EDAN H100B User Manual
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EDAN H100B User Manual

EDAN H100B User Manual

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EDAN Agile PLM Electronic Signature Information
--Signatures related to this document and performed in EDAN Agile PLM.
文件名称(Document Name)：H100B H100N 说明书_英文
文件编号(Number)：21.54.109000
版本(Version)：3.0
产品型号(Product Model)：H100A;H100B;H100N
项目编码(Project Code)：2075I000
签批信息(Signature):
作者(Originator) : 洪 珊艳 (hongshanyan)
审核人(Reviewers) : 程 亮 (chengliang)
审核人(Reviewers) : 夏 欢欢 (xiahuanhuan)
审核人(Reviewers) : 刘 烜辰 (liuxuanchen)
审核人(Reviewers) : 陈 浩杰 (chenhaojie)
审核人(Reviewers) : 陈 勇强 (chenyongqiang)
审核人(Reviewers) : 黄 志林 (huangzhilin)
审核人(Reviewers) : 潘 晟 (pansheng)
审核人(Reviewers) : 林 川露 (linchuanlu)
批准人(Approvers) : 柏 黎 (baili)
批准人(Approvers) : 唐 奇 (tangqi)
版权©深圳市理邦精密仪器股份有限公司 (Copyright©Edan Instrument,Inc.)
2022-12-02 17:47:24
2022-12-04 16:01:33
2022-12-05 14:18:37
2022-12-05 11:41:14
2022-12-06 17:33:02
2022-12-03 17:29:10
2022-12-05 19:05:14
2022-12-05 14:39:53
2022-12-06 15:48:28
2022-12-07 12:22:01
2022-12-07 10:35:16

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Summary of Contents for EDAN H100B

  • Page 1 EDAN Agile PLM Electronic Signature Information --Signatures related to this document and performed in EDAN Agile PLM. 文件名称(Document Name)：H100B H100N 说明书_英文 文件编号(Number)：21.54.109000 版本(Version)：3.0 产品型号(Product Model)：H100A;H100B;H100N 项目编码(Project Code)：2075I000 签批信息(Signature): 作者(Originator) : 洪 珊艳 (hongshanyan) 2022-12-02 17:47:24 审核人(Reviewers) : 程 亮 (chengliang) 2022-12-04 16:01:33 审核人(Reviewers) : 夏...

  • Page 3: About This Manual

    EDAN INSTRUMENTS, INC. (hereinafter called EDAN) cannot 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.

  • Page 4: Responsibility Of The Manufacturer

    EDAN. EDAN holds the rights to modify, update, and ultimately explain this manual. Responsibility of the Manufacturer EDAN only considers itself responsible for any...

  • Page 5: Terms Used In This Manual

    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.

  • Page 6: Table Of Contents

    Table of Contents 1 Safety Information ..........1 1.1 Warnings ............1 1.2 Cautions ............16 1.2.1 Personal Information Safety ..... 18 1.3 Notes ............... 22 1.4 Symbols in the Oximeter .........26 2 Introduction ............31 2.1 General Introduction ........31 2.2 Panel Introduction ...........
  • Page 7 3.3.2 Trend Graph and Trend Table ....58 3.3.3 Abnormal Measurement State ....59 3.3.4 Data Transfer State ........60 3.4 System Menu ..........61 3.4.1 System Mode ........... 64 3.4.2 Patient Type ..........64 3.4.3 Prompt Volume .........64 3.4.4 Pulse Volume ..........65 3.4.5 Audio Paused (s) ........
  • Page 8 Introduction ............79 4 Prompt Function ...........82 4.1 Prompt Categories and Levels ......82 4.2 Prompt Conditions .......... 85 4.2.1 Prompt for SpO Sensor Unconnected ..86 4.2.2 Prompt for SpO Sensor off ..... 86 4.2.3 Prompt for Abnormal State of Temp Sensor86 4.2.4 Prompt for Low Battery ......87 4.2.5 Higher than High Limit ......87 4.2.6 Lower than Low Limit .......
  • Page 9 7.2 Measured Versus Calculated Saturation ..118 8 Warranty and Service .........119 8.1 Warranty ............119 8.2 Contact Information ........120 Appendix I Specification ........121 A1.1 Classification ..........121 A1.2 Specification ..........122 A1.2.1 Size and Weight ........122 A1.2.2 Environment ......... 122 A1.2.3 Display ..........123 A1.2.4 Batteries ..........

  • Page 10: Safety Information

    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 Pulse Oximeter (hereinafter called oximeter) in the presence of flammable anesthetic mixtures with air, or with oxygen or nitrous...
  • Page 11 Pulse Oximeter User Manual WARNING Oximetry measurements and pulse signals can be affected by certain environmental conditions, sensor application errors, and certain patient conditions. The use of accessories, sensors, and cables other than those specified may result in increased emission electromagnetic radiation and/or invalid readings of the oximeter.
  • Page 12 Pulse Oximeter User Manual WARNING The oximeter is not defibrillator-proof. The measurements 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. Disconnect the oximeter and sensor from the patient throughout magnetic resonance imaging (MRI) scanning.
  • Page 13 Pulse Oximeter User Manual WARNING 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.
  • Page 14 Failure of doing so could result in an inaudible prompt tone. Use only EDAN permitted sensors and extension cables with the oximeter. Other sensors or extension cables may fail and/or cause...
  • Page 15 POST pass tone, it indicates the prompt function does not work well. Please do not use the oximeter and contact qualified service personnel or your local EDAN representative. Do not use the oximeter if the POST has not been finished successfully. - 6 -...
  • Page 16 Pulse Oximeter User Manual WARNING Before using it, the user should carefully read the applicable user manual of sensor, including warnings, cautions instructions. Before cleaning the oximeter or the sensor, make sure that the equipment is switched off and disconnected from the power line. A potential hazard can exist if different prompt presets are used for the same or similar equipment in any single area, e.g.
  • Page 17 Pulse Oximeter User Manual WARNING 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. Do not service or maintain the oximeter or any accessory which is in use with the patient.
  • Page 18 Pulse Oximeter User Manual WARNING The medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC Information provided in this user manual. Portable and mobile RF communications equipment can affect medical electrical equipment;...
  • Page 19 Pulse Oximeter User Manual WARNING The oximeter should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, you must check that normal operation possible in the necessary configuration before you start measuring patients. Only recommended rechargeable batteries and charger stand can be used for oximeter.
  • Page 20 Pulse Oximeter User Manual WARNING Verification of the temperature module is necessary as frequently as dictated by your Hospital Procedures Policy. When you need to calibrate the temperature measurement, please contact the manufacturer. 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.
  • Page 21 Pulse Oximeter User Manual WARNING Without use of data store function, the data previously measured will be cleared when the oximeter is powered off. With use of data store function, 300-hour SpO &PR data can be stored and transmitted to the computer.
  • Page 22 Pulse Oximeter User Manual WARNING Before using the device, the equipment, patient cable and sensors etc. should be checked. Replacement shall be taken if there is any evident defect or signs of aging which impair safety performance. No modification of this equipment is allowed without authorization of the manufacturer.
  • Page 23 Pulse Oximeter User Manual WARNING Correct and proper sensor application: if the sensor is too loose, it might compromise the optical alignment, and even cause the sensor to fall off. If the sensor is too tight, (such as the application site is too large or becomes large edema),...
  • Page 24 Otherwise, degradation of the performance of this equipment could result. EDAN rechargeable battery lifetime is 500 charge/discharge cycles if the battery is appropriately used and maintained. The service life of the battery depends on the service frequency and time.

  • Page 25: Cautions

    Pulse Oximeter User Manual 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. CAUTION All combinations of equipment must be in compliance with IEC/EN Standard 60601-1 systems requirements.
  • Page 26 Pulse Oximeter User Manual CAUTION Do not run the oximeter when alkaline batteries of different types are used at the same time. Federal (U.S.) Law restricts this device to sale by or on the order of a physician. The device and accessories are to be disposed of according to local regulations after their useful lives.

  • Page 27: Personal Information Safety

    To protect the personal information and ensure the proper device performance, the user should take necessary precautions in accordance with local laws and regulations institution’s policies. EDAN recommends health care organizations or medical institutions to implement a comprehensive and - 18 -...
  • Page 28 Pulse Oximeter User Manual multifaceted strategy to protect the information and systems from internal and external security threats. To ensure the patients’ safety and protect their personal health information, the user should implement practices or measures that include: 1. Physical safeguards - physical safety measures to ensure that unauthorized personnel do not have access to the oximeter.
  • Page 29 (other than removable media) are physically secure. Ensure that the oximeter is connected only to the device authorized/approved by EDAN. Users should operate all EDAN deployed and supported oximeters within EDAN authorized specifications, including EDAN approved software, software configuration, security configuration, etc.
  • Page 30 Pulse Oximeter User Manual CAUTION Protect passwords prevent unauthorized changes. Only manufacturer’s service personnel allowed to modify the Factory Maintain settings. When oximeter returned maintenance, disposed of, or removed from the medical institution for other reasons, it is necessary to ensure that all patient data are removed from the oximeter .

  • Page 31: Notes

    Pulse Oximeter User Manual 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 comply with the limits for medical device in IEC/EN60601-1-2 (International standard for testing Medical...
  • Page 32 Pulse Oximeter User Manual 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.
  • Page 33 Pulse Oximeter User Manual particular accuracy. operating time Ni-MH rechargeable battery package depends on the configuration and operation of the pulse oximeter. Sensor LED light emissions fall within Class 1 level, according to IEC 60825-1. No special safety precautions are required. If there is independent demonstration that the particular calibration curve is accurate for the combination of a pulse oximeter and...
  • Page 34 Pulse Oximeter User Manual same as the temperature of the measuring site. Ensure the volume is properly set up. When the sound pressure of audible prompt is below or equivalent to the ambient noise, it difficult operator distinguish the audio prompt. Ensure that the environment in which the oximeter is used is not subject to any sources...

  • Page 35: Symbols In The Oximeter

    Pulse Oximeter User Manual 1.4 Symbols in the Oximeter TYPE BF APPLIED PART Caution Warning (Background: yellow; Symbol and outline: black) Operating instructions Part Number Refer instruction manual/booklet (Background: blue; Symbol: white) - 26 -...
  • Page 36 Pulse Oximeter User Manual Serial Number CE marking AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY Date of manufacture Manufacturer - 27 -...
  • Page 37 Pulse Oximeter User Manual The products marked with this symbol apply to the European WEEE directive. This symbol Indicates this equipment contains electrical electronic components that must not be disposed of as unsorted municipal waste, collected separately. Contact authorized representative manufacturer information decommissioning of your...
  • Page 38 Protected against solid foreign objects of 12.5 mm Ø and greater; Protected against vertically falling water drops when enclosure tilted up to 15°) Conforms Std. 60601-1 Certified to CSA Std. C22.2 No 601.1 (H100B) No alarm system - 29 -...
  • Page 39 Pulse Oximeter User Manual This way up Fragile, handle with care Keep dry Use-by date Medical Device Unique Device Identifier NOTE: The user manual is printed in black and white. - 30 -...

  • Page 40: Introduction

    Pulse Oximeter User Manual 2 Introduction Intended Use/Indications for Use The H100B Pulse oximeter is intended for spot-checking functional arterial oxygen saturation (SpO ) and pulse rate of single adult, pediatric neonate patient hospitals, intra-hospital transport and hospital type facilities.
  • Page 41 Pulse Oximeter User Manual plethysmogram, bar graph, temperature (only for H100N), etc. H100B is installed with EDAN SpO module inside. H100N is installed with Nellcor SpO module and the manufacturer’s TEMP module inside. They both integrate parameter module, display and data output functions.

  • Page 42: Panel Introduction

    2.2 Panel Introduction This section identifies the symbols, controls, displays, and buttons on the front panel of the oximeter and the rear panel. 2.2.1 Symbols on Screen Figure 2-2 Waveform Mode Figure 2-3 H100B&H100N Large Numeric Mode - 33 -...
  • Page 43 Pulse Oximeter User Manual Icons on the screen and their meanings: value display area 100% Measured SpO Pulse Rate value display area 60 bpm Measured Pulse rate (bpm) TEMP Temperature value display area Displays when measurement value is higher than the upper limit Displays when measurement value is lower than the lower limit waveform display...
  • Page 44 Pulse Oximeter User Manual Data storage icon 04: 59 Time display in Information area: “hour: minute” Adu, Ped, Patient type in Information area: Adult, Pediatric or Neonate. ID: 99 Patient ID in Information area sensor unconnected icon sensor off Indicates the memory space is full Weak signal icon NOTE: The icons for sensor unconnected, sensor...

  • Page 45: Front Panel Buttons

    Pulse Oximeter User Manual 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 prompt silence button to control the audio prompt.
  • Page 46 Pulse Oximeter User Manual 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 or off the backlight. Prompt Silence Button Prompts that occur during the Power-On-Self-Test (POST) cannot be silenced.
  • Page 47 Pulse Oximeter User Manual parameter increase by more than one. Press and hold this button for more than one second to repeat the increment continuously. When Trend Review is set to ON, press this button to enter the latest 10-minute SpO or PR trend graph.

  • Page 48: Rear Panel

    Pulse Oximeter User Manual 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, the oximeter will enter data transfer state.

  • Page 49: Connecting Sensor Or Cable

    An extension cable can be used between the oximeter and the SpO 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.
  • Page 50 Pulse Oximeter User Manual SIO definition: H100B Name Description RSGND The RS232 GND LED+ drive signal, Anode LED- LED drive signal, Red Anode H100 RS232 RX Detector Anode Detector anode Connection Detector connection AGND Analog GND H100 RS232 TX Detector...

  • Page 51: Powered By Battery

    Pulse Oximeter User Manual Memory Return communication signal return signal return Detector Anode Detector anode connection Inner Shield Detector shield to GND Outer Shield Outer cable shield to RXD / Sensor UART /DigiCAL Memory Data communication signal Detector Detector cathode Cathode connection 2.4 Powered by Battery...
  • Page 52 Pulse Oximeter User Manual Press the battery compartment latch and 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 53 Pulse Oximeter User Manual oriented as ②. 4. Install the battery compartment cover. WARNING In order to avoid safety hazards, do not disassemble the battery pack or use battery pack with signs of wear, otherwise it may lead to a fire. Checking the Ni-MH Rechargeable Battery Package The performance of a Ni-MH rechargeable battery...
  • Page 54 Pulse Oximeter User Manual below: 1. Disconnect the oximeter from the patient and stop all measuring procedures. 2. Place the oximeter in the charger stand and connect the AC mains. Allow the battery to be charged uninterruptedly for above hours. details about charging the Ni-MH rechargeable battery...

  • Page 55: Accessory List

    Pulse Oximeter User Manual Battery Low Figure 2-7 Low Battery Icon 2.5 Accessory List Standard configuration including: Items H100B Pulse Oximeter Main Unit 02.06.109006 H100N Pulse Oximeter 02.06.110185 1.5V AA alkaline batteries (IEC LR6) 01.21.064086 SH1 Adult Reusable SpO Sensor 02.01.210120...
  • Page 56 Pulse Oximeter User Manual Items EDAN SH3 Neonate Wrap Sensor 02.01.210673 (reusable) (H100B) EDAN SH4 Adult Silicone Soft-tip Sensor (DB9, Only compatible 02.01.210122 with EDAN SpO module and EDAN extension cable) (H100B) Nellcor Reusable Adult/Neonate Sensor (OXI-A/N OxiMax) 01.15.40096 (Weak Perfusion Resistance) Connection Cable, SHEC4 01.13.110504...
  • Page 57 Pulse Oximeter User Manual Items Charger Stand, US, with battery, 83.60.113589 CS01 Charger Stand, US, without battery, 83.60.261430 CS01 Rechargeble Ni-MH Battery, 21.21.064164 4×NR49AA1500P 4.8V MAX-FAST, Adult/Pediatric, RoHS, 01.57.040436 OxiMax OXI-P/I, Pediatric/Infant, RoHS, 01.57.040437 OxiMax D-YS, Multisite, RoHS, OxiMax 01.57.040438 MAX-A/MAX-AL, Adult, RoHS,...
  • Page 58 Pulse Oximeter User Manual When selecting SpO sensor, the following should be considered:  Patient weight and activity.  Adequacy of perfusion.  Available sensor sites.  Anticipated duration of measuring. - 49 -...

  • Page 59: 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. - 50 -...
  • Page 60 If the POST is successfully finished, the oximeter sounds a tone and enters the waveform interface. If there is an error during the POST, the following error codes will display on the screen: H100B Error code Indication Battery Low Indicates error for low battery Error 02...

  • Page 61: Measurement Procedure

    Pulse Oximeter User Manual 3.2 Measurement Procedure 3.2.1 SpO Measurement Procedure Select correct patient category setting (adult/pediatric and neonatal), as this is used to optimize the calculation of the SpO and pulse numerics. During measurement, ensure that the application site: –...
  • Page 62 Pulse Oximeter User Manual that covers the optical elements.  Any sensor showing signs of damage or alteration must not be used for further patient measuring; instead, dispose of it using proper disposal procedures. Applying Finger/Soft-tip Sensors:  Nip the clamp, and choose a site that is well perfused and restricts a conscious patient’s movements least.
  • Page 63 Pulse Oximeter User Manual Applying Neonatal Finger (or Toe) Wrap Sensors:  When you perform the measurement, position the sensor over the hand or foot with optical components opposite each other.  Hold the sensor, and insert stretched strap into slot, hold it there while threading end through latch.
  • Page 64 Pulse Oximeter User Manual WARNING Inspect the application site every two to three hours to ensure skin quality and correct optical alignment. If the skin quality changes, move the sensor to another site. Change the application site at least every four hours.

  • Page 65: Temp Measurement Procedure

    Pulse Oximeter User Manual frequency checking skin changing the measurement site to prevent burns. If the initial skin temperature is less than 35°C, the temperature of all the listed sensors on the skin will not exceed 41°C during working. When a trend toward patient deoxygenation is indicated, analyze the blood samples with a laboratory co-oximeter to completely understand the patient’s condition.

  • Page 66: Measurement State

    3.3 Measurement State 3.3.1 Measurement Modes There are two measurement modes which are waveform mode and large numeric mode. By default, H100B configuration is waveform mode and H100N configuration is large numeric mode. Waveform Mode In the normal measurement state, oximeter can...

  • Page 67: Trend Graph And Trend Table

    , oxygen saturation unit (%), PR, pulse rate unit (bpm), TEMP and temperature unit (℃) in large numeric mode. Figure 3-4 H100B&H100N Large Numeric Mode 3.3.2 Trend Graph and Trend Table When Trend Review is set to ON, press the Up...

  • Page 68: Abnormal Measurement State

    Pulse Oximeter User Manual Figure 3-5 Display SpO and PR Trend Graph Trend table: Figure 3-6 Display SpO and PR Trend Table 3.3.3 Abnormal Measurement State If the SpO sensor does not connect to the oximeter, it will give a medium prompt, and display the information area.

  • Page 69: Data Transfer State

    Pulse Oximeter User Manual information area. If the Temp sensor is abnormal, it will give a low prompt, and display --- in TEMP parameter area. In menu state or trend state, if there is no operation for 30 seconds, the oximeter will return to measurement state.

  • Page 70: System Menu

    Pulse Oximeter User Manual between the oximeter and the Oximeter Viewer Data 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 3.4 System Menu Press the Function button to see the following main menu of the oximeter, select items by...
  • Page 71 Pulse Oximeter User Manual System Setup >>: Prompt Volume Pulse Volume Prompt Setup >>: Prompt Function High Limit Low Limit PR High Limit PR Low Limit Temp High Limit Temp Low Limit - 62 -...
  • Page 72 Pulse Oximeter User Manual Storage Setup >>: Figure 3-8 Menus The menus are shown above and the details for each item will be introduced in the following sections. NOTE: High Limit and SpO Low Limit stand for the upper and lower prompt limits of respectively.

  • Page 73: System Mode

    Pulse Oximeter User Manual type. 3.4.1 System Mode There are two items for selecting: Waveform mode Large numeric mode Then confirm the selection by pressing the Function button. 3.4.2 Patient Type Patient Type can be set to different measurement modes. Set Patient Type to Adu, Ped, or Neo, and confirm it by pressing the Function button.

  • Page 74: Pulse Volume

    Pulse Oximeter User Manual prompt, a medium prompt or a high prompt occurs, the oximeter sounds beep. 3.4.4 Pulse Volume The user can turn on or off the pulse volume by pressing 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 75 Pulse Oximeter User Manual Figure 3-9 Enter Password If the password is wrong, the following dialog box will pop up: 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.

  • Page 76: Default Config

    If the system time cannot be saved and resumes the default value after restart, contact the service department of EDAN to replace the button cell in main board. 3.4.7 Default Config Choose this item to resume factory default configuration.

  • Page 77: Sensitivity

    Pulse Oximeter User Manual Factory Default Configuration is shown as follows: System Mode: (H100B) (H100N) Patient Type: Prompt Function: Prompt Volume: Pulse Volume: Audio Paused (s): High Limit: Low Limit: PR High Limit: PR Low Limit: Temp High Limit: Temp Low Limit: Patient ID No.:...

  • Page 78: Prompt Function

    Pulse Oximeter User Manual 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.

  • Page 79: Spo Prompt Limit Setup

    Pulse Oximeter User Manual prompt function for seconds (the pause period can be set to 30, 60, 90 or 120s by the user, see section 3.4.5), the audio prompt off icon displays. But the visual prompt is still active. For example, if the value is higher than SpO High measured SpO...
  • Page 80 Pulse Oximeter User Manual they are 100 and 90 in Adu mode respectively. Set the SpO prompt limits as follows:  Choose SpO High Limit in the menu, press the Function button to enter setup. The SpO High Limit box will change from real line box to broken line box.

  • Page 81: Pr Prompt Limit Setup

    Pulse Oximeter User Manual turned on again.  Press the Up Arrow or Down Arrow button to increase or decrease values.  SpO High Limit is always higher than Low Limit by at least 1%.  Press the Function button, confirm the prompt range setup.

  • Page 82: Temp Prompt Limit Setup

    Pulse Oximeter User Manual  Choose PR High Limit in the menu, press the Function button to enter setup. The PR High Limit box changes from real line to broken line. The adjustable range of the upper limit of PR is from “1 + the lower limit of PR”...
  • Page 83 Pulse Oximeter User Manual limits. By default, the Temp High Limit and Temp Low Limit are set to 39.0 ℃ and 36.0 ℃respectively in both Neo and Adu modes. Set the Temp limits as follows:  Choose Temp High Limit in the menu, press the Function button to enter setup.

  • Page 84: Patient Id No. Setup

    Pulse Oximeter User Manual 3.4.13 Patient ID No. Setup The oximeter can support 100 patient IDs, and 300-hour data storage. When entering menu, press the Function button to set ID (valid range is from 1 to 100). The ID display box on the interface will change from real line to broken line.

  • Page 85: Delete All Data

    Pulse Oximeter User Manual Software. Please refer to section 3.3.4 for Data transfer procedure. When the memory space is full, an icon will be displayed in information area. Meanwhile Data Storage changes to OFF automatically. Restart the oximeter and a dialog box pops up. The user should confirm it to delete all the data.

  • Page 86: Exit (Return)

    Pulse Oximeter User Manual deleting progress shows: Figure 3-18 All Data Deleting 3.4.16 Exit (Return) Exit menu by pressing Exit in the menu. Return to the previous menu by pressing Return in the menu. 3.5 Charging the Ni-MH Rechargeable Battery Package The charger stand is intended to be used for charging the Ni-MH rechargeable battery package.
  • Page 87 Pulse Oximeter User Manual A tricolor LED display indicates the charging state. Red indicates no rechargeable battery package in the 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 cannot be operated.

  • Page 88: Oximeter Viewer Data Management Software

    Pulse Oximeter User Manual Oximeter Viewer Data Management Software Introduction Connect the oximeter to PC through the cable before running the PatientCare Viewer Data Management Software This Software implements the following functions: 1. Query or save the oximeter’s data based on the patient ID.
  • Page 89 Pulse Oximeter User Manual Figure 3-19 Main Interface Figure 3-20 Trend Graph - 80 -...
  • Page 90 Pulse Oximeter User Manual Figure 3-21 Print Preview - 81 -...

  • Page 91: Prompt Function

    Pulse Oximeter User Manual 4 Prompt Function 4.1 Prompt Categories and Levels Prompt Categories The oximeter’s prompts can be classified into two categories: physiological prompts and technical prompts. 1. Physiological prompts Physiological prompts, also called patient status prompts, are triggered by a monitored parameter value that violates setup prompt limits or an abnormal patient condition.
  • Page 92 Pulse Oximeter User Manual Prompt Levels In terms of severity, the oximeter’s prompts levels can be classified into two categories: high level prompts and medium level prompts. 1. High level prompts Indicate that the patient is in a life threatening situation and an emergency treatment is demanded.
  • Page 93 Pulse Oximeter User Manual Prompt Categories Table Physiological Prompt level prompts Too High High Too Low High PR Too High High PR Too Low High Temp Too High Medium Temp Too Low Medium Technical Prompt Action Taken prompts level Sensor Medium No SpO sensor was...

  • Page 94: Prompt Conditions

    Pulse Oximeter User Manual Temp Sensor Make sure that Abnormal cable properly connected. Prompt Indicators When a prompt occurs, the oximeter will indicate it through the following indications: ■ Character flash ■ prompt tone High level prompts: character flashes quickly and sounds triple + double + triple +double beep;...

  • Page 95: Prompt For Spo Sensor Unconnected

    Pulse Oximeter User Manual 4.2.1 Prompt for SpO Sensor Unconnected When the SpO sensor is disconnected, the oximeter gives a medium prompt. The icon displays in information area. and PR value area display “---”, and give a medium prompt. (Make sure the Prompt Function in menu is ON.) 4.2.2 Prompt for SpO Sensor off...

  • Page 96: Prompt For Low Battery

    Pulse Oximeter User Manual give a low prompt. 4.2.4 Prompt for Low Battery When the battery is too low, the oximeter gives a medium prompt for low battery. After the low battery prompt occurs, the oximeter can still be operated for a few minutes before it turns off automatically.

  • Page 97: Lower Than Low Limit

    Pulse Oximeter User Manual 4.2.6 Lower than Low Limit If the measured SpO or PR value is lower than the Low Limit (lower prompt limit), the oximeter gives a high prompt for SpO , PR, and gives a medium prompt for TEMP. Here we take SpO for example: If the measured SpO...

  • Page 98: Turning Off Prompt Function

    Pulse Oximeter User Manual function. 4.2.8 Turning off Prompt Function After the Prompt Function is turned off, the oximeter cannot give a visual or an audio prompt except for low battery icon. Set Prompt Function to ON, the prompt function will be active.

  • Page 99: Testing Prompts

    Pulse Oximeter User Manual represented by the displayed numerical values. This delay depends on the algorithmic processing time and the sensitivity setting. The lower the sensitivity configured, the longer the time needed until the numerical values reflect the physiological event. The time between the displayed numerical values exceeding an prompt limit and the prompt indication on the oximeter.

  • Page 100: Performance Considerations

    Pulse Oximeter User Manual 5 Performance Considerations 5.1 Performance Verification Qualified service personnel are responsible for performance verification procedures before the oximeter is used for the first time in a clinical setting. 5.2 Oximeter Performance Considerations There are some patient conditions that can affect the oximeter’s measurements.
  • Page 101  Saturation The oximeter displays saturation level between 1% and 100%.  Pulse rate H100B: The oximeter displays pulse rate between 25 and 300 beats per minute (bpm). The sensor accuracy ranges do not apply to pulse rates above 300 bpm.
  • Page 102 Pulse Oximeter User Manual 10 seconds in extreme conditions. Certain patient conditions affect measurements or cause the loss of the pulse signal. Inaccurate measurements can be caused but not limited by:  Incorrect application of the sensor.  High levels of ambient light sources, such as surgical lights (especially those with a xenon light...
  • Page 103 Pulse Oximeter User Manual  Low peripheral perfusion.  Defibrillation.  Electromagnetic interference. Loss-of-pulse signal occurs for the following reasons:  The sensor is applied too tightly.  A blood pressure cuff is inflated on the same extremity as the one with the sensor attached.
  • Page 104 Pulse Oximeter User Manual sensor site with opaque material. If interference due to patient activity presents a problem, try one or more of the following to correct the problem:  Verify that the sensor is properly and securely applied.  Move the sensor to a less active site. ...

  • Page 105: Assessing The Validity Of A Spo 2 Reading

    5.3 SpO Functional Test This test checks the function of the SpO measurement. Tools required: SpO simulator (Provided with a calibration curve approved by EDAN). Procedure: Connect the oximeter and the SpO simulator with a SpO cable. Switch on the oximeter and the simulator.
  • Page 106 Pulse Oximeter User Manual indications simultaneously to assess the validity of a SpO reading. Generally, the quality of the SpO pleth wave reflects the quality of the light signals obtained by the sensor. A wave of poor quality manifests a decline of the signal validity.
  • Page 107 Pulse Oximeter User Manual accuracy compared CO-oximeter measurements. The volunteer population in the studies composed of healthy men and women from age 18 to 50, with various skin pigmentations. Note that study population was healthy adults and not in the actual intended use population.

  • Page 108: Maintenance

    The oximeter does not require calibration. If service is necessary, contact qualified service personnel or your local EDAN representative. Before using the oximeter, do the following: ■ Check if there is any mechanical damage;...
  • Page 109 WARNING The maintenance operations like software upgrade device only completed EDAN-qualified service professionals. Any serious incident that has occurred in relation to the device should be reported to manufacturer competent authority of the Member State in which the user and/or patient is established.
  • Page 110 Warranty does not cover damage caused by using unapproved substances or methods. EDAN Instruments has validated the cleaning and disinfection instructions included in this User Manual. It is the responsibility of the healthcare professional to ensure that the instructions are followed so as to ensure adequate cleaning and disinfection.
  • Page 111 Pulse Oximeter User Manual devices. Signs of wear, e.g., cracks, deformation, discoloration, peeling, occur with reprocessed products. ► Check the products for signs of wear and replace them if necessary. Keep your oximeter and accessories free of dust and dirt. To prevent the device from damage, please follow the procedure: Use only recommended cleaning substances ...
  • Page 112 Pulse Oximeter User Manual CAUTION If you spill liquid on the device, or accessories, or they are accidentally immersed in liquid, contact your service personnel or EDAN service engineer. NOTE: Automated cleaning/disinfection to the device is prohibited. Cleaning If the device or accessory has been in contact with the patient, then cleaning and disinfection is required after every use.
  • Page 113 Pulse Oximeter User Manual non-abrasive cloth or paper towel each time. Refer to the cleaning agent manufacturer's instruction for use with reference to concentration, temperature and contact time. Cleaning the Oximeter: WARNING Before cleaning the oximeter or the sensor, make sure that the oximeter is switched off and batteries are taken out.
  • Page 114 Pulse Oximeter User Manual remain. After cleaning, wipe off the cleaning solution with a fresh cloth or towel dampened with tap water until no visible cleaning agent remains. Dry the oximeter in a ventilated and cool place. If the oximeter is not visually clean after cleaning, please repeat the cleaning steps through step 3 to step 6.
  • Page 115 Pulse Oximeter User Manual until no visible cleaning agent remains. Wipe off residual moisture with a dry cloth. Leave the sensor to air dry. If the SpO sensors, including cables, are not visually clean after cleaning, please repeat the cleaning steps through step 3 to step 7. Inspect the SpO sensors, including cables, to ensure that there is no damage.
  • Page 116 Pulse Oximeter User Manual step 3 to step 6. Inspect the TEMP sensors to ensure that there is no damage. Disinfection For devices or accessories that have been in contact mucosal surface, High Level disinfection must occur, for all other accessories, low level disinfection is appropriate.
  • Page 117 Pulse Oximeter User Manual CAUTION Do not use any disinfectant containing additional active ingredients other than those listed, such as disinfectant didecyl dimethyl ammonium bromide which contains quanternary ammonium salt. Although the oximeter chemically resistant most common hospital cleaners, disinfectants and non-caustic detergents, unvalidated cleaners or disinfectants are not recommended and may stain the oximeter, such as disinfectant didecyl...
  • Page 118 Pulse Oximeter User Manual WARNING The oximeter and reusable accessories shall be disinfected to avoid patient cross infection. Disinfecting the Oximeter: WARNING Before disinfecting the oximeter, make sure that the oximeter is switched off and batteries are taken out. To disinfect the oximeter, follow these steps: Switch off the oximeter and take out the batteries.
  • Page 119 Pulse Oximeter User Manual disinfectant solution to wipe the entire exterior surface of the equipment. Follow the disinfectant manufacture’s recommended contact time and mode. After disinfection, wipe off the disinfecting agent with a new sterile cloth dampened with sterile water. Dry the oximeter for at least 30 minutes in a ventilated and cool place.
  • Page 120 Pulse Oximeter User Manual cloth after disinfection. Leave the sensor to air dry for at least 30 minutes. Inspect the SpO sensors, including cables, to ensure that there is no damage. Disinfecting the TEMP Sensor: intracavitary TEMP sensors should reprocessed by high-level disinfection before and after use on each new patient.
  • Page 121 Pulse Oximeter User Manual isopropanol). Wipe off the disinfectant solution with a dry cloth after disinfection. Leave the sensor to air dry. Inspect the TEMP sensors to ensure that there is no damage. WARNING Sterilization cause damage equipment and is therefore not recommended this pulse oximeter...
  • Page 122 Pulse Oximeter User Manual After Reprocessing After reprocessing, the equipment, cables,  sensors and other accessories should be checked to ensure there are no signs of aging, wear, cracks, deformation, discoloration or peeling, etc. Replacement should be taken or contact service personal manufacturer if necessary.
  • Page 123 Pulse Oximeter User Manual included in the accompanying documents must be observed. The replacement of accessories, such as cables, sensors etc., should be taken according to actual usage. It is recommended to replace accessories once a year. Please refer to installation methods in relevant chapters for replacement.

  • Page 124: Principles Of Operation

    Pulse Oximeter User Manual 7 Principles of Operation H100 Series Oximeters adopt non-invasive double wavelength to measure SpO and PR. They can perform spot measurement. H100N can also measure TEMP by a thermistor probe (a semiconductor whose resistance changes with temperature). The system consists of Central Processing Unit, Signal Collection, Signal Input, Data Output, Display and User Input module, shown as follows:...

  • Page 125: Pulse Oximetry Measurement

    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 126 Pulse Oximeter User Manual changes during pulse (plethysmography). 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 127: Measured Versus Calculated Saturation

    Pulse Oximeter User Manual venous blood. This oximeter measures functional saturation-oxygenated hemoglobin expressed as a percentage of the hemoglobin that can transport oxygen. It does not detect significant amounts of dysfunctional hemoglobin, such carboxyhemoglobin or methemoglobin. Measured Versus Calculated Saturation When saturation is calculated from a blood gas partial pressure of oxygen (PO ), the calculated...

  • Page 128: Warranty And Service

    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 replace the defective - 119 -...

  • Page 129: Contact Information

    Pulse Oximeter User Manual part(s) free of charge. EDAN will not provide a substitute product for use when the defective product is being repaired. 8.2 Contact Information If you have any question about maintenance, technical specifications or malfunctions of devices, contact your local distributor.

  • Page 130: Appendix I Specification

    A1.1 Classification Type of Protection Internally powered equipment Degree of Type BF-Applied part Protection Ingress Protection IP22 (H100B/H100N) Mode of operation Continuous Degree of Safety Not suitable for use in in Presence of presence of flammable gases Flammable Gases Compliant with...

  • Page 131: A1.2 Specification

    A1.2.1 Size and Weight Size 160 mm(L) × 70 mm(W) × 37.6 mm(H) Weight 165 g (without battery) (H100B) Weight 185 g (without battery) (H100N) A1.2.2 Environment Temperature 0 C ~ + 40 C (32 ℉~104 ℉)

  • Page 132: A1.2.3 Display

    Pulse Oximeter User Manual A1.2.3 Display Screen 128×64 dot-matrix LCD, with white Type LED backlight Large , PR, TEMP and Bar graph Numeric displayed Mode Waveform , PR, Bar graph and Mode Plethysmogram displayed A1.2.4 Batteries Battery status symbols on screen Battery power level symbol Level 1...
  • Page 133 Pulse Oximeter User Manual voltage Capacity 2600 mAh Typical operation 48 h or longer (At 25  C, time with fully charged batteries, measurement use, backlight set to off, pulse volume set to 3, prompt volume set to 3 (without prompt triggered) Ni-MH rechargeable battery package Charge/discharge...

  • Page 134: A1.2.5 Charger Stand

    300 hours A1.3 Parameters Measurement Range ☆ 0% ~ 100% ☆ Resolution Bpm Resolution 1 bpm PR (H100B) 25 bpm ~ 300 bpm ☆ PR (H100N) 20 bpm ~ 300 bpm ☆ Accuracy (H100B) ☆ Adult and ± 2% (70%~ 100%) ☆...
  • Page 135 (70%~ 100%) ± 2% ☆ Neonate (70%~ 100%) ± 3% ☆ Low Perfusion (70%~ 100%) ± 2% Pulse Rate Accuracy (H100B) ☆ 25 bpm ~300 bpm ± 2 bpm Pulse Rate Accuracy (H100N) ☆ 20 bpm to 250 bpm ± 3 bpm...
  • Page 136 Pulse Oximeter User Manual Sensor (H100N) Wave length approximately 660 nm and 900 nm Emitted light energy <15 mW NOTE: The information about wavelength range can be especially useful to clinicians (for instance, when photodynamic therapy is performed). TEMP 0 C ~ 50 C Measurement ☆...

  • Page 137: Appendix Ii Emc Information

    For pulse oximeter and charger stand: Guidance and manufacturer’s declaration – electromagnetic emissions H100B&H100N and charger stand are intended for use in the electromagnetic environment specified below. The customer or the user of H100B&H100N and charger stand should assure that they are used in such an environment.
  • Page 138 NOTE: The EMISSIONS characteristics of H100B&H100N make them suitable for use in industrial areas and hospitals (CISPR 11 class A). If they are used in a residential environment (for which CISPR 11 class B is normally required) H100B&H100N might not offer adequate...

  • Page 139: A2.2 Electromagnetic Immunity

    For pulse oximeter: Guidance and manufacturer’s declaration – electromagnetic immunity H100B&H100N are intended for use in the electromagnetic environment specified below. The customer or the user of H100B&H100N should assure that they are used in such an environment. Immunity test IEC/EN Compliance...
  • Page 140 Pulse Oximeter User Manual t lines (>3m) ±1 kV line Surge to line IEC/EN61000-4-5 ±2 kV line to ground 0 % U cycle At 0°, 45°, 90°, 135°, 180°, 225°, 270° 315° Voltage dips, short 0 % U interruptions, and cycle voltage variations on power supply...
  • Page 141 Pulse Oximeter User Manual IEC/EN 61000-4-8 fields should levels characteristic typical location in a typical commercial or hospital environment For charger stand: Guidance and manufacturer’s declaration – electromagnetic immunity The CS-01 Battery Charger Stand is intended for use in the electromagnetic environment specified below.
  • Page 142 Pulse Oximeter User Manual humidity should be at least 30%. Mains power quality should Electrical Fast ±2 kV for ±2 kV for be that of a Transient/Burst power power typical IEC/EN61000-4-4 supply lines supply lines commercial or hospital environment. Mains power quality should ±1 kV line...
  • Page 143 Pulse Oximeter User Manual 70 % U 70 % U operation 25/30 25/30 during power cycles ) cycles ) mains Single Single interruptions, phase: phase: at 0° 0° recommended 0 % U that the CS-01 0 % U 250/300 powered 250/300 cycle from...

  • Page 144: A2.3 Electromagnetic Immunity

    For pulse oximeter and charger stand: Guidance and manufacturer’s declaration – electromagnetic immunity H100B&H100N and charger stand are intended for use in the electromagnetic environment specified below. The customer or the user of H100B&H100N and charger stand should assure that they are used in such an environment.
  • Page 145 Pulse Oximeter User Manual frequency of the transmitter. Recommended separation distance  Conducted 3 Vrms 3 Vrms RF IEC/EN 150 kHz 150 kHz to 80 150 kHz to 80 61000-4-6 6Vrms 6Vrms in ISM bands bands between between 0.15 MHz and 0.15 MHz 80 MHz and 80...
  • Page 146 Pulse Oximeter User Manual equipment (including peripherals such as antenna cables external antennas) should be used no closer than 30 cm (12 inches) to any part of the oximeter, including cables specified by the manufacturer). where p is the maximum output power rating of the transmitter in watts(W)
  • Page 147 Pulse Oximeter User Manual transmitters, determined by an electromagnetic site survey, should be less than compliance level each frequency range. Interference may occur vicinity equipment marked with the following symbol: NOTE1 At 80 MHz and 800 MHz, the frequency range applies.
  • Page 148 Complies is used exceeds the applicable compliance level above, H100B&H100N and charger stand should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating H100B&H100N and charger stand.
  • Page 149 Pulse Oximeter User Manual ± 5 430-4 S 460, deviati 1 kHz sine Pulse 704-7 modul Band ation 13, 17 217 Hz 800/9 TETR A 800, Pulse 800-9 iDEN modul 820, ation 18 Hz A 850, Band 1800; 1720 Pulse 1700- modul 1990...
  • Page 150 Pulse Oximeter User Manual Band 1970 1, 3, 4, 25; UMTS Bluet ooth, WLAN 802.1 Pulse 2400- modul 2450 2570 b/g/n, ation RFID 217 Hz 2450, Band Pulse 5240 WLAN 5100- modul 802.1 5500 5800 ation 1 a/n 5785 217 Hz NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be...

  • Page 151: A2.4 Recommended Separation Distances

    A2.4 Recommended Separation Distances For pulse oximeter and charger stand: Recommended separation distances between portable and mobile RF communications equipment and H100B&H100N and charger stand H100B&H100N and charger stand are intended for use in an electromagnetic environment which radiated disturbances are controlled. The customer or the user of the H100B&H100N and charger stand can help prevent...
  • Page 152 Pulse Oximeter User Manual For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

  • Page 153: Appendix Iii Record Table

    Pulse Oximeter User Manual Appendix III Record Table ID No. Name Time NOTE - 144 -...

  • Page 154: Appendix Iv Abbreviations

    Pulse Oximeter User Manual Appendix IV Abbreviations Abbr English Full Name/Description CISPR International Special Committee on Radio Interference European Economic Community Electromagnetic Compatibility Identification International Electrotechnical Commission Liquid Crystal Display Light Emitting Diode Medical Device Directive Personal Computer Pulse Rate Radio Frequency Pulse Oxygen Saturation - 145 -...

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