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Accuniq BP800 User Manual

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Summary of Contents for Accuniq BP800

  • Page 2 The device bears the CE label in accordance with the provisions of Medical Device Directive 93/42/EEC. THE PERSONS RESPONSIBLE FOR PLACING DEVICES ON THE EC MARKET UNDER MDD 93/42/EEC SELVAS Healthcare, Inc. 29, Gongdan 4-ro, Jillyang-eup, Gyeongsan-si, Gyeongsangbuk-do, 38470 Republic of Korea TEL: 82-53-856-0993, FAX: 82-53-856-0995 VITAKO Sp.

  • Page 3: Table Of Contents

    CONTENTS • INTRODUCTION ··································································································· 1. OVER VIEW ······························································································· 2. WORD DEFINITION ·························································································· 3. CLASSIFICATION AND COMPLIANCE ································································· 4. SAFETY PRECAUTIONS ··················································································· 5. SAFETY SYMBOLS AND INFORMATION ······························································ 6. GUIDANCE FOR ELECTROMAGNETIC COMPATIBILITY (EMC) ······························ • TERMS OF EACH PART AND FUNCTION ·····························································...
  • Page 4 INCORRECT USE ----------------------------------------------------------------------------------------------------------------------------- Because of the risk of strangulation from the tube and cuff, the ACCUNIQ BP800 may not be used for patients who are legally incompetent. The ACCUNIQ BP800 must not be used for blood pressure monitoring during surgeries. It has not been designed for alarm-giving monitoring in intensive care units.

  • Page 5: Word Definition

    SAFETY and EFFECTIVENESS WARNINGS Make sure that you are familiar with all Safety and Effectiveness considerations before using the ABPM (model - ACCUNIQ BP800). ACCESSORIES The SELVAS Healthcare, Inc. warranty can only be honored if you use SELVAS Healthcare, Inc.
  • Page 6 service. 4) The unit has previously been adjusted in the factory for optimum performance. Do not attempt to adjust switches or any other things except those specified in this manual for operation. 5) If you have experienced any trouble with the unit, switch it off immediately, and contact our company or its authorized dealer for assistance.

  • Page 7: Safety Symbols And Information

    radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to other devices, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: - Reorient or relocate the receiving device.
  • Page 8 identifies the battery Turning on the recorder Turning off the recorder Date of manufacture Manufacturer Non-ionizing radiation CE mark Serial No Refer to instruction manual/ booklet. Authorized representative in the European community. Keep dry RoHS2...

  • Page 9: Guidance For Electromagnetic Compatibility (Emc)

    1) Guidance and manufacturer’s declaration – electromagnetic emissions The ACCUNIQ BP800 is intended for use in the electromagnetic environment specified below. The customer or the user of the ACCUNIQ BP800 should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment –...
  • Page 10 3) Guidance and manufacturer’s declaration – electromagnetic immunity 2 The ACCUNIQ BP800 is intended for use in the electromagnetic environment specified below. The customer or the user of the ACCUNIQ BP800 should assure that it is used in such an environment. 60601...
  • Page 11 4) Recommended separation distances between portable and mobile RF communications equipment and the ACCUNIQ BP800 The ACCUNIQ BP800 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the ACCUNIQ BP800 can help prevent...

  • Page 12: Terms Of Each Part And Function

    TERMS OF EACH PART AND FUNCTION 1. DISPLAY ① LCD (Display) It displays time, battery status and measurement process. Also, systolic blood pressure, diastolic blood pressure and pulse result will be indicated after measurement. ② Connecting part of cuff It connects main unit and connecting hose which connected on cuff. ③...

  • Page 13: Front And Rear Part

    2. FRONT AND REAR PART ① MENU button This button is for setting the device such as time, measurement interval and etc. ② UP button Number is going up when setting the device. ③ DOWN button Number is going down when setting the device. ④...

  • Page 14: Side Part

    3. SIDE PART ① Port This port is for transmitting data to data managing program on PC. ① USB Port...

  • Page 15: Accessories

    4. Accessories ① User guide ② Cuff and connecting hose(Standard) ③ Battery (AAA X 4) ④ cable ⑤ Carrying bag and strap ⑥ Data managing program ② Cuff and connecting hose ① User guide ③ Battery (AAA X 4) ④ USB cable ⑤...

  • Page 16: Installation

    INSTALLATION 1. How to put battery Put batteries on front and rear part on the device for turning on the device. Open the battery cover and put each 2 batteries (AAA type battery) on front and rear part. [Front Part] [Rear Part] After putting batteries on rear part, turn on the ON/OFF switch as shown in the picture.

  • Page 17: How To Connect Communication Port

    2. How to connect communication port Connect the USB port which located on side part of main unit and computer USB port by USB cable.

  • Page 18: Setting

    3. Setting Time will be blinked when turning off the power and you can set up in this state. If you want to change the setting, press MENU button for 5 seconds then system will enter to setting mode. ① Date / Time setting Setting sequence is hour/minute →...
  • Page 19 ② Alarm setting Ring the alarm when measured systolic blood pressure is higher or lower than setting value. Setting maximal blood pressure alarm After setting the year, press and hold the MENU button, and the device will show ‘SYS’ and ‘H’ on the LCD screen. You may set the maximal blood pressure alarm.
  • Page 20 ③ Pressure value setting It is required to set the initial pressure for blood pressure measurement. Once the initial pressure is set, repeated pressurization is prevented for hypertension patients. Setting initial pressure After setting the alarm function, press the MENU button and the LCD screen will display ‘PULSE’...
  • Page 21 ⑤ Bed-time setting Setting the measuring intervals at bed-time and after bed-time Setting bed-time After setting the desired measuring intervals, press and hold the MENU button, and the LCD screen will display ‘P’, and enter the bed- time setting menu. Set the desired bed-time using the UP and DOWN button.

  • Page 22: Measurement

    MEASUREMENT 1. Wrapping the cuff ① Wrap the cuff around your upper arm with palm facing up. Following the directions which are printed directly on the cuff as it should be applied brachial artery. (inside forearm) ② Position the lower edge of the cuff is 2~3cm above the elbow joint as shown in the picture. ③...

  • Page 23: Measurement Preparation

    2. Measurement preparation ① Insert the cuff -end into the ring so it can be put around the upper arm. ② Align the arrow -head (▼) at the upper arm artery (brachial artery), and make the lower-end of the cuff positioned 2-3cm above the elbow joint. ③...

  • Page 24: Measurement

    3. Measurement ① Turn the power on. ② When the device is turned on, the LCD screen will show the current time, and will be ready for measurements. ③ If measuring intervals are preset, the device automat ically measures blood pressure according to the preset value.

  • Page 25: Measurement Result

    If you need more detail information about measurement result (Graph, list of 24 hour measured data), Use the data management program ACCUNIQ BP800 manager. (Program version: FAMN.E.1.0.00) Reference the manager’s user manual about detail contents of data manage program ACCUNIQ BP800 manager. (Rev 1.1)

  • Page 26: Storage And Maintenance

    STORAGE AND MAINTENACE ● Do not operate or store the device with below environments. - Store where the ambient temperature falls -20°C or exceeds 60°C. ℃ ℃ - Operate where the ambient temperature falls under 10 or exceeds 40 . - Where the atmospheric pressure falls below 70kPa (700 mbar) or exceeds 106kPa (1060 mbar).

  • Page 27: Safety Precaution

    SAFETY PRECAUTION ● The recorder should be operated by a physician who knows it well. ● Confirm that the recorder works correctly and measurement values are proper. ● Clear the old data before starting a new measurement. ● Cover the USB port using the rubber cap, to avoid dust. ●...

  • Page 28: Trouble Shooting

    TROUBLE SHOOTING 1. Measurement error and solution ERROR CAUSE SOLUTION • When inflation lever is not sufficient. • Please set higher inflation level. • When air hose is not connected Err 0 • Check if there is any ‘CAUSE’. well. •...

  • Page 29: Trouble Shooting

    2. Trouble shooting SYMPTOM CAUSE COUNTERMEASURE • The battery power is low. • Replace all four “AA” type batteries at the (When batteries same time. exhausted completely, Before change transmit the data to your mark does not appear on the computer first.

  • Page 30: After Service

    3. After service If there is any problem with the unit, please follow the steps below; ※ Contact our company’s Overseas Service Department immediately. After gathering the model name, Serial Number, date of purchase and description of the problem, contact our company with information shown below. ※...

  • Page 31: Specification

    SPECIFICATION Model ACCUNIQ BP800 Measuring method Oscillometric Display mode TN LCD display Systolic / Diastolic / Mean Blood Pressure, Pulse, Result Contents Pulse Pressure Measuring range Pressure: 30~300mmHg, Pulse: 30~240bpm Accuracy Pressure: ±3mmHg, Pulse: ±3% Resolving Power 1mmHg Pressurizing method...

  • Page 32: Warranty And Repair

    Return Authorization process. Limited Warranty Statement SELVAS Healthcare, Inc. warrants that the ACCUNIQ BP800 you have purchased meets the labeled specifications of the Product and will be free from defects in materials and workmanship that occur within 1 year after the date of purchase.
  • Page 33 ACTIVITY RECORD (24 Hour Blood Pressure Measurement) Please read the Instructions and Caution on the back of this sheet. Name : Address : Home TEL. : Office TEL. : Patient No : Chart No : Doctor : Referred By : Hospital : Unit : Recorder I.D.#...
  • Page 34 24 hours. Motion detecting sensor is embedded in ACCUNIQ BP800 and it detects the patient’s motion without recording it manually. However, the information of meal, medicine dosage, urination, excretion and how well you sleep and wake/asleep time is as important as the measurer’s activity status.
  • Page 35 Connecting possible Pass/Fail 4 Measurement Proper measurement Pass/Fail General Judgment Pass/Fail Model ACCUNIQ BP800 Serial No. Installation place Date of purchase Check date Checked by Approved by Copy this sheet for use If repair is required, write down so in the Remarks column.
  • Page 36 Pass/Fail Other 1 Clock Present date/time Pass/Fail General Judgment Pass/Fail Model ACCUNIQ BP800 Serial No. Installation place Date of purchase Check date Checked by Approved by Copy this sheet for use If repair is required, write down so in the Remarks column.
  • Page 37 EUROPEAN REPRESENTATIVE VITAKO Sp. z o.o. ul. Stanisława Żaryna 7c 02-593 Warszawa, POLAND TEL: +48 22 400 8000 BP800E-20161124 Rev 1.1...

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