MTS Systems Spo2, OX-700 User Manual

Spo2 Sleep & Fitness Monitor
Wrist Pulse Oximeter
OX-700
Users Manual
Users Manual
1. Introduction ..............................................................................................1
2. Using the Monitor .....................................................................................3
3. Maintenance.............................................................................................9
4. Troubleshooting ........................................................................................9
5. Specifications ......................................................................................... 10
6. Electromagnetic Compatibility ................................................................. 11
Contents
1. Introduction
1.1 Intended Use
The OX-700 is intended to be used for measuring, displaying and storing of oxygen saturation (SpO2) pulse rate (PR) and motion in home or a healthcare facilities environment. The App can show real-time SpO2, pulse rate and waveform, display results and share reports.
The data and results provided by this device are for pre­check screening purpose only and cannot be directly used for diagnostic or medical treatment.
Warnings and Cautionary Advices
· DO NOT squeeze the sensor or apply excessive force on the sensor &
cable.
Ÿ Do not use this device during MRI examination. Ÿ Never submerge the device in water or other liquids. Do not clean the
device with acetone or other volatile solutions.
Ÿ Do not place this device in pressure vessels or gas sterilization device. Ÿ Consult your doctor immediately if you experience symptoms that could
indicate acute disease.
Ÿ Do not self-diagnose or self-medicate on the basis of this device without
consulting your doctor. In particular, do not start taking any new medication or change the type and/or dosage of any existing medication without prior approval.
Ÿ Use only cables, sensors and other accessories specified in this manual. Ÿ Prolonged continuous SpO
undesirable changes in skin characteristics, such as irritation, reddening, blistering or burns.
Ÿ Check the SpO
positioning of the sensor and the circulation and skin sensitivity of the patient. Patient sensitivity varies depending on medical status or skin condition. For patients with poor peripheral blood circulation or sensitive
sensor application site every 6-8 hours to determine the
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monitoring may increase the risk of
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1
skin, inspect the sensor site more frequently.
Symbol
Description
CE Marking indicating
conformance to EC directive
MRI unsafe. Presents hazards in all MR
Indicate separate collection for electrical and
Ÿ Functional tester cannot be used to assess the accuracy of a SpO
sensor or a device.
Ÿ This device is designed to determine the arterial oxygen saturation
percentage of functional hemoglobin. Factors that may degrade pulse oximeter performance or affect the accuracy of the measurement include the following:
- excess ambient light
- excessive motion
- electrosurgical interference
- blood flow restrictors (arterial catheters, blood pressure cuffs, infusion lines, etc.)
- moisture in the sensor
- improperly applied sensor
- incorrect sensor type
- poor pulse quality
- venous pulsations
- anemia or low hemoglobin -concentrations
- cardiogreen and other -intravascular dyes
- carboxyhemoglobin
- methemoglobin
- dysfunctional hemoglobin
1.2 Guide to Symbols
Type BF-Applied Part
Manufacturer
European authorized representative
2
CE0197
No. 93/42/EEC concerning medical devices.
environments as device contains strongly ferromagnetic materials.
electronic equipment (WEEE).
2
Protected against spraying water and against
IP22
access to hazardous parts with a tool, per IEC
60529.
Follow Instructions for Use.
Warning and Caution!
SN Serial number
No alarm system.
1.3 OX-700 Contains
1 x Monitor 1 x Ring Sensor 1 x Charging Cable 1 x Users Manual
2 Using the Monitor
2.1 Download App
App name: ViHealth iOS: App Store Android: Google Play
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2.2 Charging
Charge the battery before using. Connect the device to the USB computer port or a USB charging adapter. After fully charged, the device will power off automatically.
2.3 POWER ON/OFF
POWER ON:
Press the button for 1 second to turn on the device.
POWER OFF:
Recommended way: Manually: press the button for about 2 seconds to turn off.
Device turns off automatically in 2 minutes if no measurement, no operation and no App connection.
2.4 Bluetooth Connection
The device Bluetooth will be enabled automatically only when the display screen is active (On). To establish a Bluetooth connection,
1) Ensure the device screen is on to keep the device Bluetooth enabled.
2) Make sure the phone Bluetooth is enabled.
3) Run the App Check O2, then select the Device ID for the initial use.
Note: DO NOT PAIR in the settings of your smartphone
2.5 Operation Mode Navigation
The device has two operation modes: Spo2 Sleep Mode and Fitness Monitor Mode. Turn on the device,
when the display is blinking, press the button to switch between modes.
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Spo2 Sleep Mode
Parameters SpO2, PR, Motion Screen Activated by button The Sensor Vibrates
Bluetooth Report Sleep report Monitor report
When SpO2 is
lower than
threshold set
On when the
screen lights up
Fitness Monitor Mode
SpO2, PR, Steps
Always on
When SpO2 is lower than threshold set
Or when step goal is
met
Always on
2.6 Spo2 Sleep Mode Recording
(Records Spo2, Pulse Rate & Motion)
START. Charge the battery. Wear the device and the Ring Sensor, press the button to power on. Go to sleep.
STOP. In the morning, take off the Ring Sensor (and the device), the recording will be over after the countdown timer stops.
DATA SYNC: Start the device by holding the start/stop button for 2 seconds. Current time will display. Now start App and it will connect with the device and upload any new files.
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2.7 Fitness Mode Recording
(Records Spo2, Pulse Rate & Steps)
1) Connect the sensor cable to the device.
2) Wear the device on the left wrist; wear the
sensor on the thumb. If it is too tight, use
another finger. The device works properly with any finger.
3) Turn on the device. After a few seconds, the
device will begin to monitor. (If the working time is less than 1 minute, the data will not be saved)
Note:
· The device can also work as a clock and pedometer without
ring sensor, and the steps will restart counting after the ring sensor plugged in.
· Please avoid excessive motion for the sensed finger during
recording and avoid any strong ambient light condition.
2.8 Stop monitoring & sync data
Take off the sensor, the countdown timer will begin. During the countdown, if you wear the sensor again, the record will be resumed. After the countdown timer
stops, the data will be ready for sync. Data Sync: Make sure the device is on (display will be
on). Start App and it will connect with the device and upload any new files.
Note: The device can store a maximum of 4 records. The oldest record will be overwritten when the 5th record is recorded. Please sync data in time to insure no
records are lost.
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O2 7.5 13
MODE
MODE
18:45
Z
Z
Z M
2.9 Display
Time, Remaining battery capacity Sleep Mode Monitor Mode
SPO2
Blood oxygen saturation Pulse rate in Sleep Mode Pulse rate in Monitor Mode Wear the sensor Steps O2 Score, SpO2 drop times
During measurement, pressing the button will change the display information.
.
2.10 Real-time Dashboard
You can check real-time SpO2, PR and pulse waveform using the App.
1) Connect the device to App.
2) On the App, select Dashboard from the Lower Tab line.
2.11 Smart Vibration
The vibrator in the sensor will be activated when the SpO2 falls below the pre-set value (Threshold). The vibration will stop when the SpO2 value goes above the set Threshold, or by pressing the mode button.
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0
10
You can customize the vibration to help you sleep better. Make sure your device is connected to App first. Then you can configure it in App->Device.
· You can switch on or off the vibration.
· You can adjust the Intensity of vibration.
· You can adjust the Threshold. This sets the
trigger value of the vibration alarm in % of Spo2.
2.12 View Results and Report
In the App, you can review all the historic data. By touching a record, the App will display a detailed report. It includes analysis results and charts. Slide a record to the left will delete it.
2.13 O2 Score
O2 Score is overall an assessment of oxygen condition, which synthesizes the frequency, depth and duration of oxygen shortage overnight. The range is 0-10 (10 is best). It is provided for each recorded in Spo2 Sleep Mode.
Example:
O2 Score 7.5 (in the APP)
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Problem
Possible Cause
Possible
Solution
3 Maintenance
3.1 Cleaning
Use a soft cloth moistened with water or alcohol to clean the device surface.
3.2 Firmware Update
1) Connect the monitor with the APP.
2) Enter the APP, visit Device à Device Update. Start
an update by selecting the update tab.
3.3 Battery
To keep the battery in good condition, charge the battery every 6 months when the device is not in use.
4 Troubleshooting
Device does not turn on or has no response .
The app cannot find the device.
Battery may be low. Charge battery and try Unexpected
software condition Device might be damaged. The Bluetooth of your phone is off. The device Bluetooth is off in Sleep Mode.
again. Press the button for about 10 seconds to reset Please contact MTS.
Turn on the Bluetooth in the phone. Press the button, the Bluetooth will be turned on when the screen lights up.
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5 Specifications
Classifications
MDD, 93/42/EEC
R&TTE, 1999/5/EC
ROHS 2.0, 2011/65/EU
Degree protection
Environmental
Item Operating
Storage
Temperature
5 to 40°C
-25 to 70°C
Relative humidity
Barometric
700 to 1060 hPa
700 to 1060 hPa
Degree of dust & water
Physical
Weight
12 g (monitor
unit) Display
OLED Wireless
Bluetooth 4.0
BLE Vibrator
Built in
Power Supply
Charge input:
DC 5V
±
10% Battery type
Rechargeable lithium
-
polymer
battery
Charge time
2 hours
SpO2
Standards
Meet standards of ISO 80601
-2-61
Measurement accuracy verification: The SpO
accuracy has been
SpO2 range 70% to 100%
SpO
Accuracy
PR range
30 to 250 bpm
EC Directive
against electrical shock
(noncondensing)
resistance
Type BF
10% to 95% 10% to 95%
IP22
2
verified in human experiments by comparing with arterial blood sample reference measured with a CO-oximeter. The pulse rate accuracy has been verified by Emulator. Pulse oximeter measurement are statistically distributed and about two-thirds of the measurements are expected to come within the specified accuracy range compared to CO-oximeter measurements.
2
(Arms)
80-100%:±2%, 70-79%:±3%
PR accuracy
±2 bpm or ±2%whichever is greater
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Wave length
660-940nm Output power
Red/Infrared: 3mW max. avg.
Pedometer
Range 0 to 99999 steps
Storage
Capacity
4
records
,10 hours for each
Sleep analysis
Record parameters
SpO2, pulse rate, motion
Record interval
4s
Drop analysis
Yes Mobile APP
iOS iOS 9.0 or above, iPhone 4s/iPad 3 or above
Android
Android 4.4 or above, with
Bluetooth
4.0 BLE
6. Electromagnetic Compatibility
The device meets the requirements of EN 60601-1-2.
Warnings and Cautions
· Using accessories other than those specified in this manual may result in
increased electromagnetic emission or decreased electromagnetic immunity of the equipment.
· The device or its components should not be used adjacent to or stacked with
other equipment.
· The device needs special precautions regarding EMC and needs to be installed
and put into service according to the EMC information provided below.
· Other devices may interfere with this device even though they meet the
requirements of CISPR.
· When the inputted signal is below the minimum amplitude provided in technical
specifications, erroneous measurements could result.
· Portable and mobile communication equipment may affect the performance of
this device.
· Other devices that have RF transmitter or source may affect this device (e.g. cell
phones, PDAs, and PCs with wireless function).
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Manufactured for:
Medical Test Supply LLC Tel: 1-855-270-5357
E-Mail: admin@medicaltestsupply.com Website: www.medicaltestsupply.com
PNOX-700M Version: B
Contents of this manual are subject to changes without prior notice.
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