F O R M 2

THE PATENTS ACT, 1970
(39 of 1970)
&
The Patents Rules, 2003
COMPLETE SPECIFICATION
(See section 10; rule 13)

1. Title of the invention:
AN IMPROVED DEVICE FOR PHYSIOLOGICAL MONITORING OF NEONATES AND PEDIATRIC PATIENT.
2. Applicant(s):

(a) NAME : LARSEN & TOUBRO LIMITED
(b) NATIONALITY : An Indian Company
(c) ADDRESS : L & T House, Ballard Estate, Mumbai 400 001,
State of Maharashtra, India and also having a place of business named as "Medical Equipments & Systems" at Gate No. 5, Mysore Campus, KIADB Industrial Area, Hebbal, Mysore- 570018 Karnataka, India

3. PREAMBLE TO THE DESCRIPTION
The following specification particularly describes the invention and the manner in which it is to be performed:

FIELD OF THE INVENTION
The present invention relates to an improved device for providing continuous physiological condition monitoring/vital signs of a patient, especially neonatal and pediatric, including periods during which the patient is in transport from one location to another and prolonged home care. More particularly, the present invention relates to an improved device that has got the circuit to check the restless, shaking, crying neonates and pediatric patients by monitoring the erratic vital signs such that device will then generate a melodious tone to attract the attention so that the neonates and pediatric patients will stop the body motion and pay attention to the tone.

BACKGROUND AND PRIOR ART OF THE INVENTION
The emotional response of a patient to a vital sign monitor with sensors attached to patients body is an important issue in medicine that has, to date, been inadequately addressed. Patient dislike, fear, and anxiety of medical devices used in procedures (including syringes, scalpels, IV lines, ECG electrodes, thermometers, SPO2 , inflatable blood pressure cuffs, finger probes, catheters ,nasal sampling lines, etc) are a major problem in medicine and can interfere significantly with necessary medical care. This aversion to medical devices, which is common to both children and adults, is broadly termed as “Patient monitor phobia”, and can cause great emotional suffering in patients.
However, for the great majority, the monotony of the color and design of patient monitors and sensors do not distract people from their fear, but rather intensify patient monitor -phobia in patients, both adult and children. These cold and unattractive conventional patient monitors are also not stimulating to physicians. Because patient monitors and sensors generally appear monotone without bright colors, variegated patterns, or realistic or abstract design, they appear cold, hard, and frightening and enhance the sensation of pain and cause further fear, anxiety, and alienation of the patient.
The United States design Patent number D640375 applied under class D24/134 with Title “Child-friendly stethoscope chest piece “describes various mechanical heart sound detectors with outer design resembling animal face. But this is only passive feature of the invention. The automatic real time monitoring and trend storage is not there.
US 5038755 describes a new type of otoscope for performing ear examinations on small children includes a handle portion, a viewing head and a speculum in addition to a toy-like object for distracting the child prior to or during the examination. The toy-like object may resemble an animal, such as a bear, dog or pig. The otoscope will appear less foreign and threatening to small children than those which are presently being used. As a result, an ear examination with the improved otoscope can be performed more safely and efficiently than was heretofore possible.

US 5038755 do not disclose anything about vital sign monitoring. This is a passive mechanical device to examine the children but improvement of signal and reduction of artifact is not achieved. Also automatic monitoring and trend storage is not there.
US 5479932, discloses an apparatus for effectively and accurately monitoring the health of an infant is realized by simultaneously detecting large motor movement, heartbeat and respiration of the infant, and sounding an alarm when an exacting combination of all three signals is not sensed. This integrated combination effectively eliminates false alarms inherent in prior art monitors. But this invention does not attempt to improve the signal by playing lullabies or musical notes. It just sounds an alarm after predetermined delay. Also the vital signs like SPO2, ECG , Capnography are not monitored.
There are various studies to check the effects of music therapy on pain and anxiety in pediatric burn patients but so far effective medical electronic auto monitoring device have not taught.
Thus there is a need for an electronic, biomedical instrumentation device which can monitor the patient in particularly pediatric and neonatal by eliminating the motion related artifact. The monitored physiological signal being clinical body temperature, respiration rate, electrocardiograph, end-tidal co2 of inhale and exhaled breath, non-invasive arterial blood pressure using inflatable bladders and cuffs and so on.
Humans typically decorate things they like, not that they dislike. The novelty and effectiveness of decorations is enhanced if it changes with time like animation which have the enhanced effect of reducing a patient's fear, dislike, and anxiety of medical devices used in procedures.
The decorations apparently stimulate areas of the patient's brain that diminish the sensations of dislike, fear, anxiety, and pain usually provoked by standard, undecorated devices. Thus, these decorated patient monitors have a powerful and reproducible therapeutic effect.

OBJECTS OF THE INVENTION
One object of the present invention is to overcome the disadvantages / drawbacks of the prior art.
A basic object of the present invention is to provide an improved device for providing continuous physiological condition monitoring/vital signs of a patient, especially neonatal and pediatric.
Another object of the present invention is to provide an improved device that has got the circuit to check the restless, shaking, crying neonates and pediatric patients by monitoring the erratic vital signs such that device will then generate a melodious tone to attract the attention so that the neonates and pediatric patients will stop the body motion and pay attention to the tone.
These and other advantages of the present invention will become readily apparent from the following detailed description taken in conjunction with the accompanying drawings.

SUMMARY OF THE INVENTION
The following presents a simplified summary of the invention in order to provide a basic understanding of some aspects of the invention. This summary is not an extensive overview of the present invention. It is not intended to identify the key/critical elements of the invention or to delineate the scope of the invention. Its sole purpose is to present some concept of the invention in a simplified form as a prelude to a more detailed description of the invention presented later.
According to one of the aspect of the present invention the system is provided an improved device for physiological monitoring of neonates and pediatric patient, said device comprising:
An enclosure means , said enclosure means comprising :
a front side of the enclosure means comprising :
a display means adapted to display waveforms, numerical value and animations,
a capacitive touch keyboard adapted to take in input from user and control the functions of the said device,
a speaker means to emit beep sounds, alarm tones, pre-recorded instrumental music or lullabies;
a visual alarm comprises LED having different colors;
a back side of the enclosure means ;and
a central module of the enclosure means operatively connected with said front and back side , said central module comprising
a controller means operatively connected with a capacitive touch keyboard; visual alarm ;
a level convertor means operatively connected with said controller means and said display means adapted to provide interface between said controller and display means;
a speaker driver operatively connected with said controller means and said speaker means to operate said speaker means;
plurality of storage means operatively connected with said controller means, said storage means comprises:
a buffer means operatively connected with said controller means adapted to store images displayed on said display means such that said controller use the data as external graphics memory;
a non-volatile storage means adapted to store volume level and control a digital potentiometer is controlled by the controller means , said potentiometer is connected to speaker driver adapted to drive the speaker means and is used for generating various tones, musical notes or even voice messages;
Plurality of electrically erasable programmable random access memory means (EEPROM) operatively connected with said controller means;
a chip means adapted to store clock and calendar data which is having coin cell battery as power backup such that the controller will get data from chip means for time, date , timer clock , calendar information and display on display means.
plurality of extraction modules operatively connected with plurality of sensor means adapted to convert the useful signal data from the patients in to digital form which also contains signal level indicator; and
plurality of analog module interface means dated to connect said extraction module and controller means adapted to pass said digital form signal and signal level indicator from extraction module to controller means;
wherein said controller means compares the present digital form signal and signal level indicator with expected signal stored and decides whether to display the waveform and numeric in display means;
wherein said controller means compares the present signals with expected signal such that if the present signal is not matching with said expected signal , said controller will not display the present signal instead will display animations via display means and emit melodious sounds via speaker means.

DETAILED DESCRIPTION OF THE INVENTION
The present invention relates to an improved device for providing continuous physiological condition monitoring of a patient, especially neonatal and pediatric , including periods during which the patient is in transport from one location to another and prolonged home care. The device has got the circuit to check the restless, shaking, crying neonates and pediatric patients by monitoring the erratic vital signs. The device will then generate a melodious tone to attract the attention so that the kids will stop the body motion and pay attention to the tone.
The device will reduce the motion artifacts generated and the quality of the vital signs derived from patients will improve. In spite of this if the motion artifacts does not stop then the device will raise an alarm tone to draw the attention of the care-giver after a predetermined delay of about 90 seconds.
The device has TFT-LCD electronic display where the simple animation figures like smiling fish , smiling doll ,smiling circus joker which are displayed automatically when the vital biological signals extracted from the kids is poor in quality due to the restlessness associated with their age. These animated images will make-believe the kids that they are looking at some aquarium or electronic toy. This will make the kids to stop all the body motion for the time being due to which the signal quality of the vital signs extracted from the kids is improved.
The entire patient monitoring device including sensors attached is designed and camouflaged such a way that it looks like a toy or attractive stuff to look into.
The outside surface of the patient monitor enclosure and the sensors are designed such a way that they are camouflaged with cartoon characters, doll pictures, star type smiles, circus jokers and so on.
In a hospital, family physicians office or other health care setting, it is frequently necessary to observe critical physiological conditions of a patient, such as blood oxygen saturation, body temperature, breath rate, pulse, blood pressure, respiration, ECG data. When the neonates and pediatric patients are brought to physician normally it is found that they are restless and the sensors those are attached give poor signals due to this.
According to one of the embodiments of the present invention there is provided an improved device for physiological monitoring of neonates and pediatric patient. The device comprises ‘an enclosure means. The enclosure means comprises a front side of the enclosure means, a back side of the enclosure means and a central module of the enclosure means.
The enclosure means is biocompatible plastic injection molded using master –batch resins.
The front side of the enclosure means comprises a display means adapted to display waveforms, numerical value and animations; a capacitive touch keyboard adapted to take in input from user and control the functions of the device; a speaker means to emit beep sounds, alarm tones, pre-recorded instrumental music or lullabies; and a visual alarm comprises LED having different colors. The display means has an ultra wide viewing angle of more than 100 ˚.
The front side of the enclosure means further comprises a wireless communication means comprises a two way wireless communication port for exchanging data in digital form.
The wireless communication means is infrared communication device , blue-tooth, Zig-bee, W-CDMA and like.
The front side of the enclosure means also comprises plurality of animation means displayed on the display means and plurality of sticker means substantially pasted on the front enclosure means.

The back side of the enclosure means comprises an air exchanger means to exchange hot and cold air in the ambient where the exchanger means having a substantially handle like design to hold and grip the device ; a container means adapted to place a battery pack means; a switch operatively connected with the container means to switch on and off the device, the switch is slid able; an external connector means adapted for deriving external DC from UPS or battery means to keep the device ON; plurality of mounting holes adapted fix the device on the wall, the holes are threaded; and an inlet connector means adapted to take 220 V ac from wall outlet and supplies to a AC to DC converter means.
The central module of the enclosure means operatively connected with the front and back side . the central module comprises a controller means operatively connected with a capacitive touch keyboard; visual alarm ; a level convertor means operatively connected with the controller means and the display means adapted to provide interface between the controller and display means; a speaker driver operatively connected with the controller means and the speaker means to operate the speaker means; plurality of storage means operatively connected with the controller means, a chip means adapted to store clock and calendar data which is having coin cell battery as power backup such that the controller will get data from chip means for time, date , timer clock , calendar information and display on display means, plurality of physiological signal extraction modules operatively connected with plurality of sensor means adapted to convert the useful signal data from the patients in to digital form which also contains signal level indicator; plurality of analog module interface means dated to connect the extraction module and controller means adapted to pass the digital form signal and signal level indicator from extraction module to controller means.
The storage means comprises a buffer means operatively connected with the controller means adapted to store images displayed on the display means such that the controller use the data as eternal graphics memory; a non-volatile storage means adapted to store volume level and control a digital potentiometer is controlled by the controller means , the potentiometer is connected to speaker driver adapted to drive the speaker means and is used for generating various tones, musical notes or even voice messages and plurality of electrically erasable programmable random access memory means (EEPROM) operatively connected with the controller means.

The plurality of memory means comprises first memory means adapted to store/record the entire user program that is run the device such that after the power on the program in EEPROM is copied and loaded into the controller means, the first memory stores music notes, animated characters ; and second memory means to store the digital trend values of the various vital signs measures from the patient.
The second memory means stores the patient vital signs in the form of waveform and numerical values with one of the three formats 72 hrs with 3 minute resolution, 48 hours with 2 minute resolution and 24 hours in one minute resolution.
The controller means compares the present digital form signal and signal level indicator with expected signal and decides whether to display the waveform and numeric in display means;
The controller means compares the present signals with expected signal such that if the present signal does not match with the expected signal , the controller will not display the present signal instead will display animations via display means and emit melodious sounds via speaker means;
The controller means checks for reduction in motion artifact and improvement in vital sign having a delay time for around 90 seconds without giving a false alarm and display the present signal (waveform and numerical data) and if otherwise alerts the caregiver by flashing red or yellow color by visual alarm means and beep tone by the speaker means.
The controller means compares the present signals with expected signal such that if the present signal is not matching with the expected signal, the controller will not display the present signal instead will display animations via display means and emit melodious sounds via speaker means that is stored in the first memory means.

The device further comprises a polarized connector means which is mounted by a color coded panel. The connector means connected with the plurality of sensor means that are connected with patients to provide various vital signs/physiological parameters from patients.

The sensor means comprises finger sensors, ECG cable/electodes,ETCo2 cannula and like to measure different vital signs/physiological parameters of patients.

The sensor means have various cartoon characters, caricatures, smiling star stickers ,circus jokers and like by imprinting, silk screen printing, embossing.

The central module of the enclosure means further comprises plurality of protection means adapted to prevent damage in the device due to surge voltage across the main line, over voltage and over current.

The protection device comprises a voltage dependent resistor / Metal oxide varistor ( MOV) is electrically connected between line and neutral points of the power supply such that the breakdown rating of the MOV is selected in such a way that surge current for the voltage above say, 300 volt a.c. is passed safely and failure is prevented; a pair of reset able fuses such that if the current through the fuses crosses a preset limit the self heat generated will increase the impedance and will bring down the short circuit current to minimum ; and a gas discharge tube which acts like a open circuit when the input voltage of around 400 volt, while if a lightning surge strikes across line and neutral then the tube will breakdown and bypass the excess current to ground .

The MOV, reset able fuse, gas discharge tube all are tightly held together by a thermally conducting epoxy so that the heat generated in the MOV due to surge is efficiently transferred to the reset able fuse and the power is disconnected due to tripping of the fuse.

The thermally conducting epoxy Teflon /silicone/polyolefin sleeve is tightly wrapped around MOV, reset able fuse, gas discharge tube.
The battery means supply the backup power to the monitor for at least three hours, consisting of a double pole slide switch which cannot be switched ON/OFF accidentally but used to disconnect the battery means during transportation .

BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWING
Other features as well as the advantages of the invention will be clear from the following description.
In the appended drawing:
Figure 1 illustrates the device for neonates and pediatric patient –overall view.
Figure 2 illustrates the device for neonates and pediatric patient -backside perspective view .
Figure 3 illustrates the block diagram –controller, clock, memory, keyboard, audio, alarm.
Figure 4 illustrates the block diagram-analog modules, infrared port, sensors, USB disk.
Figure 5 illustrates the block diagram-power supply, overvoltage and over current protection , battery pack.
Figure 6 illustrates external display and USB disk.

DETAILED DESCRIPTION OF THE ACCOMPANYING DRAWINGS
In the following detailed description, reference is made to the accompanying drawings that form a part hereof, and illustrate the best mode presently contemplated for carrying out the invention. Further functioning of the device has been discussed below to describe the way it operates. However, such description should not be considered as any limitation of scope of the present device. The structure thus conceived is susceptible of numerous modifications and variations, all the details may furthermore be replaced with elements having technical equivalence. In practice the materials and dimensions may be any according to the requirements, which will still be comprised within its true spirit.
The working of this invention can be easily understood by referring to the attached drawings Fig 1. Fig2. Fig 3, Fig 4, Fig 5, Fig 6
Fig 1, Part 100 shows the overall view of the invention explained in this disclosure. Part 102 is a plastic enclosure which is used for housing this invention. The enclosure is plastic injection molded using master-batch resins. The enclosure is biocompatible so that it will not cause skin irritation when comes in contact with humans. The enclosure is designed such a way that water or moisture will not enter inside the enclosure and cleaning or “wiping down” with germicidal solutions is easy.
This enclosure is camouflaged by imprinting various cartoon characters, caricatures, smiling star stickers, circus jokers and so on.
By way of an example, only part 124 is shown which is a smiling star.
The enclosure shown is for one of the preferred embodiment. Other enclosures with different dimensions and variety of outside surface features can also be used without deviating from the spirit and scope of the invention.
This enclosure contains the parts described in block diagram Fig 3, Fig 4 and Fig 5. Part 106 is a TFT-LCD electronic display device used to output the vital signs. When the vitals signals are good in quality and no restlessness is observed, the display 106 will show only waveforms 104 and numerical part 110 on the display. When there is disturbance and random change in waveform and numerical, the display will automatically bifurcate in to entertainment portion and vital sign portion. The entertainment portion will display animated fish 114 as shown in Fig. 1.
This is by way of an example. Other animated characters like doll, cartoon character, smiling star ,circus jokers as in part 108 can be displayed according to the marketing needs.
The part 112 is a touch type keyboard where, user will control the function of the device.
The part 122 is a color coded panel mounted polarized electrical connector. The pulse oxymeter finger sensor part 116 is connected at distal end to this connector.
The sensor itself can be camouflaged by imprinting, silk screen printing, embossing various cartoon characters, caricatures, smiling star stickers ,circus jokers and so on.
By way of an example only part 118 is shown is a butterfly. The shape of the butterfly which blends well with the finger probe clips.
Part 120 is a two way wireless communication port for exchanging data in digital form. The trend data, waveform and numerical data related to vital signs. In one of the embodiment infrared communication device is used. Other standard wireless communication devices like blue-tooth, Zig-bee, W-CDMA can be very well adopted and used for the disclosed invention.
Fig 2 shows the backside perspective view of the patient monitor.
The part 202 is an air exchange port for ambient which is also designed in the shape of a handle grip. This handle shape will help to grip-hold and carry the monitor by one hand.
The warm or cold air is exchanged through this port 202. The part 204 is an container for placing the battery pack 514.
Part 212 is a sliding electrical switch connected to the battery pack 514. When the device 100 is transported before installation from one place to another especially in cargo aircraft there is a need to electrically disconnect the battery for safety reasons.
Part 206 is a electrical connector used for deriving external DC from UPS or battery. This is needed when the patient monitor is accompanying the patient while being transported in road ambulance or air ambulance. In such cases where mains electricity is not available and the internal battery pack 514 back up is not sufficient. The DC current supplied from ambulance battery through Part 206 will keep the monitor on.
Part 208 are four mounting holes used to fix the monitor on the wall. These threaded holes will help in mounting the patient monitor to hospital wall, road / air ambulance wall.
Part 210 is mains inlet connector which takes 220 V ac from wall outlet and supplies to AC to DC converter 502.
The part 300,400 is a printed circuit board (PCB) containing all the parts and components described in part 300/Fig 3 and 400/Fig 4 and 500/Fig 5. This is also named as mother-board or main-board
The block diagram of the invention is described in Fig 3.
Part 308 is a PIC-16 bit micro-controller which is controlling the entire device. This contains graphics controller, universal serial bus (USB) port, capacitive touch sensing control port, parallel and serial communication ports.
A capacitive touch keyboard part 112 is Connected to this 308. Whenever a key is pressed a electric charge is generated and sensed by the 308.
The part 106 is a 6.5 inch TFT-LCD display with preferred resolution 640x480 pixels. Other resolutions like 480x250, 640x480, 1024x768 can also be used.
The part 302 is a TTL to LVDS (low voltage differential signal) level converter which helps to interface the display 106 and the controller 308.
The part 316 is a speaker driver audio amplifier connected to controller 308 at distal end and to a speaker 128/part 100 at proximal end. This speaker will emit beep sounds, alarm tones, pre-recorded instrumental music or lullabies.
Part 126 is visual alarm which can be in RED, YELLOW,BLUE colors. The lamps, LED s can be used. Alternatively part of TFT display 106 or keyboard 112 can be used for these visual alarm indications.
The part 304 is a frame buffer and 4 mega byte sized - Static RAM . This will store the images to be displayed on 106.
The micro-controller 308 will use this as external graphics memory since no memory is available inside the MCU 308.
The part 318 is an 8-Bit Single/Dual I2C Digital POT with non-Volatile Memory. In the prior art manual potentiometers were used for controlling the speaker volume.
The digital potentiometer is controlled by the micro-controller 308 and volume level is set in non-volatile memory. This potentiometer 318 is connected to speaker driver part 316. The speaker driver 316 will drive the speaker 128 and is used for generating various tones, musical notes or even voice messages.
Part 312 is a EEPROM (electrically erasable programmable random access memory) with preferred size 256 kilo byte. Other memory sizes can also be used. The user program to run the entire invention in part 100 is recorded in to this EEPROM. After the power on, the program in EEPROM 312 is copied and loaded into micro-controller 308.
Part 310 is another EEPROM used by the micro-controller 308 to store the digital trend values of the various vital signs measures from the patient. The storage is with one of the three formats 72 hrs with 3 minute resolution, 48 hours with 2 minute resolution and 24 hours in one minute resolution
Part 306 is a chip which contains clock and calendar. This has got a coin cell battery 314 as power backup so that it is not dependent on the power supplied by 506,514.
The controller 308 will use this 306 for time, date, timer clock, calendar information to display on 106.
The analog signal extraction from patient through the sensor 116 and connector 122 by the invention 100 can be understood by referring to Fig 3, Fig 4.
The parts 402,408,414 are the various sensors connected to patient and analog signal extraction modules 404,410,416.

The parts 406,412,418 are analog modules interface containing RS232 at module side and TTL five volt level communication on the other side which finally goes to MCU 308.

By way of an example spo2 module is described elaborately. The 402 contains 116, 122,and the entire front-end noise filter components and cables.

The analog signals extracted by the finger probe sensor 116 pass through connector 122 and reach 402. The weak electrical signals are filtered for noise using suitable electronic circuits. Also the amplification is done using operational amplifier circuits. The noise in this oxy-hemoglobin saturation signal can be due to relative shaking of probe and finger inside 116, ambient light scattered inside the probe, the weak signal due to low perfusion of oxygenated blood inside finger and so on.
There will be a limitation for the circuits inside 402 and 404 to filter out the noise and retain the useful signal which is decided by the ratio of noise strength to useful signal strength.

If the noise power becomes too high the useful signal will be masked and by measuring the signal strength in required band this can be estimated. The module 404 will convert the useful signal data in to digital form which also contains the signal level indicator. This digital signal is passed on to MCU 308 along with the signal strength level indicator. This indication can be from digits 0 to 10 or its hexadecimal or binary equivalent form. The MCU will check this with its preloaded program stored and draws the conclusion about whether to display the waveform in location 104 and numeric in location 110.

If the waveform is not matching with the expected shape and the numeric are erratic then 308 will decide not to display these waveform 104 and numeric 110. Instead it will look for a subroutine program stored in 312 which contains music notes, animated characters and will display them using 304, 302.

The information from clock and calendar chip 306 can be used to add time and date stamp to the 104 and 110. This information is also stored in digital form in trend storage EEPROM 310.
When this EEPROM is full or care-giver wants to dump this data to his personal laptop then a USB memory device 606 is used. The digital trend data is then transferred from 310 to 606.
When ever there is a need to print these waveform 104 and numeric 110, the suitable key is pressed on 112 and the exact data to be printed is selected. This information is then transmitted using internal infrared port 416 placed behind the 120. The part 416 is will communicate with any external infrared communicating device 414 consisting of thermal printer. The data is then printed on the thermal paper.

The working of power supply section can be understood by referring to the block diagram Fig 5.
Part 500 is complete power supply section. Part 210 is mains power supply inlet socket.
This socket is electrically connected to an over voltage and over current protection circuit part 504.
Further this 504 is electrically connected to AC to DC power supply part 506. This universal input AC/DC power supply will convert the energy in to regulated DC . The input a.c. can be as low as 85 volt to as high as 265 volts a.c.
This output of Part 506 can be as low as 11 volt d.c. to as high as 18 volt d.c.
This d.c. is electrically connected to DC/DC voltage converter part 510. The 510 consists of a PCB and several power converting circuits with outputs like 5 volt dc, 12 volt dc, -15 volt dc , 3.3 volt dc and so on….
This highly regulated and noise /ripple free voltage is fed to various electronic circuits assembled inside the enclosure 102. The same power also can be fed to add on modules and accessories connected to the main unit enclosure 102.
A part of the DC voltage module 510 is electrically connected to lithium ion battery charger 508 and then to a battery-pack 514 containing battery protection circuit part. This part 514 has got various electronic circuits for charging the battery pack whenever AC power is available. Whenever AC power through 506 is not available and the system is ON, the pack 514 will be discharge and feed the DC power to all the circuits inside the enclosure 102. The part 504 is a protection device for the neonatal and pediatric friendly patient monitor disclosed in this invention.
In many places it is observed that due to the surge voltage across the mains line the patient monitor gets damaged. A surge is sudden and steep increase in line-input voltage at part 210,502,506 for a brief period.
For example the part 506 can with stand ac voltage from 85 a.c. to 265 a.c.
If a sudden surge voltage of say 300 volt or 400 volt appears then any components described in Fig. 5,Fig 4, Fig 3 can get damaged. To prevent this a voltage dependent resistor / Metal oxide varistor (MOV) 522 is electrically connected between line and neutral points of the power supply. The breakdown rating of the MOV is selected such a way that surge current for the voltage above say, 300 volt a.c. is passed safely and failure is prevented. But the MOV can withstand such surges only for few seconds. If the surge voltage remains indefinitely then the MOV-522 will over heat and burn due to which a fire can start. The component 518 and 520 are reset able fuses replacing conventional filament type one time fuses. The property of the reset able fuse is chosen such a way that if the current through 518 and 520 crosses a preset limit the self heat generated will increase the impedance and will bring down the short circuit current to minimum. This property is set such a way that only when shorts between supply and ground happens with excess current flows for 508,510,506 etc.
But when surge voltage for prolonged time occurs at 502 and 506 where the current is lesser than preset short circuit current but higher than normally consumed current then 518 and 520 will not trip because the internal heat generated by the device is not sufficient. It is found by the inventors of this medical device that by externally heating 518 and 520, using the self heat generated by 522(due to the surge voltage and the current) the fuses 518 and 520 can be tripped.
When it happens the mains power supply to the parts 506,508 will be disconnected. The vital sign monitoring for neonatal and pediatric device described in this invention is a critical device where shut down due to failure is not accepted. So a logical signal is fed to the part 508,510 to activate the battery pack and supply DC power to the invention described in part 100.
It is important that the internal heat generated by MOV- 522 is transferred to 518 and 520 to the maximum so that the time taken to trip is minimum. To achieve this a thermally conducting but electrically insulated adhesive is used to bond MOV 522 and reset able fuses 518 , 520. This is done by locating these components very close to each other and filling the air gap between them using epoxy/adhesive. To increase the thermal conduction between these component a Teflon /silicone/polyolefin sleeve is tightly wrapped around 522,518,520. The part 516 is a gas discharge tube which acts like a open circuit when the input voltage is say around 400 volt. But if a lightning surge strikes across line and neutral then this will breakdown and bypass the excess current to ground.
Similar protection circuit is also provided for external DC source 206 since the battery from ambulance is charged through dynamo and engine and there is a possibility that over voltage can appear for prolonged period.
There is also a need to monitor all the critical voltages and to give a signal to controller 308 and battery charger discharger 508. The part 512 is a analog multiplex circuit. The inputs are from 504,506,510,508,206. The output is given to controller 308. The controller will decide about the power to be drawn from internal battery pack, external battery, mains supply. In case all the there sources are corrupted then the unit will shut down.
With this the invention monitors pediatric patient continuously irrespective of mains power availability.
The vital signal extraction from patient will work as follows.
The device 100 is switched on using the ON/OFF switch 112. The micro-controller 308 will do self test and check whether all the circuits described in Fig 3, Fig 4, Fig 5 are OK. A message is displayed on 104 to connect the finger probe sensor 116. When 122 connector is connected the 308 will do self-test to check the finger pulse oxymeter sensor. The index finger of the pediatric or neonatal patient is inserted into the probe 116.
The controller 308 will instruct the SPO2 module 404 to power on the sensor and extract the oxy-hemoglobin saturation signal from the finger. If the signal quality is good without motion artifact, then the waveform is displayed and numerical value is shown in location110.
When patient is restless and 116 is shaking the signal quality will start deteriorate and a point will reach when displaying waveform and numeric values on screen 104 is of no use. At that point controller 308 will switchover to an animation program stored in 312 and load it in to 308. This program will display various animated character like 114,124,108. This delay time may be around 90 seconds.
The device 100 is positioned in such a way that the patient as well as care-giver both can see the display 106. Alternatively a TFT flat panel display with ultra wide viewing angle of more than 100 degree can be used.
When pediatric patient observes these animations, the white coat tension (fear of hospital, doctor, sensors) will come down and the body motion will reduce. The kid will keenly observe the animated entertaining display 106 and the body, in particular the finger will become motionless. At this moment controller 308 will compare the noise Vs signal ratio and restart the oxymeter module 404 and a noiseless waveform and numeric display is shown on 106. This delay time may be around 90 seconds.
Fig 6, Part 600 shows another preferred embodiment of the invention described in Fig 1.
In this case the prerecorded video and audio segments are stored in external USB port based Pen drive part 606. This USB disk is inserted into the USB port part 608 of the patient monitor device . The patient monitor described in this invention will have a 15 pin D-Sub panel mounted electrical connector part 610 which is SVGA video port.
An external TFT-LCD display monitor 602, which has got the similar SVGA port as 610 is connected to the patient monitor 102 through a display interface cable 604. This external monitor is usually called slave or “remote viewing” monitor. Whenever the patient monitor is not able to get the valid vital sign from the patient it will trigger the USB drive 606 and acquires the video and audio prerecorded messages and will output through the 15 pin D-sub connector. These instrumental music, vocal songs, composed like lullaby form and the pictures of mother or the person liked by the patient are displayed on the screen.
Mothers have been singing lullabies to their babies since time immemorial. Many researches have proven the efficacy of playing soothing music for the purpose of inducing sleep in subjects of all ages. It is observed that, when babies heard the voices of their own mothers, they fell asleep. When unfamiliar voices sang to them they became restless and wakeful. However, when they listened to soothing instrumental music, the babies fell asleep easily.

WE CLAIM

1. An improved device for physiological monitoring of neonates and pediatric patient , said device comprising
an enclosure means , said enclosure means comprising :
(a) a front side of the enclosure means comprising :
a display means adapted to display waveforms, numerical value and animations;
a capacitive touch keyboard adapted to take in input from user and control the functions of the said device;
a speaker means to emit beep sounds, alarm tones, pre-recorded instrumental music or lullabies; and
a visual alarm comprises LED having different colors;
(b) a back side of the enclosure means ;and
(c) a central module of the enclosure means operatively connected with said front and back side , said central module comprising
a controller means operatively connected with a capacitive touch keyboard; visual alarm ;
a level convertor means operatively connected with said controller means and said display means adapted to provide interface between said controller and display means;
a speaker driver operatively connected with said controller means and said controller means to operate said speaker means;
plurality of storage means operatively connected with said controller means, said storage means comprises:
a buffer means operatively connected with said controller means adapted to store images displayed on said display means such that said controller use the data as eternal graphics memory;
a non-volatile storage means adapted to store volume level and control a digital potentiometer is controlled by the controller means , said potentiometer is connected to speaker driver adapted to drive the speaker means and is used for generating various tones, musical notes or even voice messages.
plurality of electrically erasable programmable random access memory means (EEPROM) operatively connected with said controller means;
a chip means adapted to store clock and calendar data which is having coin cell battery as power backup such that the controller will get data from chip means for time, date , timer clock , calendar information and display on display means.
plurality of patient signal extraction modules operatively connected with plurality of sensor means adapted to convert the useful signal data from the patients in to digital form which also contains signal level indicator;
plurality of analog module interface means dated to connect said extraction module and controller means adapted to pass said digital form signal and signal level indicator from extraction module to controller means;
wherein said controller means compares the present digital form signal and signal level indicator with expected signal and decides whether to display the waveform and numeric in display means;
wherein said controller means compares the present signals with expected signal such that if the present signal does not match with said expected signal , said controller will not display the present signal instead will display animations via display means and emit melodious sounds via speaker means;
2. Device as claimed in claim 1 wherein said enclosure means is biocompatible plastic injection molded using master –batch resins.
3. Device as claimed in claim 1 wherein said front side of the enclosure means comprises plurality of animation means displayed on said display means and
plurality of sticker means substantially pasted on said front enclosure means;
4. Device as claimed in claim 1 wherein said front side of the enclosure means further comprises a wireless communication means comprises a two way wireless communication port for exchanging data in digital form.
5. Device as claimed in claim 1 wherein said back side of the enclosure means comprising:
an air exchanger means to exchange hot and cold air in the ambient , said exchanger means having a substantially handle like design to hold and grip the device ;
a container means adapted to place a battery pack means;
a switch operatively connected with said container means to switch on and off said device, said switch is slid able;
an external connector means adapted for deriving external DC from UPS or battery means to keep said device ON;
plurality of mounting holes adapted fix said device on the wall, said holes are threaded; and
an inlet connector means adapted to take 220 V ac from wall outlet and supplies to a AC to DC converter means.
6. Device as claimed in claim 1 wherein said wireless communication means is infrared communication device, blue-tooth, Zig-bee, W-CDMA and like.
7. Device as claimed in claim 1 further comprises a polarized connector means which is mounted by a color coded panel.
8. Device as claimed in claim 7 wherein said connector means connected with said plurality of sensor means that are connected with patients to provide various vital signs/physiological parameters from patients .
9. Device as claimed in claim 8 wherein said sensor means comprises pulse oxymeter finger sensors, ECG cable/electrodes, ETCo2 nasal respiration gas sampling cannula and like to measure different vital signs/physiological parameters of patients.

10. Device as claimed in claim 9 wherein said sensor means have various cartoon characters, caricatures, smiling star stickers, circus jokers and like by imprinting, silk screen printing, embossing.

11. Device as claimed in claim 1 wherein said plurality of memory means comprises :
first memory means adapted to store/record the entire user program that is run the device such that after the power on the program in EEPROM is copied and loaded into said controller means, said first memory stores music notes , animated characters ; and
second memory means to store the digital trend values of the various vital signs measures from the patient.

12. Device as claimed in claim 11 wherein said second memory means stores the patient vital signs in the form of waveform and numerical values with one of the three formats 72 hrs with 3 minute resolution,48 hours with 2 minute resolution and 24 hours in one minute resolution.

13. Device as claimed in claim 1 wherein said controller means checks for reduction in motion artifact and improvement in vital sign having a delay time for around 90 seconds without giving a false alarm and display the present signal (waveform and numerical data) and if otherwise alerts the caregiver by flashing red or yellow color by visual alarm means and beep tone by said speaker means.

14. Device as claimed in claim 1 wherein said display means has a ultra wide viewing angle of more than 100 ˚.

15. Device as claimed in claim 1 wherein said controller means compares the present signals with expected signal such that if the present signal is not matching with said expected signal , said controller will not display the present signal instead will display animations via display means and emit melodious sounds via speaker means that is stored in said first memory means.

16. Device as claimed in claim 1 wherein said central module of the enclosure means further comprises plurality of protection means adapted to prevent damage in the device due to surge voltage across the main line, over voltage and over current .

17. Device as claimed in claim 16 wherein said protection device comprises

a voltage dependent resistor / Metal oxide varistor ( MOV) is electrically connected between line and neutral points of the power supply such that the breakdown rating of the MOV is selected in such a way that surge current for the voltage above say, 300 volt a.c. is passed safely and failure is prevented;

a pair of reset able fuses such that if the current through said fuses crosses a preset limit the self heat generated will increase the impedance and will bring down the short circuit current to minimum ; and

a gas discharge tube which acts like a open circuit when the input voltage of around 400 volt, while if a lightning surge strikes across line and neutral then said tube will breakdown and bypass the excess current to ground ;

18. Device as claimed in claim 17 wherein said MOV ,reset able fuse, gas discharge tube all are tightly held together by a thermally conducting epoxy so that the heat generated in the MOV due to surge is efficiently transferred to the reset able fuse and the power is disconnected due to tripping of the fuse.

19. Device as claimed in claim 18 said thermally conducting epoxy Teflon /silicone/polyolefin, fire retarding sleeves is tightly wrapped around MOV , reset able fuse, gas discharge tube.
20. Device as claimed in claim 1 wherein battery means supply the backup power to the monitor for at least three hours , consisting of a double pole slide switch which cannot be switched off accidentally but used to disconnect the battery means during transportation .

21. An improved device for physiological monitoring of neonates and pediatric patient as herein substantially described and illustrated with the accompanying drawings.