5000 series warmers

5000 series warmers

1. nice Ne Ö tech Medical Systems Pvt. Ltd

2. Presentation Flow COMPANY OVERVIEW CLINICAL ASPECTS OF nice 5000 SERIES OPEN CARE SYSTEM PRODUCT OVERVIEW TROUBLESHOOTING

3. Company INFO Established in the year 1997 Group of highly skilled professionals 4000+ highly satisfied customers Deep penetration in NICU and respiratory domain User friendly range of products With deep skills and high end technology , we always strive for growth and delighted customers

4. Timeline-nice Neotech 2005 First New Factory Unit 1 Opened Increase in production Line 2001 Registered as Pvt ltd Production started for different models 2013 Second New Factory Unit 2 Opened 1999 Neotech Logo Designed Designed first incubator & open care prototype 2003 Export to Vietnam 2009-2011 CE certification for products 2015 125+skilled employee strong firm Multiple range of NICU products 1997 Started Neotech Medical Systems with 2 employees First Infant Radiant Warmer

5. Why nice Neotech ? User friendly range of products Customized solutions Ethical Business practices Stringent quality control management Complete customer satisfaction

6. Why Open Care Systems are Used?

7. MODES OF HEAT LOSS: Conduction Heat Loss: Direct heat transfer from skin to object Convection Heat Loss: Heat loss through air flow Also depends on Air Temperature Radiant Heat Loss: Direct transfer by electromagnetic radiation in infrared spectrum Heat gained by radiation from external radiant energy source. Heat lost by radiation to cooler walls of incubator. Evaporation Heat Loss: Heat loss when water evaporates from skin and respiratory track. Depends on maximum relative humidity of surrounding Less Humidity = More Evaporation Heat Loss(watts/meter square) Evaporation: 60-80 watts/meter square Radiation: 50 watts/meter square Convection: 25 watts/meter square Evaporation: Negligible Total Heat Loss: 135-155 watts/meter square

8. Electromagnetic Spectrum Infrared Spectrum

9. Effects of Far IR in Infant body Far Infrared Rays are invisible waves of energy They have the ability to penetrate all layers of the infant body, penetrating into the inner-most regions of the tissues, muscles and bone. Far Infrared Rays very gently increases blood flow  by expanding the capillaries that carry blood. It also increases oxygenation and regeneration of the blood. Far Infrared boosts the immune system, increasing the amount of white blood cells and killer T-cells. Far Infrared can also increase the processing enzyme activity in digestive tract, as well as boost metabolism.

10. Types of heaters Quartz A quartz heater is a type of infrared heater. The heating comes from a heating element encased inside a quartz tube. The element produces a wavelength of infrared radiation. The quartz protects the heating element and stops convection heat from escaping. Far IR Infrared Infrared radiation is a type of electromagnetic radiation just below the frequency of visible light. Pretty much everything emits infrared radiation. The hotter something is, the more infrared it emits. Every molecule also absorbs infrared at a certain wavelength. When a molecule absorbs infrared energy, it heats up. The IR rays ,by deep penetration in skin, ensures the growth of cells by stimulating it.

11. Ceramic Heaters Ceramic heaters  are heaters that generate heat by passing electricity through heating wires embedded in ceramic plates. The ceramic coating tend to crack over a period of time and can fall over the baby causing havoc Tubular Heater A tubular   heater  is  designed from metal tubing. There are chances of heat loss and heat conduction in relative heating methods. compared with other heating methods like resistance heating , infrared heating. The heating pipe has higher cost due to metal material . Types of heaters(Cont’d…….)

12. Benefits of Heater… Far IR Heating stimulates the cells of the baby by skin penetration and in turn helps growth of baby

13. Phototherapy System outcome The Phototherapy provides light of suitable wave-length and intensity for the treatment of hyperbilirubinaemia.

14. Resuscitation Substantial physiologic changes occur in the transition from fetal to extra uterine life including: The role of the placenta in gas exchange is taken over by the lungs. Changes from fluid-filled to air filled lungs. Dramatic increase in blood flow to the lungs with reversal, then closure of intra and extra cardiac shunts. Assistance to breathe at birth Prevent neonatal death Prevent Adverse longterm neurodevelopmental sequelae Failure or disruption of these changes may result in further difficulties with resuscitation in the newborn infant The need for resuscitation of the newborn infant at birth cannot always be anticipated or predicted. Benefit

15. A range of Baby friendly equipments 6 Layer security Introducing nice Ne Ö tech 5000 series Open Care Systems Designed to perfection for your baby

16. nice 5000 series Open Care Systems Models nice 5000 RP Open Care System Servo skin, Air and manual mode Apgar timer LED Phototherapy unit Resuscitator with PIP & PEEP O2 driven Venturi slow suction nice 5000 R Open Care System Servo skin, Air and manual mode Apgar timer Resuscitator with PIP & PEEP O2 driven Venturi slow suction nice 5000 P Open Care System Servo skin, Air and manual mode Apgar timer LED Phototherapy unit O2 driven Venturi slow suction Nice 5000 Infant Radiant Warmer Servo skin, Air and manual mode Apgar timer Large LED display

17. Micro controller based electronics 6 Layer security Servo Skin ,Air and Manual mode controls LED Phototherapy with timer cut off Resuscitation with safe PIP and PEEP Calibration Free temperature probe High Intensity Quartz Heating element for effective radiation Halogen Observational Lamp Parabolic reflector for uniform heating Memory Backup restores previously entered data in case of power failure Comprehensive alarms and safety cut off Instant warming and uniform heating Short wave heater ensures instant warming Automatic safety heater cutoff at 39 °C at any mode APGAR Timer O2 activated venturi suction Auxiliary oxygen Keypad Lock Features

18. How to operate? Control Panel Operation Operating Modes Alarms Heater Module Bed Platform Operation Side Panel Operation X-ray procedure LED Phototherapy Manual Resuscitation Suction System Auxiliary oxygen

19. Control Panel Operation 1 Skin Temperature Display 17 Decrease Key 2 Skin/Air Set Temperature Display 18 Increase Key 3 Fahrenheit Indicator 19 APGAR Kay 4 Centigrade Indicator 20 ºC/ºF Conversion Key 5 Skin Probe Failure Indicator 21 Lock Key 6 Air Probe Failure Indicator 22 Heater Output Indicator 7 Heater Failure Indicator 23 Skin mode indicator 8 Skin/Air >39ºC Indicator 24 APGAR Timer Indicator 9 System Failure Indicator 25 Mute ON Indicator 10 Power Failure Indicator 26 Manual Timer Indicator 11 Lock Indicator 27 Air Temperature Low Indicator 12 APGAR/Manual Timer Indicator 28 Air Temperature High Indicator 13 Air mode Indicator 29 Skin Temperature Low Indicator 14 Manual Mode indicator 30 Skin Temperature High Indicator 15 Mode Key 31 Alarm Indicator 16 Mute Key 32 Air temperature Display

20. Resuscitation Panel 1)Gas Supply Flow rate Set the Flow rate at 5 - 7 LPM in the Flow Meter 2)Setting the Maximum Pressure Occlude PEEP knob and turn PIP control fully clockwise adjust maximum pressure control knob clockwise or counterclockwise to set desired maximum pressure 3)Setting the Peak Inspiratory Pressure (PIP) Occlude the PEEP knob, turn PIP control knob counter-clockwise until the desired peak inspiratory pressure is set. 1 2 3

21. Operating Modes Manual Mode Operation 􀂙 The environment temperature in bed platform area is manually control by varying the percentage of heater output. 􀂙 Manual Timer Setting – Press Mode key and change into Manual Mode then Press Combination of Mute Key and increase (▲)/Decrease (▼) Key Set the Manual Timer (1 min – 15 min) 􀂙 % of Heater output Setting – Press increase (▲)/Decrease (▼) switch to adjust the % of Heater Output in 10% increments. 􀂙 Manual timer alarm for 15 min by default, as an indication to monitor the patient temperature at a time the heater output is reduced.

22. Skin Mode Operation Note: The skin temperature probe must be properly attached before choosing Skin mode operation. 􀂙 The user must select a Skin control temperature (Set required Temperature) when the Infant Radiant Warmer is used in the Skin mode. 􀂙 How to set temperature in skin mode? The Skin control temperature is adjusted by pressing the increase (▲) and decrease (▼) switches. The temperature can be adjusted from 32°C to 38°C. APGAR Timer : The APGAR display indicates the APGAR timer select in the APGAR Mode. Operating Modes(cont’d…)

23. Operating Modes(cont’d…) Air Mode Operation The Air temperature probe must be properly attached on the rear Panel of the Open Care System before starting air mode operation. Select air control temperature (Set required Temperature) setting when the Open Care System is used in the air mode for the first time. The air control temperature is adjusted by pressing the increase (▲) and Decrease (▼) touch switches. The control temperature can be adjusted from 20 to 38°C. In the air mode, the temperature sensed by the air temperature probe is used by the control system to modulate the radiant heat and maintain the Environment temperature at the selected control temperature. Note: All the above mentioned modes can only be accessible when the keypad lock is off

24. Alarms

25. Heater Module The parabolic design of the heater module ensures that the Far IR radiant energy is distributed very evenly over the bed surface .The IR rays ,by deep penetration in skin, ensures the growth of cells by stimulating it. With 6 layer safety measures , the chances of hypo and hyperthermia is ruled out. The heater also comes with a thermostat temperature control for enhanced protection.

26. Bed Platform Operation The bed platform tilts for Trendelenburg and Fowler positioning capabilities. Rotate the knob placed on the right side of the machine to position the bed (up or down). Caution: when the mattress is in the tilted position, ensure an additional support is provided to minimize the baby falling.

27. Side Panel Operation To lower a side panel, pull it up and then pull the top edge away from the bed. To raise a side panel, swing it to the upright position; then allow it to engage in the latched position.

28. X-ray Procedure The X-ray cassette may be placed in the slot under the bed platform or in the X-ray cassette tray, if installed. The heater housing rotates to the left or right The X-ray cassette tray facilitates X-ray procedures while patients occupy the Infant Radiant Warmer bed. An X-ray cassette can be placed on the tray and slid into the cavity beneath the bed without disturbing the patient.

29. LED Phototherapy Designed to provide light of suitable wave-length and intensity for the treatment of hyperbilirubinaemia. The system consists of two lamp units designed for mounting on each side of the nice heater module. These are angled to focus on the bassinet mattress for maximum illumination of the infant, and each unit includes a power switch for independent operation if required. Each lamp unit contains three 50 Watts tungsten halogen lamps with infra-red and ultra-violet filters to provide a high intensity light source in the 400 to 500 nanometer range.

30. Resuscitation Designed to provide the controlled suction and oxygen based resuscitation facilities necessary in helping the new born baby with breathing difficulties to survive the immediate post- natal period. The equipment comprises of an oxygen supply, a control module, and a suction bottle with tubing mounted on the left-hand side of the bassinet support. The unit operates from oxygen cylinders, or from a central pipeline supply and a range of oxygen supply hoses are available to suit the installed pipeline terminal. The control module includes a variable suction control system, auxiliary oxygen outlet with flow control, and a manually operated positive pressure airway ventilation facility. The maximum outlet pressures are limited by internal pressure relief valves for safety.

31. Suction system Suction is achieved using an oxygen activated venturi system in the control module. This is connected to a suction bottle, mounted on the bassinet support, via a tubing adaptor on the front panel. A bacterial filter is included in the suction tube to isolate the bottle from the control system. The level of suction can be adjusted using a control knob on the front panel, and a vacuum gauge is provided to indicate the degree of suction achieved. To minimize setting-up time , an on/off switch is also provided. The level of suction required can be pre-set before resuscitation is necessary and the system switched off until required for use.

32. Auxiliary oxygen system An oxygen outlet is provided on the front panel to enable a bag resuscitator or similar equipment to be used. The oxygen flow rate can be adjusted using the flow meter control valve provided, and the maximum supply pressure is limited by an internal pressure relief valve for safety. NOTE : The lining of a new born baby's mouth and airway is very delicate. Do not apply suction continuously or at excessive levels and Switch OFF the Suction Control system after use to conserve oxygen.

33. Comparison of nice 5000 Open Care System nice 5000 RP nice 5000 R nice 5000 P nice 5000 Skin Mode Y Y Y Y Manual Mode Y Y Y Y Air Mode Y Y Y Y X Ray Facility Y Y Y Y Phototherapy Y N Y N Resuscitator Y Y N N Pivoting Warmer Module Y Y Y Y Apgar Timer Y Y Y Y

34. How nice Open Care Systems fare over competitors?

35. 6 Layer Safety Features

36. TROUBLESHOOTING AND MAINTENANCE

37. Cleaning Procedure General Cleaning Clean the Temperature Probe by gently wiping with a soft damp cloth containing detergent of disinfecting solutions. Clean the exterior of the Infant Radiant Warmer using mild detergent solution applied with a damp cloth or sponge. Do not allow liquids to seep into the electrical housing. The mattress, x-ray tray, bed & side panels may be cleaned by using disinfecting agent safe for use on the material. Halogen Lamp Cleaning When the device is taken out of service for cleaning, wipe over the outside of the Halogen based lamp housings with a damp cloth and an approved detergent/disinfectant solution. Swing the lamp housing away from the heater module a little to allow cleaning of the touching surfaces, and polish the clear panels under the lamps with a lint-free cloth. To maintain maximum therapeutic value the interior of the lamp housings should be cleaned and all the lamps replaced at least once every six months Resuscitator Cleaning The suction System and any accessories must be thoroughly cleaned after use to minimize the risk of cross infection. The State of cleanliness of components in the Suction system may be checked by taking swabs and testing them by normal bacteriological methods

38. Preventive Maintenance General Always disinfect and clean the unit and accessories before any maintenance – even when returning the unit to the supplier for repair. Always disconnect power supply before any maintenance. Use only nice Neotech’s original parts for maintenance. Warning: Periodically check the insulation and the connection of the cable it may cause fire because of poor insulation and short circuits due to aging. Warning: Don’t misaligned the EMI Shielding and the beads as it may cause the EMI interference to the equipment Side Panels: visually inspect the panels every day , for any sign of breakages or loose fit . Temperature measuring system: Measuring system should be checked by trained service personnel with calibrated test probe every year . Note: No need of calibration if a new temperature probe is replaced. Bed Up/Down Tilting: To be inspected once in every three months by the trained technical personnel. Inspection & Maintenance : Yearly by trained Service Personnel.

39. LED Phototherapy The equipment requires no maintenance between routine service periods other than a functional test each time the device is put into service, and an irradiance check at least once a month. When finished, switch OFF the power and remove light from the therapy area. At least once in every six months the equipment should be examined by qualified Service Engineer to ensure operational safety. If the equipment is dropped or damaged or becomes excessively wet, take it out of service immediately for examination by a qualified Service Engineer to ensure safety and operational integrity. T-Piece Resuscitator The suction System and any accessories must be thoroughly cleaned after use to minimize the risk of cross infection. The State of cleanliness of components in the Suction system may be checked by taking swabs and testing them by normal bacteriological methods. At least once every six months the equipment should be examined by a qualified Service Engineer to ensure safety and operational integrity. If any part of the equipment is damaged or fails to operate correctly, take it out of service immediately and contact a qualified Service Engineer to ensure operational safety. Preventive Maintenance (Cont’d….)

40. Troubleshooting General System Failure System Fault Open Care System Sl. No Problem Cau s e Re m edy 1 Pow e r failure LED is O N w i th audio alarm Power Failure Ch ec k the un i t is Plugged i n to Main su p ply Ch ec k the mains a re switched O N. Else C o ntact nice N e otech 2 System Failure LED is ON with audio a l arm System Failure Cont a c t nice Neot e c h . General System Failure

41. System Fault Open Care System Sl. No Problems Possible C a uses a n d R e me d y 1 No D i sp l ay on the Control Panel Ch ec k A/C Supply Voltage Ch ec k if Power C o rd i s disco n n e cted Check Fuse in the Rear s i de of Pillar Contact n i ce Neotech 2 No Heater O utput Ch ec k Li n k cord con n ect e d betw e en Control M o dule to Heat e r M o d u le Set Temperature may be l e ss th a n Actu a l Temperature Ch ec k H e ater Con n ecti o n Contact n i ce Neotech 3 Equipm e nt Work i ng But O b servati o n L a mp & Heat e r output not working Ch ec k Li n k cord con n ect e d betw e en Control M o dule to Heat e r M o d u le Ch ec k Fuse in the Re a r s i de of Heat e r Module Ch ec k Tr a ns f orm e r Volta g e - 12V AC Rep l ace La m p 4 Equipm e nt not give the Audio Alarm Ch ec k the T e mperature it may near to the Set temperature Check Mute ON. Contact n i ce Neotech 5 Patient Tem p erat u re D i sp l ay sh o ws “ S -O” with C o ntinu o us Alarm (S-O: Se n s o r Ope n ) Ch ec k if skin Probe i s D i sconn e cted fr o m the Equipm e nt. If skin probe i s def e c tive, repl a c e n e w p robe Contact n i ce Neotech 7 Display s h ows H - F ( H -F: H e ater Failu r e) Ch ec k Li n k cord con n ect e d betw e en Control M o dule to Heat e r M o d u le Ch ec k H e ater Con n ecti o n Contact n i ce Neotech 8 Display Show O – t (O-t: Over Te mperature ie . Temp. > 39 ° C) Ch ec k Envir o nment Tem p erat u re a b ove 39° C Check Infant Fever 9 Conti n uo u s Skin Tem p erature H i gh A l arm Ch ec k Patie n t Temperature is 1 ° C abo v e Set Te m p e rat u re Ch ec k Envir o nment Tem p erat u re is 1 °C above Set Te m p e rat u re C o ntact nice N e otech 10 Conti n uo u s Skin Tem p erature L o w Al a rm Ch ec k Patie n t Temperature is 1 ° C bel o w Set

42. Te m p e rat u re Probe may b e wet. C o ntact nice N e otech Conti n uo u s Air Tem p erature H i gh A l arm Ch ec k Envir o nment Tem p erat u re is 1 °C above Set Te m p e rat u re ,else contact niceneotech 12 Conti n uo u s Air Tem p erature Low A l arm Ch ec k Envir o nment Tem p erat u re is 1 °C below Set Te m p e rat u re ,else contact niceneotech 13 Temp e rat u re over Mattr e ss does n ot rise Ch ec k L o w a mbient Tem p erat u re it sh o uld be approximate l y (22- 3 ° C) Ch ec k draft a rou n d air co n ditioning out l et Ch ec k Perc e ntage Heater Output is Set at low in Ma n ual Mode Low Su p ply Voltage 14 Temp e rat u re over Mattr e ss ris e s exc e ss iv ely Ch ec k dir e ct Sun light, H e ating Dev i ce or oth e r H e at Source Percenta g e Heater O utput is Set at High in Manual Mode 15 Temperature over Mattress dose not stabilize Ch ec k u n sta b le ambient t e mperature (should b e 22- 30 ° C) Ch ec k for Strong Air conditi o n i ng draft 16 Temp e rat u re Display do e s not disp l ay Infant's Temp e rat u re accurately Probe T h er m al Sensitive Portion attach e d impr o perly Ch ec k Th e r m al Sensitive Portion of Pro b e covered impr o perly 17 Baby skin Te mperature no t correlate wi t h disp l ay Tem p erat u re Ch ec k s e nsit iv e portion of the Pro b e is fixed with baby sk i n pr o p e rly. Ch ec k Pro b e is fixed to the lower a bd om en of baby 18 Heat e r output is off after s o me time in manual mode Ch ec k Man u al Timer Tim e . Can be set 2 to 30 minutes Ch ec k the H e ater output is off after set time If Heater out p ut is off before set time c o ntact nice Neot e c h 19 In Skin Mode Baby getting over heat but equip m ent g i ves L o w Te m perat u re a l arm Ch ec k the probe is int a ct with lower a b domen of b ab y Ch ec k the probe is remo v ed and ke pt away Ch ec k the Set Temperature is high Ch ec k the Set Heater out p ut is high ( M anual M o d e ) System Fault Open Care System (Cont’d…)

43. Cautions Use cleaning solution sparingly on a cloth when cleaning the Infant Radiant Warmer. Do not saturate the unit - excessive solution causes damage to internal components. Do not autoclave or gas sterilize the skin temperature probe. Do not immerse the probe in liquid cleaner. Avoid placing excessive strain on the probe lead. Do not pull on the probe lead. These precautions will help avoid damage to the probe. Do not autoclave or gas sterilize the mattress. Only competent individuals trained in the repair of this equipment should attempt to service it as detailed in the service manual. The Service Manual provides detailed information solely for use by individuals having proper knowledge, tools and test equipment, and for service representatives trained by nice Neotech . Isolation from the supply mains is Detachable Power cord provided Use of nonstandard components: Consult the manufacturer for repair and replacement of components. Use of incorrect component can adversely affect Safety, performance and/or damage the equipment performance

44. Certifications and Approvals Electrical Safety : IEC 60601-1 : IEC 60601-1-4 Particular product : IEC 60601-2-21 : IEC 60601-2-50 EMC Safety : IEC 60601-1-2

45. Contact Us nice Neotech Medical Systems Private Limited No 85, Krishna Industrial Estate Mettukuppam , Vannagaram , Chennai – 600095, Tamil Nadu, INDIA Tel: [phone]. Fax: [phone] Web: www.niceneotech.com . E-mail: [email protected] , [email protected] Overseas Enquiry: [email protected] Toll Free : [phone].