DESC:Strip contains reagents to detect glucose, protein, ketones, blood, pH, urobilinogen, bilirubin, leukocytes, Albumin, Creatine and nitrites. The presence of Nitrate and Leukocytes determines the presence of Urinary tract infection.
To determine the presence of Nitrate in urine, the strip contains para-arsanillic acid. The nitrite from urine reacts with para-arsanilic acid to form a diazonium compound. This diazonium compound in turn couples with 1,2,3,4-tetrahydrobenzo(h)quinolin-3-ol to produce a pink color.
In an acid medium
Para-arsanilic acid or sulphanilamide + NO2 ? Diazonium salt
In an acid medium
Diazonium salt + tetrahydrobenzoquinoline ? Pink azo dy

Similarly, to determine the presence of Leukocytes, the strip contains Derivatised pyrrole amino acid ester. Granulocytic leukocytes contain esterases that catalyze the hydrolysis of the derivatised pyrrole amino acid ester to liberate 3-hydroxy-5-phenyl pyrrole. This pyrrole then reacts with a diazonium salt to produce a purple product.
Reaction catalyzed by leukocyte esterase
Indolecarboxylic acid ester ? Indoxyl + Acid

In acid medium
Indoxyl + Diazonium salt ? Purple\violet azole dye

AMI Urine Analyzer module takes the picture of the strip using AMI DEVICE and applies image-processing technique to detect the presence of the condition. Using the edge and boundary detection methods, the image is clipped and cropped into individual blocks that contain resultant colors after the chemical reactions. Since, the blocks are ordered, the location of the block identifies the condition that is getting diagnosed. Individual histogram plots are derived on the blocks that contained the reagents for detecting Nitrate and Leukocytes. The mean color of the histogram is taken and compared against a series of pre-defined colors that signify the severity or the absence of the condition.

The strip manufacturer independently verifies the strip accuracy level and it is found to be 93% accurate in determining Urinary tract infection. It is disclosed in the following link: http://www.healthcare.siemens.com/point-of-care/urinalysis/multistix-10-sg-reagent-strips/technical-specifications

Block Diagram explanation:

Urine Analyzer accessory:
The Urine Analyzer accessory is a box where the urine strip is inserted after dipping it in the urine sample. The accessory has provision to accommodate the AMI DEVICE and its camera facing downwards focusing on the urine strip. This accessory also avoids ambient light entering the place where strip is placed so that the color change in the strip is easily identified by the analyzer device.

AMI DEVICE:
The AMI DEVICE has camera & flash to take photo of the Siemens urine strip when it is placed inside the accessory. The AMI Urine Analyzer module of the AMI DEVICE takes pictures of the strip at different points of time (60 seconds and 120 seconds) and sends it to Smart phone / Bluetooth enabled computer via Bluetooth for analysis.

Smart phone / Bluetooth enabled computer:
The data transmitted by AMI DEVICE is received by a smart phone / Bluetooth enabled computer. The software application running in the smart phone processes the images and does photometric analysis and detects the condition.

Readiness:-

Similarities with referred 510K device
Clinitek Status Urinalysis Instrument AMI Urine Analyzer
Features The Clinitek Status reports semi-quantitatively for 12 urine analytes AMI Urine Analyzer reports semi-quantitatively assays for 12 urine analytes
Strip used Multistix 10 SG test strips
Identical - Multistix 10 SG test strips

In Vitro / In Vivo In Vitro Identical - In Vitro
Bluetooth communication No Yes
Display Reagent strip results are automatically displayed on the device’s screen. Similar - Reagent strip results are automatically displayed on any smart phone’s screen.
Printer Internal printer available to make a hardcopy of the final result Not available. Only can view the result via smart phone
EQUIPMENT AND SUPPLIES:
1. Siemens Reagent Strips
2. Clinitek Status Analyzer
3. Specimen collection container
4. Paper towels Identical –
1. Siemens Reagent Strips
2.AMI Urine Analyzer
3. Specimen collection container
4. Paper towels
Power Battery & External supply Identical - Battery & External supply
Self-test & Calibration Each time when powered ON Identical - Each time when powered ON

Readiness:

Safety Analysis:-

Major points focused on safety:

Electrical:
Major points which are taken care in electrical safety are Electric shock, battery charging patterns, EMI/EMC compliance by using TVS Diodes (ESD Protection), chokes & Ferrite beads, Keeping high frequency PCB lines as short as possible to eliminate radiation, proper electrical shielding of sensitive components, Over current fuse power protection, reverse power input protection and proper labelling of connectors are ensured in the design.
Also, the AMI Urine Analyzer device works with low voltage (5V DC Max) and does not have any high energy storing components which could ignite a spark in Oxygen rich environment.
Power interruptions will not create any unexpected results or hazards as the device has internally powered battery.
All possible human accessible parts like battery connector, Power ON Connector, Accessory connector are protected by suitable ESD Protection devices.

Emissions test:

Emissions test Compliance Electromagnetic environment - guidance
RF emissions CISPR 11 Group 1 The Wireless Blood Pressure Monitor uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 12 Class B The MONITOR is suitable for use in all establishments, Including domestic establishments and those directly connected to the public low-voltage power supply network that supplies purposes. buildings used for domestic
Harmonic emissions IEC 61000-3-2 Class A
Voltage Fluctuations/ flicker emissions IEC 61000-3-3 Complies

Immunity tests:
Immunity test IEC 60601 test level Compliance Level Electromagnetic environment -guidance
Electrostatic discharge (ESD) IEC 61000-4-2 ± 6 kV contact ± 8 kV air ± 6 kV contact ± 8 kV air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.
Electrical Fast transient/burst IEC 61000-4-4 ±2 kV for power
supply lines
±1 kV for
input/output lines ±2 kV for power
supply lines
±1 kV for
input/output lines Mains power quality should be that of a typical commercial or hospital environment.
Surge IEC 61000-4-5 ±1 kV differential mode
±2 kV common mode ±1 kV differential mode
±2 kV common mode Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interruptions and voltage variations on power supply input line IEC 61000-4-1 <5 % UT
(>95 % dip in UT)
for 0.5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles

<5 % UT
(>95 % dip in UT)
for 5 sec <5 % UT
(>95 % dip in UT)
for 0.5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles

<5 % UT
(>95 % dip in UT)
for 5 sec Mains power quality should be that of a typical commercial or hospital environment. If the user of the Wireless Blood Pressure Monitor requires continued operation during power mains interruptions, it is recommended that the Wireless Blood Pressure Monitor be powered from an uninterruptible power supply or a battery.
Power frequency (50/60 Hz)magnetic field IEC 61000-4-8 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
Conducted RF
IEC 61000-4-6

Radiated RF
IEC 61000-4-3 3 Vrms
150 kHz to 80 MHz

3 V/m
80 MHz to 2.5 GHz 3 V

3 V/m Portable and mobile RF communications equipment
.
Recommended separation distance

where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,
[1] should be less than the compliance level in each frequency range.
[2] Interference may occur in the vicinity of equipment
marked with the following symbol:

[1] Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
[2] Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Power interruptions will not create any unexpected results or hazards as the device has externally powered battery. All possible human accessible parts like battery connector, Power ON Connector, Accessory connector are protected by suitable ESD Protection devices. Standard ICs for Blood pressure measurements are used in the design. The AMI BP Devices are classified as class II type medical equipment.

Rated maximum output
power of transmitter
W Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
80 MHz to 800 MHz
80 MHz to 2.5 GHz

0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1— At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2— these guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

Physical:
The AMI Urine analyzer accessory and AMI Tricorder is placed is a light weight device and not cause injury when dropped on foot from a considerably small distance.
Unexpected movement of device is arrested, Device will not over balance during transportation or regular use, enclosure rigidity, no sharp edges, Aesthetically does not create stress for the user.

Radiative:
The technology used in Urine analyzer does not involve the user being subjected to any ionizing or non-ionizing radiation.

Chemical & Biological:
The user comes in contact with various parts of the device like Urine analyzer accessory, AMI DEVICE, Urine strip, Urine Collection box, etc., and the following points/precautions shall be followed to ensure hygienic, safe and accurate analysis.

,CLAIMS:
1.A method of detecting nitrate in urine using camera flash and transmitted to a smart phone / Bluetooth enabled computer.

2. The AMI Urine Analyzer module of the AMI DEVICE takes pictures of the strip at different points of time (60 seconds and 120 seconds) and sends it to Smart phone / Bluetooth enabled computer via Bluetooth for analysis