MedLinket AM801 Manual

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 SpO2 directly from screen display.
      

Overview

Intended Use

The Pulse Oximeter is intended for spot checking in measuring and displaying functional arterial oxygen saturation (SpO₂) and pulse rate of patients in hospitals, physician's office, clinical settings and home care environment. It's a reusable device intended for adults and pediatrics who are well or poorly perfused.

Essential Performance

The essential performance of this device is defined as SpO₂ accuracy and pulse rate accuracy, or an indication of abnormal operation. Accuracies may be affected as a result of exposure to electromagnetic disturbances that are outside of the environments listed in this Instruction For Use. If such a kind of situation appears, move the device away from the source of electromagnetic disturbances. When there's signal inadequacy, the symbol of "?" will be displayed on the screen, indicating the displayed SpO2 or pulse rate value is potentially incorrect.

About the Pulse Oximeter

The device contains a dual light source (red LED and infrared red LED) and a photo detector. Bone, tissue, pigmentation and venous vessels normally absorb a constant amount of light over time. The arteriolar bed normally pulsates and absorbs variable amounts of light during the pulsations. The ratio of light absorbed is translated in an oxygen saturation measurement (SpO₂). Because a measurement of SpO₂ is dependent on light from the device, excessive ambient light can interfere with this measurement.

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.

1. Menu button/Power button
2. %SpO₂ Display
3. Low Battery indicator
4. Pulse Rate Display (bpm)
5. PPG (photoplethysmograph)
6. Bar graph (The Pulse Amplitude Indicator)
7. Screen turn switch
8. Accessories Port Connector

Equipment Symbols

	Caution
	Non sterile Packaging
	Refer to Instruction manual/booklet
	DO NOT THROW AWAY Intended for multiple use
	Humidity limitation (Storage, Transportation and Operating)
	No SpO2 Alarm
	Compliance with WEEE Standard
	CE Mark: conforms to essential requirements of the Medical Device Directive 93/42/EEC. 0123 is Notified Body Number
	MR unsafe
	Atmospheric Pressure limitation (Storage, Transportation and Operating)
	Type BF (Body Floating) Applied Part
	Storage & transportation temperature limit
	Operation temperature limit
	Environment-friendly use period
	Batch Code
	Date of manufacture
	Protected against vertically falling water drops when enclosure tilted up to 15°

Technical Specifications

Product parts

As shown in the figure below, the Pulse Oximeter is mainly composed of main unit, menu button, screen turn switch, display screen, applied part, battery cover and lanyard.

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, O2Hb, Met Hb and COHb absorb the light of different wavelength, thereby determining O2Hb saturation of different fractions. O2Hb saturation is called "fractional" O2Hb saturation.

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%.

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 SpO₂ waveform will decrease. In this case, the measurement will be more sensitive to interference.
2. For those with a substantial amount of staining dilution drug such as monoxide hemoglobin (COHb), or methionine (MetHb) or thiosalicylic hemoglobin, and some with icterus problem, the SpO₂ determination by this device may be inaccurate.
3. The drugs like dopamine, procaine, prilocaine, lidocaine and butacaine may also be a major factor blamed for serious error of SpO₂ measure.
4. The SpO₂ value serves only as a reference value for judgement of anemic anoxia and toxic anoxia, some patients with serious anemia may also report good SpO₂ measurement.

Attentions

• Keep the oximeter away from dust, vibration, corrosive substances, explosive materials, high temperature and moisture.
• If the oximeter gets wet, please stop using.
• When it is carried from cold environment to warm and humid environment, please do not use it immediately.
• DO NOT operate keys on front panel with sharp materials.
• High temperature or high pressure steam disinfection of the oximeter is not permitted. Refer to User's Manual for instructions of cleaning and disinfection.
• Do not have the oximeter immerged in liquid. When it needs cleaning, please wipe its surface with disinfect solution by soft material. Do not spray any liquid on the device directly.
• When cleaning the device with water, the temperature should be less than 60℃.

Unpacking and Inspection

Remove the equipment of PULSE OXIMETER from the shipping carton and examine for signs of shipping damage. Please check all materials against the packing list. Save the invoice, bill of lading and all packing materials. These may be required if it is necessary to process a claim with the carrier. If anything is missing or damaged, please contact the Technical Service Department.
You can contact by:

• Phone: +86 755 61120085
• Fax: +86 755 61120055
• Email: user07@med-linket.com

Included in the package

Operation

Installation and Verification

Battery installation

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. See table 1.
2. Remove the battery cover out from the bottom of the PULSE OXIMETER.
   
3. Insert two "AAA" size batteries, making sure the battery's positive and negative poles are correctly oriented in the compartment as shown in Figure 3.
4. Closing the battery rear cover.

Explosion hazard. Do not use the PULSE OXIMETER in the presence of flammable anesthetics mixed with air, with oxygen, or nitrous oxide.

To ensure accurate performance and prevent device failure, do not expose the PULSE OXIMETER to extreme moisture such as rain.

Performance Verification

1. Performance Tests
   The power-up performance test verifies that the PULSE OXIMETER is ready for patient monitoring.
2. Power-On Self-Test
   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. The verification procedure (POST) takes 2 to 3 seconds to complete.

If any indicator or display element does not light when the PULSE OXIMETER is turned on, do not use the PULSE OXIMETER. Instead, contact qualified service personnel, your local MED-LINKET representative, or MED-LINKET's Technical Services Department.
Note: Physiological conditions, medical procedures, or external agents that may interfere with the PULSE OXIMETER's ability to detect and show measurements, including dysfunctional hemoglobin, arterial dyes, low perfusion, dark pigment, and externally applied coloring agents such as nail polish, dye, or pigmented cream.
Note: The Pulse Oximeter automatically starts the Power-On Self-Test (POST) to ensure that its internal circuits are functioning properly.

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 measure interface.
   
3. Long press the button to switch device interface of PULSE OXIMETER, adjustment parameters. See table-1.

General Operation

The PULSE OXIMETER can be measure functional oxygen saturation in the blood by itself. See table-1.

Preparative for operating

1. Open up battery compartment cover carefully and then install two "AAA" Alkaline batteries according to the (+/-) polarity.
2. Press the "power switch" key for 1 second to activate the device.

SpO₂ measure

1. Open the clip of PULSE OXIMETER, See figure 4.①.
   
2. Place a finger (The preferred application is middle finger and index finger) on the silicone (Ensure the finger position is correct that the LED (irradiancy) window against finger prominence and the accepting window against finger lunula), see figure 4.②, and then clip the finger, see figure 4.③.
3. Turn on the PULSE OXIMETER by pressing the Power button ""
4. Get the information of SpO₂ directly from screen display.

Note:

1. The detail of setting see table - 1.
2. When put finger into the silicone cushions of the clip, make sure nail is upturned.

Switch Screen turn switch

1. Press the Screen turn switch.
   
2. There are eight display modes for your choice, See Figure 6.① - Figure 6.⑧ display SpO₂ and pulse rate.
   

Function Setting Introduction

Press the Pulse Oximeter Menu button to power on and access to the testing interface, or press the Menu button repeatedly during normal operation sequentially switch parameter-setting interfaces to set up the parameters and then return to the POST display. Settable parameters include high and low SpO₂ limit, high and low bpm limits, high and pulse beep volume.
The device will power off automatically within 8 seconds when there is no any signals input, and users can also use the menu button under parameter-setting interfaces to turn the PULSE OXIMETER off.

Menu Setting

Table 1: Instruction for Menu setting

Function	Instruction for operation	Figures
Power "on" and "off"	Power on Turn on the PULSE OXIMETER by pressing the Menu/Power button "". Power off setting Short press the button, move the cursor to select the item of "power off", and then long press the button to turn the power off. Note: The device will power off automatically within 8 seconds when there is no any signal input.
Setting enter and exit	Setting enter Long press the button to enter the interface of settings. The setting interface of PULSE OXIMETER includes "Alm Setup 1", "Alm Setup 2" and "Sounds Setup".
	Exit PULSE OXIMETER setting interface Short press the button, move the cursor to select the item of "Exit", long press the button return to the POST display.
"Alm" on or off setting	"Alm" on or off setting Short time presses the menu button to enter the interface of settings of "Alm Setup 1". Move the cursor select the item of "Alm", and then long press the button turn the functions on or off. Short press the button, move the cursor to select the item of "Exit", and then long press the button return to the POST display.
"Beep" on or off setting	"Beep" on or off setting Short press the button, move the cursor to select the item of "Beep", and then long press the button to turn the functions on or off.
Default setting	Default setting Short press the button, move the cursor to select the item of "Restore", then long press the button to returns the PULSE OXIMETER to factory default setting. After completing the setting, the interface will indicate "OK". Move the cursor to select the item of "Exit" by short press the button, and then long press the button to return to the POST display.
SpO2 High Limit setting	SpO2 High Limit setting Long press the button to enter the interface of settings of "Alm Setup 2". Short press the button, move the cursor to select the item of "SpO2 Alm Hi", long press the button to adjust the parameter of SpO2 in the scope of 52% to 100%. The default upper limit is 100%.
SpO2 Low Limit setting	SpO2 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 press the button to adjust the parameter of SpO2 in the scope of 50% to 98%. The default lower limit is 94%.
Pulse Rate (PR) High Limit setting	Short press the button in the interface of "Alm Setup 2", move the cursor to select the item of "PR Alm Hi", long press the button to adjust the parameter of BPM in the scope of 32-245bpm. The default upper limit is 130 bpm.
Pulse Rate (PR) Low Limit setting	Short press the button in the interface of "Alm Setup 2", move the cursor to select the item of "PR Alm Lo", long press the button to adjust the parameter of BPM in the scope of 30-243bpm. The default lower limit is 50bpm.
Return to the POST display	After completed above setting, press the button switch to any interface of setting, move the cursor to select the item of "Exit" to return to the POST display.

• Uncomfortable or painful feeling may appear if use the device ceaselessly, especially for the microcirculation barrier patients. It is recommended that the sensor should not be applied to the same finger for over 4 hours.
• For the special patients, there should be a more prudent inspecting in the placing process. The device cannot be clipped on the edema and tender tissue.
• The light (the infrared is invisible) emitted from the device is harmful to the eyes, so the user and the maintenance man should not stare at the light.
• Testee cannot use enamel or other makeup.
• Testee's fingernail cannot be too long.
• Please refer to the correlative literature about the clinical restrictions and caution.
• This device is not intended for treatment.
• The user is not allowed to repair the equipment. Changes or modification not expressly approved by 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 "?" will be displayed on the screen when there's signal inadequacy, indicating the displayed SpO₂ or pulse rate value is potentially incorrect.

Troubleshooting

This section explains how to troubleshoot the PULSE OXIMETER. Tables list possible PULSE OXIMETER difficulties, along with probable causes, and recommended actions to correct the difficulties. Detailed see table 2 as below.
Table 2: Instruction for Menu setting

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
Table 5 — PULSE OXIMETER Clinical study Subject Demographics Record.

ARMS Results

The final analysis was performed on 241 data points collected across 12 subjects. The SpO₂ accuracy performance of each pulse oximeter and sensor combination is identified below.

Where:
ARMS is the accuracy root mean square.
SpO₂ is the test pulse oximeter readings during sample i.
SaO₂ is the Average Reference CO-Oximeter functional oxygen saturation reading during sample i. n is the number of points. The detail of the ARMS Results is below table 6 and table 7.
Table 6—Overall Average Root Mean Square (ARMS) for PULSE OXIMETER in the SpO2 range of 70%-100%.

Table 7—ARMS values measured by using PULSE OXIMETER in a clinical study.

Graphs

1. Scatter plot of the data of PULSE OXIMETER to the Reference CO-Oximeter During Non-Motion Conditions
   

   Item	70-100	90-100	80- <90	70- <80
   # pts	241	80	82	79
   Bias	0.30	1.09	0.61	-0.80
   ARMS	1.92	1.66	1.87	2.20
   Max diff	6.30
   Min diff	-5.50

2. Bland-Altman Plot Comparing the SpO2 Difference between the PULSE OXIMETER and the Reference CO-Oximeter During Non-Motion Conditions
   

   Points analyzed	Sres (%)	Standard deviation	Bias	95% limits of agreement	# of Mean ±2SD	# beyond the 95% limits of agreement	within-subject variance (σ2)	within-subject variance (σ2)
   241	1.93	1.90	0.30	-3.44, 4.05	10	12	2.47	1.12

Service and Maintenance

Cleaning and Disinfecting

1. Clean the surface of the oxmeter 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 pulse oximeter before cleaning. Clean the LED and photo-sensor with moist cloth or cotton ball and alcohol gently.
2. The aforementioned general cleaning process is not for infection prevention. Please contact the specialist for process of contagious infection.

Calibrating

1. Please use the SpO₂ simulator of Fluke Biomedical index 2 to calibrate PULSE OXIMETER for the function of SpO₂ measure. The calibration must be operated to by qualified personnel only.
2. The SpO₂ accuracy can be validated in human studies against arterial blood sample reference measured with a CO-oximeter. All of the process of the clinical study must be complied with standard of EN ISO80601-2-61:2011.

Repairing and Maintenance

1. Please change the batteries when the low-voltage indicator lightens.
2. Please clean the surface of the device before using. Wipe the device with alcohol first, and then let it dry in air or clean it by dry clean fabric.
3. Please take out the batteries if the oximeter is not in use for a long time.
4. The best storage environment of the device is -10°C to 40°C ambient temperature and not higher than 80% relative humidity.
5. Please maintain properly for ensuring the device can be used normally.
6. The device needs to be calibrated once a year (or according to the calibrating program of hospital). It can also be performed at state-appointed agent or just contact us for calibration.

• High-pressure sterilization cannot be used on the device.
• Do not immerse the device in liquid.
• It is recommended that the device should be kept in a dry environment. Humidity may reduce the using life, or even damage the device.

Warnings are identified by the WARNING symbol shown above.

• Explosion hazard. Do not use the PULSE OXIMETER in the presence of flammable anesthetics mixed with air, or with oxygen, or nitrous oxide.
• Do not spray, pour, or spill any liquid on the PULSE OXIMETER, its accessories, connectors, switches.
• Reusable sensors must be moved to a new site at least every 4 hours. Because individual skin condition affects the ability of the skin to tolerate sensor placement, it may be necessary to change the sensor site more frequently with some patients. If skin integrity changes, move the sensor to another site.
• At elevated ambient temperatures, patient skin could be severely burned after prolonged sensor application at sites that are not well perfused. To prevent this condition, be sure to check patient application sites frequently. All listed sensors operate without risk of exceeding 41℃ on the skin if the initial skin temperature does not exceed 35℃.
• Be aware that following removal of the sensor from the patient, it is possible that environmental light may cause the monitor device to continue to display a waveform or data values but these data should not be used as a basis for a clinical diagnosis.
• Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL EQUIPMENT.
• The waste of PULSE OXIMETER must not be disposed as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment.
• Please refer to the correlative literature about the clinical restrictions and caution.
• This device is not intended for treatment.
• The LCD panel contains toxic chemicals. Do not ingest chemicals from a broken LCD panel.
• Do not modify this equipment without authorization of the manufacturer.

Latex Content Statement
The PULSE OXIMETER is not made with natural rubber latex in any location that may result in patient contact.

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. It is recommended that the device should be inspected once a week at least. Please stop using the device when there is obvious damage.
   • Necessary maintenance must be performed by qualified service engineers ONLY. Users are not permitted to maintain it by themselves.
   • The oximeter cannot be used together with devices not specified in User's Manual. Please use the device recommended by Manufacturer.
   • At elevated ambient temperatures, patient skin could be severely burned after prolonged sensor application at sites that are not well perfused. To prevent this condition, be sure to check patient application sites frequently. All listed sensors operate without risk of exceeding 41℃ on the skin if the initial skin temperature does not exceed 35℃.
   • Please remove the finger from the equipment to stop measure and pull the accessories from the equipment, then the PULSE OXIMETER will power off automatically within 8 seconds if the equipment must be closed for the urgent status.
2. • Explosive hazard — DO NOT use the oximeter in environment with inflammable gas such as some ignitable anesthetic agents.
   • DO NOT use the oximeter while the testee is under measurement of MRI and CT.
   • Be cautious of the hanging rope. Please do not break the hanging rope during usage to avoid device damage. Please don't use hanging rope if allergic to hanging rope.
   • Please don't use this product if you are allergic to silica gel and ABS plastic.
   • Please dispose the device, accessory and packing (including plastic bag, foam and carton) according to local law.
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.
   • The SpO₂ sensor and photoelectric receiving tube should be arranged in a way with the testee's arteriole in a position in between.
   • The device should not be used at a location or limb tied with arterial canal or blood pressure cuff of receiving intravenous injection.
   • Make sure the optical path is free from any optical obstacles like rubberized fabric; otherwise it may result in venous pulsation and inaccurate measure of SpO₂.
   • Excessive ambient light may affect the measuring result. It includes fluorescent lamp, dual ruby light, infrared heater, direct sunlight and etc.
   • Strenuous action of the testee or extreme electrosurgical interference may also affect the accuracy.
   • Testee cannot use enamel or other makeup.
   • Please clean and disinfect the device after operating according to the user manual.

Shenzhen Med-link Electronics Tech Co., Ltd.
4th and 5th Floor, Building Two, Hualian Industrial Zone, Xinshi Community, Dalang Street, Longhua District, 518109 Shenzhen, PEOPLE'S REPUBLIC OF CHINA
Email: sales@med-linket.com

Shanghai International Holding Corp. GmbH (Europe)
Add: Eiffestrasse 80, 20537 Hamburg, Germany
Tel: +49-40-2513175
Fax: +49-40-255726