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UT100 Handheld Pulse Oximeter Service Manual
UT100 Handheld Pulse Oximeter Service Manual
Service Manual
- English
Version 1.0, June 2011
© 2011 UTECH Co., Ltd. All rights reserved.
Table of Contents
Table of Contents
Chapter 1: Introduction ..........................................................1-1
1.1 About this Manual ................................................................ 1-1
1.2 Technical Description ............................................................ 1-1
1.3 Manufacturing Quality & Safety............................................ 1-1
1.4 Declaration of Conformity with European Union Directive .... 1-1
1.5 Limited Warranty.................................................................. 1-2
Service Support .......................................................................... 1-2
Chapter 2: General Description...............................................2-1
2.1 Intended Use ........................................................................ 2-1
2.2 Patient Safety ....................................................................... 2-1
2.3 Warning Information ............................................................ 2-1
2.4 Definition of Symbols............................................................ 2-3
2.5 Preparation for Use............................................................... 2-4
2.5.1 Getting Acquainted ...................................................................... 2-4
2.5.2 Power Supply Options .................................................................. 2-6
2.5.3 Power On/Off ............................................................................... 2-7
2.5.4 Auto Power Off............................................................................. 2-7
Chapter 5: Accessories............................................................5-1
Handheld Pulse Oximeter Service Manual I
Table of Contents
Chapter 1: Introduction
1.1 About this Manual
This manual is written for technical personnel servicing the UT100 Handheld
Pulse Oximeter.
This document contains information which is proprietary and property of
UTECH CO., LTD. And may not be reproduced, stored in a retrieval system,
translated, transcribed, or transmitted, in any form, or by any means, without
the prior explicit written permission of UTECH CO., LTD.
UTECH reserves the right to change specification without notice.
1.2 Technical Description
Per requirement of IEC 601-1, the model UT100 is classified as class II
equipment, internally powered, with type BF applied part, and an enclosure
protection rating of IPX1.
Transport/Storage: -10 to +55℃ (14-131 F), 10-95% R.H. non-condensing
Operating Conditions:10 to +40℃ (50-104 F), 10-90% R.H. non-condensing
1.3 Manufacturing Quality & Safety
The UTECH manufacturing facility is certified to both ISO 13485 and EC 46002
(MDD 93/42/EEC Annex II). UTECH products bare the “CE 0482” mark; and
tested by TUV Rheinland to IEC 601-1/EN60601-1.
1.4 Declaration of Conformity with European Union Directive
The Authorized Representative for UTECH equipment is:
Wellkang Ltd t/a Wellkang Tech Consulting
Suite B, 29 Harley Street, LONDON W1G 9QR,
England, United Kingdom
Phone: +44 (20)30869438
Fax: +44 (20)76811874
Handheld Pulse Oximeter Service Manual 1-1
Chapter 1: Introduction
1.5 Limited Warranty
UTECH CO., LTD. (“Seller”) warrants each new device to be free from defects in
workmanship and materials under normal use and service for a period of one (1)
years from the date of shipment. The sole obligation of UTECH company under
this warranty will be repair or replace, at its option, products that prove to be
defective during the warranty period. The foregoing shall be the sole warranty
remedy. Except as set forth herein, seller makes no warranties, either
expressed or implied, including the implied warranties of merchantability and
fitness for a particular purpose. No warranty is provide if the products are
modified without the express written consent of UTECH company and seller
shall not be liable in any event for incidental or consequential damage. This
warranty is not assignable.
Warranties are subject to change. Please contact UTECH company for current
warranty information.
1.6 Service Support
Repairs for devices manufactured by UTECH company under warranty must be
made at authorized repair centers. If the device needs repair, contact your
local distributor or the UTECH company after-service department. When
calling, have the device’s model and serial number ready.
If you need to ship the device, pack the device and accessories carefully to
prevent shipping damage. All accessories should accompany the device.
UTECH CO., LTD.
rd
Add: 3 floor, NO.39, Jinqiao Road,
Zhangjiawan, Shapingba
District,
Chongqing, China
Phone: (+86)23-6172-8390
Fax: (+86)23-6172-8391
E-mail: service@chinautech.com
Website: http://www.chinautech.com
1-2 Handheld Pulse Oximeter Service Manual
Chapter 2: General Description
KEYWORD DEFINITION
WARNING Tells you something that could hurt the patient or hurt the
operator.
CAUTION Tells you something that could damage the device.
NOTE Tells you other important information.
Warnings
WARNING! ELECTRICAL SHOCK HAZARD when cover is removed. Do not
remove covers. Refer servicing to qualified personnel.
WARNING! EXPLOSION HAZARD: Do NOT use the device in the presence of
flammable anesthetics. Use of this instrument in such an
environment may present an explosion hazard.
WARNING! Failure of Operation: If the monitor fails to respond as
described, do not use it until the situation has been corrected
by qualified personnel.
WARNING! Patient Safety: Care should be exercised to assure continued
peripheral perfusion distal to the SpO2 sensor site after the
application.
WARNING! Do not position the sensor cable in any manner that may cause
entanglement or strangulation.
Cautions
CAUTION! Do not operate the device when it is wet due to spills or
condensation.
CAUTION! Do not operate the product if it appears to have ben dropped or
damaged.
CAUTION! Never sterilize or immerse the monitor and sensors in liquids.
CAUTION! No tension should be applied to any sensor cable.
CAUTION! Operate at temperatures between 10 to +40℃.(50 to 104F),
10-95% R.H.non-condensing.
CE Mark
Indicates separate collection for electrical and electronic
equipment.
2.5 Preparation for Use
2.5.1 Getting Acquainted
Figure 2.1: Monitor Controls, and Features
1. Sensor Connector
The sensor connects here, or an oximetry extension cable can be connected
between the monitor and the sensor.
2. SpO2 Numeric Display
A number shows the patient’s SpO2 value in percent. Dashes (- - -) mean the
monitor is not able to calculate the SpO2 value.
3. Mute icon
The mute icon is displayed at the status bar and it has three statuses:
14. Silence Indicator
This indicator flashes during temporary two-minute alarm silence. The
indictor lights steadily during permanent/indefinite alarm silence.
15. Slot for hanging strap
2.5.2 Power Supply Options
Batteries. Fresh disposable “AA” alkaline batteries provided approximately 10
hours of operation. Battery capacity maybe reduced in colder temperatures or
with excessive power cycling.
Figure 2.2: Installing the Batteries
To install/replace the batteries:
1. Depress the battery door and remove it downward.
2. Install the negative end of each battery first, compressing the battery
terminal spring until the positive terminal clears the positive tab. Press
the battery down into place.
3. Place battery door into the slots of the monitor back panel, depress the
door tab, and press the door into place.
NOTE! If you install disposable batteries, be sure to dispose of them in
compliance with your institution’s guidelines and local
ordinances.
NOTE! The unit will hold data for about one and a half minutes with
no battery power. This will insure the safety of trend data
during battery replacement.
AC Charger. The AC adapter can be used to charge rechargeable batteries and
used as a power supply without any battery.
Figure 2.2: Connecting AC Charger
2.5.3 Power On/Off
To turn the pulse oximeter on, press the power key.
! “Check ok” and software version will be displayed.
! An audible tone sounds.
! The power indicator is briefly illuminated.
To turn the pulse oximeter off, press the power key.
2.5.4 Auto Power Off
A battery power saving feature allows the pulse oximeter to shut itself off after
waiting 5 minutes without detecting any pulsatile activity.
Handheld Pulse Oximeter Service Manual 2-7
Chapter 2: General Description
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1
2Figure 3.1: Theory of Operation
1. Low intensity Red and Infrared LED light sources
2. Detector
Oximetry processes these signals, separating the time invariant parameters
(tissue thickness, skin color, light intensity, and venous blood) from the time
variant parameters (arterial volume and SpO2) to identify the pulses and
calculate functional oxygen saturation. Oxygen saturation calculations can
be performed because blood saturated with oxygen predictably absorbs
less red light than oxygen-depleted blood.
WARNING! Since measurement of SpO2 depends on a pulsating vascular
bed, any condition that restricts blood flow, such as the use of
a blood pressure cuff or extremes in systemic vascular
resistance, may cause an inability to determine accurate SpO2
and pulse rate readings.
Handheld Pulse Oximeter Service Manual 3-1
Chapter 3: Controls and Features
WARNING! Under certain clinical conditions, pulse oximeters may display
dashes if unable to display SpO2 and/or pulse rate values.
Under these conditions, pulse oximeters may also display
erroneous values. These conditions include, but are not
limited to: patient motion, low perfusion, cardiac
arrhythmias, high or low pulse rates or a combination of the
above conditions. Failure of the clinician to recognize the
effects of these conditions on pulse oximeter readings may
result in patient injury.
Figure 3.2: Circuit Structure Diagram
3.2.1 ON/OFF Switch
When the monitor is turned ON (pressing the POWER key for 3 seconds) a
positive pulse will make the signal of KEY_POWRE to a low level and the
output signal PWR_STB of U4 to a high level. Then the monitor is starting to
work. Press the POWER key for 3 seconds again which makes the output signal
PWR_STB of U4 to a low level. Then turn the monitor off.
3.2.2 3.3V Digital Supply
A switch-mode boost regulator U10 is used to generate the 3.3 volt digital
supply (VCC_MCU) from the battery voltage. It is designed to operate over an
input voltage range of 2.8V ~ 16.0V. The switch-mode controller U10 includes
an Output Voltage Sense, and use the resistor R25, R26to adjust the output
voltage. The output voltage can be calculated like this Vout = Vth (R25/R26 +
1).
Chapter 5: Accessories
5.1 Standard Configuration
CAT.NO DESCRIPTION QTY
UT100B UT100 Handheld Pulse Oximeter Each
US10BS Adult Finger SpO2 Sensor Each
1615 AA size Alkaline Batteries Four
5479 Hanging Strap Each
9230 Operation Manual Each
5.2 Optional Accessories
CAT.NO DESCRIPTION QTY
1616 AA size Ni-MH Batteries Four
2319 Hanging Strap Each
1617 AC Charger Each
4210 Reusable sensor, Adult, Finger Each
4211 Reusable sensor, Pediatric, Finger Each
4212 Reusable sensor, Neonatal/infant, Foot Each
4213 Single patient use sensor, Adult>30kg Each
4214 Single patient use sensor, Ped 3-50kg Each
4215 Single patient use sensor, neonatal <3kg Each
3425 SpO2 extension cable Each
Handheld Pulse Oximeter Service Manual 5-1
Chapter 5: Accessories
Figure 6.1: Exploded Structure Drawing
6.4.2 Reassembling the oximeter
1. Reconnect the LCD display and main board by welding the FPC.
2. Reinstall the two braces of LCD display by a tweezers.
3. Seat the display/main board assembly into the back cover.
4. Replace the top cover and the six screws, batteries and battery
compartment cover.
6.3 Troubleshooting
Table 6.1:
PROBLEM POSSIBLE CAUSE CORRECTIVE ACTION
•Patient cable or sensor •Check sensor connections
is disconnected from the to the patient cable and to
oximeter. the oximeter.
No pulse shown on •Sensor is incorrectly •Reposition the sensor.
the bargraph. positioned on the
patient. •Reposition the sensor.
•Poor patient perfusion.
•Try a new sensor or
•Defective sensor or
contact your authorized
patient cable.
repair center for help.
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Chapter 7: Specification
7.1 Equipment Classification
Type of Protection Against Internally Powered
Electric shock:
Mode of operation: Continuous
Degree of Protection Against IPX1, drip proof
ingress of Liquids:
Degree of Mobility: Handheld
Degree of Protection Against Type BF
Electric Shock:
Safety Requirements: EN60601-1:1990
7.2 SpO2
Range: 0-100%
Accuracy: ±2 at 70 - 100%
<70%, undefined
Resolution: 1%
Display Response: The display is to functional saturation. The
pulse strength bar graph is not proportional
to pulse volume.
7.3 Pulse Rate
Range: 30-250bpm
Accuracy: ±2 at 30 – 250bpm
Resolution: 1bpm
7.4 Default Settings of Alarms Limits
High Alarm Limits Low Alarm Limits
Adult Pediatric Neonatal Adult Pediatric Neonatal
SpO2 99 99 99 92 92 92
PR 100 110 120 60 70 80
7.5 Power Requirements
Four standard “AA” alkaline or Ni-MH cells (1.5Vdc,IEC Type LR6)
Chapter 8: Drawings
No. Description
1 Exploded Structure Drawing
2 Schematic, Main Board
3 Schematic, Power
4 Schematic, Battery Charger
5 Schematic, Acceleration
6 Schematic, Key
rd
3 floor, NO.39, Jinqiao Road,
Zhangjiawan, Shapingba District,
Chongqing, China
Phone (+86)23-6172-8390
Fax (+86)23-6172-8391
E-mail service@chinautech.com
Web site www.chinautech.com