Cardioline Walk200b User manual

1936
Rev. 13 –31.03.2020
Walk200b
User manual

Walk200b
All rights reserved © Cardioline SpA.
CARDIOLINE®is a registered trademark of Cardioline SpA.
This publication may not be reproduced, in whole or in part, in any form or manner, without prior written authorisation
by:
Cardioline Spa
Via Linz, 151
38121 Trento
Italy

Walk200b
Table of Contents
1. GENERAL INFORMATION ................................................................................................................................ 1
1.1. Other important information............................................................................................................... 1
2. SAFETY INFORMATION.................................................................................................................................... 2
2.1. Warnings for the patient during the exam ......................................................................................... 7
3. ELECTROMAGNETIC COMPATIBILITY (EMC).................................................................................................. 8
3.1.1. Guidance and Manufacturer's declaration - Electromagnetic emissions......................................... 8
3.1.2. Guidance and Manufacturer's declaration - Electromagnetic immunity......................................... 9
3.1.3. Guidance and Manufacturer's declaration - Electromagnetic immunity......................................... 9
3.1.4. Recommended separation distances between portable and mobile RF communications
equipment and the Walk200b........................................................................................................................ 11
4. SYMBOLS AND LABEL ...................................................................................................................................... 12
4.1. Explanation of the symbols.................................................................................................................. 12
4.2. Device label ........................................................................................................................................... 13
5. INTRODUCTION ............................................................................................................................................... 14
5.1. Purpose of the manual......................................................................................................................... 14
5.2. Recipients .............................................................................................................................................. 14
5.3. Intended use ......................................................................................................................................... 14
5.4. Description of the device ..................................................................................................................... 15
5.4.1. General overview.................................................................................................................................. 16
5.4.2. Keys........................................................................................................................................................ 17
5.4.3. Display.................................................................................................................................................... 18
5.4.4. Acoustic signals ..................................................................................................................................... 18
5.4.5. Cuff connection..................................................................................................................................... 18
6. EXECUTION OF AN EXAM................................................................................................................................ 19
6.1. Initial startup......................................................................................................................................... 19
6.2. Preparation for use............................................................................................................................... 19
6.2.1. Switching on.......................................................................................................................................... 19
6.2.2. Clearing memory................................................................................................................................... 20
6.2.3. Setting the time/date ........................................................................................................................... 20
6.2.4. Inserting patient data (ID).................................................................................................................... 20
6.2.5. Setting the measurement protocol..................................................................................................... 20
6.2.6 Activation of the connection with the PC ........................................................................................... 21

Walk200b
6.3. Putting on the recorder........................................................................................................................ 23
6.4. Starting measurements........................................................................................................................ 24
6.5. Interrupting measurements................................................................................................................. 24
6.6. Download of the recordings ................................................................................................................ 24
7. MAINTENANCE AND TROUBLESHOOTING .................................................................................................... 25
7.1. Principal sources of error ..................................................................................................................... 25
7.2. Cleaning of the recorder ...................................................................................................................... 25
7.3. Cleaning of cuffs.................................................................................................................................... 25
7.4. Display maintenance ............................................................................................................................ 26
7.5. Periodic checks...................................................................................................................................... 26
7.5.1. Checking the battery voltage:.............................................................................................................. 26
7.5.2 Calibration ............................................................................................................................................. 26
7.6. How to change the batteries ............................................................................................................... 27
7.7. Troubleshooting table .......................................................................................................................... 27
8. TECHNICAL SPECIFICATIONS........................................................................................................................... 31
8.1. Harmonised standards applied............................................................................................................ 31
8.2. Accessories............................................................................................................................................ 32
9. WARRANTY....................................................................................................................................................... 33
10. DISPOSAL.......................................................................................................................................................... 34

Walk200b
1. GENERAL INFORMATION
1
1. GENERAL INFORMATION
This manual is an integral part of the device and should always be available as support material to the clinical
practitioner or the operator. Strict compliance with the information contained in this manual is an essential
prerequisite for a proper and reliable use of the device.
Have the operator read the manual thoroughly as the information related to the different chapters is only
described once.
1.1. Other important information
This manual was written with the utmost care. Should you find any details which do not correspond to those
contained in this manual, please inform Cardioline SpA who will correct such inconsistencies as soon as
possible.
The information contained in this manual is subject to change without notice.
All changes will be in compliance with the regulations governing the manufacturing of medical equipment.
All trademarks mentioned in this document are property of their respective owners. Their protection is
guaranteed.
No part of this manual may be reprinted, translated or reproduced without the manufacturer's written
authorisation.
The code relating to this manual is listed below.
Language
Code
ENGLISH
36529364_ENG
This manual refers to the software version sw. v. 200209.

Walk200b
2. SAFETY INFORMATION
2
2. SAFETY INFORMATION
Cardioline SpA will be held responsible for the safety, reliability and functionality of the devices only if:
1. the assembly operations, modifications or repairs are carried out by Cardioline SpA or by its
Authorised Service Centre;
2. The device is used in compliance with the instructions provided in the use manual.
Always contact Cardioline SpA should you wish to connect any devices not mentioned in this manual.
Warnings
This manual provides important information on proper use and safety of the device. Failure to
comply with the described operating procedure, improper use of the device, ignoring the
specifications and recommendations supplied, may cause severe physical injuries to the operators,
patients and bystanders, or may damage the device.
The device cannot be modified in any way.
The device captures and presents the data that reflects the physiological condition of the patient;
this information can be examined by specialist medical staff and will be useful in providing an
accurate diagnosis. In any event, the data cannot be used as the only means to make an accurate
diagnosis of the patient.
The operators for whom this device is intended must have the required competence regarding
medical procedures and the treatment of patients. They must also be sufficiently trained in using the
device. Have the operator carefully read and understand the contents of the operator manual and
the other annexed documents before using the device for clinical applications. Inadequate
knowledge or training could be at a greater risk for the physical safety of operators, patients and
bystanders, or could damage the device. If the operators are not trained on device use, it is
recommended to contact Cardioline or their Authorised Distributor to schedule an adequate training
course.
In case of unexpected events or malfunctions, contact Cardioline or their Authorised Distributor
immediately.
The correct use is the pressure monitoring of adults. The recorder should be used only under
medical supervision.
The doctor must be certain that, according to the health of the patient, the use of the device will not
damage blood circulation in the arm.
Petechial haemorrhages or subcutaneous haematomas may occur in some patients; all patients
must be told when putting on the cuff that if they experience pain they should switch off the
equipment and inform the doctor.

Walk200b
2. SAFETY INFORMATION
3
The doctor should explain to the patient that, particularly when sleeping, the equipment should be
positioned in such a way that the tube cannot be compressed. If the patient is not fully competent,
the equipment should be worn only under supervision.
The shoulder strap or cuff tube can become entangled around the patient’s neck and lead to
strangulation; because of this risk from the tube and cuff, the recorder may not be used for patients
who are legally incompetent, and must not get into the hands of unsupervised children.
The air tube between the recorder and the cuff must never be knotted, compressed or stretched.
The air tube may kink when inflated.
The device is protected against the effects of a defibrillator discharge.
The cuff is the applied part.
To prevent death or any serious personal injuries during defibrillation, avoid contact with the device
or patient cables. It is furthermore necessary to properly position the defibrillation pads with respect
to the electrodes in order to minimize patient skin burns.
This device is designed to be used only with the probes and accessories specified in this manual.
The cuff may cause skin irritation; check the skin for any irritations or inflammations.
To prevent any infections, clean the reusable accessories after each use.
The quality of the signal may be adversely affected by the use of other medical equipment such as
defibrillators and ultrasound machines.
There is a risk of explosion. Do not use the device in the presence of flammable anaesthetics.
There is no safety hazard if other equipment, such as pacemakers or other stimulators, is used
simultaneously with the device; however, disturbance to the signal may occur.
Do not use the device for direct cardiac applications
The device is not designed for use with high-frequency (HF) surgical equipment, and does not
provide any protective means against hazards to the patient.
The operation may be adversely affected by the presence of strong magnetic fields such as those
produced by electrosurgery equipment.
The use of the device is not recommended in the presence of medical diagnostic imaging equipment
such as the Magnetic Resonance Imaging (MRI) or Computerised Axial Tomography (CAT) in the
same environment.
Only use the recommended batteries. Using other types of batteries may cause danger of fire or
explosion.
The low battery warning is designed for the recommended batteries only. Using other types of
batteries may lead to a lack of indication resulting in device failure.
The case of the device is not protected against liquids penetration; devices in which liquid has
infiltrated should be cleaned as quickly as possible and checked by an authorized Service Centre.
Do not clean the device or the patient cables by submersing them in liquid, autoclaving, or steam
cleaning. This may cause serious damage to equipment or reduce its lifespan. Using non-specific
detergents/disinfectants, failure to comply with the recommended procedures or contact with non-

Walk200b
2. SAFETY INFORMATION
4
specific materials may cause additional risks to operators, patients or bystanders or may damage the
device. Do not sterilise the device or the patient cable with ethylene oxide gas (EO). Refer to Section
7 for instructions on proper cleaning and disinfection.
Do not leave the air tube unattended in the presence of children as they could be accidentally
strangled.
The Walk200b device is designed to be connected to a PC. The system that consists of the Walk200b
device and the non-medical PC equipment is defined as an electromedical system. The adoption of
an electromedical system requires compliance with the requirements of the Directive.
The use of a medical separation transformer must be used with the electromedical system consisting
of the Walk200b, a PC and any other non-medical equipment (such as printer and monitor). Consult
a CARDIOLINE® Service Centre for more detailed information. Alternatively, a PC compliant with
medical standard EN60601-1 can be used. A separation transformer cannot be used unless
compliance with the following conditions has been confirmed with absolute certainty:
After measurements taken according to the EN60601-1 standard, the dispersion currents in
the case of the PC and of any other non-medical devices that are connected (monitor,
printer, etc.) are less than 0.1 mA.
The non-medical devices in the system are connected outside the patient area, that is, not
within 1.5 m of the patient and/or his or her bed.
If a separation transformer is not used, install the system in such a way that the operator
cannot touch the patient and the case of the any non-medical equipment outside the
patient area at the same time.
If the PC and any other non-medical devices that are connected (monitor, printer, etc…) are
powered by the medical separation transformer, they may be located inside the “patient
area”, i.e. within 1.5 m of the patient and/or his or her bed.
The PC and any other devices to be used in the system (monitor, printer, etc.) must only be
connected to the separation transformer using the cables and any other accessories
supplied with the system. Extension cords, socket adapters and other types of connections
may not be used unless supplied with the system.
It is categorically forbidden to connect other equipment that is not part of the system to the
separation transformer or to a multiple extension cord supplied with the system.
If a non-medical device that is part of the system is connected to a non-prescribed type of
socket (a wall socket, for example), the system no longer complies with medical standards
and the patient may be endangered.
If a non-standard device is connected to the socket of the separation transformer specified
for the system devices, this could create situations of danger for the patient, operators or
environment (overloading or overheating of the sockets and separation transformer.
The separation transformer and any multiple sockets connected to it must not be placed
directly on the floor or any area that may be flooded, or in which dirt may accumulate. The
transformer and sockets must be placed in an area that is easy to inspect, both for regular
cleaning and for the required maintenance.
The installer must install the system in the optimum way to satisfy the safety regulations and
provide the greatest facility and ease of use by both the user and the patient.

Walk200b
2. SAFETY INFORMATION
5
The user must ensure that cleaning and required maintenance of the system is performed.
In particular, the separation transformer, the socket or sockets attached to it, and to the
non-medical device (PC) must be kept in a dry area, with no accumulation of dirt and dust.
Check the integrity of the cables regularly.
The earth used by the system must be efficient and compliant with the requirements for
electrical systems for public and/or medical use.
The device is in compliance with the requisite required by the Directive R&TTE on the devices of
radio transmission. In order to protect the device from other devices not in accordance to the
normative aforesaid, we suggest to put the device away from other devices that use the Bluetooth
transmission.
On first use, make sure that the device has not been damaged during transport and that it operates
perfectly.
The device has been calibrated by the manufacturer; a label inside the battery compartment shows
the calibration’s expiry date.
It is recommended to check the calibration regularly - at least once every other year. The calibration
may be verified by Cardioline or by any authorised service centre.
The device may be used with the bag or the Walk200b Waterproof case mentioned in paragraph 8.2.
The bags are not meant to come into direct contact with the body; it is therefore recommended to
place them over a piece of clothing (e.g. a T shirt).
Attention
The device and the accessories should be cleaned before use. Check the connections for any damage
or excessive wear before each use. Replace the cable and cuff should they present any damage or be
excessively worn.
Do not pull or stretch cables as this could result in mechanical and/or electrical failures.
There are no user-serviceable parts inside the device. The device can only be dismantled by qualified
service personnel. Any malfunctioning or defective device must be excluded from use and be
checked/repaired by qualified service personnel before being reused.
The device does not require any calibration or special instrumentation for correct use and
maintenance.
When it is necessary to dispose of the device, its components and accessories (e.g.: batteries, cables,
etc) and/or packaging material, comply with local standards for waste disposal.
The recorder should not be exposed to direct sunlight and should not be placed near direct source
of heat to prevent it from overheating
Defective segments in the LCD's can cause wrong interpretation of measurement values and lead to
false diagnosis. Defective LCD's must be replaced immediately by the manufacturer or an Authorised
Service Centre.

Walk200b
2. SAFETY INFORMATION
6
Notes
The movements of the patient may generate excessive noise and affect the quality of the signal or
the correct analysis of the device.
As defined by the IEC 60601-1 and IEC 80601-2-30 safety standards, the device is classified as
follows:
IP class equipment (internal power ME)
Defibrillation-proof Type BF applied parts.
Ordinary equipment.
Not suitable for use in the presence of flammable anaesthetics.
Continuous operation
Accuracy of measurements taken with the device is compliant with IEC 80601-2-30.
The device is a Class IIa in compliance with Directive 93/42/EEC.
The device has IP 2x protection rating against the ingress of solid particles and water. It is therefore
protected against solid particles with diameter greater than 12 mm. The Walk 200b Waterproof case
(see para. 8.28.2) has IP 2x protection rating against the ingress of solid particles and water; it
therefore protects the device against water drops falling at a maximum angle of 15° when used with
the device. Without the Walk200b Waterproof case, the device is not protected against liquid
penetration.
The Walk200b Waterproof case is required for use in a domestic environment.
In order to prevent damage to the device during transportation and storage (when still in its original
packaging), comply with the following environmental conditions:
Ambient temperature .....................
-20°C to 50°C
Relative humidity ............................
15% to 95%
The device is intended for use in hospitals or doctor's offices and should comply with the following
environmental requirements:
Ambient temperature .....................
+10°C to 40°C
Relative humidity ............................
15% to 90%
Athmosferic pressure......................
700 hPa to 1060 hPa
The measurements’ accuracy level is ± 3 mmHg.

Walk200b
2. SAFETY INFORMATION
7
2.1. Warnings for the patient during the exam
The device was designed for Ambulatory Blood Pressure Monitoring (ABPM). The device can also perform
continuous recordings for 24 hours.
Clinical practice requires the Patient to wear or carry the device inside or outside the hospital, in indoor
premises as well as outdoors. It is therefore especially important for the patient to be sufficiently instructed
regarding the operations they are authorised to perform and the related risks.
In particular, the following warnings must be explained to the patient:
The device must be worn throughout the test;
If the device is used inside the bag, it may not be removed;
The device is not protected against the ingress of liquids, unless it is used inside the Walk200b
Waterproof case (see para. 8.2). It should therefore never get wet;
The device emits a sound to signal particular events, such as an empty battery. In such cases, contact
the doctor of reference or the outpatient clinic for instructions;
In case of pain during the measurement, turn off the device, remove the armband and contact a
doctor.
During the measurement procedure, the patient must be relaxed and keep the arm still. Excessive
movement (e.g. flexing the muscles) may affect the results of the measurement. Walk slowly or stop
during the measurement.
If the armband detaches accidentally, contact the doctor of reference or the outpatient clinic for
instructions;
The device might be damaged by impacts and falls, which may cause it to malfunction and interrupt
the test scheduled;
Inform the patient that the cables and armbands must be kept away from children, as they pose a
risk of suffocation or strangulation.
The measurements’ accuracy level is ± 3 mmHg.
NOTE: if the device is used in accordance with this manual and new batteries are used for every test, the
patient must not replace the battery, as its life is compatible with the duration of the test.

Walk200b
3. ELECTROMAGNETIC COMPABILITY (EMC)
8
3. ELECTROMAGNETIC COMPATIBILITY (EMC)
This device requires particular precautions regarding Electromagnetic Compatibility. It must therefore be
installed and commissioned in compliance with the information on Electromagnetic Compatibility contained
in this manual.
Portable and mobile radio communication equipment can affect operation of the device.
Using accessories, transducers or cables different than those specified in par. 8.2 can increase the emissions
or decrease the immunity of the appliance.
Warnings
This device is only intended to be used by professional healthcare personnel. This device could
generate radio interference or disturb operation of the equipment in the vicinity. Therefore it could
be necessary to take measures to mitigate these effects, such as re-directing or repositioning the
device or shielding the room.
The use of accessories and cables other than those recommended by Cardioline may cause an
increase in emissions or a lowering in the protection of the system.
The device must not be used near or superimposed to other equipment. If necessary, check that the
device works according to its standard operation.
Electromagnetic compatibility during the use of the device is required with the surrounding devices.
An electronic device can generate or receive electromagnetic interference. The electromagnetic
compatibility test (EMC) has been carried out on the electrocardiograph in compliance with the international
EMC directive for medical equipment (IEC 60601-1-2). This IEC standard has been adopted as a European
standard (EN 60601-1-2).
Fixed, portable and mobile equipment for RF communication may affect the protection of the medical
equipment. See par. 3.1.4 for the recommended separation distance between the radio equipment and the
device.
3.1.1. Guidance and Manufacturer's declaration - Electromagnetic emissions
The Walk200b is intended to operate in the electromagnetic environment specified below. The customer or
the user of the Walk200b must guarantee that it is used in this environment.
Emission test
Compliance
Electromagnetic environment –guidance
Radio frequency (RF) emissions
CISPR 11
Group 1
The Walk200b uses RF energy only for its internal function. Therefore,
its RF emissions are very low and are not likely to cause any interference
in nearby electronic equipment.
Radio frequency (RF) emissions
CISPR 11
Class B
The Walk200b is suitable for use in all establishments, including
domestic establishments and those directly connected to the public low
voltage power supply network that supplies buildings used for domestic
purposes.
Harmonics emissions
IEC 61000-3-2
Not
applicable

Walk200b
3. ELECTROMAGNETIC COMPABILITY (EMC)
9
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Not
applicable
3.1.2. Guidance and Manufacturer's declaration - Electromagnetic immunity
The Walk200b is intended for use in the electromagnetic environment specified below. The customer or the
user of the Walk200b should assure that it is used in such an environment.
Immunity test
Conformity
Compliance level
Electromagnetic Environmental Information
Electrostatic discharge
(ESD)
IEC 61000-4-2
+/- 6 kV contact
+/- 8 kV air
+/- 6 kV contact
+/- 8 kV air
Floors should be wood, concrete or ceramic tile. If
floors are covered with synthetic material, the
relative humidity should be at least 30 %.
Electrical Fast Transient/
Burst
IEC 61000-4-4
+/- 2 kV for power
supply lines
+/- 1 kV for
input/output lines
+/- 2 kV for power
supply lines
+/- 1 kV for
input/output lines
Mains power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5
+/- 1 kV line(s) to
line(s)
+/- 2 kV line(s) to
earth
+/- 1 kV line(s) to
line(s)
+/- 2 kV line(s) to
earth
Mains power quality should be that of a typical
commercial or hospital environment.
Voltage dips,
short interruption and
voltage variations
on power supply
input
lines
IEC 61000-4-11
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(60% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 s
Not applicable
The device operates with buffer batteries and is
designed for continuous operation
Power frequency and
magnetic field
(50/60 Hz)
3 A/m
3 A/m
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical
commercial or hospital environment.
NOTE: UTis the AC mains voltage prior to the application of the test level.
3.1.3. Guidance and Manufacturer's declaration - Electromagnetic immunity
The Walk200b is intended for use in the electromagnetic environment specified below. The customer or the
user of the Walk200b should assure that it is used in such an environment.
Emission test
IEC 60601 test level
Compliance level
Electromagnetic Environmental Information
Conducted RF
IEC 61000-4-6
3 V rms
From 150 kHz to 80
MHz
3 V
Portable and mobile RF communications equipment
should be used no closer to any part of the
Walk200b, including cables, than the recommended

Walk200b
3. ELECTROMAGNETIC COMPABILITY (EMC)
10
Radiated RF
IEC 61000-4-3
3 V/m
From 80 MHz to 2.5
GHz
3 V/m
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance:
From 80 MHz to 800 MHz
From 800 MHz to 2.5 GHz
where Pis the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and dis the recommended separation
distance in metres (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey (a),
should be less than the compliance level in each
frequency range (b).
Interference may occur in the vicinity of equipment
marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which the
Walk200b is used exceeds the applicable RF compliance level above, the Walk200b should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be necessary, such
as re-orienting or relocating the Walk200b.
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Walk200b
3. ELECTROMAGNETIC COMPABILITY (EMC)
11
3.1.4. Recommended separation distances between portable and mobile RF
communications equipment and the Walk200b
The Walk200b is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the Walk200b can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters)
and the Walk200b as recommended below, according to the maximum output power of the
communications equipment.
Maximum rated power output of the
transmitter (W)
Separation distance according to frequency of transmitter (m)
150 KHz to 800 MHz
800 MHz to 2.5 GHz
800 MHz to 2.5 GHz
0.01
0.12
0.12
0.23
0.1
0.37
0.37
0.74
1
1.17
1.17
2.33
10
3.69
3.69
7.38
100
11.67
11.67
23.33
For transmitters rated at a maximum output power not listed above, the recommended separation distance
din metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P
is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

Walk200b
4. SYMBOLS AND LABEL
12
4. SYMBOLS AND LABEL
4.1. Explanation of the symbols
Symbol
Description
Comply with the instructions in the use manual
CE marking –compliance with the European Union directives
Manufacturer
Reference number (product code)
Serial Number
Lot number
Year of manufacture
Type BF equipment –defibrillation protection
Device with RF communication
Separate collection of electrical waste and electronic equipment
Consult instructions for use
Temperature variation
Humidity variation
Keep dry
No Latex
1936

Walk200b
4. SYMBOLS AND LABEL
13
No PVC
No DEHP
4.2. Device label

Walk200b
5. INTRODUCTION
14
5. INTRODUCTION
5.1. Purpose of the manual
This manual deals with the Walk200b device.
The manual represents a guide for the execution of the following operations:
Reasonable use of the device, of the function keys and of the sequence of menus.
Execution of an exam. (Section 6)
Maintenance and troubleshooting. (Section 7)
5.2. Recipients
This manual is intended for professional healthcare operators. They are therefore presumed to have specific
knowledge of medical procedures and terminology, as required by clinical practice.
5.3. Intended use
Walk200b is an outpatient non-invasive Ambulatory Blood Pressure (ABP) recorder for 24-hour monitoring.
The device measures the systolic and diastolic blood pressure and the heart rate. The pressure is measured with the
application of the oscillometric method.
The recorder can communicate with a computer via a wireless Bluetooth channel.
The device is indicated for use in healthcare: hospitals, medical clinics and offices of any size.
The device is designed to perform and record blood pressure measurements that may be used for the assessment
and diagnosis of the patient’s condition.
For the specific application and the related clinical practice, an interruption of the recording, which may make it
necessary to repeat the test, has no impact on patient safety.
The device is indicated for the performance and recording of BP measurements over a period of 24 hours at
specific intervals.
The device may not be used for monitoring blood pressure in intensive therapy or during surgery.
The device isnot intended for use as a physiological monitor of vital signs.
The device is not intended as the only means of diagnosis. The test results must always be checked and
validated by a specialist doctor.
The device is indicated for use on adults and children.
The device is not intended for use on newborns.
There are no limits in terms of gender or race.

Walk200b
5. INTRODUCTION
15
The device is indicated for use by a doctor or personnel acting on the order of an authorised doctor, trained
in the use of devices measuring ambulatory blood pressure.
The device is indicated for use by patients adequately informed by the doctor of the following warnings:
The device must be worn throughout the tests;
If the device is used inside the bag, it must never be removed;
The device is not protected against the ingress of liquids, unless it is used inside its protective carry case. It
should therefore not get wet;
If the armband disconnects accidentally, contact the doctor of reference or the outpatient clinic for
instructions;
The device may be damaged by impacts and falls, which may impair its proper operation and interrupt the
tests scheduled;
Inform the patient that the armband and cables must be kept away from children, as they pose a risk of
suffocation or strangulation.
5.4. Description of the device
The device is a blood pressure Holter recorder lasting 24 hours or more designed to perform ambulatory
monitoring tests during 24 hours or more (or Holter tests).
Depending on the configuration purchased, the device may be equipped with a Bluetooth and/or USB
connection, through which it may be connected to a PC thanks to the dedicated software that is installed on
said PC. The connection works for both test preparation and download procedures.
The device is powered by battery.
The device includes:
1. Patient cable and cuff
2. Pouch
3. 2 batteries (AA 1.5V)
4. User manual

Walk200b
5. INTRODUCTION
16
5.4.1. General overview
Rear view:
1. cuff tube / air connector
2. Battery compartment
3. Bluetooth interface (not visible)
1
3
2
USB