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VE-H100B Veterinary Pulse Oximeter User Manual

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Appendix IV Abbreviations

Abbr

English Full Name/Description

CISPR

International Special Committee on Radio

Interference

EEC

European Economic Community

EMC

Electromagnetic Compatibility

Identification

IEC

International Electrotechnical Commission

LCD

Liquid Crystal Display

LED

Light Emitting Diode

MDD

Medical Device Directive

Personal Computer

Pulse Rate

Radio Frequency

SpO

Arterial Oxygen Saturation From Pulse Oximeter

理邦保密文件

EDAN CONFIDENTIAL

Summary of Contents for VE-H100B

Page 1: ...E D A N C O N F I...

Page 2: ...al may result in malfunction or accident for which EDAN INSTRUMENTS INC hereinafter called EDAN cannot be held liable EDAN owns the copyrights of this manual Without prior written consent of EDAN any...

Page 3: ...esponsibility of the Manufacturer EDAN only considers itself responsible for any effect on safety reliability and performance of the equipment if Assembly operations extensions re adjustments modifica...

Page 4: ...ises 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 da...

Page 5: ...uction 18 2 2 Panel Introduction 19 2 2 1 Symbols on Screen 20 2 2 2 Front Panel Buttons 22 2 2 3 Rear Panel 26 2 3 Connecting Sensor or Cable 26 2 4 Powered by Battery 28 2 5 Accessory List 31 3 Oxim...

Page 6: ...io Paused s 41 3 3 6 User Maintain 41 3 3 7 Default Config 42 3 3 8 Sensitivity 43 3 3 9 Alarm System 44 3 3 10 SpO2 Alarm Setup 45 3 3 11 PR Alarm Setup 46 3 3 12 Patient ID No Setup 47 3 3 13 Data S...

Page 7: ...Sensor off 60 5 2 4 Alarm for Low Battery 60 5 2 5 Higher than Hi Alarm Limit 60 5 2 6 Lower than Lo Alarm Limit 61 5 2 7 Alarm Silence 61 5 2 8 Turning off Alarm System 61 5 2 9 Alarm Priority 62 5 2...

Page 8: ...onal Versus Fractional Saturation 77 8 3 Measured Versus Calculated Saturation 78 9 Warranty and Service 79 9 1 Warranty 79 9 2 Contact information 80 Appendix I Specification 81 A1 1 Classification 8...

Page 9: ...ation 86 A2 1 Electromagnetic Emissions 86 A2 2 Electromagnetic Immunity 87 A2 3 Electromagnetic emissions 93 A2 4 Recommended Separation Distances 97 Appendix III Record Table 99 Appendix IV Abbrevia...

Page 10: ...se Oximeter hereinafter called oximeter in the presence of flammable Anesthetics mixture with air oxygen or nitrous oxide 2 Chemicals from a broken LCD display panel are toxic when ingested Use cautio...

Page 11: ...imeter is a prescription device to be operated only by trained personnel The oximeter is for attended monitoring only 8 The oximeter is not defibrillator proof The measurements may be inaccurate throu...

Page 12: ...ilure 12 Do not lift the oximeter by the sensor or extension cable because the cable could disconnect from the oximeter and the oximeter may drop on the patient 13 Do not make any clinical judgment ba...

Page 13: ...fected by certain ambient environmental conditions sensor application error and certain patient conditions See the appropriate sections of the manual for specific safety information 19 Don t mix new a...

Page 14: ...r your local EDAN representative 23 Before using it the user should carefully read the applicable user manual of sensor including warnings cautions and instructions 24 Do not use damaged sensor or ext...

Page 15: ...quipment is switched off and disconnected from the power line 31 Reusable sensors must be moved to a new site at least every 4 hours Because individual skin condition affects the ability of the skin t...

Page 16: ...in the presence of bright lights may result in inaccurate measurements In such case cover the sensor with an opaque material 38 Do not service or maintain the oximeter or any accessory which is in use...

Page 17: ...le batteries and charger stand for the oximeter 44 Do not place battery in the oximeter with the and in the wrong way 45 Setting alarm limits to extreme values may cause the alarm system to become ine...

Page 18: ...ent simultaneously Do not touch the signal input or output connector and the patient simultaneously 51 The simultaneous use of cardiac pacemaker may cause safety hazard 52 During monitoring if the pow...

Page 19: ...manufacturer If this equipment is modified appropriate inspection and testing must be conducted to ensure continued safe operation 57 Prolonged and continuous monitoring may increase the risk of unexp...

Page 20: ...ld 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 ba...

Page 21: ...ble 6 For the comfort of the animal and to avoid damaging the sensor do not pull on the cable when removing the sensor and clip from the sensor site 7 To remove the sensor and clip from the animal pre...

Page 22: ...o IEC EN 60825 1 2001 No special safety precautions are required 3 Normal operation means The oximeter is turned on A sensor is connected to the oximeter The sensor is applied to the patient The patie...

Page 23: ...terfaces in this manual are for reference only 10 A functional tester cannot be used to assess the accuracy of the oximeter probe or the oximeter 11 The operating time of the Ni MH rechargeable batter...

Page 24: ...radio transmitters mobile telephones microwaves etc 16 The oximeter can only be used on one patient at a time 17 The device is calibrated to display functional oxygen saturation 1 4 Symbols in the Ox...

Page 25: ...e Oximeter User Manual 16 6 SERIAL NUMBER 7 CE marking 8 AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY 9 Input output connector 10 Date of manufacture 11 MANUFACTURER 12 Part Number 13 Disposal...

Page 26: ...is device to sale by or on the order of a physician 15 General symbol for recovery recyclable 16 Ingress Protection IPX2 protected against vertically falling water drops when enclosure tilted up to 15...

Page 27: ...uous monitoring of canine feline and equine animals when attended by a veterinary professional 2 1 General Introduction VE H100B Pulse Oximeter displays SpO2 value pulse rate value plethysmogram bar g...

Page 28: ...ware is optional You may frequently use the follow functions SpO2 monitoring Refer to Chapter 3 Oximeter Operation for more information Alarm Refer to Chapter 5 Alarm for more information 2 2 Panel In...

Page 29: ...umeric Mode Icons on the screen and their meanings SpO2 SpO2 value display area 100 Measured SpO2 PR Pulse Rate value display area 60 bpm Measured Pulse rate bpm Displays when measurement value is hig...

Page 30: ...splay Low battery icon Audio alarm off icon Alarm off icon Data storage icon 04 59 Time display in Information area hour minute Model Model in Information area Vet ID 99 ID in Information area SpO2 se...

Page 31: ...con 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...

Page 32: ...this button to return to the measurement state Backlight Button During the POST the backlight is not available In the normal measurement press this button to turn on or off the backlight Alarm Silence...

Page 33: ...ncrement continuously Press this button in measurement state to enter the latest 10 minute SpO2 or PR trend graph Down Arrow Button In the menu state pressing the Down Arrow button can choose differen...

Page 34: ...and press the Function button to confirm then increase or decrease the value using cursor button When the oximeter is off synchronously press the On Off button and the Function button for one second...

Page 35: ...2 3 Rear Panel Figure 2 5 Rear Panel 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...

Page 36: ...ftware is also connected to this port Type BF applied part Input output connector SIO definition PIN Name Description 1 RSGND The RS232 GND 2 LED LED drive signal IR Anode 3 LED LED drive signal Red A...

Page 37: ...ight and alarm on The oximeter can also be powered by the Ni MH rechargeable battery package Battery Installation To install the alkaline batteries 1 Make sure the oximeter is turned off 2 Press the b...

Page 38: ...1 Make sure the oximeter is turned off 2 Press the battery compartment latch and remove the battery access door 3 Place the Ni MH rechargeable battery package as shown in the follow figure first push...

Page 39: ...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 hour...

Page 40: ...on The low battery icon displays and an alarm is given when few minute operation remains available After few minute operation the oximeter will turn off automatically Replace the batteries Figure 2 7...

Page 41: ...1 21 064133 1 Battery charger 02 06 112410 1 Oximeter Viewer Data management software 02 05 109016 1 Series cable 01 13 109038 1 H100 SpO2 extension cable 01 13 110504 NOTE The part name may vary depe...

Page 42: ...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...

Page 43: ...Indicates error for SpO2 board Error 03 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...

Page 44: ...nit bpm in large numeric mode Figure 3 4 Large Numeric Mode 3 2 2 Trend Graph and Trend Table In normal measuring state press the Up Arrow button to enter the latest SpO2 or PR trend graph and press t...

Page 45: ...a If the SpO2 sensor falls off from the finger it will give a 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 re...

Page 46: ...he measurement and storage are all finished turn off the oximeter Connect the oximeter and the computer with a cable for the communication between the oximeter and the Oximeter Viewer Data Management...

Page 47: ...VE H100B Veterinary Pulse Oximeter User Manual 38 oximeter select items by pressing the Up Down button and confirm it by pressing the Function button System Setup E D A N C O N F I...

Page 48: ...or 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 s...

Page 49: ...by pressing the Function button 3 3 2 Model It indicates that the oximeter can be used by veterinary only and this item is unselectable and unmodifiable 3 3 3 Alarm Volume The Alarm Volume button is u...

Page 50: ...ction 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 When Alarm Sy...

Page 51: ...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 F...

Page 52: ...ode Model VET Alarm System ON Alarm Volume 3 Pulse Volume 3 Audio Paused s 60 SpO2 Hi Alarm 100 SpO2 Lo Alarm 85 PR Hi Alarm 170 PR Lo Alarm 40 Patient ID No 1 Data Storage OFF 3 3 8 Sensitivity The S...

Page 53: ...nd the patient s state 3 3 9 Alarm System Set Alarm System to ON or OFF to turn on or off the alarm system If Alarm system is set to OFF a dialog box pops up as follows Figure 3 14 Confirm to Turn off...

Page 54: ...m Setup The user can choose SpO2 Hi Alarm and SpO2 Lo Alarm in menu to adjust SpO2 alarm limit Press the Up Arrow button or Down Arrow button to increase or decrease alarm limit By default SpO2 Hi Ala...

Page 55: ...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...

Page 56: ...ess 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...

Page 57: ...an be stored During the data storage 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 Oxi...

Page 58: ...used to delete all the stored data Choose this item by pressing the Function button a dialog box pops up as follows Figure 3 17 Delete All the Data If you choose YES to delete all the data the deletin...

Page 59: ...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 d...

Page 60: ...ewer Data Management Software Introduction Connect the oximeter to PC through the cable before running the Oximeter Viewer Data Management Software This software implements the following functions 1 Q...

Page 61: ...VE H100B Veterinary Pulse Oximeter User Manual 52 Figure 3 19 Main Interface Figure 3 20 Trend Graph E D A N C O N F I...

Page 62: ...VE H100B Veterinary Pulse Oximeter User Manual 53 Figure 3 21 Print Preview E D A N C O N F I...

Page 63: ...for a maximum of four hours provided the site is inspected routinely to ensure skin integrity and correct positioning Because individual skin condition affects the ability of skin to tolerate sensor p...

Page 64: ...e may be too thick thin or deeply pigmented to permit appropriate light transmission If any of these situations occurs reposition the sensor or try another sensor site If the sensor site is one that i...

Page 65: ...ement of the sensor on the site manually take a pulse rate reading from another site on the animal If the sensor is placed correctly the manual reading should correspond to the pulse rate reading disp...

Page 66: ...larms Technical alarms also called system status alarms are triggered by a device malfunction or a patient data distortion due to improper operation or system problems Alarm Levels In terms of severit...

Page 67: ...rm level SpO2 Too High High SpO2 Too Low High PR Too High High PR Too Low High Technical alarms Alarm level Action Taken SpO2 Sensor Unconnected Medium No SpO2 sensor was connected to the monitor SpO2...

Page 68: ...nge for auditory alarm signal is from 45 dB to 85 dB 5 2 Alarm Conditions 5 2 1 Alarm off Before the First Measurement Before the first measurement the alarm system is configured to be off At this tim...

Page 69: ...ry alarm occurs the oximeter can still be operated for a few minutes before it turns off automatically The low battery icon displays on LCD and gives a medium alarm Make sure Alarm System in menu is O...

Page 70: ...is lower than that of SpO2 Lo Alarm it will synchronously flash with SpO2 value 5 2 7 Alarm Silence If Alarm System in menu is ON pressing the alarm silence button the audio alarm will be off for the...

Page 71: ...ding alarm at the oximeter This delay has two components 1 The time between the occurrence of the physiological event and when this event is represented by the displayed numerical values This delay de...

Page 72: ...nt alarms perform the measurement on yourself or use a simulator Adjust alarm limits and check that appropriate alarm behavior is observed You must check that the character flashes and beep sound can...

Page 73: ...ctional Hemoglobins Dysfunctional hemoglobins such as carboxyhemoglobin methemoglobin and sulfhemoglobin are unable to carry oxygen SpO2 readings may appear normal however a patient may be hypoxic bec...

Page 74: ...ically and 10 seconds in extreme conditions 6 3 Sensor Performance Considerations Inaccurate measurements can be caused by Incorrect application of the sensor Placement of the sensor on an extremity w...

Page 75: ...he sensor Poor peripheral perfusion Loss of pulse cardiac arrest To use the sensor Select an appropriate sensor Apply the sensor as directed and observe all warnings and cautions presented in the sens...

Page 76: ...he following to correct the problem 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 K...

Page 77: ...by the sensor A wave of poor quality manifests a decline of the signal validity On the other hand the stability of the SpO2 values also reflects the signal quality Different from varying SpO2 reading...

Page 78: ...ter cables inserted modules and accessories are in good condition Check all the functions of the oximeter to make sure that the oximeter is in good condition If you find any damage on the oximeter sto...

Page 79: ...he oximeter may become invalid and the patient s health may be endangered Cleaning If the device or accessory has been in contact with the patient then cleaning and disinfection is required after ever...

Page 80: ...ion thoroughly until no visible contaminants remain 3 Wipe off the cleaning solution with a fresh cloth or towel dampened with tap water after cleaning until no visible cleaning agent remains 4 Dry th...

Page 81: ...ction 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 ox...

Page 82: ...he exterior surface of the equipment using a soft cloth dampened with the disinfectant solution 4 Wipe off the disinfectant solution with a dry cloth after disinfection if necessary 5 Dry the oximeter...

Page 83: ...for disinfection 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 m...

Page 84: ...short time The system consists of Central Processing Unit Signal Collection Signal Input Data Output Display and User Input module shown as follows Figure 8 1 System Principle The oximeter communicate...

Page 85: ...pendent upon light from the sensor excessive ambient light can interfere with this measurement Pulse oximetry is based on two principles Oxyhemoglobin and deoxyhemoglobin differ in their absorption of...

Page 86: ...bases its SpO2 measurements on the difference between maximum and minimum absorption measurements at systole and diastole By doing so it focuses on light absorption by pulsatile arterial blood elimin...

Page 87: ...o those from an instrument that measures fractional saturation fractional measurements must be converted 8 3 Measured Versus Calculated Saturation When saturation is calculated from a blood gas partia...

Page 88: ...roper use or maintenance c damage caused by alteration or repair by anyone not authorized by EDAN d damage caused by accidents e replacement or removal of serial number label and manufacture label If...

Page 89: ...2 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...

Page 90: ...ee of Safety in Presence of Flammable Gases Not suitable for use in presence of flammable gases Compliant with Safety Standards IEC 60601 1 2005 A1 2012 EN 60601 1 2006 A1 2013 IEC 60601 1 2 2007 EN 6...

Page 91: ...rix LCD with white LED backlight Big Numeric Mode SpO2 PR and Bar graph displayed Waveform Mode SpO2 PR Bar graph and Plethysmogram displayed A1 2 4 Batteries Alkaline batteries Quantity 4 Total rated...

Page 92: ...se volume set to 3 alarm volume set to 3 without alarm triggered Charge time No more than 2 5 hours to 80 No more than 4 hours to 100 Quantity 1 Total rated voltage 4 8 V Capacity 1500 mAh Typical bat...

Page 93: ...oltage 8 VDC Output current 0 8 A Output power 6 4 W A1 3 Parameters Measurement range SpO2 0 100 PR 25 bpm 350 bpm Accuracy Tolerance Saturation Normal condition 2 70 100 Pulse Rate Normal condition...

Page 94: ...E H100B Veterinary Pulse Oximeter User Manual 85 NOTE The information about wavelength range can be especially useful to clinicians for instance when photodynamic therapy is performed E D A N C O N F...

Page 95: ...ions VE H100B and charger stand are intended for use in the electromagnetic environment specified below The customer or the user of the VE H100B and charger stand should assure that they are used in s...

Page 96: ...rger stand Class A Voltage fluctuations flicker emissions IEC EN61000 3 3 Pulse oximeter N A Charger stand Complies A2 2 Electromagnetic Immunity For pulse oximeter Guidance and manufacturer s declara...

Page 97: ...synthetic material the relative humidity should be at least 30 Electrical Fast Transient Burst IEC EN61000 4 4 2kV for power supply lines 1kV for input output lines 3m N A N A Surge IEC EN61000 4 5 1...

Page 98: ...000 4 11 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5s Power Frequency 50 60 Hz Magnetic Field IEC EN 61000 4 8 3A m 3A m Power frequency magnetic fie...

Page 99: ...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 Emissions test Compliance Compliance level Ele...

Page 100: ...mmercial or hospital environment Surge IEC EN61000 4 5 1 kV line to line 2 kV line to ground 1 kV line to line 2 kV line to ground Mains power quality should be that of a typical commercial or hospita...

Page 101: ...for 25 cycles 5 UT 95 dip in UT for 5s hospital environment If the user of the CS 01 requires continued operation during power mains interruptions it is recommended that the CS 01 be powered from an...

Page 102: ...Guidance and manufacturer s declaration electromagnetic immunity VE H100B and charger stand are intended for use in the electromagnetic environment specified below The customer or the user of VE H100B...

Page 103: ...z to 80MHz 3 Vrms should be used no closer to any part of VE H100B and charger stand including cables than the recommend separation distance calculated from the equation applicable to the frequency of...

Page 104: ...P d 2 1 80 MHz to 800 MHz P d 3 2 800 MHz to 2 5 GHz where p is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separa...

Page 105: ...ollowing symbol NOTE1 At 80 MHz and 800 MHz the frequency range applies NOTE2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from...

Page 106: ...cessary such as reorienting or relocating the oximeter A2 4 Recommended Separation Distances For pulse oximeter and charger stand Recommended separation distances between portable and mobile RF commun...

Page 107: ...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...

Page 108: ...VE H100B Veterinary Pulse Oximeter User Manual 99 Appendix III Record Table ID No Name Time SpO2 PR NOTE E D A N C O N F I...

Page 109: ...Radio Interference EEC European Economic Community EMC Electromagnetic Compatibility ID Identification IEC International Electrotechnical Commission LCD Liquid Crystal Display LED Light Emitting Diode...

Page 110: ...E D A N C O N F I...

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