Shenzhen YKD Finger Oximeter User Manual

Shenzhen YKD Finger Oximeter User Manual

1. Product Information

Product name: Finger Oximeter
2. Explanation of Symbols
The following symbols appear on the Finger Oximeter and its packaging.

Table 1 Finger Oximeter and Packaging Symbols

    Symbol

|

    Description

|

    Symbol

|

  Description

---|---|---|---
|

BF applied part:
including F applied
part (float/insulation)

|

|

Caution, consult
accompanying
documents

|

Keep dry

| |   Fragile, handle
with care

|

Humidity limitations

| |

  Temperature
limitations

|

Atmospheric pressure limitations

|

|

Serial Number

Manufacturer address

|

Protective grade

|   |   Complicance to
WEEE standard
| | |

3. Safety Standards

The following table describes the safety standards of the Finger Dximeter

Table 2 Safety Standards

  Parameter

|

  Specification

---|---
  Protection class|   Class I, anti-shock, externally and internally
powered equipment, per IEC 60601-1
  Degree of protection|   Type BF defibrillator-proof: per IEC 60601-1
Degree of noxious-liquid proof as IPXl
Anti-shock degree as BF applied part
According to the degree of safety of application
in the presence of a flammable anaesthetic
mixture with air or with oxygen or nitrous oxide,
the equipment is not suitable for use in the
presence of a flammable anaesthetic mixture
with air or with oxygen or nitrous oxide
  Sterilization and
disinfection|   Class I, anti-shock, externally and internally
powered equipment, per IEC 60601-1
   As recommended
by manufacturer|   Continuous

4. Safety Conventions

The manual uses the following conventions for Notes, Cautions, and Warnings.

Note – A Note calls attention to an important point in the text.

Caution A Caution calls attention to a condition or possible situation that
could damage or destroy the product or the user’s work.

Warning A Warning calls attention to a condition or possible situation that could cause injury to the user and/or patient.

5.Safety Requirements

Warning The Finger Oximeter is only for use on one patient at a time. The Finger Dximeter is not for diagnostic or therapeutic use. Never use the Finger Dximeter during MRls or CT scans. Never use the Finger Oximeter in an environment of anesthetic gases.

FUNCTIONAL TESTER

cannot be used to assess ACCURACY. The skin temperature is initially at 35 °C for each Finger Oximeter, the APPLIED PART temperature can not exceed 41 °C.The material that the Finger Oximeter contacted to body is Non-toxic silica gel which meet the 15010993 requirements, so can be safety used. But to some natural rubber latex sensitive user, there may be some allergic reactions. Only use accessories recommended by the manufacturer. Using other kinds of accessories might cause damage or personal injury. Modification of the Finger Oximeter could be unsafe as applicable. The degrade sensor may degrade the performance.

Caution

To avoid personal injury, only use accessories and parts produced or recommended by SUPPLIER. Otherwise, damage to the Finger Oximeter can occur. The Finger Oximeter must conform to the international standard IEC 60601-1-2 and other applicable EMC standards. Interference takes place when electromagnetic energy is extremely high. Ensure that any nearby instruments are also in compliance with EMC standards. Never turn on or use portable communication devices like mobile phones or portable dual-channel radios near a Finger Oximeter. When power is lost for less than or equal to 30 s, the ALARM SETTINGS prior to the power loss shall be restored automatically. Ensure that qualified service representatives annually calibrate and maintain the Finger Oximeter. Periodically check the Finger Oximeter for damage. When necessary according to your local hospital waste disposal regulations. Clean and sterilize the Finger Oximeter and accessories according to local requirements. Turn off the Finger Oximeter before cleaning or sterilization. Keep all Finger Oximeter packing materials away from children, pet or pests, or dispose of them in accordance with your local environmental regulations .Inhalation or swallowing of small parts that be detached from Finger Oximeter may cause choking. Always properly dispose of the Finger Oximeter and all accessories at the end of their service life. Dispose of batteries according to your local regulations. Never incinerate batteries or expose them to high temperatures.

Ensure that no water condenses into or on the Finger Oximeter. Condensation can occur from changes in temperature or exposure to humidity.

6. Product Operation Scope

This Finger Oximeter is a kind of innovated medical detection device with non- invasive and continuous features for artery Sp02 and PR detection. It is portable and easy to measure the Sp02 and PR value quickly and precisely. This can be through the finger Finger Oximeter to measure human blood oxygen saturation and heart rate. This product is suitable for family, clinic, oxygen bar, sports health (use before and after exercise is not recommended for use during exercise), community health and other ranges. It’s for ages from 15 to 60 years old patients. This product is not suitable for Finger Oxmetering the patient’s prolonged use.

7. General Description

Haemoglobin Saturation is percentage of Oxyhemoglobin (Hb02) capacity, compounded with oxygen, by all combinativ able hJcrnoglob1n (Hb) obin (Hb02) capacity in blood. In other words, it is consistence of Oxyhemoglobin in blood. It is a very important ecological parameter for Respiratory circulation System. Many respiratory diseases can result in haemoglobin saturation being lowered in human blood. Moreover, the following factors can also lead too problems in oxygen supply, so that human haemoglobin saturation might be reduced: Automatic Organic Regulation Malfunction caused by Anesthesia, Intensive Postoperative Trauma, hurts resulted in by some medical examination and etc. In the situation, illnesses, such as light head, asthenia, vomitory and etc, might happen to patients and even endanger the patient’s life. Therefore, it is very important to know Hemoglobin saturation of patient timely in clinical medical aspects. So that doctors can find problems in time. The fingertip Finger Oximeter features in small volume, low power consumption convenient operation and being portable. It is only necessary for patient to put one of his fingers into a fingertip photoelectric sensor for diagnosis, and a display screen will directly show measured value of hemoglobin Saturation. It has been proved in clinical experiments that it features in rather high precise and repeatability.

8. Measurement principle

Principle of the oximeter is as follows: An experience formula of data process is established taking use of Lambert beer Law according to Spectrum Absorption Characteristics of reductive hemoglobin (R Hb) and Oxyhemoglobin (02 Hb) in glow and near- infrared zones. Operation principle of the instrument is photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with capacity pulse scanning and recording Technology, so that two beams of different wavelength of lights (660nm glow and 940nm near infrared light) can be focused onto human nail tip through perspective clamp finger-type sensor. Then measured signal can be obtained by a photosensitive element, information acquired through which will be shown on two groups of LED through process in electronic circuits and microprocessor.

9. Appearance introduction

10. Feature

1. Two colors OLEO display, figure and Oxygen volume chart display together on interface;
2. Adjust the display interface direction manually, according to the patient observation data needs;
3. audible alarm function;
4. Low Power consumption. 20 hours continuous to work.
5. Low Perfusion s;0.6%.
6. Low voltage indicator.
7. Automatic power off when no signal in 8 s a.small and light weight, convenient to carry.
8. A menu function can set up oxygen alarm limit, the upper and lower limits of PR, alarm switch, sound switch.

11. Operation Instructions

11.1 The product Operation Instructions

1. instilling two AAA batteries into battery cassette in correct polarities and cover it.
2. Plug one of fingers into rubber hole of the Oximeter (it is best to plug the finger thoroughly) nail surface upward, then releasing the clamp.
3. Press the switch button once on front panel.
4. Your finger do not tremble during the Oximeter is working. Your body is not recommended in moving status.
5. Read correspondent data from display screen.

Note- Please use the medical alcohol to clean the rubber touching the finger inside of Oximeter, and clean the test finger using medical alcohol before and after each test.( The rubber inside of the Oximeter belongs medical rubber, which has no toxin, and no harmful to the skin of human being).When your finger is plugged into the Oximeter, you nail surface must be upward. Disposable batteries should be unloaded when used for a long interval

Warning
The maximum application time for a Finger Oximeter PROBE at a single site is 4 hours. The misapplication of a Finger Oximeter PROBE with excessive pressure for prolonged periods can induce pressure injury. Ambient light (including photodynamic therapy); physical movement (PATIENT and imposed motion); diagnostic testing;
low perfusion; electromagnetic interference; HF SURGICAL EQUIPMENT; dysfunctional haemoglobin; there will be windage for SpO2 value.

11.2 Operation Instructions

11.2.1 Display Description (6 interface diagrams)

  Setting
interface|
---|---
  Pulse
Oximeter
Interfaces|   Without detection signal interface|   detection signal interface
  Interface 1|

|

  Interface 2| |
  Interface 3| |

  Interface 4

| |
  Interface 5| |
  Interface 6| |

11.2.2 Button opu,1ting in1truction1

1. put into two AAA batteries according to the instructions, the device will turn on automatically and display interface 1; then put into finger for measuring, if there is finger for detection and without operation, it power off automatically in 8s.
2. When there is battery, but the Finger Oximeter power off, press the button, it will be opened.
3. During the measurement (there is a measurement signal and figure), press the button shortly, the interface can turns from interface 1 to interface 6 circularly. Press the button longly during the measurement; it can turn to settings menu interface.
4. In the Settings menu interface, press button longly, it can choose 8 options circularly, they are Alarm switch (Alarm Sound on/off), the add and subtract of oxygen lower limit value (SPO2 Lo + / -), the add and subtract of PR limit value (PR Hi + / -; PR Lo + / -), PR Sound switch (BeeP) and the withdraw from the menu (Exit). The selected options foreground color will become Blue Square.
5. In the Settings menu interface, press button shortly, we can operate the value add and subtract or switch of current options. they are :The Sp02 default alarm lower limit value is 90, the adjustable range is from 70 to 95 and pressing the button shortly can do add and subtract of istep. The PR default alarm upper limit value is 110, the adjustable range is from 110 to 250 and pressing the button shortly can do add and subtract of 5steps.The PR default alarm lower limit value is 50, the adjustable range is from 15 to 95 and pressing the button shortly can do add and subtract of 5 steps.
6. 6.All the setting value will restore to default value: alarm off, oxygen lower limit value 90, PR upper limit value: 110, PR lower limit value: 50, PR sound off when we replaced the battery.
7. .In the Settings menu interface, choose to Exit option and press button shortly, it will quit the setting menu interface.

12.Al,1rm

The Pulse Oxieter uses the following alarm indicators: audible alarm and visual alarms.
Note — To correctly identify visual alarms, always observe the Finger Oximeter within 1 meter of its position.

12.1 Lowpowu.1ilum

12.1 Low power alarm
when battery power is at lowest level, the battery capacity indicates empty in OLED, remind users of replacement of battery.
Note — When power is lost for less than or equal to 30 s, the ALARM SETTINGS prior to the power loss shall be restored automatically.

12.2 Audible alarm
The audible alarm is buzzer alarm; the auditory sound pressure range is 45dB- 70dB.

12.3 Sp02 and PR alarm
Default alarming Value of PR: High Limit: 1 10BPM; Lower Limit: 50BPM Default alarming Value of 5p02: 90%. When it is under operation conditions, if the measurement of the PR and Sp02 value exceed the setting alarm limit and the alarm switch is on, the HKM-500A will has a sound alarm and its long buzzer alarm. When it is under operation conditions, if the PR sound switch is on, the measurement PR will go with a PR sound. To test the alarm according the following: a)Connect the Finger Oximeter to simulator; b)the simulator setting : 5p02 90%, PR 200bpm.; c)the Finger Oximeter alarm setting : 5p02 95%, PR High Limit 1 10bpm; d)to verify the Finger Oximeter alarm.

13. Sp02 Specifications
The update rate for the 5p02 value and pulse rate is typically 1 second. Data averaging and other signal processing on the displayed and transmitted data values of Sp02 and pulse rate is not more than 20 seconds. Depending on the magnitude of difference between the alarm limit and the displayed value, the alarm signal generation delay may be from 1 second to 20 seconds. The maximum alarm condition delay is 4 seconds, the maximum alarm signal delay is 20 seconds, the average alarm condition is 2 seconds, the average alarm signal is 10 seconds. Because Finger Oximeter measurements are statistically distributed, only approximately two-thirds of Finger Oximeter equipment measurements can be expected to fall within the Arms value measured by a CO- oximeter. The signal adequacy is indicated by waveform, and it is NORMALIZED.

Note -The Finger Oximeter EQUIPMENT is calibrated to display
FUNCTIONAL OXYGEN SATURATION. It is not necessary to have a
Sp02 calibration when the Finger Oximeter is in use.

The following table describes the Sp02 specifications.

Table 3 Sp02 Specifications

Parameter

|

Specification

---|---
  Sp02 measurement range|   35%-99%
  Sp02 accuracyl|   ±1% in the range of 90%-99%,
±2% in the range of 70%-89%,
Other scope is not defined
  Sp02 Alarm range|   Consistent with the display range, the
set step length is 1 %
  Pulse rate range|   30 bpm -240 bpm
  Pulse rate accuracy|   ±1 bpm
  Pulse rate Alarm range|   Consistent with the display range, the
set step length is 5bpm
  Data update cycle|   0.25 s-2 s
  5p02, PR average|   Bs
  Pulse rate sound|   PR tone
  Peak Wavelength range2|   500 nm – 1000nm
  Maximum optical output power|   150mW
  Pulse rate display|   Numeric
  Display Specifications|   two color OLED,0.96″
  power dissipation|   in normal measurement, Less tnan
40mA;in power off state, less than
50uA;

Sensor accuracy was obtained by performing controlled hypoxia studies
on healthy, non-smoking adult volunteers (according to 150 80607-2-67).

1. .been compared to CO-oximeter measurements on arterial blood samples. To repre- sent the general population, data from at least l D subjects (male and female) with a wide range of skin color was taken to validate Sp02 accuracy. Accuracy data for Masimo sensors is included in the sensor package insert.
2. information about wavelength ranges can be useful for clinicians performing photo dynamic therapy.

14.1 Power Specifications

The following table describes the power specifications

Table 4 Power Specifications

  The Finger □ xi meter powers off if the battery power
is almost depleted.

15. Physical Specifications

The following table describes the physical specifications.

Table 5 Physical specifications

16. Environmental Specifications

The following table describes the environmental specifications

Table 6 Environmental Specifications

  Parameter

|

  Specification

---|---
  Temperature|   Operating: O°C- 40 °c
Storage: -20 °C+SS °Cfor the device
  Relative humidity|   Operating: l 5% – 80% (noncondensing)
Storage: 10% – 93% (noncondensing)
  Barometric pressure|   Operating: 59 kPa – 107.4 kPa
Storage: 22 kPa ~ l 07.4 kPa

PlUt 3 EMC R•llltod Summllry

17. EMC R•l•t•d Summ.1iry
17,1 NOTIC!

13. Sp02 Specifications

Part 3 EMC Related Summary
17. EMC Related Summary 17.1
NOTICE

1. Finger Oximeter meets the requirement of electromagnetic compatibility in IEC60601-1-2.
2. The user needs to install and use according to electromagnetism compatibility information which is attached with it.
3. Portable and mobile RF communication devices may influence Finger Oximeter performance, so Finger Oximeter should be kept away from them during using.
4. Guidance and manufacturer’s declaration stated in the appendix.

17.2WARNING
1.The user needs to install and use Finger Oximeter according to electromagnetism compatibility information which is attached with it.
2.Portable and mobile frequency communication devices may influence its performance, so it should be kept off these devices.
3.Finger Oximeter should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the Finger Oximeter should be observed to verify normal operation in the configuration in which it will be used.
4.Speaking, Finger Oximeter could not be used for transport using, like ambulances (land and air ambulances).
Part 4 Repair and Warranty 18.Repair and Maintenance

1. Regular inspection to make sure that no obvious damage existed to affect the safety and performance of device.
2. .No flammable substance, overtop or lower temperature and humidity existed in operation conditions.
3. .When the device is dabbled or there is hydraulic set existed, stop operating.
4. .When lower power capacity light in red pls replace the battery right away. 5.Pls clean the surface before applying for detection.
5. .Pls take out the battery when device is not used for a period of time.
6. .Pls disposure the battery according to the local statute.
7. If there is dust or dirt on surface, 75% density of medical alcohol can be used to clean the surface. Pis use dry fabric with little alcohol to avoid alcohol permeates into the device.
8. The transportation and storage conditions are: Temperature: -20°C-55°C;

19 Troubleshooting

20. Accessory
Hang String–    1 pcs
User Manual –   1 pcs

22.1 warranty

The unit can not be repaired by users themselves. All services must be done by the engineers approved by SUPPLIER. The unit is guaranteed for a period of l 2 months, valid from the date of purchase. SUPPLIER warrants that each product we sell you is free from defects in labor and materials and shall conform to its product specifications as defined in the user documentation. If the product doesn’t function as warranted during the warranty period, we will repair or replace it without charge. Misuse, improper maintenance may void the warranty,

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