User Manual
129 Pages
Preview
Page 1
About this Manual P/N: 01.54.110221-13 Release Date: August 2010 © Copyright EDAN INSTRUMENTS, INC. 2008-2010. All rights reserved.
Statement This manual will help you understand the operation and maintenance of the product better. It is reminded that the product shall be used strictly complying with this manual. User’s operation failing to comply with this manual may result in malfunction or accident for which EDAN INSTRUMENTS, INC. (hereinafter called EDAN) can not be held liable. EDAN owns the copyrights of this manual. Without prior written consent of EDAN, any materials contained in this manual shall not be photocopied, reproduced or I
translated into other languages. Materials protected by the copyright law, including but not limited to confidential information such as technical information and patent information are contained in this manual, the user shall not disclose such information to any irrelevant third party. The user shall understand that nothing in this manual grants him, expressly or implicitly, any right or license to use any of the intellectual properties of EDAN. EDAN holds the rights to modify, update, and ultimately explain this manual.
Responsibility
of
the
Manufacturer EDAN only considers itself responsible for any effect on safety, reliability and performance of the equipment if: Assembly
operations,
extensions, II
re-adjustments,
modifications or repairs are carried out by persons authorized by EDAN, and The electrical installation of the relevant room complies with national standards, and The instrument is used in accordance with the instructions for use. Upon request, EDAN may provide, with compensation, necessary circuit diagrams, and other information to help qualified technician to maintain and repair some parts, which EDAN may define as user serviceable.
Terms Used in this Manual This guide is designed to give key concepts on safety precautions. WARNING A WARNING label advises against certain actions or situations that could result in personal injury or death. CAUTION A CAUTION label advises against actions or situations III
that could damage equipment, produce inaccurate data, or invalidate a procedure. NOTE A NOTE provides useful information regarding a function or a procedure.
IV
Table of Contents 1 Safety Information .................................................... 1 1.1 Warnings .............................................................. 1 1.2 Cautions...............................................................11 1.3 Notes................................................................... 14 1.4 Symbols in the oximeter..................................... 17 2 Introduction ............................................................. 19 2.1 General Introduction........................................... 19 2.2 Panels Introduction............................................. 21 2.3 Connecting Sensor or Cable ............................... 30 2.4 Powered by Battery ............................................ 32 2.5 Accessory List .................................................... 36 3 Oximeter Operation ................................................ 41 3.1 Turning on the Oximeter .................................... 41 3.2 Measurement State ............................................. 43 3.3 System Menu...................................................... 47 3.4 Charging the Ni-MH Battery Package................ 66 3.5 PatientCare Viewer Data Management Software Introduction .............................................................. 67 V
4 Alarm ........................................................................ 70 4.1 Alarm Categories and Levels ............................. 70 4.2 Alarm Conditions ............................................... 73 5 Performance Considerations .................................. 79 5.1 Performance Verification ................................... 79 5.2 Oximeter Performance Considerations............... 79 5.3 OxiMax Sensor Performance Considerations..... 81 6 Maintenance............................................................. 85 7 Principles of Operation ........................................... 90 7.1 Pulse Oximetry Measurement ............................ 91 7.2 Functional Versus Fractional Saturation ............ 94 7.3 Measured Versus Calculated Saturation............. 95 8 Warranty and Service Policy.................................. 96 8.1 Warranty............................................................. 96 8.2 Service Policy..................................................... 97 AppendixⅠ Specification ....................................... 100 A1.1 Classification ................................................. 100 VI
A1.2 Specification .................................................. 100 A1.3 Parameters ..................................................... 103 Appendix II EMC Information ............................... 105 A2.1 Electromagnetic Emissions - for all EQUIPMENT and SYSTEMS ............................... 105 A2.2 Electromagnetic Immunity - for all EQUIPMENT and SYSTEMS ............................... 107 A2.3 Electromagnetic emissions-for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING ..111 A2.4 Recommended Separation Distances..............117 Appendix Ⅲ Record Table..................................... 120 Appendix Ⅳ Abbreviations ................................... 121
VII
H100N Pulse Oximeter User Manual
Safety Information
1 Safety Information 1.1 Warnings A WARNING label advises against certain actions or situations that could result in personal injury or death. WARNING 1
Avoid explosion hazard. Do not use the
oximeter in the presence of flammable anesthetic mixtures with air, or with oxygen or nitrous oxide. 2
Chemicals from a broken LCD display panel
are toxic when ingested. Use cautions when the oximeter has a broken display panel. 3
Routinely monitor the patient to make sure the
oximeter is functioning and the sensor is correctly placed.
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Safety Information
WARNING 4
Oximetry measurements and pulse signals can
be affected by certain environmental conditions, sensor application errors, and certain patient conditions. 5
The use of accessories, sensors, and cables
other than those specified may result in increased emission of electromagnetic radiation and/or invalid readings of the oximeter. 6
Failure to cover the sensor site with opaque
material in high ambient light conditions may result in inaccurate measurements. 7
Do not silence the audio alarm function, or
decrease the audio alarm volume, if patient safety could be compromised.
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Safety Information
WARNING 8
H100N Pulse Oximeter is a prescription device
to be operated only by trained personnel. The oximeter is for attended monitoring only. 9
Dispose of batteries in accordance with local
ordinances and regulations. 10 The oximeter is not defibrillator-proof. However, it may remain attached to the patient throughout defibrillation or while an electrosurgical unit is in use. The measurements may be inaccurate throughout the defibrillation, or use of an electrosurgical unit, and shortly thereafter. To avoid shock, the caregiver should not hold the oximeter while using a defibrillator on a patient.
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WARNING 11 Disconnect the oximeter and sensor from the patient throughout magnetic resonance imaging (MRI) scanning. Induced current could potentially cause burns. 12 To ensure accurate performance and prevent device failure, do not subject the oximeter to extreme moisture, such as direct exposure to rain. Such exposure may cause inaccurate performance or device failure. 13 Do not lift the oximeter by the sensor or extension
cable
because
the
cable
could
disconnect from the oximeter and the oximeter may drop on the patient.
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Safety Information
WARNING 14 Do not make any clinical judgment based solely on the oximeter, and it is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms. 15 To ensure patient safety, do not place the oximeter in any position that might cause it to fall on the patient. 16 As with all medical equipment, carefully route patient cables to reduce the possibility of patient entanglement or strangulation. 17 Ensure that the speaker is clear of any obstruction and that the speaker holes are not covered. Failure to do so could result in an inaudible alarm tone.
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Safety Information
WARNING 18 Use only Nellcor-approved OxiMax Sensors and extension cables with the H100N Pulse Oximeter. Other sensors or extension cables may cause improper monitor performance or minor personal injury. 19 H100N Pulse Oximeter readings and pulse signals can be affected by certain ambient environmental conditions, sensor application error, and certain patient conditions. See the appropriate sections
of
the
manual
for
specific
safety
information. 20 Don’t mix new and old batteries together. Don’t mix rechargeable batteries with alkaline batteries. 21 Periodically check the battery for corrosion. Remove the batteries from the oximeter if you do not expect to use it within one month. -6-
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Safety Information
WARNING 22 The device enters POST (Power-On-Self-Test) immediately after power-on. During the POST, confirm all the display segments and icons are shown and the speaker sounds a few seconds tone. Do not use the H100N Pulse Oximeter if you do not hear the POST pass tone. Do not use the oximeter if the POST has not been finished successfully. 23 Before using it, the user should carefully read the applicable user manual of sensor, including warnings, cautions and instructions. 24 Do not use damaged sensor or extension cables, do not use sensor with exposed optical components.
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Safety Information
WARNING 25 Tissue damage may be caused by incorrect application or prolonged measurement duration using the sensor (more than 2 hours). Inspect the sensor periodically according to sensor user manual. 26 Do not immerse or wet the sensor, as this may damage the sensor. 27 There are no user-serviceable parts inside the oximeter, the cover should only be removed by qualified service personnel. 28 Do not spray, pour, spill liquid to H100N Pulse Oximeter and its accessories, connector, switch or opening in enclosure, as this may damage the oximeter.
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Safety Information
WARNING 29 Before cleaning the oximeter or the sensor, make sure that the equipment is switched off and disconnected from the power line. 30 Setting the alarm limits to extreme values can cause the alarm system useless. 31 Do not use the charger stand when the alkaline battery is depleted or no battery is installed. 32 Do not monitor the patient while the battery is being charged. 33 Do not disassemble batteries, or dispose of them in fire, or cause them to short circuit. They may ignite, explode, leak, or cause personal injury. 34 Only
use
EDAN
approved
rechargeable
batteries and charger stand for H100N pulse oximeter.
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Safety Information
WARNING 35 The temperature sensor should be disinfected after each measurement. The probe must not be sterilized in steam. Only detergents containing no alcohol can be used for disinfection. 36 The temperature sensor should not be heated above 100℃ (212℉). It should only be subjected to temperatures from 80℃ (176℉) to 100℃ (212℉). 37 The calibration of the temperature module is necessary for every two years (or as frequently as dictated by your Hospital Procedures Policy). When you need to calibrate the temperature measurement, please contact the manufacturer.
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Safety Information
WARNING 38 Take the TEMP probe and cable carefully. If you do not use them for a long time, you should coil up the probe and cable into a loose circle. If the wire inside the cable is tensely pulled, it may cause mechanical damage to the probe and the cable.
1.2 Cautions A Caution label alerts the user to exercise care necessary for the safe and effective use of the H100N Pulse Oximeter. CAUTION 1
All combinations of equipment must be in
compliance
with
IEC/EN
requirements. - 11 -
60601-1-1
system
H100N Pulse Oximeter User Manual
Safety Information
CAUTION 2
The device and accessories are to be disposed
of according to local regulations after their useful lives. Alternatively, they can be returned to the dealer or the manufacturer for recycling or proper disposal. Batteries are hazardous waste. Do NOT dispose of them together with house-hold garbage. At the end of their life hand the batteries over to the applicable collection points for the recycling of waste batteries. For more detailed information about recycling of this product or battery, please contact your local Civic Office, or the shop where you purchased the product. 3
H100N Pulse Oximeter will not operate with
dead batteries. Install new batteries.
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Safety Information
CAUTION 4 The sensor unconnected icon and associated alarm indicate the sensor has disconnected or wire fault. So check the sensor connection and, if necessary, replace the sensor, extension cables or both. 5 When adjusting any menu parameters, the oximeter does not display SpO2, PR or TEMP, but it is still recording. 6 The performance of the oximeter may be degraded if the following occur: — Operation or storage temperature and humidity outside the manufacturer’s stated range; — Mechanical shock (for example, it drops from the table). — Patient temperature is below ambient temperature (For measurement body temperature). - 13 -
H100N Pulse Oximeter User Manual
Safety Information
1.3 Notes NOTE: Notes are identified by the symbol shown above. Notes contain important information that may be overlooked or missed. NOTE: 1
This device has been tested and found to
comply with the limits for medical device in IEC/EN60601-1-2 (International standard for EMC testing of Medical Electrical Equipment, second edition). These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. 2
Sensor LED light emissions fall within Class 1
level, according to IEC 60825-1:2001. No special safety precautions are required. - 14 -
H100N Pulse Oximeter User Manual
3
Safety Information
Normal operation means: — The oximeter is turned on; — A sensor is connected to the oximeter; — The sensor is applied to the patient; — The
patient’s
SpO2,
Pulse
rate
or
Temperature readings are being reported; — No error conditions exist. 4
Wash the probe with clean water after
disinfecting it to remove any remaining solution. The probe can only be reused after being dried thoroughly. 5
Do not disinfect the probe with the means of
water boiled. 6
Any residue should be removed from the probe
before being disinfected, and avoid contacting corrosive solvent. Dip the cable into alcohol or alkalescent solvent for a long time, may reduce the flexibility of the scarfskin of the cable. Also, the - 15 -
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Safety Information
connector should not be dipped. 7
After monitoring, disinfect the probe according
to the instruction described in the user manual. 8
The materials with which the patient or any
other person can come into contact conform with the standard of ISO10993. 9
The pictures and interfaces in this manual are
for reference only. 10 A functional tester cannot be used to assess the accuracy of the pulse oximeter probe or the pulse oximeter monitor. 11 If there is independent demonstration that the particular calibration curve is accurate for the combination of a pulse oximeter monitor and a pulse oximeter probe, then a functional tester can measure the contribution of a monitor to the total error of a monitor/probe system. The functional tester can then measure how accurately a particular - 16 -
H100N Pulse Oximeter User Manual
pulse
oximeter
monitor
Safety Information
is
reproducing
that
calibration curve. 12 The operating time of the Ni-MH rechargeable battery package depends on the configuration and operation of the pulse oximeter.
1.4 Symbols in the oximeter This symbol indicates that the instrument is IEC/EN 60601-1 Type BF equipment. Symbol for Caution Consult Instructions for Use Serial Number
CE Mark - 17 -
H100N Pulse Oximeter User Manual
Safety Information
Date of Manufacture Manufacturer P/N IPX1
Part Number Ingress Protection Degree Recycle The symbol indicates that the device should be sent to the special agencies according to local regulations for separate collection after its useful life. Auxiliary Output Connector
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H100N Pulse Oximeter User Manual
Introduction
2 Introduction Intended Use H100N Pulse Oximeter (hereinafter called oximeter) is one model of H100 series Pulse Oximeter. The oximeter is intended for continuous monitoring or spot-checking of functional arterial oxygen saturation (SpO2), pulse rate and for oral, axillary and rectal temperature measurement. It is intended to be used on adult, pediatric or neonatal patient in hospitals, intra-hospital transport and hospital type facilities.
2.1 General Introduction It displays SpO2 value, pulse rate value, plethysmogram, bar graph, temperature, etc. The oximeter has been installed Nellcor SpO2 module and the manufacturer’s TEMP module inside. It integrates parameter module, display and recorder output - 19 -
H100N Pulse Oximeter User Manual
Introduction
functions. It can be powered by four 1.5V AA batteries or four 1.2V Rechargeable Ni-MH AA batteries. It can clearly display all the parameter information on LCD.
Figure 2-1 H100N Pulse Oximeter
For the oximeter, PatientCare Viewer Data Management Software is optional. - 20 -
H100N Pulse Oximeter User Manual
Introduction
2.2 Panels Introduction This section identifies the symbols, controls, displays, and buttons on the front panel and rear panel of the oximeter.
2.2.1 Symbols on Screen
Figure 2-2 Large Numeric Mode
Figure 2-3 Waveform Mode
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Introduction
Icons on display screen and their meanings: SpO2
SpO2 value display area
PR
Pulse Rate value display area
TEMP
Temperature value display area Displays when measurement value is higher than the upper alarm limit Displays when measurement value is lower than the lower alarm limit SpO2 waveform display Pulse amplitude display Low battery icon Audio alarm off icon
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Introduction
Alarm off icon Data storage icon 04: 59
Time display in Information area: “hour: minute”
ADU/NEO
Patient type in Information area: Adult or Neonate.
ID: 99
Patient ID in Information area SpO2 sensor unconnected icon SpO2 sensor off Indicates the memory space is full Weak signal icon
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H100N Pulse Oximeter User Manual
Introduction
NOTE: 1
The icons for sensor unconnected, sensor off
or weak signal are displayed on the right of Information area. Only one of them can be displayed at a time. 2
The ID icon and the icon that indicates the
memory space is full are displayed in the Information Area. Only one icon can be displayed at a time.
2.2.2 Front Panel Buttons This section describes the buttons on the front panel of the oximeter. The controls are activated by pressing the button that corresponds to that control. For example, press the Alarm Silence button to control the audio alarm.
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H100N Pulse Oximeter User Manual
Introduction
Figure 2-4 Front Panel buttons
On/Off Button Turn on or off the oximeter. On: Press and hold the On/Off button for one second. Off: Press and hold the On/Off button for two seconds. When the oximeter is off, synchronously press the On/Off button and the Function button for 1 second, the oximeter will enter Data transfer state. In the menu state, press this button to return to measurement state.
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H100N Pulse Oximeter User Manual
Introduction
Backlight Button During the POST, the backlight is not available. In the normal measurement, press this button to turn on or off the backlight. Alarm Silence Button Alarms that occur during the Power-On-Self-Test (POST) can not be silenced. When Alarm System in menu is set to ON, pressing the Alarm Silence button can turn off audio alarm. The pause period can be set to 30, 60, 90 or 120 seconds. Although the audio alarm is off, the visual alarm is still active. After the pause period is over, the audio alarm is reactivated. Set Alarm System to OFF in menu to turn off the alarm. A pop-up dialog box will display to confirm alarm setting. See details in 3.3.3. - 26 -
H100N Pulse Oximeter User Manual
Introduction
Up Arrow Button In the menu state, press the Up Arrow button to choose different items, and increase the value of some parameters. Press it repeatedly to make a parameter increase by more than one. Press and hold this button for more than 1 second to repeat the increment continuously. Press this button in measurement state to display the latest 10-minute SpO2 trend graph. Down Arrow Button In the menu state, pressing the Down Arrow button can choose different items, and decrease the value of some parameters. Press it repeatedly to make a parameter decrease by more than one. Press and hold the button for more
than
1
second
to
repeat
the
decrement
continuously. Press this button in measurement state to display the latest 10-minute PR trend graph. - 27 -
H100N Pulse Oximeter User Manual
Introduction
Function Button During the POST, the Function button is not available; Press this button in normal measuring state to enter function choice or setup menu; In the menu state, this button is also used as the Enter button. Choose one item in menu using the cursor button (the Up Arrow button and Down Arrow button), and press the Function button to confirm, then increase or decrease the value using cursor button. When the oximeter is off, synchronously press the On/Off button and the Function button for 1 second, the oximeter will enter Data transfer state.
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H100N Pulse Oximeter User Manual
Introduction
Button Combination When the oximeter is off, synchronously press the On/Off button and the Function button for 1 second, the oximeter will enter Data transfer state.
2.2.3 Rear Panel
Figure 2-5 Rear Panel
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H100N Pulse Oximeter User Manual
Introduction
2.3 Connecting Sensor or Cable
Figure 2-6 Sensor and Cable Connecting Port
SpO2 Sensor and cable port is on the top of the oximeter for connecting the SpO2 sensor. An extension cable can be used between the oximeter and the SpO2 sensor. Use only the cable permitted by the manufacturer. The cable for connecting the oximeter and PC with the PatientCare Viewer Data Management Software is also connected to this port. The temperature sensor port is only configured for H100N. - 30 -
H100N Pulse Oximeter User Manual
Introduction
Symbol for caution
Type BF applied part Auxiliary output connector SIO definition: PIN
Name
Description
1
GND
GND
2
LED+
LED drive signal, IR Anode
3
LED-
4
LED drive signal, Red Anode Tx / TXD / Sensor UART Memory Return DigiCAL communication signal return signal return - 31 -
H100N Pulse Oximeter User Manual
Introduction
5
Detector Anode
Detector connection
anode
6
Inner Shield
Detector GND
7
Outer Shield
Outer cable shield to GND
8
RXD / Sensor Memory Data
UART Rx /DigiCAL communication signal
9
Detector Cathode
Detector connection
shield
to
cathode
2.4 Powered by Battery The oximeter can be powered by four 1.5V LR6 AA alkaline batteries. It will operate for 48 hours when used for general operation, or about 24 hours of operation with the backlight and alarm on. The oximeter does not support built-in recharging mode. The oximeter can also be powered by 4 1.2V Ni-MH rechargeable batteries. - 32 -
H100N Pulse Oximeter User Manual
Introduction
Battery Installation To install the alkaline batteries:
1. 2.
Make sure the oximeter is turned off. Press the battery compartment latch and remove the battery access door.
3.
Place four AA batteries as shown in the following figure, first push it oriented as shown in ①, then press it oriented as shown in ②.
4.
Install the battery compartment cover.
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H100N Pulse Oximeter User Manual
Introduction
To install the rechargeable Ni-MH battery package: 1.
Make sure the oximeter is turned off.
2. Press the battery compartment latch and remove the battery access door. 3. Place the Ni-MH rechargeable battery package as shown in the follow figure, first push it oriented as ①, then press it oriented as ②. 4.
Install the battery compartment cover.
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H100N Pulse Oximeter User Manual
Introduction
Checking the Ni-MH Battery Package The performance of a rechargeable Ni-MH battery package may deteriorate. To check the performance of the battery, follow the procedures below: 1.
Disconnect the pulse oximeter from the patient and
stop all monitoring and measuring procedures. 2.
Place the pulse oximeter in the charger stand and
connect the AC mains. Allow the battery to be charged uninterruptedly for above 2.5 hours. 3.
Disconnect AC mains and allow the pulse oximeter
to run in the measurement state until it shuts off. The operating time of a battery reflects its performance directly. If the operating time of a rechargeable Ni-MH battery package is noticeably shorter than that stated in the specifications, replace it or contact your service personnel. - 35 -
H100N Pulse Oximeter User Manual
Introduction
Low Battery Icon The low battery icon displays and an alarm is given when 15 minutes operation remains available. After 15 minutes operation, the oximeter will turn off automatically. Replace the batteries.
Figure 2-7 Low Battery Icon
2.5 Accessory List Standard configuration including: Quantity
Items
Parts No.
1
H100N Pulse Oximeter
MS8-110185
4
1.5V AA alkaline batteries (IEC LR6）
M21R-064086
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H100N Pulse Oximeter User Manual
Introduction
Nellcor Reusable Adult SpO2 Sensor 1
(DS-100A OxiMax)
MS2-30043
(Weak Perfusion Resistance) 1
Skin Temperature Probe
M15R-040156
H100N Pulse 1
Oximeter User
MS1R-110221
Manual H100N Pulse 1
Oximeter Reference
MS1R-110222
Card 1
Carrying case
- 37 -
MS1-110165
H100N Pulse Oximeter User Manual
Introduction
Optional configuration including: Quantity
Items
Parts No.
1
H100N Pulse Oximeter MS1R-110223 Service Manual
1
H100N Protective Cover
MS1-110164
4
Rechargeable Ni-MH battery package
M21R-064133
1
Battery charger
MS8-112410
1
Nellcor Reusable Adult SpO2 Sensor (DS-100A OxiMax) MS2-30043 (Weak Perfusion Resistance) - 38 -
H100N Pulse Oximeter User Manual
1
Introduction
Nellcor ReusableAdult/Neonate SpO2 Sensor (OXI-A/N M15-40096 OxiMax) (Weak Perfusion Resistance)
1
Rectal / Oral Temperature Probe H100N Patient Information
1
management accessory package (include 1xCD、USB cable、User manual)
- 39 -
M15R-040157
H100N Pulse Oximeter User Manual
Introduction
The oximeter is compatible with Nellcor-approved OxiMax Sensors and extension cables. When selecting SpO2 sensor, the following should be considered:
Patient weight and activity.
Adequacy of perfusion.
Available sensor sites.
Anticipated duration of monitoring.
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H100N Pulse Oximeter User Manual
Oximeter Operation
3 Oximeter Operation 3.1 Turning on the Oximeter The oximeter is turned on by pressing the on/off button, it will cycle through a Power-On-Self-Test (POST) before displaying valid data values. Verify that all the circuitry and functions of the oximeter work properly during the POST. It needs a few seconds to complete the verification procedure POST. If it functions incorrectly, do not use the oximeter. Press the On/Off button for one second to turn on the oximeter.
At first the Logo EDAN is shown.
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H100N Pulse Oximeter User Manual
Oximeter Operation
And then the Logo for product model is shown.
Figure 3-1 Model
If the POST is successfully finished, the oximeter
sounds a tone and enters the main interface. If there is an error during the POST, the following error codes will display on the screen: Error code
Indication
Error 01
Indicates error for Low battery
Error 02
Indicates error for SpO2 board - 42 -
H100N Pulse Oximeter User Manual
Oximeter Operation
Error 03
Indicates error for Temp board
Error 04
Indicates error for main control board
3.2 Measurement State 3.2.1 Measurement Modes There are two measurement modes which are waveform mode and large numeric mode. By default, the configuration is waveform mode. Large Numeric Mode The oximeter can display SpO2, oxygen saturation unit (%), PR, pulse rate unit (bpm), TEMP and temperature unit (℃) in large numeric mode.
Figure 3-2 Large Numeric Mode - 43 -