Service Manual
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ENMOVE 1200 SERVICE MANUAL
March 2006
Conformity according to the Council Directive 93/42/EEC concerning Medical Devices Manufacturer’s Name: Mennen Medical Ltd. 4 Hayarden Street, Yavne, 81228 P.O. Box 102, Rehovot, 76100, Israel Tel.: +972-8-9323333 Fax: +972-8-9328510 European Representative: Charter-Kontron Limited Unit 18 Avant Business Centre 21 Denbigh Road Milton Keynes MK1 1DT England Tel.: 01908 646070 Fax: 01908 646030 US Representative: Mennen Medical Corp 101 Witmer Road Suite 100 Horsham, PA 19044-2200 Phone: 215-259-1020x1026 Fax: 215-675-6212
Toll Free: 800-223-2201-1026
Publication No. 550-OPT-013 Ver 3.8a Revision: June 2006 Copyright © Mennen Medical Mennen Medical Ltd. 2006. All RIGHTS RESERVED Registered trademarks are the intellectual property of their respective holders.
Service Manual (V 1.0)
Warranty THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANT ABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.
Exemptions Mennen's obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the substitution upon it of parts or accessories not approved by Mennen or repaired by anyone other than a Mennen authorized representative. This warranty shall not extend to any instrument which has been subjected to misuse, negligence or accident; any instrument from which Mennen's original serial number tag or product identification markings have been altered or removed, or any product of any other manufacturer.
Safety, Reliability and Performance Mennen is not responsible for the effects on safety, reliability and performance of the Enmove Patient Monitor if: ■
assembly operations, extensions, re-adjusts, modifications or repairs are carried out by persons other than those authorized by Mennen.
■
the Enmove is not used in accordance with the instructions for use, or the electrical installation of the relevant room does not comply with NFPA 70: National Electric Code or NFPA 99: Standard for Health Care Facilities (Outside the United States, the relevant room must comply with all electrical installation regulations mandated by the local and regional bodies of government).
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Return Policy Return Procedure In the event that it becomes necessary to return a unit to Mennen, the following procedure should be followed:
1.
Obtain return authorization. Contact the Mennen Service Department and obtain a Customer Service Authorization (Mennen) number. The Menneny number must appear on the outside of the shipping container. Return shipments will not be accepted if the Mennen number is not clearly visible. Please provide the model number, serial number, and a brief description of the reason for return.
2.
Freight policy. The customer is responsible for freight charges when equipment is shipped to Mennen for service (this includes customs charges).
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Service Manual (V 1.0)
Safety Precautions 1.
Meaning of Signal Words
In this manual, the signal words DANGER, WARNING, and CAUTION are used regarding safety and other important instructions. The signal words and their meanings are defined as follows. Please understand their meanings clearly before reading this manual.
Signal word
Indicates an imminently hazardous situation which, if not
DANGER
avoided, will result in death or serious injury.
WARNING
Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. Indicates a potentially hazardous situation which, if not avoided,
CAUTION
2.
Meaning
may result in minor or moderate injury.
Meaning of Safety Symbols Symbol
Description Type-BF applied part
"Attention"
(Refer to the operation manual.)
Safety Precautions Please observe the following precautions to ensure the safety of service engineers as well as operators when using this system.
DANGER:
Do not use flammable gases such as anesthetics, or flammable liquids such as ethanol, near this product, because there is danger of explosion.
WARNING:
Do not connect this system to outlets with the same circuit breakers and fuses that control current to devices such as life-support systems. If this system malfunctions and generates an over current, or when there is an instantaneous
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Service Manual (V 1.0)
current at power ON, the circuit breakers and fuses of the building’s supply circuit may be tripped.
CAUTION: 1. Malfunctions due to radio waves (1) Use of radio-wave-emitting devices in the proximity of this kind of medical electronic system may interfere with its operation. Do not bring or use devices which generate radio waves, such as cellular telephones, transceivers, and radio controlled toys, in the room where the system is installed. (2) If a user brings a device which generates radio waves near the system, they must be instructed to immediately turn OFF the device. This is necessary to ensure the proper operation of the system. 2. Do not allow fluids such as water to contact the system or peripheral devices. Electric shock may result.
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Symbols
Be Careful
Protective earth ground
Indicates that the instrument is IEC-60601-1 Type CF equipment. The unit displaying this symbol contains an F-Type isolated (floating) patient applied part providing a high degree of protection against shock, and is suitable for use during defibrillation.
Equipotential grounding terminal CE mark 93/42/EEC a directive of the European Community
Silence Symbol
！
Close all alarm volume
@
Mark Event
》
Next menu
***
Highest level alarm
**
Middle level alarm
*
Lowest level alarm
Alarm pause u
Trend graph cursor t DIA pressure(NIBP trend graph) graph)
× SN
SYS
pressure（NIBP trend graph）
*
MEAN pressure (NIBP trend
Right moving indicator
Left moving indicator
Heart beat
Pace signal √
Gain magnify Series Number
VII
Confirm
Service Manual (V 1.0)
Contents CHAPTER 1 ABOUT THE PRODUCT ...1 1.1
INTRODUCTION ...1
1.2
APPLICATION ...1
1.3
ENVIRONMENT ...3
CHAPTER 2 PRINCIPLES...4 2.1
GENERAL...4
2.2
HARDWARE DESCRIPTION...5
2.3
SOFTWARE DESCRIPTION ...17
2.4
SYSTEM PARAMETER ...19
CHAPTER 3 PRODUCT SPECIFICATIONS...25 3.1
SAFETY CLASSIFICATIONS ...25
3.2
ENVIRONMENTAL SPECIFICATIONS ...26
3.3
POWER SOURCE SPECIFICATIONS...27
3.4
HARDWARE SPECIFICATIONS ...28
3.5
WIRELESS NETWORK ...29
3.6
DATA STORAGE...30
3.7
SIGNAL OUTPUT SPECIFICATIONS ...31
3.8
ECG SPECIFICATIONS ...32
3.9
RESP SPECIFICATIONS ...34
3.10
SPO2 SPECIFICATIONS ...35
3.11
IBP SPECIFICATIONS ...37
3.12
TEMP SPECIFICATIONS ...38
3.13
IBP SPECIFICATIONS ...39
3.14
CO SPECIFICATIONS ...40
3.15
CO2 SPECIFICATIONS ...41
3.16
AG SPECIFICATIONS...44
CHAPTER 4 DISASSEMBLING/ASSEMBLING & TROUBLESHOOTING...47 4.1
EXPRESS DISASSEMBLING/ASSEMBLING... ...47
4.2
TROUBLESHOOTING ...52
CHAPTER 5 TEST AND MATERIAL LIST...55 5.1
TEST PROCEDURE ...55
5.2
NIBP CALIBRATION...59
5.3
IBP CALIBRATE...59
5.4
CO2 CHECK...62
5.5
AG CALIBRATE...63
5.6
EXPRESS MATERIAL LIST... ...65 I
Service Manual (V 1.0)
CHAPTER 6 MAINTENANCE AND CLEANING ...66 6.1
MAINTENANCE ...66
6.2
CLEANING ...66
6.3
CLEANING REAGENT ...66
6.4
STERILIZATION ...67
6.5
DISINFECTION ...67
II
Chapter 1
Chapter 1 1.1
About the Product
About the Product
Introduction
The Enmove 1200 Patient Monitor, a portable and accessible patient monitor, is supplied by rechargeable batteries or external AC power, which applies to adults, pediatric and neonates. You can select different configurations as required. Besides, the Enmove 1200 can be connected with the central monitoring system whereby a monitoring network will be formed. Parameters that the Enmove 12000 can monitor include: ECG, RESP, SpO2, NIBP, 2-channel TEMP, 2-channel IBP, CO and CO2. It, integrating the functions of parameter measurement, waveform monitoring, freezing and recording, is a compact and lightweight patient monitor. Its color TFT LCD is able to show patient parameters and 8 waveforms clearly. The compact control panel and knob control, and the easy-to-use menu system enable you to freeze, record, or perform other operations conveniently. The Enmove 1200 Patient Monitor measures patient’s ECG, NIBP, SpO2, TEMP, RESP, IBP, CO and CO2 physiological signals through the ECG electrode, SpO2 sensor, cuff, temperature sensor and pressure transducer. During the measurement, the patient monitor does not get energy or any substance from the human body, and does not release any substance to the human body. However, it releases sine wave signals to the patient when measuring the respiration rate. The patient monitor converts the measured physiological signals to the digital signals, waveforms and values, and then displays them on the screen. You can control the patient monitor through the control panel. For example, you can set different alarm limits for different patients. Thus, when the patient monitor detects any physiological parameter exceeding the preset alarm limit, it will enable the audio and visual alarm.
1.2 Application 1.2.1
General
In the treatment processes, it is necessary to monitor important physiological information of patients. Therefore, the patient monitor has been playing an outstanding role among medical devices. The development of technology does not only help medical staff get the important physiological information, but also simplifies the procedures and makes it more effective. For patients in hospital, the basic and important physiological information is required, including ECG, SpO2, RESP, IBP, CO, CO2, TEMP, etc. In recent years, the development of science and technology helping measure and get important physiological information of patients has made the patient monitor more comprehensive in performance and better in quality. Today, multi-parameter patient monitors are widely used.
1.2.2
Usage
Parameters that the Enmove 1200 can monitor include: ECG, RESP, SpO2, NIBP, TEMP, IBP, CO AGand CO2. Enmove 1200 converts these physiological signals to digital signals, 1
Chapter 1
About the Product
processes them and displays them on the screen. You can set the alarm limit as required. When the monitored parameter exceeds the preset alarm limit, the patient monitor will start the alarm function. In addition, you can control the patient monitor through the control panel. Usually, patient monitors are seen in some clinical areas in hospital, such as ICU, CCU, intensive care units for heart disease patients, operating rooms, emergency departments and observation wards. They can also be used in clinics. The Enmove 1200 patient monitor should be run under the control of clinical staff. Enmove 1200 patient monitor has the following functions: ECG
Heart Rate (HR) 2-channel ECG waveform Arrhythmia analysis and S-T analysis (optional)
RESP
Respiration Rate (RR) Respiration waveform
SpO2
Pulse Oxygen Saturation(SpO2), Pulse Rate (PR) SpO2 Plethysmogram
NIBP
Systolic pressure (NS), diastolic pressure (ND), mean pressure (NM)
TEMP
T1, T2, TD
IBP
CH1: SYS, DIA CH2: SYS, DIA IBP waveform
CO
Temperature of blood (TB) Cardiac Output (CO)
CO2
End-tidal carbon dioxide (EtCO2) Inspired minimum CO2 (InsCO2) Airway Respiration Rate (AwRR)
AG
Inhaled and exhaled CO2 (FiCO2, EtCO2) Inhaled and exhaled N2O (FiN2O, EtN2O) Inhaled and exhaled O2 (FiO2, EtO2) Inhaled and exhaled anesthetic agent (FiAA, EtAA, where AA refers to any of the following anesthetic agents.) HAL (Halothane) 2
Chapter 1
About the Product
ISO (Isoflurane) ENF (Enflurane) SEV (Sevoflurane) DES (desflurane) Airway Respiration Rate (rpm: Respiration Per Minute): AwRR Minimum Alveolar Concentration (MAC) 4 AG waveforms (CO2, N2O, O2, AA)
The Enmove provides the functions of audio/visual alarm, trend graphic storage and output, NIBP measurement, alarm event identification, large font screen, defibrillator synchronization, oxyCRG recall, drug calculation, etc.
1.3 Environment 1.3.1
Temperature
Work mode
0 – 40℃
CO2 module
+5 – +35℃
Welch Allyn mainstream CO2 module
+10 – +40℃
Microstream CO2 module
+5 – +35℃
Artema AION AG module
+10 – +35℃
Transportation & Storage
-20 – 60℃
1.3.2
Humidity
Work mode
15% – 95 % (non-condensing)
Transportation & Storage
10% – 95 % (non-condensing)
Atmospheric pressure
70.0kPa – 106.0kPa
1.3.3
Electrical specification
100 – 240 V AC, 50/60 Hz, Maximum input power: 140VA; fuse: T 3A 2.3 Ah 12V lead-acid rechargeable battery Working time of fully-charged batteries in normal status: 120 minutes (2 batteries). From the first low-battery alarm, the batteries can supply power to the patient monitor for 5 more minutes. Maximum charging time: ≤12h 4.4Ah 11.1V lithium battery Working time of fully-charged batteries in normal status: 300 minutes (2 batteries). From the first low-battery alarm, the batteries can supply power to the patient monitor for 5 more minutes. Maximum charging time: ≤ 6.5h
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Chapter 2 Principles
Chapter 2
Principles
2.1 General The intended use of the Enmove 1200 patient monitor is to monitor a fixed set of parameters including ECG, RESP, SpO2, NIBP, TEMP, IBP, CO and CO2 (IBP, CO and CO2 are optional). It consists of the following functional parts: Parameter measurement; Main control part; Man-machine interface; Power supply; Other auxiliary functions; These functional units are respectively detailed below.
Figure 2-1 Structure of the Enmove 1200
2.1.1
Parameter Measurement
The parameter measurement and monitoring are the core functions of the patient monitor. The 4
Chapter 2 Principles
parameter measurement part of the Enmove 1200 patient monitor consists of the measurement probe, parameter input socket assembly, NIBP assembly and the main control board. This part converts the physiological signals to electric signals, processes the those signals and conducts the calculation by the preset program or command delivered from the main control board, and then sends the values, waveforms and alarm information (which will be displayed by using the man-machine interface) to the main control board.
2.1.2
Main Control Part
In the Enmove 1200 patient monitor, the main control part refers to the main control part of the main control board. It drives the man-machine interface, manages the parameter measurement and provides users with other special functions, such as storage, recall of waveforms and data. (See Figure 2-1)
2.1.3
Man-Machine Interface
The man-machine interface of the Enmove 1200 patient monitor includes the TFT display, recorder, speaker, indicator, buttons and control knob. The TFT display is the main output interface. It, with the high resolution, provides users with abundant real-time and history data and waveforms as well as various information and alarm information. The recorder is a subsidiary of the display, which is used for the user to print data. The speaker provides the auditory alarm function. The indicator provides additional information about the power supply, batteries, alarms and so on. The buttons and control knob are the input interface, which are used for the user to input the information and commands to the patient monitor.
2.1.4
Power Supply
The power supply part is an important part of the patient monitor. It includes the main power PCB, backlight board, batteries and fan. The main power PCB converts the external AC current respectively to the 5V DC and 12V DC current, which are supplied for the whole system. For the TFT display, there is a special requirement on the power supply, so a backlight board is used. The batteries supply power for the system for a short time when there is no external AC current. The fan is used for the heat sink of the system.
2.1.5
Other Auxiliary Functions
The Enmove 1200 patient monitor also provides the network upgrade function for the service engineers to upgrade the system software without disassembling the enclosure.
2.2
Hardware Description
The structure of the Enmove 1200 patient monitor is shown in the following figure. 5
Chapter 2 Principles
Figure 2-2 Functional structure of the Enmove 1200
6
Chapter 2 Principles
The Enmove 1200 PCB connection is shown in the following figure.
Figure 2-3 PCB connection Basic functions and working principles of modules are described in the following sections.
2.2.1
Main Board
2.2.1.1 General The main board is the heart of the patient monitor. It implements a series of tasks, including the system control, system scheduling, system management, data processing, file management, display processing, printing management, data storage, system diagnosis and alarm.
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Chapter 2 Principles
2.2.1.2 Principle diagram
Figure 2-4 Working principle of the main board
2.2.1.3 Principle The main board is connected with external ports, including the power input port, multi-way serial port, TFT display interface, analog VGA interface, network port and analog output port. Besides, on the main board is also a BDM interface reserved for the software debugging and software downloading.
CPU System CPU is the core part of the main board. It, connected with other peripheral modules through the bus and I/O cable, implements the data communication, data processing, logical control and other functions. RTC RTC provides the calendar information (such as second, minute, hour, day, month and year). CPU can read and modify the calendar information from RTC. Ethernet Controller Ethernet Controller supports the IEEE802.3/IEEE802.3u LAN standard, and supports two data transmission rate: 10Mbps and 100Mbps. CPU exchanges data with the Ethernet through the Ethernet Controller. Analog Output The D/A converter converts the digital ECG/IBP signals sent from CPU to the analog signals, which are provided for the external after low-pass filtered by the filter and amplified by the amplifier. FPGA and VRAM VRAM stores the displayed data. CPU stores the displayed data to VRAM through FPGA. FPGA gets data from VRAM, processes them, and then sends them to the relevant graphic display device. 8
Chapter 2 Principles
In addition, FPGA also extends multiple serial ports, which communicate with peripheral modules. FPGA transfers the received data to CPU through the bus; CPU delivers data to FPGA through the bus, and then the FPGA transfers those data to the peripheral modules.
Watchdog When powered on, watchdog provides reset signals for CPU, FPGA and Ethernet Controller. The patient monitor provides the watchdog timer output and voltage detection functions. 2.2.2
ECG/RESP/TEMP Module
2.2.2.1 General This module provides the function of measuring three parameters: electrocardiograph (ECG), respiration (RESP) and temperature (TEMP).
2.2.2.2 Principle diagram
Figure 2-5 Working principle of the ECG/RESP/TEMP module
2.2.2.3 Principle This module collects the ECG, RESP and TEMP signals through the transducer, processes the signals, and sends the data to the main board through the serial port.
ECG Signal Input Circuit The input protection and filtering circuits receive the ECG signal from the transducer, and filter the high-frequency interference signal to protect the circuit against the damage by defibrillator high-voltage and ESD. The right-leg drive circuit gets the 50/60Hz power common-mode signal from the lead cable, and sends the negative feedback signal to the human body to reject the common-mode interference signal on the lead cable, which helps the detection of the ECG signal. The lead-off detecting circuit checks whether the ECG lead is off, and sends the information to CPU. ECG Signal Process Circuit The difference amplifying circuit conducts the primary amplification of the ECG signal and 9
Chapter 2 Principles
rejects the common-mode interference signal. The low-pas filtering circuit filters the high-frequency interference signal beyond the frequency band of the ECG signal. The PACE signal refers to the ECG pace signal. It has significant interference to the ECG signal detection. The PACE rejection circuit can rejects the PACE signal, which helps the ECG signal detection. The main amplifying/filtering circuit conducts the secondary amplification of the ECG signal, filters the signal, and then sends the ECG signal to the A/D conversion part.
Pace Detect This part detects the PACE signal from the ECG signal and sends it to CPU. Temperature Detect Circuit This circuit receives the signal from the temperature transducer, amplifies and filters it, and then sends it to the A/D conversion part. Carrier Generate Circuit The RESP measurement is based on the impedance method. While a man is breathing, the action of the breast leads to changes of the thoracic impedance, which modulates the amplitude of the high-frequency carrier signal. Finally, the modulated signal is sent to the measurement circuit. The purpose of this module is generating the high-frequency carrier. RESP Signal Input Circuit This circuit couples the RESP signal to the detecting circuit. RESP Signal Process Circuit The pre-amplifying circuit conducts the primary amplification of the RESP signal and filters it. The detecting circuit detects the RESP wave that has been modulated on the actuating signal. The level shifting circuit removes the DC component from the RESP signal. The main amplifying/filtering circuit conducts the secondary amplification of the RESP signal, filters the signal, and then sends it to the A/D conversion part. A/D The A/D conversion part converts the analog signal to the digital signal, and sends the signal to CPU for further processing. CPU System Implementing the logical control of all parameter parts and A/D conversion parts; Implementing the data processing for all parameters; Implementing the communication with the main board. Power & Signal isolate Circuit Isolating the external circuits to ensure the safety of human body; Supplying power for all circuits; Implementing the isolation communication between the CPU System and the main board.
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Chapter 2 Principles
2.2.3
CO/IBP Module
2.2.3.1 General This module provides the function of measuring two parameters: Cardiac Output (CO) and Invasive Blood Pressure (IBP).
2.2.3.2 Principle diagram
Figure 2-6 Working principle of the CO/IBP module
2.2.3.3 Principle This module collects the CO/IBP signal through the transducers, processes it and sends it to the main board throgh the serial port.
CO Signal Process Network The CO parameter is measured with the thermal dilution method. The transducer sends two signals (TI: Temperature of Injectate; TB: Temperature of Blood) to the CO Signal Process Network. After that, the signals are amplified and low-pass filtered, and then sent to the CPU System for processing. IBP Signal Process Network The IBP signal is the differential signal. After the common-mode filtering, the difference signal is amplified by the difference amplifying circuit which changes the dual-end signal to the single-end signal. After the low-pass filtering, the IBP signal is sent to the CPU System for processing. CPU System Converting the analog signal obtained by the circuit to the digital signal; Implementing the logical control of all parameter parts; Implementing the data processing for the two parameters; Implementing the communication with the main board. Power & Signal isolate Circuit Isolating the external circuits to ensure the safety of human body; Supplying power for all circuits; Implementing the isolation communication between the CPU System and the main board. 11