NIPPY 3+ Pos Pressure Ventilator Instruction Manual Ver 7 Nov 2017

NIPPY 3+ INSTRUCTION MANUAL INDEX Page

Introduction Description Intended Use Contraindications Features

1 2-4 5 6 7

Explanation of Controls Fascia Buttons Fascia Display Outlets Rear Panel Layout Explanation of Symbols Used

8-9 10 11 11 12

Getting Started The Main Screen How to Adjust The NIPPY 3 + The Menu Window How to use the on-screen Menu Structure of the Main Menu Breath Analyser How to use the on-screen help Using Help with the Settings Locked Breathing circuits and masks Using the NIPPY 3 + Invasively Using a Humidifier with the NIPPY 3 +

13 13 14 14 15 16 17 17 18 19 19

Setting Up Setting up the NIPPY 3 + in CPAP Mode Setting up the NIPPY 3 + in Pressure Support Mode Setting up the NIPPY 3 + in Pressure Control Mode Setting up the NIPPY 3 + in IPPV Mode

20 21 22 23

Setting up the Alarms Flow Alarm Auto Set Flow Alarm Manual Set Disconnection Alarm Apnoea Alarm Max Breath Rate Alarm

24 24 25 26 26

Alarm Conditions/Tests High Flow Disconnect

27 27

Low Flow Mains Fail High Pressure Fault Sigh Function

27 27 27 27 28

Running on Battery Power Battery Run Times Battery Care External battery

29-30 31-32 33

Connecting Auxiliary Equipment

34

Pneumatic Diagram

34

Specifications

35

International Standards

35

Operation Under Extreme Conditions

36

Accessories and Spares

36

Warnings and Cautions

37

Using Supplementary Oxygen

38

Maintenance User Maintenance Schedule Servicing/Repair Technical Information Warranty/Transportation Factory Service / Repair Disposal at end of life EMC Declaration and guidelines

39 40 40 40 40 40 41-43

Battery Run Time Test Record

44

Locking the Settings

46

Please note Breas Medical previously traded as B & D Electromedical & some photographs in these instructions still show the name B & D Electromedical.

Introduction WARNING! NIPPY 3+ must only be used: • For the intended treatment in accordance with this operating manual and with the instructions given by the responsible clinical personnel. • In accordance with the operating conditions specified in this operating manual. • In original and unmodified shape and only with accessories specified or approved by Breas Medical Ltd. Every other use may lead to risk of personal injury!

CAUTION! Read this manual thoroughly so that you completely understand how the NIPPY 3+ is operated and maintained before taking it into use, to ensure correct usage, maximum performance and service life. WARNING! This device is not intended for use as a critical care ventilator, transport ventilator or for dependent patients.

1

Description The NIPPY 3+ is a pressure controlled, positive pressure ventilator. It compresses ambient air and delivers it to the patient through a full-face mask, nasal mask, nasal pillows 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). For greater safety and convenience, the NIPPY 3+ may be equipped with an internal battery. The ventilator is capable of recharging both the internal battery and an external battery when running from the mains electrical supply. There are 4 modes of ventilation: CPAP

(Continuous Positive Airway Pressure) Constant positive pressure is applied via the mask. No respiratory support is given in this mode.

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. An adjustable back-up respiratory rate takes over in the absence of an inspiratory trigger from the patient. Ti is limited to a maximum of 3.0 seconds and minimum of 0.7 seconds.

Pressure Control

IPAP, EPAP and Ti are set by the physician. A timed inspiration is triggered by the patient’s inspiratory effort. Adjustable back-up rate takes over in the absence of an inspiratory trigger.

IPPV

IPAP and Ti are set by the physician. A timed inspiration is triggered 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.

2

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 almost depleted The user cannot replace this battery. Refer to qualified technical personnel for battery replacement. Low External Battery When running on an external battery, the alarm will operate when the battery is almost depleted. Machines fitted with an internal battery will automatically switch to internal battery power without alarming. 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. For an explanation of sensitivity settings see alarm settings, disconnection sensitivity (page 25). 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. The user cannot replace this battery. Refer to qualified technical personnel if the alarm operates when the ventilator is in daily use.

3

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. The estimated tidal volume is displayed above the bar graph display.

Inspiratory Trigger The NIPPY 3+ employs flow triggering, detecting the start of the patient’s 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 trigger and cycle the ventilator can be adjusted via the Trigger option in the Menu. For simplicity, the trigger sensitivity is scaled from 1 – 10, with 1 requiring the least patient effort and 10 requiring more patient effort.

4

Intended Use The NIPPY 3+ is intended to provide ventilation for non-dependent, spontaneously breathing adult patients with respiratory insufficiency, or respiratory failure. The device can be used for treating patients non invasively, or for invasive use, with the following interfaces; •

Tracheostomy

•

Full Face Mask

•

Nasal Mask / Nasal Pillows

The device may be operated in the hospital or home environment.

IMPORTANT! NIPPY 3+ must be prescribed by, and used only under the supervision of a qualified physician. This manual is only intended for clinical personnel, physicians and trained users who require a working knowledge of the NIPPY 3+. Alarms must be tested before use and following a change of the breathing circuit as described in the Alarms Conditions/Tests section. It is the clinicians responsibility to ensure the device is always used with the appropriate breathing circuit, to ensure sufficient CO2 elimination. All care staff should be trained to ensure that the location of this exhalation port is known and they are aware that this must not be removed, covered or blocked at any time. Batteries used for power fail back up must be kept in good condition and fully charged at all times. See Battery care section of this manual.

5

Contraindications The NIPPY 3+ is not a life support ventilator. The use of the device may be contraindicated in patients with the following: • • • • • • •

Pneumothorax or pneumomediastinum Low blood pressure Cerebrospinal fluid leak, recent cranial surgery or trauma, or raised Intercranial pressure Severe bullous lung disease Dehydration Risk of vomiting An oxygen requirement higher than achievable with 15l/min of entrained low pressure oxygen and the prescribed ventilation settings

Adverse effects Patients should report any new or unusual chest pain, severe headache or increased breathlessness or increased day time sleepiness to a clinician immediately. The following side effects may be experienced during the treatment with non invasive ventilation: • • • •

Nasal, mouth or throat dryness Bloating Ear or sinus discomfort Eye irritation from mask leak

6

Features

1.

Optional internal battery operation

2.

Comprehensive, auto setting, alarms with mute facility

3.

Can be used with Nasal mask, Nasal Pillows, Full face mask or Tracheostomy.

4.

User friendly intuitive user interface

5.

Easily understood alarm messages displayed onscreen

6.

4 modes of ventilation

7.

Universal mains input, operates anywhere in the world without transformers

8.

Adjustable flow triggers with trigger indicators

9.

Large, colour LCD display, clearly shows all settings

10.

28 days stored, On-screen compliance data

11.

Comprehensive event log stores all adjustments, settings, alarm events and user interventions, for download to PC.

12.

Breath analyser display, showing pressure and flow waveforms

13.

Fast trigger response

14.

Minimal maintenance requirement

15.

Twelve months parts and labour warranty

16.

Auto switching to internal or external battery.

17.

Automatic service reminder.

7

Explanation of controls

Fascia Buttons 1. IPAP

- Selects the Inspiratory Positive Airway Pressure adjustment (scaled in cm H2O). Value is displayed on screen adjacent to the switch.

2. EPAP

- Selects the Expiratory Positive Airway Pressure adjustment (scaled in cm H2O). Value is displayed on screen adjacent to the switch.

3. Ti

- Selects the inspiratory time adjustment (scaled in Seconds). Value is displayed on screen adjacent to the switch.

4. Back up

- Selects the Back-up Rate adjustment (scaled in Breaths Per Minute). Value is displayed on screen adjacent to the switch.

5. Mode

-

Displays the mode selection screen

6.

-

Starts and Stops the ventilator

7. ◄-

- Decrements the selected parameter or moves the selection bar down the menu.

8. Set

- Selects the current menu function displayed by the selection bar. OR double press for battery run time and hours till next service. 8

9. +►

- Increments the selected parameter or moves the selection bar up the menu

10. Mute

-

Silences the alarm for 2 minutes. Press and hold for 2 seconds to cancel alarm mute.

11. Menu

-

Displays the menu screen

12. Help

-

Displays context sensitive help messages.

13. Lo Alarm

- Selects the Low Flow Alarm adjustment (scaled in litres/minute). Value is displayed on screen adjacent to the switch. Changes colour to red in alarm condition.

14. Hi Alarm

- Selects the High Flow Alarm adjustment (scaled in litres/minute). Value is displayed on screen adjacent to the switch. Changes colour to red in alarm condition.

15. Ext. Batt

- Indicates that ventilator is running on battery power. This may be internal or external.

16. Power

- Indicates that external power is connected. Ext Batt OFF and Power ON = Battery charging

17. Start

- Indicates that the ventilator is running.

9

Fascia Display 3

2

4

8 4

9 4

5

6 7

1

12

11

10

1. Mode

-

2. Pressure Display

- Indicates airway pressure (scaled in cm H2O). Changes colour to red in under / over pressure alarm condition.

3. Rate Display

- Indicates patient breath rate (scaled in Breaths Per Minute).

4. Volume Display

- Indicates estimated inspiratory tidal volume (scaled in millilitres).

5. Flow Display

- Indicates airway flow (scaled in litres/minute) Changes colour to red in flow alarm condition.

6. Settings locked symbol -

Displays current mode of ventilation.

This symbol shows that the settings are locked.

7. Alarm Muted symbol

- This symbol shows that the audible alarm has been temporarily silenced.

8. I Trigger indicator

- “Flashes” each time the inspiratory trigger is initiated by the patient.

9. E trigger indicator

-

10. External battery

- Indicates external battery state of charge, when connected. Red when Discharged.

11. Internal battery

- Indicates internal battery state of charge. Red when Discharged.

12. Service Reminder

-

“Flashes” each time the expiratory cycle is initiated by the patient.

major service due

10

Ventilator Outlets

1. Outlet

-

Main Air Outlet to breathing circuit

2. EVC Port

-

Exhale Valve Control outlet Connected to the Exhalation valve in IPPV mode Leave disconnected in any other mode

Rear Panel Layout 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.

2

Cooling Vent

1

RS 232

3

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

SN

Fuse 2 x T1.6A

11

Explanation of Symbols used on NIPPY 3+ and Accessories -

Type B Applied parts to EN 60601-1

-

Alternating Current

-

Direct Current

T

-

Time Delay Fuse

SN

-

Serial Number

-

Date of Manufacture

-

Attention. Consult Accompanying Documents

-

Switch ON /OFF

+► -

Increase Button

◄-

-

Decrease Button

-

Locked / Unlocked, Purple = total lock, Black = settings locked

-

Alarm Muted

-

Battery charged

-

Battery Discharged

-

Service Reminder

-

Dispose of in Line with Local Authority Guidelines

-

Recycle

-

Batch code

12

Getting Started To Switch On Place the NIPPY 3+ on a clean, smooth, hard surface. (NOT carpet) Connect the power lead to the mains power connector on the rear panel. Plug into the mains power supply. Press the Start/Stop button. To Switch Off Press the Start/Stop button. The “Switch Ventilator Off” message will appear onscreen. Press the Start/Stop button again after 2 seconds. There must be a delay of 2 seconds before each push, to prevent accidental operation.

The Main Screen The Main Screen is divided into 3 areas The left-hand side shows the basic ventilator settings, IPAP, EPAP, Ti, BACK-UP, and Mode, adjacent to its setting button. The centre section shows the airway pressure, flow, estimated tidal volume and breath rate. The right-hand side shows the alarm settings and symbols for alarm mute and locked settings.

How to adjust the NIPPY 3+ Select the desired parameter with the relevant button. The reading adjacent to the button will be highlighted by a purple flashing box. Alter it with the ◄- or +► buttons. When you have finished, move on to the next adjustment or wait a couple of seconds for the flashing box to disappear. E.g. Press IPAP. IPAP setting will be surrounded by a purple flashing box. Press +► to increase the pressure setting. 13

The Menu Window The Main Menu gives access to further adjustments and allows you to view information relating to the ventilator usage.

How to use the on-screen menu Press the MENU button. The menu window will be displayed in front of the main screen. Move the selection bar up or down the menu with the ◄- or +► buttons to highlight the desired function and press the SET button. Follow the on-screen instruction at the bottom of the window Press MENU at any time to exit and return to the main screen. Eg.

Press MENU. Press ◄- button to move the selection bar over “User Preferences”. Press SET. Press SET again to move the ◄- and +► symbols either side of “Display Contrast” Press +► to increase contrast - Press MENU to exit.

14

Structure of the Main Menu 1. Adjust Trigger

I Trig

View / Adjust

E Trig

View / Adjust

2. User Preferences User Preferences Alarm Volume

View / Adjust

Display Brightness

View / Adjust

Display Contrast

View / Adjust

Display Dimming

View / Adjust

(Sets time in minutes until display dims, to night time level)

3. Compliance Data

Disconnection Alarm

View / Adjust

Apnoea Alarm

View / Adjust

BPM Alarm

View / Adjust

Sigh Settings

View / Adjust

Total Hours

View only

Compliance Hours

View only

Average Daily Use

View Only

Use + or – button to scroll through the data. Press and hold + and – buttons to reset compliance data

4. Clear Patient Settings

Resets machine to default settings and clears the compliance data, ready for a new patient.

5. Warnings & Cautions

Safety information

View only

6. Breath analyser

Displays Waveforms

Enable/Disable

View Pressure and Flow in graphical form. Press Menu button to return to standard display.

7. Service Menu

Service Information

15

Restricted Access

Breath Analyser The breath analyser changes the display to a graphical format, like an oscilloscope. This can be useful to evaluate a patient’s breathing pattern and to assess the effectiveness of the triggering. The pressure and flow waveforms are stored then displayed on the screen. •

The screen displayed shows the stored information from the previous breath.

•

The width of the trace is the period of the back-up rate, displayed in seconds on the X axis. E.g. if back up rate is set to 10BPM, the trace width represents 3 seconds.

•

The pressure in cm H2O is displayed on the left Y-axis and relates to the RED trace.

•

The flow in litres/minute is displayed on the right Y-axis and relates to the BLUE trace.

•

The insp trigger (IT) and exp trigger (ET) points are marked along the X-axis as they occur.

•

The display may be “frozen” by pressing the ◄ - button. Press the + ► button to restart the display.

16

How to use the On-screen Help Press the HELP button at any time for a list of help topics. Follow the simple onscreen instructions.

Press HELP again to exit. If during setting up, you require a description of a particular parameter, select it then press HELP. Press HELP again to clear.

Using Help with settings locked When the settings have been locked, help is limited to a list of more common problems that may arise during use and advice on how to deal with them. Follow the on-screen instructions

17