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Appendices

10.1

Emission and Immunity Declaration

The Vivo 45/Nippy 4 is tested for electromagnetic emission and immunity according to
IEC 60601-1-2 4th edition. See the Clinician

’

s Manual for declarations and information

about performed tests.

10.2

Returning Products to Breas

Use the RMA (return material authorisation) request on the Breas Extranet if you
want to return any product to Breas.
Contact your Breas representative for more information.

NOTE

Product damage caused by poor packaging or during transportation is not covered by
the factory warranty.

10.3

Service Record

Use a photocopy of this service record for the maintenance inspection described in 2

Maintenance Instructions

, page 10. Use the Notes section below for comments and notes.

Service record no ........................

Model

.............................

Serial no

................................

Inventory no

...................................

Accessories ....................................................................................

Delivery date ...........................

Device operating hours
.......................................................

Service started .........................

Signature
............................................................................

Service completed ...................

Signature
............................................................................

Product returned .....................

Signature
.............................................................................

General

See
instruc-
tion ref.

Check
OK

Open new service record and identify ventilator

2.3.3

Note number of device operating hours

2.4.2

Check all markings

2.4.3

92 Appendices

Vivo 45/Nippy 4 Series Service manual

Doc. 007132 D-2

Содержание Nippy 4 Series

Страница 1: ...D 2 007132 En Service Manual...

Страница 2: ...DOC 007132 EN EU D 2 2020 12 22 Service manual Vivo 45 Nippy 4 Series...

Страница 3: ......

Страница 4: ...arts 12 2 4 Preparing for Inspection 13 2 4 1 Initial Recording 13 2 4 2 Checking Additional Services 13 2 4 3 Inspecting the Markings 13 2 4 4 Information from the Patient User 13 2 4 5 Validity of t...

Страница 5: ...3 8 Part List 28 4 Functional Diagram 32 5 Opening the Ventilator and Replacing the Main Components 34 5 1 Replace the Internal Battery 34 5 2 Open and Close the Ventilator 34 5 3 Replace the Cooling...

Страница 6: ...3 2 External DC Battery Operation 64 7 3 3 Click In Battery Operation 64 7 3 4 Internal Battery Operation 64 7 4 Battery Charging 65 7 4 1 Mains Power Supply Operation 65 7 4 2 External Battery Operat...

Страница 7: ......

Страница 8: ...f personal injury 1 1 Manufacturer Information Legal Manufacturer Postal Address Breas Medical AB F retagsv gen 1 SE 435 33 M lnlycke Sweden Web Address www breas com Email address breas breas com Pho...

Страница 9: ...reathing comfortable for the patient A number of various internal sensor readings are monitored to ensure that the ventilator functions correctly Some of them are checked at power up some at treatment...

Страница 10: ...ghlight specific information The meaning of each icon is explained in the table below Icon Explanation Warning Risk of death or serious personal injury Caution Risk of minor or moderate injury or risk...

Страница 11: ...esigned to give users many years of trouble free breathing assistance provided that the preventive maintenance is carried out at the intervals specified in this manual Well performed maintenance servi...

Страница 12: ...cautions to prevent electrostatic discharge ESD have been taken Follow all regulations regarding ESD NOTE The Clinician s Manual contains extended lists of safety precautions 2 3 2 Service Schedule Pr...

Страница 13: ...or download from Breas Extranet Contact Breas techni cal support for more information Test connector kit Breas part no 004829 connec tors and leakage ports used when testing Vivo to PC communication c...

Страница 14: ...vice record to see whether the alarm clock battery the internal battery kit or the complete blower assembly needs to be replaced 2 4 3 Inspecting the Markings Make sure that all markings on the ventil...

Страница 15: ...es and the ventilator s power socket 2 Check the click in battery socket in the ventilator 3 If used check that the external DC power cord is not damaged 2 5 3 Inspecting the Patient Circuit Inspect t...

Страница 16: ...and the wires are not pinched or kinked 2 6 3 Checking the Fastening of Components 1 Make sure that all the components such as the pneumatic block the circuit boards and the connectors are securely f...

Страница 17: ...apacitors see section 5 15 Replace the Super Capacitors page 54 6 Reconnect the internal battery as in 5 1 Replace the Internal Battery page 34 2 8 Complete Function Test To perform the complete funct...

Страница 18: ...ure You will find the zeroing procedure under FiO2 CO2 Calibration in the Others section 3 Mount the gas regulator on the gas bottle Be careful not to damage the thread on the bottle Make sure that th...

Страница 19: ...gas span check 8 Check the CO2 Momentary reading on the ventilator Menu path Others FIO2 CO2 Calibration If the Momentary value is not between 4 5 5 5 Be absolutely sure that the CO2 sensor is in amb...

Страница 20: ...measurements made during future services If no reference values are available the value for the insulation resistance should be 70 MW 2 10 3 Leakage Currents Check NOTE The leakage current check is o...

Страница 21: ...ster with this function See the safety instructions for the tester Limit value SFC 5 mA 2 10 3 4 Leakage Currents with Mains Power Supply at the Patient connected Part This test must be done using an...

Страница 22: ...3 Parts Location 3 1 View A 1 1 4 5 11 1 11 2 11 2 16 17 18 1 19 20 24 1 2 3 2 View B 12 14 10 1 10 2 Parts Location 21 Doc 007132 D 2 Vivo 45 Nippy 4 Series Service manual...

Страница 23: ...3 3 View C 21 22 23 27 29 28 34 38 39 40 41 1 3 18 2 43 22 Parts Location Vivo 45 Nippy 4 Series Service manual Doc 007132 D 2...

Страница 24: ...3 4 View D 26 31 1 31 2 31 3 31 4 32 35 36 31 5 41 7 41 8 Parts Location 23 Doc 007132 D 2 Vivo 45 Nippy 4 Series Service manual...

Страница 25: ...3 5 View E 30 41 2 41 3 41 4 41 5 41 9 41 9 x2 33 6 7 31 5 24 Parts Location Vivo 45 Nippy 4 Series Service manual Doc 007132 D 2...

Страница 26: ...3 6 View F 42 1 42 2 42 3 42 9 Parts Location 25 Doc 007132 D 2 Vivo 45 Nippy 4 Series Service manual...

Страница 27: ...3 7 Screw Kits 3 7 1 MRT M3x6 FZB 26 Parts Location Vivo 45 Nippy 4 Series Service manual Doc 007132 D 2...

Страница 28: ...3 7 2 M3x8 and MRT 3x10 FZB M3x10 3 7 3 M2 5x6 and Isolation Screw Grommets M2 5x6 Parts Location 27 Doc 007132 D 2 Vivo 45 Nippy 4 Series Service manual...

Страница 29: ...10 1 10 2 Feet FiO2 cover Feet FiO2 cover 007252 4 1 11 11 1 11 2 Handle kit Handle assembly Bracket handle hinge METAL 007253 1 2 12 Label kit 12 1 Label O2 12 2 Label connector 12 3 Label product 12...

Страница 30: ...07258 1 17 Top casing incl swivel Nippy 4 007259 1 18 Super capacitor Clock battery kit 18 1 Super cap 18 2 Clock battery 007260 1 1 19 Super capacitor cover 007261 1 20 Top buttons incl cable 007262...

Страница 31: ...T connector 31 10 T connector 007272 1 of each 32 Cooling fan 007273 1 33 Back casing assembly 007274 1 34 PCB heated wire 007275 1 35 USB board 007276 1 36 Complete contact board Vivo 45 45 LS Nippy...

Страница 32: ...ick in battery cable 42 4 Display cable 42 5 Cable super cap 42 6 PTU main flex cable 42 7 FiO2 cable 42 8 Contact Main cable 42 9 Heated wire Main cable 007283 1 1 1 1 1 1 1 1 1 43 Piezo valve Vivo 4...

Страница 33: ...rm or Nurse call Patient heater Patient heater Isolation ctrl Blower motor ctrl Ambient air 8 Oxygen FiO2 ADC Pressure flow PCB Patient air pressure sensor Backup patient air pressure Pilot valve pres...

Страница 34: ...l See the below figure Lower Part Details Ctrl logic Patient heater Patient heater Isolation ctrl Blower motor ctrl Ambient air 8 Oxygen FiO2 ADC Pressure flow PCB Patient air pressure sensor Backup p...

Страница 35: ...tery 1 1 2 1 Remove the two screws 1 Torque 0 7 Nm Size M3x6 2 Pick up the cover using a screwdriver in the joint 2 3 Take out the battery 5 2 Open and Close the Ventilator 1 Remove the two screws one...

Страница 36: ...1 Cable 1 in the image shall be loosened from the cover Cable 2 shall be loosened from the CPU board 5 Remove the two screws at the top Torque 0 7 Nm Size M3x6 Opening the Ventilator and Replacing th...

Страница 37: ...t the front and disconnect the cables When reassembling see Assembly Precautions for FiO2 Tubes page 37 for making sure that the FiO2 tubes don t get squeezed 36 Opening the Ventilator and Replacing t...

Страница 38: ...t the left side so it doesn t interfere with the FiO2 sensor tubes When the front is assembled check that the FiO2 sensor return tube is not squeezed Wiring Layout 1 Heated circuit 2 Humidifier heater...

Страница 39: ...to 5 17 Replace the Front Cover page 55 1 3 2 2 3 3 Dismount the handle 1 by removing the two screws 2 Torque 0 7 Nm Size M3x6 4 Pull out the two pins 3 5 Remove the handle 2 1 6 Remove the side pane...

Страница 40: ...d finally remove screw 3 screw 3 is not visible in this image 8 Loosen the screw Torque 0 7 Nm Size M3x8 9 Remove the two tubes from the piezo valve Vivo 45 LS and Nippy 4 only Opening the Ventilator...

Страница 41: ...r cover 1 some coaxing is required remove the filter 2 and loosen the two screws 3 Torque 0 7 Nm Size M3x6 12 Press the tube into its hole 40 Opening the Ventilator and Replacing the Main Components V...

Страница 42: ...kwise This is for creating a bow on the tube that prevents it from being squeezed when assembling the front cover 3 4 15 Vivo 45 LS and Nippy 4 only Disconnect the exhalation valve tube 4 NOTE When as...

Страница 43: ...17 Coax the contact board loose 18 Thread these two cables through the bottom plate 1 2 19 Loosen the two screws 1 and the two clasps 2 42 Opening the Ventilator and Replacing the Main Components Viv...

Страница 44: ...r according to 5 17 Replace the Front Cover page 55 1 3 2 2 3 3 Dismount the handle 1 by removing the two screws 2 Torque 0 7 Nm Size M3x6 4 Pull out the two pins 3 5 Remove the handle 2 1 6 Remove th...

Страница 45: ...d finally remove screw 3 screw 3 is not visible in this image 8 Loosen the screw Torque 0 7 Nm Size M3x8 9 Remove the two tubes from the piezo valve Vivo 45 LS and Nippy 4 only 44 Opening the Ventilat...

Страница 46: ...r cover 1 some coaxing is required remove the filter 2 and loosen the two screws 3 Torque 0 7 Nm Size M3x6 12 Press the tube into its hole Opening the Ventilator and Replacing the Main Components 45 D...

Страница 47: ...e exhalation valve tube 4 NOTE When assembling the plastic tip 3 is to be inserted into the hole at the back of the blower Ensure that its seal doesn t slide into the hole Use a torch to check 15 Lift...

Страница 48: ...ver page 57 2 Replace the battery 5 7 Replace the PTU Board 1 Dismount the top cover according to 5 19 Replace the Top Cover page 57 1 2 2 1 2 Disconnect the two tubes 1 For Vivo 45 LS and Nippy 4 the...

Страница 49: ...entilator 3 Remove the four screws Torque 0 7 Nm Size M3x6 4 Disconnect the cable between the CPU board and the display 5 8 1 Replace the Humidifier Sense Board 1 Remove the top cover according to 5 1...

Страница 50: ...ver according to 5 17 Replace the Front Cover page 55 1 3 2 2 3 3 Dismount the handle 1 by removing the two screws 2 Torque 0 7 Nm Size M3x6 4 Pull out the two pins 3 5 Remove the handle 2 1 6 Remove...

Страница 51: ...without removing its nut and finally remove screw 3 screw 3 is not visible in this image 8 Loosen the screw Torque 0 7 Nm Size M3x6 9 Remove the side panel 50 Opening the Ventilator and Replacing the...

Страница 52: ...age 49 2 Loosen the screw to remove the SD board Torque 0 7 Nm Size M3x6 5 11 Replace the Heated Wire Board 1 Dismount the top cover according to 5 19 Replace the Top Cover page 57 2 Dismount the fron...

Страница 53: ...umidity Plate 1 Perform steps 1 12 in 5 4 Replace the Blower Assembly page 38 2 Remove the four screws to dismount the humidity plate Also loosen its flat cable from the main board to remove the humid...

Страница 54: ...iO2 cover Torque 0 7 Nm Size M3x6 5 Ensuring that you don t touch the contacts on the bottom side of the board push out the FiO2 board with its silicone seal 2 from above 5 14 Replace the Complete Con...

Страница 55: ...Board 1 Remove the USB board together with its cable 5 15 Replace the Super Capacitors 1 Remove the top cover according to 5 19 Replace the Top Cover page 57 1 1 2 3 3 2 Remove the two screws 1 Size...

Страница 56: ...ove the button board 5 17 Replace the Front Cover 1 Remove the top cover according to 5 19 Replace the Top Cover page 57 2 Remove the two screws at the top Torque 0 7 Nm Size M3x8 3 Remove the two scr...

Страница 57: ...hese cables 5 Remove the four screws Torque 0 7 Nm Size M3x6 6 Lift out the board and the display 56 Opening the Ventilator and Replacing the Main Components Vivo 45 Nippy 4 Series Service manual Doc...

Страница 58: ...2 Remove the front cover according to 5 17 Replace the Front Cover page 55 3 Remove the CPU board according to 5 8 Replace the CPU Board page 48 4 Disconnect the cable between the CPU board and the d...

Страница 59: ...ble 1 in the image shall be loosened from the cover Cable 2 shall be loosened from the CPU board 4 The cover is now loose Remove the super capacitors and the buttons 58 Opening the Ventilator and Repl...

Страница 60: ...he Breas extranet Contact Breas technical support for more information 6 2 Pressure and Flow Calibration To calibrate the ventilator you need the Service Software which can be downloaded from the Brea...

Страница 61: ...d the electronics of the ventilator you must know how to use the it study the pneumatic diagram and acquaint yourself with the mechanical construction 7 2 Circuit Board Descriptions 7 2 1 Main Board R...

Страница 62: ...use during normal operation backup only Input power selection is initially provided by the hardware The hardware will enable input power if the hardware set threshold is exceeded Based on available p...

Страница 63: ...hen the ventilator is turned off and disconnected from mains SD Card Interface The COMM processor can transfer the ventilator data memory to an SD memory card The ventilator supports SD cards up to 32...

Страница 64: ...the clock is functioning and the memory data time is correct The real time clock is the only function that is running when the Vivo is turned off and disconnected from mains When the Vivo is turned of...

Страница 65: ...ery has its own integrated processor and electronics that estimates the battery s state of charge and communicates with the ventilator main processor When the click in battery is discharged it sends a...

Страница 66: ...r capacitors will be charged as well independently from the internal and click in battery charging 7 4 2 External Battery Operation The super capacitors will be charged when the ventilator is running...

Страница 67: ...tor Clinician s Manual for how to adjust the settings 3 Disconnect the power cord 4 Connect a test lung and start the ventilator 5 The ventilator should run for at least two hours before shutdown If n...

Страница 68: ...ly The keys don t work 1 The cabling for the front panel is discon nected or faulty 2 The front panel is faulty 1 Check the cabling for the front panel 2 Replace the front panel Chapter 5 17 Replace t...

Страница 69: ...rmPipeReceiveFail Communication bewteen CPU tasks fail 76 AlarmMessageLost One or more message doesn t get a response 77 AlarmMediatorMainPipeSendFail Mediator task routes message fail 78 AlarmMediato...

Страница 70: ...and so on See 5 Opening the Ventilator and Replacing the Main Components page 34 for information about how to perform the necessary replacement procedures Error Code Text on Display Problem Action 1 I...

Страница 71: ...3 Replace the PTU board 4 Replace the CPU board or send the ventilator for service 11 Int Function Failure 11 Main and back up pressure sensors does not match 1 Restart the ventilator 2 Replace the PT...

Страница 72: ...er assembly 4 Replace the CPU board or send the ventilator for service 17 Int Function Failure 17 The blower does not function properly 1 Restart the ventilator 2 Check the cabling for the blower asse...

Страница 73: ...ilure 27 Flow sensor calibra tion error 1 Restart the ventilator 2 Re calibrate flow sensor 3 Replace PTU board 4 Send the ventilator for service 28 Int Function Failure 28 Main pressure sensor temper...

Страница 74: ...eplace the CPU board or send the ventilator for service 34 Int Function Failure 34 Treatment parameter check fails 1 Restart the ventilator 2 Replace the CPU board 3 Send ventilator for service 35 Int...

Страница 75: ...the disposal of used equipment and waste NOTE Batteries used with the ventilator shall be recycled in accordance with the local envi ronmental regulations 9 1 Disposal Procedure 1 Turn on the device 2...

Страница 76: ...screws in the bottom enclosure 9 Remove the cover 10 Open the device 11 Disconnect cables that connects top cover and the rest of the device 12 Disassemble the top cover 13 Compare the top cover part...

Страница 77: ...onnected to the side enclosures 17 Group the parts based on material The below tables provide details about groups 18 Disassemble the bottom enclosures and any parts connected to them 19 Compare the b...

Страница 78: ...Part Name Image Blower Silencer Blower Chamber Top Blower Chamber Bottom Measuring Tube Disposal 77 Doc 007132 D 2 Vivo 45 Nippy 4 Series Service manual...

Страница 79: ...ck Enclosure Latch Plate Left Mount Tray Heater Plate Heated wire Panel Con nector Socket Pilot Pressure Panel Dummy Assy Connector Panel Pilot Pressure 78 Disposal Vivo 45 Nippy 4 Series Service manu...

Страница 80: ...t Name Image Connector CPC connector Click in battery Battery Latch Torsion Spring Battery Latch Seal Battery Latch Opening Side Enclosure Disposal 79 Doc 007132 D 2 Vivo 45 Nippy 4 Series Service man...

Страница 81: ...rt Name Image Speaker Holder Latch Plate Right Cooling Air Filter Cover Front Cover Overlay Window Nippy Overlay Window Vivo45 Handle Top 80 Disposal Vivo 45 Nippy 4 Series Service manual Doc 007132 D...

Страница 82: ...Part Name Image Handle Bottom Connector Box Top Cover Air Outlet Swivel Bracket Supercap T connector Barbed Black Disposal 81 Doc 007132 D 2 Vivo 45 Nippy 4 Series Service manual...

Страница 83: ...Name Image Side Cover Right Air bypass Top Air bypass bottom Side Cover Left Assy Pilot Pressure Plug Bottom Enclosure Oxygen Sensor cover 82 Disposal Vivo 45 Nippy 4 Series Service manual Doc 007132...

Страница 84: ...ame Image Torsion Spring Battery Latch Silicone Part Name Image Gasket Blower Wire Seal Gasket Blower Mount Gasket O2 Inlet Ambient T H sensor seal Disposal 83 Doc 007132 D 2 Vivo 45 Nippy 4 Series Se...

Страница 85: ...Image Gasket Blower Silencer Gasket Blower Top Bottom Gasket Blower Inlet Gasket Blower Outlet Tubing silicone 2mm ID 5mm OD Gasket Heater Plate 84 Disposal Vivo 45 Nippy 4 Series Service manual Doc 0...

Страница 86: ...Part Name Image Swivel Seal Gasket Speaker Gasket Top seal Gasket FiO2 PCB Motor Part Name Image Radial blower and cable Disposal 85 Doc 007132 D 2 Vivo 45 Nippy 4 Series Service manual...

Страница 87: ...PCB and Electronics Part Name Image Ambient temp and humid ity cable Flow and pressure PCB Cooling fan Heater 86 Disposal Vivo 45 Nippy 4 Series Service manual Doc 007132 D 2...

Страница 88: ...Part Name Image Patient Temp and Humid ity sensor Chamber detection sensor Speaker with Cable V45 SD CARD PCB Piezo valve control Disposal 87 Doc 007132 D 2 Vivo 45 Nippy 4 Series Service manual...

Страница 89: ...Part Name Image Overlay Panel LCD display module Cable LCD display to main PCB Main Board Main board J4 88 Disposal Vivo 45 Nippy 4 Series Service manual Doc 007132 D 2...

Страница 90: ...board J10 Connector Board Connector Board USB DC in Connector Board Flex PCB Top button membrane switches including 70mm Flat Flex cable FFC Supercap PCB Disposal 89 Doc 007132 D 2 Vivo 45 Nippy 4 Se...

Страница 91: ...rt a screwdriver into the groove to open the cover A A B B C C D D D 2 Remove the two grey cable connection covers A 3 Cut the cables B 4 Remove the screws on each connector C 5 Remove the three screw...

Страница 92: ...Material Cover ABS plastics Circuit board PCB wire electronics Cable PCB wire electronics Disposal 91 Doc 007132 D 2 Vivo 45 Nippy 4 Series Service manual...

Страница 93: ...by poor packaging or during transportation is not covered by the factory warranty 10 3 Service Record Use a photocopy of this service record for the maintenance inspection described in 2 Maintenance I...

Страница 94: ...Perform a power fail alarm check 2 7 Alarm Clock Battery Super Capacitors Replace the super capacitors when Status Low 5 15 Replace the clock battery when required 5 6 Blower Assembly Replace the com...

Страница 95: ..._______________________________ ____________________________________________________________________ ____________________________________________________________________ ______________________________...

Страница 96: ...7 321820 071326 Service Manual Vivo 45 Nippy 4...

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