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50 Technical Specifications

iSleep 20 clinician’s manual

Doc. 003923 En-Us V-2

11.4 Delivery Settings

ODES

AND

UNCTIONS

ELIVERY

Ramp

Off

Clinical

Home

Off

Humidifier

Off

Wake up

Off

ARAMETERS

ELIVERY

CPAP

8 cmH

Ramp time

10 min

Ramp start pressure

4 cmH

THERS

ELIVERY

Time format

24h

Total operating time

<100 h

Total patient operating time

0 h

Pressure unit

cmH

Wake up time

7:30

Summary of Contents for iSleep 20

Page 1: ...20 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...

Page 2: ...42 9 3 Change of Patient 43 10 Maintenance 44 10 1 Regular Maintenance Control 44 10 2 Service and Repair 45 10 3 Storage 45 10 4 Disposal 45 11 Technical Specifications 46 11 1 System Description 46...

Page 3: ...with the instructions given by the responsible clinical personnel In accordance with the operating conditions specified in this manual In original and unmodified shape and only with accessories speci...

Page 4: ...adults who weigh more than 30 kg The iSleep 20 can be used in clinical settings e g hospitals sleep laboratories sub acute care institutions and home environments It must always be pre scribed by a li...

Page 5: ...4 About this Manual Audience This manual is primarily intended for care providers clinical personnel physi cians and others who require a working knowledge of the Breas iSleep 20 sys tem The manual co...

Page 6: ...s explained in the table below ICON EXPLANATION Warning Risk of death and serious personal injury Caution Risk of minor or moderate injury Risk of equipment damage loss of data extra work or unexpecte...

Page 7: ...s specified or approved by Breas Medical AB Do not use the iSleep 20 and contact your Breas representative for an inspection in the event of suspected damage to the device unexplainable or sudden pres...

Page 8: ...before cleaning Do not immerse the iSleep 20 into any fluids The operator shall not touch accessible contacts of connectors and the patient simultaneously When handling the HA 01 humidifier disconnect...

Page 9: ...levels exceeding 10 V m are avoided since this may impair the safety and performance of the iSleep 20 Measures should include but not be limited to normal precautions with regard to relative humidity...

Page 10: ...s and filter must be replaced regularly to ensure cor rect function of the iSleep 20 All replaced parts must be disposed of according to local environmental regulations regarding the disposal of used...

Page 11: ...en the air outlet and the patient circuit to prevent patient cross contamination Reuse of mask or bacteria filter may expose patients to contagious agents Do not connect any filter to the HA 01 humidi...

Page 12: ...ponsible clinician shall be contacted immediately Bloated feeling from excessive swallowing of air while awake Air continually leaking from the mouth while sleeping Dryness of air passages or nose Ear...

Page 13: ...uit When present remove the moisture Before attempting to dry the circuit disconnect it from the iSleep 20 to ensure no water back flow into the iSleep 20 The fre quency at which these checks must be...

Page 14: ...leak rate 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 deliv...

Page 15: ...15 Product Description iSleep 20 clinician s manual Doc 003923 En Us V 2 3 Product Description 3 1 Main Components The iSleep 20 system contains the following components 1 2 3 7 9 5 6 8 4...

Page 16: ...ansportation 003793 2 Users manual Product and usage information 003907 3 Patient tube Tube for mask and iSleep 20 000245 4 iSleep 20 power sup ply 003773 5 AC power cord 003725 6 Filter white disposa...

Page 17: ...03923 En Us V 2 3 2 Accessories NO COMPONENT FUNCTION PART NO 10 HA 01 Humidifier Patient air humidification 003530 11 iMask 100 003971 12 iMask 200 003972 13 Battery cable 24 V DC 004367 14 DC DC con...

Page 18: ...om kit Includes Isolated communication interface PC and iSleep iSleep iCom data cable iCom PC data cable D sub iCom PC data cable USB iCom User manual iCom PC drivers 004143 18 iSleep PC data cable Da...

Page 19: ...iSleep 20 s Front Panel NO USER BUTTONS AND DISPLAYS FUNCTION 1 Start Stop Main unit On Off 2 Display window Mode and settings display 3 Function Menu navigation 4 Decrease Decrease setting 5 Increase...

Page 20: ...EM FUNCTION 1 Air outlet Air path out to the patient 2 Locking mechanism Release and lock HA 01 humidifier or rear lid 3 HA 01 Humidifier optional Patient air humidification 4 Air inlet Air path in re...

Page 21: ...Serial number the last seven alphanumeric char acters 4 Class II electrical equipment dual isolation 5 Body floating IEC 60601 1 Type BF Isolated Applied Part 6 Read the User Manual thoroughly before...

Page 22: ...e CPAP Continuous Positive Airway Pressure mode The Ramp Function The ramp function provides a pressure increase from the ramp start pressure to the set CPAP pressure during a set time Snooze The snoo...

Page 23: ...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 The home mode hides treat ment settings and other sele...

Page 24: ...eep 20 by pressing the Start Stop button on the front panel Ensure that the iSleep 20 is running 5 Put on the mask and adjust its fit 6 Ensure that the settings are adjusted as prescribed The iSleep 2...

Page 25: ...toggle through the different functions of the iSleep 20 The plus and minus but tons are used to alter a value The ramp button is used to activate the ramp function during operation Main time pressure...

Page 26: ...c 003923 En Us V 2 Icons in the Display Window Switching between Clinical and Home Mode ICON EXPLANATION Pressure Time Ramp Humidity Information Wake Up Alarm Panel lock Keep the and buttons pressed f...

Page 27: ...nsfer while the patient is connected to the iSleep 20 Only a PC which complies to the IEC 60601 1 standards can be used for transferring data during treat ment of a patient The data cable can receive...

Page 28: ...ble to the iCom 3 Connect the iCom PC data cable between the iCom and a PC Only use either the D sub cable or the USB cable Read the chapter Usage of the HA 01 Humidifier on page 13 carefully to make...

Page 29: ...re and the iSleep 20 pressure setting The operation time is based on the following settings 1 Connect the external DC cable to the iSleep 20 Make sure it is fitted correctly 2 Connect the other end of...

Page 30: ...23 En Us V 2 When using a 12 V external power the iSleep DC DC converter 12 24 V needs to be used BATTERY TYPE HUMIDIFIER OPERATION TIME EB 2 24 V 7 2 Ah Off 13 h EB 2 24 V 7 2 Ah 5 Not recommended Ca...

Page 31: ...the first time follow the instructions below Read the chapter Safety Information on page 7 before setting up and using the iSleep 20 1 Check that all main compo nents and ordered accessories have been...

Page 32: ...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 falling on the patient as well as preventing con densated water to...

Page 33: ...0 cmH2O pressure This leakage may be achieved by small holes in the mask an adjoining leakage port 3 Connect the power cord to the power source Read the chapter Usage of Patient Circuit on page 10 car...

Page 34: ...are used for con trolling the operation of 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 mus...

Page 35: ...cmH2O to CPAP 0 5 cmH2O Humidifier Off 1 to 9 1 The operation modes and setting parameters are described in detail in the chapter Functions and Parameters of the iSleep 20 on page 22 For more informat...

Page 36: ...t 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 functio...

Page 37: ...ng up to 10 seconds The iSleep 20 will turn off automatically after 10 minutes of inactivity once the snooze function has been activated Once the snooze is activated and the mask has not been taken of...

Page 38: ...nly User the button to cycle through the screens The Device Info section contains three information screens 1 Patient Operating Time Total number of hours a patient has been using the iSleep 20 for CP...

Page 39: ...ror is shown after the treatment ses sion If the error remains contact service per sonnel 29 High humidifier temperature Turn off the iSleep 20 Disconnect the HA 01 humidifier and reconnect it If the...

Page 40: ...of in accordance with local environmental regulations regarding the disposal of used equipment and waste 9 1 Cleaning the iSleep 20 Main Unit To avoid electrical shock disconnect the power supply to t...

Page 41: ...rcuit 3 Detach the rear lid or the HA 01 humidifier if mounted 4 Disconnect all cables 5 Clean the outside of the iSleep 20 using a lint free cloth and a mild detergent solution If the iSleep 20 needs...

Page 42: ...ck the patient circuit for damage regularly In case of damage replace the circuit If the parts need to be disinfected this can be done in a bath of Virkon or Lyse tol Med for instance Then rinse the p...

Page 43: ...and the patient tube to prevent patient cross contamination A low resistant bacteria filter should not be used with the HA 01 humidifier 1 Follow the instructions in Cleaning the iSleep 20 on page 40...

Page 44: ...echnical bulletins and any special service instructions by service technicians that have been authorized after Breas iSleep 20 service training Do not under any circumstances attempt to service or rep...

Page 45: ...air of the device 10 3 Storage Empty clean and dry the HA 01 humidifier if applicable before storage of the iSleep 20 10 4 Disposal The iSleep 20 any accessories and all replaced parts must be dispose...

Page 46: ...ta NO DESCRIPTION 1 Air inlet filter 2 Blower 3 Silencer box 4 iSleep 20 casing 5 Pressure sensor 6 Humidifier 7 Patient tube 8 Leak hole 9 Mask SETTING VALUE RANGE SPECIFICATION RESOLUTION Device mod...

Page 47: ...gle fault 0 8 cmH2O at 30 l min 2 8 cmH2O at 60 l min Digital output 0 to 5 V Sound level at 10 cmH2O Less than 30 dB A Measured at 1 m INDICATIONS SPECIFICATION TOLERANCE Pressure 0 to 20 cmH2O 2 of...

Page 48: ...F 20 to 60 C Ambient pressure range 700 to 1060 mbar Humidity 10 to 95 non condensing OPERATING CONDITIONS SPECIFICATIONS Recommended leakage 20 to 40 l min at 10 cmH2O Minimum leakage 12 l min at 4...

Page 49: ...sts IEC 60601 1 4 2000 Medical electrical equipment Part 1 4 Gen eral requirements for safety Collateral Stand ard Programmable electrical medical systems ISO 17510 1 2001 Sleep apnea breathing therap...

Page 50: ...ngs MODES AND FUNCTIONS DELIVERY Ramp Off Clinical On Home Off Humidifier Off Wake up Off PARAMETERS DELIVERY CPAP 8 cmH2O Ramp time 10 min Ramp start pressure 4 cmH2O OTHERS DELIVERY Time format 24h...

Page 51: ...3 Users manual 003907 Clinician s manual 003923 Patient tube 000245 HA 01 Humidifier 003530 Rear lid 004116 Filter grey washable 004154 5 pcs Filter white disposable optional 004153 5 pcs iMask 100 iM...

Page 52: ...digital interfaces must be certified according to the respective IEC standards e g IEC 60950 for data processing equipment and IEC 60601 1 for medical equipment Furthermore all configurations shall co...

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