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Revision C List of Patient Manual Revisions ® ® GoodKnight 425 / GoodKnight 425ST The pages below are included in the American version of the patient manual Ref. M-145DFU00-40, Revision C. Current pages Revision Cover List of revisions Table of contents Introduction 1 –...
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Revision C Puritan Bennett GoodKnight GoodKnight 425ST 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.
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Revision A TABLE OF CONTENTS BEFORE STARTING................................1 .................................1 AFETY NSTRUCTIONS ................................2 NDICATIONS FOR .................................2 RECAUTIONS FOR ..............................2 ODEM RANSMISSIONS ...............................3 HECKING THE OMPONENTS DEVICE DESCRIPTION..............................4 INSTALLATION..................................7 ..............................7 TANDARD NSTALLATION ............................8 ITTING AN XYGEN DAPTER ..............................9 NSTALLING A UMIDIFIER ............................11 XTERNAL ATTERY PERATION USING THE GOODKNIGHT 425 .............................12...
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Revision A BEFORE 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: Warnings alert the user to potential serious outcomes (death, injury, or WARNING adverse events) to the patient or user.
Revision A Indications for Use The Puritan Bennett GoodKnight 425 is indicated for use in treating Obstructive Sleep Apnea (OSA) in spontaneous breathing patients weighing over 30 kg (66 lb) 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.
Revision C Checking the Components In order to use the GoodKnight 425, you must have the following items: • A breathing circuit • A 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.
Revision A DEVICE DESCRIPTION The GoodKnight 425 device is powered from an external power supply and equipped with specific accessories. The device consists of the following primary components, described below. See figures 2, 3 and 4 on page 5. 1. Display Information such as pressures, device settings, or the time of day is shown on the display.
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Revision A The items in the Figures below are described on page 4. Figure 2 – Top View Figure 3 – General View Figure 4 – Rear View GoodKnight 425 / GoodKnight 425ST Patient Manual...
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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.
Revision B Fitting an Oxygen Adapter Replace step 1 of the standard installation procedure on page 7 with the following instructions: • 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).
Revision C Installing a Humidifier Please refer to the instructions for using your humidifier for installation instructions and safety precautions. WARNING 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.
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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. 7.
Revision C External Battery Operation The GoodKnight 425 can be powered by a 12-V car battery using the special cable provided. CAUTION • 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. •...
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.
Revision A 3. If you are using a heated humidifier, turn it on according to its instructions for use. 4. Start the oxygen flow (if oxygen is used). WARNINGS • 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.
Revision A Using the Ramp Feature The ramp function enables a gradual rise in pressure after turning the device on; that is, 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.
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Revision A The starting ramp pressure value can then be increased or decreased using the following keys: ON/OFF for UP Ramp for DOWN 1. To start the ramp, press the Ramp button when the device is on. The pressure will fall to a low value, then increase progressively up to the prescribed pressure levels, so as not to wake you.
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 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).
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Revision A DIsplay Description User Action Press IS : 5 Inspiratory sensitivity set by the doctor (sensitivity of Information detecting the beginning of the inspiratory breathing phase). Access button Press ES : 5 Expiratory sensitivity set by the doctor (sensitivity of Information detecting the beginning of the expiratory breathing phase).
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). 9:42 10.0 The device is on standby. The device is running. NOTE Exit from the parameter setting menu takes place automatically when you do not press any key for 30 seconds.
Revision C LIST OF AUTHORIZED ACCESSORIES The accessories listed below can be used with the GoodKnight 425. Interfaces Adam Pillows (7 sizes): P/N’s S-616323-00A, S-616324-00C, S-616325-00A, S-616355-00C, S-616356-00C, S-616357-00C, 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 S-133335-00, S-133336-00, S-133337-00, S-133338-00, S-133339-00, S-133340-00.
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Revision C Heated humidifier GoodKnight H 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 –...
Revision A MAINTENANCE 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.
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. GoodKnight 425 / GoodKnight 425ST Patient Manual...
Revision C TROUBLESHOOTING Problem Probable Cause Recommended Action • Discomfort due to Air flow pressure of the Adapting to the nasal pressure takes a while. Try to use the a feeling of GoodKnight 425. (see the section titled ramp feature when you go to sleep excessive “...
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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. •...
Revision C TECHNICAL SPECIFICATIONS Device Performance Pressure range: 3 cmH O to 25 cmH O +/- 1 cmH Adjustable by increments of 0.5 cmH Maximum achievable pressure at the patient connection port under single fault condition: 36 cmH Ramp time: 0 minutes to 30 minutes +/- 1 minute Device adjustable by increments of 5 minutes Sound level measured in accordance with...
Revision B CAUTION • 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:...
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Details of your Service Provider Corporate Headquarters: Manufacturer: Tyco Healthcare Group LP Mallinckrodt Développement France Nellcor Puritan Bennett Division Parc d’activités du bois St-Julien 0459 4280 Hacienda Drive 10, Allée Pelletier-Doisy Pleasanton, CA 94588 USA F – 54601 VILLERS-LES-NANCY CEDEX Toll Free: 1.800.635.5267...
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