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Service Manual: For YM1000 Vital Signs Monitor

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0% found this document useful (0 votes)
463 views78 pages

Service Manual: For YM1000 Vital Signs Monitor

Uploaded by

joserojas141298
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 78

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

YM1000 Service Manual


Revised Date: 0306
Part Number‐Revision: A7080‐0

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

The information contained in this document is subject to change without notice.


Mediana makes no warranty of any kind with regard to this material, including, but not
limited to, the implied warranties or merchantability and fitness for a particular purpose.
Mediana shall not be liable for errors contained herein or for incidental or consequential
damages in connection with the furnishing, performance, or use of this material.

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

System Processing Description 67


System Overview ........................................................................................................................................... 67
NIBP Processing ............................................................................................................................................. 70
SpO2 Processing............................................................................................................................................. 72
Temperature Processing................................................................................................................................ 74

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

ii YM1000 Service Manual


Introduction
Manual Overview
Related Documents
Description of the YM1000 monitor

Warnings

Warnings are identified by the WARNING symbol shown above.

Warnings alert the user to potential serious outcomes (death, injury, or adverse
events) to the patient or user.

WARNING: Explosion hazard. Do not use YM1000 in the presence of flammable


anesthetics or gases.

WARNING: Do not spray, pour, or spill any liquid on YM1000, its accessories,
connectors, switches, or openings in the chassis.

WARNING: Do not immerse YM1000 or its accessories in liquid or clean with


caustic or abrasive cleaners.

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.

YM1000 Service Manual 1


Introduction YM1000

Cautions

Cautions are identified by the Caution symbol shown above.

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: Observe ESD (electrostatic discharge) precautions when working within


the unit and/or when disassembling and reassembling YM1000 monitor and when
handling any of the components of YM1000 monitor.

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.

2 YM1000 Service Manual


YM1000 Introduction

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:

Config. Features Config. Features


N Standard (NIBP + Pulse Rate) NP Standard + Printer
NS Standard + SpO2 NSP Standard + SpO2 + Printer
NT Standard + Temperature NTP Standard + Temperature+ Printer
NST Standard + SpO2 + Temperature NSTP Standard + SpO2 + Temperature + Printer

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.

Description of the YM1000 monitor


The purpose and function of Mediana YM1000 monitor is to monitor noninvasive
blood pressure (systolic, diastolic, and mean arterial pressures), functional arterial
oxygen saturation, pulse rate for adult, pediatric and neonate patients and temperature
for adult and pediatric patients in all hospital areas and hospital‐type facilities. It may
be used during hospital transport and in mobile, land‐based environments, such as
ambulances, within the specification of the environmental characteristics. Monitor
users should be skilled at the level of qualified health care professionals, such as a
technician, doctor, nurse or medical specialist.

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.

Note: Intra‐hospital transport includes transport of a patient within the hospital or


hospital‐type facility.

YM1000 Service Manual 3


Introduction YM1000

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

1. Blood Pressure Unit Indicators 15. %SpO2 Display


2. Systolic Blood Pressure Display 16. Mode Button
3. Patient Type Indicators 17. Pulse Amplitude Indicator
4. Diastolic Blood Pressure Display 18. Alarm Silence Indicator
5. Pulse Rate Display 19. Up/Down Selection Button
6. MAP (Mean Arterial Pressure) Display 20. Alarm Silence Button
7. Print Setting Indicators 21. BP start/stop button
8. Print Button 22. Temperature Unit/Mode Indicators
9. Alarm Button 23. Temperature Display
10. Auto Indicator 24. Power Button
11. Auto Cycle Display 25. Battery Indicator
12. Auto Button 26. Charging/AC in Indicator
13. Pulse Tone/Alarm Volume Setting Indicators 27. Time Display
14. Review Button 28. Review Indicator

Figure 1. YM1000 Front Panel

4 YM1000 Service Manual


YM1000 Introduction

AC IN
100-240V~,
50/60 Hz
28-38VA

3 4 5 6

1. Handle 4. Equipotential (Ground)


2. Air Ventilator 5. Battery Cover (Replacement)
3. AC Power Connector 6. RS‐232 Data Interface

Figure 2. YM1000 Rear Panel

YM1000 Service Manual 5


Introduction YM1000

1. Printer 3. NIBP hose connector


2. SpO2 sensor/cable connector

Figure 3. YM1000 Left Side Panel

1. Temperature probe 3. Probe holder


2. Probe cover 4. Temperature probe connector

Figure 4. YM1000 Right Side Panel

6 YM1000 Service Manual


Specification
Physical
Electrical
Environmental
Measurement Parameters
Compliance

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.

YM1000 Service Manual 7


Specification YM1000

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

NIBP (Non‐Invasive Blood Pressure)


Technique Oscillometric Measurement
Measurement modes AUTO, MANUAL and STAT
AUTO Mode Automatic NIBP measurements at intervals of 1, 2, 3, 4, 5, 10, 15,
30, 45, 60, 90, 120, and 240 minutes
MANUAL Mode Single measurement initiated by NIBP Start/Stop switch
STAT Mode Series of consecutive measurements for 5 minutes
NIBP pressure measurement range
Systolic pressure range Adult: 30 mmHg to 260 mmHg (3.9 kPa to 34.5 kPa)
Pediatric: 30 mmHg to 160 mmHg (3.9 kPa to 21.2 kPa)
Neonatal: 25 mmHg to 120 mmHg (3.3 kPa to 15.9 kPa)
Diastolic pressure range Adult: 20 mmHg to 235 mmHg (2.6 kPa to 31.2 kPa)
Pediatric: 15 mmHg to 130 mmHg (1.9 kPa to 17.2 kPa)
Neonatal: 10 mmHg to 105 mmHg (1.3 kPa to 13.9 kPa)
Mean pressure range Adult: 20 mmHg to 255 mmHg (2.6 kPa to 33.9 kPa)
Pediatric: 15 mmHg to 140 mmHg (1.9 kPa to 18.6 kPa)
Neonatal: 10 mmHg to 110 mmHg (1.3 kPa to 14.6 kPa)
Pressure Display Accuracy Meets ANSI/AAMI SP10:1992+A1:1996
Cuff Pressure Range 0 to 300 mmHg (0 to 40 kPa)
Initial Cuff Inflation Adult:
100, 120, 140, 160(Default), 180, 200, 220, 240, 270 mmHg
(13.3, 15.9, 18.6, 21.2(default), 23.9, 26.6, 29.2, 31.9, 35.9 kPa)
Pediatric:
80, 90, 100, 110, 120(default), 130, 140, 150, 160, 170 mmHg
(10.6, 11.9, 13.3, 14.6, 15.9(default), 17.2, 18.6, 19.9, 21.2, 22.6 kPa)
Neonatal:
50, 60, 70, 80, 90(default), 100, 110, 120, 132 mmHg
(6.6, 7.9, 9.3, 10.6, 11.9(default), 13.3, 14.6, 15.9, 17.5 kPa)
Overpressure protector Adult 280 mmHg (N.C.), 308 mmHg (S.F.C.)
Pediatric 220 mmHg Neonatal 154 mmHg
Standards ANSI/AAMI SP10:1992+A1:1996, IEC60601‐2‐30:1999
EN1060‐1:1995 and EN1060‐3:1997.

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.

8 YM1000 Service Manual


YM1000 Specification

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)

YM1000 Service Manual 9


Specification YM1000

Compliance

Item Compliant with


Classification Class I (on AC power) Internally powered (on battery power)
Type of protection Type BF – Applied part
General Safety 93/42/EEC Medical Device Directive
21CFS820 Code of Federal Regulations
91/157/EEC Battery Declaration Directive
93/86/EEC Battery Disposal Directive
2002/96/EC waste electrical and electronic equipment (WEEE)
ISO9001:2000 Quality Management Systems‐Requirements
ISO13485:1996
Quality systems‐Medical devices‐particular requirements for the application of
ISO9001
IEC60601‐1:1988+A1:1991+A2:1995
General requirements for safety and essential performance
IEC60529 Degree of Protection Provided by Enclosures
Water Ingress Testing (IPX0)
EN540:1993 Clinical investigation of medical devices for human subjects
EN ISO14155‐1:2003
Clinical investigation of medical devices for human subjects‐Part 1: General
requirement
AAMI HE48:1993
Human factors engineering guidelines and preferred practices for the design of
medical devices
IEC60601‐2‐49:2001
Particular requirements for the safety of multifunction patient monitoring
equipment
IEC60601‐1‐1:2000 Safety requirements for medical electrical systems
IEC60601‐1‐4:2000 Programmable medical systems
IEC60601‐1‐6:2004 Medical electrical equipment Part 1‐6:General requirements
for safety collateral standard: Usability
ISO14971:2000 Application of risk management to medical devices
ISO10993‐1:2003
Biological evaluation of medical devices‐Part 1: Evaluation and testing
Alarms EN475:1995 Electrically‐Generated alarm signals
IEC60601‐1‐8:2003
Alarm systems requirements, tests and guidances in medical electrical
equipments
Non‐invasive AAMI SP10:2002+A1:2003 Electronic or Automated sphygmomanometers
blood pressure EN1060‐1:1995 Non‐invasive sphygmomanometers
EN1060‐3:1997
Supplementary requirements for electrical‐mechanical blood pressure
measuring systems
IEC60601‐2‐30:1999
Particular requirements for the safety, including essential performance, of
automatic cycling indirect blood pressure monitoring equipment
Oxygen saturation EN865:1997 Pulse oximeters, Particular requirements
Temperature E1112‐00
monitoring Electronic thermometer for intermittent determination of patient temperature

10 YM1000 Service Manual


YM1000 Specification

Item Compliant with


Electromagnetic IEC 60601‐1, sub clause 36, IEC/
Compatibility IEC60601‐1‐2:2001+A1:2004
Electromagnetic compatibility‐requirements & test
IEC61000‐3‐2:2004 Harmonic Emission
IEC61000‐3‐3:2002 Voltage Fluctuations/Flicker Emission
IEC61000‐4‐2:2001 Electrostatic Discharge (ESD)
IEC61000‐4‐3:2002 Radiated RF electromagnetic field
IEC61000‐4‐4:2004 Electrical fast Transient/Burst (EFT)
IEC61000‐4‐5:2001 Surge current
IEC61000‐4‐6:2004 Conducted disturbances, induced by RF field
IEC61000‐4‐8:2001 Power frequency (50/60H) Magnetic field
IEC61000‐4‐11:2004 Voltage dips, short interruptions, and voltage variation on
power supply input lines
CISPR 11:1997 (EN55011:1998) RF Emissions Group 1, Class B
Limits and methods of measurement of radio disturbance characteristics of
industrial scientific and medical (ISM) radio‐frequency equipment
Labeling EN1041:1998
Information supplied by the manufacturer with medical devices
Marking IEC /TR60878:2003
Graphical symbols for electrical equipment in medical practice
EN980:2003 Graphical symbols for use in the labeling of medical devices
ISO7000:2004 Graphical symbols for use on equipment‐index and synopsis
EN60417‐1:1999
Graphical symbols for use on equipment‐overview and application
EN60417‐2:1999 Graphical symbols for use on equipment‐symbol originals
EN50419:2005 Marking of electrical and electronic equipment in accordance
with article II (2) of directive 2002/96/EC (WEEE)
Package ISTA Pre‐Shipment Test Procedures (Procedure 1A, 1994 Rev.)
Reliability IEC60068‐2‐27 Environmental testing ‐ Shock
IEC60068‐2‐6:1995 Environmental testing –Vibration (sinusoidal)
IEC60068‐2‐64:1993, Broadband random (Digital Control) and Guidance

YM1000 Service Manual 11


Specification YM1000

This page is intentionally left blank.

12 YM1000 Service Manual


Routine Maintenance
Cleaning
Periodic Safety and Functional Checks
Functional Checks
Batteries
Environmental Protection

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.

For surface‐cleaning, follow your institution’s procedures or:

YM1000 may be surface‐cleaned by using a soft cloth dampened with either


a commercial or nonabrasive cleaner, and lightly wiping the top, bottom,
and front surfaces of the monitor lightly.

Periodic Safety and Functional Checks


YM1000 requires no routine service or calibration other than cleaning and battery
maintenance. The following performance verification tests may be used following repair
or during routine maintenance (if required by your local institution).

1. Inspect the exterior of YM1000 for damage.

2. Inspect labels for legibility. If the labels are not legible, contact Mediana Technical
Services Department.

3. Verify that the unit performs properly as described in Performance Verification


section.

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.

YM1000 Service Manual 13


Routine Maintenance YM1000

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.

3. Inspect the fuses for proper value and rating


‐ qty 2, 2.0 A, 250 volts for AC mains (L/N: F1, F2)
‐ qty 1, 6.3 A, 250 volts for internal battery (L/N: F3)

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 YM1000 is to be stored for a period of 2 months or longer, it is


recommended to notify service personnel to remove the battery from the monitor prior
to storage. Recharging the battery is strongly recommended when the battery has not
been recharged for 2 or more months.

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.

14 YM1000 Service Manual


Performance Verification
Introduction
Equipment Needed
Performance Tests
Safety Tests

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.

Table 1. Required Test Equipments

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

YM1000 Service Manual 15


Performance Verification YM1000

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.

16 YM1000 Service Manual


YM1000 Performance Verification

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.

General Operation Tests

Alarms and Alarm Silence

1. Connect the monitor to an AC power source.


2. Press the monitor Power button to turn the monitor on.
3. Connect NIBP simulator to the monitor.
4. Set NIBP simulator as follows:
Systolic of 120mmHg, Diastolic of 80mmHg and pulse rate of 150 bpm.
5. Press NIBP start/stop button.
6. Verify following the monitor reaction after measurement completes:
a. The monitor displays NIBP and pulse rate as specified by the simulator.
b. Audible alarm sounds and Pulse rate display flashes indicating the parameter
has violated default alarm limits.
7. Press Alarm silence button on the front panel of the monitor.
8. Verify the following:
a. An audible alarm is temporarily silenced.
b. Pulse rate display continues flashing.
c. Alarm silence indicator is lit.
d. Audible alarm returns in approximately 90 seconds.
9. Set NIBP simulator as follows:
Systolic of 120mmHg, Diastolic of 80mmHg and pulse rate of 80 bpm.
10. Press NIBP start/stop button.
11. Verify following the monitor reaction after measurement completes:
a. The monitor displays NIBP and pulse rate as specified by the simulator.
b. The alarm is terminated.
12. Disconnect NIBP simulator from the monitor.
13. Kink NIBP cuff hose connector of monitor and then press NIBP start/stop button.
14. Verify that the monitor displays an error code, E23 and sounds audible alarm.
15. Press Alarm silence button.
16. Verify that the alarm is terminated.

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Performance Verification YM1000

Pulse Tone Volume Control

1. Connect the monitor to an AC power source.


2. Press Power button to turn the monitor on.
3. Connect SpO2 simulator to the pulse oximetry cable and connect the cable to the
monitor.
4. Set SpO2 simulator as follows: SpO2 of 90% and pulse rate of 60 bpm.
5. Verify SpO2/ pulse rate values and pulse amplitude indicator correctly display, and
pulse tone sounds.
6. Press the mode button to enter setting mode.
7. Press Up (+) selection button to adjust pulse tone volume from 1 to 8. Return to the
monitoring screen.
8. Verify beeping pulse tone increases.
9. Press the mode button to enter setting mode.
10. Press Down (‐) selection button to adjust pulse tone volume from 8 to 1. Return to
the monitoring screen.
11. Verify beeping pulse tone decreases.
12. Set pulse tone volume to 0, and return to the monitoring screen. Verify pulse tone is
no longer audible.
13. Return pulse tone volume to a comfortable level.

Alarm Volume Control

1. Connect the monitor to an AC power source.


2. Press Power button to turn the monitor on.
3. Kink NIBP cuff hose connector of the monitor and then press NIBP start/stop button.
4. Verify that the monitor ‘E23’ displays and sounds audible alarm.
5. Press the mode button to enter setting mode.
6. Press Up (+) selection button to adjust alarm volume from 1 to 8. Return to the
monitoring screen.
7. Verify alarm tone increases.
8. Press the mode button to enter setting mode.
9. Press Down (‐) selection button to adjust alarm volume from 8 to 1. Return to the
monitoring screen.
10. Verify alarm tone decreases.
11. Return alarm volume to a comfortable level.

Real‐Time Clock

1. Connect the monitor to an AC power source.


2. Press Power button to turn the monitor on.
3. Verify that Time display updates every second.

18 YM1000 Service Manual


YM1000 Performance Verification

Printer Test
If Printer option installed, the following test procedures will verify printer performance.

1. Connect the monitor to an AC power source.


2. Press Power button to turn the monitor on.
3. Connect all necessary simulators to the monitor.
4. Press Printer button when the monitor displays the measurements.
5. Verify the measurement values are printed out correctly.
6. Press the mode button over 3 seconds (configuration mode) to select Stream print.
7. Kink NIBP cuff hose connector of the monitor and then press NIBP start/stop button.
8. Verify that the monitor ‘E23’ displays and also prints out.
9. Open the printer door, and then press Print button.
10. Verify that the monitor sounds ‘invalid button tone’.

Flash Memory
Perform the following procedure to test the flash memory.

1. Connect the monitor to an AC power source.


2. Press Power button to turn the monitor on.
3. Change alarm limits and other settings.
Temperature mode CM
Alarm Limit, SYS HI 160
Alarm Limit, DIA LO 15
Alarm Limit, PR HI 180
Alarm Limit, SpO2 LO 85
4. Kink NIBP cuff hose connector of the monitor to generate an error ‘E23’.
5. Turn the monitor off.
6. Press Power button to turn the monitor on again.
7. Verify that previously changed alarm limits and settings are saved/displayed.
8. Press Review button. Verify that ‘E23’ event is saved/displayed.
9. Turn the monitor off.
10. Press Power button & NIBP start/stop button simultaneously to enter Service mode.
11. Set ‘DEFAULT RESET’ to ‘YES’. The monitor will return to the factory defaults.
12. Turn the monitor off.
13. Press Power button to turn the monitor on again.
14. Verify that alarm limits and settings of the monitor are set to the factory defaults.
Refer to Table 8 Factory defaults.
15. Press Review button. Verify invalid button tone sounds and all events of trend data
has been removed.

YM1000 Service Manual 19


Performance Verification YM1000

Measurement Parameter Operation Tests

Pneumatic System Operation

These tests verify the functionality of YM1000 pneumatic system.

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.

NIBP air leakage test


1. Connect the monitor to an AC power source.
2. Press Power button and NIBP start/stop button to enter Service mode.
3. Select NIBP Pressure Test by pressing Mode button (see figure 12).
4. Set a desired target pressure between 50and 300mmHg by pressing Up/Down (+/‐)
selection buttons.
5. Place the adult cuff with a rigid PVC vessel (9cm diameter). Connect the cuff and the
adult hose to NIBP simulator. Then connect the adult hose to the monitor.
6. Set NIBP simulator to Pressure test or Leakage test mode.
7. Select the set point of NIBP simulator as the same point of target pressure of the
monitor.
8. Press NIBP start/stop button of the monitor as simultaneously pressing start button of
NIBP simulator. Current pressure appears on the diastolic pressure display.
9. After current inflating pressure comes up to the desired target pressure, the monitor
starts deflating. Ensure that air leakage rate displays.
10. Verify that air leakage rate is within 6mmHg/min.

20 YM1000 Service Manual


YM1000 Performance Verification

NIBP overpressure test


1. Connect the monitor to an AC power source, and then press Power button to turn the
monitor on.
2. Press Mode button. Set to Adult patient type and NIBP target pressure, 270mmHg.
3. Place the adult cuff with a rigid PVC vessel (9cm diameter). Connect the cuff and the
adult hose to NIBP simulator. Then connect the adult hose to the monitor.
4. Set NIBP simulator to Pressure relief or Overpressure test mode.
5. Press NIBP start/stop button of the monitor as simultaneously pressing start button of
NIBP simulator. NIBP simulator pressurizes the system until the monitor’s over‐
pressure relief system activates.
6. Verify that peak point displayed on NIBP simulator (point of protection pressure) is
within 300mmHg.
Also this point of protection pressure may be verified at the moment of the monitor’s
NIBP valve of relieved.

NIBP transducer accuracy test


1. Follow the procedure of NIBP air leakage test specified above.
2. During the deflation of the cuff pressure, verify that the difference is within ±3mmHg
between monitor’s current pressure and simulator’s current pressure.

Pulse Oximetry Operation

If SpO2 option installed, the following test procedures will verify SpO2 performance.

1. Connect the monitor to an AC power source.


2. Turn on the monitor by pressing Power button.
3. Connect SpO2 simulator to the pulse oximetry cable and connect the cable to the
monitor.
4. Set SpO2 simulator as follows: SpO2 of 75% and pulse rate of 60 bpm.
5. The monitor will:
‐ sound an audible alarm
‐ display an SpO2 of 75 ±2 digits (flashing)
‐ display a pulse rate of 60 ±3 bpm
‐ display Pulse amplitude indicator
6. Disconnect the pulse oximetry cable from the monitor.
7. Verify that the monitor displays an error code, E42 and sounds audible alarm.

YM1000 Service Manual 21


Performance Verification YM1000

Temperature Operation

If Temperature option installed, the following test procedures will verify temperature
performance.

1. Connect the monitor to an AC power source.


2. Press Power button to turn the monitor on.
3. Connect temperature probe to the temperature connector of the monitor.
4. Set Temperature tester to 96.4° F.
5. Press the mode button (setting mode) to select ‘F M’ (monitored mode).
6. Insert the temperature probe into ‘…’ of Temperature tester when ‘Ready’ indicator of
the test is on.
7. After 3 minutes, verify that the monitor displays 96.1° F ~ 96.7° F.
Measurement accuracy: ±0.2° F
Temperature tester accuracy: ±0.1° F
8. Return the probe into the probe holder.
9. Verify that Temperature display indicates ‘‐ ‐‘.

22 YM1000 Service Manual


YM1000 Performance Verification

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.

Protective Earth Continuity

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

Earth Leakage Current

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

Enclosure Leakage Current

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.

YM1000 Service Manual 23


Performance Verification YM1000

3. Measure the leakage current between the foil and earth.


Note: The analyzer leakage current indication must note exceed the values listed in Table
3.
Table 3. Enclosure Leakage Current
Test Condition Allowable Leakage Current (microamps)
Normal Condition (NC) 100
SFC Open Supply (OS) 500
SFC Open Earth (SFC OE) 500
Normal Condition RM (NCRM) 100
SFC Open Supply RM (SFC OSRM) 500
SRC Open Earth RM (SFC OERM) 500

Patient Leakage Current

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).

1. Configure the electrical safety analyzer as recommended by the analyzer operating


instructions.
2. Connect the monitor’s AC mains power cord to the analyzer as recommended by the
analyzer operating instructions.
3. Apply NIBP cuff wrapped tightly around an appropriate metal cylinder.
4. Connect a test cable between the cylinder and an input connector on analyzer.
5. Turn on YM1000.
6. Perform the patient leakage current test as recommended by the analyzer operating
instructions.
7. Repeat the patient leakage current test for SpO2 and temperature patient connections,
if those options configured, using the appropriate test cables.
Note: Patient 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 4.
Note: This test requires a test cable for each patient connector. Test cables for NIBP, SpO2
and temperature can be configured in a similar manner, by wrapping each sensor
end individually with aluminum foil filled with conductive gel (only enough gel to
ensure conductivity). Attach a wire to the foil that is connected to a test lead from
the electrical safety analyzer.
Table 4. Patient Leakage Current Values
Test Condition Allowable Leakage Current (microamps)
Normal Condition (NC) 100
SFC Open Supply (OS) 500
SFC Open Earth (SFC OE) 500
Normal Condition RM (NCRM) 100
SFC Open Supply RM (SFC OSRM) 500
SRC Open Earth RM (SFC OERM) 500

24 YM1000 Service Manual


YM1000 Performance Verification

Patient Leakage Current ‐ (Mains Voltage on the Applied Part)

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.

1. Configure electrical safety analyzer as recommended by analyzer operating


instructions.
2. Connect the monitor’s AC mains power cord to analyzer as recommended by analyzer
operating instructions.
3. Apply NIBP cuff wrapped tightly around an appropriate metal cylinder.
4. Connect a test cable between the cylinder and an input connector on analyzer.
5. Turn on YM1000.
6. Perform test as recommended by analyzer operating instructions.
7. Repeat test for SpO2 and temperature patient connections, if those options configured,
using appropriate test cables.
Note: Patient leakage current is measured with normal and reverse mains polarity. For
each condition, the measured leakage current must not exceed that indicated in
Table 5.

Table 5. Patient Leakage Current Values—Mains Voltage on Applied Part


Test Condition Allowable Leakage Current (microamps)
Normal polarity (SFC) 5000
Reverse polarity (SFCRM) 5000

Patient Auxiliary 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.

YM1000 Service Manual 25


Performance Verification YM1000

1. Configure the electrical safety analyzer as recommended by the electrical analyzer’s


operating instructions.
2. Connect monitor’s AC mains power cord to the electrical analyzer as recommended by
the electrical analyzer’s operating instructions.
3. Connect the patient test lead combination in table 6 to the appropriate input connector
on the electrical analyzer.
4. Turn on YM1000.
5. Perform patient auxiliary current test per table 7 as recommended by electrical
analyzer’s operating instructions.
6. Repeat the patient auxiliary current test for each test lead combination as listed in
Table 7 and measure each patient auxiliary current.

Table 6. Test Lead Combinations


First Test Lead Second Test Lead
Temperature probe NIBP cuff
Temperature probe SpO2 sensor
NIBP cuff SpO2 sensor

Table 7. Allowable Leakage Current


Test Condition Allowable Leakage Current (microamps)
Normal Condition (NC) 100
SFC Open Supply (OS) 500
SFC Open Earth (SFC OE) 500
Normal Condition RM (NCRM) 100
SFC Open Supply RM (SFC OSRM) 500
SRC Open Earth RM (SFC OERM) 500

26 YM1000 Service Manual


Service Mode and Demo Mode
Introduction
Service Mode
Demo Mode

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.

Figure 5. System Version

Note: The system version shown above is only a sample.

YM1000 Service Manual 27


Service Mode and Demo Mode YM1000

Battery Voltage Level

Current battery voltage level is displayed (unit of voltage: V).

Figure 6. Battery Voltage Level

NIBP Inflation Cycle

The number of NIBP inflation cycles operated is displayed.


Note: The values of NIBP inflation cycle may not be reset, but it will be reset to zero
when a new Main PCB assembly is installed.

Figure 7. NIBP Inflation Cycle

28 YM1000 Service Manual


YM1000 Service Mode and Demo Mode

Total System Runtime

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.

Figure 8. Total Runtime

Factory Default Reset

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.

Figure 9. Factory Defaults Reset

YM1000 Service Manual 29


Service Mode and Demo Mode YM1000

Factory default settings are described in Table 8.

Table 8. Factory Default Settings for YM1000


Parameter Ranges Defaults
Systolic (mmHg) Neonatal Low: 25 to 115 High: 30 to 120 50, 100
Alarm Limits Pediatric Low: 30 to 155 High: 35 to 160 75, 145
Adult Low: 30 to 255 High: 35 to 260 75, 220
Diastolic Neonatal Low: 10 to 100 High: 15 to 105 30, 70
(mmHg)
Alarm Limits Pediatric Low: 15 to 125 High: 20 to 130 35, 100
Adult Low: 20 to 250 High: 25 to 255 35, 110
MAP (mmHg) Neonatal Low: 10 to 105 High: 15 to 110 35, 80
Alarm Limits Pediatric Low: 15 to 135 High: 20 to 140 50, 110
Adult Low: 20 to 250 High: 25 to 255 50, 120
PR (bpm) Neonatal Low: 25 to 295 High: 30 to 300 100, 200
Alarm Limits Pediatric Low: 25 to 295 High: 30 to 300 50, 150
Adult Low: 25 to 295 High: 30 to 300 50, 120
SpO2 % Neonatal Low: 50 to 98 High: 52 to 100 85, 98
Alarm Limits Pediatric Low: 50 to 98 High: 52 to 100 90, 100
Adult Low: 50 to 98 High: 52 to 100 90, 100
Patient Type Adult, Pediatric, Neonatal Adult
NIBP Units mmHg, kPa mmHg
NIBP initial Neonatal 50, 60, 70, 80, 90, 100, 110, 120, 132 mmHg 90 mmHg
cuff inflation (11.9 kPa)
(6.6, 7.9, 9.3, 10.6, 11.9, 13.3, 14.6, 15.9, 17.5 kPa)
Pediatric 80, 90, 100, 110, 120, 130, 140, 150, 160, 170 mmHg 120 mmHg
(10.6, 11.9, 13.3, 14.6, 15.9, 17.2, 18.6, 19.9, 21.2, 22.6 (15.9 kPa)
kPa)
Adult 100, 120, 140, 160, 180, 200, 220, 240, 270 mmHg 160 mmHg
(13.3, 15.9, 18.6, 21.2, 23.9, 26.6, 29.2, 31.9, 35.9 kPa) (21.2 kPa)

NIBP Auto Interval Off, STAT, 1, 2, 3, 4, 5, 10, 15, 30, 15


45, 60, 90, 120, 240
Temperature Units/Modes °C, °F, °C M, °F M °F
Pulse Tone Volume 0 to 8 4
Alarm Volume 1 to 8 4
Night Panel On, Off Off
Nurse call state Normal Open, Normal Close Normal
Open
Date format Y‐M‐D, D‐M‐Y Y‐M‐D
Sound mode Full, Mid, Mute Full
Print Control Manual, Stream Manual

30 YM1000 Service Manual


YM1000 Service Mode and Demo Mode

Night Panel

Night panel is used to adjust the light intensity of the display.


With ‘Night Panel’ selected,
‐ select ‘YES’ using only Up (+) selection button to degrade the light intensity between
21:00 to 06:00.
‐ select ‘No’ using only Down (‐) selection button not to use this option.

Figure 10. Night Panel

Nurse Call State

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.

Figure 11. Nurse Call State

YM1000 Service Manual 31


Service Mode and Demo Mode YM1000

Date Format

The monitor support two date formats.


With ‘Date Format’ selected,
‐ select ‘Y‐D’ (Year‐Month‐Day) using only Up (+) selection button.
‐ select ‘D‐Y’ (Day‐Month‐Year) using only Down (‐) selection button.

Figure 12. 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

Figure 13. Sound Mode

32 YM1000 Service Manual


YM1000 Service Mode and Demo Mode

Print Speed

This menu is intended for factory use only.

NIBP Calibration

‘NIBP Calibration’ is used to calibrate NIBP pneumatic pump.


With ‘NIBP Calibration’ selected,
1. Connect the NIBP adult hose to the monitor.
2. Kink the distal end (farthest from the monitor).
3. Press Up (+) selection button to start calibration.
4. The monitor displays ‘ING’ during the calibration.
5. Wait for about 20 seconds to complete.
6. Verify that Time display indicates one of digits from 040000 to 070000 after ‘End’
message appears. (If fails, refer to Troubleshooting section.)
7. Turn off the monitor.
8. After a few seconds, power on the monitor.

Figure 14. NIBP Calibration

NIBP Zero Setting


The NIBP pressure is calibrated at the factory. No periodic recalibrations are required
by service personnel.
The Module automatically performs a baseline (zero pressure) calibration every 10‐15
minutes during operation or sleep mode. (The exact time between baseline calibrations
can vary depending on whether a measurement cycle is in progress at the time the next
baseline calibration should take place.)

YM1000 Service Manual 33


Service Mode and Demo Mode YM1000

NIBP Pressure Test

The real‐time value of the system pneumatic pressure is displayed in mmHg.


For more information, refer to Performance Verification section.
With ‘NIBP Pressure Test’ selected,
1. Place the adult cuff with a rigid PVC vessel (9cm diameter). Connect the cuff and the
adult hose to NIBP simulator. Then connect the adult hose to the monitor.
2. Set NIBP simulator to a test mode required.
3. Adjust a desired target pressure using Up/Down (+/‐) selection buttons.
4. Press NIBP start/stop button.

Figure 15. NIBP Pressure Test

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.

Figure 16. NIBP Upgrade

34 YM1000 Service Manual


YM1000 Service Mode and Demo Mode

Sound Calibration

‘Sound Calibration’ is used to set a level of sound volume at factory.


With ‘Sound Calibration’ selected,
1. Press Up (+) selection button.
2. Verify that the level 1 of the volume sounds continuously.

Figure 17. 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.

Figure 18. Demo Mode Display

YM1000 Service Manual 35


Service Mode and Demo Mode YM1000

This page is intentionally left blank.

36 YM1000 Service Manual


Firmware download
Introduction
Equipment Needed
How to Download

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.

Table 10. Required Equipments 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.

YM1000 Service Manual 37


Firmware download YM1000

16. After completion of downloading, turn off the monitor.


17. Disconnect Firmware downloading cable from the monitor and PC.
18. Press Power button and NIBP start/stop button simultaneously to enter Service
mode of the monitor.
19. Press Mode button to go to DEFAULT RESET.
20. Select DEFAULT RESET=YES to reset the monitor to factory defaults.
21. Turn off the monitor.
22. After a few seconds, turn the monitor on.
23. Perform the tests specified in Performance Verification section.

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.

Note: If any problem during Firmware downloading, refer to Firmware Download in


Troubleshooting section.

38 YM1000 Service Manual


Troubleshooting
Introduction
How to Use This Section
Who Should Perform Repairs
Replacement Level Supported
Troubleshooting Guide

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.

How to Use This Section


Use this section in conjunction with Performance Verification section and Spare Parts
section. To remove and replace a part you suspect is defective, follow the instructions in
Disassembly Guide section.

Who Should Perform Repairs


Only qualified service personnel should open the monitor housing, remove and replace
components, or make adjustments in accordance with this service manual. If your
medical facility does not have qualified service personnel, contact Mediana Technical
Services.

Replacement Level Supported


The replacement level supported for this product is to the printed circuit board (PCB
assembly) and major subassembly level. Once you isolate a suspected PCB assembly,
follow the procedures in Disassembly Guide section, to replace the PCB assembly with
a known good PCB assembly. Check to see if the trouble symptom disappears and that
the monitor passes all performance tests.
If the trouble symptom persists, swap back the replacement PCB assembly with the
suspected malfunctioning PCB assembly (the original PCB assembly that was installed
when you started troubleshooting) and continue troubleshooting as directed in this
section.

Obtaining Replacement Parts


Mediana Technical Services provides technical assistance information and replacement
parts. To obtain replacement parts, contact Mediana. Refer to parts by the part names
and part numbers listed in Spare Parts section.

YM1000 Service Manual 39


Troubleshooting YM1000

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.

1. Before further troubleshooting of the power problems:


1‐1. Review customer complaint and determine if it is safe to plug in and turn on
YM1000.
1‐2. Verify that Charging/AC in indicator is lit (or flashing) as a power cord is
connected.
1‐3. Check fuses (F1, F2 and F3) located on SMPS. If blown, replace fuses.
1‐4. Check the connection of 8‐pin wire between Main BD and SMPS.
1‐5. Check the connection of 5‐pin wire between Battery and SMPS.

2. When AC power cord is connected to YM1000, Charging/AC in indicator on the front


panel is not lit.
2‐1. Check fuses (F1, F2 and F3) located on SMPS. If blown, replace fuses.
2‐2. Replace 8‐pin wire connected between Main BD and SMPS.
2‐3. Replace Main BD if problem persists.
2‐4. Replace SMPS if problem persists after Main BD replaced.
2‐5. Replace FND module if problem still persists.

3. YM1000 fails to power‐up when Power button is pressed.


3‐1. Check on action 1‐2 to 1‐5.
3‐2. Download Firmware (see Firmware download section).
3‐3. Replace 8‐pin wire of Main BD connected to SMPS if problem persists.
3‐4. Replace Main BD if problem persists.
3‐5. Replace Rubber button.
3‐6. Replace SMPS if problem persists.

4. YM1000 is operating on AC main, but not operating on Battery.


4‐1. Check on action 1‐2 to 1‐5.
4‐2. The battery may be discharged. To recharge the battery, connect a power cord to
AC mains over 12 hours (refer to Battery charge in Performance Verification
section).
Note: The monitor may be used with a less than fully charged battery but with a
corresponding decrease in operating time from that charge. The battery may be
defective.
4‐3. Replace Battery if problem persists after fully charged.
4‐4. Replace SMPS if problem persists after Battery replaced.

40 YM1000 Service Manual


YM1000 Troubleshooting

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.

2. Not all display segments light during POST.


2‐1. Verify that Main BD connector is properly connected to FND module.
2‐2. Replace FND module if problem persists.
2‐3. If problem persists, replace Main BD after FND module replaced.

3. Values are erratically displayed after system powers up.


3‐1. Verify that Main BD connector is properly connected to FND module.
3‐2. Replace FND module if problem persists.
3‐3. If problem persists, replace Main BD after FND module replaced.

4. No visual alarm displayed during alarm condition.


4‐1. Ensure that alarm limits are properly set.
4‐2. Ensure that patient type is correctly set.
4‐3. Ensure that patient measurement cables are properly connected and placed.
4‐4. Replace Main BD if problem persists.
4‐5. Replace acquisition modules (NIBP, SpO2 or Temperature) if problem persists.

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.

1. Audible tones do not sound after system powers up.


1‐1. Verify that Sound mode is set to 3 (min) in the service menu.
1‐2. Verify that Speaker is working properly. If necessary, replace Speaker.
1‐3. Check the connection of 2‐pin wire between Speaker and Main BD.
1‐4. If problem persists, replace Main BD.

2. Sound volume is too low to be heard.


2‐1. Check if a level of volume is set to minimum value.
Refer to page 30, 31 in the operator’s manual.
2‐2. Adjust the trim‐pot (R117) on Main BD.
2‐3. If problem persists, replace Main BD.

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.

YM1000 Service Manual 41


Troubleshooting YM1000

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.

1. Dashes ‘‐ ‐ ‐‘ are flashing on NIBP display.


1‐1. Go to Service mode. Perform NIBP Calibration (see Service Mode section).
1‐2. If NIBP Calibration is not able to perform, check the connection of 24‐pin ribbon
cable between NIBP module and Main BD.
1‐3. If problem persists, replace NIBP module.
1‐4. Replace Main BD, if problem persists after NIBP module replaced.
2. After NIBP calibration, the digit shown in Time display is outside of 040000~070000.
2‐1. Turn off the monitor.
2‐2. Go to Service mode. Perform NIBP Calibration again (see Service Mode section).
2‐3. If problem persists, verify that internal silicon tubing is kinked or disconnected.
2‐4. Replace NIBP module and pump if problem still persists.
3. Often error codes, E22, E23 and/or E24 display(s).
3‐1. Ensure that an appropriate cuff and hose are used to correspond with Patient
type selected.
3‐2. Go to Service mode. Perform NIBP Calibration (see Service Mode section).
3‐3. If problem persists, replace NIBP pump.

4. Error code, E29 displays.


4‐1. Replace both NIBP module and pump.
4‐2. If problem persists, replace Main BD.

42 YM1000 Service Manual


YM1000 Troubleshooting

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.

3. Error code, E49 displays.


3‐1. 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.

1. No displays (blank) on Temperature display.


1‐1. Check the connection of 5‐pin wire between Temperature PCB and Main BD.
1‐2. Replace Temperature PCB if problem persists.
1‐3. Replace Temperature module if problem still persists.
1‐4. If problem persists after Temperature module replaced, replace Main BD.

2. Dashes ‘‐ ‐‘ are displaying on Temperature display, but no data measured.


2‐1. Use another temperature probe.
2‐2. Check the connection of 5‐pin wire between Temperature PCB and Main BD.
2‐3. Replace Temperature PCB if problem persists.
2‐4. Replace Temperature module if problem still persists.

3. Error codes, E63 and/or E64 often display(s).


3‐1. Use another temperature probe.
3‐2. Replace Temperature module if problem persists.

4. Error code, E65 often displays.


4‐1. Replace Temperature PCB.
4‐2. Replace Temperature module if problem persists.

5. Error code, E69 displays.


5‐1. Replace Temperature module.

YM1000 Service Manual 43


Troubleshooting YM1000

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.

44 YM1000 Service Manual


YM1000 Troubleshooting

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.

6. Error code, E09 often displays.


6‐1. Replace both SMPS and Main BD.

YM1000 Service Manual 45


Troubleshooting YM1000

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.

Table 11 provides a complete list of error codes and problem identification.

Table 11. Technical Error Codes


Error Codes Description
E01 Battery failure
E02 Abnormally shutdown last time
E09 System error (malfunction)
E21 Air leakage
E22 Cuff not detected
E23 Kinked or neonate hose
E24 Cuff too large for neonate
E25 Overpressure condition
E26 Motion artifact
E27 Weak pulse or no pulse detected
E28 Valid BP not found
E29 NIBP module error (malfunction)
E41 Sensor off
E42 Sensor disconnected
E43 Bad sensor
E44 Loss of pulse
E49 SpO2 module error (malfunction)
“P” Loss of tissue contact
E62 Probe disconnected
E63 Probe error
E64 Probe heated too high
E65 Ambient temperature out of range
E69 Temperature module error (malfunction)

46 YM1000 Service Manual


Disassembly Guide
General
Replacement Level Supported
Prior to Disassembly
Fuse Replacement
Battery Replacement
Monitor Disassembly

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 can be disassembled down to all major component parts, including:


PCB assemblies
acquisition modules
FND module
Printer
SMPS
Battery
Speaker
cables & wires
brackets & cases
The following tools are required:
small, Phillips‐head (+) screwdriver
medium, Phillips‐head (+) screwdriver
5mm, Box wrench
10mm, Box wrench
0.35inch Spanner
needle‐nose pliers

YM1000 Service Manual 47


Disassembly Guide YM1000

YM1000

A B C

Front Case Rear Case Temperature Case

A1 Main Board B1 Battery Cover C1 Temperature Board


A1-1 B1-1 C1-1
Rubber Button Battery Temperature Module
A1-2
SpO2 Module B2 SMPS C2 Temperature Pod
A1-3 B2-1
FND Module SMPS Holder
B2-2
A2 SpO2 Connector Box GND Bracket

A3 Overlay B3 NIBP Module


B3-1
A4 NIBP Hose Connector NIBP Pump

B4 Printer

B5 Speaker

B6 Handle

B7 Serial Connector

B8 GND Terminal

Figure 19. Disassembly Sequence Flow Chart

Replacement Level Supported


The replacement level supported for this product is to the printed circuit board (PCB)
and major subassembly level. Once you isolate a suspected PCB, follow the procedures
in Disassembly Guide, to replace the PCB with a known good PCB. Check to see if the
trouble symptom persists, swap back the replacement PCB with the suspected
malfunctioning PCB (the original PCB that was installed when you started trouble
shooting) and continue troubleshooting as detected in this section.

48 YM1000 Service Manual


YM1000 Disassembly Guide

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

B1. Battery disassembly


5. Remove 4 small flat‐head screws (S8094‐0) fastening Battery cover.
6. Remove Battery cover.
7. Remove Battery carefully from the monitor.
8. Disconnect the wire between 2 Battery terminals.

Figure 20. Battery Disassembly

YM1000 Service Manual 49


Disassembly Guide YM1000

Monitor Disassembly
This section describes the steps to separate the front and rear case assemblies.

Figure 21. Monitor Disassembly

Table 12. Part Descriptions – Monitor Assembly


Part Codes Descriptions Qty
‐ Front case assembly (A) 1
‐ Rear case assembly (B) 1
‐ Temperature case assembly (C) 1
S8071‐0 Screw 3 × 8 (tapping) 2
S8070‐0 Screw 3 × 8 (flat‐head) 3
S8091‐0 Screw 3 × 12 3
S8092‐0 Screw 3 × 16 2

Before the steps A, B and C


1. If Temperature option installed, remove 2 tapping screws (S8071‐0) on the rear of the
temperature case.
2. Disconnect Temperature wire to separate the temperature case from the rear case.
3. Remove 3 flat‐head screws (S8070‐0) on the bottom of the monitor.
4. Remove 5 screws (S8091‐0, S8092‐0) on the rear case.
5. Separate the front case from the rear case.
6. Carefully disconnect all cables running between cases: disconnect SMPS wire, NIBP
cable, Printer wire, Speaker wire, Serial wire and NIBP hose.

50 YM1000 Service Manual


YM1000 Disassembly Guide

Front Case Disassembly (A)

This section describes the items that may be removed on the front case assembly.

Figure 22. Front Case Disassembly

Table 13. Part Descriptions – Front Case Assembly


Part Codes Descriptions Qty
T0024‐0 Front case 1
T1000‐0 Rubber button vertical 1
T1001‐0 Rubber button horizontal 1
‐ Main BD ass’y 1
S8007‐0 Screw 3 × 6 3

A1. Main BD disassembly


1. Remove the marked 3‐point screw (S8007‐0) on the Main BD.
2. Separate Main BD from the front case assembly.

A1‐1. Rubber Button disassembly


1. After step A1, remove 2 rubber buttons (T1000‐0, T1001‐0) from Main BD.

YM1000 Service Manual 51


Disassembly Guide YM1000

Figure 23. Main BD, SpO2, FND modules Disassembly

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

A1‐2. SpO2 module disassembly


1. After step A1, remove 3 screws (S8007‐0) holding SpO2 module.
2. Remove SpO2 module.

A1‐3. FND module disassembly


1. After step A1, remove 5 screws (S8007‐0) holding FND module.
2. Remove FND module.

A2. SpO2 connector box disassembly


1. After step A1, remove 2 flat‐head screws (S8010‐0).
2. Remove SpO2 connector box.

52 YM1000 Service Manual


YM1000 Disassembly Guide

Figure 24. Front Case Disassembly – Overlay, NIBP cuff hose connector

Table 15. Part Descriptions – Overlay, NIBP Cuff Hose Connector


Part Codes Descriptions Qty
T0024‐0 Front case 1
T8005‐0 ~ T8012‐0 Front overlay 1
T4104‐0 NIBP cuff hose connector 1

A3. Overlay disassembly


1. After step A1, push out Overlay from the inside of the front case to remove.
2. Remove Overlay.

A4. NIBP cuff hose connector disassembly


1. After step A1, use a spanner to unfasten NIBP cuff hose connector.
2. Remove NIBP cuff hose connector.

YM1000 Service Manual 53


Disassembly Guide YM1000

Rear Case Disassembly

This section describes the items that may be removed on the front case assembly.

Figure 25. Rear Case Disassembly‐ Battery, SMPS

Table 16. Part Descriptions – Battery, SMPS Assembly


Part Codes Descriptions Qty
M2010‐0 SMPS 1
T4108‐0 GND bracket 1
T0029‐0 SMPS holder 1
M6007‐0 Lead acid battery 1
T4107‐0 Battery cover 1
S8094‐0 Screw 3 × 8 (small flat‐head) 4
S8002‐0 Screw 3 × 8 (with washer) 1

B2. SMPS disassembly


1. Remove 1 screw (S8002‐0) located on the right top of SMPS.
2. Remove a nut holding GND bracket with 10mm box wrench
3. Pull out SMPS, and then separate SMPS holder from SMPS.

54 YM1000 Service Manual


YM1000 Disassembly Guide

Figure 26. Rear Case Disassembly‐ NIBP module

Table 17. Part Descriptions – NIBP Module Assembly


Part Codes Descriptions Qty
M0005‐0 NIBP module 1
S8007‐0 Screw 3 × 6 4
S8070‐0 Screw 3 × 8 (flat‐head) 2
S8097‐0 Nut M3 2

B3. NIBP module disassembly


1. Remove NIBP pump harness from the connector.
2. Remove 4 screws (S8007‐0) holding NIBP module.
3. Remove NIBP module.
4. Remove 2 screws (S8070‐0) and 2 nuts (S8097‐0) fastening NIBP pump.
5. Remove NIBP pump.

YM1000 Service Manual 55


Disassembly Guide YM1000

Figure 27. Rear Case Disassembly‐ Printer

Table 18. Part Descriptions – Printer Assembly


Part Codes Descriptions Qty
M4020‐0 Printer 1
S8090‐0 Screw 3 × 8 3 (1)
S8093‐0 Screw 3 × 25 0 (2)
* ( ) refers to the number of required screws if a print option is not installed in.

B4. Printer disassembly


1. Remove 1 screw (S8090‐0) holding on the right top of Printer.
2. Remove 2 screws (S8090‐0) on the front side of Printer.
* If no print option in, remove 2 screws (S8093‐0) on the front side of Printer.
3. Open Printer door.
4. Pull out Printer to remove from the rear case assembly.

56 YM1000 Service Manual


YM1000 Disassembly Guide

Figure 28. Rear Case Disassembly – Speaker, Handle, etc

Table 19. Part Descriptions – Speaker, Handle, etc Assembly


Part Codes Descriptions Qty
E9007‐0 Speaker 1
T0027‐0 Handle 1
S8066‐0 Screw 3 × 5 (tapping) 2
S8096‐0 Screw 3 × 25 (tapping) 2

B5. Speaker disassembly


1. After step B4, remove 2 screws (S8066‐0) holding Speaker.
2. Remove Speaker.

B6. Handle disassembly


1. Remove 2 screws (S8096‐0) fastening Handle.
2. Push Handle backward to separate from the rear case.

B7. Serial connector disassembly


1. Remove 2 nuts fastening Serial connector on the rear case with 5mm box wrench.
2. Remove Serial connector.

B8. GND terminal disassembly


1. After step B2, remove a nut holding GND terminal with 10mm box wrench.
2. Remove GND terminal.

YM1000 Service Manual 57


Disassembly Guide YM1000

Temperature Case Disassembly

This section describes the items that may be removed on the temperature case assembly.

Figure 29. Temperature Case Disassembly – Temperature Module

Table 20. Part Descriptions – Temperature Module Assembly


Part Codes Descriptions Qty
P1029‐0 Temperature BD 1
M0006‐0 Temperature module 1
S8007‐0 Screw 3 × 6 2
S8071‐0 Screw 3 ×8 (tapping) 4

C1.Temperature module disassembly


1. Remove 2 screws (S8007‐0) holding Temperature module.
2. Remove Temperature module.
3. Disconnect Temperature wire.
4. Remove 4 screws (S8071‐0) fastening Temperature BD.
5. Remove Temperature BD.

58 YM1000 Service Manual


YM1000 Disassembly Guide

Figure 30. Temperature Case Disassembly

Table 21. Part Descriptions – Temperature Case Assembly


Part Codes Descriptions Qty
T0030‐0 Temperature case 1
T0031‐0 Temperature probe holder 1
S8090‐0 Screw 3 × 8 2
S8002‐0 Screw 3 × 8 (with washer) 1

C2. Temperature case disassembly


1. After step C1, remove 3 screws holding Temperature probe holder.
2. Remove Temperature probe holder from Temperature case.

YM1000 Service Manual 59


Disassembly Guide YM1000

Figure 31. YM1000 Exploded View

60 YM1000 Service Manual


Spare Parts
Introduction
Obtaining Replacement Parts
Parts List

WARNING: Follow local government ordinances and recycle instructions


regarding disposal or recycling of device components, including batteries.

Introduction
Spare parts, along with part numbers, are shown in Table 21. “Item No.” corresponds to
the circled callout numbers in Figure 8.

Obtaining Replacement Parts


Mediana Technical Service provides technical assistance information and replacement
parts. To obtain replacement parts, contact Mediana. Refer to parts by the part names
and part numbers.

YM1000 Service Manual 61


Spare Parts YM1000

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.

Figure 32. YM1000 Exploded View – Spare Parts

62 YM1000 Service Manual


YM1000 Spare Parts

Table 22. YM1000 Parts List


No. Part Code Item
Cases
1 T0024‐2 Front case
2 T0025‐0 SpO2 connector box
3 T0026‐0 Rear case
4 T0027‐0 Handle
5 T0029‐0 SMPS holder
6 T0030‐0 Temperature case
7 T0031‐0 Temperature probe holder
Structure Components
8 T8005‐0 Front overlay / NST
8 T8006‐0 Front overlay / NSTP
8 T8007‐0 Front overlay / NS
8 T8008‐0 Front overlay / NSP
8 T8009‐0 Front overlay / NT
8 T8010‐0 Front overlay / NTP
8 T8011‐0 Front overlay / N
8 T8012‐0 Front overlay / NP
9 T1000‐0 Rubber button vertical
10 T1001‐0 Rubber button horizontal
11 T4104‐0 NIBP cuff hose connector
12 T1005‐0 Rubber foot circular
13 T1006‐0 Rubber foot oval
14 T1007‐0 Temperature connector cover
15 T4107‐0 Battery cover
16 T4003‐0 GND terminal
17 T4108‐0 GND bracket
Electrical Components
18 P1028‐2 Main BD
19 P1029‐0 Temperature BD
20 M2010‐1 SMPS
21 M4019‐0 FND module
22 M0005‐0 NIBP module
23 M0001‐0 SpO2 module
24 M0006‐0 Temperature module
25 M4020‐0 Printer
26 M6007‐0 Lead acid battery
27 E9007‐0 Speaker
Harness
‐ W0107‐0 SMPS wire / 8‐pin
‐ W0108‐0 Battery wire / 5‐pin
‐ W0109‐0 NIBP cable / 24‐pin

YM1000 Service Manual 63


Spare Parts YM1000

No. Part Code Item


‐ W0110‐0 Serial wire / 9‐pin
‐ W0111‐0 Temperature wire / 5‐pin
‐ W0112‐0 Printer wire / 6‐pin
Screws / Spacers
‐ S8007‐0 Screw 3 × 6
‐ S8090‐0 Screw 3 × 8
‐ S8002‐0 Screw 3 × 8 (with washer)
‐ S8091‐0 Screw 3 × 12
‐ S8092‐0 Screw 3 × 16
‐ S8093‐0 Screw 3 × 25
‐ S8010‐0 Screw 2.5 × 6 (flat‐head)
‐ S8070‐0 Screw 3 × 8 (flat‐head)
‐ S8094‐0 Screw 3 × 8 (small flat‐head)
‐ S8066‐0 Screw W 3 × 5 (tapping)
‐ S8071‐0 Screw 3 × 8 (tapping)
‐ S8096‐0 Screw 3 × 25 (tapping)
‐ S8097‐0 Nut M3

64 YM1000 Service Manual


Packing For Shipment
General Instructions
Returning the YM1000
Repacking In Original Carton
Repacking In a Different Carton

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.

Returning the YM1000


Contact Mediana Technical Services Department for shipping instructions, including a
Returned Goods Authorization (RGA) number. Unless otherwise instructed by
Mediana Technical Services Department, it is not necessary to return other accessory
items with the monitor. Pack YM1000 in its original shipping carton. If the original
carton is not available, use a suitable carton with appropriate packing material to
protect it during shipping.

Repacking In Original Carton


If available, use the original carton and packing materials. Pack the monitor as follows:

1. Place the monitor and, if necessary, accessory items in original packaging.


2. Place in shipping carton and seal carton with packaging tape.
3. Label carton with shipping address, return address and RGA number, if applicable.

YM1000 Service Manual 65


Packing For Shipment YM1000

Repacking In a Different Carton


If the original carton is not available, use the following procedure to pack YM1000:

1. Place the monitor in a plastic bag.


2. Locate a corrugated cardboard shipping carton with at least 200 pounds per square
inch (psi) bursting strength.
3. Fill the bottom of the carton with at least 2 inches of packing material.
4. Place the bagged unit on the layer of packing material and fill the box completely
with packing material.
5. Seal the carton with packing tape.
6. Label the carton with the shipping address, return address, and RGA number, if
applicable.

66 YM1000 Service Manual


System Processing Description
System Overview
NIBP Processing
SpO2 Processing
Temperature Processing

System Overview

System Block Diagram

MAIN BOARD

TEMPERATURE BOARD
Button Interface
Isolated Area

DC/DC SpO2 Module

PC
Display Driver
Patient
DATA PC Connector

Slave MCU DATA

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 Module Speaker Printer

NIBP Pump

Figure 33. YM1000 System Block Diagram

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.

YM1000 Service Manual 67


System Processing Description YM1000

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.

The monitor is essentially a battery‐powered instrument. An internal charging unit is


designed to accept only an AC line voltage.

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.

68 YM1000 Service Manual


YM1000 System Processing Description

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 Patient block


NIBP patient block measures NIBP data interfaced with WelchAllyn NIBP module POEM.
More information about NIBP measurement theory is specified in NIBP Processing.

SpO2 Patient block


SpO2 patient block measures oxygen saturation data and pulse rate interfaced with
Nellcor Oximetry module MP‐506 / Nell‐3. More information about Oximetry theory is
specified in SpO2 Processing.

Temperature Patient block


Temperature patient block measures Temperature data. interfaced with WelchAllyn
Temperature module SureTemp. More information about Temperature measurement
theory is specified in Temperature Processing.

YM1000 Service Manual 69


System Processing Description YM1000

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

Distole ● Oscillometric Response


Systole
(Pressure Pulses)

TIME
Systole

Distole
MAP

Systole ● Cuff Pressure


MAP
Distole

TIME

Overall Accuracy Discussion

Overall system accuracy shall be determined by considering various influences of the


pressure sensor accuracy, motion artifacts and other artifact created by pressure valve,
technical errors of electrical components, and the origin error of oscillometric method.
The origin error of oscillometric comes from the basic theory of that the MAP is
determined by the pulse. Therefore, there might be an error of the time between two
pulses. In another words, the greatest amplitude point of pulses could not represent
the MAP point exactly.

70 YM1000 Service Manual


YM1000 System Processing Description

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

YM1000 Service Manual 71


System Processing Description YM1000

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.

Pulse oximetry is based on two principles: that oxyhemoglobin and deoxyhemoglobin


differ in their absorption of red and infrared light (spectrophotometry), and that the
volume of arterial blood in tissue (and hence, light absorption by that blood) changes
during the pulse (plethysmography). The monitor determines SpO2 by passing red and
infrared light into an arteriolar bed and measuring changes in light absorption during
the pulsatile cycle. Red and infrared low‐voltage light‐emitting diodes (LED) in the
oximetry OXIMAX sensor serve as light sources; a photo diode serves as the photo
detector. Because oxyhemoglobin and deoxyhemoglobin differ in light absorption, the
amount of red and infrared light absorbed by blood is related to hemoglobin oxygen
saturation. To identify the oxygen saturation of arterial hemoglobin, the monitor uses
the pulsatile nature of arterial flow. During systole, a new pulse of arterial blood enters
the vascular bed, and blood volume and light absorption increase. During diastole,
blood volume and light absorption reach their lowest point. The monitor bases its SpO2
measurements on the difference between maximum and minimum absorption
(measurements at systole and diastole). By doing so, it focuses on light absorption by
pulsatile arterial blood, eliminating the effects of nonpulsatile absorbers such as tissue,
bone, and venous blood.

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.

Measured versus Calculated Saturation

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.

72 YM1000 Service Manual


YM1000 System Processing Description

pH
100
Temperature
PCO2
2,3-DPG
Fetal Hb

Saturation (%)
pH
50 Temperature
PCO2
2,3-DPG

0
50 100
PO2 (mmHg)

Oxyhemoglobin Dissociation Curve

Functional versus Fractional Saturation

This monitor measures functional saturation — oxygenated hemoglobin expressed as a


percentage of the hemoglobin that can transport oxygen. It does not detect significant
amounts of dysfunctional hemoglobin, such as carboxyhemoglobin or methemoglobin.
In contrast, hemoximeters such as the IL482 report fractional saturation — oxygenated
hemoglobin expressed as a percentage of all measured hemoglobin, including measured
dysfunctional hemoglobin. To compare functional saturation measurements to those
from an instrument that measures fractional saturation, fractional measurements must
be converted as follows:

functional saturation = fractional saturation × 100


100 – (%carboxyhemoglobin + %methemoglobin)

YM1000 Service Manual 73


System Processing Description YM1000

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

A function or mode of an electronic thermometer used to continuously monitor


temperature until it reached the thermal steady state (unchanging). The thermal steady
state is achieved orally in approximately 3 minutes, and axillary in approximately five
minutes.

Measuring Principle

The YM1000 temperature probe utilizes a negative temperature coefficient (NTC)


thermistor and control circuitry in combination with the temperature module’s
predictive algorithm to calculate patient temperatures.
NTC thermistors have a large temperature coefficient of resistance and change in
resistance as temperature changes. This predictable change in resistance is the basis for
predictive thermometry.
The Oral/axillary probe is pre‐warmed to approximately 34℃ (94℉). The probe
warming process is a closed loop feedback control system incorporating pulse width
modulation (PWM) control. The probe warmer circuitry is used to heat the probe tip
prior to taking a temperature reading in order to speed the convergence of the
prediction algorithm. A fail safe hardware shut off circuit is included to ensure the
heater will shut down in the event of a software failure.

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.

74 YM1000 Service Manual

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