Ambulatory
Blood Pressure Monitor
For 24 or 48 hour continuous monitoring
Instruction ManualABP-01
09.24.18
Table of Contents
1. Product Description
1.1 LCD display
1.2 Buttons
1.2A Start button functions
1.2B Event button functions
1.2C Day / Night button functions
2. How To Use the Monitor
2.1 Install the software
2.2 Setup the monitor
3. Programming the Monitor
4. Fit the Patient with the Monitor
5. Retrieve the Data
6. Customize, Review & Print Data
7. Manual Programming
8. Patient Information
9. Cuffs
9.1 Application
9.2 Apply the cuff
9.3 Connect the hose to the monitor
10. Batteries
11. Safety Concern
12. Cleaning and Protection
13. Maintenance
14. Disposal
15. Indications & Contraindications
16. Accessories List
17. TechnicalSpecications
18. Error Codes
19. Product Warranty Information
20. EMC Information
1. Product Description
BIOS DiagnosticsTM ABP-01 provides accurate information on blood pressure variability, overnight dipping and morning
surge for reliable hypertension management and control.
The ambulatory blood pressure monitor incorporates an algorithm validated to BHS (British Hypertension Society) and
AAMI (Association for the Advancement of Medical Instrumentation) protocols.
About the Ambulatory Blood Pressure Monitor
LCD display
START button
EVENT button
DAY/NIGHT
button
Sticker With Serial Number
Interface
Connection
Battery Compartment
Cuff Connection
1.1 LCD Display
Information displayed on ABP-01.
Normal status: time is
displayed
Blood pressure measurement
initiated (mmHg)
Pumping for measurement,
current pressure is displayed
(mmHg)
Deflation during
measurement, current
pressure is displayed (mmHg)
Systolic value of just
completed measurement
(mmHg)
Diastolic value of just
completed measurement
(mmHg)
Night mode: time is displayed,
moon sign is lit
Battery voltage display (2,37V)
Communication with a
personal computer
Pumping for measurement,
current pressure is displayed
(kPa)
Systolic value of a just
completed measurement
(19,2 kPa)
Diastolic value of a just
completed measurement (kPa)
Pulse rate value of just
completed measurements
(beats/minute)
Event marker set during a
button push
Error code display
The device is switched off
The blood pressure
measurement is cancelled
by pressing a button
Heart symbol blinking:
measurement in progress
(mmHg)
LCD check: all segments
are displayed
The crossed battery
symbol warns of low
battery
Blood pressure
measurement initiated
(kPa)
Deflation during
measurement, current
pressure displayed (kPa)
Heart symbol blinking:
measurement in progress
(kPa)
1.2 Buttons
The monitor has 3 buttons: start, event and day/night. Any blood pressure measurement can be interrupted by
pressing any button at any time while the cuff is inflated. This will result in immediate fast cuff deflation.
Start Button
- Start a manual BP recording
- Switch on/off
- LCD check
- Battery voltage check
1.2A Start Button Functions
1. To start a manual blood pressure measurement (press shortly).
Typical causes for this use: dizziness, pain (angina pectoris or headache), palpitation.
2. To switch the device off (press and hold for more than 10 seconds).
Press and hold the Start button until 2 horizontal segments appear on the LCD ( - - ).
3. To switch the device on (press and hold for more than 3 seconds) - to check the LCD.
Press and hold the start button to light up all segments of the LCD to check if they all work correctly.
4. To check battery voltage (press and hold for more than 5 seconds but less than 10 seconds).
The voltage for fully charged batteries should be over 2,5V (2_50 on the LCD).
Event Button
- Set an event marker
Day / Night Button
- Mark the time of sleeping/awakening
- Manual day/night shift
1.2B Event Button Functions
1. To set a patient event marker (press shortly).
Typical cause for this use is taking medicine. The patient should be instructed to record the reason for setting an
event marker in a diary.
12.C Day/Night Button Functions
1. Marking the time of sleeping and awakening.
If the day/night shift function is disabled during programming, the patient can press the day/night button to mark
the time of sleeping (in the evening) and awakening (in the morning).
2. Manual day/night shift (only in the 2 hour period before the prescheduled shift).
If this function is enabled during the programming, the patient can manually shift the measurement frequency
period (day or night) by pressing the day/night button.
2. How to Use the Monitor
2.1 Install the software
Install EasyABPM software to your PC from the installation CD. If the CD does not automatically start, run the
start.exe program.
Hardware & Software requirements
Minimum: CPU: 800MHz, RAM: 256 MB, VGA: 1024*768, free disk space:
10MB + 30MB for 1000 studies, USB connection port
Operating system: Windows XP SP2.
Suggested: CPU: 2 GHz, RAM: 512 MB, VGA: 1280*1024, free disk space:
10MB + 30MB for 1000 studies, USB connection port
Operating system: Windows7
2.2. Setup the monitor
Install 2 x AA batteries into the monitor.
Accumulator voltage should be over 2.5V. To check: press the START button
for at least 5 seconds.
Setup communication between the monitor and the PC
ABP-01 works with a special USB optical cable, which connects the monitor
to your PC. Always install the software before connecting the USB optical
cable to the PC! (The USB driver is installed together with the software, in the
absence of which the PC will not recognize the interface.)
Locate a USB port on your computer and connect the USB driver. Then
connect the USB optical cable into the USB driver.
IMPORTANT: It is very important to always plug the USB driver into
the computer first, and then plug the USB optical cable into the USB
driver otherwise a malfunction can occur.
The twin optical cable transfers optical signals between the interface unit and the monitor. The cable is flexible, but it is
sensitive to overfolding and to cutting forces. If you fold the optical cable in too small of a radius, or if a strong cutting
force (e.g. by the edge of a drawer) is applied to it, the optical cable may become optically distorted, which might result
in communication errors.
3. Programming the Monitor
1. Open the EasyABPM software.
2. Start a new examination/patient profile by clicking on Device New Examination or by clicking on the “New
Examination” icon .
Note: You can also select a patient from the database.
3. Enter the patients name, date of birth and gender. Assign a patient identifier number. Press OK to confirm.
4. Create a monitoring plan based on the requisition form filled out by the patient’s physician.
a. Ensure to select the correct sized cuff the patient will wear.
b. The start time of the examination can be adjusted.
c. Set the length of time to 24 hours or 48 hours.
To edit the interval program, click on the < > button.
a. Adjust the active, passive, morning and special (if applicable) period and interval times.
b. Press OK to confirm.
5. Click on the RELEASE button, the software will speak to the monitor and
set up all the parameters from the software to the ambulatory monitor.
6. Exit out of the software and unplug the monitor from the computer.
4. Fit the Patient with the Monitor
1. Apply a proper size cuff to the patient’s non-dominant arm and be sure
that the artery indicator is over the brachial artery.
2. Connect the hose to the monitor.
3. Place the monitor in the pouch and affix the patient with the belt and straps.
4. Start a manual BP reading to verify if the monitor is working properly and
to ensure proper fit and comfort for the patient.
5. Inform the patient about the goal and the expected results of the monitoring and about the use of the monitor.
5. Retrieve Data
1. Remove the monitor and the cuff from the returned patient.
2. Plug the monitor to the computer using the USB optical cable.
3. Highlight the correct patient’s name from the database.
4. Click on Device Read Data or click on the “Read Data” icon.
5. Once the data is downloaded the software will open the examination file.
6. Customize, Review & Print Data
1 Customize your standard report
EasyABPM: Tools Settings Report
2. Create and save or print the report, by clicking on File Print Review
3. Patient should follow up with their physician to discuss the results
7. Manual Programming
ABP-01 if programmed manually can be used by EasyABPM Software. Plans are stored in the inbuilt memory of the
device and they cannot be changed. The following three measurement plans can be selected during the programming
of the device:
PLAN A): measurements every 15 minutes at day and every 30 minutes at night.
PLAN B): measurements every 20 minutes at day and 40 minutes at night.
PLAN C): 30-minute periods independent of day or night time.
Other settings are the same in all the three plans: undecided cuff size, 300 mmHg pressure limit, LCD display enabled,
manual day/night shift disabled. Daytime starts at 6:00, while nighttime starts at 22:00, special session is disabled.
Patient data can be selected or created later in the database.
How To Program Manually
Press and hold the START and the DAY/NIGHT buttons simultaneously. Measurement
frequency of the measurement plans will be displayed after 10 seconds for 3-3 seconds.
To choose the measurement plan, release the buttons when the specific plan is displayed.
You will hear two beeps and the LCD will display four blinking “o” letters, which
indicates that programming the device is in progress. After successful programming you
can hear 5 beeps, and the selected plan can be seen again. If programming fails for some
reason, the E90 error code will be displayed on the LCD.
Imprecise, when programing manually, the time of measurements may be false. If you want to use the manual
programming function, do not leave the device without batteries for a long period.This happens, insert batteries
again into the device, set the inner clock by programming the device by a PC and leave the batteries in the device (the
suggested period is 24 hours).
The first measurement has a controlling purpose and it starts in the second minute after programming, then other
measurements cannot be started in the next five minutes. The rest of the measurements are taken at specific
15/20/30/40 minute intervals and there are measurements at the 6:00 and 22:00 hour shifts. The last measurement is
exactly 24 hours after the second measurement.
LCD Displays
Normal status: time is
displayed
10 second delay state
1. Measurement plan: 15/30
minute day/night intervals
2. Measurement plan:
20/40 minute day/night
intervals
3. Measurement plan:
30/30 minute day/night
intervals
Programming is in
progress: blinking signal
8. Patient Information
a. The cuff should be worn on the patient’s bare arm.
b. The cuff should be properly placed on and connected.
The cuff tube should be pointed towards the patient’s shoulder and the ’artery’ indicator on the cuff should be
placed above the brachial artery.
c. Patient should hold their arm slightly away from their chest during a measurement.
Patients should avoid excess movement during blood pressure measurements. They should hold their arm loose,
slightly away from their chest.
d. Should the blood pressure measurements cause bloodshots, torpidity or pain in the hand, the cuff
should be removed from the arm immediately and disconnected from the monitor.
Such occurrence should be reported to the physician later after the monitoring session.
e. Press any button to stop a blood pressure measurement.
Should the blood pressure measurements cause bloodshots, torpidity or pain in the hand, the cuff should be
removed from the arm immediately and disconnected from the monitor. Such occurrence should be reported to the
physician after the monitoring session.
f. Do not remove the recorder even at night.
By loosening the straps, patients can avoid problems when turning in their sleep. The recorder does not disturb
most patients at night.
g. Use the buttons, if necessary.
The patient can initiate extra blood pressure measurements by pressing the START button. By pressing the EVENT
button the patient can mark events, e.g. taking medication, etc. The time of going to and rising from bed can be
marked by the DAY/NIGHT button.
h. Should the batteries run down during a monitoring session, they can simply be replaced.
Monitoring will continue and data will not be lost.
i. Do not block the air flow in the cuff tube.
Take care to avoid blocking the air flow in the tube of the cuff and twisting the tube.
IMPORTANT: Never measure anybody else’s blood pressure with the monitor during an ambulatory
blood pressure monitoring session.
9. Cuffs
Dimensions
Name Arm Circumference Range
Small 18 - 24 cm / 7” - 9.4”
Normal 25 - 32 cm / 9.8” - 12.5”
Large 33 - 42 cm / 13” - 16.5”
If the patient’s arm circumference range is out of the ranges indicated above, use the cuff which
best fits for the patient and make a so-called undercuffing or overcuffing calculation.
9.1 Application
Set the cuff size when programming the monitor.
The monitor recognizes three different cuff sizes. The size to be used should be set during
programming of the device. Inappropriate setting of the cuff size may lead to device malfunctioning, which is
inconvenient for the patient and may lead to an unsuccessful measurement.
9.2 Apply the cuff and be sure the artery indicator is over the
brachial artery
Place the cuff on the upper arm so that the rubber tube points towards the patient’s
shoulder and the ’artery’ indication of the cuff is placed above the brachial artery, if
possible. Contrary to the usual placement with the tube pointing downwards, the advantage
is that the patient can wear a loose jacket over the cuff.
When properly applied, the end of the sleeve (the one closer to the tube) should
fall in the indicated range.
9.3 Connect the hose to the monitor
Connect the air connector of the cuff into the air connector socket of the device by turning it clockwise with slight
pressure.
NOTE: Take care to avoid blocking the air flow in the tube of the cuff and twisting the tube. Make sure the cuff and
its tubing do not cause strangulation or a circulation problem. Should the patient experience arm numbness or pain
remaining after any blood pressure reading is completed, the cuff should be removed to avoid permanent vascular
or neural injury. The application of the cuff over a wound can cause further injury! The application of the cuff and
its pressurization could result in injury to the patient because of temporary interference to blood flow on any limb
where intravascular access or therapy, or an arterio-venous (A-V) shunt is present. The pressurization of the cuff can
temporarily cause loss of function of simultaneously used monitoring medical equipment on the same limb.
No relevance can be shown in the application of the cuff and its pressurization on the arm of the side of a
mastectomy.
The cuff should be applied as tightly as comfortable for the patient.
A too loose application may result in longer or aborted measurements, because the device has to pump even to reach
the proper tightness. Longer measurements may cause inconvenience for the patient, and aborted measurements
result in less data for evaluation. If the patient removes the cuff for a period during the monitoring session, it should
be reapplied with appropriate tightness, with help from another person, if necessary.
The cuff is the component which, by definition of the relevant standard, is protected against a defibrillator discharge.
The substitution of a cuff different from that supplied by BIOS Medical might result in measurement error and/or in
certain cases it causes damage to the monitor.
10. Batteries
The ABP-01 operates either with two 1.5V AA normal batteries or with two 1.2V AA rechargeable batteries.
A set of properly charged, high capacity batteries will enable the recorder to perform 250 blood pressure
measurements during a 24-48 hour long monitoring session. If you use alkaline batteries, choose high capacity, longlife batteries to enable reliable operation.
In order to change batteries, take the recorder out of the holder pouch and remove the battery compartment cover on
the back-side. Place two properly charged, high capacity AA rechargeable or two new, long-life AA alkaline batteries
into the compartment then close it.
a. Use standard alkaline or NiCd/NiMH rechargeable batteries
Use only standard long-life (alkaline) batteries, or standard NiCd or NiMH rechargeable batteries of the proper size.
Do not use lithium batteries. Do not mix different battery types; do not mix new and old batteries. Never use batteries
of low or unknown quality or pre-used batteries, as they may not cover the power needs of the monitor, and they
may damage the monitor, or they may contain acidic electrolytes which may leak and corrode electronic components.
Never use batteries damaged in any way.
b. Do not start a new monitoring session with low batteries.
It is strongly recommended to use freshly charged or new batteries with each patient so that batteries do not run down
during monitoring, even in case of very high blood pressure values and/or a long monitoring session. After inserting
batteries in the ambulatory blood pressure monitor, it is advised to check their voltage before programming them. The
typical voltage for fully charged rechargeable batteries should be over 2,5V and for fresh alkaline batteries, over 3V.
Battery voltage check: Press the START button for at least 5 seconds.
c. If measurements do not start in due time keep fresh batteries in the recorder
If the monitor is not used for a long period (4-6 months), the built-in backup cell, ensuring the operation of the internal
clock, may get discharged. In this case keep freshly charged batteries in the monitor for at least one day; this will
recharge the backup cell. It is possible to use the monitor afterwards. If the backup cell is not properly charged, the
internal clock may work incorrectly, and the monitor may not start measurements in due time. If the recharging of the
cell is not successful, the backup cell must be replaced. This is an out of warranty act.
d. If the batteries run down, replace them even during a monitoring session
Should the batteries run down during a monitoring session, they can be replaced. Monitoring will continue and data
will not be lost.
e. Remove the batteries if the monitor is out of use
If you do not use the monitor, it is advisable to remove batteries since they may run down due to the constant small
power consumption of the integrated circuits of the device. Data in the recorder are not lost even if batteries run
down or are removed.
11. Safety Concerns
a. Electric shock hazard protection
The ABP-01 monitor meets the relevant shock hazard protection standards. The device operates with two 1.5V AA
batteries or two 1.2V AA rechargeable batteries, which excludes all electric shock hazards, even in the unlikely case
of multiple device errors.
Many personal computers do not meet shock hazard protection standards or strict safety regulations applicable to
medical devices. Therefore, during the computer-based use of the recorder, keep at least a 2 meter distance between
the patient and the computer. This is the required minimum safety distance. ABP-01 communicates via a plastic
optical cable, the 3 m standard length of which allows for the required safety distance. The plastic optical cable
ensures perfect electric separation and reduces the effects of external electric noise. It does not conduct electricity.
b. Hazardous materials
Used batteries qualify as hazardous waste and should be disposed with care. The recorder does not contain any
materials qualified as pharmaceutical substance or tissue of animal origin. They emit no material hazardous to
humans.
c. Risk of incorrect diagnosis
The basic intended use of the monitor is to record blood pressure and pulse rate values. Patients should be informed
about rules of cooperative behavior; proper handling of the monitor, and expected results of monitoring in advance.
The monitors only provide data to support diagnostic decisions of a qualified physician; they do not automatically
provide a diagnosis of any kind. During the evaluation of recorded blood pressure values, possible artefacts due to
external disturbances, motion artefacts, and electrical noise should be observed and handled with caution.
See chapter Cuffs for more information!
12. Cleaning & Protection
The ambulatory blood pressure monitor is not specially protected against spills or ingression of water or other liquids.
Cleaning the monitor
A recommended means of cleaning is to wipe the recorder with a disinfectant cleaning tissue. Alternatively, wipe
with a slightly damp cloth then dry it with an antistatic tissue. Do not expose monitors to extreme heat or radiation,
including long exposure to direct strong sunlight.
To clean the PU leather fabric cuff, please do the following:
Wipe the cuff with a damped cloth or detergent/disinfectant tissue (e.g.: ethanol 70%, isopropyl-alcohol 70%,
microzid). The bladder cannot be removed!
NOTE: Avoid any leakage into the tube while cleaning the cuff. (Plug the end of the tube.)
Don’t take the unit into a sterilizing machine!
Don’t use bleach!
Protection
Do not immerse the monitor in water or any cleaning fluid and protect it from spills and splashes. Do not expose it to
heavy rain or steam and do not wear it in a wet environment e.g.: shower, bath or swimming pool. In case of minor
effects of wet environment, wipe off water drops with a dry cloth. Keep the monitor in a normal dry room for at least
one hour before use if condensation is suspected.
In case of ingress of water in the monitor, remove batteries from the unit, and refer the unit to authorized service.
Never place the monitor in a disinfecting or sterilizing machine!
13. Maintenance
Verification of the pressure measurement accuracy is recommended biannually.
All the devices are covered by a two-year warranty under general warranty conditions of BIOS Medical,
see relevant topic. This warranty does not cover any malfunction or defects arising from improper use, the use
of inadequate accessories, accident, theft, or use of the device outside operating environmental specifications or
intended measurement range. Removing the closing label from the back side of the device voids this warranty.
There are no user serviceable parts inside the recorder; they contain high complexity electronic and fine
mechanical components. If you have any problems, please call the BIOS Blood Pressure Hotline . All consequences of
improper servicing are the sole responsibility of the user. Contact BIOS Medical for more information.
14. Disposal
Each Ambulatory Blood Pressure Monitor includes an internal NiCd coin cell which falls under the category of
hazardous waste and should be disposed with proper care. The other parts of the device should be handled as normal
electronic waste at roll-out. Used batteries may also fall under the category of hazardous waste and should be
disposed with proper care.
15. Indication & Contraindications
Indications
- Suspected white-coat hypertension
- Suspected nocturnal hypertension
- To establish dipper status
- Resistant hypertension
- Elderly patient
- As a guide to antihypertensive drug treatment
- Type 1 diabetes
- Hypertension of pregnancy, including pre-eclamptic patients
- Evaluation of hypotension
- Autonomic failure
Contraindications
- Non-cooperative patients, unconscious or otherwise incapable patients
- Patients requiring urgency/emergency cardiac care
- Patients with coagulation disturbances
- Patients with serious mobility or other impairments without supervision
- Children without supervision, or children younger than 8 years
- Though the blood pressure measurement algorithm used in the monitors has been found to function properly on
patients with atrial fibrillation or other common arrhythmias, the oscillometric blood pressure measurement method
is generally recommended for use only with special caution in patients with arrhythmias, Parkinson’s disease or
other diseases involving tremors.
16. Accessories List
- Ambulatory blood pressure monitor
- USB optical with USB driver cable
- Pouch for the recorder with shoulder and waist straps
- Small, normal and large cuffs
- 2 x AA long-life battery (recommended capacity: min. 1600 mAh)
- CD containing the latest software, user manual and patient diary
- Storage case
17. Technical Specifications
Technical Parameters
Power Supply
Display
Data Storage
Data Transmission
Operating Environment
Device Temperature
Cuff Temperature
Humidity (Non Condensing)
Atmospheric Pressure
Storage & Transportation
Temperature
Humidity (Non Condensing)
Size
Weight (Batteries Incl.)
Blood Pressure Measurement Method
Blood Pressure Maximum Storage
Measurement Range
Passive Accuracy
Blood Pressure Measurement Accuracy
Pressure Sensor
Inflation
Safety
Deflation & Rapid Air Release
2 AA rechargeable nicd or nimh batteries or 2 AA alkaline
batteries
Liquid-crystal
Internal solid state memory
USB optical cable
10-45°C / 50-113°F
10-40°C / 50-104°F
10-95%
70-106 KPa
-20 to 50 °C / -4 to 122°F
10-95%
70 x 99 x 30 mm
240 g
Oscillometric
Over 600 measurements
Blood pressure: 30 - 260 mmHg (4-35 kPa); pulse: 40-200
beat/minute
+/- 3mmHg (0,4 kPa) or +/- 2% of measured value
(stability: 2 years)
Measuring algorithm validated to BHS & AAMI protocol
Piezo resistive
Automatically controlled pump
Maximum inflation 300 mmHg (40 kPa), independent
safety release valve
Automatic pressure release valve
18. Error Codes
Error code Explanation
Measurement Error
E1: aborted measurement
E2: manually interrupted
E3: battery rundown The batteries exhausted during measurement.
E4: batteries replaced The batteries were replaced during measurement.
E8: pressure limit exceeded
E9: temporary disturbance
E31: cuff missing or loose
E32: cuff tubing clogged The cuff is clogged or the rubber tube is broken.
E33: cuff leaking or loose
E34: cuff not on arm The patient did not wear the cuff.
E90: device error The device could not measure due to a hardware error.
E99: device error
The measurement timeout is over, the measurement had
to be aborted (the patient was moving).
The measurement was stopped by pressing a button. The
display differs from others: “OFF” on the LCD.
The pressure in the pneumatic system exceeded the
preset pressure limit
External electric signal - static discharge - disturbed the
operation of the device.
Cuff Error
There was no cuff connected to the device or the cuff was
too loose on the patient’s arm.
There is a hole in the cuff or it is rather loose on the
patient’s arm.
Device Error
The device does not start automatic measurement until
the next programming.
19. Product Warranty Information
MONITOR WARRANTY. The main monitor unit will be free from defects in materials and workmanship under normal
use and service for a period of two (2) years from the date of receipt. This warranty covers the monitor only. This
warranty does not cover any accessories that might come with the monitor.
ACCESSORIES WARRANTY. The non-disposable accessories delivered with the monitor unit will be free from
defects in materials and workmanship under normal use and service for a period of one (1) year from the date of
receipt. This warranty does not cover disposable accessories, packaging materials, accumulators and batteries, cuffs,
or any of their components.
CUFF WARRANTY. The cuff - will be free from defects in materials and workmanship under normal use and service
for a period of six (6) months from the date of receipt. This warranty covers the cuff(s) delivered with a recorder unit
exclusively.
100% Satisfaction Guarantee
If at any time, you are not completely satisfied with the performance of this device, call our BIOS Medical Hotline and
speak with a customer service representative, who will make arrangements to have the device repaired or replaced to
your full satisfaction.
If you have questions regarding the operation of your monitor call the
BIOS Medical Hotline: 1-866-536-2289
Should repair be necessary, return the unit with all component pieces. Enclose proof of purchase and $5.00 for return
shipping and insurance. Ship the unit prepaid and insured (at owners option) to:
Repair Department
16975 Leslie Street
Newmarket, ON L3Y 9A1
www.biosmedical.com
Email: support@biosmedical.com
Please include your name, return address, phone number, and email address. BIOS Medical will repair or replace (at
BIOS Medical option) free of charge any parts necessary to correct the defect in material or workmanship.
Please allow 10 days for repair and return shipping.
Always consult a physician for the interpretation of the blood pressure measurements.
Note that any blood pressure recording may be affected by the body position, the physiological condition of the patient, and other factors.
No user serviceable parts inside. BIOS Medical recorders contain high complexity electronic and fine mechanical components. If you have any problems, please refer your recorder to
qualified service personnel. The device cannot be modified by the user!
This symbol is a warning that you should read the accompanying documentation.
Device type (BP5 = ABP-01)
Certification mark of the Russian Federation
Direct current
Consult the User Manual.
This symbol warns that you should read the accompanying documentation.
This signal directs attention to the description of that part.
Manufacturer
Date of production
Identification of USB optical interface
Device corresponds to the standards of USB (Universal Serial Bus)
Each device complies with the requirements of the EU Medical Devices Directive
0120 is the identifier of Notified Body (SGS UK)
MDD classification IIa. EMC class B. EMC group 1.
According to Canadian regulations the device classification is MDR II. (Medical
Device Regulations of Canada, Rule 10.1 of MDR SOR/98-282:13Mar2007.)
The monitors are internally powered type CF devices. Protection vs. ingress of water:
none. Mode of operation: continuous. The devices are not protected against
defibrillators or other high frequency surgical equipment.
Protection against environmental impact: First digit “2”: Protected against mid-sized
solid objects (>12 mm). Second digit “2”: Protected against splash (vertically in a
max. of 15 degrees). This protection refers only to BP5.
Serial number. The first four digits of the serial number of a recorder show the year
of production. The rest is the serial number. For example: 2007/123456
This symbol shows that according to regulations the monitors should be handled as
electronic waste during rollout.
Blood pressure measurements determined with the algorithm of an ABP-01 on adults are
equivalent to those obtained by a trained observer using the cuff/stethoscope auscultation
method Korotkoff phase V, within the limits prescribed by the American National Standard
for Electronic or Automated Sphygmomanometers. The algorithm used in ABP-01 fulfills
the requirements of the British Hypertension Society Validation Protocol for Automated
Blood Pressure Measuring Devices.
20. EMC Information
Medical electrical equipment should be used with precautions according to EMC, and must be installed according to
the EMC notices disclosed in this manual as mobile RF transceivers could adversely affect it.
Electromagnetic Emission
BIOS DiagnosticsTM ambulatory blood pressure monitor is suitable for use in the specified electromagnetic
environment. The purchaser or user of the device should assure that they are used in an electromagnetic environment
as described below.
Emission test Compliance Electromagnetic environment
Radiated and conducted RF
emission CISPR 11
Radiated and conducted RF
emission CISPR 11
Harmonic emission
IEC61000-3-2
Voltage fluctuations/
Flickers IEC61000-3-3
Group 1
Class B
Not applicable ---
Not applicable ---
Electromagnetic immunity
BIOS Diagnostics
TM
ambulatory blood pressure monitor is suitable for use in the specified electromagnetic
environment. The purchaser or user of BIOS DiagnosticsTM products should assure that they are used in an
electromagnetic environment as described below.
ABP-01 uses RF energy only for their internal function.
Therefore, the emission is very low and it is not likely to
cause any interference in nearby electronic equipment.
ABP-01 is suitable for use in domestic establishments and
in establishments directly connected to the low voltage
power supply network which supplies buildings used for
domestic use.
Monitor Immunity test
Electrostatic
ABP-01
discharge (ESD)
IEC 61000-4-2
Electrical fast
ABP-01
transient/burst
IEC 61000-4-4
ABP-01
Surge IEC 61000-
4-5
IEC60601 test
level
+ 6KV contact
+ 8 KV air
+ 2KV for power
supply
+ 1KV input/output
lines
+ 1KV differential
mode
+ 2KV common
mode
Compliance
level
+ 8 KV air
Not
applicable
Not
applicable
Electromagnetic
environment
Floors are wood, concrete
or ceramic tile, or floors are
covered with synthetic material
and the relative humidity is at
least 30 percent.
Mains power quality is that of
a typical commercial and/or
hospital environment.
Mains power quality is that of
a typical commercial and/or
hospital environment.
ABP-01
ABP-01
ABP-01
ABP-01
Voltage
dips, short
interruptions
and voltage
variations on
power supply
input lines IEC
61000-4-11
Power frequency
(50/60Hz)
magnetic field
IEC 61000-4-8
Conducted RF IEC
6100-4-6
Radiated RF IEC
61000-4-3
<5% UT (>95%
dip) for 0.5 cycle;
40% UT (60% dip)
for 5 cycles; 70%
UT (30% dip) for
25 cycles; <5% UT
(>95% dip) for 5
sec. Note: UT is the
nominal voltage of
mains.
3A/m 3A/m
3V eff 150KHz-
80MHz
3V/m 80MHz-
2,5GHz
Not
applicable
Not
applicable
3V/m
Mains power quality is that of
a typical commercial and/or
hospital environment.
Power frequency magnetic
fields are at levels
characteristic of a typical
location in a typical commercial
and/or hospital environment.
Mains power quality is that of
a typical commercial and/or
hospital environment
Recommended Separation
distance: d=[3,5/V1]√P
d=[3,5/3V/m]√P (80MHz
– 800MHz) d=[7/3V/m]√P
(800MHz – 2,5GHz) where:
P is the highest radiated
power disclosed by the
manufacturer of transmitter
[W] and d is the recommended
separation distance [m].
Field strengths from fixed RF
transmitters, as determined
by an electromagnetic site
survey1 a should be less than
the compliance level in each
frequency range 2 You may
observe disturbance nearby
any of those equipment which
has the following indication:
Note: in case of frequency 80MHz or 800 MHz, the formula for the higher range is applicable.
Note: these are guidelines. Actual conditions may vary.
1
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey
should be considered. If the measured field strength in the location in which the device is used exceeds the applicable
RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the device.
2
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distance
BIOS DiagnosticsTM ambulatory blood pressure monitor is intended to be used in electromagnetic environment with
controlled RF disturbances. The purchaser or user of the devices may help to reduce electromagnetic disturbances by
defining the separation distance between the transportable or mobile RF telecommunication equipment (transmitters)
and the device, depending on the highest output power of the telecommunication equipment.
Separation distance in function of the frequency of the transmitter (m)
The highest output power of the
transmitter (W)
150KHz-80MHz
d=(3,5/V1)√P
80MHz-800MHz
d=(3,5/E1)√P
800MHz-2,5GHz
d=(7/E1)√P
0,01 Not applicable 0,12 0,23
0,1 Not applicable 0,38 0,73
1 Not applicable 1,2 2,3
10 Not applicable 3,8 7,3
100 Not applicable 12 23
If this table does not contain the highest output power of the transmitter, the d separation distance [m] can be
calculated by the formula, depending on the frequency of the transmitter, where P is the rated highest output power
of the transmitter [W].
Note: in case of frequency 80MHz or 800 MHz, the formula for the higher range is applicable.
Note: These are guidelines. Actual conditions may vary.
The information in this document is subject to change without notice.
16975 Leslie Street
Newmarket, ON L3Y 9A1
www.biosmedical.com
Email: support@biosmedical.com
By: Meditech Ltd.
Mikszath Kalman Utca 24
Budapest, 1184 Hungary
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