Marquette Eagle1000 Service manual

Eagle 1000 Patient Monitor
Servicing Instructions
227 468 01 SA(e) Revision G
Caution:
During repairs/service interventions, observe the protective measures against damage due to ESD.
- assembly operations, extensions, readjustments, modifications, or
repairs are carried out by GE Medical Systems Information Technologies (GEMS IT) or by persons authorized by GE Medical Systems Information Technologies,
- the electrical installation of the relevant room complies with the applicable
national and local requirements, and
- the instrument is used in accordance with the instructions for use.
This manual contains service information; operating instructions are provided in the
operators manual of the instrument.
This manual is in conformity with the instrument at printing date.
All rights are reserved for instruments, circuits, techniques, and names appearing in the
manual.
© Copyright 1997 - 2003, GE Medical Systems Information Technologies GmbH.
All rights reserved.
Printed in Germany
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Contents
1. General overview of EAGLE 1000 ........................................................................................................ 7
1.1 Documentation and nomenclature of Marquette Hellige instrument part numbers .......................... 7
1.1.1 Configuration of instrument part number ............................................................................... 7
1.1.2 Configuration of the PCB par numbers .................................................................................. 7
1.2 Eagle 2000 system overview ............................................................................................................ 9
1.3 System overview............................................................................................................................. 10
1.3.1 Hooking up EAGLE 1000 monitors to PC Central Station SynOpsis 1000 ......................... 10
1.3.2 Patient data transfer from EAGLE 1000 via HELAN to SMU using QuickLink .................... 12
1.3.2.1 Introduction .......................................................................................................... 12
1.3.2.2 Data transfer between Eagle and Gateway ........................................................ 13
1.3.2.3 Connection to the LAN ........................................................................................ 13
1.3.2.4 EAGLE 1000 - QuickLink - HELAN - Examples of the link to networks .............. 15
1.3.2.4.1 Functional structure overview .......................................................... 15
1.3.2.4.2 Main components for the installation of QuickLink: .......................... 15
1.3.2.4.3 EAGLE 1000 - QuickLink ................................................................. 16
1.3.2.4.4 Network link - HELAN Concentrator ................................................ 17
1.3.2.4.5 Network link - HELAN Twisted Pair.................................................. 18
2. System overview .................................................................................................................................. 19
2.1 Technical specifications .................................................................................................................. 19
2.1.1 System interfaces ................................................................................................................ 19
2.1.2 Display ................................................................................................................................. 19
2.1.3 Monitor functions ................................................................................................................. 19
2.1.4 Power supply ....................................................................................................................... 20
2.1.5 Operation and storage ......................................................................................................... 21
2.1.6 ECG and heart rate ............................................................................................................. 21
2.1.7 Oxygen saturation Sp02 ...................................................................................................... 23
2.1.8 Non-invasive blood pressure ............................................................................................... 24
2.1.9 Invasive blood pressure ....................................................................................................... 25
2.1.10 Temperature......................................................................................................................... 27
2.1.11 Trend.................................................................................................................................... 28
2.2 Functional description of PCBs and subassemblies ...................................................................... 28
2.2.1 Eagle 1000 configuration and functional groups ................................................................. 28
2.2.2 PCB ECG Monitor................................................................................................................ 29
2.2.3 System power supply .......................................................................................................... 30
2.2.4 Floating system power supply and signal flow .................................................................... 31
2.2.5 Signal exchange with the processor.................................................................................... 31
2.2.6 Display ................................................................................................................................. 32
2.2.7 Block diagrams .................................................................................................................... 33
2.2.7.1 Functional groups ................................................................................................ 33
2.2.7.2 Floating system supply and signal flow ............................................................... 34
2.2.7.3 System power supply .......................................................................................... 35
2.2.7.4 PROCESSOR block diagram .............................................................................. 36
2.2.7.5 DISPLAY block diagram ...................................................................................... 37
2.2.8 ECG signal preprocessing ...................................................................................................38
2.2.8.1 Functional descriptiony ........................................................................................ 38
2.2.8.2 ECG/Pace Preprocessing ................................................................................... 40
2.2.9 PCB MP 204 Oximeter 930 117 26 ...................................................................................... 41
2.2.9.1 Function ............................................................................................................... 41
2.2.9.2 Figure of pcb MP204 Oximeter ........................................................................... 41
2.2.9.3 Pin assignment .................................................................................................... 42
2.2.10 Non-invasive blood pressure module .................................................................................. 43
2.2.10.1 Function ............................................................................................................... 43
2.2.10.2 Figure of PCB NBP Module NB11: 930 117 15 ................................................... 44
2.2.10.3 Figure of PCB NBP 2000 Module 930 117 93 or 388 032 60 ............................. 45
2.2.10.4 Pin assignment .................................................................................................... 46
2.2.11 PCB Press-Temp 388 031 75/PCB Temp 388 032 04......................................................... 47
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2.2.11.1 PRESS module .................................................................................................... 47
2.2.11.2 Temp module ....................................................................................................... 48
2.2.11.3 Internal interfaces ................................................................................................ 49
2.2.11.4 Interfaces to peripherals ...................................................................................... 50
2.2.11.5 TEMPERATURE BLOCK DIAGRAM ................................................................... 51
2.2.11.6 PRESS BLOCK DIAGRAM ................................................................................. 52
2.2.12 Recorder 50 Part No. 218 111 12 ........................................................................................ 53
2.2.12.1 Function ............................................................................................................... 53
2.2.12.2 Recorder block diagram ...................................................................................... 54
2.2.12.3 Internal interfaces ................................................................................................ 55
2.2.12.4 Interfaces to peripherals ...................................................................................... 56
2.2.13 PCB Power Supply 930 117 41 ........................................................................................... 57
2.2.13.1 Function and pin assignment .............................................................................. 57
2.2.13.2 Figure of PCB Power Supply 930 117 41 ............................................................ 58
2.2.14 Membrane keypad ............................................................................................................... 59
2.2.14.1 Pin assignment ........................................................................................................................ 59
2.2.14.2 Membrane keypad 390 001 30 and 390 001 64, circuit diagram ........................ 60
2.3 Pin configuration of panel connectors ............................................................................................ 61
2.3.1 Socket ECG 303 444 28 ......................................................................................................61
2.3.2 Socket SpO2 303 444 29.....................................................................................................62
2.3.3 Socket PRESS 303 444 30 ................................................................................................. 63
2.3.4 Socket Temperature (TEMP) 303 444 31 ............................................................................ 64
2.3.5 Socket on the rear panel of the Eagle 1000 ........................................................................ 65
2.3.6 2-Port Press Adapter 220 102 01 ........................................................................................ 66
2.4 Complete circuit diagram and mechanical diagrams ...................................................................... 67
2.4.1 Systems without a recorder 101 123 .. ................................................................................ 67
2.4.2 Systems with a recorder 101 124 .. ..................................................................................... 67
2.4.3 Complete wiring circuit (S-Plan) .................................................... Please refer to the appendix
2.5 Master Record Index (MRI) ................................................................... Please refer to the appendix
3. Maintenance and technical inspection .............................................................................................. 69
3.1 Visual check .................................................................................................................................... 69
3.2 Checkout Procedures ..................................................................................................................... 70
3.2.1 Recommended testing/calibration equipment and accessories: ......................................... 70
3.2.2 Test preliminaries ................................................................................................................. 71
3.2.3 Operating control and indicator performance checks.......................................................... 71
3.2.4 ECG performance check ..................................................................................................... 72
3.2.4.1 Patient cable identification ................................................................................... 72
3.2.4.2 ECG Simulator settings ....................................................................................... 72
3.2.4.3 Analysis of the ECG signal, HR value and QRS beep ........................................ 72
3.2.4.4 Testing alarm limits, recorder start, audible alarm activation .............................. 73
3.2.4.5 Testing the input amplifier offset .......................................................................... 73
3.2.4.6 Testing pacing detection ...................................................................................... 73
3.2.4.7 Testing the lead fail detection .............................................................................. 74
3.2.5 NI blood pressure performance check ................................................................................ 74
3.2.5.1 Leakage test ........................................................................................................ 74
3.2.5.2 Testing display errors .......................................................................................... 74
3.2.5.3 Testing the deflation pressure threshold ............................................................. 76
3.2.5.4 Dynamic blood pressure measurement .............................................................. 76
3.2.6 SpO2 performance check .................................................................................................... 76
3.2.6.1 Simulator setting .................................................................................................. 76
3.2.6.2 Monitor settings ................................................................................................... 76
3.2.6.3 Displaying waveforms and parameter readings .................................................. 76
3.2.6.4 Testing display accuracy of SpO2 and pulse rate ............................................... 77
3.2.7 Invasive blood pressure performance check (Vers. 2.0 and higher) ................................... 77
3.2.8 Temperature performance check (Vers. 2.0 or higher) ........................................................ 78
3.2.9 RS232 performance check (Vers. 2.0 or higher) ................................................................. 78
3.2.10 Nurse call output performance check .................................................................................. 79
3.2.11 Testing condition of battery .................................................................................................. 79
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3.2.12 Backup battery for the clock ................................................................................................ 79
3.3 Calibration check of the measuring system....................................................................................80
3.3.1 Technical Inspections of the Measuring System ................................................................. 80
3.4 Safety Analysis Test ........................................................................................................................ 81
3.4.1 General introduction ............................................................................................................ 81
3.4.2 Recommended Test Equipment .......................................................................................... 81
3.4.3 Protective Earth Resistance Test......................................................................................... 83
3.4.4 Leakage Current Measurement........................................................................................... 83
3.4.4.1 Enclosure Leakage Current Test ......................................................................... 83
3.4.4.2 Patient Leakage Current Test .............................................................................. 84
3.4.4.3 Enclosure Leakage Current Test (System) ......................................................... 85
4. Instrument service ............................................................................................................................... 86
4.1 Service mode tests ......................................................................................................................... 86
4.2 Instrument performance .................................................................................................................. 87
4.2.1 Start-up performance ........................................................................................................... 87
4.2.2 Operating performance ........................................................................................................ 87
4.2.3 Performance in the event of a malfunction .......................................................................... 87
4.3 Battery management ...................................................................................................................... 88
4.4 Safety information ........................................................................................................................... 89
4.4.1 Insulating foil ........................................................................................................................ 89
4.4.2 High voltage ......................................................................................................................... 89
4.4.3 ESD protection..................................................................................................................... 89
4.5 Eagle 1000 servicing information ................................................................................................... 90
4.5.1 Service repair kit .................................................................................................................. 90
4.5.2 Opening the instrument ....................................................................................................... 90
4.5.3 Removing and reinstalling assemblies ................................................................................ 91
4.5.4 Adjustment procedures ........................................................................................................ 95
4.5.4.1 Location of the adjustment devices on PCB ECG Monitor Index G to I .............. 97
4.5.5 Recorder service ................................................................................................................. 99
4.5.6 PCB Press-Temp 388 031 75, PCB Temp (partly equipped PCB Press-Temp) ................ 101
4.6 Troubleshooting tips...................................................................................................................... 101
4.7 QuickLink test ............................................................................................................................... 105
4.7.1 Technical inspections ......................................................................................................... 105
4.7.2 Tools required .................................................................................................................... 105
4.7.3 Testing QuickLink adapter leading to QuickLink Station and HELAN ............................... 105
4.7.4 Testing QuickLink adapter leading to Eagle 1000 ............................................................. 107
4.7.5 QuickLink test: RS-232 connections ................................................................................. 108
4.7.6 Maintenance and checkout procedures ............................................................................ 109
5 PCB R-Plan, P-Plan .............................................................................................................................111
5.1 PCB ECG Monitor 388 031 19 (V2.0) ........................................................................................... 111
5.2 PCB ECG Monitor 388 031 19 I (V2.01) ........................................................................................111
5.3 PCB Recorder 50: 388 031 70 ...................................................................................................... 111
5.4 PCB Press/Temp 388 031 75 ........................................................................................................ 111
5.5 PCB Temp 388 032 04................................................................................................................... 111
5.6 PCB Press Distributer 388 032 12 ................................................................................................. 111
5.7 Isolation relay Eagle 1000: 388 032 14 ......................................................................................... 111
6. Sparparts List ..................................................................................................................................... 113
7. Miscellaneous, Notes ........................................................................................................................ 117
Appendix............................................................................................................................................. 119
Circuit diagrams, mechanical diagrams ................................................................. Apprendix
Master Record Index (MRI) .................................................................................... Apprendix
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Revision History
This manual is subject to the GE Medical Systems Information Technologies change order service. The revision code, a letter that follows the document part number, changes with every update of the manual.
The initial version of the manual has the letter A.
Part No. Revision Code Date Comment
227 468 01 A 1997-05 Initial Release 227 468 01 B 1997-06 Updates 227 468 01 C 1997-08 Updates 227 468 01 D 1997-12 Updates 227 468 01 E 1998-02 ECO 063757 227 468 01 F 2001-02 ECO 065760
227 468 01 G 2003-02 ECO 068791
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1. General overview of EAGLE 1000
1.1 Documentation and nomenclature of Marquette Hellige instrument part numbers
1.1.1 Configuration of instrument part number
The instrument part number comprises 8 digits, the first 6 digits determining the instrument type, the last 2 digits the instrument version. The language is determined by configuration, thus having no influence on the part No.
E.g. Instrument Type Version
EAGLE 1000 without recorder 101 123.. with recorder 101 124..
07 complete system 02 ECG only
1.1.2 Configuration of the PCB par numbers
388 xxx yy Spare part numbers for the operative PCBs.
The instrument documentation, e.g., reference diagrams, circuit diagrams and parts lists are listed under these part numbers. The 388 number is located on the barcode label.
Configuration of the barcode labels:
Consecutive number
Consecutive number barcode Test mark
0000000219
388 011 51 3131 C3
Part No. Parts list index
Test number (batch)
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303 xxx yy Spare part numbers for PCBs tested especially thoroughly
303 numbers are only given to PCBs where the level of testing applied to 388 PCBs is inadequate for implementation when servicing in the field, or where only a complete set of PCBs can be replaced in the field. In addition to a barcode label (388 number) 303 part numbers also have an additional label with a 303 number and are to be found in the spare parts list under this number.
Exchange for defective PCBs
Where servicing is required exchange PCBs are available for the replacement of some PCBs. When using a exchange PCB, the defective PCB is to be returned to the Freiburg factory. Replacement PCB part numbers are included in the spare parts list.
1.1.3 Instrument status documentation (nominal status)
Due to the hardware and software combination unambiguous documentation of the instru­ment assembly status is necessary, also in the event of repairs.
This documentation comprises the following documents and measures:
Master Record Index (MRI)
This document is a component of this instrument documentation.
This document states the combination of permissible hardware and software for a particu­lar instrument version. The permissible PCB Index is given in the Index column with each update delivered. Further permissible PCB Indexes are given in the compatible column. The PCB Index can be found in the PCB barcode label.
Product Status Index
This document is created during manufacture. The Product Status Index documents the hardware/software product status.
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1.2 Eagle 2000 system overview
These servicing instructions describe the instrument versions with Hellige circular connec­tors.
Compact, multi-parameter patient monitor, 12 different models
101 123 02 EAGLE 1002 ECG 101 124 02 EAGLE 1003 ECG Alarm recorder 101 123 03 EAGLE 1004 ECG SPO 101 124 03 EAGLE 1005 ECG SPO 101 123 04 EAGLE 1006 ECG NBP 101 124 04 EAGLE 1007 ECG NBP Alarm recorder 101 123 05 EAGLE 1008 ECG SPO 101 124 05 EAGLE 1009 ECG SPO 101 123 06 EAGLE 1010 ECG SPO 101 124 06 EAGLE 1011 ECG SPO 101 123 07 EAGLE 1014 ECG SPO 101 124 07 EAGLE 1015 ECG SPO
2
2
2
2
2
2
2
2
Alarm recorder
NBP NBP Alarm recorder NBP TEMP NBP TEMP Alarm recorder NBP TEMP 2 x IBP NBP TEMP 2 x IBP Alarm recorder
Table of EAGLE 1000 models (NBP = non-invasive blood pressure, IBP = invasive blood pressure.
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1.3 System overview
1.3.1 Hooking up EAGLE 1000 monitors to PC Central Station SynOpsis 1000
Eagle 1000 monitors version V2.1 and higher can be connected up to the PC Central Station SynOpsis 1000. This involves the hooking up of up to eight monitors via a serial cable with an OctaBus 1000. Up to two OctaBus 1000s can be connected up to the Central Station. Each OctaBus is connected to the Central Station PC using a printer port. Alarm release ensues from one of the two OctaBus devices, these being connected ap­propriately. The OctaBus devices and the Central Station PC monitor controll each others performance and give an alarm when a malfunction is detected. For configuration see figure below.
Nurse Call
EAGLE wall outlet
Figure 1. Connection of EAGLE 1000 with current loop output to Nurse Call/ Central Station socket
Connection
The Nurse Call socket of Eagle 1000 V2.1 or higher is used for hooking up to the Central Station via the OctaBus. A current loop permits connections over distances of up to 200 m.
Connection to the OctaBus is via an 8-lead cable either from a wall outlet or directly. Refer to the Installation Instructions for more details.
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Central Station PC
Figure 2. Connection of EAGLE 1000 monitors to a PC Central Station SynOpsis 1000 using 2 OctaBus hardware interfaces.
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1.3.2 Patient data transfer from EAGLE 1000 via HELAN to SMU using
QuickLink
1.3.2.1 Introduction
To ensure continuous monitoring it is also necessary to be able to record patients vital signals during relocation and transportation. However, since during patient transfer there is no connection to the LAN, the trend data are collected and then transferred later as a block.
After taking over patient monitoring on the transport monitor recording of the data begins. No connection is being established with the Gateway. The patient remains anonymous, i.e., his name is not entered into the transport monitor.
Upon arrival at his new destination the patient is hooked up to the destination monitor and the transfer of the trend data initiated by the transport monitor operator. The transport monitor establishes a connection over an IR beam and a terminal server (QuickLink) with the LAN and transfers the data to the Gateway. In the Gateway the data are stored in a file bearing a file name indicating the ID of the transport monitor used. Assignment of patient data is carried out using the operating routi­nes of the destination monitor. The operator selects the transport monitor ID, to which the transferred patient belonged to. It is now the task of the Gateway to enter the trend data into the database correctly.
Figure 3 shows the principle of data transfer. The terminal server comprises QuickLink, the Gateway comprises VICOM TR server or VICOMport + VICOMserver.
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1.3.2.2 Data transfer between Eagle and Gateway
Eagle and Gateway will communicate while transferring trend data. Transfer is initiated by the user request function.
The data are first stored in a file and, when data transfer is complete, arranged in proper order. The transport monitor waits for the results of this processing procedure.
If an error occurs in the database during this procedure, all the data in the Gateway are deleted and the entire data must be transferred once more.
When the data transfer is initiated, the time will be sent by the transport monitor real-time clock. From this the Gateway can identify any possible time misalignment of the internal clock of the transport monitor and account for this when the trend data are entered.
Sporadic trend data, e.g., non-invasive blood pressure values, are only transferred for the period of time in which continuous trend data, e.g., ECG, are also available. Earlier or later parameter readings will be ignored.
1.3.2.3 Connection to the LAN
The QuickLink Station is connected to a Multiport or an SMX using twisted-pair wiring.
The Multiport can lead to the LAN using BNC or AUI wiring.
The SMX 008 leads to the LAN using AUI wiring, the SMX 009 to the LAN using BNC wiring.
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Configuration with BNC, AUI or twisted pair (TP)
Figure 4. QuickLink - LAN connection
twisted pair
installation option
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1.3.2.4 EAGLE 1000 - QuickLink - HELAN - Examples of the link to networks
1.3.2.4.1 Functional structure overview
The link of Eagle 1000 to the networks via QuickLink enables the transfer of patient data acquired during patient relocation and transportation for continuous and uninterrupted analysis.
A QuickLink adapter connected to the RS 232 interface of the Eagle 1000 sends the trans­portation data using IR to a QuickLink Station. The QuickLink Station acts as a terminal server and is the communication partner to the HELAN network.
The data transferred onto the HELAN are stored on a server which acts as a Gateway (VICOM TRserver or VICOMport in connection with VICOMserver).
This is where the patient data and the measured values recorded during transportation are made available for complete documentation on any patient monitor or on a clinical infor­mation system.
1.3.2.4.2 Main components for the installation of QuickLink:
Part Number Device Description
216 135 01 QuickLink Adapter IR-Interface, connectable to Eagle 1000 216 134 01 QuickLink Station Station to receive IR signal from QuickLink
adapter incl. RJ45 connection (Twisted
Pair) 216 107 01 SMX 001 Transceiver for AUI 216 133 01 SMX 005 Transceiver for RJ45 (Twisted Pair) 930 117 40 SMX 006 Multiport Repeater (12 x RJ45) 930 117 39 SMX 007 Multiport Repeater (24 x RJ45) 930 117 76 SMX 008 Repeater RJ45 to AUI 930 117 77 SMX 009 Repeater RJ45 to BNC (CheaperNet) 101 130 01 VICOM TRServer R.2.0 Patient data transfer within HELAN 101 131 01 VICOMport R.2.0 Link of HELAN to VICOM Server 101 132 01 VICOMserver R.2.0 Database for HELAN and interface to other
networks
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1.3.2.4.3 EAGLE 1000 - QuickLink
Network link - HELAN CheaperNet
SMX 008 + SMX 001 can be used in place of SMX 009 + BNC T-Plug.
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1.3.2.4.4 Network link - HELAN Concentrator
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1.3.2.4.5 Network link - HELAN Twisted Pair
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2. System overview
2.1 Technical specifications
2.1.1 System interfaces
Interface for Nurse Call and Central Station
* output for control signal in the case of alarm or warnings for connection of an Isolation
Relay 303 444 77, short-circuit-proof * trigger output (digital impulse, width 1 ms, 0 V to 9.5 to 14.5 V) * 20 mA current loop output to connect OctaBus to PC Central Station SynOpsis with
V2.1 or higher version
RS 232 interface
* RS 232/V24 interface for connection of QuickLink to HELAN, available from V 2.0 or
higher
2.1.2 Display
* size: 6-inch diagonal (14 cm) * type: monochrome liquid-crystal display * resolution: 320 by 240 pixels
Waveform display
* 3 channels * sweep speed of 25 mm/s * erase-bar mode
2.1.3 Monitor functions
Operating modes
* test, monitoring enabled/disabled, service mode, data transfer (download)
Alarm system
* text on display, alarm LED, Alarms OFF LED, audible alarm signal (can be disabled
via softkey or from the defaults menu)
Data storage in case of line failure or empty battery
* at least 5 minutes
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2.1.4 Power supply
* from the power line, monitor design in IEC protection class I
Potential equalization
* potential equalization connection according to DIN 42 801(measurement in or at the
heart) or connection for function ground (interference elimination during general cardio-
logical examinations)
Rated voltage range from 95 to 240 V AC
* operating voltage range from 85 to 264 V, 49 to 65 Hz * rated current from 0.15 to 0.3 A
Internal power supply (rechargeable battery)
* automatic toggling from line to battery operation and vice versa * integrated charge circuit with automatic adaption of charge characteristics * fast battery charging to 80% of its capacity within 3.5 hours, afterwards * normal charging to 100% of its capacity within 8 hours, afterwards * continuous trickle charging by means of charge pulses to prevent the memory effect
Charge balance
measurement of the charge and load current
compensation for battery self-discharge
graphic indication of battery capacity
Alarms
warning when battery provides power for only 5 minutes of operation (without
recorder)
automatic switch-off at 10.0 V to prevent overdischarging
Capacity of the rechargeable battery
2000 mAh, 12 volts
Charging indicator
LED
Operating time
approx. 3 hours (typical operating time with fully charged battery at 23 °C, at a
battery temperature of 60 °C the capacity may be reduced to 70%) (min. 2 hours at 25 °C ambient temperature and new, fully charged battery)
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2.1.5 Operation and storage
Operational readiness
after approximately 5 seconds
Operating position
vertical (free circulation of air under the unit and ventilation openings must not be ob-
structed)
Environmental conditions
Operation
* ambient temperature between +10 °C and +40 °C * battery charging temperature between +10 °C and +40 °C * relative humidity between 30% and 75%, no condensation * atmospheric pressure between 700 and 1060 hPa
Storage
* ambient temperature between -30 °C and +60 °C * relative humidity between 10 and 100%, no condensation * atmospheric pressure between 500 and 1060 hPa
Dimensions
width 262 mm
height 215 mm
depth 160 mm
weight 2 kg to 4.4 kg (depending on monitor model)
2.1.6 ECG and heart rate
ECG signal inputs
Electrode connection for simultaneous transfer of 2 ECG signals: ECG 1 and ECG 2 via lead selector (7 standard lead configurations each). Signal inputs for 3-lead and 5-lead patient cables with connections for electrode leads; buffer amplifier with protective circuit and HF filter; floating input circuit (isolated patient connection of the CF type, IEC); overvoltage protection for all inputs, detection of pacing pulses, monitoring of electrode-to-skin contact impedance (specifications without leads):
differential input impedance for DC > 65 MOhms, for f<=100 Hz > 6 MOhms
common-mode input impedance referred to RL
for DC > 10 GOhms, for f<=100 Hz > 50 MOhms
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overrange limit (e.g. for polarization voltages) for differential signals >0.6 V, for signals
referred to RL > 1.0 V  common-mode rejection referred to RL for f<= 50 Hz approx. 80 dB RL referred to
chassis >110 dB  patient leakage current (rms values): under normal conditions <0.005 mA, in fault condi
tion (e.g. patient in contact with mains voltage) <0.020 mA  quiescent input current <40 nA
non-destructive load for electrode connections referred to RL ± 50 V, referred to chas-
sis ± 1000 V  pulse-voltage resistance of all electrode connections and of the RL-connection referred
to chassis (either polarity, e.g. defibrillation, electrocautery) 5000 V
Signal processing
The signal in channel 1 is processed. All specifications refer to a signal free of inter ference.
Amplification, QRS detection, digitization, display
HR measuring range 15 to 300 bpm, error ± 1 BPM (EC 13)  ECG cut-off frequency >=100 Hz  differential signal range ± 4.5 mV  ECG resolution 0.005 mV  sampling rate 1000/1200 Hz  noise below 0.04 mV  time constant for ECG transfer 0.3 s (0.5 Hz)  HR averaging for displayed value: weighted average from the most recent RR intervals  display update interval: 2 seconds  trigger sensitivity 0.25 mV to 0.30 mV for pulse width of 40 ms  max. rate stabilization of 6 seconds for RR interval change of 95%  alarm delay 4 seconds  asystole alarm 4 seconds  3 signal sizes for monitor display in freeze mode or else on the recorder trace: 5  10
 20 mm/mV  1-mV calibration signal on waveform and recorder trace  detection of pacing pulses (these specifications refer to an ECG signal free of inter-
ference)
pulse duration dp>approx. 0.2 ms, <40 ms
pace marker independent of polarity
pulse amplitude ap±10 to ±700 mV
over/undershoot ao±1 mV
time constant to 25 to 100 ms
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alarm limits adjustment range: 20 to 250 BPM  trigger output on Nurse Call connection nominally 12 V 1 ms, delay max. 25 ms, tole-
rance 9.5 V to 15.5 V
rate measurement
derivation of trigger pulses from the ECG signal or from the pressure waveform or from
the Sp02 signal with automatic adaption of the trigger threshold or blanking of pacing
pulses; calculation of the mean rate; 3-digit display on the monitor screen
2.1.7 Oxygen saturation Sp0
2
Signal input
Connection for one Sp02 probe, isolated from ground, floating input circuit (isolated patient connection of the CF type, IEC). Used in conjunction with the approved probes, the module is protected from voltages generated by defibrillation discharges and electrocautery.
Signal processing
dual-wavelength pulse oximeter Sp0
measuring range 1 to 100%
2
PR measuring range 20 to 250 BPM resolution 1% Sp0
2
deviations from actual value (% Sp02 = 1st standard deviation) in combination with:
standard finger probe (DS 100A)
between 70 and 100%: ±3 digits
disposable probe for adults (D25)
between 70 and 100%: ±2 digits
disposable probe for children (OXI D20)
between 70 and 100%: ±2 digits
disposable probe for babies (J-20)
between 70 and 95%: ±2 digits
disposable probe for neonates (N-25)
between 70 and 95%: ±2 digits
unspecified between 0 and 69% Sp0
Plethysmogram
accuracy of the pulse rate measurement
±3 pulses/min between 20 and 150 pulses/min
±2% between 150 and 250 pulses/min
2
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2.1.8 Non-invasive blood pressure
Signal input
Single-lumen tubing system, type CF signal input (IEC 601-1), patient is electrically not connected to the system, thus the system is protected from defibrillation discharges and electrosurgery voltages).
Signal processing
Oscillometric method: stepwise pressure decrease, zero pressure reference prior to each measurement Two measuring modes: adult
neonate
mmHg
adult systolic 25 to 255
diastolic 10 to 220 mean 18 to 255
neonate systolic 20 to 155
diastolic 5 to 110 mean 10 to 130
The specifications are met for pulse rates between 40 and 240 BPM (adult/neonate).
Safety circuits
Redundant monitoring of the cuff pressure by means of a second independent pressure sensor; cuff deflation immediately on exceeding max. cuff pressure, on detection of faults during a measurement and on power loss.
Max. cuff pressure
adult 300 mmHg neonate 160 mmHg
Special features
When the cuff is properly applied the module recognizes in the adult mode whether the cuff matches the selected range. If the wrong cuff is applied, the measurement is interrup­ted.
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Cuff inflation pressure
adult 160 mmHg neonate 100 mmHg
Adaptive cuff inflation pressure
After a measurement the inflation pressure of the subsequent measurement depends on the previous measuring result: it is either 1.8 times the previous mean pressure or 15% above the previous inflation pressure (whichever is less).
Measurement cycles
Selectable intervals for automatic measurement cycles: 2, 5, 10, 15, 30, 60 minutes
Measuring accuracy
P
sys/Pdia
<= 8 mmHg, 1st standard deviation
error limits for cuff pressure via the pressure transducer ±3 mmHg
Measurement duration
adult: 90 seconds max. neonate: 70 seconds max. typical duration for undisturbed measurement: 30 seconds
Technical inspection, calibration
Technical inspection must be carried out once a year, calibrations every two years (refer to section 3 Maintenance and technical inspection).
2.1.9 Invasive blood pressure
Signal inputs
2 connections which are both isolated from ground (type CF according to IEC 601-1) for pressure transducers with ohmic strain-gauge bridge, diagonal resistance of 200 Ohms to 10 kOhms with a sensitivity of 0.005 mV/mmHg per V of supply voltage:
supply voltage for transducer:
5 volts DC
At 50 and 60 Hz:
differential input impedance > 100 kOhms, real component 500 kOhms  common-mode input impedance > 100 kOhms  common-mode rejection > 60 dB up to 60 Hz
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Connections
direct connection for measurement of one pressure  connection via adapter for measurement of two pressures
Display
pressure waveform with 25 mm/s sweep for both channels  pressure waveform for the following pressure sites: arterial (ART1, ART2), pulmonary
artery (PA), venous (VEN), left-atrial (LAP), intracranial (ICP) for ART, PA and LAP the
systolic, diastolic and mean values can be displayed  display update interval: 2 seconds
Signal processing
Pressure
measuring range -30 to +300 mmHg  resolution 0.25 mmHg, internal  cut-off frequency 12 Hz  accuracy ±2 mmHg ±1% of actual value  zero drift < ±0.1 mmHg/°C  5 minutes to warm up for full accuracy
Zero balancing
automatic compensation of the transducer value for a zero pressure in both channels,
every channel to be zeroed is checked for absence of pulse signals  balancing initiated after key press > 2 seconds  balancing range ±100 mmHg  storage of the balancing value for 5 minutes after power failure or when monitor is
switched off  deviation < ±1 mmHg  initiation only when signal modulation < ±1 mmHg
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2.1.10 Temperature
Signal input
Input isolated from ground (type CF according to IEC 601-1) for connection of a tempera­ture probe from the Marquette HELLIGE accessory range (these probes conform to the YSI 400 or Exacon 4000 series; as these probes have jack plug contacts which are acces­sible when not connected, they were additionally tested with 1500 V cal saline according to IEC 601-1)
Signal processing
Together with two test readings and a correction value the temperature reading is proces­sed for regular self-tests and for fine-balancing by multiplexing in a common amplification circuit:
measuring range 0 to 44 °C  error limits for module without probe: between 0 and 25 °C ±0.2 °C, between 25 and
44 °C ±0.1 °C  display update interval: 2 seconds  5 minutes to warm up for full accuracy
50 Hz in physiologi-
rms
Functional safety
Continuous self-tests prevent display of values outside the calibration error limits; when service screen is called up the test values of 38.8 °C ±0.1 °C and 4.0 °C ±0.2 °C are dis­played.
Technical inspection, calibration
Calibration tests must be carried out on the monitor every two years (refer to section 3 Maintenance and technical inspection), technical inspection once a year.
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2.1.11 Trend
* storage of parameter values * tabular trend, NBP table depending on NBP intervals * graphic trend for each parameter * storage of trend values every 20 seconds or after NBP measurement * display of trends via softkeys * automatic display of a time scale and of reference lines (labelled) * zoom function for selection of other trend periods (graphic: 45 minutes, 3 hours,
24 hours; tabular: 1 minute, 5 minutes, 15 minutes) * trend memory can be cleared with a softkey, or the memory is cleared automatically
when the monitor is switched off for more than 5 minutes
2.2 Functional description of PCBs and subassemblies
2.2.1 Eagle 1000 configuration and functional groups
see diagram Functional groups
The basic Eagle 1000 patient monitor version comprises the large PCB ECG Monitor installed in the system on the front side of an L-shaped metal plate. In addition to the ECG input circuit, the instrument control system is also located on this PCB.
The keypad, display screen, battery and the PCB Power Supply are connected to it. Also connected are the ECG input socket and the two rear panel outputs RS-232 and Nurse Call.
The keypad and CRT have conductor foil connections and care must be taken when con­necting them up and sharply bending them avoided.
The battery is installed in the bottom side of the L-shaped metal plate.
The power supply is located inside the rear panel of the system next to the power supply socket.
The recorder, if there is one, is mounted on the base plate and connected to the PCB ECG Monitor.
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In the models with additional features the PCB ECG Monitor also acts as a mother­board. The PCB Oximeter, the PCB for non-invasive blood pressure and the PCB for temperature or for temperature and 2 invasive blood pressures can be added to this board.
In conformity with Cardiac floating there is a high-impedance isolating transformer refer­red separately to the ECG input module, the PCB Oximeter, the PCB module for tempera­ture and the PCB module for 2 invasive blood pressures. Both pressure measuring com­ponents are electrically connected. These PCBs are insulated from the non-floating com­ponents of the system and each other by spacing and insulating foil.
Warning: It is thus important that when disconnecting or replacing PCBs in the
system to ensure PCBs and circuits are correctly installed and the insulat­ing foil positioned accordingly.
2.2.2 PCB ECG Monitor
The PCB ECG monitor appears as a block diagram in the PCB circuit diagrams. The circuits are arranged so that (viewing Eagle 1000 from the rear) the floating ECG Proces­sing is located in the left-hand third, in the remainder all the other functions:
Floating Non-Floating
x Display Controller
x ECG Controller
x Interface Output
x ECG Filter x Controller
x Power Supply (instrument, battery, floating)
x ECG Input x Interface Input
This means that ECG Processing and the Central System signal processing and system controller are implemented on this PCB. The description of each is given below, indicating the connected modules and their functions.
The PCB plugs and sockets are shown in the S-Plan of the system plans and are alloca­ted as listed below. This allocation is useful in finding the pin configuration in the P circuit diagrams of the PCB ECG Monitor.
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Name Connection Denotation Page P-Plan Subtitle
AA Conductor Foil Display 9 Display AB For Optrex LCD only 9 Display AC Cable Battery 6 Power AD Cable PCB Power Supply 6 Power AE Cable LCD Backlight 9 Display AF Flat cable Recorder 8 Interface_Out AG Flat cable PCB Non-Invasive Blood 5 Interface_In
Pressure AH Flat cable PCB Oximeter (Sp02) 5 Interface_In AI Debugging Connector only 7 Control AJ Stackable Connector PCB Press/Temp 5 Interface_In AK Flat cable ECG Input 2 ECG_Input AM Conductor Foil Membrane Keypad 5 Interface_In AN Flat cable RS 232 External Port 8 Interface_Out AO Flat cable Nurse Call Adapter 8 Interface_Out
2.2.3 System power supply
see diagram System Power Supply
The power supply is in protection class I with a protective ground terminal. A primary­regulated wide-range power supply unit, delivering 15.5 V DC, precludes the necessity of a power toggle switch. This unit also acts as a charger for the 12-V system battery. All con­trol functions are regulated on the PCB ECG Monitor. A charge controller measures the battery current across a resistance referred to zero, activates the front panel charge indi­cator and communicates with the processor. Should the output voltage of the power unit fail to reach 15.5 V, the battery will not be charged to full capacity.
The battery meets the temporary high current demand of the recorder and the PCB Non­Invasive Blood Pressure as well as current peaks and is also essential for retaining data.
As the battery continuously is discharged, this is indicated by an 11.5V comparator, which triggers the warning display Battery blinking and the audible alarm signal sounding. When the charge drops below 10 V after storing the data the 10V comparator switches off the system to protect the battery.
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