Bionet Oxy9Wave Vet User manual

Oxy9Wave VetOperation manual
1
Oxy9Wave Vet
Operation Manual
Ver. 1.52
www.ebionet.com

Oxy9Wave VetOperation manual
Ver. 1.52 2
Contents
1. SAFETY INFORMATION..........................................................5
1-1. CE Standard Information.............................................................6
1-2. Warning ..........................................................................................8
1-3. Caution...........................................................................................8
1-4. Note.................................................................................................8
1-5. SAFETY INFORMATION, WARNINGS, CAUTIONS, AND
NOTES....................................................................................................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. How to Use the Sensor and Precautions................................16
3. SETUP .....................................................................................17
3-1. LIST OF COMPONENTS.............................................................18
3-2. CONNECTING Oxy9Wave Vet TO DC POWER .......................18
3-3. CONNECTING A SENSOR TO Oxy9Wave Vet.........................19
3-4. CONNECTING a Clamp ..............................................................20

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4. OPERATION............................................................................21
4-1. Introduction .................................................................................22
4-2. Symbol and Icon Description ...................................................23
4-3. Basic operation...........................................................................24
4-3-1. Introduction.........................................................................................................24
4-3-2. Basic Setup...........................................................................................................24
4-4. Details of USE..............................................................................25
4-4-1. Turning On the Monitor................................................................................25
4-4-2. 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. Introduction .................................................................................37
5-2. Alarm.............................................................................................37
5-3. Alarm operation...........................................................................37
5-4. System messages.......................................................................38
6. Standard Power Supply Application..................................39
6-1. Power............................................................................................40
6-2. Battery Power Supply Application...........................................41
6-3. When to Replace the Battery....................................................42
6-4. How to Recycle the Battery.......................................................42

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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 to change without notice.

Oxy9Wave VetOperation 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

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Ver. 1.52 1.SAFETY INFORMATION 6
1-1. CE Standard Information
▷The following electromechanical safety standards have been met:
EN/IEC 60601-1 edition 3.0
Medical electrical equipment —Part 1: General requirements for basic safety and essential
performance
EN/IEC 60601-1-2 edition 4.0
Medical electrical equipment
—Part 1-2: General requirements for basic safety and essential performance
—Collateral standard: Electromagnetic compatibility
—Requirements and tests
EN/IEC 62304 edition 1.0
Medical device software –Software life-cycle processes
EN/IEC 60601-1-6 edition 3.0
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential
performance - Collateral standard: Usability
EN/IEC 60601-1-8 edition 2.0
Medical electrical equipment - Part 1-8: General requirements 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 80601-2-61:2011 edition 1.0
Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and
essential performance of pulse oximeter equipment
ISO 10993-10:2010
Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
ISO 10993-5:2009
Biological evaluation of medical vices -- Part 5: Tests for in vitro cytotoxicity
EN ISO 14971:2012
Medical devices - Application of risk management to medical devices
EN 980:2008
Symbols for use in the labeling of medical devices
ISO 15223-1:2012
Medical devices -- Symbols to be used with medical device labels, labeling and information to
be supplied -- Part 1: General requirements
MEDDEV 2.4/1 rev.9
Classification of medical devices(June 2010)
MEDDEV 2.7/1 rev.3
Clinical evaluation: Guide for manufacturers and notified bodies(December 2009)

Oxy9Wave VetOperation 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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Ver. 1.52 1.SAFETY INFORMATION 8
1-2. Warning
WARNING is provided when an action may cause a serious outcome
(i.e., injury, serious adverse affect, death) to the patient or user. Refer to the text
in the box.
1-3. Caution
CAUTION is given when any special care is to be exercised by the patient or user to avoid injury
to the patient, damage to this device, or damage to other property. Refer to the text in the box.
1-4. Note
NOTE is provided when extra general information is applicable.
1-5. SAFETY INFORMATION, WARNINGS, CAUTIONS, AND NOTES
Oxy9Wave Vet is designed to minimize the possibility of hazards due to errors in the software
program by following 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 air, oxygen-enriched environments, or nitrous
oxide.
⚫The Pulse Oximeter is NOT intended for use as apnea monitor.
⚫A Pulse Oximeter should be considered an early warning device. Given the trend toward
patient hypoxemia, blood samples should be analyzed by laboratory instruments to
understand the patient’s condition completely
⚫The Pulse Oximeter is to be operated by qualified personnel only. This manual, the
accessory directions for use, all precautionary information, and the specifications should
be read before use.
WARNING : THIS IS A SAMPLE WARNING STATEMENT.
CAUTION : THIS IS A SAMPLE CAUTION STATEMENT.
WARNING : Check the items listed below before operating the equipment.

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⚫Electric shock hazard: Do not open the pulse oximeter cover except to replace the battery
of the Handheld unit. Only a qualified operator may perform the maintenance procedures
specifically described in this manual. Refer the servicing to Bionet for repair of this
equipment.
⚫As with all medical equipment, carefully route the patient cabling to reduce the possibility
of patient entanglement or strangulation.
⚫Do not place the pulse oximeter or accessories in a place that may cause it to fall on the
patient. Do not lift pulse oximeter by the power cord or any other cable.
⚫Do not use the pulse oximeter or oximetry sensors during magnetic resonance
imaging(MRI) scanning. Induced current could potentially cause burns. The pulse oximeter
may affect the MRI image, and the MRI unit may affect the accuracy of the oximetry
measurements.
⚫When using 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 duration of the active irradiation period.
⚫Do not place the pulse oximeter on electrical equipment, which may affect the pulse
oximeter and prevent it from working properly.
⚫Do not expose the pulse oximeter to excessive moisture such as direct exposure to rain
(excessive moisture can cause the pulse oximeter to perform inaccurately or fail).
⚫Do not place containers with liquids on or near the pulse oximeter
(liquids spilled on the pulse oximeter may cause it to perform inaccurately or fail).
⚫Failure of Operation –If the pulse oximeter fails any part of the setup procedures or leak
tests, discontinue the operation of the pulse oximeter until qualified service personnel
have corrected the situation.
⚫Patient Safety –If a sensor is damaged in any way, discontinue use immediately.
⚫In case the equipment does not operate as usual, or It is damaged, do not use on the
patient; contact the equipment supply division.

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Ver. 1.52 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. How to Use the Sensor and Precautions

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Ver. 1.52 2.Product description 11
2-1. Introduction
•Intended Use
Oxy9Wave Vet is a veterinary pulse oximetery that measures blood oxygen 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 Configuration
-Major Components
WARNING : Oxy9Wave Vet is intended only for adjunct use in patient assessment.
It must be used in conjunction with clinical signs and symptoms.

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2-3. Product Specifications
•Performance
⊙SpO₂(blood oxygen saturation) ⊙BPM(Pulse rate)
- Range : 40 to 100% - Range : 30 to 250 bpm
- Accuracy : 70~100%, ±2% - Accuracy : ±2bpm
0~69% unspecified
•Display
⊙Type : 3.5”TFT LCD
⊙Pixel : 320 x 480
⊙Displayed Data : SpO₂, BPM, SpO₂Limits, BPM Limits, Level Bar, Pulse rate Wave,
Time and Date, Alarm Volume, Battery Status, and Brightness
⊙LED Display : 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 : BPM010S05N07
⊙Battery
- Type : Lithium-ion battery 4400mAh, 3.6Volts (model : ICR18650 22F-012PTC)
- Operating Times : Up to 20 hours
- Charging Times : 6.5 hours
•General Matters
⊙Operating Temperature : 5℃to 95℃
⊙Non-operating Temperature: -20℃to -70℃
⊙Humidity : 5% to 95% for Storage/Ship, 30% to 85% for Operation
⊙Operating Altitude : -1,000 ft to 12,000 ft
⊙Weight : 300g
⊙Size : 45(H) x 210(W) x 75(D) mm
⊙Memory : SpO₂, BPM (30 days at 10 second intervals)

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Ver. 1.52 2.Product description 13
2-4. GENERAL DESCRIPTION
Oxy9Wave Vet(Pulse oximetry) is a continuous, non-invasive method of measuring the level of
arterial oxygen saturation in blood. The measurement is taken by placing a sensor on a patient –
usually on the animals tongue. The sensor is connected to the pulse oximetry instrument with
patient cable, collecting signal data from the patient and sending it to the instrument
The following figure shows the general 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 principle of spectrum
measurement is used. Specifically, it measures the ratio of absorbed red(664nm) and infrared
(860nm) light generated from these two light sources using the oxygen sensor after passing
through an artery such as that in the fingers while the heart is beating. In other words, it uses the
nature of absorbing more red light when passing through dark red blood which contains less
oxygen and absorbing more infrared light when passing through scarlet blood which contains lots
of oxygen.

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2-6. SYSTEM DESCRIPTION
▣Front View
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 Setting Button
6. MENU Button
6. Pulse beep Setting Button
7. SENSOR OFF Indicator
7. Rotate Display Button

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▣Slide View
▣Back View

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2-7. How to Use the Sensor and Precautions
How to use
Place the probe on the animal’s tongue as indicated in the illustration.
WARNING : Our SPO₂Sensor 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
high-frequency RF electronics, the readings may not be correct.
⚫When used continuously
Check the sensor every 8 hours and cycle power on the unit every 4 hours.
⚫When not in use, store the unit at -20 ℃-+70℃

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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

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Ver. 1.52 3.Setup 18
3-1. LIST OF COMPONENTS
•Oxy9WaveVet Main Body ……………………………….………………………………..……
1ea
•Power Adaptor …………………………………………………………………………………..…..
1ea
•SpO₂Sensor …………………………………………………………………………………….……
1ea
•Lithium-ion Battery …………………………………………………………………………….…
1ea
•Pole Clamp …………………………………………………………………………………………….
1ea
•Manual …………………………………………………………………………………………………..
1ea
•Power Cord ……………………………………………………………………………………………
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.
Pressing the power key makes the machine ready for use.
WARNING :
The AC-DC adaptor (BPM010S05N07) supplied is to be used for medical purposes only.
Never use other DC adaptors with this product.

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Ver. 1.52 3.Setup 19
[ Battery Power ]
3-3. CONNECTING A SENSOR TO Oxy9Wave Vet
Connect a SpO2 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 SpO₂Sensor is a medical product and should be used accordingly.
Improper use or use of other sensors may cause harm to the user.

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Ver. 1.52 3.Setup 20
3-4. CONNECTING a Clamp