User Manual
98 Pages
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Page 1
About this Manual P/N: 21.54.109000-15 Release Date: Dec 2010 © Copyright EDAN INSTRUMENTS, INC. 2007-2010. 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 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 I
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, 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 II
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 that could damage equipment, produce inaccurate data, or invalidate a procedure. NOTE A NOTE provides useful information regarding a function or a procedure.
III
Table of Contents 1 Safety Information ................................................. 1 1.1 Warnings ........................................................... 1 1.2 Cautions ............................................................ 7 1.3 Notes ................................................................. 9 1.4 Symbols in the Oximeter ................................. 11 2 Introduction ..........................................................14 2.1 General Introduction........................................14 2.2 Panel Introduction ...........................................15 2.2.1 Symbols on Screen ..................................16 2.2.2 Front Panel Buttons..................................18 2.2.3 Rear Panel ...............................................22 2.3 Connecting Sensor or Cable...........................23 2.4 Powered by Battery.........................................24 2.5 Accessory List .................................................27 3 Oximeter Operation .............................................31 3.1 Turning on the Oximeter .................................31 3.2 Measurement State.........................................32 3.2.1 Measurement Modes................................32 3.2.2 Trend Graph and Trend Table .................33 3.2.3 Abnormal Measurement State .................34 3.2.4 Data Transfer State ..................................35 IV
3.3 System Menu ..................................................36 3.3.1 System Mode ...........................................38 3.3.2 Patient Type .............................................39 3.3.3 Alarm Volume...........................................39 3.3.4 Pulse Volume ...........................................39 3.3.5 Audio Paused (s)......................................40 3.3.6 User Maintain ...........................................40 3.3.7 Default Config...........................................41 3.3.8 Sensitivity .................................................42 3.3.9 Alarm System ...........................................42 3.3.10 SpO2 Alarm setup...................................44 3.3.11 PR Alarm setup ......................................46 3.3.12 Patient ID No. Setup...............................47 3.3.13 Data Storage ..........................................48 3.3.14 Delete All Data .......................................49 3.3.15 Exit (Return) ...........................................50 3.4 Charging the Ni-MH Battery Package.............50 3.5 PatientCare Viewer Data Management Software Introduction ...........................................................51 4 Alarm .....................................................................52 4.1 Alarm Categories and Levels..........................52 4.2 Alarm Conditions.............................................54 V
4.2.1 Alarm off Before the First Measurement ..54 4.2.2 Alarm for SpO2 Sensor Unconnected......55 4.2.3 Alarm for SpO2 Sensor off .......................55 4.2.4 Alarm for Low Battery...............................55 4.2.5 Higher than Hi Alarm Limit .......................56 4.2.6 Lower than Lo Alarm Limit .......................56 4.2.7 Alarm Silence ...........................................57 4.2.8 Turning off Alarm System.........................57 4.2.9 Alarm Priority............................................57 5 Performance Considerations..............................58 5.1 Performance Verification.................................58 5.2 Oximeter Performance Considerations...........58 5.3 Sensor Performance Considerations ..............59 6 Maintenance .........................................................63 7 Principles of Operation .......................................66 7.1 Pulse Oximetry Measurement.........................67 7.2 Functional Versus Fractional Saturation .........69 7.3 Measured Versus Calculated Saturation ........70 8 Warranty and Service Policy...............................71 8.1 Warranty..........................................................71 8.2 Service Policy..................................................72 AppendixⅠSpecification........................................74 VI
A1.1 Classification.................................................74 A1.2 Specification .................................................74 A1.2.1 Size and Weight .....................................74 A1.2.2 Environment ...........................................74 A1.2.3 Display ...................................................75 A1.2.4 Batteries .................................................75 A1.2.5 Charger Stand........................................76 A1.3 Parameters ...................................................76 Appendix II EMC Information.................................78 A2.1 Electromagnetic Emissions - for all EQUIPMENT and SYSTEMS................................78 A2.2 Electromagnetic Immunity - for all EQUIPMENT and SYSTEMS................................80 A2.3 Electromagnetic emissions-for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING.83 A2.4 Recommended Separation Distances ..........87 Appendix Ⅲ Record Table....................................89 Appendix Ⅳ Abbreviations ..................................90
VII
H100B Pulse Oximeter User Manual
1 Safety Information 1.1 Warnings Warnings are identified by the WARNING symbol shown above. A WARNING label advises against certain actions or situations that could result in personal injury or death. 1
2
3
4
WARNING Avoid explosion hazard. Do not use the oximeter in the presence of flammable anesthetic mixtures with air, or with oxygen or nitrous oxide. Chemicals from a broken LCD display panel are toxic when ingested. Use cautions when the oximeter has a broken display panel. Routinely monitor the patient to make sure the oximeter is functioning and the sensor is correctly placed. Oximetry measurements and pulse signals can be affected by certain environmental conditions, -1-
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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. 8 The 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 -2-
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11
12
13
14
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electrosurgical unit, and shortly thereafter. To avoid shock, the caregiver should not hold the oximeter while using a defibrillator on a patient. Disconnect the oximeter and sensor from the patient throughout magnetic resonance imaging (MRI) scanning. Induced current could potentially cause burns. 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. 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. Do not make any clinical judgment based solely on the oximeter, it is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms. To ensure patient safety, do not place the oximeter in any position that might cause it to -3-
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16
17
18
19
20
fall on the patient. As with all medical equipment, carefully route patient cables to reduce the possibility of patient entanglement or strangulation. 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. Use only EDAN permitted sensors and extension cables with the oximeter. Other sensors or extension cables may fail and/or cause improper monitor performance and/or minor personal injury. H100B 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. Don’t mix new and old batteries together. Don’t mix rechargeable batteries with alkaline batteries. -4-
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21 Periodically check the battery for corrosion. Remove the batteries from the oximeter if you do not expect to use it within one month. 22 The device enters POST (Power-On-Self-Test) immediately after power-on to confirm all the display segments and icons are shown and the speaker sounds a few seconds tone. If you do not hear the POST pass tone, it indicates the alarm system does not work well. Please do not use the H100B Pulse Oximeter and contact qualified service personnel or your local EDAN representative. 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. 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 -5-
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26 27
28
29
30 31 32
33
manual. Do not immerse or wet the sensor, as this may damage the sensor. There are no user-serviceable parts inside the oximeter, the cover should only be removed by qualified service personnel. Do not spray, pour, spill liquid to the oximeter and its accessories, connector, switch or opening in enclosure, as this may damage the oximeter. Before cleaning the oximeter or the sensor, make sure that the equipment is switched off and disconnected from the power line. Do not use the charger stand when the alkaline battery is depleted or no battery is installed. Do not monitor the patient while the battery is being charged. 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. Only use EDAN approved rechargeable -6-
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batteries and charger stand for H100B pulse oximeter. 34 A potential hazard can exist if different alarm presets are used. 35 This equipment is not intended for family usage.
1.2 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 the oximeter. 1
2
CAUTION All combinations of equipment must be in compliance with IEC/EN Standard 60601-1-1 systems requirements. 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 -7-
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3 4
5
6
7
waste. Do NOT dispose 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. H100B Pulse Oximeter will not operate with dead batteries. Install new batteries. 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. When adjusting any menu parameters, the oximeter does not display SpO2 or PR, but it is still recording. Do not run the pulse oximeter when alkaline batteries of different types are used at the same time. Federal (U.S.) Law restricts this device to sale -8-
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by or on the order of a physician.
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/EN 60825-1:2001. No special safety precautions are required. 3 Normal operation means: The oximeter is turned on; A sensor is connected to the oximeter; -9-
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4
5 6
7 8
9
The sensor is applied to the patient; The patient’s SpO2, Pulse rate are being reported; No error conditions exist. Wash the probe with clean water after disinfecting it to remove any remaining solution. The probe can only be reused after dried thoroughly. Do not disinfect the probe with the water boiled. Any residue should be removed from the probe before being disinfected, and avoid contacting corrosive solvent. Dipping the cable into alcohol or alkalescent solvent for a long time may reduce the flexibility of the scarfskin of the cable. Also, the connector should not be dipped. After monitoring, disinfect the probe according to the instruction described in the user manual. The materials with which the patient or any other person can come into contact conform with the standard of ISO10993. The pictures and interfaces in this manual are for reference only. - 10 -
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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 pulse oximeter monitor 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.
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Symbol for CAUTION
Serial number The symbol indicates that the device complies with the European Council Directive 93/42/EEC concerning medical devices. Authorized representative in the European community Date of manufacture Manufacturer P/N
Part Number
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The symbol indicates that the device should be sent to the special agencies according to local regulations for separate collection after its useful life. Federal (U.S.) Law restricts this device to sale by or on the order of a physician. Auxiliary output connector Recycle MEDICAL EQUIPMENT WITH RESPECT TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL60601-1 and CAN / CSA C22.2 No. 601.1.
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2 Introduction Intended Use The oximeter is intended for continuous monitoring or spot-checking of functional arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric or neonatal patients in hospitals, intra-hospital transport and hospital grade facilities.
2.1 General Introduction H100B Pulse Oximeter (hereinafter called oximeter) is one model of H100 series Pulse Oximeter. It displays SpO2 value, pulse rate value, plethysmogram, bar graph, etc. The oximeter is installed with EDAN SpO2 module inside. It integrates parameter module, display and recorder output functions. It can be powered by four 1.5V AA batteries or one Ni-MH rechargeable AA battery package. It can clearly display all the parameter information on LCD.
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H100B Pulse Oximeter User Manual
Figure 2-1 H100B Pulse Oximeter
For the oximeter, Oximeter Viewer Data Management Software is optional.
2.2 Panel Introduction This section identifies the symbols, controls, displays, and buttons on the front panel of the oximeter and the rear panel.
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2.2.1 Symbols on Screen
Figure 2-2 Waveform Mode
Figure 2-3 Large Numeric Mode
Icons on the screen and their meanings: SpO2
SpO2 value display area
100%
Measured SpO2%
PR
Pulse Rate value display area
60 bpm
Measured Pulse rate (bpm) Displays when measurement value is higher than the upper alarm limit Displays when measurement value is lower than the lower alarm limit - 16 -
H100B Pulse Oximeter User Manual
SpO2 waveform display
Pulse amplitude display Low battery icon Audio alarm off icon 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 - 17 -
H100B Pulse Oximeter User Manual
Weak signal icon 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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H100B Pulse Oximeter User Manual
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 one second, the oximeter will enter data transfer state. In the Menu state, press this button to return to the measurement state. Backlight Button During the POST, the backlight is not available. In the normal measurement, press this button to turn on - 19 -
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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 setup to ON, pressing the Alarm Silence button can turn off the 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 the menu to turn off the alarm. A Pop-up dialog box will display to confirm alarm setting. See details in 3.3.8. 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 one second to repeat the increment continuously. Press this button in measurement state to enter the latest - 20 -
H100B Pulse Oximeter User Manual
10-minute SpO2 or PR 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 one second to repeat the decrement continuously. Press this button in measurement state to enter the latest 10-minute SpO2 and PR trend table. Function Button During the POST, the Function button is not available; Press this button in normal measurement 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 the 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 one second, - 21 -
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the oximeter will enter data transfer state. Button Combination When the oximeter is off, synchronously press the On/Off button and the Function button for one second, the oximeter will enter Data transfer state.
2.2.3 Rear Panel
Figure 2-5 Rear Panel
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2.3 Connecting Sensor or Cable
Figure 2-6 Sensor and Cable Connecting Port
SpO2 Sensor and cable port is at the top of the oximeter. An extension cable can be used between the oximeter and the SpO2 sensor. Use only the cable permitted by EDAN. The cable for connecting the oximeter and PC with the Oximeter Viewer Data Management Software is also connected to this port.
Type BF applied part Auxiliary output connector SIO definition: PIN
Name
Description - 23 -
H100B Pulse Oximeter User Manual
1
RSGND
The RS232 GND
2
LED+
LED drive signal, IR Anode
3
LED-
LED drive Anode
4
RXD
H100 RS232 RX
5
Detector Anode
Detector anode
6
Connection
Detector connection
7
AGND
Analog GND
8
TXD
H100 RS232 TX
9
Detector Cathode Detector cathode
signal,
Red
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 can also be powered by the Ni-MH rechargeable battery package. Battery Installation To install the alkaline batteries: 1. Make sure the oximeter is turned off. 2. Press the battery compartment latch and - 24 -
H100B Pulse Oximeter User Manual
3.
4.
remove the battery access door. 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. Install the battery compartment cover.
To install the Ni-MH rechargeable 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. - 25 -
H100B Pulse Oximeter User Manual
Checking the Ni-MH Rechargeable Battery Package The performance of a Ni-MH rechargeable 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. For details about charging the Ni-MH rechargeable battery package, please refer to section 3.4. - 26 -
H100B Pulse Oximeter User Manual
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 Ni-MH rechargeable battery package is noticeably shorter than that stated in the specifications, replace it or contact your service personnel. Low Battery Icon The low battery icon displays and an alarm is given when few-minute operation remains available. After few-minute operation, the oximeter will turn off automatically. Replace the batteries.
Figure 2-7 Low Battery Icon
2.5 Accessory List Standard configuration including: - 27 -
H100B Pulse Oximeter User Manual
Quantity
Items
Parts No. in EDAN
4
1.5V AA alkaline 01.21.064086 batteries (IEC LR6）
1
SH1 Adult Reusable 12.01.109079 SpO2 Sensor
1
H100B Oximeter Manual
1
H100B Pulse Oximeter Reference 01.54.109002 Card
1
Carrying case
Pulse User 01.54.109000
11.56.110165
Optional configuration including: Quantity
Items
Parts No. in EDAN
1
H100B Pulse Oximeter Service Manual
MS1R-109017
1
H100 Protective Cover
01.51.110164
1
Ni-MH rechargeable battery package
M21R-064133
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1
Ni-MH rechargeable battery group
21.21.064164
1
Battery charger
MS8-112410
1
EDAN SH4 Adult Silicone Soft-tip SpO2 Sensor (DB9, Only compatible 12.01.110515 with EDAN SpO2 module and EDAN SpO2 extension cable)
1
EDAN SH4 Adult Silicone Soft-tip SpO2 Sensor 02.01.110531 (DB9) (Immersion Disinfection)
1
EDAN SH5 pediatric Silicone Soft-tip SpO2 Sensor ( DB9)
1
H100 Patient Information management accessory package MS1R-109038 (Include 1×CD, RS232 cable, User manual)
1
Extended cable (USB to - 29 -
12.01.110521
MS1-110166
H100B Pulse Oximeter User Manual
RS232 interface) 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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H100B Pulse Oximeter User Manual
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 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 EDAN LOGO is shown.
Figure 3-1 EDAN LOGO
Secondly the product model is displayed.
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H100B Pulse Oximeter User Manual
Figure 3-2 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
Error 03
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. Waveform Mode In the normal measurement state, oximeter can measure - 32 -
H100B Pulse Oximeter User Manual
arterial oxygen saturation and pulse rate, display oxygen saturation level and symbol（%SpO2）and PR on interface. Besides, it can also display pulse bar graph and Plethysmogram.
Figure 3-3 Waveform Mode
Large Numeric Mode The oximeter can display SpO2, oxygen saturation unit (%), PR, pulse rate unit (bpm) in large numeric mode.
Figure 3-4 H100B Large Numeric Mode
3.2.2 Trend Graph and Trend Table In normal measuring state, press the Up Arrow button to enter the latest SpO2 or PR trend graph, and press the Down Arrow button to enter latest 10-minute SpO2 and PR trend table. Shift the pages by pressing the Up - 33 -
H100B Pulse Oximeter User Manual
Arrow or Down Arrow button. Trend graph:
Figure 3-5 Display SpO2 and PR Trend Graph
Trend table:
Figure 3-6 Display SpO2 and PR Trend Table
3.2.3 Abnormal Measurement State If the SpO2 sensor does not connect to the oximeter, it will give a medium alarm, and display in the information area. If the SpO2 sensor falls off from the finger, it will give a - 34 -
H100B Pulse Oximeter User Manual
medium alarm, and display in the information area. In menu state or trend state, if there is no operation for 30 seconds, the oximeter will return to measurement state. In measurement state, if there is no measurement data and no operation for 10 minutes, the oximeter will turn off automatically. In Data transfer state, if the oximeter does not receive any responsible signals for 10 minutes, it will turn off automatically.
3.2.4 Data Transfer State Set Data Storage in menu to ON, the measurement value will be stored in the oximeter. The SpO2 and PR information can be transferred from oximeter to Oximeter Viewer Data Management Software. Data transfer procedure:
After the measurement and storage are all finished, turn off the oximeter;
Connect the oximeter and the computer with a cable for the communication between the oximeter and the Oximeter Viewer Data - 35 -
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Management Software; Synchronously press the On/Off button and the Function button, after POST, the oximeter enters Data Transfer State automatically. The interface displays as below:
Figure 3-7 Data Transfer State
3.3 System Menu Press the Function button to see the following main menu of the oximeter, select items by pressing the Up/Down button, and confirm it by pressing the Function button.
System Setup >>: - 36 -
H100B Pulse Oximeter User Manual
Alarm Setup >>:
Storage Setup >>: - 37 -
H100B Pulse Oximeter User Manual
Figure 3-8 Menus
The menus are shown above and the details for each item will be introduced in the following sections. NOTE: 1 The SpO2 Hi Alarm and SpO2 Lo Alarm stand for the upper and lower alarm limits of SpO2 respectively. 2
The PR Hi Alarm and PR Lo Alarm stand for the upper and lower alarm limits of PR respectively.
3
If the user changes the default value of Lo Alarm or Hi Alarm, after restarting the oximeter, the value will resume to the default value for the corresponding patient type.
3.3.1 System Mode There are two items for selecting: Waveform mode - 38 -
H100B Pulse Oximeter User Manual
Large numeric mode Then confirm the selection by pressing the Function button.
3.3.2 Patient Type Patient Type can be set to different measurement modes: Adu for Adult or Pediatric patient or Neo for Neonatal patient. Set Patient Type to Adu or Neo, and confirm it by pressing the Function button. Note: When patient type is changed to Neo, please use the Neonate SpO2 Sensor for accurate measurement.
3.3.3 Alarm Volume The Alarm Volume button is used to adjust alarm volume and its range is from one to five. When Alarm System is setup to ON, if a low alarm, a medium alarm or a high alarm occurs, the oximeter sounds beep.
3.3.4 Pulse Volume The user can turn on or off the pulse volume by pressing - 39 -
H100B Pulse Oximeter User Manual
Pulse Volume, and change volume level to 1, 2, 3, 4, 5 or OFF. Press the Function button to enter setup state, then use the Up Arrow or the Down Arrow button to choose, then confirm it by pressing the Function button. The oximeter implements variable pulse tone and its frequency varies with the saturation
3.3.5 Audio Paused (s) Set the pause period for audio alarm to 30, 60, 90 or 120 seconds. When Alarm System is ON, pressing the Alarm Silence button can turn off the audio alarm, the pause period is set by the Audio Paused (s).
3.3.6 User Maintain Enter the User Maintain menu by inputting “819”.
Figure 3-9 Enter Password
If the password is wrong, the following dialog box will pop up: - 40 -
H100B Pulse Oximeter User Manual
Figure 3-10 Wrong Password
If the password is right, the following menu will display:
Figure 3-11 User Maintain
● Language: the user can select language to be displayed. ● Time Setup >>: select this item, the following interface displays:
Figure 3-12 Time Setup
3.3.7 Default Config Choose this item to resume factory default configuration. - 41 -
H100B Pulse Oximeter User Manual
A dialog box pops up:
Figure 3-13 Factory Default Config
Factory Default Configuration is shown as follows: System Mode: Patient Type: Alarm System: Alarm Volume: Pulse Volume: Audio Paused (s): SpO2 Hi Alarm: SpO2 Lo Alarm: PR Hi Alarm: PR Lo Alarm: Patient ID No.: Data Storage:
ADU ON 3 3 60 100 90 120 50 1 OFF
3.3.8 Sensitivity The SpO2 reading is the average of data collected within - 42 -
H100B Pulse Oximeter User Manual
a specific time. You can set the Sensitivity to Hi or Low via the menu. The higher the sensitivity is, the quicker the pulse oximeter responds to the changes in the patient’s oxygen saturation level. Contrarily, the lower the sensitivity is, the slower the pulse oximeter responds to the changes in the patient’s oxygen saturation level, but the measurement accuracy will be improved. When a critical patient is monitored, selecting high sensitivity will help to understand the patient’s state.
3.3.9 Alarm System Set Alarm System to ON or OFF to turn on or off the alarm system. If Alarm system is set to OFF, a dialog box pops up as follows:
Figure 3-14 Confirm to Turn off Alarm
If Alarm System is ON and an alarm occurs, the oximeter will give a visual alarm and an audio alarm. Pressing the Alarm Silence button can pause the alarm - 43 -