EDAN H100B User Manual
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EDAN H100B User Manual

Pulse oximeter
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  • Page 2: About This Manual

    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.
  • Page 3 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...
  • Page 4 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.

  • Page 5: Table Of Contents

    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...
  • Page 6 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 SpO Alarm setup........44 3.3.11 PR Alarm setup ........46 3.3.12 Patient ID No.
  • Page 7 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...
  • Page 8 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...

  • Page 9: Safety Information

    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. WARNING Avoid explosion hazard. Do not use the...
  • Page 10 H100B Pulse Oximeter User Manual sensor application errors, and certain patient conditions. 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. Failure to cover the sensor site with opaque material in high ambient light conditions may result in inaccurate measurements.
  • Page 11 H100B Pulse Oximeter User Manual 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.
  • Page 12 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.
  • Page 13 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.
  • Page 14 H100B Pulse Oximeter User Manual 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...

  • Page 15: Cautions

    H100B Pulse Oximeter User Manual batteries and charger stand for H100B pulse oximeter. A potential hazard can exist if different alarm presets are used. This equipment is not intended for family usage. 1.2 Cautions Cautions are identified by the CAUTION symbol shown above.
  • Page 16 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.

  • Page 17: Notes

    H100B Pulse Oximeter User Manual 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: This device has been tested and found to...
  • Page 18 H100B Pulse Oximeter User Manual  The sensor is applied to the patient;  The patient’s SpO , Pulse rate are being reported;  No error conditions exist. Wash the probe with clean water after disinfecting it to remove any remaining solution.

  • Page 19: Symbols In The Oximeter

    H100B Pulse Oximeter User Manual A functional tester cannot be used to assess the accuracy of the pulse oximeter probe or the pulse oximeter monitor. If there is independent demonstration that the particular calibration curve is accurate for the combination of a pulse oximeter monitor and a...
  • Page 20 H100B Pulse Oximeter User Manual 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 Part Number - 12 -...
  • Page 21 H100B Pulse Oximeter User Manual 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.

  • Page 22: Introduction

    ) 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 value, pulse rate value, plethysmogram, bar graph, etc.

  • Page 23: Panel Introduction

    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.

  • Page 24: Symbols On Screen

    H100B Pulse Oximeter User Manual 2.2.1 Symbols on Screen Figure 2-2 Waveform Mode Figure 2-3 Large Numeric Mode Icons on the screen and their meanings: value display area Measured SpO 100% Pulse Rate value display area 60 bpm Measured Pulse rate (bpm)
  • Page 25 H100B Pulse Oximeter User Manual 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.

  • Page 26: Front Panel Buttons

    H100B Pulse Oximeter User Manual Weak signal icon NOTE: 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. The ID icon and the icon that indicates the memory space is full are displayed in the Information Area.
  • Page 27 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.
  • Page 28 H100B Pulse Oximeter User Manual 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.
  • Page 29 H100B Pulse Oximeter User Manual 10-minute SpO 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.

  • Page 30: Rear Panel

    H100B Pulse Oximeter User Manual 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...

  • Page 31: Connecting Sensor Or Cable

    H100B Pulse Oximeter User Manual 2.3 Connecting Sensor or Cable Figure 2-6 Sensor and Cable Connecting Port Sensor and cable port is at the top of the oximeter. An extension cable can be used between the oximeter and the SpO sensor.

  • Page 32: Powered By Battery

    H100B Pulse Oximeter User Manual RSGND The RS232 GND LED+ LED drive signal, IR Anode LED- drive signal, Anode H100 RS232 RX Detector Anode Detector anode Connection Detector connection AGND Analog GND H100 RS232 TX Detector Cathode Detector cathode 2.4 Powered by Battery The oximeter can be powered by four 1.5V LR6 AA...
  • Page 33 H100B Pulse Oximeter User Manual 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.
  • Page 34 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.

  • Page 35: Accessory List

    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...
  • Page 36 H100B Pulse Oximeter User Manual Quantity Items Parts No. in EDAN 1.5V AA alkaline 01.21.064086 batteries (IEC LR6） SH1 Adult Reusable 12.01.109079 Sensor H100B Pulse Oximeter User 01.54.109000 Manual H100B Pulse Oximeter Reference 01.54.109002 Card Carrying case 11.56.110165 Optional configuration including: Parts No.
  • Page 37 H100B Pulse Oximeter User Manual Ni-MH rechargeable 21.21.064164 battery group Battery charger MS8-112410 EDAN SH4 Adult Silicone Soft-tip SpO Sensor (DB9, Only compatible 12.01.110515 with EDAN SpO module and EDAN SpO extension cable) EDAN SH4 Adult Silicone Soft-tip SpO Sensor 02.01.110531...
  • Page 38 H100B Pulse Oximeter User Manual RS232 interface) When selecting SpO sensor, the following should be considered:  Patient weight and activity.  Adequacy of perfusion.  Available sensor sites.  Anticipated duration of monitoring. - 30 -...

  • Page 39: Oximeter Operation

    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. - 31 -...

  • Page 40: Measurement State

    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:...

  • Page 41: Trend Graph And Trend Table

    The oximeter can display SpO , 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...

  • Page 42: Abnormal Measurement State

    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 SpO sensor does not connect to the oximeter, it...

  • Page 43: Data Transfer State

    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.

  • Page 44: System Menu

    H100B Pulse Oximeter User Manual 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...
  • Page 45 H100B Pulse Oximeter User Manual Alarm Setup >>: Storage Setup >>: - 37 -...

  • Page 46: System Mode

    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: The SpO Hi Alarm and SpO Lo Alarm stand for the upper and lower alarm limits of SpO respectively.

  • Page 47: Patient Type

    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.

  • Page 48: Audio Paused (S)

    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.

  • Page 49: Default Config

    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...

  • Page 50: Sensitivity

    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): Hi Alarm: Lo Alarm: PR Hi Alarm: PR Lo Alarm: Patient ID No.:...

  • Page 51: Alarm System

    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,...

  • Page 52: Spo Alarm Setup

    H100B Pulse Oximeter User Manual system for seconds (the pause period can be set to 30, 60, 90 or 120s by the user, see section 3.3.5), the audio alarm off icon displays. But the visual alarm is still active. For example, if the measured SpO...
  • Page 53 H100B Pulse Oximeter User Manual mode are set to 95 and 90 respectively; while they are 100 and 90 in Adu mode respectively. Set the SpO alarm limits as follows:  Choose SpO Hi Alarm in the menu, press the Function button to enter setup.

  • Page 54: Pr Alarm Setup

    H100B Pulse Oximeter User Manual limit of SpO Alarm - 1”. If the value of SpO2 Lo Alarm is set to less than 85, it will restore to 85 after the oximeter is turned on again.  Press the Up Arrow or Down Arrow button to increase or decrease values.

  • Page 55: Patient Id No. Setup

    H100B Pulse Oximeter User Manual PR Alarm is from “1 + the lower limit of PR Alarm” to 300.  Press the Up Arrow or Down Arrow button to increase or decrease values.  Choose PR Lo Alarm in menu, press the Function button enter setup.

  • Page 56: Data Storage

    H100B Pulse Oximeter User Manual After choosing ID, press the Function button to confirm the setup. If the ID exists, the following confirmation dialog box will pop up. Figure 3-15 Confirm to Cover Data 3.3.13 Data Storage Choose Data Storage, and set it to ON, then the measurement data can be stored.

  • Page 57: Delete All Data

    H100B Pulse Oximeter User Manual data. Figure 3-16 Memory Space Full 3.3.14 Delete All Data Delete All Data is used to delete all the stored data. Choose this item by pressing the Function button, a dialog box pops up as follows:...

  • Page 58: Exit (Return)

    H100B Pulse Oximeter User Manual 3.3.15 Exit (Return) Exit menu by pressing Exit in the menu. Return to the previous menu by pressing Return in the menu. 3.4 Charging the Ni-MH Rechargeable Battery Package To charge the Ni-MH rechargeable battery package: 1.

  • Page 59: Patientcare Viewer Data Management Software Introduction

    H100B Pulse Oximeter User Manual machine or the device isn’t placed properly. Orange indicates the device is being charged. Green indicates that the charging is complete. CAUTION When the device is being charged, it can not be operated. PatientCare Viewer...

  • Page 60: Alarm

    H100B Pulse Oximeter User Manual 4 Alarm 4.1 Alarm Categories and Levels Alarm Categories The oximeter’s alarms can be classified into two categories: physiological alarms and technical alarms. 1. Physiological alarms Physiological alarms, also called patient status alarms, are triggered by a monitored parameter value that violates setup alarm limits or an abnormal patient condition.
  • Page 61 H100B Pulse Oximeter User Manual Alarm Levels In terms of severity, the oximeter’s alarms levels can be classified into two categories: high level alarms and medium level alarms. 1. High level alarms Indicate that the patient is in a life threatening situation and an emergency treatment is demanded.

  • Page 62: Alarm Conditions

    H100B Pulse Oximeter User Manual Unconnected Sensor off Low Battery Alarm Indicators When an alarm occurs, the oximeter will indicate it through the following indications: ■ Character flash ■ Alarm tone High level alarms: character flashes quickly and sounds triple + double + triple +double beep;...

  • Page 63: Alarm For Spo2 Sensor Unconnected

    H100B Pulse Oximeter User Manual 4.2.2 Alarm for SpO Sensor Unconnected When the SpO sensor is disconnected, the oximeter gives a medium alarm. The icon displays in information area. and PR value area display “---”, and give a medium alarm. (Make sure the alarm system in menu is ON.)

  • Page 64: Higher Than Hi Alarm Limit

    H100B Pulse Oximeter User Manual gives a medium alarm. (Make sure the alarm system in menu is ON.) 4.2.5 Higher than Hi Alarm Limit If the measured SpO or PR value is higher than the Hi Alarm (upper alarm limit), the oximeter gives a high alarm.

  • Page 65: Alarm Silence

    H100B Pulse Oximeter User Manual measured value is lower than that of SpO Lo Alarm, it will synchronously flash with SpO value. 4.2.7 Alarm Silence If alarm system in menu is ON, pressing the alarm silence button, the audio alarm will be off for the pause period set by the user, but the visual alarm is still active.

  • Page 66: Performance Considerations

    H100B Pulse Oximeter User Manual 5 Performance Considerations 5.1 Performance Verification Qualified service personnel responsible performance verification procedures before the oximeter is used for the first time in a clinical setting. Oximeter Performance Considerations There are some patient conditions that can affect the oximeter’s measurements.

  • Page 67: Sensor Performance Considerations

    H100B Pulse Oximeter User Manual Anemia causes decreased arterial oxygen content. Although SpO readings may appear normal, an anemic patient may be hypoxic. Correcting anemia can improve arterial oxygen content. The oximeter may fail to provide SpO if hemoglobin levels fall below 5 gm/dl.

  • Page 68: Low Perfusion

    H100B Pulse Oximeter User Manual  Placement of the sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line.  Excessive patient activity.  Intravascular dyes, such as indocyanine green or methylene blue.  Externally applied coloring, such as nail polish or pigmented cream.
  • Page 69 H100B Pulse Oximeter User Manual To use the sensor:  Select an appropriate sensor.  Apply the sensor as directed, and observe all warnings and cautions presented in the sensor user manual.  Clean and remove any substances, such as nail polish, from the application site.
  • Page 70 H100B Pulse Oximeter User Manual  Verify that the sensor is properly and securely applied.  Move the sensor to another site.  Use an adhesive to the sensor.  Use a new sensor with fresh adhesive backing.  Keep the patient still, if possible.

  • Page 71: Maintenance

    H100B Pulse Oximeter User Manual 6 Maintenance WARNING Before cleaning the oximeter or the sensor, make sure that the oximeter is switched off. The oximeter does not require calibration. If service is necessary, contact qualified service personnel or your local EDAN representative.
  • Page 72 H100B Pulse Oximeter User Manual  Inspect the devices for mechanical and functional damage  Inspect the relevant labels for legibility All the checks that need to open the oximeter should be performed by qualified customer service technician. The safety and maintenance check can be conducted by personnel from this company.
  • Page 73 H100B Pulse Oximeter User Manual  Use a soft cloth saturated with a solution of 10% chlorine bleach in tap water. Disinfecting Clean the pulse oximeter before disinfecting it. The recommended disinfectants include: ethanol 70%, isopropanol 70%, glutaraldehyde-type liquid disinfectants.

  • Page 74: Principles Of Operation

    H100B Pulse Oximeter User Manual 7 Principles of Operation H100B Pulse Oximeter adopts non-invasive double wavelength to measure SpO and PR. It can perform spot and continuous measurement for a short time. The system consists of Central Processing Unit, Signal...

  • Page 75: Pulse Oximetry Measurement

    H100B Pulse Oximeter User Manual 7.1 Pulse Oximetry Measurement The oximeter uses oximetry to measure functional oxygen saturation in the blood. Pulse oximetry works by applying the sensor to a pulsating arteriolar vascular bed, such as a finger or a toe. The sensor contains a dual light source and a photonic detector.
  • Page 76 H100B Pulse Oximeter User Manual The oximeter determines SpO 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) serve as light sources; a photonic diode serves as the photo detector.

  • Page 77: Functional Versus Fractional Saturation

    H100B Pulse Oximeter User Manual Wavelength The sensor contains LEDs that emit red light at a wavelength of approximately 660 nm and infrared light at a wavelength of approximately 900 nm. Functional Versus Fractional Saturation This oximeter measures functional saturation-oxygenated hemoglobin expressed as a percentage of the hemoglobin that can transport oxygen.

  • Page 78: Measured Versus Calculated Saturation

    H100B Pulse Oximeter User Manual Measured Versus Calculated Saturation When saturation is calculated from a blood gas partial pressure of oxygen (PO ), the calculated value may differ from the SpO measurement of a pulse oximeter. This usually occurs because the calculated saturation...

  • Page 79: Warranty And Service Policy

    If a product covered by this warranty is determined to be defective because of defective materials, components, or workmanship, and the warranty claim is made within the warranty period, EDAN will, at its discretion, repair or - 71 -...

  • Page 80: Service Policy

    H100B Pulse Oximeter User Manual replace the defective part(s) free of charge. EDAN will not provide a substitute product for use when the defective product is being repaired. 8.2 Service Policy All repairs on products must be performed or approved by EDAN.
  • Page 81 & custom charges for product. Contact information: If you have any question about maintenance, technical specifications or malfunctions of devices, contact your local distributor. Alternatively, you can send an email to EDAN service department at: support@edan.com.cn. - 73 -...

  • Page 82: Appendixⅰspecification

    H100B Pulse Oximeter User Manual AppendixⅠSpecification A1.1 Classification Type of Protection Internally powered equipment EMC Compliance Class B Degree of Protection Type BF-Applied part Ingress Protection IPX2 Mode of operation Continuous measuring and spot checking Compliant with Safety UL 60601-1* Standards: CAN/CSA C22.2 No.601.1*...

  • Page 83: A1.2.3 Display

    H100B Pulse Oximeter User Manual + 5 C ~ + 40 C Working -20 C ~ + 55 C Storage Humidity Working 25% ~ 80% (No coagulate) Storage 25% ~ 93% (No coagulate) Atmospheric pressure Working 860 hPa ~ 1060 hPa...

  • Page 84: A1.2.5 Charger Stand

    H100B Pulse Oximeter User Manual Capacity 1500 mAh/1800 mAh Typical battery life 30 hours/36 hours Charge time 2.5 hours to 80% 4 hours to 100% Note: Only the battery of 1500mAh capacity meets the UL requirements. A1.2.5 Charger Stand Input 100 to 240 VAC, 50Hz /60Hz, 0.4A - 0.15A...
  • Page 85 H100B Pulse Oximeter User Manual Pulse Rate Accuracy 25bpm ~300bpm ± 2bpm Resolution 1 bpm - 77 -...

  • Page 86: Appendix Ii Emc Information

    H100B Pulse Oximeter User Manual Appendix II EMC Information -Guidance and Manufacture’s Declaration Refer to the following tables for specific information regarding this device’s compliance IEC/EN 60601-1-2. A2.1 Electromagnetic Emissions - for all EQUIPMENT and SYSTEMS Guidance and manufacturer’s declaration – electromagnetic...
  • Page 87 H100B Pulse Oximeter User Manual nearby electronic equipment. RF emissions The device is suitable Class B CISPR11 for use in all establishments other Harmonic emissions than domestic and those IEC/EN61000-3-2 directly connected to the Voltage fluctuations public low-voltage /flicker emissions...

  • Page 88: A2.2 Electromagnetic Immunity - For All Equipment And Systems

    H100B Pulse Oximeter User Manual A2.2 Electromagnetic Immunity - for all EQUIPMENT and SYSTEMS Guidance and manufacturer’s declaration – electromagnetic immunity The oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of the oximeter should assure that it is used in such an environment.
  • Page 89 H100B Pulse Oximeter User Manual Electrical Fast ±2kV for Mains power Transient/Burst power supply quality IEC/EN61000-4-4 lines should be that ±1kV for of a typical input/output commercial or lines (>3m) hospital environment. Surge line to line IEC/EN61000-4-5 line to ground Voltage dips, short <5%UT(>95...
  • Page 90 H100B Pulse Oximeter User Manual interruptions, it UT)for 5s is recommend that the product be powered from uninterruptible power supply or a battery. Power Power Frequency( 50/60 frequency Hz)Magnetic Field magnetic fields IEC/EN 61000-4-8 should be at levels characteristic of...
  • Page 91 H100B Pulse Oximeter User Manual A2.3 Electromagnetic emissions-for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING Guidance manufacturer’s declaration – electromagnetic immunity The oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of the oximeter should assure that it is used in such an environment.
  • Page 92 H100B Pulse Oximeter User Manual than the recommend separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance   MHz to 800  MHz to 2.5 GHz where p is the - 84 -...
  • Page 93 H100B Pulse Oximeter User Manual maximum output power rating of the transmitter in watts(W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic...
  • Page 94 H100B Pulse Oximeter User Manual frequency range. Interference may occur in the vicinity of equipment marked with the following symbol: NOTE1 At 80MHz and 800MHz, the frequency range applies. NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

  • Page 95: A2.4 Recommended Separation Distances

    H100B Pulse Oximeter User Manual be considered. If the measured field strength in the location in which the oximeter is used exceeds the applicable RF compliance level above, the oximeter should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the oximeter.
  • Page 96 H100B Pulse Oximeter User Manual                      0.01 0.12 0.12 0.23 0.37 0.37 0.74 For transmitters rated at a maximum output power not listed...

  • Page 97: Appendix Ⅲ Record Table

    H100B Pulse Oximeter User Manual Appendix Ⅲ Record Table ID No. Name Time NOTE - 89 -...

  • Page 98: Appendix Ⅳ Abbreviations

    H100B Pulse Oximeter User Manual Appendix Ⅳ Abbreviations Abbr English Full Name/Description CISPR International Special Committee Radio Interference European Economic Community Electromagnetic Compatibility Identification International Electrotechnical Commission Liquid Crystal Display Light Emitting Diode Medical Device Directive Personal Computer Pulse Rate...

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