Breas NIPPY ST + Instructions for Use Ver 6 Nov 2017

NIPPY ST+ 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 10 11

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

12 12 13 13 14 15 15 16

Setting Up Setting up the NIPPY ST+ in CPAP Mode Setting up the NIPPY ST+ in Pressure Support Mode

17 18

Setting up the Alarms Disconnection Alarm Apnoea Alarm Max Breath Rate Alarm

19 19 20

Alarm Conditions/Tests Disconnect Low Flow Mains Fail High Pressure Fault

21 21 21 21

Sigh Function

22

Running the NIPPY ST+ on Battery Power Battery Run Times Battery Care External battery Connecting Auxiliary Equipment Pneumatic Diagram

23 25-26 27 28 28

Specifications International Standards Operation Under Extreme Conditions Accessories and Spares Warnings and Cautions Using Supplementary Oxygen

29 29 30 30 31 32

Maintenance User Maintenance Servicing/Warranty/Transportation Factory Service / Repair EMC Declaration and guidelines

33 34 34 35-37

Battery Run Time Test Record

38

Locking the Settings

40

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 ST+ 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 ST+ 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 ST+ is a pressure controlled, bi-level ventilator. It compresses ambient air and delivers it to the patient through a close fitting nasal mask. The output pressure, can be adjusted by controls on the fascia panel. The Pressure, 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 three buttons to the right of the display provide access to more advanced features and adjustments (accessed via a menu). For greater safety and convenience the NIPPY ST+ 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 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.

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.

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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 optional 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 disconnect alarm is provided. This is activated by analysis of the inspiratory and expiratory flow waveform. 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 Alarm 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 bargraph display.

Inspiratory Trigger The NIPPY ST+ 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 1 requiring the least patient effort and 10 requiring more patient effort.

4

Intended Use The NIPPY ST+ is intended to provide non-invasive ventilation for non-dependent, spontaneously breathing adult patients with respiratory insufficiency, or respiratory failure. The NIPPY ST+ is not intended for life support or life-sustaining applications or for transport of critical care patients. The NIPPY ST+ is intended for use in clinical settings (e.g., hospitals and sub-acute care institutions) and home environments. The NIPPY ST+ is intended for non-invasive use only. The NIPPY ST+ shall only be used by patients who are spontaneously breathing. The NIPPY ST+ must always be prescribed by a competent physician. The NIPPY ST+ is intended for treatment of adult patients only. The NIPPY ST+ is intended to be operated by qualified and trained personnel only.

IMPORTANT! NIPPY ST+ 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 ST+. 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.

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Contraindications The NIPPY ST+ 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

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Features

1.

Comprehensive alarms with mute facility

2.

User friendly intuitive user interface

3.

Easily understood alarm messages displayed onscreen

4.

2 modes of ventilation

5.

Universal mains input, operates anywhere in the world without transformers

6.

Optional internal battery

7.

Adjustable flow triggers with trigger indicators

8.

Large, colour LCD display, clearly shows all settings

9.

28 days stored, On-screen compliance data

10.

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

11.

Fast trigger response

12.

Minimal maintenance requirement

13.

Twelve months parts and labour warranty

14.

Auto switching to back-up battery

15.

Automatic service reminder

7

Explanation of controls 1

2

12

3

4

11

Clear

10

5 13 14 6

15

7

8

9

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

-

Starts and Stops the ventilator

6. 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

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. Ext. Batt

-

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

14. Power

-

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

15. Start

-

Indicates that the ventilator is running.

8

Fascia Display 3

2

4

7 4

11

8 4 12

5

6 1 13

10

9

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. Settings locked symbol -

Displays current mode of ventilation.

This symbol shows that the settings are locked.

6. Alarm Muted symbol

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

7. I Trigger indicator

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

8. E trigger indicator

-

9. External battery

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

10. Internal battery

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

11. Total Hours

- Shows total machine running time.

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

Used to determine service intervals 12. Hours Used

- Shows total hours of use. (Compliance Hours)

13. Service Reminder

- Major service due

9

Ventilator Outlets

1 1. Outlet

-

Main Air Outlet to breathing circuit

Rear Panel Layout 1.

Aux. Power

-

24 Volt connection for external battery. Connect only recommended battery, 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

10

Explanation of Symbols used on NIPPY ST+ 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

11

Getting Started To Switch On Place the NIPPY ST+ 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, estimated tidal volume and breath rate. The right-hand side shows the Total hours, hours used and symbols for alarm mute and locked settings.

Clear

How to adjust the NIPPY ST+ 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.

12

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.

13

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. Service Menu

Service Information

Restricted Access

14

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

15

Breathing Circuits Breathing circuits to be assembled in the order A-B-C-D from the ventilator end. The NIPPY ST+ uses a single limb circuit. Always use a ventilated mask.

Part Number 0792 Breathing circuit volume = 570 ml including filter.

16

Setting up the NIPPY ST+ in CPAP mode 1. Place the NIPPY ST+ on a clean, level surface. 2. Connect the breathing circuit tube to the outlet. It is recommended that a bacterial filter be fitted between the outlet and the 22mm diameter breathing tube. 3. The breathing circuit must contain an intentional leak to prevent re-breathing of exhaled air. This may be achieved with either an integrated leakage in the mask or a leakage/exhalation port. 4. Connect the mask to the outlet tubing on the breathing circuit. Note: Do not fit the mask onto the patient at this point. 5. Press the Start/Stop button and select CPAP mode. 6. Carry out alarm tests as described in “Alarm conditions / tests”. Note: If any of the alarms fail to operate, DO NOT USE until the fault has been rectified. 7. Set EPAP to the prescribed pressure. 8. The patient may now hold the mask to the face. 9. Allow the patient to get used to the mask. Then fasten the interface to the patient. 10. Lock the settings to prevent unauthorised adjustment. See back page. 11. Remove the patient interface or disconnect the patient circuit from the outlet port, before switching off.

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