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Oxy9Wave

Vet

Operation manual

Ver. 1.52 1.SAFETY INFORMATION 7

MEDDEV 2.12/1 rev.8

Guidelines on a Medical Devices Vigilance System(January 2013)

EN ISO 13485 :2012

Medical devices

—

Quality management systems

—

Requirements for regulatory purposes

(ISO13485:2003)

EN/IEC 62366 edition 1.0

Medical devices-Application of usability engineering to medical devices

IEC 62471:2006

Photobiological safety of lamps and lamp systems.

IEC 60529:2001

Degrees of protection provided by enclosures (IPCode)

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Содержание Oxy9Wave Vet

Страница 1: ...Oxy9Wave Vet Operation manual 1 Oxy9Wave Vet Operation Manual Ver 1 52 www ebionet com...

Страница 2: ...OTES 8 2 Product description 10 2 1 Introduction 11 2 2 Product Configuration 11 2 3 Product Specifications 12 2 4 GENERAL DESCRIPTION 13 2 5 PRINCIPLE OF OPERATION 13 2 6 SYSTEM DESCRIPTION 14 2 7 Ho...

Страница 3: ...2 Sensor Attached 26 4 4 3 Button Description 27 4 4 4 How to use the monitor 28 4 4 5 MENU SETUP 29 ANIMAL TYPE 31 Alarm Setup 31 General Setup 33 Clock Setup 34 ABOUT 35 5 Alarms Messages 36 5 1 In...

Страница 4: ...ual Ver 1 52 4 7 References and Others 43 7 1 Cleaning and Maintenance 44 7 2 Warranty Period 44 7 3 How to Contact Us 45 Due to continuing product innovation specifications in this manual are subject...

Страница 5: ...Oxy9Wave Vet Operation manual Ver 1 52 1 SAFETY INFORMATION 5 1 SAFETY INFORMATION 1 1 CE Standard Information 1 2 Warning 1 3 Caution 1 4 Note 1 5 SAFETY INFORMATION WARNINGS CAUTIONS AND NOTES...

Страница 6: ...for basic safety and essential performance Collateral Standard General requirements tests and guidance for alarm systems in medical electrical equipment and medical electrical systems ISO 80601 2 61...

Страница 7: ...3 EN ISO 13485 2012 Medical devices Quality management systems Requirements for regulatory purposes ISO13485 2003 EN IEC 62366 edition 1 0 Medical devices Application of usability engineering to medic...

Страница 8: ...wing sound engineering design processes Risk Analysis and Software Validation Explosion hazard Do not use the pulse Oximeter near flammable anesthetics or other flammable substance in combination with...

Страница 9: ...g pulse oximetry during full body irradiation keep the sensor out of the irradiation field If the sensor is exposed the irradiation the reading may be inaccurate or the unit may read zero for the dura...

Страница 10: ...52 2 Product description 10 2 Product description 2 1 Introduction 2 2 Product Configuration 2 3 Product Specifications 2 4 GENERAL DESCRIPTION 2 5 PRINCIPLE OF OPERATION 2 6 SYSTEM DESCRIPTION 2 7 Ho...

Страница 11: ...xygen saturation from Canine and feline This device is for use by trained veterinary personnel in veterinary centers The device is restricted to be used on one patient at a time 2 2 Product Configurat...

Страница 12: ...Sensor Separation Alarm Silence Charging Status and Power Connection Power Supply Power Consumption 25VA max During Charging power is off 18VA Adapter Input 100 240V 50 60Hz 0 3A Output 5V 2 0A Model...

Страница 13: ...monitoring setup 2 5 PRINCIPLE OF OPERATION Ox9Wave Vet uses the difference in absorbance that occurs when two lights with unique wavelength pass through a substance with different density The princip...

Страница 14: ...1 Speaker 1 ALARM Silence Indicator 2 ALARM LED 2 BATTERY Charging Indicator 3 POWER ON OFF Button 3 POWER Indicator 4 DISPLAY Monitor 4 Alarm Silence Setting Button 5 PULSE RATE LED 5 BACKLIGHT Setti...

Страница 15: ...Oxy9Wave Vet Operation manual Ver 1 52 2 Product description 15 Slide View Back View...

Страница 16: ...NG Our SPO Sensor is a medical product and should be used accordingly Improper use or use of other sensors may cause harm to the user CAUTION When used near EMI devices such as a microwave oven or hig...

Страница 17: ...Oxy9Wave Vet Operation manual Ver 1 52 3 Setup 17 3 SETUP 3 1 LIST OF COMPONENTS 3 2 CONNECTING Oxy9Wave Vet TO DC POWER 3 3 CONNECTING A SENSOR TO Oxy9Wave Vet 3 4 CONNECTING a Clamp...

Страница 18: ...ord 1ea 3 2 CONNECTING Oxy9Wave Vet TO DC POWER The DC power and battery power can be used simultaneously The DC Power LED lights up when DC Power is plugged into the inlet on the side of the product...

Страница 19: ...pO2 sensor cable to the SpO2 sensor port 2 of the side panel CAUTION Check the electrodes of the batteries before charging them Connect the DC adaptor when changing the battery WARNING Our SpO Sensor...

Страница 20: ...Oxy9Wave Vet Operation manual Ver 1 52 3 Setup 20 3 4 CONNECTING a Clamp...

Страница 21: ...4 2 Symbol and Icon Description 4 3 Basic operation 4 3 1 Introduction 4 3 2 Basic Setup 4 4 Details of USE 4 4 1 Turning On the Monitor 4 4 2 Sensor Attached 4 4 3 Button Description 4 4 4 How to use...

Страница 22: ...set on an individual basis by the clinician these settings will remain in effect until Oxy9Wave Vet is turned off Parameter Range Factory Default ANIMAL TYPE CAT DOG CAT SpO Lower Alarm Limit 40 99 90...

Страница 23: ...equipment Power button on off Menu button Alarm silence Alarm OFF Screen brightness Adjusted as one of 5 levels based on the brightness Pulse beep Volume Adjusted as one of 5 levels based on the volu...

Страница 24: ...transmission of light between the light source and the photo detector 5 Press the power button 6 Attach the sensor to the hand or foot of the patient 7 Check the following on the screen SpO max min al...

Страница 25: ...d on as described in the following procedure 1 Turn on Oxy9Wave Vet by pressing the POWER ON OFF button for 1 2 seconds 2 The Oxy9Wave Vet software version is displayed for approximately 2 seconds 3 T...

Страница 26: ...is searching for a valid pulse Once a valid pulse is detected the monitor shifts to Monitoring Mode and displays the patient parameters Check for the movement of the level bar or waveform which indic...

Страница 27: ...e alarm sounds 1 Press the Alarm Silence button when the alarm sounds in the patient monitoring mode NOTE The alarm silence can be set for these duration 90 120 OFF A timer is shown next to the bell i...

Страница 28: ...beep sound tone is changed automatically according to the value of SpO Rotate Display 1 Press the Rotate Display Button NOTE The display rotates 90 degrees 4 4 4 How to use the monitor Setting the Pat...

Страница 29: ...LARM GENERAL CLOCK and ABOUT 1 Press the menu button to go to the corresponding menu setup screen 2 The icons on the right side show the functions of the 4 buttons NOTE The menu setup screen and monit...

Страница 30: ...tton on the right side using the touch keys The icons of the menu items that can be set appear on the screen The following sub sections describe each menu item in more detail ANIMAL TYPE CAT DOG ALARM...

Страница 31: ...Menu Alarm Setup Set the proper alarm when monitoring each patient Alarm setup is used to indicate that the designated range is exceeded during measurement You can set the Max Min Value volume and si...

Страница 32: ...alarm can be 30bpm 249bpm and it can be adjusted by 1bpm NOTE The Min limit must be smaller than the Max limit LEVEL SpO BPM This menu allows the user to set the alarm level HIGH MEDIUM LOW VOLUME Thi...

Страница 33: ...W Menu for the screen settings GRAPHICS SpO and Pulse rate are displayed as a figure the LEVEL bar of the middle signal is displayed In addition the Pulse rate wave is displayed at the bottom of the s...

Страница 34: ...utton to go to the desired value 2 Press to set the value 3 Press the button to return to the Menu Setup Menu Description TIME Adjust the hour minute and second Time is displayed based on 24 hour nota...

Страница 35: ...ess to set the value 3 Press the button to return to the Menu Setup Menu Description KEY SOUND ON Turn on the KEY tone OFF Turn off the KEY tone PULSE LED ON OFF OFF Turn off the Pulse Rate LED indica...

Страница 36: ...Oxy9Wave Vet Operation manual Ver 1 52 5 Alarms Messages 36 5 Alarms Messages 5 1 Introduction 5 2 Alarm 5 3 Alarm operation 5 4 System messages...

Страница 37: ...ure and Disconnect LOW PRIORITY Patient is not connected to the SpO Sensor Main body and SpO Sensor are not connected properly HIGH Alarm Red LED Flicker 2 flickers per 1 second MEDIUM Alarm Yellow LE...

Страница 38: ...om the patient Check the probe The factory default for this alarm is MESSAGE ALARM Poor Signal The SPO signal is too low No SPO data is displayed This can be due to low patient pulse patient motion or...

Страница 39: ...Operation manual Ver 1 52 6 Standard Power Supply Application 39 6 Standard Power Supply Application 6 1 Power 6 2 Battery Power Supply Application 6 3 When to Replace the Battery 6 4 How to Recycle...

Страница 40: ...flicker and the battery will not charge Take the necessary caution CAUTION This Product is intended for indoor use only Not water resistant This product should be protected from excessive force or sh...

Страница 41: ...ery type The lithium ion battery is a rechargeable battery containing lithium ion cells Each battery contains an integrated electronic fuel gauge a safety protection circuit and a temperature sensor 5...

Страница 42: ...ttery will be charged automatically 6 4 How to Recycle the Battery When the battery can no longer be recharged it should be replaced The battery is recyclable Remove the old battery from the monitor a...

Страница 43: ...Oxy9Wave Vet Operation manual Ver 1 52 7 References and Others 43 7 References and Others 7 1 Cleaning and Maintenance 7 2 Warranty Period 7 3 How to Contact Us...

Страница 44: ...r ethylene or oxidizer may damage the equipment Make sure both cables and accessories are free of dust or contaminants wipe them with soft cloth wet with warm water 40 and at least once a week Clean t...

Страница 45: ...Bionet always welcomes your enquiries Please contact us In the event of a malfunction or failure contact Service Dept Of Bionet Co Ltd along with the model name serial number date of purchase and expl...

Страница 46: ...val Date Serial Number Warranty Period 2 years USA Canada Europe 1 year other countries Date of Purchase Customer Section Hospital Name Address Name Phone Distributor Manufacture Thank you for purchas...

Страница 47: ...Oxy9Wave Vet Operation manual Ver 1 52 47...

Страница 48: ...et com U S A sales service representative Bionet America Inc 2691 Dow Ave Suite B Tustin CA 92780 U S A Toll Free 1 877 924 6638 Fax 1 714 734 1761 e mail support bionetus com Website www bionetUS com...

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