B & D Electromedical NIPPY Clearway User manual

0985 Version 2 February 2011
NIPPY CLEARWAY
COUGH ASSISTOR
INSTRUCTIONS FOR USE
This book must be kept with the machine
B & D Electromedical
Unit A2 The Bridge Business Centre
Timothy’s Bridge Road
Stratford–upon-Avon,
Warwickshire. CV37 9HW
Tel: [phone] Sales
01789 721577 Technical Support
Fax: [phone]
www.nippyventilator.com
Copies of these instructions may be downloaded from
www.nippyventilator.com/downloads

0985 Version 2 February 2011

0985 Version 2 February 2011
NIPPY Clearway
INSTRUCTION MANUAL INDEX
Page
Operation
Description 1-2
Intended Use 3
Contraindications 3
Features 4
Explanation of Controls
Explanation of Symbols Used 5
Fascia Buttons 6-7
Fascia Display 7
Rear Panel Layout 8
Outlets 8
Internal Memory Back up Battery 9
Handheld Ins/Exs Switch 9
Getting Started
Breathing circuits 10
Switching on/off 10
The Main Screen 11
How to Adjust The Nippy Clearway 11
The Menu Screen 12
How to use the on-screen Menu 12
Structure of the Main Menu 13
How to use the on-screen help 14
Using Help with the Settings Locked 14
Setting Up
Mode Selection 15
Nippy Clearway in Manual Mode 16
Auto Modes Treatment Review Screen 17
Auto Modes manual Override 18
Nippy Clearway in Basic Auto Mode 18-19
Nippy Clearway in Prog. Timed Auto Mode 20-21
Nippy Clearway in Prog. Triggered Auto Mode 22-23
Nippy Clearway in NIV. Mode 24
Advanced Settings - Airway Pressure Vibration 25
Advanced Settings – Post Exsufflation Breaths 25
Compliance data 25
Running on Battery Power 26
External battery 26
Battery Care 27-28
Connecting Auxiliary Equipment 29
Pneumatic Diagram 29
Operation Under Extreme Conditions 30
Accessories and Spares 30
Warnings and Cautions 31
Maintenance
User Maintenance 32
Servicing 33
Warranty/Transportation 33
Factory Service / Repair 33
Specifications 34
International Standards 34
EMC Information 35-37
Locking the Settings 39

0985 Version 2 February 2011

1
Description
The Nippy Clearway is a pressure controlled, mechanical insufflator / exsufflator
cough assist machine. It assists in the mobilisation and clearance of bronchial
secretions by inflating the lungs with a positive airway pressure then providing a
rapid change to negative pressure to assist the patient’s cough. In auto modes a
graphical representation of the treatment and an audible synchronisation signal is
provided to help synchronise the cough effort with the shift to negative pressure.
Ambient air is compressed by a turbine and delivered to the patient through a close
fitting facemask, mouthpiece or a tracheotomy. Very accurate and consistent
pressure control is achieved using the Clearway’s unique bi-directional servo control
valve and remote pressure sensing. The pressure displayed on-screen is the actual
working pressure at the mask/patient interface.
The output pressure and timing 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 settings can be achieved using the buttons around the outside of the display.
More advanced features and adjustments can be accessed via the menu.
It is designed for non-continuous use. The Nippy Clearway may be used for up to 30
minutes in any 1 hour period.
For greater convenience the Nippy Clearway may be powered by an external
battery.
There are 5 modes of operation:-
Manual Positive and negative pressures are applied using the
manual switch on the front of the machine or with a remote
handheld switch plugged into the RS232 input.
Basic Auto In basic auto mode the clearway cycles between insufflation
and exsufflation followed by a pause, for a maximum of 20
cycles.
Timed Programmable Auto The Nippy Clearway can be pre programmed to
deliver a timed sequence, which could include one or more
insufflations before exsufflation. This sequence can be
repeated up to 10 times if desired.
Triggered Programmable Auto This is the same as the timed auto mode with
patient trigger on insufflations.
NIV NIV mode is provided to give the patient up to 15 minutes of
respiratory support to aid the recovery from the exertion of
the cough assist treatment.

2
Alarms
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.
High Pressure A pre-set high-pressure alarm is provided. If the pressure rises above
120% of the working pressure, a visual alarm will operate after a 2 second delay.
Patient Pressure Tube Disconnected If the pressure pick up tube is not
connected the clearway will use the internally measured pressure for control. A
visual alarm will operate after a 2 second delay. This does not compensate for the
length of the circuit. Reconnect the pressure tube for most effective treatment.
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 cancelled by pressing the Set button.
Low Internal Alarm/Memory Battery If the machine has been stored for more
than a few months, the internal memory back up battery will self discharge. An
intermittent alarm (short beep) with no onscreen message indicates a depleted
memory back up battery. The alarm will stop after the battery has started to
recharge. This may take a few minutes.
The user cannot replace this battery. Refer to qualified technical personnel if
the alarm operates when the Nippy Clearway is in daily use.
Inspiratory Trigger
The Nippy Clearway employs a unique triggering mechanism. When the patient
starts to inhale, the decrease in pressure and increase in flow rate causes the
internal control valve to move as an automatic response in order to compensate for
the pressure drop. This movement signals the start of inspiration.

3
Intended Use
This device is intended to assist with cough and/or clear secretions in patients
whose expiratory flow during cough is severely reduced due to;-
fatigue associated with intrinsic lung disease, spinal cord injury, neuro-muscular
weakness.
Secretions will usually be cleared to the mouth so yankauer suction may be required
to clear from the mouth. Very young or weak individuals may still need to use naso
pharengeal suction.
Nippy Clearway must be prescribed by, and used only under the supervision
of a qualified physician.
Contraindications
Pneumothorax or pneumo-mediasinum
Facial trauma – interface should be considered
Tracheoesophageal fistula,
Recent or existing barotrauma,
Bullous emphysema
Spinal Instability
High/low blood pressure – monitor
Acute pulmonary oedema
Acute lung injury

4
FEATURES
1. Lightweight, compact fully self-contained unit with lockable settings.
2. Can be used with mouthpiece, full-face mask or tracheotomy.
3. 5 Treatment modes.
4. User friendly intuitive software.
5. Easily understood alarm messages displayed onscreen.
6. Employs state of the art microprocessor control.
7. Universal internal mains input, operates anywhere in the world without
transformers.
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, and user
interventions, for download to PC.
11. Very low maintenance requirements, therefore maintenance costs are
extremely low.
12. Twelve months parts and labour warranty.
13. Auto switching to external battery.
14. Automatic service reminder.

5
Explanation of Symbols used on Nippy Clearway 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
- Settings Locked / Unlocked
- Battery Charged
- Battery Discharged
- Service Reminder
- Dispose of in Line with Local Authority Guidelines
- Recycle
- Do Not Reuse
- Batch Code
-Consult Instructions for Use
-Green = Manual Control. Faded and Flashing = Manual Override
available.
- 2 post exsufflation breaths selected at end of auto mode
M

6
Fascia Buttons
1. Ins - Selects the insufflation positive airway pressure adjustment (scaled
in cmH
2
O). Value is displayed on screen adjacent to the switch.
2. Ti - Selects the insufflation time adjustment (scaled in seconds). Value is
displayed on screen adjacent to the switch.
3. Pause - Selects adjustment of the pause time between insufflations (scaled
in seconds). Value is displayed on screen adjacent to the switch.
4 .Ins Rpt. - Selects adjustment of the number of insufflations in an auto cycle.
Value is displayed on screen adjacent to the switch.
5 .Mode - Displays the mode selection screen.
6. Exs - Selects the exsufflation negative airway pressure adjustment (scaled
in cmH
2
O). Value is displayed on screen adjacent to the switch.
7. Te - Selects the exsufflation time adjustment (scaled in seconds). Value
is displayed on screen adjacent to the switch.
8. Cycle Rpt. - Selects adjustment of the number of complete cycles in an auto
sequence. Value is displayed on screen adjacent to the switch.
9. Menu/Clear - Displays the menu screen.
10. Help - Displays context sensitive help messages.
11. +►- Increments the selected parameter or moves the selection bar up
the menu.

7
12.Set - Selects the current menu function displayed by the selection bar OR
double press for hours till next service.
13.◄- - Decrements the selected parameter or moves the selection bar up
the menu.
14. Start/Stop - Press to start or stop treatment
15. Start LED - Indicates that the Clearway is running.
16 . - Press to switch on/off.
17. Power LED - Indicates that power is connected.
18. Ext.Batt LED - Indicates that the Clearway is running on external battery power.
Fascia Display
1. Pressure Display - Indicates insufflation and exsufflation pressure
(scaled in cm H
2
O).
2. Service Reminder - Flashing = major service due
3. External battery - Indicates external battery is connected, Shows red
when depleted.
4. Settings locked symbol - This symbol indicates that the settings are locked.
5. Trigger indicator - “Flashes” each time the insufflation cycle is initiated
by the patient. The number in the box represents the
trigger sensitivity setting.
6. Manual Indicator - Solid Green Hand indicates Clearway in manual
mode. Flashing hand indicates manual override
available.

8
Clearway Fascia
1. Ins/Exs Switch - Manual insufflation/exsufflation switch
2. Mask Pressure - Pressure input.
3. Outlet - Patient outlet port.
Rear Panel Layout
1. Aux. Power - 24 Volt connection for external battery. Connect only
recommended batteries, part no 0788.
2. Cooling Vent - Cooling air outlet. Do not obstruct.
3. RS232 Port - For connection to a personal computer. Isolated to
1500 Volts.
4. Power Inlet - Input mains power connector. Double fused.
Use B&D supplied power cable

9
Internal Memory Back-up Battery
The Clearway contains a rechargeable internal memory back-up battery. This
battery is charged when the Clearway is switched on. Due to the intermittent
nature of use, this battery may discharge, particularly after long periods of
storage.
If the battery becomes discharged, a message will be displayed on the screen
accompanied by an audible beep.
To recharge the battery, plug the Clearway into the mains and switch it on.
Leave it switched on for approx 7 hours.
Handheld Ins/Exs Switch
The handheld ins/exs switch mimics the operation of the front panel mounted
ins/exs switch.
To use the handheld ins/exs switch plug its connector into the RS232 connector
on the back of the Clearway.
In manual mode or during manual over-ride of auto sequence, the insufflation
and exsufflation functions may be operated by either the machine mounted or
handheld switch.

10
Getting Started
The Breathing circuit
Breathing circuit volume = 570 ml including filter.
The breathing circuit supplied consists of a 1.5m smoothbore tube with a proximal
pressure pick up/exhale port and a bacterial filter. The bacterial filter is always used
at the patient outlet end of the circuit.
Connecting the breathing circuit
Push the large tube onto the Outlet port. To
disconnect, twist the tube before pulling it off.
Push the small tube onto the Mask Pressure port.
To disconnect, twist the tube before pulling it off.
Connect the patient interface to the opposite end
of the large tube.
To Switch On
Place the Nippy Clearway 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 on/off button.
To Switch Off
Press the on/off button. The “Switch Clearway Off” message will appear
onscreen.
Press the on/off button again to switch off. Press any other button to cancel
switching off the machine.

11
The Main Screen
The left-hand side shows the insufflation settings, INS, Ti, PAUSE, INS RPT and
also the MODE, adjacent to its setting button.
The centre section shows a bargraph display of the airway pressure.
The right-hand side shows the exsufflation settings, EXS. Te
Also number of times to repeat the cycle, CYCLE RPT and icons for ext battery and
locked settings.
How to adjust the Nippy Clearway
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 INS.
INS setting will be surrounded by a purple flashing box.
Press +► to increase the pressure setting.

12
Menu Screen
The Main Menu gives access to further adjustments and allows you to view
information relating to the machine 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 to
select it.
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 “Settings and Options”.
Press SET.
Press SET button to select “User
Preferences”.
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. Treatment Review Screen View only
2. Adjust Trigger Levels View / Adjust
3. Settings and Options
User Preferences
Alarm Volume View / Adjust
Display Brightness View / Adjust
Display Contrast View / Adjust
Keypad Tone Select On/Off
Advanced Setting
Ins vibration level View / Adjust
Exs Vibration level View / Adjust
Post Exsufflation breaths View / Select
Mode Select
Manual View / Select
Basic Auto View / Select
Programmed Timed Auto View / Select
Triggered Timed Auto View / Select
NIV View / Select
3. Clear Patient Settings Resets machine to default settings and
clears the compliance data, ready for a
new patient.
4. Warnings & Cautions Safety information View only
5. Compliance Data Total Hours View only
Compliance Hours View only
Average Treatment View Only
Use + or – button to scroll through the data.
Press and hold + and – buttons to reset compliance data
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 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 for a context sensitive help message. 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
Operation
All parameters and user inputs are displayed on a large, clear, colour LCD screen.
Insufflation and exsufflation pressures are set using the keypad. Settings may be
locked to prevent accidental adjustment.
The patient must not be left unattended during treatment.
Modes of Operation
Mode Selection Options
The physician may select the modes available
to the user.
Only the selected modes will be displayed on
the mode selection screen.
From the main menu select Settings and
Options then Mode Select Options. Use the
Set button to move up and down the list, and
the ◄- and +►buttons to select a mode on or
off. Only modes set to On will be available in
the mode selection screen.
Mode Selection
Press the Mode switch to display the list of
available operating modes.
Use the ◄- and +►buttons to highlight the
desired mode. Press the Set button to select.

16
Manual mode
Ins / exs is controlled with the integral
joystick switch or remote hand held
joystick. The machine outputs the set
pressures as the joystick is operated.
There are no graphical treatment
display screens associated with
manual mode
Setting up the Clearway in manual mode.
Switch on the clearway and select Manual mode from the Mode select list. (If manual
does not appear in the list, this function is not available).
Press INS to select the insufflation pressure and use the ◄- and +►buttons to
adjust to the required pressure.
Press EXS to select the exsufflation pressure and use the ◄- and +►buttons to
adjust to the required pressure.
Use either the front panel or handheld INS/EXS switch to administer the treatment.