NIPPY Clearway User Manual Text
Contents
1. In the event of a breakdown or damage to the machine refer servicing or repair to qualified and competent technical personnel Factory Service Repair Damage to either the machine or its mains lead must be inspected by competent technical personnel before use B amp D Electromedical products returned for factory service or repair must have a Return Material Authorisation RMA number assigned This is essential for efficient processing of repairs You can obtain your RMA number by calling 01789 293460 with the following information 1 Unit Model 2 Serial number 3 Your name address and telephone number 4 Complete description of the malfunction or service required When the RMA number has been issued we will arrange for the unit to be collected Place the RMA number on the outside of the carton The unit must be properly packaged before shipment Preferably in the original packaging Please ensure unit is accompanied by a declaration of decontamination B amp D Electromedical are not responsible for inbound transit damage When enquiring about a returned item you must quote the RMA number Disposal at end of Life The Nippy Clearway should be disposed of in line with local authority guidelines regulations Spent batteries should be disposed of in line with local authority guidelines regulations 35 Specification Modes Manual integral or hand held remote switch Basic Auto Programmable Timed Auto Programma2. Battery Power Maintenance External battery Battery Care Connecting Auxiliary Equipment Pneumatic Diagram Operation Under Extreme Conditions Accessories and Spares Warnings and Cautions User Maintenance Servicing Warranty Transportation Factory Service Repair Specifications International Standards EMC Information Locking the Settings Page KW W PO OO COON N O1 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
3. Clearway and breathing system Nippy Clearway and circuit is less than 6cm H20 60 l min This value must not be exceeded when adding attachments or fittings to the breathing circuit Accessories and Spares 1 A range of mouth pieces and facemasks Is available in various sizes Please contact us for details 2 A range of breathing circuits is available for use with mouth piece facemask or tracheotomy Input Air Filter Element pt no 0960 116 pack of 5 4 Inline Bacterial Filter pt no 0960 107 99 999 filtration Resistance 0 75mMB 50 l min deadspace 55ml 22mm tapered fittings These components listed above are for single patient use 5 External battery part number 0960 111A 1062 6 Hand held switch Part number 0960 109 7 Mobility Bag Part number 0960 114 U 32 WARNINGS No modification of this equipment is allowed Do not attempt to pass oxygen into the panel mounted air inlet or use with flammable anaesthetic agents e g Ether etc CAUTIONS e The Nippy Clearway should only be used in accordance with the instructions of the supervising physician Personnel using and operating the Nippy Clearway must become familiar with this instruction manual before using the unit e Ensure patient safety through the presence of a trained attendant and an alternative means of treatment e The Nippy Clearway should not be placed close to high frequency surgical diathermy defibrillator or short wave therapy e
4. Clearway will cycle between IPAP and EPAP at the back up rate unless the patient triggers the inspiratory breath Press the Mode switch Select N V from the mode select screen Set the desired IPAP Ti EPAP and Rate Press the Start Stop switch to begin Press again to stop Ins trigger sensitivity may be adjusted by selecting Trigger levels from the eee main menu NIV will continue for a maximum of 15 minutes Do not leave the patient unattended At the end of treatment a warning will be displayed on screen accompanied by a double beep sound Ensure an exhalation port is connected in the breathing circuit when using NIV mode Manual override is NOT available in NIV mode Setting up the Clearway in NIV mode e Switch on the Clearway and select NIV mode from the Mode select list If NIV does not appear in the list this function is not available to the user The modes available are selected from the Mode Selection menu see page 15 e Press INS to select the inspiratory pressure IPAP and use the lt and P buttons to adjust to the required pressure e Press Ti to select the inspiratory time Ti and use the lt and buttons to adjust to the required time e Press INS Rpt to select the back up rate and use the lt and buttons to adjust to the required rate e Press Exs to select the expiratory pressure EPAP and use the lt and P buttons to adjust to the required pressure e Press menu and select treatme
5. Connect only recommended batteries part no 0960 111A 1062 Cooling Vent Cooling air outlet Do not obstruct RS232 Port For connection to accessories Isolated to 1500 Volts 4 Power Inlet Input mains power connector Double fused Use B amp D supplied power cable 8 Internal Memory Back up 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 lf 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 approximately 7 hours Handheld Ins Exs Switch The handheld dual function switch allows remote manual operation and start stop of auto sequences To use the handheld switch plug its connector into the RS232 connector on the back of the Clearway With the Clearway switched on and auto or NIV mode selected treatment may be started or stopped by pressing the on off button once 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 Getting Started The Breathing circuit W Breathing circuit volume 570 ml including filter The breathing circuit supplied consists
6. Press INS to select the insufflation pressure and use the lt and gt buttons to adjust to the required pressure e Press Ti to select the insufflation time and use the lt and gt buttons to adjust to the required time e Press Pause to select the pause time between insufflations and use the lt and gt buttons to adjust to the required time e Press Ins Rpt to select the number of insufflations before exsufflation Use the lt and gt buttons to adjust to the required number e Press EXS to select the exsufflation pressure and use the lt and gt buttons to adjust to the required pressure e Press Te to select the exsufflation time and use the lt and buttons to adjust to the required time e Press Cycle Rpt To select the number of insufflation exsufflation cycles in the sequence Use the lt and gt buttons to adjust to the required number e Press menu and select treatment review screen to view the waveform if desired Press Menu again to escape e Insufflation trigger sensitivity may be adjusted by selecting trigger sensitivity from the main menu e Press Start Stop to begin treatment e Further adjustments may be made to the pressure time and profile settings during treatment Press SET to leave the treatment display screen and make the necessary adjustments 23 NIV Mode Up to 15 minutes of non invasive Ventilation may be used to provide respiratory Support prior to or post treatment The
7. Trigger levels from the main menu For example the sequence might be Active Treatment Display 2 2 x insufflation followed by exsufflation repeated twice Press the Start Stop button to initiate treatment The Clearway will wait for the patient to trigger the start of the sequence and the display will change to the active treatment display This is a graphical representation of the treatment sequence Insufflation is shown as a positive waveform and exsufflation is shown as negative The numbers in the top right hand corner of the display indicate the progress In this example it is showing repetition number 1 of a total of 2 Use the Set button to toggle between the active treatment display and the normal display if desired To aid synchronisation with the exsufflation an audible beep will sound just before the start of each exsufflation Press the Start Stop button to end treatment A double beep will sound at the end of the sequence Manual override may be used at any time during the treatment and is available for 1 minute after the treatment has finished to provide safer airway clearance 22 Setting up the Clearway in Triggered Programmable Auto mode e Switch on the Clearway and select Prog Trig Auto mode from the Mode select list If Prog Trig Auto does not appear in the list this function is not available to the user The modes available are selected from the Mode Selection menu see page 15 e
8. adjust to the required time e Press Cycle Rpt To select the number of insufflation exsufflation cycles in the sequence Use the lt and buttons to adjust to the required number e Press menu and select treatment review screen to view the waveform if desired Press Menu again to escape e Press Start Stop to begin treatment e Further adjustments may be made to the pressure time and profile settings during treatment Press SET to leave the treatment display screen and make the necessary adjustments 21 Triggered Programmable Auto mode The Nippy Clearway can be pre programmed to deliver a triggered timed sequence which could include one or more insufflations before exsufflation or with the exsufflation pressure set to zero repeated triggered insufflations This sequence can be repeated up to 10 times if desired When using the triggered mode consider lengthening the pause time to allow the patient a comfortable period of time to trigger the breath If the breath is not triggered before the set pause time is reached then the device will deliver a timed insufflation As an option at the end of the sequence two insufflations may be added to assist re recruitment This is set through advanced settings see page 25 In Triggered mode the sequence will not start until the machine detects the patient s inspiratory effort each insufflation can be triggered by the patient Inspiratory trigger sensitivity may be adjusted by selecting
9. from transmitters such as base stations for radio mobile cordless telephones amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Nippy Clearway is used exceeds the applicable RF compliance level above the Nippy Clearway should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as relocating the Nippy Clearway Recommended Separation Distances between Portable and Mobile RF Communications Equipment and This Nippy Clearway The Nippy Clearway is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The user of this Nippy Clearway can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and this Nippy Clearway as recommended below according to the maximum output power of the communications equipment Rated Maximum Power Separation Distance According to Frequency of Transmitter Output of Transmitter W m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2 VP d 1 2 VP d 2 3 VP 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 38 For transmitters rated at a m
10. lt 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 O 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 F Exs Pressure F i 1 Pressure Display Indicates insufflation and exsufflation pressure scaled in cm H20 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 unlocked 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 Clearway Fascia 1 2 3 1 Ins Exs Switch Manual insufflation exsufflation switch 2 Mask Pressure Pressure input 3 Outlet Patient outlet port Rear Panel Layout B amp D Electromedical Stratford on Avon England CV37 SHW www nippyventilator com 100 240V 0 7 1 3 Amperes 47 63Hz Fuse 2 x ie aay Aux Power 24 E 4A 0086 1 Aux Power 24 Volt connection for external battery
11. of a 1 5m smoothbore tube with a patient monitoring line 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 sess 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 D 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 10 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 NIPPY Clearway dil How to adjust the Nippy Clearway select the desired parameter with the relevant button The reading adjacent to the button
12. than normal make sure that the battery is fully charged e Do not charge your battery near sources of ignition e Check the running time of your system regularly e lf you have more than one battery use them in rotation e Do not use if any of the cables or components show any sign of damage e Most reported problems arise from incorrect battery charging Disposal of depleted batteries Depleted batteries may be disposed of in line with local authority regulations 30 Connecting auxiliary monitoring equipment For monitoring or downloading data the Nippy Clearway may be connected to a PC or Laptop computer The Nippy Clearway 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 For example most computers do not comply with this standard so it should be sited at a distance which makes it impossible to touch the computer and the patient at the same time Clearway System Pneumatic Diagram Fresh air inlet Vacuum connection Pressure Connection Outlet connector Mask Pressure port Pressure transducer 1 Pressure transducer 2 Exhaust Port 9 Breathing Circuit 10 Pressure Exhalation Port 2 3 Blower gt ae oo eS a a a 11 Patient Connection Port Valve eee eee 4 i 7 8 lt SE a D L 11 lt 10 5 a 31 Operation Under Extreme Conditions Ambient Temperature in the ran
13. to view the waveform if desired Press Menu again to escape e Press Start Stop to begin treatment e Further adjustments may be made to the pressure time and profile settings during treatment Press SET to leave the treatment display screen and make the necessary adjustments 19 Timed Programmable Auto mode 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 As an option at the end of the sequence two insufflations may be added to assist re recruitment This is set through advanced settings see page 25 For example the sequence might be 2 x insufflation followed by exsufflation repeated twice In this example a 1 second insufflation 10cm is followed by a pause of 2 seconds This is repeated and followed by a 1 second exsufflation 10cm The whole cycle is then repeated Press the Start Stop button to initiate treatment The Clearway will start the sequence and the display will change to the active treatment display This is a graphical representation of the treatment sequence Insufflation is shown as a positive waveform and exsufflation is shown as negative The numbers in the top right hand corner of the display indicate the progress In this example it is showing repetition number 1 of a total of 2 Use the Set button to toggle between the active treatment display and th
14. type There are no user adjustable alarms Alarm Audible Machine Status UserAction High Pressure High Pressure alarm Max working pressure more than Stop using the Clearway message on screen 120 of Insufflation setting Patient Pressure Patient Pressure tube Low Proximal pressure line not Reconnect tube disconnected message connected Device still functions tube disconnected on screen with possible reduced effectiveness Low External battery depleted Recharge or replace Machine will function until battery battery or switch to is exhausted mains power Low Internal Low Internal memory Low Memory battery voltage low Run Clearway for 1 hour memory Battery Battery message on Machine still functions to recharge battery screen Fault Machine Fault message Low Internal fault Machine Stop use Refer on screen with fault malfunction machine to approved details repairer These alarms may be silenced by pressing the Set button Low External Low External battery battery message on screen Inspiratory Trigger The Nippy Clearway employs a differential pressure triggering mechanism By comparing the pressure at the mask end of the breathing circuit with the pressure at the machine end of the circuit the Clearway is able to detect the start of inspiration sensitivity of the trigger is adjustable The range of adjustment is dependent on the mode selected In triggered auto mode the range is 0 5 to 3 5 cm H20 In NIV mode the range
15. Battery Life The end of life is defined by the maximum running time falling to 75 of that of a new battery For a battery that is used occasionally service life is 2 years Replace the battery when running times drop below those indicated or after 2 years Battery Storage This type of battery is best stored partly charged A battery that is not in use will slowly discharge This rate of discharge increases with temperature Ideally the storage temperature should be above 20 C and below 20 C It must be below 40 C After storage in a cold environment allow 24 hours for the battery to reach room temperature before use Fully charge the battery every 2 months Battery Test Test the battery monthly or if the running time seems low a fault is suspected or to confirm that the battery is good e Ensure the battery is fully charged e Run the machine from the battery until the low battery alarm operates and record the running time If the battery run time is less than 30 minutes replace it e lf the battery is good fully recharge it immediately after testing Hints and Tips for Reliable Operation e Always make sure that the battery is fully charged before use e Do not switch off charger until battery is fully charged e Avoid the temptation to give the battery a quick boost This is of no benefit e lf you are in doubt the state of charge charge for at least 24 hours e f running time suddenly seems considerably shorter
16. NIPPY CLEARWAY COUGH ASSISTOR UK Patent GB2498121 INSTRUCTIONS FOR USE This book must be kept with the machine B amp D Electromedical Unit A2 The Bridge Business Centre Timothy s Bridge Road Stratford upon Avon Warwickshire CV37 9HW Tel 01789 293460 Sales 01789 721577 Technical Support Fax 01789 262470 www nippyventilator com Copies of these instructions may be downloaded from www nippyventilator com downloads Doc 2007 Version 4 July 2014 Operation INSTRUCTION MANUAL INDEX Description Intended Use Contraindications Features Explanation of Controls Explanation of Symbols Used Fascia Buttons Fascia Display Rear Panel Layout Outlets Internal Memory Back up Battery Handheld Ins Exs Switch Getting Started Setting Up Breathing circuits Switching on off The Main Screen How to Adjust The Nippy Clearway The Menu Screen 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 Mode Selection Nippy Clearway in Manual Mode Auto Modes Treatment Review Screen Auto Modes manual Override Nippy Clearway in Basic Auto Mode Nippy Clearway in Prog Timed Auto Mode Nippy Clearway in Prog Triggered Auto Mode Nippy Clearway in NIV Mode Advanced Settings Airway Pressure Vibration Advanced Settings Post Exsufflation Breaths Insufflation Profile Settings Compliance data Using Supplementary Oxygen Running on
17. SER 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 machine the input air filter and the breathing circuit The machine and the detachable mains cord set should be inspected for signs of external damage weekly If any damage is evident particularly to the mains cord set refer repair to appropriately qualified technical personnel DO NOT immerse the machine in or spray with water DO NOT use solvent cleaning agents or detergents DO NOT use abrasive cleaning agents Mains Power Lead Before using the Clearway inspect the mains lead for damage Do not use if there is any damage to the plug socket or the insulation Exterior of Case To clean wipe the exterior of the case with a soft cloth moistened with water Input Air Filter The input air filter should be inspected weekly Replace when visibly soiled It is located on the rear of the machine To remove the filter grip the filter housing with the thumb and forefinger across the top corners and pull the filter cover away from the machine Remove and inspect the element If the filter element requires replacement use only recommended spares see spares list The use of any other filtering material may impair the performance of the machine Never attempt to clean the filter element with solvent cleaning agents Do not operate the machine unless the in
18. aximum output power not listed above the recommended separation distance din meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W Note 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 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 100 KW Typical transmission power of FM radio station with 50 km range 72 m 1 kW 1000 W ieee oa RF power from a amateur radio transceiver without 73m 100 W Typical maximum output RF power from a amateur_radio transceiver 23m 5 W Typical maximum output RF power from a hand held amateur radio 5m transceiver AW Typical maximum output power for a Citizens band radio station 27 MHz in 4 6m many countries 2 W Maximum output from a UMTS 3G mobile phone Power class 1 mobiles 3 25m Maximum output from a GSM850 900 mobile phone 500 mW Typical cellular phone transmission power 1 6m Maximum ou
19. be achieved using the buttons around the outside of the display More advanced features and adjustments can be accessed via the menu lt 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 When using Clearway as a portable device it should be placed in its mobility bag pt no 0960 114 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 RS2382 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 mode is provided to give the patient up to 15 minutes of respiratory Support prior to or post treatment Alarms The Clearway alarms are all Low Priority The alarms require operator awareness and alert the operator to a change in the status of the device The alarm signal consists of an audible alarm and an on screen message to describe the alarm
20. ble Triggered Auto NIV Basic Auto mode Insufflation pressure Exsufflation pressure Run Time Programmable Auto modes Insufflation pressure Exsufflation pressure Number of Insufflations prior to exsufflation Insufflation time Ti Exsufflation time Te Pause time Number of cycles total of insufflations exsufflation 1 cycle Trigger NIV mode pressure controlled Inspiratory Time Ti Back up Rate Run Time Trigger Size Weight Supply Voltage Supply Frequency Type of protection against electric shock Degree of protection against electric shock Fuse Mode of operation External battery Li lon IP Rating 60cmH20 0 6 kPa 60cmH O 0 6 kPa 20 cycles 60cmH20 0 6 kPa 60cmH O 0 6 kPa 1 10 0 5 5 sec 0 5 5 sec 0 5 sec at zero pressure 1 10 1 5 cmH 2O 3 40cmH20 0 3 4 kPa 3 10cmH 2O 0 3 1 kPa 0 5 3 sec 6 60 BPM 15 minutes 0 5 2 5 cmH O 297 x 223 x 132mm 3kg 100 240 Vac 47 63 Hz Class Il equipment Type BF to EN 60601 1 2x 11 6A L 250V Intermittent 30 minutes use in 1 hour 25 5Vdc 155Whr 20 Protection against flammable anaesthetic mixtures Not suitable for use in the presence of a FLAMMABLE ANAESTHETIC MIXTURE WITH AIR OR WITH OXYGEN OR NITROUS OXIDE International Standards EN 60601 1 2006 EN 60601 1 8 EN 60601 1 11 EN 60601 1 6 Safety of Electromedical Instruments General Requirements Electromagnetic Compa
21. e normal display if desired To aid synchronisation with the exsufflation an audible beep will sound just before the start of each exsufflation Press the Start Stop button to end treatment A double beep will sound at the end of the sequence Active Treatment Display ea Manual override may be used at any time during the treatment and is available for 1 minute after the treatment has finished to provide safer airway clearance 20 Setting up the Clearway in Timed Programmable Auto mode e Switch on the Clearway and select Prog Timed Auto mode from the Mode select list If Prog Timed Auto does not appear in the list this function is not available to the user The modes available are selected from the Mode Selection menu see page 15 e Press INS to select the insufflation pressure and use the lt and buttons to adjust to the required pressure e Press Ti to select the insufflation time and use the lt and gt buttons to adjust to the required time e Press Pause to select the pause time between insufflations and use the lt and gt buttons to adjust to the required time e Press Ins Rpt to select the number of insufflations before exsufflation Use the lt and gt buttons to adjust to the required number e Press EXS to select the exsufflation pressure and use the lt and gt buttons to adjust to the required pressure e Press Te to select the exsufflation time and use the lt and buttons to
22. e reviewed prior to use in the treatment review screen Treatment review screen Once an Auto sequence has been determined and set up it can be viewed ina graphical format by selecting the treatment review option in the main menu Insufflation Ti is shown as a positive waveform pause P as zero and exsufflation Te is shown as negative The Y axis shows pressure in cm H20 and the X axis time in seconds Treatment Review Screen lf the entire sequence can be displayed on one screen width the review screen will look like this In this example the machine has been programmed to deliver two insufflations followed by one exsufflation The following insufflations are the optional additional breaths which may be added to re inflate the lungs an SA 40 ae JA F ia A 10 2A 2a 40 50 RHA Da a lf the sequence Is repeated or unusually long times are involved it may not be possible to display the whole sequence clearly on one screen width In this case the review screen will look like this Treatnent Heview ftcorern In this example the screen shows the first insufflation and exsufflation To view the rest of the sequence use the lt and buttons to scroll the display to the left or right 17 Manual override Occasionally secretions mobilised by this treatment can cause obstruction of the airways making the auto sequence inappropriate for the desired outcome The treatment can be cancelled and fo
23. e run time is expected to be approx 1 hour External Batteries The external battery pack is supplied specifically to power the Nippy Clearway External battery part number 0960 111A 1062 External battery charger part number 0960 112 0999 These batteries should never be used to run any other type of equipment DO NOT attempt to connect any battery other than those supplied by the manufacturer Use of any other type of battery could lead to personal injury and damage to the machine The external battery connector is of a touch proof self locking design lt has two polarising keys of different sizes which must be aligned with the corresponding recesses in the aux power socket To connect the external battery grip the battery connector body coloured blue and insert into the aux power socket Twist clockwise to lock in place To disconnect grip the battery connector locking sleeve coloured grey turn anticlockwise and withdraw the connector 28 Instructions For Use e Connect the battery to the Nippy Clearway Aux Power input e The Power light will illuminate e Switch on the Nippy Clearway The Ext Batt light will flash and a Running on battery power message will be displayed on the Nippy Clearway screen Press the Set button to hide the message e To disconnect a battery Always switch off the machine first To Charge a Battery e Place the charger on a smooth flat surface e Connect the charger to the batt
24. er Levels 3 Settings and Options User Preferences Alarm Volume Display Brightness Display Contrast Keypad Tone Advanced Setting Ins vibration level Exs Vibration level Post Exsufflation breaths Profile Settings 3 Clear Patient Settings Mode Select Manual Basic Auto __ Programmed Timed Auto rill Timed Auto _ _ Resets machine to default settings and View only View Adjust View Adjust View Adjust View Adjust Select On Off View Adjust View Adjust View Select View Adjust View Select View Select View Select View Select View Select clears the compliance data ready for a new patient 4 Warnings amp 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 13 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 How Press the button you need help on alternatively oecleot the soreen box using the and buttons then press Set Press Help Button to Exit Help Press HELP again to exit lf during setting up you require a description
25. ery charge socket before switching on the mains power e Connect the mains plug to the AC supply and switch on e Leave on charge until the charged ready indicator lights Batteries may produce explosive gases during charging Always charge away from sparks or sources of ignition Do not smoke near a battery whilst charging Disconnect the mains power before disconnecting the battery from the charger Batteries may be left connected to the charger until required for use Safety Warning High voltages exist inside the charger Do not remove the cover Return to B amp D Electromedical if a fault occurs Do Not expose to water or dust Do not cover the charger whilst in use Ensure that the mains lead is not damaged Do not attempt to charge any other type of battery with it Battery pack cleaning To clean wipe the exterior of the case with a soft cloth moistened with water Battery Care DO NOT use any other type of battery charger This could lead to damage to the battery and personal injury e The battery should be recharged as soon as possible after use e 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 e Batteries like to be used A new battery may require several charge discharge cycles before it reaches its maximum performance The same applies to a battery that is only used occasionally with long periods in storage 29
26. flation pressure profile or rise time may be adjusted The adjustment may be accessed via the Settings and Options screen Press Menu and select Settings and Options and then Profile Settings from the list Exsuffl ation Use the lt and buttons to select the desired setting Press menu to exit the profile screen The profile symbol to the left of the main pressure display will give an approximate indication of the profile selected Exs Pressure The rise time may be set to 10 80 of Ti up to a maximum of Ti 1 second So if Ti is less than 1 second rise time is a percentage of Ti Therefore 50 50 Ti lf Ti is greater than 1 second rise time is a percentage of 1 second Therefore 50 500mS Compliance data Up to 28 days compliance data may be viewed on the compliance data screen Press Menu and select Compliance Data from the list The compliance data is displayed in a chronological list format Use the lt and buttons to scroll up and down the list 26 Using Supplementary Oxygen with the Nippy Clearway lf 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 Oxygen Port Proximal pressure Line 1 ey Be eS re a e a a a a i i goe Clearway ir 4 4 ee eer te Bgl ledge he i oy i oe oe is 4 i a i BLL Outlet Port Mask Trach
27. ge of 5 to 50 C Between 5 and 40 degrees functioning of the machine should not be affected Extremes of temperature below 5 C above 40 C may affect the colour of the LCD display This will return to normal with the temperature Operation above 40 degrees is not recommended The machine may overheat at elevated temperatures A visual alarm will be activated in the event of over temperature Internal ambient gt 50 Air conditioning should be employed to keep the room temperature below 40 degrees Ambient Relative Humidity in the range of 10 to 100 RH The machine is expected to function correctly at extremes of humidity High humidity levels may affect the colour of the LCD display This will return to normal with the humidity Atmospheric Pressure in the range of 600mBar to 1100mBar The machine is expected to function correctly between 600 and 1100 mBar Supply Voltage Range from 20 to 10 of specified value The Nippy Clearway will operate normally Failure of Electrical Power Supply The machine may be operated normally using an external battery During total power failure there will be no output from the machine The patient will be able to breathe spontaneously through the machine and out through the exhale port However some re breathing of exhaled gas is inevitable During power machine failure disconnect the patient from the breathing circuit as soon as possible The inspiratory expiratory resistance of the Nippy
28. gs for each mode willbe retained in memory This enables different en settings to be used in each mode 4 T Fresse 15 Manual mode Ins exs is controlled with the integral Ins Exs switch or remote hand held switch The machine outputs the set pressures as the switch is operated Move the switch to the left for Insufflation hold to maintain pressure until switch is released Move the switch to the right for Exsufflation hold to maintain pressure until switch is released Exs There are no graphical treatment Pressure 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 lt and buttons to adjust to the required pressure Press EXS to select the exsufflation pressure and use the lt and buttons to adjust to the required pressure Use either the front panel or handheld INS EXS switch to administer the treatment 16 Automatic modes A range of automatic treatment modes is available The Clearway may be programmed to administer the treatment as a sequence of insufflation and exsufflation As an option at the end of the sequence two insufflations may be added to assist re recruitment This is set through advanced settings see page 25 The treatment sequence may b
29. is 0 5 to 2 5 cm H20 Intended Use The Nippy Clearway may be used in hospital or homecare environment The NIPPY Clearway is typically used in patients who are unable to cough and effectively clear secretions due to reduced peak cough expiratory flow as a result of neuromuscular disorders spinal cord injuries or severe fatigue associated with intrinsic lung disease It may be used either with a face mask or mouthpiece or tracheostomy tube secretions will usually be cleared to the mouth so yankauer suction may be required 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 Acute pulmonary oedema Acute lung injury Caution is advised in patients with cardiovascular instability oe a oe Sl ae oe CT 10 Ti 12 13 14 15 FEATURES Lightweight compact fully self contained unit with lockable settings Can be used with mouthpiece full face mask or tracheotomy 5 treatment modes With independent settings Adjustable insufflation pressure profile rise times User friendly intuitive software Easily understood alarm messages displayed onscreen Employs state of the art microprocessor control Universa
30. l internal mains input operates anywhere in the world without transformers Large colour LCD display clearly shows all settings 28 days stored on screen compliance data Comprehensive event log stores all adjustments settings and user interventions for download to PC Very low maintenance requirements therefore maintenance costs are extremely low Twelve months parts and labour warranty Auto switching to external battery Automatic service reminder Explanation of Symbols used on Nippy Clearway and Accessories OXY T SN m A o gt a ou E m X 7 aS pi 2 Ins Ins Exs TUL ALL IP20 D Type BF 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 Settings Locked Unlocked Battery Charged Battery Discharged Service Reminder Dispose of in Line with Local Authority Guidelines Recycle Do Not Reuse Batch Code Consult Operating Instructions Green Manual Control Flashing Manual Override available 2 post exsufflation breaths selected at end of auto mode Approximate indication of selected insufflation profile Ins and or Exs oscillation feature selected showing selected amplitude Protected against Ingress of solid objects greater than 12 5mm Finger Cooling fan vent Standby Stop Start Fa
31. nt review screen to view the waveform if desired Press Menu again to escape e Press Start Stop to begin treatment e Further adjustments may be made to the pressure time and back up rate settings during treatment 24 Advanced Settings Oscillation of airway pressure In some cases it may be benificial in the mobilisation of secretions to vibrate the airway pressure The Nippy Clearway can be set to vibrate the insufflation or exsufflation pressure at 4Hz cycles per second The level of vibration can be preset to 25 50 75 or 100 of the working pressure The Airway vibration function may be accessed via the Advanced Settings screen Press Menu and select Settings and Options and then Advanced Settings from the list Set SELECT Use the Set button to move between Ins and Exs vibration and post breaths settings Use the lt and buttons to select the desired vibration level and then Set to accept Default setting is for vibration settings to be off Post exsufflation breaths The post exsufflation breaths function may be accessed via the Advanced Settings screen Press Menu and select Settings and Options and then Advanced Settings from the list Use the Set button to move between Ins and Exs vibration and post breaths settings Use the lt and buttons to toggle between on and off Press Set to accept Default setting is for post exsufflation breaths to be off 25 Profile Settings The insuf
32. 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 GENERAL HELP to famlliarise yourself with the Aipey Clearway operation Clearway indicates a fault Fress Help Button to Exit Help Pressure 14 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 lt 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 lt and buttons to highlight the desired mode Press the Set button to select ig apir Pasio Auto a Prog Tined tuto The individual settin
33. on with the exsufflation an audible beep will sound just before the start of each exsufflation Active Treatment Display af al Press the Start Stop button to end treatment The treatment will continue for a maximum of 20 cycles then the Clearway will stop A double beep will sound at the end of the sequence The patient must not be left unattended during treatment Manual override may be used at any time during the treatment and is available for 1 minute after the treatment has finished to provide safer airway clearance 18 Setting up the Clearway in Basic Auto mode e Switch on the Clearway and select Basic Auto mode from the Mode select list If basic auto does not appear in the list this function is not available to the user The modes available are selected from the Mode Selection menu see page 15 e Press INS to select the insufflation pressure and use the lt and buttons to adjust to the required pressure e Press Ti to select the insufflation time and use the lt and buttons to adjust to the required time e Press EXS to select the exsufflation pressure and use the lt and gt buttons to adjust to the required pressure e Press Te to select the exsufflation time and use the lt and buttons to adjust to the required time e Press Pause to select the pause time between cycles and use the lt and gt buttons to adjust to the required time e Press menu and select treatment review screen
34. ppy Clearway uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment The Nippy Clearway is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network Electromagnetic Immunity This Nippy Clearway is intended for use in the electromagnetic environment specified below The user of the Nippy Clearway should make sure it is used in such an environment Compliance Level 6 kV contact 8 kV air 2 kV for supply mains 1 kV for input output lines 1 kV differential mode 2 kV for common mode gt 95 dip in Voltage for 0 5 periods 230Vac and 100Vac 60 dip in Voltage for 5 periods 230Vac and 100Vac 30 dip in Voltage for 25 periods 230Vac and 100Vac 3 A m 37 Electromagnetic Environment Guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical home or hospital environment Mains power quality should be that of a typical home or hospital environment Mains power quality should be that of a typical home or hospital environment If the user of the Nippy Clearway requires continued operation during power mains interruptions it is recommended that the Nippy Clearway be powered from an
35. put air filter is in place User Maintenance Schedule init Fer Pomc rset fT Breathing Circuit Cleaning The breathing circuit is considered disposable and for single patient use 34 Servicing Repair Only suitably qualified technically competent personnel should attempt servicing of this machine The expected service life of the clearway and its remote switch is 5 years To maintain its performance the machine will require periodic servicing at the following intervals Annual electrical safety test Interim service every 3 years Details of service requirements are contained in the technical manual In the event of damage occurring to the machine it should be inspected by technically competent personnel prior to use Technical Information A technical manual incorporating circuit diagrams and descriptions will be made available on request to enable appropriately qualified technical personnel to repair the parts of the equipment designed to be repairable Warranty The Nippy Clearway is covered by a full 2 years parts and labour warranty provided that the unit is properly operated under conditions of normal use This warranty does not apply to any unit that has been subjected to misuse or accidental damage or repaired or modified by unauthorised personnel Transportation When shipping damage as a result of inadequate packing is the customer s responsibility Use the original packing materials whenever possible
36. quipment as it may adversely affect the operation e The functioning of the machine can be adversely affected by electromagnetic interference exceeding the level of 3V m in the test conditions of EN60601 1 2 e g mobile telephone operation may adversely affect the operation of the machine e Ifthe Nippy Clearway is moved from cold surroundings into a well heated room condensation may form Do not operate the unit for at least 2 hours to allow any condensation to evaporate e Do not operate the machine in direct sunlight e Avoid places where there is excessive humidity or dust which may cause damage to internal parts e Keep the Nippy Clearway away from extreme direct heat such as fires heating radiators etc and always allow a 100mm 4 0in air soace around the unit when in use e f liquids are allowed to enter the unit serious damage could occur If you spill any liquid into the Nippy Clearway consult qualified service personnel e Do not place any form of cover over the machine especially near the air intake e DONOT use anti static or electrically conductive tubing e Adding extra components sub assemblies to the breathing circuit may cause the pressure during expiration at the patient connection port of the breathing circuit to increase e lf intending to transport the device or use in multiple locations the device should be placed in the mobility bag 0960 114 to provide protection against the elements 33 U
37. rced into manual mode by operation of the manual switch at any time during the auto sequence and for 1 minute after the treatment has finished Operate once momentarily to cancel the auto sequence and revert to the normal bargraph display and then use as normal for manual operation until secretions are cleared The Clearway will remain in manual control for as long as the switch is being used Auto control will be restored when the Start Stop button is pressed or after 20 seconds of inactivity Basic Auto Mode In basic auto mode the Clearway cycles between insufflation and exsufflation followed by a pause for a maximum of 20 cycles As an option at the end of the sequence two insufflations may be added to assist re recruitment This is set through advanced settings see page 25 After setting pressures and timing the waveform may be viewed using the Treatment Review screen Press the Start Stop button to initiate treatment The Clearway will start the sequence and the display will change to the active treatment display This is a graphical representation of the treatment sequence Insufflation is shown as a positive waveform and exsufflation is shown as negative The numbers in the top right hand corner of the display indicate the progress In this example it is showing repetition number 5 of a total of 20 Use the Set button to toggle between the active treatment display and the normal display if desired To aid synchronisati
38. scia Buttons Max on time 30 minutes in any 1 hour period Ins is SEB i00 sec 7 Ja o E Pressure 10 18 _ 17 NIPPY ETEA lt gt a 16 15 14 13 12 1 Ins Selects the insufflation positive airway pressure adjustment scaled in cmH20 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 cmH20 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 gt Increments the selected parameter or moves the selection bar up the menu 12 Set Selects the current menu function displayed by the selection bar OR double press for hours till next service 13
39. tibility In accordance with the EMC Directive 2004 108 EC B amp D Electromedical declares that the Nippy Clearway complies with the following EMC standards EN60601 1 2 2007 Test results available for review from B amp D Electromedical C 0086 36 Emissions Test RF emissions radiated CISPR 11 RF emissions conducted CISPR 11 Harmonic emissions IEC 61000 3 2 Voltage fluctuations Flicker emissions IEC 61000 3 3 Immunity Test Electrostatic Discharge ESD IEC 61000 4 2 Electrical Fast Transient Burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 Standard EN5501 1 EN55011 EN61000 3 2 EN61000 3 2 IEC 60601 Test Level 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode gt 95 dip in Voltage for 0 5 periods 230Vac and 100Vac 60 dip in Voltage for 5 periods 230Vac and 100Vac 30 dip in Voltage for 25 periods 230Vac and 100Vac 3 A m EMC Information Guidance and Manufacturer s Declaration Electromagnetic Emissions The Nippy Clearway is intended for use in the electromagnetic environment specified below The user of the Nippy Clearway should make sure it is used in such an environment Electromagnetic Environment Guidance The Ni
40. tput from a UMTS 3G mobile phone Power class 2 mobiles 400 mW Access point for Wireless networking 1m 250 mW Maximum output from a UMTS 3G mobile phone Power class 3 mobiles 1 15m 32 mW Typical WiFi transmission power in laptops 40cm 2 5 mW Bluetooth Class 2 radio 10 m range 11 5cm T Bluetooth standard Class 3 radio 1 m range 77 2cm 100 uW ee received signal power 10 to 30 dBm of wireless 2 30m 39 THIS PAGE MAY BE REMOVED BEFORE THE INSTRUCTION MANUAL IS PASSED TO THE USER Locking the settings The settings can be locked to prevent unauthorised adjustment To lock press lt 4 and P buttons simultaneously and hold for 2 seconds To unlock press lt 4 and P buttons simultaneously and hold for 2 seconds This prevents adjustment but allows the user to switch the machine on and off
41. uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical hospital or home environment Electromagnetic Immunity This Nippy Clearway is intended for use in the electromagnetic environment specified below The user of this Nippy Clearway should make sure it is used in such an environment Immunity Test IEC 60601 TestLevel Compliance Level Electromagnetic Environment Guidance Conducted RF 3 Vrms 3 Vrms Recommended separation distance IEC 61000 4 6 150 kHz to 80 MHz d 1 2VP 150 kHz to 80 MHz Radiated RF 3 V m 3 V m d 1 2VP 80 MHz to 800 MHz IEC 61000 4 3 80 MHz to 2 5 GHz d 2 3VP 800 MHz to 2 5 GHz Portable and mobile RF communications equipment should be used no closer to any part of the Nippy Clearway including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Where P is the maximum output power rating of the transmitter in watts W d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by the proximity of structures objects and people a Field strengths
42. will be highlighted by a pink flashing box Alter it with the lt d or buttons When you have finished move on to the next adjustment or wait a couple of seconds for the flashing box to disappear Pressing the SET button will also end the selection and store the setting E g Press INS INS setting will be surrounded by a pink flashing box Press to increase the pressure setting 11 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 MAIN MENU Move the selection bar up or down the menu with the lt d or buttons to highlight the 3 Settings amp Options desired function and press the SET button to 4 Clear Patient Settings select it J Harnings and Cautions 6 Compliance Data T Service Menu 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 lt d 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 lt and gt symbols either side of Display Contrast Press P to increase contrast Press MENU to exit 12 Structure of the Main Menu 1 Treatment Review Screen 2 Adjust Trigg
43. y Switch on the Clearway before the oxygen When treatment is complete switch off and disconnect the oxygen supply Switch off the Clearway and disconnect the breathing circuit Store the breathing circuit in a clean bag or other suitable container DO NOT leave the oxygen connected when not in use This can cause a build up of oxygen in or around the machine DO NOT block the end of the breathing circuit with oxygen connected DO NOT expose oxygen to naked flames DO NOT smoke in the vicinity DO NOT use a gas cooker in the vicinity DO NOT use a gas oil or solid fuel heater in the vicinity Precaution always follow user instructions when entraining Oxygen 2 Running the Nippy Clearway on Battery Power Nippy Clearway may be powered from the mains or an external battery The machine will select its power source according to the power available in the following sequence 1 Mains Electricity 2 External Battery if connected In order to save battery power the machine will always run on mains electricity if it is present lf the mains fails or is not connected the machine will select external battery as the next choice lf there is no external battery the machine will shut down Battery Run Times Battery run times are dependent on the machine settings and the amount of leak High pressures and or high breath rates use power and therefore shorten run times Large leaks use power and shorten run times Averag
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