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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 Insufflation Profile Settings 26 Compliance data 26 Using Supplementary Oxygen 27 Running on Battery Power 28 External battery 28 Battery Care 29-30 Connecting Auxiliary Equipment 31 Pneumatic Diagram 31 Operation Under Extreme Conditions 32 Accessories and Spares 32 Warnings and Cautions 33 Maintenance User Maintenance 34 Servicing 35 Warranty/Transportation 35 Factory Service / Repair 35 Specifications 36 International Standards 36 EMC Information 37-39 Locking the Settings 41

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.

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 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 prior to or post treatment.

2

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3

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

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. With independent settings

4. Adjustable insufflation pressure profile / rise times.

5. User friendly intuitive software.

6. Easily understood alarm messages displayed onscreen.

7. Employs state of the art microprocessor control.

8. Universal internal mains input, operates anywhere in the world without transformers.

9. Large, colour LCD display, clearly shows all settings.

10. 28 days stored, on-screen compliance data.

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

12. Very low maintenance requirements, therefore maintenance costs are extremely low.

13. Twelve months parts and labour warranty.

14. Auto switching to external battery.

15. Automatic service reminder.

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1. Treatment Review Screen View only

2. Adjust Trigger Levels View / Adjust

3. Settings and Options

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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

Profile Settings View / Adjust

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

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17

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18

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19

Setting up the Clearway in Basic Auto mode.

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 availableto the user. The modes available are selected from the Mode Selection menu see page 15).

Press INS to select the insufflation pressure and use the ◄- and +►buttons to adjust to the required pressure.

Press Ti to select the insufflation time and use the ◄- and +►buttons to adjust to the required time.

Press EXS to select the exsufflation pressure and use the ◄- and +►buttons to adjust to the required pressure.

Press Te to select the exsufflation time and use the ◄- and +►buttons to adjust to the required time.

Press Pause to select the pause time between cycles and use the ◄- and +►buttons to adjust to the required time.

Press menu and select treatment review screen to view the waveform if desired. Press Menu again to escape.

Press Start/Stop to begin treatment.

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.

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20

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21

Setting up the Clearway in Timed Programmable Auto mode.

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



Press Pause to select the pause time between insufflations and use the ◄- and +►buttons to adjust to the required time.

Press Ins Rpt. to select the number of insufflations before exsufflation. Use the ◄- and +►buttons to adjust to the required number.



Press Cycle Rpt. To select the number of insufflation/exsufflation cycles in the sequence. Use the ◄- and +►buttons to adjust to the required number.



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.

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be used atreatment

22

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23

Setting up the Clearway in Triggered Programmable Auto mode.

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).



Press Pause to select the pause time between insufflations and use the ◄- and +►buttons to adjust to the required time.

Press Ins Rpt. to select the number of insufflations before exsufflation. Use the ◄- and +►buttons to adjust to the required number.



Press Cycle Rpt. To select the number of insufflation/exsufflation cycles in the sequence. Use the ◄- and +►buttons to adjust to the required number.


Insufflation trigger sensitivity may be adjusted by selecting trigger sensitivity from the main menu.


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

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24

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25

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. Use the Set button to move between Ins and Exs vibration and post breaths settings. Use the ◄- 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 ◄- and +►buttons to toggle between on and off. Press Set to accept. Default setting is for post exsufflation breaths to be off.

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26

Profile S

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27

Using Supplementary Oxygen with the Nippy Clearway

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.

ClearwayOutlet Port Mask/Trachy

Proximal pressure Line

Oxygen Port

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.

28

NEUTRIK

NL2

2P

OL E

KEY

ED

Polarisingrecesses

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.

If the mains fails or is not connected, the machine will select external battery as the next choice.

If 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.

Average 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.

It 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.

29

Instructions For Use

Connect the battery to the Nippy Clearway Aux Power input. The Power light will illuminate. 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.

To disconnect a battery: Always switch off the machine first.

To Charge a Battery

Place the charger on a smooth flat surface. Connect the charger to the battery charge socket before switching on the

mains power. Connect the mains plug to the AC supply and switch on. 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 & 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.

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. 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.

30

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 -20oC and below 20oC. It must be below 40oC. 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. Ensure the battery is fully charged. 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. If the battery is good, fully recharge it immediately after testing.

Hints and Tips for Reliable Operation

Always make sure that the battery is fully charged before use.

Do not switch off charger until battery is fully charged.

Avoid the temptation to give the battery “a quick boost”. This is of no benefit.

If you are in doubt the state of charge, charge for at least 24 hours.

If running time suddenly seems considerably shorter than normal, make sure that

the battery is fully charged.

Do not charge your battery near sources of ignition.

Check the running time of your system regularly.

If you have more than one battery, use them in rotation.

Do not use if any of the cables or components show any sign of damage.

Most reported problems arise from incorrect battery charging.

Disposal of depleted batteries

Depleted batteries may be disposed of in line with local authority regulations.

31

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.

1. Fresh air inlet

2. Vacuum connection

3. Pressure Connection

4. Outlet connector

5.

6.

7. Pressure transducer 2

8. Exhaust Port

9.

10. Pressure / Exhalation Port

11.

Mask Pressure port

Pressure transducer 1

Breathing Circuit

Patient Connection Port

Clearway System Pneumatic Diagram

2 3

4

56

7

11

9

Blower

Valve

108

32

Operation Under Extreme Conditions

Ambient Temperature in the range of +5 to +50 oC Between 5 and 40 degrees functioning of the machine should not be affected. Extremes of temperature (below 5oC, above 40oC) 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 >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 Clearway and breathing system (Nippy Clearway and circuit) is less than 6cm H2O @ 60 l/min. This value must not be exceeded when adding attachments or fittings to the breathing circuit.

Accessories and Spares A range of mouth pieces and facemasks is available in various sizes.

Please contact us for details 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) Inline Bacterial Filter pt.no. 0960.107 - 99.999% filtration – Resistance,

0.75mB @ 50 l/min – deadspace 55ml – 22mm tapered fittings.

These components listed above are for single patient use.

External battery, part number 0960.111A (1062)

Hand held switch. Part number 0960.109

Mobility Bag. Part number 0960.114

33

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

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.

Ensure patient safety through the presence of a trained attendant and an alternative means of treatment.

The Nippy Clearway should not be placed close to high frequency surgical diathermy, defibrillator or short wave therapy equipment as it may adversely affect the operation.

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.

If the 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.

Do not operate the machine in direct sunlight.

Avoid places where there is excessive humidity or dust, which may cause damage to internal parts.

Keep the Nippy Clearway away from extreme direct heat, such as fires, heating radiators etc., and always allow a 100mm (4.0in) air space around the unit when in use.

If liquids are allowed to enter the unit, serious damage could occur. If you spill any liquid into the Nippy Clearway, consult qualified service personnel.

Do not place any form of cover over the machine, especially near the air intake.

DO NOT use anti static or electrically conductive tubing.

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.

If 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.

34

USER 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 input air filter is in place.

User Maintenance Schedule Before Use Daily Weekly Monthly

Batteries Test

Breathing Circuit

Inspect Replace

Inlet Filter Inspect/Replace

Power Cord Inspect

Breathing Circuit Cleaning

The breathing circuit is considered disposable and for single patient use.

GRIP GRIP

35

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 Major service after 10000 hours use. The service reminder symbol will be displayed on screen. 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.

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 & 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 & 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.

36

Specification Modes

Manual – integral or hand held remote switch Basic Auto Programmable Timed Auto Programmable Triggered Auto NIV

Basic Auto mode Insufflation pressure 60cmH2O (0 – 6 kPa) Exsufflation pressure -60cmH2O (0 - -6 kPa)

Run Time 20 cycles Programmable Auto modes

Insufflation pressure 60cmH2O (0 – 6 kPa) Exsufflation pressure -60cmH2O (0 - -6 kPa) Number of Insufflations (prior to exsufflation) 1 - 10 Insufflation time (Ti) 0.5 - 5 sec Exsufflation time (Te) 0.5 – 5 sec Pause time 0 - 5 sec (at zero pressure) Number of cycles 1 –10 (total of insufflations + exsufflation = 1 cycle)

Trigger 1 – 5 cmH2O NIV mode (pressure controlled)

IPAP 3 - 40cmH2O (0.3 – 4 kPa) EPAP 3 - 10cmH2O (0.3 - 1 kPa) Inspiratory Time (Ti) 0.5 - 3 sec Back up Rate 6 – 60 BPM Run Time 15 minutes Trigger 0.5 – 2.5 cmH2O Size 297 x 223 x 132mm Weight 3kg

Supply Voltage - 100 - 240 V ac

Supply Frequency - 47 - 63 Hz

Type of protection against electric shock - Class ll equipment

Degree of protection against electric shock - Type BF to EN 60601-1

Fuse - 2 x T1.6A L 250V

Mode of operation - Intermittent. 30 minutes use in 1 hour External battery (Li-Ion) - 25.5Vdc 155Whr IP Rating - 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

EN60601-1:2006, EN 60601-1-8, EN 60601-1-11, EN 60601-1-6

Safety of Electromedical Instruments, General Requirements

Electromagnetic Compatibility (In accordance with the EMC Directive 2004/108/EC)

B & D Electromedical declares that the Nippy Clearway complies with the following EMC standards. EN60601-1-2: 2007

Test results available for review from B & D Electromedical

0086

37

EM

C In

form

atio

n

Gui

danc

e an

d M

anuf

actu

rer’

s D

ecla

rati

on –

Ele

ctro

mag

neti

c Em

issi

ons:

T

he N

ippy

Cle

arw

ay is

inte

nded

for u

se in

the

elec

trom

agne

tic e

nviro

nmen

t spe

cifie

d be

low

. The

use

r of t

he N

ippy

Cle

arw

ay sh

ould

mak

e su

re it

is u

sed

in su

ch a

n en

viro

nmen

t. Em

issio

ns T

est

Stan

dard

Elec

trom

agne

tic E

nvir

onm

ent-

Gui

danc

eRF

em

issi

ons

(rad

iate

d)CI

SPR

11

EN55

011

The

Nip

py C

lear

way

uses

RF

ener

gy o

nly

for i

ts in

tern

al fu

nctio

n. T

here

fore

, its

RF

emis

sion

s ar

e ve

ry lo

w

and

are

not l

ikel

y to

cau

se a

ny in

terf

eren

ce in

nea

rby

elec

tron

ic e

quip

men

t. RF

em

issi

ons

(con

duct

ed)

CISP

R 11

EN

5501

1 Th

e N

ippy

Cle

arw

ayis

sui

tabl

e fo

r use

in a

ll es

tabl

ishm

ents

, inc

ludi

ng d

omes

tic e

stab

lishm

ents

and

thos

e di

rect

ly c

onne

cted

to th

e pu

blic

low

-vol

tage

pow

er s

uppl

y ne

twor

k.

Har

mon

ic e

mis

sion

sIE

C 61

000-

3-2

EN61

000-

3-2

Volta

ge fl

uctu

atio

ns/F

licke

r em

issi

ons

IEC

6100

0-3-

3

EN61

000-

3-2

E

lect

rom

agn

etic

Im

mu

nit

y:

Thi

s Nip

py C

lear

way

is in

tend

ed fo

r use

in th

e el

ectr

omag

netic

env

ironm

ent s

peci

fied

belo

w. T

he u

ser o

f the

Nip

py C

lear

way

shou

ld m

ake

sure

it is

use

d in

such

an

envi

ronm

ent.

Imm

unity

Tes

tIE

C 6

0601

Tes

tLe

vel

Com

plia

nce

Leve

l El

ectr

omag

netic

Env

ironm

ent-

Gui

danc

e El

ectr

osta

tic

Dis

char

ge (E

SD)

IEC

6100

0-4-

2

±6 k

V co

ntac

t ±8

kV

air

±6 k

V co

ntac

t±8

kV

air

Floo

rs s

houl

d be

woo

d, c

oncr

ete

or c

eram

ic ti

le. I

f flo

ors a

re c

over

ed w

ith

synt

hetic

mat

eria

l, th

e re

lativ

e hu

mid

ity s

houl

d be

at l

east

30%

.

Elec

tric

al F

ast

Tran

sien

t/Bu

rst

IEC

6100

0-4-

4

±2 k

V fo

r pow

er s

uppl

y lin

es±1

kV

for i

nput

-out

put l

ines

±2

kV

for s

uppl

y m

ains

±1 k

V fo

r inp

ut/o

utpu

t lin

es

Mai

ns p

ower

qua

lity

shou

ld b

e th

at o

f a ty

pica

l hom

e or

hos

pita

len

viro

nmen

t.

Surg

e IE

C 61

000-

4-5

±1 k

V di

ffere

ntia

l mod

e±2

kV

com

mon

mod

e ±1

kV

diffe

rent

ial m

ode

±2 k

V fo

r com

mon

mod

e M

ains

pow

er q

ualit

y sh

ould

be

that

of a

typi

cal h

ome

or h

ospi

tal

envi

ronm

ent.

Volta

ge d

ips,

sho

rt

inte

rrup

tions

and

vo

ltage

var

iatio

ns

on p

ower

sup

ply

inpu

t lin

es

IEC

6100

0-4-

11

>95%

dip

in V

olta

ge fo

r 0.5

pe

riods

@

230

Vac

and

100V

ac

60%

dip

in V

olta

ge fo

r 5 p

erio

ds

@ 2

30Va

c an

d 10

0Vac

30

% d

ip in

Vol

tage

for 2

5 pe

riods

@

230

Vac

and

100V

ac

>95%

dip

in V

olta

gefo

r 0.5

pe

riods

@

230

Vac

and

100V

ac

60%

dip

in V

olta

ge fo

r 5 p

erio

ds

@ 2

30Va

c an

d 10

0Vac

30

% d

ip in

Vol

tage

for 2

5 pe

riods

@

230

Vac

and

100V

ac

Mai

ns p

ower

qua

lity

shou

ld b

e th

at o

f a ty

pica

l hom

e or

hos

pita

l en

viro

nmen

t. If

the

user

of t

he N

ippy

Cle

arw

ay re

quire

s co

ntin

ued

oper

atio

n du

ring

pow

er m

ains

inte

rrup

tions

, it i

s re

com

men

ded

that

the

Nip

py C

lear

way

be

pow

ered

from

an

unin

terr

uptib

le p

ower

sup

ply

or a

ba

tter

y.

Pow

er fr

eque

ncy

(50/

60 H

z) m

agne

tic

field

3 A

/m

3 A

/mPo

wer

freq

uenc

y m

agne

tic fi

elds

sho

uld

be a

t lev

els

char

acte

ristic

of a

ty

pica

l loc

atio

n in

a ty

pica

l hos

pita

l or h

ome

envi

ronm

ent.

38

IEC

6100

0-4-

8 El

ectr

omag

netic

Im

mun

ity:

Thi

s Nip

py C

lear

way

is in

tend

ed fo

r use

in th

e el

ectr

omag

netic

env

ironm

ent s

peci

fied

belo

w. T

he u

ser o

f thi

s Nip

py C

lear

way

shou

ld m

ake

sure

it is

use

d in

such

an

envi

ronm

ent.

Im

mun

ity T

est

IEC

606

01 T

estL

evel

Com

plia

nce

Leve

l El

ectr

omag

netic

Env

iron

men

t-G

uida

nce

Co

nduc

ted

RF

IEC

6100

0-4-

6 Ra

diat

ed R

F IE

C 61

000-

4-3

3 Vr

ms

15

0 kH

z to

80

MH

z 3

V/m

80

MH

z to

2.5

GH

z

3 Vr

ms

3 V/

m

Reco

mm

ende

d se

para

tion

dis

tanc

e:d

= 1.

2√P

@15

0 kH

z to

80

MH

z d

= 1.

2√P

@ 8

0 M

Hz

to 8

00 M

Hz

d =

2.3√

P @

800

MH

z to

2.5

GH

z Po

rtab

le a

nd m

obile

RF

com

mun

icat

ions

equ

ipm

ent s

houl

d be

use

d no

clo

ser t

o an

y pa

rt o

f the

N

ippy

Cle

arw

ay, i

nclu

ding

cab

les,

than

the

reco

mm

ende

d se

para

tion

dist

ance

cal

cula

ted

from

the

equa

tion

appl

icab

le to

the

freq

uenc

y of

the

tran

smitt

er.W

here

P is

the

max

imum

out

put p

ower

ratin

g of

the

tran

smitt

er in

wat

ts (W

) d

is th

e re

com

men

ded

sepa

ratio

n di

stan

ce in

met

ers

(m).

Fiel

d st

reng

ths

from

fixe

d RF

tran

smitt

ers,

as

dete

rmin

ed b

y an

ele

ctro

mag

netic

site

sur

vey,

sho

uld

be

less

than

the

com

plia

nce

leve

l in

each

freq

uenc

y ra

nge

NO

TE 1

: At 8

0 M

Hz

and

800

MH

z, th

e hi

gher

freq

uenc

y ra

nge

appl

ies.

NO

TE 2

: The

se g

uide

lines

may

not

app

ly in

all

situ

atio

ns. E

lect

rom

agne

tic p

ropa

gatio

n is

affe

cted

by

the

prox

imity

of s

truc

ture

s, ob

ject

s, a

nd p

eopl

e.

a: F

ield

str

engt

hs fr

om tr

ansm

itter

s, s

uch

as b

ase

stat

ions

for r

adio

(mob

ile/c

ordl

ess)

tele

phon

es, a

mat

eur r

adio

, AM

and

FM

radi

o br

oadc

ast a

nd T

V br

oadc

ast c

anno

t be

pred

icte

d th

eore

tical

ly w

ith a

ccur

acy.

To

asse

ss th

e el

ectr

omag

netic

env

ironm

ent d

ue to

fixe

d RF

tran

smitt

ers,

an

elec

trom

agne

tic s

ite s

urve

y sh

ould

be

cons

ider

ed. I

f the

m

easu

red

field

str

engt

h in

the

loca

tion

in w

hich

the

Nip

py C

lear

way

is u

sed

exce

eds

the

appl

icab

le R

F co

mpl

ianc

e le

vel a

bove

, the

Nip

py C

lear

way

sho

uld

be o

bser

ved

to

verif

y no

rmal

ope

ratio

n. If

abn

orm

al p

erfo

rman

ce is

obs

erve

d, a

dditi

onal

mea

sure

s may

be

nece

ssar

y, s

uch

as r

eloc

atin

g th

e N

ippy

Cle

arw

ay.

R

ecom

men

ded

Sepa

ratio

n D

istan

ces b

etw

een

Port

able

and

Mob

ile R

F C

omm

unic

atio

ns E

quip

men

t and

Thi

s Nip

py C

lear

way

: T

he N

ippy

Cle

arw

ay is

inte

nded

for u

se in

an

elec

trom

agne

tic e

nviro

nmen

t in

whi

ch ra

diat

ed R

F di

sturb

ance

s are

con

trol

led. T

he u

ser o

f thi

s Nip

py C

lear

way

can

hel

p pr

even

t el

ectr

omag

netic

inte

rfere

nce

by m

aint

aini

ng a

min

imum

dist

ance

bet

wee

n po

rtab

le a

nd m

obile

RF

com

mun

icat

ions

equ

ipm

ent (

tran

smitt

ers)

and

this

Nip

py C

lear

way

as r

ecom

men

ded

belo

w, a

ccor

ding

to th

e m

axim

um o

utpu

t pow

er o

f the

com

mun

icat

ions

equ

ipm

ent.

Rat

ed M

axim

um P

ower

Out

put

of T

rans

mitt

er (W

) Se

para

tion

Dist

ance

Acc

ordi

ng to

Fre

quen

cy o

f Tra

nsm

itter

(m

)

15

0 kH

z to

80

MH

zd

= 1.

2 √P

80

MH

z to

800

MH

zd

= 1.

2 √P

80

0 M

Hz

to 2

.5 G

Hz

d =

2.3

√P

0.01

0.12

0.12

0.23

0.

10.

380.

380.

73

11.

21.

22.

3

103.

83.

87.

3

100

1212

23

39

For t

rans

mitt

ers

rate

d at

a m

axim

um o

utpu

t pow

er n

ot li

sted

abo

ve, t

he re

com

men

ded

sepa

ratio

n di

stan

ce d

in m

eter

s (m

) can

be

estim

ated

usi

ng th

e eq

uatio

n ap

plic

able

to

the

freq

uenc

y of

the

tran

smitt

er, w

here

P is

the

max

imum

out

put p

ower

ratin

g of

the

tran

smitt

er in

wat

ts (W

). N

ote

1: A

t 80

MH

z an

d 80

0 M

Hz,

the

sepa

ratio

n di

stan

ce fo

r the

hig

her f

requ

ency

rang

e ap

plie

s. N

ote

2: T

hese

gui

delin

es m

ay n

ot a

pply

in a

ll si

tuat

ions

. Ele

ctro

mag

netic

pro

paga

tion

is a

ffect

ed b

y ab

sorp

tion

and

refle

ctio

n fr

om s

truc

ture

s, o

bjec

ts, a

nd p

eopl

e.

Typ

ical

Po

wer

Ou

tpu

t o

f S

om

e C

om

mo

n T

ran

smit

ters

T

his

list i

s pr

ovid

ed fo

r ge

nera

l gui

danc

e. I

t is

not e

xhau

stiv

e or

spe

cific

. It n

ot in

tend

ed to

rep

lace

the

findi

ngs

of a

n el

ectr

omag

netic

sur

vey.

Po

wer

N

ote

s

Su

gg

este

d M

inim

um

Sep

arat

ion

Dis

tan

ce

Thi

s is

a v

ery

appr

oxim

ate

guid

e. If

abn

orm

al o

pera

tion

is

obse

rved

, dis

rega

rd th

is fi

gure

and

take

cor

rect

ive

actio

n.

100

kW

Typ

ical

tran

smis

sion

pow

er o

f FM

rad

io s

tatio

n w

ith 5

0 km

ran

ge

727m

1 kW

= 1

000

W

Max

imum

allo

wed

out

put R

F p

ower

from

a a

mat

eur

radi

otra

nsce

iver

with

out

spec

ial p

erm

issi

ons

73m

100

W

Typ

ical

max

imum

out

put

RF

pow

er fr

om a

am

ate

ur r

adio

tran

scei

ver

23m

5 W

T

ypic

al m

axim

um o

utpu

t R

F p

ower

from

a h

and

held

am

ateu

r ra

diot

rans

ceiv

er

5m

4 W

T

ypic

al m

axim

um o

utpu

t po

wer

for

a C

itize

ns' b

and

radi

o s

tatio

n, (

27 M

Hz)

in

man

y co

untr

ies

4.6m

2 W

M

axim

um o

utpu

t fro

m a

UM

TS

/3G

mo

bil

e p

ho

ne

(Pow

er c

lass

1 m

obile

s)

Max

imum

out

put f

rom

a G

SM

850/

900

mob

ile p

hone

3.

25m

500

mW

T

ypic

al c

ellu

lar

phon

e tr

ansm

issi

on p

ower

M

axim

um o

utpu

t fro

m a

UM

TS

/3G

mob

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32 m

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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 ◄- and +► buttons simultaneously and hold for 2

seconds. To unlock press ◄- and +► buttons simultaneously and hold for 2

seconds. This prevents adjustment but allows the user to switch the machine on and off.

cough assistor instructions for use · cough assist machine. it assists in the mobilisation and...

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