Table of Contents
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Table of Contents
1
Intended Use of the iSleep 20+ ...................................................................................... 3
1.1
1.2
1.3
1.4
2
Safety Information........................................................................................................... 7
2.1
2.2
2.3
2.4
2.5
2.6
2.7
2.8
2.9
3
Product Description....................................................................................................... 14
3.1
3.2
3.3
3.4
4
Functions and Parameters of the iSleep 20+................................................................ 19
4.1
5
Using the iSleep 20+..................................................................................................... 21
5.1
5.2
5.3
5.4
5.5
6
Preparing the iSleep 20+ for Use.................................................................................. 28
6.1
6.2
6.3
6.4
7
Setting up the iSleep 20+ ........................................................................................... 31
7.1
7.2
7.3
8
Indications..................................................................................................................... 33
9
Cleaning the iSleep 20+ and Replacing the Filters ....................................................... 36
9.1
9.2
10
Maintenance ................................................................................................................. 39
10.1
Doc. 004270 En-Eu T-3b
What is the iSleep 20+? .................................................................................... 3
Indications for Use ............................................................................................ 4
Contraindications .............................................................................................. 4
.......................................................................................... 5
General User Precautions ............................................................................... 7
............................................................................................ 8
Environmental Conditions ............................................................................... 9
Usage of Filters ............................................................................................... 10
Cleaning and Maintenance ............................................................................. 11
Adverse Patient Symptoms............................................................................. 11
Usage of the HA 01 Humidifier ...................................................................... 12
Usage of Oxygen ........................................................................................... 13
Main Components ........................................................................................... 14
Equipment Designation and Safety Label .................................................... 18
Settings ........................................................................................................... 19
Checking the iSleep 20+ before Use .............................................................. 21
Switching the iSleep 20+ On and Off .............................................................. 21
Using the Menu ............................................................................................. 22
Using the integrated Humidifier....................................................................... 23
Using an External Battery ............................................................................... 26
Installing the iSleep 20+.................................................................................. 28
Placing the iSleep 20+ .................................................................................. 29
Connecting the iSleep 20+ to the Mains Supply ............................................. 29
Connecting the Patient Circuit ........................................................................ 30
Settings Applicable for iSleep 20+ ................................................................ 31
Setting the Parameters ................................................................................... 31
Cleaning the iSleep 20+ ................................................................................. 36
Cleaning and Replacing the Patient Air Filter ................................................. 38
Regular Maintenance Control ......................................................................... 39
............................................................................... 10
.................................................................. 16
................................................................... 17
......................................................................... 32
Table of Contents
iSleep 20+ users manual
1
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Summary of Contents for Breas iSleep 20+
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Page 1: Table Of Contents
Table of Contents Intended Use of the iSleep 20+ ..................3 What is the iSleep 20+? ..................3 Indications for Use .................... 4 Contraindications ....................4 About this Manual ..................5 Safety Information......................7 General User Precautions ................7 Electrical Safety .................... - Page 2 Service and Repair..................40 10.3 Storage......................40 10.4 Disposal ......................40 Technical Specifications ....................41 11.1 Data ....................41 Accessories........................43 12.1 Breas Accessories List..................43 Patient Settings......................44 2 Table of Contents iSleep 20+ users manual Doc. 004270 En-Eu T-3b...
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Page 3: Intended Use Of The Isleep 20
WARNING! Do not use the iSleep 20+ for any kind of life support treatment. Breas Medical AB reserves the right to make changes to this product without any prior notification. 1.1 What is the iSleep 20+? The iSleep 20+ is a CPAP system that provides a continuous positive airway pressure. -
Page 4: Indications For Use
The iSleep 20+ has a memory that stores the usage, and can be downloaded by your care provider to a PC. 1.2 Indications for Use The iSleep 20+ is intended for non-invasive use. The iSleep 20+ shall only be used by patients with spontaneous breathing. The CPAP function is intended to deliver continuous positive airway pressure therapy for the treatment of obstructive sleep apnea in adults (who weigh more than 30 kg). -
Page 5: About This Manual
Always read this manual before setting up and using the iSleep 20+ or performing maintenance on the iSleep 20+, to ensure correct usage, maximum performance and serviceability. Breas Medical AB reserves the right to make changes to the contents of this manual without any prior notification. Audience This manual is intended for patients and other lay users operating the iSleep 20+. - Page 6 ICON EXPLANATION Note Information that may be valuable but is not of critical impor- tance, tips. Reference Reference to other manuals with additional information on a specific topic. 6 Intended Use of the iSleep 20+ iSleep 20+ users manual Doc. 004270 En-Eu T-3b...
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Page 7: Safety Information
– in accordance with the operating conditions specified in this manual; – in original and unmodified shape and only with accessories specified or approved by Breas Medical AB. • Do not use the iSleep 20+ and contact your responsible care provider for... -
Page 8: Electrical Safety
2.2 Electrical Safety • Do not operate the iSleep 20+ if it has a damaged power cord, power sup- ply or casing. • The iSleep 20+ may not work properly if any part has been dropped, dam- aged or submerged in water. •... -
Page 9: Environmental Conditions
2.3 Environmental Conditions • Do not use the iSleep 20+ in any toxic environment. • Do not use the iSleep 20+ in environments where there are explosive gases or other flammable anesthetic agents present. • The performance of the iSleep 20+ may deteriorate at: –... -
Page 10: Usage Of Patient Circuit
2.4 Usage of Patient Circuit • Only use the iSleep 20+ with a mask, patient tube and ventilation valve (if applicable) recommended by Breas Medical AB and your health care pro- fessional. • Do not breathe in the connected patient circuit unless the iSleep 20+ is turned on and operating properly. -
Page 11: Cleaning And Maintenance
Breas service instructions. • The iSleep 20+ should only be repaired or modified in accordance with Breas service manuals, technical bulletins, and any special service instruc- tions, by service technicians authorized by Breas Medical AB. -
Page 12: Usage Of The Ha 01 Humidifier
2.8 Usage of the HA 01 Humidifier • The HA 01 humidifier and the iSleep 20+ are intended for non-invasive use. • When using an external humidifier, it should be located below the iSleep 20+ and the patient to prevent personal injury from accidental spill- age. -
Page 13: Usage Of Oxygen
2.9 Usage of Oxygen • The presence of oxygen can speed up combustion of inflammable materi- als. • If oxygen has been prescribed, connect the oxygen supply tube to the appropriate oxygen port of the nasal mask or breathing system connector. •... -
Page 14: Product Description
Product Description 3.1 Main Components The iSleep 20+ system contains the following components: 14 Product Description iSleep 20+ users manual Doc. 004270 En-Eu T-3b... - Page 15 OMPONENT UNCTION ART NO Carrying bag Storage for transportation 003793 Users manual Product and usage information 004270 Patient tube Tube for mask and iSleep 20+ 000245 iSleep power supply 003773 Mains power cord 003723 HA 01 Humidifier Patient air humidification 003530 Rear lid Usage without HA 01 Humidi-...
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Page 16: The Isleep 20+'S Front Panel
3.2 The iSleep 20+'s Front Panel UTTONS AND ISPLAYS UNCTION Start/Stop Main unit: On/Off Display window Mode and settings display Navigation Navigation in menu system 16 Product Description iSleep 20+ users manual Doc. 004270 En-Eu T-3b... -
Page 17: The Isleep 20+'S Side Panels
3.3 The iSleep 20+'s Side Panels UNCTION Air outlet Air path out to the patient Locking mechanism Release and lock HA 01 humidifier or rear HA 01 Humidifier Patient air humidification (optional) Air inlet Air path in, replaceable filters Data connection Data cable connection Memory card slot Read and write memory card... -
Page 18: Equipment Designation And Safety Label
3.4 Equipment Designation and Safety Label 1, 2 3, 4, 5, 6, 7 YMBOL XPLANATION Model designation Serial number (the last seven alphanumeric char- acters) Class II electrical equipment; dual isolation Body floating (IEC 60601-1 Type BF, Isolated Applied Part) Read the User Manual thoroughly before con- necting the iSleep 20+ to the patient. -
Page 19: Functions And Parameters Of The Isleep 20
Functions and Parameters of the iSleep 20+ 4.1 Settings All the parameters that are used for controlling the breathing by the iSleep 20+ are listed below. The Ramp function The ramp function provides a pressure increase from the ramp start pressure to the set CPAP pressure during a set time. - Page 20 The iSleep 20+ will exclude any mask-off time and ramp time when registering the patient operating time. If the mask is not fitted properly to the patient, the iSleep 20+ may incor- rectly detect that the mask is taken off and may change the delivered pressure to the reduced mask-off level.
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Page 21: Using The Isleep 20
Using the iSleep 20+ 5.1 Checking the iSleep 20+ before Use Always make the following checks before using the iSleep 20+: Connect a cleaned or a new patient circuit to the iSleep 20+. Connect the iSleep 20+ to the mains supply. Check patient settings. -
Page 22: Using The Menu
5.3 Using the Menu Read chapter “The iSleep 20+'s Front Panel” on page 16 for exact position of the buttons. Use the 4 buttons under the display to navigate in the menu. Depending on the location in the menu, the buttons have different function. The following icons are used: XPLANATION Increase the selected value or turn a function On. -
Page 23: Using The Integrated Humidifier
Icons in the Display Window XPLANATION The iSleep 20+ is operating Wake up alarm Humidity Ramp Panel lock Panel lock 5.4 Using the integrated Humidifier Read the chapter “Usage of the HA 01 Humidifier” on page 12 carefully to make sure all conditions are fulfilled and considered. The humidifier is intended to humidify the patient air. - Page 24 At the main menu, choose “Humid- ity” to navigate to the humidifier sec- tion. The humidity setting range from Off, 1 to 9, where 9 generates the maximum humidity. Always set the humidity control to the setting recommended by your doctor. Adding Water to the Humidifier •...
- Page 25 Follow the instruction in the illustration below. Use the same procedure when emptying water from the humidifier. Add distilled water or boiled, chilled tap water to the humidifier until it reaches the marking “Max” on the humidifier. A full humidifier contains approximately 400 ml.
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Page 26: Using An External Battery
5.5 Using an External Battery The iSleep 20+ can be powered from: • The Breas external EB 2 Battery Pack. • A 12 V external power source. The iSleep DC converter 12-24 V needs to be used. Connect the external DC cable to the iSleep 20+. - Page 27 ATTERY TYPE UMIDIFIER PERATION EB 2 (24 V, 7.2 Ah) Not recommended Car battery (12 V, 60 Ah)* 90 h Car battery (12 V, 60 Ah)* 25 h * When using a 12 V external power, the iSleep DC converter 12-24 V needs to be used.
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Page 28: Preparing The Isleep 20+ For Use
Preparing the iSleep 20+ for Use Read the chapter “Safety Information” on page 7 before setting up and using the iSleep 20+. 6.1 Installing the iSleep 20+ When using the iSleep 20+ for the first time, follow the instructions below: Check that all main compo- nents and ordered accessories have been delivered (refer to... -
Page 29: Placing The Isleep 20
6.2 Placing the iSleep 20+ Read the chapter “Environmental Conditions” on page 9 carefully to make sure all conditions are fulfilled and considered. Place the iSleep 20+ on a solid, flat surface. The iSleep 20+ should be placed lower than the patient in order to prevent the device from fall- ing on the user. -
Page 30: Connecting The Patient Circuit
This leakage may be achieved by: • small holes in the mask • an adjoining ventilation valve In order to receive a suitable leakage the Breas iMask™ Nasal CPAP Mask is recommended. 30 Preparing the iSleep 20+ for Use iSleep 20+ users manual... -
Page 31: Setting Up The Isleep 20
The configuration of the iSleep 20+ therapy settings must always be pre- scribed by a licensed physician and carried out by an authorized health care professional. For more information about the Breas iSleep 20+’s settings, please contact your care provider. 7.1 Settings Applicable for iSleep 20+... -
Page 32: Viewing Device Information
Humidifier (optional) Setting range: 1 to 9, Off (where 9 is the maximum humidity). Navigate to the “Humidity” section. If the HA 01 humidifier is not attached to the iSleep 20+, the “Humidity” section will not be availa- ble in the menu. The HA 01 humidifier can only be activated during operation. -
Page 33: Indications
Indications This chapter describes the iSleep 20+’s indication functions, messages shown in the display window. Power Fail Indication ESCRIPTION Definition A power fail indication will be given when the iSleep 20+ is disconnected from the mains power source more than 5 seconds. Action The iSleep 20+ will terminate treatment. - Page 34 ESCRIPTION 45: Internal function failure. Contact your care provider. 64: Low power. Check the power cables and the mains connection. 130: Settings corrupt. Check that the settings of the iSleep 20+ are according to prescription. 131: The HA 01 humidifier has been discon- nected when the iSleep 20+ was running.
- Page 35 ESCRIPTION The leakage has been too high during the night for an accumulated time longer than 30 minutes. Check the mask fitting. 133: Low humidifier temperature. Check that the humidifier is connected correctly (this error is shown after the treatment session). If the error remains, contact your care provider.
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Page 36: Cleaning The Isleep 20+ And Replacing The Filters
Cleaning the iSleep 20+ and Replacing the Fil- ters The patient-connected parts and the filter must be cleaned and replaced regu- larly to ensure correct function of the iSleep 20+. All replaced parts must be dis- posed of in accordance with local environmental regulations regarding the disposal of used equipment and waste. - Page 37 HA 01 Humidifier The HA 01 humidifier must be cleaned regularly. Information on cleaning the HA 01 humidifier can be found in the Breas HA 01 humidifier User Manual. The HA 01 humidifier shall be replaced in intervals according to the care pro- vider’s instructions.
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Page 38: Cleaning And Replacing The Patient Air Filter
Always clean the parts or use a new set when used by a new patient. All parts that come into contact with the respiration gas must be cleaned as fol- lows: Place the dismantled parts in hot water containing washing-up liquid. Remove fouling with a brush. -
Page 39: Maintenance
10 Maintenance WARNING! • iSleep 20+ should be subjected to maintenance, service and con- trol and any applicable upgrades, in accordance with Breas serv- ice instructions. • iSleep 20+ should only be repaired or modified in accordance with Breas service manuals, technical bulletins, and any special service instructions, by service technicians that have been authorized after Breas iSleep 20+ service training. -
Page 40: Service And Repair
10.2 Service and Repair The service and repair of the iSleep 20+ must only be carried out by authorized service personnel in accordance with Breas service instructions. Service inspec- tions must always be carried out after any repair of the device. -
Page 41: Technical Specifications
11 Technical Specifications 11.1 Data The iSleep 20+ and it’s packaging do not contain any natural rubber latex. ETTING ALUE ANGE PECIFICATION ESOLUTION CPAP 4 to 20 cmH 0.5 cmH Ramp time 5 to 60 min 5 min Ramp start pressure 4 cmH O to CPAP 0.5 cmH Humidifier... - Page 42 100 to 240 V AC, tolerance: -15%/+10%, 50 to 60 Hz, max 140 VA. DC output: 24 V. External DC supply 24 V DC, tolerance: -15%/+25% (20.4 to 30 Max 2.5 A, 60 W with Breas external battery. Standby power NVIRONMENTAL PECIFICATION...
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Page 43: Accessories
Only use accessories recommended by Breas Medical AB. Breas Medical AB cannot guarantee the performance and safety for the use of other accessories with the iSleep 20+. The following Breas accessories are currently available for the iSleep 20+: ESCRIPTION Carrying bag... -
Page 44: Patient Settings
13 Patient Settings Patient Settings - Breas iSleep 20+ Patient ....................Date ....................Clinic ....................Set by ....................iSleep 20+ serial number ................. CPAP ......Humidifier ....Ramp Time ......Ramp Start Pressure ....Notes ........................................................................................................................