Berry BM1000B User manual

Operation Manual
Pulse Oximeter
BM1000B/BM1000D
Shanghai Berry Electronic Tech Co., Ltd.
Release date: 07/28/2020 Version: 3.2
Product Description
Pulse Oximeter is an important and common device to check oxygen saturation (SpO2) and pulse
rate. It’s a small, compact, simple, reliable and durable physiological mnitoring device. Include the
mainboard, OLED display and dry batteries.
Intended Use

The pulse oximeter is reuse device and intended use for spot checking of the pulse oxygen
saturation and pulse rate for adult in clinic environment. This medical device can be reused. Not
for continuously monitoring.
Applicable people and scope
It is suitable for monitoring adults. It is used in clinic section office, out-patient department,
sickroom. It can also be used in the recovery and health care organizations, the community
medical treatments.
Contraindications
The product only applies to adults. Please don’t use the product for children, infant and neonatal.
The damaged skin tissue can’t be measured.
Measurement Principle
The operating principle is based on light transmission through the hemoglobin. The light
transmission of a substance is determined by the Beer-Lambert law, which determines the
concentration of a solute (oxyhemoglobin) in a solvent (hemoglobin) can be determined by light
absorption. The blood stain depends on the blood oxygen levels, and the blood with high oxygen
concentration presents red color due to high concentration of oxyhemoglobin. When the
concentration is reduced, the blood takes on a more bluish, due to a greater presence of
deoxyhemoglobin (combination of hemoglobin molecules with carbon dioxide). That is, blood is
based on spectrophotometry, measuring the amount of light transmitted through the capillaries of
the patient, synchronized with the heart pulse.
1. Infrared Light Emitting 2. Infrared Light receiver
Safety Information
⚫The person who uses the pulse oximeter must receive adequate training before use.
⚫The pulse oximeter is intended only as adjunct in patient assessment. It must be used in
conjunction with clinical signs and symptoms. It is not intended as a device used for
treatment purposes.
⚫When using the pulse oximeter together with the electrical surgery equipment, the user
should pay attention to and guarantee safety of the patient being measured.
⚫EXPLOSION HAZARD: Do not use the pulse oximeter in the presence of flammable

anesthetics, explosive substances, vapors or liquids.
⚫Make sure not to use the pulse oximeter during MRI (magnetic resonance imaging)
scanning or CT (Computed Tomography)environment because induced current could
potentially cause burns.
⚫The pulse oximeter is without alarm function. Continuous monitoring for a long time is
not suitable.
⚫No modification of this product is allowed. Maintenance should be operated by
professional maintenance personnel who are approved by manufacturers.
⚫Please shut off the power before clean the pulse oximeter. Never permit high-pressure
and high-temperature disinfection of the device. Never use cleaning agents/disinfectants
other than the recommended.
⚫The product is commonly seal product. Keep its surface dry and clean, and prevent any
liquid from infiltrating it.
⚫The pulse oximeter is precision and fragile. Avoid pressure, knock, strong vibration or
other mechanical damage. Hold it carefully and lightly. If it is not in use, it should be
appropriately placed.
⚫For disposal of pulse oximeter and accessories, follow local regulations or your
hospital’s policy regarding disposal of such pulse oximeter and accessories. Do not
dispose randomly.
⚫Use AAA alkaline batteries. Do not use carbon or poor quality batteries. Remove the
batteries if the product is not to be used for a long time.
⚫A functional tester can’t be used to assess the accuracy.
⚫If patient is an intended operator, you must read the operation manual carefully and
understand deeply or consult with the doctor and manufacturer before using. If you
have any discomfort in use, please stop using immediately and go to the hospital.
⚫Avoid static electricity, before using the pulse oximeter, confirmed direct or indirect
static electricity of all the operators and patients who contact with the instrument.
⚫When in use, try to make the pulse oximeter keep away from radio receiver.
⚫If the pulse oximeter uses unspecified and without EMC test system configuration, it
can enhance electromagnetic radiation or reduce anti-electromagnetic interference
performance. Please use the specified configuration.
⚫Portable and mobile radio frequency communication equipment can affect the normal
use of the pulse oximeter.
⚫The pulse oximeter should not be close to or stacked with other equipments, if you must
be close to or stacked them in use, you should observed and verify that it can run
normally with the configuration which it uses.
⚫It should ensure that there is no dirt or wound on the tested part.
⚫Federal law restricts this device to sale by or on the order of a physician.
⚫If the product is intended to allow direct diagnosis or monitoring of vital physiological
processes, then it is likely to result in the immediate danger to the patient.
⚫Please keep this oximeter and its accessories in a safe place to prevent pet bites from
breaking or pests from entering. Keep oximeters and small parts such as batteries out of
the reach of children to avoid accidents.
⚫Mental retarded persons must be used under the guardianship of normal adults to

avoid strangulation due to Lanyard.
⚫Connect accessory carefully to avoid the patient being twined or strangulated.
Product Feature
◆Simple and convenient usage of product, simple one-touch operation.
◆Small volume, light weight, convenient to carry.
◆Lower consumption, original twoAAA batteries can continuously work for 15 hours.
◆Low voltage reminder shows in screen when there’s low battery.
◆The machine will automatically power off after 10 seconds when there’s no signal generated.
◆Communication can be realized between the product and mobile phone with its wireless
Bluetooth. (Except “BM1000D”)
Display Introduction
Figure 1
Measuring Steps
1. Hold the product in one hand with the front panel facing the palm. Put the other hand’s big
finger on the battery cabinet lid’s press sign as shown in Figure 2, press downwards and push
the lid open at the same time. The battery cabinet is opened.
2. Install batteries into the slots per the “+”and “-”symbols as shown in Figure 3.
Cover the lid onto the cabinet and push it upwards to make it close well.
3. Press Clip’s press sign in the figure 1and open the clip. Let the testee’s finger put into the
rubber cushions of the clip, make sure the finger is in the right position as shown in Figure 4,
and then clip the finger.
4. Press the power and function switch button on the front panel to turn on the product. Using

first finger, middle finger or ring finger when doing test. Don’t shank the finger and keep the
testee at case during the process. The readings will be displayed on the OLED screen a
moment later as shown in Figure 5.
⚫The positive and negative electrodes of batteries should be installed correctly. Otherwise
the device will be damaged.
⚫When install or remove batteries, please follow the correct operation sequence to
operate. Otherwise the battery compartment will be damaged.
⚫If the pulse oximeter isn’t used for long time, please remove the batteries of it.
⚫Make sure to place the product on the finger in a correct direction. The LED part of the
sensor should be at the backside of the patient hand and photodetector part at the inside.
Make sure to insert the finger to suitable depth into the sensor so that the fingernail is
just opposite to the light emitted from the sensor.
⚫Don’t shake the finger and keep the testee calm during the process.
⚫Data update period is less than 30 seconds.
Figure 2 Figure 3
Figure 4 Figure 5
NOTE:
⚫Before measuring, the pulse oximeter should be checked whether it is normal, if it is
damaged, please don’t use.
⚫Don’t put the pulse oximeter on extremities with arterial catheter or venous syringe.
⚫Don’t perform SpO2monitoring and NIBP measurements on the same arm
simultaneously. Obstruction of blood flow during NIBP measurements may adversely
affect the reading of the SpO2value.
⚫Don’t use the pulse oximeter to measure patients whose pulse rate is lower than 30bpm,
lid’s press sign

which may cause incorrect results.
⚫The measurement part should be chosen well perfusion and be able to fully cover the
test window of the sensor. Please clean the measurement part before place the pulse
oximeter, and ensure drying.
⚫Cover the sensor with opaque material under the condition of strong light. Failure to do
so will result in inaccurate measurement.
⚫Make sure that there is no contamination and scar on the tested part. Otherwise, the
measured result may be incorrect because the signal received by the sensor is affected.
⚫When used on different patients, the product is prone to crossed contamination, which
should be prevented and controlled by the user. Disinfection is recommended before
using the product on other patients.
⚫Incorrect placement of the sensor may affect the accuracy of the measurement, and it is
at the same horizontal position with heart, measurement effect is the best.
⚫The highest temperature of sensor contacts with patient’s skin don’t be allowed more
than 41℃.
⚫Prolonged use or the patient’s condition may require changing the sensor site
periodically. Change sensor site and check skin integrity, circulatory status, and correct
alignment at least even 2 hours.
Factors affecting measurement accuracy:
⚫The measurements also depend on absorption of special wavelength ray by oxidized
hemoglobin and deoxyhemoglobin. Concentration of nonfunctional hemoglobin may
affect the accuracy of the measurement.
⚫Shock, anemia, hypothermia and the application of vasoconstriction drug may decrease
arteria blood flow to an unmeasurable level.
⚫Pigment, or deep color (for example: nail polish, artificial nails, dye or pigmented
cream) may cause inaccurate measurements.
Function Description
a. When the data has been displayed on the screen, short press the “POWER/FUNCTION” button
one time, the display direction will be rotated. (as shown in Figure 6,7)
b. Then short press the “POWER/FUNCTION” button once again, the display direction will be
restored to the previous state. And buzzer indicating will disappear at the same time, the buzzer
will be turned off. (as shown in Figure8)
c. When Bluetooth function is not connected successfully, Bluetooth indicating will flicker. When
Bluetooth function is connected successfully, Bluetooth indicating will continue to be alight.
d. When the received signal is inadequacy, “ ” will be displayed on the screen. (as
shown in Figure 9)
e. The product will automatically be powered off when no signal after 10 seconds.

Figure 6 Figure 7
Figure 8 Figure 9
Bluetooth Communication Function (optional)
BM1000B pulse oximeter is with the Bluetooth communication function. It can send data to
intelligent terminal and computer (Related software has been installed.) with communication
function.
NOTE: The usage of Bluetooth communication software which is installed in the computer or
intelligent terminal is written into the “APP operation guide”.
Hang lace Installation
1. Thread thinner end of the hang lace through the hanging hole. The position of the hanging
hole as shown in Figure 10. ( Notice: the hanging hole is on both sides. )
2. Thread thicker end of the lace through the threaded end before pulling it tightly.
Figure 10
Cleaning and Disinfection
Hanging hole

⚫Never immerse or soak the pulse oximeter.
⚫We recommend cleaning and disinfecting the product when necessary or when used in
different patients to avoid damage to the product.
⚫Never use cleaning agents/disinfectants other than the recommended.
⚫Never permit high-pressure and high-temperature disinfection of the device.
⚫Please shut off the power and take out the batteries before clean and disinfect.
Cleaning
1. Clean the product with cotton or soft cloth moistened with water.
2. After cleaning, wipe off the water with a soft cloth.
3. Allow the product to air dry.
Disinfection
The recommended disinfectants include: ethanol 70%, isopropanol 70%, glutaraldehyde (2%)
solution disinfectants.
1. Clean the product as instructed above.
2. Disinfect the product with cotton or soft cloth moistened with one of the recommended
disinfectants.
3. After disinfection, be sure to wipe off the disinfectant left on the product with a soft cloth
moistened with water.
4. Allow the product to air dry.
Packing List
The standard configuration
Pulse Oximeter
1pc
Hang lace
1pc
The operation manual
1pc
Expected service life: 3 years
Technical Specifications
1. Display mode: OLED
2. SpO2:
Measurement range: 35~100%
Accuracy: ±2%（80%~100%）; ±3%（70%~79%）
3. Pulse Rate:
Measurement range: 25~250bpm
Accuracy: ±2bpm
⚫Pulse Rate accuracy has passed proving and comparison with SpO2 simulator.
4. Electrical specifications:
Working voltage: D.C.2.2 V~D.C.3.4V
Battery Type: Two 1.5VAAA alkaline batteries
Power consumption: smaller than 50mA

5. Product specifications:
Size: 58 (H) × 34 (W) × 30(D) mm
Weight: 50g (include two AAA batteries)
6. Environment requirements:
NOTE：
⚫When the environment temperature is 20℃, the time required for Pulse Oximeter to
warm from the minimum storage temperature between uses until it is ready for
intended use is 30 to 60 minutes.
⚫When the environment temperature is 20℃, the time required for Pulse Oximeter to
cool from the maximum storage temperature between uses until it is ready for intended
use is 30 to 60 minutes.
Temperature:
Operation: +5~+40℃
Transport and storage: -10~+50℃
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 the accuracy.
⚫The method of confirming the blood oxygen measurement accuracy is to compare the
oximetry measurement value with the value of blood gas analyzer.
Troubleshooting
Trouble
Possible reason
solution
The SpO2and PR
can’t be displayed
normally and
the value
disappeared.
1. The finger is not properly
positioned.
2. The patient’s SpO2is too low to
be detected.
3. Bluetooth signal is interrupted.
1. Please the finger properly and try
again.
2. Try again; Go to a hospital for a
diagnosis if you are sure the device
works all right.
3. Check the Bluetooth connection
and reconnect.
The SpO2and PR
display instable.
1. The finger is not placed inside
enough.
2. The finger is shaking or the
testee is moving.
1. Place the finger properly and try
again.
2. Let the testee keep calm.
The device can’t
be powered on.
1. The batteries are drained or
almost drained.
2. The installation of batteries is
not correct.
3. The device’s malfunction.
1. Change batteries.
2. Reinstall batteries.
3. Please contact the supplier.

The screen is
suddenly off.
1. The product is automatically
powered off when no signal is
detected longer than 10
seconds.
2. Power quantity of the batteries
is exhausted.
1. Normal.
2. Replace the batteries.
Symbol Meaning
Symbol
Meaning
“CAUTIOUS”! Please refer to the operation manual.
Type BF Equipment.
The product does not contain alarm function.
When the end-user wishes to discard this product, it must be sent to separate
collection facilities for recovery and recycling.
European Union for approval.
Information of manufacture, including name and address.
Date of manufacture.
Serial Number.
Batch Code.
Type Number.
The European Union authorized.
IP22
The product is protected against harmful effects of dripping water per IEC
60529.
Shanghai Berry Electronic Tech Co., Ltd.
Unit 104, 1st Floor, 7th Building, No.1188 Lianhang Road, Minhang District,
Shanghai, China 201112
TEL: [phone] FAX: [phone]
WEB: www.shberrymed.com

Prolinx GmbH
Brehmstr. 56, 40239, Duesseldorf
Germany
If you need additional information, please contact with us.

Appendix A EMC Declaration
Table 1 –EMISSION limits per environment
Phenomenon
HOME HEALTHCARE
ENVIRONMENT
Conducted and
radiated RF
EMISSIONS
Group 1 Class B
Harmonic distortion
See IEC 61000-3-2
Voltage fluctuations
and flicker
See IEC 61000-3-3
Table 2 –* ENCLOSURE PORT
Phenomenon
Basic EMC
standard or test
method
IMMUNITY TEST LEVELS
HOME HEALTHCARE
ENVIRONMENT
ELECTROSTATIC
DISCHARGE
IEC 61000-4-2
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
Radiated RF EM
fields
IEC 61000-4-3
10 V/m
80 MHz –2,7 GHz
80 % AM at 1 kHz
Proximity fields from RF
wireless
communications
equipment
IEC 61000-4-3
See Table4
RATED power frequency
magnetic fields
IEC 61000-4-8
30 A/m
50 Hz or 60 Hz
Table 3–* PATIENT coupling PORT
Phenomenon
Basic EMC
standard
IMMUNITY TEST LEVELS
HOME HEALTHCARE
ENVIRONMENT
ELECTROSTATIC
DISCHARGE
IEC 61000-4-2
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
Conducted
disturbances
induced by RF
fields
IEC 61000-4-6
3 V
0,15 MHz –80 MHz
6 V in ISM and amateur radio
bands between 0,15 MHz and
80 MHz
80 % AM at 1 kHz

Table 4–Test specifications for ENCLOSURE PORT IMMUNITY to
RF wireless communications equipment
Test
frequency
(MHz)
Band a)
(MHz)
Modulation
Distance
(m)
TEST LEVEL
IMMUNITY
(V/m)
385
380 –390
Pulse
modulation
18 Hz
0,3
27
450
430 –470
FM
± 5 kHz deviation
1 kHz sine
0,3
28
710
704 –787
Pulse
modulation
217 Hz
0,3
9
745
780
810
800 –960
Pulse
modulation
18 Hz
0,3
28
870
930
1 720
1 700 –
1 990
Pulse
modulation
217 Hz
0,3
28
1 845
1 970
2 450
2 400 –
2 570
Pulse
modulation
217 Hz
0,3
28
5 240
5 100 –
5 800
Pulse
modulation
217 Hz
0,3
9
5 500
5 785