Tecno-gaz H100B User Manual
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Tecno-gaz H100B User Manual

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H1 OOB/H1 OON
Pulse Oximeter
Version 1 .8
User Manual
�TECNO-GAZ
�l'
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  • Page 1 H1 OOB/H1 OON Pulse Oximeter Version 1 .8 User Manual �TECNO-GAZ �l' industries...
  • Page 2 About this Manual P/N: 21.54.110178 MPN: 21.54.110178018 Release Date: January, 2019 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 the manufacturer cannot be held liable.
  • Page 3 The user shall understand that nothing in this manual grants him, expressly or implicitly, any right or license to use any of the intellectual properties of the manufacturer. The manufacturer holds the rights to modify, update, and ultimately explain this manual. Responsibility of the Manufacturer The manufacturer only considers itself responsible for any effect on safety, reliability and performance of the...
  • Page 4 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 5: Table Of Contents

    Table of Contents 1 Safety Information ............ 1 1.1 Warnings .............. 1 1.2 Cautions .............. 14 1.3 Notes ..............16 1.4 Symbols in the Oximeter ........20 2 Introduction ............. 24 2.1 General Introduction ........... 24 2.2 Panel Introduction ..........26 2.2.1 Symbols on Screen ........
  • Page 6 3.3.2 Trend Graph and Trend Table ..... 47 3.3.3 Abnormal Measurement State ..... 48 3.3.4 Data Transfer State ........49 3.4 System Menu ............50 3.4.1 System Mode ..........53 3.4.2 Patient Type ..........53 3.4.3 Alarm Volume ..........54 3.4.4 Pulse Volume ..........
  • Page 7 3.6 Oximeter Viewer Data Management Software Introduction .............. 68 4 Alarm ................ 71 4.1 Alarm Categories and Levels ......71 4.2 Alarm Conditions ..........74 4.2.1 Alarm for SpO Sensor Unconnected ..74 4.2.2 Alarm for SpO Sensor off ......75 4.2.3 Alarm for Abnormal State of Temp Sensor .
  • Page 8 7 Principles of Operation ........... 97 7.1 Pulse Oximetry Measurement ......98 7.2 Measured Versus Calculated Saturation ... 100 8 Warranty and Service ........... 101 8.1 Warranty ............101 8.2 Contact information .......... 102 Appendix I Specification .......... 103 A1.1 Classification ..........103 A1.2 Specification ..........
  • Page 9 Appendix III Record Table ........126 Appendix IV Abbreviations ........127 VIII...

  • 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 oxide.
  • 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 of electromagnetic radiation and/or invalid readings of the oximeter.
  • Page 12 Pulse Oximeter User Manual WARNING The oximeter is not defibrillator-proof. The measurements may be 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)
  • Page 13 Pulse Oximeter User Manual WARNING Do not make any clinical judgment based solely on the oximeter, it is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms. To ensure patient safety, do not place the oximeter in any position that might cause it to fall on the patient.
  • Page 14 Pulse Oximeter User Manual WARNING Only use sensors and extension cables permitted by the manufacturer with the oximeter. Other sensors or extension cables may fail and/or cause improper monitor performance and/or minor personal injury. Oximeter readings and pulse signals can be affected by certain ambient environmental conditions, sensor application error, and certain patient conditions.
  • Page 15 Pulse Oximeter User Manual WARNING 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.
  • Page 16 Pulse Oximeter User Manual WARNING 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.
  • Page 17 Pulse Oximeter User Manual WARNING Patient's weak pulse or disturbed SpO signal may affect measurement and alarm accuracy. 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 affect...
  • Page 18 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 is possible in the necessary configuration before start monitoring patients.
  • Page 19 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 20 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. During monitoring, if the power supply is off, the oximeter will be off, and only the patient information and alarm settings can be saved.
  • Page 21 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 too large due to edema), excessive pressure and local tissue ischemia, hypoxia and lack of nutrition may occur on the application site.
  • Page 22 Pulse Oximeter User Manual WARNING No modification of this equipment is allowed without authorization of the manufacturer. If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe operation. When serious arrhythmia is present, the SpO pulse rate may differ from ECG heart rate but this does not indicate an inaccurate PR (SpO value.

  • Page 23: 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 24 Pulse Oximeter User Manual CAUTION The device and accessories are to be disposed of according to local regulations after their useful lives. Alternatively, they can be returned to the dealer or the manufacturer for recycling or proper disposal. Batteries are hazardous waste.

  • Page 25: Notes

    Pulse Oximeter User Manual CAUTION The performance of the oximeter may be degraded if the following occur: - Operation or storage temperature and humidity outside the manufacturer’s stated range; - Mechanical shock (for example, it drops from the table). - Patient temperature is below ambient temperature (For measurement...
  • Page 26 Pulse Oximeter User Manual EMC testing of Medical Electrical Equipment, third edition). These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. Normal operation means:  The oximeter is turned on;  A sensor is connected to the oximeter; ...
  • Page 27 Pulse Oximeter User Manual 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 to the standard of ISO10993-1: 2013. The pictures and interfaces in this manual are for reference only.
  • Page 28 Pulse Oximeter User Manual combination of a pulse oximeter and a pulse oximeter probe, then a functional tester can measure the contribution of an oximeter to the total error of an oximeter/probe system. The functional tester can then measure how accurately a particular pulse oximeter is reproducing that calibration curve.

  • Page 29: Symbols In The Oximeter

    Pulse Oximeter User Manual radio transmitters, mobile telephones, microwaves, etc. The oximeter can only be used on one patient at a time. The device is calibrated to display functional oxygen saturation. 1.4 Symbols in the Oximeter TYPE APPLIED PART Caution Warning (Background: yellow;...
  • Page 30 Pulse Oximeter User Manual Part Number Refer to User Manual (Background: blue; Symbol: white) SERIAL NUMBER CE marking AUTHORISED REPRESENTATIVE EUROPEAN COMMUNITY Date of manufacture MANUFACTURER - 21 -...
  • Page 31 Pulse Oximeter User Manual Disposal method Caution: Federal (U.S.) Law restricts this device to sale by or on the order of a physician. Input/output connector General symbol recovery/recyclable Ingress Protection IP22 (Protected against access to hazardous parts with a finger; Protected against solid foreign objects of 12.5 mm Ø...
  • Page 32 Pulse Oximeter User Manual Conforms to UL Std. 60601-1 Certified to CSA Std. C22.2 No 601.1 (H100B) No alarm system This way up Fragile Keep away from rain NOTE: The user manual is printed in black and white. - 23 -...

  • Page 33: Introduction

    Pulse Oximeter User Manual 2 Introduction Intended Use/Indications for Use The H100B Pulse oximeter is intended for continuous monitoring or spot-checking of functional arterial oxygen saturation (SpO ) and pulse rate of single adult, pediatric or neonate patient in hospitals, intra-hospital transport and hospital type facilities.
  • Page 34 Pulse Oximeter User Manual 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. They can be powered by four 1.5 V AA batteries or four 1.2 V Rechargeable Ni-MH AA batteries.

  • Page 35: 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 - 26 -...
  • Page 36 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 alarm limit Displays when measurement value is lower than the lower alarm limit waveform display...
  • Page 37 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 off or...

  • Page 38: Front Panel Buttons

    Pulse Oximeter User Manual 2.2.2 Front Panel Buttons This section describes the buttons on the front panel of the oximeter. The controls are activated by pressing the button that corresponds to that control. For example, press the Alarm Silence button to control the audio alarm.
  • Page 39 Pulse Oximeter User Manual 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. When Alarm System in menu is setup to ON, pressing the Alarm Silence button can turn off the audio alarm.
  • Page 40 Pulse Oximeter User Manual 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 41: Rear Panel

    Pulse Oximeter User Manual 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. Button Combination When the oximeter is off, synchronously press the On/Off button and the Function button for one second,...

  • Page 42: Connecting Sensor Or Cable

    Pulse Oximeter User Manual 2.3 Connecting Sensor or Cable Figure 2-6 Sensor and Cable Connecting Port Sensor and cable port is at the top of the oximeter. An extension cable can be used between the oximeter and the SpO sensor. Use only the cable permitted by the manufacturer.
  • Page 43 Pulse Oximeter User Manual SIO definition: H100B Name Description RSGND The RS232 GND LED+ LED drive signal, IR Anode LED- drive signal, Anode H100 RS232 RX Detector Anode Detector anode Connection Detector connection AGND Analog GND H100 RS232 TX Detector Cathode Detector cathode...

  • Page 44: Powered By Battery

    Pulse Oximeter User Manual signal return Detector Anode Detector anode connection Inner Shield Detector shield to GND Outer Shield Outer cable shield to GND Sensor UART /DigiCAL Memory Data communication signal Detector Cathode Detector cathode connection 2.4 Powered by Battery The oximeter can be powered by four 1.5 V LR6 AA alkaline batteries.
  • Page 45 Pulse Oximeter User Manual 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.
  • Page 46 Pulse Oximeter User Manual WARNING order avoid safety hazards, 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 package may deteriorate.
  • Page 47 Pulse Oximeter User Manual connect the AC mains. Allow the battery to be charged uninterruptedly for above 2.5 hours. details about charging Ni-MH rechargeable battery package, please refer to section 3.5. 3. Disconnect AC mains and allow the oximeter to run in the measurement state until it shuts off.

  • Page 48: Accessory List

    Pulse Oximeter User Manual 2.5 Accessory List Standard configuration including: Quantity Items H100B Pulse Oximeter Main 02.06.109006 Unit H100N Pulse Oximeter 02.06.110185 1.5V AA alkaline batteries 01.21.064086 (IEC LR6) SH1 Adult Reusable SpO 02.01.210120 Sensor (H100B) Nellcor Reusable Adult SpO Sensor (DS-100A OxiMax) 01.15.30043...
  • Page 49 SH3 Neonate Wrap Sensor 02.01.210673 (reusable) (H100B) SH4 Adult Silicone Soft-tip Sensor (DB9, Only compatible with EDAN SpO 02.01.210122 module and EDAN SpO extension cable) (H100B) Nellcor Reusable Adult/Neonate SpO Sensor 01.15.40096 (OXI-A/N OxiMax) (Weak Perfusion Resistance) H100 SpO extension cable 01.13.110504...
  • Page 50 Pulse Oximeter User Manual Quantity Items management software USB to series cable (For 01.13.110200 H100N) Series cable (For H100B) 01.13.109038 Charger stand 83.60.112409 Charger stand 83.60.316030 4.8 V Ni-MH rechargeable 21.21.064164 battery NOTE: The part name may vary depending on context, but the part number is constant.

  • Page 51: Oximeter Operation

    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 Indicates error for low battery...

  • Page 52: Measurement Procedure

    Pulse Oximeter User Manual H100N Error code Indication Battery Low Indicates error for Low battery Indicates error for SpO board Error 02 Error 03 Indicates error for Temp board Indicates error for main control board Error 04 3.2 Measurement Procedure 3.2.1 SpO Measurement Procedure Select the correct patient category setting (adult/pediatric...
  • Page 53 Pulse Oximeter User Manual Mounting of the Sensor 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 54 Pulse Oximeter User Manual arterial catheter, intravascular venous infusion line, or inflated NIBP cuff. If the surrounding temperature increases, the operator should pay attention to the site of poor perfusion, and increase the frequency of checking skin changing measurement site to prevent burns. If the initial skin temperature is less than 35°...

  • Page 55: Temp Measurement Procedure

    The patient is an intended operator. Follow the steps above for measurement. 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 waveform mode H100N configuration is large numeric mode.

  • Page 56: Trend Graph And Trend Table

    , oxygen saturation unit (%), PR, pulse rate unit (bpm), TEMP and temperature unit (℃) in large numeric mode. Figure 3-2 H100B&H100N Large Numeric Mode 3.3.2 Trend Graph and Trend Table When Trend Review is set to ON, press the Up Arrow...

  • Page 57: Abnormal Measurement State

    Pulse Oximeter User Manual Trend graph: Figure 3-3 Display SpO and PR Trend Graph Trend table: Figure 3-4 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 alarm, and display in the information area.

  • Page 58: Data Transfer State

    Pulse Oximeter User Manual medium alarm, and display in the information area. If the Temp sensor is abnormal, it will give a low alarm, 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 59: System Menu

    Pulse Oximeter User Manual  Connect the oximeter and the computer with a cable for the communication 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.
  • Page 60 Pulse Oximeter User Manual System Setup >>: Alarm Setup >>: - 51 -...
  • Page 61 Pulse Oximeter User Manual Storage Setup >>: Figure 3-6 Menus The menus are shown above and the details for each item will be introduced in the following sections. NOTE: Hi Alarm and SpO Lo Alarm stand for the upper and lower alarm limits of SpO respectively.

  • Page 62: System Mode

    Pulse Oximeter User Manual If the user changes the default value of Lo Alarm or Hi Alarm, after restarting the oximeter, the value will resume to the default value for the corresponding patient type. 3.4.1 System Mode There are two items for selecting: Waveform mode Large numeric mode Then confirm the selection by pressing the Function...

  • Page 63: Alarm Volume

    Pulse Oximeter User Manual 3.4.3 Alarm Volume The Alarm Volume button is used to adjust alarm volume and its range is from one to five. When Alarm System is setup to ON, if a low alarm, a medium alarm or a high alarm occurs, the oximeter sounds beep.

  • Page 64: User Maintain

    Pulse Oximeter User Manual 3.4.6 User Maintain Enter the User Maintain menu by inputting “819”. Figure 3-7 Enter Password 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 ●...

  • Page 65: Default Config

    Pulse Oximeter User Manual ● Temp Unit: the user can set the temperature unit to ℃ or ℉. ● Time Setup >>: select this item, the following interface displays: Figure 3-10 Time Setup ● Trend Review: the user can choose whether to turn on or off the trend review function.
  • Page 66 Pulse Oximeter User Manual Figure 3-11 Factory Default Config Factory Default Configuration is shown as follows: System Mode: (H100B) (H100N) Patient Type: Alarm System: Alarm Volume: Pulse Volume: Audio Paused (s): Hi Alarm: Lo Alarm: PR Hi Alarm: PR Lo Alarm:...

  • Page 67: Sensitivity

    Pulse Oximeter User Manual Data Storage: Trend Review: 3.4.8 Sensitivity The SpO reading is the average of data collected within 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.
  • Page 68 Pulse Oximeter User Manual Figure 3-12 Confirm to Turn off Alarm If Alarm System is ON and an alarm occurs, the oximeter will give a visual alarm and an audio alarm. Pressing the Alarm Silence button can pause the alarm 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.

  • Page 69: Spo 2 Alarm Setup

    Pulse Oximeter User Manual 3.4.10 SpO 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. By default, SpO Hi Alarm and SpO Lo Alarm in Neo...
  • Page 70 Pulse Oximeter User Manual  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. The adjustable range for the lower Alarm is from 0 to “the upper limit of SpO limit of SpO...

  • Page 71: Pr Alarm Setup

    Pulse Oximeter User Manual 3.4.11 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; while they are 120 and 50 in Adu mode respectively.

  • Page 72: Temp Alarm Setup

    Pulse Oximeter User Manual range setup.  Hi Alarm is always higher than Lo Alarm by at least 1 bpm.  Press the On/Off button to exit the menu, and return to measurement state. 3.4.12 Temp Alarm Setup The user can use Temp Hi Alarm and Temp Lo Alarm in menu to adjust body temperature alarm limits.

  • Page 73: Patient Id No. Setup

    Pulse Oximeter User Manual  Choose Temp Lo Alarm in menu, and press the Function button to enter setup. The Temp Lo Alarm box changes from real line to broken line. The adjustable range for the lower limit of Temp Alarm is from 0 to “the upper limit of Temp Alarm - 0.1 ℃”.

  • Page 74: Data Storage

    Pulse Oximeter User Manual Figure 3-13 Confirm to Cover Data 3.4.14 Data Storage Choose Data Storage, and set it to ON, then the measurement data can be stored. During the data storage, patient ID cannot be changed. If the user wants to change ID, he should change Data Storage to OFF, then set a new ID.

  • Page 75: Delete All Data

    Pulse Oximeter User Manual Figure 3-14 Memory Space Full 3.4.15 Delete All Data Delete All Data is used to delete all the stored data. Choose this item by pressing the Function button, a dialog box pops up as follows: Figure 3-15 Delete All the Data If you choose YES to delete all the data, the deleting progress shows: Figure 3-16 All Data Deleting...

  • Page 76: Exit (Return)

    Pulse Oximeter User Manual 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 77: Oximeter Viewer Data Management Software Introduction

    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 78 Pulse Oximeter User Manual 1. Query or save the oximeter’s data based on the patient 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.
  • Page 79 Pulse Oximeter User Manual Figure 3-18 Trend Graph Figure 3-19 Print Preview - 70 -...

  • Page 80: Alarm

    Pulse Oximeter User Manual 4 Alarm 4.1 Alarm Categories and Levels Alarm Categories The oximeter’s alarms can be classified into two categories: physiological alarms and technical alarms. 1. Physiological alarms Physiological alarms, also called patient status alarms, are triggered by a monitored parameter value that violates setup alarm limits or an abnormal patient condition.
  • Page 81 Pulse Oximeter User Manual Alarm Levels In terms of severity, the oximeter’s alarms levels can be classified into two categories: high level alarms and medium level alarms. 1. High level alarms Indicate that the patient is in a life threatening situation and an emergency treatment is demanded.
  • Page 82 Pulse Oximeter User Manual Alarm Categories Table Physiological alarms Alarm level High Too High Too Low High PR Too High High High PR Too Low Temp Too High Medium Medium Temp Too Low Technical Alarm Action Taken alarms level Sensor Medium No SpO sensor was...

  • Page 83: Alarm Conditions

    Pulse Oximeter User Manual 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;...

  • Page 84: Alarm For Spo Sensor Off

    Pulse Oximeter User Manual information area. and PR value area display “---”, and give a medium alarm. (Make sure the alarm system in menu is ON.) 4.2.2 Alarm for SpO Sensor off When the SpO sensor falls off from the finger, the oximeter will give a medium alarm, and the icon displays in information area.

  • Page 85: Alarm For Low Battery

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

  • Page 86: Lower Than Lo Alarm Limit

    Pulse Oximeter User Manual 4.2.6 Lower than Lo Alarm Limit If the measured SpO or PR value is lower than the Lo Alarm (lower alarm limit), the oximeter gives a high alarm for SpO , PR, and gives a medium alarm for TEMP.

  • Page 87: Turning Off Alarm System

    Pulse Oximeter User Manual 4.2.8 Turning off Alarm System After the alarm system is turned off, the oximeter can not give a visual or an audio alarm except for low battery icon alarm. Set alarm system to ON, the alarm system will be active. It will give an audio alarm and a visual alarm if an alarm occurs.

  • Page 88: Testing Alarms

    Pulse Oximeter User Manual the time needed until the numerical values reflect the physiological event. The time between the displayed numerical values exceeding an alarm limit and the alarm indication on the oximeter. This delay is the combination of the configured alarm delay time plus the general system delay time.

  • Page 89: Performance Considerations

    Pulse Oximeter User Manual 5 Performance Considerations 5.1 Performance Verification Qualified service personnel responsible performance verification procedures before the oximeter is used for the first time in a clinical setting. 5.2 Oximeter Performance Considerations There are some patient conditions that can affect the oximeter’s measurements.
  • Page 90 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. H100N: The oximeter displays pulse rate between 20 and 300 beats per minute (bpm).
  • Page 91 Pulse Oximeter User Manual Certain patient conditions can affect the measurements or cause the loss of the pulse signal. Inaccurate measurements can be caused but not limited  Incorrect application of the sensor.  High levels of ambient light sources, such as surgical lights (especially those with a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, and direct...
  • Page 92 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 93 Pulse Oximeter User Manual 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 94: Spo 2 Functional Test

    Pulse Oximeter User Manual 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 the manufacturer). Procedure: Connect the oximeter and the SpO simulator with a cable.
  • Page 95 Pulse Oximeter User Manual 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. On the other hand, the stability of the SpO values also reflects the signal quality.
  • Page 96 Pulse Oximeter User Manual population in the studies composed of healthy men and women from age 19 to 37 (for H100B), from age 18 to 50 (for H100N), with various skin pigmentations. Note that the study population was healthy adults and not in the actual intended use population.

  • Page 97: Maintenance

    Pulse Oximeter User Manual 6 Maintenance Maintenance shall be carried out at least once every two years, or as specified by local regulations. The oximeter does not require calibration. If service is necessary, contact qualified service personnel your local representative manufacturer.
  • Page 98 Pulse Oximeter User Manual  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.
  • Page 99 Pulse Oximeter User Manual The validated cleaning agents for cleaning the oximeter and reusable accessories are:  Mild near neutral detergent  Ethanol (75%)  Isopropanol (70%) Cleaning agents should be applied and removed using a clean, soft, non-abrasive cloth or paper towel. Cleaning the Oximeter: WARNING Before cleaning the oximeter or the sensor, make...
  • Page 100 Pulse Oximeter User Manual Dry the oximeter in a ventilated and cool place. Cleaning the SpO Sensor: Wipe the surfaces of the sensor and cable using a soft cloth dampened with the cleaning solution until no visible contaminants remain. Wipe the patient contact area of the sensor with the cotton swab dampened with the cleaning solution until no visible contaminants remain.
  • Page 101 Pulse Oximeter User Manual Disinfecting 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. Clean the oximeter and reusable accessories before they are disinfected. The validated disinfectants for cleaning the oximeter and reusable accessories are: ...
  • Page 102 Pulse Oximeter User Manual CAUTION Although the oximeter chemically resistant to most common hospital cleaners, disinfectants and non-caustic detergents, different cleaners or disinfectants are not recommended and may stain the oximeter, such as disinfectant didecyl dimethyl ammonium bromide which contains quanternary ammonium salt.
  • Page 103 Pulse Oximeter User Manual To disinfect the oximeter, follow these steps: Switch off the oximeter and take out the batteries. Wipe the display screen using a soft, clean cloth dampened with the disinfectant solution. Wipe the exterior surface of the equipment using a soft cloth dampened with the disinfectant solution.
  • Page 104 Pulse Oximeter User Manual level disinfection. Refer to the instructions of the disinfectant for the methods of disinfection. High level disinfection has been validated with a 12 minute soak. Rinse and dry according to the labeled instructions of Cidex OPA. Do not dampen the sensor connector. For the skin TEMP sensors, disinfect them as follows using ethanol or isopropanol only: Wipe the patient contact area with a soft cloth...
  • Page 105 Pulse Oximeter User Manual 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. Production date can be found on labels. The service life for main machine (not including replaceable accessories or parts) is 5 years when working time is 8 hours per day.

  • Page 106: 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 and continuous measurement for a short time. H100N can also measure TEMP by a thermistor probe (a semiconductor whose resistance changes with temperature).

  • Page 107: 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 108 Pulse Oximeter User Manual The oximeter determines SpO by passing red and infrared light into an arteriolar bed and measuring changes in light absorption during the pulsatile cycle. Red and infrared low-voltage light-emitting diodes (LED) serve as light sources; a photonic diode serves as the photo detector.

  • Page 109: Measured Versus Calculated Saturation

    Pulse Oximeter User Manual 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 methemoglobin. Measured Versus Calculated Saturation When saturation is calculated from a blood gas partial pressure of oxygen (PO ), the calculated value may differ from the SpO...

  • Page 110: Warranty And Service

    Pulse Oximeter User Manual 8 Warranty and Service 8.1 Warranty The manufacturer warrants that its 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 is void in cases of: a) damage caused by mishandling during shipping.

  • Page 111: Contact Information

    Pulse Oximeter User Manual manufacturer 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. - 102 -...

  • Page 112: Appendix I Specification

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

  • Page 113: A1.2.1 Size And Weight

    Pulse Oximeter User Manual 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 Function Configuration Optional Product Standard Configuration Configuration Data , PR, data storage,...

  • Page 114: A1.2.4 Display

    Pulse Oximeter User Manual Atmospheric pressure Working 70 kPa ~ 106 kPa Storage 70 kPa ~ 106 kPa A1.2.4 Display Screen Type 128× 64 dot-matrix LCD, with white LED backlight Large , PR, TEMP and Bar graph Numeric displayed Mode Waveform , PR, Bar graph and Mode...
  • Page 115 Pulse Oximeter User Manual Level 4 Alkaline batteries Quantity Total rated voltage Capacity 2600 mAh 48 h or longer (At 25 C, with Typical operation time new fully charged batteries, measurement in use, backlight set to off, pulse volume set to 3, alarm volume (without alarm triggered)

  • Page 116: A1.2.6 Charger Stand

    Pulse Oximeter User Manual 30 h or longer (At 25 C, with Typical battery life new fully charged batteries, measurement in use, backlight set to off, pulse volume set to 3, alarm volume set to 3 (without alarm triggered) Charge time No more than 2.5 h to 80% No more than 4 h to 100% A1.2.6 Charger Stand...
  • Page 117 Adult ☆ (70%~ 100%) ± 3% Neonate 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 Alarm Range (H100B)
  • Page 118 Pulse Oximeter User Manual Perfusion Range(H100N) Measurement range 0.03% ~ 20% Sensor (H100B) Red Light (6603) nm Infrared Light (90510) nm Emitted Light Energy < 15 mW Sensor (H100N) Wave length approximately 660 nm and 900 nm Emitted light energy <15 mW...
  • Page 119 Pulse Oximeter User Manual TEMP 0 C ~ 50 C ☆ Measurement range (32 ℉ ~ 122 ℉) (25 C ~ 45 C) ± 0.1 C ☆ Accuracy (0 C ~ 25 C and 45 C ~50 C) ± 0.2 C 0.1 C Resolution Position...

  • Page 120: 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 121: 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 - 112 -...
  • Page 122 Pulse Oximeter User Manual environment. Immunity test IEC/EN Compliance Electromagnetic 60601 test level environment - level guidance Floors should wood, concrete ceramic tile. If Electrostatic ± 8 kV ± 8 kV floors discharge(ESD) contact contact covered with IEC/EN61000-4-2 ± 15 kV air ±...
  • Page 123 Pulse Oximeter User Manual power supply input 90° , 135° , lines 180° , 225° , IEC/EN61000-4-11 270° 315° 0 % U cycle 70 % U 25/30 cycles ) Single phase: at 0° 0 % U 250/300 cycle Power frequency magnetic fields should Power...
  • Page 124 Pulse Oximeter User Manual 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. The customer or the user of CS-01 Battery Charger Stand should assure that it is used in such an environment.
  • Page 125 Pulse Oximeter User Manual Mains power quality should ±1 kV line be that of a ±1 kV line Surge to line typical ±2 kV line IEC/EN61000-4-5 to line commercial to ground hospital environment. 0 % U 0 % U Mains power cycle cycle...

  • Page 126: 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 127 Pulse Oximeter User Manual Portable and mobile RF communications equipment should be used no closer to any part of the H100B&H100N and charger stand, including cables, than recommend separation distance calculated from the equation applicable to the frequency of the transmitter.
  • Page 128 Pulse Oximeter User Manual Radiated RF 3 V/m 3 V/m IEC/EN 80 MHz 80 MHz to 2.7 80 MHz to 800 61000-4-3 MHz to 2.7 GHz See Table Comply with Table 1 wireless communications equipment bands (Portable communications equipment (including peripherals such as antenna cables and external...
  • Page 129 Pulse Oximeter User Manual watts(W) according to the transmitter manufacturer and recommended separation distance in metres (m). Field strengths from fixed transmitters, determined by an electromagnetic site survey, should less than compliance level in each frequency range. Interference may occur vicinity equipment marked with the following...
  • Page 130 Complies is used exceeds the applicable RF compliance level above, the 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 131 Pulse Oximeter User Manual Table 1 Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Test Band Servic Modula Maxi Dista Immu freque (MHz) tion nity power test (MHz level (V/m) Pulse 380-39 TETR modula A 400 tion 18 Hz ±...
  • Page 132 Pulse Oximeter User Manual 1800; 1720 1900; Pulse 1700-1 modula 1845 1900; tion DECT; 217 Hz Band 1, 3, 4, 1970 UMTS Blueto oth, Pulse 802.11 2400-2 modula 2450 b/g/n, tion RFID 217 Hz 2450, Band Pulse 5240 5100-5 modula 5500 802.11 tion...

  • Page 133: A2.4 Recommended Separation Distances

    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 in which radiated RF disturbances are controlled. The customer or the user of the H100B&H100N and...
  • Page 134 Pulse Oximeter User Manual 0.01 0.12 0.12 0.23 0.38 0.38 0.73 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 135 Pulse Oximeter User Manual Appendix III Record Table ID No. Name Time NOTE - 126 -...
  • Page 136 Pulse Oximeter User Manual Appendix IV Abbreviations Abbr English Full Name/Description CISPR International Special Committee Radio Interference European Economic Community Electromagnetic Compatibility Identification International Electrotechnical Commission Liquid Crystal Display Light Emitting Diode Medical Device Directive Personal Computer Pulse Rate Radio Frequency Pulse Oxygen Saturation - 127 -...

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