Med-Linket Saturimetro da dito Professionale Certificato

Product Information

This Manual, Section1-Overview, Intended Use, About the PulseOximeter, Identification of Front Panel, Left Panel Buttons andSymbols, Equipment Symbols, Technical Specifications, Product partsand accessories, Principle of Measurement, Contraindication,Attentions, Unpacking and Inspection, Included in the package,Section 2- Operation, Installation and Verification, GeneralOperation, Safety, Function Setting Introduction, Menu Setting,Section 3- Troubleshooting, Section 4- Electromagnetic Environment,Electromagnetic Interference Caution, Electromagnetic Environment,Section 5- Measurement Validation, Subject Demographics, ARMSResults, Graphs, Section 6- Service and Maintenance, Cleaning andDisinfecting, Calibrating, Repairing and Maintenance, Disposal,Warranty, Qualified certificate

Product Usage Instructions

1. Open the battery compartment cover and insert two new AAAalkaline batteries, ensuring the correct polarity.
2. Open the clip of the pulse oximeter and insert a finger(preferably middle finger or index finger).
3. Make sure the sensor LED is positioned above thefingernail.
4. Turn on the pulse oximeter by pressing the Power button.
5. View the SpO2 information directly from the screendisplay.

For more detailed instructions, please refer to the user manual in PDF or watch the instruction video.

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 below.
4. Turn on the pulse oximeter by pressing the Power button.
5. Get the information of SpO2 directly from screen display.

Scan the QR code to download the user manual or watch the instruction video, thanks!

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. Failure to follow these instructions can cause measuring abnormality, equipment damage and personal injury. The manufacturer is NOT responsible for the safety, reliability and performance issues and any monitoring abnormality, personal injury and equipment damage due to user’s negligence of the operation instructions.
The Pulse Oximeter is a medical device, and can be used repeatedly.

Warning

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 and its accessories.
• 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 , be sure to check patient application sites frequently. The temperature of the sensor contacting with skin won’t exceed 41℃ if the initial skin temperature doesn’t exceed 35℃.
• Be aware that following removal of the sensor from the patient, it is possible that environmental light may cause the oximeter 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 ELECTRI-CAL  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 disposal of your equipment.
• 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.
• Don’t reuse disposable temperature probe or it may cause cross-infection among patients.

Latex Content Statement

The PULSE OXIMETER and accessories are not made with natural rubber latex in any location that may result in patient contact.

About This Manual

The PULSE OXIMETER is to be operated by qualified personnel only. Before servicing this product, read the operator’s manual carefully to get a thorough understanding of operation.

Section 1- Overview

Intended Use
The Pulse Oximeter is intended for spot checking in measuring and displaying functional arterial oxygen saturation (SpO2), pulse rate and temperature of patients in hospitals, physician’s office, clinical settings and home care environment.
Target population: Adult, adolescent and child.

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.

Equipment Symbols

Technical Specifications

Pulse Oximeter

SpO2 Range| 70% to 100%
SpO2 Resolution| 1%
SpO2 Accuracy (under good & low perfusion)| 90% to 100% range: ±2%;
70% to 89% range: ±3%
<70%: unspecified;
Reminder| Battery-low indicator
Method| Dual wavelength LED
Pulse Rate Range| 30 to 245 bpm
Pulse Rate Resolution| 1 bpm
Pulse Accuracy (under good & low perfusion)| ±3 bpm
LED Wavelengths| Red: approximately 660nm; Infrared: approximately 905nm
Optical output power| Less than 15mW
Temperature

Note:The function of temperature measurement works by the accessory of temperature probe.

Shortest measurement time recommended| 5min
Measuring site| skin surface
Reference body site| Oral cavity and axilla
Range, Accuracy| 77°to 113°F (25℃ to 45℃): ±0.1℃
Display Resolution| ±0.1℃
Power Supply Requirements

Note: The Oximeter does not include batteries.

Batteries| 1.5V (AAA) alkaline batteryX2 (IEC Type LR03)
Adaptable Range| 2.6V～3.6V
Only SpO2 function works| Less than 55mA
Only Temp function works| Less than 40mA
SpO2 and Temp function work together| Less than 60mA
Display Parameters| SpO2, Pulse Rate, Pulse Waveform Display, Bar Graph and Low Battery Indicator
Data Update Period| 8s
Reminder Response Time| <2s
SpO2 plethysmogram,

pulse sound

| 50Hz
Value of Pulse and SpO2| 1Hz
Environment

Operating environment| Temperature 41°~104°(5℃~40℃), humidity ≤80%
Transportation and Storage environment| Temperature 14°~104°(-10℃~40℃), humidity ≤80%
Hyperbaric Pressure (Storage, Transportation and Operating)| ****

86kPa～106kPa

Classification
Medical device| ClassⅡa by EU Directive 93/42/EEC
Protection Against Liquids| IPX2
Dimension and Weighting| Weight: 31.5g (Not including batteries), Size: 613430.5mm
Compliance
Item                                        Compliant with
Type of protection| Internally powered equipment (on battery power)
Degree of protection| Type BF Applied part
Mode of operation| Continuous
Compatibility| The surface material has no harm or toxicity for the person in contact.

Product parts and accessories

The Pulse Oximeter is composed of instrument and accessories. The accessories include adapter cable and temperature probe . Detail of the instrument and accesso-ries see figure 2 and figure 3.

Instrument

Accessories (Separate Purchase)

multi-functional adapter

Probes

Adapter Cable

Principle of Measurement
The measurement of PULSE OXIMETER uses a multi-functional oxyhemoglobinome-ter 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 saturatiion is between 70% to 100%.
Regarding temperature measurement, it’s based on the principle that resistance of thermistor based on the metal conductor increases with temperature decrease, and changes linearly with the temperature measurement characteristics.

Contraindication
The device can not be used for patients with diseases or conditions including blood microcirculation disorder, excessive staining in the blood, disorders of important hemoglobin indicators and severe arrhythmia.

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℃.
• Temperature probe that is compatible with pulse oximeter mentioned in this IFU include W0024E.
• The operator is responsible for checking the compatibility of the equipment connected,probe cable extender and probe before use.
• Incompatible components can result in degraded performance.

Unpacking and Inspection
Remove the instrument 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

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 does not input outer power.

Install new batteries.

1. Unplug all accessories from the Pulse Oximeter, and press the menu bar to access the Setting Interface, turn the PULSE OXIMETER off. See table 1.
2. Remove the battery rear cover towards the direction indicated on the cover.
3. Insert two “AAA” size batteries, making sure the battery’s positive and negative poles are correctly oriented in the battery compartment as shown in Figure 4.
4. Close the battery rear cover.

Performance Verification

1. Performance Tests
   Power up the device to get the oximeter ready for measurement.

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.

Caution: 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 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 measurement interface.
3. Long press the button to switch device interface of PULSE OXIMETER, and adjust parameters. See table-1.

Low perfusion test

SpO2 simulator is used to simulate SpO2 and pulse rate values to verify oximeter’s performance under low perfusion condition. First, the oximeter is clamped onto the optical signal generator of the SpO2 simulator, then the simulator is turned on to set specific SpO2 and pulse rate values. In addition, different perfusion levels like 0.1%can also be set on the simulator. The values of SpO2 and pulse rate displayed on the oximeter are then compared to those preset on the SpO2 simulator to verify whether accuracy requirements can be met.

General Operation

The PULSE OXIMETER can be measure functional oxygen saturation in the blood
by itself or plug an accessory of MED-LINKET SpO2 probe into the instrument. To measure the body temperature by apply a temperature probe of MED-LINK. See table-1.

Preparative for operating

1. Insert batteries according to the installation procedure above.
2. Press the “power ” key for 1 second to activate the device.

SpO2 measurement

1. 1. Open the clip of PULSE OXIMETER, See figure 5.①.

2. Place a finger ( The preferred application is middle finger and index finger) on the silicone and ensure the finger position is correct , see figure 5.②, and then clamp the finger, see figure 5.③.

2. 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.

Temperature measurement

1. Plug the temperature probe connector side into the instrument’s USB female connector , and then place another side of the temperature probe to patient’s surface or Esophageal/Rectal for collecting the temperature signal.
2. Get the information of Temperature directly from screen display.

Switch screen display mode

1. Press the Display mode switch, See figure 6.
2. There are nine display modes for your choice, See Figure 7. Figure 7.①-Figure 7.⑧ display SpO2 and pulse rate, Figure 7. ⑨ display SpO2, pulse rate and temperature.

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.
• Please remove the finger from the instrument to stop measure and pull the acces-sories from the instrument, then the PULSE OXIMETER will power off automatically within 8 seconds if the instrument must be closed for the urgent status.

Warnings

• 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 cable. Please do not break the cable during usage to avoid device damage. Please don’t use cable if allergic to cable.
• Please don’t use this product if you are allergic to silicone pad and ABS plastic.
• Please dispose the device, accessory and packing (including plastic bag, foam and carton) according to local law.

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 5 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 SpO2 sensor should not be used at a location or limb tied with arterial cathe-ter 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.
• The device is not intended for use under motion conditions.

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 to switch to 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, which can also be turned off by using the menu button under parameter-setting interfaces.

Menu Setting

Warning

• 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 clamped 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.
• 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.
• 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.

Note: The device has No Alarm System, just only warning signal is provided.

Section 3- 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

Phenomena| Possible Causes| Solutions|
---|---|---|---
 | The power button was not pressed in place| Re-press the power button in place, and keep 1-2 seconds|
 | Not Install battery| Install battery|
Abnormal starting-up| Battery use-out| Replace battery|
of Pulse-Oximeter|
 |  |
(display screen and| Install battery improperly Partial| Check and re- install battery|
transmitting tube of| damage of Metal dome (which is| Contact authorized|
LCD presenting lights

off ）

| directly connected to the battery).| distributors|
 |  |
 | Damage in Connection between|  |
 | mainboard and battery holder

(i.e. Damage in flexible printed circuit board (FPCB) or break in

| Contact authorized

distributors

|
 | welding spot).|  |
No display on screen, but the transmitting tube of LED lights on.| With damage in display screen or break in the connection spot of display screen| Contact authorized

distributors

---|---|---

No reading display on Pulse-Oximeter

| Poor perfusion problem (general- ly, there’s no display on pulse amplitude indicator but the light of LED transmitting tube is on and the finger is inserted in place)| If there’s no pulse amplitude displayed on the screen, Please,Adjust the finger position;Use your middle or index finger in preference; Warm your fingers;
The transmitting tube of LED lights off| Contact authorized

distributors

Fail auto-off

| External Temp-probe is still working| Pull out the external temp-probe
Damage in collection tube or other device parts.| Contact authorized

distributors

Inaccurate Temp

Measurement

| The surface Temp-Probe did not firmly stick on the skin surface.| Stick the Temp-Probe on the proper measuring position by medical proof fabric

Wrong position of Temp-Probe

| Place the Temp-Probe in proper position according to the specification

No enough measuring time

| Keep the correct measuring method by 10 mins, and then get the result.

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. However, because of the proliferation of radio-frequency transmitting equipment and other sources of electrical noise in healthcare environments (for example, electrosurgical units, cellular phones, mobile two- way radios, electrical appliances, and high-definition television), it is possible that high levels of such interference due to close proximity or strength of a source may result in disruption of performance of this device. This Fingertip pulse oximeter is not designed for use in environments in which the pulse can be obscured by electromagnetic interference. During such interference, measurements may seem inappropriate or the monitor may not seem to operate correctly.

Electromagnetic Environment
The PULSE OXIMETER is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the PULSE OXIMETER can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the PULSE OXIMETER as recommended below, according to the maximum output of the communications equipment.

Warning:

PULSE OXIMETER should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, PULSE OXIMETER should be observed to verify normal operation in the configuration in which it will be used.

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

RF emissions CISPR 11

| ****

Group 1

| The PULSE OXIMETER uses RF energy for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

| ****

Class B

| The PULSE OXIMETER is suitable for use in domestic establishment and in establishment directly connected to a low voltage power supply network which supplies buildings used for domestic purposes.

Guidance & Declaration – Electromagnetic Immunity

Table 4—Guidance & Declaration — electromagnetic immunity

The PULSE OXIMETER is intended for use in the electromagnetic environment specified below. The customer or the user of the PULSE OXIMETER should assure that It is used in such an environment.

Immunity test| IEC 60601

test level

| Compliance level| Electromagnetic environment-guidance

Electrostatic discharge (ESD) lEC 61000-4-2

| ****

±8 kVcontact

±2 kV,±4kV,

±8 kV,

±15 kV air

| ****

±8kVcontact

±2 kV,±4kV±8 kV

±15 kV air

| Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.
Radiated RF Electromagnetic Fields IEC61000-4-3| 10 V/m

80MHz to2.7GHz 80% AM at 1kHz

| ****

10 V/m

|

Power frequency magnetic field IEC 61000-4-8

| ****

30 A/m

50 Hz or 60 Hz

| ****

30 A/m

50 Hz or 60 Hz

| Power frequency mag- netic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

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

Table 5—PULSE OXIMETER Clinical study Subject Demographics Record.

Subject

#

| Gender| Age| Height

(cm)

| Weight

(kg)

| Skin Tone| Remark
---|---|---|---|---|---|---
1#| M| 31| 160| 70| Light| Asian (Chinese)
2#| M| 24| 165| 55| Light| Asian (Chinese)
3#| F| 22| 160| 45| Light| Asian (Chinese)
4#| M| 29| 175| 60| Medium Dark| Asian (Chinese)
5#| F| 22| 160| 49| Light| Asian (Chinese)
6#| F| 19| 160| 45| Light| Asian (Chinese)
7#| F| 21| 162| 54| Light（White）| Caucasian
8#| M| 34| 192| 102| Light（White）| Caucasian
9#| F| 27| 178| 58| Light（White）| Caucasian
10#| M| 23| 178| 78| Dark dark| African
11#| F| 24| 174| 80| Dark dark| African
12#| M| 26| 169| 65| Dark dark| African

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.

Table 6—Overall Average Root Mean Square (ARMS) for PULSE OXIMETER in the SpO2 range of 70%-100%.

Compared to Avg. Reference CO-Oximeter, Functional SaO2 Apr 6-8, 2012| Functional SaO2 70-100%

ARMS

| ****

of Points

| Specification 70-100% ARMS
---|---|---|---
PULSE OXIMETER| 1.92| 241| Pass ARMS of 3

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

Compared to Avg. Reference CO-Oximeter, Functional SaO2 Apr 6-8, 2012| SaO2 ranges of 70-80%

ARMS

| SaO2 ranges of 80-90%

ARMS

| SaO2 ranges of 90-100%

ARMS

---|---|---|---
PULSE OXIMETER| 2.20| 1.87| 1.66

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

Bland-Altman Plot Comparing the SpO2 Difference between the PULSE OXIME-TER 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
---|---|---|---|---|---|---
241| 1.93| 1.90| 0.30| -3.44, 4.05| 10| 12

Section 6- 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 it lightly the surfaces of the oximeter. 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 measurement. The calibration must be operated to by qualified personnel only.
2. Please use the Temperature simulator of BC Biomedical MULTI-PARAMETER PATIENT SIMULATOR to calibrate PULSE OXIMETER for the function of temperature measurement. This calibration must be operated by qualified personnel only.
3. 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.

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℃ to 40℃ 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.

Warnings

• 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.

Disposal

• Used batteries should not be disposed of in the household rubbish. Used Batteries should be deposited at a collection point.
• At the end of its life, the appliance should not be disposed of in household rubbish. Enquire about the options for regulations into account.

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.
• Damage to the device resulting from misconnection with other devices.
• Damage to the device resulting from accidents.
• Changes performed by users without the prior written authorization of the company.

Qualified certificate

(QUALIFIED CERTIFICATE)

PRODUCT NAME| See product labels
PRODUCT MODEL| See product labels
DATE|
INSPECTOR| QC001

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

UK Responsible Person: Lotus Global Co Ltd

• Add: 23 Maine Street, Reading, RG2 6AG, England, United Kingdom
• Tel: 0044-20-70961611

References

• LINKET Design & Code

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