Walk200b

User manual

Rev. 13 – 31.03.2020
1936
 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. 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.

1
 Walk200b
2. SAFETY INFORMATION

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.

2
 Walk200b
2. SAFETY INFORMATION

 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-

3
 Walk200b
2. SAFETY INFORMATION

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.

4
 Walk200b
2. SAFETY INFORMATION

 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.

5
 Walk200b
2. SAFETY INFORMATION

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.

6
 Walk200b
2. SAFETY INFORMATION

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.

7
 Walk200b
3. ELECTROMAGNETIC COMPABILITY (EMC)

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

The Walk200b uses RF energy only for its internal function. Therefore,
Radio frequency (RF) emissions
Group 1 its RF emissions are very low and are not likely to cause any interference
CISPR 11
in nearby electronic equipment.
Radio frequency (RF) emissions The Walk200b is suitable for use in all establishments, including
Class B
CISPR 11 domestic establishments and those directly connected to the public low
Harmonics emissions Not voltage power supply network that supplies buildings used for domestic
IEC 61000-3-2 applicable purposes.

8
 Walk200b
3. ELECTROMAGNETIC COMPABILITY (EMC)

Voltage fluctuations/
Not
flicker emissions
applicable
IEC 61000-3-3

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 Floors should be wood, concrete or ceramic tile. If
+/- 6 kV contact +/- 6 kV contact
(ESD) floors are covered with synthetic material, the
+/- 8 kV air +/- 8 kV air
IEC 61000-4-2 relative humidity should be at least 30 %.
+/- 2 kV for power +/- 2 kV for power
Electrical Fast Transient/
supply lines supply lines Mains power quality should be that of a typical
Burst
+/- 1 kV for +/- 1 kV for commercial or hospital environment.
IEC 61000-4-4
input/output lines input/output lines
+/- 1 kV line(s) to +/- 1 kV line(s) to
Surge line(s) line(s) Mains power quality should be that of a typical
IEC 61000-4-5 +/- 2 kV line(s) to +/- 2 kV line(s) to commercial or hospital environment.
earth earth
<5% UT
(>95% dip in UT)
for 0.5 cycle
Voltage dips, 40% UT
short interruption and (60% dip in UT)
voltage variations for 5 cycles The device operates with buffer batteries and is
on power supply Not applicable
70% UT designed for continuous operation
input
lines (60% dip in UT)
IEC 61000-4-11 for 25 cycles
<5% UT
(>95% dip in UT)
for 5 s
Power frequency and Power frequency magnetic fields should be at levels
magnetic field 3 A/m 3 A/m characteristic of a typical location in a typical
(50/60 Hz) commercial or hospital environment.

NOTE: UT is 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
3 V rms Portable and mobile RF communications equipment
Conducted RF
From 150 kHz to 80 3V should be used no closer to any part of the
IEC 61000-4-6
MHz Walk200b, including cables, than the recommended

9
 Walk200b
3. ELECTROMAGNETIC COMPABILITY (EMC)

separation distance calculated from the equation

applicable to the frequency of the transmitter.
Recommended separation distance:

From 80 MHz to 800 MHz

3 V/m From 800 MHz to 2.5 GHz

Radiated RF
From 80 MHz to 2.5 3 V/m
IEC 61000-4-3
GHz
where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is 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.

10
 Walk200b
3. ELECTROMAGNETIC COMPABILITY (EMC)

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 Separation distance according to frequency of transmitter (m)
transmitter (W) 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
d in 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.

11
 Walk200b
4. SYMBOLS AND LABEL

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

1936

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

12
 Walk200b
4. SYMBOLS AND LABEL

No PVC

No DEHP

4.2. Device label

13
 Walk200b
5. INTRODUCTION

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 is not 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.

14
 Walk200b
5. INTRODUCTION

 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

15
 Walk200b
5. INTRODUCTION

5.4.1. General overview

USB

Rear view:

1. cuff tube / air connector

2. Battery compartment
3. Bluetooth interface (not visible)

16
 Walk200b
5. INTRODUCTION

Top view:

4. Start Key
5. Day/Night Key
6. Event Key
7. ON/OFF Key
8. LCD Display

5.4.2. Keys

ON/OFF
This key switches the Walk200b recorder on and off. To prevent switching it on or off by mistake, the key
reacts only after 2 seconds. As with all other keys blood pressure measurement can also interrupted
prematurely, causing the pressure in the cuff to be released rapidity. Warning: switch the unit on again to
continue.

Start
You have to press the start button to begin a 24 hours measurement session, and to perform a
measurement outside of measuring cycles previously indicated. Attention: The physician must verify the
reliability of the values of the first measurement, so that we can continue with successive measurements
correct, and the proper positioning of the cuff. In the event of an error, follow the directions in the
paragraph "preparation for the measurement and search of errors”. When you press the START button, on
the display appears the number of measurements recorded up to that moment, and start the manual
measurement. During the first measurement the cuff will inflate gradually. Once the necessary pressure in
the cuff for the measurement of the systolic blood pressure value has been determined, that value will be
stored and will be reached automatically in the subsequent automatic measurements. The patient can use
the START button to record an additional manual measurement outside of the recording protocol.

17
 Walk200b
5. INTRODUCTION

Night and day

This key allows waking and sleeping phases differentiated when recording, wich is important from the point
of view of statistical evaluation and graphic presentation. Briefly: the patient is instructed to operate the
DAY/NIGHT Key on going to bed and again when getting up in the morning. This adjusts the monitoring
interval to suit the individual patient and helps you in assessing the BP profile. As well as adjusting the
interval, the appropriate notes are shown on the printout. If this key is not operated, the change in interval
will take place according to the protocol selected

Event Marker
This key allows the patient to record the time at which medication in taken or any events happen that may
cause blood pressure to rise or fall.
Pressing this key directly triggers a measurement. The patient should note the reason for pressing the Event
Key in the event diary.

5.4.3. Display

The LCD display is located on the front of the recorder housing. It displays useful information for the doctor
and patient on measurement data, monitor settings and measurement errors.

5.4.4. Acoustic signals

The acoustic signals used consist of single or multiple beeps.

The following signals are emitted:
 1 beep: Switching on or off, start and completion of a measurement (except for night intervals),
removal of interface cable, end of IR communication, set-up and end of Bluetooth communication,
and measuring error
 3 beep: system error
 Continuous beep: Serious system error (e.g. cuff pressure is greater than 15 mmHg for more than 10
seconds outside of a measurement)
 Combined beeps: When deleting measurements manually, first one beep is emitted and 2 seconds
later 5 beeps

5.4.5. Cuff connection

The cuff connection is fitted on the front of the recorder housing. This metal plug is used to connect the
recorder with the cuff via the cuff tube and the metal cuff socket.

NOTE: Both the doctor and the patient should be aware that the metal plug (air connector) must always
engage with an audible “click”. Otherwise there will be a leaky connection between recorder and the tube
that will produce incorrect measurements.

18
 Walk200b
6. EXECUTION OF AN EXAM

6. EXECUTION OF AN EXAM

6.1. Initial startup

 Connect the cuff tube with one of the cuffs supplied (according to instructions in par. 6.3), by
pushing it onto the plastic connector.
 Connect the cuff tube with the socket on the front of the recorder housing.
 First check that the batteries have been inserted correctly. You should always use fully charged
batteries for a new monitoring session. Alternatively, you can use alkaline batteries. Take care to
insert the batteries the right way round.

NOTE: Use only the Ni-Mh rechargeable batteries with minimum capacity of 1500 mAh and maximum
capacity of 2450 mAh (AA) or alkaline batteries 1,5 V ( AA). Other types of batteries with higher capacity o
lithium ones MUST NOT be used.

NOTE: it is recommended to charge and discharge sometimes the rechargeable Ni-Mh batteries before use
with the device.

6.2. Preparation for use

6.2.1. Switching on

Always check the condition of your recorder first, before you give it to a patient. You can do this by observing
the initial displays shown on the recorder shortly after switching it on.
Press the ON/OFF key and look at the following sequence of displays should appear:

 Battery status (Volts): for Ni-Mh rechargeable batteries min. 2.75; for alkaline batteries min. 3.10
 Display segment test: 999:999 to 000:000; Along with the numbers, all the other LCD symbols are
shown. Check whether all segments are being shown correctly and completely (the complete code is
constantly being checked for correctness in the background)
 Current 24 hour time : Example: 12:55

If a fault occurs during the internal test, the recorder shows E004 on the display and emits an acoustic signal.
For safety reasons, use of the recorder is blocked. Return the recorder to your specialist dealer or directly to
Cardioline.

19
 Walk200b
6. EXECUTION OF AN EXAM

6.2.2. Clearing memory

The memory must be cleared before each monitoring session, i.e. no blood pressure data from the previous
patient must be left in the memory. However, should values still be present, you can delete them with the
delete function of the analysis software.
You can clear the memory manually, by holding the START key for more than 5 seconds. A number will
appear in the display indicating the number of measurements present in the memory (after the prompt clr).
To confirm that you want to erase the memory press and hold the event key (within 5 seconds after the
prompt clr). The following prompt 000 in the display confirms that the memory has been erased.

6.2.3. Setting the time/date

The Walk200b has an internal buffer battery that allows the clock to continue running even after the
batteries have been removed. You should nevertheless check the time and date before each measurement
series.
The time and date can be set with the CUBE analysis software. You can also set the time and date manually
by holding the START key and then pressing the EVENT key. Now you are in the “Set time” mode. Use the
START key to change the number in question, and use the EVENT key to jump to the next.

6.2.4. Inserting patient data (ID)

The recorder must be prepared inserting the patient data (ID), so that measurements are allocated correctly
when reading out.
Patient data can be transmitted to the recorder using one of the compatible Cardioline software (Cubeabpm
or Webuploader). Please refer to the user manual of these software for more instructions.

6.2.5. Setting the measurement protocol

The protocols can be set using the Cubeabpm software

You can set the protocols manually pressing the DAY/NIGHT key, keep hold, and then pressing the EVENT
key. Use the START key to change the protocol, and confirm with the EVENT key.

Measurements Acoustic
Protocol Interval Measurements shown on display
per hours signal
08:00 ÷ 23:59 4 YES
1 YES
00:00 ÷ 07:59 2 NO
08:00 ÷ 22:59 4 YES
2 YES
23:00 ÷ 07:59 1 NO
07:00 ÷ 21:59 4 YES
3 NO
22:00 ÷ 06:59 2 NO
08:00 ÷ 23:59 4 YES
4 NO
00:00 ÷ 07:59 2 NO

20
 Walk200b
6. EXECUTION OF AN EXAM

Measurements Acoustic
Protocol Interval Measurements shown on display
per hours signal
18:00 ÷ 09:59 4 YES
5 YES
10:00 ÷ 17:59 2 NO
07:00 ÷ 23:59 4 YES
6 YES
00:00 ÷ 06:59 2 NO
06:00 ÷ 22:59 4 YES
7 NO
23:00 ÷ 05:59 2 NO
07:00 ÷ 09:00 6 YES
8 08:59 ÷ 23:59 4 YES YES
00:00 ÷ 06:59 2 NO
9 09:00 ÷ 08:59 30 NO YES
10 telemedicine 08:00 ÷ 07:59 30 YES NO

NOTE: protocols 1,2 and 10 are set as standard, but can be changed. Protocol 5 is suitable for night time
activity (night shift). Protocol 9 is the Schellong-test.

6.2.6 Activation of the connection with the PC

Setting patient data or the measurement protocol via software, as indicated in the previous paragraphs,
requires the Walk200b to be connected to the computer on which the software is installed.
If the device is equipped with a USB connection:
 Open the recorder's battery door and put in the batteries, then close the door;
 Connect the device to the PC using the USB cable supplied.

 Press the key to turn on the recorder, wait for CO to appear on the screen

If the device is equipped with a Bluetooth connection:

 Open the recorder's battery door and put in the batteries, then close the door;

 Press the key to turn on the recorder, wait for the clock to appear on the screen;

 Press the key for 5 seconds to activate the Bluetooth connection, BT should appear on the
screen;
 On first activation, you must carry out the pairing procedure;
 On the PC, click on the Bluetooth icon and select Add new Bluetooth device > Add Bluetooth or other
type of device > Bluetooth > Select the walk200b serial number; if asked, use the pairing code 6624.

21
 Walk200b
6. EXECUTION OF AN EXAM

>

>
 Wait until Windows has finished the installation, then click again on Other Bluetooth options and
COM ports;
 Note down the output COM port and serial number;

 When asked, select the output COM port from the drop-down menu and press the key Add COM
port;
 Press the Retry key;

22
 Walk200b
6. EXECUTION OF AN EXAM

6.3. Putting on the recorder

Put the equipment pouch on the patient. By varying the length of the strap you can use it either as a hip belt
or a shoulder strap. Alternatively, use a normal belt that matches the patient’s clothing.
Now fit the cuff on the patient; correct cuff fit is extremely important for accurate measurement (see figure
beloe). The cuff can also be worn over the shirt or blouse. We recommend that the cuff be fitted on the bare
upper arm. In this case, bring the tube out between the buttons of the shirt or blouse, around the back
of the neck to the ABP monitor on the right-hand side.

Placing the cuff

Please note the following points:

1. When putting the recorder on the patient, the recorder must not be connected to other external
equipment.
2. The cuff must fit so that the air tube cannot be kinked or compressed at any point. The tube
connection on the cuff should therefore be directed upwards. The air tube should allow free
movement of the upper arm and should run over the back of the neck to the other side of the body.
3. It is essential to ensure that the artery symbol lies over the brachial artery. When the cuff fits
correctly, the metal strip is on the outer side of the upper arm (elbow side).
4. The material loop must cover the skin under the metal strip.
5. The lower edge of the cuff should be about 2 cm above the bend of the patient’s elbow.
6. The cuff should fit relatively snugly on the upper arm. Correct fit can be checked by a simple test:
there should be room to slip one finger under the cuff.
7. The correct cuff size is also important if blood pressure is to be measured correctly.
8. To obtain reproducible results, standardised monitoring conditions are required, so the cuff must be
the correct size for the patient. Using the tape measure supplied, measure the circumference at the
middle of the upper arm and select the appropriate cuff:

Upper arm circumference cuff

20 - 24 cm S
24 - 32 cm M
32 - 38 cm L
38 - 55 cm XL

23
 Walk200b
6. EXECUTION OF AN EXAM

9. Connect the air tube from the cuff to the ABP recorder.
10. Push the tube firmly over the connection until a click is heard as it engages; to disconnect, simply
pull back the outer metal ring on the plug.
11. The recorder is now correctly fitted and ready for use.

NOTE: The bag and the Walk 200b Waterproof case, mentioned in paragraph 8.2, are not intended 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).

6.4. Starting measurements

Once all these steps have been completed, the monitor can be started. First, a manual measurement must
be carried out by pressing the START key.
This measurement is used to determine whether the recorder is working correctly.
If errors occur, check once more that the procedure followed in setting up and fitting the equipment was
correct. Should this not solve the problem, repeat the setting-up procedure.
Only after a successful manual measurement the patient can be allowed to leave with the equipment.

6.5. Interrupting measurements

During a measurement, any key can be used to interrupt the measurement.
The display then shows “-STOP-” and beeps 5 times.
The process is also saved in the table of measurements under “Interruption”.

6.6. Download of the recordings

At the end of the measurement the recordings can be downloaded from the recorder using one of the
compatible Cardioline software (Cubeabpm or Webuploader). Please refer to the user manual of these
software for more instructions.

24
 Walk200b
7. MAINTENANCE AND TROUBLESHOOTING

7. MAINTENANCE AND TROUBLESHOOTING

7.1. Principal sources of error

The following may cause faulty measurements or undesired results:
 Arm movement by the patient during the measurement
 Switching off the device (e.g. at night)
 Incorrect cuff size fitted
 Slipping of the cuff in use
 Absence of successful manual measurement at the surgery
 Failure to take medication
 Incorrect protocol set by the user
 Batteries not fully or correctly charged, or worn out
 Defect in the charging unit

7.2. Cleaning of the recorder

Cleaning operations must be performed by medical staff.
Don’t sterilize the device.
To clean and disinfect the equipment surface, use a sterilizing detergent solution as generally used in
hospitals, with low alcohol content. The unit surface may be cleaned with a wet tissue, but the liquid must
never infiltrate the equipment.
Wash the electrodes with water and/or use only cool sterilization.
NOTE: remove the battery before the cleaning.

7.3. Cleaning of cuffs

Cleaning operations must be performed by medical staff.
The cuffs are reusable for an unlimited period of time.
Before washing, remove the air cushion. Take care not to kink the air cushion in the covering cloth after
replacement. Wash the covering cloth with warm water(~30°C) using a mild washing powder (do not spin).
Do not use fabric softeners or other aids (disinfectant rinses or textile deodorants), these solutions may
leave residues and damage the materials.
The cuff sleeve is not suitable for drying in a tumble dryer.
Wash the bladder only with warm water, adding a mild cleaning solution if necessary and wipe off. Take care
to ensure that no water enters the tube opening.

25
 Walk200b
7. MAINTENANCE AND TROUBLESHOOTING

When using other disinfectants not recommended by IEM, the user is responsible for proving harmless
application. Never use disinfectants that leave a residue on the product or which are unsuitable for use in
contact with skin.

7.4. Display maintenance

Keep the display dry avoiding the formation of condensation. Failure to respect these strategies may result in
the loss of liquid crystals. To clean the display surface, use a soft cloth. The use of cloths that are too rough
may scratch it. Do not use solvent-based chemical products.
Warning: if the display panel breaks, do not swallow the liquid that comes out. In case of contact with the
skin or clothing, immediately wash them using plenty of soap and water.
Abnormalities in the display of fonts may be caused by heavy pressure during use. Normal functioning will be
re-established.

7.5. Periodic checks

Cuffs and tubes control when necessary and at least once a year.
General check of the functionality of the instrument and of the leakage current: when necessary or at least
every 2 years. Check the calibration every other year.

Check the printout carefully for:

 Correctly entered times and intervals in accordance with the protocol
 Times of day/night changeovers
 Correctness of standard values (nocturnal reduction)
 Battery voltage

7.5.1. Checking the battery voltage:

The fully charged batteries are installed in the monitor directly from the charging unit. The battery voltage is
shown in the LCD display of the Walk200b monitor shortly after switching on the device, for approx. 3 sec.
This voltage should be at least 2.75 V to guarantee measurement over 24 hours.

7.5.2 Calibration

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.

26
 Walk200b
7. MAINTENANCE AND TROUBLESHOOTING

Calibration expiry label

7.6. How to change the batteries

The batteries, 2 AA ultra alkaline or rechargeable NiMh (at least 1500mAh), should be substituted if the
special indicator on the display shows a charge of less than 2,75%.
Rechargeable batteries are subject to aging. In case the rechargeable batteries are damaged or is no longer
possible to make measurements for the 24 hours with it, they must be replaced immediately. Ni-Mh
rechargeable batteries last longer if they are discharged completely before a new recharging. Batteries run
depending on the temperature. It is suggested to leave the rechargeable batteries into its charger until they
need to be used.

WARNING: Before removing or inserting the batteries from the recorder ensure that the same is turned off
and that the patient is disconnected.
 Open the battery compartment door.
 Insert the batteries placing their polarities in the correct position.
 Close the battery compartment door.

WARNING: The insertion of batteries with incorrect polarities means that the device will not work.
WARNING: do not dispose of the substituted batteries in the environment.
WARNING: do not use battery types that are different from each other in terms of technology and
specifications.
WARNING: remove the batteries from the unit if it will be out of use for a long time.
NOTE: Removal of the batteries does not mean the loss of data.

7.7. Troubleshooting table

Problem Cause Solution

After replacing The internal buffer battery is The date and time can be set after each
batteries, the clock still empty. change of batteries.
shows 00.00 and the The biennial calibration has not Send the device for calibration to your
date 01.01.xxxx been performed. dealer or directly to Cardioline SpA

27
 Walk200b
7. MAINTENANCE AND TROUBLESHOOTING

The buffer battery is changed at the

metrological check.
The measurement data An error has occurred during saving Delete the patient concerned (menu bar)
can no longer be called of patient data. and re-enter.
up or displayed.

The connection from 1. The incorrect COM interface is 1. Set the correct interface in the utilities
the Walk200b to the set. program
PC is faulty. 2. Walk200b is not in transfer mode 2. Switch the Walk200b off and then on
(the time is shown on the display). again, without removing the connector
cable.
The patient ID number The monitor is not initialised, the The patient ID number can still be
is missing. patient ID number has not been transferred after the measurement.
transmitted during preparation for The data obtained will not be affected.
a 24-hour monitoring session.
No measurements 1. The batteries were drained 1. The rechargeable batteries may be
were carried out during prematurely. defective (please contact your dealer).
the night phase. 2. The patient switched off the 2. Alert the patient to the urgency of
Walk200b obtaining a complete 24-hour recording
The message bt does You are not in transfer mode Press and hold Event button again, till to
not appear on the see bt on the screen.
display.
No automatic 1. No manual measurement was 1. After putting on the equipment a
measurements are performed after putting on the successful measurement must always be
performed. equipment. performed manually
2. Incorrect protocol set 2. Set protocol 1 or 2
The measurement 1. Incorrect protocol set 1. The programmed protocol is not the
interval is not as you 2. No manual measurement was protocol set in the Walk200b.
expected. performed after putting on the Check the protocol manually
equipment. 2. Perform a manual measurement to
activate the set protocol.
Err 1 1. The patient has severe 1. Monitor not applicable
arrhythmia 2. Keep the arm still during measurement
2. The arm was moved during the 3. Re-fit the cuff
measurement
3. Not enough valid heartbeats
detected
1. The arm was moved during the 1. Keep the arm still during measurement
Err 2 measurement 2. Check the fit of the cuff and monitor
2. Cuff not fitted correctly on the
arm
Err 3 1.Blood pressure outside 1. If this message continues, the monitor
measurement range is not suitable for the patient
2. Severe arm movement 2. Keep the arm still during measurement
3. Problems with pneumatics 3. If this error continues, send the unit to
dealer or directly to Cardioline SpA
Err 5 1. Battery voltage too low 1. Replace the batteries

28
 Walk200b
7. MAINTENANCE AND TROUBLESHOOTING

bAtt 2. Betteries defective 2. The battery voltage is correct but

3. Battery contacts are corroded during cuff inflation bAtt is shown on
display. Replace the batteries
3. Clean the battery contacts with a
cotton cloth and some alcohol
Err 6 + 1. Air tube blocked 1. Check the cuff for a blockage or kink in
Possible continuous 2. Blood pressure cuff is not the tube. If there is a kink in the cuff tube,
alarm until a key is correctly connected release the tube. Otherwise send the
pressed 3. Leak in cuff or connecting tube equipment for repair without delay to
Cardioline SpA
2. Connect the cuff with the device
3. If necessary, replace the cuff or
connecting tube
Err 7 The recorder memory is full Delete data from the monitor, but make
(maximum 300 measurements and sure that the data has been saved
events may be stored)
Err 8 Measurement interrupted by
pressing a key
Err 9 + 1. Pressure remains in the cuff 1. Wait for the cuff to deflate completely
Possible continuous 2. Zero-point adjustment could not 2. Send the unit without delay to your
alarm until a key is be performed successfully dealer or directly to Cardioline SpA for
pressed checking
Err 10 + continuous 1.Serious fault due to pressure Send the unit without delay to your dealer
alarm until a key is build-up outside the measurement or directly to Cardioline SpA for checking
pressed process (pump has switched on and repair
illegally)
2. these error messages all indicate
a serious error in the program code
Walk200b takes Protocol 9 has been set in the Set protocol 1 or 2
measurements every Walk200b
two minutes

The required protocol Measurements from the last

cannot be set by patient are still in the memory
pressing key
combinations
The monitor cannot be 1. The batteries were installed 1. insert both batteries again and check
switched on incorrectly for correct polarity
2. The battery voltage is too low 2. Replace the batteries
3. Display difettive 3. Send the unit without delay to your
dealer or directly to Cardioline SpA
A fault occurs during The cuff does not fit the upper arm Using the tape measure supplied,
the first measurement of the patient measure the arm circumference and
compare it with the printing on the cuff
Code 1 Walk200b Bluetooth interface has Send the unit without delay to your dealer
not started up correctly. or directly to Cardioline SpA
Possible hardware error.

29
 Walk200b
7. MAINTENANCE AND TROUBLESHOOTING

Code 2 Walk200b Bluetooth interface Try again.

could not be configured correctly. If the error continues, send the unit to
(Communication problem between your dealer or directly to Cardioline SpA
Walk200b and Bluetooth module) for checking

Code 3 The status of Walk200b Bluetooth Try again.

interface could not be ascertained If the error continues, send the unit to
(Communication problem between your dealer or directly to Cardioline SpA
Walk200b and Bluetooth module) for checking
Code 4 Walk200b Bluetooth interface is Follow the steps described in “cube
not yet paired with the Bluetooth installation guide” (see § “Device
dongle configuration”)
Code 5 Walk200b Bluetooth interface Try again.
could not connect to the If the error continues, send the unit to
computer’s Bluetooth dongle. your dealer or directly to Cardioline SpA
for checking

30
 Walk200b
8. TECHNICAL SPECIFICATION

8. TECHNICAL SPECIFICATIONS

Pressure measurement range............ Systolic: 60 to 290 mmHg

Dyastolic: 30 to 195 mmHg

Accuracy ........................................... ± 3 mmHg in the range indicated

Static pressure range......................... 0 to 300 mmHg

Pulse range ....................................... 30 to 240 beats per minutes

Method ............................................. oscillometric

Measurement intervals ..................... 0,1,2,4,5,6,12 or 30 measurements per hour

Monitoring protocol .......................... 2 modifiable interval groups

Storage capacity ................................ 300 measurements

Battery capacity ................................ > 300 measurements

Interfaces .......................................... Bluetooth (Class 1 / 100 m)

Power supply..................................... 2 Ni-MH batteries each 1,2 V, 1500 mAh min and max 2450 mAh (AA)
or 2 alkaline 1,5 V batteries( AA, Mignon)
Dimensions ....................................... 128 x 75 x 30 mm

Weight .............................................. approx 240 g including batteries

8.1. Harmonised standards applied

STANDARD DESCRIPTION
EN 15223-1 Medical devices -- Symbols to be used with medical device
labels, labelling and information to be supplied -- Part 1:
General requirements
EN 1041 Information supplied by the manufacturer of medical devices
EN ISO 13485 Medical devices - Quality management systems -
Requirements for regulatory purposes
EN ISO 14971 Medical devices - Application of risk management to medical
devices
EN 60601-1 Medical electrical equipment - Part 1: General requirements
for basic safety and essential performance

31
 Walk200b
8. TECHNICAL SPECIFICATION

STANDARD DESCRIPTION
EN 60601-1-2 Medical electrical equipment - Part 1: General requirements
for basic safety and essential performance - Collateral
standard: Electromagnetic compatibility - Requirements and
tests
EN 60601-1-6 Medical electrical equipment - Part 1: General safety
requirements - Collateral standard: Usability
IEC 80601-2-30 Medical electrical equipment - Part 2-30: Particular
requirements for the basic safety and essential performance of
automated non-invasive sphygmomanometers
EN 62304 Medical device software - Software life cycle processes
EN 62366 Medical devices - Application of usability engineering to
medical devices

8.2. Accessories

CODE DESCRIPTION
63090645 Large cuff for Walk200b
63090646 Standard cuff for Walk200b
63090647 Small cuff for Walk200b
63090648 Extralarge cuff for Walk200b
69400074 Under-cuff band
65090070 Pouch
63090733 Walk200b waterproof case (waterproof bag)

32
 Walk200b
9. WARRANTY

9. WARRANTY

Cardioline SpA guarantees this equipment to be free of defects in material and workmanship for 24 months
from date of purchase of the device and for 3 months for spare parts and accessories. The date of purchase
shall be proven by a document, issued upon delivery, which shall be submitted in the case of any claim under
the warranty.
The warranty provides for free-of-charge repairing or replacement of the equipment parts with
manufacturing or material defects. The possible replacement of the equipment is at the manufacturer's
discretion. Extended warranty after repairing is not available.
This warranty does not cover defects resulting from:
 tampering, third party negligence, including servicing or maintenance by unauthorised personnel;
 failure to comply with the usage instructions, improper use or use of the equipment different than
that for which it was intended;
 improper operation of the power supplies;
 damages caused by fires, explosions or natural disasters;
 use of non-original consumable parts;
 transportation carried out without any precautionary measures;
 use of software programs not associated with the primary function of the machine;
 other circumstances not attributable to manufacturing defects.

Unless otherwise specified, the removable parts, the accessories and the parts which are subject to normal
wear are excluded under the warranty; for example: patient cables, batteries, connection cables, electrodes,
glass parts, computer supports, ink cartridges, etc.
Cardioline Spa declines all liability for any damage which may be caused, directly or indirectly, to persons or
property as a consequence of non-compliance with all the prescriptions specified in the manual, especially
warnings regarding installation, safety, use and maintenance of the equipment, as well as non-operation of
the equipment.
In the event of repair and/or replacement of the equipment or its spare parts, take the equipment to the
nearest Cardioline Spa authorised service centre or send it to Cardioline S.p.A. All costs of material and
labour will be free of charge and transport costs shall be at the customer's expense.
After 24 months from the date of purchase of the equipment and 3 months from the date of purchase of the
accessories and spare parts, the warranty becomes void and service will be provided charging for the parts
replaced and labour costs according to the current rates.
Any derogation from the present warranty conditions shall be valid only if expressly approved by Cardioline
SpA.

33
 Walk200b
10. DISPOSAL

10. DISPOSAL

Pursuant to Italian Legislative Decree no. 49 dated 14 March 2014 "Implementation of Directive 2012/19/EU
on Waste Electrical and Electronic Equipment (WEEE)", the crossed-out "wheeled bin" symbol on the
medical device indicates that, at the end of its service life, the product must be collected separately from
other wastes. Therefore, when disposing of the product at the end of its service life, the user is required to
contact the supplier or the manufacturer.
Suitable differentiated collection to allow for the subsequent recycling of the decommissioned device, with
environmentally-compatible treatment and disposal, helps to prevent any negative effects on the
environment and health and to promote the recycling of the materials from which the device is made.
The illegal disposal of the product by the user entails the application of administrative sanctions envisioned
by Italian Legislative Decree no. 22/1997 (Art. 50 and subsequent to the Italian Legislative Decree no.
22/1997).

34
 Walk200b

35
 Walk200b

Sales Office:
Via F.lli Bronzetti, 8
20129 Milan, Italy
T. +39 02 94750470
F. +39 02 94750471

Factory:
Via Linz, 151
38121 Trento
Italy
T. +39 0463 850125
F. +39 0463 850088