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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.
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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...
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The instrument is used in accordance with the instructions for use. Upon request, EDAN may provide, with compensation, necessary circuit diagrams, and other information to help qualified technician to maintain and repair some parts, which EDAN may define as user serviceable.
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that could damage equipment, produce inaccurate data, or invalidate a procedure. NOTE A NOTE provides useful information regarding a function or a procedure.
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A1.2 Specification ..........100 A1.3 Parameters ............. 103 Appendix II EMC Information ....... 105 A2.1 Electromagnetic Emissions - for all EQUIPMENT and SYSTEMS ....... 105 A2.2 Electromagnetic Immunity - for all EQUIPMENT and SYSTEMS ....... 107 A2.3 Electromagnetic emissions-for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING ..111 A2.4 Recommended Separation Distances....117 Appendix Ⅲ...
H100N Pulse Oximeter User Manual Safety Information 1 Safety Information 1.1 Warnings A WARNING label advises against certain actions or situations that could result in personal injury or death. WARNING Avoid explosion hazard. Do not use the oximeter in the presence of flammable anesthetic mixtures with air, or with oxygen or nitrous oxide.
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H100N Pulse Oximeter User Manual Safety Information 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 of electromagnetic radiation and/or invalid readings of the oximeter.
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H100N Pulse Oximeter User Manual Safety Information WARNING H100N Pulse Oximeter is a prescription device to be operated only by trained personnel. The oximeter is for attended monitoring only. 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.
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H100N Pulse Oximeter User Manual Safety Information WARNING 11 Disconnect the oximeter and sensor from the patient throughout magnetic resonance imaging (MRI) scanning. Induced current could potentially cause burns. 12 To ensure accurate performance and prevent device failure, do not subject the oximeter to extreme moisture, such as direct exposure to rain.
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H100N Pulse Oximeter User Manual Safety Information WARNING 14 Do not make any clinical judgment based solely on the oximeter, and it is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms.
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H100N Pulse Oximeter User Manual Safety Information WARNING 18 Use only Nellcor-approved OxiMax Sensors and extension cables with the H100N Pulse Oximeter. Other sensors or extension cables may cause improper monitor performance or minor personal injury. 19 H100N Pulse Oximeter readings and pulse...
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Do not use the H100N Pulse Oximeter if you do not hear the POST pass tone. Do not use the oximeter if the POST has not been finished successfully.
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27 There are no user-serviceable parts inside the oximeter, the cover should only be removed by qualified service personnel. 28 Do not spray, pour, spill liquid to H100N Pulse Oximeter and its accessories, connector, switch or opening in enclosure, as this may damage the oximeter.
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33 Do not disassemble batteries, or dispose of them in fire, or cause them to short circuit. They may ignite, explode, leak, or cause personal injury. 34 Only EDAN approved rechargeable batteries and charger stand for H100N pulse oximeter. - 9 -...
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H100N Pulse Oximeter User Manual Safety Information WARNING 35 The temperature sensor should be disinfected after each measurement. The probe must not be sterilized in steam. Only detergents containing no alcohol can be used for disinfection. 36 The temperature sensor should not be heated ℃...
1.2 Cautions A Caution label alerts the user to exercise care necessary for the safe and effective use of the H100N Pulse Oximeter. CAUTION All combinations of equipment must be in...
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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. H100N Pulse Oximeter will not operate with dead batteries. Install new batteries. - 12 -...
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H100N Pulse Oximeter User Manual Safety Information CAUTION 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, PR or TEMP, but it is still recording.
H100N Pulse Oximeter User Manual Safety Information 1.3 Notes NOTE: Notes are identified by the symbol shown above. Notes contain important information that may be overlooked or missed. NOTE: This device has been tested and found to comply with the limits for medical device in...
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H100N Pulse Oximeter User Manual Safety Information Normal operation means: — The oximeter is turned on; — A sensor is connected to the oximeter; — The sensor is applied to the patient; — The patient’s SpO2, Pulse rate Temperature readings are being reported;...
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H100N Pulse Oximeter User Manual Safety Information 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.
H100N Pulse Oximeter User Manual Safety Information pulse oximeter monitor 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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H100N Pulse Oximeter User Manual Safety Information Date of Manufacture Manufacturer Part Number Ingress Protection Degree IPX1 Recycle The symbol indicates that the device should be sent to the special agencies according to local regulations for separate collection after its useful life.
H100N Pulse Oximeter User Manual Introduction 2 Introduction Intended Use H100N Pulse Oximeter (hereinafter called oximeter) is one model of H100 series Pulse Oximeter. The oximeter is intended for continuous monitoring or spot-checking of functional arterial oxygen saturation (SpO ), pulse rate and for oral, axillary and rectal temperature measurement.
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H100N Pulse Oximeter User Manual Introduction functions. It can be powered by four 1.5V AA batteries or four 1.2V Rechargeable Ni-MH AA batteries. It can clearly display all the parameter information on LCD. Figure 2-1 H100N Pulse Oximeter For the oximeter, PatientCare Viewer Data Management Software is optional.
H100N Pulse Oximeter User Manual Introduction 2.2 Panels Introduction This section identifies the symbols, controls, displays, and buttons on the front panel and rear panel of the oximeter. 2.2.1 Symbols on Screen Figure 2-2 Large Numeric Mode Figure 2-3 Waveform Mode...
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H100N Pulse Oximeter User Manual Introduction Icons on display screen and their meanings: value display area Pulse Rate value display area TEMP Temperature value display area Displays when measurement value is higher than the upper alarm limit Displays when measurement value is...
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H100N Pulse Oximeter User Manual Introduction Alarm off icon Data storage icon Time display in Information area: 04: 59 “hour: minute” Patient type in Information area: ADU/NEO Adult or Neonate. ID: 99 Patient ID in Information area sensor unconnected icon...
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H100N Pulse Oximeter User Manual Introduction 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.
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H100N Pulse Oximeter User Manual Introduction Figure 2-4 Front Panel buttons On/Off Button Turn on or off the oximeter. On: Press and hold the On/Off button for one second. Off: Press and hold the On/Off button for two seconds. When the oximeter is off, synchronously press the On/Off button and the Function button for 1 second, the oximeter will enter Data transfer state.
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H100N Pulse Oximeter User Manual Introduction Backlight Button During the POST, the backlight is not available. In the normal measurement, press this button to turn on or off the backlight. Alarm Silence Button Alarms that occur during the Power-On-Self-Test (POST) can not be silenced.
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H100N Pulse Oximeter User Manual Introduction Up Arrow Button In the menu state, press the Up Arrow button to choose different items, and increase the value of some parameters. Press it repeatedly to make a parameter increase by more than one. Press and hold this button for more than 1 second to repeat the increment continuously.
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H100N Pulse Oximeter User Manual Introduction Function Button During the POST, the Function button is not available; Press this button in normal measuring state to enter function choice or setup menu; In the menu state, this button is also used as the Enter button.
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H100N Pulse Oximeter User Manual Introduction Button Combination When the oximeter is off, synchronously press the On/Off button and the Function button for 1 second, the oximeter will enter Data transfer state. 2.2.3 Rear Panel Figure 2-5 Rear Panel - 29 -...
H100N Pulse Oximeter User Manual Introduction 2.3 Connecting Sensor or Cable Figure 2-6 Sensor and Cable Connecting Port Sensor and cable port is on the top of the oximeter for connecting the SpO sensor. An extension cable can be used between the oximeter and the SpO sensor.
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H100N Pulse Oximeter User Manual Introduction Symbol for caution Type BF applied part Auxiliary output connector SIO definition: Name Description LED drive signal, LED+ IR Anode LED drive signal, LED- Red Anode UART Sensor DigiCAL Memory Return communication signal return...
H100N Pulse Oximeter User Manual Introduction Detector Anode Detector anode connection Inner Shield Detector shield Outer Shield Outer cable shield to Sensor UART Rx /DigiCAL Memory Data communication signal Detector Cathode Detector cathode connection 2.4 Powered by Battery The oximeter can be powered by four 1.5V LR6 AA alkaline batteries.
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H100N Pulse Oximeter User Manual Introduction Battery Installation To install the alkaline batteries: Make sure the oximeter is turned off. 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...
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H100N Pulse Oximeter User Manual Introduction To install the rechargeable Ni-MH battery package: Make sure the oximeter is turned off. Press the battery compartment latch and remove the battery access door. 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.
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H100N Pulse Oximeter User Manual Introduction Checking the Ni-MH Battery Package The performance of a rechargeable Ni-MH battery package may deteriorate. To check the performance of the battery, follow the procedures below: Disconnect the pulse oximeter from the patient and stop all monitoring and measuring procedures.
H100N Pulse Oximeter User Manual Introduction Low Battery Icon The low battery icon displays and an alarm is given when 15 minutes operation remains available. After 15 minutes operation, oximeter will turn automatically. Replace the batteries. Figure 2-7 Low Battery Icon 2.5 Accessory List...
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H100N Pulse Oximeter User Manual Introduction The oximeter is compatible with Nellcor-approved OxiMax Sensors and extension cables. When selecting SpO sensor, the following should be considered: Patient weight and activity. Adequacy of perfusion. Available sensor sites. Anticipated duration of monitoring.
POST. It needs a few seconds to complete the verification procedure POST. If it functions incorrectly, do not use the oximeter. Press the On/Off button for one second to turn on the oximeter. At first the Logo EDAN is shown. - 41 -...
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H100N Pulse Oximeter User Manual Oximeter Operation And then the Logo for product model is shown. Figure 3-1 Model If the POST is successfully finished, the oximeter sounds a tone and enters the main interface. If there is an error during the POST, the following error...
H100N Pulse Oximeter User Manual Oximeter Operation Error 03 Indicates error for Temp board Error 04 Indicates error for main control board 3.2 Measurement State 3.2.1 Measurement Modes There are two measurement modes which are waveform mode and large numeric mode. By default, the configuration is waveform mode.
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H100N Pulse Oximeter User Manual Oximeter Operation Waveform Mode In the normal measurement state, oximeter can measure arterial oxygen saturation and pulse rate, display oxygen saturation level and symbol (%SpO ) and PR on interface. Besides, it can also display pulse bar graph and Plethysmogram.
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H100N Pulse Oximeter User Manual Oximeter Operation Figure 3-4 Display SpO2 and PR Trend Graph 3.2.3 Abnormal Measurement State If the SpO sensor does not connect to the oximeter, it will give a medium alarm, and display in the Information area.
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H100N Pulse Oximeter User Manual Oximeter Operation In menu state or trend graph 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.
H100N Pulse Oximeter User Manual Oximeter Operation Connect the oximeter and the computer with a cable communication between oximeter PatientCare 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...
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H100N Pulse Oximeter User Manual Oximeter Operation System Setup >>: - 48 -...
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H100N Pulse Oximeter User Manual Oximeter Operation Alarm Setup >>: Storage Setup >>: Figure 3-6 Menus NOTE: The SpO Hi Alarm and SpO Lo Alarm stand for the upper and lower alarm limits of SpO - 49 -...
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H100N Pulse Oximeter User Manual Oximeter Operation respectively. The PR Hi Alarm and PR Lo Alarm stand for the upper and lower alarm limits of PR respectively. The Temp Hi Alarm and Temp Lo Alarm stand for the upper and lower alarm limits of Body temperature respectively.
H100N Pulse Oximeter User Manual Oximeter Operation button. 3.3.2 Patient Type Patient Type can be set to Adult (Adu) or Neonate (Neo) for different measurement modes. Set Patient Type to Adu or Neo, and confirm it by pressing the Function button.
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H100N Pulse Oximeter User Manual Oximeter Operation the volume, and 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.
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H100N Pulse Oximeter User Manual Oximeter Operation If the password is wrong, the following dialog box will pop up: Figure 3-8 Wrong Password If the password is right, the following menu will display: Figure 3-9 User Maintain Language: the user can select language to be displayed.
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H100N Pulse Oximeter User Manual Oximeter Operation interface displays: Figure 3-10 Time Setup 3.3.7 Default Config Choose this item to resume factory default configuration. A dialog box pops up: Figure 3-11 Factory Default Config Factory Default Configuration is shown as follows:...
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H100N Pulse Oximeter User Manual Oximeter Operation Alarm System: Alarm Volume: Pulse Volume: Audio Paused (s): SpO2 Hi Alarm: SpO2 Lo Alarm: PR Hi Alarm: PR Lo Alarm: Temp Hi Alarm: Temp Lo Alarm: Patient ID No.: Data Storage: 3.3.8 Sensitivity The SpO2 reading is the average of data collected within a specific time.
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H100N Pulse Oximeter User Manual Oximeter Operation 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.
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H100N Pulse Oximeter User Manual Oximeter Operation oximeter gives a visual alarm and an audio alarm. Pressing the Alarm Silence button can suspend the alarm 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.
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H100N Pulse Oximeter User Manual Oximeter Operation 3.3.10 SpO2 Alarm Setup The user can choose SpO Hi Alarm and SpO Alarm in menu to adjust SpO alarm limit. Press the Up Arrow button or Down Arrow button to increase or decrease alarm limit.
H100N Pulse Oximeter User Manual Oximeter Operation on again. Press the Up Arrow or Down Arrow button to increase or decrease values. Choose SpO Lo Alarm in the menu, press the Function button to set it. The SpO Lo Alarm box will change from real line box to broken line box.
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H100N Pulse Oximeter User Manual Oximeter Operation 3.3.11 PR Alarm setup The user can use PR Hi Alarm and PR Lo Alarm in menu to adjust pulse rate alarm limits. By default, PR Hi Alarm and PR Lo Alarm in Neo mode are 200 and 100 respectively;...
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H100N Pulse Oximeter User Manual Oximeter Operation the lower limit of PR Alarm is from 0 to “the upper limit of PR Alarm – 1”. Press the Function button, confirm the alarm range setup. Hi Alarm is always higher than Lo Alarm by at least 1 bpm.
H100N Pulse Oximeter User Manual Oximeter Operation Function button to enter setup. The Temp Hi Alarm box changes from real line to broken line. The adjustable range of the upper limit of Temp Alarm is from “0.1℃ + the lower limit of Temp Alarm” to 50.0℃.
H100N Pulse Oximeter User Manual Oximeter Operation 3.3.13 Patient ID No. setup The oximeter can support 100 patient IDs, and 300-hour data storage. When entering the 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.
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H100N Pulse Oximeter User Manual Oximeter Operation During the data storage, patient ID can not be changed. If the user wants to change ID, he should change Data Storage to OFF, then set a new ID. Data stored in the oximeter can be exported through PatientCare Viewer Data Management Software.
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H100N Pulse Oximeter User Manual Oximeter Operation 3.3.15 Deleting 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: Figure 3-15 Deleting all the data...
H100N Pulse Oximeter User Manual Oximeter Operation Return to the previous menu by pressing Return in the menu. 3.4 Charging the Ni-MH Battery Package To charge the rechargeable Ni-MH battery package: Turn off the device. Place the pulse oximeter in the charger stand.
H100N Pulse Oximeter User Manual Oximeter Operation PatientCare 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...
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H100N Pulse Oximeter User Manual Oximeter Operation 2. Edit and manage patient information. 3. Review each ID’s data in trend graph format. 4. Print all data information via PC Refer to the PatientCare Viewer Data Management Software user manual for detailed information.
H100N Pulse Oximeter User Manual Alarm 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.
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H100N Pulse Oximeter User Manual Alarm Alarm Levels In terms of severity, the oximeter’s alarms levels can be classified into three categories: high level alarms, medium level alarms and low level alarms. 1. High level alarms Indicate that the patient is in a life threatening situation and an emergency treatment is demanded.
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H100N Pulse Oximeter User Manual Alarm Alarm Categories Table High Medium Low Level Level Level Alarm Alarm Alarm Too High Temp Too Low High Physiological alarm Temp High Sensor Unconnected Temp Technical Sensor Sensor alarm Abnormal Low Battery - 72 -...
H100N Pulse Oximeter User Manual Alarm 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.
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H100N Pulse Oximeter User Manual Alarm configured to be off. At this time, if the SpO or Temp sensor is unconnected or the sensor is off, the oximeter will not give an alarm. 4.2.2 Alarm for SpO2 Sensor Unconnected When the SpO sensor is disconnected, the oximeter gives a medium alarm.
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H100N Pulse Oximeter User Manual Alarm 4.2.4 Alarm for Abnormal State of Temp Sensor In the measurement state, if the Temp sensor falls off the oximeter, it will display --- in the TEMP display area and give a low alarm. (Make sure Alarm System in menu is set to ON.)
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H100N Pulse Oximeter User Manual Alarm The low battery icon displays on LCD, and gives a medium alarm. (Make sure Alarm System in menu is set to ON.) 4.2.6 Higher than Hi Alarm Limit If the measured value is higher than the Hi Alarm (upper alarm limit), the oximeter gives a high alarm for or PR, and gives a medium alarm for TEMP.
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H100N Pulse Oximeter User Manual Alarm alarm limit), the oximeter gives a high alarm for SpO PR, and gives a medium alarm for TEMP. Here we take SpO for example: When the measured SpO value is lower than the set Lo Alarm, the oximeter gives a low SpO alarm.
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H100N Pulse Oximeter User Manual Alarm When the audio alarm is off, press Alarm Silence button to reactivate the audio alarm function. 4.2.9 Turning off Alarm System After Alarm system is turned off, the oximeter can not give a visual and an audio alarm except for low battery icon alarm.
H100N Pulse Oximeter User Manu Performance Considerations 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.
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H100N Pulse Oximeter User Manu Performance Considerations patient may be hypoxic because less hemoglobin is available to carry oxygen. Further assessment beyond pulse oximeter is recommended. Anemia Anemia causes decreased arterial oxygen content. Although SpO readings may appear normal, an anemic patient may be hypoxic.
H100N Pulse Oximeter User Manu Performance Considerations Temperature The oximeter normally displays temperature from 0℃ to + 50℃, there are abnormal state if the temperature is out of the range. 5.3 OxiMax Sensor Performance Considerations Inaccurate measurements can be caused by: Incorrect application of the OxiMax sensor.
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H100N Pulse Oximeter User Manu Performance Considerations pigmented cream. Failure to cover the OxiMax sensor site with opaque materials in high ambient light conditions. Venous pulsation. Dysfunctional hemoglobin. Low perfusion. Loss-of-pulse signal occurs for the following reasons: The OxiMax sensor is applied too tightly.
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H100N Pulse Oximeter User Manu Performance Considerations Apply the OxiMax sensor as directed, and observe all warnings and cautions presented in the OxiMax sensor user manual. Clean and remove any substances, such as nail polish, from the application site. Periodically check to ensure that the OxiMax sensor remains properly positioned on the patient.
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H100N Pulse Oximeter User Manu Performance Considerations If interference due to patient activity presents a problem, try one or more of the following to correct the problem: Verify that the OxiMax sensor is properly and securely applied. Move the OxiMax sensor to another site.
H100N Pulse Oximeter User Manu Maintenance 6 Maintenance The oximeter does not require calibration. If the service is necessary, contact qualified service personnel or your local the manufacturer representative. Before using the oximeter, do the following: Check if there is any mechanical damage;...
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H100N Pulse Oximeter User Manu Maintenance 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 persons from this company. You can obtain the material about the customer service contract from the local company’s office.
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H100N Pulse Oximeter User Manu Maintenance Inspect the devices for mechanical and functional damage Inspect the relevant labels for legibility Cleaning You can surface-clean and disinfect the oximeter and sensor. To surface-clean the oximeter: Use a soft cloth dampened with either a commercial, nonabrasive cleaner, or a solution of 70% alcohol in water.
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H100N Pulse Oximeter User Manu Maintenance Cleaning reusable TEMP probes: The TEMP probe should not be heated above 100℃ (212℉). It should only be subjected briefly to temperatures between 80℃ (176℉) and 100℃ (212 ). ℉ The probe must not be sterilized in steam.
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H100N Pulse Oximeter User Manu Maintenance WARNING Sterilization may cause damage to the equipment and is therefore not recommended for this pulse oximeter unless otherwise indicated in your hospital’s servicing schedule. CAUTION Never use EtO or formaldehyde for disinfection. - 89 -...
H100N Pulse Oximeter User Manu Principles of Operation 7 Principles of Operation H100N Pulse Oximeter adopts non-invasive double wavelength to measure SpO and PR. It can perform spot measuring and continuous measuring for a short time. It can also measure TEMP by a thermistor probe (a...
H100N Pulse Oximeter User Manu Principles of Operation The oximeter communicates with external devices through RS-232 interface. 7.1 Pulse Oximetry Measurement The oximeter uses oximetry to measure functional oxygen saturation in the blood. Pulse oximetry works by applying sensor to a pulsating arteriolar vascular bed, such as a finger or a toe.
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H100N Pulse Oximeter User Manu Principles of Operation Pulse oximetry is based on two principles: Oxyhemoglobin and deoxyhemoglobin differ in their absorption infrared light (spectrophotometry). The volume of arterial blood in tissue (hence light absorption by the blood) changes during the pulse (plethysmography).
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H100N Pulse Oximeter User Manu Principles of Operation hemoglobin, the oximeter uses the pulsatile nature of arterial flow. During systole, a new pulse of arterial blood enters the vascular bed, and blood volume and light absorption increase. During diastole, blood volume and light absorption reach their lowest point.
H100N Pulse Oximeter User Manu Principles of Operation than 15 mW. This information may be useful to clinicians, such as those performing photodynamic therapy. 7.2 Functional Versus Fractional Saturation This oximeter measures functional saturation-oxygenated hemoglobin expressed as a percentage of the hemoglobin that can transport oxygen.
H100N Pulse Oximeter User Manu Principles of Operation To compare functional saturation measurements to those from an instrument that measures fractional saturation, fractional measurements must be converted as follows: 7.3 Measured Versus Calculated Saturation When saturation is calculated from a blood gas partial...
Warranty and Service Policy 8 Warranty and Service Policy 8.1 Warranty EDAN warrants that EDAN’s products meet the labeled specifications of the products and will be free from defects in materials and workmanship that occur within warranty period. The warranty period begins on the date the products are shipped to distributors.
EDAN will, at its discretion, repair or replace the defective part(s) free of charge. EDAN will not provide a substitute product for use when the defective product is being repaired.
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Freight policy: Under warranty: the service claimer is responsible for freight & insurance charges when a return is shipped to EDAN for service including custom charges. EDAN is responsible for freight, insurance & custom charges from EDAN to service claimer.
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& 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. - 99 -...
H100N Pulse Oximeter User Manu Specification AppendixⅠ Specification A1.1 Classification Type of Protection Internally powered equipment EMC Compliance Class B Degree of Protection Type BF-Applied part Ingress Protection IPX1 Mode of operation Continuous measuring and spot measuring IEC 60601-1:1988+A1+A2, Compliant...
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H100N Pulse Oximeter User Manu Specification Weight 185 g (without battery) A1.2.2 Environment Temperature + 5 °C ~ + 40 °C Working -20 °C ~ + 55 °C Storage Humidity Working 25% ~ 80% (No coagulate) Storage 25% ~ 93% (No coagulate)
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H100N Pulse Oximeter User Manu Specification Waveform Mode , PR, Bar graph and Plethysmogram displayed A1.2.4 Batteries Alkaline batteries Quantity Total rated voltage Capacity 2600 mAh Typical battery life 48 hours Ni-MH rechargeable battery package Quantity Total rated voltage 4.8 V...
H100N Pulse Oximeter User Manu EMC Information 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 manufacturer’s declaration –...
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H100N Pulse Oximeter User Manu EMC Information RF emissions The oximeter uses RF CISPR11 energy only for its internal function. Therefore, Group 1 emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions...
H100N Pulse Oximeter User Manu EMC Information /flicker emissions supplies buildings used IEC/EN61000-3-3 for domestic purpose. 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.
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H100N Pulse Oximeter User Manu EMC Information covered with synthetic material, the relative humidity should be at least 30%. Electrical Fast ±2kV for Mains power Transient/Burst power supply quality IEC/EN61000-4-4 lines should be that of ±1kV for a typical input/output commercial or lines (>3m)
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H100N Pulse Oximeter User Manu EMC Information Voltage dips, short <5%UT(>95% Mains power interruptions, and dip in UT)for quality voltage variations 0.5 cycle should be that of on power supply a typical input lines 40%UT(60% commercial or IEC/EN61000-4-11 dip in UT)for hospital environment.
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H100N Pulse Oximeter User Manu EMC Information that the product be powered from uninterruptible power supply or a battery. Power Power frequency magnetic fields Frequency( 50/60 should be at Hz)Magnetic Field levels IEC/EN 61000-4-8 characteristic of 3A/m 3A/m a typical location...
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H100N Pulse Oximeter User Manu EMC Information 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.
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H100N Pulse Oximeter User Manu EMC Information 61000-4-6 80MHz equipment should be used 3V/m no closer to any Radiated 3V/m part of the 80 MHz oximeter, IEC/EN including cables, 61000-4-3 2.5GHz than the recommend separation distance calculated from the equation...
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H100N Pulse Oximeter User Manu EMC Information distance 80 MHz to 800 800 MHz to 2.5 where p is the maximum output power rating of the transmitter in watts(W) according to the - 113 -...
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H100N Pulse Oximeter User Manu EMC Information transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each...
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H100N Pulse Oximeter User Manu EMC Information 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.
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H100N Pulse Oximeter User Manu EMC Information Field strengths from fixed transmitters, such as base stations for radio(cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To...
H100N Pulse Oximeter User Manu EMC Information A2.4 Recommended Separation Distances Recommended separation distances between portable and mobile RF communications equipment and the oximeter The oximeter is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
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H100N Pulse Oximeter User Manu EMC Information Rated Separation distance according maximum frequency of transmitter (m) output 150 kHz to 800 MHz to power 80 MHz 2.5GHz transmitter ⎡ ⎤ ⎡ ⎤ ⎢ ⎥ ⎢ ⎥ ⎣ ⎦ ⎣ ⎦...
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H100N Pulse Oximeter User Manu EMC Information 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.
H100N Pulse Oximeter User Manu Abbreviations Appendix Ⅳ Abbreviations Abbr English Full Name/Description CISPR International Special Committee Radio Interference Electromagnetic Compatibility Identification International Electrotechnical Commission Liquid Crystal Display Light Emitting Diode Medical Device Directive Personal Computer Pulse Rate Radio Frequency...
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