SLE SLE5000 Model J Service Manual
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SLE SLE5000 Model J Service Manual

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SLE5000
Model J service manual
Version 4.3.1 & 4.3.2 software

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  • Page 1 SLE5000 Model J service manual Version 4.3.1 & 4.3.2 software...
  • Page 2 All rights reserved. No part of this publication may be reproduced, stored in any retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopy, recording or otherwise, without prior permission of SLE. © Copyright SLE 30/09/2016. Manual: SM31 Issue 3 SLE Part Nº:...

  • Page 3: Table Of Contents

    Contents 1. Warnings and Cautions ..................... 10 1.1. Warnings ......................10 1.2. Cautions ......................11 2. Principles of Operation ....................14 2.1. Electronic System................... 14 2.2. Pneumatic System ..................15 3. Description of Symbols ..................... 18 4. Equipment list ......................22 5.
  • Page 4 14.1. Battery indicator ....................69 15. Extended storage ....................71 16. Maintenance and Overhaul ..................74 16.1. Preventative Maintenance Kit ...............74 16.2. 12 & 36 month preventative maintenance procedure ........76 16.3. 24 month and 48 month overhaul procedures ..........84 16.4. 24 month / 10,000 hour overhaul procedure..........86 16.5.
  • Page 5 23. Cleaning, disinfection and sterilization ..............197 23.1. Preparation of a new ventilator..............197 23.2. Cleaning and disinfection of an in-service ventilator ........197 23.3. Cleaning method ..................198 23.4. Disinfection method ..................199 23.5. Sterilization method ..................200 24. Technical Specification ................... 201 24.1.
  • Page 6 33. Illustrated Parts List ....................240 Ventilator assembly ....................242 Base plate and side door assembly ..............249 Front facia assembly .....................251 Electronic module ....................253 Pneumatic module ....................273 DISS air and oxygen fittings ..................285 34. Modifications ......................288 34.1. Equipotential stud modification ..............288 34.2. Modification A as per SI120401 - (Bypassing of oxygen volume chamber)..290 34.3.
  • Page 7 37.2. Connecting the SLE5000 to the VueLink patient monitor......332 37.3. Parameter Descriptions ................333 37.4. Data transferred to the VueLink system from the SLE5000 ......334 37.5. Alarm and inoperative indications..............336 37.6. VueLink Task Window Layout ..............339 37.7.
  • Page 8 This page is intentionally blank Page 8 (Model J)
  • Page 9 Warnings and Cautions (Model J) Page 9...

  • Page 10: Warnings And Cautions

    If you make a warranty claim and these seals are broken SLE may deem the warranty claim null and void. If the ventilator develops a fault within the warranty period please refer to your warranty documentation.

  • Page 11: Cautions

    Disposal of the Oxygen Sensor should be in accordance with local regulations for hazardous substances. Do not incinerate. SLE offer a cell disposal service. The ventilator must have its batteries charged every 14 days. The ventilator must be connected to a mains power source for 24 hours to ensure a full charge.
  • Page 12 11. The SLE5000 contains several batteries, three 2 cell sealed lead acid batteries and 2 AA alkaline batteries. At the end of their useful life these batteries should be disposed of in accordance with local authority guidelines. 12. Apart from the batteries, the ventilator and accessories do not contain any hazardous components therefore no special precautions are required for their disposal.
  • Page 13 Principles of Operation (Model J) Page 13...

  • Page 14: Principles Of Operation

    2. Principles of Operation The SLE5000 infant ventilator consists of an electronic system in the upper section of the ventilator and a pneumatic system in the lower. 2.1 Electronic System The electronic system comprises three autonomous subsystems, one responsible for monitoring the patient, one responsible for controlling the valves of the pneumatic system and one for the user interface (touchscreen and displayed data).

  • Page 15: Pneumatic System

    2.2 Pneumatic System The pneumatic system comprises of the tubing and electro-mechanical valves necessary to provide the gas in conventional and oscillatory ventilation modes. The two gas controlling functions are blending and pressure generation 2.2.1 Blending The method used for blending air and oxygen in known proportions is to pressure regulate the two supplies (air and oxygen) so they produce equal flow rates and then allow each supply into a mixing chamber for a time period equivalent to the proportions required.
  • Page 16 Note that all jet pressures actually sum in the exhalation block, for example, to ventilate a patient with a PEEP pressure of 5 mbar and a PIP pressure of 30 mbar, the mean jet will be set to generate a continuous circuit pressure of 5 mbar and the forward jet will be set to generate a circuit pressure varying between zero (exp phase) and 25 mbar (insp.
  • Page 17 Description of Symbols (Model J) Page 17...

  • Page 18: Description Of Symbols

    3. Description of Symbols Symbol Description Type BF connection (Situated on front panel) Read manual (Situated on rear panel) Date of Manufacture (Appears on serial number label) Do not dispose of as general waste (WEEE directive) (Appears on serial number label) EEC conformity marking showing compliance with the Medical Devices Directive (Appears on serial number label) Indicates the mains power switch...
  • Page 19 Symbol Description Indicates a note in the manual Indicates a caution in the manual Check list item. (Model J) Page 19...
  • Page 20 This page is intentionally blank. Page 20 (Model J)
  • Page 21 Equipment List (Model J) Page 21...

  • Page 22: Equipment List

    4. Equipment list To service the SLE5000 infant ventilator the service personnel will require the following equipment. Items marked with an SLE part number can be obtained by contacting the service department. • Electronic engineers tool kit. • Calibration analyser (calibrated in mbar) ..SLE Part Nº: N2830 •...
  • Page 23 Engineering Mode Software (Model J) Page 23...

  • Page 24: Engmode

    5. ENGMODE The SLE5000 ventilator is calibrated via two calibration programs, one for the ventilator and one for the Touch screen. The calibration programs are accessed via the Controller Services panel in the user interface. 5.1 Accessing the Calibration Programs Step 1 Press the Options and Service Data Button.
  • Page 25 Step 4 Press the Controller button. Step 5 Enter the code supplied by SLE into the ventilator, via the controller services panel to activate the calibration program. Begin psv is the A button. End psv is the B button. Apnea sup is the C button.

  • Page 26: Ventilator Calibration Program

    5.2 Ventilator Calibration Program The calibration program has four main functions. 1. Sensor Calibration 2. Jet Calibration 3. O & Flow System Calibration 4. Elapsed Time Reset. 5. Language Selection 6. Exit 5.2.1 Sensor Calibration The sensor calibration panel allows the following sensors to be calibrated. Controller The setting of the block and leak sensor...

  • Page 27: O2 & Flow System Calibration

    5.2.2 Jet Calibration The jet calibration panel allows the forward jet, reverse jet and mean jet to be adjusted. Also contained within this panel are the controls to adjust the inspiratory and expiratory leading edges of the CMV wave form. Associated controls to set the ventilator in CMV or HFO mode are also displayed.

  • Page 28: Reset Elapsed Time

    5.4 Reset Elapsed Time The reset elapsed time panel allows the ventilators time counter to be reset to zero days and minutes. This function is only used at the 20,000 hour overhaul. 5.5 Language Selection The “Language Selection Program” panel displays the languages choices that can be installed.

  • Page 29: Activation Of Language Selection Program Form User Interface

    * Please contact SLE or your distributor for information on the availability of secondary languages. To install a secondary language select the language required. The name of the selected...

  • Page 30: Touch Screen Calibration Program

    Warning: Failure to carry out the touch screen calibration correctly can cause the ventilator to become unusable. A failed touch screen calibration can only be corrected by connection of a specialist device. Please contact SLE or your distributor in this situation. Page 30 (Model J)
  • Page 31 Component Replacement (Model J) Page 31...

  • Page 32: Component Replacement Procedure

    • Blender manifold block......SLE Part Nº: N0280/01 • Pressure regulators PR3, PR4 & PR6 ..SLE Part Nº: N0280/02/S46 • High speed jet valves SV9, 10, 11 & 12..SLE Part Nº: N0280/03 • Regulator input air PR1......SLE Part Nº: N0280/05 • Regulator input oxygen PR2 .....SLE Part Nº: N0280/06 •...

  • Page 33: Preparing The Sle5000

    7. Preparing the SLE5000 Caution: the SLE5000 ventilator weighs 21.8kg fully assembled. Care should be taken when handling the ventilator. If preparing to work on both the electronic and pneumatic units of the SLE5000 remove the ventilator from the stand and place it on a flat stable surface. The SLE5000 ventilator is attached to the trolley or pole by two screws with shake proof washers.
  • Page 34 Warning: If the ventilator is under a warranty agreement removal of the inner covers may void the agreement. Please refer to the warranty documentation. Step 3 Remove the screws (B) (2 screws) (C) (4 screws) to release the electronic inner cover. Step 4 Remove the screws (D) (6 screws) to release the pneumatic unit base plate.

  • Page 35: Component Replacement (Electronic Unit)

    8. Component Replacement (Electronic unit) 8.1 N6631/21/CF/50 Compact Flash Card 1. Slide the compact flash card (B) out of its socket in the direction of the arrow. 2. Insertion of the compact flash card is the reverse of removal. Caution: Do not force the compact flash card out of the carrier, as it may catch on the connector mounted on the edge of the board Setup: If the same or new card is inserted software then a full functional test is required for this component.

  • Page 36: N6634/Oem2 Can Card

    8.3 N6634/OEM2 CAN Card Warning: The CAN card is a static sensitive device. 1.The CAN card (A) is already loose from the removal of the N6331/LX800 PC board. 2. Disconnect the CAN card ribbon cables (B). 3. The CAN card (A) can now be removed. 4.

  • Page 37: L0275/Oem2 Computer/Display Control Assembly

    8.5 L0275/OEM2 Computer/Display Control assembly Warning: The Computer/Display Control assembly is a static sensitive device. 1. Remove the PCB locking screw. This will allow the top board assembly to slide forward a small amount which gives better access to the edge connectors of the top board.

  • Page 38: A0763/02/M Control/Monitor Board

    8.6 A0763/02/M Control/Monitor Board Warning: The Control/Monitor Board is a static sensitive device. 1. Remove the L0275/OEM2 Computer/Display Control assembly as described in section 8.5. 2. Disconnect the following cables. 3. CAN card link ribbon cable controller side (A). (P3) 4.CAN card link ribbon cable controller side (B).

  • Page 39: M0915 Power Supply Unit

    8.7 M0915 Power Supply Unit 1. Disconnect the main power supply. 2. Remove the four fixing screws. 3. Disconnect the battery monitor cable (A). 4. Disconnect the main loom power cable (B). 5. Disconnect the battery monitor cable (C). 6. Disconnect the Mains Present LED cable (D).

  • Page 40: M0901 Batteries

    8.8 M0901 Batteries 1. Remove the L0275/OEM2 Computer/Display Control assembly as described in section 8.5. 2. Remove the Control /Monitor board as described in section 8.6. 3. Disconnect all the battery terminal leads. 4. Remove the four retaining screws for the first two battery blocks.

  • Page 41: A0761 Transducer Pcb Assembly

    8.9 A0761 Transducer PCB Assembly Warning: The Transducer PCB is a static sensitive device. Note: Screen removed for clarity. 1. Remove the L0275/OEM2 Computer/ Display Control assembly as described in section 8.5. 2. Remove the Control/Monitor board as described in section 8.6. 3.

  • Page 42: N6631/13 Inverter Pcb

    8.10 N6631/13 Inverter PCB Warning: The Transducer PCB is a static sensitive device. Note: Screen removed for clarity. 1. Remove the L0275/OEM2 Computer/Display Control assembly as described in section 8.5. 2. Remove the Control/Monitor board as described in section 8.6. 3.

  • Page 43: N6631/02 Lcd & N6631/05 Touch Screen

    8.11 N6631/02 LCD & N6631/05 Touch Screen 1. Remove the L0275/OEM2 Computer/Display Control assembly as described in section 8.5. 2. Remove the Control / Monitor board as described in section 8.6. 3. Remove the 4 screws (A) retaining the screen tie bars. 4.
  • Page 44 16. Remove the 2 nuts, washers (K) and screws (L) retaining the left hand side of the LCD / touch screen assembly. 17. Separate the LCD / touch screen assembly from the mounting plate. 18. Disconnect the connecting cable (M) from the rear of the LCD assembly. 19.

  • Page 45: Component Replacement (Pneumatic Unit)

    9. Component Replacement (Pneumatic unit) 9.1 Duckbill and conical filters. Note: The air inlet connector is used to illustrate the process, the procedure is the same for the O inlet connector. Note: The O connector is a left hand thread and the Air connector is a right hand thread.
  • Page 46 9.1.1 N0280/01 blender manifold block Location in pneumatic unit Part number: N0280/01 1. Disconnect and remove the following tubes: (A) fresh gas supply tube, (B) fresh gas dump tube, (C) O cell sample dump tube, (D) fresh gas to PRV1 tube, (E) blender O supply tube, (F) air inlet tube,...
  • Page 47 2. Remove the nuts and washers (I) to release the blender manifold assembly (J). 3. Lift the manifold assembly (J) off the four chassis studs. Note: Leave the old oxygen cell fitted to the assembly. This is to stop any debris entering the oxygen cell manifold.
  • Page 48 9.1.2 N0280/02/S46 Pressure regulators (PR3, PR4 & PR6) Location in pneumatic unit Part number: N0280/02 1. Disconnect the following tubes: (A) forward jet supply tube (B) reverse jet supply tube (C) mean jet delivery tube 2. Disconnect the electrical connectors from PR3 (D), PR4 (E) and PR6 (F).
  • Page 49 3.Remove the four nuts and washers (G) securing the pressure regulator manifold assembly. 4. To remove the pressure regulators (H, I & J) from the manifold block (K) remove the screws (L), two per regulator. Note: that the ‘O’ rings (M) will be released once the regulator has been removed.
  • Page 50 9.1.3 N0280/03 High Speed Jet Valve Assembly Location in pneumatic unit Part number: N0280/03 1. Disconnect the electrical connectors from PR3 (A), PR4 (B) and PR6 (C). PR3 cable is tagged 3. PR4 cable is tagged 4. PR6 cable is tagged 6. 2.
  • Page 51 3. The high speed valve assembly and loom (E) can now be removed by disengaging the valves from the rear of the forward and reverse jet manifold (F). 4. Assembly is reversal of removal. Setup: Pneumatic setup and full system calibration is required for this component. (Model J) Page 51...
  • Page 52 9.1.4 N0280/05 inlet air pressure regulator 1.Remove the remaining tube (A) from the inlet air pressure regulator (B). 2. Remove the two nuts (C). 3. Withdraw the regulator (B). 4. Assembly is reversal of removal. Setup: Full system calibration is required for this component.
  • Page 53 9.1.5 N0280/06 inlet oxygen pressure regulator 1. Disconnect the tube (A) from the inlet manifold elbow (B). 2. Disconnect the tube (C) from the inlet manifold elbow (D). 3. Remove the two fixing nuts (E). 4. Draw the regulator (F) from the exhaust block (G) disengaging the tube (H) from the fitting (I).
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  • Page 55 A0763/02/M Board (Model J) Page 55...

  • Page 56: A0763/02/M Monitor And Control Board

    10. A0763/02/M Monitor and control board The SLE5000 uses the base A0760 Rev F PCB to make up the A0763/02/M board. 10.1 A0763/02/M board programmable devices The A0763/02/M board is divided into two sections a) the monitor side and b) the control side.The monitor section is divided into a further two sections c) monitor isolated and d) monitor non islolated.

  • Page 57: A0763/02/M Board Hardware Identifier

    10.2 A0763/02/M Board Hardware Identifier The A0763/02/M board has a group of resistors that allow the software to recognize the pneumatic unit configuration. There are 10 hardware idents possible on the board. The table below outlines the resistor groups to produce specific hardware ID’s. The SLE5000 Model G ventilator uses Hardware Ident 3.
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  • Page 59 Electrical Safety Testing (Model J) Page 59...
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  • Page 61: Electrical Safety Testing Of The Sle5000

    11. Electrical Safety Testing of the SLE5000 This test is performed using an approved electrical safety testing device. The electrical safety test must be carried out on the unit with all the electrical connections intact. Connect the ventilator to the electrical safety tester and turn the unit ON. Connect the flow sensor connector via a test loom to the electrical safety tester.
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  • Page 63 PSU Testing (Model J) Page 63...
  • Page 64 This page is intentionally blank. Page 64 (Model J)

  • Page 65: Psu Testing

    12. PSU Testing This check should only be carried out if the PSU is suspected to be faulty. a) Unplug the battery connector from the PSU. b) Remove the the top board assembly. c) Turn on the ventilator and check the output voltages of the power supply at the following points on the wireloom.
  • Page 66 This page is intentionally blank. Page 66 (Model J)
  • Page 67 Power Up-Down & Battery Care (Model J) Page 67...

  • Page 68: Ventilator Power Up And Power Down

    13. Ventilator Power up and Power down. 13.0.1 Mains power indicator. The ventilator has a LED indicator on the front facia to indicate when mains power is present. The indicator unlike previous models does not indicate that the machine is ON. The mains power present indicator allows the user to see that the ventilator is charging the batteries.

  • Page 69: Back-Up Battery Charging

    14. Back-up Battery Charging Prior to first use, the ventilator should be connected to a suitable power outlet that is ON for a minimum of 24 hours. The ventilator does not need to be turned on to charge the battery. The ventilator will indicate that mains power is present via the indicator LED on the front of the machine.
  • Page 70 The battery status icon has seven states. With mains power connected or disconnected a) Charged to 75% or greater, the battery icon displays three green blocks. With mains power disconnected b) Discharged to between 50% and 75% of battery capacity. c) Discharged to between 25% and 50% of battery capacity.

  • Page 71: Extended Storage

    15. Extended storage If the ventilator is not going to be used for a period in excess of 40 days then the following protocol has to be followed. The batteries will require charging prior to disconnection for 24 hours. This is required to protect the batteries against damage due to deep discharge.
  • Page 72 This page is intentionally blank. Page 72 (Model J)
  • Page 73 Maintenance and Overhaul (Model J) Page 73...

  • Page 74: Maintenance And Overhaul

    16. Maintenance and Overhaul The ventilator has the following maintenance / overhaul schedule. 12 months Preventative maintenance Kit: N9010/12/G 24 months (10,000hrs) Overhaul Kit: N9010/24/G 36 months Preventative maintenance Kit: N9010/12/G 48 months (20,000hrs) Overhaul Kit: N9010/48/G 16.1 Preventative Maintenance Kit The N9010/12/G contains the following: Conical filter Qty 2...
  • Page 75 12 & 36 Month Maintenance (Model J) Page 75...

  • Page 76: 36 Month Preventative Maintenance Procedure

    16.2 12 & 36 month preventative maintenance procedure 16.2.1 Ventilator preparation 1. Preventative maintenance should be carried out with the ventilator still attached to the trolley. 2. Disconnect the air and oxygen supply hoses. 3. Remove the five fixing screws (A) indicated from the rear cover.
  • Page 77 Warning: If the ventilator is under a warranty agreement removal of the inner covers may void the agreement. Please refer to the warranty documentation. 5. Remove the screws (B) to release the electronic inner cover. The ventilator is now ready for maintenance.
  • Page 78 16.2.2 Duckbill and conical filter replacement. The procedure is the same for both air and oxygen inlets. 1.Remove the inlet connector (A). Note: The O connector is a left hand thread and the Air connector is a right hand thread. 2.
  • Page 79 16.2.3 Replacement of N2042 “O” Rings 1. Remove the silencer and exhalation block from the ventilator. 2. Locate the two ’O’ rings located (A & B) on gas ports. 3. Using a blunt probe lift out the old ’O’ ring and discard. Repeat the process for the other ’O’...
  • Page 80 16.2.4 Replacement of N2191/10 O Cell 1. Remove the O2 cell cover plate (A). 2. Pull out the cable until the connector (B) is visible. Gently pull apart the connector. 3. Unscrew the cell anti-clockwise until free and discard, treat the cell as a battery and dispose of in the appropriate method.
  • Page 81 16.2.5 Replacement of CMOS backup batteries 1. Remove the two AA batteries and discard in accordance with local waste authority guidelines. 2. Replace the batteries taking care to correctly insert the cells. (Model J) Page 81...
  • Page 82 This page is intentionally blank. Page 82 (Model J)
  • Page 83 24 & 48 Month Overhaul (Model J) Page 83...

  • Page 84: Month And 48 Month Overhaul Procedures

    16.3 24 month and 48 month overhaul procedures The ventilator has two overhaul points, the first at 24 months or 10,000 hours (whichever is sooner) and 48 months or 20,000 hours (whichever is sooner). The 24 month / 10,000 hour overhaul consists of the replacement of the following components.
  • Page 85 24 Month / 10,000 Hour Overhaul (Model J) Page 85...

  • Page 86: Month / 10,000 Hour Overhaul Procedure

    16.4 24 month / 10,000 hour overhaul procedure The following instructions, list the order in which the 24 month overhaul should be carried out. 1. Remove the five fixing screws (A) indicated from the rear cover. 2. Slide the rear cover towards the rear of the machine.
  • Page 87 Warning: If the ventilator is under a warranty agreement removal of the inner covers may void the agreement. Please refer to the warranty documentation. 3. Remove the screws (B) (2 screws) (C) (4 screws) to release the electronic inner cover. 4.
  • Page 88 16.4.1 L0275/OEM2 Computer/Display Control assembly Warning: The Computer/Display Control assemblies are static sensitive devices. 1. Remove the PCB locking screw. This will allow the top board assembly to slide forward a small amount which gives better access to the edge connectors of the top board.
  • Page 89 16.4.2 A0763/02/M Control/Monitor Board Warning: The Control/Monitor Board is a static sensitive device. 1. Disconnect the following cables. 3. CAN card link ribbon cable controller side (A). (P3) 4.CAN card link ribbon cable controller side (B). (JP3) 5. Power supply connector controller side, main loom (C).
  • Page 90 16.4.3 Removal of the Backup Batteries 1. Disconnect all the battery terminal leads. 2. Remove the four retaining screws for the first two battery blocks. 3. Remove the two batteries. 4. Remove the two fixing screws and washers (A), securing the fixing bracket (B) for the third battery. 5.
  • Page 91 7. Remove the two screws retaining the bracket to the battery. 8. Reversing the procedure for replacement of the batteries, re-install all the electronic module components. Note: When refitting the batteries the screws require a torque setting of 1.2Nm 9. Carry out the following to complete the 24 month overhaul. 10.
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  • Page 93 48 Month / 20,000 Hour Overhaul (Model J) Page 93...

  • Page 94: Month / 20,000 Hour Overhaul Procedure

    16.5 48 month / 20,000 hour overhaul procedure The procedure for the 48 month / 20,000 overhaul is as follows for Options 1 and 2. 1. Remove the outer cover, inner cover and base plate 2. Remove the front facia panel by removing the attaching countersunk screws.
  • Page 95 6. Attach the new pneumatic unit (reverse of removal). Note: The service exchange or the new pneumatic unit will be Model M-1 in design. Please refer to the Model M & M-1 service manual available from the SLE service department.

  • Page 96: Month Overhaul Procedure Using N9410/48/G Overhaul Kit

    16.6 48 month overhaul procedure using N9410/48/G overhaul kit. The overhaul of the electronic unit follows the same procedure as that of a 24 month overhaul. 16.6.1 Pneumatic unit 48 month overhaul procedure Note: Replace any tubing deemed to be brittle, damaged or discoloured. Tubing should be removed and replaced as the item it is attached to is removed from the pneumatic unit.
  • Page 97 3. Disconnect the earth strap (G). Retain the fixing screw. Disconnect the electrical connector (H). 4. Remove the four nuts and washers (J) securing the pressure regulator manifold assembly. 5. Remove the pressure regulator manifold with the high speed valve assembly attached.
  • Page 98 8. Remove and discard the following two tubes. Fresh gas supply tube (M). 9. Remove the nut and washer (O) retaining the other end of the earth strap (P). 10. Locate the two screws (Q) retaining the jet block. 11. Remove the old jet block (R) and discard.
  • Page 99 16.6.3 Removal of N0280/01 blender 1. Disconnect and remove the following tubes: (A) fresh gas supply tube, (B) fresh gas dump tube, (C) O cell sample dump tube, (D) fresh gas to PRV1 tube, (E) blender O supply tube, (F) air inlet tube, (G) forward jet supply tube, (H) proximal airway bleed tube, 2.
  • Page 100 3. Remove the nuts and washers (K) to release the blender manifold assembly (L). 4. Lift the manifold assembly (J) off the four chassis studs. Disconnect the O cell (K). 16.6.4 Removal of the pressure regulators from the old manifold 1.
  • Page 101 16.6.5 Assembly of the pressure regulators to the new manifold 2. Using the original screws (E) refit the pressure regulator (G) to the new manifold (H). Use the new ‘O’rings (I). The process is the same for the remaining regulators. Note: Pressure regulator design may vary.
  • Page 102 16.6.7 Installation of new high speed valve assembly 1. Insert the new high speed valve assembly (A) into the partition assembly (B). Connect the electrical connectors (C) as per the following diagram. Ensure that the black foam pad is next to the bulkhead. Ensure that tube (D) is below the jet block.
  • Page 103 3. Secure the earth strap with the original screw and washer (F). 4. Secure the pressure regulator assembly (G) with the three of the original nut and washers (H). Note: the new pressure regulator assembly can only be secured by three of the nuts.
  • Page 104 5. Ensure the pressure regulator leads (J) are routed as shown. 6. Connect the electrical connectors to PR3 (K), PR4 (L) and PR6 (M). PR3 cable is tagged 3. PR4 cable is tagged 4. PR6 cable is tagged 6. 16.6.8 Installation of the new blender assembly (L0S80/405/002) 7.
  • Page 105 8. Re-connect the following tubes: (A) fresh gas to PRV1 tube, (B) O cell sample dump tube, (C) fresh gas dump tube, (D) fresh gas supply tube, (E) blender O supply tube, (F) proximal airway bleed tube, (G) forward jet supply tube, (H) reverse jet supply tube, (J) air inlet tube.
  • Page 106 9. Reconnect the pressure regulator assembly and High speed valve assembly pneumatic tubing as follows: Tube (K) volume chamber to PR3. Tube (L) PR3 to SV9 & SV10. Tube (M) PR4 to SV11 & SV12. Tube (N) volume chamber to PR4 Tube (P) PR6 to mean jet.
  • Page 107 Calibration Procedure V4.3.1 & V4.3.2 (Model J) Page 107...

  • Page 108: Calibration Procedure For V4.3.1 & V4.3.2 Software

    17. Calibration Procedure for V4.3.1 & V4.3.2 software The calibration procedure is to be used in-conjunction with a checklist. The checklist is used to record the calibration values set during the procedure. This checklist will be become part of the service record of the ventilator. A template checklist (which should be copied) is to be found in Appendix 1 of this manual on page 305.

  • Page 109: Preliminary Inspection Before Calibration

    17.2 Preliminary Inspection before calibration a) Check all tubing connections are fully home in their fittings. b) Check that the oxygen cell is properly located (finger tight) and that its electrical connector is connected. c) Check that the electrical connections to the PR3, PR4 and PR6 are screwed on tightly (finger tight).

  • Page 110: Pneumatic Set Up

    17.3 Pneumatic set up PRV1 Test point 1 Test point 4 Test point 3 Test point 5 Test point 6 Test point 2 SV10 SV12 SV11 SV12 Page 110 (Model J)
  • Page 111 Note: Hospital medical gas pipeline systems conforming ISO 7396 operate between 2.8 to 6 bar. The SLE5000 ventilator can operate throughout this range, but requires adjustment for operation with a medical gas pipeline system that operates between 2.8 to 3.3 bar. Operating an SLE5000 ventilator set for 3.3 to 6 bar operation at 2.8 to 3.2 bar input pressures, causes the No Gas, No Air and No Oxygen alarms to be triggered continually.
  • Page 112 g) With the fresh gas valve SV7 de- energised (ventilator turned off), ensure the flow at the fresh gas port is at least 1.2LPM (typ. 1.8LPM). Check list Item 6. h) Monitor the flow from the proximal airway pressure port using a precision flow meter and adjust regulator PR7 (approx.

  • Page 113: Calibration Of Controller And Monitor Subsystems

    17.4 Calibration of Controller and Monitor subsystems a) Before the controller can be calibrated it is necessary to calibrate the pressure sensors of the Monitor Subsystem. b) Enter the Calibration program. See “Accessing the Calibration Programs” on page 24. c) Disconnect the gas supplies. 17.4.1 Monitor Pressure sensor calibration Note: The ventilator must be at working temperature with the metal electronic unit top cover on before calibrating the pressure transducers,...
  • Page 114 j) Enter Sensor Calibration screen and adjust the gain of both the pressure sensors so that the 1psi and the 2.5psi pressure transducers agree with each other and with the Calibration Analyser. Acceptable tolerance: ±1mbar. k) Go to Jet Calibration screen and set the PIP as specified in PIP Pressure Setting column of the table below.

  • Page 115: Controller "Block And Leak" Pressure Sensor Calibration

    17.5 Controller “Block and Leak” pressure sensor calibration a) Connect the block and leak Y piece assembly to the fresh gas port and monitor generated pressure with the calibration analyser. Note: Step b) is to be carried out with new control/monitor boards only, otherwise leave values as set and move to step c).

  • Page 116: Controller Blender Pressure Sensor Zeroing And Input Pressure Reg. Trim

    h) Repeat steps f and g until pressure sensor and calibration analyser agree Acceptable tolerance: ± 1 mbar i) Re-connect the block and leak Y piece assembly to the fresh gas port and monitor generated pressure with the calibration analyser. Verify the setting by setting the following pressures via the restrictor.

  • Page 117: Mean Jet Pressure Regulator Calibration

    17.7 Mean Jet Pressure Regulator Calibration a) Connect a full patient circuit to the ventilator. b) Enter the Jet Calibration screen. c) Connect the ET manifold to the calibration analyser. d) Set up the ventilator to CMV mode and set the following parameters: BPM to 30 Insp.
  • Page 118 f) Set the reverse jet gain to 430 g) Set the PEEP control to zero and increase the CMV offset on the reverse jet to achieve 0 mbar. h) Repeat steps c, d and e until the set and measured agree. i) Verify PEEP pressure setting by setting the following pressures on the CMV control panel and verifying the displayed pressure in the pressure display bar.

  • Page 119: Forward Jet Pressure Regulator Calibration

    17.8 Forward Jet Pressure Regulator Calibration a) Set up the ventilator to CMV mode and set the following parameters: BPM to 30 Insp. time to 1.5 sec Set the PIP control to 60 mbar PEEP to 0 b) Adjust the Forward Jet Gain to achieve 60 mbar ± 1 mbar on the plateau of the Inspiratory phase.

  • Page 120: Reverse Jet Pressure Regulator Calibration

    17.9 Reverse Jet Pressure Regulator Calibration Note: The ventilator must be at working temperature with the metal electronic unit top cover on before calibrating the reverse jet pressure regulators, (machine must be on for at least half an hour). a) Occlude ET manifold. Set up the ventilator to HFO Pure mode and set the following parameters: Set the Mean to 0 mbar...

  • Page 121: Time Constant For Pressure Measurement Waveform

    17.10 Time Constant for pressure measurement waveform Set the Mean to 0 mbar Set the Delta P to 40 mbar HFO rate to 5Hz Starting with the P Meas Filter set at 255, reduce it until the transient overshoot on the positive cycle is in range of 25 mbar ±...
  • Page 122 b) Using the insp leading edge adjustment controls, shape the leading edge to produce a square response. Starting with the insp leading edge calibration values for the fast and slow rise times set to zero, and the F/S balance set to 255.

  • Page 123: O2 System Calibration

    17.12 O System Calibration Ensure that the ventilator has been turned on and connected to air for 1 hour prior to carrying out the O system calibration. Connect the oxygen supply. Press start the O System Calibration button. This takes about 6 minutes, the system will indicate when calibration is finished.

  • Page 124: Blender And Oxygen Monitoring Verification

    17.16 Blender and Oxygen Monitoring Verification Ensure that the ventilator has been turned on and connected to air for 1 hour prior to carrying out the verification. Using a calibrated oxygen analyser, check the accuracy of the blender and the oxygen measurement throughout the range at the following ventilator mode settings.

  • Page 125: Soak Test

    100% O cell will need to be fitted. (This device is available from SLE on request, part number: L0291). Connect a full patient circuit with test lung. Carry out a 100% oxygen calibration (One point) with the dummy 100% O cell.

  • Page 126: Battery Charge Verification

    17.17.3 CMV soak test Part 3 of 3 Set the ventilator to CMV mode Set BPM to 100 PIP to 50 PEEP to 10 Insp Time to 0.35 sec. set to 96% Run for a minimum of 25 hours. After 25 hours of CMV soak, Check the PIP pressure is unchanged.

  • Page 127: Pressure Calibration Verification

    17.20 Pressure Calibration Verification a) Check the CPAP pressure settings in CPAP mode at the following settings: PIP 30 mbar CPAP Setting Acceptable tolerance 0 mbar ±1mbar 5 mbar ±1mbar 10 mbar ±1mbar 15 mbar ±1mbar 20 mbar ±1mbar b) Check the pressure settings and wave shapes in CMV mode at the following settings: BPM 25 Insp time 1.5 seconds...
  • Page 128 This page is intentionally blank. Page 128 (Model J)
  • Page 129 Functional Testing (Model J) Page 129...

  • Page 130: Functional Testing

    18. Functional Testing The functional test procedure is to be used in-conjunction with a checklist. The checklist is used to record that each test has been passed. This checklist will be become part of the service record of the ventilator. A template checklist (which should be copied) is to be found in Appendix 2 of this manual on page 313.
  • Page 131 Depress and hold down the mains power switch for 2 seconds. The ventilator will power down but the “Complete Power Fail Alarm” will be active. To cancel the alarm depress the mains switch again but do not hold down. Re-connect mains power. Turn ON the ventilator and wait for it to enter the Ventilation OFF mode.
  • Page 132 18.1.5 Calibration of the Flow sensor Step 5 Make sure that there is no flow passing the through the sensor. For this purpose, occlude the flow sensor by holding it between two fingers, closing both ends as shown in the following picture. Press the Options and Service Data button.
  • Page 133 18.1.6 Oxygen Alarm Test Step 6 In Ventilation OFF mode panel press the Oxygen Alarm Test button. The Oxygen alarm testing window will now be displayed in the Mode Panel. With the Alarm Auto-Track button set to ON set the FiO parameter to 45% O Once set, press the Alarm Auto-Track button.
  • Page 134 Decrease the percentage of oxygen to 37%. The blender will reduce the percentage of oxygen to the set value. The Low Oxygen Alarm will now be triggered. Further decrease the percentage of oxygen to 21% and press the Return button to cancel the Oxygen alarm test.
  • Page 135 18.1.7 Function and Alarm Testing Step 9 Set the following parameters in the CPAP preview mode: Ti......1 sec. CPAP ....5 mbar PIP....... 20 mbar ..... 21% After pressing the confirm button the user will be presented with the CPAP screen.
  • Page 136 Note: If functional testing the ventilator without a flow sensor plus fitted the TTV button will not appear and the Flow v Time & Tidal Volume v Time windows will be replaced by the Breath Trigger Level bar. Step 12 Remove the test lung and connect the ET manifold to the calibration analyser.
  • Page 137 Pull the test lung to mimic a breath, then acknowledge and reset the alarm. Verify that: after 10 seconds that the ventilator delivers a backup breath and the visual and audible Apnoea alarm is triggered. Note: Functional testing with a flow sensor, but with the patient circuit occluded, the Breath Not Detected alarm will be triggered on the second mechanical breath.
  • Page 138 Step 19 Press the Mode Select button and select CMV from the Mode Select panel, but DO NOT press the confirm button. Advance to Step 20. Step 20 Set the following parameters in the CMV preview mode: BPM .....30 Ti ......1 sec. PEEP....5mbar PIP .......20 mbar ......21%...
  • Page 139 Step 22 Modify the BPM and Insp.Time parameters: BPM..... 18 Insp. Time ... 3 sec Step 23 Remove the test lung and connect the calibration analyser to the ET manifold. Verify that the calibration analyser alternates between the PEEP and PIP settings.
  • Page 140 18.1.10 Breath Not Detected Alarm Step 26 Set the PEEP to 1 mbar. Remove the test lung from the flow sensor. Occlude the flow sensor. After 20 seconds this should initiate an audible and visual Breath Not Detected alarm. Refit the test lung to the flow sensor. The Alarm should self cancel.
  • Page 141 18.1.11 Leak / Block Alarm Step 27 Disconnect the fresh gas tubing from the ventilator. This should initiate an audible and visual LEAK alarm indication. Step 28 Occlude the fresh gas outlet. This should initiate an audible and visual BLOCK alarm indication. Reconnect the tubing, audible and visual alarms should reset.
  • Page 142 18.1.13 Gas Supply Alarms Warning: Disconnect the gas supplies from the wall outlet only. DO NOT unscrew the hose connections from the rear of the ventilator. Step 30 Disconnect Air supply from wall outlet, an audible / visual alarm should be activated.
  • Page 143 18.1.14 Flow Sensor Disconnect Alarm Note: If functional testing without the flow sensor advance to . Step 33 Disconnect the flow sensor plug from the ventilator an audible / visual alarm should be activated. Press the Continue without flow button. 18.1.15 Cycle Fail Alarm Step 34 When the ventilator is used without a flow...
  • Page 144 Step 35 Reconnect the flow sensor and a new audible / visual alarm Calibrate Flow Sensor should be activated and replace the Connect Flow Sensor alarm. Recalibrate the flow sensor. Step 36 Press the Mode Select button to enter the Mode select panel. Step 37 Select HFO Only from the Mode Select panel, but do not press the confirm button.
  • Page 145 18.1.16 Functional Test of HFO Mode Step 38 Set the following parameters in the HFO Only preview mode. HFO Rate .... 10Hz Mean ....5mbar ..... 21% Delta P....Not available in preview mode After pressing the confirm button the user will be presented with the HFO screen.
  • Page 146 Note: If functional testing the ventilator without a flow sensor fitted the Flow v Time & Tidal Volume v Time windows will not appear. Step 40 Press the Mode Select button and select HFO+CMV from the Mode Select panel, but do not press the confirm button.
  • Page 147 18.1.17 Functional Test of CMV Mode Step 41 For the functional test set the following parameters in the CMV preview mode: BPM..... 20 Ti......1 sec. PEEP ....5mbar PIP....... 20 mbar ..... 21% After pressing the confirm button the user will be presented with the CMV screen.
  • Page 148 Note: If functional testing the ventilator without a flow sensor fitted the Volume Limit button and the Flow v Time & Tidal Volume v Time windows will not appear. Step 42 Verify that: the ventilator is cycling, the I:E ratio in the breath parameter panel reads 1.0 : 1.0, the waveforms appear in the waveform windows.
  • Page 149 Step 44 Verify that: the pressure wave form is modified accordingly. Default position Midway position Step 45 Return the indicator bar to its original position and press the Return button to return to the Services panel. Step 46 Press the Next.. button to reach the More Options panel.
  • Page 150 plus Step 49 From the mode select panel press the TTV button. (Skip Step 49 to Step 53, if functional testing without a flow sensor). Step 50 Turn on the Volume targeting by pressing the button marked OFF. The text in the button will change to ON.
  • Page 151 Step 52 Set a Tidal volume (Vte (TTV)) of 8ml and a Max PIP of 30mbar Verify that: The displayed waveform changes showing a rise in flow with a sharp cut off. Step 53 Turn off the volume limiting. Step 54 Press the Mode Select button and select PSV from the Mode Select panel, but do...
  • Page 152 18.1.18 Functional Test of PSV Mode Step 55 For the functional test set the following parameters in the PSV preview mode: Backup ....20 BPM PEEP....5 mbar PIP .......20 mbar Max Ti ....1 sec.......21% After pressing the confirm button the user will be presented with the PSV screen.
  • Page 153 Note: If functional testing the ventilator without a flow plus sensor fitted the TTV button will not appear and the Flow v Time & Tidal Volume v Time windows will be replaced by the Breath Trigger Level bar. Step 57 Press the PSV Setup button to display the Pressure Support panel.
  • Page 154 Step 58 Reduce the back up rate to 19 BPM. The Apnoea Setup button should now become active. Press the Apnoea Setup button on the Mode Panel. The Apnoea Settings panel should now be displayed. Set the Apnoea Delay to 10 seconds. Press the Return button to return to the Mode panel.
  • Page 155 18.1.19 Functional Test of SIMV Mode Step 61 For the functional test set the following parameters in the SIMV preview mode: BPM..... 20 Ti......1 sec. PEEP ....4mbar PIP....... 25 mbar ..... 21% After pressing the confirm button the user will be presented with the SIMV screen.
  • Page 156 Note: If functional testing the ventilator without a flow plus sensor fitted the TTV button will not appear and the Flow v Time & Tidal Volume v Time windows will be replaced by the Breath Trigger Level bar. Step 63 Wait for the ventilator to deliver a mandatory breath, on completion of this breath pull the test lung.
  • Page 157 Step 65 Remove the test lung and connect the calibration analyser. Verify that: the PIP is 25 mbar. Refit the test lung. Step 66 Press the PSV Setup button to display the Pressure Support settings panel. Ensure that support is provided at 50%. Press the ON button (F).
  • Page 158 18.1.20 Functional Test of HFO+CMV Mode Step 69 For the functional test set the following parameters in the HFO+CMV preview mode BPM .....30 Ti ......1 sec. HFO Rate.....10Hz PEEP....4mbar PIP .......30 mbar Delta P ....Not available in preview mode ......21% After pressing the confirm button the user will be presented with the HFO + CMV screen.
  • Page 159 Note: If functional testing the ventilator without a flow sensor fitted Flow v Time & Tidal Volume v Time windows will not appear. Step 70 Verify that: the ventilator cycles with oscillations in both the inspiratory and expiratory phases, the waveforms appear in the waveform windows, the I:E ratio in the breath parameter panel reads 1.0 : 2.0.
  • Page 160 18.1.21 Pressure Change Alarm Step 73 Disconnect the flow sensor and test lung from the ET manifold for a maximum of 3 seconds then reconnect. Verify that: the visual and audible Pressure Change Detected alarm is triggered. Press the reset button to clear the alarm panel of the alarm notification.
  • Page 161 Trouble shooting (Model J) Page 161...

  • Page 162: Trouble Shooting Chart

    19. Trouble Shooting Chart 1. Symptom: Mains present LED is OFF but ventilator is connected to mains power supply. Possible Cause Mains power supply turned off. Blown main fuse. Power supply has developed a fault. Remedy Turn on mains supply. Replace main fuse.
  • Page 163 3. Symptom: Ventilator freezes, displaying software version start up screen with a grey square present in corner. Possible Cause Dip switches on CAN Card oxidized or incorrectly set. Remedy Toggle switches. Reset switches as follows 1 off, 2 on, 3 on, 4 off, 5 off, 6 off, 7 off and 8 on If switches hardwired (on underside of board) and this fault is present, exchange the CAN card.
  • Page 164 6. Symptom: Touch screen buttons do not operate. Possible Cause Touch screen cable disconnected. Touch screen failure. Remedy Examine touch screen cable. Replace touch screen. (See “N6631/02 LCD & N6631/05 Touch Screen” on page 43). 7. Symptom: Total power fail alarm active (Audible Only) after turning off the ventilator.
  • Page 165 10. Symptom: Sub ambient pressure alarm. Alarm Message: Sub Ambient Pressure. Possible Cause Failure of reverse pressure regulator PR3. Remedy Replace pressure regulator PR3. 11. Symptom: Controller failure alarm. Alarm Message: Controller Not Responding. (Displayed below alarm panel). Possible Cause Controller services activated from user interface.
  • Page 166 14. Symptom: No Gas alarm. Alarm Message: No Gas. Possible Cause Air and Oxygen supplies not connected to ventilator. Air and Oxygen supply Failed. Air and Oxygen supplies below 4bar. Remedy Connect Air and Oxygen supplies to ventilator. Restore Air and Oxygen supplies. Increase input pressure to 4bar.
  • Page 167 17. Symptom: Pressure sensor drift alarm. Alarm Message: Pressure Sensor Drift. Possible Cause A pressure sensor transducer has failed an internal system check. Remedy Re-calibrate the ventilator. Replace Transducer PCB assembly. (See “A0761 Transducer PCB Assembly” on page 41). 18. Symptom: System fail alarm Alarm Message: System Fail with one of the following sub messages (Monitor Isolated System fail) or (Monitor Error Comms) or (Monitor Isol System Fail) or (Unable to calibrate flow ADC) or (Alarm controller Fail)
  • Page 168 20. Symptom: User interface failure alarm. Alarm Message: User interface failure. Possible Cause Internal hardware reset has occurred. Remedy Re-start the ventilator. 21. Symptom: Fresh gas solenoid fail alarm. Alarm Message: Fresh Gas Solenoid Fail. Possible Cause Block and leak pressure transducer out of calibration. Fresh gas solenoid fail.
  • Page 169 24. Symptom: Set PIP / PEEP pressure do not meet delivered pressures. Possible Cause Tolerance of 1 mbar. Pressure transducers out of calibration. Forward and mean jets out of calibration. Remedy Re-calibrate pressure transducers. Re-calibrate forward and mean jets. 25. Symptom: Set O % is not the same as displayed O Possible Cause cell has aged.
  • Page 170 This page is intentionally blank. Page 170 (Model J)
  • Page 171 Software Version History (Model J) Page 171...

  • Page 172: Software Version History

    20. Software Version History The following is a list of software versions used on the SLE 5000 infant ventilators. Software Display Controller Controller Controller Monitor Monitor Version subsystem hardware software Checksum software software N°: Isolated Isolated 21-03-03 23-07-03 19-11-03 V3.1 19-11-03 V3.2...

  • Page 173: Technical Information

    Technical Information (Model J) Page 173...

  • Page 174: Oxygen Calibration Routines

    21. Oxygen Calibration Routines The SLE5000 ventilator has two oxygen cell calibration routines. The first calibration is the 100% oxygen calibration (One Point). This calibration is carried at the following intervals after the unit is turned on: 0.5 min, 10 minutes, 30 minutes, 60 minutes, 90 minutes and then at 8 hourly intervals.
  • Page 175 The second through the engineering mode software from the & Flow System Calibration screen. Warning: The user must not carry out the two point calibration whilst connected to a patient. The Calibration process only functions in Ventilation Off mode and would deliver 21% O to the patient for 7 minutes.

  • Page 176: Alarms

    22. Alarms 22.1 Alarm Protocols The following descriptions summarizes the alarms to be generated by the ventilator. The alarms are sorted by their priority ratings. An alarm of a higher priority can interrupt a lower priority alarm, effectively, masking lower priority alarms.

  • Page 177: Alarm Descriptions And Actions To Be Taken

    22.3 Alarm Descriptions and actions to be taken Alarm 1. Monitor Failure Alarm message........Monitor failure Alarm sub message ......Remove ventilator from service Priority of alarm........1 Monitor mode........N/A Can alarm be muted ......No Sounder Priority ........High Alarm Description: If the monitor system fails this alarm is generated by the controller system.
  • Page 178 Alarm 3. Sub-ambient Pressure Alarm message ........Sub ambient pressure Alarm sub message ......Safety shutdown activated and ventilator restarting Priority of alarm ........3 Monitor mode ........All Can alarm be muted ......No Sounder Priority........High Alarm Description: If the proximal pressure falls below -2mbar for <50ms a sub-ambient alarm is generated but mean pressure is maintained.
  • Page 179 Alarm 5. 101 System Fail (Memory Checksum Error) Alarm message........Monitor EEPROM fail Alarm sub message ......Monitor checksum Fail Alarm code........... 101 Priority of alarm........5 Monitor mode........All Can alarm be muted ......No Sounder Priority ........High Alarm Description: At power up flow data in EEPROM corrupt.
  • Page 180 Alarm 8. 104 System Fail (Memory Checksum Error) Alarm message ........Monitor EEPROM fail Alarm sub message ......Monitor checksum Fail Alarm code ...........104 Priority of alarm ........8 Monitor mode ........All Can alarm be muted ......No Sounder Priority........High Alarm Description: At power up pressure gain data in EEPROM corrupt. Action: Remove ventilator from service.
  • Page 181 Alarm 11. Continuing Positive Pressure Alarm message........Continuing positive pressure Alarm sub message ......Check patient circuit Priority of alarm........11 Monitor mode........All Can alarm be muted ......Yes Sounder Priority ........High Alarm Description: When the ventilator detects a increase of 5mbar above the PEEP that is maintained for more than 10 seconds this alarm is generated.
  • Page 182 Alarm 14. Pressure Change Detected Alarm message ........Pressure Change Detected Alarm sub message ......Check Patient Connection Priority of alarm ........14 Monitor mode ........HFO+CMV only Can alarm be muted ......Yes Sounder Priority........High Alarm Description: When the user changes a pressure related parameter the ventilator stores the maximum inspiration and expiration pressure values.
  • Page 183 Alarm 17. Unexpected Rise in Mean P Alarm message........Unexpected rise in mean P Alarm sub message ......Press autoset to adjust HFO alarms to new pressures Priority of alarm........17 Monitor mode........HFO Only Can alarm be muted ......Yes Sounder Priority ........
  • Page 184 Alarm 20. Unexpected Drop in Max P Alarm message ........Unexpected drop in max P Alarm sub message ......Press autoset to adjust HFO alarms to new pressures Priority of alarm ........20 Monitor mode ........HFO Only Can alarm be muted ......Yes Sounder Priority........High Alarm Description: When the ventilator set alarm threshold of 5mbar below the max pressure is crossed this alarm is generated.
  • Page 185 Alarm 23. No Gas Alarm message........No gas Alarm sub message ......Connect ventilator to gas Priority of alarm........23 Monitor mode........All Can alarm be muted ......No Sounder Priority ........High Alarm Description: If no gas is detected by the ventilator this alarm is generated. Action: Connect gas supplies to ventilator.
  • Page 186 Alarm 26. Battery Fault Alarm message ........Battery fault Alarm sub message ......Internal battery not detected Priority of alarm ........26 Monitor mode ........All Can alarm be muted ......No Sounder Priority........High Alarm Description: The battery can not be detected by the ventilators monitoring system Action: Remove ventilator from service.
  • Page 187 Alarm 29. Leaking Fresh Gas Alarm message........Leaking fresh gas Alarm sub message ......Fresh gas supply to patient may be leaking Priority of alarm........29 Monitor mode........All Can alarm be muted ......No Sounder Priority ........High Alarm Description: If the fresh gas supply is detected to be leaking this alarm is generated.
  • Page 188 Alarm 32. Flow Monitor (Flow ADC Unable to Calibrate) Alarm message ........System Fail Alarm sub message ......Unable to calibrate flow ADC Priority of alarm ........32 Monitor mode ........Flow Can alarm be muted ......Yes Sounder Priority........High Alarm Description: Errors detected within the flow monitoring device. Action: Remove patient to alternative form of ventilation, then remove ventilator from service.
  • Page 189 Alarm 35. Connect Flow Sensor Alarm message........Connect flow sensor Alarm sub message ......Flow sensor is not connected Priority of alarm........35 Monitor mode........Flow Can alarm be muted ......Yes Sounder Priority ........Medium Alarm Description: If the sensor is not connected or both wires have been broken this alarm is generated. Action: Connect flow sensor, if sensor already in situ replace and discard the defective flow sensor.
  • Page 190 Alarm 38. User Interface Failure Alarm message ........User interface failure Alarm sub message ......User interface has reset unexpectedly Priority of alarm ........38 Monitor mode ........All Can alarm be muted ......Yes Sounder Priority........High Alarm Description: When a hardware reset has taken place within the ventilator this alarm is generated. Action: Remove patient to alternative form of ventilation, then remove ventilator from service.
  • Page 191 Alarm 41. Low Tidal Volume Alarm message........Low tidal volume Alarm sub message ......Tidal volume below low threshold Priority of alarm........41 Monitor mode........Flow Can alarm be muted ......Yes Sounder Priority ........High Alarm Description: Tidal volumes lower than a user-selected threshold will generate this alarm. Action: Check patient.
  • Page 192 Alarm 44. Breath Not Detected Alarm message ........Breath not detected Alarm sub message ......Check patient connection Priority of alarm ........44 Monitor mode ........Flow Can alarm be muted ......Yes Sounder Priority........Medium Alarm Description: If after a machine delivered breath the ventilator does not detect a patient response within 10 seconds then this alarm is generated.
  • Page 193 Alarm 47. Main Power Failure Alarm message........Main power fail Alarm sub message ......Running on internal battery Priority of alarm........46 Monitor mode........All Can alarm be muted ......Yes Sounder Priority ........High Alarm Description: If the mains supply fails this alarm is generated. Action: Check mains connection.
  • Page 194 Alarm 50. Calibrate Oxygen Cell Alarm message ........Calibrate oxygen cell Alarm sub message ......The oxygen cell needs calibrating Priority of alarm ........49 Monitor mode ........All Can alarm be muted ......Yes Sounder Priority........Medium Alarm Description: If at any time the measured oxygen is >100% this alarm will be generated. Action: Recalibrate O sensor.
  • Page 195 Alarm 53. High Oxygen Level Alarm message........High oxygen level Alarm sub message ......The O is higher than desired Priority of alarm........52 Monitor mode........All Can alarm be muted ......Yes Sounder Priority ........High Alarm Description: If the delivered oxygen differs from the user selected level by more than 5% the above alarm is generated.

  • Page 196: Software And System Fail Protocols

    Alarm 56. Alarm Controller Fail Alarm message ........System Fail Alarm sub message ......Alarm Controller Fail Priority of alarm ........55 Monitor mode ........All Can alarm be muted ......No Sounder Priority........High Alarm Description: If the alarm controller fails this message is generated. Action: Remove patient to alternative form of ventilation, then remove ventilator from service.

  • Page 197: Cleaning, Disinfection And Sterilization

    62°C. DO NOT immerse any part of the ventilator in any liquid, with the exception of the expiratory exhalation block (SLE part No N6622). 23.1 Preparation of a new ventilator Remove all transit packaging. Inspect the fresh gas port and proximal airway port for any packing material.

  • Page 198: Cleaning Method

    • Unlock the exhalation block by turning the clamp through 90 degrees until it is horizontal. • Gently pull away the exhalation block and silencer from the gas ports. • Separate the silencer and exhalation block. Refitting the silencer and exhalation block is the reversal of removal. Do not force the exhalation block into place.

  • Page 199: Disinfection Method

    Ensure that the detergent solution does not enter the unit or the exhalation block gas ports on the side of the machine. (Touch Screen) Do not use any abrasive cleaners on the touch screen surface. Flow Sensor Wash in hand hot water/mild general purpose detergent solution (as prescribed by the appropriate hospital authority).

  • Page 200: Sterilization Method

    23.5 Sterilization method The silencer (N2186/01), flow sensor (N5201) and exhalation block (N6622) must be sterilized between use on patients. The ventilator cannot be sterilized. The exhalation block must be cleaned as an essential prerequisite to sterilization. For the silencer, flow sensor and exhalation block. Autoclave with pure dry saturated steam at: 134ºC (277ºF) (Allowable variation of temperature of +3ºC) at 220kPa (32psi) with a minimum holding time of 3 minutes...

  • Page 201: Technical Specification

    24. Technical Specification This section summarizes the specification of the ventilator in terms of the modes, ranges and limits that are required on the controls and the displays. It also summarizes the mechanical and electrical power constraints. 24.1 Operating Modes Conventional Ventilation 24.1.1 CPAP Inspiratory Time: 0.1 to 3.0 seconds (Resolution 0.01 seconds)
  • Page 202 24.1.4 PSV Inspiratory Time: 0.1 to 3.0 seconds (Resolution 0.01 seconds) CPAP Pressure: 0 mbar to 20 mbar (Resolution 1mbar) Inspiratory Pressure: 0 mbar to 65 mbar (Resolution 1mbar) Volume Targeting: 2 ml to 200 ml From 2ml to 6ml the parameter increments in 0.2ml steps (Fine resolution). From 6ml to 100ml the parameter increments in 1ml steps (Standard resolution).

  • Page 203: Hfo Ventilation

    24.2 HFO Ventilation 24.2.1 HFO Only Frequency Range: 3-20Hz. (1Hz resolution.) I:E Ratio Delta Press Range: 4 mbar to 180 mbar for 3.3 to 6 bar inlet gas pressues 4 mbar to 140 mbar 2.8 to 3.2 bar inlet gas pressues (Resolution 2mbar) Mean airway range: 0 mbar to 35 mbar maximum (Resolution 1mbar)
  • Page 204 24.2.3 Controls (Via touch screen display) Adjust button: Activates alarm thresholds for modification Alarm Auto-Track button: Sets selected % 0 for testing Apnea Sup Button: Sends diagnostic pulse Apnoea setup button: Activates Backup/Apnea settings panel Arrow buttons: Increments value Auto set Button: Autoset high, cycle and low alarm thresholds Backup parameter control: 1 to 150 bpm (Resolution 1 bpm)
  • Page 205 Folder button: Retrieves loop from memory Graphs button: Activates waveform and loops panels HFO activity button: Activates HFO activity panel HFO Only button: Selects HFO only mode HFO rate parameter control: 3 to 20 Hz (Resolution 1 Hz) HFO+CMV button: Selects HFO+CMV mode Hist.
  • Page 206 Reset button: Resets current alarm Reset contamination alarm button: Resets the alarm Return button: Returns to previous panel Select button: Tabs between time and date values Set BPM button: Selects BPM against time display Set time and date button: Activates time and date panel Set Trigger button Activates breath detection trigger threshold SIMV button:...

  • Page 207: Measurement

    24.3 Measurement 24.3.1 Flow and Volume Flow Sensor Type: 10 mm dual-hot-wire-anemometer with replaceable hot- wire subassembly, autoclaveable. Sensor electrically isolated. Flow Rate: 0.2 lpm to 32 lpm (Accuracy ±8 % maximum) Expiratory Tidal Volume: 0 to 999ml (0.1ml) Expiratory Minute Volume: 0 to 18L (Resolution: 1ml) Deadspace: 1 ml...

  • Page 208: Exhalation Block Port Jet Sizes

    24.3.3 Pressure Real Time Pressure: Resolution 1mbar, accuracy ±1mbar Drift detection: detects drift when there is a pressure difference of more than 5mbar between the two pressure transducers. Only active when the measured pressure is below 70mbar. Sampling Time: Peak Pressure: 0 to 175 mbar (resolution 1mbar, accuracy ±0.75% of full scale range) PEEP Pressure:...

  • Page 209: Alarms

    24.5 Alarms 24.5.1 User settable Alarms High Pressure: Autoset when patient pressure controls are adjusted, or manually adjustable. Range: 10 to 110 mbar Resolution: 0.5 mbar Cycle Fail: Autoset when patient pressure controls are adjusted, or manually adjustable. Range: 0 or 5 mbar above low-pressure threshold (whichever is lower) to 5 mbar below high-pressure threshold.

  • Page 210: Patient Circuits

    24.5.2 Obligatory Alarms (non adjustable by user) Monitor Failure Sustained sub ambient Sub ambient Controller Failure System fail, Memory checksum error System fail, Alarm controller error Gas not connected not connected Air not connected Block alarm Leak alarm Battery fault Battery low Continuing positive pressure Pressure sensor drift...

  • Page 211: Outputs

    Trigger Count Measured Minute Volume Measured Leak Measure Resistance Measured Compliance Measured C20/C Current Alarm ID For more details refer to the RS232 addendum. Contact SLE for more details. Compatability with: Vuelink. Contact SLE for more details. (Model J) Page 211...

  • Page 212: Gas Supplies

    24.8 Gas supplies The air and oxygen high pressure gas supplies are used as fresh gas. 24.8.1 Oxygen supply The ventilator requires a supply of pure oxygen between 2.8 to 6 bar (Please refer to section 24.8.3 for further details). 24.8.2 Air supply The ventilator requires a supply of medical grade compressed air to ISO8573.1 Class 1.4.1 (minimum level of filtration) between 2.8 to 6 bar...

  • Page 213: Power, Dimensions, Classification Etc

    10ºC-40ºC Humidity: 30-75% (Non condensing) Size, Ventilator only: 330mm W x 330mm H x 470mm D Height on pole: 1140 mm Weight (ventilator only):SLE5000 Model J, 21.8Kgs Connectors Exhalation block: Conical to ISO5356-1 Proximal Airway: Non Conical Fresh Gas Port: Non Conical 24.10 Classification...

  • Page 214: Emc Compliance

    25. EMC compliance The SLE5000 electro magnetic compatibility was tested to and meets the requirements of the following relevant standards: EN60601-1-2 EN61000-3-2 EN61000-3-3 Guidance and manufacturer's declaration - electromagnetic emissions The SLE5000 is intended for use in the electromagnetic environment specified below. The customer or the user of the SLE5000 should assure that it is used in such an environment.

  • Page 215: Electromagnetic Immunity

    25.1 Electromagnetic immunity Guidance and manufacturer's declaration - electromagnetic immunity The SLE5000 is intended for use in the electromagnetic environment specified below. The customer or the user of the SLE5000 should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level...
  • Page 216 Guidance and manufacturer's declaration - electromagnetic immunity The SLE5000 is intended for use in the electromagnetic environment specified below. The customer or the user of the SLE5000 should assure that it is used in such an electromagnetic environment. Immunity test IEC 60601 TEST Compliance Electromagnetic environment - guidance...

  • Page 217: Recommended Separation Distances Between Portable And Mobile Rf Communications Equipment And The Sle5000

    25.2 Recommended separation distances between portable and mobile RF communications equipment and the SLE5000 Recommended separation distances between portable and mobile RF communications equipment and the SLE5000 The SLE5000 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the SLE5000 can help prevent electromagnetic interference by maintaining a minimum between portable and mobile RF communications equipment (transmitters) and the SLE5000 as recommended according to the maximum output power of the communications equipment.

  • Page 218: Ventilator Labelling

    26. Ventilator labelling Page 218 (Model J)
  • Page 219 Schematic & Circuit Diagrams (Model J) Page 219...

  • Page 220: Electrical Block Diagram

    27. Electrical Block Diagram Page 220 (Model J)

  • Page 221: L0280/Kv Pneumatic Unit Layout & Schematic

    28. L0280/KV Pneumatic Unit Layout & Schematic 28.1 Layout PRV1 SV10 SV11 SV12 (Model J) Page 221...

  • Page 222: Schematic

    28.2 Schematic Page 222 (Model J)

  • Page 223: Main Loom Circuit Diagram

    29. Main Loom Circuit Diagram (Model J) Page 223...

  • Page 224: L0275/Oem2 Assembly Schematic

    30. L0275/OEM2 Assembly Schematic Page 224 (Model J)
  • Page 225 A0761 Circuit Diagram (Model J) Page 225...

  • Page 226: A0761 Circuit Diagram

    31. A0761 circuit diagram 31.1 Transducer PCB Assembly Page 226 (Model J)
  • Page 227 A0763/02 Circuit Diagrams (Model J) Page 227...

  • Page 228: A0763/02 Circuit Diagrams

    32. A0763/02 circuit diagrams 32.1 Micro Controller Page 228 (Model J)

  • Page 229: Conventional Valve Drive

    32.2 Conventional Valve Drive (Model J) Page 229...

  • Page 230: Power Distribution And Hardware Identifier

    32.3 Power Distribution And Hardware Identifier Page 230 (Model J)

  • Page 231: Analogue Valve Drive / Non Volatile Memory / Interboard Comms

    32.4 Analogue Valve Drive / Non Volatile Memory / Interboard Comms. (Model J) Page 231...

  • Page 232: High Speed Valve Drive

    32.5 High Speed Valve Drive Page 232 (Model J)

  • Page 233: Analogue Data Acquisition/Monitor Port

    32.6 Analogue Data acquisition/Monitor port (Model J) Page 233...

  • Page 234: Control & Monitor, Pcb Psu Circuit

    32.7 Control & Monitor, PCB PSU Circuit Page 234 (Model J)

  • Page 235: Control & Monitor, Micro Non-Isolated

    32.8 Control & Monitor, Micro Non-isolated (Model J) Page 235...

  • Page 236: Control & Monitor, Micro Isolated

    32.9 Control & Monitor, Micro Isolated Page 236 (Model J)

  • Page 237: Control & Monitor, Analog Isolated

    32.10 Control & Monitor, Analog Isolated (Model J) Page 237...

  • Page 238: Control & Monitor, Alarm Controller

    32.11 Control & Monitor, Alarm Controller Page 238 (Model J)
  • Page 239 Illustrated Parts List (Model J) Page 239...

  • Page 240: Illustrated Parts List

    SLE Part Nº: refers to the items SLE part number. This number should be quoted when ordering spares. Where two items with part numbers that are same are followed by a number in brackets;...
  • Page 241 The Dot classification system. Items within the parts list have a dot prefix. The item with no dot as a prefix is the main assembly for that figure. Any item with one dot belongs to the main assembly. Any item with two dots is attached to the one dot item above it. (Three dot items are attached to two dot items etc).

  • Page 242: Ventilator Assembly

    View A Ventilator assembly Figure 1 (Sheet 1 of 5) Page 242 (Model J)
  • Page 243 View B Ventilator assembly Figure 1 (Sheet 2 of 5) (Model J) Page 243...
  • Page 244 Ventilator assembly Figure 1 (Sheet 3 of 5) Page 244 (Model J)
  • Page 245 Ventilator assembly Figure 1 (Sheet 4 of 5) (Model J) Page 245...
  • Page 246 Ventilator assembly Figure 1 (Sheet 5 of 5) Page 246 (Model J)
  • Page 247 Units Item SLE Part Nº Description Effectivity code Assy. L5007 Infant Ventilator, Model J N6622 .Exhalation Block Assy N21866/01 .Silencer, Long  T1267/M1 .Moulding, Case rear Attaching Parts H4116 ..Screw (M4 x 16mm) H4095 ..Washer, nylon (M4)  T1270/01/UK/09 .Label, air vent Part of the T1270/01/UK label set T1270/01/UK/06 .Label, Mains switch...
  • Page 248 Units Item SLE Part Nº Description Effectivity code Assy. T1270/01/UK/11 .Label, Fuse rating Part of the T1270/01/UK label set T1270/01/UK/10 .Label, Air O inlet Part of the T1270/01/UK label set T1270/01/UK/04 .Label, Input pressures Part of the T1270/01/UK label set M0219 .Label, serial number...

  • Page 249: Base Plate And Side Door Assembly

    Base plate and side door assembly Figure 2 (Model J) Page 249...
  • Page 250 Units Item SLE Part Nº Description Effectivity code Assy. L0274/M3 Base plate & side door assembly (See figure 1 for next highest assembly) T1269/M3 .Side Door Attaching Parts T1252/M6 ..Stud plate T1239/01 ..Plate, hinge H3091/03 ..Nut, (M3) H3093 ..Washer, plain (M3) H4095 ..Washer, plain Nylon (M4)

  • Page 251: Front Facia Assembly

    Front facia assembly Figure 3 (Model J) Page 251...
  • Page 252 Units Item SLE Part Nº Description Effectivity code Assy. L5007-1002 Front facia assembly (See figure 1 for next highest assembly) N6633 .Seal, cover N6632 .Seal, screen  W0334/01 .Loom, flow senor M0767/06 .Core, ferrite hinged M0767 .Core, ferrite hinged Attaching Parts T1261 ..Bezel...

  • Page 253: Electronic Module

    Electronic module Figure 4 (Sheet 1 of 13) (Model J) Page 253...
  • Page 254 View A View B Electronic module Figure 4 (Sheet 2 of 13) Page 254 (Model J)
  • Page 255 Electronic module Figure 4 (Sheet 3 of 13) (Model J) Page 255...
  • Page 256 View C Electronic module Figure 4 (Sheet 4 of 13) Page 256 (Model J)
  • Page 257 View D Electronic module Figure 4 (Sheet 5 of 13) (Model J) Page 257...
  • Page 258 View E Electronic module Figure 4 (Sheet 6 of 13) Page 258 (Model J)
  • Page 259 View F Electronic module Figure 4 (Sheet 7 of 13) (Model J) Page 259...
  • Page 260 View G Electronic module Figure 4 (Sheet 8 of 13) Page 260 (Model J)
  • Page 261 View H View I Electronic module Figure 4 (Sheet 9 of 13) (Model J) Page 261...
  • Page 262 View J Electronic module Figure 4 (Sheet 10 of 13) Page 262 (Model J)
  • Page 263 View K View L Electronic module Figure 4 (Sheet 11 of 13) (Model J) Page 263...
  • Page 264 Electronic module Figure 4 (Sheet 12 of 13) Page 264 (Model J)
  • Page 265 View M Electronic module Figure 4 (Sheet 13 of 13) (Model J) Page 265...
  • Page 266 Units Item SLE Part Nº Description Effectivity code Assy. L0270 Electronic module assembly (See figure 1 for next highest assembly) W0358 .Cable, ribbon, long W0359 .Cable, ribbon, short  N6631/22 .Cable LCD assembly Obsolete item, use item 10A N6631/024/001 .Cable LCD assembly M0767/12 .Core, ferrite hinged...
  • Page 267 Units Item SLE Part Nº Description Effectivity code Assy. N6631/2216 ..Serial controller PCB Attaching Parts H3091 ..Nut (M3) H3094 ..Washer, shakeproof (M3)  H0305/36 ..Spacer Attaching Parts H3106 ..Screw (M3 x 6mm) H3094 ..Washer, shakeproof (M3)  W0346 ..Cable, assembly ...
  • Page 268 Units Item SLE Part Nº Description Effectivity code Assy. 4 285 N6631/02 .Liquid Crystal display (Supplier: L.G.Philips) (Part Nº LB121S02-A2) N6631/05 .Touch screen Attaching Parts M0907 ..Tape  T0253/02 ..Spacer, block Attaching Parts H3106 ..Screw (M3 x 6mm)  L5007-1005 .Screen Mounting Assembly...
  • Page 269 Units Item SLE Part Nº Description Effectivity code Assy. 4 385 M0856 .Clamp, cable tie M0305/10 .Spacer, Nylon (12mm long) Attaching Parts H3220 ..Screw (M3 x 20mm) H3093 ..Washer (M3)  T1240 .Screen Mounting Plate  N6631/13 .Inverter PCB Attaching Parts M0305/36 ..Pillar...
  • Page 270 Units Item SLE Part Nº Description Effectivity code Assy. 4 490 M0306 (1) ..Screw M0306 (2) ..Nut M0306 (3) ..Washer  A0761 .Transducer PCB Assembly Attaching Parts M0305/36 ..Pillar H3206 ..Screw (M3 x 6mm) H3091 ..Nut (M3) H3094 ..Washer, shakeproof (M3) ...
  • Page 271 Units Item SLE Part Nº Description Effectivity code Assy. L5007/001/001 PCB Bracket Runner Assembly (See items 560-600) Attaching Parts H3210 ..Screw (M3 x 10mm)  M0901 .Battery, Back-up T1254 .Bracket, Battery Attaching Parts H5110 ..Screw (M5 x 10mm)  M0904 .PCB Runner...
  • Page 272 Units Item SLE Part Nº Description Effectivity code Assy. N6616 (1) .Pneumatic connector (Supplier: West Group) Attaching Parts N6616 (2) ..Nut, Locking (Supplier: West Group)  M0706/02 .label, earth  O0431 (1) .Switch, Push Button Attaching Parts O0431 (2) .Nut, locking ...

  • Page 273: Pneumatic Module

    View A Pneumatic module Figure 5 (Sheet 1 of 7) (Model J) Page 273...
  • Page 274 View B Pneumatic module Figure 5 (Sheet 2 of 7) Page 274 (Model J)
  • Page 275 View C Pneumatic module Figure 5 (Sheet 3 of 7) (Model J) Page 275...
  • Page 276 View D Pneumatic module Figure 5 (Sheet 4 of 7) Page 276 (Model J)
  • Page 277 Pneumatic module Figure 5 (Sheet 5 of 7) (Model J) Page 277...
  • Page 278 View E Pneumatic module Figure 5 (Sheet 6 of 7) Page 278 (Model J)
  • Page 279 View F Pneumatic module Figure 5 (Sheet 7 of 7) (Model J) Page 279...
  • Page 280 Units Item SLE Part Nº Description Effectivity code Assy. L0280/KV Pneumatic module assembly (See Figure 1 for next highest assembly) N0280/75 .Tube, Polyurethane (Length 330mm) N0280/75 .Tube, Polyurethane (Length 330mm) N0280/75 .Tube, Polyurethane (Length 140mm) N0280/75 .Tube, Polyurethane (Length 255mm) N0280/75 .Tube, Polyurethane (Length 210mm)
  • Page 281 Units Item SLE Part Nº Description Effectivity code Assy. 5 130 N0280/75 .Tube, Polyurethane (Length 210mm) N0280/75 .Tube, Polyurethane (Length 190mm) N0280/75 .Tube, Polyurethane (Length 210mm) N0280/75 .Tube, Polyurethane (Length 35mm)  N0280/02/S46 .Pressure regulator assembly N0280/02/01 .O ring Attaching parts H3150 ..Screw (M3 x 50mm)
  • Page 282 Units Item SLE Part Nº Description Effectivity code Assy. 5 235 N0280/04 .Air & Oxygen Inlet assembly (See items 275-310) Attaching parts H4212 ..Screw (M4 x 12)  N0280/07 .Jet mounting block (See items 385-405) Attaching parts N0280/50/05 ..Screw, self tapping (M4 x 12) ...
  • Page 283 Units Item SLE Part Nº Description Effectivity code Assy. N0280/10/02 .Oxygen inlet connector, N0280/10/08 .O-ring N2185/06 .Filter, Nylon cone N0280/10/04 .Washer, duckbill N2185/05 .Check valve, duckbill N0280/10/06 .Connector N0280/10/08 .O-ring  N0280/10/01 .Air inlet connector, N0280/10/08 .O-ring N2185/06 .Filter, Nylon cone N0280/10/04 .Washer, duckbill...
  • Page 284 Units Item SLE Part Nº Description Effectivity code Assy. 5 425 N0280/40/07 .Tube connector  N0280/09/04 . Connector, proximal airway Attaching parts H1091 ..Nut (M10) H1094 ..Washer (M10)  N0280/40/07 .Tube connector  N0280/09/05 .Bracket, pressure regulators (Issue 2) Attaching parts H4091/03 ..Nut, self locking (M4)

  • Page 285: Diss Air And Oxygen Fittings

    DISS air and oxygen fittings Figure 6 (Sheet 1 of 1) (Model J) Page 285...
  • Page 286 Units Item SLE Part Nº Description Effectivity code Assy. N2185/33 .Oxygen connector, DISS  N2185/33 (1) .Oxygen inlet connector, . N6618 ..O-ring N2185/06 ..Filter, Nylon cone T1170 ..Washer, duckbill N2185/05 ..Check valve, duckbill N2185/33 (2) ..Connector N6618 ..O-ring  N2185/32 .
  • Page 287 Modifications (Model J) Page 287...

  • Page 288: Modifications

    34. Modifications 34.1 Equipotential stud modification Units Item SLE Part Nº Description Effectivity code Assy. T1193/EP Top cover with EP stud T1193/EP/01 (1) Stud, EP Attaching Parts H6091 H6093 Washer H6094 Washer, shakeproof H6093 Washer, M6  W0325/EP Cable, EP stud earthing ...
  • Page 289 34.1.1 Equipotential stud connection The T1193/EP assembly is connected to the earth bonding stud. Note: Illustration does not show the PCB boards or brackets for clarity. Note: The user will have to discard one lock nut to allow fitment of the earthing cable. (Model J) Page 289...

  • Page 290: Modification A As Per Si120401 - (Bypassing Of Oxygen Volume Chamber)

    34.2 Modification A as per SI120401 - (Bypassing of oxygen volume chamber). This is the standalone instruction for modification A. The output of the oxygen pressure regulator is currently connected to the oxygen volume chamber. The modification will bypass the oxygen volume chamber and connect the output of the pressure regulator directly to the oxygen input of the blender.
  • Page 291 Fit the two plugs to the inlet and outlet ports of the oxygen volume chamber. Note: The plug must be fitted with the groove facing the rear of the ventilator. Fit plugs supplied in kit to inlet and outlet. Refit the base plate as described in the service manual. Carry out the Controller blender pressure sensor zeroing and input pressure regulator trim section of the calibration procedure.

  • Page 292: Modification 1, 2 & 4 As Per Emc Upgrade

    34.3 Modification 1, 2 & 4 as per EMC upgrade This modification instruction is for SLE4000 and SLE5000 models J to N and describes the method of installation of Modification 1, 2 & 4 These modifications are required to improve the conducted emission at 67dB and radiated immunity at 829 and 100 MHz for the group of ventilators listed below.

  • Page 293: Contents Of N9020/000/Kit Kit

    34.4 Contents of N9020/000/KIT kit The kit contains, PDS1218 Instruction leaflet......Qty 1 C0522 Ceramic capacitor 1000PF, 100V, X7R, 10%, RADIAL........ Qty 2 L5040/EMC/001 EMC shielding strip MOD 1 (RH) .. Qty 1 L5040/EMC/002 EMC shielding strip MOD 1 (LH)... Qty 1 N5040/EMC/001 EMC shielding strip MOD 1 ..
  • Page 294 34.5.1 Preparing the SLE4000/SLE5000 Caution: the SLE4000/SLE5000 ventilator weighs 23.6 kg fully assembled. Care should be taken when handling the ventilator. When preparing to work on the electronic unit of the SLE4000/SLE5000 remove the ventilator from the stand and place it on a flat stable surface. The SLE4000/SLE5000 ventilator will be attached to the trolley or pole by two screws with shake proof washers.

  • Page 295: Checking The Modification Status

    Step 11 Remove the 2 screws (B) and 4 screws (C) to release the electronic inner cover. Note: design of inner cover may vary. 34.6 Checking the modification status. Inspect the label on the side of the electronic unit. If the label has Mod status 1, 2 & 3 or 1, 2 &...

  • Page 296: Emc Upgrade Procedure

    34.7 EMC upgrade procedure 34.7.1 Disassembly 34.7.1.1 Computer/Display control assembly removal Warning: The Computer/Display Control assembly is a static sensitive device. Step 12 Remove the PCB locking screw. This will allow the top board assembly to slide forward a small amount which gives better access to the edge connectors of the top board.
  • Page 297 34.7.2 Control/Monitor Board removal Warning: The Control/Monitor Board is a static sensitive device. Step A17 Disconnect the following cables. Power supply connector controller side, main loom (A). (P4) Controller to A0761 transducer assembly ribbon cable (B). (P5) Conventional valve drive ribbon cable (C).

  • Page 298: Modification 1 (Mod1)

    34.8 Modification 1 (MOD1) Modification 1 (MOD1) consist of the application of four foam EMC strips. Step 23 Identification of EMC strips. Part Nº: N5040/EMC/001 Qty 2 Part Nº: L5040/EMC/001 Qty 1 Part Nº: L5040/EMC/002 Qty 1 Step 24 Prepare the area where the strip is to be applied by cleaning with alcohol. Apply the first strip N5040/EMC/001 to the location indicated in the illustration.
  • Page 299 Step 25 Prepare the area where the strip is to be applied by cleaning with alcohol. Apply the first strip L5040/ EMC/001 to the location indicated in the illustration. Step 26 Prepare the area where the strip is to be applied by cleaning with alcohol.

  • Page 300: Modification 2 (Mod2)

    34.9 Modification 2 (MOD2) Modification 2 (MOD2) consist of the addition of two 1nF capacitors to the JP4 connector of the control monitor board. Warning: The Control/Monitor Board is a static sensitive device. Step 28 Take the Control/Monitor board and turn it over and locate the JP4 connector.

  • Page 301: Modification 4 (Mod4)

    34.10 Modification 4 (MOD4) Modification 4 (MOD4) consist of the fitting of the L9019/MD4/001 mains loom capacitor filter assembly. Warning: The ventilator must be disconnected from the mains electrical supply before performing this modification. Risk of electric shock. Step 33 Locate the mains inlet filter.

  • Page 302: Re-Assembly And Testing

    Step 37 Cable tie the capacitor loom to the mains inlet loom as shown. Cable tie Step 38 Modification 4 (MOD4) complete. Mains inlet loom 34.11 Re-assembly and testing 34.12 MOD identification Step 39 Locate the electronic unit serial number label. and cross through number 1, 2 &...
  • Page 303 Appendix 1. Calibration Checklist (Model J) Page 303...
  • Page 304 This page is intentionally blank. Page 304 (Model J)

  • Page 305: Appendix 1. Calibration Checklist

    Appendix 1. Calibration Checklist Please make copies of this checklist to record the calibration values at overhaul/service intervals. Item 1: Ventilator Serial Number Record Ventilator Serial Number: Item 2: Elapsed time record Elapsed time: Item 3: Service Date Service Date: Item 4: Service Engineer Name:...
  • Page 306 Record of pre-calibration constants. Block and Leak Blender ±1 PSI Sensor ±2.5 PSI Sensor Gain: Gain: Gain: Gain: Offset: Offset: Offset: Offset: Mean Jet Forward Jet Reverse Jet Gain: Gain: Gain: HFO Offset: HFO Offset: CMV Offset: CMV Offset: CMV Offset: Insp Leading Edge Exp Leading Edge Fast Rise:...
  • Page 307 Item 5: Fresh gas flow with SV7 energised. Lower limit Actual reading Upper limit 7.75 lpm 8.25 lpm Item 6: With SV7 de-energised, check the fresh gas flow is within range Lower limit Actual reading Upper limit 1.2 lpm 2 lpm Item 7: Monitor the flow from the proximal airway pressure port and ensure that it is within range.
  • Page 308 Item 11: Pressure Triggering Verification Pressure Trigger Verified: Item 12: Gas Fail Detection Verification Gas Fail Detection Verified: Item 13: Blender and Oxygen Monitoring Verification CPAP Set Oxygen concentration Lower Limit Actual Upper limit Reading 100% 100% Item 14: Battery Life Verification Results of battery life test: Start Time: Battery Low Alarm Time:...
  • Page 309 Item 16: Total Power Fail Alarm Test Total power fail alarm test: Initial Item 17: Pressure Calibration Verification a) CPAP PIP Setting Lower limit Actual reading Upper limit 0 mbar 0 mbar 1 mbar 5 mbar 4 mbar 6 mbar 10 mbar 9 mbar 11 mbar...
  • Page 310 Record of post-calibration constants. Block and Leak Blender ±1 PSI Sensor ±2.5 PSI Sensor Gain: Gain: Gain: Gain: Offset: Offset: Offset: Offset: Mean Jet Forward Jet Reverse Jet Gain: Gain: Gain: HFO Offset: HFO Offset: CMV Offset: CMV Offset: CMV Offset: Insp Leading Edge Exp Leading Edge Fast Rise:...
  • Page 311 Appendix 2. Check list (Model J) Page 311...
  • Page 312 This page is intentionally blank. Page 312 (Model J)

  • Page 313: Appendix 2. Check List

    Appendix 2. Check list The ventilator must pass all the test’s. Pass Fail Step 1: Complete power fails alarm test.   Audible alarm triggered and cancelled. Step 2: Setting FiO   Measured value corresponds to set. Step 3: Test of Touch Screen Beep ...
  • Page 314 Pass Fail Step 25: Low Pressure alarm.   Alarm triggered and cancelled Step 26: Breath Not Detected Alarm.   Alarm triggered and cancelled Step 27: Leak alarm.   Alarm triggered and cancelled Step 28: Block alarm.  ...
  • Page 315 Pass Fail Step 47: Waveform display synchronisation. Waveforms should be displayed   starting at the left hand edge of the window. Step 48: Waveform display synchronisation. Waveforms should be displayed   starting any where in the window. Step 52: Wave shape modified by TTV. ...
  • Page 316 Pass Fail Step 65:Pressure Support functional test.   Analyser reads PIP as 25mbar Step 66:Pressure Support functional test.   Ventilator displays PIP as 2-13mbar Step 70: HFO+CMV functional test. the ventilator cycles with oscillations in both the inspiratory and expiratory phases the waveforms appear in the waveform windows the I:E ratio in the breath parameter panel ...
  • Page 317 Appendix 3. List of Technical Bulletins & Service Information Letters (Model J) Page 317...

  • Page 318: Appendix 3. Tb & Si Index

    The following is a list of Technical Bulletins and Service Information Letters that have been issued in relation to both the SLE5000 and SLE4000 infant ventilators. Please contact the SLE Service Department for copies of the bulletins or letters. Note: The list is retrospective and includes all bulletins or letters issued in relation to the ventilator, and may not be applicable to a Model G ventilator.
  • Page 319 Service exchange of the L0272 top board SI070402 18/04/07 Equipment: SLE4000/5000 Introduction of A0763/02/M control monitor board. SI071001 03/10/07 Equipment: SLE4000/5000 Change in 20,000 hour procedure used at SLE Ltd. (UK). SI071102 28/11/07 Equipment: SLE5000 HFO high speed valve assembly SI080401 04/04/08 Equipment: SLE4000/5000 Modification of battery disconnection fuse holder.

  • Page 320: Technical Bulletins

    35.2 Technical Bulletins TB030302 25/03/03 Equipment: SLE5000 Hardware/software upgrade. TB040201 09/02/04 Equipment: SLE5000 2 point O calibration warnings TB040701 21/09/04 Equipment: SLE5000 Setting the Low Alarm in CMV on the 5000 Ventilator. TB020501 28/02/05 Equipment: SLE5000 Release 3.2 ventilator software. TB050501 12/05/05 Equipment: SLE5000...
  • Page 321 Appendix 4. RS232 (Model J) Page 321...

  • Page 322: Rs232

    Appendix 4. 36. RS232 This section describes the data format and connections for the serial interface of the SLE5000 infant ventilator using V4.1 to V4.3.2. software. 36.1 Warnings for RS232 Any computer connected to the ventilator must be specified for medical use (i.e. it must comply with the requirements of BS-EN-60601:1990).

  • Page 323: Overview

    36.3 Overview 36.4 Data and Pinout description. 36.4.1 Version 3.3 Data Format: RS232-C compatible, 9600 bps, 8 data bits, 1 stop bit, no parity. The data output is a comma delimited ASCII text string terminated by carriage return and linefeed (<CR>,<LF>).

  • Page 324: Parameter Descriptions And Format

    36.6 Parameter Descriptions and format The text string that is output contains: 41 parameters for V4.3 to V4.3.2 40 parameters for V4.1, (no DCO parameter) 39 parameters for V3.3, (no High Tidal volume & DCO parameters) e.g. for V4.3.2 60,2,6,10,23,100,4,2,100,1,0,5,20,0,45,20,30,160,280,0,0,15000,60,3,10,145,139,3,25,99, 22,13,0,824,10,3275,6,39,00,64, A description of each parameter follows;...
  • Page 325 Details Param. Nº Description Units TTV Status 0 = off 255 = on Set Termination Set percentage Sensitivity 0 to 50 = percentage of max. flow that triggers termination, if value < 0 then termination sens. is off Set Breath Trig. lpm for flow 2 to 200 (0.2 to 20lpm for flow Threshold...
  • Page 326 Details Param. Nº Description Units Measured Insp. 0.1ml 0 to 32768 (0 to 3.2768 l) Volume Measured Exp. 0.1ml 0 to 32768 (0 to 3.2768 l) Volume Measured PEEP mbar -175 to 175 mbar Measured PIP mbar -175 to 175 mbar Measured FiO2 0 to 100 % Measured HFO Delta...

  • Page 327: Table Of Current Alarm Condition Codes

    36.8 Table of current alarm condition codes. Value Currently Displayed alarm condition No Current Alarms Oxygen Cell Disconnected Calibrate Oxygen Cell Oxygen Cell Exhausted O2 Calibration Fail High Oxygen Level Low Oxygen Level Monitor EEPROM Fail System Fail - Monitor Isolated System Fail Pressure Sensor Drift High Pressure Low Pressure...
  • Page 328 Battery Fault High Minute Volume Low Minute Volume Low Tidal Volume High Patient Leak Apnoea - Volume Breath Not Detected High Tidal Volume Blocked Fresh Gas Leaking Fresh Gas No O2 Supply No Air Supply No Gas Max. Pressure too low Fresh Gas Solenoid Fail Controller Failure - control subsys.

  • Page 329: Rs232 Connection Settings And Testing Data Output

    Monitor/Display Comms Fail EEProm Flow data corrupt EEProm Oxygen data corrupt EEProm Pressure Offset data corrupt EEProm Pressure Gain data corrupt EEProm Pressure Time constant Data corrupt 36.9 RS232 Connection Settings and Testing Data Output 36.9.1 Version 3.3 Connect a standard serial cable from the ventilator to the test computer. Turn on the ventilator and allow it to enter ventilation off mode.
  • Page 330 This page is intentionally blank. Page 330 (Model J)
  • Page 331 Appendix 5. VueLink Technical Data (Model J) Page 331...

  • Page 332: Appendix 5. Vuelink

    The module must be of the ‘Ventilator’ type. The cable from the M1032A module (Agilent part number: M1032-61654) requires the SLE VueLink adaptor (SLE part number: W0344) to connect it to the 9-pin RS232 socket on the back of the SLE5000 ventilator.

  • Page 333: Parameter Descriptions

    BPM on the VueLink system refers to pulse rate (beats per minute) whereas AWRR refers to airway respiratory rate. Therefore the names of parameters on the VueLink monitor are not the same as those on the SLE5000. A cross reference table follows. SLE 5000 VueLink Nomenclature Nomenclature Pressure (waveform)

  • Page 334: Data Transferred To The Vuelink System From The Sle5000

    37.4 Data transferred to the VueLink system from the SLE5000 The RS232 interface to the VueLink monitor enables the SLE5000 to send monitored patient data, ventilator settings, waveforms and alarms. Three digital waveforms are transmittable to the VueLink system, which are Pressure (AWP), Flow(AWF) and Tidal Volume(AWV).
  • Page 335   Rdyn 0 to 999.9 mbar/l/ Measured dynamic resistance. Same as resist. on the display. Only available with a flow sensor. Set to zero in HFO modes.   Leak 0 to 100 Patient leak. Only available with a flow sensor.

  • Page 336: Alarm And Inoperative Indications

    The textual alarm messages on the VueLink system are brief summaries of the ventilator alarm conditions. The following table shows how the SLE5000 messages correspond to VueLink display messages. VueLink Message Type Corresponding SLE Notes and text 5000 Alarm conditions...
  • Page 337 GREEN Inop - “O2 CELL None Indicates that the oxygen cell is CALIB” currently being calibrated. The parameter value for FIO_2 is displayed as -?- GREEN Inop - “PR. Pres. Sens. Drift (11) Indicates that pressure sensor SENS. DRIFT” drift has occurred. RED Alarm - Sust.
  • Page 338 YELLOW Alarm - High Minute Vol (34) Indicates either high or low “MIN. VOL. ALARM” Low Minute Vol (37) minute volume alarm has occurred. YELLOW Alarm - Pat. Leak Alarm (35) “PATIENT LEAK” YELLOW Alarm - Low Tidal Vol. (36) “LOW TIDAL VOL.”...

  • Page 339: Vuelink Task Window Layout

    37.6 VueLink Task Window Layout The VueLink task window for the SLE5000 will display the parameters as shown below. |-------------------|-------------------|-------------------| | sPEEP mbar | sPIP mbar | sAWRR | PEEP mbar | PIP mbar | Trig trig/min | |-------------------|-------------------|-------------------| | sFIO_2 % | sInsTi | sTV | FIO_2...

  • Page 340: Notes On General System Behaviour

    37.7 Notes on General System Behaviour The VueLink-SLE5000 communication link is automatically established if the physical link is present, this communication can take about 40 seconds to establish. If the physical connection between the SLE5000 and the VueLink monitor is broken, communication between the two will continue on reconnection but will take about 40 seconds to start again.

  • Page 341: Activation Of Vuelink

    VueLink is activated by entering the activation code into the SLE4000/SLE5000 ventilator. To access the VueLink activation screen, goto the controller services panel within the user interface. Enter the code provided by SLE into the ventilator via the controller services panel to display the activation screen. Begin psv is the A button.

  • Page 342: Disabling Vuelink

    SLE Limited will then provide the activation code which is entered via the 6 input boxes. An example activation code would be 20, 53, 45, 203, 229, 104. This code would be entered as follows. Digit 1 Digit 2 Digit 3...
  • Page 343 SLE reserves the right to make changes without prior notice in equipment, publications and prices as may be deemed necessary or desirable. (Model J) Page 343...

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