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Page 26 of 128

7. Operation

7.1 Power up

1. Push the power button on the rear of the 

machine for 3 seconds.

Note: If the battery indicator and mains indicator lights on the front panel 
are both illuminated, the unit cannot be turned on. See “Battery and mains 
indicators” on page 53.

2. Start of self test by cycling the LED’s. 

The unit will sound 2 speaker tones. 
This is to confirm the speaker 
operation.

3. The battery low and mains 

disconnected icons will flash briefly.

4. At 3 in the Apnoea display window, 

the light bar and audio paused button 
should become illuminated with red 
LEDS.

Summary of Contents for SLE1000

Page 1: ...SLE1000 User manual Version 2 6 4 software ...

Page 2: ...chanical photocopy recording or otherwise without prior permission of SLE Copyright SLE 10 08 2016 Manual UM114 Issue 21 SLE Part Nº L1009 UMA 0UK SLE Limited Twin Bridges Business Park 232 Selsdon Road South Croydon Surrey CR2 6PL Telephone 44 0 20 8681 1414 Fax 44 0 20 8649 8570 E mail Sales Training enquires sales sle co uk Technical enquires service sle co uk Web site www sle co uk ...

Page 3: ...ore using the SLE1000 CPAP Therapy System Failure to do so could lead to injury of the patient 1 SETUP THE SLE1000 Page 70 2 MAKE SURE THAT THE SLE1000 s BACK UP POWER SUPPLY IS FULLY CHARGED Page 77 3 THE SLE1000 IS READY FOR PATIENT CONNECTION AND USE Page 88 For more information see Technical Section page 106 For trouble shooting see Troubleshooting Chart page 90 ...

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Page 5: ...ht bar 25 7 Operation 26 7 1 Power up 26 7 2 Oxygen calibration routine description 29 7 3 Power down 30 8 Standby mode 31 8 1 Exiting Standby mode 31 9 Selecting a parameter display or calibration function 32 9 1 Upper and lower level functions 32 9 2 Upper level functions displays and parameters 37 9 3 Showing battery charge level 39 9 4 Alarm history 42 9 5 Set Flow 44 9 6 Elapsed time counter ...

Page 6: ...age and transportation 78 15 Functional testing prior to patient use 80 15 1 Battery test 81 15 2 Mains disconnect alarm 81 15 3 Total power fail alarm test 82 15 4 High leak and high pressure alarm 82 15 5 Apnoea alarm 82 15 6 Zero pressure alarm and purge check 83 15 7 Gas supply alarms 83 16 Operational considerations 86 16 1 General 86 16 2 CPAP 86 17 Basic operation 88 17 1 Monitoring 88 17 2...

Page 7: ...4 Product life cycle 109 22 Maintenance schedule 110 22 1 SLE1000 service requirements 110 22 2 Maintenance schedule 110 22 3 Preventative Maintenance 111 23 EMC compliance 112 23 1 Electromagnetic immunity 113 23 2 Recommended separation distances between portable and mobile RF communications equipment and the SLE1000 115 24 RS232 116 24 1 RS232 output specification 116 25 Pneumatic unit schemati...

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Page 9: ...Page 9 of 128 Introduction ...

Page 10: ...to 7 bar The SLE1000 has been designed so that it can be used with only a compressed air supply The SLE1000 automatically corrects the flow rate to maintain the set CPAP or maintains the set flow Typical flow CPAP relationship is shown by the centre line in the nomogram below This is the relationship produced by common Nasal Generators The line also represents the SLE1000 default calibration setti...

Page 11: ... within tolerance of chart 1 1 3 Intended use The SLE1000 is intended to provide pressure support up to 12 mbar to neonates and infants The device is intended for use in the hospital environment where care is provided by medical professionals and includes use at bedside and for intra hospital transport provided compressed gas is available 1 4 Intended users The SLE1000 is to be used by appropriate...

Page 12: ...Page 12 of 128 This page is intentionally blank ...

Page 13: ...Page 13 of 128 SLE1000 Description ...

Page 14: ...ription Front View Light bar Main LCD display Battery icon Mains disconnect Fresh gas port Oxygen Proximal airway port CPAP Boost button Alarm mute button Main control knob icon display Set pressure display Set apnoea time display ...

Page 15: ...5 of 128 Rear View Mains power inlet RS232 Water trap Air supply inlet Oxygen supply inlet Mains Fuse Holder Exhaust port Connector Battery Fuse Holder Mains power switch Equipotential stud Oxygen cell cover ...

Page 16: ...number label EEC conformity marking showing compliance with the Medical Devices Directive Symbol for degree of protection against electric shock Type B applied part Appears on front panel Alarm mute CPAP boost Indicates the mains power switch Equipotential point Mains power not present when illuminated Battery icon Indicates a warning in the manual Indicates a note in the manual Indicates a cautio...

Page 17: ...Page 17 of 128 Operational and Clinical Warnings ...

Page 18: ...sed until all necessary repairs and or maintenance have been completed and a factory authorised service representative has certified that the equipment is fit and ready for use This equipment its accessories or component parts should not be modified The use of non approved parts or accessories will invalidate the warranty The owner user of this equipment shall have the sole responsibility and liab...

Page 19: ...that the Air or O2 hose has not come into contact with oil or grease 8 Audible and Visual warning alarms indicate a potentially harmful condition to the patient 9 The patient must not be connected to the unit in Standby mode The unit does not deliver any therapeutic flow in this modes In Standby mode all patient and gas alarms are disabled with the exception of the Low battery alarm and all system...

Page 20: ... or fabric 21 The SLE1000 does not support automatic record keeping 22 The SLE1000 has no emergency air intake 23 The SLE1000 functional test routine must be carried out each time the SLE1000 is used on a patient If any of these tests do not function as described then there is a problem and the SLE1000 must not be used until it is rectified 24 Failure to comply with the recommended service program...

Page 21: ...azardous substances Do not incinerate SLE offers a cell disposal service 35 The SLE1000 contains one sealed lead acid battery At the end of its useful life this battery should be disposed of in accordance with local authority guidelines Note the battery should only be replaced by service personnel 36 Apart from the battery and O2 cell the SLE1000 and accessories do not contain any hazardous compon...

Page 22: ...tal and infant patient These may include 1 Damage to nares 2 Under or over ventilatory support with consequent abnormalities in blood gases 3 Incorrect humidification could cause mobilisation of secretions and airway blockage 4 Damage to trachea and bronchi 5 Over or under inflation of the lung 6 Atalectasis 7 Air leak syndrome pneumothorax pneumomediastinum pneumopericardium pulmonary interstitia...

Page 23: ...Page 23 of 128 User interface ...

Page 24: ...sured bpm mean airway pressure flow oxygen concentration and airway pressure bar graph It also displays the function names alarm messages alarm history and battery status Note The functions shown in this display are referred to as upper level functions and display 6 2 LED display windows 2 The LED displays show the set values for the Apnoea alarm CPAP pressure and percentage oxygen Note The functi...

Page 25: ...ed button mutes the audible component of the alarm for 120 seconds Pressing the audio paused when no alarms are active mutes the unit for a period of 120 seconds For any alarms generated within this period only the visual component will activate The unit will display the text Audio Paused and will alternate this message with any alarm message in an alarm condition Pressing the button for a second ...

Page 26: ...oth illuminated the unit cannot be turned on See Battery and mains indicators on page 53 2 Start of self test by cycling the LED s The unit will sound 2 speaker tones This is to confirm the speaker operation 3 The battery low and mains disconnected icons will flash briefly 4 At 3 in the Apnoea display window the light bar and audio paused button should become illuminated with red LEDS ...

Page 27: ...low LEDS 6 At 1 in the Apnoea display window the light bar only should become illuminated with blue LEDS 7 At 0 in the Apnoea display window the light bar should switch off 8 The unit will run through a self test routine It will start with a Pneumatic test Note Air has to be connected for the unit to pass the pneumatic test ...

Page 28: ...his is indicated by CAL being displayed in the lower right of the LCD 11 The unit will now calibrate the oxygen monitoring system starting with the 100 point This is indicated by cal being displayed in the lower right of the LCD 12 The stabilisation period for the oxygen system is indicated by the being displayed in the lower right of the LCD ...

Page 29: ... text CAL in upper case characters The second 90 seconds the unit calibrates the system using 100 oxygen The unit displays the text cal in lower case characters Note The user can when the unit is displaying cal in lower case letters set the oxygen percentage The following 30 seconds the unit displays as the unit allows the oxygen monitoring system to stabilize Note If the unit is being used with a...

Page 30: ... High Oxygen or Low Oxygen alarm In this instance the user can manually recalibrate the 100 oxygen See 100 O2 Calibration on page 40 This check is not limited to the first four hours of operation The unit automatically recalibrates the oxygen every 8 hours unless a calibration error has occurred i e using the SLE1000 with air only then the unit calibrates every hour Note If the SLE1000 is started ...

Page 31: ...does not deliver any therapeutic flow in this mode and all patient and gas alarms are disabled with the exception of the Battery Low alarm Note In standby mode the user can only select the Oxygen CPAP Apnoea and Set Flow 8 1 Exiting Standby mode The user has three routes to exit standby mode A Selecting a CPAP pressure B Selecting a flow of 6 l min or if a flow has already been set the last set fl...

Page 32: ...on upper level function Start O2 Calib Calib Calibration Calibration function upper level function Show Alarm Hist Hist History Display function upper level function Set Flow Parameter upper level function 9 1 1 Selecting lower level functions Oxygen CPAP Apnoea and Set Flow values Lower level functions Note Please see the CPAP and Flow mode chapter for a detailed description on page 55 Note If th...

Page 33: ...arameters displays or calibration functions The screen will display the title of the parameter that can be adjusted Push the knob to adjust the flashing parameter The LCD display changes from Set Apnoea time to Adjust Parameter Rotate the knob to change the set parameter value ...

Page 34: ...isplay will return to displaying Flow Mode Note If the unit is delivering CPAP then the Cycle indicator bargraph is displayed See section 12 1 on page 51 Note Failure to push the knob to confirm the setting will cause the set value to be discarded after 8 seconds ...

Page 35: ...n upper level function the unit will have to be in either Flow Mode or CPAP mode The procedure is the same for all the settable functions or displays The display messages are located in the LCD window Push or turn the knob Rotate the knob until the upper line of text starts to flash ...

Page 36: ...Page 36 of 128 Push the knob to select ...

Page 37: ...vel functions displays and parameters 9 2 1 Pressure trigger sensitivity Push or turn the knob Rotate the knob until the text Set Trigger Sen appears and starts to flash Push the knob to select The default value of 3 is displayed ...

Page 38: ...a range of 1 to 6 with the default being 3 1 being least sensitive 6 being most sensitive Push the knob to select the new sensitivity setting The unit display returns to the Flow mode Note If the unit is delivering CPAP then the cycle indicator bargraph is displayed See section 12 1 on page 51 ...

Page 39: ... charge level Rotate the knob to select the Show Batt level and starts to flash Push the knob and the battery charge level will be displayed Push the knob to return to the default display Note The battery level times out after 8 seconds ...

Page 40: ...Page 40 of 128 9 3 1 100 O2 Calibration Push or turn the knob Rotate the knob until the text Start O2 Calib appears and starts to flash Push the knob to select ...

Page 41: ...the word cal in the measured percentage of Oxygen area See Oxygen calibration routine description on page 29 Note If the unit is delivering CPAP then the Cycle indicator bargraph is displayed See section 12 1 on page 51 Note If the unit has been setup to operate with air only the 100 oxygen calibration will time out after 3 minutes The unit will return to displaying No alarms will be generated ...

Page 42: ...m Hist appears and starts to flash Push the knob to select The most recent alarm to be generated will be displayed This is indicated by 1 The alarms are tagged 1 to 25 1 being the most recent Note As a new alarm is generated the last alarm is deleted and all the existing alarms move up in ranking ...

Page 43: ...otate the knob to scroll through the last 25 alarm messages Push the knob to return to the default display Note The alarm history times out after 6 seconds Note The alarm history is cleared when the unit is turned off ...

Page 44: ...ate the knob until the text Set Flow appears and starts to flash Push the knob to select The default flow value of 6 l min will be displayed in the right hand corner Note If a Flow value has already been set during the session the unit will use this value ...

Page 45: ...e the knob to select the required flow As the flow value is changed the text will flash Confirm the setting The unit will enter flow mode Note Please see the CPAP and Flow mode chapter for a detailed description on page 55 ...

Page 46: ...n hour counter which records the total elapsed in use time To access the display press the Audio paused and Boost buttons together The text Been used for N h will be displayed Press mute button to cancel the display Note The Been used for h does not time out ...

Page 47: ...raph The unit will flash the light bar Blue when the text Audio Paused is displayed The pre mute will last for two minutes The user can cancel the pre mute by re pressing the audio paused button Note Any alarms that are generated during the pre mute period will only be able to initiate the visual component i e the alarm bar and alarm message The alarm message will alternate between the alarm messa...

Page 48: ...The mute will last for two minutes The alarm message will alternate with audio paused message The user can cancel the mute by re pressing the audio paused button Note Any latching alarms active during audio paused mode are reset on the second press of the button See Latching and non latching alarms on page 98 Note The user needs to be aware that the Mains disconnect No oxygen supply and O2 Calib E...

Page 49: ...tion has not been cleared then the alarm will be re instated If the alarm condition has been cleared the SLE1000 returns to CPAP mode Note The audio mute button has a third function of setting alarm thresholds in flow mode See page 67 ...

Page 50: ...feature The user can re apply the boost if required by releasing and repressing the Boost button Note The Boost button has minimal effect between 10 12 mbar Note On pressing the boost button the patient trigger detection is suspended for 5 seconds Warning When the set pressure is 11 or 12 mbar and the user applies the boost the delivered pressure might go above 15 5 mbar momentarily and trigger th...

Page 51: ...or patient The bargraph has a span of 2 5 mbar around the measured mean airway pressure The decimal point in the measured mean airway pressure reading denotes the centre point the bargraph The bargraph gives a visual indicator to breath cycling 12 2 Breath detection When the SLE1000 registers inspiratory effort from the patient it displays a star character in the upper left line of the LCD display...

Page 52: ...averaged value from a 30 second rolling window 12 4 Measured values 12 4 1 MAP The Mean Airway Pressure MAP is a measured value in mbar 12 4 2 Flow The Flow is a measured value in l min 12 4 3 Oxygen The oxygen is a measured value of the fraction of inspired O2 ...

Page 53: ... connected If both the battery and mains indicator lights are flashing this indicates that there is a hardware fault The unit should be removed from service Note If the battery icon is illuminated and fixed the battery has failed or has been disconnected 12 6 2 With mains power disconnected If both the battery and mains indicator lights are flashing whilst pressing the mains power on button the ma...

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Page 55: ...Page 55 of 128 CPAP Flow mode ...

Page 56: ... detail the procedure of selecting either CPAP or Flow mode 13 1 Standby to Flow mode Push the knob The Oxygen parameter will start to flash Rotate the knob to the left to the CPAP parameter Push the knob to select the parameter The display reverts to Standby ...

Page 57: ...the knob to the right to set the control to the Push the knob to confirm the setting The unit will enter Flow Mode mode set at 6 l min Note If a Flow value has already been set during the session the unit will use this value ...

Page 58: ...Page 58 of 128 13 2 Setting a flow in flow mode Push the knob Note The default value of 6 l min is used The Oxygen parameter will start to flash Rotate the knob to the right to select Set Flow ...

Page 59: ...ct The flow will now be displayed in the top right hand corner of the display Rotate the knob to the right to set the required flow The text will starts to flash Push the knob to confirm the required flow The text will change to Flow mode ...

Page 60: ...fault to 2mbar Leak and 6 mbar Exhaust When the user increases or decreases the set flow the MAP will cross one of the previously set thresholds triggering the appropriate alarm This alarm will not clear unless the thresholds are set by the user around the new MAP that is being used to achieve the set flow or if the MAP crosses back to within the previously set threshold parameters Depress and hol...

Page 61: ...Page 61 of 128 13 3 Flow mode to CPAP mode The user is in Flow Mode Push or turn the knob Rotate the knob to the left to select the Set CPAP level ...

Page 62: ...er The message Set CPAP Level will change to Adjust Parameter Rotate the knob to the right to adjust CPAP parameter Push the knob to confirm the setting The SLE1000 will now adjust the pressure The message display now changes to the airway pressure bargraph ...

Page 63: ...Page 63 of 128 13 4 Standby to CPAP mode Push or turn the knob The Oxygen parameter will start to flash Rotate the knob to the left to the CPAP parameter Push the knob to select the parameter ...

Page 64: ...ue past the Continuing to rotate the knob to set the required CPAP The text adjust parameter will be displayed Push the knob to confirm the setting The SLE1000 will now adjust the pressure The message display now changes to the airway pressure bargraph ...

Page 65: ...Page 65 of 128 13 5 CPAP to Flow mode The user is in CPAP mode Push the knob Rotate the knob to the right to select Set Flow ...

Page 66: ...ct The flow will now be displayed in the top right hand corner of the display Rotate the knob to the right to set the required flow The text will starts to flash Push the knob to confirm the required flow The text will change to Flow mode ...

Page 67: ...lt to 2 mbar Leak and 6 mbar Exhaust When the user increases or decreases the set flow the MAP will cross one of the previously set thresholds triggering the appropriate alarm This alarm will not clear unless the thresholds are set by the user around the new MAP that is being used to achieve the set flow or if the MAP crosses back to within the previously set threshold parameters Depress and hold ...

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Page 69: ...Page 69 of 128 SLE1000 Set up ...

Page 70: ...p 1 Take the SLE1000 out of its transport carton and remove the protective film Step 2 Remove the air and oxygen inlet port caps Step 3 Check that the following ports are free from any packing material A Fresh gas port B Proximal pressure port C Air inlet D Oxygen inlet E Exhaust port A B C D E ...

Page 71: ...nsert the fuse into the fuse holder T2 0A 250V The fuse is located in the accessory pack Part nº M0457 2AC 001 Step 6 Insert the fuse holder and fuse into the receptacle Do not over tighten Step 7 Remove the screw and washer holding the P clip Insert the power cable into the socket and secure the cable with the P clip Allow 75mm of cable to form the loop 75mm ...

Page 72: ...micrometer Microns in size 14 3 1 Setup Prior to first use of the SLE1000 the outlet of this water trap needs to be connected to a drain hose and water collection cup Not supplied The hose should have an internal diameter of 4mm and be pliable enough to fit over the hose tail bard on the outlet of the water trap The other end of the hose should feed any collected water into an open topped collecti...

Page 73: ...3 and for air only start with section 14 4 2 on page 74 14 4 1 With Air and Oxygen from a wall supply between 2 and 7 bar Step 1 Connect the air and oxygen hoses to the SLE1000 Step 2 Connect the air and oxygen hoses to the wall supplies Step 3 Connect SLE1000 to mains power Do not turn the SLE1000 on Proceed to Functional testing prior to patient use on page 80 ...

Page 74: ...ll supply between 2 and 7 bar Step 4 Connect the air hose to the SLE1000 Step 5 Connect the air hose to the wall supply Step 6 Connect SLE1000 to mains power Do not turn the SLE1000 on Proceed to Functional testing prior to patient use on page 80 ...

Page 75: ...9 Turn on the compressor and allow the pressure to build up above 2 bar Note The water trap particulate filter may bleed air due to the auto drain mechanism not closing Block the outlet momentarily to allow the mechanism to close Step 10 Connect SLE1000 to mains power Do not turn the SLE1000 on Proceed to Functional testing prior to patient use on page 80 ...

Page 76: ...0 does not produce any pneumatic noise when turned off Always disconnect the air and oxygen hoses from the wall outlets prior to disconnection from the unit Step 1 Disconnect the air and oxygen hoses to the wall supplies Step 2 Disconnect the air and oxygen hoses to the SLE1000 ...

Page 77: ...he unit is stored or placed out of service without recharging the batteries the deep discharged state will reduce the battery life Warning For a battery that has been allowed to remain in a deep discharged state the damage is irreversible On re charging a damaged battery the service life will be curtailed 14 8 Using the SLE1000 on battery power The SLE1000 is not designed to be started and used on...

Page 78: ...ngs on page 19 then the following procedure is recommended Refer the ventilator to a qualified technician 14 10 2 Transportation If the user is intending to transport the driver then the battery fuse must be removed Refer the ventilator to a qualified technician 14 10 2 1 Fuse removal procedure Step 1 Charge the batteries for 8 hours Step 2 Remove the battery fuse by reversing the process describe...

Page 79: ...Page 79 of 128 Functional Testing ...

Page 80: ...not be used until it has been repaired Please contact an SLE approved engineer or SLE 1 Connect the delivery circuit and flow generator as per the manufacturer s instructions Flow generators and delivery circuits may differ in construction from what is shown below Note DO NOT connect the proximal airway tube to the driver at this time Connection may cause the pneumatic test to fail Gas flow error ...

Page 81: ...orm its self test 4 Confirm that the alarm sounder generated an alarm tone all the LCD and LED displays cycled through the test as described in section 7 1 on page 26 Warning If the user notes that on power up the unit sounder did not produce an alarm tone or that the LCD or LED did not function as described then remove the unit from service and route for repair investigation 5 Re connect mains po...

Page 82: ...red Press the alarm button twice to clear the alarm message 21 Remove the occlusion from the generator outlet 22 The SLE1000 should display and sound the HIGH LEAK alarm after approximately 1 minute 23 Occlude the generator outlet and the exhaust tube 24 The SLE1000 should display and sound the HIGH PRESSURE alarm the driver should cut the fresh gas flow 25 Remove the occlusion from the generator ...

Page 83: ...pressing the alarm button twice 15 7 Gas supply alarms Warning Disconnect the gas supplies from the wall outlet only DO NOT unscrew the hose connections from the rear of the SLE1000 15 7 1 Procedure when using air and oxygen 1 Select fixed flow mode of 6 l min 2 Set the of Oxygen to 25 3 Disconnect the air supply from wall outlet The SLE1000 should display and sound the NO AIR SUPPLY alarm 4 Recon...

Page 84: ...ct a CPAP pressure of 12 mbar 2 Turn off the compressor The SLE1000 should display and sound the NO AIR SUPPLY alarm Note The user may have to wait for the pressure in the compressor reservoir to drop before the alarm is generated As the pressure drops the Zero Pressure alarm is generated as the pressure drops before the No Air Supply alarm is generated 3 Turn on the compressor Occlude the watertr...

Page 85: ...Page 85 of 128 Operational Considerations ...

Page 86: ...sed on rate and magnitude of change in the pressure measured in the patient interface that is shown on the bar graph The sensitivity of the technology has limitations with the smallest patients 1000g and if a leak exists or if the patient opens breathes by the mouth The apnoea monitor may be disabled if breath non detection results in nuisance apnoea alarms 16 2 2 Setting pressure trigger sensitiv...

Page 87: ...Page 87 of 128 Operation ...

Page 88: ...n 14 4 on page 73 Step 2 Ensure that the SLE1000 has been functionally tested as described in section 15 on page 80 Step 3 Ensure the unit has calibrated the oxygen system Note If you are using the unit with air only the O2 CALIB ERROR will be triggered Press the alarm button twice to clear the alarm message The unit will display Do not set the O2 above 21 as this will trigger the NO O2 SUPPLY ala...

Page 89: ...Page 89 of 128 Troubleshooting Chart ...

Page 90: ...wall connection Ensure oxygen pressure is between 2 and 7 bar Alarm message High Leak Unable to attain set CPAP level and flow has reached maximum level Possibly the circuit or patient interface has become disconnected Flow mode selected without alarm thresholds being set Check patient connection Check patient circuit Set alarm threshold Alarm message Zero Pressure MAP drops to zero Proximal press...

Page 91: ...d with complete circuit attached Disconnect proximal airway line and cycle power Alarm message High BPM rate Water in circuit creating circuit noise See High BPM rate on page 100 Check patient circuit Adjust trigger sensitivity Symptom Possible Cause Remedy ...

Page 92: ...Page 92 of 128 This page is intentionally blank ...

Page 93: ...Page 93 of 128 Technical Information ...

Page 94: ...ored in a cold or humid environment whilst in transit storage Disinfect the driver as per section 19 4 on page 95 19 2 Cleaning and disinfection of an in service driver Before cleaning or disinfecting the exterior of the driver the following tasks should be performed The mains cable should be disconnected from the mains supply Remove the patient circuit and bacterial filters Discard any single use...

Page 95: ...aining cloth Care should be taken to ensure that the driver gas ports are not blocked by any debris Warning Ensure that the detergent solution does not enter the unit LCD and LED windows Do not use any abrasive cleaners these surfaces 19 4 Disinfection method Note Alcohols such as 70 isopropanol have a good activity against bacteria and viruses They should only be used after all visible surface di...

Page 96: ...or is pressed again Adjust Parameter Second stage of user interacting with device where the parameter is adjusted Turning the dial will increment decrement the parameter in focus Pressing the dial will confirm selection Times out and reverts to original value after 3 sec of inaction Battery N Display of the battery charge level in percent Clears itself after 10 sec Flow Mode Displayed to indicate ...

Page 97: ...dicator that the Trigger Sensitivity can be selected Clears itself after 5 sec If selected clears after 10 sec Start O2 Calib Indicator that the O2 calibartion routine can be selected Clears itself after 5 sec If selected clears after 10 sec Been used for Display of the battery charge level in percent The user has to press the alarm mute button to cancel display SLE1000 Ver N N Version display dur...

Page 98: ... both the audible and visual elements only during the alarm condition If the alarm condition clears the audible and visual elements self cancel Alarm message Description Action Simultaneous Battery Error and Mains disconnect blank display Total power loss Battery has emptied or battery fuse has failed while in battery operating mode The 1 to 2 l min bypass air flow will cease once the volume chamb...

Page 99: ... pressure exceeds 15 5 mbar Non latching HIGH priority alarm Priority HIGH Type TECHNICAL Cuts fresh gas flow and evacuates pressure from the circuit 1 5 l min bypass flow is delivered to flush CO2 build up Device will restart after 5 seconds Check Patient check patient circuit Adjust ventilation parameters If alarm repeats after the above checks remove patient to an alternative form of ventilatio...

Page 100: ...to deliver air only gas to patient User can prevent recurrence by setting FiO2 to 21 Connect oxygen supply If no oxygen present set the unit to run on air only by canceling the alarm message If ventilating remove patient to an alternative form of ventilation Remove the unit from service High BPM rate The measured breath rate exceeds 90 BPM for at least 6 seconds when the Apnoea is set in the range...

Page 101: ...eck Patient check patient circuit High Leak Flow mode High leak alarm in triggered when delivered pressures goes below the captured pressure by more than 2mbar and remains active for 10 seconds Note If the measured value is 2 mbar the alarm operates for pressures less than 1 mbar Possibly the circuit or patient interface has become disconnected Non latching HIGH priority alarm Cannot be disabled P...

Page 102: ...red pressures goes above the captured pressure by more than 2mbar and remain active for 10 seconds Non latching HIGH priority alarm Cannot be disabled Priority HIGH Type TECHNICAL Check patient circuit Set alarm threshold If alarm does not clear remove patient to an alternative form of ventilation Remove the unit from service Exhaust Impeded CPAP mode Exhaust alarm is generated if the flow remains...

Page 103: ...xygen alarm during current session once acknowledged but continuously maintain BLUE indicator light bar If oxygen cell is not known to have expired perform oxygen cell re calibration when user acknowledges This suspends oxygen monitoring for 4 minutes If alarm repeats remove patient to an alternative form of ventilation Remove the unit from service Battery Low Device is operating on battery power ...

Page 104: ...ll response during calibration Either the oxygen supply is not connected or the O2 cell has expired Continued use of the device is tolerated for a limited time only as accuracy of monitoring cannot be relied on Non latching LOW priority alarm Priority LOW Type TECHNICAL If running on air cancel the alarm The unit should be set to 21 oxygen Trying to set a higher percentage will re trigger the alar...

Page 105: ...tone bursts followed by 2 tone bursts which is repeated after 1 second with a 4 second gap before restarting total alarm cycle of 8 seconds The Medium alarm sound consists of 3 tone bursts followed by a 8 second gap The Low alarm sound consists of 2 tone bursts followed by a 16 second gap 20 2 3 Alarm tone pitch High priority alarm tone c a f a f Medium priority alarm tone c a f Low priority alarm...

Page 106: ...splay precision 1 Breath rate 0 150 BPM Flow 0 20 l min accuracy 2 l min display precision 0 1l min 21 3 Indicators 21 3 1 Non numeric Pressure Cycle Indicator Breath detection indicator 21 3 2 Numeric Rate MAP Flow Oxygen Apnoea CPAP 21 4 Controls ON OFF push button Control of mains power Boost button Delivers positive 3 mbar boost to existing CPAP level up to 30 seconds Alarm mute pre mute Silen...

Page 107: ...ero Pressure Exhaust Impeded High Oxygen Low Oxygen Battery Low Mains Disconnect Battery Error O2 Calib Error 21 6 Outputs Digital Outputs RS232C Serial Port IBM AT compatible serial port 9 pin DSub Available parameters Alarm message BPM rate MAP Mean Airway Pressure Flow rate FiO2 For more details see section 24 1 RS232 output specification on page 116 21 7 Oxygen sensor life Life 900 000 O2 hrs ...

Page 108: ...3 1 Class 1 4 1 minimum level of filtration between 2 to 7 bar Recommended level of filtration is class 1 1 1 Description of Class 1 4 1 1 particle size of 0 1 microns 4 Pressure dewpoint of 3ºC 1 oil content 0 01Mg m3 Description of Class 1 1 1 1 particle size of 0 1 microns 1 Pressure dewpoint of 70ºC 1 oil content 0 01Mg m3 21 8 3 Flows Input Peak inlet gas flow 20 l min Output Pressure mode Fr...

Page 109: ...ISO5356 1 Proximal Airway Non Conical 21 12 Classification Type of protection against electric shock Class I Degree of protection against electric shock Type B IPX rating IP20 Unit must be earthed 21 13 Environmental storage conditions When packed for transport or storage Ambient Temperature 25 C to 55 C Relative Humidity 10 to 90 non condensing Atmospheric Pressure 500 hPa to 1060 hPa 21 14 Produ...

Page 110: ...n assumes an annual use of 4 000 hours The planned maintenance should be brought forward if the actual use exceeds the assumed number of hours However the plan should not be delayed if the actual use is less than the assumed number of hours due to fact that certain ageing still occurs even if the device is not in use e g seals oxygen cell and battery 22 2 Maintenance schedule The SLE1000 has the f...

Page 111: ...onent parts should not be modified The use of non approved parts or accessories can put patient safety at risk and will invalidate any warranty The owner user of this equipment shall have the sole responsibility and liability for any damage or injury to persons or property including the equipment itself resulting from faulty maintenance not in accordance with the authorised maintenance instruction...

Page 112: ...herefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class A The SLE1000 is suitable for use in all establishments other than domestic and may be used in domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes provided th...

Page 113: ...e s to line s 1 kV line s to earth 1 kV line s to line s 1 kV line s to earth Mains power quality should be that of a typical commercial or hospital environment If the user of the SLE1000 requires continued operation during power mains interruptions it is recommended that the SLE1000 be powered from an uninterruptible power aupply or a battery Voltage dips short interruptions and voltage variation...

Page 114: ...ns Electromagnetic propagation is affected by absorption and reflection from structures objects and people a The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz bThe compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz t...

Page 115: ...power not listed above the recommended separation distance d in metres m be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 The ISM industrial scientific and...

Page 116: ...x denotes an ascii character 0 15 xxxxxxxxxxxxxxxx Status in 16 characters No Current Alarm or alarm message 16 Comma separator 17 19 xxx BPM rate in 3 characters 20 Comma separator 21 24 xx x MAP in 4 characters 25 Comma separator 26 29 xx x Flow Rate in 4 characters 30 Comma separator 31 33 xxx FiO2 in 4 characters 34 0x0A Line feed 35 0x0D Carriage return Note the text No Current Alarm in the s...

Page 117: ...Page 117 of 128 25 Pneumatic unit schematic SLE1000 Below is a schematic representation of the pneumatic unit of the SLE1000 ...

Page 118: ...Page 118 of 128 26 SLE1000 Overlay Labels are supplied as a set of 4 and cannot be ordered individually Units in cmH2O are also available Please contact SLE or your distributor for more information ...

Page 119: ...es are supplied separately Note Please contact SLE or your distributor for more information on the start up pack SLE1000 Qty1 L1009 020 0XX User Manual Qty1 L1009 UMA 0UK Mains lead UK Qty1 M0255 07 Trolley Fixing Screws Qty2 H6212 L1009 010 0UK Accessory pack Battery fuse Qty1 M0457 2AC 001 ...

Page 120: ...Page 120 of 128 This page is intentionally blank ...

Page 121: ...Page 121 of 128 Consumables Accessories ...

Page 122: ...filter Replacement TBA SLE1000 roll stand deluxe with drip pole medi rail basket and hose hook Medicart 4 L1009 014 000 SLE1000 roll stand basic Medipole 1000 L1009 015 000 SLE1000 user manual L1009 UMA 0UK SLE1000 service manual Model B 01 B 02 for V2 5 3 software L1009 SMA 0UK SLE1000 service manual Model B 03 B 04 for V2 6 4 software L1009 SMA 4UK ...

Page 123: ...Page 123 of 128 Glossary ...

Page 124: ...Pressure EMC Electromagnetic Compatibility FiO2 Fractional Concentration of Inspired Oxygen Kg Kilogram LCD Liquid Crystal Display LED Light Emitting Diode l min Litres per Minute MAP Mean airway pressure mbar Millibar ml Millilitres ms Millisecond NCPAP Nasal Continuous Positive Airway Pressure PEEP Positive End Expiratory Pressure RS232C RS232 is a long established standard for low speed serial ...

Page 125: ...6 88 Battery care 77 Battery charging 77 Battery low indicator 53 Battery deep discharge 77 Battery display of charge 44 Boost button 25 50 BPM 52 Breath detection 51 86 C Classification device 109 Cleaning 95 Cleaning prior to first use 94 Cleaning when in service 94 Controls 106 CPAP boost 16 CPAP driver 10 CPAP mode 47 Cycle indicator 51 D Description of ventilator features 14 Device 10 Dimensi...

Page 126: ...neumatic test 96 Power down 30 Power manager hardware fault 53 Power requirements 109 Power up 26 Pre mute of alarm 47 Pressure trigger sensitivity 42 86 Product life cycle 109 Prongs 11 Push and turn knob 25 R Responsibility user owner 18 Rotation of gas inlets 72 RS232 107 116 124 S Schematic pneumatic unit 117 Set Apnoea Time 96 Set CPAP Level 96 Set Flow 97 Set Oxygen Level 97 Set Trigger Sen ...

Page 127: ...Page 127 of 128 SLE reserves the right to make changes without prior notice in equipment publications and prices as may be deemed necessary or desirable ...

Page 128: ......

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