BIOS Diagnostics ABP-01 Instruction Manual

BIOS Diagnostics ABP-01 Instruction Manual

Ambulatory blood pressure monitor. for 24 or 48 hour continuous monitoring

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Ambulatory
Blood Pressure Monitor
For 24 or 48 hour continuous monitoring
ABP-01
Instruction Manual
09.24.18

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Table of Contents
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Summary of Contents for BIOS Diagnostics ABP-01

  • Page 1 Ambulatory Blood Pressure Monitor For 24 or 48 hour continuous monitoring ABP-01 Instruction Manual 09.24.18...
  • Page 2: Table Of Contents

    Table of Contents Product Description LCD display Buttons 1.2A Start button functions 1.2B Event button functions 1.2C Day / Night button functions How To Use the Monitor Install the software Setup the monitor Programming the Monitor Fit the Patient with the Monitor Retrieve the Data Customize, Review &...
  • Page 3: Product Description

    1. Product Description BIOS Diagnostics 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.
  • Page 4: Lcd Display

    1.1 LCD Display Information displayed on ABP-01. Pulse rate value of just Normal status: time is completed measurements displayed (beats/minute) Blood pressure measurement Event marker set during a initiated (mmHg) button push Pumping for measurement, current pressure is displayed Error code display...
  • Page 5: Buttons

    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 Event Button - Switch on/off...
  • Page 6: How To Use The Monitor

    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.)
  • Page 7: Fit The Patient With The Monitor

    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.
  • Page 8: Retrieve The Data

    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.
  • Page 9: Patient Information

    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 2. Measurement plan: Normal status: time is 20/40 minute day/night displayed intervals 3. Measurement plan: 10 second delay state 30/30 minute day/night intervals...
  • Page 10: Cuffs

    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”...
  • Page 11: Batteries

    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.
  • Page 12: Safety Concern

    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.
  • Page 13: Maintenance

    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.
  • Page 14: Technical Specifications

    - 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.
  • Page 15: Error Codes

    18. Error Codes Error code Explanation Measurement Error The measurement timeout is over, the measurement had E1: aborted measurement to be aborted (the patient was moving). The measurement was stopped by pressing a button. The E2: manually interrupted display differs from others: “OFF” on the LCD. E3: battery rundown The batteries exhausted during measurement.
  • Page 16 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.
  • Page 17 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.
  • Page 18: Emc Information

    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 ABP-01 uses RF energy only for their internal function. Radiated and conducted RF Group 1 Therefore, the emission is very low and it is not likely to emission CISPR 11 cause any interference in nearby electronic equipment.
  • Page 19 40% UT (60% dip) interruptions for 5 cycles; 70% Mains power quality is that of and voltage UT (30% dip) for ABP-01 a typical commercial and/or variations on 25 cycles; <5% UT applicable hospital environment. power supply (>95% dip) for 5 input lines IEC sec.
  • Page 20 Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Recommended separation distance BIOS Diagnostics 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.

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