Accutorr V Service Manual
Accutorr V Service Manual
Accutorr V Service Manual
Accutorr is a registered trademark of Mindray DS USA, Inc. Masimo SET is a U.S. registered trademark of Masimo Corp. Mindray is a trademark or a registered trademark of Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Nellcor is a U.S. registered trademark of Tyco International Ltd. SmarTemp is a trademark of Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Copyright Mindray DS USA, Inc., 2009. All rights reserved. Contents of this publication may not be reproduced in any form without permission of Mindray DS USA, Inc.
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Table of Contents
Introduction ....................................................................................................................................................1 - 2 Controls and Indicators....................................................................................................................................1 - 2 System Overview ............................................................................................................................................1 - 2 Hardware Structure .........................................................................................................................................1 - 4 Main Board ............................................................................................................................................1 - 5 Power Board...........................................................................................................................................1 - 6 Key and Displays Board ...........................................................................................................................1 - 7 Parameter Boards ....................................................................................................................................1 - 8 Recorder ................................................................................................................................................1 - 10 Bar Code Scanner ...................................................................................................................................1 - 11 Introduction ....................................................................................................................................................2 - 2 NIBP Measurement .........................................................................................................................................2 - 2 Blood Pressure ........................................................................................................................................2 - 2 Static Accuracy .......................................................................................................................................2 - 2 Maximum Cuff Pressure ............................................................................................................................2 - 2 Cuff Inflation ...........................................................................................................................................2 - 3 Maximum Leakage ..................................................................................................................................2 - 3 Deflation Rate .........................................................................................................................................2 - 3 Update Period.........................................................................................................................................2 - 3 Initial NIBP Pressure Setup and Range........................................................................................................2 - 3 NIBP Measurement Cycle.................................................................................................................................2 - 4 Cuff Inflation Time....................................................................................................................................2 - 4 Automatically Adjusted Inflation Value after First Measurement......................................................................2 - 5 Pulse Rate ...............................................................................................................................................2 - 5 SpO2 Measurement ........................................................................................................................................2 - 6 DPM SpO2 Module Performance...............................................................................................................2 - 6 Masimo MS-2013 SpO2 Performance........................................................................................................2 - 7 Nellcor NELL-3 SpO2 Performance.............................................................................................................2 - 9 Temperature ...................................................................................................................................................2 - 10 Display Area, Indicator, and Controller .............................................................................................................2 - 10 Display Area...........................................................................................................................................2 - 10 Overlay and labeling ...............................................................................................................................2 - 11 Alarm Lamp ............................................................................................................................................2 - 12 Keys ......................................................................................................................................................2 - 13 Patient Cable Connectors .........................................................................................................................2 - 14 Audio Indicator ..............................................................................................................................................2 - 14 Pulse Tone Function..................................................................................................................................2 - 14 Multiple-Level Volume...............................................................................................................................2 - 14 Real-time Clock...............................................................................................................................................2 - 14 Standby Mode ...............................................................................................................................................2 - 15 Alarm Information ...........................................................................................................................................2 - 16 Basics ....................................................................................................................................................2 - 16 Alarm Notification ...................................................................................................................................2 - 16 Audio Alarm Pause, Audio Alarm Off, and Audio Alarm Silencing ................................................................2 - 16 Configuration management..............................................................................................................................2 - 16 Barcode scanner.............................................................................................................................................2 - 16 Introduction ....................................................................................................................................................3 - 2 Part Replacement ............................................................................................................................................3 - 2 Monitor Status Check ......................................................................................................................................3 - 2 Technical Alarm Check ....................................................................................................................................3 - 3 Troubleshooting Guide ....................................................................................................................................3 - 4 Power On/Off Failures ............................................................................................................................3 - 4
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Display Failure ........................................................................................................................................3 - 4 LED Digital Display and Indication Lamp Failure ..........................................................................................3 - 4 Alarm Problems ......................................................................................................................................3 - 5 Key Failure ............................................................................................................................................3 - 5 Recorder Failures.....................................................................................................................................3 - 6 Interface Failures ....................................................................................................................................3 - 6 Power Supply Failures ..............................................................................................................................3 - 6 Network Related Problems .......................................................................................................................3 - 7 Software Upgrade Problems ....................................................................................................................3 - 8 Bar Code Scanner Failures .......................................................................................................................3 - 8 NIBP Measurement Failures ......................................................................................................................3 - 9 SpO2 Measurement Failure ......................................................................................................................3 - 9 Temperature Measurement Failures ...........................................................................................................3 - 9 Tools .............................................................................................................................................................4 - 2 Preparation for Disassembly .............................................................................................................................4 - 2 Disassembly ..................................................................................................................................................4 - 3 Separating the Front and Rear Halves of the Monitor ..................................................................................4 - 3 Disassembling the Front Housing Assembly ................................................................................................4 - 6 Removing the Main Rack Assembly............................................................................................................4 - 9 Removing NIBP Module ...........................................................................................................................4 - 11 Removing the Main (CPU) Board ..............................................................................................................4 - 12 Removing the Power Board .......................................................................................................................4 - 13 Removing the Battery Connector Assembly..................................................................................................4 - 13 Removing the Fan and Speaker .................................................................................................................4 - 14 Removing the Power Socket .....................................................................................................................4 - 15 Disassembling the Temperature Module......................................................................................................4 - 16 Disassembling SpO2 Modules ...................................................................................................................4 - 17 Disassembling the NIBP Module ................................................................................................................4 - 20 Main Assembly...............................................................................................................................................5 - 2 Front Assembly (Color LCD)..............................................................................................................................5 - 3 Front Assembly (Black and White LCD) ..............................................................................................................5 - 8 Rear Housing Assembly ...................................................................................................................................5 - 12 Main Bracket Assembly ...................................................................................................................................5 - 13 NIBP Assembly (Pump M6Q-100003- - -) ...........................................................................................................5 - 16 NIBP Assembly (Pump 082-000056-00) ............................................................................................................5 - 19 Temperature Module Subassembly ....................................................................................................................5 - 22 Temperature Power Module Subassembly ..........................................................................................................5 - 24 Introduction ....................................................................................................................................................6 - 2 Test Report..............................................................................................................................................6 - 3 Recommended Frequency .........................................................................................................................6 - 3 Visual Test......................................................................................................................................................6 - 4 Power-on Test .................................................................................................................................................6 - 4 NIBP Calibration.............................................................................................................................................6 - 4 NIBP Accuracy Test .........................................................................................................................................6 - 8 NIBP Leakage Test ...................................................................................................................................6 - 9 SpO2 Test ......................................................................................................................................................6 - 12 SpO2 Test Under Normal Conditions .........................................................................................................6 - 12 SpO2 Test in Motion Mode .......................................................................................................................6 - 12 Summary of Test Methods .........................................................................................................................6 - 13 Testing the Optional Temperature Module..........................................................................................................6 - 14 Nurse Call Performance Test ............................................................................................................................6 - 16 Bar Code Scanner Test ....................................................................................................................................6 - 18
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Electrical Safety Tests ......................................................................................................................................6 - 20 Enclosure Leakage Current Test .................................................................................................................6 - 20 Earth Leakage Current Test .......................................................................................................................6 - 20 Patient Leakage Current Test .....................................................................................................................6 - 21 Patient Auxiliary Leakage Current Test........................................................................................................6 - 21 Recorder Check ..............................................................................................................................................6 - 22 Software upgrade ...........................................................................................................................................6 - 23
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Preface
Introduction
Preface
This manual provides detailed information about the assembling, disassembling, testing, and troubleshooting of the equipment to support effective troubleshooting and repair. It is not intended to be a comprehensive, in-depth explanation of the product architecture or technical implementation. Observance of the manual is a prerequisite for proper equipment maintenance and prevents equipment damage and personnel injury. Refer to the Accutorr V Operating Instructions: P/N 0070-00-0699-XX for information for operating this instrument. This manual is based on the maximum configuration. Therefore, some contents may not be applicable. For questions, contact Service. This manual is for biomedical engineers, authorized technicians, or service representatives responsible for troubleshooting, repairing, and maintaining the monitors. Contents of this manual are subject to change without prior notice. A password is required to access the service mode. The service password is 321. The Accutorr V configurations are: Accutorr V with Nellcor Pulse Oximetry includes NIBP, Nellcor SpO2, a Liquid Crystal Display (LCD), and Recorder Accutorr V with Nellcor Pulse Oximetry and SmarTemp includes NIBP, Nellcor SpO2, SmarTemp, a Liquid Crystal Display (LCD), and Recorder Accutorr V with Masimo SET Pulse Oximetry includes NIBP, Masimo SpO2, a Liquid Crystal Display (LCD), and Recorder Accutorr V with Masimo SET Pulse Oximetry and SmarTemp includes NIBP, Masimo SpO2, SmarTemp, a Liquid Crystal Display (LCD), and Recorder Accutorr V with DPM Pulse Oximetry includes NIBP, DPM SpO2, a Liquid Crystal Display (LCD), and Recorder Accutorr V with DPM Pulse Oximetry and SmarTemp includes NIBP, DPM SpO2, SmarTemp, a Liquid Crystal Display (LCD), and Recorder Accutorr V with NIBP and SmarTemp includes NIBP, SmarTemp, a Liquid Crystal Display (LCD), and Recorder Accutorr V with NIBP only includes NIBP, a Liquid Crystal Display (LCD), and Recorder All Accutorr V configurations can be upgraded with a barcode scanner. Masimo Patents: This device (MASIMO SpO2 Module) is covered under one or more of the following U.S. Patents 5,758,644, 5,823,950, 6,011,986, 6,157,850, 6,263,222, 6,501,975, and other applicable patents listed at: www.masimo.com/patents.htm. Possession or purchase of this device does not convey any express or implied license to use the device with replacement parts which would, alone, or in combination with this device, fall within the scope of one or more of the patents relating to this device.
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Introduction
Preface
Nellcor Patents: This device (Nellcor SpO2 Module) is covered under one or more of the following U.S. Patents Patent No. 5,485,847, 5,676,141, 5,743,263, 6,035,223, 6,226,539, 6,411,833, 6,463,310, 6,591,123, 6,708,049, 7,016,715, 7,039,538, 7,120,479, 7,120,480, 7,142,142, 7,162,288, 7,190,985, 7,194,293, 7,209,774, 7,400,919, and 7,212,847. Possession or purchase of this device does not convey any express or implied license to use the device with replacement parts which would, alone, or in combination with this device, fall within the scope of one or more of the patents relating to this device.
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Introduction
Warnings
WARNING: Internal Electrical Shock Hazard - This unit does not contain any user-serviceable parts. Do not remove instrument covers. Refer servicing to qualified personnel. When the integrity of the protective earth conductor, in the installation or its arrangement, is in doubt, the equipment should be operated from its internal battery. Observe all CAUTION and WARNING labels on the unit. WARNING: Possible explosion hazard. Do not operate machine near flammable anesthetic agents or other flammable substances. Do not use flammable anesthetic agents (i.e., ether or cyclopropane.) WARNING: Always place the unit on a flat, rigid surface or onto a Mindray approved stable mounting bracket. WARNING: To ensure proper performance and safety and to prevent the voiding of the warranty, only use authorized parts and accessories with the Accutorr V. Use of unauthorized accessories may result in erroneous readings. WARNING: Use only cuffs with approved quick connect type connectors. WARNING: The Accutorr V is not intended for use in a magnetic resonance imaging (MRI) environment and may interfere with MRI procedures. WARNING: Danger of explosion if battery is incorrectly replaced. Replace only with the same or equivalent type recommended by the manufacturer. Dispose of used batteries according to the manufacturers instructions and local regulations. Batteries used in this device may present a risk of fire or chemical burn if mistreated. Do not incinerate battery, possible explosion may occur. WARNING: Do not use a damaged or broken unit or accessory. WARNING: Operation of the Accutorr V below the minimum amplitude or value of patient physiological signal may cause inaccurate results.
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Introduction
Cautions
WARNING: Use of accessories, transducers, and cables other than those specified in the manual may result in increased Electromagnetic Emissions or decreased Electromagnetic Immunity of the Accutorr V. It can also cause delayed recovery after the discharge of a cardiac defibrillator. WARNING: Perform the decontamination or cleaning process with the unit powered down and power cord removed. WARNING: Electrical safety tests are a proven means of verifying the electrical safety of the monitor. They are intended for determining potential electrical hazards. Failure to identify these hazards in a timely manner may cause personnel injury. WARNING: Commercially available test equipment such as a safety analyzer can be used for electrical safety tests. Verify that the test equipment can be safely and reliably used with the monitor before use. The service personnel should acquaint themselves with the use of the test equipment. WARNING: Electrical safety tests should meet the requirements of the latest editions of EN 60601-1 and UL 60601. WARNING: These electrical safety tests do not supersede local requirements. WARNING: All devices using the AC mains and connected to medical equipment within patient environments must meet the requirements of the IEC 60601-1-1 medical electrical systems standard and should be put under electrical safety tests at the frequency recommended for the monitor.
Cautions
CAUTION: Observe extreme caution when a defibrillator is in use. Do not touch any part of the patient, table, or monitor when a defibrillator is in use. The Accutorr V should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Accutorr V should be observed to verify normal operation in the configuration in which it will be used. The unit should be checked periodically for obstructed vents. If an obstruction is found, refer the unit to qualified service personnel. At the end of their life, dispose of the Accutorr V, accessories, and single use supplies in accordance with local regulations. Dispose of packaging waste in accordance with local regulations. When equipped with Nellcor SpO2, use only Nellcor oxygen transducers including Nellcor Oxisensor patient dedicated adhesive sensors. Use of other oxygen transducers may cause improper oximeter performance. When equipped with MASIMO SpO2, use only MASIMO oxygen transducers including MASIMO LNOP and MASIMO LNCS patient dedicated adhesive sensors and MASIMO PC Series Patient Cable. Use of other oxygen transducers may cause improper Oximetry performance.
CAUTION:
CAUTION:
CAUTION:
CAUTION:
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Cautions
Introduction
CAUTION:
Inaccurate readings may be caused by incorrect sensor application or use; significant levels of dysfunctional hemoglobins (i.e. carbohemoglobins or methemoglobin); or intra-vascular dyes such as indocyanine green or methylene blue; exposure to excessive illumination, such as surgical lamps (especially ones with a Xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, or direct sunlight; excessive patient movement; venous pulsations; electro-surgical interference; and placement of a sensor on an extremity that has a blood pressure cuff, arterial catheter, or intra-vascular line. Route cables neatly. Ensure cables, hoses, and wires are kept away from patients neck to avoid strangulation. Keep floors and walkways free of cables to reduce risk to hospital personnel, patients, and visitors. If the sensor or patient cable is damaged in any way, discontinue use immediately. When cleaning sensors, do not use excessive amounts of liquid. Wipe the sensor surface with a soft cloth, dampened with the cleaning solution. To prevent damage, do not soak or immerse the sensor in any liquid solution. DO NOT ATTEMPT TO STERILIZE. Recharge the Lithium ion battery while in the unit at room temperature. If using the Accutorr V in a hot environment, the Lithium ion battery may not charge when the unit is connected to the AC mains. Remove the battery if the Accutorr V is not used for an extended period of time. The Communications Connectors on the Accutorr V are only for use with IEC 60601-1-1 compliant equipment. Never place fluids on top of this monitor. If fluid spills on the unit, wipe clean immediately and refer the unit to qualified service personnel. Before disassembling the monitor, eliminate static charges. When disassembling the parts labeled with static-sensitive symbols, wear electrostatic discharge protection such as antistatic wristband or gloves. Follow the correct sequence to disassemble the monitor. Otherwise, the monitor may be damaged permanently. Disconnect all the cables before disassembling any parts. Take care not to damage any cables or connectors. Properly connect the cables or wires when reassembling the monitor to avoid short circuit. When assembling the monitor, select proper screws. If the wrong size screw is tightened by force, the monitor may be damaged and the screw or the part may not function as expected. All tests should be performed by qualified personnel only. Disconnect the monitor from the patient and make sure that important data is saved before upgrading the monitor. Do not shut down or power off the equipment when upgrading the bootstrap program. Otherwise, it may cause the equipment to break down.
CAUTION:
CAUTION:
CAUTION:
CAUTION:
CAUTION:
CAUTION:
CAUTION:
CAUTION:
CAUTION: CAUTION:
CAUTION:
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Introduction
Notes
CAUTION:
Notes
NOTE: The Accutorr V should be operated only by trained and qualified personnel. Use disposable and single use accessories only once. Place the equipment in a location where the screen can easily be seen and the operating controls can easily be accessed. The instructions in this manual are based on the maximum configuration. The optional Temperature module kit must be installed only by trained personnel, and proper ESD prevention methods must be followed. Only devices specified by Mindray DS USA, Inc. shall be connected the RS-232 port When the RS-232 connector is used for DIAP, barcode power must be set to OFF. Disconnect the Accutorr V from the mains to isolate it from the mains power during an emergency. NOTE: NOTE:
NOTE:
NOTE:
NOTE:
NOTE:
NOTE:
Safety Designations
Safety designations per IEC 60601-1 Standard: Type of protection against electric shock Class 1 with internal electric power source. Where the integrity of the external protective earth (ground) in the installation or its conductors is in doubt, the equipment shall be operated from its internal electric power source. Degree of protection against electric shock Monitor - Type B applied part. NIBP - Type BF defibrillation protected applied part. SpO2 - Type BF protected applied part. Temp - Type BF protected applied part. Supply Connection 100 240 VAC 50/60 Hz 0.85 0.5 A Mode of Operation Continuous
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Product Limitations
Introduction
Protection Against Hazard of Explosion Protection Against Ingress of Liquids Degree of Electrical Connection Between Equipment and Patient Degree of Mobility
Not Protected (Ordinary) IPX1 Equipment designed for direct electrical and non-electrical connection to the patient. Portable
Product Limitations
Non-invasive blood pressure (NIBP) accuracy depends on the application of the proper cuff size. See Chapter 3.0 of the Operating Instructions for detailed information. The Accutorr V will not operate effectively on patients who are experiencing convulsions or tremors. The Accutorr V is a portable device intended for intra-hospital use. If the pressure cuff is not placed at the patients heart level, the NIBP measurement may be subject to error, due to the hydrostatic effect. The pulse rate data displayed on the Accutorr V is computed from the measurement of peripheral pulses (peripheral pulses taken only during a measurement cycle). The rate measured by the Accutorr V may differ from the rate of an ECG monitor. This is because the ECG is an electrical signal that may not always result in a peripheral pulse. Administration of certain vasoconstrictor drugs (for example, norepinephrine), may reduce peripheral perfusion to a level that prevents the Accutorr V from taking pulse rate measurements. Arterial compression, tricuspid regurgitation, or other conditions may reduce perfusion to a level that prevents the Accutorr V from taking pulse rate measurements. The presence of arrhythmias may increase the time required to complete a measurement and may extend this time so that a measurement cannot complete. The Accutorr V is not intended for use during CPR. The monitor uses an oscillometric technique based on normal peripheral circulation to compute blood pressure.
Unpacking
Remove the instrument from the shipping carton and examine it for signs of shipping damage. Save all packing materials, invoice, and bill of lading. These may be required to process a claim with the carrier. Check all materials against the packing list. Contact the Customer Service Department (800) 288-2121 or (201) 265-8800 for prompt assistance in resolving shipping problems.
NOTE: The Accutorr V should only be shipped in its original packing materials to avoid shipping damage.
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Introduction
Attention, Consult Accompanying Documents / Refer to Manual Equipotentiality Equipotential grounding Defibrillator-proof Type BF Equipment Type BF Equipment
Adult
T1 SpO2
Pediatric/Child
Neonate
Manufacturer
NIBP Connector
Recycle
Serial number
Up key
REF
Part Number
Confirm key
Down key
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Introduction
SYMBOL
DESCRIPTION
SYMBOL
DESCRIPTION
NC1
Nurse Call connector RS-232 connector (Serial Port 1) Network connector Alarm Disabled indicator on LCD display Audio Alarm Off indicator on LCD display
SP1
CS1
Classified by Underwriters Laboratories Inc. with respect to electric shock, fire and mechanical hazards, only in accordance with UL 60601-1, CAN/CSA C22.2 NO.601-1, IEC 60601-1-1, IEC 60601-2-30, IEC 60601-2-49.
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1.0
Theory of Operation
Introduction.................................................................................................... 1-2 Controls and Indicators ................................................................................... 1-2 System Overview............................................................................................ 1-2 Hardware Structure......................................................................................... 1-4
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1-1
Introduction
Theory of Operation
1.1
Introduction
The Accutorr V monitors the following patient vital signs: non-invasive blood pressure (NIBP), pulse oxygen saturation (SpO2), pulse rate (PR), and temperature (Temp) for a single adult, pediatric, or neonatal patient. Temperature is measured using the optional Temperature Module.
1.2 1.3
System Overview
FIGURE 1-1 shows the relationship of the Accutorr V monitoring systems mechanical, hardware, and software components. FIGURE 1-2 shows the Accutorr V monitoring systems PC board connections. SYSTEM
MECHANICAL
HARDWARE
MAIN UNIT
MAIN BOARD
RECORDER
POWER BOARD
PARAMETER SOFTWARE
UPGRADE SOFTWARE
PARAMETER BOARDS
PRINT SOFTWARE
RECORDER BOARD
GATEWAY SOFTWARE
BARCODE SCANNER
1-2
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Theory of Operation
System Overview
PARAMETER RECEPTACLE
J1 SpO2 J2
J2 TEMP J4 NIBP J2
J2 J1 J1 J7 POWER P3 P5 J6
J2
J4
J5
J11
J12
J13
RS232
J3
J4
J5
NURSE CALL
AC INLET
FAN
BATTERY LCD
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1-3
Hardware Structure
Theory of Operation
1.4
Hardware Structure
FIGURE 1-3 shows the Accutorr Vs Hardware Structure. The core of the system is the main board, which supplies power for all parameter modules. The parameter modules directly communicate with the main board. The the main board processes measurements and the status of all modules, and displays them through the key and display board.
NIBP MODULE
SpO2 MODULE
TEMP MODULE
ISOLATION POWER BOARD COMMUNICATIONS /POWER SUPPLY LED & KEY KEY & DISPLAY BOARD
ETHERNET
LCD
MAIN BOARD
RS232
POWER SUPPLY
NURSE CALL
SPEAKER
RECORDER
1-4
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Theory of Operation
Hardware Structure
1.4.1
Main Board
FIGURE 1-4 shows the main board, which provides resources and support for the overall system. It controls the LCD, LED, keyboard, speaker, and recorder. It also communicates with parameter modules and connectors. The main board also controls communication with the speaker, the recorder, and all external connectors.
PHY RTL8201
CPU
AUDIO PROCESS CIRCUIT
SDRAM 1.5V
FLASH
FPGA
LINEAR POWER
3.3V
5.0V
12V
LCD
LED
KEY
FIGURE 1-4 Main Board Principle Diagram The main board communicates with all parameter modules and the recorder through an FPGA extended serial port. The main board supplies information using FPGA to the key and display board. It drives the display, detects the keys, and implements the user interface. The main board controls the alarm indicator using FPGA. The main board controls the speaker to give audible alarms, key tones, and Pitch Tone. The main board provides the nurse call connection, network connection, and R232 connection. The real-time clock is implemented by the RTC chip. The RT clock is powered by the AC mains, battery, or button cell on the main board. The button cell ensures the continuous working of the clock in the event that the AC mains and batteries are not available. SDRAM stores running program instructions and data temporarily. The system memory and trend data memory is flashed. The device configuration memory is EEPROM.
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1-5
Hardware Structure
Theory of Operation
1.4.2
Power Board
The power board, shown in FIGURE 1-5, converts the input power (AC mains or battery) to different working voltages for other boards. It also charges the battery.
16.8V AC INPUT EMI FILTER RECTIFIER & FILTER FLYBACK CONVERTER RECTIFIER & FILTER DC/DC CONVERTER 12V OUTPUT
0VP&0CP
DC/DC CONVERTER CURRENT DETECTION PMW CONTROLLER COUPLER FEEDBACK & ISOLATION CIRCUIT CHARGING CIRCUIT 0VP&0PP
5V OUTPUT
BATTERY
DC/DC CONVERTER
3.3V OUTPUT
SWITCH CIRCUIT
0VP&0CP
PCON
FIGURE 1-5 Power Board Principle Diagram The AC flows through the EMI filter and the rectifier and filter. The rectifier and filter converts the AC to 16.8V DC voltage by the Flyback converter. The 16.8V DC voltage is the main input to the DC/DC converters and charging circuit. The DC/DC converters convert 16.8V DC to 12V, 5V, and 3.3V DC. The charging circuit charges the lithium battery. When the Accutorr V is not connected to the AC mains, the battery supplies power to the DC/DC converters. The 16.8V DC output is protected against over-voltage and over-power. The 12V, 5V, and 3.3V DC outputs are protected against over-voltage, short-circuit, and overcurrent.
1-6
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Theory of Operation
Hardware Structure
1.4.3
LCD SIGNAL
LED
CPLD
LED&KEY
3.3V DISABLE
START-UP CIRCUIT
KEY MATRIX
Switch
DETECTION
FIGURE 1-6 Key and displays Board Principle Diagram The LCD module adjusts contrast and brightness (only for black-and-white LCD display).
NOTE: The monitor with color LCD does not have a Contrast setting item in the common setup menu.
The 7-segment digit units display parameter data. The AC indicator is driven by the ADV output from the power board, and the working status indicator (built in the Power On/Off key) is driven by 3.3V voltage. The battery indicator is jointly controlled by the flash control signal, ADV signal, and VBC signal. The keypad contains the power ON/OFF key and the other 13 function keys.
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1-7
Hardware Structure
Theory of Operation
1.4.4 1.4.4.1
CPU
FLASH LED DRIVE CIRCUITRY
OFFSET DAC
OFFSET AMPLIFIER
FIGURE 1-7 SpO2 Module Principle Diagram The SpO2 sensor collects the pulsing red and infrared light signals transmitting through the finger or toe, and processes the collected signals to create the measured result. The SpO2 module controls the LED drive circuit and the amplifying circuit gain corresponding to the finger or toe perfusions and transmittances.
1-8
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Theory of Operation
Hardware Structure
1.4.4.2
NIBP Module
FIGURE 1-8 shows the NIBP module parameter board diagram.
PRESSURE SIGNAL AMPLIFIER CIRCUITS FOR PROTECT
CUFF
WATCHDOG
CPU
PRESSURE SENSOR
PRESSURE SIGNAL
A/D CONVERTER
MANIFOLD
FLASH
DRAM
FIGURE 1-8 NIBP Module Principle Diagram The Accutorr V calculates NIBP values using the oscillometric method of noninvasive blood pressure measurement. These measurements correspond to comparisons with auscultatory values, measured using the fifth Korotkoff sound within ANSI/AAMI SP10 standards for accuracy.
1.4.4.3
A/D CIRCUIT
MAIN BOARD
FIGURE 1-9 Optional Temperature Module Principle Diagram The Temperature Module uses a thermistor as a sensor for measuring temperature. The resistance of a given thermistor is nonlinearly relative to the temperature. The Temperature Module measures the resistance of the thermistor and converts it into temperature.
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1-9
Hardware Structure
Theory of Operation
1.4.5
Recorder
The recorder receives data from the main board and sends it to the thermal printhead for printing. It has a button to start or stop printing and a green LED to indicate the presence or absence of paper.
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Theory of Operation
Hardware Structure
1.4.6
Basic settings of the bar code scanner are listed in the following table:
HOST PARAMETERS Baud Rate Data Bits Stop Bits Calibration bit Handshaking BAR CODE SCANNER 9600 8 1 0 None FACTORY DEFAULT 9600 8 1 0 None
USER PARAMETERS Beeper Tone Beeper Volume Trigger Mode Parameter Scanning
DATA FORMAT Prefix Value Suffix 1 Value Suffix 2 Value Scan Data Transmission Format
BAR CODE SCANNER 7013 <CR><LF> 7013 <CR><LF> <PREFIX><DATA><SUFFIX 1><SUFFIX 2>
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1 - 11
Hardware Structure
Theory of Operation
To change parameter settings, scan the following bar codes in sequence. 1. Set parameter defaults:
1 - 12
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Theory of Operation
Hardware Structure
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1 - 13
Hardware Structure
Theory of Operation
1 - 14
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2.0
Specifications
Introduction.................................................................................2-2 NIBP Measurement ......................................................................2-2 NIBP Measurement Cycle .............................................................2-4 SpO2 Measurement.....................................................................2-6 Temperature ................................................................................2-10 Display Area, Indicator, and Controller ..........................................2-10 Audio Indicator ...........................................................................2-14 Real-time Clock ...........................................................................2-14 Standby Mode ............................................................................2-15 Alarm Information........................................................................2-16 Configuration management ..........................................................2-16 Barcode scanner .........................................................................2-16
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2-1
Introduction
Specifications
2.1
Introduction
The Accutorr V monitors patient vital signs (including non-invasive blood pressure (NIBP), pulse oxygen saturation (SpO2), and pulse rate (PR)) for a single adult, pediatric, or neonatal patient. It also monitors oral or rectal mode temperature (Temp) for a single adult or pediatric patient; or axillary mode temperature for a single neonate, adult, or pediatric patient using the optional Temperature Module.
2.2
NIBP Measurement
The NIBP module is used to measure the systolic pressure, diastolic pressure, and mean pressure in the neonatal, pediatric, and adult modes. The Accutorr V calculates NIBP values using the oscillometric method of noninvasive blood pressure measurement. These measurements correspond to comparisons with auscultatory values, measured using the fifth Korotkoff sound within ANSI/AAMI SP10 standards for accuracy.
2.2.1
Blood Pressure
PARAMETER Systolic pressure measurement PATIENT SIZE Adult Pediatric Neonate Adult Pediatric Neonate Adult Pediatric Neonate Mean error: <5 mmHg Standard deviation: <8 mmHg RANGE 55 235 mmHg 55 160 mmHg 45 120 mmHg 30 200 mmHg 30 150 mmHg 20 100 mmHg 30 235 mmHg 30 160 mmHg 20 120 mmHg
Measurement accuracy
2.2.2
Static Accuracy
Measurement range: Static pressure measurement accuracy: 0 300 mmHg 3 mmHg
2.2.3
2-2
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Specifications
NIBP Measurement
Single Fault Over-pressure protection In single fault conditions, the hardware controls the cuff deflation to prevent the cuff pressure from exceeding the following ranges: Adult Pediatric Neonate 330 mmHg 220 mmHg 165 mmHg
2.2.4
Cuff Inflation
The Non-Invasive Blood Pressure inflation source brings a volume of 200 ccs to a pressure of 300 mmHg in less than or equal to 10 seconds
2.2.5
Maximum Leakage
The Non-Invasive Blood Pressure Cuff driver allows a pressure drop to be, at most, 1 mmHg in 10 seconds as measured with a 200 cc volume at differential pressures of 250 mmHg, 150 mmHg, and 50 mmHg.
2.2.6
Deflation Rate
The Non-Invasive Blood Pressure Cuff venting mechanism in adult mode vents a volume of 500 cc, reduced from a pressure of 260 mmHg to a pressure of 15 mmHg in a maximum of 10 seconds. The Non-Invasive Blood Pressure Cuff venting mechanism in neonatal mode vents a volume of 500 cc, reduced from a pressure of 150 mmHg to a pressure of 5 mmHg in a maximum of 5 seconds.
2.2.7 2.2.8
Update Period
The Non-Invasive Blood Pressure Parameter has an update period of one (1) second.
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Specifications
2.3
The maximum adult and pediatric measurement cycle is 180 seconds. The maximum neonatal measurement cycle is 90 seconds. The NIBP module adjusts the inflation pressure automatically according to the systolic pressure of the last measurement. If the first measurement is unsuccessful, the subsequent inflation pressures change to 50 mmHg higher than the previous systolic pressure in adult or pediatric mode, and 40 mmHg higher than the previous systolic pressure in neonate mode. (The subsequent inflation pressure should be greater than the systolic pressure in the previous measurement).
2.3.1
2.3.1.1
NUMBER OF RETRIES 3 3
NUMBER OF RETRIES 3
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Specifications
2.3.2
2.3.3
Pulse Rate
Accuracy: 3 BPM or 3%, whichever is greater. Resolution: 1 BPM
PATIENT TYPE Adult Pediatric Neonate PULSE RANGE 35 245 BPM 35 245 BPM 70 245 BPM
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SpO2 Measurement
Specifications
2.4
SpO2 Measurement
When configured with the DPM SpO2 module, NELLCOR NELL-3 SpO2 module, or MASIMO MS-2013 SpO2 module, the Accutorr V can perform SpO2 measurements. The SpO2 measurement function complies with the requirements of ISO9919.
2.4.1
2.4.1.1
SpO2
Range: 0 100% Resolution: 1% Accuracy in the static condition:
SPO2 RANGE PATIENT TYPE Adult or pediatric Neonate 70% TO 100% 2 digits 3 digits 0 69% Undefined Undefined
2.4.1.2
Pulse Rate
Range: 20 254 BPM Resolution: 1 bpm Accuracy in the static condition:
PATIENT TYPE Adult / Pediatric / Neonate PR RANGE 20 254 bpm ACCURACY 3 digits
2.4.1.3
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Specifications
SpO2 Measurement
2.4.2
2.4.2.1
SpO2
Compatible Sensors: See Section 6.6 for a list of compatible sensors. Measurement range: 1 100% Resolution: 1% Accuracy no motion conditions:
PATIENT TYPE Adult Pediatric Neonate SPO2 RANGE: 70% 100% 2 digits 2 digits 3 digits SPO2 RANGE: 1% 69% Undefined Undefined Undefined
SpO2 response time: Under the condition that the PR is 75 BPM and the averaging is 8 seconds, the maximum response time for the SpO2 value to increase from 60% to 95% is 20 seconds. Low Perfusion Performance:
LOW PERFUSION CONDITION PULSE AMPLITUDE > 0.02% % LIGHT TRANSMISSIBILITY > 5% SPO2 ACCURACY 2 digits PR ACCURACY 3 digits
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SpO2 Measurement
Specifications
2.4.2.2
Pulse Rate
Resolution: 1 BPM Update frequency: 1 Hz Range and Accuracy:
The Masimo MS-2013 pulse oximeter with an LNOP- Adt sensor was validated for no motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies in the range of 70% to 100% SpO2 against a laboratory co-oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population. The Masimo MS-2013 pulse oximeter with LNOP- Adt sensor has been validated for motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies while performing rubbing and tapping motions at 2 to 4 Hz. At an amplitude of 1 to 2 cm and non-repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3cm in induced hypoxia studies in the range of 70% to 100% SpO2 against a laboratory co-oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population. The Masimo MS-2013 pulse oximeter with LNOP-Neo and Neo Pt sensors has been validated for neonatal motion accuracy in human blood studies on neonates while moving the neonates foot at 2 to 4 Hz at an amplitude of 1 to 2 cm against a laboratory co-oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population. The Masimo MS-2013 pulse oximeter has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and Masimos simulator with signal strengths of greater then 0.02% and transmission of greater than 5% for saturations ranging from 70 to 100%. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population.
2.4.2.3
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Specifications
SpO2 Measurement
2.4.3
2.4.3.1
SpO2
Compatible Sensors: See Section 6.6 for a list of compatible sensors Measurement Range and Accuracy:
ACCURACY1,2 SENSOR MAX-A, MAX-P, and MAX-I OxiCliq A, OxiCliq N, OxiCliq P and OxiCliq I D-YS, DS-100A, OXI-A/N and OXI-P/I MAX-R, D-YSE and D-YSPD 1 70% 100% 2% 2.5% 3% 3.5% 0% 69% Undefined Undefined Undefined Undefined
When sensors are used on neonatal subjects as recommended, the specified accuracy range increases by 1 digit, to account for the theoretical effect on oximeter measurements of fetal hemoglobin in neonatal blood. Neonatal accuracy specifications are based upon testing neonatal sensors on healthy adult volunteers in induced hypoxia studies, in the range of 70-100% SpO2. The specified accuracy also takes into account published literature which predicts that there may be a small difference in % SpO2 reported by the oximeter when measurements from adult and fetal blood with 100% fetal hemoglobin are compared. Fetal hemoglobin is present in concentrations varying from 10% to 90% in neonatal blood, and this percentage declines over time. As the percentage of fetal hemoglobin in neonatal blood declines, the theoretical effect on accuracy due to this source is reduced
2.4.3.2
Pulse Rate
MEASUREMENT RANGE 20 250 BPM 251 300 BPM ACCURACY 3 BPM Undefined
2.4.3.3
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Temperature
Specifications
2.5
Temperature
MODE monitor MEASUREMENT RANGE 25 C 44 C (77 F 111.2 F)
ACCURACY 25 C (77 F) 32 C (89.6 F), not including 32 C (89.6 F) 32 C (89.6 F) 44 C (111.2 F), including 32 C (89.6 F) 0.2 C (0.4 F)
0.1 C (0.2 F)
predict
35 C 43 C (95 F 109.4 F)
Not defined
2.6
2.6.1
Display Area
The display area includes 1 LCD, 7 groups of 7-segment digit display, and 7 groups of monochrome LED indicators.
2.6.1.1
LCD
DISPLAYED CONTENTS Startup screen, menus/ dialogs, time and date, prompt messages, patient ID, patient size, trend data (including scroll bar), SpO2 waveform, and time to the next NIBP measurement Startup screen, menus/ dialogs, time and date, prompt messages, patient ID, patient size, trend data (including scroll bar), SpO2 waveform, and time to the next NIBP measurement
Color TFT
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Specifications
2.6.1.2
2.6.1.3
2.6.1.4
Power Indicator
AC power indicator Green LED Illuminates when the Accutorr V is connected to the AC mains. Battery indicator Green LED Illuminates when the unit is on and the battery is inserted. Flashes when the battery voltage is too low. On/Standby indicator Green LED Illuminates when the device is powered on or in standby mode. Darkens when the device is shut down.
2.6.2
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Specifications
2.6.3
Alarm Lamp
The monitor provides 2 alarm priority levels: high level alarms or low level alarms. The Alarm lamp is on the front panel of the monitor. It is a group of (red/yellow) LED indicators. During a high alarm, the red LED, of which the duty cycle is 50%, flashes at a frequency of 1.4 2.8 Hz (84 times per minute). During a low alarm, the yellow LED illuminates continuously. In case a high alarm and a low alarm occur simultaneously, only the red LED flashes.
NOTE: The audio alarm indication complies with EN60601-1-8.
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Specifications
2.6.4
Keys
There are 14 keys on the front panel of the monitor.
KEYS
DESCRIPTION Turn the monitor on, off, or switch to standby. In the operating state, press and hold for less than 1 second to switch the device to the standby or press and hold for 2s to turn the device off. Press to start an NIBP measurement. During an NIBP measurement, stops the measurement. Also, suspends interval mode until the next time NIBP Start is pressed. Start recording trend data/real-time waveform. Press again to stop recording. When recording trend data, press and hold for less than 1 second to record the current data displaying on the LCD, or press and hold for 2 seconds to record all data of the current patient. This button has dual functions: Press and hold for less than 1 second to pause an audio alarm (parameters in alarm continue to flash). Press and hold for 2 seconds to silence an alarm. Sets alarm parameters. Sets the measurement mode and time interval. Option: STAT mode, Off, and interval mode (options: 1, 2, 3, 5,10, 15, 20, 30, 60, 120, and 240 minute intervals). In the Off mode, perform measurement manually. Press to view the menu options. Press to switch between the normal views, PLETH waveform. Press to automatically create a patient ID. Press to change patient size Press to perform menu operations on the LCD.
Silence
Set Alarms
Interval
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Audio Indicator
Specifications
2.6.5
DESCRIPTION The NIBP cuff connector label is The SpO2 connector label is SpO2. Connects the DPM, Masimo, or Nellcor cable. The Label is SpO2 with the manufacturer name. Apply standard round DPM 6 pin connector (same as used on Trio) to the monitor configured with the DPM SpO2 board. Apply the Masimo connector to the monitor configured with the MS-2013 SpO2 board. The monitor configured with the Masimo SpO2 board must be labeled with the Masimo SET registered trademark. Apply the Nellcor connector to the monitor configured with the Nell-3 SpO2 board. The monitor configured with the Nellcor SpO2 board must be labeled with the Nellcor mark. Uses optional Mindray Smartemp predictive temperature module. The connector of temperature probe (oral/axillary or rectal) is labeled T1. The oral/axillary probe is blue, and the rectal probe is red. .
Temperature probe
2.7
Audio Indicator
A built-in speaker sounds audio alarms, button tones, and pulse tones. The Accutorr V supports pitch tone and multiple-level volume.
2.7.1
2.7.2
Multiple-Level Volume
There are 11 alarm levels. The alarm may be disabled or set to a level between 1 and 10.
2.8
Real-time Clock
Range Accuracy Resolution 0:0:0, 2001 23:59:59, 2099 At 21 3o C, 1 min/month 1 second
The real-time clock is powered by an independent battery and functions when the device is powered off.
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Specifications
Standby Mode
2.9
Standby Mode
To enter the standby mode, the monitor must be disconnected from the patient and receive no physiological signals from a patient with no low-battery alarm. To enter the standby mode, press and confirm the operation in the pop-up dialog. After the monitor enters the standby mode: The LCD and the LEDs no longer display data. The SYS. LEDs Display flashes . The current monitoring configuration and history data are saved. All current alarms are cleared. The NURSE CALL function is disabled. The NURSE CALL function is re-enabled when the monitor resumes in normal mode. The connection with the central monitoring system stays the same as before entering the standby mode. To resume normal mode: 1. Press any key on the front panel. 2. Confirm the resume operation at the confirm dialog. After confirming the resume operation, the monitor exits the standby mode and enters the normal mode. If the operation is not confirmed within 30 seconds, the system automatically selects Cancel, and the monitor stays in the standby mode. In the following conditions, the monitor exits the standby mode and enters the normal mode: The monitor receives SpO2 physiological signals for 5 seconds. The predictive temperature sensor is removed from its sheath. The monitor is powered by battery, and a low-battery alarm occurs. Once the monitor enters the normal mode: The alarm function is re-enabled. The history data, patient information, and other settings from before the monitor entered the standby mode are restored. Data communication is restored. The LCD displays. The LEDs display parameter data. Saving trend data starts.
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Alarm Information
Specifications
2.10
2.10.1
Alarm Information
Basics
There are two types of alarms: Physiological alarms: The physiological parameters of the monitored patient exceed the specified ranges, or the physiological exceptions of the patient cannot be judged according to a single physiological parameter. Technical alarms: The patient cannot be monitored normally and accurately due to faults in manual operation, technical faults, or faults in the monitor. The high priority alarm indicates only physiological alarms and a low battery alarm. The low priority alarm indicates only technical alarms, other than low battery. The Accutorr V provides functionality for selecting the upper limit and lower limit of each physiological alarm.
2.10.2
Alarm Notification
1. When an alarm occurs, the system notifies the user through the speaker, alarm indicator, relevant 7-segment LED digit displays, and LCD status bar. 2. When alarms of multiple levels occur simultaneously, the system notifies the user of the alarm with the highest level through the speaker and alarm indicator. 3. If the hospital Nurse Call system is available and connected to the monitor, the user can be notified of relevant alarms through the Nurse Call system.
2.10.3
Audio Alarm Pause, Audio Alarm Off, and Audio Alarm Silencing
The monitor provides functionality for pausing (disabling) an audio alarm for 120 seconds. After 120 seconds, the audio alarm notification functionality resumes. The user can resume the audio alarm notification at any time. An alarm causes the monitor to terminate the paused state. The monitor provides the ability to turn the audio alarm off globally. During audio alarm off, a remind signal reminds the user every minute. The monitor provides the ability to silence an alarm. The monitor automatically exits the alarm silenced status if a new technical or physiological alarm occurs.
2.11
Configuration management
The monitor provides a factory configuration and a user configuration. The monitor loads the selected configuration when it is switched on. If no user configuration exists, the factory configuration is automatically loaded.
2.12
Barcode scanner
The monitor can admit a patient using the barcode scanner.
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3.0
Troubleshooting
Introduction.................................................................................................... 3-2 Part Replacement............................................................................................ 3-2 Monitor Status Check ...................................................................................... 3-2 Technical Alarm Check.................................................................................... 3-3 Troubleshooting Guide .................................................................................... 3-4
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3-1
Introduction
Troubleshooting
3.1 3.2
Introduction
This chapter details potential monitor issues with possible causes and corrective actions. For additional information on troubleshooting, contact service.
Part Replacement
Printed circuit boards (PCBs), major parts, and components in the monitor are replaceable. Isolate a PCB suspected to be defective, follow the instruction to replace it, and retest. If the trouble remains, exchange the replacement PCB with the original suspicious PCB and continue troubleshooting as directed in this chapter.
3.3
FIGURE 3-1 3.
3-2
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Troubleshooting
Example VERSION dialog or to highlight TOTAL RUN TIME or MODULE VERSION. to display the data.
3.4
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3-3
Troubleshooting Guide
Troubleshooting
3.5
3.5.1
SYMPTOMS
Troubleshooting Guide
Power On/Off Failures
POSSIBLE CAUSE AC mains not connected or battery too low Power supply protection Cables defective or poorly connected CORRECTIVE ACTIONS Confirm that the AC mains is properly connected and that the battery capacity is sufficient. Refer to Power Supply Failures. Confirm that the cables from the power switch and the LED board to the keyboard, keyboard to the main board, and the power module to the main board are correctly connected. Confirm that the cables and connectors are not damaged.
The monitor fails to start. AC LED or battery LED does not light
Power switch and LED board defective Power module defective Main board Defective
Replace the power switch and LED board. Replace the power module. Replace the main board.
3.5.2
SYMPTOMS
Display Failure
POSSIBLE CAUSE Cables defective or poorly connected CORRECTIVE ACTIONS Backlight defective LCD defective Confirm that the cables from the display to the main board are correctly connected. Confirm that the cables and connectors are not damaged.
The display is black or blank, but the monitor still works correctly.
Replace the LCD. Replace the LCD. Update or upgrade FPGA. Confirm that the cable from the display to the main board is correctly connected. Confirm that the cables and connectors are not damaged.
3.5.3
SYMPTOMS
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Troubleshooting
Troubleshooting Guide
3.5.4
SYMPTOMS
Alarm Problems
POSSIBLE CAUSE Cables defective or poorly connected CORRECTIVE ACTIONS Key and display board failure Main board failure Confirm that the cables from alarm LED board to keyboard and keyboard to main board are properly connected. Confirm that the connecting cables and connectors are not damaged.
The alarm lamp does not light or is extinguished, but alarm sounds
Replace the key and display board. Replace the main board. 1. Press to display the SYSTEM SETUP dialog as shown in FIGURE 3-1. 2. Press or to highlight MAINTENANCE.
3. Once MAINTENANCE is highlighted, press to display the MAINTENANCE dialog as shown in FIGURE 3-2. 4. Press or to select USER MAINTENANCE. to
5. Once USER MAINTENANCE is highlighted, press display the USER MAINTENANCE dialog. 6. Enter the required password. 7. In the pop-up menu, set the [MIN ALARM VOL] to a value other than zero. Cable defective or poorly connected Audio program error identified in the system program Speaker failure Main board failure
Confirm that the cable between speaker and main board is properly connected. Confirm that the connecting cables and connectors are not damaged.
3.5.5
SYMPTOMS Keys do not work
Key Failure
POSSIBLE CAUSE Cables defective or poorly connected CORRECTIVE ACTIONS Keyboard failure Confirm that the cable between keyboard and main board is properly connected. Confirm that the connecting cables and connectors are not damaged.
Replace keyboard.
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Troubleshooting Guide
Troubleshooting
3.5.6
SYMPTOMS No printout
Recorder Failures
POSSIBLE CAUSE Recorder module disabled Paper reversely installed Cable defective or poorly connected CORRECTIVE ACTION Confirm that the recorder status LED is on. If yes, reset the recorder. If no, check for other possible causes. Confirm that the cable between recorder and main board is appropriately connected. Confirm that the connecting cables and connectors are not damaged.
Recorder power supply failure Recorder failure Poor print quality or paper not feeding properly Paper roll not properly installed Dirty thermal print head
Confirm that the power module outputs 5V DC and 16.8V DC correctly. Replace the recorder. Stop the recorder and re-install the paper roll. Confirm that the thermal print head and the paper roller do not contain foreign matter. Clean the thermal print head with an appropriate detergent.
Recorder failure
3.5.7
SYMPTOMS
Interface Failures
POSSIBLE CAUSE Incorrect function settings CORRECTIVE ACTION 1. Press to display the SYSTEM SETUP dialog as shown in FIGURE 3-1. 2. Press or to highlight MAINTENANCE. to
3. Once MAINTENANCE is highlighted, press display the MAINTENANCE dialog as shown in FIGURE 3-2. 4. Press or to select NURSE CALL. to
5. Once NURSE CALL is highlighted, press display the NURSE CALL dialog. 6. Select desired nurse call output. Main board failure Bar code scanner unable to be used Bar code scanner failure Serial port failure Replace the main board. Refer to Bar Code Scanner Failures. Replace the main board.
3.5.8
SYMPTOMS
3-6
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Troubleshooting
Troubleshooting Guide
CORRECTIVE ACTION Replace battery. Confirm that the cable between battery interface board and the power module is properly connected. Confirm that the connecting cables and connectors are not damaged.
Replace the power board. Replace battery and recharge the replacement battery. If the replacement battery can be recharged, the original one fails. Confirm that the cable between battery interface board and the power module is properly connected. Confirm that the connecting cables and connectors are not damaged. Turn off the monitor then restart it. If the problem remains, disconnect the AC mains for 5 seconds and reconnect it, then restart the monitor. If the problem still remains, replace power board.
Power board failure No +3.3 V output No +5.0 V output No +12 V output NOTE: Power supply protection Power board failure
If the power module fails, it may damage other components (e.g. the monitor suddenly shuts down during the start-up). In this case, troubleshoot the power module using the procedure described in the previous table. If the parameter module, recorder, or bar code scanner malfunctions, check if the operating voltage is correct.
NOTE:
3.5.9
SYMPTOMS
Frequent dropouts and network disconnections Improper LAN cable connection Incorrect IP address configuration
Confirm that the LAN cable is connected. The LAN cable must not be longer than 50 m. Check for IP address conflict. Reconfigure IP address.
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Troubleshooting Guide
Troubleshooting
3.5.10
SYMPTOMS
Confirm that the monitor is connected to the network. Confirm that the hub or the switcher is functioning. Confirm that the net cables are of the right type and have been connected correctly.
Incorrect upgrade package .mup files were used. Select package according to the program to upgrade. Configure a fixed IP address in range as specified for the monitor. Do not upgrade a program while the monitor is connected to a network.
3.5.11
SYMPTOMS
3. Once MAINTENANCE is highlighted, press display the MAINTENANCE dialog as shown in FIGURE 3-2. 4. Press or
5. Once USER MAINTENANCE is highlighted, press to display the USER MAINTENANCE dialog. 6. Enter the required password. 7. Set [BARCODE POWER] to [ON] in the menu to switch on the bar code scanner. Incorrect interface cables used Loose Interface cables Bar code scanner cannot decode the target bar codes Bar code scanner not programmed correctly. Unreadable bar code Scanner and bar code at improper distance and angle Scanned characters incorrectly displayed on the monitor The monitors bar code recognition configuration does not meet the format of the target bar code. Scanner serial port output incorrectly set Replace interface cables. Confirm that the interface cables are attached securely. Re-program the bar code scanner to decode the specified bar codes. Check if bar codes of the same type can be decoded. Aim the scanner at the bar code and adjust the distance between the scanner and the bar code. Download the correct bar code recognition configuration for the monitor.
Configure the scanners serial port output according to the host serial port settings.
3-8
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Troubleshooting
Troubleshooting Guide
3.5.12
SYMPTOMS
3.5.13
SYMPTOMS
3.5.14
SYMPTOMS
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3-9
Troubleshooting Guide
Troubleshooting
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4.0
Tools ............................................................................................................. 4-2 Preparation for Disassembly............................................................................. 4-2 Disassembly................................................................................................... 4-3 Separating the Front and Rear Halves of the Monitor ......................................... 4-3 Disassembling the Front Housing Assembly ....................................................... 4-6 Removing the Main Rack Assembly................................................................... 4-9 Removing NIBP Module .................................................................................. 4-11 Removing the Main (CPU) Board ..................................................................... 4-13 Removing the Power Board .............................................................................. 4-13 Removing the Battery Connector Assembly......................................................... 4-13 Removing the Fan and Speaker ........................................................................ 4-14 Removing the Power Socket ............................................................................ 4-15 Disassembling the Temperature Module ............................................................. 4-16 Disassembling SpO2 Modules ......................................................................... 4-17 Disassembling the NIBP Module ....................................................................... 4-20
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Tools
4.1
Tools
During disassembly and replacement, the following tools may be required: Phillips screwdrivers Wire cutters Sharp nose pliers Metric wrenches Metric nut drivers
4.2
CAUTION:
4-2
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Disassembly
4.3
4.3.1
Disassembly
Separating the Front and Rear Halves of the Monitor
1. If the monitor is not configured with an Optional Temperature module, proceed to step 2. If the monitor is configured with an Optional Temperature module: a. Remove the two (2) M36 cross-head screws (as shown in Figure 4-1).
FIGURE 4-1 Remove two (2) M3x6 cross-head screws. b. Disconnect the Temp cable connector from the PCBA as shown in Figure 4-2.
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4-3
Disassembly
2. Remove the four (4) M38 cross-head screws (as shown in Figure 4-3).
FIGURE 4-3 Remove four (4) M3x8 cross-head screws. 3. Release the clips (as shown in Figure 4-4) on the front and rear housings.
Clips
4-4
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Disassembly
4. Disconnect the cables and air tubing connecting the front and the rear housings. 5. Separate the front and the rear housings (Figure 4-5).
Cable Connector
Cable Connector
Cable Connector
Tubing Connection
Cable Connector
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4-5
Disassembly
4.3.2
M3x6 cross-head screw M3x6 cross-head screw M3x6 cross-head screw M3x6 cross-head screw
M3x6 cross-head screw M3x6 cross-head screw M3x6 cross-head screw M3x6 cross-head screw
4-6
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Disassembly
2. For the black and white LCD model, remove the four (4) M38 cross-head screws (as shown in Figure 4-7). For the color LCD model, skip this step.
FIGURE 4-7 Remove four (4) M3x8 cross-head screws (black and white LCD model only). 3. Disconnect the flexible cables on the button board. 4. Remove the LCD. 5. Remove the two (2) M36 cross-head screws (as shown in FIGURE 4-8), and take out the SpO2 rack.
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4-7
Disassembly
6. Remove the screw (as shown in FIGURE 4-9) to remove the SpO2 module from the SpO2 rack.
Screw
Screw
Screw
FIGURE 4-9 Remove the screw. 7. Remove the two (2) screws for the SpO2 signal cable (as shown in Figure 4-10). 8. Take out the SpO2 signal cable.
Screw Screw
FIGURE 4-10 Remove two (2) screws. 9. For DPM SpO2 only, unscrew the plastic nut for the DPM SpO2 signal cable (as shown in Figure 4-11).
Plastic Nut
FIGURE 4-11 For DPM SpO2 only, unscrew the plastic nut.
4-8
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Disassembly
4.3.3
Clip
Clip
FIGURE 4-12 Remove two (2) M3x6 cross-head screws. 3. Unplug the two (2) cable connectors (as shown in Figure 4-13) from the recorder.
Cable Connector
Cable Connector
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4-9
Disassembly
4. If the device is not configured with an optional Temperature module, skip to Step 6. 5. If the device is configured with an optional Temperature module, remove the Temperature module board.
FIGURE 4-14 Remove optional temperature module board. 6. Remove the six (6) M36 cross-head screws (as shown in Figure 4-15). 7. Take out the main rack assembly.
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Disassembly
4.3.4
FIGURE 4-16 Unplug the NIBP module. 2. Remove the three (3) M36 cross-head screws (as shown in Figure 4-17). 3. Take out the NIBP rack.
M3x6 cross-head screw
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Disassembly
4.3.5
Cable Connector
Cable Tie
FIGURE 4-18 Unplug the Main board cable connector and cut one (1) tie wrap. 3. Unplug the speaker cable (J10) from the Main board (see FIGURE 4-19). 4. Unplug the recorder cable (J8) from the Main board (see FIGURE 4-19). 5. Take out the main board by removing the four (4) M36 cross-head screws (as shown in FIGURE 4-19).
FIGURE 4-19 Unplug (2) two cable connectors and remove four (4) M3x6 cross-head screws.
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Disassembly
4.3.6
4.3.7
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Disassembly
4.3.8
Fan Cushion
FIGURE 4-22 Remove the Fan Cushion. 3. Remove the three (3) M325 cross-head screws (as shown in Figure 4-23). 4. Remove the fan. 5. Remove the speaker from the main rack.
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Disassembly
4.3.9
Retaining Nut
FIGURE 4-24 Remove the retaining nut. 3. Remove the two (2) M38 cross-head screws (as shown in Figure 4-25). 4. Remove the power socket.
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Disassembly
4.3.10
FIGURE 4-26 Remove Two (2) M3x6 cross-head screws 3. Remove the three (3) M36 cross-head screws (as shown in Figure 4-27). 4. Remove the Temperature module board. 5. Remove the mylar sleeve.
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Disassembly
4.3.11 4.3.11.1
FIGURE 4-28 Remove one M3 X 6 cross-head screw.z 2. Remove the SpO2 board (as shown in Figure 4-29).
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Disassembly
4.3.11.2
FIGURE 4-30 Remove three (3) M3 nuts, and three (3) M3x6 cross-head screws. 3. Remove the SpO2 board.
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Disassembly
4.3.11.3
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4 - 19
Disassembly
4.3.12 4.3.12.1
Tie Wraps
4.3.12.2
Screw
Screw
4 - 20
0070-10-0702
Disassembly
4.3.12.3
Screws
0070-10-0702
4 - 21
Disassembly
4 - 22
0070-10-0702
5.0
Parts
Main Assembly .............................................................................................. 5-2 Front Assembly (Color LCD) ............................................................................. 5-3 Rear Housing Assembly................................................................................... 5-12 Main Bracket Assembly ................................................................................... 5-13 NIBP Assembly (Pump M6Q-100003- - -)........................................................... 5-16 NIBP Assembly (Pump 082-000056-00) ............................................................ 5-19 Temperature Module Subassembly .................................................................... 5-22 Temperature Power Module Subassembly .......................................................... 5-24
0070-10-0702
5-1
5.1
Main Assembly
5 6
Main Assembly
10
4 3 2 1
ITEM 1 2 3 4 5 6 7 8 9 10
PART NUMBER 801-6101-00003-00 801-6101-00023-00 M6G-020015- - M04-004012- - 6101-30-46616 801-6101-00011-00 M04-000605- - 6101-20-46742 9211-20-87369 801-6101-00010-00 M04-002505- - -
DESCRIPTION Front Shell Assembly (B&W) Front Shell Assembly (Color) Hose Silicone,1.6mmODX0.8mmID 10m/per Screw, Crosshead M36 Main Bracket Assembly Recorder module package Screw, Pan Head Phillips M3X8 Rear Overlay (6101) AC Inlet Retainer Clip Rear Housing Assembly Screw M36
Parts
5.2
Parts
15
11
16
ITEM
17
PART NUMBER 115-016544-00 * 0010-20-12194 043-001894-00 6101-20-46722 6101-20-46723 6101-20-46762 M04-051003- - M04-021000- - 6101-20-46743
18
11 12 13 14 15 16 17 18
DESCRIPTION Front Assembly Service Kit (Color LCD) Includes all parts below: Machine Pneumatic Socket Subassembly Front Bezel (Color LCD) Alarm Light Cover (6101) Silicon Keypad (6101) Key Pad Fixer 2 Screw, Pan Head Phillips PT2.0X6 Flat Washer Key Pad Fixer (6101)
NOTE:
* To upgrade the Black & White LCD requires FRU# 801-6101-00023-00. Included in this FRU are: FRU# 8016101-000211-00 (Main board), 009-002037-00 (LCD signal cable), 042-004637-00 (Ferrite Fixer Plate), 051-000875-00 (Display and Key panel), 049-000280-00 (Color LCD Rubber), 021-000056-00 (LCD) for the new assembly, and 115-016544-00. Please refer to the figures 5 -2, 5-4, 5-5 and 5-12.
Parts
19 20 25 19 30
19
21
26 31 27
22
23
28 33 34 24 29 35
ITEM 19 20 21 22 23 24 25 26 27 28 29
PART NUMBER 6101-20-46734 6101-30-46622 801-0010-00002-00 801-6101-00017-00 801-0010-00018-00 6101-20-46719-51 6101-30-46621 801-6101-00016-00 801-6101-00015-00 801-0010-00019-00 6101-20-46720-51
DESCRIPTION SpO2 Mounting Bracket (6101) Nellcor SpO2 module package Nellcor SpO2 Board Nellcor Power Isolation Board Nellcor SpO2 Flex Cable Nellcor SpO2 Interface Bracket Masimo SpO2 Module Package Masimo SpO2 Board Masimo Power Isolation Board PCBA Masimo SpO2 Flex Cable Masimo SpO2 Interface Bracket
ITEM PART NUMBER DESCRIPTION 30 6101-30-46620 DPM SpO2 Module Package 31 801-9211-00108-00* DPM SpO2 Isolation Board* 32 801-9211-00107-00* DPM SpO2 Board* 33 801-6006-00029-00 DPM SpO2 Signal Cable 34 6101-20-46718-51 DPM SpO2 Interface Bracket 35 6101-20-46733 DPM SpO2 Interface Bracket Plate * Upgrading the 9006 SpO2 module to the 9008 SpO2 module requires FRU# 801-9211-00107-00, 801-9211-00108-00, 6101-20-46734.
5-6
36 37 38
0070-10-0702
39
ITEM 3 36
DESCRIPTION Screw, Crosshead M36 6101 Display and key panel PCBA (Color)* (FRU# 801-6101-00023-00 contains these parts.) 37 6101-20-46763 Ferrite Fixer Plate Isolation Sheet 38 042-004637-00* Ferrite Fixer Plate (Color LCD)* (FRU# 801-6101-00023-00 contains these parts.) 39 0000-10-10996 Spring Strip * Upgrading the Black-and-White LCD assembly to the new Color LCD assembly requires FRU# 801-6101-00021-00(Main board),009-002037-00(LCDsignal cable), 042-004637-00(Ferrite Fixer Plate), 051-000875-00(Display and Key panel), 049-000280-00(Color LCD Rubber), 021-000056-00(LCD) for the new assembly. Please refer to the figures 5 -2, 5-4, 5-5 and 5-12.
Parts
40
0070-10-0702
43 42 41
ITEM 3 41 42 43 40
PART NUMBER DESCRIPTION M04-004012- - Screw Crosshead M36 6101-20-46732 Grounding Washer (6101) 049-000280-00* Color LCD Rubber* 049-000056-00* LCD panel TFT 3.5inch 272*480 3.3V* Front Overlay (6101), English 047-005559-00 Front Overlay (6101), Italy 047-005560-00 Front Overlay (6101), French 047-005561-00 Front Overlay (6101), German 047-005562-00 Front Overlay (6101), Spanish 047-005563-00 Front Overlay (6101), Portuguese 047-005564-00 Front Overlay (6101), Dutch 047-005565-00 * Upgrading the Black-and-White LCD assembly to the new Color LCD assembly requires FRU# 801-6101-00021-00 (Main board), 009-002037-00 (LCD signal cable), 042-004637-00 (Ferrite Fixer Plate), 051-000875-00 (Display and Key panel), 049-000280-00 (Color LCD Rubber), 021-000056-00 (LCD) for the new assembly. Please refer to the figures 5 -2, 5-4, 5-5 and 5-12.
5.3
14
11 15
16
ITEM 11 44 13 14 15 16 17 18
PART NUMBER 115-016543-00 0010-20-12194 6101-20-46710 6101-20-46722 6101-20-46723 6101-20-46762 M04-051003- - M04-021000- - 6101-20-46743
17 18
DESCRIPTION Front Assembly Service Kit (Black & White) Includes all parts below: Machine Pneumatic Socket Subassembly Front Bezel (6101) Alarm Light Cover (6101) Silicon Keypad (6101) Key Pad Fixer 2 Screw, Pan Head Phillips PT2.0X6 Flat Washer Key Pad Fixer (6101)
Parts
Parts
19 20 25 19 30
19
21
26 32 27
22
23
28 33 34 24 29 35
ITEM 19 20 21 22 23 24 25 26
PART NUMBER 6101-20-46734 6101-30-46622 801-0010-00002-00 801-6101-00017-00 801-0010-00018-00 6101-20-46719-51 6101-30-46621 801-6101-00016-00
DESCRIPTION SpO2 Mounting Bracket (6101) Nellcor SpO2 module package Nellcor SpO2 Board Nellcor Power Isolation Board Nellcor SpO2 Flex Cable Nellcor SpO2 Interface Bracket Masimo SpO2 Module Package Masimo SpO2 Board
ITEM 27 28 29 30 32 33 34 35
PART NUMBER 801-6101-00015-00 801-0010-00019-00 6101-20-46720-51 6101-30-46620 801-9006-00001-00 801-6006-00029-00 6101-20-46718-51 6101-20-46733
DESCRIPTION Masimo Power Isolation Board PCBA Masimo SpO2 Flex Cable Masimo SpO2 Interface Bracket DPM SpO2 Module Package DPM SpO2 Board DPM SpO2 Signal Cable DPM SpO2 Interface Bracket DPM SpO2 Interface Bracket Plate
5 - 10
47 3 46 45 48
0070-10-0702
52 49 50 51
ITEM 3 45 46 47 48 49 50 51 52
PART NUMBER M04-004012- - M04-011002- - 0000-10-11179 6101-30-46609 6101-20-46752 6101-20-46763 M04-004015- - M04-021024- - 6006-20-39502
DESCRIPTION Screw, Crosshead M36 Hex Locknut with Conical Washer M3 LCD Module FSTN 320x160 LED White Backlight Display Keyboard PCBA Ferrite Fixer Plate Ferrite Fixer Plate Isolation Sheet Screw, Pan Head Phillips with Washer M3X8 Large Washer LCD Display Back Plate
Parts
Parts
ITEM 3 53 54
53
PART NUMBER M04-004012- - 6101-20-46732 047-002718-00 6101-20-46741-52 6101-20-46741-53 6101-20-46741-54 6101-20-46741-55 6101-20-46741-56
DESCRIPTION Screw Crosshead M36 Grounding Washer (6101) Front Overlay (6101), English Front Overlay (6101), French Front Overlay (6101), German Front Overlay (6101), Spanish Front Overlay (6101), Portuguese Front Overlay (6101), Dutch
5.4
61 57
51 55 56 57 58 59 60 61
60
59
58
55
56
57
Parts
5.5
Parts
72 62 71
73
78 79
80 67 64
81
65 84 66 83 82
68 69 70
ITEM 3 62 63 64 65 66 67 68
PART NUMBER M04-004012- - 6101-20-46725 6101-20-46736 6101-20-46735-51 6006-20-39451 0000-10-10996 6101-20-46738 6101-20-46753
DESCRIPTION Screw, Crosshead M36 Main Bracket (6101) Power Supply Board Isolation Sheet (6101) I/O Overlay (6101) Main Board Insulating Plate Spring Strip Battery Box Isolation Sheet (6101) Battery Hook Torsion Spring
ITEM 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84
PART NUMBER 7000-20-24365 6006-20-39486 6101-20-46739 M04-051172- - 6101-20-46731 801-9201-00001-00 6006-20-39379 801-6006-00048-00 801-6006-00019-00 2102-20-17166 M04-004401- - M04-004504- - M04-021003- - 0509-20-00098 M04-000405- - 6006-21-39386
DESCRIPTION Torsion Spring Battery Bar Setscrew Fan Gasket (6101) Screw, Flat Head Phillips M3X25 Fan Binder Plate (6101) Fan (KDE1204PKV3) Speaker Spacer Speaker and Cables Lithium Battery Connector Assembly Protective Ground Label Hex Nut, M6 Spring Washer Flat Washer Grounding Terminal Screw, Crosshead M38 Power Board AC Input cable
5 - 14
89 85 88 45 87 90 86 91 97 3 96 95 94 93
92
0070-10-0702
3
ITEM 90 91 92
ITEM 3 45 85 86 87 88 89
DESCRIPTION Screw, Crosshead M36 Nut, M3 with Spring Washer AC-DC Power Supply PCBA Bolt, M37 Keyboard Power Cable Recorder Power Cable NIBP Assembly
PART NUMBER DESCRIPTION 6006-20-39381 Recorder Signal Cable 6006-20-39380 Host Board Power Cable 6006-20-39384 LCD Signal Cable (for B&W LCD) 009-002037-00* LCD Signal Cable (for color LCD) * 93 M09A-20-62081 Communication Cable from Host Board to Isolation Board 94 6006-20-39382 SpO2 Module Cable 95 6006-20-39383 Keyboard Signal Cable 96 M05-010R03- - Button Battery Lithium 3V35mAh D12.5x2.0 97** 801-6101-00001-00 Main Board (for B&W LCD) 801-6101-00021-00* Main Board (for color LCD)* * Upgrading the Black-and-White LCD assembly to the new Color LCD assembly requires FRU# 801-6101-00021-00 (Main board),009-002037-00 (LCD signal cable), 042-004637-00 (Ferrite Fixer Plate), 051-000875-00 (Display and Key panel), 049-000280-00 (Color LCD Rubber), 021-000056-00 (LCD) for the new assembly. Please refer to the figures 5 -2, 5-4, 5-5 and 5-12.
Parts
NOTE:
**After replacing the Main Board, a System Reconfiguration should be performed by following this procedure: While the monitor is powered on, press and hold the MENU key for two seconds. While the MENU key is still depressed, press and hold the power ON/OFF key. Verify that the message Clear system config and restarting appears. Release the MENU and ON/OFF keys. The monitor will shutdown and restart. Then the message Checking system config... appears. After the monitor is successfully configured, the message System configure succeed. Restarting... is displayed and the monitor shuts down and restarts automatically.
5.6
10
ITEM 10
Parts
5 - 17
104 102 106 103 102 105 101 01
00
100
99 98
PART NUMBER M04-051004- - 801-6100-00019-00 A21-000002- - S1-0378-02-0004 S1-0008-10-0206 3001-10-07066 6101-20-46756 6101-20-46755 6101-20-46610
DESCRIPTION Screw, PT2.66 NIBP PCBA Module Tubing, Silicone,1/8"X1/4" X100ft,2800546-100 Filtered Orifice Restricto Tubing, Silicone,1/16"X3/16",TYGON 3350 (1foot) T-Connector NIBP Bracket Manifold NIBP Manifold Cable, Main Board to NIBP Module Board
Parts
Parts
111
115 110
ITEM 107 108 109 110 111 112 113 114 115
PART NUMBER 047-001582-00* M04-051137- - M90-000002-00 042-001417-00* M6Q-100003- - 6101-20-46761 082-000057-00 M04-004905- - 082-000058-00 009-000588-00 A90-000031- - -
DESCRIPTION NIBP Bracket Label* Screw, M24 Insulation Washer F2 NIBP Bracket* (FRU# 801-6101-00018-00 contains these parts.*) Rolling Pump Pump Cushion Valve Solenoid Screw, M318 Valve Pump connection cable Cable Tie CHS-4x150mm
* Upgrading the old pump (082-000056-00) to the new rolling pump (M6Q-100003- - -) requi FRU# 801-6101-00018-00 (pump kit), 047-001582-00 (label), and 042-001417-00 (bracke See section 5.7 (pg. 5-19) NIBP Assembly (Pump 082-000056-00) for the old pump assem
5.7
10
ITEM 10
Parts
5 - 20
103 102
102
104
105
106
100
101
100
99 98
PART NUMBER M04-051004- - 801-6100-00019-00 A21-000002- - S1-0378-02-0004 S1-0008-10-0206 3001-10-07066 6101-20-46756 6101-20-46755 6101-20-46610
DESCRIPTION Screw, PT2.66 NIBP PCBA Module Tubing, Silicone,1/8"X1/4" X100ft,2800546-100 Filtered Orifice Restricto Tubing, Silicone,1/16"X3/16",TYGON 3350 (1foot) T-Connector NIBP Bracket Manifold NIBP Manifold Cable, Main Board to NIBP Module Board
Parts
Parts
113
114
115
112
118
117
116
108
ITEM 116 108 109 117 118 112 113 114 115
PART NUMBER 6101-20-46737 M04-051137- - M90-000002-00 6101-20-46730 082-000056-00* 6101-20-46761 801-6101-00002-00 082-000057-00 M04-004905- - 082-000058-00
109
DESCRIPTION NIBP Fram Overlay (6101) Screw, M24 Insulation Washer F2 NIBP Bracket (6101) Pump* Pump Cushion Pump Kit (includes pump 082-000056-00 and cushion 6101-20-46761) Valve Solenoid Screw, M318 Valve
* Upgrading the old pump (082-000056-00) to the new rolling pump (M6Q-100003- - -) requires FRU# 801-6101-00018-00 (pump kit), 047-001582-00 (label), and 042-00141700 (bracket). See section 5.6 (pg. 5-16) NIBP Assembly (Pump M6Q-100003- - -) for the new rolling pump assembly.
5.8
Parts
10
121
120
119
DESCRIPTION Screw, M36 Temp Module Water Ingress Blocker Temp Measurement Board Subassembly Temp Module Inner Cover
5 - 23
125 124 123
0070-10-0702
122
DESCRIPTION Temp Probe Cover Holder Temp Module External Cover Temperature Probe Holder Ring (6101) Screw, Phillips PT36
5.9
Parts
128
10
DESCRIPTION Screw, M36 Communication Cable from Power Isolation Board to Temp Measurement Board Rear Inner Cover Plate (6101) Temp Module Power Supply Board PCBA
6.0
Introduction.................................................................................................... 6-2 Visual Test...................................................................................................... 6-4 Power-on Test ................................................................................................. 6-4 NIBP Calibration ............................................................................................ 6-4 NIBP Accuracy Test ......................................................................................... 6-8 SpO2 Test ...................................................................................................... 6-12 Testing the Optional Temperature Module .......................................................... 6-14 Nurse Call Performance Test ............................................................................ 6-16 Bar Code Scanner Test .................................................................................... 6-18 Electrical Safety Tests ...................................................................................... 6-20 Recorder Check.............................................................................................. 6-22 Software upgrade........................................................................................... 6-23
0070-10-0702
6-1
Introduction
6.1
Introduction
To ensure the monitor always functions properly, qualified personnel should perform regular inspections, maintenance, and testing. This chapter provides the test procedures for the monitor and includes recommended test equipment and frequency. Qualified personnel should perform the testing and maintenance procedures as required and use appropriate test equipment. The testing procedures provided in this chapter are intended to verify that the monitor meets the performance specifications. If the monitor or a module fails to perform as specified in any test, repair or replacement is required to correct the problem. If the problem persists, contact service.
CAUTION: NOTE: All tests should be performed by qualified personnel only. Qualified personnel should acquaint themselves with the test tools and confirm that test tools and cables are applicable. When fields or buttons in a dialog have a line through them, they are not available for selection or modification.
NOTE:
6-2
0070-10-0702
Introduction
6.1.1
Test Report
After completing the tests, service personnel should record test results in this table and retain them for hospital records.
TEST RECORD No. 1 2 CONCLUSION Pass/Fail: Tested by: Date: Test Item Test Site Test Results
6.1.2
Visual test Power on test
Recommended Frequency
FREQUENCY When first installing or after reinstalling. 1. When first installing or after reinstalling. 2. Following any maintenance or replacement of any main unit parts. Accuracy test Leakage test Calibration 1. If the user suspects that the measurement is incorrect. 2. Following any repairs or replacement of the NIBP module. 3. At least once every two years.
CHECK/MAINTENANCE ITEM
NIBP tests
SpO2 test Temperature test Bar code scanner test Electrical safety tests Enclosure leakage current test Earth leakage current test Patient leakage current test Patient auxiliary current test Recorder check Following any repair or replacement of the recorder. If the user suspects that bar code scan is incorrect. 1. Following any repair or replacement of the power module. 2. At least once every two years.
0070-10-0702
6-3
Visual Test
6.2
Visual Test
Inspect the equipment for obvious signs of damage. Follow these guidelines when inspecting the equipment: Carefully inspect the case, the display screen, and the buttons for physical damage. Inspect all external connections for loose connectors, bent pins, or frayed cables. Inspect all connectors on the equipment for loose connectors or bent pins. Make sure that the labels on the equipment are clearly legible.
6.3
Power-on Test
Verify that the monitor can power up correctly by following this procedure: 1. Insert the lithium battery in the battery compartment and connect the monitor to the AC mains. The AC mains LED and battery LED light. 2. Press the Power On/Off button to turn on the monitor. The operating status LED built into the Power On/Off button illuminates. The system beeps to indicate it has passed the alarm sounds self test. All the LEDs on the front panel illuminate. The technical alarm lamp illuminates yellow, then red, and then turns off to indicate it has passed the alarm lamp self test. The start-up screen clears, and the monitor enters the main screen, indicating start-up is complete.
6.4
NIBP Calibration
Required Tools: One (1) T-Connector Three (3) pieces of Tubing One (1) Metal Vessel with volume of 500 25 ml One (1) Reference manometer with accuracy of 1 mmHg To calibrate NIBP: 1. Attach the calibration vessel and reference manometer as shown in FIGURE 6-1.
Accutorr V
Reference Manometer
Hose
Calibration Vessel
FIGURE 6-1 NIBP calibration configuration 2. If needed, press (11) to display the Normal Screen.
6-4
0070-10-0702
NIBP Calibration
3. Press 4. Press
(12) to display the SYSTEM SETUP dialog. (16) or (19) to highlight MAINTENANCE.
5. Once MAINTENANCE is highlighted, press (18) to display the MAINTENANCE dialog as shown in FIGURE 6-2.
FIGURE 6-2 MAINTENANCE dialog 6. Press (16) or (19) to highlight NIBP TOOLS. (18) to display the NIBP TOOLS
FIGURE 6-3 NIBP TOOLS dialog 9. Once CALIBRATION is highlighted, press dialog, as shown in FIGURE 6-4. (18) to display the Enter Password
0070-10-0702
6-5
NIBP Calibration
10. In the Enter Password dialog, press 11. Press 12. Press 13. Press 14. Press 15. Press 16. Press 17. Press 18. Press 19. Press 20. Press 21. Press 22. Press
NOTE:
(16) or (18). (16) or (18). (16) or (18). (16) or (18). (16) or (18). (16) or (18).
(19) to set the first password digit to 3. (19) to highlight the second password digit. (19) to set the second password digit to 2. (19) to highlight the third password digit. (19) to set the third password digit to 1. (19) to highlight OK.
When the NIBP CALIBRATION dialog is first displayed, INFLATE is highlighted, as shown in FIGURE 6-5.
FIGURE 6-5 NIBP CALIBRATION dialog with INFLATE highlighted 23. Press
NOTE:
(18) to cancel the calibration. NOTE: After the calibration vessel is pressurized, the reference pressure field is highlighted, as shown in FIGURE 6-6.
FIGURE 6-6 NIBP CALIBRATION dialog with the reference pressure field highlighted
6-6
0070-10-0702
NIBP Calibration
24. Press the (16) or (19) to adjust the reference pressure value in 1 mm increments until it matches the MEASURED PRESSURE value. 25. Press (18) to set the reference pressure value. After the reference pressure value is set, ACCEPT is highlighted, as shown in FIGURE 6-6.
FIGURE 6-7 NIBP CALIBRATION dialog with ACCEPT highlighted 26. Press the 27. Press
NOTE:
(16) or
The Accutorr V uses the new calibration factor until another calibration sequence is performed.
0070-10-0702
6-7
6.5
Accutorr V
Hose
Reference Manometer
Calibration Vessel
Ball Pump
FIGURE 6-8 NIBP accuracy test configuration 2. If needed, press 3. Press 4. Press or to display the Normal Screen. to highlight MAINTENANCE. to display the MAINTENANCE
5. Once MAINTENANCE is highlighted, press dialog. 6. Press or to highlight NIBP TOOLS. 7. Once NIBP TOOLS is highlighted, press shown in FIGURE 6-3.
6-8
0070-10-0702
8. Press
or
10. Use the ball pump to pressurize the vessel to each of the three different ranges shown in following table.
RANGE Low approximately 50 mmHg Medium approximately 150 mmHg High approximately 250 mmHg ACCURACY 3 mmHg 3 mmHg 3 mmHg
The pressure value in the MAP LED display should match the value shown on the reference manometer within the accuracy for each test range as shown in the table. 11. Use or accuracy test. to highlight STOP ACCURACY TEST, then press to end the
If the accuracy test failed, send the Accutorr V to service for repair.
6.5.1
0070-10-0702
6-9
Adult
Pediatric
Neonate
FIGURE 6-10 Patient size graphics and indicators The Patient size indicator illuminates to indicate the selected size as shown in FIGURE 610. The factory default setting for the Patient size is Adult. 2. Connect the metal vessel with the NIBP connector on the Accutorr V monitor.
Accutorr V
Hose
Calibration Vessel
FIGURE 6-11 Leakage test configuration 3. If needed, press 4. Press 5. Press or to display the Normal Screen. to highlight MAINTENANCE. to display the MAINTENANCE
6. Once MAINTENANCE is highlighted, press dialog. 7. Press or to highlight NIBP TOOLS. 8. Once NIBP TOOLS is highlighted, press shown in FIGURE 6-3. 9. Press or to highlight LEAK TEST.
10. Once LEAK TEST is highlighted, press to start the leak test. The Accutorr V automatically deflates in approximately 60s, and the NIBP leakage test is complete.
6 - 10
0070-10-0702
11. If the system leaks, the message PNEUMATIC LEAK will be displayed in the technical alarm area/prompt area. In this case, check for a loose connection and perform the test again.
NOTE: If the system does not leak, the Accutorr V does not display a message.
0070-10-0702
6 - 11
SpO2 Test
6.6
SpO2 Test
NOTE: A functional tester cannot be used to assess the accuracy of a pulse oximeter probe or a pulse oximeter monitor.
Required Tool: SpO2 simulator. For the monitor equipped with the DPM SpO2 module, Nellcor SpO2 module, or Masimo SpO2 module, a calibrated SpO2 simulator is recommended.
6.6.1
6.6.2
SPO2 SENSOR 512E, 512G, 512F, 512H, 518B, 520A, 520P, 520I 520N LNCS-NeoPt-L, LNCS Neo-L, LNOP DCI, LNOP DCIP, LNOP TCI, LNOP YI-Multisite, LNOP DCSC, LNOP Adt, LNOP Pdt, LNOP II Inf-L, LNOP II NeoNeonatal L, LNOP NeoPt Preterm Neonatal Y, LNOP II NeoPt Preterm Neonatal Y LNCS Inf-L, LNCS-Pdtx, LNCS-Adtx, LNCS DCI,LNCS DC-I Pt, TC-I
SPO2 96%2% 96%3% 96%3% (without motion) 96%3% (with motion) 96%2% (without motion) 96%3% (with motion) 96%2% 96%3% 96%4%
PR (BPM) 803
MAX-A, MAX-P, MAX-I, DS-100A, OXI-A/N (Adult), OXI-P/I, MAX-N OXI-A/N (Neonate)
803 bpm
NOTE:
The SpO2 simulator can only be used to verify that the pulse oximeter operates properly. It cannot be used to verify the accuracy of the pulse oximeter or the SpO2 sensor. To verify the accuracy, clinical tests are required.
6 - 12
0070-10-0702
SpO2 Test
6.6.3 6.6.3.1
6.6.3.2 6.6.3.3
Nellcor SpO2
The Nellcor SpO2 module was tested for accuracy using a simulator.
Masimo SpO2
The Masimo SpO2 module was tested by Masimo to verify accuracy.
0070-10-0702
6 - 13
6.7
FIGURE 6-13 SYSTEM SETUP dialog 3. Press or to highlight TEMP SETUP. to display the TEMP SETUP dialog as
FIGURE 6-14 Example TEMP SETUP dialog 5. Press 7. Press 9. Press or or or to highlight the TEMP TYPE pull-down list. to view the selections. to set it. to view the selections. to change the selection to MONITOR. to highlight the TEMP UNIT pull-down list.
6. Once the pull-down list is highlighted, press 8. Once MONITOR is highlighted, press 10. Once the pull-down list is highlighted, press
NOTE:
For this test, the monitor and test tank temperature units are in Celsius.
11. Press
or
to change the selection to C. to set it. to exit the TEMP SETUP dialog.
12. Once C is highlighted, press 13. Once the choices are set, press
6 - 14
0070-10-0702
14. Remove the Temperature probe from the probe sheath, insert a probe cover, and place the probe into the oil tank. 15. Wait till the Temp value displayed on the monitor stabilizes. Verify that the displayed value is 370.1 C. Contact Technical Support if the temperature test fails.
0070-10-0702
6 - 15
6.8
5. Once MAINTENANCE is highlighted, press dialog shown in FIGURE 6-2. 6. Press or to highlight NURSE CALL. 7. Once NURSE CALL is highlighted, press dialog shown in FIGURE 6-15.
FIGURE 6-15 NURSE CALL SETUP dialog 8. Press 10. Press 12. Press 14. Press 16. Press 18. Press or or or or or or to highlight the SIGNAL DURATION pull-down list. to select it. to highlight the PULSE. to select it. to select it. to highlight the SIGNAL TYPE pull-down list. to highlight the NORMAL OPEN. to select it. to highlight either HIGH or LOW for ALM LEV. to select it. to select it. to highlight either TECH or PHYS for ALM TYPE.
9. Once the SIGNAL DURATION pull-down list is highlighted, press 11. Once the PULSE is highlighted, press
13. Once the SIGNAL TYPE pull-down list is highlighted, press 15. Once the NORMAL OPEN is highlighted, press 17. Once an ALM LEV is highlighted, press 19. Once an ALM TYPE is highlighted, press
20. Trigger an alarm and measure the contact output with the multimeter. The output should be square waves with an interval of 1s. 21. Press 23. Press or or to highlight the SIGNAL DURATION pull-down list. to select it. to highlight the CONTINUOUS. to select it. 22. Once the SIGNAL DURATION pull-down list is highlighted, press 24. Once the CONTINUOUS is highlighted, press
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25. In the NURSE CALL SETUP dialog, set SIGNAL TYPE to NORMAL OPEN. Trigger an alarm and measure the contact output with the multimeter. The output should be continuous high level. Contact Technical Support if the nurse call test fails.
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6.9
FIGURE 6-16 MAINTENANCE dialog 5. Press or to select USER MAINTENANCE. to display the Enter Password
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8. Enter the password 321 to display the USER MAINTENANCE dialog as shown in FIGURE 6-18. See Section 6.4, steps 10 22 for the password procedure.
FIGURE 6-18 Example USER MAINTENANCE dialog 9. Press 11. Press or or to highlight the BARCODE POWER selection field. select it. select it. to select ON.
10. Once the selection field is highlighted, press 12. Once the selection is highlighted, press
NOTE:
When the RS-232 connector is used for DIAP, barcode power must be set to OFF.
13. Aim the bar code scanner at the target bar code. Adjust the field of view to capture the bar code. 14. Hold the trigger until the bar code scanner beeps, indicating the bar code is successfully decoded. The indication lamp turns green and scanned characters are displayed on the monitor. Contact Technical Support if the bar code scanner does not work as described.
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6.10
Electrical safety tests are intended to check the potential electrical hazards to the patient, operator, or service personnel. Electrical safety tests should be performed under normal ambient conditions of temperature, humidity, and atmospheric pressure. The electrical safety test plan described here uses a calibrated safety analyzer. Different safety analyzers may be used. Choose an applicable calibrated safety analyzer and test plan.
6.10.1
6.10.2
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3. Connect the EUT to the safety analyzers auxiliary output connector by using a power cord. 4. Power on the safety analyzer and then press the Earth leakage button on the analyzers panel to enter the earth leakage test screen. Under normal condition, the earth leakage current should be no greater than 300A. Under single fault condition, the leakage current should be no greater than 1000 A.
6.10.3
6.10.4
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Recorder Check
6.11
Recorder Check
1. Print SpO2 Pleth waveforms. The recorder should print correctly and printout should be clear. 2. Open the recorder door and verify the monitor gives the proper message. Close recorder door before proceeding to the next step. 3. Set the recorder to print trend data. Check that the recorder prints accordingly. Contact Technical Support if the recorder test fails.
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Software upgrade
6.12
Software upgrade
CAUTION: Disconnect the monitor from the patient and make sure that important data is saved before upgrading the monitor. Do not shut down or power off the equipment when upgrading the bootstrap program. Otherwise, it may cause the equipment to break down. Program upgrades should be performed by qualified service personnel only. After upgrading the boot program, re-upgrade the system program and other programs to ensure compatibility. Make sure the version of the upgrade package is the correct one. To obtain the latest upgrade package, contact Service. CAUTION:
CAUTION:
NOTE:
NOTE:
The following is a list of upgrade programs: Bootstrap program System program Bar code recognition configuration Multilingual library General configurations (including passwords, company logo) System functional configuration FPGA program Parameter module programs: SpO2 module (DPM), NIBP module and optional Temperature module. 1. In the MAINTENANCE dialog (see FIGURE 6-19), check the installed software version and compare it with the currently released version to determine if an upgrade is needed.
FIGURE 6-19 MAINTENANCE dialog 2. Download the upgrade software through a network to a portable PC or desktop PC. Connect the PC to the monitor using a cable plugged into the network connectors. 3. Run the upgrade software.
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Rev E
November 7, 2012