Oxitone 1000M User Manual

Spot check wrist worn pulse oximeter

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User Manual

Oxitone 1000M

Spot check wrist worn pulse oximeter

CAT.NO.OM2002

25.01.2021

Rev. 1.2

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Page 1 User Manual Oxitone 1000M Spot check wrist worn pulse oximeter CAT.NO.OM2002 25.01.2021 Rev. 1.2...
Page 2 Oxitone. Oxitone Medical Ltd. Is liable for the safety, reliability or the performance of this instrument only if:  The instrument has been used according to the accompanying operating instructions.
Page 3 Information provided by Oxitone Medical Ltd. is believed to be accurate and reliable. However, Oxitone Medical Ltd. assumes no responsibility for the use of such information, nor for any infringements of patents or other rights of third parties, that may result from its use.
Page 4: Table Of Contents
ESCRIPTION OF EVICE 3. Conditions for Use 3.1. I ............................7 NDICATIONS FOR USE 3.2. C ............................7 ONTRAINDICATIONS 3.3. O 1000M BLE C ………………………………………………………………………………………………………………. 7 XITONE ONNECTIVITY 4. Safety 4.1. E ............................... 8 LECTRICAL AFETY 4.2. EMC C .............................. 8 OMPLIANCE 4.3.
Page 5: About This User Manual
User Manual Rev. 1.2 1. ABOUT THIS USER MANUAL This User Manual provides the information necessary to operate and maintain the Oxitone 1000M wrist worn pulse oximeter device. PLEASE READ THIS USER MANUAL BEFORE OPERATING THE SYSTEM. If any part of this User Manual is not clear, contact Customer Support for assistance.
Page 6: Overview Of System
User Manual Rev. 1.2 2. OVERVIEW OF SYSTEM 2.1. DESCRIPTION OF DEVICE The Oxitone 1000M wrist worn pulse oximeter is a small, lightweight, portable device that non- invasively monitors and displays numeric values of arterial blood functional oxygen saturation of arterial Hemoglobin (%SPO ) and pulse rate (P.R.).
Page 7: Conditions For Use
3. CONDITIONS FOR USE 3.1. INDICATIONS FOR USE The Oxitone Model 1000M Pulse Oximeter is a small, wrist-worn device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate. It is intended for spot-checking of adult patients with wrist between 13-22 cm circumferences in hospitals, clinics, long-term care, and home use.
Page 8: Safety
Avoid excessive pressure to the sensor application site as this may cause damage to the skin beneath the sensor (device straps tighten). The Oxitone 1000M is located on the patient wrist to activate the device properly. Check the application site every 4 hours for skin integrity. If there is any concern, remove the Oxitone 1000M and replace with another pulse oximeter with a different application site.
Page 9 Excessive device wearing pressure for prolonged periods can induce pressure injury. Only apply the device on clean, intact wrist skin. Do not use the Oxitone 1000M outside the declared environmental conditions (see Section Error! Reference source not found.). Operating the device outside the declared environmental conditions can lead to incorrect measurements.
Page 10 Pulse rate measurement is based on the optical signal detection of a peripheral blood flow pulse and therefore may not detect certain arrhythmias. Do not expose the Oxitone 1000M to excessive moisture such as direct exposure to rain. Excessive moisture can cause the monitor to perform inaccurately or fail.
Page 11 Bluetooth radio to a compatible Bluetooth device giving patience increased ability to move freely – without being hindered by cables. Oxitone 1000M module uses a Bluetooth radio with a range of about 10 meters (33 feet) (spherical radius). Moving outside this range may cause missing or lost data.
Page 12: Setting Up The System
Oxitone 1000M User Manual Rev. 1.2 5. SETTING UP THE SYSTEM 5.1. SYSTEM COMPONENTS The components of the Oxitone 1000M system are shown below: Wrist device – front view 5.1.1 Device enclosure OLED screen Attachment Velcro (wristband) Power On/Off Page 12 of 39...
Page 13: Preparing For Use
 Understand its status and messages (see Section 6.1. Monitoring Screen and Display Symbols and Section Error! Reference source not found.). Caution: The Oxitone 1000M is designed to operate on adult patients with wrist between 13-22 cm circumferences. 5.2.1. INITIAL SETUP ...
Page 14: Putting On The Wrist Worn Device
Oxitone 1000M User Manual Rev. 1.2 5.3. PUTTING ON THE WRIST WORN DEVICE Note: Make sure the device is fully charged before wearing it. See Section 9.1. Charging the Battery for charging instructions. Place the device on your hand wrist with the optical aperture elastic concave surface (see below) on top of the Ulna bone (the knobby protrusion of the wrist).
Page 15: Incorrect Placement
To start the system, press the Power On button on the front of the device for ½ a second: Power On button The OLED screen will be illuminated and after releasing the button, the Oxitone logo will briefly appear: The Measurement in Progress screen will be displayed for a few seconds, during which the user...
Page 16: Monitoring
Red Bluetooth symbol, indicates there is a problem with the BLE component, if the indication persists after a power cycle, the device needs servicing at Oxitone's service center. White Bluetooth symbol, indicates the BLE is functioning but not connected.
Page 17 BLE roles are split into pre-connection and post-connection. Pre-connection At startup the Oxitone 1000M is either a peripheral or a central.  A peripheral advertises itself and waits for a central to connect to it.  A central scans for other devices, a central is usually a smartphone PC.
Page 18: Numeric Display - Spo2
• Low arterial perfusion • Motion artifact 6.3. NUMERIC DISPLAY – PULSE RATE The pulse rate displayed on the Oxitone 1000M may differ slightly from the heart rate displayed on ECG monitors due to differences in averaging times. Power off Strong click, aprox.
Page 19: Steps Screen
Oxitone 1000M User Manual Rev. 1.2 If you tap the button again, the Steps screen will display (see below). Otherwise, after 30 seconds the Measurement screen will automatically be displayed. 6.5. STEPS SCREEN While viewing the Time screen, tap briefly on the button to display the Steps screen: Note: Steps are calculated for the current day, from 12 am to 12 pm.
Page 20: Alarm And Messages
6.6. ALARM AND MESSAGES Event Message type and duration Vibration type and duration Power on Oxitone logo and version number is Strong vibration for 1 second displayed for aprox. 5 seconds Signal acquisition on "Stay still measurement in progress" power up...
Page 21: Labels And Symbols
Oxitone 1000M User Manual Rev. 1.2 7. LABELS AND SYMBOLS 7.1. DEVICE LABEL 7.2. CHARGER LABEL Page 21 of 39...
Page 22: Symbols
Oxitone 1000M User Manual Rev. 1.2 7.3. SYMBOLS A number of internationally recognized symbols are found on the labels. These relate to safety requirements and standards and are described below. Symbol Meaning Follow instructions for use Consult instructions for use Type BF Applied Part (Patient isolation from electrical shock) CE marking indicating conformance to EC Directive No.
Page 23: Cleaning And Disinfecting
A soft cloth dampened lightly with water may be used. In-between patients the Oxitone 1000M should be cleaned and low-level disinfected. To clean, wipe the device surfaces with a soft cloth swab moistened in ethyl alcohol. Note that ethyl...
Page 24: Service And Maintenance
 Whenever the Oxitone 1000M (client/host) tries to connect for the first time to the watch, the Oxitone 1000M (watch) will vibrate and display a message to the user that a device (the device name will be displayed on the screen) tries to connect to it.
Page 25 BLE uses a license-free, globally available frequency range in the ISM band, which ensures communication compatibility worldwide. Oxitone's use of BLE technology allows all the device's measurements to be transmitted compatible BLE-enabled device. BLE connectivity gives patients increased ability to move freely.
Page 26 A server can send data to the client without a read/write request using indicate and notify operations. Oxitone 1000M has the role of a peripheral (server/slave) Connecting to Oxitone 1000M Whenever a device (client/host) tries to connect for the first time to the watch, the watch will ...
Page 27: Service And Repair Policy
User Manual Rev. 1.2 9.3. SERVICE AND REPAIR POLICY Warranty repair and service must be performed by Oxitone Ltd. When Oxitone warranty is not applicable, repairs are made by Oxitone or authorized representatives, using current list price for replacement part(s) plus a reasonable labor and handling charge.
Page 28 Power ON. 10.1. REPLACING THE STRAPS ON THE OXITONE 1000M Follow the below steps to replace your Oxitone 1000M starps. 1. Slide the band’s spring bar inwards. 2. Pull the band away from the Oxitone 1000M body.
Page 29 Oxitone 1000M User Manual Rev. 1.2 3. Insert one end of the spring bar into the Oxitone 1000M. 4. Slide the spring bar inwards and connect the band. Page 29 of 39...
Page 30: Specifications And Compliance Standards
Oxitone 1000M User Manual Rev. 1.2 SPECIFICATIONS AND COMPLIANCE STANDARDS Performance Measurement Range 0%-100% PR (pulse rate) 30-250 bpm Accuracy Arterial Oxygen Saturation, 70% to 100% ± 3% Pulse Rate Accuracy ± 3 bpm Resolution Arterial Oxygen Saturation (SpO Pulse Rate...
Page 31 Oxitone 1000M User Manual Rev. 1.2 Display / Indicators Data display: SpO %, pulse rate (PR) beats per minute, battery level indicator, system status poor signal indicator and skin temperature. Type OLED Compliance Equipment Classification IEC 60601-1 Type of Protection (battery power)
Page 32: Accuracy Testing
Co-Oximeter per ISO 80601-2-61. The variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population. Accuracy summary of Oxitone 1000M – comparison to reference CO-oximetry: Spec 3% for Oxitone1000M 70—100...
Page 33: Manufacturer's Declaration (Emc)
Oxitone 1000M User Manual Rev. 1.2 Oxitone 1000M has been validated to pulse rate accuracy for the range of 30-250 bpm in bench top testing against a Fluke ProSim 8 simulator. This variation equals plus or minus one standard deviation which encompasses 68% of the population.
Page 34 Oxitone 1000M User Manual Rev. 1.2 Federal Communication Commission (FCC) Notice (Canada) The term "IC" before the certification/registration number only signifies that the industry Canada technical specifications were met. Le terme "IC" devant le numéro de certification / d'enregistrement signifie seulement que les spécifications techniques Indsutrie Canada ont été...
Page 35 Oxitone 1000M User Manual Rev. 1.2 Table 1: Electromagnetic Emission Emission Test Compliance Electromagnetic Environment - Guidance This device is intended for use in the electromagnetic environment specified below: The customer and / or user of this should ensure that it is used in such an environment...
Page 36 Oxitone 1000M User Manual Rev. 1.2 Table 2: Electromagnetic Immunity Immunity Test IEC Test Level Compliance Electromagnetic Environment Guidance 60601-1-2 Level This device is intended for use in the electromagnetic environment specified below:The customer and / or user of this should ensure that it is used in such an environment...
Page 37 Oxitone 1000M User Manual Rev. 1.2 NOTE: U is the AC mains voltage before application of the test level. Table 3: Guidance and Manufacturer's Declaration-Electromagnetic Immunity Immunity Test IEC 60601-1-2 Test Level Compliance Electromagnetic Environment Guidance Level This device is intended for use in the electromagnetic environment specified below:...
Page 38 Oxitone 1000M User Manual Rev. 1.2 a. Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless) telephones and land mobile radios, amateur radio, AM and FM radiobroadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
Page 39: Warranty
11.1.2 WARRANTY Oxitone Ltd. warrants to the initial purchaser for a period of one (1) year from the date of purchase that: (1) each new product and the software media as delivered are free from defects in workmanship or materials, and (2) the product and software will perform substantially as labeled in the directions for use.