PDS

Contents  Introduction  Definitions  1) Performance 1.0 Function 2.0 Appearance 3.0 Reliability 4.0 Environment 5.0 Ergonomics 6.0 Quality 7.0 Weight  2) Operation Requirements 8.0 Use 9.0 Maintenance 10.0 Safety  3) Manufacture Requirements 11.0 Process 12.0 Materials 13.0 Assembly 14.0 Packing 15.0 Quality  4) Standards

Introduction The PDS is being created so we can see in detail what the product has to do, more detail included means a more successful product. It also allows designers to see the customer needs more clearly and design around these specifications. My product will be an easier alternative product to test blood sugar for diabetics. The aim is to create something that will be less time consuming and easier to test when on the go, e.g. flat surface won’t be required like most other blood meters. It is also important the product interacts well with the user and it is something the enjoy carrying around, making it harder to forget an important piece of medical equipment.

Definitions  MMOL/L – MILLIMOLES/LITRE  mmol/l mg/dl interpretation   extremely low, danger of unconsciousness  low, marginal insulin reaction  slightly low, first symptoms of lethargy etc.  mecca  normal pre-prandial in nondiabetics  normal postprandial in nondiabetics  maximum postprandial in nondiabetics   a little high to very high depending on patient   getting up there  max mg/dl for some meters and strips  high danger of severe electrolyte imbalance

1) Performance requirements 1.0 Function 1.1 Product must be able to allow user to test blood glucose, or show how it would work 1.2 Must allow blood testing be less time consuming than existing products 2.0 Appearance 2.1 It must be discreet so it won’t draw attention from others (doesn’t look medical) 2.2 It will be aesthetically pleasing so user enjoys wearing it (looks like a normal wrist watch) 3.0 Reliability 3.1 Must be powered by a strong battery as it will be in constant use(1.5 V, type AAA, LR03, AM 4 or Micro) 3.2 Battery life: Approximately 500 tests or approximately 1 year 3.3 Must last several years with constant use 4.0 Environment 4.1 Must operate accurately when in temperatures -10 to 70 degrees 4.2 Must remain comfortable on the wrist after several hours of use 5.0 Ergonomics 5.1 Must be adjustable to fit on a wide range of different sizes of wrists 5.2 Must be easy to operate and understand, so it interacts well with the user 5.3 Must appeal to a wide range of users so it can be available to every diabetic, so it is a product they enjoy wearing and it won’t feel like as much of a chore to test blood if they enjoy the product. Must be no bigger than 75 x 50 x 30 mm L W H 5.4 Must be comfortable at all times. 5.5 Strap must be adjustable between 152.4mm(6inches) and 203.2mm (8inches)

Performance requirements 6.0 Quality Must function properly, I.e. be a high quality product that allows extremely accurate testing. Must help the user maintain blood glucose between 5.0 mmol/l to 9.9 mmol/l 7.0 Weight Weight must not exceed 100g Must be light enough to still be comfortable after frequent use Must not strain the user in anyway by being too heavy.

Manufacturing 8.0 Process 8.1 The product would be injection moulded if it was being mass produced. 8.2 A moulding press is loaded within the mould cavities, and a pellet of encapsulating material 8.3 Encapsulation of the integrated circuits (of the glucose detector) is achieved by heating the encapsulating material pellet and pressing it within the chamber using a transfer plunger, which causes the pellet to liquefy and flow into the mould cavities through small passages between the chamber and the mold cavities. 8.4 After allowing the encapsulating material to solidify again, the moulding press is opened and the mould parts are separated. 8.5 After removal of the encapsulated integrated circuits, the open moulding press is ready to receive new inserts and encapsulating material pellet to repeat the encapsulating process. 9.0 Materials 9.1 Thermoplastic resins would be used in the injection moulding such as phenol resin, epoxy resin, silicone resin, unsaturated polyester resin, and other thermosetting resins. 9.2 The meter itself is composed of a plastic case that houses the printed circuit board and sensors. There is a liquid crystal display (LCD) that will show the readings of the blood glucose Assembly 10.1 Two plastic casings would be made, the circuit board and other components placed, and the casings would be glued together Product must be easy to assemble, all components must fit together and function 10.3 Must take no longer than 9-10 weeks to manufacture prototype 10.4 Must be easy to operate 10.5 Prototype will use some existing components (such as the cassette which carries sample and is changed after 50 tests) 10.6 Product will include backup finger pricker in case it is forgotten 10.7 Cassette and finger pricker should connect together and work efficiently 10.8 Must display blood glucose in mmol/l 10.9 Allow the cleaning of the cassette to be easy Packing 11.1Packaging and transport costs kept to a minimum, preferably 5% of the unit cost 12.0 Quality 12.1 Product should not fail within a year 12.2 Product life span should last up to at least 3 years and have no major issues within that time.

Operation Requirements 13.0 Use 13.1 The product will be a wrist watch blood glucose meter 13.2 The product will be a new product that allows diabetics to test blood sugar more easily The product will be discreet, meaning it doesn’t look medical and won’t draw attention from others The whole blood test process should take less than 10 seconds 13.5 Will be worn on the wrist, and looks like a watch test memory plus 7, 14, 30 and 90 day averages 14.0 Maintenance 14.1 Should be maintenance free apart from battery change and disposing of cassettes No special tools should be required for maintenance Safety 15.1 Electric circuit must not fail and cause danger to the user 15.2 Must perform well.

Standards  16.0 BS – British Standards 16.1 BS 7671 Requirements for electrical installations  National standards international  ISO – International Standard Organisation  EN – European Standards  UL – Underwriters laboratories inc (product safety testing)  CE – Certificate European