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.