Service Manual: For YM1000 Vital Signs Monitor
Service Manual: For YM1000 Vital Signs Monitor
EU Representative
TECNOMED 2000 S.L.
Valencia, 25 ‐ 28012 Madrid Spain
Manufacturer
Mediana Co., Ltd.
Wonju Medical Industry Park, 1650‐1 Donghwa‐ri,
Munmak‐eup, Wonju‐si, Gangwon‐do, Korea
Tel: (82) 2 542 3375 (82) 33 742 5407
Fax: (82) 2 542 7447 (82) 33 742‐5483
Printed in Korea
Copyright © 2006 Mediana Co.,Ltd. All rights reserved.
Notice
This document contains proprietary information that is protected by copyright. All Rights
Reserved. Reproduction, adaptation, or translation without prior written permission is
prohibited, except as allowed under the copyright laws.
Warranty
Revision History
The documentation part number and revision number indicate its current edition. The
revision number changes when a new edition is printed in accordance with the revision
history of the documentation. Minor corrections and updates which are incorporated at
reprint do not cause the revision number to change. The document part number changes
when extensive technical changes are incorporated.
Contents
Figures
Tables
Introduction 1
Manual Overview ............................................................................................................................................ 3
Related Documents.......................................................................................................................................... 3
Description of the YM1000 monitor .............................................................................................................. 3
Specification 7
Physical.............................................................................................................................................................. 7
Electrical ............................................................................................................................................................ 7
Environmental.................................................................................................................................................. 7
Measurement Parameters ............................................................................................................................... 8
Compliance ..................................................................................................................................................... 10
Routine Maintenance 13
Cleaning .......................................................................................................................................................... 13
Periodic Safety and Functional Checks....................................................................................................... 13
Functional Checks.......................................................................................................................................... 14
Batteries ........................................................................................................................................................... 14
Environmental Protection............................................................................................................................. 14
Performance Verification 15
Introduction .................................................................................................................................................... 15
Equipment Needed........................................................................................................................................ 15
Performance Tests .......................................................................................................................................... 16
Safety Tests...................................................................................................................................................... 23
Service Mode and Demo Mode 27
Introduction .................................................................................................................................................... 27
Service Mode .................................................................................................................................................. 27
Demo Mode .................................................................................................................................................... 35
Firmware download 37
Introduction .................................................................................................................................................... 37
Equipment Needed........................................................................................................................................ 37
How to Download ......................................................................................................................................... 37
Troubleshooting 39
Introduction .................................................................................................................................................... 39
How to Use This Section ............................................................................................................................... 39
Who Should Perform Repairs....................................................................................................................... 39
Replacement Level Supported ..................................................................................................................... 39
Troubleshooting Guide ................................................................................................................................. 40
Disassembly Guide 47
General ............................................................................................................................................................ 47
Replacement Level Supported ..................................................................................................................... 48
Prior to Disassembly...................................................................................................................................... 49
Fuse Replacement .......................................................................................................................................... 49
Battery Replacement...................................................................................................................................... 49
Monitor Disassembly..................................................................................................................................... 50
Spare Parts 61
Introduction .................................................................................................................................................... 61
Obtaining Replacement Parts ....................................................................................................................... 61
Parts List.......................................................................................................................................................... 62
Packing For Shipment 65
General Instructions ...................................................................................................................................... 65
Returning the YM1000................................................................................................................................... 65
Repacking In Original Carton ...................................................................................................................... 65
Repacking In a Different Carton .................................................................................................................. 66
Contents YM1000
Figures
Figure 1. YM1000 Front Panel ...................................................................................................................................................................................... 4
Figure 2. YM1000 Rear Panel ....................................................................................................................................................................................... 5
Figure 3. YM1000 Left Side Panel ................................................................................................................................................................................. 6
Figure 4. YM1000 Right Side Panel............................................................................................................................................................................... 6
Figure 5. System Version .............................................................................................................................................................................................. 27
Figure 6. Battery Voltage Level.................................................................................................................................................................................... 28
Figure 7. NIBP Inflation Cycle .................................................................................................................................................................................... 28
Figure 8. Total Runtime................................................................................................................................................................................................ 29
Figure 9. Factory Defaults Reset ................................................................................................................................................................................. 29
Figure 10. Night Panel................................................................................................................................................................................................. 31
Figure 11. Nurse Call State .......................................................................................................................................................................................... 31
Figure 12. Date Format ............................................................................................................................................................................................... 32
Figure 13. Sound Mode................................................................................................................................................................................................ 32
Figure 14. NIBP Calibration ....................................................................................................................................................................................... 33
Figure 15. NIBP Pressure Test ..................................................................................................................................................................................... 34
Figure 16. NIBP Upgrade............................................................................................................................................................................................ 34
Figure 17. Sound Calibration ...................................................................................................................................................................................... 35
Figure 18. Demo Mode Display................................................................................................................................................................................... 35
Figure 19. Disassembly Sequence Flow Chart............................................................................................................................................................ 48
Figure 20. Battery Disassembly ................................................................................................................................................................................... 49
Figure 21. Monitor Disassembly.................................................................................................................................................................................. 50
Figure 22. Front Case Disassembly............................................................................................................................................................................. 51
Figure 23. Main BD, SpO2, FND modules Disassembly ............................................................................................................................................ 52
Figure 24. Front Case Disassembly – Overlay, NIBP cuff hose connector ................................................................................................................ 53
Figure 25. Rear Case Disassembly- Battery, SMPS .................................................................................................................................................... 54
Figure 26. Rear Case Disassembly- NIBP module...................................................................................................................................................... 55
Figure 27. Rear Case Disassembly- Printer................................................................................................................................................................ 56
Figure 28. Rear Case Disassembly – Speaker, Handle, etc......................................................................................................................................... 57
Figure 29. Temperature Case Disassembly – Temperature Module............................................................................................................................ 58
Figure 30. Temperature Case Disassembly ................................................................................................................................................................. 59
Figure 31. YM1000 Exploded View.............................................................................................................................................................................. 60
Figure 32. YM1000 Exploded View – Spare Parts....................................................................................................................................................... 62
Figure 33. YM1000 System Block Diagram................................................................................................................................................................. 67
Tables
Table 1. Required Test Equipments .............................................................................................................................................................................. 15
Table 2. Earth Leakage Current Values ....................................................................................................................................................................... 23
Table 3. Enclosure Leakage Current............................................................................................................................................................................ 24
Table 4. Patient Leakage Current Values..................................................................................................................................................................... 24
Table 5. Patient Leakage Current Values—Mains Voltage on Applied Part ............................................................................................................... 25
Table 6. Test Lead Combinations ................................................................................................................................................................................. 26
Table 7. Allowable Leakage Current............................................................................................................................................................................ 26
Table 8. Factory Default Settings for YM1000 ............................................................................................................................................................ 30
Table 9. Sound Mode .................................................................................................................................................................................................... 32
Table 10. Required Equipments for Firmware download............................................................................................................................................ 37
Table 11. Technical Error Codes.................................................................................................................................................................................. 46
Table 12. Part Descriptions – Monitor Assembly ........................................................................................................................................................ 50
Table 13. Part Descriptions – Front Case Assembly ................................................................................................................................................... 51
Table 14. Part Descriptions – Main BD, SpO2, FND Modules Assembly .................................................................................................................. 52
Table 15. Part Descriptions – Overlay, NIBP Cuff Hose Connector .......................................................................................................................... 53
Table 16. Part Descriptions – Battery, SMPS Assembly.............................................................................................................................................. 54
Table 17. Part Descriptions – NIBP Module Assembly............................................................................................................................................... 55
Table 18. Part Descriptions – Printer Assembly.......................................................................................................................................................... 56
Table 19. Part Descriptions – Speaker, Handle, etc Assembly .................................................................................................................................... 57
Table 20. Part Descriptions – Temperature Module Assembly.................................................................................................................................... 58
Table 21. Part Descriptions – Temperature Case Assembly........................................................................................................................................ 59
Table 22. YM1000 Parts List........................................................................................................................................................................................ 63
Warnings
Warnings alert the user to potential serious outcomes (death, injury, or adverse
events) to the patient or user.
WARNING: Do not spray, pour, or spill any liquid on YM1000, its accessories,
connectors, switches, or openings in the chassis.
WARNING: Ensure that conductive portions of the cables do not come into contact
with any other conductive parts.
WARNING: Electrical shock hazard. Disconnect the power cord from YM1000
before attempting to open or disassemble YM1000.
WARNING: The use of accessories, transducers and cables other than those specified
may result in increased emission and/or decreased immunity of YM1000 monitor.
WARNING: Do not silence YM1000 audible alarm or decrease its volume if patient
safety could be compromised.
WARNING: During safety tests, AC mains voltage will be present on the applied
part terminals. Exercise caution to avoid electrical shock hazard.
WARNING: Do not place YM1000 into operation after repair or maintenance until
Performance, Safety Tests and NIBP Calibration listed in this service manual have
been performed. Failure of these tests could result in erroneous readings.
Cautions
Cautions alert the user to exercise care necessary for the safe and effective use of YM1000
monitor.
CAUTION: U.S. Federal law restricts this device to sale by or on the order of a
licensed healthcare practitioner.
CAUTION: When reassembling YM1000, over‐tightening could strip out the screw
holes in the cases, rendering it unusable.
CAUTION: If any problem with YM1000 built in an optional printer, check a printer’s
door is closed well. Operating error may be caused if the cover is not closed correctly.
CAUTION: If internal battery cable has been disconnected, pay particular attention to
polarity of the cable before reattaching. If battery cable polarity is reversed, it is likely
that circuit damage will occur.
CAUTION: Ferrite Cores are used for electromagnetic compatibility. Please do not
remove Ferrite Cores while disassembling or reassembling, otherwise the monitor can
be affected by electromagnetic interference and measure inaccurate data to be
displayed or stored.
CAUTION: For continued protection against risk of fire, replace only with same type
and rating of fuse.
Manual Overview
This manual contains information for servicing YM1000 monitor.
The monitor subsequently referred to as YM1000 throughout this manual. Only qualified
service personnel should service this product. Before servicing YM1000, read the
operator’s manual carefully for a thorough understanding of safe operation.
Read and understand all safety warnings and service notes printed in this service
manual and the operator’s manual.
This manual contains information about YM1000 monitor. YM1000 monitor includes the
following configuration:
All information in this manual, including the illustrations, is based on the monitor
configured with Temperature, SpO2 and Printer options. If your monitor lacks any
of these options, some information in this manual does not apply.
Related Documents
To perform test and troubleshooting procedures and to understand the principles of
operation and circuit analysis sections of this manual, you must know how to operate
the monitor. Refer to YM1000 operator’s manual.
To understand the various blood pressure cuffs, SpO2 sensors and temperature probes
that work with the monitor, refer to the individual directions for use that accompany
these accessories.
Note: Hospital use typically covers such areas as general care floors, operating rooms,
special procedure areas, intensive and critical care areas, within the hospital plus
hospital‐type facilities. Hospital‐type facilities include physician office based facilities,
sleep labs, skilled nursing facilities, surgicenters, and sub‐acutecenters.
The physical and operational characteristics of the monitor are described in the
operator’s manual and in the Specification section of this manual.
Figure 1 and 2 identify the displays, controls, indicators and symbols of the front and
rear panels.
28
27
26
25
1
2 24
3 23
22
4 21
5
8 9 10 11 12 13 14 15 16 1718 19 20
AC IN
100-240V~,
50/60 Hz
28-38VA
3 4 5 6
Physical
Instrument
Dimensions 130×180×278 (mm)
Weight 2.7 (kg)
Electrical
AC Power
Power 100Vac to 240Vac, 50 Hz/60 Hz, 28 to 38 VA
Battery
Type Lead acid
Voltage/Capacity 6 V/ 4 Ampere‐Hours
Recharge 12 hours with YM1000
Shelf Life 2 years, new fully charged battery
Complies with 91/157/EEC
Environmental
Operation
Temperature 10 °C (50 °F) to 40 °C (104 °F)
Exemption: thermometry module
– operating temperature 16 °C (60 °F) to 40 °C (104 °F)
Humidity 15 % RH to 95% RH, non‐condensing
Altitude 170 m (557 ft) below sea level
4,877 m (16,000 ft) above sea level
Transport and Storage
Temperature –20 °C (‐4 °F) to 50 °C (122 °F)
Humidity 15 % RH to 95% RH, non‐condensing
Altitude –610 m (–2,000 ft) below sea level
12,192 m (40,000 ft) above sea level
Note: The system may not meet its performance specifications if stored or used outside the
manufacturer’s specified temperature and humidity range.
Measurement Parameters
NIBP
Pulse Rate
Pulse Rate Range Adult/Pediatric/Neonatal 30 BPM to 220 BPM
Pulse Rate Accuracy ±3 BPM or ±3%, whichever is greater
Note: Systolic and diastolic blood pressure measurements determined with this device are equivalent to
those obtained by a trained observer using the cuff/stethoscope auscultation method, within the limits
prescribed by the American National Standard, Electronic or automated sphygmomanometers.
SpO2/Pulse Rate
%Saturation
Range 1% to 100%
Low Perfusion 0.03% to 20%
Accuracy Without Interference‐Adults 70% to 100% ±2 digits
1% to 69% unspecified
Without Interference‐Neonate 1 70% to 100% ±3 digits
1% to 69% unspecified
Low Perfusion 2 70% to 100% ±2 digits
1% to 69% unspecified
Pulse Rate
Range 20 BPM to 300 BPM
Accuracy Without Interference2 20 BPM to 300 BPM ±3 digits
Low Perfusion2 20 BPM to 300 BPM ±3 digits
Standards EN865:1997
1Neonate specifications are shown for neonate sensors with YM1000. Saturation accuracy will vary by
sensor type recommended by the manufacturer..
2Specification applies to monitor performance and was validated with Biotek and Nellcor simulators
Temperature
Probe Type Thermistor probe
Range 26° C to 43° C (80° F to 110°F)
Display Accuracy ±0.1° C (±0.2° F)
Measurement units ° C, ° F
Measurement modes Predictive, Monitored
Predictive Mode One‐time measurement in a single temperature reading which
is displayed at the end of the brief measurement period
Monitored Mode Continuous measurement over an indefinite period.
Standards ASTM E1112‐00, EN12470‐3
Printer
Type Thermal
Resolution 8 (dots/mm)
Printing speed 45 (mm/s)
Paper width 57 (mm)
Compliance
WARNING: Do not spray or pour any liquid on the monitor or its accessories. Do
not immerse YM1000 or its accessories in liquid or clean with caustic or abrasive
cleaners.
Cleaning
To clean YM1000, dampen a cloth with a commercial, nonabrasive cleaner and wipe the
exterior surfaces lightly.
CAUTION: Do not allow any liquids to come in contact with the power connector or
switches or to penetrate connectors or openings in the instrument.
Note: For cuffs, sensors and probes, follow the cleaning instructions in the directions
for use that accompany these accessories.
Note: If liquid is spilled on the monitor, clean and dry thoroughly before reuse.
Note: If in doubt about the monitor safety, refer the unit to qualified service personnel.
2. Inspect labels for legibility. If the labels are not legible, contact Mediana Technical
Services Department.
4. Perform the electrical safety tests detailed in Performance Verification section. If the
unit fails these electrical safety tests, do not attempt to repair. Contact Mediana
Technical Services Department.
Functional Checks
The following checks should be performed at least every 2 years by a qualified service
technician.
1. If the monitor has been visibly damaged or subjected to mechanical shock (for
example, if dropped), perform the performance tests as described in Performance
Verification section.
2. Perform the electrical safety tests as described in Safety Tests section. If the unit fails
these electrical safety tests, refer to Troubleshooting section.
Batteries
If YM1000 has not been used for a long period of time, more than 2 months, the battery
will need charging. To charge the battery, connect YM1000 to an AC outlet as described
in Performance Verification section of this service manual or the Battery Operation
section of the operator’s manual.
Mediana recommends replacing the instrument’s battery every 2 years. When YM1000 is
going to be stored for 2 months or more, it is recommended to remove the battery prior
to storage. To replace or remove the battery, refer to Disassembly Guide.
Note: Storing YM1000 for a long period without charging the battery may degrade the
battery capacity. The battery may require a full charge/discharge cycle to restore
normal capacity. A full charge of a dead battery takes approximately 12 hours
while the monitor is turned off. Mediana recommends that YM1000’s sealed, lead
acid batteries be replaced at 2‐year intervals. Refer to Disassembly Guide Section.
CAUTION: If the battery shows any signs of damage, leakage, or cracking, it must be
replaced immediately.
CAUTION: Discarded battery may explode during incineration. Recycle used batteries
properly. Do not dispose of batteries in refuse containers.
Environmental Protection
Follow local governing ordinances and recycling plans regarding disposal or recycling
batteries and other device components.
Introduction
This section discusses the tests used to verify performance following repairs or during
routine maintenance. All tests can be performed without removing YM1000 covers. All
tests except battery charge and battery performance tests must be performed as the last
operation before the monitor is returned to the user.
If YM1000 fails to perform as specified in any test, repairs must be made to correct the
problem before the monitor is returned to the user.
Equipment Needed
Table 1 lists the equipment required for performance verification.
Equipment Description
Digital Multi Meter (DMM) Fluke Model 87 or Equivalent
NIBP Cuff Durable, Adult 11cm
NIBP Cuff Durable, Neonatal 5cm
NIBP Hose Adult, 8 feet
NIBP Hose Neonatal, 6 feet
NIBP Rigid PVC Vessel 9cm diameter
NIBP Rigid PVC Vessel 5cm diameter
SpO2 Sensor Extension Cable DOC‐10
Temperature Probe Oral Probe
NIBP Simulator Bio‐Tek BP Pump 2 or Equivalent
SpO2 Simulator NELLCOR SRC‐MAX
Temperature Simulator WelchAllyn 9600 Calibration Tester
Safety Analyzer METRON QA‐90 or Equivalent
Stopwatch Manual or electronic
Performance Tests
The battery charge and battery performance test should be performed before the
monitor repairs whenever the battery is suspected as being a source of the problems.
All other tests may be used following repairs or during routine maintenance (if
required by your local institution). Before performing the battery performance test,
ensure that the battery is fully charged. This section is written using factory defaults set
as power‐up. If your institution has preconfigured custom defaults, those values will be
displayed.
Power
1. Connect the monitor to AC power source using proper power cord.
2. Verify Charging/AC in indicator is lit (or flashing).
3. Press Power button over 1 second, and then verify that the monitor is turned on.
4. After the monitor operates in normal mode, disconnect the power cord.
5. Verify Battery indicator is lit instead of Charging/AC in indicator.
6. Press Power button over 1 second, and then verify that the monitor is turned off.
Battery Charge
1. Connect the monitor to AC power source using proper power cord. (the monitor is
turned off)
2. Verify Charging/AC in indicator is lit (or flashing).
Note: If Charging/AC in indicator is flashing, the battery needs fully charging.
3. Charge the battery fully until Charging/AC in indicator is no more flashing. It takes
for at least 12 hours.
4. To check for a full charge, disconnect the power cord. Press Power button and the
NIBP start/stop button simultaneously over 1 second to enter the Service mode. Then
select battery voltage level displayed.
5. Verify that current battery voltage display in Service mode indicates ‘6.0V’ or greater.
Note: The battery may require a complete charge/discharge cycle to restore its normal
capacity, depending on its previous usage.
Battery Discharge
1. Disconnect the power cord from the monitor with fully charged battery.
2. Turn on the monitor by pressing Power button over 1 second.
3. Connect NIBP simulator to the monitor. Set NIBP simulator:
SYS of 120mmHg, DIA of 80mmHg, PR of 80 bpm.
4. Set NIBP Auto interval of the monitor to 15 minutes.
5. After more than 2 hours of the monitor operating, verify an audible alarm is sounding
and the battery level of the monitor is under 5.4V.
6. Allow the monitor to operate until it automatically powers down due to low battery
condition. Verify that high priority alarm occurs 5 seconds before the monitor
automatically shuts down.
7. If the monitor passes this test, immediately recharge battery.
Power‐On Self‐Test
1. Connect the monitor to AC power source and verify Charging/AC in indicator is lit.
2. Observe the monitor front panel. With the monitor off, press Power button. The
monitor must perform the following sequence.
a. All FNDs and indicators are illuminated.
b. Power‐on beeps sounds consecutively.
c. Upon successful completion of power‐on self‐test, the display will enter the
normal mode.
Note: Power‐on self‐test takes approximately 7 seconds to complete.
Note: If an error code is displayed, please refer to Troubleshooting section.
Real‐Time Clock
Printer Test
If Printer option installed, the following test procedures will verify printer performance.
Flash Memory
Perform the following procedure to test the flash memory.
1. Place the neonatal cuff with a rigid PVC vessel (5cm diameter). Connect the cuff to
NIBP cuff hose connector via the neonatal hose.
2. Connect the monitor to an AC power source, and then press Power button to turn the
monitor on.
3. Press NIBP start/stop button.
4. Verify that Systolic blood pressure display indicates an error code E23 and an audible
alarm sounds.
5. Press the mode button (setting mode) to change Patient type to Neonatal. Return to
the monitoring screen.
6. Press NIBP start/stop button. Verify that the monitor inflates.
7. Press NIBP start/stop button. Verify that the monitor deflates.
8. Place the adult cuff with a rigid PVC vessel (9cm diameter). Connect the cuff to NIBP
cuff hose connector via the adult hose.
9. Press NIBP start/stop button.
10. Verify that Systolic blood pressure display indicates an error code E22 (or E24) and
an audible alarm sounds.
11. Press the mode button (setting mode) to change Patient type to Adult. Return to the
monitoring screen.
12. Press NIBP start/stop button. Verify that the monitor inflates.
13. Press NIBP start/stop button. Verify that the monitor deflates.
If SpO2 option installed, the following test procedures will verify SpO2 performance.
Temperature Operation
If Temperature option installed, the following test procedures will verify temperature
performance.
Safety Tests
YM1000 safety tests meet the standards of, and are performed in accordance with,
IEC60601‐1, Clause 19 (Second Edition, 1988; Amendment 1, 1991‐11, Amendment 2,
1995‐03), for instruments classified as Class I, Type BF.
This test checks the integrity of the power cord ground wire from the AC plug to the
instrument chassis ground. The current used for this test is less than or equal to 4 Volts
RMS, 50 to 60 Hz, and 25 Amperes.
1. Connect the monitor AC mains plug to the analyzer as recommended by the analyzer
operating instructions.
2. Connect the analyzer resistance input lead to the equipotential terminal (ground lug)
on the rear of the instrument. Verify that the analyzer indicates 100 milliohms or less.
Electrical Leakage
This test is in compliance with IEC60601‐1 earth leakage current. The applied voltage for
IEC60601‐1 the voltage is 264 Volts AC, 50 to 60 Hz. All measurements shall be made
with the power switch in both “On” and “Off” positions.
1. Connect the monitor AC plug to the electrical safety analyzer as recommended by the
analyzer operating instructions.
2. Perform test as recommended by analyzer operating instructions.
Table 2. Earth Leakage Current Values
Test Condition Allowable Leakage Current (microamps)
Normal Condition (NC) 500
SFC Open Supply (SFC OS) 1000
Normal Condition RM (NCRM) 500
SFC Open Supply RM (SFC OSRM) 1000
Note: Earth leakage current is measured under various conditions of the AC mains and
protective earth conductor. For each condition, the measured leakage current must
not exceed that indicated in Table 2.
Note: NC‐normal condition / SFC‐single fault condition / RM‐reverse mains/line voltage
This test is in compliance with IEC60601‐1 enclosure leakage current. This test is for
ungrounded enclosure current, measured between enclosure parts and earth. The
applied voltage for IEC60601‐1 the applied voltage is 264 Volts AC at 50 to 60 Hz.
1. Connect the monitor AC plug to the electrical safety analyzer as recommended by the
analyzer operating instructions.
2. Place a 200 cm2 foil in contact with the instrument case making sure the foil is not in
contact with any metal parts of the enclosure that may be grounded.
This test measures patient leakage current in accordance with IEC60601‐1, clause 19, for
Class I, Type BF equipment. Patient leakage current in this test is measured from any
individual patient connection to earth (power ground).
WARNING: AC mains voltage will be present on the applied part terminals during
this test. Exercise caution to avoid electrical shock hazard.
WARNING: Do not touch the patient leads clips or the simulator parts connected to
patient leads during this test as an electrical shock will occur.
This test measures patient leakage current in accordance with IEC60601‐1, clause 19, for
Class I, type BF equipment. In this test, 110% of mains voltage is applied between each
patient connection and earth (power ground). Patient leakage current is then measured
from any individual patient connection to earth.
Note: Keep the patient test cable length as short as possible during the leakage test.
Note: This test requires the same test cables for each patient connector as described
above Patient Leakage Current.
This test measures patient auxiliary current in accordance with IEC60601‐1, clause 19, for
Class I, type BF equipment. The applied voltage for IEC60601‐1 the voltage is 264 volts,
50 to 60 Hz. Patient auxiliary current is measured between each test cable for all possible
connections.
Note: Keep the patient test cable length as short as possible during the leakage test.
Note: This test requires the same test cables for each patient connector as described in
Patient Leakage Current.
Introduction
This section describes Service mode that allows authorized personnel to review/check
system version, battery voltage level, NIBP inflation cycle, total system runtime, factory
default reset, night panel, NIBP calibration, NIBP pressure test and sound calibration in
order to obtain service‐related information about the monitor. Also this section explains
how to demonstrate the monitor (Demo mode).
Service Mode
Follow the procedure below to enter Service mode.
1. With the monitor powered off, press Power button and NIBP start/stop button
simultaneously.
2. System version displays on the monitor.
3. Press Mode button to select a mode item.
System Version
The revision level of the system software displays: system software version, NIBP
module version, SpO2 module version and Temperature module version.
Total Runtime displays the number of hours, rounded to the nearest hour, that the
monitor has been operational.
Note: The values of Total Runtime may not be reset, but it will be reset to zero when a
new Main PCB assembly is installed.
To reset the monitor operating parameters to the factory default settings, press the
Mode button until “ DEFAULT RESET=NO” is displayed.
To reset to the factory default values, select ‘YES’ using only Up (+) selection button.
The monitor immediately resets to the defaults and the confirmation tone sounds.
To leave the settings unchanged, select ‘NO’ using only Down (‐) selection button.
Night Panel
Nurse call state is used to select the operating type for Nurse call.
With ‘Nurse Call State’ selected,
‐ select ‘NO’ (Normal Open) using only Up (+) selection button.
‐ select ‘NC’ (Normal Close) using only Down (‐) selection button.
Date Format
Sound Mode
You can activate the specific sound as indicated in the following table via Sound Mode.
With ‘Sound Mode’ selected, select a number between from 1 to 3 using Up (+) or Down
(‐) selection button. The number, 1, 2 or 3, is corresponded to full, mid or mute.
Table 9. Sound Mode
Variety Measur‐ Temp AC Confir‐‐ Valid/
power‐on ement probe in/out mation Invalid
beep done in/out tone button tone
1 (full) O O O O O O
2 (mid) X X X O X O
3 (mute) X X X X X X
Print Speed
NIBP Calibration
NIBP Upgrade
This menu is used for the software upgrade of NIBP module. Call Mediana Technical
Service Department for the software if required. Refer to the instructions for use for the
software upgrade for the detailed information.
Sound Calibration
Demo Mode
The purpose of Demo mode is to show a visual presentation demonstrating how
YM1000 monitor works. The following procedure is set to Demo mode.
1. With the monitor powered off, press Power button and Alarm silence button
simultaneously.
2. The monitor is now set to Demo mode, and demonstrates a typical the monitoring
display.
Note: No setting changes allowed.
Note: Only beep tones may be off or on by pressing Up/Down (+/‐) selection buttons.
Alarm silence button can be accessed in order to demonstrate Alarm silence
indicator illuminated.
Introduction
This section is for the purpose of reloading Firmware into the monitor when the
possibility of corrupted Firmware exists, or updating Firmware with a new system
revision (system/device version). Call Mediana Technical Service Department for the
latest version of Firmware and utility required.
Equipment Needed
Table 10 lists the equipment required for Firmware download.
Equipment Description
Firmware Downloading Cable 9‐pin Serial Cable (use only Mediana provided)
Firmware Downloading Software Rabbit Field Utility
Personal Computer With Serial Port
How to Download
1. Turn off the monitor.
2. Connect Firmware downloading cable to the data interface port of the monitor.
3. Connect the other side of Firmware downloading cable to a PC.
4. Run RFU.EXE (Rabbit Field Utility) on the PC.
5. Choose Setup.
6. Click on Communication.
7. Check Use Serial Connection and Enable Processor Detection.
8. Set Baud Rate to 115200.
9. Select an appropriate COM Port that current Firmware downloading cable connected.
10. Click OK.
11. Press Power button to turn on the monitor.
12. Verify that Network indicator is flashing.
13. Choose File > Load Flash Image.
14. Use the browser to select a binary file e.g. 20040630_VER1.00_MEDIANA.BIN.
15. Click OK to start downloading.
Note: Only Mediana provided Firmware download cable must be used. Otherwise,
Main BD may be damaged.
Note: Software versions of OEM boards are not field‐upgradeable. (NIBP, SpO2 or
Temperature module.) Replace the subsystem board with a higher (current)
version if necessary.
Introduction
This section explains how to troubleshoot YM1000 if problems arise.
Tables are supplied that list possible difficulties and recommended actions to correct the
difficulty.
Troubleshooting Guide
Problems with YM1000 are separated into the categories for further troubleshooting
instructions.
Note: Taking the recommended actions discussed in this section will correct the majority
of problems you will encounter. However, problems not covered here can be
resolved by calling Mediana Technical Services.
Power
Power problems are related to AC and/or Battery as follows. If the action requires
replacement of the components, refer to Disassembly Guide.
CAUTION: Electrical shock hazard. Disconnect a power cord from YM1000 before
attempting to open or disassemble YM1000.
Display
The followings are symptoms of problems relating to non‐functioning displays, and
recommended actions. If the action requires replacement of a PCB assembly or module,
refer to Disassembly Guide.
1. Display is totally black (no data is visible) after system powers up.
1‐1. Replace Main BD.
1‐2. Replace FND module.
Sound
The followings are symptoms of problems and recommended actions relating to sound.
If the action requires replacement of a PCB assembly or module, refer to Disassembly
Guide.
3. Audible tones sound, but a level of sound volume does not change even a level is
set to 8.
3‐1. Adjust the trim‐pot (R117) on Main BD.
3‐2. If problem persists, replace Main BD.
Buttons
The following is a symptom of problems and recommended actions relating to buttons. If
the action requires replacement of a PCB assembly, refer to Disassembly Guide.
1. Buttons do not respond and/or buttons are operating with pressed.
1‐1. Replace Rubber button on Main BD.
1‐2. If problem persists, replace Main BD.
2. Buttons do respond, but no button tones when pressed.
2‐1. Verify that Sound mode is set to 3 (min) in service menu.
2‐2. Ensure that Speaker is damaged to fail.
2‐3. Check the connection of 2‐pin wire between Speaker and Main BD.
2‐4. Adjust the trim‐pot (R117) on Main BD.
2‐5. If problem persists, replace Main BD.
NIBP Performance
The followings are symptoms of problems and recommended actions relating to NIBP
operational performance. If the action requires replacement of a PCB or module, refer to
Disassembly Guide.
SpO2 Performance
The followings are symptoms of problems and recommended actions relating to SpO2
operational performance. If the action requires replacement of a PCB or module, refer to
Disassembly Guide.
1. No displays (blank) on SpO2 display.
1‐1. Replace SpO2 module.
1‐2. If problem persists, replace Main BD.
2. Dashes ‘‐ ‐‘ are displaying on SpO2 display, but no data measured.
2‐1. Verify that red LED of SpO2 sensor is on. If not, replace the SpO2 sensor.
2‐2. Ensure that the LED intensity increases when opening the SpO2 sensor.
2‐3. If problem persists, replace SpO2 module.
Temperature Performance
The followings are symptoms and recommended actions to address problems with
temperature operational performance. If the action requires replacement of a PCB or
module, refer to Disassembly Guide.
Printer
The followings are symptoms of problems and recommended actions related to printing.
If the action requires replacement of a PCB or module, refer to Disassembly Guide.
1. Print setting indicator does not light after system powers up.
1‐1. Check the connection of 6‐pin wire between Printer and Main BD.
1‐2. Replace Printer.
1‐3. Replace Main BD if problem persists after Printer replaced.
2. Print setting indicator is lit, but no printing after Print button pressed.
2‐1. Ensure that Printer door is properly closed.
2‐2. Check if Printer paper runs out.
2‐3. Ensure that Printer paper is placed appropriately.
2‐4. Check the connection of 6‐pin wire between Printer and Main BD.
2‐5. Replace Printer if problem still persists.
Firmware download
The followings are symptoms and recommended actions to address problems with
firmware download. If the action requires replacement of a PCB, refer to Disassembly
Guide.
1. Network indicator is not flashing with the pressure of Power button after Firmware
downloading cable connected.
1‐1. Check on action 1‐2 to 1‐5 of Power troubleshooting (page…).
1‐2. Ensure that Mediana Firmware downloading cable is connected.
1‐3. Ensure that Firmware downloading cable is properly connected to the data
interface port of the monitor. Also ensure that the other side of Firmware
downloading cable is well connected to a PC.
1‐4. Check the connection of 9‐pin serial wire of the monitor inside.
1‐5. Replace Main BD if problem persists.
2. Network indicator is flashing, but Firmware download/update fails.
2‐1. Ensure that COM port of Field utility is properly set.
2‐2. Verify that COM port of a PC operates correctly.
2‐3. Reboot a PC.
2‐4. Ensure that Mediana Firmware downloading cable is connected.
2‐5. Ensure that Firmware downloading cable is properly connected to the data
interface port of the monitor. Also ensure that the other side of Firmware
downloading cable is well connected to a PC.
2‐6. Check the connection of 9‐pin serial wire of the monitor inside.
2‐7. Replace Main BD if problem persists.
Others
The followings are symptoms of problems and recommended actions that may happen
related to operating the monitor. If the action requires replacement of a PCB or module,
refer to Disassembly Guide.
1. No operation but Network indicator flashing after system powers up.
1‐1. If a cable connected to the data interface port of the monitor, disconnect the cable.
Then, turn on the monitor.
1‐2. Replace Main BD if problem persists.
1‐3. Replace 9‐pin serial wire if problem persists after Main BD replaced.
2. During POST, all display segments and indicators are illuminated but stopped to
process.
2‐1. Press Power button to turn the monitor off.
2‐2. Verify that the monitor powers off. If the system still powered on, open Battery
cover. Then separate Battery terminals to power off the system.
2‐3. Download the latest version of Firmware if problem persists.
2‐4. Replace Main BD if problem still persists.
3. Error code, E02 often displays after completion of POST.
3‐1. Check the connection of 8‐pin wire between SMPS and Main BD.
3‐2. Check the connection of 5‐pin wire between SMPS and Battery.
3‐3. Ensure that Battery is fully charged.
3‐4. Replace Battery if problem persists.
3‐5. Replace Main BD if problem persists after Battery replaced.
4. Settings and/or measured data are not saved in the memory of the monitor.
4‐1. Replace Main BD.
5. Time display is not updated and/or does not indicate current time.
5‐1. Replace Lithium battery (BT1) on Main BD.
5‐2. Replace Main BD if problem persists.
Error Codes
When YM1000 detects an error condition, the monitor will attempt to show an error code
on the display screen.
If such an error occurs during the monitoring operation, the monitor will sound a low‐
priority alarm. Audible alarm can be terminated if the alarm silence button pressed, but
it depends on error codes and conditions.
WARNING: Do not place YM1000 into operation after repair or maintenance until
Performance, Safety Tests and NIBP Calibration listed in this service manual have
been performed. Failure of these tests could result in erroneous readings.
WARNING: Electrical shock hazard. Disconnect the power cord from YM1000
before attempting to open or disassemble YM1000.
CAUTION: Observe ESD (electrostatic discharge) precautions when working within the
unit.
Note: Some spare parts have a business reply card attached. When you receive these
spare parts, please fill out and return the card.
General
This section describes disassembly procedures detailed disassembly instructions and
accompanied by illustrations. Disassembly Sequence Flow Chart that is used to access
replaceable parts of YM1000 is illustrated in Figure 19. The boxes on the flow chart
represent the various components or sub‐assemblies. A complete listing of the available
spare parts and part numbers is in Spare Parts section. Follow the reverse sequence of
the disassembly procedures for reassembly.
YM1000
A B C
B4 Printer
B5 Speaker
B6 Handle
B7 Serial Connector
B8 GND Terminal
Prior to Disassembly
1. Turn YM1000 off by pressing the Power On/Off switch.
2. Disconnect the monitor from the AC power source
Fuse Replacement
1. After Step B2, remove 2 AC main fuses (F1, F2: 250V/2A) out of the socket if required.
2. Remove 1 battery fuse (F3: 250V/6.3A) out of the socket if required.
3. Replace (a) new fuse(s).
4. Reassembly the monitor.
Battery Replacement
This section describes the steps to remove the battery from YM1000 for replacement
without disassembling the main case of the monitor
Monitor Disassembly
This section describes the steps to separate the front and rear case assemblies.
This section describes the items that may be removed on the front case assembly.
Table 14. Part Descriptions – Main BD, SpO2, FND Modules Assembly
Part Codes Descriptions Qty
M4019‐0 FND module 1
T0025‐0 SpO2 connector box 1
P1028‐0 Main BD 1
M0001‐0 SpO2 module 1
S8007‐0 Screw 3 × 6 8
S8010‐0 Screw 2.5 × 6 (flat‐head) 2
Figure 24. Front Case Disassembly – Overlay, NIBP cuff hose connector
This section describes the items that may be removed on the front case assembly.
This section describes the items that may be removed on the temperature case assembly.
Introduction
Spare parts, along with part numbers, are shown in Table 21. “Item No.” corresponds to
the circled callout numbers in Figure 8.
Parts List
Mediana Technical Service provides technical assistance information and replacement
parts. To obtain replacement parts, contact Mediana. Refer to parts by part numbers
and part names.
General Instructions
To ship the monitor for any reason, follow the instructions in this section.
Pack the monitor carefully. Failure to follow the instructions in this section may result
in loss or damage not covered by the Mediana warranty. If the original shipping carton
is not available, use another suitable carton; North American customers may call
Mediana Technical Services to obtain a shipping carton.
Prior to shipping the monitor, contact your supplier or the Mediana office (Technical
Services Department) for a returned goods authorization (RGA) number. Mark the
shipping carton and any shipping documents with the returned goods authorization
number.
Pack to shipping the monitor, contact your supplier or the Mediana office (Technical
Services Department) for a returned goods authorization number. Mark the shipping
carton and any shipping documents with the returned goods authorization (RGA)
number. Return YM1000 by any method that provides proof of delivery.
System Overview
MAIN BOARD
TEMPERATURE BOARD
Button Interface
Isolated Area
PC
Display Driver
Patient
DATA PC Connector
Isolated Area
Main MCU Isolated Area
DC/DC DC/DC
Temperature
PC Temperature DATA PC
Module DATA DATA RS232 Driver
Connector
Patient PC
DATA
PC
Connector
NurseCall
PC
Relay
DATA
DATA
Power Regulators
Sound Driver PC
(+3.3V / +5V)
PC Serial Connector
SMPS / Speaker
+12V Power Connector NIBP Connector Printer Connector
Battery Charger Connector
NIBP Pump
YM1000 monitor is a multi‐function the monitor for use on adult, pediatric and neonatal
patients; non‐invasive blood pressures, arterial oxygen saturation, pulse rate, and
temperature.
In addition to the monitoring and displaying the status of these physiological parameters,
the instrument performs various microprocessor‐programmed analytical functions;
Creating both visual and audible alarm signals when settable limits are violated;
Creating and displaying error codes when conditions are detected that would degrade
or prevent valid measurements;
Creating and reviewing saved data/event;
Providing input to an optional recorder for printout of data.
Unit Description
SMPS
The YM1000 allows the user to connect the monitor to AC power ranging from 100 volts
AC to 240 volts AC. AC power enters directly the YM1000’s Power Supply. A 2‐amp fuse
protects both the “Line” and “Neutral” lines. These user‐non‐accessible fuses are located
on a fuse socket, which is part of the Power Supply located in the YM1000. The YM1000
uses a switch mode power supply (SMPS). This Power Supply provides the DC power
needed to charge the battery and to power the Main Board. The output of the transformer
varies, depending on load and input. High frequency noise from the AC line and from the
Main Board is filtered before passing through the bridge rectifier. The bridge rectifier
provides the DC power used in the YM1000. The positive output is 12 volts DC.
Battery Charger
The power supply will charge the battery any time YM1000 is connected to AC power
even if the monitor is not turned on. The voltage applied to the battery is 7.5 ± 0.3 volts
DC.
Battery
A lead‐acid battery is used in the YM1000. It is rated at 6 volts DC, 4 amp hours. When
new and fully charged, the battery will operate the monitor for 2 hours. A new battery
will last 10 minutes from the time the low battery alarm is declared until the unit is shut
down due to battery depletion. Recharging the battery to full capacity takes 12 hours.
Changing from AC to battery power does not interrupt the normal monitoring operation
of the YM1000.
Power Regulator
The Power Regulator receives the inputs from the SMPS, the Battery, and generates an
appropriate power rate.
Main MCU
The Main MCU is the heart of the YM1000. The MCU is a Rabbit 3000. Rabbit 3000
manages each modules to generate signal outputs from data received on the base of the
internal algorithm. The MCU controls sound generation, button check and SMPS
operation. The Rabbit 3000 also communicates with NIBP Module, SpO2 Module,
Temperature Module, Printer, Display driver and Personal Computer.
Slave MCU
Slave MCU is Toshiba TMP86PM47U. Slave MCU is mainly used for display driver. Slave
MCU checks on Battery voltage level to transfer the level to Main MCU, and also it
controls SMPS function during Firmware downloading mode.
Button Interface
10 buttons including Power button interfaces Main board directly. Button access controls
the monitor functions including power on/off, operating mode transition, alarm limit
adjustment, alarm silence function, and etc.
Display Driver
Front panel display provides visual patient data and monitor status. At power up, all
indicators are illuminated to allow verification of their proper operation. Display consists
of FND Module. FND module is integrated with Display Drive IC, GM6486. FND module
is able to display red, amber and/or green.
7‐segments display patient measurement data, time and/or values. Pulse amplitude
indicator displays in the format of 8‐segments. The pulse amplitude indicator illuminates
with each pulse beat. The number of segments illuminated indicates the relative signal
strength of the pulse beat. Indicators are also located on the front panel display. Indicators
are illuminated indicating a function that is active. Functions indicated by the Indicators
are AC/battery status, alarm silence, patient type, NIBP & temperature unit and print
mode.
Sound Driver
Sound frequency generated from Main MCU is transferred to output to the Speaker via
LM386 audio amplifier. The gain of this amplifier changes sound level of volume as a
resistor is adjusted.
NIBP Processing
Overview
The oscillometric technique does not use Korotkoff sounds to determine blood
pressure. The oscillometric technique monitors the changes in cuff pressure caused by
the flow of blood through the artery. The monitor inflates the cuff to a pressure that
occludes the artery. Even when the artery is occluded, the pumping of the heart against
the artery can cause small pressure pulses in the cuff baseline pressure. The monitor
lowers cuff pressure at a controlled rate. As the cuff pressure goes down, blood starts
to flow through the artery. The increasing blood flow causes the amplitude of the
pressure pulses in the cuff to increase. These pressure pulses continue to increase in
amplitude with decreasing cuff pressure until they reach a maximum amplitude at
which point they begin to decrease with decreasing cuff pressure. The cuff pressure at
which the pulse amplitude is the greatest is known as Mean Arterial Pressure(MAP).
The manner in which the pulse amplitudes vary is often referred to as the pulse
envelope. The envelope is an imaginary line that connects the peak of each pressure
pulse and forms an outline. The shape of the envelope is observed by the monitor
using a variety of techniques to determine the diastolic and systolic blood pressure.
MAP
TIME
Systole
Distole
MAP
TIME
On clinical trial perspective, overall system accuracy is not easy to be determined. The
clinical trial test protocols have been tried and have been described in many treatises,
and international standards. So, there are many methods to determine the overall
system accuracy of Automated Sphygmomanometer using the oscillometric method.
But, there are no absolute test protocols to determine the overall system accuracy of the
Automated Sphygmomanometer using oscillometric method. Normally, the Gold
standards of Blood pressure for the reference are the intra‐arterial pressure and the
auscultatory method.
The popular standard for the overall system accuracy is AAMI, SP‐10 1992; 1996
(Electronic or automated sphygmomanometers).
The main test conditions are as follow:
A. Data comparing the Intra‐arterial or the auscultatory by the clinical experts with
the automated sphygmomanometer.
B. For data collection and the data analysis, Bland‐Altman Plot is used.
C. On the systolic, diastolic, and MAP, the Deltas of all measurements shall be met
under +/‐ 5mmHg of mean difference (MD), and +/‐ 8mmHg of standard deviation
(SD).
(Delta = Intra‐arterial or Auscultatory – Automated sphygmomanometer)
SYSTOLIC PRESSURE
Mean difference(MD): 0 mmHg
20 Standard deviation(SD): 6 mmHg
Difference between test and reference methods (mmHg)
15
mean + 2 SD
10
0 mean
-5
-10
mean - 2 SD
-15
-20
100 120 140 160 180 200
Average of test and reference methods (mmHg)
(EXAMPLE) Agreement between test and reference methods for systolic pressure. Hypothetical data
SpO2 Processing
Overview
Pulse oximetry works by applying a sensor to a pulsating arteriolar vascular bed. The
sensor contains a dual light source and photodetector. Bone, tissue, pigmentation, and
venous vessels normally absorb a constant amount of light over time. The arteriolar bed
normally pulsates and absorbs variable amounts of light during systole and diastole, as
blood volume increases and decreases. The ratio of light absorbed at systole and diastole
is translated into an oxygen saturation measurement (SpO2). Because a measurement of
SpO2 is dependent upon light from the sensor, excessive ambient light can interfere with
this measurement.
Automatic Calibration
Because light absorption by hemoglobin is wavelength dependent and because the mean
wavelength of LEDs varies, an oximeter must know the mean wavelength of the
OXIMAX sensor’s red LED to accurately measure SpO2. During the monitoring, the
instrument’s software selects coefficients that are appropriate for the wavelength of that
individual sensor’s red LED; these coefficients are then used to determine SpO2.
Additionally, to compensate for differences in tissue thickness, the light intensity of the
sensor’s LEDs is adjusted automatically.
The measured SpO2 value from an oximeter may differ from the saturation value that is
calculated from a blood gas partial pressure of oxygen (PO2). This usually occurs
because the calculated saturation was not appropriately corrected for the effects of
variables that shift the relationship between PO2 and saturation: pH, temperature,
partial pressure of carbon dioxide (PCO2), 2, 3‐DPG, and fetal hemoglobin.
pH
100
Temperature
PCO2
2,3-DPG
Fetal Hb
Saturation (%)
pH
50 Temperature
PCO2
2,3-DPG
0
50 100
PO2 (mmHg)
Temperature Processing
Overview
Patient temperature can be measured via an oral/axillary, rectal, or skin surface probe. A
predictive algorithm in conjunction with the thermistor based thermometer is used for
fast temperature or monitoring temperature.
Predictive temperature
Thermometers that render a temperature reading before steady state is achieved are
classified as predictive thermometers. Predictive thermometers reduce the time required
for measurement by using algorithms to “predict” what the temperature would be if the
probe were left in place until steady state is achieved.
Monitor temperature
Measuring Principle
When the probe is first extracted and colder than 33.9℃, the heater pulse
widths are at a maximum percentage On vs Off to warm the probe quickly.
When the probe reached 33.9℃, the pulse widths narrow to a duty cycle just
enough to maintain temperature.
When the probe is placed in the mouth, the heat supplied by the mouth makes
the pulse widths reduce to zero. This reduction to zero (and probe being at
least up to 33.1℃ (91.6℉) triggers the start of the prediction algorithm.
The shape of the rising temperature curve is monitored and the best fit to a curve is
found. When the curve fit is stable, the final predicted temperature is provided.