MedLinket AM-806 Instruction Manual

MedLinket AM-806 Instruction Manual

Temp-pulse oximeter
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20211230 A.1
Temp-pulse oximeter
REF: AM-806
Instruction Manual
(Suitable for A4 paper printing)
Manual de Instrucciones
(Adecuado para impresión en papel A4)
Original
Traducción
P
2-24
P
1-23

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Summary of Contents for MedLinket AM-806

  • Page 1 Temp-pulse oximeter REF: AM-806 Instruction Manual Original 2-24 (Suitable for A4 paper printing) Manual de Instrucciones Traducción 1-23 (Adecuado para impresión en papel A4) 20211230 A.1...
  • Page 2: Table Of Contents

    Contents Quick Start Guide………………………………………………………………………………………… Foreword …………………………………………………………………………………………………… Warning ……………………………………………………………………………………………………… Latex Content Statement …………………………………………………………………………… Section1-Overview ……………………………………………………………………………………… Intended Use ………………………………………………………………………………………………… Essential Performance …………………………………………………………………………………… About the Pulse Oximeter ……………………………………………………………………………… Identification of Front Panel, Left Panel Buttons and Symbols ………………………… Equipment Symbols ………………………………………………………………………………………… Technical Specifications …………………………………………………………………………………… Product parts and accessories …………………………………………………………………………...
  • Page 3: Quick Start Guide

    Quick Start Guide How to begin? 2. Open the clip of the pulse oximeter, insert a 1. Open battery compartment cover and insert two finger (The preferred application is middle finger new AAA alkaline batteries as indicated below to and index finger), as shown below. ensure the polarity (<+>...
  • Page 4: Foreword

    Foreword The Pulse Oximeter manual is intended to provide information for proper operation and maintenance. General knowledge of monitoring and understanding of the features and functions of the Pulse Oximeter are prerequisites for proper use. Please read these instructions carefully before using this equipment. The manual describing the operating procedures should be followed strictly.
  • Page 5: Latex Content Statement

    Latex Content Statement The PULSE OXIMETER is not made with natural rubber latex in any location that may result in users contact. Section 1- Overview Intended Use This pulse oximeter is not a medical device and is not intended to diagnose and/or treat any medical condition or disease.
  • Page 6: Identification Of Front Panel, Left Panel Buttons And Symbols

    Identification of Front Panel, Left Panel Buttons and Symbols Refer to the PULSE OXIMETER Operator’s manual for a complete description of all buttons, symbols, controls, displays and indicators. Figure 1: PULSE OXIMETER Front Panel and Left Panel 1—Menu button/Power button 6—PPG (photoplethysmograph) 2—%SpO Display...
  • Page 7: Technical Specifications

    Technical Specifications Pulse Oximeter Range 70% to 100% Resolution 90% to 100% range: ±2% Accuracy (under good & 70% to 89% range: ±3% low perfusion) <70%: unspecified Reminder Battery-low indicator Dual wavelength LED Method Pulse Rate Range 30 to 245 bpm Pulse Rate Resolution 1 bpm Pulse Accuracy...
  • Page 8: Product Parts And Accessories

    Environment Operating environment Temperature 41 ~104 (5℃~40℃), humidity ≤80% ℉ ℉ Transportation and Temperature 14 ~104 (-10℃~40℃), humidity ≤80% ℉ ℉ Storage environment Hyperbaric Pressure (Storage, Transportation 86kPa~106kPa and Operating) Classification Protection Against Liquids IPX2 Dimension and Weighting Weight: 31.5g (Not including batteries), Size: 61*34*30.5mm Compliance Item Compliant with...
  • Page 9: Principle Of Measurement

    2. Temperature probe Connector Cable Applied part Figure 3: Temperature probe 3. Accessories (Separate Purchase) 3.1 Wrist strap adapter Accessories Port Connector Figure 4-1: Wrist strap adapter 3.2 Adapter Cable Cable Connector Yoke for connect with SpO probe Figure 4-2: Adapter Cable Principle of Measurement The measurement of PULSE OXIMETER uses a multi-functional oxyhemoglobinometer to transmit some narrow spectrum light bands through...
  • Page 10: Contraindication

    Present SpO2 oximeter transmits light of two wavelengths only, red light and infrared, to differentiate HbO2 from HbR. One side of the sensor contains two LEDs, and the other side contains a photoelectric detector. SpO2 oximeter measures HbO2 saturation in the blood by the light plethysmograph when the pulse beats. The result is quite precise when HbO2 saturation is between 70% to 100%.
  • Page 11: Section 2- Operation

    Section 2- Operation Installation and Verification ● Battery installation Caution: The Pulse Oximeter does not operate with dead batteries and can not be powered by external power source. Install new batteries. 1. Unplug all accessories from the Pulse Oximeter, and press the menu button to access the Setting Interface, turn the PULSE OXIMETER off.
  • Page 12: General Operation

    Procedure 1) Turn on the PULSE OXIMETER by pressing the Menu button. 2) After the device completes the Power-On Self-Test (POST), it will directly switch to measurement interface. %SpO2 3) Long press the button to switch device interface of PULSE OXIMETER, and adjust parameters.
  • Page 13 Note: 1. The detail of setting see table - 1. 2. When placing finger onto the silicone pad, make sure nail is upturned. ● Temperature measurement 1) Plug the temperature probe connector side into the instrument’s USB female connector . 2) Place another side of the temperature probe to user’s surface or esophageal/rec- tal for collecting the temperature signal.
  • Page 14: Safety

    2) There are nine display modes for your choice, See Figure 8. Figure 8.①-Figure 8.⑧ display SpO2 and pulse rate, Figure 8. ⑨ display SpO2, pulse rate and tem- perature. %SpO %SpO %SpO ① ② ③ %SpO ④ ⑤ ⑥ 96.8 %SpO ℉...
  • Page 15: Function Setting Introduction

    3) The attention of Operation ● The equipment should be fully tested to see if it can be used normally before using. ● The finger should be placed properly (see figure 4 of this manual), or else it may cause inaccurate measurement. ●...
  • Page 16 Setting enter Long press the button to enter the interface of settings. The setting interface of PULSE OXIME- TER includes “Alm Setup 1”, “Alm Setup 2” and “Sounds Setup”. Setting enter and exit Exit PULSE OXIMETER setting interface ● Short press the button, move the cursor to select the item of “Exit”, long press the button to return to the POST display.
  • Page 17 Low Limit setting Short press the button in the interface of “Alm Setup 2”, move the cursor to select the item of “SpO2 Alm Lo”, long Limit setting press the button to adjust the parameter of SpO2 in the scope of 50% to 98%.
  • Page 18: Section 3- Troubleshooting

    Warning ● Uncomfortable or painful feeling may appear if use the device ceaselessly, espe- cially for the microcirculation barrier users. It is recommended that the sensor should not be applied to the same finger for over 4 hours. ● For the special users, there should be a more prudent inspecting in the placing process.
  • Page 19: Section 4- Electromagnetic Environment

    No display on With damage in display screen or Contact authorized screen, but the break in the connection spot of distributors transmitting tube of display screen LED lights on. Poor perfusion problem (general- If there's no pulse amplitude ly, there's no display on pulse displayed on the screen, amplitude indicator but the light Please adjust the finger...
  • Page 20 Table 3—Declaration electromagnetic emissions PULSE OXIMETER is intended for use in the electromagnetic environment specified below. The customer or the user of the Oximeter probe should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment-guidance The PULSE OXIMETER uses RF energy for its RF emissions internal function.
  • Page 21: Section 5- Measurement Validation

    Section 5- Measurement Validation The Pulse oximeter accuracy has been validated in human studies against arterial blood sample reference measured with a CO-Oximeter. In a controlled desaturation study, healthy adult volunteers with saturation levels between 70% and 100% SaO2 were studied. Subject Demographics The population characteristics for those studies as follow table 5.
  • Page 22: Graphs

    Table 6—Overall Average Root Mean Square (A ) for PULSE OXIMETER in the range of 70%-100%. Compared to Avg. Reference Functional SaO Specification CO-Oximeter, Functional SaO 70-100% # of Points 70-100% Apr 6-8, 2012 PULSE OXIMETER 1.92 Pass A of 3 Table 7—A values measured by using PULSE OXIMETER in a clinical study.
  • Page 23: Section 6- Service And Maintenance

    Section 6- Service and Maintenance Cleaning and Disinfecting 1. Clean the surface of the oximeter by using a soft cloth dampened with either a commercial, non-abrasive cleaner or a solution of 70% isopropyl alcohol in water, and wiping the surfaces of the oximeter lightly. Please switch off...
  • Page 24: Warranty

    Warranty Our company warrants pulse oximeter at the time of its original purchase and for the subsequence time period of one year. The warranty does not cover the followings: ● The device series number label is torn off or cannot be recognized. ●...

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