Akern BIA 101 BIVA PRO User manual

INSTRUCTION MANUAL

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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

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INSTRUCTION MANUAL
CHAPTER 1 GENERAL AND SAFETY INFORMATION 6
1.1 INTENDED USE 6
1.2 INTENDED USERS 6
1.3 INTENDED PLACE OF USE 6
1.4 MISUSE 6
1.5 DEFINITIONS AND SIMBOLS 7
1.6 ELECTROMAGNETIC COMPATIBILITY 8
1.7 SAFETY WARNINGS 8
1.8 NORMATIVE REFERENCES 10
1.9 CLASSIFICATION OF DEVICE 10
1.10 CLINICAL VALIDATION 10
1.11 APPLIED PARTS 10
CHAPTER 2 PERFORMING A TEST 11
2.1 SWITCHING THE DEVICE ON AND OFF 11
2.2 TETRAPOLAR PATIENT LEAD 11
2.3 ELECTRODES 12
2.4 ELECTRODE PLACEMENT 12
2.4.1 P    13
2.5 STANDARD OPERATING PROCEDURE (SOP) 13
2.6 PERFORMING A TEST 14
2.7 APPLICATION ADVICE FOR SPECIAL CASES 16
2.8 INDICATIONS AND CONTRAINDICATIONS 17
CHAPTER 3 USE OF THE DEVICE 18
3.1 DATA TRASMISSION TO THE BODYGRAM 18
3.2 INSTALLING THE BLUETOOTH MODULE 18
3.3 FIRST CONNECTION PROCEDURE 18
3.4 DATA TRANSFER PROCEDURE 19
3.5 TROUBLESHOOTING 20
CONTENTS

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BIA101BIVA
CHAPTER 4 DEVICE MAINTENANCE 21
4.1 POWER SUPPLY 21
4.2 HOW TO RECHARGE THE DEVICE 21
4.3 BIA101BIVA SYSTEM ALARMS 23
4.3.1 G         24
4.4 CALIBRATION AND TESTING 24
4.4.1 H     25
4.4.2 T   25
4.5 CLEANING AND STERILIZING THE SYSTEM 26
4.5.1 S 26
CHAPTER 5 TECHINICAL SUPPORT AND SERVICE 27
5.1 WARRANTY TERMS AND CONDITIONS 27
5.2 TROUBLESHOOTING 27
5.2.1 I      28
5.2.2 I       28
5.2.3 I         28
5.2.4 I     29
5.3 MAINTENANCE AND REPAIR 29
5.4 RMA (Return Material Authorization) PROCEDURES 29
5.5 TECHNICAL SUPPORT SERVICE CONTACS 29
5.6 REPORTIG INCIDENTS OR NEAR MISSES 30
CHAPTER 6 OPERATING PRINCIPLES 31
6.1 THEORICAL BASES OF BIOIMPEDANCE ANALYSIS 31
6.2 BLOCK DIAGRAM OF OPERATION OF THE BIA101BIVA DEVICE 32
6.3 TECHNICAL SPECIFICATIONS 33
CHAPTER 7 DECLARATION OF CONFORMITY 34
CHAPTER 8 CONTENTS CHECKLIST 35

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INSTRUCTION MANUAL
INTENDED USE 1.1
The BIA101BIVA medical device was developed for measurement of the electrical properties of
tissues (Rz, Xc and Phase Angle), used to evaluate body composition and to monitor physiological
changes such as hydration and nutritional status.
INTENDED USERS 1.2
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.
Data obtained using BIA101BIVA may only be interpreted for therapeutic, clinical or diagnostic
purposes by suitably qualified health professionals.
Akern declares that the device, used in accordance with the aforesaid conditions and within the
limits set out in the “Safety Warnings” section point 1.7 SAFETY WARNINGS, has been designed
and manufactured to have no effect on the patient’s clinical condition and to ensure the safety of
the patient, user or any third parties.
INTENDED PLACE OF USE 1.3
Akern considers any location which complies with the environmental operating conditions
specified in point 6.3 TECHNICAL SPECIFICATIONS as an intended place of use.
MISUSE 1.4
“Misuse” is any condition of use not appropriately covered by the intended use, fields of
application or operating conditions.
Any research or application protocols must comply with a specific procedure agreed with the
manufacture, which conforms to the relevant regulations.
The user must refer to the instruction manual to ensure correct use.
CHAPTER 1 GENERAL AND SAFETY INFORMATION

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BIA101BIVA
DEFINITIONS AND SYMBOLS 1.5
DEFINITIONS
Rz (Ω): Symbol for electric Resistance; i.e. the opposition of a conductor (electrolytes) to the flow
of an alternating electric current. Value expressed in Ohm.
Xc (Ω): Symbol for capacitive Reactance, i.e. the opposition of a capacitor (cells) to the flow of an
alternating electric current. Value expressed in Ohm.
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,
as amended
Paragraphs marked with this symbol contain a warning notice
Symbol indicating the protection class against direct and indirect BF
electrical contact
Symbol recommending the recycling of polluting components
Symbol indicating controlled disposal of the product at the end of
its life cycle (in compliance with the WEEE directive)
Production site symbol

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INSTRUCTION MANUAL
ELECTROMAGNETIC COMPATIBILITY 1.6
The device has passed electromagnetic compatibility testing in accordance with the relevant stan-
dard, IEC 60601-1-2, as required by directive 93/42/EEC as amended.
SAFETY WARNINGS 1.7
This section explains the precautions to be adopted to avoid injury to users
of this device, and to prevent damage to property. Please familiarise yourself
with this information to ensure the safety of procedures when using this devi-
ce, in order to minimise the risk related to its use.
BIA101BIVA complies with IEC 60601-1 concerning the general requirements for the electrical safety
of medical devices.
A risk management procedure in accordance with EN ISO 14971 has been implemented by
the manufacturer and was approved at the time of certification. The device has also undergone
the required electromagnetic compatibility tests and complies with IEC 60601-1-2. Contact the
manufacturer if you wish to receive the certification documentation.
BIA101BIVA is designed for use in conjunction with other medical and/or electronic equipment
belonging to the same certification class.
Do not use the device in the presence of flammable gases, anaesthetic gases and any gaseous
mixture containing oxygen or flammable substances.
A potential risk may be caused by the injection of a 12 volt direct current into the human body.
However, the probability of this event is zero because the electrode/skin contact has a high
capacitive component and the skin offers very high impedance to direct current. The use of a
power distribution unit (PDU) with IEC 60601-1 certification for charging the battery further
reduces the residual risk.
The use of insulated alligator clips eliminates the risk of the electrical grounding of the patient, a
possibility that may arise in the extremely unlikely eventuality of accidental disconnection of the
clip. In addition, the charging/measurement input is physically self-excluding: since there is only
one connection, analysis and charging cannot be carried out simultaneously. The residual risk
is therefore largely theoretical. However, we recommend to avoid accidental clip detachment.
Before starting a test, verify that the patient is suitably insulated. Besides being exposed to risks,
“grounded” patients cause unreliable measurements.

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BIA101BIVA
Comply with the recommendations and warning symbols in the manual and
the messages displayed on the device.
•Do not use the device close to water and do not pour water onto it.
The IPX0 protection class does not protect against penetration by liquids and the device
might be irreversibly damaged, without service or warranty cover.
•Do not place the device on unstable surfaces or trolleys.
The device may fall and be seriously damaged.
•To ensure operation of the device throughout its life-cycle, avoid exposure to temperatures
above 60°C and therefore do not place it near radiators or in containers lacking adequate
ventilation.
•During storage,relative humidity in the environment must not exceed 95% without condensation.
•Never apply any weight to the battery charger cable,the patient cable,the measuring electrodes
or the device itself.
•Do not place the device in an obstructing position when it is being charged.
•Do not plug any object into the multipole socket of the battery charger/patient cable.
•Use only the accessories supplied.
•Do not try to repair the device: it does not contain any parts which can be repaired by unskilled
staff.
•Maintenance and repair must only be performed by qualified technical personnel.
All tampering by unauthorised staff causes expiry of the warranty and the certification. This could
damage the device beyond repair and put the user and the patient being analysed at risk.
•The device must only be charged using the PDU supplied.
•Do not recharge the device when:
the battery charger power cord shows signs of damage or pinches;
the device does not work properly although operating instructions have been followed
correctly;
the device has been dropped and/or the container is damaged;
the device shows clear signs of malfunction that may require technical servicing.
•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.
Do not remove it or throw it away.
Lithium-ion batteries must be disposed of in compliance with statutory legislation.
Caution: use only BIATRODES electrodes, as per manufacturer’s indications. The
use of different electrodes may interfere with measurements and is defined as an
UNACCEPTABLE risk. The user is completely responsible for any use of different
electrodes.

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INSTRUCTION MANUAL
NORMATIVE REFERENCES 1.8
This manual was prepared in compliance with Annexes I – VI – VII of Directive 93/42/EEC, as
amended.
STANDARDS APPLIED:
•Quality management system ISO 9001
•Medical electrical equipment - Electrical safety IEC 60601-1
•Medical electrical equipment - Electromagnetic compatibility IEC 60601-1-2
•Radio frequency ETSI EN 300328 V1.8.1 / ETSI EN 301489-1; ETSI EN 301489-17
•IEC 60601-1-6 Usability
•EN 62366 Application of usability engineering to medical devices
•Risk analysis and management EN ISO 14971
•Directive 2001/65/EC RoHS 2
•IEC 62304: Medical device software
CLASSIFICATION OF THE DEVICE 1.9
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.
APPLIED PARTS 1.11
Akern defines the Biatrodes electrode as the only type BF applied part in direct contact with the
patient.

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BIA101BIVA
SWITCHING THE DEVICE ON AND OFF 2.1
The device’s On/Off switch is located on the rear panel and identified by the symbol.
CHAPTER 2 PERFORMING A TEST
Press the button once to power it up.
Press the button again to shut the device down.
If the device is disconnected from the patient and not used for over 15 seconds, the auto-off
system is triggered to conserve the battery charge.
TETRAPOLAR PATIENT LEAD 2.2
The patient cable is fitted with insulated red
and black alligator clips.
To perform the measurement the cable must
be completely extended, with no loops or spi-
rals that could induce an auto-inductive effect
and interfere with the measurement.
To avoid damaging the cable, do not twist or
bend it at its ends.

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INSTRUCTION MANUAL
ELECTRODES 2.3
Each device is complete with a set of BIATRODES single-
use electrodes, compliant with Directive 93/42/EEC as
amended.
The electrodes are compliant with ISO 10993 and are non-
cytotoxic, non-irritant and non-sensitising.
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. The quality and technical characteristics of
the contact electrode are of critical importance for correct
reading of the bioimpedance values and to ensure the
device retains its performance characteristics, as defined
in the risk analysis.
Warning: the use of unsuitable electrodes, not certified for bioimpedance measurement,
may interfere with the device’s essential performance characteristics, generating incorrect
measurements with poor repeatability, and in the worst cases leading to incorrect interpretation.
ELECTRODE PLACEMENT 2.4
High repeatability with a low variation coefficient can only be achieved if electrodes are placed
properly and carefully.Therefore, it is necessary to take care to connect the electrodes and position
the patient cable clips correctly.
Only use electrodes that are certified for bioimpedance analysis.
Standard electrode position: hand-foot, at least 5 cm between electrode pairs.
•Sensing electrode (black clip): placed between the
distal prominences of the radius and the ulna of the
right wrist, exactly on the theoretical line bisecting the
radius and the ulna.
•Sensing electrode (black clip): placed between the
median and lateral malleoli of the right ankle. Exactly
on the theoretical line bisecting the malleolus and the
ankle
•Injecting electrode (red clip): placed on the dorsal
surface of the right hand at the distal metacarpal level.
•Injecting electrode (red clip): placed on the dorsal
surface of the right foot at the distal metatarsal level.
electrode placement

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BIA101BIVA
P    ..
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.
STANDARD OPERATING PROCEDURE (SOP) 2.5
PREPARING THE PATIENT
•Have the subject lie on a non-metallic medical or massage couch. Otherwise, subjects may be
positioned on the floor, on an electrically insulated mat.
•Measure the weight and height accurately with calibrated instruments.
•Clean the skin in the measuring electrode fitting points with alcohol or just a neutral soap.
•Subjects may wear any type of jewellery, watches or other metal objects without any problems
or interference with the impedance measurement.
•There is no need to empty the bladder since third space fluids are not analysed.
•If the test is performed within two hours after meals, the measurement is not influenced by
digestive processes.
SURROUNDING CONDITIONS AND WARNINGS
•Implanted metal prostheses such as screws, plates, discs or bone tissue replacements do not
affect the bioimpedance measurement.
•Large prostheses may affect the body composition estimate data.
•For research processes, a restrictive measurement protocol should be drawn up to increase
the measurement’s repeatability in the same conditions, and eliminate the influence of external
factors on the analysis.
•Room temperature affects the impedance measurement due to its influence on the peripheral
blood supply. Only use the device in the environmental operating conditions specified on the
technical datasheet.
•Unsuitable electrodes, not certified for bioimpedance measurement, inevitably seriously
impair the bioelectric measurement and considerably increase the risk of diagnostic errors.
Theoretical
position of the
subject

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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.
•On patients with monolateral amputations, make the measurement on the intact hemisoma,
estimating the weight of the missing limb if necessary.
In case of changes in body temperature (fever, hypothermia or physical exercise), body
impedance measurement is not reliable.1
Do not make measurements with body temperature over 38°C.
Remark: if a precise measurement of the fat mass percentage is required, a more restrictive pro-
tocol must be adopted to minimise all the factors which may cause a non tissue-related weight
variation.
PERFORMING A TEST 2.6
•Position the patient as shown, lying face upwards on a non-conductive surface (i.e. wooden
couch, padded couch, exercise mat).
•Wait for at least two minutes to allow uniform distribution of bodily fluids.
•If the patient is naked, it is important to avoid contact between limbs and torso, as this may alter
the standard route of the injected current.
•Apply the BIATRODES electrodes on dry and non-greasy skin in the application points
recommended by the bioimpedance guidelines as shown in point 2.4 ELECTRODE
PLACEMENT. If necessary, scrub the application points with alcohol and wait for the skin to air
dry before applying the electrodes.
•Connect the patient cable to the device.
•Connect the cable with the insulated red (distal) and black (proximal) alligator clips to the
single-use electrodes.
•Power on the device.
•Switch-on and selftest screen:
1. Di Iorio, et al. “Bioelectrical impedance measurement: errors and artifacts.” Journal of renal
nutrition9.4 (1999): 192-197.

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BIA101BIVA
Selftest: Check 1: battery
Check 2: internal function test
Check 3: sensor calibration test (performed at every switch-on)

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•Screen showing the results and any data transmission via Bluetooth®
APPLICATION ADVICE FOR SPECIAL CASES 2.8
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.
In elderly patients: check the skin hydration condition and contact quality; if the skin is very gre-
asy, dry or humid, electric measurements are altered. Attempt to normalise the skin’s condition.
In children: keep a distance of 5 cm between the injection-scanning pair, if necessary proximally
moving sensors from wrist and ankle.
Sportsmen and women: in people who exercise a lot or sportsmen and women, the measure-
ments should be made at a point in time distant from physical exercise (at least 24-30 h for exerci-
se at VO2max > 75% with duration over 2h; 12 h for exercise at 50%<VO2max<75%). Wait for the
skin temperature to normalise.
Subjects with metal prostheses: no particular precautions are required when measuring patien-
ts with metal orthopaedic prostheses.
PICC and PORT wearers: perform the test on the hemisoma without the implant.

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BIA101BIVA
INDICAZIONI E CONTROINDICAZIONI 2.9
Body impedance analysis is regarded as safe by the scientific community.
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.
The device’s safety analyses are included in the clinical validation document.
Contact the Akern scientific department for any conditions not covered here.
CAUTION: NO THERAPY OR TREATMENT MUST BE ADMINISTERED DURING MEASUREMENT.

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INSTRUCTION MANUAL
CHAPTER 3 USE OF THE DEVICE
DATA TRANSMISSION TO THE BODYGRAM PLUS SOFTWARE 3.1
BIA101BIVA is able to transmit the bioelectric values measured to the desktop Bodygram Plus software
via a Bluetooth® protocol.
INSTALLING THE BLUETOOTH MODULE 3.2
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.
•The Bodygram Plus software must not be running.
•The Internet connection must be active to enable installation of the correct driver using the Ms
Windows update service.
FIRST CONNECTION PROCEDURE 3.3
A the first start-up, the BIA101 BIVA device and the PC must be “paired”.
ATTENTION: Do not connect the Bluetooth module supplied if the PC already has a Bluetooth
module.
•Connect the tester and switch on the device,
•Start Bodygram Plus, click on the Bluetooth button,
•The Bluetooth configuration will open:

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BIA101BIVA
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.
DATA TRANSFER PROCEDURE 3.4
•Start Bodygram Plus
•Perform a BIA analysis following the standard protocol. If the analysis is correct, this screen will
appear on the device:
•Locate in the patient folder to which the data are to be sent
and click “New Assessment”:
•Click the Discover button to start the Bluetooth pairing

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•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.
•Save the data acquired on the Bodygram Plus software .
•The device shuts down automatically to conserve battery charge.
TROUBLESHOOTING 3.5
Before activating a service request, users are advised to follow these simple instructions:
•If more than one Bluetooth® device is installed on the PC, they may cause compatibility errors.
Check that only one Bluetooth device is installed.
•If there are several devices and communication fails, check that the device is actually paired
with the correct Bluetooth® module.
•Bluetooth mice and keyboards may interfere with communication, since they occupy the
communication channel.
•On first installation of the Bluetooth® module, it may be necessary to reboot the PC.