About this Manual P/N: 21.54.109000-15 Release Date: Dec 2010 © Copyright EDAN INSTRUMENTS, INC. 2007-2010. All rights reserved. Statement This manual will help you understand the operation and maintenance of the product better. It is reminded that the product shall be used strictly complying with this manual. User’s operation failing to comply with this manual may result in malfunction or accident for which EDAN INSTRUMENTS, INC. (hereinafter called EDAN) can not be held liable.
manual, the user shall not disclose such information to any irrelevant third party. The user shall understand that nothing in this manual grants him, expressly or implicitly, any right or license to use any of the intellectual properties of EDAN. EDAN holds the rights to modify, update, and ultimately explain this manual.
qualified technician to maintain and repair some parts, which EDAN may define as user serviceable. Terms Used in this Manual This guide is designed to give key concepts on safety precautions. WARNING A WARNING label advises against certain actions or situations that could result in personal injury or death. CAUTION A CAUTION label advises against actions or situations that could damage equipment, produce inaccurate data, or invalidate a procedure.
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...........................
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..................................
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..................................
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 .........................
H100B Pulse Oximeter User Manual 1 Safety Information 1.1 Warnings Warnings are identified by the WARNING symbol shown above. A WARNING label advises against certain actions or situations that could result in personal injury or death. 1 2 3 4 WARNING Avoid explosion hazard. Do not use the oximeter in the presence of flammable anesthetic mixtures with air, or with oxygen or nitrous oxide. Chemicals from a broken LCD display panel are toxic when ingested.
H100B Pulse Oximeter User Manual sensor application errors, and certain patient conditions. 5 The use of accessories, sensors, and cables other than those specified may result in increased emission of electromagnetic radiation and/or invalid readings of the oximeter. 6 Failure to cover the sensor site with opaque material in high ambient light conditions may result in inaccurate measurements.
H100B Pulse Oximeter User Manual 11 12 13 14 15 electrosurgical unit, and shortly thereafter. To avoid shock, the caregiver should not hold the oximeter while using a defibrillator on a patient. Disconnect the oximeter and sensor from the patient throughout magnetic resonance imaging (MRI) scanning. Induced current could potentially cause burns. To ensure accurate performance and prevent device failure, do not subject the oximeter to extreme moisture, such as direct exposure to rain.
H100B Pulse Oximeter User Manual 16 17 18 19 20 fall on the patient. As with all medical equipment, carefully route patient cables to reduce the possibility of patient entanglement or strangulation. Ensure that the speaker is clear of any obstruction and that the speaker holes are not covered. Failure to do so could result in an inaudible alarm tone. Use only EDAN permitted sensors and extension cables with the oximeter.
H100B Pulse Oximeter User Manual 21 Periodically check the battery for corrosion. Remove the batteries from the oximeter if you do not expect to use it within one month. 22 The device enters POST (Power-On-Self-Test) immediately after power-on to confirm all the display segments and icons are shown and the speaker sounds a few seconds tone. If you do not hear the POST pass tone, it indicates the alarm system does not work well.
H100B Pulse Oximeter User Manual 26 27 28 29 30 31 32 33 manual. Do not immerse or wet the sensor, as this may damage the sensor. There are no user-serviceable parts inside the oximeter, the cover should only be removed by qualified service personnel. Do not spray, pour, spill liquid to the oximeter and its accessories, connector, switch or opening in enclosure, as this may damage the oximeter.
H100B Pulse Oximeter User Manual batteries and charger stand for H100B pulse oximeter. 34 A potential hazard can exist if different alarm presets are used. 35 This equipment is not intended for family usage. 1.2 Cautions Cautions are identified by the CAUTION symbol shown above. Cautions alert the user to exercise care necessary for the safe and effective use of the oximeter. 1 2 CAUTION All combinations of equipment must be in compliance with IEC/EN Standard 60601-1-1 systems requirements.
H100B Pulse Oximeter User Manual 3 4 5 6 7 waste. Do NOT dispose them together with house-hold garbage. At the end of their life hand the batteries over to the applicable collection points for the recycling of waste batteries. For more detailed information about recycling of this product or battery, please contact your local Civic Office, or the shop where you purchased the product. H100B Pulse Oximeter will not operate with dead batteries. Install new batteries.
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: 1 This device has been tested and found to comply with the limits for medical device in IEC/EN60601-1-2 (International standard for EMC testing of Medical Electrical Equipment, second edition).
H100B Pulse Oximeter User Manual 4 5 6 7 8 9 The sensor is applied to the patient; The patient’s SpO2, Pulse rate are being reported; No error conditions exist. Wash the probe with clean water after disinfecting it to remove any remaining solution. The probe can only be reused after dried thoroughly. Do not disinfect the probe with the water boiled. Any residue should be removed from the probe before being disinfected, and avoid contacting corrosive solvent.
H100B Pulse Oximeter User Manual 10 A functional tester cannot be used to assess the accuracy of the pulse oximeter probe or the pulse oximeter monitor. 11 If there is independent demonstration that the particular calibration curve is accurate for the combination of a pulse oximeter monitor and a pulse oximeter probe, then a functional tester can measure the contribution of a monitor to the total error of a monitor/probe system.
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.
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. Auxiliary output connector Recycle MEDICAL EQUIPMENT WITH RESPECT TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL60601-1 and CAN / CSA C22.2 No. 601.1.
H100B Pulse Oximeter User Manual 2 Introduction Intended Use The oximeter is intended for continuous monitoring or spot-checking of functional arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric or neonatal patients in hospitals, intra-hospital transport and hospital grade facilities. 2.1 General Introduction H100B Pulse Oximeter (hereinafter called oximeter) is one model of H100 series Pulse Oximeter. It displays SpO2 value, pulse rate value, plethysmogram, bar graph, etc.
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.
H100B Pulse Oximeter User Manual 2.2.
H100B Pulse Oximeter User Manual SpO2 waveform display Pulse amplitude display Low battery icon Audio alarm off icon Alarm off icon Data storage icon 04: 59 Time display in Information area: “hour: minute” ADU/NEO Patient type in Information area: Adult or Neonate.
H100B Pulse Oximeter User Manual Weak signal icon NOTE: 1 The icons for sensor unconnected, sensor off or weak signal are displayed on the right of Information area. Only one of them can be displayed at a time. 2 The ID icon and the icon that indicates the memory space is full are displayed in the Information Area. Only one icon can be displayed at a time. 2.2.2 Front Panel Buttons This section describes the buttons on the front panel of the oximeter.
H100B Pulse Oximeter User Manual Figure 2-4 Front Panel buttons On/Off Button Turn on or off the oximeter. On: Press and hold the On/Off button for one second. Off: Press and hold the On/Off button for two seconds. When the oximeter is off, synchronously press the On/Off button and the Function button for one second, the oximeter will enter data transfer state. In the Menu state, press this button to return to the measurement state. Backlight Button During the POST, the backlight is not available.
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. The pause period can be set to 30, 60, 90 or 120 seconds. Although the audio alarm is off, the visual alarm is still active. After the pause period is over, the audio alarm is reactivated. Set Alarm System to OFF in the menu to turn off the alarm.
H100B Pulse Oximeter User Manual 10-minute SpO2 or PR trend graph. Down Arrow Button In the menu state, pressing the Down Arrow button can choose different items, and decrease the value of some parameters. Press it repeatedly to make a parameter decrease by more than one. Press and hold the button for more than one second to repeat the decrement continuously. Press this button in measurement state to enter the latest 10-minute SpO2 and PR trend table.
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.
H100B Pulse Oximeter User Manual 2.3 Connecting Sensor or Cable Figure 2-6 Sensor and Cable Connecting Port SpO2 Sensor and cable port is at the top of the oximeter. An extension cable can be used between the oximeter and the SpO2 sensor. Use only the cable permitted by EDAN. The cable for connecting the oximeter and PC with the Oximeter Viewer Data Management Software is also connected to this port.
H100B Pulse Oximeter User Manual 1 RSGND The RS232 GND 2 LED+ LED drive signal, IR Anode 3 LED- LED drive Anode 4 RXD H100 RS232 RX 5 Detector Anode Detector anode 6 Connection Detector connection 7 AGND Analog GND 8 TXD H100 RS232 TX 9 Detector Cathode Detector cathode signal, Red 2.4 Powered by Battery The oximeter can be powered by four 1.5V LR6 AA alkaline batteries.
H100B Pulse Oximeter User Manual 3. 4. remove the battery access door. Place four AA batteries as shown in the following figure, first push it oriented as shown in ①, then press it oriented as shown in ②. Install the battery compartment cover. To install the Ni-MH rechargeable battery package: 1. Make sure the oximeter is turned off. 2. Press the battery compartment latch and remove the battery access door. 3.
H100B Pulse Oximeter User Manual Checking the Ni-MH Rechargeable Battery Package The performance of a Ni-MH rechargeable battery package may deteriorate. To check the performance of the battery, follow the procedures below: 1. Disconnect the pulse oximeter from the patient and stop all monitoring and measuring procedures. 2. Place the pulse oximeter in the charger stand and connect the AC mains. Allow the battery to be charged uninterruptedly for above 2.5 hours.
H100B Pulse Oximeter User Manual 3. Disconnect AC mains and allow the pulse oximeter to run in the measurement state until it shuts off. The operating time of a battery reflects its performance directly. If the operating time of a Ni-MH rechargeable battery package is noticeably shorter than that stated in the specifications, replace it or contact your service personnel. Low Battery Icon The low battery icon displays and an alarm is given when few-minute operation remains available.
H100B Pulse Oximeter User Manual Quantity Items Parts No. in EDAN 4 1.5V AA alkaline 01.21.064086 batteries (IEC LR6） 1 SH1 Adult Reusable 12.01.109079 SpO2 Sensor 1 H100B Oximeter Manual 1 H100B Pulse Oximeter Reference 01.54.109002 Card 1 Carrying case Pulse User 01.54.109000 11.56.110165 Optional configuration including: Quantity Items Parts No. in EDAN 1 H100B Pulse Oximeter Service Manual MS1R-109017 1 H100 Protective Cover 01.51.
H100B Pulse Oximeter User Manual 1 Ni-MH rechargeable battery group 21.21.064164 1 Battery charger MS8-112410 1 EDAN SH4 Adult Silicone Soft-tip SpO2 Sensor (DB9, Only compatible 12.01.110515 with EDAN SpO2 module and EDAN SpO2 extension cable) 1 EDAN SH4 Adult Silicone Soft-tip SpO2 Sensor 02.01.
H100B Pulse Oximeter User Manual RS232 interface) When selecting SpO2 sensor, the following should be considered: Patient weight and activity. Adequacy of perfusion. Available sensor sites. Anticipated duration of monitoring.
H100B Pulse Oximeter User Manual 3 Oximeter Operation 3.1 Turning on the Oximeter The oximeter is turned on by pressing the on/off button, it will cycle through a POST before displaying valid data values. Verify that all the circuitry and functions of the oximeter work properly during the POST. It needs a few seconds to complete the verification procedure POST. If it functions incorrectly, do not use the oximeter. Press the On/Off button for one second to turn on the oximeter.
H100B Pulse Oximeter User Manual Figure 3-2 Model If the POST is successfully finished, the oximeter sounds a tone and enters the main interface. If there is an error during the POST, the following error codes will display on the screen: Error code Indication Error 01 Indicates error for low battery Error 02 Indicates error for SpO2 board Error 03 Indicates error for main control board 3.2 Measurement State 3.2.
H100B Pulse Oximeter User Manual arterial oxygen saturation and pulse rate, display oxygen saturation level and symbol（%SpO2）and PR on interface. Besides, it can also display pulse bar graph and Plethysmogram. Figure 3-3 Waveform Mode Large Numeric Mode The oximeter can display SpO2, oxygen saturation unit (%), PR, pulse rate unit (bpm) in large numeric mode. Figure 3-4 H100B Large Numeric Mode 3.2.
H100B Pulse Oximeter User Manual Arrow or Down Arrow button. Trend graph: Figure 3-5 Display SpO2 and PR Trend Graph Trend table: Figure 3-6 Display SpO2 and PR Trend Table 3.2.3 Abnormal Measurement State If the SpO2 sensor does not connect to the oximeter, it will give a medium alarm, and display in the information area.
H100B Pulse Oximeter User Manual medium alarm, and display in the information area. In menu state or trend state, if there is no operation for 30 seconds, the oximeter will return to measurement state. In measurement state, if there is no measurement data and no operation for 10 minutes, the oximeter will turn off automatically. In Data transfer state, if the oximeter does not receive any responsible signals for 10 minutes, it will turn off automatically. 3.2.
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 menu of the oximeter, select items by pressing the Up/Down button, and confirm it by pressing the Function button.
H100B Pulse Oximeter User Manual Alarm Setup >>: Storage Setup >>: - 37 -
H100B Pulse Oximeter User Manual Figure 3-8 Menus The menus are shown above and the details for each item will be introduced in the following sections. NOTE: 1 The SpO2 Hi Alarm and SpO2 Lo Alarm stand for the upper and lower alarm limits of SpO2 respectively. 2 The PR Hi Alarm and PR Lo Alarm stand for the upper and lower alarm limits of PR respectively.
H100B Pulse Oximeter User Manual Large numeric mode Then confirm the selection by pressing the Function button. 3.3.2 Patient Type Patient Type can be set to different measurement modes: Adu for Adult or Pediatric patient or Neo for Neonatal patient. Set Patient Type to Adu or Neo, and confirm it by pressing the Function button. Note: When patient type is changed to Neo, please use the Neonate SpO2 Sensor for accurate measurement. 3.3.
H100B Pulse Oximeter User Manual Pulse Volume, and change volume level to 1, 2, 3, 4, 5 or OFF. Press the Function button to enter setup state, then use the Up Arrow or the Down Arrow button to choose, then confirm it by pressing the Function button. The oximeter implements variable pulse tone and its frequency varies with the saturation 3.3.5 Audio Paused (s) Set the pause period for audio alarm to 30, 60, 90 or 120 seconds.
H100B Pulse Oximeter User Manual Figure 3-10 Wrong Password If the password is right, the following menu will display: Figure 3-11 User Maintain ● Language: the user can select language to be displayed. ● Time Setup >>: select this item, the following interface displays: Figure 3-12 Time Setup 3.3.7 Default Config Choose this item to resume factory default configuration.
H100B Pulse Oximeter User Manual A dialog box pops up: Figure 3-13 Factory Default Config Factory Default Configuration is shown as follows: System Mode: Patient Type: Alarm System: Alarm Volume: Pulse Volume: Audio Paused (s): SpO2 Hi Alarm: SpO2 Lo Alarm: PR Hi Alarm: PR Lo Alarm: Patient ID No.: Data Storage: ADU ON 3 3 60 100 90 120 50 1 OFF 3.3.
H100B Pulse Oximeter User Manual a specific time. You can set the Sensitivity to Hi or Low via the menu. The higher the sensitivity is, the quicker the pulse oximeter responds to the changes in the patient’s oxygen saturation level. Contrarily, the lower the sensitivity is, the slower the pulse oximeter responds to the changes in the patient’s oxygen saturation level, but the measurement accuracy will be improved.
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 SpO2 value is higher than SpO2 Hi Alarm or lower than SpO2 Lo Alarm, there will be↑or↓icon displayed on screen, and the SpO2 or PR character will flash. If Alarm system is set to OFF, all audio alarms and visual alarms are turned off.
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 SpO2 alarm limits as follows: Choose SpO2 Hi Alarm in the menu, press the Function button to enter setup. The SpO2 Hi Alarm box will change from real line box to broken line box. The adjustable range for upper limit of SpO2 is from “1 + the lower limit of SpO2” to 100.
H100B Pulse Oximeter User Manual limit of SpO2 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. SpO2 Hi Alarm is always higher than SpO2 Lo Alarm by at least 1%. Press the Function button, confirm the alarm range setup. Press the On/Off button to exit the menu, and return to measurement state. 3.3.
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. The PR Lo Alarm box changes from real line to broken line. The adjustable range for 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.
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. 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.
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.
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. Turn off the device. 2. Place the pulse oximeter in the charger stand. 3. Connect the power cord. 4. Plug the power cord into the AC mains. A tricolor LED display indicates the charging state.
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. 3.5 PatientCare Viewer Data Management Software Introduction For details about this software, please refer to PatientCare Viewer Data Management Software User Manual.
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. 2.
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. 2. Medium level alarms The patient’s vital signs appear abnormal or the oximeter system status appears abnormal, indicate that prompt operator response is required.
H100B Pulse Oximeter User Manual Unconnected SpO2 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; Medium level alarms: character flashes slowly and sounds triple beep; The sound pressure range for auditory alarm signal is from 45dB to 85dB. 4.2 Alarm Conditions 4.2.
H100B Pulse Oximeter User Manual 4.2.2 Alarm for SpO2 Sensor Unconnected When the SpO2 sensor is disconnected, the oximeter gives a medium alarm. The icon displays in information area. SpO2 and PR value area display “---”, and give a medium alarm. (Make sure the alarm system in menu is ON.) 4.2.3 Alarm for SpO2 Sensor off When the SpO2 sensor falls off from the finger, the oximeter will give a medium alarm, and the icon displays in information area.
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 SpO2 or PR value is higher than the Hi Alarm (upper alarm limit), the oximeter gives a high alarm. Here we take PR for example: If the measured PR value is higher than the setup PR Hi Alarm, the oximeter gives a high alarm (Make sure alarm system in menu is ON).
H100B Pulse Oximeter User Manual measured value is lower than that of SpO2 Lo Alarm, it will synchronously flash with SpO2 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. When the audio alarm is off, press the Alarm Silence button to reactivate the audio alarm function. 4.2.
H100B 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.
H100B Pulse Oximeter User Manual Anemia causes decreased arterial oxygen content. Although SpO2 readings may appear normal, an anemic patient may be hypoxic. Correcting anemia can improve arterial oxygen content. The oximeter may fail to provide SpO2 if hemoglobin levels fall below 5 gm/dl. Saturation The oximeter displays saturation level between 1% and 100%. Pulse rate The oximeter displays pulse rate between 30 and 254 beats per minute (bpm).
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. Failure to cover the sensor site with opaque materials in high ambient light conditions. Venous pulsation. Dysfunctional hemoglobin. Low perfusion.
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. Periodically check to ensure that the sensor remains properly positioned on the patient.
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.
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.
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. You can obtain the material about the customer service contract from the local company’s office.
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 2% liquid disinfectants. 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.
H100B Pulse Oximeter User Manual 7 Principles of Operation H100B Pulse Oximeter adopts non-invasive double wavelength to measure SpO2 and PR. It can perform spot and continuous measurement for a short time. The system consists of Central Processing Unit, Signal Collection, Signal Input, Data Output, Display and User Input module, shown as follows: Figure 7-1 System Principle The oximeter communicates with external devices through RS-232 interface.
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. Bone, tissue, pigmentation, and venous vessels normally absorb a constant amount of light over time.
H100B Pulse Oximeter User Manual The oximeter determines SpO2 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. Because oxyhemoglobin and deoxyhemoglobin differ in light absorption, the amount of red and infrared light absorbed by blood is related to hemoglobin oxygen 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. 7.2 Functional Versus Fractional Saturation 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 as carboxyhemoglobin or methemoglobin.
H100B Pulse Oximeter User Manual 7.3 Measured Versus Calculated Saturation When saturation is calculated from a blood gas partial pressure of oxygen (PO2), the calculated value may differ from the SpO2 measurement of a pulse oximeter. This usually occurs because the calculated saturation was not appropriately corrected for the effects of variables that shift the relationship between PO2 and pH, the partial pressure of carbon dioxide (PCO2), 2,3-DPG, and fetal hemoglobin.
H100B Pulse Oximeter User Manual 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. The warranty is void in case of: a) damage caused by handling during shipping. b) subsequent damage caused by improper use or maintenance.
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. Unauthorized repairs will void the warranty. In addition, whether or not covered under warranty, any product repair shall be exclusively be performed by EDAN certified service personnel.
H100B Pulse Oximeter User Manual 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. Out of warranty: the service claimer is responsible for any freight, insurance & custom charges for product.
H100B Pulse Oximeter User Manual AppendixⅠSpecification A1.1 Classification Type of Protection Internally powered equipment Class B Type BF-Applied part IPX2 Continuous measuring and spot checking EMC Compliance Degree of Protection Ingress Protection Mode of operation Compliant Standards: with Safety UL 60601-1* CAN/CSA C22.2 No.601.1* IEC 60601-1:1988+A1+A2, EN 60601-1:1990+A1+A2, IEC/EN 60601-1-2:2001+A1, ISO 9919: 2005 Note: The above standard marking “*” is only applicable for UL marked product.
H100B Pulse Oximeter User Manual Working Storage Humidity Working Storage + 5 C ~ + 40 C -20 C ~ + 55 C 25% ~ 80% (No coagulate) 25% ~ 93% (No coagulate) Atmospheric pressure Working Transport and Storage 860 hPa ~ 1060 hPa 700 hPa ~ 1060 hPa A1.2.3 Display Screen Type Big Numeric Mode Waveform Mode 128×64 dot-matrix LCD, with white LED backlight SpO2, PR and Bar graph displayed SpO2, PR, Bar graph and Plethysmogram displayed A1.2.
H100B Pulse Oximeter User Manual Capacity Typical battery life Charge time 1500 mAh/1800 mAh 30 hours/36 hours 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 Output 100 to 240 VAC, 50Hz /60Hz, 0.4A - 0.15A 6.0VDC, 0.8 A A1.
H100B Pulse Oximeter User Manual Pulse Rate Accuracy 25bpm ~300bpm ± 2bpm Resolution 1% SpO2 Bpm 1 bpm - 77 -
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 to IEC/EN 60601-1-2. A2.1 Electromagnetic Emissions - for all EQUIPMENT and SYSTEMS Guidance and manufacturer’s declaration – electromagnetic emissions The device is intended for use in the electromagnetic environment specified below.
H100B Pulse Oximeter User Manual in nearby electronic equipment. RF emissions CISPR11 Harmonic emissions IEC/EN61000-3-2 Class B N/A The device is suitable for use in all establishments other than domestic and those Voltage fluctuations directly connected to the /flicker emissions public low-voltage IEC/EN61000-3-3 N/A power supply net work that supplies buildings used for domestic purpose.
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.
H100B Pulse Oximeter User Manual Electrical Fast ±2kV for Mains power Transient/Burst power supply quality IEC/EN61000-4-4 lines N/A ±1kV for Surge should be that of a typical input/output commercial or lines (>3m) hospital line to line IEC/EN61000-4-5 line to ground N/A Mains power Voltage dips, short <5%UT(>95 interruptions, and % dip voltage variations UT)for on power supply cycle environment. quality in should be that 0.
H100B Pulse Oximeter User Manual % dip in interruptions, it UT)for 5s is recommend that the product be powered from an uninterruptible power supply or a battery.
H100B Pulse Oximeter User Manual A2.3 Electromagnetic emissions-for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING 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.
H100B Pulse Oximeter User Manual than the recommend separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d 3.5 P 3 d 3.5 P 80 3 MHz to 800 MHz d 7 P 3 800 MHz to 2.
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).
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.
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. A2.
H100B Pulse Oximeter User Manual 3.5 d P V1 3.5 d P E1 GHz 0.01 0.12 0.12 0.23 0.1 0.37 0.37 0.74 1 1.2 1.2 2.3 10 3.7 3.7 7.
H100B Pulse Oximeter User Manual Appendix Ⅲ Record Table ID No.
H100B Pulse Oximeter User Manual Appendix Ⅳ Abbreviations Abbr English Full Name/Description CISPR International Special Committee on Radio Interference EEC European Economic Community EMC Electromagnetic Compatibility ID Identification IEC International Electrotechnical Commission LCD Liquid Crystal Display LED Light Emitting Diode MDD Medical Device Directive PC Personal Computer PR Pulse Rate RF Radio Frequency SpO2 Arterial Oxygen Saturation From Pulse Oximeter - 90 -
