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Goodknight 425 User Manual

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1. a aseo bietet lead eee ua iE 19 MAINTENANCE AND CLEANING 5 444 4001 21 OOODENIGHLD 21 WU d SEA S MU A BON CIS UP TR 21 BREATHING CIRCO taces a d amba 21 INA SA DATE ME RE AGE EEE 22 HUMIDE PHP CH 22 R boschi cn a a 22 PROBBEESHOOTING eee dto dena 23 TECHNICAL SPECIFICATIONS 555 25 DEVICE PERFORMANCE oni PT T E NT S 25 PHYSICAL CHARACTERS HG 6 de 25 ENVIRONMENTAL CONDITIONS ne ps n atte ue umen ene MM M UEM 25 POWER SUPPLY MODULE ELECTRICAL CHARACTERISTICS iiis 25 DEVICE ELEC FRICAT CHARACTERISTICS 5245 6 26 SYMBOL M LUDUM IM EMI 26 DISPOSAL OF THE CIQOODKNIGEHT4 25 cited bedeutete 26 GoodKnight 425 GoodKnight 425ST Patient Manual V This page is left blank intentionally GoodKnight 425 GoodKnight 425ST Patient Manual Revision A BEFORE
2. Connect the breathing circuit to the outlet connector of the device Figure 3 item 6 on page 5 p Breathing Bc circuit Leas SS Pressure tube Figure 5 Breathing Circuit Connection Take care that the pressure tube is not kinked or blocked Prepare the interface as described in its instructions for use Connect the interface mask to the breathing circuit s free end Connect the power supply module cable to the supply connector located on the back of the device Figure 4 item 8 on page 5 CAUTION Use only the specific power supply module provided with the device Connect the power supply module plug to the mains The device type 15 displayed temporarily then the following standby screen appears that shows the time The colon is flashing The device is ready to operate Proceed to the chapter titled Using the GoodKnight 425 on page 12 GoodKnight 425 GoodKnight 425ST Patient Manual 7 Revision B Fitting an Oxygen Adapter Replace step 1 of the standard installation procedure on page 7 with the following instructions e Connect the oxygen adapter onto the device s outlet connector and connect the other end of the adapter onto the end of the breathing circuit see Figure 6 Connect the pressure tube to the pressure port Figure 3 item 5 on page 5 Figure 6 Oxygen Adapter Connection Perform steps 2 through 6 of the standard installation procedure When usin
3. STARTING Safety Instructions To ensure that you use your device safely and efficiently please read all the information contained in this user manual Contact your doctor or your home service provider for further information Please pay special attention to the passages preceded by the following terms CAUTION Warnings alert the user to potential serious outcomes death injury or adverse events to the patient or user Cautions alert the user to exercise care necessary for the safe and effective use of the GoodK night 425 NOTE Notes indicate information of particular interest for more efficient and convenient operation 10 11 Before using your GoodKnight 425 device refer to the chapter section titled Checking the Components on page 3 When using an additional oxygen supply carefully observe the safety instructions for oxygen in the section titled Starting Treatment on page 12 Use only the accessories that have been given to you by your home care provider Check that you have all the instructions for using these accessories and read them carefully Use only the specific power supply module provided with the device Do not use the device in the presence of flammable anaesthetics Follow the device s installation instructions as specified in this manual in the chapter entitled Installation on page 7 In particular keep the machine away from water Do not accidentally or intentionally obstruct the air outl
4. the chapter section entitled Using the Ramp Feature on page 14 ratio Inspiratory time Expiratory time ratio NOTE This function 1s accessible only the GoodKnight 425ST GoodkKnight 425 GoodKnigh 425 ST Patient manual Revision A User Action Display Description Press Inspiratory sensitivity set by the doctor sensitivity of Information detecting the beginning of the inspiratory breathing phase Access button Press Expiratory sensitivity set by the doctor sensitivity of detecting the beginning of the expiratory breathing phase Information Access button Press Pressure rise time set by the doctor period of time over which the pressure gradually increases from the EPAP to the IPAP pressure levels Information Access button Press Hour meter value device operating time The hourglass symbol stands for time The value displayed in the lower right corner represents the minutes Information Access button Press Operation meter value time during which the patient has breathed with the mask Hourglass and human symbols stand for patient time The value displayed in the lower right corner represents the minutes Information Access button Press Information Access button Software version The version number is shown in two digits for example the screen may display Id 1 0 Press the Information Access button again to exit the parameter setting menu GoodKnight
5. 425 GoodKnight 425ST Patient Manual 17 Revision A The display shows one of the following two screens indicating the status of the device the values are given as a guide only The device 15 on standby The device 15 running NOTE Exit from the parameter setting menu takes place automatically when you do not press any key for 30 seconds Setting the Time You can set the time only when the device 15 on standby To do so press the Ramp button for one second Figure 2 item 3 on page 5 then while continuing to hold the Ramp button down press the ON OFF button Figure 2 item 4 on page 5 Release the buttons and the adjustment symbol appears under the hour shown below NOTE The time will only be displayed in a 24 hour format Thus 14 47 represents 2 47 P M Setting the Hour The letter h indicating hours flashes Increase or reduce the value using the ON OFF or Ramp buttons Setting the Minutes Press the Information Access button The minutes symbol blinks Increase or decrease the value using the ON OFF or Ramp keys Exiting the Menu Press the Information Access button again to exit the menu NOTE Exit from the parameter setting menu takes place automatically when you do not press any button for 30 seconds 18 GoodkKnight 425 GoodKnigh 425 ST Patient manual Revision C LIST OF AUTHORIZED ACCESSORIES The accessories listed below can be used with the GoodKnight 425 Interfaces Ada
6. ANCE AND CLEANING INSTRUCTIONS To ensure that you use your GoodKnight 425 safely and efficiently observe the maintenance instructions specified below GoodKnight 425 The hard plastic case protecting the internal components of the device does not require any special maintenance When necessary clean the device by using a soft cloth dampened with warm soapy water Dry the device thoroughly e Always unplug the device before cleaning it Do not use a spray because chemical residues may lodge the air outlet foam filter or inside the device These residues could cause irritation of the patient s airways Never submerge the device in water Never allow water to run onto the GoodKnight 425 or drip into any of its openings Never use the GoodKnight 425 without verifying that the filter has been installed Contact your service provider to have the device output pressure checked at least once year Air Inlet Filters Change the filters as soon as they are torn or dirty Figure 4 item 9 on page 5 Clean the outer foam filter at least once a week or more often if necessary by following these steps 1 Remove the filter and wash it with warm mild soapy water 2 Rinse it thoroughly to remove all traces of soap 3 Patthe filter dry with a towel 4 Letthe filter air dry completely before replacing it 5 Replace the filter at the back of the device The optional white fabric filter cannot be washed instea
7. EL tete id ta Sie dans 2 MODEM TRANSMISSIONS desinant data doen dum uides diu ats td dodi me does autos n ets 2 CHECKING WE OMPONEN ES CR pe 3 DEVICE DESCRIPTIONS Sn Vei po edu e cope di vecti Tos 4 INSTALLATION m S 7 STANDARD INSTALLA 8 mnt 7 PATTING AN OXYGEN ADAPT TR a aa 8 Be sheets botes hh 9 EOTERNATSDATTERY OPERA LION ut sns 11 USING THE GOODKNIGBHT 425 UNS eR ERAS tn ERRORS EORR ins 12 STARTING ERE A WU N crc rcr 12 DIOPPING IRF ATMEN bcati a a i tnos 13 USING TIE RS WIPE el URE ND Te TA S 14 USING THE DEVICE TOACCESS INFORMATION 16 VIDI Mn Ed CE 18 LIST OF AUTHORIZED ACCESSORIES currieri rrr a r r iH UE 19 INIER CE anea a a E A E beet be i 19 c E 19 OTHER ACCESSORIES
8. Information Access button Figure 10 Control buttons Repeatedly press the information button until the following screen 1s displayed Ramp indicator 14 GoodkKnight 425 GoodKnigh 425 ST Patient manual Revision A The starting ramp pressure value can then be increased or decreased using the following keys ON OFF for UP 2 Ramp for DOWN 1 To start the ramp press the Ramp button when the device 15 The pressure will fall to a low value then increase progressively up to the prescribed pressure levels so as not to wake you The device will run normally delivering treatment pressures throughout the night 2 To end the ramp press the Ramp button again and the function will be disabled It 1s possible to reset the ramp time by reactivating the ramp function the ramp indicator 1s displayed when this 1s enabled Pressure Positive Inspiratory Pressure level dP 1 Positive Expiratorv abu Pressure level EP AP Starting ramp pressure mafa Mm 2 H TO ES Tne Pressure rise time Pressure rise time Resetting the ramp Startup and RAMP function active Figure 11 Pressure Changes and the Ramp Function GoodKnight 425 GoodKnight 425ST Patient Manual 15 Revision C Using the Device to Access Information The display enables you to view but not change the settings on the GoodKnight 425 The setting information is accessible when the device is
9. PURITAN BENNETT 2 GoodKnight 425 GoodKnight 425ST Patient Manual Ref M 145DFU00 40 Revision C Revision C List of Patient Manual Revisions GoodKnight 425 GoodKnight 4255 The pages below are included in the American version of the patient manual Ref M 145DFU00 40 Revision Current pages Revision List of revisions Table of contents A Introduction l 2 4 5 12 15 17 18 21 22 24 3 7 9 1116 19 20 23 25 Reference or Revision Description Date M 145DFU00 40 Revision Creation of the manual July 2004 Revision B Implementation of CE mark symbol symbols section June 2005 Revision C Modification of the manual Installing a Humidifier External July 2005 Battery Operation List of authorized accessories sections for GoodKnight 425 GoodKnight 425ST Nellcor Puritan Bennett trademark 2004 2005 Nellcor Puritan Bennett Inc All rights reserved ii GoodKnight 425 GoodKnight 425ST Patient Manual Revision C PURITAN BENNETT 2 The Puritan Bennett GoodKnight 425 GoodKnight 4255 device GK425 GK425ST is intended for the treatment of patients suffering from Obstructive Sleep Apnea Syndrome OSAS The main characteristic of this pathology is the occurrence of multiple respiratory events during the night caused by closure of the upper airways that disturbs sleep GK425 GK425ST delivers two pressure levels one inspiratory one expirator
10. d it must be changed at least once a month more often if it 1s visibly dirty Never use the GoodKnight 425 without an air inlet filter Breathing circuit Please refer to the cleaning instructions that were supplied with your breathing circuit GoodKnight 425 GoodKnight 425ST Patient Manual 21 Revision A Nasal Interface Please refer to the instructions for use that were supplied with your nasal interface Humidifier Please refer to the instructions for use that were supplied with your humidifier Oxygen Adapter Please refer to the instructions for use that were supplied with your oxygen adapter 22 GoodKnight 425 GoodKnight 425ST Patient Manual Revision C TROUBLESHOOTING Problem Probable Cause Recommended Action Discomfort due to Air flow pressure of the e Adapting to the nasal pressure takes a while Try to use the a feeling of GoodKnight 425 ramp feature when you go to sleep see the section titled excessive Using the Ramp Feature on page 14 pressure Relax and breathe slowly through your nose Device is not Pressure port hose Check that the pressure tube is properly connected to the delivering correct disconnected device pressures Moisture entering Dry the pressure tube To do this connect the breathing display pressure port tube circuit to device leaving the pressure tube disconnected Block the breathing circuit outlet with your hand and turn the device on so that air is forced ou
11. d at 25 with a 4 mm leak 1 1 A Direct current 13 V power supply battery connector IUT Symbols ON OFF 7 Information access e Ramp lt gt RS 232 PC connection A Increases setting values Reduces setting values gt Output connector IP X1 Drip proof B device N Consult the instructions for use before using this device C C 0459 Device complies with the requirements of the directive 93 42 relating to medical appliances For USA only Rx ONLY Federal law restricts this device for sale by or on the order of a physician Disposal of the GoodKnight 425 In order to protect the environment various parts of the equipment and its accessories must be disposed of in conformity with the local regulations 26 GoodKnight 425 GoodKnight 425ST Patient Manual PURITAN BENNETT 2 Details of your Service Provider C 0459 Corporate Headquarters Tyco Healthcare Group LP Nellcor Puritan Bennett Division 4280 Hacienda Drive Pleasanton CA 94588 USA Toll Free 1 800 635 5267 Tel 1 800 255 6774 Manufacturer Mallinckrodt D veloppement France Parc d activit s du bois St Julien 10 All e Pelletier Doisy F 54601 VILLERS LES NANCY CEDEX Telephone 33 3 83 44 85 00 Fax 33 3 83 44 85 01
12. difier for correct and safe operation 1 Remove the water chamber 2 Carefully fill the water chamber with water through the outlet connector opening refer to the Installation section of the GoodKnight H20 user s manual Do not fill past the maximum water level mark 3 Place the GoodKnight heated humidifier onto a flat even surface Equip the GoodKnight 425 device with the connection adapter provided with the GoodKnight heated humidifier 5 Position GoodKnight 425 device onto GoodKnight heated humidifier as shown in Figure 7 e The front of the GoodKnight 425 device must be turned towards the connections of the GoodKnight H20 heated humidifier e The base of the GoodKnight 425 device must be inserted into the recessed area of the humidifier CAUTION e Install the humidifier and bi level device onto a flat stable surface and keep them out of contact with flammable materials e Never place GoodKnight on top of the bi level device Doing so could allow water into the device potentially causing damage GoodKnight 425 GoodKnight 425ST Patient Manual 9 Revision C Patient circuit Pressure tube Figure 7 Connection of the GoodKnight 425 to the GoodKnight H O heated humidifier 6 Replace the water chamber being careful to avoid spillage and ensure that the inlet connector of the humidifier reaches the thrust on the connection adapter Connect the pressure tube from the b
13. dity Relative pressure range Operation Temperature Relative humidity Relative pressure range Altitude range Revision C 3 cmH20 to 25 cmH20 cmH2O Adjustable by increments of 0 5 2 36 cmH 0O 0 minutes to 30 minutes 1 minute Device adjustable by increments of 5 minutes 25 5 dB A 31 dBA to 10 cmH5O 5 years 5 6 in x 2 9 in x 7 7 in without power supply 1 55 Ib without power supply module 20 C to 60 C 4 F to 140 F Up to 95 without condensation 500 hPa to 1060 hPa 1 hecto Pascal 0 5 C to 40 C 41 F to 104 F Between 15 and 95 without condensation 700 hPa to 1060 hPa 1 hecto Pascal 0 to approximately 7 800 ft 0 2400 m Power Supply Module Electrical Characteristics Class II power supply Output current 4 A Input voltage 100 240 VAC 15 10 50 60 Hz 1 Hz E Input current 1 5 A Output voltage 13 V Power supply provided with the device ONTOP type SA165A 1250U 3 GoodKnight 425 GoodKnight 425ST Patient Manual 25 Revision B CAUTION e Use only the specific power supply module provided with the device The power supply module is not intended to be repaired In case of failure please contact your service provider for replacement Device Electrical Characteristics Input voltage 13 V Input current 3A Maximum power consumed 40 W without humidifier Current consume
14. eration indicator Positive Expiratory Pressure 1 compliance is on 0 compliance is off Indicator of patient respiratory Device operation indicator cycle detection on the GK425ST only Figure 9 Display When Device is Running NOTES The units of measure displayed for pressure hPa or cmH O can be modified by the Practitioner e The compliance operation indicator is not displayed until the device has been operating for at least 15 minutes 2 Put the patient interface nasal mask place according to its instructions for use If an interface with an exhalation vent 15 used it includes a hole by which the exhaled gases will be flushed out preventing them from being rebreathed If an interface without an exhalation vent 15 used your doctor must provide you with a Pirouette silent leak or equivalent adapter allowing gases to be flushed out as close as possible to the nose NOTE When using this device always remember to breathe normally for best results The vent hole associated with the interface should never be blocked This CPAP device is intended for use with interfaces or connectors that have vent holes to allow a continuous flow of air out of the interface When the CPAP device is turned on and is operating properly fresh air from the CPAP device flushes the exhaled air out through the interface vent hole However when the CPAP device is not functioning adequate fresh air will not be provided throu
15. et or any other opening in the device or the respiratory circuit Do not introduce liquids or objects into the air outlet Contact the medical team if when using the GoodKnight 425 the following symptoms appear dryness in your airways or nose skin sensitivity running nose earache sinus trouble daytime drowsiness mood changes disorientation irritability or memory loss If the GoodKnight 425 malfunctions contact your home care provider Maintenance of this equipment should only be performed by trained and authorised personnel Do not attempt to open the device The air flow produced by the GoodKnight 425 can as much as 7 F higher than the room temperature Exercise caution if the room temperature is warmer than 90 F GoodKnight 425 GoodKnight 425ST Patient Manual 1 Revision A Indications for Use The Puritan Bennett GoodKnight 425 15 indicated for use in treating Obstructive Sleep Apnea OSA in spontaneous breathing patients weighing over 30 kg 66 Ib within a homecare or hospital environment Precautions for Use The GoodKnight 425 device must be used with caution for patients with the following conditions If you are affected by one of the conditions listed below contact your doctor at the beginning of your treatment e Pneumothorax or pneumomediastinum e Severe bullous emphysema or previously complicated by pneumothorax e Massive epistaxis or previous massive epistaxis Pneumoencephalus traumatism
16. g oxygen strictly follow the instructions of your physician or home care provider Never smoke the presence of oxygen Never inject oxygen through the air inlet of the device Carefully follow all instructions contained in the chapter titled Using the GoodKnight 425 on page 12 If supplemental oxygen is used the oxygen flow must be turned off when the GoodKnight 425 is not operating If the oxygen flow is left on when the device is not operating oxygen delivered to the interface circuit may accumulate within the GoodKnight 425 Oxygen accumulated in the device could create a fire hazard CAUTION If the supplemental oxygen flow rate is fixed the inhaled oxygen concentration will vary depending on the pressure settings patient breathing pattern interface selection and the leak rate 8 GoodKnight 425 GoodKnight 425ST Patient Manual Revision C Installing a Humidifier Please refer to the instructions for using your humidifier for installation instructions and safety precautions The humidifier must be filled before being connected to the device CAUTION To avoid water damage always ensure that the humidifier is placed lower than the GoodKnight 425 device Replace step 1 of the standard installation procedure on page 7 with the steps below The following instructions are general instructions for connecting GoodKnight H O humidifier Always follow specific instructions supplied with your humi
17. gh the interface and exhaled air may be rebreathed Rebreathing exhaled air for longer than several minutes could in some circumstances lead to suffocation 12 GoodkKnight 425 GoodKnigh 425 ST Patient manual Revision A 3 Ifyou are using a heated humidifier turn it on according to its instructions for use 4 Start the oxygen flow if oxygen 15 used When the device is in operation mode check that it delivers an air flow If no air flow exists stop the device immediately and contact the service provider At lower CPAP pressures the flow through the exhalation port may be inadequate to clear all exhaled gas from the tubing Some rebreathing may occur Stopping Treatment When the device 16 in operation follow the instructions below to stop the treatment 1 Stop the oxygen flow if oxygen 15 used 2 Remove the interface nasal mask 3 If you are using a heated humidifier turn it off as described in its instructions for use Always disconnect the humidifier from the unit CAUTION Do not leave the humidifier connected to the GoodKnight 425 or to the tubing when the humidifier is not in use to prevent humidity from entering the device or the sensing line and degrading its performance 4 Turn the device off by pressing the ON OFF button The device returns to standby mode and displays the following standby screen that shows the time CAUTION Check that no humidity appears in the tubing particularly i
18. gs for damage The interface should not have any cracks or distortion in the mask or pillows the part of the mask coming in contact with the face Carefully check the device and the specific power supply module and verify that there 15 no obvious fault Plug the device into the power outlet using the power supply module referring to steps 4 and 5 of the section entitled Standard Installation on page 7 The device type 1s displayed temporarily then the following standby screen appears that displays the time in the 24 hour format the value displayed is given as an example only Flashing Colon Standby Indicator Figure 1 Display in Standby Mode If the device 1s disconnected and then power restored the screen displays the pressure The device s pressure settings remain the same as those used when the power supply cord was disconnected Start the device by pressing the ON OFF button 90 See item 4 in Figure 2 Top View on page 5 You should hear the turbine start and increase speed to deliver the set pressure Stop the device by pressing the ON OFF button and unplug the power supply cord from the power outlet If you encounter any problems with the device contact your home service provider and do not start treatment GoodKnight 425 GoodKnight 425ST Patient Manual 3 Revision A DEVICE DESCRIPTION The GoodKnight 425 device 15 powered from an external power supply and equipped with specific accessories The dev
19. ice consists of the following primary components as described below see figures 2 3 and 4 on page 5 1 Display Information such as pressures device settings or the time of day 1s shown on the display For further information refer to the section titled Using the Device to Access Information page 16 2 Information Access button The information access button allows you to scroll through the device settings For further details refer to the section titled Using the Device to Access Information page 16 3 Ramp button Used for starting or stopping the pressure increase ramp for further information refer to the section titled Using the Ramp Feature on page 14 It 1s also used to decrease the value of the parameters when changing device settings 4 ON OFF button Used for switching the device on or off It 1s also used to increase the value of the parameters during the device settings 5 Pressure port This 1s the connector onto which the breathing circuit pressure tube 1s connected For further information refer to the chapter titled Installation on page 7 6 Outlet connector This 1s the air outlet onto which the breathing circuit 15 connected For further information refer to the chapter titled Installation on page 7 T Serial link connector This connector is intended for use solely by your doctor or your home service provider Do not connect anything to it 8 Supply connector Used for
20. in either standby or operation mode To display device settings press the Information Access button for one second Figure 2 item 2 on page 5 With each additional key press data 1s displayed as shown below NOTE On the following examples of GoodKnight 425 screens the device 15 shown in operation mode The values shown below are for use as examples only User Action Display Press The screen displays Information Access button for one second Press Information Access button Press Information Access button Press Information Access button Press Information Access button Press Information Access button 16 Description Back Up rate of your device NOTE This function is accessible only on the GoodKnight 425ST IPAP Inspiratory Positive Airway Pressure level set on your device high pressure level for the inspiration EPAP Expiratory Positive Airway Pressure level set on your device low pressure level for the expiration Ramp time set by the doctor period of time over which the pressure gradually increases from the starting ramp pressure to the prescribed pressure levels Starting ramp pressure pressure level at the beginning of ramp This parameter is adjustable and visible only if the ramp time is other than 0 The symbol shows that the parameter is adjustable You can increase or decrease the value displayed by using the ON OFF or Ramp key For further details refer to
21. m Pillows 7 sizes P N s 5 616323 00 5 616324 00 5 616325 00 5 616355 00 5 616356 00 5 616357 00 Y 101969 00 Adam CPAP systems P N s Y 100871 00 Y 100872 00 Y 100873 00 Y 100874 00 SoftFit Interface System P N s 5 133335 00 5 133336 00 5 133337 00 5 133338 00 5 133339 00 5 133340 00 SoftFit Ultra Interface System P N s Y 233335 00 Y 233336 00 Y 233337 00 Y 233338 00 Y 233339 00 Y 233340 00 Nasal interface Breeze P N Y 101400 00 DreamSeal mask P N Y 103074 00A Y 102616 00 103059 00 DreamFit mask 3 sizes P N DF301 DF302 DF303 Tubing 6 ft long patient tubing with internal pressure line P N Y 261000 27 8 ft long patient tubing with internal pressure line P N Y 261000 30 Other Accessories Oxygen adapter P N Y 616155 03 Heated humidifier Fisher amp Paykel HC100 and HC150 GoodKnight 425 GoodKnight 425ST Patient Manual 19 Revision C Heated humidifier GoodKnight P N M 114600 US Air inlet filter P N M 413950 02 Thin optional filter P N M 413950 04 Serial connection cable P N M 213930 04 Battery cable P N M 214530 00 Battery cable cigarette lighter plug P N M 214530 01 Carrying case P N M 214531 01 Modem kit P N M 213930 12 includes modem cable and adapter modem cable P N M 213530 11 modem adapter P N M 213930 05 20 GoodKnight 425 GoodKnight 425ST Patient Manual Revision A MAINTEN
22. n the sensing line If so let the tubing dry before you use it again GoodKnight 425 GoodKnight 425ST Patient Manual 18 Revision A Using the Ramp Feature The ramp function enables a gradual rise in pressure after turning the device on that 1s the pressure levels are low at the start of the night to help you fall asleep You can also use this function if you have to get up during the night and have difficulty going back to sleep The pressure rise time up to the final pressures 15 prescribed by your medical team and the setting carried out by your service provider is between 0 no progressive rise and 30 minutes in 5 minute increments The ramp may have been preset to 0 according to the prescription provided by your medical team In this case the ramp function is disabled and pressing the Ramp button on the front panel of the machine has no effect Figure 2 item 3 on page 5 The initial ramp pressure be set to a value between 3 cmH5O and the Positive Expiratory Pressure level prescribed by your physician This function allows you to set the starting pressure level that enables you to fall asleep To access the parameter setting menu just press for one second the Information Access button Figure 10 NOTE This function can be used when the device 15 in either the standby mode or the operation mode GoodKnight 425ST Puritan Bennett Increases the starting Decreases the starting ramp pressure ramp pressure
23. or recent surgery with after effect of a cranio nasopharyngeal fistula e Acute sinusitis otitis media or perforation of the tympanic membrane Modem Transmissions When it 1s time to review the information stored in your GoodKnight 425 your home care provider may set up a modem connection The modem translates computer signals into telephone signals that are then sent over telephone lines and converted to a format suitable for computer input Finally the data 1s fed to a computer that features special software to assist 1n the analysis and review of the data NOTE Your home care provider will set up the modem connection and instruct you in its use 2 GoodKnight 425 GoodKnight 425ST Patient Manual Revision C Checking the Components In order to use the GoodKnight 425 you must have the following items breathing circuit e non invasive patient interface mask and all related accessories as specified in the instructions for using it In addition to these accessories your doctor may have prescribed the use of a humidifier If so check that you have all the accessories required for the humidifier specified in the operating instructions If supplemental oxygen 15 required you will also need an adapter unless the oxygen supply connects directly onto the interface See the section titled Fitting an Oxygen Adapter on page 8 of this manual Carefully check the device and each accessory Check especially the tubin
24. powering the device from the specific power supply module or from an external battery For further information refer to the section titled External Battery Operation page 11 9 Air inlet filters These filters prevent dust from entering the device and contaminating the air flow Please refer to the chapter titled Maintenance and cleaning instructions on page 21 for further information on maintaining these filters 4 GoodKnight 425 GoodKnight 425ST Patient Manual Revision A The items in the Figures below are described on page 4 GoodKnight 425ST Puritan Bennett Information ON OFF 3 Figure 2 Top View 4 Figure 3 General View Figure 4 Rear View GoodKnight 425 GoodKnight 425ST Patient Manual 5 This page is left blank intentionally GoodKnight 425 GoodKnight 425ST Patient Manual Revision C INSTALLATION This chapter shows you how to connect the different accessories and cables to your device Before starting the installation please check your device and its accessories by referring to the section titled Checking the Components on page 3 CAUTION Place the device on a stable surface Avoid placing it too near a wall or any other obstacle which could obstruct the intake of air into the machine Standard Installation l Connect the breathing circuit to the device To do this connect the pressure tube to the pressure port Figure 3 item 5 on page 5
25. reathing circuit to the GoodK night 425 pressure port 8 Connect the breathing circuit to the outlet connector of the humidifier located on the water chamber Perform steps 2 to 6 of the standard installation described on page 7 to continue installing the equipment CAUTION Disconnect the GoodKnight 425 from the humidifier and empty the water chamber before moving the assembly Failure to do so risks introducing water into the device which could cause irreversible damage 10 GoodkKnight 425 GoodKnigh 425 ST Patient manual Revision C External Battery Operation The GoodKnight 425 can be powered by a 12 V car battery using the special cable provided CAUTION e Do not use any battery power cable other than the optional cable supplied with the GoodKnight 425 Doing so risks damaging the device and the battery e Only use 12 Volt DC sources and ensure that the polarity connections and are correct The device can be used for a minimum of eight hours with a fully charged car battery in normal operation conditions To connect the battery cable replace steps 4 and 5 of the standard installation by the following steps 1 Connect the battery power cable onto the supply connector located at the back of the device see Figure 4 page 5 2 Connect the other end of the battery power cable directly to the battery Figure 8 Connection of the GoodKnight 425 to the battery cable NOTE Because of its high power con
26. sumption fully charge the GoodKnight 425 s battery before using the device The GoodKnight 425 can be powered through a vehicle cigarette lighter using the cable provided To do so replace steps 4 and 5 of the standard installation by the following steps 1 Connect the battery power cable to the supply connector located at the back of the device see Figure 4 on page 5 2 Connect the other end of the battery power cable directly to the cigarette lighter plug GoodKnight 425 GoodKnight 425ST Patient Manual 11 Revision A USING THE GOODKNIGHT 425 This chapter shows you how to use the GoodKnight 425 after installing it as described in the previous chapter It also shows you how to use the pressure increase ramp function and how to access information on device settings NOTE You will not be able to alter the device s settings you can only view them In the sections Starting Treatment and Stopping Treatment below carefully follow the order given Failure to do so could increase the potential for fire in cases where oxygen is used Refer to the general warning on using oxygen on page 1 Starting Treatment Once the device has been installed follow the instructions below to start treatment 1 Startthe device by pressing the ON OFF button C9 The display shows the pressure measured as well as the operation and compliance indicators see Figure 9 Indication of a Positive Inspiratory Pressure Compliance op
27. t through the pressure tube Repeat if necessary Ramp enabled Check whether the ramp indicator is displayed Press the Ramp button to cancel the function Figure 2 item 3 on page 5 NOTE The pressure levels were prescribed by your doctor and can be modified only under medical prescription Dry or irritated Air is too dry Humidify the delivered air using a humidifier Ask the nose or throat medical team to obtain a humidifier Cold nose Room temperature is too e Increase the temperature of the room low e Place the breathing circuit under blankets to reduce heat loss Runny nose Reaction to air flow and Stop treatment Pressures Try high efficiency filter if problem persists Contact your physician Device air tempe Air inlet filters dirty Clean or replace filters refer to the chapter titled rature too hot Maintenance and cleaning instructions on Air inlet clogged 21 Room temperature too high Move any linen bedding or clothing away from the GK425 Lower the thermostat for the room Ensure that the device is away from any heat source Remove the breathing circuit from under the blankets Pain in nose Sinus infection or nasal Stop treatment and contact your physician or home care sinuses or ears congestion provider immediately Dryness or Air leak around interface Reposition the interface irritation of the eyes Ask the attending doctor or the service provider
28. ted or if you press the ON OFF button twice over 30 seconds Otherwise check patient circuit connection In 2 displayed Over pressure detected by Check the connection of the pressure tube Check device for over 10 seconds that it is not trapped and that it is properly clean and dry see the instructions for use of the breathing circuit In 3 displayed Reduction of power supply Check connections between power supply module voltage device and power outlet Unplug supply module then connect it again to the power outlet Check the battery and replace it if necessary If the problem remains contact the homecare provider In 4 displayed Detected frequency too high Press the GK425 ON OFF button twice Check breathing circuit connection If the problem remains contact the service provider Er XX displayed Operating fault detected Contact your home care provider XX lt 2 digit code 24 GoodKnight 425 GoodKnight 425ST Patient Manual TECHNICAL SPECIFICATIONS Device Performance Pressure range Maximum achievable pressure at the patient connection port under single fault condition Ramp time Sound level measured accordance with ISO 17510 1 2002 Maximum sound level warrantied at one meter Internal battery life according to the manufacturer s data Physical Characteristics Dimensions W x H x L Weight Environmental Conditions Transport and Storage Temperature Relative humi
29. to try different sized masks Redness of skin in Headgear too tight or too Adjust the harness Contact the attending physician or the contact with small service provider to try on harnesses or masks of different interface sizes Allergic reaction to interface components Stop using the interface Contact your physician or home care provider GoodKnight 425 GoodKnight 425ST Patient Manual 23 Revision A Problem Probable Cause Recommended Action Recurrence of sleep Device not set to correct Ask the home care provider to check operation of the apnea symptoms pressures or not operating GK425 correctly Contact the ordering physician or home care provider Your physical condition or pressure needs have changed Device display Verify that power supply Check the connections between power supply module inoperative module 15 425 and electric outlet connected Use another appliance e g lamp radio etc to check No AC power that the a c power supply is present at the outlet Device fuse has blown Contact your physician or home care provider The GoodKnight 425 Excessive electromagnetic Move the device away from sources of interference is not running interference such as halogen lamps and cell telephones etc properly and seems to be subject to interference In 1 displayed Major leak disconnection This message disappears as soon as the interface is detected in patient circuit for connec
30. y that prevent the upper airways from becoming obstructed and thus eliminate respiratory events On the GoodKnight 425ST a Back Up rate can be adjusted It is essential for you to understand the limitations on the use of this device Therefore please read this manual carefully before using the GoodKnight 425 GoodKnight 4255 device This manual provides information on the safe and effective operation of this device For any questions relative to the equipment and its use contact your medical team or your home service provider Your doctor has prescribed the GoodKnight 425 GoodKnight 425ST as a method of treatment This method includes specific device parameter values that are set by the hospital or home service provider Do not adjust these parameter settings yourself the information contained in this manual is valid for models GoodKnight 425 and GoodKnight 425ST unless stated otherwise CAUTION Federal U S A law restricts this device to sale by or on the order of a physician GoodKnight is a registered trademark of Nellcor Puritan Bennett Inc GoodKnight 425 GoodKnight 425ST Patient Manual iii This page is left blank intentionally GoodKnight 425 GoodKnight 425ST Patient Manual Revision A TABLE OF CONTENTS BERORE STARTING oco em e EH cus RE non n EE 1 dieat rope 1 INDICATIONS FOR OU SE nd 2 DPREC XU DIONS PORSU S

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