SantaMedical sm165 Generation 2 Finger Pulse Oximeter User Manual

SantaMedical sm165 Generation 2 Finger Pulse Oximeter User Manual

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 the user’s safety and monitoring performance about cables and transducers. It is recommended that the device should be inspected once a week at least. When there is obvious damage, stop using the monitor.
• 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 the User’s Manual. Only accessories that are provided or recommended by the manufacture can be used with this device.
• This product is calibrated before leaving the factory.

Warnings

• Explosive hazard
• DO NOT use the oximeter in an environment with flammable gas such as some ignitable anesthetic agents.
• DO NOT use the oximeter while the testee is being measured by MRI and/or CT.
• A person who is allergic to rubber cannot use this device.
• The disposal of scrap instruments and their accessories and packings (including batteries, plastic bags, foam and paper boxes) should follow local laws and regulations.
• Please check the packing before use to make sure the device and accessories are totally in accordance with the packing list, or else the device may have the possibility of working abnormally.
• Please don’t measure this device with function test paper for the device’s related information.

Attentions

• Keep the oximeter away from dust, vibration, corrosive substances, explosive materials, high temperature and moisture.
• If the oximeter gets wet, please stop operating it.
• When it is carried from a cold environment to a warm or humid environment, please do not use it immediately.
• DO NOT operate buttons on front panel with sharp materials.
• High temperature or high pressure steam disinfection of the oximeter is not permitted. Refer to User Manual in the relative chapter for instructions of cleaning and disinfection.
• Do not have the oximeter submerged in liquid. When it needs cleaning, please wipe its surface with medical alcohol by soft material. Do not spray any liquid on the device directly.
• When cleaning the device with water, the temperature should be lower than 60°C/140°F.
• As to the fingers which are too thin or too cold, it would probably affect the normal measure of the users’ SpO, and pulse rate; please clip the thick finger such as thumb and middle finger deeply enough into the probe.
• Do not use the device on infant or neonatal users.
• The product is suitable for children above four years old and adults (Weight should be between 15kg/33lb to 110kg/2421b).
• The device may not work for all users. If you are unable to achieve stable readings, discontinue use.
• The update period of data is less than 5 seconds, which will vary according to different individual pulse rate.
• The waveform is normalized. Please read the measured value when the waveform on screen is equably and steady-going, Here this measured value is optimal value. And the waveform at the moment is the standard one.
• If some abnormal conditions appear on the screen during the test process, pull out the finger and reinsert to restore normal use.
• The device has normal useful life of three years since the first electrified use.
• The hanging rope attached to the product is made from Non-allergenic material; if particular group are sensitive to the hanging rope, stop using it. In addition, pay attention to the use of the hanging rope; do not wear it around the neck to avoid harm to the user.
• The instrument does not have a low-voltage alarm function, it only shows the low-voltage; please change the battery when the battery energy is used up.
• The instrument does not have an alarm function. Do not use the device in situations where alarms are required.
• Batteries must be removed if the device is going to be stored for more than one month, or else batteries may leak.
• A flexible circuit connects the two parts of the device. Do not twist or pull on the connection.

Overview

The pulse oxygen saturation is the percentage of HbO, out of the total Hb in the blood, so-called the O, concentration in the blood. It is an important bio-parameter for respiration. For the purpose of measuring the SpO more easily and accurately, our company developed the Pulse Oximeter. At the same time, the device can measure the pulse rate

Classification:

Class Il b, (MDD93/42/EEC IX Rule 10)

Features

• Operation of the product is simple and convenient.
• The product is small in volume, light in weight (total weight is about 50g including batteries) and convenient in carrying.
• Power consumption of the product is low, and the two originally equipped AAA batteries can be operated continuously for 20 hours.
• The product will automatically be powered off when no signal is in the product within 5 seconds.

Major Applications and Scope of Application

This device is intended for non-medical use in healthy people to monitor their pulse and blood oxygen levels for sports and/or aviation only. Finger should not be moving, it should be stationary while using the oximeter, otherwise it will give inaccurate results. It is suitable for users between 15 to 60 years old. Do not use it for continuous monitoring.

Environment Requirements

Storage Environment

• Temperature :-40°C~+60°C
• Relative humidity :≤95%
• Atmospheric pressure :500hPa~1060hPa

Operating Environment

• Temperature : 10°C -40°C
• Relative Humidity :≤75%
• Atmospheric pressure :700hPa~1060hPa

Principle and Caution

Principle of Measurement

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 (Hb) and Oxyhemoglobin (HbOz) in glow & near-infrared zones. Operation principle of the instrument is: Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning & Recording Technology, so that two beams of different wavelength of lights can be focused onto a human nail tip through perspective clamp finger-type sensor. A measured signal can then be obtained by a photosensitive element, information acquired through which will be shown on screen through treatment in electronic circuits and microprocessor.

Caution

• The finger should be placed properly (see the attached illustration of this manual ,Figure 5), or else it may cause inaccurate measurement.
• The SpO, sensor and photoelectric receiving tube should be arranged in a way with the subject’s arteriole in a position there between.
• Make sure the optical path is free from any optical obstacles like rubberized fabric.
• Excessive ambient light may affect the measuring result. It includes fluorescent lamp, dual ruby light, infrared heater, direct sunlight, etc.
• Strenuous action of the subject or extreme electrosurgical interference may also affect the accuracy.
• Testee cannot use enamel or other makeup.
• Due to the sensitivity of the pulse oximeter, you should keep your finger stationary during measurement. It is recommended that you use this instrument for measurement before or after sports. Do not use for continuous monitoring.

Technical Specifications

1. Display Format: OLED Display;
   SpO, Measuring Range: 0% – 100%;
   Pulse Rate Measuring Range: 30 bpm – 250 bpm;
   Pulse Wave Display: columniation display and the waveform display.
2. Power Requirements: 2 x1.5V AAA alkaline battery (or using rechargeable battery instead), adaptable range: 2.6V-3.6V.
3. Power Consumption: Smaller than 30mA.
4. Resolution: 1% for SpOz and 1 bpm for Pulse Rate.
5. Measurement Accuracy: #2% in stage of 70%-100% SpOz, and meaningless when stage being smaller than 70%. #2 bpm or:2% (select larger) for Pulse Rate.
6. Measurement Performance in Weak Filling Condition: SpO, and pulse rate can be shown correctly when pulse-filling ratio is 0.4%. SpO, error is $4%, pulse rate error is +2 bpm or ÷2% (select larger).
7. Resistance to surrounding light: The deviation between the value measured in the condition of man-made light or indoor natural light and that of darkroom is less than ÷1%.
8. It is equipped with a function switch. The Oximeter can be powered off in case no finger is in the Oximeter within 5 seconds.
9. Optical Sensor
   Red light (wavelength is 660nm, 6.65mW)
   Infrared (wavelength is 880nm, 6.75mW)

Accessories

• One hanging rope and carrying case
• Two batteries (optional);
• One User Manual.

Installation

View of the Front Panel

Battery

• Step 1. Refer to Figure 3. and insert the two AAA size batteries properly in the right direction.
• Step 2. PLEASE LOOK AT +/ – SIGN BEFORE INSTALLING THE BATTERY
• Step 3. Replace cover by sliding battery cover back on in line with inside tab. Please take care when you insert the batteries as the improper insertion may damage the device.

(since we have used a new battery placement design, we will use the new placement instruction replace this paragraph)

Mounting the Hanging Rope

• Step 1. Put the end of the rope through the hole.
• Step 2. Put another end of the rope through the first one and then tighten it.

Operating Guide

• Insert the two batteries properly to the direction, and then replace the cover.
• Open the clip as shown in Figure 5.

• Let the user’s finger go into the rubber cushions of the clip (make sure the finger is in the right position), and then clip the finger.
• Press the switch button once on front panel.
• Do not shake the finger and keep the user at case during the process. Meanwhile, human body is not recommended to be in movement status.
• Get the information directly from screen display.
• The button B-& has three functions. When the device is powered off, pressing the button will tum it on; when the device is powered on, pressing the button shortly can change direction of the screen; when the device is powered on, pressing the button long can change brightness of the sereen.
• A Fingernails and the luminescent tube should be on the same side.

Repairing and Maintenance

• Please change the batteries when the low-voltage is displayed on the screen.
• Please clean the surface of the device before using. Wipe the device with medical alcohol first, and then let it dry in air or clean it by dry clean fabric.
• Please take out the batteries if the oximeter is not in use for a long time.
• The best storage environment of the device is – 40°C to 60°C ambient temperature and not higher than 95% relative humidity.
• Users are advised to calibrate the device intermittently . It also can be performed at the 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 useful life of the device, or even damage it.

Troubleshooting

Trouble

• The SpO, and Pulse Rate can not be displayed normally
• The SpOz and Pulse Rate are not displayed stably

Possible Reason

• The device can not be turned on
• The display is off suddenly
• The finger is not properly positioned.
• The user’s SpO, is too low to be detected.
• The finger is not placed inside deep enough.
• The finger is shaking or the user is moving.
• The batteries are drained or almost drained.
• The batteries are not inserted properly.
• The malfunction of the device.
• The device will power off automatically when it gets no signal within 5 seconds.
• The batteries are almost drained.

Solution

• Place the finger properly and try again.
• Place the finger properly and try again.
• Let the user keep calm
• Change batteries.
• Reinstall batteries.
• Please contact the local service center.
• Normal.
• Change batteries.

Key of Symbols

Function Specification

Display Information
The Pulse Oxygen Saturation(SpOz)
Pulse Rate(PR)
Pulse Intensity (bar-graph)
Pulse wave
SpO, Parameter Specification
Measuring range
Accuracy
Optical Sensor
Display Mode
OLED
OLED
OLED bar-graph display
OLED
0%~100%, (the resolution is 1%).
70%~ 100%:‡2%, Below 70% unspecified.
Red light (wavelength is 660nm)
Infrared (wavelength is 880nm)
Pulse Parameter Specification
Measuring range
Accuracy
Pulse Intensity
Range
30bpm~250bpm (the resolution is 1 bpm) | ÷2bpm or:2% select larger
Continuous bar-graph display; a higher display indicates a stronger pulse.
Battery Requirement
1.5V (AAA size) alkaline batteries × 2 or rechargeable battery
Battery Useful Life
Two batteries can work continually for 20 hours
Dimensions and Weight
Dimensions
57(L) × 31(W) × 32(H) mm
Weight
About 50g (with the batteries)

REFRENCE LINK

https://santamedical.com/