accurate Bio-Medical WS Series Pulse Oximeter User Manual

accurate Bio-Medical WS Series Pulse Oximeter User Manual

Introduction

Thank you for your purchase of our pulse oximeter (“oximeter”). Prior to use of the product, please read the content of this manual carefully to ensure proper use of the product. After reading, please keep this manual properly for future reference.

Hunan Accurate Bio-Medical Technology Co., Ltd. (“Accurate”) owns the intellectual property rights associated with this User Manual and the product described herein.

© Copyright owned by Hunan Accurate Bio-Medical Technology Co., Ltd.
Without the written permission of Accurate, no individual or organization shall reproduce, amend or translate any part of this manual.

Version of Manual: V1.1
Issue date: 2023–8

Product Information

Product Name: Pulse Oximeter
Product Model: WS20A
Software Version ：V1.0

Manufacturer: Hunan Accurate Bio-Medical Technology Co., Ltd.
Address: Accurate Industrial Park, No.108, Zhixian Road， Xuelian Community，Xueshi Street of Yuelu District, 410208 Changsha, Hunan Province, PEOPLE’S REPUBLIC OF China
Tel: +86 731-85598539

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

Foreword

Introduction

• This manual introduces in detail the use and functions of the product as well as how to operate it. Prior to use of the product, please carefully read and understand the content of this manual to ensure proper use of the product and safety of user.
• This manual introduces the product having the most complete configurations. Therefore, some content hereof may not apply to the product you have purchased. If you have any question, please feel free to contact us.
• Please keep this manual near the product for easy and prompt access when needed.

Illustrations

All illustrations provided herein are for reference only. The settings or data as can be seen in the illustrations may differ from those actually shown on the product.

Conventions

• Bold and italic: Represents chapters quoted.
• [Character]: Represents character strings in the software.
• →: Represents operating steps.

Safety

1.1 Safety Information

DANGER

• Indicates an imminently hazardous situation, which, if not avoided, could result in death, serious injury or property damage.

Warning

• Alerts you to potential dangers or unsafe operations, which, if not avoided, may result in death or serious injury or property damage.

CAUTION

• Alerts you to potential dangers or unsafe operations, which, if not avoided, may result in minor injury, product failure or damage, or property damage.

▲ NOTE

• Emphasizes important precautions and provides instructions or explanations for better use of the product.

1.1.1 DANGER
This product does not involve any information about danger levels.

1.1.2 WARNING

• Prior to use, please first check the oximeter; do not use it if any abnormality is found. If it is found that the device works abnormally during use, please stop using it immediately.

• In order to avoid fire or explosion, do not use the device in an environment with anesthetic agent or other inflammables or explosives.

• Do not open the housing of the device. In case of any problem, please contact your dealer or the manufacturer.

• The patient’s safety should be guaranteed when the device is used in conjunction with electrosurgical equipment.

• Please carefully place the power cord and the cables of various accessories to prevent the patient from getting wound or suffocated, entanglement of the cables, or electrical interference.

• Only use the SpO2 probe supplied by the manufacturer; use of a SpO2 probe from other source could result in performance degradation or damage of the device or cause safety risks.

• Do not use the SpO2 probe supplied by the manufacturer in conjunction with other equipment; otherwise, safety risks could be caused.

• This device is not suitable for neonate or infant patients or people weighing less than 30KG.

• This device is just auxiliary equipment for clinical diagnosis; the physiological parameters and waveforms it displays are only for reference by doctors, which cannot be directly used as a basis for clinical treatment.

• A functional tester cannot be used to assess the accuracy of the SpO2 probe or oximeter.

• The computer connected with the oximeter for file transfer should conform to IEC 60950-1.

• Don’t near active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances is high.

• Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation.
  If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.

• Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.”

• Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the equipment, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

• The temperature of the enclosure such as the button and LCD display can reach 44.4 degrees . The internal temperature of the shell near the battery can reach 47.1 degrees .So don’t touch buttons and screens for more than 10 minutes.

1.1.3 CAUTION

• For the sake of user’s safety, please use accessories specified in this manual.
• For scrapping and disposal of the oximeter and its package, please observe the local laws and regulations.
• The oximeter could be subjected to interference by other equipment even if such equipment conforms to the requirements of applicable national standard on emission.
• Please properly install or carry the device to avoid damage due to drop, collision, strong oscillation or other mechanical forces.
• This device is used to measure the O2 content in blood; the following factors could degrade the measurement performance and accuracy of the oximeter:

1. Strong interference by light (e.g., fluorescent light, dual ruby light, infrared heater, operating light, direct sunlight) in the application environment will affect the measurement accuracy.
2. Water vapor and mist in the device.
3. The size of finger measured is out of range.
4. Weak pulse.
5. Venous pulse.
6. The shock, anemia, hypothermia or application of vasoconstrictors may reduce the arterial blood flow to a non-measurable level.
7. Stain exists in blood vessels.
8. Concentration of the non-functional hemoglobin, like COHb or MetHb.
9. Dysfunction of important indices of hemoglobin (e.g., carboxyhemoglobin and methemoglobin).
10. Arrhythmia.
11. External light radiation.
12. Intense activity of user, interference from electrosurgical equipment.
13. Existence of certain stains, such as methylene blue and indigo carmine.
14. Improper position of SpO2 probe, or use of incorrect SpO2 probe.
15. Not suitable for user with arrhythmia, heart failure, hypoperfusion (PI＜0.3), finger shivering, etc.
16. The finger is too thin or too cold.

1.1.4 NOTE

NOTE

• Please install the device at a position where observation, operation and maintenance can be easily carried out.
• The software for this device has been developed in accordance with the requirements of IEC 60601-1-4 to minimize the probability of risks caused by program error.
• Do not attempt to open the housing for repair. If the product is damaged and needs repair, it can be repaired by qualified service personnel designated by the manufacturer. The manufacturer may provide the service personnel with the Service Manual which contains information necessary for repair such as circuit diagram, component list, legend and correction rules.
• It is not suggested to place the SpO2 probe at the same position of fingertip too long within 24h.

1.2 Device Symbols

Overview

2.1 Introduction

2.1.1 Scope of Application
The product is intended for monitoring of user’s SpO2 and PR in hospitals and at home.

WARNING

• The oximeter should be used by or under the guidance of medical workers. When using the device at home, user should carefully read the User Manual before use and where necessary, consult the doctor, dealer or manufacturer. Human contact part of the equipment meet the bio-compatibility requirements and complies with ISO 10993-1, ISO 10993-5 and ISO10993-10 standards.

NOTE

• The oximeter can be used in hospitals or for home care.
• The Pulse Oximeter is not suitable for use under hypoperfusion and exercise conditions

2.1.2 Intended Use
The Pulse Oximeter is intended to measure functional arterial oxygen saturation (SpO2) and pulse rate of patients in Home Health Care and Medical Facility.

2.1.3 Intended operator
This pulse Oximeter is intended for use only by clinical professionals or under their guidance. It must only be used by persons who have received adequate training in its use. Anyone unauthorized or untrained must not perform any operation on it.

2.1.4 Intended Patient Population
The Pulse Oximeter is intended for adult patients. The patient’s finger thickness should between 8 to 25.4 mm.

2.1.5 Medical Condition
The Pulse Oximeter is intended to be used in hospital, clinical institution, helth care community. We recommend index finger, middle finger and ring finger are suitable position for monitor.

2.1.6 Contraindications
None

2.2 Appearance

1. Display screen
   Display the SpO2 and SpO2 measurement trend graph; PR value, PR measurement trend graph, pulse intensity bar chart, perfusion index (PI) value, pulse wave, operating state of main unit, measurement duration, user ID, battery level, and time.

2. Power/Confirm key
   ♦ Power: Press this key to start the oximeter.
   ♦ In Menu mode, it serves as the Confirm key.

3. Up key
   This key has different functions in different situations. Press this key to move the cursor upward, increase the value of a menu item, etc.

4. Down key
   This key has different functions in different situations. Press this key to move the cursor downward, reduce the value of a menu item, etc.

5. Multi-purpose multiplex interface Connect the charging cable or SpO2 probe.

6. Watchband

7. SpO2 probe (model: A401-201)

2.3 Product Function List

※ “√” represents that the device has this function;
“/” represents that the device does not have this function.

Preparation before Use

3.1 Unpacking Inspection
Please check the packing box carefully before opening it. Please get in touch with the carrier immediately if any damage is found. Properly open the packing box; carefully take the device and other components out of the packaging box, and count them item by item according to the Packing List. Check whether the device has any mechanical damage and whether all articles are complete. If you have any question, please contact us immediately.

▲
NOTE

• Please properly keep the packaging box and packaging materials for use in future transport or storage.

WARNING

• Please keep the packaging materials out of the reach of children. Please observe the local regulations or the hospital’s waste disposal rules when disposing of packaging materials.
• The device may be contaminated with microorganisms during storage, transport and use. Please confirm the package is complete prior to use, and do not use the device if any damage is found.

3.2 Environmental Requirements
The operating environment for this device must conform to the environmental requirements specified in this manual. When the device is moved from one environment to another, condensation of the device could occur due to difference in temperature or humidity. In such case, the device can be used only after condensation disappears.

WARNING

• Please make sure the device works under the specified environmental conditions; otherwise, the technical specifications stated herein will not be achieved, and unforeseeable consequences such as device damage may take place.
• If the oximeter is damaged or cannot work normally, it should not be used for patient monitoring. Please contact the service personnel or our Company immediately.

3.3 Start up

1. Prior to startup, please check whether the oximeter has any mechanical damage.
2. Make sure the remaining battery capacity is adequate.
3. Press the Power key to enter the main interface.

3.4 Shutdown

Please shut down the oximeter according to the following steps:

1. Confirm that the measurement is to be ended.
2. Disconnect the SpO2 probe from the oximeter.
3. Place the main unit of oximeter still for a while (time can be set under Menu Setup); then the oximeter will shut down automatically.

Basic Operations

4.1 User Setup
Measurement interface → Press the Confirm key to enter the interface → Main interface → Press the Up/Down key to select a user menu, and press the Confirm key to enter the user menu interface.

• Set User ID
  1. Press the Confirm key to confirm the selection of User ID;
  2. Press the Up/Down key for selection;
  3. Press the Confirm key to confirm the modification and return to other menu for selection.

• Set Age
  1. Press the Confirm key to confirm the selection of Age;
  2. Press the Up/Down key for selection;
  3. Press the Confirm key to confirm the modification and return to other menu
  for selection.

• Set Sex
  1. Press the Confirm key to confirm the selection of Sex;
  2. Press the Up/Down key for selection;
  3. Press the Confirm key to confirm the modification and return to other menu for selection.

• SpO2 Reminder ON/OFF
  1. Press the Confirm key to confirm the selection of Reminder;
  2. Press the Up/Down key to select ON/OFF;
  3. Press the Confirm key to confirm the modification and return to other menu for selection.

• Set low limit for SpO2 reminder
  1. Press the Up/Down key to set the range of lower limit for SpO2 reminder: 70%~94%;
  2. Press the Confirm key to confirm the modification and return to other menu for selection.

• PR Reminder ON/OFF
  1. Press the Confirm key to confirm the selection of Reminder;
  2. Press the Up/Down key to select ON/OFF;
  3. Press the Confirm key to confirm the modification and return to other menu for selection.

• Set high limit for PR reminder
  1. Press the Confirm key to confirm the start of setting;
  2. Press the Up/Down key to set the range of upper limit for PR reminder: (lower limit + 1bpm)~250bpm;
  3. Press the Confirm key to confirm the modification and return to other menu for selection.

• Set low limit for PR reminder
  1. Press the Confirm key to confirm the start of setting;
  2. Press the Up/Down key to set the range of lower limit for PR reminder: 25bpm~(upper limit – 1bpm);
  3. Press the Confirm key to confirm the modification and return to other menu for selection.Remark: When the Reminder function is set to ON, if the value measured by the pulse oximeter is beyond the reminder setting range and this state lasts for some time, the measured value will flicker automatically and meanwhile the vibration function will be turned on. You can press any key to end this state.

4.2 System Setup

• Time Setup (disabled when the main unit is inserted with a probe)
  1. Measurement interface → Press the Confirm key to enter the interface → Main menu → Setting → Time;
  2. Press the Up/Down key to select the setting item, and press the Confirm key to confirm the selection;
  3. After selecting the item, press the Up/Down key to change the value, and press the Confirm key to confirm the modification.

• Backlight Brightness
  1. Measurement interface → Press the Confirm key to enter the interface → Main menu → Setting → Brightness;
  2. Press the Confirm key to confirm the selection; press the Up/Down key to select the level, and press the Confirm key to confirm the modification.

• Backlight Time
  1. Measurement interface → Press the Confirm key to enter the interface → Main menu → Setting → Light Time;
  2. Press the Confirm key to confirm the selection; press the Up/Down key to select the option, and press the Confirm key to confirm the modification;
  3. “10s” represents that backlight will be turned off automatically in 10s after stop of operation; other options can be explained similarly.

• Factory
  1. Measurement interface → Press the Confirm key to enter the interface → Main menu → Setting → Factory;
  2. Press the Confirm key to confirm the selection; press the Up/Down key to select the option, and press the Confirm key to confirm the modification;

4.3 Review

1. Measurement interface → Press the Confirm key to enter the interface → Main menu → Review;
2. Display abnormality data in the measurement process.

4.4 Report

After the device continuously monitors SpO2 and PR for some time, the software will automatically generate a report according to the measured data for view by user. For example, the device can provide long-time monitoring during sleep, and the software will summarize and generate a sleep report according to the measured SpO2 and PR for user to view and know the measured results

Note: The report is for reference only and cannot be used as a basis for treatment.

4.5 Battery Level Detection

The device automatically monitors the battery level, and displays and updates it on the display screen. When the battery level is displayed as , please charge the battery timely.

4.6 Transmission via Bluetooth

Turn on Bluetooth on your smart phone; launch the specific application to connect
the device so that you can upload data via Bluetooth.
▲ Note: This device only support Bluetooth Protocol 4.0 and higher version.

4.7 Data Transmission

In USB mode, the PC can correctly display data files saved during measurement, and such files can be copied to the PC.

4.8 Measurement Duration

Turn on the SpO2 main unit and connect the probe; insert your finger into the probe and start measurement. The main interface displays 00:00:00; when a value is obtained, it will update the measurement time in real time. Unplug the probe, the measurement time will continue accruing until the main unit can no longer receive detection data, and then it will stop automatically.

4.9 Main Unit State Indication

• When the probe is not inserted after the SpO2 main unit is turned on, the state indication is “No Senser”;
• When the probe is inserted after the SpO2 main unit is turned on, the state indication is “Testing…”.

SpO2 Measurement and Information

5.1 Overview

Continuous non-invasive pulse SpO2 oximetry is employed for SpO2 measurement. It measures the luminous flux of light of specific wavelength emitted by the luminous light source of SpO2 probe after absorption by oxyhemoglobin in the patient’s tissue and arrival at the photoelectric detector, thus to obtain SpO2 and PR. This oximeter has been calibrated to display functional SpO2.

The oximeter provides:

1. Time
2. Bluetooth connection state
3. Battery level
4. SpO2: The percentage of oxyhemoglobin in total hemoglobin.
5. PR: The detected number of pulses per minute.
6. Bar chart: The amplitude of bar chart represents the level of pulse strength.
7. PI: Perfusion index.
8. Measurement duration: Records the duration of measurement.
9. Main unit operating state: The current state of the main unit.
10. PR measurement trend graph
11. SpO2 measurement trend graph
12. Pulse wave
13. ID: User’s ID code (where applicable)

Statement: All waveforms displayed have been normalized.

5.2 Safety Information

WARNING

• When the patient has the hypoxia tendency, the blood sample should be analyzed so as to completely know the patient’s condition.
• Avoid using the oximeter when MRI equipment is used; otherwise, the induced current may cause severe burn to the patient.
• During long-time continuous monitoring, the position where the SpO2 probe is fitted should be checked every two hours; also, the probe should be properly moved in case of any skin change or every four hours. Some patients may require more frequent examinations, such as patients with skin allergy. This is because long-time continuous monitoring may increase the possibility of unforeseeable skin changes, such as allergy, erythrosis, blistering or pressure necrosis.
• It is suggested to change the wearing position every 2-3h; if the patient feels uncomfortable or suffers allergy, stop using the device immediately and where necessary, seek medical advice.
• The cable of electrosurgical equipment should not be entangled with the cable of SpO2 probe.
• Do not place the SpO2 probe on a limb with any arterial duct or intravenous line.
• Do not place the SpO2 probe and the BP cuff on the same limb since blood flow occlusion during BP measurement will affect the SpO2 reading.

5.3 Measurement Steps

1. Clean the measuring position, such as colored nail polish.
2. Place the SpO2 probe at the measuring position.
3. Connect the main unit and SpO2 probe.
4. Generally measured data can be read from the screen in 10s.

5.4 Factors Affecting Measurement

If you have any doubt about the accuracy of the measured result, please first use other method to check the patient’s vital signs, and then check the SpO2 main unit and the SpO2 probe. See 1.1.3 for factors that could affect the measurement accuracy:

▲ Note: When signal is incomplete (signal noise is too high, signal quality becomes poorer or signal disappears), the SpO2 and PR values will become invalid, and the main unit screen will display the component as “–”.

Battery

6.1 Overview

The oximeter is powered by the internal rechargeable lithium battery.

WARNING

• To charge the battery, please use a power adapter (DC5V output voltage and 500mA current) conforming to the safety requirements in IEC 60601-1 and the electromagnetic compatibility requirements in IEC 60601-1-2.
• It is forbidden to use the device during charging.
• Do not disassemble the battery, place it in fire, or short-circuit it. Combustion, explosion or leakage of the battery could cause injury.

6.1.1 Lithium Battery Charging

Operation steps:

1. Connect the charging cable to the multi-purpose multiplex interface of the oximeter;
2. Connect the other end of the charging cable to the charger;
3. Disconnect the adapter after full charging.

▲ NOTE

• The service life of lithium battery depends on the time and frequency of use. If the lithium battery is maintained and stored properly, its service life is subject to the general standard for batteries and the warranty standard. If the lithium battery is used improperly, its service life could be shortened. The voltage supply time of the battery depends on the device configuration and operation.
• When the multi-purpose multiplex interface is used as the signal port, it can only connected with equipment having no external voltage risk (conforming to IEC 60601-1-1).
• Lithium batteries can be recharged 200 times and have a lifespan of approximately 2 years. Improper use of batteries may lead to shortened battery life. It is recommended to replace the lithium battery every 2 years or when the charging frequency exceeds 200 times.

Maintenance and Cleaning

Only use materials and methods listed in this chapter for cleaning or disinfection of the device.
For any damage or accident arising from use of other materials or methods, the Company will not provide any warranty. The Company will not assume any liability for the effectiveness of listed chemicals or methods when they are used as infection control means. For infection control methods, please consult the Infection Prevention Department or an epidemiologist in your hospital.
Please keep the device and its parts and accessories dustless. In order to avoid damage of the device, please observe the following requirements:

• Never soak the device in any liquid.
• Never pour any liquid onto the device or its accessories.
• Never allow any liquid to flow into the housing.
• Never use abrasive materials (e.g., steel wool or silver polish) or strong solvents

(e.g., acetone or detergents containing acetone).

WARNING

• Before cleaning the device, please power it off and disconnect the charging cable and SpO2 probe.

CAUTION

• If any liquid is poured onto the device or its accessories by accident, please contact the service personnel or our Company immediately.

7.1 Check

Before initial use or after repair or upgrade of the oximeter, a comprehensive check should be performed by qualified service personnel to ensure normal operation and working of the oximeter.

Items for checking should include:

• The environment and power supply conform to relevant requirements.
• The device and its accessories have no mechanical damage.
• The power cord has no abrasion, and the insulating property is good.
• Specified accessories are used.
• The battery performance is good.
• The device is in good working state.

If any damage or abnormality is found, please stop using the oximeter and contact the hospital’s medical engineer or our service personnel.

7.2 Cleaning and Disinfection

1. When dust or stain exists on the surface of the oximeter, 75% medicinal alcohol can be used for wiping. During wiping, please use a dry cloth to dip with small amounts of alcohol, and do not allow alcohol to drop or flow into the device.
2. Air-dry the device or use a dry, clean cloth to wipe the surface.

Recommended period: After each use of the device.

WARNING: Do not use high-temperature and high-pressure gas to disinfect the device.

7.3 Scrapping

To avoid contaminating the environment or other equipment or infecting other people, please disinfect and purify the device and its accessories according to applicable national laws or regulations before scrapping, and also observe the local regulations on scrapping of medical wastes. Packages should be scrapped according to applicable national laws or regulations.

Troubleshooting

A. Product Specifications

Technical Description

The table below shows the statistical conclusion of the study on invasive controlled desaturation according to Annex EE “Guideline for evaluating and documenting SpO2 accuracy in human objects” of ISO 80601-2-61. The statistical result shows the accuracy distribution within the range of 70%~100%, which is helpful for user.

Below shows the Bland-Altman plot of sample for study on invasive controlled desaturation.

B. Network Security

The WS Series Pulse Oximeter is available with USB port or Bluetooth function.
The management software is described as follows:

• B.1 The mobile phone management software for the pulse oximeter: The operating environment is a mobile phone installed with Android 8.0 OS or higher compatible version. Minimum hardware configuration requirements:
  CPU: 1GHz or faster; memory: 1GB or larger; Bluetooth: 4.0 or higher. There is no requirement on network environment.

• B.2 Software Update
  Update the instructions in the accompanying documents after independent registration.

C. EMC

The device meets the requirements of IEC 60601-1-2
Transmission power：<10 dBm
Wireless frequency range：2402MHz~2480MHz
Hereby, [Hunan Accurate Bio-Medical Technology Co., Ltd.], declares that this [WS20A] is in compliance with the essential requirements and other relevant provisions of RE Directive 2014/53/EU. A copy of the full DoC is attached.

NOTE

• Using accessories, transducers and cables other than those specified may result in increased electromagnetic emission or decreased electromagnetic immunity of the person monitoring equipment.
• The device or its components should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the device or its components should be observed to verify normal operation in the configuration in which it will be used.
• The device needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided below.
• Other devices may affect this pulse oximeter even though they meet the requirements of CISPR.
• When the inputted signal is below the minimum amplitude provided in technical specifications, erroneous measurements could result.
• Portable and mobile communication equipment will have impact on the performance of the pulse oximeter.

Appendix

D. Default Factory Settings

E. Product and Accessories

※ The main unit of oximeter is provided with a two-year warranty period starting from the date of purchase, and the SpO2 probe has a six-month warranty period.

Copy Right. Hunan Accurate Bio-Medical Technology Co., Ltd

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