Mortara AMBULO 2400 Service Manual
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Mortara AMBULO 2400 Service Manual

Amulatory blood pressure monitor
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REF 9516-182-50-ENG Rev C1
Manufactured by Mortara Instrument, Inc., Milwaukee, Wisconsin U.S.A.
CAUTION: Federal law restricts this device to sale by or on the order of a physician.
AMBULO 2400
AMULATORY BLOOD PRESSURE MONITOR
SERVICE MANUAL

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  • Page 1 REF 9516-182-50-ENG Rev C1 AMBULO 2400 AMULATORY BLOOD PRESSURE MONITOR SERVICE MANUAL Manufactured by Mortara Instrument, Inc., Milwaukee, Wisconsin U.S.A. CAUTION: Federal law restricts this device to sale by or on the order of a physician.
  • Page 2 7865 N. 86th Street Milwaukee, Wisconsin 53224 This document contains confidential information that belongs to Mortara Instrument, Inc. No part of this document may be transmitted, reproduced, used, or disclosed outside of the receiving organization without the express written consent of Mortara Instrument, Inc. Mortara is a registered trademark of Mortara Instrument, Inc. E-Scribe, ELI, ®...
  • Page 3 TECHNICAL SUPPORT AND SERVICE Sales Support/ Headquarters Supplies & Accessories Mortara Instrument, Inc. 7865 North 86th Street Mortara Instrument, Inc. Milwaukee, WI 53224 U.S.A. 7865 North 86th Street Tel: 414.354.1600 Milwaukee, WI 53224 Tel: 800.231.7437 U.S.A. Fax: 414.354.4760 Tel: 414.354.1600 Internet: http://www.mortara.com...

  • Page 4: Notices

    Equipment Identification Mortara Instrument, Inc. equipment is identified by a serial and reference number on the back of the device. Care should be taken so that these numbers are not defaced.

  • Page 5: Warranty Information

    Product/s. If Mortara should be found liable to anyone under any theory (except the expressed warranty set forth herein) for loss, harm, or damage, the liability of Mortara shall be limited to the lesser of the actual loss, harm, or...
  • Page 6 PRODUCT/S FOR ANY AND ALL LOSSES AND DAMAGES RESULTING FROM ANY CAUSE SHALL BE THE REPAIR OR REPLACEMENT OF DEFECTIVE PRODUCT/S TO THE EXTENT THAT THE DEFECT IS NOTICED AND MORTARA IS NOTIFIED WITHIN THE WARRANTY PERIOD. IN NO EVENT, INCLUDING THE CLAIM FOR NEGLIGENCE, SHALL MORTARA BE LIABLE FOR INCIDENTAL,...

  • Page 7: User Safety Information

    Inflation Pressure” above 300mmHg is entered the system will automatically enter the value of 300mmHg. Further, if a “Top Inflation Pressure” above 285mmHg is entered and sent to an AMBULO 2400 device the HDS software returned an error message. If the AMBULO 2400 device is then disconnected from the system running the HDS software, the device displays an error “SE 18”...
  • Page 8 • NIBP cuffs and hoses supplied with the Ambulo 2400 do NOT contain any Latex. If the patient develops an allergic reaction or rashes, immediately remove the cuff. •...
  • Page 9 USER SAFETY INFORMATION • Do not operate the device in conjunction with or in close proximity to other devices such as high frequency surgical instruments, defibrillators, imaging systems, or other diagnostic or therapeutic devices. Simultaneous operation may damage the device or lead to erroneous results. •...

  • Page 10: Equipment Symbols And Markings

    EQUIPMENT SYMBOLS AND MARKINGS Symbol Delineation Attention, consult accompanying documents. Indicates device has been tested for safety from vertically dripping water; specifically, it indicates DRIP PROOF, a higher than ordinary level of IPX1 protection from drips, leaks, and spills. Defibrillator-proof type BF applied part. Tested for safety by the Canadian Standards Association according to applicable U.S.

  • Page 11: Electromagnetic Compatibility (Emc)

    Operation of the equipment beyond its specified ranges, or beyond normal physiological conditions of human subjects, may cause inaccurate results. The use of accessories, transducers, and cables other than those specified by Mortara Instrument may result in increased emissions or decreased immunity of the equipment.
  • Page 12 ELECTROMAGNETIC COMPATIBILITY (EMC) Guidance and Manufacturer’s Declaration: Electromagnetic Immunity The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or the user of the equipment should ensure that it is used in such an environment. Emissions Test Compliance Compliance Level...
  • Page 13 ELECTROMAGNETIC COMPATIBILITY (EMC) Guidance and Manufacturer’s Declaration: Electromagnetic Immunity The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or the user of the equipment should ensure that it is used in such an environment. IEC 60601 Test Compliance Emissions Test...
  • Page 14 ELECTROMAGNETIC COMPATIBILITY (EMC) Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Equipment The equipment is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the equipment can help to prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the equipment as recommended in the table below, according to the maximum output power of the communications equipment.

  • Page 15: Table Of Contents

    Conformance Testing ..............................26 Conformance Test Data Record ..........................38 UNIT DISASSEMBLY Ambulo 2400 Unit Disassembly ..........................40 Ambulo 2400 Item Identification Table ........................43 Sub-Assembly BOM Listing ............................45 Screw Identification Table............................45 DEVICE SPECIFICATIONS Ambulo 2400 Specifications ............................46 TROUBLESHOOTING System Troubleshooting Chart ...........................
  • Page 16 TABLE OF CONTENTS...

  • Page 17: Device Configuration

    The device configuration settings are entered by Mortara Instrument at the time of device manufacture and are not intended to be changed by the user. Configuration settings should only be changed by authorized Mortara service personnel if a new main circuit board is being installed during service operations.

  • Page 18: Device Cleaning & Disinfecting

    MAINTENANCE & CALIBRATION Device Cleaning & Disinfecting Warning • Remove the batteries from the device before inspecting or cleaning. • Do not get the device wet or immerse in water. • Do not drop the device or subject it to shock and/or vibration. •...
  • Page 19 WARNING Certain maintenance and calibration operations of the Ambulo 2400 system, such as safety processor calibration and deflation rate calibration, should only be performed by Mortara authorized service personnel. Confidence Test •...

  • Page 20: Maintenance And Calibration Procedure

    Tiba devices also have a plastic air socket, which has since been replaced with a more durable metal design. In the event that a Tiba branded Ambulo 2400 needs service of the outer case, it is recommended that the complete case be replaced with Mortara branded plastics.
  • Page 21 PC, and retry. Once successfully configured, put the device in AUTOMATIC mode by holding the START button for 3-5 seconds. Ensure that the Ambulo 2400 shows the correct time of day (per the PC clock) and a countdown to the next scheduled measurement. Proceed to Calibration/Calibration Verification.
  • Page 22 CAUTION: Incorrectly calibrating the device will result in erroneous measurements. Only attempt to calibrate the device when absolutely certain the process can be completed successfully. UUT correct calibration setup requires the following components: • Ambulo 2400 device • Manometer/NIBP Simulator • T-connector air hose • Sphygmomanometer Manual Hand pump •...
  • Page 23 MAINTENANCE & CALIBRATION 3. Command cct.py –s com5 –m 285 (Enter) 4. Command cct.py –s com5 –c (Enter) 5. Once the calibration setup asks for pressures, enter the first as "250" mmHg. 6. Manually raise the pressure by pumping the bulb on the simulator to just above the 250 mmHg level. Watch the deflation on gage, and once it is exactly 250 mmHg, press ENTER to confirm this to the software.
  • Page 24 Clinical Dynamics AccuPulse NIBP simulator equivalent 008-0008-01 AMBULO 2400 USB cable 11070-001-50 AMBULO 2400 Hypertension Diagnostics Suite software 1. The following picture indicates the recommended setup for the components of safety processor calibration, with the fixture handle ½ way up.
  • Page 25 4. Once the simulator is correct setting. Turn on the External DC power supply. 5. Plug the USB cable into both the AMBULO 2400 and the computer. The PC must recognize the AMBULO 2400, and should install an appropriate USB-to-Serial driver. This process can be confirmed by viewing the Device Manager application under Windows Control Panel –...
  • Page 26 MAINTENANCE & CALIBRATION 11. Drop the pressure to 10 mmHg, then save the reading by entering the following command and then pressing “ENTER” exactly when the pressure is 10 mmHg. Command cct.py –s com5 --pump 1 12. Turn of the External DC power supply and disconnect the USB cable from the board. Next turn on the External power supply again.

  • Page 27: Calibration & Test Record

    MAINTENANCE & CALIBRATION Ambulo 2400 Calibration Record Unit Serial #: Incoming Firmware Version: □ Clean Device □ Device Inspection □ Pass □ Fail Communication Testing Device Calibration Yes – to version ___________ □ No Firmware Update Main Processor Calibration (Method used= □ HDS □ CCT) □...

  • Page 28: Conformance Testing

    2 AA BATTERY RECHARGEABLE NiMH • Computer workstation loaded with AMBULO programming software (TF-0827 CNR) • AMBULO 2400 Hypertension Diagnostics Suite software; P/N: 11070-001-50 • AMBULO2400 USB cable; P/N: 008-0008-01 Make sure the far left manifold switch is placed in the “Test” position.
  • Page 29 CONFORMANCE TESTING Initial Device Configuration 1. Install the batteries. (See picture below) A. Always use fully-charged rechargeable NiMH AA batteries for each ABPM procedure. B. Ensure the batteries are in the correct polarity. C. The device will beep and it should power-on when the batteries are inserted correctly. Close the battery cover.
  • Page 30 CONFORMANCE TESTING 4. Open the computers device manager screen and open Command prompt. 5. Turn on the EL374 RIGEL by press & hold until it beeps, then release. 6. Press F3 “NIBP”, verify the EL374 RIGEL displays the correct setting as shown below: Heart Rate: 80 bpm/ Systolic: 140 mmHg/ Diastolic: 100 mmHg •...
  • Page 31 CONFORMANCE TESTING 10. At the computer, the command prompt will display as below: • Go to C:\Documents and Settings\team1> Then type cd\cct as below C:\Documents and Settings\team1>cd\cct (Enter) • Go to C:\CCT> Then Type this command follow cct.py -s com5 -d as below C:\CCT>cct.py -s com5 -d (Enter) 11.
  • Page 32 CONFORMANCE TESTING Leak Testing and Pressure Sensor Test 1. UUT raise the maximum allowed pressure by issuing the following command: Command cct.py –s com5 –m 285 2. Close the dump valve by issuing the following command: Command cct.py –s com5 -- --dump 1 3.
  • Page 33 This will cause the calibration process to fail and the process must be repeated. Configuration Setup for BP Measurement Test (See connections below) Correct calibration setup requires the following components: • Ambulo 2400 device • Manometer/NIBP Simulator • T-connector air hose •...
  • Page 34 CONFORMANCE TESTING 1. On the PC go to the Hypertension Diagnostics Suite screen as below: Select “Configure Device” icon. 2. Select “Demo” Folder...
  • Page 35 CONFORMANCE TESTING 3. UUT select “Configure Device Parameters”. 4. UUT select “Send Data to ABPM Device”. 5. Select “Yes” when the window appears stating: “The entire data in the device will be erased. Do you wish to continue?”...
  • Page 36 CONFORMANCE TESTING 6. Select “OK” when the screen displays: “The device has been programmed successfully.”...
  • Page 37 CONFORMANCE TESTING BP Measurement Test 1. UUT once successfully completed, disconnect the USB cable from the device. 2. When the device is flashing PAUSE/TIME, put the device in AUTOMATIC mode by holding the START button for three to five seconds. Ensure that the AMBULO2400 shows the correct time of day (per the PC clock) and shows a countdown to the next scheduled measurement.

  • Page 38: Data Download

    CONFORMANCE TESTING Data Download 1. Connect the device via USB cable to a PC, and open the Hypertension Diagnostics Suite software. Wait 3-5 seconds for the PC to recognize the device, and click “download data from device” on the main menu. If software freezes or crashes during download, force quit the software, disconnect device, open the software, reconnect the device, and retry download.
  • Page 39 6. Indicate the testing results on the test data record. 7. Disconnect the USB cable and the tubing from the device. Safety Testing Safety testing is not required for the Ambulo 2400, unless the device is being distributed in countries INMETRO (Brazil). accredited by...

  • Page 40: Conformance Test Data Record

    CONFORMANCE TESTING Ambulo 2400 Conformance Test Record Unit Serial #: Incoming Firmware Version: □ Clean Device □ Device Inspection Leak Test (<4 mmHg drop over 10 seconds) / Pressure Sensor Test (+/- 3 mmHg) mmHg □ Pass □ Fail Deflation Rate @ 250 mmHg / Actual Input mmHg Reported mmHg □...
  • Page 41 CONFORMANCE TESTING...

  • Page 42: Unit Disassembly

    Unit Disassembly Ambulo 2400 Unit Disassembly NOTE: Unit assembly is the reverse of the disassembly procedure. Removing Bottom Cover 1. Remove the battery door and 4 T6 Torx screws from bottom cover (2 in the battery compartment). The bottom cover is now secured only by the battery connector.
  • Page 43 UNIT DISASSEMBLY Removing the Electro-mechanical Assembly and Manifold 3. Disconnect the electro-mechanical lead from the 6-pin mating connector on the PCB, and disconnect the manifold where it connects to the lower nozzle of the pump. 4. Remove the 2 screws that secure the electro-mechanical assembly to the PCB, one will be hidden under the left side of the manifold.
  • Page 44 UNIT DISASSEMBLY 5. Gently lift the right side of the electromechanical assembly (the side opposite the air socket) until you feel the manifold disconnect from the pressure sensor port on the PCB. The assembly will now be secured only by its connection to the air socket.

  • Page 45: Ambulo 2400 Item Identification Table

    UNIT DISASSEMBLY Ambulo 2400 Item Identification Table Part # Description Picture 010-0003- SUBASSY ELECTRO MECH AMBULO 2400 010-0004- SUBASSY MOTHERBOARD AMBULO 2400 500-0001- DISPLAY LCD 40x15MM 8362-005- TOP BUTTON AMBULO 2400...
  • Page 46 UNIT DISASSEMBLY Ambulo 2400 Item Identification Table Part # Description Picture 8362-007- COUPLER THREADED BARB AMBULO 2400 SUBASSY BACK COVER AMBULO 2400 010-0001- (refer to item BOM below for listing of subcomponents) SUBASSY TOP COVER AMBULO 2400 010-0002- (refer to item BOM below for listing of...

  • Page 47: Sub-Assembly Bom Listing

    010-0001-01 610-0004-01 CONNECTOR,RECEPTACLE,2P,2MM CTR,ST 3400-025 CONTACT FEMALE 24-28AWG CRIMP TIN DF3 500-0001-01 DISPLAY LCD 40x15MM 650-0001-01 TAPE DOUBLE COATED 0.8MM AMBULO 2400 7401-010 TAPE DBL COATED URETHANE FOAM 0.045x0.75 8362-001-50 TOP COVER AMBULO 2400 010-0002-01 8362-004-50 LCD BEZEL AMBULO 2400...

  • Page 48: Device Specifications

    DEVICE SPECIFICATIONS Ambulo 2400 Specifications FEATURE SPECIFICATION Dimensions 4.7 x 2.7 x 1.2" (119 x 68 x 32 mm) Weight 9.0 oz (253 g) (with batteries) Measurement Principle Patented oscillometric technique with linear deflation. Systolic: 60 to 280 mmHg Measurement Ranges...

  • Page 49: Troubleshooting

    Either the customer must calibrate the calibrated, or calibration has device using the HDS instructions been corrupted (requires a manometer - preferably digital, tubing, and a hand pump), or have serviced by Mortara. SE 1 No main processor calibration Calibrate main processor detected SE 18 Bad configuration Configure device.

  • Page 50: Device Programming

    Device Programming Programming the Main Processor Required Equipment Part number Description / Specification TF-0539 Computer workstation loaded with AMBULO2400 programming software TF-0541 Serial Cable with Spark fun LPC programmer EL109 or DC Power Supply equivalent 1. Place TF-0541 in the corresponding programming leads on the board at location P163 (see picture below).
  • Page 51 DEVICE PROGRAMMING 2. Run the Flash Magic utility, by opening the Flash Magic icon from the TF-0539 desktop. Select the appropriate COM port and a speed of 38400. Select LPC2146 for the Device, none for Interface, and 12 MHz for Oscillator. 3.

  • Page 52: Safety Processor Programming

    DEVICE PROGRAMMING Safety Processor Programming (NOTE: If the UUT continually fails the BP Measurements Test, then perform the “Programming the Safety Processor” for the main board.) (NOTE: Programing the safety Processor can be performed at the production facility due to the availability of the “Required Equipment”.) Required Equipment Part number...
  • Page 53 DEVICE PROGRAMMING 2. Ensuring the correct polarity (with the board positioned as shown below, the colored cable on the programming cable should be on the right side; see below picture), insert the AVRISP mkII header into the board at location P174. Ensure power is connected to UUT at location P379 using back cover assembly.
  • Page 54 DEVICE PROGRAMMING 5. In the Program tab indicated in the picture below, select the ‘Program’ button. Confirm that the software reported the programming has been completed successfully. 6. After programming is completed, note the firmware version provided at the bottom of the programming software window.

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