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SLE SLE4000 Service Manual

Model c
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SLE4000
Model C service manual
Version 4.1 to 4.3.2 software

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Summary of Contents for SLE SLE4000

  • Page 1 SLE4000 Model C service manual Version 4.1 to 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 21/06/2011. Manual : SM0022 Issue 4 SLE Part Nº:...
  • Page 3 5.7. Exit ......................... 27 5.8. Touch Screen Calibration Program ..............28 6. Component Replacement Procedure ................ 30 7. Preparing the SLE4000 ..................... 31 8. Component Replacement (Electronic unit) ............... 33 8.1. Compact Flash Card (Part of N6631/21 PC board)........33 8.2.
  • Page 4 10. A0763/4B Monitor and control board ...............60 10.1. A0763/4B board progammable devices............60 10.2. A0763/4B Board Hardware Identifier ............61 11. Electrical Safety Testing of the SLE4000 ..............65 12. PSU Testing ......................69 13. Maintenance and Overhaul ..................72 13.1. Preventative Maintenance ................72 13.2. 12 & 36 month preventative maintenance procedure ........74 13.3.
  • Page 5 21.8. Power, Dimensions, Standards etc.............. 196 21.9. Environmental Storage Conditions ............... 196 22. Ventilator labelling ....................197 22.1. SLE4000....................... 197 23. Electrical Block Diagram ..................200 24. L0288 Pneumatic Unit Layout ................. 201 25. Pneumatic Unit Schematic ..................202 25.1.
  • Page 6 Appendix 5. VueLink .....................316 34. VueLink Technical Data ..................316 34.1. Glossary......................316 34.2. Connecting the SLE4000 to the VueLink patient monitor ......316 34.3. Parameter Descriptions ................317 34.4. Data transferred to the VueLink system from the SLE4000......318 34.5. Alarm and inoperative indications ..............320 34.6.

  • Page 7: Warnings And Cautions

    Warnings and Cautions (Model C) Page 7...

  • Page 8: Warnings And Cautions

    1. Warnings and Cautions 1.1 Warnings The electronic and pneumatic units of the SLE4000 infant ventilator are sealed at the factory with two Warranty Void If Label Broken seals. If the ventilator is subject to a warranty agreement do not attempt to carry out any procedure that would involve breaking these seals.

  • Page 9: Cautions

    The equipment is not suitable for use with, or in the presence of flammable anaesthetic mixtures. The SLE4000 flow monitoring system is calibrated to work in an air / oxygen mixture, the use of other gas mixtures may affect the flow monitoring accuracy of the ventilator.
  • Page 10 12. There is no special protection provided against ingress of water or liquids. 13. Do not use solvent based cleaning solutions to clean the touch screen or covers. Page 10 (Model C)
  • Page 11 Principles of Operation (Model C) Page 11...

  • Page 12: Principles Of Operation

    2. Principles of Operation The SLE4000 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 13: Pneumatic System

    2.2 Pneumatic System The pneumatic system comprises of the tubing and electro-mechanical valves necessary to provide the gas in conventional 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 14 This page is intentionally blank. Page 14 (Model C)

  • Page 15: Description Of Symbols

    Description of Symbols (Model C) Page 15...

  • Page 16: Description Of Symbols

    3. Description of Symbols Symbol Description Type BF connection (Situated on front panel) Type B device (Situated on rear 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).
  • Page 17 Symbol Description Mains/Battery power indicator (Situated on front panel) Indicates a warning in the manual Observe anti static precautions Indicates a note in the manual Indicates a caution in the manual Check list item. (Model C) Page 17...
  • Page 18 This page is intentionally blank. Page 18 (Model C)
  • Page 19 Equipment List (Model C) Page 19...

  • Page 20: Equipment List

    4. Equipment list To service the SLE4000 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 21 Engineering Mode Software (Model C) Page 21...

  • Page 22: Engmode

    5. ENGMODE The SLE4000 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. Note: The calibration program is common to SLE4000 and SLE5000 ventilators.
  • Page 23 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 24: 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 25 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 are also displayed.

  • Page 26: 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 27: 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 28: 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 28 (Model C)
  • Page 29 Component Replacement (Model C) Page 29...

  • Page 30: Component Replacement Procedure

    • Touch screen..........SLE Part Nº: N6631/05 • Inverter PCB ..........SLE Part Nº: N6631/13 Pneumatic Unit • Conical and Duckbill filters......SLE Part Nº: N2185/06 & /05 • Blender............SLE Part Nº: L0287 • Fresh gas bypass solenoid SV7 ....SLE Part Nº: N2195/16 •...

  • Page 31: Preparing The Sle4000

    Caution: the SLE4000 ventilator weighs 23.6kg fully assembled. Care should be taken when handling the ventilator. If preparing to work on both the electronic and pneumatic units of the SLE4000 remove the ventilator from the stand and place it on a flat stable surface. The SLE4000 ventilator is attached to the trolley or pole by two screws with shake proof washers.
  • Page 32 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.

  • Page 33: Component Replacement (Electronic Unit)

    8. Component Replacement (Electronic unit) 8.1 Compact Flash Card (Part of N6631/21 PC board) Warning: The Compact flash card is a static sensitive device. 1. Slide the compact flash card (A) out of its socket in the direction of the arrow. 2.

  • Page 34: N6634 Can Card

    8.3 N6634 CAN Card Warning: The CAN card is a static sensitive device. 1. Remove the PC board support pillars (A) to release the CAN card (B). 2. Disconnect the Can card ribbon cables (C). 3. Assembly is the reverse of removal.

  • Page 35: L0275 Computer/Display Control Assembly

    8.5 L0275 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. 2.

  • Page 36: A0763/4B Control/Monitor Board

    8.6 A0763/4B Control/Monitor Board Warning: The Control/Monitor Board is a static sensitive device. 1. Remove the L0275 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 37: M0900 Power Supply Unit

    8.7 M0900 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. Lift the power supply to reveal the mains inlet cable (D).

  • Page 38: M0901 Batteries

    8.8 M0901 Batteries 1. Remove the L0275 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. 5.

  • Page 39: 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 Computer/Display Control assembly as described in section 8.5. 2. Remove the Control/Monitor board as described in section 8.6.

  • Page 40: 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 Computer/Display Control assembly as described in section 8.5. 2. Remove the Control/Monitor board as described in section 8.6. 3.

  • Page 41: N6631/02 Lcd & N6631/05 Touch Screen

    8.11 N6631/02 LCD & N6631/05 Touch Screen 1. Remove the L0275 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 42 15. Remove the 2 screws (J) retaining the right hand side of the LCD / touch screen assembly. 16. Remove the 2 nuts, washers (K) and screws (L) retaining the left hand side of the LCD / touch screen assembly. 17.

  • Page 43: Component Replacement (Pneumatic Unit)

    9. Component Replacement (Pneumatic unit) 9.1 N2185/05 & 06 Duckbill and conical filters. Note: The O inlet connector is used to illustrate the process, the procedure is the same for the Air inlet connector. 1. Remove the inlet connector (A). 2.

  • Page 44: L0287 Blender Assembly

    9.2 L0287 Blender Assembly Location in pneumatic unit. 1. Disconnect the two mixing chamber tubes (A). 2. Disconnect the PR1 tube (B). 3. Disconnect the PR2 tube (C). 4. Disconnect the electrical connectors from SV8 (D). 5. Disconnect the electrical connectors from SV7 (E).

  • Page 45: N2195/06 Sv7 Fresh Gas Supply Solenoid

    9.3 N2195/06 SV7 fresh gas supply solenoid Location in pneumatic unit. 1. Disconnect the SV7 fresh gas supply tube (A). 2. Disconnect the SV7 to PRV1 tube (B). 3. Disconnect the SV7 to overboard dump tube (C). 4. Remove the two screws (D), nuts (E) and washers (F) securing the SV7 solenoid assembly to the bulkhead.

  • Page 46: N6612 Fr7 Flow Regulator

    9.4 N6612 FR7 flow regulator Location in pneumatic unit. 1. Remove the outlet hose (A). 2. Remove the purge regulator (B) using a spanner to undo the base nut. Take care not to loosen the bulkhead flitting (C). 3. Assembly is reversal of removal. Setup: The pneumatic setup procedure is required for this component.

  • Page 47: N6615/01 Pr1 Input Air Regulator

    9.5 N6615/01 PR1 input air regulator Location in pneumatic unit. 1. Remove the Oxygen cell. 2. Disconnect the following tubes. Oxygen cell to overboard dump (B). Air inlet to 40PSI air regulator (C). 40PSI air regulator to differential pressure transducer (D). 40PSI air regulator to blender port 1 (E).
  • Page 48 3. Using a spanner remove the pneumatic fitting (F). 4. Remove the two screws and washers (G) to release the Oxygen cell manifold (H). Note: The Oxygen cell manifold should be removed with the tube (I) attached. 5. Remove the two screws and washers (J).

  • Page 49: N6615/02 Pr2 Input Oxygen Regulator

    9.6 N6615/02 PR2 Input Oxygen Regulator Location in pneumatic unit. 1. Remove the 40PSI air regulator as described on page 47. 2. Disconnect the following tubes. 40PSI oxygen regulator to SV8 (A). 40PSI oxygen regulator to blender O inlet (B). 3.
  • Page 50 5. Disconnect the connector assembly (E) from the regulator by removing the adaptor fitting (F). 6. Assembly is reversal of removal. Setup: The pneumatic setup procedure is required for this component. Page 50 (Model C)
  • Page 51 9.6.1 N6625 SV8 O calibration solenoid Location in pneumatic unit. 1. Remove the two fixing screws (A). 2. Remove the solenoid assembly (B) from the bulkhead and disconnect the tube (C, D & 3. Disconnect the tube connectors (F, G & H). 4.

  • Page 52: L0289 Pressure Regulator Module

    9.7 L0289 Pressure regulator module Location in pneumatic unit. 1. Remove the two screws and washers (A) retaining the partition assembly (D). 2. Remove the two screws (B) and nuts and washers (C) retaining the partition assembly (D). 3. Gently release the assembly so access the tubing. 4.
  • Page 53 8. Disconnect the following tubes. Fresh gas monitoring tube (H). Proximal airway monitoring tube (I). Blender port 3 to mixing chamber tube (J). Blender port 4 to mixing chamber tube (K). Mixing chamber to SV8 tube (L). FR8 connection regulator tube (M).

  • Page 54: N2181 Pr5 Regulator

    9.8 N2181 PR5 regulator Location in pneumatic unit. 1. Remove the L0289 module as described in section 9.7 on page 52. 2. Disconnect the following tubes. PR5 blended gas inlet (A) and regulated blended gas outlet (B). 3. Remove the two retaining screws (C) and nuts and washers (D).

  • Page 55: N6623/S38 Pr4 & Pr6 Pressure Regulators

    9.9 N6623/S38 PR4 & PR6 pressure regulators Location in pneumatic unit. 1. Remove the L0289 module as described in section 9.7 on page 52. 2.Disconnect the electrical connectors (A) from the pressure regulators. 3.Remove the two Allen cap screws (B) retaining the PR4 (C) and PR5 (D) to their manifold blocks Note: On removing the...
  • Page 56 5. Remove the screws (J) nuts and washers (K) to release the manifold blocks (L) for PR4 and PR6. 6. Remove the pneumatic tube connectors (M & N) from the manifold blocks (L). Note: For PR6 withdraw the reducer (O) from the pneumatic fitting.

  • Page 57: N2195/16 Sv13 Solenoid

    9.10 N2195/16 SV13 solenoid Location in pneumatic unit. 1. Remove the L0289 module as described in section 9.7 on page 52. 2.Disconnect the electrical connectors (A) from SV13 (B). 3. Remove the two screws (C). Note: When the screws (C) are removed the packing washers (D) will become loose.
  • Page 58 This page is intentionally blank. Page 58 (Model C)
  • Page 59 A0763/4B Board (Model C) Page 59...

  • Page 60: A0763/4B Monitor And Control Board

    10. A0763/4B Monitor and control board The SLE4000 uses the base A0760 Rev E PCB to make up the A0763/4B board. 10.1 A0763/4B board progammable devices The A0763/4B 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...

  • Page 61: A0763/4B Board Hardware Identifier

    The A0763/4B board has a group of resistors that allow the software to recognise 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 SLE4000 Model C ventilator uses Hardware Ident 10. (Model C) Page 61...
  • Page 62 This page is intentionally blank. Page 62 (Model C)
  • Page 63 Electrical Safety Testing (Model C) Page 63...
  • Page 64 This page is intentionally blank. Page 64 (Model C)

  • Page 65: Electrical Safety Testing Of The Sle4000

    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. Perform the tests. Equipment under test is: SLE4000 Infant Ventilator Class 1B (flow sensor is a Floating type applied part). Test...
  • Page 66 This page is intentionally blank. Page 66 (Model C)
  • Page 67 PSU Testing (Model C) Page 67...
  • Page 68 This page is intentionally blank. Page 68 (Model C)

  • Page 69: 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 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 70 This page is intentionally blank. Page 70 (Model C)
  • Page 71 Maintenance and Overhaul (Model C) Page 71...

  • Page 72: Maintenance And Overhaul

    13. Maintenance and Overhaul The ventilator has the following maintenance / overhaul schedule. 12 months Preventative maintenance Kit: N9010/12 24 months (10,000hrs) Overhaul Kit: N9410/24 36 months Preventative maintenance Kit: N9010/12 48 months (20,000hrs) Overhaul Kit: N9410/48 13.1 Preventative Maintenance The N9010/12 contains the following: Conical filter Qty 2...
  • Page 73 12 & 36 Month Maintenance (Model C) Page 73...

  • Page 74: Month Preventative Maintenance Procedure

    13.2 12 & 36 month preventative maintenance procedure 13.2.1 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 5 fixing screws (A) indicated from the rear cover.
  • Page 75 Warning: If the ventilator is under a warranty agreement removal of the inner covers may void the agreement. Please refer to the warranty docu- mentation. 5. Remove the screws (B) to release the electronic inner cover. The ventilator is now ready for maintenance.
  • Page 76 13.2.2 Duckbill and conical filter replacement. The procedure is the same for both air and oxygen inlets. 1. Using a spanner remove the inlet connector (A). Note: The O connector is a left hand thread and the Air connector is a right hand thread.
  • Page 77 13.2.3 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 78 Note: Disposal of the old oxygen sensor cell should be in accordance with local regulations for hazardous substances. Do not incinerate. SLE offer a cell disposal service. 5. In addition to the tests carried out in the previous preventative maintenace procedure, carry out a 2 point oxygen calibration routine.
  • Page 79 13.2.5 Replacement of CMOS backup batteries These batteries are fitted to units that have had the CMOS battery backup upgrade. 1. Remove the two AA batteries and discard in accordance with local waste authority guidlines. 2. Replace the batteries taking care to correctly insert the cells. (Model C) Page 79...
  • Page 80 This page is intentonally blank. Page 80 (Model C)
  • Page 81 24 & 48 Month Hour Overhaul (Model C) Page 81...

  • Page 82: Month And 48 Month Overhaul Procedures

    13.3 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 83 24 Month / 10,000 Hour Overhaul (Model C) Page 83...

  • Page 84: Month / 10,000 Hour Overhaul Procedure

    13.4 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 seven fixing screws (A) indicated from the rear cover. 2. Slide the rear cover towards the rear of the machine.
  • Page 85 Warning: If the ventilator is under a warranty agreement removal of the inner covers may void the agree- ment. Please refer to the warranty documentation. 3. Remove the screws (B) (10 screws) to release the electronic inner cover. Note: The design of the inner cover and number of fixing screws may vary.
  • Page 86 13.4.1 L0275 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 87 10. The Control monitor board can now be accessed. 11. Disconnect the following cables. 12. CAN card link ribbon cable controller side (H). (P3) 13.CAN card link ribbon cable controller side (I). (JP3) 12. Power supply connector controller side, main loom (J). (P4) 13.
  • Page 88 13.4.2 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.
  • Page 89 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. 9. Carry out the following to complete the 24 month overhaul. 10. Carry out the 12 & 36 month preventative maintenance procedure. 13.4.3 Setup 1.
  • Page 90 48 Month / 20,000 Hour Overhaul Page 90 (Model C)

  • Page 91: Month / 20,000 Hour Overhaul Procedure

    13.5 48 month / 20,000 hour overhaul procedure The procedure for the 48 month / 20,000 overhaul is as follows for option 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 92 6. Attach the new pneumatic unit (reverse of removal). Note: The service exchange or the new pneumatic unit will be Model N in design. Please refer to the Model N service manual available from the SLE service department. 7. Refit the front facia panel.

  • Page 93: Month Overhaul Procedure Using N9410/48 Overhaul Kit

    13.6 48 month overhaul procedure using N9410/48 overhaul kit. The overhaul of the electronic unit follows the same procedure as that of a 24 month overhaul. 13.6.1 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 pnuematic unit.
  • Page 94 7. Disconnect the following tubes. Fresh gas monitoring tube (N). Proximal airway monitoring tube (O). Blender port 3 to mixing chamber tube (P). Blender port 4 to mixing chamber tube (Q). Mixing chamber to SV8 tube (R). FR8 connection regulator tube (S). 8.
  • Page 95 13.6.3 Removal of the Blender Assembly Location in pneumatic unit. 1. Disconnect the Port 4 to mixing chamber tube (A) and Port 4 to mixing chamber tube (B) 2. Disconnect the PR1 tube (C). 3. Disconnect the PR2 tube (D). Note: The air and oxygen regulators have not been shown for clarity.
  • Page 96 13.6.4 Installation of the L0287/50 replacement blender 1. Install the blender using the two shake proof nuts, washers and O-rings (A). 2. Reconnect the electrical connectors from SV8 (B). 3. Reconnect the blender loom connector (C) to the bulk head connector (D). 4.
  • Page 97 13.6.5 Removal of N6623/S38 (PR4 & PR6) pressure regulators 1.Disconnect the electrical connectors (A) from the pressure regulators. 2.Remove the two Allen cap screws (B) retaining the PR4 (C) and PR5 (D) to their manifold blocks Note: Discard the old ‘O’ rings (E). 3.
  • Page 98 13.6.6 Removal N2181 PR5 regulator 1. Disconnect the following tubes. PR5 blended gas inlet (A) and regulated blended gas outlet (B). 2. Remove the two retaining screws (C) and nuts and washers (D). 3. Remove the PR5 regulator. 4. Remove the screws and washers (E) to remove the bracket (F) from the regulator (H).
  • Page 99 13.6.7 Installation of N2181 PR5 regulator 1. Install the regulator using the two retaining screws (A) and nuts and washers (B). 2. Reconnect the following tubes. PR5 blended gas inlet (C) and regulated blended gas outlet (D). 13.6.8 Installation of N6623/S38/50 (PR4 & PR6) pressure regulators 1.
  • Page 100 3.Re-connect the electrical connectors (G) from the pressure regulators. 4. Assemble PR6 (H) and PR4 (I) to their manifold blocks using the two Allen cap screws (J). Ensure that the new O-ring’s (K) are fitted between the pressure regulators and their manifold blocks. 5.
  • Page 101 8. Reconnect the following tubes. Fresh gas monitoring tube (N). Proximal airway monitoring tube (O). Blender port 3 to mixing chamber tube (P). Blender port 4 to mixing chamber tube (Q). Mixing chamber to SV8 tube (R). Manifold to air regulator tube (S). 9.
  • Page 102 Page 102 (Model C)
  • Page 103 Calibration Procedure V4.1 to 4.3.2 (Model C) Page 103...

  • Page 104: Calibration Procedure For V4.1 To 4.3.2 Software

    14. Calibration Procedure for V4.1 to 4.3.2 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 289.

  • Page 105: Pneumatic Set Up

    14.2 Pneumatic set up a) Connect the ventilator to gas supplies at 4 bar. b) Set the air and oxygen input pressure regulators PR1 and PR2 to 40 psi ± 0.1 psi. c) Set the oxygen regulator to 40 psi ± 0.1 psi. Tighten the tension nut to lock the spindle in position ensure that the pressure is still within 0.1 psi of 40.

  • Page 106: Calibration Of Controller And Monitor Subsystems

    14.3 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 22. 14.3.1 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, (machine must be on for at least half an hour).
  • Page 107 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 by connecting the proximal airway tube between the analyser and ventilator. Acceptable tolerance: ±1mbar.

  • Page 108: Controller "Block And Leak" Pressure Sensor Calibration

    14.4 Controller “Block and Leak” pressure sensor calibration a) Connect a Y-piece with a variable restrictor to the fresh gas port and monitor generated pressure with the calibration analyser. b) Set up the ventilator to CMV mode and set the following parameters: Set the controls in the CMV Panel as follows BPM to 0 Insp.
  • Page 109 g) Re-connect the Y-piece with a variable restrictor to the fresh gas port and monitor generated pressure with the calibration analyser. Verify the setting by setting the following pressures via the restrictor. Set Pressure Tolerance ± 1 mbar ± 1 mbar ±...

  • Page 110: Mean Jet Pressure Regulator Calibration

    14.6 Mean Jet Pressure Regulator Calibration a) Enter the Jet Calibration screen. b) Connect the ET manifold to the calibration analyser. c) Set up the ventilator to CMV mode and set the following parameters: BPM to 30 Insp. time to 0 sec Set the PIP control to 0 mbar PEEP to 0 Note: Setting the Gain is to be carried out with new control/monitor boards...

  • Page 111: Forward Jet Pressure Regulator Calibration

    e) Verify PEEP pressure setting by setting the following pressures on the CMV control panel and verifying the displayed pressure in the pressure display bar. Set PEEP Pressure Acceptable tolerance: 0 mbar +1 mbar 5 mbar +1 mbar 10 mbar +1 mbar 15 mbar +1 mbar...

  • Page 112: Wave Shaping For Leading And Trailing Edge Of Insp. Phase

    d) Verify mean pressure setting by setting the following PIP pressures and verifying the displayed pressure in the pressure display bar. Set PIP Pressure Acceptable tolerance: 0 mbar +1 mbar 5 mbar ±1 mbar 10 mbar ±1 mbar 20 mbar ±1 mbar 30 mbar ±1 mbar...

  • Page 113: Flow System Calibration

    Increase the slow rise time to minimise the initial spike (probably somewhere between 10 and 20) Decrease the F/S balance until the waveform is square. c) Using the insp. trailing edge adjustment controls, shape the trailing edge to reduce overshoot. d) Increase the exp leading edge, slow rise time control to minimize the overshoot on the fall waveshape.

  • Page 114: Gas Fail Detection Verification

    14.12 Gas Fail Detection Verification a) With the air and oxygen hoses connected to separately controllable pressure sources Set the ventilator to CMV Gas inlet pressures to 4 Bar BPM: 60 Insp Time: 0.5 PIP: 30 mbar PEEP: 0 mbar b) Ensure there are no current alarm conditions.

  • Page 115: Blender And Oxygen Monitoring Verification

    14.13 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 116: Soak Test

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

  • Page 117: Battery Charge Verification

    14.15 Battery Charge Verification Check that the battery has fully charged by checking the battery connector voltage is at least 13.7V when the unit is powered from the mains. Acceptable tolerance: >13.7 mbar. Check list Item 15. 14.16 Battery Life Verification After the battery has been fully charged (from the soak test), leave the unit in CMV mode at 80 BPM on the battery alone.

  • Page 118: Pressure Calibration Verification

    14.18 Pressure Calibration Verification Note: The ventilator must be at working temperature with the metal electronic unit top cover on and connected to air for 1 hour prior to verification. Connect the proximal airway line to the calibration analyser. Check the zero level in CMV mode at the following settings: BPM 5 Insp time 0.10 seconds...
  • Page 119 Functional Testing (Model C) Page 119...

  • Page 120: Functional Testing

    15. 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 297.
  • Page 121 This will trigger the mains power fail alarm. Slowly depress the battery power termination switch. Before the switch reaches the end of its full travel, the audible complete power fail alarm should be initiated. Once the alarm has been triggered release the button, the alarm should continue.
  • Page 122 15.1.5 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 123 15.1.6 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 124 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 125 15.1.7 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 126 Note: If functional testing the ventilator without a flow 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 12 Remove the test lung and connect the ET manifold to the calibration analyser. Check that the analsyer reads 5 mbar.
  • Page 127 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 128 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 .....18 Ti ......3 sec PEEP....5mbar PIP .......20 mbar ......21%...
  • Page 129 Step 22 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. Refit the test lung. 15.1.8 High Pressure Alarm Step 23 Reduce high alarm setting to 19mbar. This should initiate an audible alarm and a High Pressure visual alarm.
  • Page 130 15.1.10 Breath Not Detected Alarm Step 25 Set the PEEP to 1 mbar Remove the test lung from the flow sensor. Occlude the flow sensor. After 10 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 131 15.1.11 Leak / Block Alarm Step 26 Disconnect the fresh gas tubing from the ventilator. This should initiate an audible and visual LEAK alarm indication. Step 27 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 132 15.1.13 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 29 Disconnect Air supply from wall outlet, an audible / visual alarm should be activated.
  • Page 133 15.1.14 Flow Sensor Disconnect Alarm Note: If functional testing without the flow sensor advance to Step 33. Step 32 Disconnect the flow sensor plug from the ventilator an audible / visual alarm should be activated. Press the Continue without flow button. 15.1.15 Cycle Fail Alarm When the ventilator is used without a flow sensor a Cycle Fail alarm threshold...
  • Page 134 Step 34 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. Repeat Step 5 and then advance to Step 35. Step 35 Press the Mode Select button to enter the Mode select panel.
  • Page 135 15.1.16 Functional Test of CMV Mode Step 37 For the functional test set the following parameters in the CMV preview mode: BPM..... 30 Ti......1 sec PEEP ....5mbar PIP....... 20 mbar ..... 21% After pressing the confirm button the user will be presented with the CMV screen.
  • Page 136 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 38 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 137 Step 40 Verify that: the pressure wave form is modified accordingly. Default position Midway position Step 41 Return the indicator bar to its original position and press the Return button to return to the Services panel panel. Step 42 Press the Next.. button to reach the More Options panel.
  • Page 138 Step 45 From the mode select panel press the TTV button. (Skip Step 45 to Step 49, if functional testing without a flow sensor). Step 46 Turn on the Volume targeting by pressing the button marked OFF. The text in the button will change to ON.
  • Page 139 Step 48 Set a Tidal volume of 5ml, Max Ti of 0.40sec and a Max PIP of 20mbar. Verify that: The displayed waveform changes showing a rise in flow with a sharp cut off. Step 49 Turn off the volume limiting. Step 50 Press the Mode Select button and...
  • Page 140 15.1.17 Functional Test of PSV Mode Step 51 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 141 Note: If functional testing the ventilator without a flow 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 53 Press the PSV Setup button to display the Pressure Support panel.
  • Page 142 Step 54 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. For version 4.1: Set Apnoea detection after 10 seconds.
  • Page 143 15.1.18 Functional Test of SIMV Mode Step 57 For the functional test set the following parameters in the SIMV preview mode: BPM..... 20 Ti......1 sec PEEP ....4 mbar PIP....... 25 mbar ..... 21% After pressing the confirm button the user will be presented with the SIMV screen.
  • Page 144 Note: If functional testing the ventilator without a flow 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 58 Verify that: the ventilator cycles, the cycle waveform appears in the waveform windows, after 1 minute the BPM Tot should read 20 BPM in the breath...
  • Page 145 Step 61 Remove the test lung and connect the calibration analyser Verify that: the PIP is 25 mbar. Refit the test lung. Step 62 Press the PSV Setup button to display the Pressure Support settings panel. Set provide support to 50% of PIP and stop support at 5% of peak flow.
  • Page 146 This page is intentionally blank. Page 146 (Model C)

  • Page 147: Trouble Shooting

    Trouble shooting (Model C) Page 147...

  • Page 148: Trouble Shooting Chart

    16. Trouble Shooting Chart 1. Symptom: Ventilator does not power up when turned on but is connected to mains supply. Possible Cause Mains power supply turned off. Blown main fuse. Remedy Turn on mains supply. Replace main fuse. 2. Symptom: Ventilator screen remains blank on power up. Power LED is On.
  • Page 149 3. Symptom: Ventilator screen blank. Power LED is Off. Continuous alarm tone being generated. Possible Cause Complete power failure. Remedy Restore mains power and restart ventilator. If the ventilator does not display any battery related alarms. To check battery level turn off ventilator at rear (do not press the battery disconnect switch).
  • Page 150 7. Symptom: Mains power fail alarm active even though connected to mains. Alarm Message: Main Power Fail. Possible Cause Mains power has failed. The ventilators main power switch has been set to off. Power supply has developed a fault. Remedy Restore mains power.
  • Page 151 11. Symptom: System fail alarm. Alarm Message: System Fail (Memory Checksum Error). Possible Cause Error in the monitor software. Remedy Complete re-calibration of the ventilator monitor/controller subsystems. 12. Symptom: Controller alarm. Alarm Message: Controller Failure. Possible Cause Hardware fault in the controller subsystem or fault in the Controller/CAN link. Fuse F4 on control/monitor board blown.
  • Page 152 15. Symptom: Battery fault alarm. Alarm Message: Battery Fault. Possible Cause Batteries have no charge. Ventilator was turned off and on again in very short period of time. The internal battery has failed or the power supply has developed a fault. Remedy Charge batteries.
  • Page 153 18. Symptom: Faulty flow sensor alarm. Alarm Message: Faulty flow sensor. Possible Cause A flow sensor heated wire has broken. Faulty flow sensor cable. Loose connection in flow sensor wiring harness. Defective control/monitor board. Remedy Replace flow sensor. Replace flow sensor cable. Inspect flow sensor wiring harness.
  • Page 154 21. Symptom: Monitor/display comms fail alarm. Alarm Message: Monitor/display comms fail. Possible Cause Hardware fault in the monitor subsystem or fault in the monitor/CAN link. Remedy Check the CAN card ribbon cable. Replace the control/monitor board. 22. Symptom: High Patient Leak alarm. Alarm message: High Patient Leak Possible Cause Flow sensor just within specification.
  • Page 155 Software Version History (Model C) Page 155...

  • Page 156: Software Version History

    17. Software Version History The following is a list of software versions used on the SLE4000 infant ventilator. Software Display Controller Controller Controller Monitor Monitor Version subsystem hardware software Checksum software software N°: Isolated Isolated 121203-4 V3.2 270105-4 V3.3 230305-4 V3.3.1...

  • Page 157: Technical Information

    Technical Information (Model C) Page 157...

  • Page 158: Oxygen Calibration Routines

    18. Oxygen Calibration Routines The SLE4000 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: Version 3.2: 10 minutes, 30 minutes, 60 minutes, 90 minutes and then at 8 hourly intervals.
  • Page 159 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 will deliver 21% O to the patient for 7 minutes. Warning: (For version 3 to 3.3 software) The user must set the blender to 21% before commencing with the two point calibration when calibrating from the user interface.

  • Page 160: Alarms

    19. Alarms 19.1 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 161: Alarm Descriptions And Actions To Be Taken

    19.3 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 162 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 163 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 164 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 165 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 166 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 167 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 168 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 169 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 170 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 171 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 172 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 173 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 174 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 175 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 176 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 177 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 178 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 179 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 180: 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 181: 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). 20.1 Preparation of a new ventilator Remove all transit packaging. Inspect the fresh gas port and proximal airway port for any packing material.

  • Page 182: 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 183: 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 184: Sterilization Method

    20.5 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 185: Technical Specification

    21. 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. 21.1 Operating Modes Conventional Ventilation 21.1.1 CPAP Inspiratory Time: 0.1 to 3.0 seconds, steps of 0.01 seconds...
  • Page 186 21.1.4 PSV Inspiratory Time: 0.1 to 3.0 seconds, steps of 0.01 seconds CPAP Pressure: 0 mbar to 20 mbar Inspiratory Pressure: 0 mbar to 65 mbar Volume Targeting: 2 ml to 200 ml 21% to 100% Backup breaths are pressure limited, time cycled. 21.1.5 SIMV BPM: 1 to 150...
  • Page 187 21.1.6 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 Backup parameter control: 1 to 150 bpm Begin psv Button: Sends diagnostic pulse...
  • Page 188 Language button: Change interface language Manual Breath button: Delivers one manual breath Min Vol button: Selects minute volume against time display Mode select button: Activates mode select panel Monitor button: Activates monitor services panel Monitor Pressure Button: Toggles between waveforms, diagnostic use only Mute button: Mutes a mutable alarm for 1 minute.
  • Page 189 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: Selects SIMV mode Standby button: Sets ventilator into 90 second standby mode Stored loop button Displays stored loops Ti parameter: control:...

  • Page 190: Measurement

    21.2 Measurement 21.2.1 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 191: Exhalation Block Port Jet Sizes

    21.2.3 Pressure Real Time Pressure: Resolution 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) PEEP Pressure: 0 to 175 mbar (resolution 1mbar) 21.3 Exhalation Block Port Jet Sizes...

  • Page 192: Alarms

    21.4 Alarms 21.4.1 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 193: Patient Circuits

    21.4.2 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 194: 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. Page 194 (Model C)

  • Page 195: Gas Supplies

    21.7 Gas supplies Note: The ventilator requires the gas input pressures to be between 4-5bar. The ventilator can operate with the gas pressures at 3-4bar, but when there is a high demand for gas, No O Supply or No Air Supply alarms can be triggered.

  • Page 196: Power, Dimensions, Standards Etc

    21.8 Power, Dimensions, Standards etc. Voltage: 100-240V/ 50-60Hz Power: 115 VA Fuses: 100-250V~50-60Hz: Fuse T(2.0AH) 250v Battery Back up 12 volt. Up to 45-60 minutes dependant on mode. Battery life 10 years Battery Charging Full charge 24 Hours 80% charge 8 hours Rating: Class 1.

  • Page 197: Ventilator Labelling

    22. Ventilator labelling 22.1 SLE4000 (Model C) Page 197...
  • Page 198 This page is intentionally blank. Page 198 (Model C)
  • Page 199 Schematic & Circuit Diagrams (Model C) Page 199...

  • Page 200: Electrical Block Diagram

    23. Electrical Block Diagram Page 200 (Model C)

  • Page 201: L0288 Pneumatic Unit Layout

    24. L0288 Pneumatic Unit Layout PRV1 SV1 to SV6 SV13 (Model C) Page 201...

  • Page 202: Pneumatic Unit Schematic

    25. Pneumatic Unit Schematic 25.1 Schematic Below is a schematic representation of the pneumatic unit of the SLE4000 ventilator. Page 202 (Model C)

  • Page 203: Pneumatic Unit Tubing Connections

    26. Pneumatic Unit Tubing connections (Model C) Page 203...

  • Page 204: Main Loom Circuit Diagram

    27. Main Loom Circuit Diagram Page 204 (Model C)
  • Page 205 A0761 Circuit Diagram (Model C) Page 205...

  • Page 206: A0761 Circuit Diagram

    28. A0761 circuit diagram 28.1 Transducer PCB Assembly Page 206 (Model C)
  • Page 207 A0763/02 Circuit Diagrams (Model C) Page 207...

  • Page 208: A0763/02 Circuit Diagrams

    29. A0763/02 circuit diagrams 29.1 Micro Controller Page 208 (Model C)

  • Page 209: Conventional Valve Drive

    29.2 Conventional Valve Drive (Model C) Page 209...

  • Page 210: Power Distribution And Hardware Identifier

    29.3 Power Distribution And Hardware Identifier Page 210 (Model C)

  • Page 211: Analogue Valve Drive / Non Volatile Memory / Interboard Comms

    29.4 Analogue Valve Drive / Non Volatile Memory / Interboard Comms. (Model C) Page 211...

  • Page 212: High Speed Valve Drive

    29.5 High Speed Valve Drive Page 212 (Model C)

  • Page 213: Analogue Data Acquisition/Monitor Port

    29.6 Analogue Data acquisition/Monitor port (Model C) Page 213...

  • Page 214: Control & Monitor, Pcb Psu Circuit

    29.7 Control & Monitor, PCB PSU Circuit Page 214 (Model C)

  • Page 215: Control & Monitor, Micro Non-Isolated

    29.8 Control & Monitor, Micro Non-isolated (Model C) Page 215...

  • Page 216: Control & Monitor, Micro Isolated

    29.9 Control & Monitor, Micro Isolated Page 216 (Model C)

  • Page 217: Control & Monitor, Analog Isolated

    29.10 Control & Monitor, Analog Isolated (Model C) Page 217...

  • Page 218: Control & Monitor, Alarm Controller

    29.11 Control & Monitor, Alarm Controller Page 218 (Model C)
  • Page 219 Illustrated Parts List (Model C) Page 219...

  • Page 220: Illustrated Parts List

    30. Illustrated Parts List How to use the illustrated parts list The parts list is divided into five columns, Items Nº, SLE Part Nº, Description, Effectivity code and Units Per Assy. Item Nº: refers to the numbered part in the appropriate figure. An item number preceded by a dash (-20) is not illustrated.
  • Page 221 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 222: Ventilator Assembly

    View A Ventilator assembly Figure 1 (Sheet 1 of 5) Page 222 (Model C)
  • Page 223 View B Ventilator assembly Figure 1 (Sheet 2 of 5) (Model C) Page 223...
  • Page 224 Ventilator assembly Figure 1 (Sheet 3 of 5) Page 224 (Model C)
  • Page 225 Ventilator assembly Figure 1 (Sheet 4 of 5) (Model C) Page 225...
  • Page 226 Ventilator assembly Figure 1 (Sheet 5 of 5) Page 226 (Model C)
  • Page 227 Units Item SLE Part Nº Description Effectivity code Assy. L5400C Infant Ventilator, Model C N6622 .Exhalation Block Assy N21866/01 .Silencer, Long  T1267 .Moulding, Case rear Attaching Parts H4116 ..Screw (M4 x 16mm) H4095 ..Washer, nylon (M4)  T1301 .Label, air vent T1300 .Label, battery disconnect...
  • Page 228 Units Item SLE Part Nº Description Effectivity code Assy. L5400C-1001 .Base plate and side door assembly (See figure 2 for detailed breakdown) Attaching Parts H3208 ..Screw (M3 x 8mm)  H4110 .Screw, trolley fixing (M4 x10mm) H4094 .Washer, shakeproof (M4) ...

  • Page 229: Base Plate And Side Door Assembly

    View A Base plate and side door assembly Figure 2 (Model C) Page 229...
  • Page 230 Units Item SLE Part Nº Description Effectivity code Assy. L5400C-1001 Base plate & side door assembly (See figure 1 for next highest assembly) L5400C-1003 .Side Door Assembly (See items 25-55) T1194 .Pneumatic Unit Base Tray Attaching Parts T1252 ..Plate, flap door fixing H3098 ..Screw, (M3 x 8mm)

  • Page 231: Front Facia Assembly

    Front facia assembly Figure 3 (Model C) Page 231...
  • Page 232 Units Item SLE Part Nº Description Effectivity code Assy. L5400C-1002 Front facia assembly (See figure 1 for next highest assembly) N6633 .Seal, cover N6632 .Seal, screen  W0334 .Loom, flow senor M0767/06 .Core, ferrite hinged M0767 .Core, ferrite hinged Attaching Parts T1261 ..Bezel...

  • Page 233: Electronic Module

    Electronic module Figure 4 (Sheet 1 of 13) (Model C) Page 233...
  • Page 234 View A View B Electronic module Figure 4 (Sheet 2 of 13) Page 234 (Model C)
  • Page 235 Electronic module Figure 4 (Sheet 3 of 13) (Model C) Page 235...
  • Page 236 View C Electronic module Figure 4 (Sheet 4 of 13) Page 236 (Model C)
  • Page 237 View D Electronic module Figure 4 (Sheet 5 of 13) (Model C) Page 237...
  • Page 238 View E Electronic module Figure 4 (Sheet 6 of 13) Page 238 (Model C)
  • Page 239 View F 365A Electronic module Figure 4 (Sheet 7 of 13) (Model C) Page 239...
  • Page 240 View G Electronic module Figure 4 (Sheet 8 of 13) Page 240 (Model C)
  • Page 241 View h View I Electronic module Figure 4 (Sheet 9 of 13) (Model C) Page 241...
  • Page 242 View J Electronic module Figure 4 (Sheet 10 of 13) Page 242 (Model C)
  • Page 243 View K View L Electronic module Figure 4 (Sheet 11 of 13) (Model C) Page 243...
  • Page 244 Electronic module Figure 4 (Sheet 12 of 13) Page 244 (Model C)
  • Page 245 View M Electronic module Figure 4 (Sheet 13 of 13) (Model C) Page 245...
  • Page 246 Units Item SLE Part Nº Description Effectivity code Assy. L0270 Electronic module assembly (See figure 1 for next highest assembly) W0329 .Cable, ribbon assembly  N6631/22 .Cable LCD assembly Obsolete item use item 15A N6631/024/001 Cable LCD assembly M0767/12 .Core, ferrite hinged M0434 .Cable Tie, Nylon...
  • Page 247 Units Item SLE Part Nº Description Effectivity code Assy. 4 85 N6631/06 ..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, ribbon assembly...
  • Page 248 Units Item SLE Part Nº Description Effectivity code Assy. 4 190 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)  L5400C-1005 .Screen Mounting Assembly...
  • Page 249 Units Item SLE Part Nº Description Effectivity code Assy. 4 305 M0305/29 .Spacer (For Serial Nº: 51164 onwards) Attaching Parts H3208 .Screw (M3 x 8mm)  M0856 .Clamp, cable tie M0305/10 .Spacer, Nylon (12mm long) Attaching Parts H3220 ..Screw (M3 x 20mm) H3093 ..Washer (M3)
  • Page 250 Units Item SLE Part Nº Description Effectivity code Assy. 4 410 N2373 .Tube, Polyurethane (Length165mm) -415 M0434 .Cable tie  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)
  • Page 251 Units Item SLE Part Nº Description Effectivity code Assy. L5400C-1008 PCB Bracket Runner Assembly (See items 955-985) 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 252 Units Item SLE Part Nº Description Effectivity code Assy. 4 660 O0431 (1) .Switch, Push Button Attaching Parts O0431 (2) .Nut, locking  M0856 .Clamp, cable tie Attaching parts H3206 ..Screw (M3 x 6mm) H3091 ..Nut (M3) H3094 ..Washer, shakeproof (M3) ...

  • Page 253: Pneumatic Module

    View A Pneumatic module Figure 5 (Sheet 1 of 4) (Model C) Page 253...
  • Page 254 View B View C Pneumatic module Figure 5 (Sheet 2 of 4) Page 254 (Model C)
  • Page 255 View D Pneumatic module Figure 5 (Sheet 3 of 4) (Model C) Page 255...
  • Page 256 View E Pneumatic module Figure 5 (Sheet 4 of 4) Page 256 (Model C)
  • Page 257 Units Item SLE Part Nº Description Effectivity code Assy. L0288 Pneumatic module assembly (See Figure 1 for next highest assembly) N2373 .Tube, Polyurethane (Length 40mm) N6605 .Tube connetor, equal tee. N2373 .Tube, Polyurethane (Length 250mm) N2373 .Tube, Polyurethane (Length 165mm) N2373 .Tube, Polyurethane (Length 40mm)
  • Page 258 Units Item SLE Part Nº Description Effectivity code Assy. N6617/14 .Double twin banjo elbow N6620 .Plug, plastic N6601/05 .Elbow connector, swivel T1160 .Mounting block, oxygen cell Attaching Parts H3108 ..Screw (M3 x 8mm) H3094 ..Washer, shakeproof (M3)  N6615/01 .Pressure regulator T1169 .Bracket, regulator...
  • Page 259 Units Item SLE Part Nº Description Effectivity code Assy. 5 280 L0285/40. Partition Assembly (See Figure 8 for detailed breakdown) N2373 .Tube, Polyurethane (Length 165mm) Attaching Parts H3108 ..Screw (M3 x 8mm) H3094 ..Washer, shakeproof (M3)  T1187 .Pneumatic module, sub assembly (See Figure 9 for detailed breakdown) ...

  • Page 260: Pressure Regulator Module

    Pressure regulator module Figure 6 (Sheet 1 of 4) Page 260 (Model C)
  • Page 261 View A 120 110 Pressure regulator module Figure 6 (Sheet 2 of 4) (Model C) Page 261...
  • Page 262 View B 180 160 185 View C View D Pressure regulator module Figure 6 (Sheet 3 of 4) Page 262 (Model C)
  • Page 263 View E Pressure regulator module Figure 6 (Sheet 4 of 4) (Model C) Page 263...
  • Page 264 Units Item SLE Part Nº Description Effectivity code Assy. L0289 Pressure regulator module (See figure 5 for next highest assembly) N6644 .Tube, Polyurethane (Length 650mm) Attaching Parts M0907 ..Tape  N2373 .Tube, Polyurethane (Length 100mm) N2373 .Tube, Polyurethane (Length 142mm) N2373 .Tube, Polyurethane (Length 200mm)
  • Page 265 Units Item SLE Part Nº Description Effectivity code Assy. N2181 .Regulator, pressure 0-4 bar, with plug N2180/01 ..Plug N6601/18 .Tube connector, swivel elbow N6600/18 .Tube connector, stud male T0233 . Bracket, clamp block Attaching Parts H3110 ..Screw (M3 x 10mm) T0224 ..Nut, captive...
  • Page 266 Units Item SLE Part Nº Description Effectivity code Assy. 6 195 T0611 .Post, guide T1280/41 .Plate, packing Attaching Parts H3108 ..Screw (M3 x 8mm)  T1199 .Latch, exhalation block Attaching Parts N6619 ..Spring, latch T1236 ..Spacer H4940 ..Screw, (M4 x 40mm) H4091 ..Nut (M4)
  • Page 267 Units Item SLE Part Nº Description Effectivity code Assy. N6623/S38 (3) .Manifold block N6642 .Reducer, plug in N6600/18 .Tube connector, stud male N6601/18 .Tube connector, swivel elbow  - Item Not illustrated (Model C) Page 267...

  • Page 268: Oxygen Regulator Module

    View A Oxygen regulator module Figure 7 (Sheet 1 of 2) Page 268 (Model C)
  • Page 269 View B View C Oxygen regulator module Figure 7 (Sheet 2 of 2) (Model C) Page 269...
  • Page 270 Units Item SLE Part Nº Description Effectivity code Assy. L0282 Oxygen regulator assembly (See figure 5 for next highest assembly) N6615/02 .Pressure regulator, captive T1159 .Input connector block, Air & O L5400C-1013 .O hose connector assembly (See items 50-75) L5400C-1014 .Air hose connector assembly...

  • Page 271: Partition Assembly

    View A Partition assembly Figure 8 (Sheet 1 of 2) (Model C) Page 271...
  • Page 272 View B View C Partition assembly Figure 8 (Sheet 2 of 2) Page 272 (Model C)
  • Page 273 Units Item SLE Part Nº Description Effectivity code Assy. L0285/40 Partition Assembly (See figure 5 for next highest assembly) N2373 .Tube, Polyurethane (Length 225mm)  L5400C-1015 .Soleniod valve assembly (See items 70-110) Attaching parts H3125 ..Screw (M3 x 25mm) H3091 ..Nut (M3)
  • Page 274 Units Item SLE Part Nº Description Effectivity code Assy. T1235 .Pressure relief block N6600/05 .Tube connector, stud male N2194 .Valve, relief  - Item Not illustrated Page 274 (Model C)

  • Page 275: Pneumatic Module, Sub Assembly

    Pneumatic module, sub assembly Figure 9 (Sheet 1 of 5) (Model C) Page 275...
  • Page 276 View A Pneumatic module, sub assembly Figure 9 (Sheet 2 of 5) Page 276 (Model C)
  • Page 277 View B View C Pneumatic module, sub assembly Figure 9 (Sheet 3 of 5) (Model C) Page 277...
  • Page 278 View D View E Pneumatic module, sub assembly Figure 9 (Sheet 4 of 5) Page 278 (Model C)
  • Page 279 Pneumatic module, sub assembly Figure 9 (Sheet 5 of 5) (Model C) Page 279...
  • Page 280 Units Item SLE Part Nº Description Effectivity code Assy. T1187 Pneumatic module, sub assembly (See figure 5 for next highest assembly) L0287 .Blender & loom assembly M0630 .Pad, foam Attaching parts H3230 ..Screw (M3 x 30mm) H3091/03 ..Nut, shakeproof (M3) H3091 ..Nut (M3)
  • Page 281 Units Item SLE Part Nº Description Effectivity code Assy. 9 100 T1238 .Connector, fresh gas T1238/01 .Restrictor Attaching parts N6604/05 .Tube connector, tee N2373 .Tube, Polyurethane (Length 230mm) N6614/40 .Speed controller H1093 ..Nut (M10) H1091 ..Washer (M10)  T1172 .Connector, proximal airway N2373 .Tube, Polyurethane (Length 230mm)
  • Page 282 Units Item SLE Part Nº Description Effectivity code Assy. 9 200 T1237 .Block, fixing Attaching parts H3208 ..Screw (M3 x 8mm)  N6630 ..Catch, magnetic Attaching parts H3210 ..Screw (M3 x 10mm) H3091 ..Nut (M3) H3094 ..Washer, shakeproof (M3) ...
  • Page 283 Equipotential Stud Modification (Model C) Page 283...

  • Page 284: Equipotential Stud Modification

    31. Equipotential stud modification Units Item SLE Part Nº Description Effectivity code Assy. T1193/EP Top cover with EP stud T1193/EP/01 Stud, EP Attaching Parts H6091 H6093 Washer H6094 Washer, shakeproof H6093 Washer, M6  W0325/EP Cable, EP stud earthing ...

  • Page 285: Equipotential Stud Connection

    31.1 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 C) Page 285...
  • Page 286 This page is intentionally blank. Page 286 (Model C)
  • Page 287 Appendix 1. Calibration Checklist (Model C) Page 287...
  • Page 288 This page is intentionally blank. Page 288 (Model C)

  • Page 289: 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 290 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 Gain: Gain: CMV Offset: CMV Offset: Insp Leading Edge Insp Trailing Edge Fast Rise: Fast Rise: Slow Rise: Slow Rise:...
  • Page 291 Item 5: FR8 adjustment with SV7 energised Lower limit Actual reading Upper limit 0.20 mbar 0.30 mbar Item 6: Fresh gas flow with SV7 energised. Lower limit Actual reading Upper limit 7.75 lpm 8.25 lpm Item 7: With SV7 de-energised, check the fresh gas flow is within range Lower limit Actual reading Upper limit...
  • Page 292 Item 12: Pressure Triggering Verification Pressure Trigger Verified: Item 13: Gas Fail Detection Verification Gas Fail Detection Verified: Item 14: Blender and Oxygen Monitoring Verification CPAP Set Oxygen concentration Lower Limit Actual Upper limit Reading 100% 100% Item 15: Battery Charge Verification Lower limit Actual reading Upper limit...
  • Page 293 Item 17: Total Power Fail Alarm Test Total power fail alarm test: Initial Item 18: 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 294 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 Gain: Gain: CMV Offset: CMV Offset: Insp Leading Edge Insp Trailing Edge Fast Rise: Fast Rise: Slow Rise: Slow Rise:...
  • Page 295 Appendix 2. Check list (Model C) Page 295...
  • Page 296 This page is intentionally blank. Page 296 (Model C)

  • Page 297: 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 298 Pass Fail Step 24: Low Pressure alarm.   Alarm triggered and cancelled Step 25: Breath Not Detected Alarm.   Alarm triggered and cancelled Step 26: Leak alarm.   Alarm triggered and cancelled Step 27: Block alarm.  ...
  • Page 299 Pass Fail Step 43: Waveform display synchronisation. Waveforms should be displayed   starting at the left hand edge of the window. Step 44: Waveform display synchronisation. Waveforms should be displayed   starting any where in the window. Step 48: Wave shape modified by TTV. ...
  • Page 300 Pass Fail Step 61:Pressure Support functional test.   Analyser reads PIP as 25mbar Step 62:Pressure Support functional test.   Ventilator displays PIP of 12-13mbar Page 300 (Model C)
  • Page 301 Appendix 3. List of Technical Bulletins & Service Information Letters (Model C) Page 301...

  • Page 302: Appendix 3. Tb & Si Index

    32. Technical Bulletin & Service Information Letters The following are lists 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.
  • Page 303 Equipment: SLE4000/5000 Design change of N2521/03 and the N2521/04 pressure transducer. SI061001 25/10/06 Equipment: SLE4000/5000 Introduction of Model C SLE4000 and Model D SLE5000 Infant ventilators SI070302 29/06/07 Equipment: SLE5000 Introduction of SLE5000 model E & G. and SLE4000 model F...

  • Page 304: Technical Bulletins

    Ventilator freezing on startup due to N6634 CAN card dip switch movement. TB060902 15/09/06 Equipment: SLE5000 N9053 restrictor tubing assembly. TB070401 20/04/07 Equipment: SLE4000/5000 Deep discharge of ventilator backup batteries. TB071001 12/10/07 Equipment: SLE4000/5000 False “Battery Fail Alarm” TB080301 10/03/08...
  • Page 305 Appendix 4. RS232 (Model C) Page 305...

  • Page 306: Appendix 4. Rs232

    This section describes the data format and connections for the serial interface of the SLE4000 infant ventilator. Note: The RS232 data software is common to both SLE4000 and SLE5000 ventilators. Where HFO data is mentioned the output value will be 0.

  • Page 307: Overview

    33.3 Overview 33.4 Data and Pinout description. 33.4.1 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 308: Parameter Descriptions And Format

    33.6 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 309 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 310 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 311: Table Of Current Alarm Condition Codes

    33.8 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 312 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 313: 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 33.9 RS232 Connection Settings and Testing Data Output 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 314 This page is intentionally blank. Page 314 (Model C)
  • Page 315 Appendix 5. VueLink Technical Data (Model C) Page 315...

  • Page 316: 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 SLE4000 ventilator.

  • Page 317: 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 SLE4000. A cross reference table follows.

  • Page 318: Data Transferred To The Vuelink System From The Sle4000

    34.4 Data transferred to the VueLink system from the SLE4000 The RS232 interface to the VueLink monitor enables the SLE4000 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 319 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  ...

  • Page 320: 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 SLE4000 messages correspond to VueLink display messages.
  • Page 321 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 322 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 323: Vuelink Task Window Layout

    34.6 VueLink Task Window Layout The VueLink task window for the SLE4000 will display the parameters as shown below. |-------------------|-------------------|-------------------| | sPEEP mbar | sPIP mbar | sAWRR | PEEP mbar | PIP mbar | Trig trig/min | |-------------------|-------------------|-------------------| | sFIO_2 %...

  • Page 324: Notes On General System Behaviour

    40 seconds to start again. Only one alarm is condition is visible on the SPI at a time. As with the SLE4000, if there are several alarm conditions present then only the highest priority alarm will be displayed.

  • Page 325: Activation Of Vuelink

    34.8 Activation of VueLink VueLink is activated by entering the activation code into the SLE4000/SLE4000 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.

  • Page 326: 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 327 SLE reserves the right to make changes without prior notice in equipment, publications and prices as may be deemed necessary or desirable. (Model C) Page 327...

This manual is also suitable for:

Sle4000 model b

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