used), and the ambient sensing system (for detecting the general
behavioral patterns in the occupied space) as detailed above.
[NOTE: Data storage – All patient data from the C.Net5000 device as well as other sensing
devices will be collected wirelessly in the patient’s home and sent anonymously to a secured
server, where it can be analysed by the SAPHE analysis systems and then made available to
the CMs through terminals in their offices. The data will not be identifiable to specific
patients except through a code given to the Community Matrons during the study.]
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20.2
Description of procedures to record and report serious adverse events and
adverse device related events.
All the studies with utilise the Imperial College Standard Operating Procedure (SOP) for
managing and reporting Adverse Events for Imperial College sponsored studies of both
Investigational Medicinal Products (IMPs) and non-IMPs in the UK.
1. Definitions. Adverse Events are defined as follows:
Adverse device-related event (ADRE): Any untoward medical occurrence in a patient or
clinical trial subject administered a medical device, and which does not necessarily have a
causal relationship with this treatment.
Serious Adverse Event/ Reaction (SAE/SAR): Any adverse event or adverse reaction that:
 results in death
 is life-threatening
 Requires hospitalisation, or prolongation of existing
hospitalisation.
 results in persistent or significant disability or incapacity
 is a congenital anomaly or birth defect
inpatients’
[NOTE: Life-threatening, in the definition of an SAE or SAR, refers to an event in which the
subject was at risk of death at the time of event; it does not refer to an event which
hypothetically might have caused death if it were more severe. Medical judgement will be
exercised in deciding whether an adverse event/reaction is serious in other situations.
Important adverse events/reactions that are not immediately life-threatening or do not
result in death or hospitalisation but may jeopardise the subject or may require intervention
to prevent one of the other outcomes listed in the definition above, will also be considered
serious.]
2.
Responsibilities. Below is a list of responsibilities for both the Investigator and the
Sponsor (for Imperial College sponsored studies, the Clinical Research Office (CRO) will act
on behalf of the sponsor).
The Chief Investigators (CI) have overall responsibility for the conduct of the study and coordinating responsibility for reporting adverse events to the Medicines and Healthcare
products Regulatory Agency (MHRA) and to the relevant Research Ethics Committee (REC).
The Principal Investigator (PI) has responsibility for the research at a local site where the
study involves specified procedures requiring site-specific assessment. The PI is responsible
for informing the CI, or the organising research team, of all adverse events that occur at
their site following the guidelines below.
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The following responsibilities will be met:
a. PI to report all SAEs and ADREs within agreed timelines to the CI.
b. CI to report all SAEs and ADREs within agreed timelines to Sponsor, MHRA, REC and
relevant NHS Trust Research and Development Office (R&D)
c. Providing the Sponsor with details of all AEs identified in the protocol as critical to
the evaluation of safety within the agreed timeframes specified in the protocol.
d. Assessing each event for causality and seriousness between the IMP and/or
concomitant therapy and the adverse event.
e. Supplying the Sponsor, MHRA, REC and relevant NHS Trust R&D with any
supplementary information they request.
Sponsor’s Responsibilities will be as follows:
a. Ongoing safety evaluation of any IMP(s).
b. Promptly notify all Investigators, REC(s) and MHRA, of any findings that may
affect the health of subjects. This may include informing investigators using the
same IMP in different studies.
c. Keep detailed written reports of all AEs reported by PIs and performing an
evaluation with respect to seriousness, causality and expectedness.
d. Report all relevant safety information to the relevant REC and MHRA.
e. Report all SUSARs to the MHRA, REC and relevant NHS Trust R&D in concerned
Member States associated with comparator product(s) and Marketing
Authorisation (MA) holder(s), within given timelines.
f. Break treatment codes before submitting expedited reports to MHRA and REC
for specific subjects, even if the Investigator has not broken the code.
g. Submit the annual safety report to MHRA and REC.
h. Encourage the set up of Independent Data Monitoring Committees for phase III
clinical trials that have high morbidity/mortality and describe their function in
the protocol.
i.
Ensure written SOPs and systems are in place to ensure quality standards are
met.
As Imperial College is Sponsor for this study, a-g will be delegated to the Chief Investigator.
Correspondence for Imperial College sponsored studies will be sent to the Clinical Research
Office (CRO).
3. During the Trial
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Each AE will be evaluated for seriousness, causality, and expectedness. The responsibility
for this evaluation will be shared between the CI and PIs. The PI will evaluate each an event,
before reporting it to the Sponsor and CI simultaneously. As expedited reporting may be
required, this SOP assumes that responsibility of initial assessment and reporting to the CI
lies with the PI. The flowchart below shows this process:
4. Causality
Adverse reactions will be assessed for causality using the definitions below.
Relationship
Description
Unrelated
There is no evidence of any causal relationship
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Relationship
Description
Unlikely
There is little evidence to suggest there is a causal relationship (e.g. the event did not
occur within a reasonable time after administration of the trial medication). There is
another reasonable explanation for the event (e.g. the patient’s clinical condition,
other concomitant treatment).
Possible
There is some evidence to suggest a causal relationship (e.g. because the event
occurs within a reasonable time after administration of the trial medication).
However, the influence of other factors may have contributed to the event (e.g. the
patient’s clinical condition, other concomitant treatments).
Probable
There is evidence to suggest a causal relationship and the influence of other factors is
unlikely.
Definitely
There is clear evidence to suggest a causal relationship and other possible
contributing factors can be ruled out.
Not assessable
There is insufficient or incomplete evidence to make a clinical judgement of the
causal relationship.
5. Reporting Guidelines
Once the CI/PI has evaluated the AE in terms of seriousness, causality and expectedness, the
following guidelines will be followed:
AEs that are not considered serious will be included on the relevant case report forms
(CRFs). The completed form will be filed along with the other CRFs for the study and a copy
provided to the Sponsor as agreed.
SAEs - If the AE is assessed as serious, the PI must report the event to the CI immediately or
within 24 hours of being made aware of the event (other than those SAEs identified in the
protocol as not requiring immediate reporting). The initial report can be made verbally but
must be promptly followed with a detailed, written report. The PI must record the event
with his assessment of seriousness, (along with causality, expectedness and severity) on a
trial SAE form provided by the CI (see pages 20-21 ). This form should be completed in
typescript and reported within 15 days of the CI becoming aware of the event. The PI should
ensure that follow-up information is provided when available. The CI should include all SAEs
in the annual safety report. Local clinical governance procedures at each local site, e.g. NHS
Trust, should also be followed.
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SAE Reporting Form
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6. Annual Reports
All SAEs should be reported to the CRO, MHRA, and REC. The annual report may be done in
conjunction with the IDMC. The annual safety report should include:
Report on the Subjects’ Safety

Concise safety analysis and benefit-risk evaluation describing all new findings related to
the safety of the device and critical analysis of it with respect to its impact for subjects.

An analysis of the implications for the population of the clinical study, analysis of the
safety profile of the tested device and its implication to subjects’ exposure, taking in to
account all available safety data.

Any specific safety issues related to special populations
20.3 Description and justification of statistical design, method and analytical procedures
(if relevant).
The primary objective of the SAPHE trial is to make an assessment of the qualitative impact
of the impact such a system could make on the way CMs support their patients. This is a
complex and multivariate question, and the principal approach is qualitative, not
quantitative, at this stage in the development of the technologies involved.
The effects and impacts of the SAPHE system will be assessed using a range of tools
developed to assess qualitative data by the SAPHE team, especially those at Imperial,
Dundee and in collaboration with Prof Andrew Sixsmith (through Smart Sol Ltd).
In addition, the data collected from the SAPHE sensing systems will also be subjected to
Exploratory Data Analysis (EDA)4. As part of the EDA we will be looking for the presence of
strong, medically plausible, correlations between different sensor outputs (for example,
between SPO2 and heart rate). This is valuable, as if we know that one physiological variable
can be inferred from another we may not need to measure both of them. We will also be
looking for precursor events to changes or events reported by the CMs. This will be done by
automated feature identification techniques, as well as detailed ‘eyeball’ inspection of the
data and will be carried out with analytical tools which are already in place or are being
developed as part of the SAPHE project by the teams at Imperial, BT and Dundee.
Sample Size Considerations:
4
Understanding Robust and Exploratory Data Analysis, by Hoaglin, Mosteller and Tukey. Published by John
Wiley
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Formal sample size and power calculations have not been carried out as this is a qualitative
study, and there are no previous studies using wireless collection of both personal and
environmental activity data with any specific outcomes. However, it is anticipated that the
results of this study will provide a useful guide for power calculations for further studies.
The number of patients has been determined primarily on the basis of the practicability of
the study within the resources of the project and the Liverpool PCT Community Matron
service.
ACUTE STUDY
The primary objective of the trial is to assess the relevance of the SAPHE technology in
support of service users in their own homes. As such, it is not planned to involve service
users who are in an acute condition in this trial although the final selection will be done in
conjunction by the CMs. During the progress of the trial, it is possible that some of the
service users may develop acute conditions. In such cases, the conduct of the trial during
these phases will be discussed and agreed with the CMs at the regular cases conferences: it
is likely that data collection will suspended until the service users return to their own
homes.
21
DEVICE DETAILS: Cardionetics C.Net5000 with low power radio
21.1 *Brief description of device and other devices designed to be used in combination
with it. It is helpful if the information includes a drawing/photograph of the device.
The Cardionetics C.Net5000 is a single channel ECG monitor and event recorder
incorporating fully automatic arrhythmia analysis. The device is CE marked (CE0120) and on
the market. Cardionetics’ notified body is SGS. The device is in widespread use in primary
care, and has proved very successful in the detection of both symptomatic and
asymptomatic arrhythmia.
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The C.Net5000 is a small battery operated ambulatory ECG monitor with automated
analysis, designed specifically to assist in the diagnosis of cardiac arrhythmia. The
C.Net5000 is intended for monitoring of adult patients with symptoms that suggest
arrhythmia, such as syncope, dizziness, falls, palpitations, or chest discomfort, and also for
at-risk patients likely to be developing asymptomatic arrhythmia such as AF that could lead
to stroke. Unlike a traditional Holter monitor, which involves a review of the entire ECG
trace by a cardiac technician after each test, the C.Net5000 automatically detects and
classifies arrhythmia in real time, producing an instant on-screen analysis.
The C.Net5000 also features a symptom button for the patient to press whenever symptoms
are felt, which causes the monitor to record an ECG trace at that time.
The C.Net5000 is especially useful where symptoms occur infrequently, or where resting
ECG monitoring is unlikely to capture symptomatic or asymptomatic arrhythmias. It can be
used for short duration tests, either at the surgery or during a home visit, or for up to 24
hours of ambulatory monitoring.
21.2 *Identification of any features of design that are different from similar previously
marketed product (if relevant).
For the purposes of the SAPHE Trial, the C.Net5000 has been modified by the addition of a
Philips low power radio (low power wireless transmitter) module. This is designed to allow
wireless communication of the information from the C.Net5000 to the SAPHE system, and
consists of a Texas Instrument radio transceiver CC1000, Texas Instrument microprocessor
MSP430F1612, Analog Device accelerometer ADXL330, National Semiconductor Voltage
Regulator LP3995-2.1, and the RainSun 868MHz Chip antenna.
Texas Instrument radio transceiver CC1000:
The CC1000 radio transceiver is a low power radio UHF RF transceiver with the following
properties:
 Complies with EN 300 220 (Electromagnetic compatibility and Radio)
 Spectrum Matters (ERM); Short range devices;) and FCC CFR47 part 15
 Supply voltage: 2.1V to 3.6V
 Temperature, operating range:-40°C to +85°C
 Output power: 0dB
 Maximum bitrate 38.4 kbit/s
 Typical receiver sensitivity (10^-3 ber): -96 dB
 Average receive current consumption: 9.6 mA
 Driven from a 16 MHz 20 ppm crystal
Details of the CC1000 can be found at: http://www.ti.com/lit/gpn/cc1000
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Micro processor: Texas Instrument MSP430F1612
The MSP430F1612 is an ultra low power 16-bit RISC processor with the following features:
 Supply voltage: 1.8V to 3.6V
 Ultralow-Power consumption (Active: 330uA, Standby: 1.1uA and Off mode:
0.2uA)
 3-channel internal DMA
 12-bit D/A converter
 Serial communication interfa ce
 55KB Flash
 5KB RAM
 Temperature, operating range: -40oC to +85oC
Details of the MSP430F1612 can be found at: http://www.ti.com/lit/gpn/msp430f1612
Accelerometer: Analog Devices ADXL330
This records movement relative to X, Y, and Z axes. The ADXL330 is a small, thin, low power,
complete 3-axis accelerometer with signal conditioned voltage outputs, all on a single
monolithic IC. The product measures acceleration with a minimum full-scale range of ±3 g. It
can measure the static acceleration of gravity in tilt-sensing applications, as well as dynamic
acceleration resulting from motion, shock, or vibration. For further information please refer
to the manufacturer’s website: http://www.analog.com/en/prod/0,2877,ADXL330,00.html .
NB: the accelerometer is not functional in the SAPHE configuration of this radio module.
Voltage regulator: National Semiconductor LP3995-2.1
The LP3995 linear regulator is a micropower 150mA CMOS voltage regulator with active
shutdown designed for portable battery-powered applications, and it has the following
features:
 2.5V to 6V input range
 Accurate Output Voltage 75mA/2%
 60mW Typical dropout with 150mA load
 Guaranteed 150mA output current
 Fast turn-on; 30us
 Fast turn-off; 175us
 Output Voltage 2.1V
Details of the LP3995 can be found at: http://cache.national.com/ds/LP/LP3995.pdf
Antenna: RainSun 868 MHz chip antenna:
The RainSun 868MHz chip antenna is a miniaturised antenna designed for 868MHz radio:
 Dimensions: 16.0 x 3.0 mm
 Bandwidth: 10MHz
 Center Frequency: 868MHz
 Gain: 0.5dBi
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 Impedence: 50 Ohms
 Temperature Range: -40/+85oC
 Polarity: Linear
21.3 *Details of any new or previously untested features of the device including, where
applicable, functions and principles of operation.
Not applicable
21.4 *Summary of any experience with any similar devices manufactured by the
company including length of time on the market and a review of performance related
complaints.
The C.Net5000 is a development of an earlier version of the event monitor, the C.Net2000
that was originally placed on the market in 1999, and which is still in widespread use.
Performance concerns raised by users included physical size and battery requirements; both
of these issues were addressed in the design of the C.Net5000, which is 30% smaller than
the previous model, and uses 2 x AA batteries instead of 4 x AA, and can be run on
rechargeable batteries as an alternative to disposables.
21.5 *Identification of hazards and estimated risks associated with the manufacture and
use of the device (ISO 14971) together with a description of the actions that have been
taken to minimise or eliminate the identified risks.
The National Research Ethics Service, part of the National Patient Safety Agency, has
assessed the use of the C.Net5000 in an investigational trial as one of service evaluation,
and not research, and is also an evaluation of an existing CE-marked device. Provided its use
is within the indications for use there is no additional risk to participants, and therefore such
investigations fall outside the remit of the NHS Research Ethics Committees.
Hazard Analysis (Extract from Device Technical File; to ISO14971: 2007)
Self-Medication
Hazardous Event
Severity of Hazard
Cause(s) of the Hazard
Method of Control
Corrective Measures
Verification
31
The user decides to self-medicate as a result of the information provided in a
C.Net5000 test report.
The severity of the hazard is dependent on the type and quantity of medication
taken.
1. False Positive (artefact reported as valid arrhythmia)
2. False Negative (valid arrhythmia not reported)
1. The C.Net5000 is specified not for use in life-critical situations or situations
where any delay in the user receiving treatment could cause harm.
2. C.Net5000 test reports contain no diagnostic or medication advice.
3. The User Manual and product labelling provide clear and unambiguous
instructions that the test reports from the C.Net5000 must never be used for
disease diagnosis or for self-medication, and that any change in treatment or
medication must only be made on the advice of a qualified physician.
A medically qualified care provider must undertake further clinical assessment
before any form of treatment is provided.
Not applicable. The corrective measures identified are beyond Cardionetics
control.
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Misdiagnosis by Care Provider
Hazardous Event
Severity of Hazard
Cause(s) of the Hazard
Method of Control
Corrective Measures
Verification
A care provider decides to medicate as a result of the information provided in a
C.Net5000 test report.
The severity of the hazard is dependent on the type and quantity of medication
taken.
1. False Positive (artefact reported as valid arrhythmia)
2. False Negative (valid arrhythmia not reported)
1. The C.Net5000 is specified not for use in life-critical situations or situations
where any delay in the user receiving treatment could cause harm.
2. C.Net5000 test reports contain no diagnostic or medication advice.
3. The User Manual and product labelling provide clear and unambiguous
instructions that the test reports from the C.Net5000 must never be used for
disease diagnosis or for self-medication.
4. C.Net5000 test reports must never be used in isolation for the purpose of
diagnosis or provision of treatment.
A medically qualified care provider must undertake further clinical assessment
before any form of treatment is provided.
Not applicable. The corrective measures identified are beyond Cardionetics
control.
Accidentally Stopping a Test
Hazardous Event
Severity of Hazard
Cause(s) of the Hazard
Method of Control
Corrective Measures
Verification
The user may accidentally stop a test by pressing the [Stop] button. The
C.Net5000 does not capture important ECG events because it is not
monitoring the ECG when the user thinks that it is.
Minor
Inadvertent operation of key strokes
Design of key stroke sequence allows user intervention to be locked out
The user is required to confirm that the test should be stopped. The keystroke
sequence is [Stop], [Up], [Select], which should be difficult to perform
accidentally. Additionally, user access can be locked out.
System tests
Losing Test Results by Starting a New Test
Hazardous Event
Severity of Hazard
Cause(s) of the Hazard
Method of Control
Corrective Measures
Verification
The test results may contain recordings of significant ECG events which could
be lost because the C.Net5000 erases the previous test results when starting a
new test
Minor
Inadvertent operation of key strokes
Design of key stroke sequence
If the C.Net5000 contains a previous test report, the message "Starting a test
will cause the existing test report to be erased" is displayed. The user is then
required to confirm that a new test should be started. The keystroke sequence
is [Start], [Up], [Select], which should be difficult to perform accidentally, and
which should cause the user to question whether to start the test, and whether
the previous test report should be kept.
System tests
Residual risk
Hazardous Event
32
No further hazardous events identified
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Severity of Hazard
Cause(s) of the Hazard
Method of Control
Corrective Measures
Verification
Minor
Not applicable
Not applicable
Not applicable
Not applicable
21.6 *Description of materials coming into contact with the body; why such materials
have been chosen; standards with which they comply (if relevant).
Standard Ag/AgCl loaded ECG electrodes are used on the participant’s body. These are
branded “off-the-shelf” items compliant with the following standards:
Essential Requirements of Medical Device Directive 93/42/EEC Annex I
UK Transposition of 93/42: Medical Device Regulations SI2002 No 618 (as amended)
EN980
Graphic Symbols for use in Labelling medical devices
BS EN ISO 14971
Medical devices - Risk analysis 2007
BS 10993-1
Biological evaluation of devices
ISO 13485
Quality Systems for medical Devices 2003
ANSI / AAMI EC12
Disposable ECG Electrodes
21.7
*Identification of any pharmacological components of device
None
21.8
*Identification of any tissue of animal origin
None
21.9 *Identification of any special manufacturing conditions required and if so how such
requirements have been met
No special manufacturing condition is required; all manufacturing conforms with quality
standards to ISO 13485: 2003
21.10 *Description of packaging used for sterilisation of device
The device does not require sterilisation
21.11 *A summary of the relevant standards applied in full or in part, and where
standards have not been applied, descriptions of the solutions adopted to satisfy the
Essential Requirements.
93/42/EC
33
Medical Devices directive
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EN540
EN60601-1
EN60601-1-2
EN60601-1-4
EN60601-2-47
EN980
BS EN ISO 14971: 2007
BS EN ISO 13485: 2003
BS 10993-1
EN1041
MEDDEV 2.12/1
Clinical Investigations of Medical Devices for Human Subjects
Medical Electrical Equipment: basic safety and essential performance
Medical Electrical Equipment: collateral standard for EMC
Medical Electrical Equipment: collateral standard for programmable systems
Medical Electrical Equipment: Ambulatory ECG Equipment
Graphic Symbols for use in Labelling medical devices
Medical devices - Risk analysis
Quality Systems for medical devices
Biological evaluation of devices
Information supplied by the manufacturer
Guidelines, medical devices vigilance system April 2007 rev. 5
21.12 *Instruction for use, and where relevant, installation of the device. Alternatively
enclose a copy of the manufacturer’s instructions for use that will accompany the device
and be issued to the user.
Intended Use: The C.Net5000 is intended for in-context monitoring of adult patients, where
symptoms occur infrequently, or where resting ECG monitoring is unlikely to capture
symptomatic or asymptomatic arrhythmia.
Symptoms commonly indicative of arrhythmia include syncope, presyncope, dizziness, and
palpitation. Shortness of breath, chest discomfort, weakness, diaphoresis, or neurological
symptoms such as transient ischaemic attack may also be caused by arrhythmia.
Where clinically appropriate, the C.Net5000 can assist in ongoing monitoring of the
frequency of arrhythmia in patients receiving antiarrhythmic medication or rehabilitation
therapy.
Exclusion criteria: The C.Net5000 should not be used on patients who exhibit severe
symptoms (such as acute chest pain) or any life-threatening indications. The C.Net5000
should also not be used when immediate treatment is required, or if the time taken to
perform monitoring would introduce unnecessary or unacceptable delay in treatment.
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