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Caution: Federal (U.S.A) law restricts this device to sale by or on the order of a physician.
How to begin?
1. Open battery compartment cover and insert two new
AAA alkaline batteries as indicated below to ensure the
polarity (<+> and <->) of the batteries are correct and then
close it.
2. Open the clip of the pulse oximeter, insert a finger
(The preferred application is middle finger and index
finger), as shown below.
3. Make sure the sensor LED is above the fingernail as
shown in the below.
4. Turn on the pulse oximeter by pressing the Power
button.
5. Get the information of parameter directly from screen
display.
Scan the QR Code to download the user manual or watch the instruction video, thanks!
User manual in PDF
English, Spanish
Temp-Pulse Oximeter BZ0300A REV: A.0 December. 05, 2022
Quick Start Guide
Model: AM801, AM801R, AM805, AM806, AM806B
Scan the QR code to watch the instruction video on YouTube!
Instruction video
2*AAA
alkaline
battery
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Table of Contents
Related Manuals for MedLinket AM801
Summary of Contents for MedLinket AM801
- Page 1 Temp-Pulse Oximeter BZ0300A REV: A.0 December. 05, 2022 Quick Start Guide Model: AM801, AM801R, AM805, AM806, AM806B Caution: Federal (U.S.A) law restricts this device to sale by or on the order of a physician. How to begin? 1. Open battery compartment cover and insert two new...
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Page 2: Table Of Contents
Temp-Pulse Oximeter BZ0300A REV: A.0 December. 05, 2022 Instruction for Use Model: AM801, AM801R, AM805, AM806, AM806B CONTENTS Foreword..............................1 Warning..............................1 Latex Content Statement........................1 About This Manual..........................2 Section 1 Overview..........................2 Intended Use................................2 Essential Performance............................2 About the Pulse Oximeter............................2 Identification of Front Panel, Left Panel Buttons and Symbols................2... - Page 3 Temp-Pulse Oximeter BZ0300A REV: A.0 December. 05, 2022 Graphs................................... 21 Section 6 Service and Maintenance....................23 Cleaning and Disinfecting............................23 Calibrating................................23 Repairing and Maintenance..........................23 Warnings................................23 Disposal................................. 24 Warranty................................24 Qualified certificate.............................. 24...
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Page 4: Foreword
Temp-Pulse Oximeter BZ0300A REV: A.0 December. 05, 2022 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. -
Page 5: About This Manual
Temp-Pulse Oximeter BZ0300A REV: A.0 December. 05, 2022 About This Manual The PULSE OXIMETER is to be operated by qualified personnel only. Before servicing this product, read the operator's manual carefully and a thorough understanding of operation. Section 1 Overview Intended Use Med-link Pulse Oximeter is a reusable device intended for spot checking in measuring and displaying functional arterial oxygen saturation (SpO... -
Page 6: Equipment Symbols
Temp-Pulse Oximeter BZ0300A REV: A.0 December. 05, 2022 3—Pulse rate display (bpm) 9—Bar graph (the pulse amplitude indicator) 4—Perfusion index display (PI) 10—Signal inadequacy display 5—Low battery indicator 11—Screen turn switch 6—Temperature display 12—Accessories Port Connector Equipment Symbols Type BF (body floating) Atmospheric pressure limitation (storage, applied part transportation and operating) - Page 7 Temp-Pulse Oximeter BZ0300A REV: A.0 December. 05, 2022 range 30% to 100% resolution 90% to 100% range: ±2%; accuracy (under good & low perfusion) 70% to 89% range: ±3% <70%: unspecified Low perfusion index ≤0.3% Reminder Battery-low indicator Method Dual wavelength LED Pulse rate range 30 to 300 bpm Pulse rate resolution...
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Page 8: Product Parts And Accessories
Temp-Pulse Oximeter BZ0300A REV: A.0 December. 05, 2022 Medical device ClassⅡa by EU Directive 93/42/EEC Protection against liquids IPX2 Weight: 31.5g (Not including batteries) Dimension and weighting Size: 61*34*30.5mm Compliance Item Compliant with Type of protection Internally powered equipment (on battery power) Degree of protection Type BF Applied part Mode of operation... -
Page 9: Principle Of Measurement
Temp-Pulse Oximeter BZ0300A REV: A.0 December. 05, 2022 Figure 3-1: Wrist strap adapter 2.2 Probes Figure 3-2: Temperature probe 2.3 Adapter Cable Figure 3-3: Adapter Cable Principle of Measurement The measurement of PULSE OXIMETER uses a multi-functional oxyhemoglobinometer to transmit some narrow spectrum light bands through blood samples, and to measure attenuation of spectrum with different wavelengths according to the characteristic that RHb, O Hb, Met Hb and COHb absorb the light of different wavelength,... -
Page 10: Clinical Restrictions
Temp-Pulse Oximeter BZ0300A REV: A.0 December. 05, 2022 characteristics. Clinical Restrictions 1) As the measure is taken on the basis of arteriole pulse, substantial pulsating blood flow of the testee is required. For a testee with weak pulse due to shock, low ambient, major bleeding, or use of vascular contracting drug, the waveform will decrease. -
Page 11: Included In The Package
1 Piece AM801 standard configuratio Temperature probe 1 Piece AM801, AM805 standard configuratio 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. -
Page 12: Procedure
Temp-Pulse Oximeter BZ0300A REV: A.0 December. 05, 2022 Before using the PULSE OXIMETER, you must verify that the PULSE OXIMETER is working properly and is safe to use. Proper working conditions are verified each time when the PULSE OXIMETER is turned on as described in the following procedure. - Page 13 Temp-Pulse Oximeter BZ0300A REV: A.0 December. 05, 2022 Ensure the finger position is correct that the LED (irradiancy) window against finger prominence and the accepting window against finger lunula), see figure 5.②, and then clip the finger, see figure 5.③. 3) Turn on the PULSE OXIMETER by pressing the Power button “...
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Page 14: Safety
Temp-Pulse Oximeter BZ0300A REV: A.0 December. 05, 2022 2) There are eight display modes for your choice, See Figure 7. Figure 7.①-Figure 7.⑨ display SpO and pulse rate. Figure 7 Safety 1) Safety Instructions for safe operations ● Check the main unit and all accessories periodically to make sure that there is no visible damage that may affect patient’s safety and monitoring performance. -
Page 15: Function Setting Introduction
Temp-Pulse Oximeter BZ0300A REV: A.0 December. 05, 2022 ● It's not an apnea monitor and should not be used for arrhythmia analysis. ● The device should not be used on patients with severe arrhythmia (defined as three or more events of irregularity observed within 30 seconds) because the presence of these irregular cardiac rhythms may cause inaccurate values or the loss of displayed information. - Page 16 Temp-Pulse Oximeter BZ0300A REV: A.0 December. 05, 2022 Note: The device will power off automatically within 8 seconds when there is no any signal input. Setting enter Long press the button to enter the interface of settings. The setting interface of PULSE OXIMETER includes “Setup 1”, “Setup 2”...
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Page 17: Warning
Temp-Pulse Oximeter BZ0300A REV: A.0 December. 05, 2022 low limit setting Short press the button in the interface of“Setup 2” , move the cursor to select the item of“SpO Low” , long press the button limit setting to adjust the parameter of SpO in the ≤SpO High-2 and ≥... -
Page 18: Section 3 Troubleshooting
Temp-Pulse Oximeter BZ0300A REV: A.0 December. 05, 2022 Shenzhen Med-link may void the warranty. Removing the batteries to avoid battery leakage and device damage if long time no use. Note: The device has No Alarm System, just only warning signal is provided. The symbol of "?"... -
Page 19: Section 4 Electromagnetic Environment
Temp-Pulse Oximeter BZ0300A REV: A.0 December. 05, 2022 Section 4 Electromagnetic Environment Electromagnetic Interference Caution This device has been tested and found to comply with the limits for medical devices to the IEC 60601-1-2 and MDD 93/42/EEC. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. - Page 20 Temp-Pulse Oximeter BZ0300A REV: A.0 December. 05, 2022 discharge (ESD) ±2 kV, ±4kV, ±2 kV, ±4kV, ceramic tile. If floors are covered with lEC 61000-4-2 ±8 kV, ±8 kV, synthetic material, the relative humidity ±15 kV air ±15 kV air should be at least 30 %.
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Page 21: Section 5 Measurement Validation
Temp-Pulse Oximeter BZ0300A REV: A.0 December. 05, 2022 Section 5 Measurement Validation The SpO 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% SaO were studied. - Page 22 Temp-Pulse Oximeter BZ0300A REV: A.0 December. 05, 2022 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—ARMS values measured by using PULSE OXIMETER in a clinical study. Compared to Avg.
- Page 23 Temp-Pulse Oximeter BZ0300A REV: A.0 December. 05, 2022 Furthermore, the Respiration Rate accuracy performance of the Med-link oximeter has been evaluated during non-motion conditions as compared to the respiration rate of the ETCO monitoring. The final analysis was performed on 218 data points collected across 33 adult subjects, with subjects in sitting or supine position. The results showed the Shenzhen Med-link Pulse Oximeter to have a mean error of -0.19 and an Arms of 1.05 during steady state conditions over the range of 4-45BPM.
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Page 24: Graphs
Temp-Pulse Oximeter BZ0300A REV: A.0 December. 05, 2022 Male Yellow / Asia hospitalized volunteer Male Yellow / Asia hospitalized volunteer Female flat car flat car Yellow / Asia hospitalized volunteer Male Yellow / Asia hospitalized volunteer Results: The final analysis was performed on 218 data points collected across 33 subjects. The respiration rate accuracy performance of each pulse oximeter combination is identified below. - Page 25 Temp-Pulse Oximeter BZ0300A REV: A.0 December. 05, 2022 Figure 9 — Scatter plot of analysis to compare the difference between DUT and REF respiration rate values During Non-Motion Conditions (using the scattered points of different signs to represent the corresponding subjects) ltrm 4 - 45...
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Page 26: Section 6 Service And Maintenance
Temp-Pulse Oximeter BZ0300A REV: A.0 December. 05, 2022 analyzed deviation limits of Mean exceedi bject ubject agreeme 95% limits variance variance ±2SD (σ2) (σμ2) ±2 agreement -2.22, 1.06 1.04 -0.19 1.066 0.004 1.87 Section 6 Service and Maintenance Cleaning and Disinfecting 1. -
Page 27: Disposal
Temp-Pulse Oximeter BZ0300A REV: A.0 December. 05, 2022 Disposal 1) Used batteries should not be disposed of in the household rubbish. Used Batteries should be deposited at a collection point. 2) At the end of its life, the appliance should not be disposed of in household rubbish. Enquire about the options for regulations into account.
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