Breas Medical NIPPY JUNIOR + Instruction Manual
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Breas Medical NIPPY JUNIOR + Instruction Manual

Positive pressure ventilator
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DOC 0915
INSTRUCTION MANUAL
FOR THE NIPPY JUNIOR +
This book must be kept with the machine
Version 8 November 2017
POSITIVE PRESSURE
VENTILATOR
Breas Medical Ltd
Unit A2, The Bridge Business Centre
Timothy's Bridge Road
Stratford Enterprise Park
Stratford–upon-Avon,
Warwickshire. CV37 9HW
Tel: 01789 293460
www.nippyventilator.com

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  • Page 1 DOC 0915 INSTRUCTION MANUAL FOR THE NIPPY JUNIOR + POSITIVE PRESSURE VENTILATOR This book must be kept with the machine Breas Medical Ltd Unit A2, The Bridge Business Centre Timothy’s Bridge Road Stratford Enterprise Park Stratford–upon-Avon, Warwickshire. CV37 9HW Tel: 01789 293460 www.nippyventilator.com...
  • Page 3 NIPPY JUNIOR + INSTRUCTION MANUAL INDEX Page Introduction Description Intended Use Contraindications Features Explanation of Controls Fascia Buttons Fascia Display Outlets Rear Panel Layout Explanation of Symbols Used Getting Started The Main Screen How to Adjust The NIPPY Junior + The Menu Window How to use the on-screen Menu Structure of the Main Menu...
  • Page 4 Disposal at end of life EMC Declaration and guidelines 41-43 Battery Run Time Test Record Locking the Settings Please note Breas Medical previously traded as B & D Electromedical & some photographs in these instructions still show the name B & D Electromedical.

  • Page 5: Introduction

    • 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!

  • Page 6: Description

    Description The NIPPY Junior+ 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.
  • Page 7 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.
  • Page 8 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.

  • Page 9: Intended Use

    Intended Use The NIPPY Junior+ 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; •...

  • Page 10: Contraindications

    Contraindications The NIPPY Junior+ 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 •...

  • Page 11: Features

    Features Optional internal battery operation Comprehensive, auto setting, alarms with mute facility Can be used with Nasal mask, Nasal Pillows, Full face mask or Tracheostomy User friendly intuitive user interface. Easily understood alarm messages displayed onscreen 4 modes of ventilation Universal mains input, operates anywhere in the world without transformers Adjustable flow triggers with trigger indicators Large, colour LCD display, clearly shows all settings...

  • Page 12: Fascia Buttons

    Explanation of controls Fascia Buttons 1. IPAP - Selects the Inspiratory Positive Airway Pressure adjustment (scaled in cm H 2 O). Value is displayed on screen adjacent to the switch. 2. EPAP - Selects the Expiratory Positive Airway Pressure adjustment (scaled in cm H 2 O). Value is displayed on screen adjacent to the switch.
  • Page 13 +► - 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.
  • Page 14 Fascia Display 1. Mode Displays current mode of ventilation. 2. Pressure Display - Indicates airway pressure (scaled in cm H Changes colour to red in under / over pressure alarm condition. 3. Rate Display - Indicates patient breath rate (scaled in Breaths Per Minute).

  • Page 15: Outlets

    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 Aux. Power 24 Volt connection for external battery. Connect only recommended batteries, part no 0910 RS232 Port For connection to remote alarm or personal...

  • Page 16: Explanation Of Symbols Used

    Explanation of Symbols used on NIPPY jnr+ and Accessories Type B Applied parts to EN 60601-1 Alternating Current Direct Current Time Delay Fuse 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...

  • Page 17: Getting Started

    Getting Started To Switch On Place the NIPPY Junior+ 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.

  • Page 18: The Menu Window

    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.

  • Page 19: Structure Of The Main Menu

    Structure of the Main Menu . 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) Disconnection Alarm...

  • Page 20: Breath Analyser

    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. •...

  • Page 21: How To Use The On-Screen Help

    How to use the On-screen Help Press the HELP button at any time for a list of help topics. Follow the simple on- screen instructions. Press HELP again to exit. If during setting up, you require a description of a particular parameter, select it then press HELP.
  • Page 22 Breathing Circuits The type of breathing circuit used will depend on the mode of ventilation selected:- Breathing circuits to be assembled in the order A-B-C-D from the ventilator end. In CPAP, Pressure Support and Pressure Control modes, a single limb circuit with an exhalation port will be required.

  • Page 24: Using The Nippy Junior + Invasively

    Using the NIPPY Junior+ Invasively The NIPPY Junior+ is safe for use with a tracheostomy or endotracheal tube. An exhalation port must be fitted between the breathing circuit and the tracheostomy fitting. DO NOT USE THIS TYPE OF CIRCUIT FOR IPPV MODE Invasive circuits Invasive 15mm dry circuit 15mm circuit including anti-bacterial filter, heat/moisture exchange (HME) flexible adapter...
  • Page 25 Setting up the NIPPY Junior+ in CPAP mode • Place the NIPPY Junior+ on a clean, level surface. • Connect the breathing circuit tube to the outlet. It is recommended that a bacterial filter be fitted between the outlet and the breathing tube. •...
  • Page 26 Setting up the NIPPY Junior+ in Pressure Support mode Place the NIPPY Junior+ on a clean, level surface. Connect a clean or new breathing circuit tube to the outlet. It is recommended that a bacterial filter be fitted between the outlet and the breathing tube. The breathing circuit must contain an intentional leak to prevent re-breathing of exhaled air.
  • Page 27 Setting up the NIPPY Junior+ in Pressure Control mode Place the NIPPY Junior+ on a clean and level surface. Connect a clean or new breathing circuit tube to the outlet. It is recommended that a Bacterial filter be fitted between the outlet and the 22mm diameter breathing tube.
  • Page 28 Setting up the NIPPY Junior+ In IPPV mode Place the NIPPY 3+ on a clean, level surface. Connect a clean or new breathing circuit tube to the outlet. It is recommended that a Bacterial filter be fitted between the outlet and the 22mm diameter breathing tube.
  • Page 29 Setting Up the Alarms Flow Alarm Automatic Setting For convenience, the high and low flow alarms may be set automatically. Varying leak or the patient getting out of synch with the ventilator may disrupt the measurement process. Therefore it is vital that the alarms are tested after setting up. Low Flow Alarm •...

  • Page 30: Disconnection Alarm

    Disconnection Alarm The disconnection alarm acts as a back up to the high flow alarm. The inspiratory and expiratory flow waveform of the patient is analysed. If the waveform indicates that a significant leak maybe present in the breathing circuit an audible and visual alarm will operate after 10 seconds.

  • Page 31: Apnoea Alarm

    Apnoea alarm Select USER PREFERENCES from the main menu. From the OPTIONS MENU, select APNOEA ALARM. An apnoea event is defined as a cessation of spontaneous breathing for a set time delay. The apnoea alarm will be activated if this condition is detected. Ventilation will continue at the backup rate during apnoea events.

  • Page 32: Disconnect

    Alarm Conditions / Tests Test the alarms prior to use or daily for machines that are in constant use. Before testing alarms, ensure that the alarm is not muted. To cancel the Mute, press and hold the mute switch until a beep is heard (2 seconds). High Flow Alarm If the inspiratory flow exceeds the high alarm value, the alarm will be activated accompanied by the on-screen, high flow alarm message.

  • Page 33: Sigh Function

    Sigh Function The ventilator can be programmed to deliver an occasional sigh with a larger tidal volume. This prevents collapse of the alveoli (atelectasis) which can result from the patient constantly inspiring the same volume of gas. Sigh is available in all modes except CPAP.

  • Page 34: Battery Run Times

    Running the NIPPY Junior+ on Battery Power The NIPPY + may be powered from the mains, internal or external battery. IMPORTANT BATTERY CARE RULES 1. Regularly check battery run times for your system at your prescription settings and record in the log. 2.

  • Page 35: Battery Run Times

    Battery Run Time Estimate Screen Double press the SET button to display a bar graph of run time. The time for each battery connected will be calculated, according to the ventilator settings, and shown on the screen. This is an indication of the battery state of charge not its health. For most accurate result, run the ventilator on battery power for 5 minutes prior to this check.

  • Page 36: Battery Care

    Battery Care • Check the running time of your system regularly. • Always make sure batteries are fully charged before use. • The battery should be recharged as soon as possible after use. • This type of battery does not suffer from the memory effect that is widely talked about and does not need to be fully discharged before charging.
  • Page 37 Battery Run Time Test (Health test) • Ensure the battery is fully charged. • Run the ventilator from the battery until the low battery alarm operates and record the running time. Look up the run time in the table. If the battery is not achieving minimum run time replace it.
  • Page 38 Safety • Warning! High voltages exist inside the charger. • Do not remove the cover. Return to Breas Medical Ltd if a fault occurs. • Do not expose to water or dust. • Do not cover the charger whilst in use •...
  • Page 39 Connecting auxiliary monitoring equipment For monitoring or downloading data the NIPPY jnr+ may be connected to a PC or Laptop computer. The NIPPY jnr+ isolated RS232 port is safe for use with any domestic PC or laptop computer. However, when assembling a system, the completed system should comply with EN60601-1 (medical systems).

  • Page 40: Specifications

    Safety of Electromedical Instruments, General Requirements Electromagnetic Compatibility (In accordance with the EMC Directive 89/336/EMC) Breas Medical Ltd declares that the NIPPY Junior + Ventilator complies with the following EMC standards. EN60601-1-2: 2001 Test results available for review from Breas Medical Ltd...

  • Page 41: Operation Under Extreme Conditions

    Operation Under Extreme Conditions Ambient Temperature in the range of +5 to +50 Between 5 and 40 degrees functioning of the ventilator should not be affected. Extremes of temperature (below 5 C, above 40 C) may affect the colour of the LCD display.
  • Page 42 WARNINGS This ventilator is intended to augment the patient breathing. It MUST NOT BE USED AS A LIFE SUPPORT VENTILATOR. It is not intended to provide the total ventilatory requirement of the patient Do not attempt to pass oxygen into the panel mounted air inlet, or use with flammable anaesthetic agents e.g.

  • Page 43: Using Supplementary Oxygen

    Using Supplementary Oxygen with the NIPPY Junior+ If required, supplementary oxygen may be entrained into the breathing circuit up to a maximum of 15 L/minute. When adding oxygen, fit an entrainment port at the mask / tracheotomy end of the circuit.
  • Page 44 MAINTENANCE YOU MUST DISCONNECT THE NIPPY FROM THE MAINS SUPPLY BEFORE ANY MAINTENANCE IS CARRIED OUT User maintenance is limited to cleaning and visual inspection of the ventilator, the input air filter and the breathing circuit. The ventilator and the detachable mains cord set should be inspected for signs of external damage weekly.

  • Page 45: Technical Information

    Use the original packing materials whenever possible. Breas Medical Ltd are not responsible for inbound transit damage. Factory Service / Repair Breas Medical Ltd products returned for factory service or repair must have a Return Material Authorisation (RMA) number assigned. This is essential for efficient processing of repairs.

  • Page 46: Emc Information

    EMC Information Guidance and Manufacturer’s Declaration – Electromagnetic Emissions: This device is intended for use in the electromagnetic environment specified below. The user of this device should make sure it is used in such an environment. Emissions Test Standard Electromagnetic Environment- Guidance RF emissions (radiated) EN55011 The device uses RF energy only for its internal function.
  • Page 47 Electromagnetic Immunity: This device is intended for use in the electromagnetic environment specified below. The user of this device should make sure it is used in such an environment. Immunity Test IEC 60601 Compliance Level Electromagnetic Environment- Guidance TestLevel Conducted RF 3 Vrms 3 Vrms Recommended separation distance:...
  • Page 48 Typical Power Output of Some Common Transmitters This list is provided for general guidance. It is not exhaustive or specific. It not intended to replace the findings of an electromagnetic survey. Suggested Minimum Separation Distance Power Notes This is a very approximate guide. If abnormal operation is observed, disregard this figure and take corrective action.

  • Page 49: Battery Run Time Test Record

    NIPPY+ Battery run time test record Use this table to record the battery run times when performing the monthly battery health test. Replace the battery when the run time is less than 75% of a new battery or the battery is 2 Years old. Fully charge the battery, connect the breathing circuit and using your normal settings run the ventilator until the low battery alarm operates.

  • Page 51: Locking The Settings

    Locking the settings Adjustment lock The settings can be locked to prevent unauthorised adjustment. ◄- +► To lock press buttons simultaneously and hold for 2 seconds. ◄- +► To unlock press buttons simultaneously and hold for 2 seconds. This prevents adjustment but allows the user to switch the ventilator on and off. Total lock The ventilator can be locked to prevent unauthorised adjustment or power off.

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