Huntleigh Dopplex ABIlity DA100PB Service Manual
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Huntleigh Dopplex ABIlity DA100PB Service Manual

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SERVICE MANUAL
771402-2 dopplex ABIlity Service Manual
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Summary of Contents for Huntleigh Dopplex ABIlity DA100PB

  • Page 1 SERVICE MANUAL 771402-2 dopplex ABIlity Service Manual...

  • Page 2: Table Of Contents

    1 Table of Contents Table of Contents ..........................2 General ..............................5 Standards compliance ........................5 CE Mark ............................5 Classification ..........................5 Symbols ............................6 Warnings ............................6 Cautions ............................6 System Connection ........................6 Electromagnetic Compatibility ......................7 Electrostatic Discharge ........................
  • Page 3 Disassembly & Assembly ........................30 Tools Required ..........................30 Case Front (SP-771054) Removal ....................31 Case Rear Removal ........................32 Base PCB (SP-7711067) Removal ....................34 KEYPAD (SP-771335) REPLACEMENT ..................35 CONNECTOR REMOVAL/REPLACEMENT .................36 IEC MAINS INLET (SP-771499) REPLACEMENT.................37 Printer Door/Roller (SP-771535) Replacement ................38 Printer Mechanism (SP-771537) Replacement ................39 9.10 Fuse (SP-771539) replacement ....................41 9.11...
  • Page 4 As part of the ongoing development programme the company reserves the right to modify specifications and materials without notice. Dopplex, Ability and Huntleigh are registered trademarks of Huntleigh Technology Ltd. 2011. © Huntleigh Healthcare Ltd. 2011 771402-2 dopplex ABIlity Service Manual...

  • Page 5: General

    General 2 General Standards compliance The dopplex Ability complies with: EN60601-1: 1990 + A1, A2, A11, Medical Electrical Equipment Part 1 A12 & A13 General Requirements for Safety EN60601-1-1: 2001 Safety Requirements for Medical Electrical Systems [collateral standard] EN60601-1-2: 2001 General requirements for safety: Electromagnetic compatibility [collateral standard] EN10993-1: 2009 &...

  • Page 6: Symbols

    IEC60601-1:2005; clause 16. If there is any doubt as to whether your system complies, consult the technical service department of your local Huntleigh representative. 771402-2 dopplex ABIlity Service Manual...

  • Page 7: Electromagnetic Compatibility

    General Electromagnetic Compatibility Make sure the environment in which dopplex Ability is installed is not subject to strong sources of electromagnetic interference (e.g. radio transmitters, mobile phones). This equipment generates and uses radio frequency energy. If not installed and used properly, in strict accordance with the manufacturer’s instructions, it may cause or be subject to interference.
  • Page 8 General Guidance and Manufacturer’s declaration - electromagnetic immunity The dopplex Ability is intended for use in the electromagnetic environment specified below. The customer or the user of the dopplex Ability should assure that it is used in such an environment. Immunity Test IEC 60601 test Compliance...

  • Page 9: Electrostatic Discharge

    If this happens, simply perform the usual checks and repeat the test. 2.10 Service & Warranty Huntleigh Healthcare's standard terms and conditions apply to all sales. These contain full details of warranty terms and do not limit the statutory rights of the consumer. A copy is available on request.

  • Page 10: Addresses

    General 2.11 Addresses Huntleigh Healthcare Ltd. – Diagnostic Products Division 35 Portmanmoor Road, Cardiff, CF24 5HN United Kingdom T: +44 (0)29 20485885 F: +44 (0)29 20492520 E: sales@huntleigh-diagnostics.co.uk W: www.huntleigh-diagnostics.com E-mail: cardiff.service@huntleigh-diagnostics.co.uk 771402-2 dopplex ABIlity Service Manual...

  • Page 11: Introduction

    This document is not intended as a full diagnostic tool because many of the boards and modules cannot be satisfactorily repaired in the field and must be returned to Huntleigh Healthcare if faulty. If any warranty claim is intended then it is important to ensure that any security seals are intact on the items to be returned if the warranty is not to be invalidated.

  • Page 12: Initial Unit Set-Up

    Initial Unit Set-Up 4 Initial Unit Set-Up On delivery of a new unit the battery will not be connected. Prior to performance testing the battery will need to be connected and conditioned. The conditioning routine will automatically operate when the dopplex Ability is switched on for the first time.

  • Page 13: Product Description

    Product Description 5 Product Description It is intended to be used on all patients considered to be at risk of having, or developing peripheral arterial disease (PAD). Dopplex Ability is intended for the rapid measurement of ankle-brachial pressure index (ABPI) or ankle-brachial index (ABI) in adults and pulse volume recording (PVR) / volume plethysmography.

  • Page 14: Base

    Product Description Base Battery Cover Battery Cover Retaining Screw Slide Plate Mounting Boss Air Filter Product Labelling 771402-2 dopplex ABIlity Service Manual...
  • Page 15 Product Description 771402-2 dopplex ABIlity Service Manual...

  • Page 16: User Interface

    Product Description User Interface User Set-Up Options Menu - Exit - Contrast - Set Time/Date - Paper Type - Audio Volume - Classification - Waveforms - Language - Battery Conditioner Service Menu Map Refer to User Service Menu Map - Service Menu 771402-2 dopplex ABIlity Service Manual...
  • Page 17 Product Description - Exit - Demo Mode PIN Code 5315 - Calibration - ADC Check (Also tests overpressure sensor) - Cuff Leak Test - Tests cuffs for leakage - Record Service - Enters Date of Service into memory - Print Service Report - Prints report using internal printer - Test Printer - Initiates a Test Printout - Flow Test -...

  • Page 18: System Connection

    IEC60601-1-1/EN60601-1-1. If there is any doubt as to whether your system complies, consult the Service Department of your local Huntleigh representative. 771402-2 dopplex ABIlity Service Manual...

  • Page 19: System Block Diagram

    System Block Diagram 6 System Block Diagram Sensor Signals Solenoids Reset Solenoid control Pump control Overcurrent signal Linear Valves Charging On-off control Power up sequencing System power rails The unit is divided into six main assemblies: 771402-2 dopplex ABIlity Service Manual...

  • Page 20: Base Pcb Assembly

    System Block Diagram • Base PCB assembly. • Daughter PCB assembly. • Regulator PCB assembly. • Front panel PCB assembly. • Printer PCB. • Manifold assembly. Base PCB assembly: MCU: This is the main control / data processing block of the system. The MCU is responsible handling user input, presenting data on LCD, handling of printer, and processing of raw PVR signals.

  • Page 21: Daughter Pcb Assembly

    System Block Diagram Daughter PCB assembly: ADC: Provides high-precision (24bit) digitisation of the seven pressure sensor signals. Solenoid Drivers: Provides ON/OFF control of four of the solenoid valves. 5V Linear Reg: Provides a low-noise analogue supply for the ADC. Regulator PCB assembly: MCU: Provides ON/OFF control and power sequencing of the internal power rails.

  • Page 22: Pneumatic Circuit Diagram

    System Block Diagram Pneumatic Circuit Diagram 771402-2 dopplex ABIlity Service Manual...
  • Page 23 System Block Diagram 771402-2 dopplex ABIlity Service Manual...
  • Page 24 System Block Diagram 771402-2 dopplex ABIlity Service Manual...

  • Page 25: Operating Principles

    Operating Principles 7 Operating Principles The Dopplex Ability is a medical device that can be used by relatively low-skilled operators to obtain ABPI measurements rapidly and reliably. The Ability uses unique dual-chamber DuoSense cuffs to occlude and detect the presence of blood flow. The occlusion chamber is inflated until the blood flow is cut off, whilst the detect chamber is inflated to a constant lower pressure of 45 mmHg and used to monitor blood flow distal to the occlusion chamber.

  • Page 26: Cuff Inflation & Deflation Control

    Operating Principles Cuff Inflation & Deflation Control The Ability includes a small compressor that provides air for cuff inflation. As there are effectively eight pneumatic channels (four occlude and four detect), valves are included to direct the air to the appropriate channels at the appropriate time.
  • Page 27 Operating Principles HD771 Rhoose Project Pump and Valve Sequencing (4-Limb Test) Key: 3-Way Valve Date:24th Aug, 2009 Linear Bleed Drawn: JPL Pump R Arm L Arm Arm Bleed Arm Dump Pump Divert Pump L Leg LL Bleed R Leg RL Bleed Leg Dump Duration (s) Fields markes '.' are of <500ms...

  • Page 28: Product Specifications

    Product Specifications 8 Product Specifications Equipment Classification Performance Systolic Pressure Arms : 80 - 220 mmHg Range Ankles : 55 - 205 mmHg Dopplex Ability provides valid ABI results for at least 80% of the patients tested. Valid results consist of both compressible vessels (where Dopplex Ability agrees with the Doppler method to ±...

  • Page 29: General

    Product Specifications General 771402-2 dopplex ABIlity Service Manual...

  • Page 30: Disassembly & Assembly

    Disassembly & Assembly 9 Disassembly & Assembly Observe ESD (electrostatic discharge) precautions when working within the unit and/or when disassembling and reassembling the Ability unit and when handling any of the components of the Ability unit To isolate the Ability from the mains or line supply, disconnect the power cable from the mains inlet at the rear of the unit •...

  • Page 31: Case Front (Sp-771054) Removal

    Disassembly & Assembly Case Front (SP-771054) Removal Remove the 3 off KB30x10 countersunk screws On Reassembly torque to 60cNm Remove the 2 off KB30x14 pan head screws On Reassembly torque to 60cNm Disconnect the 8 pieces of tubing from the front panel connectors Disconnect the display ribbon cable.

  • Page 32: Case Rear Removal

    Disassembly & Assembly Case Rear Removal Using the Hex key, remove the Battery lid M3x8 hex pan head screw. On reassembly torque to 25cNm Remove the Battery lid, Air filter pad (SP-771516) and unplug the Battery pack (SP-771332). Remove the 2 off M3x8 countersunk screws On reassembly torque to 50cNm Remove the 2 off M3x12 pan head screws.
  • Page 33 Disassembly & Assembly Disconnect the Printer Power and Signal cables from the Base PCB. Disconnect the IEC Mains Inlet and Earth cables from the Base PCB. The case rear has now been removed. Rear moulding (SP-771319) 771402-2 dopplex ABIlity Service Manual...

  • Page 34: Base Pcb (Sp-7711067) Removal

    Disassembly & Assembly Base PCB (SP-7711067) Removal Remove the 2 off M3x16 countersunk screws. On reassembly torque to 90cNm Remove the 2 off KB30-10 pan head screws On reassembly torque to 60cNm Unplug the Battery cable from the PCB. Unplug the tubing from the pump to the base. Slide the Base PCB forwards so that it clears the 2 plastic locating tabs then lift off the Base PCB.

  • Page 35: Keypad (Sp-771335) Replacement

    Disassembly & Assembly KEYPAD (SP-771335) REPLACEMENT Remove the foam tape and unplug the keypad flexi-cable. Carefully remove the faulty keypad from the Display panel. Locate the new keypad over the Display panel. Push the flexi-cable (FFC) tail through the recess in the Display panel Remove the backing from the keypad.

  • Page 36: Connector Removal/Replacement

    Disassembly & Assembly CONNECTOR REMOVAL/REPLACEMENT BLACK connector (SP-771339/B) GREEN connector (SP-771339/G) RED connector (SP-771339/R) YELLOW connector (SP-771339/Y) REMOVAL Using the Long Nose pliers, compress the locking tab of the Cuff connector, then carefully push out that side of the connector. Repeat this for the other side of the connector REPLACEMENT Insert the Cuff connector, with the locating tab/notch...

  • Page 37: Iec Mains Inlet (Sp-771499) Replacement

    Disassembly & Assembly IEC MAINS INLET (SP-771499) REPLACEMENT Using the long nose pliers, compress the 2 locking tabs, then carefully push out that side of the IEC Mains Inlet connector Repeat this for the locking tab on the other side of the IEC Mains Inlet connector IEC Mains Inlet cable (SP-771501) 771402-2 dopplex ABIlity Service Manual...

  • Page 38: Printer Door/Roller (Sp-771535) Replacement

    Disassembly & Assembly Printer Door/Roller (SP-771535) Replacement Printer Door: Lift the existing printer door from its mounting lugs. Snap fit the new Printer door onto the Hinge pin. Printer Roller (SP-771536): Remove the existing roller by pulling out of the lugs in the door using fingers.

  • Page 39: Printer Mechanism (Sp-771537) Replacement

    Disassembly & Assembly Printer Mechanism (SP-771537) Replacement Complete the CASE REAR removal To remove the Carriage + Printer. Remove the 4 off KB30-8 screws. Lift out the Carriage/Printhead assembly. On reassembly torque to 40cNm To remove the Printer PCB: Unplug the Printer mechanism flexi-cable. Unplug the Printer power cable.
  • Page 40 Disassembly & Assembly To remove the Printer mechanism: Remove the 2 off M2 nuts, crinkle washers and M2x6 and M2x8 pan head screws. On reassembly torque to 20cNm Replacement: Unpack the Printer mechanism. Remove the roller and protective paper from the printer mechanism Insert the Printer mechanism into the Printer carriage.

  • Page 41: Fuse (Sp-771539) Replacement

    Disassembly & Assembly When locating the carriage/printhead assembly into position. Take care not to dislodge the hinge pin. 9.10 Fuse (SP-771539) replacement Complete the CASE REAR removal Remove the fuse cover. Remove the fuse. Replace the fuse. Replace the cover. 771402-2 dopplex ABIlity Service Manual...

  • Page 42: Psu Module (Sp-771517) Replacement

    Disassembly & Assembly 9.11 PSU Module (SP-771517) Replacement Complete the CASE FRONT removal Complete the CASE REAR removal Unplug the PSU to Regulator PCB cable. Remove the 2 off M3x5 screws and shakeproof washers On reassembly torque to 60cNm Unplug the Ferrite PCB. Remove the 2 off M3x6 screws and shakeproof washers On reassembly torque to 60cNm Lift off the PSU module.

  • Page 43: Regulator Pcb (Sp-771551) Replacement

    Disassembly & Assembly 9.12 Regulator PCB (SP-771551) Replacement Complete the CASE FRONT removal Complete the CASE REAR removal Complete the PSU Module removal Using the M4 nut spinner, remove the 4 nylon spacers. On reassembly torque to 35cNm Carefully unplug the Regulator PCB from the Base PCB. NOTE The orange Regulator PCB to Base PCB cable will still be connected.

  • Page 44: Pump (Sp-771552) Replacement

    Disassembly & Assembly 9.13 Pump (SP-771552) Replacement Desolder the Black and Red wires from the pump to the PCB. Using solder-braid clean out the two PCB holes. IMPORTANT: Note tubing connections before removing. Unplug the two tubes from the pump. Cut the two tie wraps, and lift out pump.

  • Page 45: Valve (Sp-771505) Replacement

    Disassembly & Assembly 9.14 Valve (SP-771505) Replacement IMPORTANT: Note tubing connections before removal. Disconnect tubes from valve to be replaced. Desolder the 2 black wires. Using solder braid, clean out the 2 PCB holes. Remove the 2 off M3x 5 Pozidriv pan head screws and shakeproof washers securing the valve to the PCB.

  • Page 46: Over Pressure Pcb (Sp-771507) Replacement

    Disassembly & Assembly 9.16 Over Pressure PCB (SP-771507) Replacement Desolder the 8 pins of the Over-pressure PCB. Using solder braid clean out the 8 PCB holes. Put the Overpressure Detect PCB in place with the unpopulated side towards the pump. Solder in place using lead free solder.

  • Page 47: Base Pcb (Sp-771067) Replacement

    Disassembly & Assembly 9.17 Base PCB (SP-771067) Replacement Complete the CASE FRONT removal Complete the CASE REAR removal Complete the BASE removal Complete the PSU Module removal Complete the Regulator PCB removal Complete the Manifold removal Reuse the 4 metal Regulator PCB spacers, M3x8 screws and shakeproof washers on the replacement Base PCB.

  • Page 48: Manifold (Sp-771053) Replacement

    Disassembly & Assembly 9.18 Manifold (SP-771053) Replacement Complete the CASE FRONT removal Complete the CASE REAR removal Complete the BASE removal Unplug the 7 tubes shown. Remove the M3x8 screw and shakeproof washer securing the Manifold to the Base PCB. On Reassembly torque to 20cNm Using the Long Nose pliers, compress the locking tab of the PCB spacer then carefully pull off the PCB.
  • Page 49 Disassembly & Assembly Unplug the 4 tubes from the valves. The manifold with its tubing has now been removed. 771402-2 dopplex ABIlity Service Manual...

  • Page 50: Real Time Clock Battery (Sp-771514) Replacement

    Disassembly & Assembly 9.19 REAL TIME CLOCK BATTERY (SP-771514) Replacement Complete the CASE FRONT removal Complete the CASE REAR removal Complete the BASE removal Complete the MANIFOLD removal NOTE: When handling batteries ensure Gloves are worn. Do NOT handle batteries with bare hands. Remove the battery from the battery holder on the Base PCB.

  • Page 51: Safety Testing

    Safety Testing 10 Safety Testing 10.1 Product Classification The Dopplex Ability is a Class II product as defined by EN60601-1. As such, it does not rely on, or include, a protective earth. It does actually have an earth connection, but this is not included for safety purposes. The earth provides a shunt connection for the internal EMI filters, and is therefore defined as a functional earth according to EN60601-1.

  • Page 52: Electrical Safety Test: Usb (Enclosure Leakage) Test

    Safety Testing 10.3 Electrical Safety Test: USB (Enclosure Leakage) Test 10.3.1 Connect the unit under test as illustrated below to a suitable electrical safety analyser. Earth Live Neutral Neutral from Analyser USB Socket Earth from Analyser Live from Analyser Enclosure Socket of Analyser 10.3.2 Switch on the unit.

  • Page 53: Electrical Safety Test: Printer (Enclosure Leakage) Test

    Safety Testing 10.4 Electrical Safety Test: Printer (Enclosure Leakage) Test 10.4.1 Connect the unit under test as illustrated below to a suitable electrical safety analyser Earth Open the printer Live Neutral Enclosure Socket of Analyser Neutral from Analyser Earth from Analyser Live from Analyser 10.4.2 Switch on the unit.

  • Page 54: Maintenance

    A service report can be printed at any time. This contains useful information including a record of the dates of all services recorded. Services carried out by Huntleigh are identified by the text “HUNTLEIGH”. To obtain a service report, simply select “Print Service Report” in the service menu. (ensure there is sufficient paper in the printer).

  • Page 55: Cuffs

    Maintenance 11.3.3 Press the buttons directly below the symbols to highlight the Battery conditioner. 11.3.4 Press the button below the symbol to enter the battery conditioning screen. 11.3.5 Press the button below the symbol to enable battery conditioning. Battery conditioning will take 8 to 10 hours.

  • Page 56: General Inspection

    Maintenance 11.5 General Inspection The following areas should be inspected during every service: • Front panel keypad buttons, ensuring that they are not split or damaged • Cuff connectors, particularly the sealing ‘O’ rings • Display window & LCD • All areas of the enclosure •...

  • Page 57: Performance Verification

    12.1 Flow Test The flow test ensures that the pneumatic system is operating correctly, and is free from leaks and obstructions. To perform the flow test, you will need the following accessories, obtainable from Huntleigh Healthcare, Service department: •...

  • Page 58: Leak Test

    12.3.1 Overpressure Reset Test In order to perform this procedure, the following equipment is required: • Calibration input adapter SP-771541. This can be obtained from Huntleigh Healthcare Service Dept.. • Calibrated manual sphygmomanometer or equivalent. Procedure: 1. Connect the Calibration input adapter SP-771541 to the four cuff connectors on the front panel.

  • Page 59: Pressure Calibration

    Performance Verification 12.4 Pressure Calibration In order to perform this procedure, the following equipment is required: • Calibration input adapter SP-771541. This can be obtained from Huntleigh Healthcare Service Dept.. • Calibrated manual sphygmomanometer or equivalent. Procedure: 1. Connect the calibration input adapter to the four cuff connectors on the front of the unit.

  • Page 60: Hardware Monitor Test

    To make this process easy to carry out in the field we have developed an Upgrade Utility. This software program can be downloaded from the Internet, please contact the Service Department for the link. Cardiff.service@huntleigh-diagnostics.co.uk To determine the installed software version, switch the unit on, and view the first screen displayed (“dopplex ABIlity Duo Sense Technology”).
  • Page 61 5. In the status window within the Upgrade Utility, you should see the program connect to the Internet (Huntleigh cloud) and download the latest application software for the Ability unit. 6. Enter your e-mail address in the Email box and click on the ‘Read SN’ button. If the serial number cannot be read automatically from the unit then type the serial number located on the base of the Ability unit into the box.

  • Page 62: Upgrade Utility User Instructions - Non-Internet Method

    2. Contact the Huntleigh Service Department on the above link, providing the serial number of the unit(s) for upgrade. Corresponding PIN numbers for each unit will be provided to you, and our device history records will be updated.

  • Page 63: Fault Modes

    Huntleigh Service or the user’s EBME may be required.
  • Page 64 Fault Modes Figure 1 - Timing of Leak Detection (during period shown above with white background) Source of Leak Cuff Chamber Source Displayed Right Ankle Detect Right Ankle Cuff Occlusion Left Ankle Detect Left Ankle Cuff Occlusion Right Arm Detect Right Arm Cuff Occlusion Arm Cuffs...
  • Page 65 Fault Modes 14.2.2 Inflation Problem This message is displayed at any point during the test when inflation is in progress and the rate of inflation falls outside of the expected range. Figure 2 shows the applicable stages of the test, phase 2 of the ankle test is not shown for clarity, however monitoring of the inflation rate still applies.
  • Page 66 Fault Modes Figure 3: Inflation Envelope 771402-2 dopplex ABIlity Service Manual...
  • Page 67 Fault Modes 14.2.3 Cuffs Not Connected This fault is triggered upon detection of a missing cuff. This could either result from failure to connect the cuff, failing to attach cuffs to the patient or performing a test on an amputee without selecting amputee mode. This fault is detected and only generated during the initial inflation as highlighted in Figure 4 by checking the pressure in each of the cuffs at the point eight seconds after inflation begins.
  • Page 68 Fault Modes 14.2.4 Excess Pressure This fault is generated at any time during an ABPI test if the pressure in any of the detect or occlusion chambers exceeds 70 or 250 mmHg respectively. Causes of excessive pressure could result from: •...

  • Page 69: Internal Faults

    Fault Modes 14.3 Internal Faults An internal fault is generated when a section of the product hardware or software encounters a problem. Each fault is classified and dealt with according to the severity of the fault as follows: • Soft: User required to press to continue operation.
  • Page 70 Fault Modes 14.3.4 Internal Fault 004 (Hard): I C DAC Failure An attempt to write to the DAC (bleed valve control) has failed twice. The bleed valves form an essential part of the ABPI test and deflate the occlusion chambers from pressures up to 230 mmHg. This is a critical fault and the unit will not continue to function.
  • Page 71 Spare Parts Internal Test Fault Source Description Fault Code Code (FF) (SS) Arm Deflation Failure Left Ankle Deflation Failure Right Ankle Deflation Failure Arm Dump Failure Ankle Dump Failure Table 3: Test Fault Codes Notes: • Deflation failures can arise from either pneumatic failure or an excessively long deflation period in excess of 60 seconds (The later suggesting external influence).

  • Page 72: Spare Parts

    DO NOT USE A SOLDERING IRON FITTED WITH A TIP WHICH HAS BEEN USED WITH LEADED SOLDER. Orders for spare parts may be sent by post, fax, email or telephoned to Huntleigh Healthcare or approved agents or distributors.
  • Page 73 ©Huntleigh Healthcare Limited 2012 AN ARJOHUNTLEIGH COMPANY, MEMBER OF THE GETINGE GROUP ® and ™ are trademarks of Huntleigh Technology Limited As our policy is one of continuous improvement, we reserve the right to modify designs without prior notice. 771402-2...

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