BERRY BM1000 Fingertip Pulse Oximeter User Manual

BERRY BM1000 Fingertip Pulse Oximeter

Product Information

Specifications

• Product Name: Fingertip Pulse Oximeter
• Model: BM1000
• Manufacturer: Shanghai Berry Electronic Tech Co., Ltd.
• Release Date: 26/11/2021
• Version: 1.0

Product Description

• The pulse oximeter is an important, common device that checks oxygen saturation (SpO2) and pulse rate.
• It is a small, compact, simple, reliable, and durable physiological monitoring device.
• The device contains the mainboard, and OLED display, and uses dry batteries.

Intended Use

• The pulse oximeter is a reusable device intended for intermittent checks of oxygen saturation and pulse rate for adults in a clinical environment. It is not designed for continuous monitoring.

Applicable Users and Scope

• The pulse oximeter is intended for monitoring adults in clinical settings, outpatient departments, sickrooms, recovery and healthcare organizations, as well as community medical treatment centres.

Measurement Principle

• Arterial oxygen saturation is measured via a method called oximetry. It is a continuous, non-invasive method based on the different spectra absorption of hemoglobin and oxyhemoglobin (spectrophotometer principle).

Safety Information

• Read carefully or consult with a doctor and/or manufacturer before usage. If there’s any discomfort while using the pulse oximeter, stop usage immediately and seek medical attention.

Product Structure

1. To remove the back cover compartment, push the white button and follow the direction of the printed arrows.
2. Install two AAA batteries into the battery compartment. Match the plus (+) and minus (-) signs in the compartment.
3. Slide the battery door cover horizontally in the direction of the arrow as shown in the manual.

Warning

Keep the oximeter away from young children as small parts can be choking hazards.

Product Usage Instructions

Directions for Use

1. Install two AAA batteries following the provided instructions.
2. Open the clip by pushing down on the lid’s press sign.
3. Place the testee’s finger between the rubber cushions of the clip with the nail upward.
4. Ensure the finger is positioned correctly and release the clip gently.
5. Remain motionless during the reading of SpO2 and Pulse Rate data.

FAQ

Q: Can the pulse oximeter be used on children?

A: The pulse oximeter is intended for adults only. Consult a pediatrician for suitable devices for children.

Q: How often should I change the batteries?

A: Change the batteries when the device indicates a low battery or at least every 6 months for optimal performance.

Install Battery

1. To remove the back cover compartment, push the white button and follow the direction of the printed arrows.
2. Install two AAA batteries into the battery compartment. Match the plus (+) and minus (-) signs in the compartment. If the polarities are not matched, damage to the oximeter may occur.
3. Slide the battery door cover horizontally in the direction of the arrow as shown in the picture.

Measurement

1. Press the Power/Function button as shown below.
2. Place one finger into the rubber hole of the oximeter (it is best to plug the finger thoroughly) before releasing the clamp, with the nail upward, as indicated below:
3. The data (SpO2 and Pulse Rate) will read as below. Don’t move the finger; be sure to remain motionless during the reading.
4. Once the measurement is finished, it will display “Thank you” as shown below. Remove finger. The device will turn off automatically.
   • Thank you

Product Description

• The pulse oximeter is an important, common device that checks oxygen saturation (SpO2) and pulse rate. It is a small, compact, simple, reliable, and durable physiological monitoring device. It contains the mainboard, OLED display, and dry batteries.

Intended Use

• The pulse oximeter is a reusable device intended for intermittent checks of oxygen saturation and pulse rate for adults in a clinical environment. This medical device is not intended for continuous monitoring.

Applicable Users and Scope

• The pulse oximeter is intended for monitoring adults. It is used in clinical settings, outpatient departments, and sickrooms. It can also be used in recovery and healthcare organizations as well as community medical treatment centres.

Contraindications

• The pulse oximeter only applies to adults. It is not suitable for injured skin tissue.

Measurement Principle

• Arterial oxygen saturation is measured via a method called oximetry. It is a continuous, non-invasive method based on the different spectra absorption of hemoglobin and oxyhemoglobin (called the spectrophotometer principle).
• The data processed by the device is obtained via a formula based on the Lambert Beer Law, according to the spectrum absorption characteristics of hemoglobin (Hb) and oxyhemoglobin (HbO2) in the glow and near-infrared zones.
• The instrument operates on the principle of Photoelectric Oxyhemoglobin Inspection Technology. Two beams of different wavelengths of light (666nm visible red light and 905nm near-infrared light) can be focused on the human nail tip via emitters by adopting the Capacity Pulse Scanning and Recording Technology. It will obtain a measured signal via a photosensitive element. The amount of light absorbed relates to the amount of oxygen in the blood during these pulses.
• The ratio of the two absorbed spectrums can be calculated via the microprocessor, and the results are compared with the saturation value in the memory. This is how the blood oxygen saturation value is obtained.
• Diagram of Measurement Principle

Safety Information

• Anyone who uses the pulse oximeter must receive adequate training before use.
• The pulse oximeter is only meant to assess patients’ physiological conditions. It must be used in conjunction with clinical symptoms. It is not intended for treatment.
• When using the pulse oximeter in conjunction with the electrical surgery equipment, the user should ensure the safety of the patient.
• EXPLOSION HAZARD: Do not use the pulse oximeter in the presence of flammable anesthetics, explosive substances, vapours, or liquids.
• It is forbidden to use the pulse oximeter in MRI (magnetic resonance imaging) scanning or CT (Computed Tomography) because the induced current could cause potential burning.
• The pulse oximeter does not include an alarm function. Therefore, continuous monitoring for long periods is not suitable.
• Modification of the pulse oximeter is not allowed. Any product maintenance should be done by manufacturer-approved, professional maintenance personnel.
• Please shut off the power before cleaning the pulse oximeter. Disinfecting the pulse oximeter via high-pressure and high-temperature methods is prohibited. Any cleaning agents/disinfectants other than the recommended ones listed in the operation manual are not allowed for use.
• The pulse oximeter is not waterproof. Keep its surface dry and clean and prevent any liquid from infiltrating the product.
• The pulse oximeter is fragile and requires precision to function properly. Avoid any pressure, jostling, strong vibrations, or other potential mechanical damage. Hold it carefully and lightly. If it is not in use, the pulse oximeter should be appropriately stored.
• Do not dispose of the pulse oximeter randomly. Disposal procedures should follow local regulations or hospital policy regarding disposal of the pulse oximeter and accessories.
• Use AAA alkaline batteries. Do not use carbon or poor-quality batteries. Remove the batteries if the pulse oximeter hasn’t been used for a long time.
• A functional tester can’t be used to assess the accuracy.
• If the patient is the intended operator, the patient must read the operation manual carefully or consult with a doctor and/or manufacturer before usage. If there’s any discomfort while using the pulse oximeter, stop usage immediately and go to the hospital.
• To avoid any static electricity damage to the pulse oximeter, direct or indirect static electricity should be discharged before usage.
• Try to keep the pulse oximeter away from any radio receivers when in use.
• If the pulse oximeter is used in a configuration that does not pass the EMC test, it can enhance electromagnetic radiation or reduce anti-electromagnetic interference performance. Please use the specified configuration.
• The pulse oximeter should not be closed (or stacked) with other devices. If that cannot be avoided, it should be observed and verified that the oximeter can run normally with the proximity/stacked configuration.
• There should be no dirt or wound on the tested surface (i.e., finger).
• Federal law restricts this device to sale by the order of a physician.

Precaution

• Check the pulse oximeter for damage before use. If it’s damaged, don’t use it.
• Don’t put the pulse oximeter on extremities with an arterial catheter or venous syringe.
• Don’t perform SpO2 and NIBP measurements on the same arm simultaneously. Obstruction of blood flow during NIBP measurements may adversely affect the reading of the SpO2 value.
• Don’t use the pulse oximeter to measure patients whose pulse rates are lower than 30 bpm (this may cause incorrect results).
• The well perfusion of the measuring instrument should fully cover the test window of the sensor. Clean and dry the measurement part before storing the pulse oximeter.
• Cover the sensor with opaque material under strong light. Otherwise, the light can cause inaccurate measurements.
• Make sure there is no contamination or scarring on the tested finger. Otherwise, the results may be incorrect.
• The product is prone to cross-contamination when used on different patients. Disinfection is recommended before using the product on other patients.
• Incorrect placement of the sensor may affect the accuracy of the measurements. To achieve the best measurements, hold the device in the same horizontal position (parallel) with the heart.
• Do not use the device if the temperature exceeds 41°C.
• Change sensor location and check skin integrity and circulatory status at least every 2 hours.

Factors affecting measurement accuracy:

• The measurements depend on the absorption of a special wavelength ray by oxidized hemoglobin and deoxyhemoglobin.
• The concentration of non-functional hemoglobin may affect the accuracy of the measurement.
• Shock, anemia, hypothermia, and vasoconstrictive drugs may decrease arterial blood flow to an unmeasurable level.
• Pigments or deep colours (i.e., nail polish, artificial nails, dyes, or pigmented cream) may cause inaccurate measurements.

Product Structure

Display Introduction

Battery and Lanyard Installation

• To remove the back cover compartment, push the white button and follow the direction of the printed arrows.
• Install two AAA batteries into the battery compartment. Match the plus (+) and minus (-) signs in the compartment. If the polarities are not matched, damage to the oximeter may occur.
• Slide the battery door cover horizontally in the direction of the arrow as shown in Figure 3, 4.

Note:

• Please remove the batteries if the pulse oximeter will not be used for long periods.
• Please replace the batteries when the power indicator starts flickering.
• Thread the thinner end of the lanyard through the hanging hole.
• Thread the thicker end of the lanyard through the threaded end before pulling it tightly.

Warning!

• Keep the oximeter away from young children. Small items such as the battery door, battery, and lanyard are choking hazards.

Directions for Use

1. After properly installing two AAA batteries, push down on the lid’s press sign as shown in Figure 5 and open the clip. Place the testee’s finger between the rubber cushions of the clip. Make sure the finger is in the right position as shown in Figure 5, then release the clip.
2. The device takes only a moment to take the reading. The SpO2 value and PR value will be displayed on the OLED screen after the plethysmograph wave and measured values are stable, as shown in Figure 6.

• Be sure to place the patient’s finger in the device in the correct orientation. The LED part of the sensor should be on the end that is closer to the patient’s wrist.
• Be sure to insert the finger deep enough into the sensor so that the fingernail is opposite the light emitted from the sensor.
• Don’t move the finger; remain motionless during the process.
• The data update period is less than 30 seconds.

Function Description

1. Press the “POWER/FUNCTION” button to power on the device. Press it again to rotate the display orientation, as shown in Figure 7 and Figure 8.
2. Press and hold the “POWER/FUNCTION” button for more than 3 seconds to show the IMEI and SIM card number. Press it again to exit, as shown in Figure 9.
3. When there is no finger inserted, the invalid value “ ” will be displayed on the screen, as shown in Figure 10.
4. When the measurement is finished and the network is available, the upload procedure will be started automatically, as shown in Figure 11. It will end with “Success” or “Failed,” as shown in Figure 12 and Figure 13. If the upload fails, the current measurement record will be saved automatically and re-uploaded next time.
5. The product will automatically shut down when there is no finger inserted for more than 10 seconds or after the upload is finished.

Network Indicator Description

Cleaning and Disinfection

• Do not immerse the oximeter and any relevant accessories in water or disinfectant.
• We recommend that the product be disinfected only when necessary to avoid long-term damage to the product.
• Don’t use cleaning agents/disinfectants other than the recommended models.
• Don’t disinfect the device via high-pressure or high-temperature methods.
• Shut off the power and take out the batteries before cleaning and disinfecting.

Cleaning

1. Clean the product with cotton or a soft cloth moistened with water.
2. After cleaning, wipe off the water with a soft cloth.
3. Leave the device to dry naturally.

Disinfection

1. The recommended disinfectants include the following: ethanol 70%, isopropanol 70%, and glutaraldehyde (2%) solution disinfectants.
2. Clean the product as instructed above.
3. Disinfect the product with cotton or a soft cloth moistened with one of the recommended disinfectants.
4. After disinfection, be sure to wipe off the disinfectant left on the product with a soft cloth moistened with water.
5. Leave the device to dry naturally.

Packing List

THE STANDARD CONFIGURATION

Pulse oximeter| 1pc
Lanyard| 1pc
The operation manual| 1pc
Alkaline battery| 2pcs

Expected service life: 3 years

Technical Specifications

1. Display Mode: OLED
2. SpO2:
   • Measurement range: 0~100%
   • Accuracy: ±3% (70%~100%)
3. Pulse Rate:
4. Measurement range: 25~250bpm
5. Accuracy: ±2bpm
6. Pulse Rate accuracy has passed verification and comparison with the SpO2 simulator.
7. Low Perfusion:
   • Range: 0.5%~20%
   • SpO2 Accuracy: ±3% (70%~100%)
   • PR Accuracy: 25~250bpm ±2bpm
8. Electrical Specifications:
   • Working Voltage: D.C.2.2V~D.C.3.4V
   • Battery   Type: Two 1.5V AAA alkaline batteries
   • Battery Life: Measurement and upload in normal conditions over 500 times
9. Product Specifications:
   • Size: 58 (H) × 34 (W) × 30(D) mm
   • Weight: 50g (includes two AAA batteries)
10. Environment Requirements:
    • Temperature:
    • Operation: +5~+40°C
    • Transport and Storage: -10~+50°C
    • Humidity:
    • Operation: 15%~80% (noncondensing)
    • Transport and Storage: 10%~90% (noncondensing)
    • Atmospheric Pressure:
    • Operation: 860hPa~1060hPa
      Transport   and Storage: 700hPa~1060hPa

NOTE:

• A functional tester can’t be used to assess this product’s accuracy.
• The purpose of confirming the blood oxygen measurement’s accuracy is to compare the oximetry measurement value with the value of a blood gas analyzer.

LED:

• Wavelength: 660nm/905nm
• Output Power: <0.1mW

Arms Specifications

SpO2 Arms:

Clinical Data Graphical Plot:

Troubleshooting

The finger is not properly positioned.

2.       The patient’s SpO2 is too low to be detected.

| 1.       Please try again.

2.       Try again. Go to a hospital for a diagnosis if you are sure the device is working correctly.

The SpO2 and PR display are unstable.| 1.       The finger is not placed deep enough inside the device.

2.       The finger is shaking or the testee is moving.

| 1.       Place the finger properly and try again.

2.       Encourage the testee to keep calm.

The device can’t be powered on.| 1.       The batteries are drained or almost drained.

2.       The installation of the batteries is not correct.

3.       The device has malfunctioned.

| 1.       Change batteries.

2.       Reinstall batteries.

3.       Please contact the supplier.

The screen suddenly turned off.| 1.       The product will automatically shut down when there is no finger inserted for more than 10 seconds or after the upload is finished.

2.       The power of the batteries is exhausted.

| 1.       Normal.

2.       Replace the batteries.

Symbol Meaning

• Shanghai Berry Electronic Tech Co., Ltd.
• Unit 104, 1st Floor, 7th Building, No.1188 Lianhang Road, Minhang District, Shanghai, China 201112
• TEL: +86-21-5853 1958
• FAX: +86-21-5853 0420
• WEB:www.shberrymed.com
• If you need additional information, please contact the manufacturer.

Appendix A—EMC Declaration

Guidance and manufacturer’s declaration—electromagnetic emissions—for all EQUIPMENT and SYSTEMS

Guidance and manufacturer’s declaration—electromagnetic emission

The Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of the Pulse Oximeter should ensure that it is used in such an environment.
Emission

Test

| Compliance| Electromagnetic Environment—Guidance
RF emissions CISPR 11| Group 1| The Pulse Oximeter uses RF energy only 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 CISPR11| Class B| The Pulse Oximeter is suitable for use in all establishments, including domestic establishments and those directly connected to a low-voltage power supply network that supplies buildings used for domestic purposes.

Guidance and manufacturer’s declaration—electromagnetic immunity—for all EQUIPMENT and SYSTEMS

• a) Discharges shall be applied with no connection to an artificial hand and no connection to the PATIENT simulation. PATIENT simulation may be connected after the test as needed to verify BASIC SAFETY and ESSENTIAL PERFORMANCE.
• b) Applies only to ME EQUIPMENT and ME SYSTEMS with magnetically sensitive components or circuitry.
• c) During the test, the ME EQUIPMENT or ME SYSTEMS may be powered at any NOMINAL input voltage, but with the same frequency as the test signal (see Table 1).
• d) This test level assumes a minimum distance of at least 15 cm between the ME EQUIPMENT or ME SYSTEMS and sources of power frequency magnetic field.
• If the RISK ANALYSIS shows that the ME EQUIPMENT or ME SYSTEMS will be used closer than 15 cm to sources of power frequency magnetic field, the IMMUNITY TEST LEVEL shall be adjusted as appropriate for the minimum expected distance.

Guidance and manufacturer’s declaration—electromagnetic immunity—for all EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING

Guidance and manufacturer’s 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 ensure that it is used in such

an environment.

Immunity Test| IEC 60601 Test Level| Compliance Level
Conducted disturbances included by RF fields a) IEC 61000-4-6

**** Radiated RF EM fields c) IEC 61000-4-3

| 3 V b)

0.15 MHz – 80 MHz

6 V b) in ISM and amateur radio bands between 0.15 MHz and 80 MHz

80% AM at 1 kHz

**** 10 V/m b)

80 MHz – 2.7 GHz d)

80% AM at 1 kHz e)

| 3 V b)

6 V b)

10 V/m b)

a) The following apply:

– All PATIENT-COUPLED cables shall be tested, either individually or bundled

–  PATIENT-COUPLED cables shall be tested using a current clamp unless a current clamp is not suitable. In cases where a current clamp is not suitable, an EM clamp shall be used.

–  No intentional decoupling device shall be used between the injection point and the PATIENT COUPLING POINT in any case.

–  Testing may be performed at other modulation frequencies identified by the RISK MANAGEMENT PROCESS.

– Tubes that are intentionally filled with conductive liquids and intended to be connected to a PATIENT shall be considered to be PATIENT-COUPLED cables.

–  If the frequency stepping skips over an ISM or amateur radio band, as applicable, an additional test frequency shall be used in the ISM or amateur radio band. This applies to each ISM and amateur radio band within the specified frequency range

• The ISM (industrial, scientific and medical) bands between 0.15 MHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. The amateur radio bands between 0.15 MHz and 80 MHz are 1.8 MHz to 2.0 MHz, 3.5 MHz to 4.0 MHz, 5.3 MHz to 5.4 MHz, 7 MHz to 7.3 MHz, 10.1 MHz to 10.15 MHz, 14 MHz to 14.2 MHz, 18.07 MHz to 18.17 MHz, 21.0 MHz to 21.4 MHz, 24.89 MHz to 24.99 MHz, 28.0 MHz to 29.7 MHz and 50.0 MHz to 54.0 MHz.

• b) Before modulation is applied

• c) The interface between the PATIENT physiological simulation, if used, and the ME EQUIPMENT or ME EQUIPMENT shall be located within 0, 1 m of the vertical plane of the uniform field area in one orientation of the ME EQUIPMENT of ME SYSTEM.
  d) ME EQUIPMENT and ME SYSTEM that intentionally receive RF electromagnetic energy for their operation shall be tested at the frequency of reception. Testing may be performed at other modulation frequencies identified by the RISK MANAGEMENT PROCESS. This test assesses the BASIC SAFETY and ESSENTIAL PERFORMANCE of an intentional receiver when an ambient signal is in the passband. It is understood that the receiver might not achieve normal reception during the test.

• e) Testing may be performed at other modulation frequencies identified by the RISK MANAGEMENT PROCESS.

Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment

Test Frequency (MHz)| Band a) (MHz)| Service a)| Modulation b)| Maximum Power (W)| Distance (m)| IMMUNITY TEST LEVEL (V/m)
---|---|---|---|---|---|---
385| 380—390| TETRA 400| Pulse modulation b) 18 Hz| 1.8| 0.3| 27
450| 430—470| GMRS 460, FRS 460| FM c) ± 5 kHz deviation 1 kHz sine| 2| 0.3| 28
710| 704—787| LTE Band 13, 17| Pulse modulation b) 217 Hz| 0.2| 0.3| 9
745
780
810| 800—960| GSM 800/900, TETRA 800,

iDEN 820,

CDMA 850,

LTE Band 5

| Pulse modulation b) 18 Hz| 2| 0.3| 28
870
930
1720| 1700—1990| GSM 1800; CDMA 1900;| Pulse modulation b) 217 Hz| 2| 0.3| 28
1845
1970|  | GSM 1900; DECT;

LTE Band 1, 3, 4,

25; UMTS

|  |  |  |
---|---|---|---|---|---|---
2450| 2400—2570| Bluetooth, WLAN,

802.11 b/g/n,

RFID 2450,

LTE Band 7

| Pulse modulation b) 217 Hz| 2| 0.3| 28
5240| 5100—5800| WLAN 802.11 a/n| Pulse modulation b) 217 Hz| 0.2| 0.3| 9
5500
5785
NOTE: If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting

antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.

a) For some services, only the uplink frequencies are included.

b) The carrier shall be modulated using a 50 % duty cycle square wave signal.

c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be the worst case.

References

• Pulse Oximeter-Berry Electronic
• Pulse Oximeter-Berry Electronic

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