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Breas Medical NIPPY+ Series User Manual

Breas Medical NIPPY+ Series
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Doc 0930
Technical Manual
for the
NIPPY+ Range of Ventilators
This manual covers all of the NIPPY+ range of ventilators
This manual contains confidential information
and it is supplied on the understanding that it
shall not be copied, loaned or distributed to any
other persons or organisations, in whole or in
part, without the written consent of:
Breas Medical Ltd
Unit A2, The Bridge Business Centre
Timothy’s Bridge Road
Stratfordupon-Avon
CV37 9HW
Tel: 01789 293460
www.nippyventilator.com
Version 10, December 2017
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Breas Medical NIPPY+ Series Specifications

General IconGeneral
Pressure range4-30 cmH2O
Tidal Volume50-2000 ml
PEEP0-20 cmH2O
Data StorageSD card
TypeNon-invasive ventilator
Target patientAdult and pediatric
Inspiratory Time0.3-3 s
AlarmsHigh pressure, Low pressure, Apnea, Power failure, Low battery
Power Supply100-240 V AC, 50/60 Hz
Battery BackupUp to 4 hours
DisplayColor LCD

Summary

Introduction

Description

Modes of Ventilation

CPAP

Constant positive pressure applied via mask; no respiratory support.

Pressure Support

IPAP/EPAP set by physician; augments spontaneous breathing.

Pressure Control

IPAP, EPAP, Ti set by physician; timed inspiration cycled by patient effort.

IPPV

IPAP, Ti set by physician; timed inspiration cycled by patient effort.

Alarms

Power Fail

Audible alarm if electrical power is interrupted; can be muted.

Low Internal Battery

Operates when internal battery is low, lasting up to 1 hour.

Low External Battery

Operates when external battery is low, lasting up to 1 hour.

Low Pressure

Alarm if control pressure falls below 50% of IPAP for 10 sec.

High Pressure

Alarm if pressure rises above 120% of working pressure after 2 sec delay.

Breathing Circuit Disconnect

Alarm indicates a significant leak in the breathing circuit.

Breathing Circuit Malfunction

Warns of malfunction of the exhale valve in IPPV mode.

High Flow alarm

Warns of excess inspiratory flow; activated when flow exceeds set level.

Low Flow alarm

Warns of insufficient inspiratory flow; activated when flow fails set level.

Apnoea Alarm

Audible alarm with visual indication when apnoea is detected.

Max Breath Rate

Alarm if the maximum breath rate is exceeded.

Fault

Alarm operated by internal fault; fault displayed on screen.

Low Internal Alarm/Memory Battery

Intermittent alarm for depleted mains fail alarm battery.

Estimated Tidal Volume

Inspiratory Trigger

Expiratory Trigger

Battery Charging

The Service Menu

Accessing the service menu

Power up machine holding alarm buttons, select 'Service menu'.

Set Time and Date

Allows adjustment of date, time, and time zone via service menu.

Service Period

Calibration Screen

Diagnostic Screen

Box internal temp

Internal temperature reading; alarm if above 60 degrees.

Blower current

Current consumed by the blower.

Pressure Error

Pressure servo loop error; should be near zero.

PSU Voltage

Internal power supply voltage, nominally 24V dc.

Int. Li. Batt. Vlt.

Internal lithium battery voltage, nominally 18.75V.

Int. Li. Batt. Curr.

Charge or operating current of the internal battery.

Ext. Li. Batt. Vlt.

External lithium battery voltage, nominally 18.75V.

Ext. NiMh.Batt.V

External NiMH battery voltage, nominally 24V.

Ext. Pb.Batt.Vlt

External Lead Acid battery voltage, nominally 24V.

Ext. Batt. Cur

External battery current (charge/discharge).

Charge Voltage

Battery charging voltage; 20.5V fully charged.

Alarm Log

Alarm Log Summary

Summary of alarm events, occurrences, and last occurrence timestamps.

Alarm Log Entry

Detailed list of alarm events and their explanations.

Install Defaults

WARNING

Confirms erasure of current settings and data upon reverting to factory defaults.

Fault messages

The Event Log

Opening the Case

Disconnect the RS232 connector (4) and the board to board ribbon cable (3).

Disconnects specific connectors before lifting the lid.

Fig 1. Opening the NIPPY

Diagram illustrating the process of opening the NIPPY ventilator case.

Fig 2. Inside the Base

1. Mains Power Supply

Identifies the mains power supply unit within the base.

2. Battery Clamp

Locates the battery clamp assembly.

3. Battery

Identifies the internal battery unit.

4. Internal Battery Connector

Locates the connector for the internal battery.

5. Blower Connector

Identifies the connector for the blower unit.

6. PSU Connector

Locates the connector for the Power Supply Unit.

7. External Battery Connector

Identifies the connector for the external battery.

8. Cooling Fan Connector

Locates the connector for the cooling fan.

9. Pressure Transducer

Identifies the pressure transducer component.

10. Flow Transducer

Locates the flow transducer component.

11. Flow Head

Identifies the flow head assembly.

12. Patient Outlet Port

Locates the port for connecting the patient breathing circuit.

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

Identifies the control line for the IPPV exhale valve.

Fig 3. Inside the base with the control board removed

Fig 4. Inside the Lid

1. RS 232 Port

Identifies the RS232 communication port.

2. Board to Board Ribbon Connector

Locates the ribbon cable connecting boards.

3. Memory Battery Switch

Identifies the switch for the memory battery.

4. Display Connector

Locates the connector for the display unit.

5. Display Back-light Connector (Input)

Identifies the input connector for the display back-light.

6. Keypad Connector

Locates the connector for the keypad interface.

7. Alarm Sounder

Identifies the primary alarm sounder component.

8. Display Back-light Connector (Output)

Locates the output connector for the display back-light.

9. Second Alarm Sounder

Identifies the secondary alarm sounder component.

10. Alarm and Memory Back-up Battery

Locates the battery for alarm and memory backup.

Removal of major components

The Battery

Procedure for disconnecting and removing the internal battery.

The Power Supply

Procedure for disconnecting and removing the power supply unit.

The Control Board

Procedure for disconnecting and removing the control board.

The Blower

The Command Board

The Display

The Cooling Fan

Preventative Maintenance Guide

Before use

Checks to perform before each use of the ventilator.

Every 12 months

Routine maintenance tasks to be performed annually.

Every 2 years

Maintenance tasks scheduled for every two years of operation.

Every 10000 hours

Major service tasks required at 10000 hours of operation.

Cleaning the Flow Head

Suggested Acceptance Test

Visual Inspection

Check for any transit damage on the NIPPY+.

Functional Tests

Test ventilator modes and functionality with a breathing circuit and test lung.

Maximum Pressure

Verify NIPPY+ achieves set pressure at maximum IPAP.

Alarm tests

Perform tests for high flow, disconnection, and occlusion alarms.

Internal Battery

Verify 'Running on Battery Power' message and duration.

Buttons

Check that all buttons on the keypad function correctly.

Help

Ensure the help window is available for each button.

Electrical Safety Test

Confirms NIPPY+ devices are Class I, type B.

Internal Battery

Battery Life

Defines end of life and factors affecting battery lifespan.

Battery Storage

Recommendations for storing the ventilator's battery.

Battery Test

Procedure to test battery condition by measuring run time.

Quick Test

A quick method to identify a potentially failed battery.

Run Times

Table showing typical running times for various settings and conditions.

Replacement of the pcb mounted Alarm Battery

Calibration of Pressure and Flow reading.

Note:

Important notes on software limitations and transducer issues during calibration.

Theory of operation

Ventilator System Pneumatic Diagram

1. Fresh air inlet

Identifies the point where fresh air enters the system.

2. Blower (compressor)

Locates the blower component responsible for compressing air.

3. Flow Sensor

Identifies the sensor that measures airflow.

4. Outlet connector

Locates the connector for air output.

5. EVC Port (IPPV mode only)

Identifies the EVC port, specific to IPPV mode.

6. Breathing Circuit

Represents the connection for the patient's breathing circuit.

7. Exhalation Port

Identifies the port for exhaled air.

8. Patient Connection Port

Locates the main port for connecting to the patient.

9. Exhalation Valve (IPPV mode only)

Identifies the exhalation valve, used in IPPV mode.

NIPPY 3+ BLOCK DIAGRAM

Display/ User Interface

Represents the user interface for interaction and display.

Microprocessor

Central processing unit for command board functions.

Alarm Microcontroller

Dedicated microcontroller for managing alarm functions.

Alarm

The audible or visual alarm output device.

RS232 Port

Interface for external communication via RS232.

Microcontroller and Control Electronics

Control unit for ventilator functions and blower/battery management.

EVC Solenoid Valve

Solenoid valve used for Exhalation Valve Control.

Blower

The component responsible for air compression.

Flow Transducer

Measures the flow rate of air.

Pressure Transducer

Measures the air pressure within the system.

Flow Head

Component related to the flow measurement.

Patient Outlet Port

Connection point for the patient breathing circuit.

IPPV mode EVC Port

Specific port for EVC in IPPV mode.

Block Diagram of Nippy 3+ Control Board

Control Micro

The central microcontroller on the control board.

Pressure Amp

Amplifier for the pressure signal.

Pressure Transducer

Sensor for measuring pressure.

Flow Transducer

Sensor for measuring flow.

EVC Solenoid

Solenoid valve for Exhalation Valve Control.

Blower Drive

Circuitry to drive the blower motor.

Battery Control/ Charging

Circuitry for managing battery charging and status.

Block Diagram of Nippy 3 Command Board

Command Micro

The central microcontroller on the command board.

Display Drive

Circuitry responsible for driving the display.

Backlight Inverter

Inverter for powering the display back-light.

Keypad Interface

Interface for connecting and reading the keypad.

Isolated RS232 Interface

Isolated interface for RS232 communication.

Back up Battery & mains Alarm PIC

Includes backup battery and alarm PIC for system stability.

Battery Backed up Memory

Memory unit backed up by a battery.

Flash Memory

Non-volatile flash memory for program storage.

Non volatile Memory

General non-volatile memory storage.

Circuit Diagrams

PCB assembly for Control Board primary side

PCB assembly for Control Board secondary side

Component Layout for Nippy 3 Command Board

LCD DRIVER SECTION

FLASH MEMORY SECTION

ISOLATED RS232 PORT

ALARM SECTIN

POWER SECTION

LCD BACK LIGHT INVERTER

SPECIFICATIONS

Supply Voltage

Input power voltage range.

Supply Frequency

Input power frequency range.

Maximum Input Current

Maximum current drawn by the ventilator.

Fuse Ratings

Specifications for the protective fuses.

Dimensions (mm)

Physical dimensions of the ventilator.

Weight

Weight of the ventilator, with and without battery.

Ambient Operating Temperature

Recommended operating temperature range.

Digital Output

Details about the digital output capabilities.

All displayed readings expressed as

Units for all displayed readings.

Max. Output Pressure

Maximum pressure the ventilator can deliver.

Calibrated pressure Range

Range of pressure that can be calibrated.

Accuracy of pressure reading

Tolerance for pressure measurement accuracy.

Max. Output Flow

Maximum airflow the ventilator can deliver.

Max Volume Reading

Maximum volume reading capability.

Accuracy of volume reading

Tolerance for volume measurement accuracy.

Accuracy of Flow reading

Tolerance for flow measurement accuracy.

Inspiratory Trigger

Range for inspiratory trigger sensitivity.

Expiratory Trigger

Range for expiratory trigger sensitivity.

Low Flow Alarm

Setting range for the low flow alarm.

High Flow Alarm

Setting range for the high flow alarm.

Inspiratory Time

Range for inspiratory time setting.

Back-up Rate

Range for the backup breath rate.

Type of protection against electric shock

Classification of protection against electric shock.

Degree of protection against electric shock

Specific standard for electric shock protection.

Mode of operation

Default or primary modes of operation.

IP rating

Ingress Protection rating for dust and water.

Storage environment

Environmental conditions for storage.

Internal battery

Specifications for the internal battery.

Running time

Expected running time on internal battery.

External battery

Specifications for the external battery.

Protection against flammable anaesthetic mixtures

Suitability for use with flammable anaesthetic mixtures.

International Standards

List of relevant international standards complied with.

Spare Parts

Case

Part number for the ventilator casing.

PCB assy Control Board

Part number for the control board assembly.

PCB assy Command Board

Part number for the command board assembly.

Power supply

Part number for the power supply unit.

Cable Assy Mains

Part number for the mains cable assembly.

Cable Assy PSU Harness

Part number for the PSU harness cable assembly.

Cable Assy Battery Link

Part number for the battery link cable assembly.

Cable Assy RS232

Part number for the RS232 cable assembly.

Cable Assy Board Interconnect

Part number for the board interconnect cable assembly.

Cable Assy Inverter connector

Part number for the inverter connector cable assembly.

Membrane switch panel

Part number for the membrane switch panel.

LCD Display

Part number for the LCD display unit.

Display window

Part number for the display window.

Blower assembly

Part number for the blower assembly.

Blower to outlet tube

Part number for the tube connecting blower to outlet.

Hose Clip Blower

Part number for the blower hose clip.

Outlet adapter / Flow head

Part number for the outlet adapter or flow head.

EVC Outlet adapter

Part number for the EVC outlet adapter.

Inlet Filter Housing

Part number for the inlet filter housing.

Inlet Filter Media

Part number for the inlet filter media.

Cooling Fan

Part number for the cooling fan.

Mains Fuse T1.6A

Part number for the T1.6A mains fuse.

Mains lead

Part number for the mains power lead.

Rubber Feet

Part number for the rubber feet.

EVC tube green

Part number for the green EVC tube.

EVC tube yellow

Part number for the yellow EVC tube.

10k hour Service Kit

Part number for the 10k hour service kit.

Internal battery

Part number for the internal battery.

External battery

Part number for the external battery.