Table of Contents
Advertisement
Quick Links
Advertisement
Table of Contents
Troubleshooting
Related Manuals for Akern BIA101BIVA
Summary of Contents for Akern BIA101BIVA
- Page 1 INSTRUCTION MANUAL...
- Page 3 BIA101BIVA Read this instruction manual carefully and keep it on hand for future consultation Document code: HB BVA-01 ENG Revision Status: rev. 0 of 03/2019 Rev. 0 03/2019 Page 3 to 36...
-
Page 4: Table Of Contents
INSTRUCTION MANUAL CONTENTS CHAPTER 1 GENERAL AND SAFETY INFORMATION INTENDED USE INTENDED USERS INTENDED PLACE OF USE MISUSE DEFINITIONS AND SIMBOLS ELECTROMAGNETIC COMPATIBILITY SAFETY WARNINGS NORMATIVE REFERENCES CLASSIFICATION OF DEVICE 1.10 CLINICAL VALIDATION 1.11 APPLIED PARTS CHAPTER 2 PERFORMING A TEST SWITCHING THE DEVICE ON AND OFF TETRAPOLAR PATIENT LEAD ELECTRODES... - Page 5 TECHNICAL SUPPORT SERVICE CONTACS REPORTIG INCIDENTS OR NEAR MISSES CHAPTER 6 OPERATING PRINCIPLES THEORICAL BASES OF BIOIMPEDANCE ANALYSIS BLOCK DIAGRAM OF OPERATION OF THE BIA101BIVA DEVICE TECHNICAL SPECIFICATIONS CHAPTER 7 DECLARATION OF CONFORMITY CHAPTER 8 CONTENTS CHECKLIST Rev. 0 03/2019...
-
Page 6: Chapter 1 General And Safety Information
INTENDED USERS The use of BIA101BIVA is intrinsically safe and non invasive; it can therefore be used without restrictions by any adult who has read the instruction manual with care. Blind users are unable to use the device unaided. -
Page 7: Definitions And Simbols
PA (°): Symbol for phase angle, i.e. the ratio between Resistance and Reactance. Value in degrees. SYMBOLS Symbol referring to the manual Icon of Bluetooth, used for wireless communication between the BIA101BIVA and the selected device Symbol indicating conformity to medical device Directive 93/42/EEC,... -
Page 8: Electromagnetic Compatibility
BIA101BIVA complies with IEC 60601-1 concerning the general requirements for the electrical safety of medical devices. - Page 9 • Do not replace batteries without contacting Akern or an authorized dealer. Lithium batteries have a high explosion risk if not correctly recharged. Remark: To replace the battery contact the Technical Support Service or Authorised Dealer Caution! The lithium-ion battery may explode if handled incorrectly.
-
Page 10: Normative References
Directive 2001/65/EC RoHS 2 • IEC 62304: Medical device software CLASSIFICATION OF THE DEVICE BIA101BIVA is classified as a CLASS IIA medical device (annex IX, rule 9, points 3.1, 3.2, Directive 93/42/EEC, as amended). CLINICAL VALIDATION 1.10 All clinical validation documents for the device are contained in the Clinical Evaluation Report (CER), available for consultation by the competent authorities and for audit by notified bodies. -
Page 11: Chapter 2 Performing A Test
BIA101BIVA CHAPTER 2 PERFORMING A TEST SWITCHING THE DEVICE ON AND OFF The device’s On/Off switch is located on the rear panel and identified by the symbol. Press the button once to power it up. Press the button again to shut the device down. -
Page 12: Electrodes
These electrodes can be used only for bioimpedance analyses and are defined as an BF Applied Part. All devices produced by Akern are tested and calibrated with relation to the physical specifications of this type of electrode, which provides the user with a stable, accurate measurement. -
Page 13: Positioning Of The Subject
BIA101BIVA Positioning of the subject 2.4.1 Important: the position shown also guarantees correct measure- ment in the case of subjects with BMI over 40 and unclothed be- dridden patients. The general rule is to avoid contact between the limbs and between the limbs and torso to avoid altering the path followed by the measurement current. -
Page 14: Performing A Test
INSTRUCTION MANUAL • The vectorial bioimpedance analyser correctly identifies changes in hydration status due to hormonal variations during the menstrual cycle. Any water retention is analysed by the device and calculated using the Hydragram™ algorithm; predictive estimates of FFM and FM are unaffected by these changes, since they are automatically compensated by the predictive formula. - Page 15 BIA101BIVA Selftest: Check 1: battery Check 2: internal function test Check 3: sensor calibration test (performed at every switch-on) Rev. 0 03/2019 Page 15 to 36...
-
Page 16: Application Advice For Special Cases
INSTRUCTION MANUAL • Screen showing the results and any data transmission via Bluetooth® APPLICATION ADVICE FOR SPECIAL CASES In patients with amputations: perform measurement on the intact hemisoma. To estimate the body composition parameters, the weight of the missing limb must be estimated. In patients with AV Fistula: use the hemisoma without vascular access for bioelectrical evalua- tion. -
Page 17: Indications And Contraindications
The bioimpedance measurement system has been validated in all clinical and pathological con- ditions for over 30 years. The BIA101BIVA device emits a weak current, well below the 500 microamp threshold recognised as critical for risks of interaction with other active medical devices. -
Page 18: Chapter 3 Use Of The Device
INSTRUCTION MANUAL CHAPTER 3 USE OF THE DEVICE DATA TRANSMISSION TO THE BODYGRAM PLUS SOFTWARE BIA101BIVA is able to transmit the bioelectric values measured to the desktop Bodygram Plus software via a Bluetooth® protocol. INSTALLING THE BLUETOOTH MODULE If the PC DOES NOT have a Bluetooth module, and only in this case, the module provided can be installed by simply connecting it to a USB 2.0 or 3.0 port. -
Page 19: Data Transfer Procedure
BIA101BIVA • Click the Discover button to start the Bluetooth pairing Once the first connection has been made with the relative pairing, it will not be necessary to repe- at the procedure. Bodygram Plus will look for the previously paired BIA101 BIVA device by default. -
Page 20: Troubleshooting
INSTRUCTION MANUAL • The software will automatically connect to the device selected previously • Check that the results display screen on the device contains the blue Bluetooth® icon indicating correct pairing and thus that data can be transmitted. • Confirm the transfer of data to the Bodygram Plus by clicking the icon. -
Page 21: Chapter 4 Device Maintenance
Battery charger output is a controlled 12 Vdc signal. The permissible input is from 100 to 240 Vac. BIA101BIVA has sufficient charge for about 16 hours’ continuous use and is equipped with an auto switch-off system and a low battery warning message, to preserve battery efficiency and durability. - Page 22 INSTRUCTION MANUAL To recharge the battery, proceed as follows: • Connect the battery charger to a wall power outlet. • Connect the battery charger to the device by means of the connector marked “SENSOR/ CHARGE” located in the centre of the rear of the device. Complete charging takes about 6 hours;...
-
Page 23: Bia101Biva System Alarms
BIA101BIVA BIA101BIVA SYSTEM ALARMS For easier interpretation of the messages on the screen, the error signal consists of just one ico- nographic window, shown below. The message includes all factors which prevent correct reading, from a disconnected cable to a measuring electronics fault. -
Page 24: General Error Which Cannot Be Corretted By The User
INSTRUCTION MANUAL General error which cannot be corrected by the user 4.3.1 The device performs an internal check on its functions at every switch-on, to prevent measurement errors. This error appears when the device fails one or more of the internal checks. This error does not depend on external factors and cannot be corrected or resolved except by suitably trained staff. -
Page 25: How To Use The Tester
It is important to check the reading of the nominal values covered by the tester with a frequency proportional to the measuring accuracy required. To ensure optimal efficiency and precision, Akern advises users to have the sensors checked in its laboratories every two years. -
Page 26: Cleaning And Sterilizing The System
INSTRUCTION MANUAL CLEANING AND STERILIZING THE SYSTEM • Clean the device with a damp cloth. Do not use solvents. They could damage the plastic container or the display. • If a damp cloth is not sufficient, use ordinary alcohol. • Clean the sensor cable with a cloth moistened with alcohol. -
Page 27: Chapter 5 Techinical Support And Service
Shipping costs are generally borne by the dispatching party. The theoretical lifetime of the device as declared by Akern is 5 years, during which term the avai- lability of replacement parts is guaranteed. Any damages arising due to the fault or negligence of Akern are covered up to the maximum amount of the list price of the device at the time of purchase. -
Page 28: If Measurements Are Inaccurate Or Unintelligible
INSTRUCTION MANUAL If measurements are inaccurate or unintelligible 5.2.1 To obtain full benefits from the sensor’s outstanding sensitivity, take care to use high-quality mea- suring electrodes and do not reuse the single-use electrodes. Keep packages away from heat sources. Check the expiry date shown on the package. The use of some types of medication (e.g. -
Page 29: If Data Transfer Is Unsuccesful
• The device may be damaged by rough handling; pack with great care. • Akern declines all responsibility for damage to the device in transit. The shipment should be insured; many couriers offer this service. TECHNICAL SUPPORT SERVICE CONTACTS •... -
Page 30: Reportig Incidents Or Near Misses
The manufacturer has established a single procedure for reporting incidents or near misses. This procedure requires users to report all incidents or near misses occurring during use of the device to Akern. The user has access to a link managed by the Italian Health Ministry, established in January 2014 http://www.salute.gov.it/DispoVigilancePortaleRapportoOperatoreWeb/ where incidents... -
Page 31: Chapter 6 Operating Principles
BIA101BIVA CHAPTER 6 OPERATING PRINCIPLES THEORETICAL BASES OF BIOIMPEDANCE ANALYSIS The bioimpedance analysis method is based on the principle that biological tissues act as con- ductors, semiconductors or dielectrics (insulators). The intra and extracellular electrolyte solu- tions of lean tissues are excellent conductors, while bone and fat are dielectric substances, and the currents used in clinical plethysmographs do not pass through them. -
Page 32: Block Diagram Of Operation Of The Bia101Biva Device
INSTRUCTION MANUAL BLOCK DIAGRAM OF OPERATION OF THE BIA101BIVA DEVICE The device consists of an impedance sensor powered by a lithium-ion battery pack, a cable/sen- sor equipped with insulated alligator clips. The simplified block diagram is as follows: Patient cable-... -
Page 33: Technical Specifications
BIA101BIVA TECHNICAL SPECIFICATIONS DEVICE TYPE: Body impedance vector analyser MODEL: BIA 101 BIVA RESISTANCE (R): Range (Ω) 0 – 1000 ohm Resolution 0.1 ohm REACTANCE (Xc): Range (Ω) 0 – 200 ohm Resolution 0.1 ohm POWER SUPPLY Lithium-ion battery 7.4 V 2600 mAh... -
Page 34: Chapter 7 Declaration Of Conformity
3 of annex VII. Notified Body BUREAU VERITAS ITALIA S.p.A. Viale Monza, 347 20126 Milan - Italia Conformity marking YANN GIOVANNI SILVIO INGHILESI GIALLONI Chief Executive Officer AKERN srl Page 34 to 36 Rev. 0 03/2019... -
Page 35: Chapter 8 Contents Checklist
BIA101BIVA CHAPTER 8 CONTENTS CHECKLIST Model BIA 101 BIVA Serial Number Art no. Item √ 0CB12BMED-03 Battery charger 12 V DC 2.5 A certified 60601-1 0CP4-003 Patient cable 0ELB100 Biatrodes electrodes (100 pcs) 0MBT USB/Bluetooth accessory 0TEST00C Electronic testing circuit (tester) - Page 36 INSTRUCTION MANUAL The information in this document is subject to change without notice Copyright © Akern S.r.l. Via Lisbona 32/34 50065 Pontassieve (Florence, Italy) Tel. +39 0558315658 FAX +39 0558323516 akern@akern.com All rights reserved. No part of this document may be photocopied, reproduced or translated into other languages without prior written consent.
Need help?
Do you have a question about the BIA101BIVA and is the answer not in the manual?
Questions and answers