Table of Contents
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Table of Contents
1
Intended Use of the iSleep 20 ........................................................................................ 3
1.1
What is the iSleep 20? ...................................................................................... 3
1.2
Indications for Use ............................................................................................ 4
1.3
Contraindications .............................................................................................. 4
1.4
2
Safety Information........................................................................................................... 7
2.1
General User Precautions ............................................................................... 7
2.2
2.3
Environmental Conditions ............................................................................... 9
2.4
Usage of Patient Circuit ................................................................................. 10
2.5
Usage of Filters ............................................................................................... 11
2.6
Cleaning and Maintenance ............................................................................. 11
2.7
Adverse Patient Symptoms............................................................................. 12
2.8
Usage of the HA 01 Humidifier ...................................................................... 13
2.9
Usage of Oxygen ........................................................................................... 14
3
Product Description....................................................................................................... 15
3.1
Main Components ........................................................................................... 15
3.2
3.3
3.4
3.5
Equipment Designation and Safety Label .................................................... 21
4
Functions and Parameters of the iSleep 20.................................................................. 22
4.1
Settings ........................................................................................................... 22
4.2
Home and Clinical Mode ................................................................................. 23
5
Using the iSleep 20....................................................................................................... 24
5.1
Checking the iSleep 20 before Use................................................................. 24
5.2
Switching the iSleep 20 On and Off ................................................................ 24
5.3
Using the Menu ............................................................................................. 25
5.4
Transferring Data between the iSleep 20 and a PC ....................................... 27
5.5
5.6
Using an External Battery ............................................................................... 29
6
Preparing the iSleep 20 for Use .................................................................................... 31
6.1
Installing the iSleep 20 .................................................................................... 31
6.2
Placing the iSleep 20 .................................................................................... 32
6.3
Connecting the iSleep 20 to the Power Source ............................................. 32
6.4
Connecting the Patient Circuit ........................................................................ 33
7
Setting up the iSleep 20 ............................................................................................. 34
7.1
Settings Applicable for iSleep 20 .................................................................. 35
7.2
Setting the Parameters ................................................................................... 35
7.3
8
Internal Function Error .................................................................................................. 39
9
Cleaning the iSleep 20 and Replacement of Accessories ............................................ 40
9.1
Cleaning the iSleep 20 ................................................................................... 40
Doc. 003923 En-Us V-2
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Table of Contents
iSleep 20 clinician's manual
1
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Table of Contents
Summary of Contents for Breas iSleep 20
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Page 1: Table Of Contents
Checking the iSleep 20 before Use..............24 Switching the iSleep 20 On and Off ..............24 Using the Menu ..................... 25 Transferring Data between the iSleep 20 and a PC ........27 Using the integrated HA 01 Humidifier ............28 Using an External Battery ................ - Page 2 Technical Specifications ....................46 11.1 System Description .................. 46 11.2 Data ....................46 11.3 Compliance of Standards ................49 11.4 Delivery Settings ..................50 Accessories........................51 12.1 Breas Accessories List..................51 2 Table of Contents iSleep 20 clinician’s manual Doc. 003923 En-Us V-2...
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Page 3: Intended Use Of The Isleep 20
1.1 What is the iSleep 20? The iSleep 20 is a CPAP system that provides a continuous positive airway pres- sure. This can prevent the user’s upper airways from collapsing and therefore avoid breathing problems associated with airway collapse and obstruction. -
Page 4: Indications For Use
The internal memory of the iSleep 20 can be downloaded to a PC where you can view the patient compliance data in the Breas iSleep PC Software. -
Page 5: About This Manual
The manual comprises detailed information on the settings and functions of the iSleep 20 to be handled by trained health care personnel only. • Patients and other lay users operating the iSleep 20 will find all the informa- tion they need in the User Manual. - Page 6 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 clinician’s manual Doc. 003923 En-Us V-2...
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Page 7: Safety Information
Safety Information 2.1 General User Precautions • The iSleep 20 should not be used for any kind of life support treatment. • The iSleep 20 shall only be used by patients with spontaneous breathing. • If the patient is admitted to a hospital or is prescribed any other form of medical treatment, always inform the medical staff that the patient is on CPAP treatment. -
Page 8: Electrical Safety
2.2 Electrical Safety • Do not operate the iSleep 20 if it has a damaged power cord, power supply 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
95% RH. – atmosphere pressure below 700 mbar and above 1060 mbar. • Do not use the iSleep 20 while positioned in a warm place, such as direct sunlight. • The device complies with the EMC requirements of standards listed in “Compliance of Standards”... -
Page 10: Usage Of Patient Circuit
2.4 Usage of Patient Circuit • Only use the iSleep 20 with a mask and a patient tube recommended by Breas Medical AB and your health care professional. • Do not breathe in the connected patient circuit unless the iSleep 20 is turned on and operating properly. -
Page 11: Usage Of Filters
• When operating the iSleep 20, make sure that the air inlet and the filter is not obstructed or occluded. • If the iSleep 20 is used in a clinic by several patients, a low resistance bacte- ria filter is recommended between the air outlet and the patient circuit to prevent patient cross-contamination. -
Page 12: Adverse Patient Symptoms
2.7 Adverse Patient Symptoms If the patient experiences any of the following symptoms while using the iSleep 20, a physician or responsible clinician shall be contacted immediately: • Bloated feeling from excessive swallowing of air while awake • Air continually leaking from the mouth while sleeping •... -
Page 13: Usage Of The Ha 01 Humidifier
• The HA 01 humidifier shall be disconnected from the iSleep 20 during transportation. • The iSleep 20 shall not be placed in the bag with the HA 01 humidifier attached. Safety Information iSleep 20 clinician’s manual... -
Page 14: Usage Of Oxygen
• When oxygen is used with the iSleep 20, the oxygen flow must be turned off when the iSleep 20 is not operating. If the iSleep 20 is not in operation, and the oxygen flow is left on, oxygen delivered into the patient tubing may accumulate within the iSleep 20 enclosure. -
Page 15: Product Description
Product Description 3.1 Main Components The iSleep 20 system contains the following components: Product Description iSleep 20 clinician’s manual Doc. 003923 En-Us V-2... - Page 16 Filter (grey, washable) Inlet air filtration 004154 (5 pcs) Rear lid Usage without HA 01 Humidi- 003591 fier iSleep 20 main unit * Not included in the iSleep 20 basic package. 16 Product Description iSleep 20 clinician’s manual Doc. 003923 En-Us V-2...
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Page 17: Accessories
3.2 Accessories OMPONENT UNCTION ART NO HA 01 Humidifier Patient air humidification 003530 iMask 100 003971 iMask 200 003972 Battery cable 24 V DC 004367 DC/DC converter 004139 12-24 V Product Description iSleep 20 clinician’s manual Doc. 003923 En-Us V-2... - Page 18 • iSleep-iCom data cable • iCom-PC data cable (D-sub) • iCom-PC data cable (USB) • iCom User manual • iCom PC drivers iSleep-PC data cable Data cable: PC and iSleep 20 003588 (RJ45 to D-sub) iSleep-iCom Data cable: iSleep 20 and iCom 003574...
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Page 19: The Isleep 20'S Front Panel
3.3 The iSleep 20's Front Panel UTTONS AND ISPLAYS UNCTION Start/Stop Main unit: On/Off Display window Mode and settings display Function Menu navigation Decrease Decrease setting Increase Increase setting Ramp start and stop Ramp function start and stop Product Description iSleep 20 clinician’s manual... -
Page 20: The Isleep 20'S Side Panels
3.4 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... -
Page 21: Equipment Designation And Safety Label
Body floating (IEC 60601-1 Type BF, Isolated Applied Part) Read the User Manual thoroughly before con- necting the iSleep 20 to the patient. CE marking applies in accordance with the direc- tive MDD 93/42/EEC. Read “Disposal” on page 45 for information about recycling and disposal. -
Page 22: Functions And Parameters Of The Isleep 20
This chapter includes descriptions of the settings used for controlling the func- tions of the iSleep 20. 4.1 Settings All the parameters that are used for controlling the breathing by the iSleep 20 are listed below. Read the chapter “Settings Applicable for iSleep 20” on page 35 for information about the modes and ranges the different settings work with. -
Page 23: Home And Clinical Mode
The iSleep 20 will restart after a power failure with a duration shorter than 5 sec- onds. Wake Up (optional) The wake up function will initiate an alarm at a set time when activated. 4.2 Home and Clinical Mode In order to prevent the patient to change the settings, the home mode shall be activated before giving the iSleep 20 to the user. -
Page 24: Using The Isleep 20
This operation switches the iSleep 20 between standby and operating mode. The iSleep 20 is connected to a power supply when the LCD display is lit up. 24 Using the iSleep 20 iSleep 20 clinician’s manual Doc. 003923 En-Us V-2... -
Page 25: Using The Menu
5.3 Using the Menu Read chapter “The iSleep 20's Front Panel” on page 19 for exact position of the buttons. Use the function button to toggle through the different functions of the iSleep 20. The plus (“+“) and minus (“-“) but- tons are used to alter a value. - Page 26 Wake Up Alarm Panel lock Switching between Clinical and Home Mode Keep the “+” and “-” buttons pressed for 5 seconds. Home mode is indicated by the panel lock. 26 Using the iSleep 20 iSleep 20 clinician’s manual Doc. 003923 En-Us V-2...
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Page 27: Transferring Data Between The Isleep 20 And A Pc
Communication Unit The iCom can be used to transfer data between the iSleep 20 and a PC during treatment of a patient. The PC does not need to comply with the IEC 60601-1 standard if the iCom is used. -
Page 28: Using The Integrated Ha 01 Humidifier
HA 01 humidifier. Instructions about safety, warnings, product description, using, cleaning and tech- nical information can be found in the Breas HA 01 humidifier User Manual. If the HA 01 humidifier is refilled according to instructions after usage, the iSleep 20 will remember the humidity setting used. -
Page 29: Using An External Battery
• Always make a function check to test the battery condition before operat- ing the iSleep 20 from an external battery source. • The battery must be disconnected when the iSleep 20 is switched off, oth- erwise the battery will be discharged. - Page 30 90 h Car battery (12 V, 60 Ah)* 25 h * When using a 12 V external power, the iSleep DC/DC converter 12-24 V needs to be used. 30 Using the iSleep 20 iSleep 20 clinician’s manual Doc. 003923 En-Us V-2...
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Page 31: 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... -
Page 32: Placing The Isleep 20
Make sure that nothing can block the patient air inlet at the side of the iSleep 20. 6.3 Connecting the iSleep 20 to the Power Source Read the chapter “Electrical Safety” on page 8 carefully to make sure all conditions are fulfilled and considered. -
Page 33: Connecting The Patient Circuit
This leakage may be achieved by: • small holes in the mask • an adjoining leakage port In order to receive a suitable leakage the Breas iMask™ Nasal CPAP Mask is recommended. Preparing the iSleep 20 for Use iSleep 20 clinician’s manual... -
Page 34: Setting Up The Isleep 20
Read the chapter “Safety Information” on page 7 before setting up and using 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. -
Page 35: Settings Applicable For Isleep 20
Off, 1 to 9 The operation modes and setting parameters are described in detail in the chapter “Functions and Parameters of the iSleep 20” on page 22. 7.2 Setting the Parameters For more information about how to use the menu, please read the chapter “Using the Menu”... - Page 36 O to CPAP. Resolution: 0.5 cmH The first time the ramp function is activated, the iSleep 20 will immediately start the ramp. The following activations in the same treatment session will have a 10 second delay before starting the ramp function. This is indicated by flashing the ramp time.
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Page 37: Viewing Device Information
Start/Stop button shortly. The iSleep 20 will then increase the pressure to the set level during up to 10 seconds. • The iSleep 20 will turn off automatically after 10 minutes of inactivity once the snooze function has been activated. - Page 38 The “Device Info” section contains three information screens: Patient Operating Time: Total number of hours a patient has been using the iSleep 20 for CPAP treatment (ramp not included). Total Operating Time: Total number of hours the iSleep 20 has been operating.
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Page 39: Internal Function Error
Internal Function Error The indication function of the iSleep 20 consists of a message shown in the display window. ESCRIPTION Definition An internal function error will be given when the iSleep 20 has an internal function failure. The fol- lowing error codes exist: •... -
Page 40: Cleaning The Isleep 20 And Replacement Of Accessories
Accessories 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 41 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 manufac- turer's instructions.
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Page 42: Cleaning And Replacing The Patient Air Filter
Wash the filter using warm water and a mild detergent. Rinse thoroughly. Dry the filter by squeezing it out in a towel. Do not wring the filter. Disposable Filter (white color, optional) 42 Cleaning the iSleep 20 and Replacement of Accessories iSleep 20 clinician’s manual Doc. 003923 En-Us V-2... -
Page 43: Change Of Patient
Do not wash or reuse the disposable filter. 9.3 Change of Patient If the iSleep 20 is used in a clinic by several patients, a low resistant bacteria filter may be used between the air outlet and the patient tube to prevent patient cross- contamination. -
Page 44: Maintenance
PERSONAL INJURY 10.1 Regular Maintenance Control The iSleep 20 should not require any regular maintenance inspections if it is used and maintained in accordance with the instructions in this manual. Do not use the device and contact your responsible care provider for an inspection of the device in the event of: •... -
Page 45: 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 46: Technical Specifications
• Clinical • Home 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 46 Technical Specifications iSleep 20 clinician’s manual Doc. 003923 En-Us V-2... - Page 47 100 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 Technical Specifications iSleep 20 clinician’s manual...
- Page 48 × 201 mm (with HA 01 humidifier) × × Weight 1.3 kg (with rear lid), 1.4 kg (with HA 01 humidifier) Air outlet 22 mm male conical standard connector 48 Technical Specifications iSleep 20 clinician’s manual Doc. 003923 En-Us V-2...
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Page 49: Compliance Of Standards
II, Type BF body floating (isolated) applied part according to IEC 60601-1. IPX1 Degree of protection provided by enclosure. The iSleep 20 and its packaging do not contain any natural rubber latex. Technical Specifications iSleep 20 clinician’s manual Doc. 003923 En-Us V-2... -
Page 50: Delivery Settings
8 cmH Ramp time 10 min Ramp start pressure 4 cmH THERS ELIVERY Time format Total operating time <100 h Total patient operating time Pressure unit Wake up time 7:30 50 Technical Specifications iSleep 20 clinician’s manual Doc. 003923 En-Us V-2... -
Page 51: 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 52 IEC 60601-1-1. If in doubt, consult the technical service department or your local Breas representative. 52 Accessories iSleep 20 clinician’s manual...