NIPPY + Range Technical Manual Ver 10 Dec 2017

Contents Introduction

1

Description

2-5

Service Menus Time and Date

6

Service Period / Calibration

7

Diagnostic Screen

8

Alarm Log

9

Install Defaults

10

Fault Messages

11-12

Event Log

13

Opening the Case Fig 1, Opening the Case

14

Fig 2, Inside the base

15

Fig 3, Inside the base – Control bd removed

16

Fig 4, Location of Components – Lid

17

Removal of Major Components

18-19

Preventative Maintenance Guide

20

Suggested Acceptance tests

22

Internal Battery

23

Replacement of Alarm Battery

24

Calibration

25

Theory of Operation

26

System Pneumatic Diagram

27

Block Diagram

28

Block diagram of Control Board

29

Block diagram of Command Board

30

Circuit Diagrams

31- 42

Specification

43

Spare Parts List

44

Introduction The purpose of this manual is to enable suitably qualified competent technical personnel to perform first line maintenance on the NIPPY+ family of ventilators. The NIPPY+ range consists of :- NIPPY 3+, NIPPY junior+, NIPPY St+ and NIPPY S+. They all use the same hardware and service procedures. Component level fault finding will not be considered. Due to the complexity of the circuit boards used in the NIPPY+ range, it is not considered practical or cost effective to try to trace faults to component level. Second-hand or “service exchange” boards are not available. This manual will deal with routine maintenance, calibration and replacement of major components.

IMPORTANT Read this manual before attempting service or repair of the NIPPY+ Please contact Breas Medical Ltd if training is required or you have any questions. NIPPY+ must be subjected to regular inspection according to Breas Medical Ltd service instructions. Repairs shall be carried out in accordance with this technical manual and any special service instructions or bulletins provided by Breas Medical Ltd. Before opening the case, disconnect the NIPPY+ from the mains supply. Do not work on the NIPPY+ with the case open and the power supply connected. Make sure that all precautions to prevent Electrostatic Discharge (ESD) have been taken. Do not use explosive gases and/or fluids near the NIPPY+.

1

Description The NIPPY+ range ventilators are intended to provide ventilation for nondependent, spontaneously breathing adult patients with respiratory insufficiency, or respiratory failure. The NIPPY+ range devices are pressure controlled, positive pressure ventilators. They compress ambient air and deliver it to the patient through a close fitting nasal mask or a tracheostomy. The output pressure, timing and alarms can be adjusted by controls on the fascia panel. The Pressure, estimated Tidal Volume, Rate and all settings are displayed on a colour LCD (Liquid Crystal Display) screen. The screen can be set to dim after a pre-set time (accessed via the user preferences in the main menu). To restore the display, press any button once. The basic ventilator settings can be achieved using the four buttons to the left of the display. The four buttons to the right of the display adjust the alarms and provide access to more advanced features and adjustments (accessed via a menu). NIPPY 3+ and NIPPY junior+ are normally supplied with an internal battery fitted. This is available as an option on NIPPY ST+ and NIPPY S+. All can run on an internal or external battery or both if extended run times or extra back up is required. All are capable of recharging their internal batteries and the external Lithium ion packs. The internal battery has priority over the external one.

2

Modes of Ventilation CPAP

(Continuous Positive Airway Pressure) Constant positive pressure is applied via the mask. No respiratory support is given in this mode. NIPPY 3+, NIPPY Junior+, NIPPY ST+.

Pressure Support

IPAP (Inspiratory positive airway pressure) and EPAP (Expiratory positive airway pressure) are set by the physician. The ventilator augments the patient’s spontaneous breathing. Adjustable back-up rate takes over in the absence of an inspiratory trigger. NIPPY 3+, NIPPY Junior+, NIPPY ST+, NIPPY S+.

Pressure Control

IPAP, EPAP and Ti are set by the physician. A timed inspiration is cycled by the patients inspiratory effort. Adjustable back-up rate takes over in the absence of an inspiratory trigger. NIPPY 3+, NIPPY Junior+.

IPPV

(Intermittent Positive Pressure Ventilation) IPAP and Ti are set by the physician. A timed inspiration is cycled by the patient’s inspiratory effort. Patient exhales to atmosphere via an exhale valve fitted in the breathing circuit. EPAP is not used in this mode. Adjustable back-up rate takes over in the absence of an inspiratory trigger. NIPPY 3+, NIPPY Junior+.

3

Alarms Power Fail If the electrical power to the ventilator is interrupted, an audible alarm will sound. This alarm will run for 5 minutes unless cancelled with the mute button. Once cancelled the power fail alarm will not re-activate. Low Internal Battery When running on its internal battery, the alarm will operate when the battery is low. This could last for up to 1 hour. When the alarm becomes constant there is approximately 10 minutes running time left. Low External Battery When running on its external battery, the alarm will operate when the battery is low. This could last for up to 1 hour. When the alarm becomes constant there is approximately 10 minutes running time left. Low Pressure A pre-set low pressure alarm is provided. If the control pressure falls to below 50% of the set IPAP level for 10 seconds an audible and visual alarm will operate. High Pressure A pre-set high-pressure alarm is provided. If the pressure rises above 120% of the working pressure, an audible and visual alarm will operate after a 2 second delay. Breathing Circuit Disconnect A disconnection alarm is provided as a back up to the high flow alarm. If the patients flow waveform indicates that a significant leak maybe present in the breathing circuit an audible and visual alarm will operate. The sensitivity of the alarm is adjustable. Breathing Circuit Malfunction This alarm warns of a malfunction of the exhale valve in the IPPV mode circuit. High Flow alarm An adjustable alarm is provided to warn of excess inspiratory flow. This is activated when the inspiratory flow exceeds the set high flow alarm level for 5 seconds. An audible and visual alarm will operate. Low Flow alarm An adjustable alarm is provided to warn of insufficient inspiratory flow. This is activated when the inspiratory flow fails to achieve the set low flow alarm level for 10 seconds. An audible and visual alarm will operate. Apnoea Alarm An adjustable Apnoea alarm is provided. If an apnoea is detected an audible alarm will sound with a visual indication on screen. Max Breath Rate An adjustable maximum breath rate alarm is provided. If the max breath rate is exceeded an audible and visual alarm will operate. Fault The alarm may also be operated by an internal fault. In this case the fault will be displayed on screen. These alarms may be muted for approximately 2 minutes to allow for setting up of the ventilator. Low Internal Alarm/Memory Battery An intermittent alarm (short beep) with no onscreen message indicates a depleted mains fail alarm battery. If the ventilator has been stored for more than a few weeks the internal battery will self-discharge. In this case the alarm will stop after the battery has recharged.

4

Estimated Tidal Volume The estimated tidal volume is a calculated value, based on time and calibrated flow values. The constant leak through the breathing circuit exhalation port is subtracted from this calculation to give a reasonably accurate estimation of tidal volume. If a different exhalation port is used (a ventilated mask for example) this calculation may be affected by the possible change in exhalation port flow rate. This must be taken into consideration when reading the tidal volume. A ventilated mask with a higher flow exhalation port will cause the estimated flow reading to be slightly higher than normal. Inspiratory Trigger The NIPPY+ employs flow triggering, detecting the start of the patients’ inspiratory effort when the flow rate exceeds the level set by the Inspiratory Trigger sensitivity. Expiratory Trigger The expiratory trigger is used in Pressure Support mode only. Towards the end of inspiration, when the inspiratory flow rate drops to the baseline (standing flow caused by exhale port leak) minus the expiratory trigger sensitivity the ventilator will cycle into the expiratory phase. The inspiratory and expiratory effort required to cycle the ventilator can be adjusted via the Trigger option in the Menu. For simplicity the trigger sensitivity is scaled 1 –10, with 10 being the most difficult.

Battery Charging Both internal and external batteries are of Lithium Ion construction. Charging is fully automatic. When the ventilator is connected to mains power but not running, batteries will be charged continuously. The internal battery is charged to approx. 95%, and then the external battery (if present) is charged to the same level, before switching back to internal to complete the charge. The charge will be terminated when both batteries are fully charged. Whilst the ventilator is running, the batteries are charged during the EPAP period of the breathing cycle. When the ventilator is switched off it is in standby mode. It will “wake up” every 16 seconds to check the state of its batteries and start a charge sequence if necessary.

5

The Service Menu Accessing the service menu To access the service menu, power up the machine whilst holding down the Hi and Lo alarm setting buttons (Menu and Mute on NIPPY S+ and ST+). Press Menu and select Service menu from the main menu.

Set Time and Date

Press the set button to select the value and use the + and – buttons to adjust. Time zone may be set for anywhere in the World. Press menu to leave this screen.

6

Service Period

The service period screen shows the total running time and running time since the last major service. When a 10000 hour service has been completed, press the + and – buttons together for 2 seconds. The current date will be entered into the service record and the service indicator will be reset. This provides an on-screen record of major services.

Calibration Screen

In this screen the calibration of the flow and pressure transducers is accessed. The machine then generates its own pressure or flow to be compared to a calibrated standard. Altering the blower speed varies the pressure and flow. Use the Set button to move from blower speed to pressure or flow. Use the + and – buttons to adjust the values. Press and hold Hi and Lo alarm buttons for 2 seconds to restore default calibration values.

7

Diagnostic Screen

This screen shows the following information:Box internal temp

The internal temperature. If this value rises above 60 degrees, an alarm will be activated.

Blower current

Current consumed by the blower

Pressure Error

The pressure servo loop error. This should ideally be close to zero.

PSU Voltage

The internal power supply voltage. Nominally 24V dc

Int. Li. Batt. Vlt.

The internal lithium battery voltage, if present. Nominally 18.75V.

Int. Li. Batt. Curr.

Charge or operating current of the internal battery.

Ext. Li. Batt. Vlt.

The external lithium battery voltage, if present. Nominally 18.75V.

Ext. NiMh.Batt.V

The external Nickel Metal Hydride battery voltage, if present. Nominally 24V.

Ext. Pb.Batt.Vlt

The external Lead Acid battery voltage, if present. Nominally 24V.

Ext. Batt. Cur

External battery current in Amps. A positive value represents a charge current and negative represents discharge. Charging is only possible for Lithium batteries.

Charge Voltage

Battery charging voltage. 20.5V fully charged. 8

Alarm Log

The alarm log shows the number of alarm events and the time and date of the last occurrence. Alarm Log Entry “Over Pressure” "Under Press." "High Flow" "Low Flow” "Low Bat.V." "Disconnection" "Mains -> Batt." "Defs.Loaded" "Power Lost" "L.Saved.Ld." "Press.Meas.Flt" “Safe mode” "Blower Flt." "Blower Spd.Flt." "Box Ov/Un Tmp." "Main Power Flt" "Int.Coms.Flt." "Alarm PIC Flt." "Alarm PIC Bat." "B.Ram0.Flt."; "B.Ram1.Flt."; "B.Ram2.Flt."; "EE.Mem.Flt.";

Explanation Pressure exceeded 120% of IPAP setting Pressure failed to reach 50% of set IPAP level Flow exceeded the high flow alarm level. Disconnected or excessive leak. Flow failed to reach low flow alarm level for more than 10 seconds. Airway blockage. External battery voltage low Breathing circuit disconnection. Auto switch to internal or external battery after mains failure. Default values loaded. Power failure. Last saved values loaded Loss of pressure signal Blower at minimum speed following Press.Meas.Flt Blower controller fault or blower stopped. Error between blower speed command and actual blower speed. Internal temperature below 5 degrees or above 60 degrees. Internal power supply voltage out of spec. Less than 22 volts or greater than 26 volts. Communication failure between internal micros. Communication error with alarm micro. Internal alarm / memory back up battery voltage low or high. Battery backed-up memory access fault. Battery backed-up memory access fault. Battery backed-up memory access fault. Eprom memory access fault. Machine loads default values.

9

Install Defaults

If the ventilator is to be re-used for a different patient, the settings may be restored to the factory defaults. These are:NIPPY 3+

NIPPY Junior+

IPAP

12cm

12cm

EPAP

3cm

3cm

Ti back-up

1.0 seconds

1.0 seconds

Mode

Pressure Support

Pressure Support

Hi Alarm

100L/min

60L/min

Lo Alarm

20L/min

20L/min

I Trigger

4

4

E Trigger

4

4

10

Fault messages Fault Message

Fault Log Entry

Explanation

Pressure Measurement fault

"Press.Meas.Flt"

Loss of pressure signal

Technical Fault Vent Now in Safe Mode Stop Using This Machine

Safe Mode

Ventilator has set to minimum output following a pressure measurement fault. This prevents operation with no feedback.

Blower Control fault

"Blower Flt."

Blower controller fault or blower stopped.

Blower speed fault

"Blower Spd.Flt."

Enclosure Temperature fault

"Box Ov/Un Tmp."

Error between blower speed command and actual blower speed. Internal temperature below 5 degrees or above 60 degrees.

Power supply fault

"Main Power Flt"

Control System fault

"Int.Coms.Flt."

Probable Cause

Possible Remedy

Pressure transducer pipe disconnected. Pressure transducer fault. Pressure transducer pipe disconnected. Pressure transducer fault.

Reconnect pipe and restart machine. Replace power board. Reconnect pipe and restart machine. Replace power board.

Seized Blower motor Controller fault Motor fault Controller fault Machine covered, operated in high ambient temperature or cooling vents blocked. Power supply fault

Replace blower Replace power board. Replace blower Replace controller Check operational environment. Check cooling fan operation and vents. Replace power supply

Failure of command micro or power micro.

Replace command board or power board.

Note 1

Internal power supply voltage out of spec. Less than 22 volts or greater than 26 volts. Communication failure between internal micros.

Note 1: The technical fault message informs the user that the ventilator has switched to safe mode to protect against operation without pressure feedback. The output is sufficient to clear exhaled gas only. If the original fault (pressure measurement fault) is still present, this message will alternate with the pressure measurement fault message with each press of Mute. If the original fault has cleared, only the technical fault message will be shown. Mute time in this configuration is reduced to 10 seconds. The pressure measurement fault should be investigated.

11

Fault Message

Alarm back up battery fault

Fault Log Entry

Explanation

"Alarm PIC Flt."

Communication error with alarm micro.

"Alarm PIC Bat."

Internal alarm / memory back up battery voltage low or high.

"B.Ram0.Flt.";

Battery backed-up memory access fault.

"B.Ram1.Flt.";

Battery backed-up memory access fault.

"B.Ram2.Flt.";

Battery backed-up memory access fault.

"EE.Mem.Flt.";

Eprom memory access fault. Machine loads default values.

12

Probable Cause

Possible Remedy

Power interruption has caused communication error. Battery self discharges when not in use. Faulty battery Machine failed to access memory, probably because of sudden power down. Machine failed to access memory, probably because of sudden power down. Machine failed to access memory, probably because of sudden power down. Machine failed to load from Eprom memory.

No action required. Unless there are multiple occurrences, then change command board Run machine for 12 hours to recharge battery. Replace battery. No action required. Alternative memory location will have been used. No action required. Alternative memory location will have been used. No action required. Alternative memory location will have been used. Change command board.

The Event Log The ventilator automatically stores every event during its lifetime. This event log is not displayed on-screen but may be downloaded to a PC using download lead part no. 0858. The following events will be stored in the memory:Power on / off Power interruptions Any button push Any adjustment Any alarm event Switching to battery and/or back to mains Battery voltage when running on battery Viewing of the service menu Any calibration alteration Pressure, and settings are logged at intervals when there are no other events to log These events are stored in chronological order. To view the event log, the PC must have NIPPY for Windows software loaded. With the software running and the RS232 download lead connected, go to the Tools menu and select Event Log. Click on Get Latest to view the most recent events. Click on Previous or Next to scroll through the events. 2

Cooling Vent

1

RS 232

3

100 - 240V 0.4 - 1.0 Amperes 47 - 63Hz 0086

SN

Fuse 2 x T1.6A

1.

Aux. Power

-

24 Volt connection for external battery. Connect only recommended batteries, part no 0910

2.

RS232 Port

-

For connection to remote alarm or personal computer. Isolated to 1500 Volts.

3.

Power Inlet

-

Input mains power connector. Double fused and fitted with connector retaining clip.

13

Opening the Case IMPORTANT Disconnect the ventilator from the mains supply and / or any external battery. Invert the ventilator and remove the seven recessed, hexagon socket screws. Stand the ventilator on its base and ease the lid upwards, away from the rear panel. When the rear of the lid is clear of the rear panel, lift it from the left hand side. Disconnect the RS232 connector (4) and the board to board ribbon cable (3).

1

3

4

2 Fig 1. Opening the NIPPY 1. Command board 2. Control Board 3. Board to Board Ribbon Cable 4. RS 232 Connection.

14

9

10 11 12

8 13

7

6

5

3

4

2

1

Fig 2. Inside the Base 1. Mains Power Supply

9. Pressure Transducer

2. Battery Clamp

10. Flow Transducer

3. Battery

11. Flow Head

4. Internal Battery Connector

12. Patient Outlet Port

5. Blower Connector

13. IPPV Exhale Valve Control Line (NIPPY 3+ and jnr+ only)

6. PSU Connector 7. External Battery Connector 8. Cooling Fan Connector

15

Fig 3. Inside the base with the control board removed

16

4

5

3

2 6 1

7

10

8

9 Fig 4. Inside the Lid

1. RS 232 Port

6. Keypad Connector

2. Board to Board Ribbon Connector

7. Alarm Sounder

3. Memory Battery Switch

8. Display Back-light Connector (Output)

4. Display Connector

9. Second Alarm Sounder

5. Display Back-light Connector (Input)

10. Alarm and Memory Back-up Battery

17

Removal of major components IMPORTANT Before opening the case, disconnect the NIPPY+ from the mains supply. Do not work on the NIPPY+ with the case open and the power supply connected. Make sure that all precautions to prevent Electrostatic Discharge (ESD) have been taken. Do not use explosive gases and/or fluids near the NIPPY+.

Unscrew the 7 case screws to separate the two halves of the case. Disconnect the board to board ribbon cable and the RS232 lead (fig 1). Lay the ventilator lid next to the base. The Battery Refer to fig 2 Disconnect the battery connector (4). There is no need to remove the board to do this. Support the corner of the board with thumb and forefinger and gently wiggle the connector downwards until it comes free. Remove the battery clamp by removing the 2 M4 x 10 screws. Remove the battery. Reverse this procedure to refit.

The Power Supply Refer to fig 2. Disconnect the 2 way mains connector and the earth terminal. Disconnect the 12 way output connector. Remove the 4 securing screws and lift the power supply out of the case. Reverse this procedure to refit. The Control Board Refer to fig 2. Disconnect the internal battery first. Disconnect the 3 Molex connectors. (Int Battery, PSU, Ext Battery, Cooling fan). Disconnect the blower connector. Disconnect the 4mm silicon tubes from the pressure and flow transducers. Disconnect the green and yellow small bore tubes from the Exhale valve control solenoid. Located on the underside of the board. Remove the 4 securing screws. To refit:Connect the 2 small bore tubes. NOTE: the green tubes fits on the port nearest the back edge of the board. The yellow tube fits on the adjacent port. If the ends of the tubes are stretched, trim off approx. 2mm of tube. Connect the PSU and connector. Place the board into the lid and fit the 4 mounting screws. 18