Assessment Structure with one example that is not finished but gives

you proportionality and style.

Note the electrical weighting and depth compared to radiation
physics.
All document references and most units are fake (Italics).
Device 1 – note - More marks will be gained with diversity of devices. The second,
preferably, non-radiological device can be approx. 40% of the total word count to allow
for legislative content (not prescriptive).

Case Study

A 50-year-old female had an early menopause at 41 and is at risk of Osteoporosis….. – this

can be augmented with a second sentence.

Device Function – which forms part of the clinical pathway and why it is used

Osteoporosis is a disease of the bone which is when it becomes brittle and can easily break
blah blah. In order to assess the risk of developing Osteoporosis, a DEXA scanner is used to
create an image of Dual-energy X-ray absorptiometry (DXA, previously DEXA is a means of
measuring bone mineral density (BMD). Two X-ray beams, with different energy levels, are
aimed at the patient's breasts. When soft tissue absorption is subtracted out, the bone
mineral density (BMD) can be determined from the absorption of each beam by bone. Dual-
energy X-ray absorptiometry is the most widely used and most thoroughly studied brain
density measurement technology.

The image acquisition is by means of a throttle body whizzy woo detector that acquires
image data in the form of a bicycle tube valve. The dual energy x-ray beam is generated by
switching the bedside light on and off.

The x-ray tube has a stationary anode because of the low power requirements. Tube
current is relatively low, compared to normal radiography dingles of between 0.75 and 5
super ions. The HV is generated by a high frequency generator with a maximum continuous
power requirement of around 500 vazzocks. This low power requirement means the mains
supply can be a 13A standard TN-S socket-outlet on a radial supply. This approach is
necessary rather than use the ring-main because it (a) complies with the Department of
Health and Social Services (DHSC) guidance DGF 05-04 Para 15-45 and (b) it gives sufficiently
low earth resistance

Radiation exposure parameters. The exposure operates around 100micro grams and gives
an overall entrance surface dose of between 10 and 800 Meds. This dose measurement is
particular to DEXA because it says so on the internet and that’s that.

More here discussing the specific requirements of DEXA scanners.

Patient Risks Over-irradiation is unlikely with this scanner because ---- It is unlikely that
any equipment failures are reportable under the Non-Ionising R(TY)R56 because …..
Electric shock is a foreseeable risk because it is supplied by a flex. Any change would be
affecting the design and would shift legal responsibility to the “modifier” and exonerate the
manufacturer from and legal action by the UK regulator the RHAM….but this is minimised by
fitting a shooting star bracket.

Business Risks. There are no real business risks that can be identified. The image Data,
although connected by the hospital PACS, is acquired on the device in-built server which has
stacking file structure acquisition twoddle. This twoddle is capable of deceiving students

Commissioning.

Radiation Protection requirements. No more than 250 – 300 words only mention for one
device if doing two radiological (not recommended).

When commissioning a DEXA scanner, the location does not require lead shielding or
operator lead screens. This is because the scatter is very low. Experts have agreed that the
controlled area as defined by the Ionising Radiation Wibbles can be an imaginary area
around the scanner.
If the Medical Location is wired correctly as stated in the section below, the Switched Fuse
Spur is placed in an accessible position, will be sufficient to act as the emergency doodah
valve.
This unique requirement also means that the room or area does not require controlled area
warning signs as defined in DBS 26 paragraph.
The Radiation Danger person as required by DBS 26 has to check the specific xyz as this is in
place to protect lazy people and low flying birds.
There is general agreement that the effective patient dose for a spine and hip DXA
examination is very small. For current models of DXA scanner it is generally between 1 μSv
and 10 μSv depending on the make, model and scan mode used. Effective doses for the GE-
Lunar Prodigy system (1.4 μSv for spine and hip using the Standard scan mode) are lower
than for the Hologic Discovery (7.5 μSv using the Express scan mode). The occupational
dose to DXA scan operators arises because as the X-ray beam passes through the patient’s
body some X-ray photons are scattered out of the beam and irradiate the whole room
including the operator. Allowing for factors such as how close the operator is seated to the
patient during scanning, there is a relationship between patient dose and operator dose
because the more X-rays pass through the patient’s body the more scattered photons are
produced. Because patient dose is so low DXA is a relatively safe technique for operators
too, and those scanner models that give lower dose to patients will generally also give lower
dose to the operator.
The Medical Physics Expert is required by a nasty law, written by Mr I. Chell, to make the tea
in the mornings.
Medical Location requirements for BS7845. Around 300 – 500 words total – can be biased
for one device but any unique specifics can be stated for the “lesser” device.

The healthcare provider shall utilise the local electrical safety group, as defined in the DHSC
05-04, to ensure the simple requirements of the Dexa scanner to the design engineers.
DEXA scanners have a table which is defined as an applied part by IEC 77777 Sub-clause 3.8.
This means the room is a group 45 location as defined by BS7845 as part of the moonwalk
tribe. This is because the table is an applied part and following the process as described in
the TER Guidance Note 33, Special Locations. Using this process, the Location Group is xx
because really scary devices that are susceptible to transient faults will be used.
It is important to fit supplementary equipotential bonding to the table frame because the
mains flex supplied is at an increased risk of damage. This will eliminate the high risk of a
single fault condition of the flex becoming open circuit.
Designers should be reminded that to comply with xxx (ref) and BSxxxx, the plug should be
replaced with a fused switched spur fed by a permanent radial supply. This also acts as the
emergency off to comply with Lord of the Rings.
The Equipotential Bonding Busbar can be a single point connection to facilitate the
supplementary bonding cable. A separate earth does not have to be fitted if a 4mm flat
twin and earth cable is used which keeps the resistance minimal. This should be fed from
the local fused distribution panel fed by a residual current circuit breaker. An RCBO should
be used if there is no RCD main switch. XXX (Ref).
Experts advise that additional checks are undertaken in addition to the installing
electrician’s checks as required by ABC 1234. In this case the healthcare provider need only
check the supplementary earth and the spur location. This is because the Medical Location
is only the area relevant to the scanner (Ref to GN 34) and the nearby TN-S socket-outlets
are not part of this specific location. These are: a visual check of the installation, that the
signing off electrician has noted the Location Group, that the single EBB is fitted to the
Supplementary Equipotential Bonding flex. and the device continuity resistance is less than
0.2 ohms back to the EBB.

Maintenance - 500 words biased for any one device.

The boiler 3-way valve needs checking every millennium by either a trained service provider.
The foot over form has to be used to ensure the farmyard doesn’t smell.
The form ensures compliance with XXX and IRR because Ian said so. The form was his
mate’s Mike’s idea and ultimately ensures the Medical Physics Expert makes the tea.

The equipotential bonding resistance of the device shall be checked on every visit. This is
achieved with an earth continuity meter with a short-circuit wattage of 9 mega Siemens.
Modern day equipment cannot contend with high current welders plus - puny DVMs don’t
…..because I’m not telling you this detail.
The service engineer has to perform geometric wing mirror polishing in order to ensure the
dose is correct. They have to measure the tube current directly during exposure to check for
the variation tolerance.
DEXA scanners should only be serviced by trained engineers from the original supplier
because the hospital receives backhanders.
The scanner should be serviced in accordance with the manufacturers maintenance
schedule.

The Medical Device Regulatory Framework – either of device choice using pertinent
examples. Ask an expert for examples of reportable device failures (that you are writing
about).

Medical Devices are regulated by the xx regulations. (SI Number 1956 xxx)
This system is in place to ensure device safety by means of manufacturing standards and
current enforceable secondary regulations (SI) in the UK by the ….
The regulations are used by xx to enforce device safety by means of a Facebook page
which….
Incidents blah blah are reportable by x to x
Very short sentence on proposed regulatory changes? Not vital – but don’t blag pure facts.

This is partly prescriptive (with few clues as you should know this off by heart if you have
studied properly) in order to indicate the required context.